Medication Safety Committee

Tuesday April 20, 2010 10:00 A.M. – 2:00 P.M.

California Hospital Association 1215 K Street, Ste. 800

Sacramento, CA

* ACTION ITEM

MEDICATION SAFETY COMMITTEE April 20, 2010 / 10:30 a.m. – 2:00 p.m.

California Hospital Association

1215 K Street, Ste. 800 Sacramento, CA 95814

(916) 443-7401

Conference Call Options: (800) 882-3610, and pass code 5968133#

AGENDA

ITEM TIME SUBJECT REPORTING PAGE I. 10:00 AM CALL TO ORDER / INTRODUCTIONS / PRIORITY

ISSUES DISCUSSION HANNI / WHALEY –

WELTY 3

II. 10:15 AM *MINUTES OF February 18, 2010 MEETING Recommendation: Approval

HANNI / WHALEY –WELTY

7

III. 10:20 AM OPERATIONS

Mission/Purpose Revision Review CHA Vision, Goals, Mission CHA Board of Trustees

HANNI / WHALEY –WELTY

13 17 19

IV. 10:25 AM RESULTS OF TASKS FORCE MEETINGS *MERP

• ISMP

*Emergency Medication Order

• TJC Medication Reconciliation *High Risk/High Alert Drugs

HANNI

MAAS

BENTON

23 25 33 37 39

V. 12:00 PM LUNCH

VI. 12:30 PM REPORTS Board of Pharmacy CDPH Collaboratives

HEROLD

DEMARTINI CARSON / LOPEZ /

LINDSEY

1

Medication Safety Committee Meeting — Agenda April 20, 2010

* ACTION ITEM

Page 2

ITEM TIME SUBJECT REPORTING PAGE VII. 1:00 PM LEGISLATION

SB 971 Blood Products AB 2077 (AB 1370, 2009) Centralized Hospital

Packaging Pharmacy AB 1916 Reporting Medication Errors AB 2130 (AB 294, 2009) Sunset Diversion

Programs AB 2548 CURES Prescription Drug

Monitoring

45 53

63 65

89

VIII. 1:30 PM ADDITIONAL BUSINESS ICU Sedation Guidelines Assessment

Algorithm IV Infusion Bundle AHRQ Request Administrative Penalties Spreadsheet (Mtg.

Handout) 2010 Meeting Schedule

HANNI / WHALEY-WELTY

97

159 167

169

IX. 2:00 PM ADJOURNMENT HANNI / WHALEY-WELTY

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MEDICATION SAFETY COMMITTEE MEETING MINUTES

February 18, 2010 / 1:30 p.m. – 4:30 p.m. Hyatt Regency

Sacramento, CA Members Present: Sylvia Banzon, Dawn Benton, Carolyn Brown (via phone), Diane Brown,

Edna DeLeon, Loriann DeMartini, John Eastman, Mary Foley, Terri Gately, Amy Gutierrez, Jim Hauenstein, Virginia Herold, Rory Jaffe, Jan Kiely, Robert LeWinter, Frank Maas, Patricia McFarland, Robert Menet, Richard Rabens, Allen Schaad, Jeffrey Uppington, Lynne Whaley Welty

Members Absent: Mary Ann Cone, Steve Gold, Jeannette Hanni, Ilona Horton, Kenneth

Schell Invited Guests: Nancy Blake, Randy Kajzoka Regional Advisors: Catherine Carson, Mary Lopez, Judith Yates CHA Staff: Dorel Harms, Debby Rogers

I. CALL TO ORDER/INTRODUCTIONS/PRIORITY ISSUES DISCUSSION

Meeting was called to order by Whaley Welty, self introductions were made.

II. MINUTES OF DECEMBER 2, 2009, MEETING

Minutes from December 2, 2009, meeting were approved with the following changes.

Dawn Benton was present and listed absent Allen Schaad was present and listed absent Under section IV, item I: change CDPH to Board of Pharmacy

III. OPERATIONS

A. *Medication Safety Committee Revised Purpose/Mission

The Committee revised the “Purpose” to read as follows: PURPOSE

The purpose of the Medication Safety Committee is to provide a forum for diverse multi-disciplinary health care organizations, which includes health care delivery organizations, patient safety organizations, discipline specific

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professional associations/organizations and regulatory agencies, to promote safe medication practices in the state of California. The Committee will focus on acting as a source of medication safety expertise, providing a venue for the coordination of medication safety activities and making recommendations related to medication safety legislation and regulations.

The “Mission” was revised to read as follows: MISSION

The mission of the Medication Safety Committee is to provide leadership within the health care community to promote the highest standards related to the safe and effective use of medications.

B. CHA Vision, Goals, Mission This section in provided for information only

C. Guidelines

This section is provided as a reference and will be included in every agenda package.

IV. RESULTS OF TASK FORCE MEETINGS

A. Medication Error Reduction Plan (MERP) Minutes of the MERP work group (WG) conference call were provided in the agenda package. Regarding the draft evaluation tool, the California Department of Public Health (CDPH) cannot distribute the document until it is final. *The document will be available in April at which time CDPH will share with the MERP WG. CDPH would like to share best practices but it will be challenging because the survey did not readily lend itself to gleaning best practices. *The WG will review and make suggestions as to how to standardize. Findings of MERP surveys can be shared with the group. CDPH is working to categorize medication-related events utilizing, in part, the 11 elements that define a medication error (HSC 1339.63). CDPH would like to have the definitions for medication-related event categories completed by April. The definitions will be the basis for the Med-SET (Medication System Event Tracking) project. Data from Med-SET will assist CDPH in identifying medication safety system vulnerabilities. The findings of MERP surveys are

8

projected to feed into the Med-SET system. Suggestion: use pre-existing taxonomy (e.g. AHRQ PSO) rather than spending time creating a new process. *Next Steps: Review composition of WG – additional members may be needed Review survey findings and share discussion with members of Committee prior to next meeting

B. Emergency Medication Orders Minutes of the Emergency Medication Orders conference call were provided in the agenda packet. All agreed more data is necessary and using survey monkey would be the best approach. Surveyor Le Winter would like to see a review of every set of orders. However, this is not possible, especially in small and rural hospitals that do not have a pharmacist available 24/7. Clinics that are out-patient departments of the hospital also stock emergency drugs. Pharmacists are not available to the clinics 24/7. Question: Should data be collected and analyzed through CHPSO? Answer: CHPSO will not collect or analyze patient specific data. CHPSO can collect data related to vulnerabilities and it is non-discoverable. Hospitals from which data is collected would need to be a member of CHPSO. A description of CHPSO was provided. Surveying Emergency Department (ED) pharmacy practices could serve as a catalyst to integrate pharmacy directors into the medication administration system in the ED. Data is necessary to determine types of errors occurring in EDs and what can be done to eliminate them.

A request for more clinicians on the WG was made by the chair. Nancy Blake and Rich Rabens volunteered. *Next Steps: Create survey monkey tool Committee to review survey prior to distribution Discuss the three categories identified by the WG Research articles regarding impact of ED pharmacist in the ED Consider developing business plan depending on results of research

C. High Risk/High Alert Drugs Dawn Benton is chair. Group has not met, but now has eleven people and will be meeting in the next few weeks. *Next Steps: Schedule first meeting

9

Develop WG goals

V. REPORTS

A. Board of Pharmacy No report.

B. CDPH Gearing up for a budget impasse. Increasing the number of MERP surveys especially in rural areas and northern California.

C. Collaboratives Southern California Patient Safety Collaborative (SCPSC)

Status of Funding Anthem Blue Cross, the three regional hospital associations (the Hospital Association of San Diego & Imperial Counties, Hospital Association of Southern CA and the Hospital Council of Northern & Central CA) and the National Health Foundation have finalized an agreement to produce innovative patient safety collaboratives throughout California. The agreement provides 3 years of funding, 2010-2013, with options for extending funding and initiatives addressed. The program will build upon existing peer-to-peer learning networks such as the Southern California Patient Safety Collaborative which work to facilitate accelerated implementation of evidence-based patient safety and quality improvement practices. As the marquee sponsor, ABC will fund experienced, knowledgeable partners to expand efforts to hospitals throughout California and be acknowledged for its support of a nationally recognized patient safety and quality improvement effort. This new statewide quality and safety initiative will be named Patients First California…A Partnership for Safety.

Each Regional Association will operate patient safety collaboratives focusing on:

Peri-natal Care – reducing elective pre-term deliveries and birth trauma Sepsis – reducing mortality and length of stay, and Hospital-acquired Infections in the ICU – reducing ventilator-associated

pneumonia, central line blood stream infections, MRSA infections, and catheter-associated urinary tract infections.

The Southern California Patient Safety Collaborative will incorporate these safety initiatives into its work and will also continue its partnership with the Health Services Advisory Group (HSAG) and the initiatives of:

Pressure Ulcers – reducing hospital-acquired pressure ulcers and partner with area long term care facilities

10

Surgical Care Improvement Project – increase compliance with all measures

and understand the new SCIP measures MRSA – reducing hospital-acquired MRSA infections.

The San Francisco collaborative’s first task force standardized IV concentrations of high risk medications. The task force did not standardize pediatric/NICU concentrations or smart pump alert limits. It was suggested that California’s children’s hospitals get together to so pediatric/NICU concentrations.

VI. LEGISLATION

Board of Pharmacy and California Department of Public Health excused themselves from the discussion item on legislation.

A. AB 1370 – Centralized Hospital Packaging Pharmacies A summary of the bill was provided. *CHA staff directed to research FDA requirements

B. AB 977 – Immunization Administration A summary of the bill was provided

C. SB 294 – Diversion Program SB 294 would delete diversion programs for licensed healthcare professions except for MDs. The MD diversion program was deleted previously.

ACNL and ANA/C will fight elimination of diversion program. Most think that diversion programs need to remain. Pharmacists at the table support a diversion program through their board. However, this does not resonate with the general population. They want punishment. Department of Consumer Affairs is looking at this thru the lens of the population.

*Amy will send link.

VII. ADDITIONAL BUSINESS

A. Administrative Penalties

Rogers created a spread sheet that lists the administrative penalties and the general categories. The medication errors section should be of interest to the Committee. *The spread sheet will be provided in the next Committee meeting agenda packet.

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Medication Safety Committee Meeting Page 6 February 18, 2010

B. 2010 Meeting Schedule

The December meeting is scheduled for the 8th which is in conflict with National Pharmacy meeting and IHI. Preferred date is the 15th. Staff will re-schedule.

VIII. ADJOURNMENT

The meeting was adjourned at 3:40 PM.

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GUIDELINES FOR THE CALIFORNIA HOSPITAL ASSOCIATION

MEDICATION SAFETY COMMITTEE Revised 02/18/10

I. NAME

The name of this committee shall be the Medication Safety Committee. II. MISSION

The mission of the Medication Safety Committee is to provide leadership within the health care community to promote the highest standards related to the safe and effective use of medications. (revised 2/18/10)

III. PURPOSE

The purpose of the Medication Safety Committee is to provide a forum for diverse multi-disciplinary health care organizations, that include health care delivery organizations, patient safety organizations, discipline specific professional associations/organizations and regulatory agencies, to promote safe medication practices in the state of California. The Committee will focus on acting as a source of medication safety expertise, providing a venue for the coordination of medication safety activities and making recommendations related to medication safety legislation and regulations. (revised 2/18/10

IV. COMMITTEE

The Committee (the “Committee”) shall consist of a minimum of 16 representatives and not more than 35 representatives from the following organizations:

California Department of Public Health California Society of Health System Pharmacists California Board of Pharmacy Centers for Medi-Care and Medi-Caid Services Association of California Nurse Leaders California Medical Association California Hospitals Patient Safety Organization Risk Management Association Representatives from the following CHA committees/centers:

Center for Behavioral Health Rural Health Center Quality Committee Joint Committee on Accreditation and Licensing Center for Hospital Medical Executives EMS/Trauma Committee Hospital Based Clinics Committee Center for Rehabilitation Services

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Hospital Services for Continuing Care Committee Governance Quality Directors Health Informatics and Technology Committee

A. MEMBERSHIP

1. Membership on the Committee shall be based upon membership in CHA, or

organizations that have a direct relationship to the purpose and mission of the committee. Non hospital member representatives can only be appointed to the Committee at the discretion of the CHA President.

2. In addition to the Committee/Centers named above, the CHA Committee

members shall consist of various representatives from large hospital systems, public institutions, private facilities, free-standing facilities, small and rural facilities, university/teaching facilities and specialty facilities. A member may fulfill more than one required membership.

3. Hospital members are appointed by CHA Staff.

4. Term:

(a) The initial term of office shall be three years, except that one-half

of the initial members shall be appointed to two-year terms to ensure continuity of committee members in the future.

(b) As the terms of the members appointed in 2009 expire, or members

otherwise leave, vacancies shall be filled to achieve the requirements of Article IV. Members are limited to two, three-year consecutive terms. An exception shall be granted in cases where a member is elected as a chair officer. Following two consecutive terms there must be a one-year interval before a member is eligible for another term.

B. MEMBER RESPONSIBILITIES

1. Provide hospital-industry leadership to the Committee. 2. Identify issues and develop possible solutions and best practices to improve the

safety of medication storage and distribution administration. 3. Work cooperatively with key stakeholders to develop creative solutions.

4. Provide communication to member hospitals regarding medication safety issues.

5. Maintain/increase awareness of the legislative and regulatory environment with

regard to medication safety issues.

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C. COMMITTEE MEETINGS

1. Meetings of the Committee shall be held quarterly in person. 2. To maintain continuity substitution of members is not acceptable.

3. Three consecutive unexcused absences by a Committee member will initiate a

review by the Chair and CHA staff for determination of the Committee member’s continued service on the Committee.

4. Special meetings may be scheduled by the Chair, majority vote or CHA staff.

D. VOTING

1. Voting rights shall be limited to members of the Committee, and each member present shall have one vote. Voting by proxy is not acceptable.

2. All matters requiring a vote of the Committee must be passed by a majority of a

quorum of the Committee members present at a duly called meeting or telephone conference call.

E. QUORUM

Except as set forth herein, a quorum shall consist of a majority of members present or not less than eight.

F. MINUTES

Minutes of the Committee shall be recorded at each meeting, disseminated to the membership, and approved as disseminated or as corrected at the next meeting of the Committee.

V. OFFICERS

The officers of the Committee shall be the Committee Chair, Vice Chair, Immediate Past Chair and CHA staff.

The Chair shall be elected by the Committee for a two-year term, except for the initial Chair, who shall be appointed by CHA staff for one year. Should a Chair vacate his/her position prior to the end of the term, CHA staff will appoint a replacement to complete the remainder of the term.

Past-chairs will remain as a member of the Committee.

A. SUB-COMMITTEES

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Operating Guidelines Revised September 14, 2009 Page 4 1. Task forces of the Committee may be formed at the discretion of the Committee

Chair and members and CHA staff for the purpose of conducting activities specific to a special topic or goal.

VI. GENERAL PROVISIONS

The strategic plan defining the goals, objectives, and work plans shall be developed annually by the Committee with approval by CHA staff. Quarterly updates and progress reports shall be completed by the Committee and CHA staff.

Staff leadership at the state level shall be provided by CHA with local staff leadership provided by Hospital Council, the Hospital Association of Southern California, and the Hospital Association of San Diego and Imperial Counties. The primary office and public policy development and advocacy staff of the Committee shall be located within the CHA office.

The Committee staff shall be an employee of CHA.

VII. AMENDMENTS

These Guidelines may be amended by a majority vote of the members of the Committee at any regular meeting of the Committee and with approval by CHA.

VIII. LEGAL LIMITATIONS

Any portion of these Guidelines which may be in conflict with any state or federal statutes or regulations shall be declared null and void as of the date of such determination.

Any portion of these Guidelines which are in conflict with the Bylaws and policies of CHA shall be considered null and void as of the date of the determination.

Information provided in meetings is not to be sold or misused.

IX. CONFIDENTIALITY FOR MEMBERS

Many items discussed are confidential in nature, and confidentiality must be maintained. All Committee communications are considered privileged and confidential, except as noted.

X. CONFLICT OF INTEREST

Any member of the Committee who shall address the Committee in other than a volunteer relationship excluding CHA staff and who shall engage with the Committee in a business activity of any nature, as a result of which such party shall profit either directly or indirectly, shall fully disclose any such financial benefit expected to CHA staff for approval prior to contracting with the Committee and shall further refrain, if a member of the Committee, from any vote in which such issue is involved.

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V I S I ON

CHA’s vision is “an optimally healthy society.”

GOAL

CHA’s goal is that every Californian has equitable access to affordable,high-quality medically necessary health care. Only through high ideals and

practical, progressive steps can the health status of Californians be improved.This challenge must be shared by all stakeholders, including individuals,

employers, health care providers, payers and government.

M I SS I ON

The unity that CHA brings to the health care community is the foundationof its mission: Through effective leadership and member participation,CHA seeks to develop consensus, establish public policy priorities, and

represent and serve hospitals and health systems. In concert with its memberorganizations, CHA is committed to establishing and maintaining a

financial and regulatory environment within which hospitals can continueto provide high-quality patient care.

1215 K Street, Suite 800, Sacramento, CA 95814 • Telephone: 916.443.7401 • Facsimile: 916.552.7596 • Website: www.calhospital.org

Corporate Members: Hospital Council of Northern and Central California, Hospital Association of Southern California, and Hospital Association of San Diego and Imperial Counties17

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California Hospital Association

2010 CHA Board of Trustees

ChairPatrick E. FryPresident/CEOSutter Health, Sacramento

Chair-ElectRonald C. WerftPresident/CEOCottage Health System, Santa Barbara

Past ChairArnold R. SchafferVice President, Chief ExecutiveProvidence Health and Services,

California Region, Burbank

Secretary/Treasurer Steven J. Packer, MDPresident/CEOCommunity Hospital of the Monterey

Peninsula, Monterey

PresidentC. Duane Dauner President/CEOCalifornia Hospital Association,

Sacramento

Board Officers

19

California Hospital Association

2010 CHA Board of Trustees

Gregory A. AdamsPresident, Northern

California RegionKaiser Permanente,

Oakland

Larry K. AinsworthPresident/CEOSt. Joseph Hospital,

Orange

Douglas D. BagleyChief Executive OfficerRiverside County

Regional Medical Center, Moreno Valley

B.J. Bartleson, RNDirector, Patient Care

Services/CNOShriners Hospitals

for Children Northern California, Sacramento

Steven R. BlakeChief Financial OfficerIntegrated Healthcare

Holdings, Inc., Santa Ana

Robert G. CarmenPresident/CEOAdventist Health,

Roseville

William B. CaswellSenior Vice President,

OperationsKaiser Permanente,

Pasadena

Benjamin K. Chu, MDPresident, Southern

California Region Kaiser Permanente,

Pasadena

Marcy L. FeitPresident/CEOValleyCare Health

System, Pleasanton

Jeffery E. FlockenSenior Vice PresidentTenet Healthcare

Corporation, California Region, Anaheim

Charles P. FrancisSenior Vice President/

Chief Strategy OfficerCatholic Healthcare

West, San Francisco

David R. GreenChief Executive OfficerEl Centro Regional

Medical Center, El Centro

Daniel L. Gross, RN, DNScExecutive Vice PresidentSharp HealthCare

Hospital Operations, San Diego

Robert R. HerrickPresidentUnited Hospital

Association, Los Angeles

Robert IssaiPresident/CEODaughters of Charity

Health System, Los Altos Hills

Board Members

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California Hospital Association

2010 CHA Board of Trustees

Deborah Kania, RNAdministrative DirectorSutter Oaks Nursing

Center – Midtown, Sacramento

Dale A. KirbyChief Executive OfficerColusa Regional Medical

Center, Colusa

Mark R. LaretChief Executive OfficerUniversity of California

San Francisco Medical Center, San Francisco

Wright L. Lassiter, IIIChief Executive OfficerAlameda County Medical

Center, Oakland

Larry Lawler, LCSWSenior Director, Neuro-

Behavioral ServicesCommunity Hospital of

San Bernardino, San Bernardino

Lou LazatinPresident/CEOSaint John’s Health

Center, Santa Monica

John R. “Rick” LeMoine, MDChief Medical

Information OfficerSharp HealthCare,

San Diego

Michael P. MahoneyPresident/CEOSt. Rose Hospital,

Hayward

Curtis MorrisDirectorPomona Valley Hospital

Medical Center, Pomona

J.W. “Bill” NewboldVolunteerNorthridge Hospital

Medical Center, Northridge

Nathaniel L. Oubre, Jr.Senior Vice President/

Area ManagerKaiser Permanente

East Bay, Oakland

Joseph P. RandolphExecutive Vice President/

COOSt. Joseph Health

System, Orange

Richard L. RawsonPresident/CEOAdventist Health/

Hanford Community Medical Center, Hanford

Evan J. RaynerChief Executive OfficerNorth Sonoma County

Healthcare District, Healdsburg

Lex Reddy, MBA, MHAPresident/CEOPrime Healthcare

Services, Victorville

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California Hospital Association

2010 CHA Board of Trustees

1215 K Street, Suite 800 • Sacramento, CA 95814 • (916) 443-7401 • Fax (916) 552-7596 • www.calhospital.org

Bryan R. RogersPresident, Far West

DivisionHCA – Hospital

Corporation of America, Henderson, NV

Roger E. SeaverPresident/CEOHenry Mayo Newhall

Memorial Hospital, Valencia

Kathleen SellickPresident/CEORady Children’s

Hospital – San Diego, San Diego

Sharon A. SpurgeonChief Executive OfficerCoalinga Regional

Medical Center, Coalinga

Marion L. WatsonDirector, Rehabilitative

Medicine ServicesAdventist Health/

Glendale Adventist Medical Center, Glendale

Robert J. WentzPresident/CEOOroville Hospital,

Oroville

Robert Wiebe, MDSenior Vice President/

Chief Medical OfficerCatholic Healthcare

West, San Francisco

James D. BarberPresident/CEOHospital Association of Southern California,

Los Angeles

Steven A. EscobozaPresident/CEOHospital Association of San Diego and Imperial

Counties, San Diego

Arthur A. SponsellerPresident/CEOHospital Council of Northern and Central

California, Sacramento

AdvisersBoard Members (cont.)

Richard E. YochumPresident/CEOPomona Valley Hospital

Medical Center, Pomona

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April 1, 2010 TO: Medication Safety Committee Members FROM: Jeannette Hanni, Director of Pharmacy Mills-Peninsula Health Services SUBJECT: MERP Work Group Minutes – 04/01/10 Participants: Banzon, DeLeon, Eastham, Gold, Hanni, Harms, Menet, Richter Discussion: Hanni presented an overview of discussion topics for the meeting, including follow-up items. They were:

• Review of minutes from the last meeting • Review of documentation of goals for the work group • CDPH MERP survey tool update • ISMP article on the CA MERP survey process • Ideas for communication tools to use to disseminate the work of the work group • Survey results rumor control discussion

The minutes from the meeting held on February 12, 2010, were reviewed and approved. A discussion followed regarding the documentation of the goals of the work group. The committee felt that the minutes accurately reflected the thoughts of the committee regarding a direction to focus our efforts towards. Menet informed the work group that the MERP survey tool was still in draft form and the CDPH is unable to share the document at this time. The documents are currently being reviewed by their senior management. They will then move on to their legal department. They are still in discussion with their attorneys regarding the ability to share the documents in final form. The recent ISMP article highlighting the California MERP Survey Program was discussed. The work group felt that it was a very well-written and thoughtful article. The work group also commented that the article seemed to be a balanced presentation of the advantages of a program like this and the possible pitfalls one might encounter (personal fines, disciplinary actions, etc.). They also emphasized that this type of program really puts California at the forefront of patient safety endeavors and is a model for the rest of the country. The work group agreed that the

23

MERP Work Group Minutes – 04/01/10

Page 2

MERP surveys, although difficult at first, are a positive step towards quality care and improved patient safety. The work group also discussed the issue of communication and transfer of information from this work group to the organizations and people who would most benefit. It is probably the most difficult challenge of the work group. There is concern for duplication of efforts and the lack of a direct tool. There was discussion of how we might be able to leverage CHPSO for a communication tool for best practices. There was also discussion of how to partner with CSHP to use their internet communication to members (eg. blog, bulletin boards, etc.). The Work group would like to explore the expansion of information on the CDPH site to always include both the citations and immediate jeopardy situations and to include the fines with more detail on the facilities plan of correction, to enable other to learn from their experiences and potentially adopt similar practices in order to avoid a bad outcome. They would also like to see the site “topic searchable”. The final discussion point was a question about how we could possibly partner with the statewide collaboratives to share information. Hanni brought up a topic for discussion involving tools to help the health care community with rumor control regarding survey findings. Her concern was in passing on key information that might help eliminate embellishments and fear around hot issues. The work group decided to let this one percolate a bit in our brains. The work group also discussed the meeting frequency desired by the group. It was decided to meet once between each meeting of the larger Medication Safety Committee group. Next steps from the meeting:

• Hanni will speak with Benton about partnering to use the blog/bulletin board as a communication tool.

• Eastham and Menet will pursue the possible expansion of information on the citation

website. JH:lw

24

ISMP has long been an advocate forlearning from the experiences of others—to take certain aspects of another’s experi-ence and incorporate them into your ownwork and life for the purpose of improve-ment. It is in this spirit of learning that weshare with readers our support of a state-wide initiative in California (CA) to reducemedication-related errors that can be usedas an example for all US hospitals to volun-tarily adopt a similar initiative.

As a condition of licensure, every generalacute care hospital in CA was required toadopt a Medication Error Reduction Plan(MERP; not to be confusedwith the ISMPMERP [Medication Errors ReportingProgram]) to substantially reduce medica-tion–related errors (http://law.justia.com/california/codes/hsc/1339.63.html) by January1, 2002. The plans were required toinclude the implementation of technologyproven to reduce errors. The submittedplans were approved by the CaliforniaDepartment of Public Health (CDPH),and each hospital was required to imple-ment its plan before January 1, 2005. Each

hospital must review andapprove the plan annually.

MERP ComponentsDetails regarding the requiredcomponents in the hospital’sMERP are provided in Table 1(page 3). In brief, each hospitalmust adopt a methodology toassess, improve, and evaluatemedication safety, with partic-

ular attention paid to pprreessccrriibbiinngg, pprreessccrriipp--ttiioonn oorrddeerr ccoommmmuunniiccaattiioonn, pprroodduucctt llaabbeell--iinngg, pprroodduucctt ppaacckkaaggiinngg aanndd nnoommeennccllaattuurree,ccoommppoouunnddiinngg, ddiissppeennssiinngg, ddiissttrriibbuuttiioonn,aaddmmiinniissttrraattiioonn, eedduuccaattiioonn, mmoonniittoorriinngg, anduussee. This methodology must include asystem or process to proactively identifyactual or potential medication-related errorsas well as concurrent and retrospectivereview of clinical care. The regulationdefines a “medication-related error” as anypreventable medication-related event that

adversely affects a patient and is related toprofessional practice or healthcareproducts, procedures, and systems,including but not limited to the elementslisted above in bold text. A multidiscipli-nary process that includes pharmacists,nurses, physicians, and administrativeleaders must be established to regularlyanalyze all identified actual or potentialmedication-related errors—not just aggre-gate reports about these conditions orevents—and to use these findings tochange current procedures and systems toreduce medication-related errors.

The MERP also must include plans for theimplementation of technology and explainhow it is expected to reduce medicationerrors (small and rural hospitals wereexempt from implementing technologyalthough many did not claim this exemp-tion). Hospitals are required to conduct anannual review to assess the effectiveness ofeach of the 11 components of medicationuse (in boldface text above), and to makechanges to interventions when weaknessesor deficiencies have been identified for thepurpose of reducing medication errors.

Another essential feature of the CA MERPrequires establishing a process to incorpo-rate and learn from external medication-related error alerts, and to take action tomodify current processes and systems asappropriate to reduce the risk of similarerrors. Organizations cannot assume thatsystems are safe until proven dangerous bya tragic event. No news is not good newswhen it comes to patient safety. The regula-tion suggests that each organization needsto accurately assess how susceptible itssystems are to the same errors that havehappened in other organizations, and toacknowledge that the absence of similarerrors is not evidence of safety. Personalexperience is a powerful teacher, but theprice is too high to learn all we need toknow from firsthand experiences. Learningfrom the mistakes of others is imperative,

Look-alike Sandoz antibiotics.A pharmacist reported a look-alike problem

with ampicillin 2 g and nafcillin 2 g from Sandoz,packaged in ADD-Vantage containers (Figure 1). Anurse discovered a dispensing error as she was

hanging a mini-bag. If both prod-ucts are availablein your facility, asa temporarymeasure, considercircling or high-lighting the drugname on theADD-Vantagecontainer to drawattention to it.

We’ve had complaints about other Sandoz productsand believe label redesign is in order.

California Department of Public Health Medication Error Reduction PlanMarch 25, 2010 Volume 15 Issue 6

SafetyBriefs

continued on page 2 -- MMEERRPP

continued on page 2 — SSaaffeettyyBriefs

Hospital

Hospital

MedicationSafetyAlert!AAccuuttee CCaarree

ISMP

EEdduuccaattiinngg tthhee hheeaalltthhccaarree ccoommmmuunniittyy aabboouutt

ssaaffee mmeeddiiccaattiioonn pprraaccttiicceess

A federally certified Patient Safety Organization

©2010 Institute for Safe Medication Practices

Figure 1. Ampicillin andnafcillin 2 gm ADD-Vantagevials look similar.

Genetic testing and warfarin dosing.Results of a study on the management of

warfarin with genetic testing as part of the care ofpatients were presented last week at an AmericanCollege of Cardiology meeting by researchers fromMedco Health and Mayo Clinic. Thestudy, which will be published in theJournal of the American College ofCardiology, showed that hospitalizationrates due to adverse drug events incardiac patients taking warfarindropped by approximately 30% whengenetic information was available todoctors prescribing the drug. Warfarinis the leading cause of drug-relatedemergency department visits amongthe elderly. Patients starting warfarin have widelyvarying responses to the medication due to a varietyof factors including an individual’s genotype. It isestimated that up to 20% or more of patients can behospitalized for bleeding within 6 months of startingthe drug. The study shows that testing for an individ-ual’s unique genetic predisposition can significantlyimprove warfarin’s safety and effectiveness by pro-viding information about the patient’s sensitivity tothe drug. The FDA recently approved a labelingchange that provides dose recommendations basedon genetic testing results.

InTheNews

25

March 25, 2010 Volume 15 Issue 6

2

e-Rx error. Here’s an interesting exam-ple of a potential error caused by an elec-

tronically generated prescription form (Figure 1). Theelectronic prescription was faxed recently to a com-munity pharmacy from a physician’s office.Apparently, space ran out on the first line of thedirections and the word “until” was split so that thelower case L appeared on the second line. The phar-macy technician mistook the letter L as the number1, which resulted in entering the directions into the

pharmacy computer incorrectly. Fortunately, thepharmacist caught the error and made the correctionbefore the prescription was dispensed to the patient.This type of error may not be easily identified andcould result in an incorrect dose or wrong instruc-tions for the patient. Electronic prescription vendorsneed to design systems so that words won’t truncatein unconventional ways. ISMP will continue trackingerrors like this, hoping to share them with computersystem vendors and oversight agencies. If you haveexamples of errors with electronic prescribing sys-tems both in the acute care and ambulatory settings,please report them to ISMP through our MedicationErrors Reporting Program (MERP), which can beaccessed at: www.ismp.org/orderforms/reporterrortoismp.asp (or you can send an email message toismpinfo@ismp.org).

A three-in-one packageinsert? A pharmacist who was called

with a question about eye drops went to the boxof Alcon Steri-Units tetracaine 0.5% eye drops in2 mL units to remove the package insert for refer-ence. She was surprised to find information on theinsert for atropine sulfate 1% solution. Thinkingthat the package insert had been accidentallyswitched, she opened a second box and found thesame insert. Later, a pharmacist discovered thatinformation about pilocarpine solutions and tetra-caine 0.5% solutions was on the other side of theinsert. Apparently, all of the eye products packaged

and ISMP is especially supportive andpleased that the CA initiative requires thiscomponent in its MERP regulations.

Survey FindingsIn January 2009, CDPH began conductingtriennial onsite visits to monitor eachfacility’s implementation of its previouslyapproved MERP. Of the 112 hospitalssurveyed in 2009 (29% of all CA hospitals),15% were following their approved MERPand 81% were deficient in implementingtheir plan. About half of the hospitals withdeficiencies were cited for failing to estab-lish and follow policies and proceduresrelated to safe and effective systems forprocurement, storage, and dispensing ofdrugs, or for not including physicians onthe multidisciplinary team that reviews allmedication-related reports. About a quarterof deficient hospitals were cited for failingto conduct an annual review to assess theeffectiveness of the MERP itself and theerror-reduction strategies in the plan,and/or for failing to identify weaknesses ordeficiencies that could contribute to errorsusing both internal (e.g., hospital reportingprogram) and external (e.g., ISMP, FDA,Joint Commission) sources. In most cases,the deficiencies did not rise to the level ofan “immediate jeopardy” to patients butinstead required the hospital to establishan approved plan of correction.

ConclusionsISMP supports the CA MERP initiativebecause it advances many of the error-reduction strategies we have supported overthe years, including: a proactive approachto risk identification and analysis; carefullyplanned technology implementation; multi-disciplinary teams to analyze medication-related risks and errors; use of externalinformation to improve medication safety;effective and timely use of measure-ment/assessment systems to evaluate theimpact of selected error-reduction strate-gies; and the design of an annually reviewedstrategic plan to reduce medication errors.While we recognize significant resourcesand expertise are necessary to design andimplement a robust MERP—coordinationby a medication safety officer is highlyrecommended—we believe such an effortcan significantly impact patient safety. We

hope hospital leaders who work outside CAwill provide the necessary staffing andresources to voluntarily establish a medica-tion safety strategic plan in their hospitalswith similar components. While we saw nomention in the CA regulations regarding afocus on high-alert medications and high-risk processes and populations, weencourage practitioners to devote theirefforts on the drugs and processes that canharm vulnerable patients.

Requiring a multidisciplinary team toreview all actual and potential medication-related errors individually may not befeasible in hospitals that have successfullyincreased the volume of error reports theyreceive, which often includes potentialhazards and near misses. To require reviewof all medication-related errors could evendiscourage reporting. As an alternative, theteam should establish error categories thatshould be reviewed individually (e.g., thosethat are more serious or have great poten-tial for harm) while those less serious canbe aggregated to work on as a whole (e.g.,drug omissions which had no conse-quence). To do this, establish a systemwhere data is prescreened by a medicationsafety officer or a similarly qualified profes-sional to ensure that the multidisciplinaryteam is provided with the most relevantdetails about risks and errors that couldlead to an adverse outcome in patients.

Next is the concern that regulatory agenciescan sometimes become too prescriptiveand/or too punitive when determiningcompliance with regulations. Indeed, wewrote about one such concern with CDPHand its citations in hospitals that had goneto great lengths to remove recalled drugsonly to find supplies in unlikely places orfrom uncontrolled sources during a survey(Collaboration focused on priority issuespromotes safety. ISMP Medication SafetyAlert! Oct. 9, 2008). While we stronglyoppose unreasonable sanctions of health-care practitioners or too narrow assessmentof healthcare providers that are meeting theintent of regulations, we must, however,support the CA MERP initiative to improvemedication safety and encourage hospitalsoutside CA to adopt a similar program.

SafetyBriefs continued from page 1 MERP continued from page 1

Table 1 appears on page 3 — MMEERRPPcontinued on page 3 — SSaaffeettyyBriefs

Please encourage your patients and staff to visit www.consumermedsafety.org often. It may save a life!

[[ FFoollllooww uuss oonn TTwwiitttteerr..ccoomm ((IISSMMPP11)) ]]

Figure 1. The letter“l” in “until”dropped to thenext line (top) andwas misunder-stood as the

number “1” which changed the directions onthe label from 7 to 17 days (bottom).

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March 25, 2010 Volume 15 Issue 6

3

in Steri-Units share the same package insert,although this may be easily missed. The pharma-cist was concerned that someone might read infor-mation about atropine on the package insert andsubsequently provide the wrong directions for tetra-caine drops, for example. If you check the list ofFDA-approved medications using the drugs@fdasection of the www.FDA.gov Web site, these oph-thalmic solutions, which have been available formany years, do not appear to be approved drugs.Thus, the package insert may not meet currentFDA standards for labeling. We’ve contacted FDAand Alcon to express our concerns. At a minimum,a header or instructions alerting practitioners tothis unique package insert would be helpful.

SafetyBriefs continued from page 2

Please encourage your patients and staff to visit www.consumermedsafety.org often. It may save a life!

[[ FFoollllooww uuss oonn TTwwiitttteerr..ccoomm ((IISSMMPP11)) ]]

IISSMMPP MMeeddiiccaattiioonn SSaaffeettyy AAlleerrtt!! AAccuuttee CCaarree(ISSN 1550-6312) ©©22001100 IInnssttiittuuttee ffoorr SSaaffeeMMeeddiiccaattiioonn PPrraaccttiicceess ((IISSMMPP)). Permission isgranted to subscribers to reproduce material forinternal communications. Other reproduction isprohibited without permission. Report medica-tion errors to the ISMP Medication ErrorsReporting Program (MERP) at 11--880000--FFAAIILL--SSAAFF((EE)). Unless noted, published errors werereceived through the MERP. ISMP guaranteesconfidentiality of information received andrespects reporters' wishes as to the level of detailincluded in publications. EEddiittoorrss:: Judy Smetzer,RN, BSN, FISMP; Michael R. Cohen, RPh,MS, ScD; Russell Jenkins, MD. IISSMMPP,, 220000LLaakkeessiiddee DDrriivvee,, SSuuiittee 220000,, HHoorrsshhaamm,, PPAA 1199004444..Email: ismpinfo@ismp.org; Tel: 215-947-7797;Fax: 215-914-1492. This is a peer reviewedpublication.

Free webinar. ISMP has reviewed andaggregated data for key areas addressed in theISMP Medication Safety Self Assessmentfor Antithrombotic Therapy in Hospitals. Afree webinar to discuss the results will be heldon both April 27 and April 29, 2010. You canregister for the webinar at: www.pharmacyadvisor.com. The webinar is one of several fea-tured in a section called “In the Bin” (right sideof the home page screen).

New ISMP webinar series. JoinISMP for an ongoing series of ISMP ActionAgenda webinars designed exclusively forpharmacy and therapeutics or safety committeesto bring your medication safety review process tolife. The first webinar on April 22 is offered at asignificant discount so you can see how thesesessions, led by ISMP President Michael R.Cohen, can help advance your medication safetyagenda and help you meet several JointCommission standards. For details and to regis-ter, visit: www.ismp.org/educational/webinars.

Special Announcement s . . .

MERP cont’d from page 2

MERP Requirements Examples of Self-Assessment Questions

Evaluate, assess, and include a method toaddress each of the 11 procedures or sys-tems associated with medication use toidentify weaknesses or deficiencies thatcould contribute to errors.

11 procedures/systemsPrescribingPrescription order communicationProduct labelingProduct packaging and nomenclatureCompoundingDispensingDistributionAdministrationEducationMonitoringUse

What committee/team oversees the MERP? Have interventions to reduce medication errors been identified for each of the 11

procedures/systems?How does the hospital determine effectiveness and identify weaknesses or defi-

ciencies in the 11 procedures/systems? Does the method include the use of metrics such as process measures? Aggregate

trending reports? FMEA? Self-assessments? RCA? Observation? Robust reportingsystem?

Does the method include analysis of all medication error data to identify problems?Does the method provide objective and relevant data that helps inform decision-

making?What are the procedure/system weaknesses or deficiencies that contribute to

errors?How has the assessment process been used to address system deficits and reduce

medication errors? Were the implementation strategies used to address the system deficits effective

in reducing medication errors?How and why has your MERP evolved since its implementation date to present?

Include an annual review to assess the effec-tiveness of the implementation of each of theprocedures and systems listed in require-ment #1 (may review all 11 procedures/systems at once in an overall review or asindividual components throughout the year).

How do you know that a specific intervention is working to reduce errors?Has the MERP and actions taken in accordance with execution of the plan (inter-

ventions to reduce errors with the 11 procedures/systems) been evaluated annually?Did the annual reviews identify interventions that were ineffective? Is the MERP effective in reducing errors?

Include modification as warranted whenweaknesses or deficiencies are noted inorder to achieve the reduction of medica-tion errors.

What weaknesses/deficiencies has the hospital noted upon review? How was the plan modified to address the noted deficiencies? Did the hospital reassess the MERP after it had been modified?Was the revised plan or the modification effective in addressing the noted deficiencies?

Describe the technology to be implement-ed and how it is expected to reduce med-ication-related errors associated with oneor more of the 11 procedures or systemslisted in requirement #1.

Does the MERP include technology implementation and how it will reduce errors? Is the selected technology based on independent or expert scientific advice

demonstrating that it has been effective in reducing errors?Does the MERP include an implementation plan for the technology?Has the hospital implemented the technology specified in its plan? How has the technology been effective in reducing medication errors?

Include a system or process to proactivelyidentify actual or potential medication-related errors. The system or process shallinclude concurrent and retrospectivereview of clinical care. (The intent is forthe hospital to have a robust medicationerror reporting system, identify medicationsystem vulnerabilities, and develop correc-tive actions.)

What is the hospital’s process to proactively identify medication errors and risks?Does the process include concurrent (such as observation, investigating the use of trig-

ger drugs) and retrospective (such as analysis of error reports, RCA) review of care?Does the process include a proactive component?Does it include a variety of methods to identify risk, harm, and errors, such as error-

reporting, process/outcome metrics, FMEA, self-assessments, RCA, capture of pharmacy ornursing interventions, trigger drugs, observation, chart review, and/or survey data?

Is the process effective? How do you know it’s effective?Does the error-reporting program include hazards that could cause errors? Errors that

were caught before they reached the patient?Is there a culture of safety which encourages reporting? How is reporting encouraged?

Include a multidisciplinary process, includinghealthcare professionals responsible forpharmaceuticals, nursing, medical, andadministration, to regularly analyze all identi-fied actual or potential medication-relatederrors and describe how the analysis will beutilized to change current procedures andsystems to reduce medication-related errors.

How does your hospital analyze reported medication errors? Are pharmacists, nurses,physicians, and administrators part of the process?

Are all medication errors analyzed via the multidisciplinary process?How frequently does this occur? How has this analysis been used to change current procedures or systems? What examples can you provide to demonstrate such a change in procedures or sys-

tems? Were the changes in the procedure or system effective in reducing medication errors?

Include a process to incorporate externalmedication-related error alerts to modifycurrent processes and systems as appro-priate.

What external sources does the hospital use for identification of potential/actual riskpoints related to medication errors (ISMP newsletter, ISMP Quarterly Action Agenda,Action Agenda webinars, FDA alerts, Joint Commission alerts, other national alerts)?

How has the hospital used these external alerts to modify processes and systems?Were changes in the procedure or system effective in reducing medication errors?

Table 1. MERP Requirements and Assessment Questions*

*Sources: Chapter 2.05 Minimization of Medication-Related Errors in the California Health and Safety Code Section 1339.63 (http://law.justia.com/california/codes/hsc/1339.63.html); All Facility Letter from CDPH issued on August 10, 2009 (www.cdph.ca.gov/certlic/facilities/Documents/LNC-AFL-09-31.pdf); All Facility Letter from CDPH issued on December 9, 2008 (www.cdph.ca.gov/certlic/facilities/Documents/LNC-AFL-08-39.pdf).

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March 17, 2010

Voluntary reporting of medication errors through ISMP has an impact By Julia Talsma, Editor-in-Chief

The Institute for Safe Medication Practices (ISMP), a nonprofit organization devoted to medication error prevention and safe medication use, has a voluntary practitioner error-reporting program that has helped to identify a variety of medication errors and their causes. Since its inception in the mid-1970s, ISMP has been sharing this information with healthcare professionals through its Medication Safety Alert newsletters, including its monthly edition for pharmacists, “ISMP Medication Safety Alert Community/Ambulatory Edition.”

ISMP receives about 1,000 medication error reports annually and follows up on every report to determine what went wrong, according to Matthew C. Grissinger, RPh, FISMP, FASCP, director of Error Reporting Programs at ISMP, Horsham, Pa. He spoke at the annual PPSI (Pharmacists Planning Service) breakfast during the American Pharmacists Association meeting that took place this week.

“If there are medication errors, it is not an individual pharmacist but the medication-use process that is responsible,” Grissinger said. The breakdowns in the medication-use process usually occurs in the prescribing, order entry, storage, or dispensing of the drug, he said.

ISMP also is responsible for reviewing all medication error reports that are submitted to the Commonwealth of Pennsylvania Patient Safety Authority. Since June 2004, ISMP has received approximately 260,000 reports from over 400 organizations required to report all potential medication errors and harmful events. The organization offers its consulting services to hospitals to identify and prevent medication errors, using a team of doctors, nurses, and pharmacists to determine the causes of these errors.

Examples of medication errors that have occurred in hospitals include confusion with look-alike vials of medication, the use of devices for medication delivery, similar drug names and similar brand-name extensions for over-the-counter drugs, dosing mixups, and ambiguous orders written by prescribers, Grissinger noted. He showed examples of how the medication process breakdown occurred and steps to help avoid these errors in the future.

ISMP’s subsidiary, Med-E.R.R.S. (Medication Error Recognition and Revision Strategies) works directly and confidentially with pharmaceutical industry to prevent such errors as confusing or misleading names, labeling, packaging, and device design.

ISMP encourages pharmacists to report any medication errors, so that they can be included in its newsletter and shared with other healthcare practitioners. “One person can make a difference by reporting an error,” Grissinger said.

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To report a medication error, contact ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044-2321. Phone: 215-947-7797; Fax: 215-914-1492. The Web site for error reporting is https://www.ismp.org/orderforms/reporterrortoismp.

2010 Advanstar Communications Inc.. Permission granted for up to 5 copies. All rights reserved. You may forward this article or get additional permissions by typing http://license.icopyright.net/3.7503?icx_id=661665 into any web browser. Advanstar Communications Inc. and Modern Medicine logos are registered trademarks of Advanstar

Communications Inc. The iCopyright logo is a registered trademark of iCopyright, Inc.

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March 24, 2010

Pharmacists Identify Medication Errors in Hospitalized Patients, Prevent Harm, Study Finds

Two pharmacists who independently reviewed 651 inpatient medication histories found that 35.9% of hospital inpatients had 309 medication order errors that were then changed by a physician, according to a study published February 24, 2010, online in the Journal of General Internal Medicine.1 "Among the 309 prescription medication errors, 4 (1.3%) were rated as involving potentially longer hospitalization, 32 (10.4%) rated as potentially causing temporary harm, and 162 (52.4%) rated as potentially requiring increased monitoring or intervention to preclude harm," the study found. During the intervention, two pharmacists independently reviewed patients' electronic medical record, medication history, admission medication orders, and demographic information over a 14-month period in 2006 and 2007 at Northwestern Memorial Hospital in Chicago, Ill. Patients and/or caregivers then were interviewed by a pharmacist to identify the patient's current medication regimen and any medication error risk factors. "When feasible, hospital pharmacists can also be invaluable in obtaining complex medication histories and collaborating with physicians, nurses and other health care providers on medication reconciliation," the study's authors concluded. An abstract of the study is available at http://springerlink.com/content/y123197m86431v18/?p=817873a72e9742ccbfa64e2b98b2299c&pi=1 1. Gleason KM, McDaniel MR, Feinglass J et al. Results of the medications at transitions and

clinical handoffs (MATCH) study: An analysis of medication reconciliation errors and risk factors at hospital admission. J Gen Intern Med. 2010 Feb 24 [epub ahead of print].

To View ASHP's Policy Alert Archive click http://www.ashp.org/policy-alert.

Questions about ASHP Health Policy Alerts can be directed to Lisa Daigle, policy analyst, at (301) 664-8651 or ldaigle@ashp.org. ASHP Health Policy Alerts are synopses of new studies highlighting the medication-use process in health care, especially studies assessing contemporary pharmacists’ role in improving medication-use outcomes. The American Society of Health-System Pharmacists encourages recipients to keep a copy of this synopsis for future reference.

Copyright 2008 American Society of Health-System Pharmacists. All rights reserved. 7272 Wisconson Avenue, Bethesda, Maryland 20814 | 301-657-3000

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April 1, 2010 TO: Medication Safety Committee Members FROM: Frank Maas, Administrative Director Emergency Department Little Company of Mary Hospital SUBJECT: Emergency Medication Orders Workgroup Minutes – 03/31/10 Participants: Hanni, Harms, Hauenstein, LeWinter, Lopez, Maas, Raben Discussion:

1. Minutes Minutes from the last work group meeting were reviewed. Paragraph four was revised to read, “The group divided drugs into three broad categories. The work group will then decide which specific drugs should be reviewed by a pharmacist, before given.”

2. Drug Categories

After several minutes of discussion the group chose the following categories of medications on which to focus; hypoglycemics, procedural sedation, antibiotics, anticoagulants and pain medications.

3. Frequency of Meetings

The work group decided that meetings should be held monthly. Maas will have side bar with members during April 20 meeting of the larger group to chose specific dates and times.

DH:lw

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March 31, 2010 TO: Medication Safety Committee Members FROM: Frank Maas, Administrative Director Emergency Department Little Company of Mary Hospital SUBJECT: Revised 02/08/10 Emergency Medication Orders Work Group Minutes Participants: Gutierrez, Hauenstein, Maas, LeWinter, Rogers Discussion: Discussion related to mining more data to assess where hospitals are vulnerable, mistakes being made and what could be remedied. This information would inform the work group as to its work plan. A survey of this nature would need to by anonymous. Using Survey Monkey is a possibility. There was also a desire to collect best practices that could be vetted among the members and shared. A plan to disseminate best practices would be needed. Rather than taking the broader approach of evaluating whether the drugs should be administered to any patient, the work group thought it best to confine its work to emergency department patients at this time. The group divided drugs into three broad categories. The work group will then decide which specific drugs should be reviewed by a pharmacist, before given.

1. Resuscitation drugs 2. OTC and some post-op medications (Naprison, antibiotics, Tylenol, etc.) 3. Drugs that are potentially very dangerous (and there is time to review)

Rather than being prescriptive the work group determined that each hospital needs to develop their own policies. The focus of the work group should be to help hospitals to tailor their own individual programs. DH:lw

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Home > Standards > Field Reviews

Field Reviews March 30, 2010

National Patient Safety Goal: NPSG.03.07.01(Medication Reconciliation)

Accredited organizations have indicated that although the Medication Reconciliation NPSG addresses an important safety issue, the 2009 version was difficult to implement because it was too detailed and too broad in scope. The Joint Commission researched the implementation challenges pertaining to medication reconciliation and revised the goal to address these concerns. The revised NPSG places a spotlight on specific risk points in the process that are critical and readily achievable. The remaining components of the medication reconciliation process are covered in standards.

Input from the field is essential to improvement, so The Joint Commission is seeking your input on the revised goal. Please select your program from the list below to review the proposed revisions and provide feedback for NPSG.03.07.01.

Ambulatory Health Care Behavioral Health Care Critical Access Hospital Home Care Hospital Long Term Care Office-Based Surgery

We would appreciate receiving comments before April 30, 2010; however, this field engagement will remain open until May 11, 2010.

Accreditation Programs | Certification Programs | Quality Check | Achieve the Gold Seal | Library Standards | Patient Safety | Performance Measurement | Sentinel Event | Public Policy | Search Contact Us | Site Map | Careers | Newsroom | About Us © 2010 The Joint Commission, All Rights Reserved

Page 1 of 1National Patient Safety Goal: NPSG.03.07.01 | Joint Commission

4/1/2010http://www.jointcommission.org/Standards/FieldReviews/fr_npsg030701.htm

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March 3, 2010

TO: Medication Safety Committee Members FROM: Dawn Benton, EVP/CEO

CSHP SUBJECT: High Risk/High Alert Work Group Minutes – 3/3/10 Participants: Banzon, Benton, DeMartini, Gutierrez, Herold, Schaad, Swanger

Discussion: The work group defined what they are looking to accomplish. It was suggested that the work group focus on various hospitals and health-systems throughout California to establish recommendations for high risk/high alert medications.

Most hospitals currently have a list of core high risk/high alert medications; however, there is not universal list for California hospitals. The work group could act as a repository for high risk/high alert drug resources, including a list of core high risk/high alert drugs and suggested protocols surrounding those drugs.

The California Department of Public Health uses All Facility Letters (AFL’s) to educate institutions about high risk drugs, emergency medications, and storage requirements. The work group could supplement their efforts to provide additional resources and educational materials to providers, and the Board of Pharmacy has offered their subscriber alert system to share pertinent information with pharmacy licentiates.

The work group will ask for various California hospitals’ high risk/high alert drug lists and then combine them into a core list. The idea is to start with hospitals from stakeholders in this work group and then potentially expand and modify the list as time goes on. Once refined, this list would go out to licentiates and also be placed on a stakeholder’s website. Other stakeholder’s would be encouraged to have links on their websites to the resources. Lastly, it was suggested that the work group focus on standardizing IV infusions.

Next steps: 1. Work group members to send all high risk/high alert drug lists from their institution to Benton.

Benton to combine this list with ISMP’s high risk drugs. 2. CSHP to survey all hospitals associated with the Medication Safety Committee to create “core

list” high risk/high alert drug lists. 3. Determine what agency or association should serve as the repository for the work group’s

resources (internet access to general public). 4. Work group to meet the week of March 22-26.

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March 25, 2010

TO: Medication Safety Committee Members FROM: Dawn Benton, EVP/CEO

CSHP SUBJECT: High Risk/High Alert Workgroup Minutes – 3/25/10 Participants: Benton, Eastham, Gutierrez, Herold, Schaad, Schell, Swanger

Discussion: Work group members reviewed all high risk/high alert drugs that were submitted by individual work group members. The high risk/high drug lists came from: CHW, DHS, and ISMP. Members of the work group then discussed the best way to group high risk/high alert drugs common on these institutions’ lists. After reviewing all three lists, it was noted that there was already a great deal of crossover among the lists. Once the core list is created, the work group will create general guidelines that accompany each high risk/high alert drugs. It was suggested that work group members (and potentially the public) be asked to submit their guidelines surrounding each high risk/high alert drug found on the core list. Hospital pharmacists-in-charge were identified as the appropriate contact person at the hospitals to request their guidelines surrounding high risk/high alert drugs. The following core list was created:

CHA HR/HA DRUG CORE LIST

Anti-Neoplastic Agents: Parenteral Routes Only *

Electrolytes, Concentrated (Potassium, Sodium, Magnesium, Calcium, Phosphate)

Epoprostanol

Anticoagulants (e.g. Warfarin, Heparin)

Insulin (IV, SC)

Magnesium Infusions

Methotrexate (Oral, Non-Chemotherapy Use)

Neuromuscular Blocking Agents

Nitroprusside

Opiate Infusions (Parenteral, Intrathecal, Epidural)

Oxytocin (Pitocin)

Thrombolytics

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Lastly, in an effort to incentivize people to submit their protocols/best practices surrounding a high risk/high alert drug (insulin/heparin/chemotherapy), the work group could create an award, which could be a CSHP adopted annual award. Another option is to review the protocols received from the various hospitals and determine which agent should be focused on through the award. Next steps: 1. Herold to determine if she can pull an email list of hospital pharmacists-in-charge. If she cannot,

she can pull the contact information for approximately 533 hospitals to which the high drug/high risk drug guidelines can be solicited.

2. Work group member to draft letter to accompany survey on CHA High Risk/High Alert Core Drug List. Gutierrez offered to assist in drafting the letter.

3. CSHP to send survey to Board of Pharmacy list with letter from CHA work group and get feedback on core drug list. Survey will remain open for only 3-weeks.

4. Next meeting will be in person on April 20 at the CHA Medication Safety Committee meeting. 5. Eastham to contact Michael Cohen at ISMP to follow up on whether ISMP will be pursuing IV

infusion standardization.

Parking Lot: 1. Standardization for pediatric dosing. 2. Guidelines surrounding sterile water for injection.

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Institute for Safe Medication Practices www.ismp.org

Institute for Safe Medication Practices

Classes/Categories of Medications

adrenergic agonists, IV (e.g., epinephrine, phenylephrine, norepinephrine)

adrenergic antagonists, IV (e.g., propranolol, metoprolol, labetalol)

anesthetic agents, general, inhaled and IV (e.g., propofol, ketamine)

antiarrhythmics, IV (e.g., lidocaine, amiodarone)

antithrombotic agents (anticoagulants), including warfarin, low-molecular-weightheparin, IV unfractionated heparin, Factor Xa inhibitors (fondaparinux), directthrombin inhibitors (e.g., argatroban, lepirudin, bivalirudin), thrombolytics (e.g.,alteplase, reteplase, tenecteplase), and glycoprotein IIb/ IIIa inhibitors (e.g., eptifi-batide)

cardioplegic solutions

chemotherapeutic agents, parenteral and oral

dextrose, hypertonic, 20% or greater

dialysis solutions, peritoneal and hemodialysis

epidural or intrathecal medications

hypoglycemics, oral

inotropic medications, IV (e.g., digoxin, milrinone)

liposomal forms of drugs (e.g., liposomal amphotericin B)

moderate sedation agents, IV (e.g., midazolam)

moderate sedation agents, oral, for children (e.g., chloral hydrate)

narcotics/opiates, IV, transdermal, and oral (including liquid concentrates, immediateand sustained-release formulations)

neuromuscular blocking agents (e.g., succinylcholine, rocuronium, vecuronium)

radiocontrast agents, IV

total parenteral nutrition solutions

ISMP’s List of High-Alert Medicationsigh-alert medications are drugs that bear a heightened risk ofcausing significant patient harm when they are used in error.

Although mistakes may or may not be more common with thesedrugs, the consequences of an error are clearly more devastating topatients. We hope you will use this list to determine which medica-tions require special safeguards to reduce the risk of errors. Thismay include strategies like improving access to information about

these drugs; limiting access to high-alert medications; usingauxiliary labels and automated alerts; standardizing the ordering,storage, preparation, and administration of these products; andemploying redundancies such as automated or independent double-checks when necessary. (Note: manual independent double-checksare not always the optimal error-reduction strategy and may not bepractical for all of the medications on the list).

Specific Medications

colchicine injection***

epoprostenol (Flolan), IV

insulin, subcutaneous and IV

magnesium sulfate injection

methotrexate, oral, non-oncologic use

opium tincture

oxytocin, IV

nitroprusside sodium for injection

potassium chloride for injection concentrate

potassium phosphates injection

promethazine, IV

sodium chloride for injection, hypertonic (greater than 0.9% concentration)

sterile water for injection, inhalation, and irrigation (excluding pour bottles) in containers of 100 mL or more

Background

Based on error reports submitted to the USP-ISMP Medication Errors ReportingProgram, reports of harmful errors in the literature, and input from practitioners andsafety experts, ISMP created and periodically updates a list of potential high-alertmedications. During February-April 2007, 770 practitioners responded to an ISMPsurvey designed to identify which medications were most frequently consideredhigh-alert drugs by individuals and organizations. Further, to assure relevance andcompleteness, the clinical staff at ISMP, members of our advisory board, and safetyexperts throughout the US were asked to review the potential list. This list of drugsand drug categories reflects the collective thinking of all who provided input.

H

© ISMP 2008. Permission is granted to reproduce material for internal newsletters or communications with proper attribution. Otherreproduction is prohibited without written permission. Unless noted, reports were received through the USP-ISMP Medication ErrorsReporting Program (MERP). Report actual and potential medication errors to the MERP via the web at www.ismp.org or by calling1-800-FAIL-SAF(E). ISMP guarantees confidentiality of information received and respects reporters’ wishes as to the level of detailincluded in publications.

© IS

MP

2008

***Although colchicine injection should no longer be used, it will remain on the list untilshipments of unapproved colchicine injection cease in August 2008. For details,please visit: www.fda.gov/bbs/topics/NEWS/2008/NEW01791.html.

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AMENDED IN SENATE APRIL 7, 2010

SENATE BILL No. 971

Introduced by Senator Pavley

February 8, 2010

An act to add Article 5 (commencing with Section 125286.1) toChapter 2 of Part 5 of Division 106 of the Health and Safety Code,relating to genetic disease services.

legislative counsel’s digest

SB 971, as amended, Pavley. Bleeding disorders: blood clottingproducts.

Existing law, the Holden-Moscone-Garamendi GeneticallyHandicapped Person’s Program, requires the Director of Health CareServices to establish and administer a program for the medical care ofpersons with genetically handicapping conditions, including hemophilia.

This bill would impose specified requirements on providers of bloodclotting products for home use used for the treatment and preventionof symptoms associated with bleeding disorders, including all forms ofhemophilia. This bill would require the California State Board ofPharmacy to administer and enforce these provisions.

Vote: majority. Appropriation: no. Fiscal committee: yes.

State-mandated local program: no.

The people of the State of California do enact as follows:

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SECTION 1. Article 5 (commencing with Section 125286.1)is added to Chapter 2 of Part 5 of Division 106 of the Health andSafety Code, to read:

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Article 5. Standards of Service for Providers of Blood ClottingProducts for Home Use Act

125286.1. This article shall be known, and may be cited, asthe Standards of Service for Providers of Blood Clotting Productsfor Home Use Act.

125286.2. The Legislature hereby finds and declares all of thefollowing:

(a)  Hemophilia is a rare, hereditary, bleeding disorder affectingat least 4,000 persons in California and is a chronic, lifelong, andincurable, but treatable, disease.

(b)  Von Willebrand disease is a human bleeding disorder causedby a hereditary deficiency or abnormality of the von WillebrandFactor in human blood, which is a protein that helps clot blood.Von Willebrand disease is a chronic, lifelong, incurable, buttreatable, disease affecting at least 360,000 Californians.

(c)  Until the 1970s, people with severe hemophilia sufferedfrom uncontrollable internal bleeding, crippling orthopedicdeformities, and a shortened lifespan. More recently, the productionof highly purified blood clotting factors have provided people withhemophilia and other bleeding disorders with the opportunity tolead normal lives, free of pain and crippling arthritis.

(d)  The preferred method of treatment of hemophilia today isintravenous injection, or infusion, of prescription blood clottingproducts several times per week, along with case management andspecialized medical care at a federally designated regionalhemophilia treatment center.

(e)  Pharmacies and other entities specializing in the delivery ofblood clotting products and related equipment, supplies, andservices for home use form a growing enterprise in California. Allof these entities are licensed by the state or are located at federallydesignated regional hemophilia treatment centers, or both.

(f)  Timely access to federally designated regional hemophiliacenters and appropriate products and services in the home,including infusion of blood clotting products and relatedequipment, and supplies and services for persons with hemophiliaand other bleeding disorders, reduces mortality and bleeding-relatedhospitalizations, and is extremely cost effective, according to thefederal Centers for Disease Control and Prevention and the Medical

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and Scientific Advisory Council of the National HemophiliaFoundation.

(g)  Eligible persons with hemophilia or other bleeding disordersmay receive treatment through the Genetically HandicappedPersons Program, the California Children’s Services Program, andMedi-Cal. Access to quality blood clotting products for home useand related equipment, supplies, and services for people withhemophilia or other bleeding disorders promotes cost containmentin each of these publicly funded programs as well as in the healthinsurance and health care industries more generally.

(h)  For the benefit of persons with hemophilia or other bleedingdisorders, as well as for cost containment in health care, thepurposes of this article are to do the following:

(1)  Establish standards of service for entities that deliver bloodclotting products and related equipment, supplies, and services forhome use.

(2)  Promote access to a full range of essential, cost effective,lifesaving, blood clotting products and related equipment, supplies,and high-quality services for home use for persons with hemophiliaand other bleeding disorders.

125286.3. Unless context otherwise requires, the followingdefinitions shall apply for purposes of this article:

(a)  “340B Program” means an outpatient pharmacy licensed todispense blood clotting products in California and that isconditionally or fully designated as a covered entity under theVeterans Health Care Act of 1992 (Public Law 102-585), whichenacted Section 340B of the Public Health Service Act (41 U.S.C.Sec. 201 et seq.).

(b)(a)  “Assay” means the amount of a particular constituent of a

mixture or of the biological or pharmacological potency of a drug.(c)(b)  “Ancillary infusion equipment and supplies” means the

equipment and supplies required to infuse a blood clotting productinto a human vein, including, but not limited to, syringes, needles,sterile gauze, field pads, gloves, alcohol swabs, numbing creams,tourniquets, medical tape, sharps or equivalent biohazard wastecontainers, and cold compression packs.

(d)

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(c)  “Bleeding disorder” means a medical condition characterizedby a severe deficiency or absence of one or more essential bloodclotting proteins in the human blood, often called “factors,”including all forms of hemophilia and other bleeding disordersthat result in uncontrollable bleeding or abnormal blood clottingwithout treatment.

(e)(d)  “Blood clotting product” means an intravenously

administered medicine manufactured from human plasma orrecombinant biotechnology techniques, approved for distributionby the federal Food and Drug Administration, that is used for thetreatment and prevention of symptoms associated with bleedingdisorders. Blood clotting products include, but are not limited to,Factor VII, Factor VIIa, Factor VIII, and Factor IX products, vonWillebrand Factor products, bypass products for patients withinhibitors, and activated prothrombin complex concentrates.

(f)(e)  “Consumer” means a person needing a blood clotting product

for home use.(g)(f)  “Emergency” means a situation in which a prudent layperson

could reasonably believe that the consumer’s condition requiresimmediate medical attention.

(h)(g)  “Hemophilia” means a human bleeding disorder caused by

a hereditary deficiency of the Factors I, II, V, VIII, IX, XI, XII,or XIII blood clotting protein in human blood.

(i)(h)  “Hemophilia treatment center” means a facility for the

treatment of bleeding disorders, including, but not limited to,hemophilia, that receives funding from the federal governmentsources, including, but not limited to, the federal Centers forDisease Control and Prevention and the federal Health Resourcesand Services Administration (HRSA) of the United StatesDepartment of Health and Human Services.

(j)(i)  “Home nursing services” means specialized nursing care

provided in the home setting to assist a patient in the reconstitutionand administration of blood clotting products.

(k)

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(j)  “Home use” means infusion or other use of a blood clottingproduct in a place other than a state-recognized hemophiliatreatment center. Places where home use occurs include, withoutlimitation, a home or physician office.

(l)(k)  “Provider of blood clotting products for home use” means

a seller and provider of blood clotting products, ancillary infusionequipment, home nursing services, and patient assistance for themanagement of bleeding disorders for home use. These providersinclude, without limitation, 340B programs, other pharmacies,and, when treatment is not provided onsite, hemophilia treatmentcenters.

125286.4. Each provider of blood clotting products for homeuse shall meet all of the following requirements:

(a)  Have sufficient knowledge and understanding of bleedingdisorders and the medical and psychosocial management thereof,including, but not limited to, home therapy.

(b)  Have sufficient clinical experience providing services topersons with bleeding disorders and a sufficient nonclinicalunderstanding of bleeding disorders that enables the provider toknow when patients have an appropriate supply of clotting factoron hand and about proper refrigeration of clotting factors.

(c)  Ensure that its customer service staff meets the requirementsof subdivisions (a) and (b).

(d)  Have a pharmacist available at all times, knowledgeablepharmacy staffing on call 24 hours a day, seven days a week, everyday of the year, either onsite or on call, to fill prescriptions forblood clotting products. to initiate emergency requests for clottingfactors.

(e)  Supply blood clotting products and home nursing services,as prescribed by the consumer’s treating physician, and, pursuantto Section 4073 of the Business and Professions Code, not makeany substitutions of blood clotting products or assay amounts.

(f)  Ask the The prescribing physician shall indicate whichspecific blood clotting product is intended whenever a prescriptiondoes not indicate the specific product and then use the productnamed in the physician’s response. is written.

(g)  Supply all brands of blood clotting products approved bythe federal Food and Drug Administration in multiple assay ranges(low, medium, and high, as applicable) and vial sizes, including

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products manufactured from human plasma and those manufacturedwith recombinant biotechnology techniques, provided manufacturersupply exists and payer authorization is approved.

(h)  Supply all necessary ancillary infusion equipment andsupplies with each prescription, as needed.

(i)  Maintain adequate stocks of blood clotting products andancillary infusion equipment and supplies.

(j)  Store and ship, or otherwise deliver, all blood clottingproducts in conformity with all state and federally mandatedstandards, including, but not limited to, the standards set forth inthe product’s approved package insert (PI).

(k)  When home nursing services are prescribed by the treatingphysician, provide these services either directly or through aqualified third party with experience in infusing bleeding disordersand coordinate pharmacy services with the third party when oneis used to provide home nursing services.

(l)  Upon receiving approved authorization for a nonemergencyprescription, ship the prescribed blood clotting products andancillary infusion equipment and supplies to the consumer within:two business days or less for established and new consumers.

(1)   Two business days or less for established consumers.(2)  Three business days or less for new consumers.(m)  Upon receiving approved authorization to dispense a

prescription for an emergency situation, deliver prescribed bloodproducts, ancillary infusion equipment and supplies, medications,and home nursing services to the consumer within 12 hours afterreceipt of the prescription for patients living within 100 miles ofa major metropolitan airport, and within one day for patientsliving more than 100 miles from a major metropolitan airport.

(n)  Maintain 24-hour oncall service seven days a week for everyday of the year, adequately screen phone calls for emergencies,and respond to all phone calls within one hour or less.

(o)  Provide consumers who have ordered their products with adesignated contact phone number for reporting problems with adelivery and respond to these calls immediately.

(p)  Provide patients with notification of recalls and withdrawalsof blood clotting products and ancillary infusion equipment within24 hours and participate in the National Patient Notification Systemfor blood clotting product recalls.

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(q)  Provide language translation services, both over the phoneand in person, as needed by the consumer.

(r)  Have a detailed plan for meeting the requirements of thisarticle in the event of a natural or manmade disaster or otherdisruption of normal business operations.

(s)  Provide for proper collection, removal, and disposal ofhazardous waste pursuant to state and federal law, including, butnot limited to, sharps containers for the removal and disposal ofmedical waste.

(t)  Clearly inform the Inform a consumer of his or her copay,deductible, and coinsurance payment responsibilities each time heor she orders a blood clotting product. initially and when changedby the consumer’s insurance, health plan, or other third-partypayer.

(u)  Provide consumers with a copy of all billing invoices.(v)  Provide appropriate and necessary recordkeeping and

documentation as required by state and federal law and retaincopies of the patient’s prescriptions.

(w)  Comply with the privacy and confidentiality requirementsof the Health Insurance Portability and Accountability Act of 1996(HIPAA).

125286.5. The California State Board of Pharmacy shalladminister and enforce this article.

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AMENDED IN ASSEMBLY APRIL 13, 2010

california legislature—2009–10 regular session

ASSEMBLY BILL No. 2077

Introduced by Assembly Member Solorio

February 18, 2010

An act to amend Section 4029 of, and to add Article 7.6 (commencingwith Section 4128) to Chapter 9 of Division 2 of, the Business andProfessions Code, relating to pharmacies, and making an appropriationtherefor. An act to amend Sections 4029 and 4033 of the Business andProfessions Code, relating to pharmacy.

legislative counsel’s digest

AB 2077, as amended, Solorio. Centralized hospital packagingpharmacies. Pharmacy.

Existing law, the Pharmacy Law, provides for the licensure andregulation of pharmacies, including hospital pharmacies, by theCalifornia State Board of Pharmacy. Existing law prohibits the operationof a pharmacy without a license and a separate license is required foreach pharmacy location. Under existing law, a hospital pharmacy, asdefined, includes a pharmacy located outside of the hospital in anotherphysical plant. However, as a condition of licensure by the board forthese pharmacies, pharmaceutical services may only be provided toregistered hospital patients who are on the premises of the same physicalplant in which the pharmacy is located and those services must bedirectly related to the services or treatment plan administered in thephysical plant. Existing law imposes various requirements onmanufacturers, as defined, and states that a manufacturer does notmean a pharmacy compounding a drug for parenteral therapy, pursuantto a prescription, for delivery to another pharmacy for the purpose of

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delivering or administering the drug to the patient or patients, providedthat neither the components for the drug nor the drug are compounded,fabricated, packaged, or otherwise prepared prior to receipt of theprescription. A knowing violation of the Pharmacy Law is a crime.

This bill would authorize a centralized hospital packaging pharmacy,as defined, to prepare medications, by performing specified functions,for administration only to patients within its own general acute carehospital and one or more general other acute care hospitals if thehospitals are under common ownership, in California, and within a 100mile radius of the pharmacy. The bill would prohibit a person fromconducting a centralized hospital packaging pharmacy without aspecialty license from the board and would require applicants to applyannually to the board on forms developed by the board. The bill wouldcondition both the issuance and renewal of a specialty license on a boardinspection of the centralized hospital packaging pharmacy to ensurethat the pharmacy is in compliance with the bill’s provisions andregulations established by the board. The bill would impose specifiedissuance and annual renewal fees for a specialty license and becausethese fees would be deposited into the Pharmacy Board ContingentFund, a continuously appropriated fund, the bill would make anappropriation.

The bill would impose various requirements on centralized hospitalpackaging pharmacies, including, but not limited to, that drugs preparedin advance of receipt of a patient specific prescription shall meetspecified standards, that medications be barcoded to be readable at thepatient’s bedside, and that medication labels contain specifiedinformation. The bill would make these pharmacies and pharmacistsresponsible for the integrity, potency, quality, and labeled strength ofany unit dose drug product prepared by the packaging pharmacy.Because a knowing violation of these provisions would be a crime, thebill would impose a state-mandated local program.

The California Constitution requires the state to reimburse localagencies and school districts for certain costs mandated by the state.Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this actfor a specified reason.

This bill would provide that a hospital pharmacy also includes apharmacy, licensed by the board, that may be located in anotherphysical plant on the same premises or on a separate premises regulatedunder a hospital’s license. The bill would eliminate the conditions of

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licensure by the board that limit the services provided by the pharmacyin the other physical plant. The bill would also provide that a“manufacturer” does not mean a pharmacy compounding orrepackaging a drug for parenteral therapy or oral therapy in a hospitalfor delivery to another pharmacy or hospital in order to dispense oradminister the drug to the patient or patients pursuant to a prescriptionor order.

Vote: majority. Appropriation: yes no. Fiscal committee: yes.

State-mandated local program: yes no.

The people of the State of California do enact as follows:

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SECTION 1. The Legislature makes the following findings anddeclarations:

(a)  Hospitals have been encouraged to move toward the use ofautomation and bedside barcode checking to improve the safetyand efficiency of drug distribution and administration to patients.For many hospitals, the technology to enable them to achieve thispatient-safety goal is cost prohibitive.

(b)  Many drugs received from manufacturers are not in theproper unit dose for immediate administration to patients, and arenot barcoded. As a result, individual hospitals must locally prepareand package these drugs or contract with a packager, that is notlicensed by either the California State Board of Pharmacy ormanaged by a pharmacist-in-charge who is licensed by theCalifornia State Board of Pharmacy, to do so.

(c)  The Business and Professions Code definition of drug“manufacturer” allows one hospital pharmacy to compound andpackage medications for another hospital only for specific patients,without being licensed as a manufacturer. This restriction doesnot support the most current hospital drug distribution processes,nor does it accommodate innovations that will improve patientsafety.

(d)  The federal Food and Drug Administration (FDA) hasamended its position to allow hospitals under common controland operating within a state to consolidate resources at a singlelocation for timely, economic repackaging and distribution withgreater, more dedicated expertise, without becoming federallyregistered manufacturers for those products. This FDA action is

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in recognition that the compounding and repackaging activity isnot truly drug manufacturing.

(e)  A centralized pharmacy compounding and packagingoperations approach allows hospitals to take advantage ofhigh-speed automated equipment, economies of scale, spaceefficiencies, and more consistent standardized quality controlsystems. Likewise, a centralized licensed pharmacy approachallows for greater regulatory control via the pharmacist-in-chargeand greater assurance of safety by concentrating the professionalexpertise among a centralized management, staff, and qualityassurance program.

(f)  Centralization of the packaging operations as a licensedpharmacy under the license of a hospital, rather than as a“manufacturer,” assures the patient-safety oversight of theCalifornia State Board of Pharmacy and other hospital regulatoryand accreditation bodies, and adherence to the new strongerpharmacy compounding regulations.

SEC. 2. Section 4029 of the Business and Professions Code isamended to read:

4029. (a)  “Hospital pharmacy” means and includes a pharmacy,licensed by the board, located within any licensed hospital,institution, or establishment that maintains and operates organizedfacilities for the diagnosis, care, and treatment of human illnessesto which persons may be admitted for overnight stay and that meetsall of the requirements of this chapter and the rules and regulationsof the board.

(b)  A hospital pharmacy also includes a pharmacy, licensed bythe board, that may be located outside of the hospital, in anotherphysical plant on the same premises or on a separate premisesthat is regulated under a hospital’s consolidated license issuedpursuant to Section 1250.8 of the Health and Safety Code. As acondition of licensure by the board, the pharmacy in anotherphysical plant shall provide pharmaceutical services only toregistered hospital patients who are on the premises of the samephysical plant in which the pharmacy is located. The pharmacyservices provided shall be directly related to the services ortreatment plan administered in the physical plant. Nothing in thisparagraph subdivision shall be construed to restrict or expand theservices that a hospital pharmacy may provide.

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SEC. 3. Section 4033 of the Business and Professions Code isamended to read:

4033. (a)  (1)  “Manufacturer” means and includes every personwho prepares, derives, produces, compounds, or repackages anydrug or device except a pharmacy that manufactures on theimmediate premises where the drug or device is sold to the ultimateconsumer.

(2)  Notwithstanding paragraph (1), “manufacturer” shall notmean a pharmacy compounding and repackaging a drug forparenteral therapy, pursuant to a prescription, or oral therapy ina hospital for delivery to another pharmacy or hospital for thepurpose of delivering dispensing or administering the drug,pursuant to a prescription or order, to the patient or patients namedin the prescription, provided that neither the components for thedrug nor the drug are compounded, fabricated, packaged, orotherwise prepared prior to receipt of the prescription or order.

(3)  Notwithstanding paragraph (1), “manufacturer” shall notmean a pharmacy that, at a patient’s request, repackages a drugpreviously dispensed to the patient, or to the patient’s agent,pursuant to a prescription.

(b)  Notwithstanding subdivision (a), as used in Sections 4034,4163, 4163.1, 4163.2, 4163.3, 4163.4, and 4163.5, “manufacturer”means a person who prepares, derives, manufactures, produces,or repackages a dangerous drug, as defined in Section 4022, device,or cosmetic. Manufacturer also means the holder or holders of aNew Drug Application (NDA), an Abbreviated New DrugApplication (ANDA), or a Biologics License Application (BLA),provided that such application has been approved; a manufacturer’sthird party logistics provider; a private label distributor (includingcolicensed partners) for whom the private label distributor’sprescription drugs are originally manufactured and labeled for thedistributor and have not been repackaged; or the distributor agentfor the manufacturer, contract manufacturer, or private labeldistributor, whether the establishment is a member of themanufacturer’s affiliated group (regardless of whether the membertakes title to the drug) or is a contract distributor site.

SECTION 1. Section 4029 of the Business and ProfessionsCode is amended to read:

4029. (a)  “Hospital pharmacy” means and includes a pharmacy,licensed by the board, located within any licensed hospital,

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institution, or establishment that maintains and operates organizedfacilities for the diagnosis, care, and treatment of human illnessesto which persons may be admitted for overnight stay and that meetsall of the requirements of this chapter and the rules and regulationsof the board.

(b)  A hospital pharmacy also includes a pharmacy that may belocated outside of the hospital, in another physical plant that isregulated under a hospital’s consolidated license issued pursuantto Section 1250.8 of the Health and Safety Code. As a conditionof licensure by the board, the pharmacy in another physical plantshall provide pharmaceutical services only to registered hospitalpatients who are on the premises of the same physical plant inwhich the pharmacy is located, except as provided in Article 7.6(commencing with Section 4128). The pharmacy services providedshall be directly related to the services or treatment planadministered in the physical plant. Nothing in this subdivisionshall be construed to restrict or expand the services that a hospitalpharmacy may provide.

SEC. 2. Article 7.6 (commencing with Section 4128) is addedto Chapter 9 of Division 2 of the Business and Professions Code,to read:

Article 7.6. Centralized Hospital Packaging Pharmacies

4128. (a)  Notwithstanding Section 4029, a centralized hospitalpackaging pharmacy may prepare medications, by performing thefollowing specialized functions, for administration only to patientswithin its own general acute care hospital and one or more othergeneral acute care hospitals if the hospitals are (1) under commonownership, (2) in California, and (3) located within a 100 mileradius of the centralized hospital packaging pharmacy.

(1)  Preparing unit dose packages for single administration topatients from bulk containers, if each unit dose package is barcodedto contain at least the information required by Section 4128.4.

(2)  Preparing compounded unit dose drugs for parenteral therapyfor administration to patients, if each compounded unit dose drugis barcoded to contain at least the information required by Section4128.4.

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(3)  Preparing compounded unit dose drugs for administrationto patients, if each unit dose package is barcoded to contain at leastthe information required by Section 4128.4.

(b)  For the purposes of this article, a “centralized hospitalpackaging pharmacy” means a licensed hospital pharmacy locatedwithin a general acute care hospital, as defined in subdivision (a)of Section 1250 of the Health and Safety Code.

4128.1. (a)  No person shall conduct a centralized hospitalpackaging pharmacy unless it has obtained a specialty license fromthe board.

(b)  A licensed hospital pharmacy serving only its own patientsshall not be required to obtain a specialty license as described insubdivision (a).

4128.2. (a)  In addition to the pharmacy license requirementdescribed in Section 4110, a centralized hospital packagingpharmacy shall obtain a specialty license from the board prior toengaging in the functions described in Section 4128.

(b)  An applicant seeking a specialty license pursuant to thisarticle shall apply to the board on forms established by the board.

(c)  Before issuing the specialty license, the board shall inspectthe pharmacy and ensure that the pharmacy is in compliance withthis article and regulations established by the board.

(d)  A license to perform the functions described in Section 4128may only be issued to a pharmacy that is licensed by the board asa hospital pharmacy.

(e)  A license issued pursuant to this article shall be renewedannually and is not transferrable.

(f)  An applicant seeking renewal of a specialty license shallapply to the board on forms established by the board.

(g)  A license to perform the functions described in Section 4128shall not be renewed until the pharmacy has been inspected by theboard and found to be in compliance with this article andregulations established by the board.

(h)  The fee for issuance or annual renewal of a centralizedhospital packaging pharmacy license shall be six hundred dollars($600) and may be increased by the board to eight hundred dollars($800).

4128.3. A centralized hospital packaging pharmacy may prepareand store a limited quantity of the unit dose drugs authorized bySection 4128 in advance of receipt of a patient specific prescription

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in a quantity as is necessary to ensure continuity of care for anidentified population of patients of the general acute care hospitalbased on a documented history of prescriptions for that patientpopulation. The expiration date for these drugs shall meetestablished compendium standards as stated in the United StatesPharmacopiea and other widely accepted references.

4128.4. Any unit dose medication produced by a centralizedhospital packaging pharmacy shall be barcoded to be readable atthe patient’s bedside. The bar code shall contain at least thefollowing information:

(a)  Expiration date.(b)  Lot number or control number.(c)  National Drug Code Directory number.4128.5. The label for each unit dose medication produced by

a centralized hospital packaging pharmacy shall contain all of thefollowing information:

(a)  Expiration date.(b)  Established name of the drug.(c)  Quantity of the active ingredient.(d)  Special storage or handling requirements.(e)  Name of the packaging pharmacy.4128.6. All compounding and packaging functions specified

in Section 4128 shall be performed only in the licensed centralizedhospital packaging pharmacy and that pharmacy shall comply withall applicable regulations, including, but not limited to, regulationsregarding compounding and when appropriate, sterile injectablecompounding.

4128.7. A centralized hospital packaging pharmacy and thepharmacists working in the pharmacy shall be responsible for theintegrity, potency, quality, and labeled strength of any unit dosedrug product prepared by the centralized hospital packagingpharmacy.

SEC. 3. No reimbursement is required by this act pursuant toSection 6 of Article XIIIB of the California Constitution becausethe only costs that may be incurred by a local agency or schooldistrict will be incurred because this act creates a new crime orinfraction, eliminates a crime or infraction, or changes the penaltyfor a crime or infraction, within the meaning of Section 17556 ofthe Government Code, or changes the definition of a crime within

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the meaning of Section 6 of Article XIII B of the CaliforniaConstitution.

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AMENDED IN ASSEMBLY APRIL 8, 2010

california legislature—2009–10 regular session

ASSEMBLY BILL No. 1916

Introduced by Assembly Member Davis

February 16, 2010

An act to relating to pharmacy. An act to add Section 4126.7 to theBusiness and Professions Code, relating to pharmacies.

legislative counsel’s digest

AB 1916, as amended, Davis. Pharmacies: prescriptions: reports.Existing law, the Pharmacy Law, provides for the licensure and

regulation of pharmacies by the California State Board of Pharmacy.Existing law requires any pharmacy that contracts to compound a drugfor parenteral therapy for delivery to another pharmacy to report thatcontractual arrangement to the board. Existing law authorizes apharmacy to furnish dangerous drugs only to, among others, a patientor another pharmacy pursuant to a prescription or as otherwiseauthorized by law. Existing law requires every pharmacy to establisha quality assurance program to assess errors in dispensing or furnishingprescription drugs. A knowing violation of the Pharmacy Law is a crimeunless otherwise specified.

This bill would declare the intent of the Legislature to require apharmacy to report to the board when a patient is given a prescriptionthat belongs to another person.

This bill would require a pharmacy to report to the board anyoccurrence known by the pharmacy of a prescription being furnishedto a person other than the patient named on the prescription or thatpatient’s representative. The bill would also require the pharmacy toreport any adverse reaction that may have occurred as a result of the

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person to whom the prescription was furnished using the prescribeddrug. Because a knowing violation of these requirements would be acrime, the bill would impose a state-mandated local program.

The California Constitution requires the state to reimburse localagencies and school districts for certain costs mandated by the state.Statutory provisions establish procedures for making thatreimbursement.

This bill would provide that no reimbursement is required by this actfor a specified reason.

Vote: majority. Appropriation: no. Fiscal committee: no yes.State-mandated local program: no.

The people of the State of California do enact as follows:

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SECTION 1. Section 4126.7 is added to the Business andProfessions Code, to read:

4126.7. A pharmacy shall promptly report to the board anyoccurrence known by the pharmacy of a prescription beingfurnished to a person other than the patient named on theprescription or that patient’s representative. That report shallinclude any adverse reaction that may have occurred as a resultof the person to whom the prescription was furnished using theprescribed drug.

SEC. 2. No reimbursement is required by this act pursuant toSection 6 of Article XIII B of the California Constitution becausethe only costs that may be incurred by a local agency or schooldistrict will be incurred because this act creates a new crime orinfraction, eliminates a crime or infraction, or changes the penaltyfor a crime or infraction, within the meaning of Section 17556 ofthe Government Code, or changes the definition of a crime withinthe meaning of Section 6 of Article XIII B of the CaliforniaConstitution.

SECTION 1. It is the intent of the Legislature to enactlegislation requiring a pharmacy to report to the California StateBoard of Pharmacy when a patient is given a prescription thatbelongs to another person, in order to determine how to possiblydecrease the number of mix-ups and thereby save lives.

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california legislature—2009–10 regular session

ASSEMBLY BILL No. 2130

Introduced by Assembly Member Huber

February 18, 2010

An act to amend Sections 22, 101.1, 1917.2, 2001, 2450.3, 2460,2531, 2569, 2570.19, 2602, 2607.5, 2701, 2841, 3010.5, 3502.1, 3504,3685, 3710, 4001, 4615, 4800, 4809.8, 4989, 4990.24, 5000, 5510,5810, 6510, 6710, 7304, 7501, 8710, 9882, 11506, and 22259 of, toamend and repeal Section 1601.1 of, to add Sections 7200.2, 7611, and9815 to, and to repeal Division 1.2 (commencing with Section 473) of,the Business and Professions Code, and to amend Sections 9148.51 and9148.52 of the Government Code, relating to professions and vocations.

legislative counsel’s digest

AB 2130, as introduced, Huber. Professions and vocations: sunsetreview.

Existing law establishes the Joint Committee on Boards, Commissions,and Consumer Protection and, until January 1, 2012, requires thecommittee to hold public hearings at specified times and to evaluatewhether a board or regulatory program has demonstrated a need for itscontinued existence. Existing law states the intent of the Legislaturethat all existing and proposed state boards be subject to review every4 years to evaluate and determine whether each has demonstrated apublic need for its continued existence, as specified.

This bill would abolish the Joint Committee on Boards, Commissions,and Consumer Protection. The bill would instead make specified boardsand regulatory programs subject to review by the Joint Sunset ReviewCommittee. The bill would provide that its provisions would not become

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operative unless Assembly Bill 1659 is enacted and establishes the JointSunset Review Committee.

Vote: majority. Appropriation: no. Fiscal committee: yes.

State-mandated local program: no.

The people of the State of California do enact as follows:

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SECTION 1. Section 22 of the Business and Professions Codeis amended to read:

22. (a)  “Board,” as used in any provision of this code, refersto the board in which the administration of the provision is vested,and unless otherwise expressly provided, shall include “bureau,”“commission,” “committee,” “department,” “division,” “examiningcommittee,” “program,” and “agency.”

(b)  Whenever the regulatory program of a board that is subjectto review by the Joint Sunset Review Committee on Boards,Commissions, and Consumer Protection, as provided for inDivision 1.2 (commencing with Section 473) Article 7.5(commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code, is taken over by thedepartment, that program shall be designated as a “bureau.”

SEC. 2. Section 101.1 of the Business and Professions Codeis amended to read:

101.1. (a)  It is the intent of the Legislature that all existingand proposed consumer-related boards or categories of licensedprofessionals be subject to a review every four years to evaluateand determine whether each board has demonstrated a public needfor the continued existence of that board in accordance withenumerated factors and standards as set forth in Division 1.2(commencing with Section 473) Article 7.5 (commencing withSection 9147.7) of Chapter 1.5 of Part 1 of Division 2 of Title 2of the Government Code.

(b)  (1)  In the event that If any board, as defined in Section 47722, becomes inoperative or is repealed in accordance with the actthat added this section, or by subsequent acts, the Department ofConsumer Affairs shall succeed to and is vested with all the duties,powers, purposes, responsibilities and jurisdiction not otherwiserepealed or made inoperative of that board and its executive officer.

(2)  Any provision of existing law that provides for theappointment of board members and specifies the qualifications

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and tenure of board members shall not be implemented and shallhave no force or effect while that board is inoperative or repealed.Every reference to the inoperative or repealed board, as definedin Section 477 22, shall be deemed to be a reference to thedepartment.

(3)  Notwithstanding Section 107, any provision of lawauthorizing the appointment of an executive officer by a boardsubject to the review described in Division 1.2 (commencing withSection 473) Article 7.5 (commencing with Section 9147.7) ofChapter 1.5 of Part 1 of Division 2 of Title 2 of the GovernmentCode, or prescribing his or her duties, shall not be implementedand shall have no force or effect while the applicable board isinoperative or repealed. Any reference to the executive officer ofan inoperative or repealed board shall be deemed to be a referenceto the director or his or her designee.

(c)  It is the intent of the Legislature that subsequent legislationto extend or repeal the inoperative date for any board shall be aseparate bill for that purpose.

SEC. 3. Division 1.2 (commencing with Section 473) of theBusiness and Professions Code is repealed.

SEC. 4. Section 1601.1 of the Business and Professions Code,as added by Section 1 of Chapter 35 of the Statutes of 2008, isamended to read:

1601.1. (a)  There shall be in the Department of ConsumerAffairs the Dental Board of California in which the administrationof this chapter is vested. The board shall consist of eight practicingdentists, one registered dental hygienist, one registered dentalassistant, and four public members. Of the eight practicing dentists,one shall be a member of a faculty of any California dental college,and one shall be a dentist practicing in a nonprofit communityclinic. The appointing powers, described in Section 1603, mayappoint to the board a person who was a member of the prior board.The board shall be organized into standing committees dealingwith examinations, enforcement, and other subjects as the boarddeems appropriate.

(b)  For purposes of this chapter, any reference in this chapterto the Board of Dental Examiners shall be deemed to refer to theDental Board of California.

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(c)  The board shall have all authority previously vested in theexisting board under this chapter. The board may enforce alldisciplinary actions undertaken by the previous board.

(d)  This section shall remain in effect only until January 1, 2012,and as of that date is repealed, unless a later enacted statute, thatis enacted before January 1, 2012, deletes or extends that date. Therepeal of this section renders the board subject to the reviewrequired by Division 1.2 (commencing with Section 473) Article7.5 (commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code.

SEC. 5. Section 1601.1 of the Business and Professions Code,as added by Section 3 of Chapter 31 of the Statutes of 2008, isrepealed.

1601.1. (a)  There shall be in the Department of ConsumerAffairs the Dental Board of California in which the administrationof this chapter is vested. The board shall consist of eight practicingdentists, one registered dental hygienist, one registered dentalassistant, and four public members. Of the eight practicing dentists,one shall be a member of a faculty of any California dental collegeand one shall be a dentist practicing in a nonprofit communityclinic. The appointing powers, described in Section 1603, mayappoint to the board a person who was a member of the prior board.The board shall be organized into standing committees dealingwith examinations, enforcement, and other subjects as the boarddeems appropriate.

(b)  For purposes of this chapter, any reference in this chapterto the Board of Dental Examiners shall be deemed to refer to theDental Board of California.

(c)  The board shall have all authority previously vested in theexisting board under this chapter. The board may enforce alldisciplinary actions undertaken by the previous board.

(d)  This section shall remain in effect only until January 1, 2012,and as of that date, is repealed, unless a later enacted statute thatis enacted before January 1, 2012, deletes or extends that date. Therepeal of this section renders the board subject to the reviewrequired by Division 1.2 (commencing with Section 473).

SEC. 6. Section 1917.2 of the Business and Professions Codeis amended to read:

1917.2. (a)  The committee shall license as a registered dentalhygienist a third- or fourth-year dental student who is in good

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standing at an accredited California dental school and who satisfiesthe following requirements:

(1)  Satisfactorily performs on a clinical examination and anexamination in California law and ethics as prescribed by thecommittee.

(2)  Satisfactorily completes a national written dental hygieneexamination approved by the committee.

(b)  A dental student who is granted a registered dental hygienistlicense pursuant to this section may only practice in a dentalpractice that serves patients who are insured under Denti-Cal, theHealthy Families Program, or other government programs, or adental practice that has a sliding scale fee system based on income.

(c)  Upon receipt of a license to practice dentistry pursuant toSection 1634, a registered dental hygienist license issued pursuantto this subdivision section is automatically revoked.

(d)  The dental hygienist license is granted for two years uponpassage of the dental hygiene examination, without the ability forrenewal.

(e)  Notwithstanding subdivision (d), if a dental student fails toremain in good standing at an accredited California dental school,or fails to graduate from the dental program, a registered dentalhygienist license issued pursuant to this section shall be revoked.The student shall be responsible for submitting appropriateverifying documentation to the committee.

(f)  The provisions of this section shall be reviewed pursuant toDivision 1.2 (commencing with Section 473) Article 7.5(commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code. However, the reviewshall be limited to the fiscal feasibility and impact on thecommittee.

(g)  This section shall become inoperative as of on January 1,2012.

SEC. 7. Section 2001 of the Business and Professions Code isamended to read:

2001. (a)  There is in the Department of Consumer Affairs aMedical Board of California that consists of 15 members, sevenof whom shall be public members.

(b)  The Governor shall appoint 13 members to the board, subjectto confirmation by the Senate, five of whom shall be public

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members. The Senate Committee on Rules and the Speaker of theAssembly shall each appoint a public member.

(c)  Notwithstanding any other provision of law, to reduce themembership of the board to 15, the following shall occur:

(1)  Two positions on the board that are public members havinga term that expires on June 1, 2010, shall terminate instead onJanuary 1, 2008.

(2)  Two positions on the board that are not public membershaving a term that expires on June 1, 2008, shall terminate insteadon August 1, 2008.

(3)  Two positions on the board that are not public membershaving a term that expires on June 1, 2011, shall terminate insteadon January 1, 2008.

(d)  This section shall remain in effect only until January 1, 2013,and as of that date is repealed, unless a later enacted statute, thatis enacted before January 1, 2013, deletes or extends that date. Therepeal of this section renders the board subject to the reviewrequired by Division 1.2 (commencing with Section 473) Article7.5 (commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code.

SEC. 8. Section 2450.3 of the Business and Professions Codeis amended to read:

2450.3. There is within the jurisdiction of the OsteopathicMedical Board of California a Naturopathic Medicine Committeeauthorized under the Naturopathic Doctors Act (Chapter 8.2(commencing with Section 3610)). This section shall becomeinoperative on January 1, 2013, and, as of that date is repealed,unless a later enacted statute that is enacted before January 1, 2013,deletes or extends that date. The repeal of this section renders theNaturopathic Medicine Committee subject to the review requiredby Division 1.2 (commencing with Section 473) Article 7.5(commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code.

SEC. 9. Section 2460 of the Business and Professions Code isamended to read:

2460. (a)  There is created within the jurisdiction of the MedicalBoard of California the California Board of Podiatric Medicine.

(b)  This section shall remain in effect only until January 1, 2013,and as of that date is repealed, unless a later enacted statute, thatis enacted before January 1, 2013, deletes or extends that date. The

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repeal of this section renders the California Board of PodiatricMedicine subject to the review required by Division 1.2(commencing with Section 473) Article 7.5 (commencing withSection 9147.7) of Chapter 1.5 of Part 1 of Division 2 of Title 2of the Government Code.

SEC. 10. Section 2531 of the Business and Professions Codeis amended to read:

2531. (a)  There is in the Department of Consumer Affairs aSpeech-Language Pathology and Audiology and Hearing AidDispensers Board in which the enforcement and administration ofthis chapter are vested. The Speech-Language Pathology andAudiology and Hearing Aid Dispensers Board shall consist of ninemembers, three of whom shall be public members.

(b)  This section shall remain in effect only until January 1, 2012,and as of that date is repealed, unless a later enacted statute, thatis enacted before January 1, 2012, deletes or extends that date. Therepeal of this section renders the board subject to the reviewrequired by Division 1.2 (commencing with Section 473) Article7.5 (commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code.

SEC. 11. Section 2569 of the Business and Professions Codeis amended to read:

2569. The powers and duties of the board, as set forth in thischapter, shall be subject to the review required by Division 1.2(commencing with Section 473) Article 7.5 (commencing withSection 9147.7) of Chapter 1.5 of Part 1 of Division 2 of Title 2of the Government Code. The review shall be performed as if thischapter were scheduled to become inoperative on July 1, 2003,and would be repealed as of January 1, 2004, as described inSection 473.1.

SEC. 12. Section 2570.19 of the Business and ProfessionsCode is amended to read:

2570.19. (a)  There is hereby created a California Board ofOccupational Therapy, hereafter referred to as the board. The boardshall enforce and administer this chapter.

(b)  The members of the board shall consist of the following:(1)  Three occupational therapists who shall have practiced

occupational therapy for five years.(2)  One occupational therapy assistant who shall have assisted

in the practice of occupational therapy for five years.

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(3)  Three public members who shall not be licentiates of theboard or of any board referred to in Section 1000 or 3600.

(c)  The Governor shall appoint the three occupational therapistsand one occupational therapy assistant to be members of the board.The Governor, the Senate Rules Committee, and the Speaker ofthe Assembly shall each appoint a public member. Not more thanone member of the board shall be appointed from the full-timefaculty of any university, college, or other educational institution.

(d)  All members shall be residents of California at the time oftheir appointment. The occupational therapist and occupationaltherapy assistant members shall have been engaged in renderingoccupational therapy services to the public, teaching, or researchin occupational therapy for at least five years preceding theirappointments.

(e)  The public members may not be or have ever beenoccupational therapists or occupational therapy assistants or intraining to become occupational therapists or occupational therapyassistants. The public members may not be related to, or have ahousehold member who is, an occupational therapist or anoccupational therapy assistant, and may not have had, within twoyears of the appointment, a substantial financial interest in a personregulated by the board.

(f)  The Governor shall appoint two board members for a termof one year, two board members for a term of two years, and oneboard member for a term of three years. Appointments madethereafter shall be for four-year terms, but no person shall beappointed to serve more than two consecutive terms. Terms shallbegin on the first day of the calendar year and end on the last dayof the calendar year or until successors are appointed, except forthe first appointed members who shall serve through the lastcalendar day of the year in which they are appointed, beforecommencing the terms prescribed by this section. Vacancies shallbe filled by appointment for the unexpired term. The board shallannually elect one of its members as president.

(g)  The board shall meet and hold at least one regular meetingannually in the Cities of Sacramento, Los Angeles, and SanFrancisco. The board may convene from time to time until itsbusiness is concluded. Special meetings of the board may be heldat any time and place designated by the board.

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(h)  Notice of each meeting of the board shall be given inaccordance with the Bagley-Keene Open Meeting Act (Article 9(commencing with Section 11120) of Chapter 1 of Part 1 ofDivision 3 of Title 2 of the Government Code).

(i)  Members of the board shall receive no compensation fortheir services, but shall be entitled to reasonable travel and otherexpenses incurred in the execution of their powers and duties inaccordance with Section 103.

(j)  The appointing power shall have the power to remove anymember of the board from office for neglect of any duty imposedby state law, for incompetency, or for unprofessional ordishonorable conduct.

(k)  A loan is hereby authorized from the General Fund to theOccupational Therapy Fund on or after July 1, 2000, in an amountof up to one million dollars ($1,000,000) to fund operating,personnel, and other startup costs of the board. Six hundred tenthousand dollars ($610,000) of this loan amount is herebyappropriated to the board to use in the 2000–01 fiscal year for thepurposes described in this subdivision. In subsequent years, fundsfrom the Occupational Therapy Fund shall be available to the boardupon appropriation by the Legislature in the annual Budget Act.The loan shall be repaid to the General Fund over a period of upto five years, and the amount paid shall also include interest at therate accruing to moneys in the Pooled Money Investment Account.The loan amount and repayment period shall be minimized to theextent possible based upon actual board financing requirementsas determined by the Department of Finance.

(l)  This section shall become inoperative on July 1, 2013, and,as of January 1, 2014, is repealed, unless a later enacted statutethat is enacted before January 1, 2014, deletes or extends the dateson which it becomes inoperative and is repealed. The repeal ofthis section renders the board subject to the review required byDivision 1.2 (commencing with Section 473) Article 7.5(commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code.

SEC. 13. Section 2602 of the Business and Professions Codeis amended to read:

2602. The Physical Therapy Board of California, hereafterreferred to as the board, shall enforce and administer this chapter.This section shall become inoperative on July 1, 2013, and, as of

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January 1, 2014, is repealed, unless a later enacted statute, whichbecomes effective on or before January 1, 2014, deletes or extendsthe dates on which it becomes inoperative and is repealed.

The repeal of this section renders the board subject to the reviewrequired by Division 1.2 (commencing with Section 473) Article7.5 (commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code.

SEC. 14. Section 2607.5 of the Business and Professions Codeis amended to read:

2607.5. The board may appoint a person exempt from civilservice who shall be designated as an executive officer and whoshall exercise the powers and perform the duties delegated by theboard and vested in him or her by this chapter.

This section shall become inoperative on July 1, 2013, and, asof January 1, 2014, is repealed, unless a later enacted statute, whichbecomes effective on or before January 1, 2014, deletes or extendsthe dates on which it becomes inoperative and is repealed.

The repeal of this section renders the board subject to the reviewrequired by Division 1.2 (commencing with Section 473).

SEC. 15. Section 2701 of the Business and Professions Codeis amended to read:

2701. (a)  There is in the Department of Consumer Affairs theBoard of Registered Nursing consisting of nine members.

(b)  Within the meaning of this chapter, board, or the board,refers to the Board of Registered Nursing. Any reference in statelaw to the Board of Nurse Examiners of the State of California orCalifornia Board of Nursing Education and Nurse Registrationshall be construed to refer to the Board of Registered Nursing.

(c)  This section shall remain in effect only until January 1, 2013,and as of that date is repealed, unless a later enacted statute, thatis enacted before January 1, 2013, deletes or extends that date. Therepeal of this section renders the board subject to the reviewrequired by Division 1.2 (commencing with Section 473) Article7.5 (commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code.

SEC. 16. Section 2841 of the Business and Professions Codeis amended to read:

2841. (a)  There is in the Department of Consumer Affairs aBoard of Vocational Nursing and Psychiatric Technicians of theState of California, consisting of 11 members.

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(b)  Within the meaning of this chapter, “board,” or “the board,”refers to the Board of Vocational Nursing and PsychiatricTechnicians of the State of California.

(c)  This section shall remain in effect only until January 1, 2012,and as of that date is repealed, unless a later enacted statute, thatis enacted before January 1, 2012, deletes or extends that date. Therepeal of this section renders the board subject to the reviewrequired by Division 1.2 (commencing with Section 473) Article7.5 (commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code.

SEC. 17. Section 3010.5 of the Business and Professions Codeis amended to read:

3010.5. (a)  There is in the Department of Consumer Affairsa State Board of Optometry in which the enforcement of thischapter is vested. The board consists of 11 members, five of whomshall be public members.

Six members of the board shall constitute a quorum.(b)  The board shall, with respect to conducting investigations,

inquiries, and disciplinary actions and proceedings, have theauthority previously vested in the board as created pursuant toSection 3010. The board may enforce any disciplinary actionsundertaken by that board.

(c)  This section shall remain in effect only until January 1, 2013,and as of that date is repealed, unless a later enacted statute, thatis enacted before January 1, 2013, deletes or extends that date. Therepeal of this section renders the board subject to the reviewrequired by Division 1.2 (commencing with Section 473) Article7.5 (commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code.

SEC. 18. Section 3502.1 of the Business and Professions Codeis amended to read:

3502.1. (a)  In addition to the services authorized in theregulations adopted by the board, and except as prohibited bySection 3502, while under the supervision of a licensed physicianand surgeon or physicians and surgeons authorized by law tosupervise a physician assistant, a physician assistant mayadminister or provide medication to a patient, or transmit orally,or in writing on a patient’s record or in a drug order, an order to aperson who may lawfully furnish the medication or medical devicepursuant to subdivisions (c) and (d).

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(1)  A supervising physician and surgeon who delegates authorityto issue a drug order to a physician assistant may limit this authorityby specifying the manner in which the physician assistant mayissue delegated prescriptions.

(2)  Each supervising physician and surgeon who delegates theauthority to issue a drug order to a physician assistant shall firstprepare and adopt, or adopt, a written, practice specific, formularyand protocols that specify all criteria for the use of a particulardrug or device, and any contraindications for the selection.Protocols for Schedule II controlled substances shall address thediagnosis of illness, injury, or condition for which the Schedule IIcontrolled substance is being administered, provided, or issued.The drugs listed in the protocols shall constitute the formulary andshall include only drugs that are appropriate for use in the type ofpractice engaged in by the supervising physician and surgeon.When issuing a drug order, the physician assistant is acting onbehalf of and as an agent for a supervising physician and surgeon.

(b)  “Drug order” for purposes of this section means an orderfor medication that is dispensed to or for a patient, issued andsigned by a physician assistant acting as an individual practitionerwithin the meaning of Section 1306.02 of Title 21 of the Code ofFederal Regulations. Notwithstanding any other provision of law,(1) a drug order issued pursuant to this section shall be treated inthe same manner as a prescription or order of the supervisingphysician, (2) all references to “prescription” in this code and theHealth and Safety Code shall include drug orders issued byphysician assistants pursuant to authority granted by theirsupervising physicians and surgeons, and (3) the signature of aphysician assistant on a drug order shall be deemed to be thesignature of a prescriber for purposes of this code and the Healthand Safety Code.

(c)  A drug order for any patient cared for by the physicianassistant that is issued by the physician assistant shall either bebased on the protocols described in subdivision (a) or shall beapproved by the supervising physician and surgeon before it isfilled or carried out.

(1)  A physician assistant shall not administer or provide a drugor issue a drug order for a drug other than for a drug listed in theformulary without advance approval from a supervising physicianand surgeon for the particular patient. At the direction and under

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the supervision of a physician and surgeon, a physician assistantmay hand to a patient of the supervising physician and surgeon aproperly labeled prescription drug prepackaged by a physician andsurgeon, manufacturer as defined in the Pharmacy Law, or apharmacist.

(2)  A physician assistant may not administer, provide, or issuea drug order to a patient for Schedule II through Schedule Vcontrolled substances without advance approval by a supervisingphysician and surgeon for that particular patient unless thephysician assistant has completed an education course that coverscontrolled substances and that meets standards, includingpharmacological content, approved by the committee. Theeducation course shall be provided either by an accreditedcontinuing education provider or by an approved physician assistanttraining program. If the physician assistant will administer, provide,or issue a drug order for Schedule II controlled substances, thecourse shall contain a minimum of three hours exclusively onSchedule II controlled substances. Completion of the requirementsset forth in this paragraph shall be verified and documented in themanner established by the committee prior to the physicianassistant’s use of a registration number issued by the United StatesDrug Enforcement Administration to the physician assistant toadminister, provide, or issue a drug order to a patient for acontrolled substance without advance approval by a supervisingphysician and surgeon for that particular patient.

(3)  Any drug order issued by a physician assistant shall besubject to a reasonable quantitative limitation consistent withcustomary medical practice in the supervising physician andsurgeon’s practice.

(d)  A written drug order issued pursuant to subdivision (a),except a written drug order in a patient’s medical record in a healthfacility or medical practice, shall contain the printed name, address,and phone number of the supervising physician and surgeon, theprinted or stamped name and license number of the physicianassistant, and the signature of the physician assistant. Further, awritten drug order for a controlled substance, except a written drugorder in a patient’s medical record in a health facility or a medicalpractice, shall include the federal controlled substances registrationnumber of the physician assistant and shall otherwise comply withthe provisions of Section 11162.1 of the Health and Safety Code.

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Except as otherwise required for written drug orders for controlledsubstances under Section 11162.1 of the Health and Safety Code,the requirements of this subdivision may be met through stampingor otherwise imprinting on the supervising physician and surgeon’sprescription blank to show the name, license number, and ifapplicable, the federal controlled substances number of thephysician assistant, and shall be signed by the physician assistant.When using a drug order, the physician assistant is acting on behalfof and as the agent of a supervising physician and surgeon.

(e)  The medical record of any patient cared for by a physicianassistant for whom the physician assistant’s Schedule II drug orderhas been issued or carried out shall be reviewed and countersignedand dated by a supervising physician and surgeon within sevendays.

(f)  All physician assistants who are authorized by theirsupervising physicians to issue drug orders for controlledsubstances shall register with the United States Drug EnforcementAdministration (DEA).

(g)  The committee shall consult with the Medical Board ofCalifornia and report during its sunset review required by Division1.2 (commencing with Section 473) Article 7.5 (commencing withSection 9147.7) of Chapter 1.5 of Part 1 of Division 2 of Title 2of the Government Code the impacts of exempting Schedule IIIand Schedule IV drug orders from the requirement for a physicianand surgeon to review and countersign the affected medical recordof a patient.

SEC. 19. Section 3504 of the Business and Professions Codeis amended to read:

3504. There is established a Physician Assistant Committeeof the Medical Board of California. The committee consists ofnine members. This section shall become inoperative on July 1,2011, and, as of January 1, 2012, is repealed, unless a later enactedstatute, which becomes effective on or before January 1, 2012,deletes or extends the dates on which it becomes inoperative andis repealed. The repeal of this section renders the committee subjectto the review required by Division 1.2 (commencing with Section473) Article 7.5 (commencing with Section 9147.7) of Chapter 1.5of Part 1 of Division 2 of Title 2 of the Government Code.

SEC. 20. Section 3685 of the Business and Professions Codeis amended to read:

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3685. (a)  The repeal of this chapter renders the committeesubject to the review required by Division 1.2 (commencing withSection 473) Article 7.5 (commencing with Section 9147.7) ofChapter 1.5 of Part 1 of Division 2 of Title 2 of the GovernmentCode.

(b)  The committee shall prepare the report required by Section473.2 no later than September 1, 2010.

SEC. 21. Section 3710 of the Business and Professions Codeis amended to read:

3710. (a)  The Respiratory Care Board of California, hereafterreferred to as the board, shall enforce and administer this chapter.

(b)  This section shall remain in effect only until January 1, 2013,and as of that date is repealed, unless a later enacted statute, thatis enacted before January 1, 2013, deletes or extends that date. Therepeal of this section renders the board subject to the reviewrequired by Division 1.2 (commencing with Section 473) Article7.5 (commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code.

SEC. 22. Section 4001 of the Business and Professions Codeis amended to read:

4001. (a)  There is in the Department of Consumer Affairs aCalifornia State Board of Pharmacy in which the administrationand enforcement of this chapter is vested. The board consists of13 members.

(b)  The Governor shall appoint seven competent pharmacistswho reside in different parts of the state to serve as members ofthe board. The Governor shall appoint four public members, andthe Senate Committee on Rules and the Speaker of the Assemblyshall each appoint a public member who shall not be a licensee ofthe board, any other board under this division, or any board referredto in Section 1000 or 3600.

(c)  At least five of the seven pharmacist appointees to the boardshall be pharmacists who are actively engaged in the practice ofpharmacy. Additionally, the membership of the board shall includeat least one pharmacist representative from each of the followingpractice settings: an acute care hospital, an independent communitypharmacy, a chain community pharmacy, and a long-term healthcare or skilled nursing facility. The pharmacist appointees shallalso include a pharmacist who is a member of a labor union thatrepresents pharmacists. For the purposes of this subdivision, a

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“chain community pharmacy” means a chain of 75 or more storesin California under the same ownership, and an “independentcommunity pharmacy” means a pharmacy owned by a person orentity who owns no more than four pharmacies in California.

(d)  Members of the board shall be appointed for a term of fouryears. No person shall serve as a member of the board for morethan two consecutive terms. Each member shall hold office untilthe appointment and qualification of his or her successor or untilone year shall have elapsed since the expiration of the term forwhich the member was appointed, whichever first occurs.Vacancies occurring shall be filled by appointment for theunexpired term.

(e)  Each member of the board shall receive a per diem andexpenses as provided in Section 103.

(f)  In accordance with Sections 101.1 and 473.1, this Thissection shall remain in effect only until January 1, 2013, and as ofthat date is repealed, unless a later enacted statute, that is enactedbefore January 1, 2013, deletes or extends that date. The repeal ofthis section renders the board subject to the review required byDivision 1.2 (commencing with Section 473) Article 7.5(commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code.

SEC. 23. Section 4615 of the Business and Professions Codeis amended to read:

4615. This chapter shall be subject to the review required byDivision 1.2 (commencing with Section 473) Article 7.5(commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code.

SEC. 24. Section 4800 of the Business and Professions Codeis amended to read:

4800. There is in the Department of Consumer Affairs aVeterinary Medical Board in which the administration of thischapter is vested. The board consists of seven members, three ofwhom shall be public members.

This section shall become inoperative on July 1, 2011, and, asof January 1, 2012, is repealed, unless a later enacted statute, whichbecomes effective on or before January 1, 2012, deletes or extendsthe dates on which it becomes inoperative and is repealed.

The repeal of this section renders the board subject to the reviewprovided for by Division 1.2 (commencing with Section 473)

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Article 7.5 (commencing with Section 9147.7) of Chapter 1.5 ofPart 1 of Division 2 of Title 2 of the Government Code.

SEC. 25. Section 4809.8 of the Business and Professions Codeis amended to read:

4809.8. (a)  The board shall appoint a voluntary, advisorymultidisciplinary committee to assist, advise, and makerecommendations for the implementation of rules and regulationsnecessary to ensure proper administration and enforcement of thischapter. Members of the committee shall be appointed from listsof nominees solicited by the board. The committee shall consistof no more than nine members.

(b)  The committee shall be subject to the requirements of Article9 (commencing with Section 11120) of Chapter 1 of Part 1 ofDivision 3 of Title 2 of the Government Code.

(c)  Committee members shall receive a per diem as providedin Section 103 and shall be compensated for their actual travelexpenses in accordance with the rules and regulations adopted bythe Department of Personnel Administration.

(d)  This section shall become inoperative on July 1, 2011, andas of January 1, 2012, is repealed, unless a later enacted statute,that becomes operative on or before January 1, 2012, deletes orextends the dates on which it becomes inoperative and is repealed.The repeal of this section renders the committee subject to thereview required by Division 1.2 (commencing with Section 473)Article 7.5 (commencing with Section 9147.7) of Chapter 1.5 ofPart 1 of Division 2 of Title 2 of the Government Code.

SEC. 26. Section 4989 of the Business and Professions Codeis amended to read:

4989. The powers and duties of the board, as set forth in thischapter, shall be subject to the review required by Division 1.2(commencing with Section 473). The review shall be performedas if this chapter were scheduled to become inoperative on July 1,2005, and would be repealed as of January 1, 2006, as describedin Section 473.1 Article 7.5 (commencing with Section 9147.7) ofChapter 1.5 of Part 1 of Division 2 of Title 2 of the GovernmentCode.

SEC. 27. Section 4990.24 of the Business and ProfessionsCode is amended to read:

4990.24. The powers and duties of the board, as set forth inthis chapter, shall be subject to the review required by Division

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1.2 (commencing with Section 473) Article 7.5 (commencing withSection 9147.7) of Chapter 1.5 of Part 1 of Division 2 of Title 2of the Government Code.

SEC. 28. Section 5000 of the Business and Professions Codeis amended to read:

5000. There is in the Department of Consumer Affairs theCalifornia Board of Accountancy, which consists of 15 members,seven of whom shall be licensees, and eight of whom shall bepublic members who shall not be licentiates of the board orregistered by the board. The board has the powers and dutiesconferred by this chapter.

The Governor shall appoint four of the public members, and theseven licensee members as provided in this section. The SenateRules Committee and the Speaker of the Assembly shall eachappoint two public members. In appointing the seven licenseemembers, the Governor shall appoint members representing a crosssection of the accounting profession with at least two membersrepresenting a small public accounting firm. For the purposes ofthis chapter, a small public accounting firm shall be defined as aprofessional firm that employs a total of no more than fourlicensees as partners, owners, or full-time employees in the practiceof public accountancy within the State of California.

This section shall become inoperative on July 1, 2011, and asof January 1, 2012, is repealed, unless a later enacted statute, thatbecomes effective on or before January 1, 2012, deletes or extendsthe dates on which this section becomes inoperative and is repealed.The repeal of this section renders the board subject to the reviewrequired by Division 1.2 (commencing with Section 473) Article7.5 (commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code. However, the reviewof the board shall be limited to reports or studies specified in thischapter and those issues identified by the Joint Sunset ReviewCommittee on Boards, Commissions, and Consumer Protectionand the board regarding the implementation of new licensingrequirements.

SEC. 29. Section 5510 of the Business and Professions Codeis amended to read:

5510. There is in the Department of Consumer Affairs aCalifornia Architects Board which consists of 10 members.

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Any reference in law to the California Board of ArchitecturalExaminers shall mean the California Architects Board.

This section shall become inoperative on July 1, 2011, and, asof January 1, 2012, is repealed, unless a later enacted statute, whichbecomes effective on or before January 1, 2012, deletes or extendsthe dates on which it becomes inoperative and is repealed. Therepeal of this section renders the board subject to the reviewrequired by Division 1.2 (commencing with Section 473) Article7.5 (commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code.

SEC. 30. Section 5810 of the Business and Professions Codeis amended to read:

5810. (a)  This chapter shall be subject to the review requiredby Division 1.2 (commencing with Section 473) Article 7.5(commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code.

(b)  This chapter shall remain in effect only until January 1,2013, and as of that date is repealed, unless a later enacted statute,that is enacted before January 1, 2013, deletes or extends that date.

SEC. 31. Section 6510 of the Business and Professions Codeis amended to read:

6510. (a)  There is within the jurisdiction of the departmentthe Professional Fiduciaries Bureau. The bureau is under thesupervision and control of the director. The duty of enforcing andadministering this chapter is vested in the chief of the bureau, whois responsible to the director. Every power granted or duty imposedupon the director under this chapter may be exercised or performedin the name of the director by a deputy director or by the chief,subject to conditions and limitations as the director may prescribe.

(b)  The Governor shall appoint, subject to confirmation by theSenate, the chief of the bureau, at a salary to be fixed anddetermined by the director with the approval of the Director ofFinance. The chief shall serve under the direction and supervisionof the director and at the pleasure of the Governor.

(c)  This section shall become inoperative on July 1, 2011, and,as of January 1, 2012, is repealed, unless a later enacted statute,that becomes operative on or before January 1, 2011 2012, deletesor extends the dates on which it becomes inoperative and isrepealed. The repeal of this section renders the bureau subject tothe review required by Division 1.2 (commencing with Section

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473) Article 7.5 (commencing with Section 9147.7) of Chapter 1.5of Part 1 of Division 2 of Title 2 of the Government Code.

Notwithstanding any other provision of law, upon the repeal ofthis section, the responsibilities and jurisdiction of the bureau shallbe transferred to the Professional Fiduciaries Advisory Committee,as provided by Section 6511.

SEC. 32. Section 6710 of the Business and Professions Codeis amended to read:

6710. (a)  There is in the Department of Consumer Affairs aBoard for Professional Engineers and Land Surveyors, whichconsists of 13 members.

(b)  Any reference in any law or regulation to the Board ofRegistration for Professional Engineers and Land Surveyors isdeemed to refer to the Board for Professional Engineers and LandSurveyors.

(c)  This section shall become inoperative on July 1, 2011, and,as of January 1, 2012, is repealed, unless a later enacted statute,that becomes effective on or before January 1, 2012, deletes orextends the dates on which it becomes inoperative and is repealed.The repeal of this section renders the board subject to the reviewrequired by Division 1.2 (commencing with Section 473) Article7.5 (commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code.

SEC. 33. Section 7200.2 is added to the Business andProfessions Code, to read:

7200.2. The board shall be subject to the review required byArticle 7.5 (commencing with Section 9147.7) of Chapter 1.5 ofPart 1 of Division 2 of Title 2 of the Government Code.

SEC. 34. Section 7304 of the Business and Professions Codeis amended to read:

7304. The board shall be subject to review pursuant to Division1.2 (commencing with Section 473) Article 7.5 (commencing withSection 9147.7) of Chapter 1.5 of Part 1 of Division 2 of Title 2of the Government Code.

SEC. 35. Section 7501 of the Business and Professions Codeis amended to read:

7501. (a)  There is in the Department of Consumer Affairs aBureau of Security and Investigative Services. The bureau is underthe supervision and control of the director. The director shalladminister and enforce the provisions of this chapter.

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(b)  The bureau shall be subject to the review required by Article7.5 (commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code.

SEC. 36. Section 7611 is added to the Business and ProfessionsCode, to read:

7611. The bureau shall be subject to the review required byArticle 7.5 (commencing with Section 9147.7) of Chapter 1.5 ofPart 1 of Division 2 of Title 2 of the Government Code.

SEC. 37. Section 8710 of the Business and Professions Codeis amended to read:

8710. (a)  The Board for Professional Engineers and LandSurveyors is vested with power to administer the provisions andrequirements of this chapter, and may make and enforce rules andregulations that are reasonably necessary to carry out its provisions.

(b)  The board may adopt rules and regulations of professionalconduct that are not inconsistent with state and federal law. Therules and regulations may include definitions of incompetence andnegligence. Every person who holds a license or certificate issuedby the board pursuant to this chapter, or a license or certificateissued to a civil engineer pursuant to Chapter 7 (commencing withSection 6700), shall be governed by these rules and regulations.

(c)  This section shall become inoperative on July 1, 2011, and,as of January 1, 2012, is repealed, unless a later enacted statute,which becomes effective on or before January 1, 2012, deletes orextends the dates on which it becomes inoperative and is repealed.The repeal of this section shall render the board subject to thereview required by Division 1.2 (commencing with Section 473)Article 7.5 (commencing with Section 9147.7) of Chapter 1.5 ofPart 1 of Division 2 of Title 2 of the Government Code.

SEC. 38. Section 9815 is added to the Business and ProfessionsCode, to read:

9815. The bureau shall be subject to the review required byArticle 7.5 (commencing with Section 9147.7) of Chapter 1.5 ofPart 1 of Division 2 of Title 2 of the Government Code.

SEC. 39. Section 9882 of the Business and Professions Codeis amended to read:

9882. (a)  There is in the Department of Consumer Affairs aBureau of Automotive Repair under the supervision and controlof the director. The duty of enforcing and administering this chapteris vested in the chief who is responsible to the director. The director

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may adopt and enforce those rules and regulations that he or shedetermines are reasonably necessary to carry out the purposes ofthis chapter and declaring the policy of the bureau, including asystem for the issuance of citations for violations of this chapteras specified in Section 125.9. These rules and regulations shall beadopted pursuant to Chapter 3.5 (commencing with Section 11340)of Part 1 of Division 3 of Title 2 of the Government Code.

(b)  In 2003 and every four years thereafter, the Joint SunsetReview Committee on Boards, Commissions, and ConsumerProtection shall hold a public hearing to receive testimony fromthe Director of Consumer Affairs and the bureau. In those hearings,the bureau shall have the burden of demonstrating a compellingpublic need for the continued existence of the bureau and itsregulatory program, and that its function is the least restrictiveregulation consistent with the public health, safety, and welfare.The committee shall evaluate and review the effectiveness andefficiency of the bureau based on factors and minimum standardsof performance that are specified in Section 473.4. The committeeand shall report its findings and recommendations to theLegislature as specified in Section 473.5 Article 7.5 (commencingwith Section 9147.7) of Chapter 1.5 of Part 1 of Division 2 of Title2 of the Government Code. The bureau shall prepare an analysisand submit a report to the committee as specified in Section 473.2subdivision (c) of Section 9147.7 of the Government Code.

SEC. 40. Section 11506 of the Business and Professions Codeis amended to read:

11506. This part shall be subject to the review required byDivision 1.2 (commencing with Section 473) Article 7.5(commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code. This part shallremain in effect only until January 1, 2012, and as of that date isrepealed, unless a later enacted statute, that is enacted beforeJanuary 1, 2012, deletes or extends that date.

SEC. 41. Section 22259 of the Business and Professions Codeis amended to read:

22259. This chapter shall be subject to the review required byDivision 1.2 (commencing with Section 473). This Article 7.5(commencing with Section 9147.7) of Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code.

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This chapter shall remain in effect only until January 1, 2012,and as of that date is repealed, unless a later enacted statute, thatis enacted before January 1, 2012, deletes or extends that date.

SEC. 42. Section 9148.51 of the Government Code is amendedto read:

9148.51. (a)  It is the intent of the Legislature that all existingand proposed state boards be subject to review every four yearsto evaluate and determine whether each has demonstrated a publicneed for its continued existence in accordance with enumeratedfactors and standards as set forth in Chapter 2 (commencing withSection 474) of Division 1.2 of the Business and Professions CodeArticle 7.5 (commencing with Section 9147.7).

(b)  In the event that If any state board becomes inoperative oris repealed in accordance with the act that added this section, anyprovision of existing law that provides for the appointment ofboard members and specifies the qualifications and tenure of boardmembers shall not be implemented and shall have no force or effectwhile that state board is inoperative or repealed.

(c)  Any provision of law authorizing the appointment of anexecutive officer by a state board subject to the review describedin Chapter 2 (commencing with Section 474) of Division 1.2 ofthe Business and Professions Code Article 7.5 (commencing withSection 9147.7), or prescribing his or her duties, shall not beimplemented and shall have no force or effect while the applicablestate board is inoperative or repealed.

(d)  It is the intent of the Legislature that subsequent legislationto extend or repeal the inoperative date for any state board shallbe a separate bill for that purpose.

SEC. 43. Section 9148.52 of the Government Code is amendedto read:

9148.52. (a)  The Joint Sunset Review Committee on Boards,Commissions, and Consumer Protection established pursuant toSection 473 of the Business and Professions Code 9147.7 shallreview all state boards, as defined in Section 9148.2, other than aboard subject to review pursuant to Chapter 1 (commencing withSection 473) of Division 1.2 of the Business and Professions Code,every four years.

(b)  The committee shall evaluate and make determinationspursuant to Chapter 2 (commencing with Section 474) of Division

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1.2 of the Business and Professions Code Article 7.5 (commencingwith Section 9147.7).

SEC. 44. This act shall not become operative unless AssemblyBill 1659 of the 2009–10 Regular Session is also enacted andbecomes operative on or before January 1, 2011, and adds Article7.5 (commencing with Section 9147.7) to Chapter 1.5 of Part 1 ofDivision 2 of Title 2 of the Government Code to establish the JointSunset Review Committee.

O

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california legislature—2009–10 regular session

ASSEMBLY BILL No. 2548

Introduced by Assembly Member Block

February 19, 2010

An act to amend Sections 11165 and 11165.1 of, and to add Sections11165.2 and 11165.3 to, the Health and Safety Code, relating tocontrolled substances.

legislative counsel’s digest

AB 2548, as introduced, Block. CURES: Prescription DrugMonitoring Program.

Existing law, the Uniform Controlled Substances Act, provides forthe electronic monitoring and reporting of the prescribing and dispensingof Schedule II, Schedule III, and Schedule IV controlled substancespursuant to the Controlled Substance Utilization Review and EvaluationSystem (CURES) program. The act further provides that in order toprevent the inappropriate, improper, or illegal use of Schedule II,Schedule III, or Schedule IV controlled substances, the Department ofJustice may initiate the referral of the history of controlled substancesdispensed to an individual based on data contained in CURES to licensedhealth care practitioners, pharmacists, or both, providing care or servicesto the individual. A violation of any of these provisions is amisdemeanor, punishable as specified.

This bill would establish the Prescription Drug Monitoring Program(PDMP) in state government under the Department of Justice to monitorany practitioner or pharmacist (PDMP subscriber) who has obtainedapproval, as specified, to access, using the Internet, the electronic historyof controlled substances dispensed to an individual under his or hercare based on data contained in CURES, as well as the number, amount,

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and type of controlled substances being dispensed to an individual underhis or her care, in order to control the diversion and resultant abuse of,and to ensure the safe and lawful dispensing of, Schedule II, ScheduleIII, and Schedule IV controlled substances. This bill would provide thatthe Department of Justice may establish, by regulation, a system forthe issuance to a PDMP subscriber of a citation which may contain anorder of abatement or an order to pay an administrative fine assessedby the department, if the subscriber is in violation of any provision of,or any regulation adopted by the department pursuant to, the UniformControlled Substances Act. This bill would further provide that the theftor loss of prescription information or prescription forms shall bereported, as specified, no later than 3 days after the discovery of thetheft or loss. By creating a new crime, this bill would impose astate-mandated local program.

The California Constitution requires the state to reimburse localagencies and school districts for certain costs mandated by the state.Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this actfor a specified reason.

Vote: majority. Appropriation: no. Fiscal committee: yes.

State-mandated local program: yes.

The people of the State of California do enact as follows:

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SECTION 1. Section 11165 of the Health and Safety Code isamended to read:

11165. (a)   To assist law enforcement and regulatory agenciesin their efforts to control the diversion and resultant abuse ofSchedule II, Schedule III, and Schedule IV controlled substances,and for statistical analysis, education, and research, the Departmentof Justice shall, contingent upon the availability of adequate fundsfrom the Contingent Fund of the Medical Board of California, thePharmacy Board Contingent Fund, the State Dentistry Fund, theBoard of Registered Nursing Fund, and the Osteopathic MedicalBoard of California Contingent Fund, maintain the ControlledSubstance Utilization Review and Evaluation System (CURES)for the electronic monitoring and Internet accessing of theprescribing and dispensing of Schedule II, Schedule III, andSchedule IV controlled substances by all practitioners authorizedto prescribe or dispense these controlled substances.

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(b)  The reporting of Schedule III and Schedule IV controlledsubstance prescriptions to CURES shall be contingent upon theavailability of adequate funds from the Department of Justice. TheDepartment of Justice may seek and use grant funds to pay thecosts incurred from the reporting of controlled substanceprescriptions to CURES. Funds shall not be appropriated from theContingent Fund of the Medical Board of California, the PharmacyBoard Contingent Fund, the State Dentistry Fund, the Board ofRegistered Nursing Fund, the Naturopathic Doctor’s Fund, or theOsteopathic Medical Board of California Contingent Fund to paythe costs of reporting Schedule III and Schedule IV controlledsubstance prescriptions to CURES.

(c)  CURES shall operate under existing provisions of law tosafeguard the privacy and confidentiality of patients. Data obtainedfrom CURES shall only be provided to appropriate state, local,and federal persons or public agencies for disciplinary, civil, orcriminal purposes and to other agencies or entities, as determinedby the Department of Justice, for the purpose of educatingpractitioners and others in lieu of disciplinary, civil, or criminalactions. Data may be provided to public or private entities, asapproved by the Department of Justice, for educational, peerreview, statistical, or research purposes, provided that patientinformation, including any information that may identify thepatient, is not compromised. Further, data disclosed to anyindividual or agency as described in this subdivision shall not bedisclosed, sold, or transferred to any third party.

(d)  For each prescription for a Schedule II, Schedule III, orSchedule IV controlled substance, the dispensing pharmacy orclinic shall provide the following information to the Departmentof Justice on a weekly basis and in a format specified by theDepartment of Justice:

(1)  Full name, address, and the telephone number of the ultimateuser or research subject, or contact information as determined bythe Secretary of the United States Department of Health and HumanServices, and the gender, and date of birth of the ultimate user.

(2)  The prescriber’s category of licensure and license number;federal controlled substance registration number; and the statemedical license number of any prescriber using the federalcontrolled substance registration number of a government-exemptfacility.

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(3)  Pharmacy prescription number, license number, and federalcontrolled substance registration number.

(4)  NDC (National Drug Code) number of the controlledsubstance dispensed.

(5)  Quantity of the controlled substance dispensed.(6)  ICD-9 (diagnosis code), if available.(7)  Number of refills ordered.(8)  Whether the drug was dispensed as a refill of a prescription

or as a first-time request.(9)  Date of origin of the prescription.(10)  Date of dispensing of the prescription.(e)  This section shall become operative on January 1, 2005.SEC. 2. Section 11165.1 of the Health and Safety Code is

amended to read:11165.1. (a)  (1)  A licensed health care practitioner eligible

to prescribe Schedule II, Schedule III, or Schedule IV controlledsubstances or a pharmacist may make a written request formanually or electronically submit to the Department of Justice anotarized application developed by the department to obtainapproval to access, using the Internet, the electronic history ofcontrolled substances dispensed to an individual under his or hercare based on data contained in CURES, and the Department ofJustice may, upon approval of the application, release to thatpractitioner or pharmacist, the electronic history of controlledsubstances dispensed to an individual under his or her care basedon data contained in CURES.

(2)  Any request for, or release of, a controlled substance historypursuant to this section shall be made in accordance with guidelinesdeveloped by the Department of Justice.

(3)  An application by a practitioner or pharmacist may bedenied, or access authorized pursuant to this section for apractitioner or pharmacist may be suspended, for cause, including,but not limited to, the following:

(A)   Materially falsifying an application.(B)   Failure to maintain effective controls for access to the

patient activity report.(C)  The suspension or revocation of a Drug Enforcement Agency

registration.(D)  An arrest or conviction for any controlled substance offense

or violation of this section.

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(E)  Accessing information pursuant to this section for anyreason not related to the care of a patient.

(4)  Any practitioner or pharmacist authorized pursuant to thissection to access a patient’s history of dispensed controlledsubstances shall notify the department within 10 days of any changeof pertinent information regarding the practitioner or pharmacist.

(b)  In order to prevent the inappropriate, improper, or illegaluse of Schedule II, Schedule III, or Schedule IV controlledsubstances, the Department of Justice may initiate the referral ofthe history of controlled substances dispensed to an individualbased on data contained in CURES to licensed health carepractitioners, pharmacists, or both, providing care or services tothe individual.

(c)(b)  The history of controlled substances dispensed to an

individual based on data contained in CURES that is received bya practitioner or pharmacist from the Department of Justicepursuant to this section shall be considered medical informationsubject to the provisions of the Confidentiality of MedicalInformation Act contained in Part 2.6 (commencing with Section56) of Division 1 of the Civil Code.

SEC. 3. Section 11165.2 is added to the Health and SafetyCode, to read:

11165.2. (a)  This section may be cited and known as thePrescription Drug Monitoring Program (PDMP).

(b)  The PDMP shall be established in state government underthe Department of Justice to monitor any practitioner or pharmacistwho has obtained approval under Section 11165.1 to access, usingthe Internet, the electronic history of controlled substancesdispensed to an individual under his or her care based on datacontained in CURES, as well as the number, amount, and type ofcontrolled substances being dispensed to an individual under hisor her care, in order to control the diversion and resultant abuseof, and to ensure the safe and lawful dispensing of, Schedule II,Schedule III, and Schedule IV controlled substances. For thepurposes of this section, a “PDMP subscriber” means a practitioneror pharmacist who has obtained approval under Section 11165.1to access, using the Internet, the electronic history of controlledsubstances dispensed to an individual under his or her care basedon data contained in CURES.

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(c)  The Department of Justice may establish, by regulation, asystem for the issuance to a PDMP subscriber of a citation whichmay contain an order of abatement or an order to pay anadministrative fine assessed by the department, if the subscriberis in violation of any provision of this chapter or any regulationadopted by the department pursuant to this chapter.

(d)  A citation system shall contain the following provisions:(1)  Citations shall be in writing and shall describe with

particularity the nature of the violation, including specific referenceto the provision of law or regulation of the department determinedto have been violated.

(2)  Whenever appropriate, the citation shall contain an order ofabatement fixing a reasonable time for abatement of the violation.

(3)  In no event shall the administrative fine assessed by thedepartment exceed two thousand five hundred dollars ($2,500) foreach violation. In assessing a fine, due consideration shall be givento the appropriateness of the amount of the fine with respect tosuch factors as the gravity of the violation, the good faith of thesubscriber, and the history of previous violations.

(4)  An order of abatement or a fine assessment issued pursuantto a citation shall inform the subscriber that if the subscriber desiresa hearing to contest the finding of a violation, that hearing shallbe requested by written notice to the CURES program of theDepartment of Justice within 30 days of the date of issuance ofthe citation or assessment. Hearings shall be held pursuant toChapter 5 (commencing with Section 11500) of Part 1 of Division3 of Title 2 of the Government Code.

(5)  In addition to requesting a hearing, the subscriber may,within 10 days after service of the citation, request in writing anopportunity for an informal conference with the departmentregarding the citation. At the conclusion of the informal conference,the department may affirm, modify, or dismiss the citation,including any fine levied or order of abatement issued. The decisionshall be deemed to be a final order with regard to the citationissued, including the fine levied and the order of abatement.However, the subscriber does not waive its right to request ahearing to contest a citation by requesting an informal conference.If the citation is dismissed after the informal conference, the requestfor a hearing on the matter of the citation shall be deemed to bewithdrawn. If the citation, including any fine levied or order of

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abatement, is modified, the citation originally issued shall beconsidered withdrawn and a new citation issued. If a hearing isrequested for a subsequent citation, it shall be requested within 30days of service of that subsequent citation.

(6)  Failure of a subscriber to pay a fine within 30 days of thedate of assessment or comply with an order of abatement withinthe fixed time, unless the citation is being appealed, may result indisciplinary action being taken by the department. If a citation isnot contested and a fine is not paid, the subscriber account shallbe terminated.

(7)  A citation may be issued without the assessment of anadministrative fine.

(8)  Assessment of administrative fines may be limited to onlyparticular violations of the law or department regulations.

(9)  Notwithstanding any other provision of law, if a fine is paidto satisfy an assessment based on the finding of a violation,payment of the fine shall be represented as satisfactory resolutionof the matter for purposes of public disclosure.

(e)  Administrative fines collected pursuant to this section shallbe deposited in a fund under the Department of Justice relating toCURES. These special funds shall be utilized to provide supportfor costs associated with informal and formal hearings under,maintenance of, and updates to CURES.

(f)  The sanctions authorized under this section shall be separatefrom, and in addition to, any other administrative, civil, or criminalremedies; however, a criminal action shall not be initiated for aspecific offense if a citation has been issued pursuant to this sectionfor that offense, and a citation may not be issued pursuant to thissection for a specific offense if a criminal action for that offensehas been filed.

SEC. 4. Section 11165.3 is added to the Health and SafetyCode, to read:

11165.3. (a)  A PDMP subscriber, as defined in Section11165.2, shall manually or electronically report any theft or lossof prescription information or prescription forms to the CURESprogram no later than three days after the discovery of the theft orloss.

(b)  The notification may be, reported electronically or in writingutilizing a form approved by the Department of Justice.

99

AB 2548— 7 —

95

96

Tool Kit

ICU Sedation Guidelines of Care

December 2009

97

ICU Sedation 2009

2

About This Document

The purpose of this document is to provide Intensive Care settings with recommendations and tools for the development and implementation of an evidence-based standard for safe and effective management of pain, sedation, and delirium in adult intensive care unit (ICU) ventilated patients.

Intended Audience

The document is intended for Intensive Care Clinical Leaders involved in the care of ICU patients.

Organization of This Document

The document is organized into two main sections: 1) clinical guidelines for adult, sedated ICU patients and

2) plan for implementing the guidelines in your institution.

Acknowledgement

The San Diego Patient Safety Council wishes to acknowledge the financial grant provided by Cardinal

Health/CareFusion Foundation, as well as each of the institutions listed on the cover that contributed the valuable time of its expert clinicians in the creation of this document. Key physician contributor: David Willms, MD, FCCP

PCA Council Members

Facilitator: Nancy Pratt, RN, MSN, Senior Vice President, Clinical Effectiveness, Sharp HealthCare

Alvarado Hospital Daniel Floyd, PharmD Patricia Walker, RN

CareFusion Tim Vanderveen, PharmD, MS Steve Lewis, MD

Fallbrook Hospital David Dirig, RPh, PhD

Hospital Association of San Diego and Imperial Counties

Palomar Pomerado Health Lourdes Januszewicz, RN, MSN, CNS, CCRN Catherine Konyn, RN, CNS Jeremy Lee, PharmD, BCPS

Rady Children’s Hospital San Diego Charles "Rich" Richards, PharmD

Scripps Health Shiva Bojak, Pharm PhD Christine Low, PharmD Scot Nolan, MS, RN, CNS, PHN, CCRN, CNRN, WCC Mark Parmenter, PharmD Elizabeth Shopes, RN

Sharp HealthCare Cheryl Dailey, RN, MS Marjorie Ethridge, RN Bernice Hammer, RN, CCRN Henry Milner, PharmD Donna Murphy, RT Albert Rizos, PharmD Jason Trimble, PharmD

Tri-City Medical Center Linda Fair, RN, BSN, CCRN Caroline Sanchez, RN, BSN

UCSD Medical Center Kevin Box, PharmD Meghan Carney, RN Katrina Derry, PharmD Erik Kistler, MD, PhD Jennifer Namba, PharmD Mary Ritter, RN

VA Healthcare San Diego Jennifer Howard, PharmD Kimberly Quicci-Roberts, MS

Contents Introduction.................................................................................................................................. 3

Current State ............................................................................................................................ 3

Charter..................................................................................................................................... 3

Scope....................................................................................................................................... 4

Performance Improvement.......................................................................................................... 4

Guidelines .................................................................................................................................... 4

Care Map .................................................................................................................................. 4

Promote Natural Sleep Cycle ....................................................................................................... 5

Patient Assessment Algorithm ..................................................................................................... 5

Pain Assessment........................................................................................................................ 7

Sedation..................................................................................................................................11

Delirium ..................................................................................................................................13

Implement Protocols .................................................................................................................19

Perform Daily Awakening Trial ....................................................................................................22

Guidelines for Implementing Care.................................................................................................. 24

References ................................................................................................................................. 26

Tools to Drive Success ................................................................................................................. 27

This document is in the public domain and may be used and reprinted without permission provided appropriate reference is made to the San Diego Patient Safety Council and the authors of the included tools and documents. The information and tools in this document are also available in electronic format at: www.carefusion.com/center, www.hasdic.org, and www.sharp.com. CareFusion does not accept any responsibility for the information contained in this document.

98

Current State

ICU Sedation 2009

3

Figure 1: Balancing Pain and Anxiety Treatment

INTRODUCTION

CURRENT STATE One third of all patients in intensive care units (ICUs)

worldwide are mechanically ventilated.1 Common conditions in mechanically ventilated, critically ill, trauma patients are acute pain, anxiety, and delirium.2

ICU patients frequently experience pain and physical discomfort from obvious factors, such as pre-existing diseases, invasive procedures, or trauma. Pain and discomfort also can be caused by:

• Monitoring and therapeutic devices such as catheters, drains, and endotracheal tubes

• Performing routine nursing care (e.g., airway suctioning, physical therapy, dressing changes, patient mobilization)

• Prolonged immobility.3

Jacobi et al (2002) found unrelieved pain may contribute to inadequate sleep and disorientation, and evoke a stress response. Severely ill patients in a stressful environment for prolonged periods may also experience delirium. Delirium itself is attributed to increased length of hospital stay, increased health care costs, and higher mortality. Additionally, the adult ICU patient may experience heart, lung, liver, and kidney complications, Post Traumatic Stress Disorder (PTSD), and long-term cognitive decline.

Further evaluation of clinical processes, protocols, and order management by San Diego Patient Safety Council members identified the following potential patient safety concerns for sedated adult ICU patients:

• Inconsistent interpretation of provider orders

• Inconsistent practice in the use of sedation and analgesia

• Lack of an executable plan with objective assessment tools and protocols for nursing to follow

This has resulted in the following consequences:

• Over and under sedation

• Variability between caregivers

• Variable and undesirable outcomes

Achieving an optimum level of comfort during continuous mechanical ventilation is a major goal in the care of critically ill patients.3 To do so, critical care health care professionals need a straightforward protocol that can be consistently executed.

CHARTER Safe and effective management of an adult ICU

patient’s pain and anxiety demands a delicate balance of analgesia and sedation protocols while managing delirium. As shown in Figure 1, an optimum state of analgesia, sedation, and delirium management result in reduced pain, decreased anxiety, managed delirium, amnesia, and recovery. Absence of coordinated care for these situations negatively affects the patient experience and clinical outcomes.

The San Diego Patient Safety Council developed an evidence-based standard for safe and effective

management of pain, sedation, and delirium in the adult ICU ventilated patient. The objectives of this evidenced-based tool kit are to:

• Decrease pain

• Decrease anxiety

• Decrease ventilator days

• Decrease ICU length of stay

• Reduce long-term cognitive decline

• Avoid heart, lung, liver, and kidney complications

• Reduce the incidence of PTSD

• Reduce occurrences of spontaneous extubation

• Reduce the occurrence of delirium and/or improve the management of delirium.

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ICU Sedation Guidelines of Care

ICU Sedation 2009

4

SCOPE The scope of the San Diego Patient Safety Council

project includes intubated patients in adult ICUs who require more than 24 hours of ventilatory support.

This project excludes the following types of patients:

• Extubated patients in adult ICUs

• Pediatrics

• Head trauma and burn injuries

• End of Life care

• Non-Intensive care

• Chemically paralyzed

• Chronic substance abuse

PERFORMANCE IMPROVEMENT The San Diego Patient Safety Council consists of

county wide representatives from acute facilities across multiple disciplines including nurses, pharmacists, physicians, and respiratory therapists. Council members reviewed literature, applied process improvement tools, and shared best practices to obtain consensus in building a comprehensive set of recommendations for safe and effective management of pain, sedation, and delirium in adult ICU ventilated patients. The tool kit consists of these consensus recommendations along with the tools from the literature to assist acute care organizations in

implementing these recommendations.

Figure 2: ICU Adult Sedated Patient

Care Process Map

Abbreviations

BIS Bi-spectral Index – depth of anesthesia, used for sedation

CAM-ICU Confusion Assessment Method for the Intensive Care Unit

CPOT Critical Care Pain Observation Tool

HAM Hamilton Rating Scale – measure of agitation

ICDSC Intensive Care Delirium Screening Checklist

ICU Intensive Care Unit

LOS Length of Stay

NSAID Non-Steroidal Anti-Inflammatory

NREM Sleep stages 1 through 3

NVPS Non-Verbal Pain Scale

PEEP Positive End-Expiratory Pressure

PTSD Post Traumatic Stress Disorder

QTc QT Interval (QTc) – the QT interval corrected for heart rate

RASS Richmond Agitation Sedation Scale

REM A recurring sleep state during which dreaming occurs – a state of rapidly shifting eye movements during sleep

RSBI Rapid Shallow Breathing Index – designed as a weaning parameter and is calculated by dividing the tidal volume by the respiratory rate

SAS Riker Sedation-Agitation Scale

SCCM Society of Critical Care Medicine

VAP Ventilator Associated Pneumonia

GUIDELINES

CARE MAP To ensure a balance of protocols in the care of ICU adult sedated patients, the San Diego Patient Safety Council developed a high level process map (Figure 2) outlining the care process of this patient population. Beginning with therapeutic sedation/analgesic, the patient’s care providers promote a natural sleep cycle, enhance the care environment, continuously assess the patient’s comfort, implement protocols including daily awakening trials, and evaluate therapy and

adjust as needed. This tool kit provides findings and recommendations for each care component.

100

Promote Natural Sleep Cycle

ICU Sedation 2009

5

PROMOTE NATURAL SLEEP CYCLE Sleep Cycle: A sequence of sleep stages that usually begins with a period of about 80 minutes of NREM sleep followed by about 10 minutes of REM sleep. This cycle of approximately 90 minutes is repeated four to six times each night. If the sequence is interrupted (e.g., by external noise or a sleep disorder), the quality of sleep can suffer.

4

Sleep-related problems and sleep deprivation affect a patient’s health, well-being, and quality of life. The restorative powers of sleep must be incorporated into the care of any critically ill patient. The San Diego Patient Safety Council recommends the following

practices to promote a patient’s natural sleep cycles.

Promote sleep hygiene by establishing and restoring natural sleep cycles and creating a therapeutic environment for sleep (90 minutes minimum cycle), as follows:

• Allow natural sleep at night. Adjust protocols and activities to provide a respite that nurtures relaxation and leads to natural sleep. Conduct patient activities and mobility during the day such as physical therapy/occupational therapy.

• Stick to the schedule for sleep. A specific sleep time must be established early in the patient’s care and consistently followed throughout treatment.

• Avoid frequent waking tasks and prevent interruptions. A minimum increment of 90 minutes of sleep is required; therefore, care providers must work to prevent frequent (i.e., every 15 minutes or 30 minutes) waking activities during the sleep period.

• Allow uninterrupted naps for the patient during the day. Regular 60- to 90-minute naps should be allowed and encouraged.

• Use back massage to relax the patient for sleep. Approximately 5-10 minutes of massage initiates the relaxation response.3

• Create a quiet, dark environment conducive to sleep. As much as possible, lessen outside lighting, turn off lights including flashing indicators, and reduce human and mechanical noise.

• Use natural sleep cues. When establishing the patient’s sleep at night, use natural sleep cues, such as lighting, noise, and smells. If possible, provide a room with a window or provide lighting that mimics the 24 hour day to help patients regulate to daylight/darkness.

• Use music therapy to encourage sleep. Music therapy can decrease heart rate, respiratory rate, myocardial oxygen demand, anxiety, and improve sleep.3 Head phones with soft music preferred by the patient and comforting family messages are recommended.

• Facilitate patient’s familiarity with environment.

Employ comfort measures:

• Provide complementary holistic therapies

• Encourage family to stay at bedside

• Remove unnecessary lines and tubes

• Remove or minimize restraints

• Encourage family to be at the bedside and engage the patient in activities as well as sitting quietly with the patient to promote rest

PATIENT ASSESSMENT

ALGORITHM Considering the physiologic, behavioral, and pharmacological variables that exist with critically ill sedated adults, a problem-solving approach is

important to consistent patient care. Key elements of this algorithm include measurable objectives, common language, and simple presentation of pertinent information. Figure 3 illustrates the San Diego Patient Safety Council’s recommended algorithm for care providers to achieve systematic decisions in the care delivery of sedated adult ICU patients.

101

Patient Assessment Algorithm

IC

U S

edation 2

009

6

Figure 3: Assessment Algorithm for Sedated Adult ICU Patients

Is

patient comfortable

and at goal for

Sedation and

Analgesics?

Reassess goal daily

Titrate and taper therapy to maintain goal

Perform awakening trial, if appropriate

No

Yes

TARGET: Non-Verbal Pain Scale: 0 –2

Critical Care Pain Observation Tool: 0 -1

Is patient in pain?

Use

pain

scale

to a

ssess

patie

nt

Set goal fo

r analg

esi

a

See Daily Awakening Protocol

Is patient delirious?

Use

sca

le to a

ssess

patie

nt

Confusion Assessment Method for the ICU (CAM-ICU)

Intensive Care Delirium Screening Checklist (ICDSC)

Pain

Delirium

Consi

der

pote

ntial c

auses

Consi

der

po

tentia

l cause

s

Is patient agitated / anxious?

Use

sca

le to a

ssess

patie

nt

Set goa

l for

sedation

TARGET:

Richmond Agitation Sedation Scale (RASS): 0 to -3

Riker Sedation-Agitation Scale (SAS): 3 to 4

Sedation

Hemodynamically Stable

-F

enta

NY

L-

HY

DR

Om

orp

hone

-M

orp

hin

eHemodynamically Unstable

-F

enta

NY

LRenal Impairment

-F

enta

NY

L-

HY

DR

Om

orp

hone

-FentaNYL in

fusi

on a

t 25 –

50 m

cg/h

r

-HYDROmorphone

infu

sion a

t 0.4

–0.8

mg/h

r

-Morphine

infu

sio

n a

t 2 –

4 m

g/h

r

Prim

ary

appro

ach

for

pain

: bolu

s for

pain

co

ntr

ol a

nd

then in

fusio

n

to s

usta

in c

ontr

ol.

Signs & Symptoms of Opiate Withdrawal

Pupil

dila

tion

Vom

itin

gS

weatin

gD

iarr

hea

Lacrim

atio

nH

ypert

ensi

on

Rhin

orr

hoea

Feve

rP

iloere

ctio

nT

ach

ypnea

Tach

yca

rdia

Agita

tion

TITRATING OFF INFUSIONS:

The p

ote

ntial f

or

opio

ids

with

dra

wal sh

ould

be c

onsid

ere

d for

patients

receiv

ing h

igh d

ose

s or

seve

n (

7)

da

ys o

f co

ntin

uous

thera

py.

D

ose

s s

hould

be tapere

d s

yste

matic

ally

(i.e

. 10-3

0%

per

day)

to p

revent w

ithdra

wal s

ympto

ms.

Consi

der

pote

ntia

l cause

s

DRUG SELECTION:

Anticipate sedation (<72 hours)

-M

ida

zola

m-

Pro

pofo

l-

Dexm

edeto

mid

ine

Anticipate sedation (> 72 hours)

-LO

Raze

pam

Patient has renal impairment

-LO

Raze

pam

-P

ropofo

l

SEDATION:

Use for RASS greater or equal to 2 levels below what is ordered

(e.g

., R

AS

S o

f -2

with a

n o

rdere

d g

oal o

f 0)

1.) LORazepam/midazolam continuous infusion

: H

old

infu

sion u

ntil p

atie

nt re

ach

es

RA

SS

goal, then r

esum

e a

t one-h

alf

pre

vious r

ate

. T

itrate

per

written o

rders

.

2.) Propofol continuous infusion

: D

ecr

ease

rate

5-1

0 m

cg/k

g/m

in e

very

10 m

inute

s until p

atie

nt re

ach

es

RA

SS

goal.

Titra

te p

er

written o

rders

.

3.) Morphine/HYDROmorphone/fentaNYL continuous infusion

: H

old

until

patient

reach

es

RA

SS

goal,

then r

esu

me a

t one-h

alf

pre

vious

rate

. T

itrate

pe

r w

ritten o

rders

.

Pharmacologic Treatment for Delirium:

NPO: Dexm

edeto

mid

ine 0

.2-1

.5 m

cg/k

g/h

r (C

on

sider

in p

atie

nts

faili

ng

sponta

neous b

rea

thin

g trials

seco

ndary

to a

gitatio

n)

Halo

peridol 2.5

-5m

g IV

q 1

5 m

in p

rn +

delir

ium

(su

ggest

ed m

ax

35 m

g/

day)

(Consi

der

decr

ease

d d

ose

in h

ypoact

ive d

elir

ium

) PO:

Aripip

razo

le 1

0-1

5 m

g p

o d

aily

(C

onsi

der

when b

aselin

e Q

Tc>

440 m

sec)

Halo

peridol 2.5

-5 m

g p

o q

6 h

r (C

autio

n if

baselin

e Q

Tc >

440 m

sec)

QU

Etia

pin

e 5

0-2

00 m

g p

o q

12 h

r (C

onsid

er

if s

edative

pro

pert

ies d

esired)

Ris

peridone 0

.5-1

mg p

o q

12 h

r (C

autio

n b

ase

line Q

Tc

>440 m

sec)

Non-Pharmacologic Treatments for Delirium:

-E

nsu

re D

aily

Aw

ake

nin

g T

rials

conduct

ed

-C

ontinually

reorient patient

-P

erf

orm

early

mobili

zatio

n-

Pro

mote

effectiv

e s

leep / a

wake

cyc

les

-P

erf

orm

tim

ely

rem

ova

l of cath

ete

rs/p

hys

ical

rest

rain

ts-

Ensu

re the u

se o

f eye

gla

sse

s, m

agnifyi

ng

lenses,

and h

earing a

ids

-M

inim

ize n

ois

e/s

tim

ula

tion a

t nig

ht

-M

inim

ize B

enzo

dia

zepin

es for

sedatio

n

Rule out/correct reversible causes

Use nonpharmacologic treatment

Optimize the environment

NOTE:Provided dosing ranges are general guidelines and are

not intended to supersede clinical judgment of prescriber.

102

ICU Sedation Guidelines of Care

ICU Sedation 2009

7

Pain is an unpleasant sensory or emotional experience that is associated with tissue damage or described in terms of tissue damage. (International Association for the Study of Pain www.iasp-pain.org. Retrieved November 2009)

PAIN ASSESSMENT All critically ill patients have the right to adequate analgesia and management of their pain. Some patients

recall unrelieved pain when interviewed about their ICU stays.3 A patient’s pain experience in the ICU need not be memorable given effective attention and application of pain management and amnesic agents. This begins with an accurate and standard method of assessing and caring for a patient’s pain (Figure 4).

Although critical care clinicians strive to obtain self-report of pain from the patient, many factors compromise patients’ ability to communicate verbally, including the use of sedative agents, mechanical ventilation, and changes in level of consciousness.5 The use of validated pain scales for both the self-reporting and non-verbal reporting patient is strongly recommended by the council.

Additionally, the council recommends the following guidelines:

• Evaluate the patient’s sedation and pain together. A patient’s level of comfort is impacted by these two variables. An assessment should be conducted systematically on both.

• Conduct pain assessment using an appropriate pain scale. Effective pain assessment and response to therapy must be performed regularly using a validated scale appropriate to the patient population. Furthermore, a single, validated non-verbal pain scale should be used across an organization.

• Search for presence of pain. A sedated patient’s pain assessment must include further investigation and observation to better determine the presence of pain. Care providers should consider painful lines/tubes, injuries, procedures, and pain history in their assessment.

• Determine the time since the patient’s last analgesic. A patient’s pathology and analgesic history, specifically the time since the last analgesic agent was administered, as well as the dose and the effectiveness of the dose, need to be included when evaluating a patient’s pain intensity.

• Ensure consistent analgesic therapy. A therapy plan and goal of analgesia should be established for each patient and communicated to all caregivers. The goal of analgesia therapy should be re-evaluated and communicated to all caregivers as the patient’s clinical condition changes.

• Provide bolus of analgesia to get ahead of the pain, especially before doing a patient procedure (e.g., turning, dressing changes, suction), and then infuse analgesia to sustain control.

• Scheduled opioid doses or a continuous infusion are preferred over an “as needed” regimen to ensure consistent analgesia.

Figure 4: Pain Management Algorithm

103

Pain Assessment

ICU Sedation 2009

8

• Start sedation therapy of agitated, critically ill patients only AFTER providing adequate analgesia and

treating reversible physiological causes (e.g., hypoxemia, hypoglycemia, hypotension, and withdrawal from alcohol or other drugs).

• A Non-Steroidal Anti-Inflammatory (NSAID) or acetaminophen is recommended as an adjunct to opioids unless contraindicated.

• Anticipate pain. Preventing pain is more effective than treating established pain. Effective pain management requires care providers to anticipate a patient’s pain and adjust therapy as needed.

For pain assessment tools and the order set provided in this tool kit, see Appendix: Tools to Drive Success on page 26.

For additional education and resources on pain management including the 18 language pain assessment tool, refer to the Purdue Web Site (www.PartnersAgainstPain.com).

Self-Reporting of Pain

For the self-reporting patient, the 0-10 Numerical Pain Intensity Rating Scale, 0-10 Numeric Pain Distress Scale, and Wong-Baker FACES Pain Rating Scale6 may be considered for systematic use across critical care units. The following self-reporting pain assessment scale is a combination of all three scales (Figure 5).

Figure 5: Self-Reporting Pain Assessment Scale

Wong-Baker FACES Pain Rating Scale* Directions: When the patient is awake, show this card with the faces. Explain to the person that each face is for a person who feels happy because he has no pain (hurt) or sad because he has some or a lot of pain. Point to each face and ask the person to choose the face that best describes how he is feeling. Based on his response, circle the appropriate scale number.

NOTE: Although the numbers associated with this scale are 0-5, the scale number should be doubled to a scale of 0-10 in order to apply the standard order set.

Alert

Smiling No humor

Serious Face Furrowed brow Pursed lips

Breath holding

Wrinkled nose Raised upper lip Rapid breathing

Slow blink Open mouth

Eyes closed Moaning Crying

No

Pain

Can be

ignored

Interferes

with tasks

Interferes

with concentration

Interferes with basic

needs

Bed rest required

Activity Tolerance Scale

0-10 Numeric Pain Scales** (circle one)

*Adapted from: Hockenberry MJ, Wilson D: Wong’s essentials of pediatric nursing, ed. 8, St. Louis, 2009, Mosby. Used with permission. Copyright Mosby.

**Adapted from: Acute Pain Management: Operative or Medical Procedures and Trauma, Clinical Practice Guideline No. 1. AHCPR Publication No. 92-0032: February 1992; Agency for Healthcare Research & Quality, MD; 116-117.

RECOMMENDATION: One pain assessment scale should be used consistently across the health care organization.

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9

Non-Verbal Reporting of Pain

In non-verbal patients unable to self-report pain

level, the critical care clinician should use a validated, non-self-reporting pain scale. The non-verbal reporting pain tools evaluated by the council were the Critical-Care Pain Observation Tool (CPOT) and 10 Point Non-Verbal Pain Scale.7

There was not a clear preference from the council among the non-verbal pain scales. Both scales need additional research and both meet the assessment needs of care today. Therefore, the council voted to place both in this tool kit. It is the council’s

recommendation that either pain scale may be used as part of assessing a patient’s sedation status.

For patient’s unable to self-report pain, observable behavioral/facial expressions (e.g., grimacing) and physiological indicators (e.g., tachycardia, hypertension) represent important indices for the assessment of pain.8 Other measures should be used to detect pain and evaluate intervention, such as searching for potential causes of pain and surrogate reporting (family members, caregivers) of pain and behavior/activity changes.6

Evaluation of the 10 Point Non-Verbal Pain Scale (Figure 6) by the council determined that the scale is condensed, easy-to-follow, more established, and includes and standardizes physiologic factors in the assessment. However, these same standardized physiologic indicators allow for arbitrary measurements, and there are too many other variables, which do not easily align with the 0-1-2 numbers. For this reason, the council recommended including the CPOT as another option to consider for pain assessment.

The Critical-Care Pain

Observation Tool

Evaluation of the behavioral pain assessment tool, CPOT (Figure 7) by the council determined that CPOT

is an easy to use and teach scale that may be used on all patients regardless of their level of consciousness and intubation status. This pain scale is less demanding of the provider, because it can be seamlessly integrated into daily care delivery and clinical assessment. The CPOT is a relatively new scale, which will require an education plan for implementation.

Figure 6: 10 Point Non-Verbal Pain Scale

Directions: Observe patient per category and, based on your findings, circle the appropriate scale number.

FACIAL EXPRESSION

Score Description

0 No particular smile or expression

1 Occasional grimace, tearing, frowning, and/or wrinkled forehead

2 Frequent grimacing, tearing, frowning, and/or wrinkled forehead

ACTIVITY

Score Description

0 Lying quietly, normal position

1 Seeking attention through movement or slow cautious movement

2 Restless excessive activity and/or withdrawal reflexes

GUARDING

Score Description

0 Lying quietly, no positioning of hands over area of body

1 Splitting areas of the body, tense

2 Rigid, stiff

PHYSIOLOGIC PARAMETER

Score Description

0 Stable vital signs

1 Change over past 4 hours in any of the following SBP > 20mmHg or heart rate > 20 bpm

2 Change over past 4 hours in any of the following SBP > 30mmHg or heart rate > 26 bpm

RESPIRATORY

Score Description

0 Baseline respiratory rate/oxygen saturation, compliant with ventilator

1 RR > 10 above baseline or 5% decrease in oxygen saturation, mild ventilator asynchrony

2 RR > 20 above baseline or 10% decrease in oxygen saturation, mild ventilator asynchrony

SCORE: Target Pain: 0 - 1

105

Pain Assessment

ICU Sedation 2009

10

Figure 7: The Critical-Care Pain Observation Tool (CPOT)

Indicator Score Description

Relaxed, neutral 0 No muscle tension observed

Tense 1 Presence of frowning, brow lowering, orbit tightening and levator contraction or any other change (e.g., opening eyes or tearing during nociceptive procedures)

Facial expression

Caroline Arbour, RN, B.Sc., M.Sc.A(c)

School of Nursing, McGill University

Grimacing 2 All previous facial movements plus eyelid tightly closed (the patient may present with mouth open or biting the endotracheal tube)

Absence of movements or normal position

0 Does not move at all (doesn’t necessarily mean absence of pain) or normal position (movements not aimed toward the pain site or not made for the purpose of protection)

Protection 1 Slow, cautious movements, touching or rubbing the pain site, seeking attention through movements

Body movements

(Puntillo et al., 1997 ; Devlin et al.,

1999)

Restlessness 2 Pulling tube, attempting to sit up, moving limbs/thrashing, not following commands, striking at staff, trying to climb out of bed

Tolerating ventilator or movement

0 Alarms not activated, easy ventilation

Coughing but tolerating

1 Coughing, alarms may be activated but stop spontaneously

Compliance with the ventilator (intubated patients)

(Harris et al. 1991. Payen et al., 2001)

OR Fighting ventilator 2 Asynchrony: blocking ventilation, alarms frequently activated

Talking in normal tone or no sound

0 Talking in normal tone or no sound

Sighing, moaning 1 Sighing, moaning

Vocalization (extubated patients)

(Mateo et Krenzischek, 1992)

Crying out, sobbing 2 Crying out, sobbing

Relaxed 0 No resistance to passive movements

Tense, rigid 1 Resistance to passive movements

Muscle tension

Evaluation by passive flexion and extension of upper limbs when patient is at rest (Ambuel et al., 1992) or when patient is being turned

Very tense or rigid 2 Strong resistance to passive movements, incapacity to complete them

SCORE: __ Target Pain: 0 - 1

Directions for use of the CPOT: 1. The patient must be observed at rest for one minute to

obtain a baseline value of the CPOT. 2. The patient should be observed during nociceptive

procedures (e.g., turning, endotracheal suctioning, wound dressing) to detect any changes in the patient’s behaviors to pain.

3. The patient should be evaluated before and at the peak effect of an analgesic agent to assess if the treatment was effective in relieving pain.

4. For the rating of the CPOT, the patient should be attributed the highest score observed during the observation period.

5. The patient should be attributed a score for each behavior included in the CPOT and muscle tension should be evaluated last, especially when the patient is at rest because just the stimulation of touch (passive flexion and extension of the arm) may lead to behavioral reactions.

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Figure 8: Sedation Management Algorithm

TARGET:

Richmond Agitation Sedation Scale (RASS): 0 to -3

Riker Sedation-Agitation Scale (SAS): 3 to 4

Sedation

TITRATING OFF INFUSIONS:

The potential for benzodiazepine or propofol withdrawal should be considered for patients receiving high doses or seven (7) days of continuous therapy. Doses should be tapered systematically (i.e. 10-30 percent per day) to prevent withdrawal symptoms.

Symptoms of benzodiazepine withdrawal: Fever, Hypertension, Tachycardia, Tachypnea, Tremors/seizures, Hyper-reflexia, Altered mental status, Disorientation, Hallucinations,Psychotic behavior.

EXCESSIVE SEDATION INVOLVING BENZODIAZEPINES

Flumazenil (Romazicon) - use lower doses in patients receiving benzodiazepines ≥ 7 days

Flumazenil 0.2 mg (2 mL) IV over 30 seconds. Wait 30 seconds. Reassess.

May give additional 0.3 mg (3 mL) over 30 seconds if needed. Reassess.

Additional doses of 0.5 mg (5 mL) can be administered over 30 seconds at 1-minute

intervals as needed (maximum cumulative dose = 3 mg).

DRUG SELECTION:

Anticipate sedation (< 72 hours)

- Midazolam- Propofol- Dexmedetomidine

Anticipate sedation (> 72 hours)

- LORazepam

Patient has renal impairment

- LORazepam- Propofol

Notify primary team if unable to maintain target sedation score at maximum dosages.The titration of the sedative dose to a defined endpoint is recommended with systematic tapering of the dose or daily interruption with retitration to minimize prolonged sedative effects.

Consider potential causes

Is patient agitated / anxious?

- Use scale to assess patient- Set goal for sedation

SEDATION:

Use for RASS greater or equal to 2 levels below what is

ordered (e.g., RASS of -2 with an ordered goal of 0)

1.) LORazepam/midazolam continuous infusion: Hold infusion until patient reaches RASS goal, then resume at one-half previous rate. Titrate per written orders.

2.) Propofol continuous infusion: Decrease rate 5-10 mcg/kg/min every 10 minutes until patient reaches RASS goal. Titrate per written orders.

3.) Morphine/HYDROmorphone/fentaNYL continuous

infusion: Hold until patient reaches RASS goal, then resume at one-half previous rate. Titrate per written orders.

SEDATION Sedatives are drugs that calm a patient down, easing agitation and permitting sleep. Sedatives generally work by modulating signals within the central nervous system.

9

Robinson et al (2008) found continuous sedative infusions for critically ill patients have been shown to increase the duration of mechanical ventilation and length of intensive care stay, despite perceived advantages. The weaning of

patients from mechanical ventilation is often hampered by the sedation they receive. Additionally, coordinated daily interruption of sedative infusions with objective re-titration in critically ill patients has been shown to decrease the durations of mechanical ventilation and length of ICU stay.

Clinical care practice guidelines and parameters developed by the Society of Critical Care Medicine (SCCM) recommend regular assessment and response to sedation therapy.3 The appropriate target level of sedation is a calm patient that can be easily aroused with maintenance of the normal sleep-wake cycle. Some patients may require deep levels of sedation to facilitate mechanical ventilation.10 Figure 8 illustrates the San Diego Patient Safety Council recommendations for managing patient sedation.

For sedation scales, both the Richmond Agitation Sedation Scale (RASS)11, 12 and the Riker

Sedation-Agitation Scale (SAS)13 are in practice at San Diego Patient Safety Council organizations. The RASS and SAS scales have been included in this tool kit for reference (Tables 1 and 2). The San Diego community has experience with both sedation scales and recommends each health care organization conduct its own evaluation of these two scales. It is important that a common scale is adopted for consistent and effective use throughout the organization.

For sedation assessment tools and the order set provided in this tool kit, see Appendix: Tools to Drive Success on page 26.

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RASS is a 10-point scale, with four levels of anxiety or agitation (+1 to +4 [combative]), one level to denote a

calm and alert state (0), and 5 levels of sedation (-1 to -5) culminating in unarousable (-5). The values and definitions for each level of agitation and sedation are displayed in Table 1, as are the instructions for assessment.

Table 1: Richmond Agitation Sedation Scale (RASS)

Score Description

RASS Target Sedation = 0 to -3

+4 Combative Overtly combative, violent, immediate danger to staff

+3 Very Agitated Pulls or removes tube(s) or catheter(s),aggressive

+2 Agitated Frequent non-purposeful movement, fights ventilator

+1 Restless Anxious but movements not aggressive vigorous

00 AAlleerrtt aanndd CCaallmm

-1 Drowsy Not fully alert, but has sustained awakening (>10 seconds) (eye-opening/eye contact) to voice

-2 Light Sedation Briefly awakens with eye contact to voice (<10 seconds)

-3 Moderate Sedation Movement or eye opening to voice (but no eye contact)

-4 Deep Sedation No response to voice, but movement or eye opening to physical stimulation

-5 Unarousable No response to voice or physical stimulation

Procedure for RASS Assessment: The basis of the RASS assessment is to see what amount of stimulation is necessary to evoke a response and evaluate sedation.

• Observe patient.

a. Patient is alert, restless, or agitated. (Score 0 to +4)

• If not alert, state patient’s name and say “open eyes and look at (speaker).”

b. Patient awakens with sustained eye opening and eye contact. (Score –1)

c. Patient awakens with eye opening and eye contact, but not sustained. (Score –2)

d. Patient has any movement in response to voice but no eye contact. (Score –3)

• When no response to verbal stimulation, physically stimulate patient by shaking shoulder and/or rubbing sternum.

e. Patient has any movement to physical stimulation. (Score –4)

f. Patient has no response to any stimulation. (Score –5)

SAS was the first scale proven to be reliable and valid in critically ill adults. SAS scores a patient’s level of

consciousness and agitation from a 7 point list describing patient behavior.13

Table 2: Riker Sedation-Agitation Scale (SAS)

Score Term Descriptor

SAS Target Sedation = 3 to 4

7 Dangerous Agitation

Pulling at ET tube, trying to remove catheters, climbing over bedrail, striking at staff, thrashing side-to-side

6 Very Agitated Requiring restraint and frequent verbal reminding of limits, biting ETT

5 Agitated Anxious or physically agitated, calms to verbal instructions

4 Calm and Cooperative

Calm, easily arousable, follows commands

3 Sedated Difficult to arouse but awakens to verbal stimuli or gentle shaking, follows simple commands but drifts off again

2 Very Sedated Arouses to physical stimuli but does not communicate or follow commands, may move spontaneously

1 Unarousable Minimal or no response to noxious stimuli, does not communicate or follow commands

Guidelines for SAS Assessment

1. Agitated patients are scored by their most severe degree of agitation, as described.

2. If patient is awake or awakens easily to voice (“awaken” means responds with voice or head shaking to a question or follows commands), that is a SAS 4 (same as calm and appropriate – might even be napping).

3. If more stimuli such as shaking is required but patient eventually does awaken, that is a SAS 3.

4. If patient arouses to stronger physical stimuli (may be noxious) but never awakens to the point of responding yes/no or following commands, that is a SAS 2.

5. Little or no response to noxious physical stimuli is a SAS 1.

This helps separate sedated patients into those you can eventually awaken (SAS 3), those you can not awaken, but can arouse (SAS 2), and those you can not arouse (SAS 1).

Non-Pharmacologic Sedation

Strategies

If the patient is anxious or agitated, consider non-

medication or environmental strategies to assist with management, such as environment modification, relaxation, back massage, and music therapy when appropriate.

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Figure 9: Delirium Management Algorithm

Assess for delirium using:Confusion Assessment Method for the ICU (CAM-ICU)Intensive Care Delirium Screening Checklist (ICDSC)

Delirium Algorithm

Non-Pharmacologic Treatments for Delirium:

- Ensure Daily Awakening Trials conducted- Continually reorient patient- Perform early mobilization- Promote effective sleep / awake cycles- Perform timely removal of catheters/physical restraints- Ensure the use of eyeglasses, magnifying lenses, hearing aids- Minimize noise/stimulation at night- Minimize Benzodiazepines for sedation

Is patient delirious?

Use scale to assess patientSet goal for delirium

Consider potential causes

Pharmacologic Treatment for Delirium:

Large randomized trials comparing agents for efficacy are minimal and no single agent has overwhelming evidence to support superiority for delirium treatment. Agent selection based on patient specific factors is recommended.

NOTE: Provided dosing ranges are general guidelines and are not intended to

supersede clinical judgment of prescriber.

NPO:

Dexmedetomidine 0.2-1.5 mcg/kg/hr (Consider in patients failing

spontaneous breathing trials secondary to agitation)

Haloperidol 2.5-5mg IV q 15 min prn + delirium (suggested max 35 mg/day)

(Consider decreased dose in hypoactive delirium) PO:

Aripiprazole 10-15 mg po daily (Consider when baseline QTc>440 msec)

Haloperidol 2.5-5 mg po q6 hr (Caution if baseline QTc >440 msec)

QUEtiapine 50-200 mg po q12 hr (Consider if sedative properties desired)

Risperidone 0.5-1 mg po q12 hr (Caution baseline QTc >440 msec)

DELIRIUM Delirium, characterized by fluctuations in mental status such as inattention, disorganized thinking, hallucinations, disorientation, and an altered level of consciousness, is a frequent occurrence in the intensive care unit (ICU).

14

Delirium occurs in up to 65 percent of hospitalized

patients, and up to 87percent of patients admitted to the ICU.15 The outcomes of delirium can be serious for the patient and should be considered as another organ failure that affects patient outcome. Delirium is associated with higher mortality and increased length of hospital stay and health care costs.15 Delirium must be considered when assessing pain based on ICU sedation. Figure 9 illustrates the San Diego Patient

Safety Council recommendations for managing delirium in sedated adult ICU patients.

Delirium can further be defined as:

• Hyperactive delirium: previously referred to as ICU psychosis, hyperactive delirium includes such symptoms as hypervigilance, restlessness, anger, irritability, and uncooperativeness and is associated with better overall outcomes.16

• Hypoactive delirium: the more common and

deleterious form, is characterized by lack of awareness, decreased alertness, sparse or slow speech, lethargy, decreased motor activity, and apathy.17, 18

• Mixed delirium: is apparent in those patients with a mixed clinical picture and may occur in up to 54 percent of patients.19

Risk Factors for Delirium

Delirium in patients usually develops

between 24 and 72 hours after admission to ICU.20 Factors placing patients at risk for delirium before or during hospitalization exist and must be considered in assessing and treating delirium. Known risk factors for delirium include:

• Risk factors before hospitalization: cognitive impairment, chronic illness (including hypertension), advanced age

(over 65 years), depression, smoking, alcoholism, and severity of illness.

• Risk factors during hospitalization: Congestive heart failure, sepsis, prolonged restraint use and immobility, withdrawal, seizures, dehydration, hyperthermia, head trauma, intracranial space-occupying

lesions, and the use of specific medications: LORazepam/ Midazolam, Morphine/fentaNYL, and Propofol.

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Figure 10: Electrocardiogram of a Normal Sinus Rhythm

www.skippinghearts.com

Assessing for Delirium

Delirium is categorized according to level of alertness and level of psychomotor activity.21 Careful evaluation, accurate

identification, and prompt treatment of delirium can successfully minimize or prevent adverse patient outcomes. Practical recommendations for care providers to consider when assessing delirium include:

• Assess with a validated scale – It is recommended that the nurse assess for the existence of delirium using a validated delirium scale. This assessment should be performed once a shift. Tools used to assess for the presence of delirium were evaluated by the council and included: Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) and Intensive Care Delirium Screening Checklist (ICDSC) (Tables 3 and 4).

• Assess for QTc Prolongation – QTc is the QT interval corrected for heart rate. All standard EKGs display the QTc (Figure 10).22 QTc > 440-460 msec is generally considered prolonged, but each institution is encouraged to address monitoring guidelines as appropriate. Baseline QTc monitoring is recommended for patients receiving agents that put them at risk for increased QTc (see agents listed in Table 7 on page 21). More frequent monitoring for patients with multiple risk factors should be considered.

• Perform Daily Awakening Trial – A Daily Awakening Trial ensures the patient is not overly sedated and allows drugs to be cleared from the system. In turn, this allows for an assessment of ventilatory status (see Daily Awakening Trial on page 19).

Treating Delirium

The treatment of a patient’s delirium should include both pharmacologic and non-pharmacologic therapy. For

pharmacologic therapy, large randomized trials comparing agents for efficacy are minimal, and no single agent has overwhelming evidence to support superiority for treatment of delirium. Drug selection based on patient-specific factors is recommended in treating delirium. For a comparison of suggested agents for delirium, see Table 7: Agents for Delirium on page 21. During the council’s discussion on maximum dosage of agents, a debate existed regarding Haloperidol; some sources suggested a maximum total daily dose of 35 mg/day and other sources suggested a maximum total daily dose of 20 mg/day. The council recommends careful consideration when determining maximum total daily dose for agents treating delirium. NOTE: Dosing ranges provided in this tool kit are general guidelines and are not intended to supersede clinical judgment of prescriber.

Suggested non-pharmacologic treatments of delirium include:

• Ensure Daily Awakening Trials performed

• Continually reorient patient to environment/surroundings

• Perform early mobilization

• Promote effective sleep/awake cycles

• Perform timely removal of catheters/physical restraints

• Ensure the use of eyeglasses, magnifying lenses, hearing aids

• Minimize continuous noise/stimulation at night

• Minimize benzodiazepine for sedation

For delirium assessment tools and the order set provided in this tool kit, see the Appendix: Tools to Drive Success on page 26.

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Confusion Assessment Method for the Intensive Care Unit

The CAM-ICU considers patients delirious when an acute onset of mental status changes or a fluctuating course is

accompanied by either disorganized thinking or an altered level of consciousness.23 The CAM-ICU addresses verbal and non-verbal patients and is a more established, reliable, faster, and easy to interpret tool. It provides higher sensitivity and incorporates the RASS scale. The CAM-ICU is not a hallucination assessment and assesses only a point in time. Educating staff on the CAM-ICU requires significant instruction and demands focused time to perform the assessment correctly. Figure 11 provides an algorithm for using the CAM-ICU to assess for delirium.

For additional educational resources on ICU delirium including the CAM-ICU Training Manual and

CAM-ICU Worksheet, go to the Vanderbilt University Medical Center web site at www.icudelirium.org.

Figure 11: Delirium Assessment (CAM-ICU) Algorithm

Copyright © 2003, Vanderbilt Medical Center. Harvard CAM-ICU Flowsheet (by Houman Amirfarzan, M.D., Wes Ely, M.D.)

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Table 3: Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)

FEATURE 1: Acute Onset or Fluctuating Course Positive, if answer ‘yes’ to either 1A or 1B. YES NO

1A: Is the patient different than his/her baseline mental status?

OR

1B: Has the patient had any fluctuation in mental status in the past 24 hours as evidenced by fluctuation on a sedation scale (e.g., RASS), GCS, or previous delirium assessment?

FEATURE 2: Inattention Positive, if either score for 2A or 2B is less than 8 Positive Negative

First, attempt the Letters (ASE). If patient is able to perform this test and the score is clear, record this score and move to Feature 3. If patient is unable to perform this test or the score is unclear, then perform the Pictures ASE. If you perform both tests, use the ASE Pictures’ results to score this Feature.

2A: AUDITORY (Letter – ASE) Record score (enter NT for not tested) Score (out of 10):

Directions: Say to the patient, “I am going to read you a series of 10 letters.

Whenever you hear the letter ‘A’ indicate by squeezing my hand.” Read letters from the following letter list in a normal tone:

____

S A V E A H A A R T

Scoring: Errors are counted when patient fails to squeeze on the letter “A” and when the patient squeezes on any letter other than “A.”

2B: VISUAL (Pictures - ASE) Record score (enter NT for not tested)

Directions: Use the Picture Packets (A and B) on the next page. Score (out of 10):

____

FEATURE 3: Disorganized Thinking Positive, if the combined score isles than 4 Positive Negative

3A: Yes/No Questions

(Use either Set A or B, and alternate on consecutive days if necessary):

Combined Score

(3A + 3B):

Set A Set B ____ (out of 5)

1. Will a stone float on water?

2. Are there fish in the sea?

3. Does one pound weigh more than two pounds?

4. Can you use a hammer to pound a nail?

1. Will a leaf float on water?

2. Are there elephants in the sea?

3. Do two pounds weigh more than one pound?

4. Can you use a hammer to cut wood?

(Patient earns 1 point for each correct answer out of 4) 3A Score ____

3B: Command

Say to patient: “Hold up this many fingers: (Examiner holds two fingers in front of patient) “Now do the same thing with the other hand: (Not repeating the number of fingers). *If patient is unable to move both arms, for the second part of the command ask patient to “Add one more finger”)

(Patient earns 1 point if able to successfully complete the entire command) 3B Score ____

FEATURE 4: Altered level of Consciousness Positive, if the actual RASS score is anything other than “0” (zero)

Positive Negative

Is the patient’s current level of consciousness anything other than alert such as vigilant, lethargic, or stupor (e.g.,

score on Richmond Agitation Sedation Scale other than 0 at time of assessment)?

Alert Spontaneously fully aware of environment and interacts appropriately

Vigilant Hyper alert

Lethargic

Drowsy but easily aroused, unaware of some elements in the environment, or not spontaneously

interacting appropriately with the interviewer; becomes fully aware and appropriately interactive when prodded minimally

Stupor Becomes incompletely aware when prodded strongly; can be aroused only by vigorous and repeated stimuli, and as soon as the stimulus ceases, stuporous subject lapses back into the unresponsive

state.

(Features 1 and 2 and either Feature 3 or 4): Overall CAM-ICU: Positive Negative

Copyright © 2002, E. Wesley Ely, MD, MPH and Vanderbilt University, all rights reserved.

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2B: VISUAL (Pictures - ASE)

Step 1: 5 pictures

Directions: Say to the patient, “Mr. or Mrs. _________, I am going to show you pictures of some common objects. Watch carefully and try to remember each picture, because I will ask what pictures you have seen.” Then show Step 1 of either Packet A or Packet B, alternating daily if repeat measures are taken. Show the first 5 pictures for 3 seconds each.

Packet A

Packet B

Step 2: 10 pictures

Directions: Say to the patient, “Now I am going to show you some more pictures. Some of these you have already seen and some are new. Let me know whether or not you saw the picture before by nodding your head yes (demonstrate) or no (demonstrate).” Then show 10 pictures (5 new 5 repeat) for 3 seconds each (Step 2 of Packet A or B, depending upon which form was used in Step 1 above).

Scoring: This test is scored by the number of correct “yes” or “no” answers during the second step (out of a possible 10). To improve the visibility for elderly patients, the images are printed on 6”x10” buff colored paper and laminated with a matte finish. Note: If a patient wears glasses, make sure he/she has them on when attempting the Visual ASE.

Packet A

Packet B

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The Intensive Care Delirium Screening Checklist (ICDSC)

The ICDSC evaluates the level of consciousness, inattention, disorientation, hallucinations, psychomotor activity,

speech or mood disturbance, sleep disturbance, and fluctuation of symptoms.24 The ICDSC tool includes all of the relevant components needed in a delirium assessment and provides scoring based on 12 hours of behavior, which affords better specificity and higher, over time reliability. However, the tool is labor intensive and the 0-8 scale implies a range of more or less delirium. Furthermore, the tool’s complicated scoring is a teaching challenge.

Table 4: Intensive Care Delirium Screening Checklist (ICDSC)

Intensive Care Delirium Screening Checklist SCORE

1. Altered level of consciousness. Choose ONE from A-E.

Note: May need to reassess patient if recent administration of sedation therapy.

A. Exaggerated response to normal stimulation SAS = 5, 6, or 7 Score 1 point

B. Normal wakefulness SAS = 4 Score 0 point

C. Response to mild or moderate stimulation SAS = 3 Score 1 point

(follows commands) If LOC related to recent sedation/analgesia, score 0

D. Response only to intense and repeated stimulation (e.g., loud voice and pain)

SAS = 2 **Stop assessment

E. No response SAS = 1 **Stop assessment

2. Inattention. Score 1 point for any of the following abnormalities:

A. Difficulty in following commands OR

B. Easily distracted by external stimuli OR

C. Difficulty in shifting focus

Does the patient follow you with their eyes?

3. Disorientation. Score 1 point for any of the following abnormality:

A. Mistake in either time, place, or person

Does the patient recognize ICU caregivers who have cared for him/her and not recognize those that

have not? What kind of place are you in? (list examples)

4. Hallucinations or Delusions. Score 1 point for either:

A. Equivocal evidence of hallucinations or a behavior due to hallucinations (Hallucination = perception of something that is not there with NO stimulus) OR

B. Delusions or gross impairment of reality testing (Delusion = false belief that is fixed/unchanging)

Any hallucinations over past 24 hrs? Are you afraid of the people or things around you? (fear that is inappropriate to clinical situation)

5. Psychomotor Agitation or Retardation. Score 1 point for either:

A. Hyperactivity requiring the use of additional sedative drugs or restraints in order to control potential danger (e.g., pulling IV lines out or hitting staff) OR

B. Hypoactive or clinically noticeable psychomotor slowing or retardation

Based on documentation and observation over shift by primary caregiver

6. Inappropriate Speech or Mood. Score 1 point for either:

A. Inappropriate disorganized or incoherent speech OR

B. Inappropriate mood related to events or situation

Is the patient apathetic to current clinical situation (i.e., lack of emotion)?

Any gross abnormalities in speech or mood? Is patient inappropriately demanding?

7. Sleep/Wake Cycle Disturbance. Score 1 point for either:

A. Sleeping less than four hours at night OR

B. Waking frequently at night (do not include wakefulness initiated by medical staff or loud environment) OR

C. Sleep ≥ 4 hours during day Based on primary caregiver assessment

8. Symptom Fluctuation. Score 1 point for:

Fluctuation of any of the above items (i.e., 1–7) over 24 hours (e.g., from one shift to another)

Based on primary caregiver assessment

TOTAL ICDSC SCORE (Add 1 through 8):

A total ICDSC score ≥ has a 99 percentage sensitivity correlation for a psychiatric diagnosis of delirium

Source: Bergeron N et al. (2001). Intensive Care Med. Vol. 27. pp. 869-64 - Revised July 22, 2005

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IMPLEMENT PROTOCOLS

ICU Sedation Order Set

The San Diego Patient Safety Council developed a standard order set establishing clear and complete orders and

guidelines to reduce variability in dosages by various practitioners for the same patient (see Tables 5, 6, and 7). When implementing this order set, consider the following recommendations:

• Individualize medication, dosage, route, and frequency to patient assessments of patient status

• Encourage intermittent dosing rather than continuous infusion

• Adhere to Propofol guidelines

• Ensure specific orders for assessing and performing Daily Awakening Trials

Table 5: Agents for Analgesia

Approximate Equivalent Single IV

Dose b 1,2

Typical Infusion

Rate b 1,2

Onset to Peak Effect1

Duration1 Average

Price/Daya

Comments

Opioids

FentaNYL 100-200 mcg 50-200 mcg/hr 2-5 min 0.5-2 hours

$26/day

at a rate of

100 mcg/hr

Fastest onset and shortest duration.

HYDROmorphone (Dilaudid

®)

1.5-2 mg 0.2-3 mg/hr 20-30 min 3-4 hours

$23/day

at a rate of

1.6 mg/hr

5-10x more potent than morphine.

Morphine 10 mg 2-10 mg/hr 20-30 min 3-4 hours

$20/day

at a rate of

10 mg/hr

Avoid in hypotension. Active metabolite accumulates in renal dysfunction. May cause itching due to histamine release (not a true allergy). Decreases preload, which may be beneficial in pulmonary edema.

NSAIDs (Parenteral)

Ibuprofen (Caldolor

®)

400-800 mg IVPB over 30 mg Not

reported 6 hours

$7 per 400mg dose

Infuse over 30 minutes. Not to exceed 3200 mg/day. Black box warnings: Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular thrombotic events. Risk may increase with duration of use. Contraindicated in setting of CABG. NSAIDs increase the risk of gastrointestinal adverse effects.

Ketorolac

(Toradol®)

15-60 mg IV push 1-2 hours 4-6 hours

$0.50-0.80 per

15 mg dose

Max adult dose 120 mg/day (60 mg/d in elderly or weight <50 kg). Do not use for >5 days. Avoid use in renal dysfunction. Monitor for gastrointestinal adverse effects. Black box warning: Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular thrombotic events. Contraindicated in setting of CABG.

a Equivalent prices and doses are approximations and may vary by institution and patient-specific differences in onset and duration of effect.

b Doses higher than recommended in the chart above may be required. Weight-based doses are reported for the following agents, but use may result in high infusion rates (fentaNYL 0.7-10 mcg/kg/hr, HYDROmorphone 7-15 mcg/kg/hr, morphine 0.07-0.5 mg/kg/hr). Based on clinical experience, more typical infusion rates are included in the table.

References:

1. Crit Care Med. 2008. Vol. 36. pp. 953-963.

2. Crit Care Med. 2002. Vol. 30: pp. 122-123.

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Table 6: Agents for Sedation

Drug Typical IV Bolus Dose1

Typical Infusion Rate 1,2

Onset to Peak 1

Duration1 Average

Price/Daya

Comments

Propofol (Diprivan

®)

0.03-0.15 mg/kg

(max 20 mg)

5-80 mcg/kg/min

1-2 min <20 min

$36/day

at a rate of

50 mcg/kg/min

Fastest onset and shortest duration. Avoid in hypotension. Dose/rate related hypotension/ bradycardia. Avoid IV push bolus due to increased risk of hypotension (if bolus required and low risk of hypotension, limit dose to 10-20 mg). Monitor triglycerides. Provides 1.1 kcal/mL. Monitor for propofol-related infusion syndrome.

Midazolam b

(Versed®)

1-6 mg 1-10 mg/hr 5-10 min 1.5-2 hours

$70/day

at a rate of

8 mg/hr

Fast onset - good for acute agitation/anxiety. Active metabolite accumulates in renal dysfunction. Midazolam 2-3 mg is approximately equivalent to 1 mg LORazepam. Midazolam is associated with increased incidents of delirium.

LORazepam b 6

(Ativan®)

1-3 mg 1-5 mg/hr 15-20 min6 2-4 hours

$38/day

at a rate of

4 mg/hr

Slower onset but longer duration. Risk of propylene glycol toxicity with high doses (anion-gap acidosis, ↑ Serum Creatinine, ↑ Lactate). Monitor serum osmolality if rate > 6 mg/hour and consider possible PG toxicity if osmol gap >10-15 3-5

LORazepam is associated with increased incidents of delirium.

Dexmedetomidine (Precedex

®)

1 mcg/kg over 20 min (not

recommended)

0.2-1.5 mcg/kg/hr

30 min 2-4 hours

$408/day

at a rate of

0.8 mcg/kg/hr

Limited data for use as a 1st line agent. FDA approved for use <24 hrs (studied up to 7 days in literature). FDA approved max dose = 0.7 mcg/kg/hr (studied up to 1.5 mcg/kg/hr). No respiratory depression - consider for patient failing spontaneous breathing trial due to agitation/anxiety. Dose/rate related hypotension and bradycardia–bolus not recommended. May cause hyper/hypotension. Consider higher starting dose if used as monotherapy. Expensive.

a Equivalent prices and doses are approximations and may vary by institution and patient-specific differences in onset and duration of effect.

b Midazolam and LORazapem doses higher than recommended in the chart above may be required. Weight-based doses are reported for the following agents, but use may result in high bolus doses and infusion rates (Midazolam bolus 0.02-0.08 mg/kg and infusion 0.04-0.2 mg/kg/hr; LORazepam bolus 0.02-0.06 mg/kg and infusion 0.01-0.1 mg/kg/hr). Based on clinical experience, more typical bolus doses and infusion rates are included in the table.

References:

1. Crit Care Med. (2008). Vol. 36: pp. 953-963. (for all references unless indicated otherwise)

2. Crit Care Med. (2002). Vol. 30: pp. 122-123.

3. Yahwak. Chest. (2003). Vol. 124. pp. 178S.

4. Arroliga. CCM. (2004). Vol. 32: pp. 1709.

5. Barnes. Pharmacotherap. (2006). Vol. 26: pp. 23.

6. Micromedex. LORazepam monograph. (Oct 2009).

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IC

U S

edation 2

009

21

Table 7: Agents for Delirium

Adverse Effects

Antipsychotic

Agent

Dosage

Form

Metabolism

Metabolizing

Enzyme

Equiv.

Dosages

(approx)

(mg)

Max Dose

(mg/day)

QTc

Pro

longation

Pote

ntial D

ose

Rela

ted E

ffecta

Sedation

Dopam

inerg

ic2

Recepto

r Affin

ity/

Extr

apyra

mid

al

Sym

pto

ms

b

Anticholinerg

ic

Effects

O

rthosta

tic

Hypote

nsio

n

Black Box Warning:

Incre

ased m

ort

alit

y seen w

hen u

sed in e

lderly

patients

with d

em

entia

-rela

ted p

syc

hosis

due t

o c

ard

iova

scula

r or

infe

ctious c

om

plic

ations.

The u

se o

f th

ese a

gents

for

delir

ium

in I

CU

patie

nts

has n

ot been test

ed in la

rge,

random

ized, pla

cebo-c

ontr

olle

d trials

.

Haloperidol

(Haldol)

Tab, IV

in

jectio

n

T½

:: 21 h

rs

Hepatic

CY

P3A

4,

2D

6

2

35*

Low

Low

H

igh

Low

Low

b

* Use heightened caution and be aware that there is a dose related QT interval prolongation and torsades de pointes (TdP) risk when using in excess of >20 mg per day.

QUEtiapine c

(SEROquel)

Tab

T½

:: 6 h

rs

Hepatic

CY

P3A

4

125

400

Modera

te

Modera

te

Low

M

odera

te

Hig

h

Risperidone

(Risperdal)

Tab,

OD

T

tab, solu

tion

(1 m

g/m

l)

T½

:: 3 h

rs

Hepatic

CY

P2D

6, 3A

4

1

4

Modera

te

Low

H

igh

Low

M

odera

te

Aripiprazole

(Abilify)

Tab,

solu

tion

(5m

g/m

l),

IM inje

ctio

n

T½

:: 75 h

rs

Hepatic

CY

P2D

6, 3A

4

5

30

Low

Low

Low

Low

Low

The following agents are NOT recommended for ICU use.

Ziprasidone d

(Geodon)

Capsule

T

½::

7 h

rs

Hepatic

CY

P3A

4,

1A

2

40

160

Hig

h

Low

H

igh

Low

M

odera

te

OLANZapine e

(ZyPREXA)

Tab,

OD

T

tab, IM

in

jectio

n

T½

:: 30 h

rs

Hepatic

CY

P1A

2

5

20

Low

M

odera

te

Low

M

odera

te

Low

a L

ow: 3

-10

mse

c, M

ediu

m: 1

0-15

mse

c, H

igh:

> 1

5 m

sec

b In

crea

sed

with

IV fo

rmul

atio

n

c C

autio

n: B

one

mar

row

sup

pres

sion

; blo

od d

yscr

asia

s d

Sec

onda

ry to

hig

h ris

k fo

r Q

T p

rolo

ngat

ion

e

Sec

onda

ry to

hig

h ris

k fo

r m

etab

olic

syn

drom

e

117

Guidelines

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22

Figure 12: Daily Awakening Trial and Spontaneous Breathing Trial

Assess for Daily Awakening

Exclusions: Increased Intracranial pressure issuesNeuromuscular blockade Significant ventilation support required, such as very high PEEP, FiO2CABG immediate post-opAnd other site specific exclusionary criteria

Perform Daily Awakening

Wean / Stop sedationConsider decreasing narcotics infusion by 25-50%

Restart Sedation at ½ previous dose(No Rapid Shallow Breathing Index)

Daily Awakening Algorithm

Is patient awake and calm?

Use sedation scale

(SAS 3-4 or RASS 0 to -1)

Spontaneous

Breathing Trial

- Take opportunity to assess patient’s pain

- Titrate narcotics as needed for pain

Assess for Spontaneous Breathing Trial (SBT)

(RN and RCP)

*** Must meet all criteria to proceed***

Calm and co-operative (SAS score of 3 to 4; RASS 0 to -1)

Hemodynamically stablePEEP < 8FiO2 < 0.60PH > 7.34SpO2 > 90%

Do not proceed with SBT

Return to previous ventilator settings

Conduct SBT for up to 2 hours

Continuously Reassess

Successful Completion SBT

Discuss Arterial Blood Gases and Extubation Plan with Physician

SBT Termination Criteria:

- Respiration Rate >35/minute for > 5 minutes- SpO2 < 90% for > 2 minutes- New Ectopy- Heart Rate change 20% from baseline- Blood Pressure change 20% from baseline- Accessory muscle use- Increased anxiety/diaphoresis

***Return patients who fail a SBT to their previousventilator settings and re-screen in 24 hours

***Discuss with MD prn vs. continuous sedation/pain

Conduct SBT for 1 Minute

Mode CPAP PEEP = 0Pressure support vent. at least 5 - 10FIO2 unchanged

After 1 minute, calculate Rapid Shallow

Breathing Index (RSBI): RSBI = Respiratory Rate/Tidal Volume in liters

<105 = 80% success

>105 = 95% failure

The following algorithm contains recommendations from the San Diego Patient Safety Council. Elements may vary based on your patient population and unit needs.

PERFORM DAILY AWAKENING TRIAL

A Daily Awakening Trial

determines a patient’s minimum level of sedation and identifies the minimum effective dose. Once the patient is awake and responsive, an accurate sedation, pain, and delirium assessment can be obtained, as well as a spontaneous breathing

trial of the ventilated patient. It is recommended to couple spontaneous breathing trial protocols with sedation protocols. Findings show that combining a spontaneous breathing trial protocol with a daily wakening trial results in patients spending less time on mechanical ventilation, less time in coma, and less time in intensive care and the hospital.1

Figure 12 illustrates the combining of a daily awakening trial and spontaneous breathing trial to achieve improved clinical outcomes. Please note this algorithm provides recommendations for each element, which may vary based on the

patient population and unit needs.

A Daily Awakening Trial (or Sedation Vacation) is titrating down continuous infusions of sedatives or holding sedation bolus until the patient is awake.

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For the standard of care and order set for Daily Awakening Trials provided

in this tool kit, see the Appendix: Tools to Drive Success on page 26.

Daily Awakening Trials – Summary Recommendations

• Components recommended for a Daily Awakening Trial:

• Consistency – should follow a standardized nurse-driven protocol

• Continuity – need to ensure a set time for the patient during daylight hours

• Coordination – need to ensure Daily Awakening Trial is coordinated with other disciplines, specifically physical therapy, occupational therapy, and respiratory therapy activities.

• Exclusions to a Daily Awakening Trial:

• Increased intracranial pressure issues

• Neuromuscular blockade

• Pressure-regulated pulmonary ventilation with an inverse ratio

• Coronary artery bypass graft immediate post-operation

• Process for weaning drug (per drug)

• Target – Use sedation scale targets (-1 on the RASS)

• Sedatives – decrease by 50 percent or off

• Narcotics – consider reducing narcotics if still sedated (or SAS of 3-4)

• Assess as part of Daily Awakening Trial:

• Pain

• Delirium

• Spontaneous Breathing Trial / rapid-shallow breathing index

• If continued sedation required, start at lower dose than previously—50 percent of original or lowest effective dose during titration—the most recent titration dose (before reaching -1 RASS)

• Bolus and titrate up to reach target goal as appropriate; do not resume at previous rate

• Abort Daily Awakening Trial if patient becomes physiologically unstable during procedure

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GUIDELINES FOR IMPLEMENTING CARE This section provides a description of the methodology used by the San Diego Patient Safety Council to develop the guidelines in this tool kit. It is recommended that this same methodology is used to implement these guidelines at a healthcare facility.

Mobilize Commitment

To start, form a council and manage resistance by identifying the organization stakeholders, such as:

• Anesthesia

• Nursing Leadership

• Clinical Pharmacists

• Critical Care Nurses

• Clinical Nurse Specialists/Educators

• Intensivists

• Information Technology

• Pain Service

• Pharmacy and Therapeutics Committee

• Pharmacy Leadership, Buyers/Wholesaler Supplier

• Policy and Procedure Committee

• Process Improvement Department

• Standard order sets owners and developers.

Define and Evaluate the Current State

The current state must be identified to effectively target change. The council needs to gather the data in preparation for implementing these recommendations. It is important to work with all stakeholders to obtain

agreement on suggested standards for the organization.

Create a Shared Need

The case for standardization must be based on

research, literature reviews, etc. Additionally, facilitation should be encouraged to allow for discussion and clarification on the front-end to be sure that the group is in full alignment on what is included and excluded in the project. The outcome should be a concise description of the case for standardization.

Elevator Speech

An “Elevator Speech” can be used to quickly convey

key elements of the campaign to staff, such as:

• What: The goal of the project is to implement an evidence-based standard for safe and effective management of pain, sedation, and delirium in adult ICU ventilated patients.

• Why: It is important because the use of sedation in these complex patients is challenging to manage and poses a high risk of patient harm.

• Success: We will achieve success when we have implemented an effective system to guide the multidisciplinary team in providing safe, effective, and reliable sedation.

• Need: We need your support and commitment to successfully implement this new ICU process of care.

Standardize, Simplify, and Clarify

A standard approach to ICU sedation administration

across healthcare facilities within a region should extend beyond assessments, therapy, and dosing units. It is recommended that policies and procedures, documentation, tools, and standard orders are standardized to simply and clarify administration for improved patient safety.

Policies, Procedures, and Process

Standard policies, procedures, and work processes are effective methods that provide a margin of safety in minimizing variance in managing pain, sedation, and delirium in adult ICU ventilated patients.

Documentation

A comprehensive and careful analysis of

documentation should be conducted to identify documentation forms, both paper and computerized, that need to be changed and standardized. For example, Nursing Assessment, Medication Administration Record, and Input and Output documentation need to be updated with new assessment guidelines, therapies, etc.

Establish Standard Order Sets

Standard order sets ensure consistent and accurate product ordering, delivery, and use, thereby reducing potential medication errors. The council recommends that each hospital establishes standard order sets for pain, sedation, and delirium in adult ICU ventilated patients.

Measures of Success

The focused improvement effort must include clearly

defined methods of measuring the success of safety procedures. These success metrics should be continually referenced and validated throughout the project.

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ICU Sedation Project Charter

Project Title: ICU Sedation

Sponsor: Hospital Association of San Diego & Imperial County

Process Owner: Hospital, Critical Care

Facilitator: Nancy Pratt, RN, MSN

Project Start Date: 29 January 2009

Project End Date: 31 December 2009

Team Members:

• Alvarado Hospital

• CareFusion

• Fallbrook Hospital

• Hospital Association of San Diego & Imperial Counties

• Palomar Pomerado Health

• Rady Children’s Hospital San Diego

• Scripps Health

• Sharp HealthCare

• Tri-City Medical Center

• UCSD Medical Center

• VA Healthcare San Diego

Problem Statement:

For patients in adult ICUs, there are:

• Inconsistent interpretation of provider orders

• Inconsistent practice in the use of sedation and analgesia

• Lack of an executable plan with objective assessment tools and protocols for nursing to follow

The effect of these shortcomings has resulted in

the following consequences:

• Over and under sedation

• Variability between caregivers

• Variable and undesirables outcomes

Project Scope:

This project includes intubated patients in adult ICUs who require more than 24 hours of ventilatory support.

This project excludes the following types of patients:

• Extubated patients in adult ICUs

• Pediatrics

• Head trauma and burn injuries

• End of Life care

• Non-Intensive care

• Chemically paralyzed

• Chronic substance abuse

Customer(s) and Requirements:

Critical care health care professionals need a straightforward protocol that can be consistently executed.

Deliverables:

Tool kit for the assessment and management of intubated ICU adult patients who need sedation to include:

1. Guidelines/Protocols and Algorithm

2. Assessment Tools (pain, sedation, and delirium scales)

3. Evidenced-based Order Set

Goal and Other Potential Benefits of

Appropriate Sedation Protocol:

To develop an evidenced-based tool kit that supports the achievement of the following metrics of appropriate sedation:

• Decrease pain

• Decrease anxiety

• Decrease patient’s ventilator days

• Decrease patient’s ICU length of stay

• Reduce long term cognitive decline

• Avoid heart, lung, liver, and kidney complications

• Reduce the incidence of PTSD

• Reduce occurrences of spontaneous extubation

• Reduce the occurrence of delirium and/or improve the management of delirium

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References

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26

REFERENCES

Girard, T. D., Kress, J. P., Fuchs, B.D., Thomason, J. W. W., Schweickert, W. D., Pun, B. T., et al. (2008). Efficacy and safety of a paired sedation and ventilator weaning protocol for mechanically ventilated patients in intensive care (Awakening and Breathing Controlled trial): a randomised controlled trial. The Lancet, 371, 126.

2 Robinson, B. R. H., Mueller, E. W., Henson, K., Branson, R. D., Barsoum, S., & Tsuei, B. J. (2008). An Analgesia–Delirium–Sedation Protocol for Critically Ill Trauma Patients Reduces Ventilator Days and Hospital Length of Stay. The Journal of Trauma Injury, Infection, and Critical Care. 65, 3, 517.

3 Jacobi, J., Fraser, G. L., Coursin, D. B., Riker, R. R., Fontaine, D., Wittbrodt, E. T., et al. (2002). Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 30, 1, 119-141.

4 Retrieved November 2009 from http://www.pbs.org/secondopinion/episodes/ sleepdisorders/medicalglossary/story348.html

5 Gélinas, C., Fillion, L., Puntillo, K. A., Viens, C., & Fortier, M. (July 2006). Validation of the Critical-Care Pain Observation Tool in Adult Patient. American Journal of Critical Care, 15, 4, 420.

6 Hockenberry M. J., Wilson, D. (2009) Wong’s essentials of pediatric nursing, ed. 8, St. Louis. Used with permission. Copyright Mosby. Acute Pain Management: Operative or Medical Procedures and Trauma, Clinical Practice Guideline No. 1. AHCPR Publication No. 92-0032: (February 1992). Agency for Healthcare Research & Quality, Rockville, MD, 116-117.

7 Herr, K., Coyne, P. J., Key, T., Manworren, R., McCaffery, M., Merkel, S., et al. (June 2006). Pain Assessment in the Nonverbal Patient: Position Statement with Clinical Practice Recommendations. Pain Management Nursing, 7, 2, 44-52.

8 Gélinas, C., & Johnston, C. (July/August 2007). Pain Assessment in the Critically Ill Ventilated Adult: Validation of the Critical-Care Pain Observation Tool and Physiologic Indicators. Clin J Pain, 23, 6, 497.

9 Retrieved November 2009 from www.memorydisorder.org/glossaryterms.htm

10 Kress, J. P., Pohlman, A. S., O’Connor, M. F., & Hall, J. B. (2000). Daily interruption of sedative infusions in critically ill patients undergoing mechanical ventilation. New Engl J Med, 342, 1471–1477.

11 Sessler, C. N., Gosnell, M., Grap, M. J., Brophy, G. T., O’Neal, P. V., Keane, K. A., et al. (2002). The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care patients. Am J Respir Crit Care Med, 166, 1338-1344.

12 Ely, E. W., Truman, B., Shintani, A., Thomason, J. W. W., Wheller, A. P., Gordon, S., et al. (2003). Monitoring sedation

status over time in ICU patients: the reliability and validity of the Richmond Agitation Sedation Scale (RASS). JAMA. 289, 2983-2991.

13 Riker, R. R., Picard, J. T., & Fraser, G. L. Prospective evaluation of the Sedation-Agitation Scale for adult critically ill patients. Crit Care Med. 1999, 27, 1325-1329.

14 Devlin, J. W.., Russel, R. J., Fong, J. J., Skrobik, Y., Riker, R. R., Hill N. S., et al. (2009) Efficacy and safety of quetiapine in critically ill patients with delirium: A prospective, multicenter, randomized, double-blind, placebo-controlled pilot study. Crit Care Med, 38, 2.

15 Rea, R. S., Battistone, S., Fong, J. J., & Devlin, J. W. (2007). Atypical Antipsychotics versus Haloperidol for Treatment of Delirium in Acutely Ill Patient. Pharmacotherapy, 27, 4.

16 Meagher, D. J., O'Hanlon, D., O'Mahony, E., Casey, P. R., & Trzepacz, P. T. (2000). Relationship between symptoms and motoric subtype of delirium. J of Neuropsychiatry and Clin Neurosciences. 12. 51-56.

17 Milisen, K., Foreman, M. D., Godderis, J., et al. (1998). Delirium in the hospitalized elderly: nursing assessment and management. Nurse Clin North Am. 33. 417-436.

18 O'Keeffe, S. T., Lavan, J. N. (1999). Clinical significance of delirium subtypes in older people. Age Ageing. 28. 115-119.

19 Peterson, J. F., Pun, B. T., Dittus, R. S., et al. (2006). Delirium and its motoric subtypes: a study of 614 critically ill patients. J Am Geriatr Soc. 54. 479-484.

20 Roberts, B., Rickard, C. M., Rajbhandarli, D., Turner, G., Clarke, J., Hill Dianne, et al. (2005). Multicentre study of delirium in ICU patients using a simple screening tool. Australian Critical Care, 18(1), 6-16.

21 Truman, B., Ely, E. W. (April 2003). Monitoring Delirium in Critically Ill Patients: Using the Confusion Assessment Method for the Intensive Care Unit. Critical Care Nurse, 23(2), 26.

22 Retrieved November 2009 from http://www.skippinghearts.com

23 Van Eijk, M. M., Van Marum, R. J., Klijn, I. A., De Wit, N., Kesecioglu, J., Slooter, A. J. (2009). Comparison of delirium assessment tools in a mixed intensive care unit. Crit Care Med, 37, 6, 1882.

24 Bergeron, N., Dubois, M. J., Dumont, M., Dial, S., & Skrobik, Y. (2001). Intensive Care Delirium Screening Checklist: evaluation of a new screening tool. Intensive Care Med, 27, 859-864.

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TOOLS TO DRIVE SUCCESS

123

Tools to Drive Success

ICU Sedation 2009

28

ADULT ICU PAIN ORDERS 1. Target pain score _______ (based on pain assessment)

2. For patient’s pain, select one of the following:

FENTANYL CONTINUOUS INFUSION

FentaNYL infusion at _______ mcg/hr (e.g., 25–50 mcg/hr)

A. FentaNYL bolus at _______ mcg (e.g,. 12.5 mcg) IV every 5 minutes prn pain score 2-3 (mild pain).

B. FentaNYL bolus at _______ mcg (e.g., 25 mcg) IV every 5 minutes prn pain score 4-6 (moderate pain).

C. FentaNYL bolus at _______ mcg (e.g., 50 mcg) IV every 5 minutes prn pain score 7-8 (severe pain).

• Repeat boluses until pain controlled.

• If the patient requires >2 boluses in an hour, increase rate by _______ mcg/hr (e.g., 12.5–25 mcg/hr) every hour.

• Maximum dosage = _______ mcg/hr (e.g., 100–200 mcg/hr).

• Notify physician for oversedation or when target pain score not achieved at maximum dosage.

_________________________________________________________________________________________________

HYDROMORPHONE (DILAUDID®) CONTINUOUS INFUSION

HYDROmorphone infusion at _______ mg/hr (e.g., 0.4–0.8 mg/hr)

A. HYDROmorphone bolus at _______ mg (e.g., 0.2 mg) IV every 10 minutes prn pain score 2-3 (mild pain).

B. HYDROmorphone bolus at _______ mg (e.g., 0.4 mg) IV every 10 minutes prn pain score 4-6 (moderate pain).

C. HYDROmorphone bolus at _______ mg (e.g., 0.8 mg) IV every 10 minutes prn pain score 7-8 (severe pain).

• Repeat boluses until pain controlled.

• If the patient requires >2 boluses in an hour, increase rate _______ mg/hr (e.g., 0.2 – 0.4 mg/hr) every hour.

• Maximum dosage = _______ mg/hr (e.g., 3 mg/hr).

• Notify physician for oversedation or when target pain score not achieved at maximum dosage.

_________________________________________________________________________________________________

MORPHINE CONTINUOUS INFUSION (Avoid in patients with cardiovascular instability or renal impairment)

Morphine infusion at _______ mg/hr (e.g., 2–4 mg/hr)

A. Morphine bolus at _______ mg (e.g., 1 mg) IV every 10 minutes prn pain score 2-3 (mild pain).

B. Morphine bolus at _______ mg (e.g., 2 mg) IV every 10 minutes prn pain score 4-6 (moderate pain).

C. Morphine bolus at _______ mg (e.g., 4 mg) IV every 10 minutes prn pain score 7-8 (severe pain).

• Repeat boluses until pain controlled.

• If the patient requires >2 boluses in an hour, increase rate by _______ mg/hr (e.g., 1–2 mg/hr) every hour.

• Maximum dosage = _______ mg/hr (e.g., 10 mg/hr).

• Notify physician for oversedation or when target pain score not achieved at maximum dosage.

Prescriber / PID: _____________________ Date/Time: ________________ Nurse: ______________________ Date/Time: _____________

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29

ICU PAIN MANAGEMENT PROTOCOL

SELF-REPORTING PAIN ASSESSMENT SCALE

Wong-Baker FACES Pain Rating Scale*

Directions: When the patient is awake, show this card with the faces. Explain to the person that each face is for a person who feels happy because he has no pain (hurt) or sad because he has some or a lot of pain. Point to each face and ask the person to choose the face that best describes how he is feeling. Based on his response, circle the appropriate scale number.

NOTE: Although the numbers associated with this scale are 0-5, the scale number should be doubled to a scale of 0-10 in order to apply the standard order set.

Alert Smiling

No humor Serious Face

Furrowed brow Pursed lips

Breath holding

Wrinkled nose Raised upper lip Rapid breathing

Slow blink Open mouth

Eyes closed Moaning Crying

No

Pain

Can be

ignored

Interferes

with tasks

Interferes

with concentration

Interferes with basic

needs

Bed rest required

Activity Tolerance Scale

0-10 Numeric Pain Scales** (circle one)

*Adapted from: Hockenberry MJ, Wilson D: Wong’s essentials of pediatric nursing, ed. 8, St. Louis, 2009, Mosby. Used with permission. Copyright Mosby.

**Adapted from: Acute Pain Management: Operative or Medical Procedures and Trauma, Clinical Practice Guideline No. 1. AHCPR Publication No. 92-0032: February 1992; Agency for Healthcare Research & Quality, MD; 116-117.

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NON-VERBAL PAIN SCALE

Directions: Define target pain score using the 10 Point Numerical Rating Scale. Observe the patient per category and, based on your findings, circle the appropriate scale number.

FACIAL EXPRESSION

Score Description

0 No particular smile or expression

1 Occasional grimace, tearing, frowning, and/or wrinkled forehead

2 Frequent grimacing, tearing, frowning, and/or wrinkled forehead

ACTIVITY

Score Description

0 Lying quietly, normal position

1 Seeking attention through movement or slow cautious movement

2 Restless excessive activity and/or withdrawal reflexes

GUARDING

Score Description

0 Lying quietly, no positioning of hands over area of body

1 Splitting areas of the body, tense

2 Rigid, stiff

PHYSIOLOGIC PARAMETER

Score Description

0 Stable vital signs

1 Change over past 4 hours in any of the following SBP > 20mmHg or heart rate > 20 bpm

2 Change over past 4 hours in any of the following SBP > 30mmHg or heart rate > 26 bpm

RESPIRATORY

Score Description

0 Baseline respiratory rate/oxygen saturation, compliant with ventilator

1 RR > 10 above baseline or 5% decrease in oxygen saturation, mild ventilator asynchrony

2 RR > 20 above baseline or 10% decrease in oxygen saturation, mild ventilator asynchrony

SCORE: Target Pain: 0-1

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31

NON-VERBAL PAIN SCALE (CPOT)

Define target pain score using the Non-Verbal Pain Scale (Critical Care Pain Observation Tool or CPOT) when appropriate.

Indicator Score Description

Relaxed, neutral 0 No muscle tension observed

Tense 1 Presence of frowning, brow lowering, orbit tightening and levator contraction or any other change (e.g. opening eyes or tearing during nociceptive procedures)

Facial expression

Caroline Arbour, RN, B.Sc., M.Sc.A(c)

School of Nursing, McGill University

Grimacing 2 All previous facial movements plus eyelid tightly closed (the patient may present with mouth open or biting the endotracheal tube)

Absence of movements or normal position

0 Does not move at all (doesn’t necessarily mean absence of pain) or normal position (movements not aimed toward the pain site or not made for the purpose of protection)

Protection 1 Slow, cautious movements, touching or rubbing the pain site, seeking attention through movements

Body movements

(Puntillo et al., 1997; Devlin et al.,

1999)

Restlessness 2 Pulling tube, attempting to sit up, moving limbs/thrashing, not following commands, striking at staff, trying to climb out of bed

Tolerating ventilator or movement

0 Alarms not activated, easy ventilation

Coughing but tolerating

1 Coughing, alarms may be activated but stop spontaneously

Compliance with the ventilator (intubated patients)

(Harris et al. 1991. Payen et al., 2001)

OR Fighting ventilator 2 Asynchrony: blocking ventilation, alarms frequently

activated

Talking in normal tone or no sound

0 Talking in normal tone or no sound

Sighing, moaning 1 Sighing, moaning

Vocalization (extubated patients)

(Mateo et Krenzischek, 1992)

Crying out, sobbing 2 Crying out, sobbing

Relaxed 0 No resistance to passive movements

Tense, rigid 1 Resistance to passive movements

Muscle tension

Evaluation by passive flexion and extension of upper limbs when patient is at rest (Ambuel et al., 1992) or when patient is being turned

Very tense or rigid 2 Strong resistance to passive movements, incapacity to complete them

SCORE: __ Target Pain: 0 - 1

Directions for use of the CPOT: 1. The patient must be observed at rest for one minute to

obtain a baseline value of the CPOT. 2. The patient should be observed during nociceptive

procedures (e.g., turning, endotracheal suctioning, wound dressing) to detect any changes in the patient’s behaviors to pain.

3. The patient should be evaluated before and at the peak effect of an analgesic agent to assess if the treatment was effective in relieving pain.

4. For the rating of the CPOT, the patient should be attributed the highest score observed during the observation period.

5. The patient should be attributed a score for each behavior included in the CPOT and muscle tension should be evaluated last, especially when the patient is at rest because just the stimulation of touch (passive flexion and extension of the arm) may lead to behavioral reactions.

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ADULT ICU SEDATION ORDERS

1. Target sedation score _______ (based on sedation assessment)

2. Perform Daily Awakening Protocol

3. Select from below one of the agents ±±±± boluses to treat agitation/anxiety.

4. Notify physician if patient has hemodynamic instability or if target sedation score not achieved at maximum dosages.

________________________________________________________________________________________________________________________________________________________________________________________________

BOLUSES FOR BREAKTHROUGH AGITATION/ANXIETY (Recommended for rapid control)

• Midazolam _________ mg (e.g., 1 – 2 mg) IV every 10 minutes prn mild agitation (e.g., RASS +1 to +2) , and

• Midazolam _________ mg (e.g., 2 – 5 mg) IV every 10 minutes prn moderate/severe agitation (e.g., RASS +3 to +4)

OR

• Lorazepam _________ mg (e.g., 0.5) IV every 20 minutes prn mild agitation (e.g., RASS +1 to +2), and

• Lorazepam _________ mg (e.g., 1 mg) IV every 20 minutes prn moderate/severe agitation (e.g., RASS +3 to +4).

________________________________________________________________________________________________________________________________________________________________________________________________

PROPOFOL (DIPRIVAN®) Infusion (Recommended for sedation <72 hours. Avoid in patients with cardiovascular instability.)

• Start propofol IV infusion at _________ mcg/kg/min (e.g., 5-10 mcg/kg/min).

• Bolus (if checked above) with midazolam as directed or propofol _________ mg (0.03-0.15 mg/kg, max 10-20 mg) for breakthrough agitation

• Titrate propofol by _________ mcg/kg/min (e.g., 5-10 mcg/kg/min) every 5 minutes until target sedation score achieved.

• Maximum rate = _________ mcg/kg/min (e.g., 60 mcg/kg/min).

• Reduce infusion rate by ½ for SBP < _________ mm Hg. Notify physician if patient has hemodynamic instability.

• Notify physician if target sedation score not achieved at maximum dosages.

• Oversedation: Wean Propofol by 10 mcg/kg/min every 10 min until sedation score at goal.

_________________________________________________________________________________________________

MIDAZOLAM (VERSED®) Infusion (Recommended for sedation <72 hours. Not recommended in impaired renal function.

• Start midazolam infusion at _________ mg/hr (e.g., 1 – 3 mg/hr).

• Bolus (if checked above) with midazolam as directed for breakthrough agitation/anxiety.

• If the patient requires >2 boluses in an hour, increase rate by _________ mg/hr (e.g., 1 – 2 mg/hr) every hour.

• Maximum infusion rate = _________ mg/hr (e.g., 10 mg/hr).

• Notify physician if target sedation score not achieved at maximum dosages.

• Oversedation: Hold infusion until sedation score at goal. Restart infusion at ½ previous rate.

_________________________________________________________________________________________________

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LORAZEPAM (ATIVAN®) Infusion (Recommended for sedation >72 hours)

• Start LORazepam infusion at _________ mg/hr (e.g., 0.5–1 mg/hr).

• Bolus (if checked above) with midazolam OR lorazepam as directed for breakthrough agitation/anxiety.

• If the patient requires >2 boluses in an hour, increase rate by _________ mg/hr (e.g., 1 – 2 mg/hr) every hour.

• Maximum infusion rate = _________ mg/hr (e.g., 10 mg/hr).

• Notify physician if target sedation score not achieved at maximum dosages.

• Oversedation: Hold infusion until sedation score at goal. Restart infusion at ½ previous rate.

________________________________________________________________________________________________________________________________________________________________________________________________

PATIENTS FAILING SPONTANEOUS BREATHING TRIALS DUE TO AGITATION:

DEXMEDETOMIDINE (PRECEDEX®) (Recommended for short-term use. Avoid in patients with cardiovascular instability.)

• Start dexmedetomidine infusion at _________ mcg/kg/hr (e.g., 0.2 – 0.7 mcg/kg/hr).

• Bolus (if checked) with midazolam for breakthrough agitation as directed below.

• Titrate dexmedetomidine by _________ mcg/kg/hr (e.g., 0.1 – 0.2 mcg/kg/hr) every hour until target sedation score achieved.

• Maximum rate = _________ mcg/kg/hr (e.g., 1 – 1.5 mcg/kg/hr).

• Notify physician if patient has hemodynamic instability or if target sedation score not achieved at maximum dosages.

Prescriber / PID: _____________________ Date/Time: ________________ Nurse: ______________________ Date/Time: _____________

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RICHMOND AGITATION SEDATION SCALE

Richmond Agitation Sedation Scale (RASS)

Score Description

RASS Target Sedation = 0 to -3

+4 Combative Overtly combative, violent, immediate danger to staff

+3 Very Agitated Pulls or removes tube(s) or catheter(s); aggressive

+2 Agitated Frequent non-purposeful movement, fights ventilator

+1 Restless Anxious but movements not aggressive vigorous

00 AAlleerrtt aanndd CCaallmm

-1 Drowsy Not fully alert, but has sustained awakening (>10 seconds) (eye-opening/eye contact) to voice

-2 Light Sedation Briefly awakens with eye contact to voice (<10 seconds)

-3 Moderate Sedation Movement or eye opening to voice (but no eye contact)

-4 Deep Sedation No response to voice, but movement or eye opening to physical stimulation

-5 Unarousable No response to voice or physical stimulation

Procedure for RASS Assessment: The basis of the RASS assessment is to see what amount of stimulation is necessary to evoke a response and evaluate sedation.

• Observe patient.

a. Patient is alert, restless, or agitated. (Score 0 to +4)

• If not alert, state patient’s name and say “open eyes and look at (speaker).”

b. Patient awakens with sustained eye opening and eye contact. (Score –1)

c. Patient awakens with eye opening and eye contact, but not sustained. (Score –2)

d. Patient has any movement in response to voice but no eye contact. (Score –3)

• When no response to verbal stimulation, physically stimulate patient by shaking shoulder and/or rubbing sternum.

e. Patient has any movement to physical stimulation. (Score –4)

f. Patient has no response to any stimulation. (Score –5)

Sessler CN, et al. (2002). The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care patients. Am J Respir Crit Care Med. Vol. 166. pp. 1338-1344.

Ely EW, et al. (2003). Monitoring sedation status over time in ICU patients: the reliability and validity of the Richmond Agitation Sedation Scale (RASS). JAMA ; Vol. 289. pp. 2983-2991

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RIKER SEDATION-AGITATION SCALE (SAS)

Riker Sedation-Agitation Scale (SAS)

Score Term Descriptor

SAS Target Sedation = 3 to 4

7 Dangerous Agitation Pulling at ET tube, trying to remove catheters, climbing over bedrail, striking at staff, thrashing side-to-side

6 Very Agitated Requiring restraint and frequent verbal reminding of limits, biting ETT

5 Agitated Anxious or physically agitated, calms to verbal instructions

4 Calm and Cooperative Calm, easily arousable, follows commands

3 Sedated Difficult to arouse but awakens to verbal stimuli or gentle shaking, follows simple commands but drifts off again

2 Very Sedated Arouses to physical stimuli but does not communicate or follow commands, may move spontaneously

1 Unarousable Minimal or no response to noxious stimuli, does not communicate or follow commands

Jacobi J, Fraser GL, Coursin DB, et al. (2002). Clinical practice guidelines for the sustained use of sedatives and analgesics in the

critically ill adult. Crit Care Med. Vol. 30, No. 1

Guidelines for SAS Assessment

1) Agitated patients are scored by their most severe degree of agitation as described

2) If patient is awake or awakens easily to voice (“awaken” means responds with voice or head shaking to a question or follows commands), that is a SAS 4 (same as calm and appropriate – might even be napping).

3) If more stimuli such as shaking is required but patient eventually does awaken, that is SAS 3.

4) If patient arouses to stronger physical stimuli (may be noxious) but never awakens to the point of responding yes/no or following commands, that is a SAS 2.

5) Little or no response to noxious physical stimuli represents SAS 1

This helps separate sedated patients into those you can eventually wake up (SAS 3), those you can't awaken, but can arouse (SAS 2), and those you can’t arouse (SAS 1).

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ADULT ICU DELIRIUM ORDERS ���� Assess for Delirium using standardized scale (e.g., CAM-ICU or ICDSC)

NOTE: Provided dosing ranges are general guidelines and are not intended to supersede clinical judgment of prescriber.

FOR BREAKTHROUGH AGITATION - check box to select agent(s):

HALOPERIDOL (HALDOL®) BOLUSES

• Haloperidol _________ mg (e.g., 2.5-5 mg) IV every 15 min prn agitation/delirium.

• Maximum daily dose = _________ mg/day (Suggested max total daily dose is 35 mg/day)

• Monitor for Qtc prolongation ________

MAINTENANCE TREATMENT FOR AGITATION/DELIRIUM - check box to select agent(s):

HALOPERIDOL (HALDOL®)

• Haloperidol _________ mg (e.g., 2.5-5 mg) PO every _________ hours (e.g., 6 hours).

• Maximum daily dose (including PRN doses) = _________ mg/day (Suggested max daily dose is 35 mg/day)

• Monitor for Qtc prolongation ________

RISPERIDONE (RISPERDAL®) TABLET OR ORALLY DISINTEGRATING TABLET (ODT)

• Risperidone _________ mg (e.g., 1 – 2 mg) PO every _________ hours (e.g,. 12 hours).

• Maximum daily recommended dose is 4 mg/day

• Monitor for Qtc prolongation ________

ARIPIPRAZOLE (ABILIFY®)

• Aripiprazole _________ mg (e.g., 5 – 10 mg) PO daily OR _________mg (e.g., 9.75 mg) IM daily.

• Maximum daily recommended dose is 30 mg/day

• Monitor for Qtc prolongation ________

QUETIAPINE (SEROQUEL®)

• Quetiapine _________ mg (e.g., 50 mg) PO every _________hours (e.g., 12 hours).

• Maximum daily recommended dose is 200 mg q12h.

• Monitor for Qtc prolongation ________

DEXMEDETOMIDINE (PRECEDEX®) (Consider in patients failing spontaneous breathing trials secondary to agitation)

Loading dose _________ mcg (1 mcg/kg) over 20 min (not recommended due to risk of hypotension).

• Start dexmedetomidine infusion at _________ mcg/kg/hr (e.g., 0.2 – 0.7 mcg/kg/hr).

• Titrate dexmedetomidine by _________mcg/kg/hr (e.g., 0.1 – 0.2 mcg/kg/hr) every hour until target sedation score achieved.

• Maximum rate = _________ mcg/kg/hr (e.g., 1 – 1.5 mcg/kg/hr).

• Notify physician if patient has hemodynamic instability or if target sedation score not achieved at maximum dosages.

Note: Provided dosing ranges are general guidelines and are not intended to supersede clinical judgment of prescriber.

Prescriber / PID: _____________________ Date/Time: ________________ Nurse: ______________________ Date/Time: _____________

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CONFUSION ASSESSMENT METHOD IN THE ICU (CAM-ICU)

Directions: If patient’s RASS is above -4 (-3 through +4), refer to the following chart and assess for delirium using the Confusion Assessment Method in the ICU (CAM-ICU) on the next page.

Harvard CAM-ICU Flowsheet (by Houman Amirfarzan, M.D., Wes Ely, M.D.) Copyright © 2003, Vanderbilt Medical Center

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CONFUSION ASSESSMENT METHOD FOR THE INTENSIVE CARE UNIT (CAM-ICU)

Table 3: Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)

FEATURE 1: Acute Onset or Fluctuating Course Positive, if answer ‘yes’ to either 1A or 1B. YES NO

1A: Is the patient different than his/her baseline mental status?

OR

1B: Has the patient had any fluctuation in mental status in the past 24 hours as evidenced by fluctuation on a sedation scale (e.g. RASS), GCS, or previous delirium assessment?

FEATURE 2: Inattention Positive, if either score for 2A or 2B is less than 8 Positive Negative

First, attempt the Letters (ASE). If patient is able to perform this test and the score is clear, record this score and move to Feature 3. If patient is unable to perform this test or the score is unclear, then perform the Pictures ASE. If you perform both tests, use the ASE Pictures’ results to score this Feature.

2A: AUDITORY (Letter – ASE) Record score (enter NT for not tested) Score (out of 10):

Directions: Say to the patient, “I am going to read you a series of 10 letters. Whenever you hear the letter ‘A’ indicate by squeezing my hand.” Read letters from the following letter list in a normal tone:

____

S A V E A H A A R T

Scoring: Errors are counted when patient fails to squeeze on the letter “A” and when the patient squeezes on any letter other than “A.”

2B: VISUAL (Pictures - ASE) Record score (enter NT for not tested)

Directions: Use the Picture Packets (A and B) on the next page. Score (out of 10):

____

FEATURE 3: Disorganized Thinking Positive, if the combined score isles than 4 Positive Negative

3A: Yes/No Questions

(Use either Set A or B, alternate on consecutive days if necessary):

Combined Score

(3A + 3B):

Set A Set B ____ (out of 5)

5. Will a stone float on water?

6. Are there fish in the sea?

7. Does one pound weigh more than two pounds?

8. Can you use a hammer to pound a nail?

5. Will a leaf float on water?

6. Are there elephants in the sea?

7. Do two pounds weigh more than one pound?

8. Can you use a hammer to cut wood?

(Patient earns 1 point for each correct answer out of 4) 3A Score ____

3B: Command

Say to patient: “Hold up this many fingers: (Examiner holds two fingers in front of patient) “Now do the same thing with the other hand: (Not repeating the number of fingers). *If patient is unable to move both arms, for the second part of the command ask patient to “Add one more finger”)

(Patient earns 1 point if able to successfully complete the entire command) 3B Score ____

FEATURE 4: Altered level of Consciousness Positive if the actual RASS score is anything other than “0” (zero)

Positive Negative

Is the patient’s current level of consciousness anything other than alert such as vigilant, lethargic, or stupor (e.g.,

score on Richmond Agitation Sedation Scale other than 0 at time of assessment)?

Alert Spontaneously fully aware of environment and interacts appropriately

Vigilant Hyper alert

Lethargic

Drowsy but easily aroused, unaware of some elements in the environment, or not spontaneously interacting appropriately with the interviewer; becomes fully aware and appropriately interactive when prodded minimally

Stupor Becomes incompletely aware when prodded strongly; can be aroused only by vigorous and repeated

stimuli, and as soon as the stimulus ceases, stuporous subject lapses back into the unresponsive state.

(Features 1 and 2 and either Feature 3 or 4): Overall CAM-ICU: Positive Negative

Copyright © 2002, E. Wesley Ely, MD, MPH and Vanderbilt University, all rights reserved.

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2B: VISUAL (Pictures - ASE)

Step 1: 5 pictures

Directions: Say to the patient, “Mr. or Mrs. _________, I am going to show you pictures of some common objects. Watch carefully and try to remember each picture, because I will ask what pictures you have seen.” Then show Step 1 of either Packet A or Packet B, alternating daily if repeat measures are taken. Show the first 5 pictures for 3 seconds each.

Packet A

Packet B

Directions: Say to the patient, “Now I am going to show you some more pictures. Some of these you have already seen and some are new. Let me know whether or not you saw the picture before by nodding your head yes (demonstrate) or no (demonstrate).” Then show 10 pictures (5 new, 5 repeat) for 3 seconds each (Step 2 of Packet A or B, depending upon which form was used in Step 1 above).

Scoring: This test is scored by the number of correct “yes” or “no” answers during the second step (out of a possible 10). To improve the visibility for elderly patients, the images are printed on 6”x10” buff colored paper and laminated with a matte finish. Note: If a patient wears glasses, make sure he/she has them on when attempting the Visual ASE.

Packet A

Packet B

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INTENSIVE CARE DELIRIUM SCREENING CHECKLIST (ICDSC)

Intensive Care Delirium Screening Checklist SCORE

1. Altered level of consciousness. Choose ONE from A-E.

Note: May need to reassess patient if recent administration of sedation therapy

A. Exaggerated response to normal stimulation SAS = 5, 6, or 7 Score 1 point

B. Normal wakefulness SAS = 4 Score 0 point

C. Response to mild or moderate stimulation SAS = 3 Score 1 point

(follows commands) If LOC related to recent sedation/analgesia, score 0

D. Response only to intense and repeated stimulation (e.g., loud voice and pain)

SAS = 2 **Stop assessment

E. No response SAS = 1 **Stop assessment

2. Inattention. Score 1 point for any of the following abnormalities:

A. Difficulty in following commands OR

B. Easily distracted by external stimuli OR

C. Difficulty in shifting focus

Does the patient follow you with their eyes?

3. Disorientation. Score 1 point for any of the following abnormality:

A. Mistake in either time, place, or person

Does the patient recognize ICU caregivers who have cared for him/her and not recognize those that have not? What kind of place are you in? (list examples)

4. Hallucinations or Delusions. Score 1 point for either:

A. Equivocal evidence of hallucinations or a behavior due to hallucinations (Hallucination = perception of something that is not there with NO stimulus) OR

B. Delusions or gross impairment of reality testing (Delusion = false belief that is fixed/unchanging)

Any hallucinations over past 24 hrs? Are you afraid of the people or things around you? (fear that is inappropriate to clinical situation)

5. Psychomotor Agitation or Retardation. Score 1 point for either:

A. Hyperactivity requiring the use of additional sedative drugs or restraints in order to control potential danger (e.g., pulling IV lines out or hitting staff) OR

B. Hypoactive or clinically noticeable psychomotor slowing or retardation

Based on documentation and observation over shift by primary caregiver

6. Inappropriate Speech or Mood. Score 1 point for either:

A. Inappropriate disorganized or incoherent speech OR

B. Inappropriate mood related to events or situation

Is the patient apathetic to current clinical situation (i.e., lack of emotion)?

Any gross abnormalities in speech or mood? Is patient inappropriately demanding?

7. Sleep/Wake Cycle Disturbance. Score 1 point for either:

A. Sleeping less than four hours at night OR

B. Waking frequently at night (do not include wakefulness initiated by medical staff or loud environment) OR

C. Sleep ≥ 4 hours during day Based on primary caregiver assessment

8. Symptom Fluctuation. Score 1 point for:

Fluctuation of any of the above items (i.e., 1–7) over 24 hours (e.g., from one shift to another)

Based on primary caregiver assessment

TOTAL ICDSC SCORE (Add 1 – 8)

A total ICDSC score ≥ has a 99 percentage sensitivity correlation for a psychiatric diagnosis of delirium

Source: Bergeron N et al. (2001). Intensive Care Med. Vol. 27. pp. 869-64 - Revised July 22, 2005

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AGENTS FOR ANALGESIA

Approximate

Equivalent Single IV

Dose b 1,2

Typical

Infusion

Rate b 1,2

Onset to

Peak Effect1

Duration1 Average

Price/Daya

Comments

Opioids

FentaNYL 100-200 mcg 50-200 mcg/hr 2-5 min 0.5-2 hours

$26/day

at a rate of

100 mcg/hr

Fastest onset and shortest duration.

HYDROmorphone (Dilaudid

®)

1.5-2 mg 0.2-3 mg/hr 20-30 min 3-4 hours

$23/day

at a rate of

1.6 mg/hr

5-10x more potent than morphine.

Morphine 10 mg 2-10 mg/hr 20-30 min 3-4 hours

$20/day

at a rate of

10 mg/hr

Avoid in hypotension. Active metabolite accumulates in renal dysfunction. May cause itching due to histamine release (not a true allergy). Decreases preload, which may be beneficial in pulmonary edema.

NSAIDs (Parenteral)

Ibuprofen (Caldolor

®)

400-800 mg IVPB over 30 mg Not

reported 6 hours

$7 per 400mg dose

Infuse over 30 minutes. Not to exceed 3200 mg/day. Black box warnings: Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular thrombotic events. Risk may increase with duration of use. Contraindicated in setting of CABG. NSAIDs increase the risk of gastrointestinal adverse effects.

Ketorolac

(Toradol®)

15-60 mg IV push 1-2 hours 4-6 hours

$0.50-0.80 per

15 mg dose

Max adult dose 120 mg/day (60 mg/d in elderly or weight <50 kg). Do not use for >5 days. Avoid use in renal dysfunction. Monitor for gastrointestinal adverse effects. Black box warning: Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular thrombotic events. Contraindicated in setting of CABG.

a Equivalent prices and doses are approximations and may vary due by institution and due to patient-specific differences in onset and duration of effect.

b Doses higher than recommended in the chart above may be required. Weight-based doses are reported for the following agents, but use may result in high infusion

rates (fentaNYL 0.7-10 mcg/kg/hr, HYDROmorphone 7-15 mcg/kg/hr, morphine 0.07-0.5 mg/kg/hr). Based on clinical experience, more typical infusion rates are included in the table.

References:

1. Crit Care Med. 2008. Vol. 36. pp. 953-963.

2. Crit Care Med. 2002. Vol. 30: pp. 122-123.

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AGENTS FOR SEDATION

Drug Typical IV

Bolus Dose1

Typical

Infusion Rate 1,2

Onset to

Peak 1 Duration1

Average

Price/Daya

Comments

Propofol (Diprivan

®)

0.03-0.15 mg/kg

(max 20 mg)

5-80 mcg/kg/min

1-2 min <20 min

$36/day

at a rate of

50 mcg/kg/min

Fastest onset and shortest duration. Avoid in hypotension. Dose/rate related hypotension/ bradycardia. Avoid IV push bolus due to increased risk of hypotension (if bolus required and low risk of hypotension, limit dose to 10-20 mg). Monitor triglycerides. Provides 1.1 kcal/mL. Monitor for propofol-related infusion syndrome

Midazolam b

(Versed®)

1-6 mg 1-10 mg/hr 5-10 min 1.5-2 hours

$70/day

at a rate of

8 mg/hr

Fast onset - good for acute agitation/anxiety. Active metabolite accumulates in renal dysfunction. Midazolam 2-3 mg is approximately equivalent to 1 mg LORazepam. Midazolam is associated with increased incidents of delirium.

LORazepam b 6

(Ativan®)

1-3 mg 1-5 mg/hr 15-20 min6 2-4 hours

$38/day

at a rate of

4 mg/hr

Slower onset but longer duration. Risk of propylene glycol toxicity with high doses (anion-gap acidosis, ↑ Serum Creatinine, ↑ Lactate). Monitor serum osmolality if rate > 6 mg/hour and consider possible PG toxicity if osmol gap >10-15 3-5

LORazepam is associated with increased incidents of delirium.

Dexmedetomidine (Precedex

®)

1 mcg/kg over 20 min (not

recommended)

0.2-1.5 mcg/kg/hr

30 min 2-4 hours

$408/day

at a rate of

0.8 mcg/kg/hr

Limited data for use as a 1st line agent. FDA approved for use <24 hrs (studied up to 7 days in literature). FDA approved max dose = 0.7 mcg/kg/hr (studied up to 1.5 mcg/kg/hr). No respiratory depression - consider for patient failing spontaneous breathing trial due to agitation/anxiety. Dose/rate related hypotension and bradycardia–bolus not recommended. May cause hyper/hypotension. Consider higher starting dose if used as monotherapy. Expensive.

a Equivalent prices and doses are approximations and may vary due by institution and due to patient-specific differences in onset and duration of effect.

b Midazolam and LORazapem doses higher than recommended in the chart above may be required. Weight-based doses are reported for the following agents, but use

may result in high bolus doses and infusion rates (Midazolam bolus 0.02-0.08 mg/kg and infusion 0.04-0.2 mg/kg/hr; LORazepam bolus 0.02-0.06 mg/kg and infusion 0.01-0.1 mg/kg/hr). Based on clinical experience, more typical bolus doses and infusion rates are included in the table.

References:

1. Crit Care Med. (2008). Vol. 36: pp. 953-963. (for all references unless indicated otherwise)

2. Crit Care Med. (2002). Vol. 30: pp. 122-123.

3. Yahwak. Chest. (2003). Vol. 124. pp. 178S.

4. Arroliga. CCM. (2004). Vol. 32: pp. 1709.

5. Barnes. Pharmacotherap. (2006). Vol. 26: pp. 23.

6. Micromedex. LORazepam monograph. (Oct 2009).

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IC

U S

edation 2

009

43

AGENTS FOR D

ELIRIUM

Adverse Effects

Antipsychotic

Agent

Dosage

Form

Metabolism

Metabolizing

Enzyme

Equiv.

Dosages

(approx)

(mg)

Max Dose

(mg/day)

QTc

Pro

longation

Pote

ntial D

ose

Rela

ted E

ffecta

Sedation

Dopam

inerg

ic2

Recepto

r Affin

ity/

Extr

apyra

mid

al

Sym

pto

ms

b

Anticholinerg

ic

Effects

O

rthosta

tic

Hypote

nsio

n

Black Box Warning:

Incre

ased m

ort

alit

y seen w

hen u

sed in e

lderly

patients

with d

em

entia

-rela

ted p

syc

hosis

due t

o c

ard

iova

scula

r or

infe

ctious c

om

plic

ations.

The u

se o

f th

ese a

gents

for

delir

ium

in I

CU

patie

nts

has n

ot been test

ed in la

rge,

random

ized, pla

cebo-c

ontr

olle

d trials

.

Haloperidol

(Haldol)

Tab, IV

in

jectio

n

T½

:: 21 h

rs

Hepatic

CY

P3A

4,

2D

6

2

35*

Low

Low

H

igh

Low

Low

b

* Use heightened caution and be aware that there is a dose related QT interval prolongation and torsades de pointes (TdP) risk when using in excess of >20 mg per day.

QUEtiapine c

(SEROquel)

Tab

T½

:: 6 h

rs

Hepatic

CY

P3A

4

125

400

Modera

te

Modera

te

Low

M

odera

te

Hig

h

Risperidone

(Risperdal)

Tab,

OD

T

tab, solu

tion

(1 m

g/m

l)

T½

:: 3 h

rs

Hepatic

CY

P2D

6, 3A

4

1

4

Modera

te

Low

H

igh

Low

M

odera

te

Aripiprazole

(Abilify)

Tab,

solu

tion

(5m

g/m

l),

IM inje

ctio

n

T½

:: 75 h

rs

Hepatic

CY

P2D

6, 3A

4

5

30

Low

Low

Low

Low

Low

The following agents are NOT recommended for ICU use.

Ziprasidone d

(Geodon)

Capsule

T

½::

7 h

rs

Hepatic

CY

P3A

4,

1A

2

40

160

Hig

h

Low

H

igh

Low

M

odera

te

OLANZapine e

(ZyPREXA)

Tab,

OD

T

tab, IM

in

jectio

n

T½

:: 30 h

rs

Hepatic

CY

P1A

2

5

20

Low

M

odera

te

Low

M

odera

te

Low

a L

ow

: 3-1

0 m

se

c,

Me

diu

m: 1

0-1

5 m

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139

Tools to Drive Success

ICU Sedation 2009

44

SBT Termination Criteria:

� Respiration Rate >35/minute for >5 minutes

� SpO2 < 90% for > 2 minutes

� New Ectopy

� Heart Rate change 20% from baseline

� Blood Pressure change 20% from baseline

� Accessory muscle use

� Increased anxiety/diaphoresis

__________________

����Return patients who fail a SBT to their previous

ventilator settings and re-screen in 24 hours

����Discuss with MD prn vs. continuous sedation/pain

DAILY AWAKENING TRIAL PROTOCOL SHEET (TEMPLATE) The following protocol sheet contains recommendations from the San Diego Patient Safety Council. Elements may vary based on your patient population and unit needs.

1. Assess for Daily Awakening

Exclusions:

� Increased Intracranial pressure issues

� Neuromuscular blockade

� Significant ventilation support required, such as very high PEEP (____), FiO2 (____)

� CABG immediate post-op

� Other site specific exclusionary criteria:

•

•

2. Perform Daily Awakening

� Wean / Stop sedation

� Consider decreasing narcotics infusion by 25-50%

3. Is Patient Awake and Calm? Use sedation scale (SAS 3-4 or RASS 0 to -1)?

- Take opportunity to assess patient’s pain

- Titrate narcotics as needed for pain

���� If no, Restart Sedation at ½ previous dose (No Rapid Shallow Breathing Index)

���� If yes, proceed to Spontaneous Breathing Trial

4. Assess for Spontaneous Breathing Trial (SBT) (performed by RN and RCP)

*** Patient must meet all criteria to proceed to conduct SBT***

� Calm and co-operative (SAS score of 3 to 4; RASS 0 to -1)

� Hemodynamically stable

� PEEP < 8

� FiO2 < 0.60

� PH > 7.34

� SpO2 > 90%

5. Conduct SBT for 1 Minute

� Mode CPAP

� PEEP = 0

� Pressure support vent. at least 5 - 10

� FIO2 unchanged

After 1 minute, calculate Rapid Shallow

Breathing Index (RSBI):

RSBI = Respiratory Rate/Tidal Volume in liters

<105 = 80% success

>105 = 95% failure

���� If RSBI successful, continue to conduct SBT for up to 2 hours

���� If RSBI failure, return to previous ventilator settings

6. Conduct SBT for up to 2 hours and Continuously Reassess

~~~ Successful Completion SBT ~~~

� Discuss Arterial Blood Gases and Extubation Plan with Physician

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ICU Sedation Guidelines of Care

Is

patient comfortable

and at goal for

Sedation and

Analgesics?

�Reassess goal daily

�Titrate and taper therapy to maintain goal

�Perform awakening trial, if appropriate

No

Yes

TARGET: Non-Verbal Pain Scale: 0 – 2

Critical Care Pain Observation Tool: 0 - 1

Is patient in pain?

�Use pain scale to assess patient

�Set goal for analgesia

See Daily Awakening Protocol

Is patient delirious?

�Use scale to assess patient

Confusion Assessment Method for the ICU (CAM-ICU)

Intensive Care Delirium Screening Checklist (ICDSC)

Pain

Delirium

Consider

potential causes

Consider potential

causes

Is patient agitated / anxious?

�Use scale to assess patient

�Set goal for sedation

TARGET:

Richmond Agitation Sedation Scale (RASS): 0 to -3

Riker Sedation-Agitation Scale (SAS): 3 to 4

Sedation

Hemodynamically Stable

- FentaNYL

- HYDROmorphone

- Morphine

Hemodynamically Unstable

- FentaNYL

Renal Impairment

- FentaNYL

- HYDROmorphone

- FentaNYL infusion at 25 – 50 mcg/hr

- HYDROmorphone infusion at 0.4 – 0.8 mg/hr

- Morphine infusion at 2 – 4 mg/hr

Primary approach for

pain: bolus for pain

control and then infusion

to sustain control.

Signs & Symptoms of Opiate Withdrawal

Pupil dilation

Vomiting

Sweating

Diarrhea

Lacrimation

Hypertension

Rhinorrhoea

Fever

Piloerection

Tachypnea

Tachycardia

Agitation

TITRATING OFF INFUSIONS:

The potential for opioids withdrawal should be considered for

patients receiving high doses or seven (7) days of continuous

therapy. Doses should be tapered systematically (i.e. 10-30%

per day) to prevent withdrawal symptoms.

Consider

potential causes

DRUG SELECTION:

Anticipate sedation (< 72 hours)

- Midazolam

- Propofol

- Dexmedetomidine

Anticipate sedation (> 72 hours)

- LORazepam

Patient has renal impairment

- LORazepam

- Propofol

SEDATION:

Use for RASS greater or equal to 2 levels below what is ordered

(e.g., RASS of -2 with an ordered goal of 0)

1.) LORazepam/midazolam continuous infusion: Hold infusion until patient reaches

RASS goal, then resume at one-half previous rate. Titrate per written orders.

2.) Propofol continuous infusion: Decrease rate 5-10 m

cg/kg/min every 10 minutes

until patient reaches RASS goal. Titrate per written orders.

3.) Morphine/HYDROmorphone/fentaNYL continuous infusion: Hold until patient

reaches RASS goal, then resume at one-half previous rate. Titrate per written orders.

Pharmacologic Treatment for Delirium:

NPO:

�Dexmedetomidine 0.2-1.5 m

cg/kg/hr (Consider in patient s failing

spontaneous breathing trials secondary to agitation)

�Haloperidol 2.5-5mg IV q 15 min prn + delirium (suggested max 35 mg/

day) (Consider decreased dose in hypoactive delirium)

PO:

�Aripiprazole 10-15 mg po daily (Consider when baseline QTc>440 msec)

�Haloperidol 2.5-5 mg po q6 hr (Caution if baseline QTc >440 msec)

�QUEtiapine 50-200 mg po q12 hr (Consider if sedative pr operties desired)

�Risperidone 0.5-1 mg po q12 hr (Caution baseline QTc >440 msec)

Non-Pharmacologic Treatments for Delirium:

- Ensure Daily Awakening Trials conducted

- Continually reorient patient

- Perform

early mobilization

- Promote effective sleep / awake cycles

- Perform

timely removal of catheters/physical

restraints

- Ensure the use of eyeglasses, magnifying

lenses, and hearing aids

- Minimize noise/stimulation at night

- Minimize Benzodiazepines for sedation

�Rule out/correct reversible causes

�Use nonpharmacologic treatment

�Optimize the environment

NOTE: Provided dosing ranges are general guidelines and are

not intended to supersede clinical judgment of prescriber.

Assessment Algorithm for Sedated Adult ICU Patients

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ADULT ICU PAIN ORDERS

1. Target pain score _______ (based on pain assessment)

2. For patient’s pain, select one of the following:

FENTANYL CONTINUOUS INFUSION

FentaNYL infusion at _______ mcg/hr (e.g., 25–50 mcg/hr)

A. FentaNYL bolus at _______ mcg (e.g,. 12.5 mcg) IV every 5 minutes prn pain score 2-3 (mild pain).

B. FentaNYL bolus at _______ mcg (e.g., 25 mcg) IV every 5 minutes prn pain score 4-6 (moderate pain).

C. FentaNYL bolus at _______ mcg (e.g., 50 mcg) IV every 5 minutes prn pain score 7-8 (severe pain).

• Repeat boluses until pain controlled.

• If the patient requires >2 boluses in an hour, increase rate by _______ mcg/hr (e.g., 12.5–25 mcg/hr) every hour.

• Maximum dosage = _______ mcg/hr (e.g., 100–200 mcg/hr).

• Notify physician for oversedation or when target pain score not achieved at maximum dosage.

_________________________________________________________________________________________________

HYDROMORPHONE (DILAUDID®) CONTINUOUS INFUSION

HYDROmorphone infusion at _______ mg/hr (e.g., 0.4–0.8 mg/hr)

A. HYDROmorphone bolus at _______ mg (e.g., 0.2 mg) IV every 10 minutes prn pain score 2-3 (mild pain).

B. HYDROmorphone bolus at _______ mg (e.g., 0.4 mg) IV every 10 minutes prn pain score 4-6 (moderate pain).

C. HYDROmorphone bolus at _______ mg (e.g., 0.8 mg) IV every 10 minutes prn pain score 7-8 (severe pain).

• Repeat boluses until pain controlled.

• If the patient requires >2 boluses in an hour, increase rate _______ mg/hr (e.g., 0.2 – 0.4 mg/hr) every hour.

• Maximum dosage = _______ mg/hr (e.g., 3 mg/hr).

• Notify physician for oversedation or when target pain score not achieved at maximum dosage.

_________________________________________________________________________________________________

MORPHINE CONTINUOUS INFUSION (Avoid in patients with cardiovascular instability or renal impairment)

Morphine infusion at _______ mg/hr (e.g., 2–4 mg/hr)

A. Morphine bolus at _______ mg (e.g., 1 mg) IV every 10 minutes prn pain score 2-3 (mild pain).

B. Morphine bolus at _______ mg (e.g., 2 mg) IV every 10 minutes prn pain score 4-6 (moderate pain).

C. Morphine bolus at _______ mg (e.g., 4 mg) IV every 10 minutes prn pain score 7-8 (severe pain).

• Repeat boluses until pain controlled.

• If the patient requires >2 boluses in an hour, increase rate by _______ mg/hr (e.g., 1–2 mg/hr) every hour.

• Maximum dosage = _______ mg/hr (e.g., 10 mg/hr).

• Notify physician for oversedation or when target pain score not achieved at maximum dosage.

Prescriber / PID: _____________________ Date/Time: ________________ Nurse: ______________________ Date/Time: _____________

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ICU PAIN MANAGEMENT PROTOCOL

SELF-REPORTING PAIN ASSESSMENT SCALE

Wong-Baker FACES Pain Rating Scale*

Directions: When the patient is awake, show this card with the faces. Explain to the person that each face is for a person who feels happy because he has no pain (hurt) or sad because he has some or a lot of pain. Point to each face and ask the person to choose the face that best describes how he is feeling. Based on his response, circle the appropriate scale number.

NOTE: Although the numbers associated with this scale are 0-5, this number scale numbers should be doubled to a scale of 0-10 in order to apply the standard order set.

Alert Smiling

No humor Serious Face

Furrowed brow Pursed lips Breath holding

Wrinkled nose Raised upper lip Rapid breathing

Slow blink Open mouth

Eyes closed Moaning Crying

No Pain

Can be

ignored

Interferes

with tasks

Interferes

with concentration

Interferes with basic needs

Bed rest required

Activity Tolerance Scale

0-10 Numeric Pain Scales** (circle one)

*Adapted from: Hockenberry MJ, Wilson D: Wong’s essentials of pediatric nursing, ed. 8, St. Louis, 2009, Mosby. Used with permission. Copyright Mosby.

**Adapted from: Acute Pain Management: Operative or Medical Procedures and Trauma, Clinical Practice Guideline No. 1. AHCPR Publication No. 92-0032: February 1992; Agency for Healthcare Research & Quality, MD; 116-117.

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NON-VERBAL PAIN SCALE

Directions: Define target pain score using the 10 Point Numerical Rating Scale. Observe the patient per category and, based on your findings, circle the appropriate scale number.

FACIAL EXPRESSION

Score Description

0 No particular smile or expression

1 Occasional grimace, tearing, frowning, and/or wrinkled forehead

2 Frequent grimacing, tearing, frowning, and/or wrinkled forehead

ACTIVITY

Score Description

0 Lying quietly, normal position

1 Seeking attention through movement or slow cautious movement

2 Restless excessive activity and/or withdrawal reflexes

GUARDING

Score Description

0 Lying quietly, no positioning of hands over area of body

1 Splitting areas of the body, tense

2 Rigid, stiff

PHYSIOLOGIC PARAMETER

Score Description

0 Stable vital signs

1 Change over past 4 hours in any of the following SBP > 20mmHg or heart rate > 20 bpm

2 Change over past 4 hours in any of the following SBP > 30mmHg or heart rate > 26 bpm

RESPIRATORY

Score Description

0 Baseline respiratory rate/oxygen saturation, compliant with ventilator

1 RR > 10 above baseline or 5% decrease in oxygen saturation, mild ventilator asynchrony

2 RR > 20 above baseline or 10% decrease in oxygen saturation, mild ventilator asynchrony

SCORE: Target Pain: 0-1

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NON-VERBAL PAIN SCALE (CPOT)

Define target pain score using the Non-Verbal Pain Scale (Critical Care Pain Observation Tool or CPOT) when appropriate.

Indicator Score Description

Relaxed, neutral 0 No muscle tension observed

Tense 1 Presence of frowning, brow lowering, orbit tightening and levator contraction or any other change (e.g. opening eyes or tearing during nociceptive procedures)

Facial expression

Caroline Arbour, RN, B.Sc., M.Sc.A(c)

School of Nursing, McGill University

Grimacing 2 All previous facial movements plus eyelid tightly closed (the patient may present with mouth open or biting the endotracheal tube)

Absence of movements or normal position

0 Does not move at all (doesn’t necessarily mean absence of pain) or normal position (movements not aimed toward the pain site or not made for the purpose of protection)

Protection 1 Slow, cautious movements, touching or rubbing the pain site, seeking attention through movements

Body movements

(Puntillo et al., 1997; Devlin et al.,

1999)

Restlessness 2 Pulling tube, attempting to sit up, moving limbs/thrashing, not following commands, striking at staff, trying to climb out of bed

Tolerating ventilator or movement

0 Alarms not activated, easy ventilation

Coughing but tolerating

1 Coughing, alarms may be activated but stop spontaneously

Compliance with the ventilator (intubated patients)

(Harris et al. 1991. Payen et al., 2001)

OR Fighting ventilator 2 Asynchrony: blocking ventilation, alarms frequently

activated

Talking in normal tone or no sound

0 Talking in normal tone or no sound

Sighing, moaning 1 Sighing, moaning

Vocalization (extubated patients)

(Mateo et Krenzischek, 1992)

Crying out, sobbing 2 Crying out, sobbing

Relaxed 0 No resistance to passive movements

Tense, rigid 1 Resistance to passive movements

Muscle tension

Evaluation by passive flexion and extension of upper limbs when patient is at rest (Ambuel et al., 1992) or when patient is being turned

Very tense or rigid 2 Strong resistance to passive movements, incapacity to complete them

SCORE: __ Target Pain: 0 - 1

Directions for use of the CPOT: 1. The patient must be observed at rest for one minute to

obtain a baseline value of the CPOT. 2. The patient should be observed during nociceptive

procedures (e.g., turning, endotracheal suctioning, wound dressing) to detect any changes in the patient’s behaviors to pain.

3. The patient should be evaluated before and at the peak effect of an analgesic agent to assess if the treatment was effective in relieving pain.

4. For the rating of the CPOT, the patient should be attributed the highest score observed during the observation period.

5. The patient should be attributed a score for each behavior included in the CPOT and muscle tension should be evaluated last, especially when the patient is at rest because just the stimulation of touch (passive flexion and extension of the arm) may lead to behavioral reactions.

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ADULT ICU SEDATION ORDERS

1. Target sedation score _______ (based on sedation assessment)

2. Perform Daily Awakening Protocol

3. Select from below one of the agents ±±±± boluses to treat agitation/anxiety.

4. Notify physician if patient has hemodynamic instability or if target sedation score not achieved at maximum dosages.

________________________________________________________________________________________________________________________________________________________________________________________________

BOLUSES FOR BREAKTHROUGH AGITATION/ANXIETY (Recommended for rapid control)

• Midazolam _________ mg (e.g., 1 – 2 mg) IV every 10 minutes prn mild agitation (e.g., RASS +1 to +2) , and

• Midazolam _________ mg (e.g., 2 – 5 mg) IV every 10 minutes prn moderate/severe agitation (e.g., RASS +3 to +4)

OR

• Lorazepam _________ mg (e.g., 0.5) IV every 20 minutes prn mild agitation (e.g., RASS +1 to +2), and

• Lorazepam _________ mg (e.g., 1 mg) IV every 20 minutes prn moderate/severe agitation (e.g., RASS +3 to +4).

________________________________________________________________________________________________________________________________________________________________________________________________

PROPOFOL (DIPRIVAN®) Infusion (Recommended for sedation <72 hours. Avoid in patients with cardiovascular instability.)

• Start propofol IV infusion at _________ mcg/kg/min (e.g., 5-10 mcg/kg/min).

• Bolus (if checked above) with midazolam as directed or propofol _________ mg (0.03-0.15 mg/kg, max 10-20 mg) for breakthrough agitation

• Titrate propofol by _________ mcg/kg/min (e.g., 5-10 mcg/kg/min) every 5 minutes until target sedation score achieved.

• Maximum rate = _________ mcg/kg/min (e.g., 60 mcg/kg/min).

• Reduce infusion rate by ½ for SBP < _________ mm Hg. Notify physician if patient has hemodynamic instability.

• Notify physician if target sedation score not achieved at maximum dosages.

• Oversedation: Wean Propofol by 10 mcg/kg/min every 10 min until sedation score at goal. (Oversedation “patient exceeds target sedation scale.”)

_________________________________________________________________________________________________

MIDAZOLAM (VERSED®) Infusion (Recommended for sedation <72 hours. Not recommended in impaired renal function.

• Start midazolam infusion at _________ mg/hr (e.g., 1 – 3 mg/hr).

• Bolus (if checked above) with midazolam as directed for breakthrough agitation/anxiety.

• If the patient requires >2 boluses in an hour, increase rate by _________ mg/hr (e.g., 1 – 2 mg/hr) every hour.

• Maximum infusion rate = _________ mg/hr (e.g., 10 mg/hr).

• Notify physician if target sedation score not achieved at maximum dosages.

• Oversedation: Hold infusion until sedation score at goal. Restart infusion at ½ previous rate.

_________________________________________________________________________________________________

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LORAZEPAM (ATIVAN®) Infusion (Recommended for sedation >72 hours)

• Start LORazepam infusion at _________ mg/hr (e.g., 0.5–1 mg/hr).

• Bolus (if checked above) with midazolam OR lorazepam as directed for breakthrough agitation/anxiety.

• If the patient requires >2 boluses in an hour, increase rate by _________ mg/hr (e.g., 1 – 2 mg/hr) every hour.

• Maximum infusion rate = _________ mg/hr (e.g., 10 mg/hr).

• Notify physician if target sedation score not achieved at maximum dosages.

• Oversedation: Hold infusion until sedation score at goal. Restart infusion at ½ previous rate.

________________________________________________________________________________________________________________________________________________________________________________________________

PATIENTS FAILING SPONTANEOUS BREATHING TRIALS DUE TO AGITATION:

DEXMEDETOMIDINE (PRECEDEX®) (Recommended for short-term use. Avoid in patients with cardiovascular instability.)

• Start dexmedetomidine infusion at _________ mcg/kg/hr (e.g., 0.2 – 0.7 mcg/kg/hr).

• Bolus (if checked) with midazolam for breakthrough agitation as directed below.

• Titrate dexmedetomidine by _________ mcg/kg/hr (e.g., 0.1 – 0.2 mcg/kg/hr) every hour until target sedation score achieved.

• Maximum rate = _________ mcg/kg/hr (e.g., 1 – 1.5 mcg/kg/hr).

• Notify physician if patient has hemodynamic instability or if target sedation score not achieved at maximum dosages.

Prescriber / PID: _____________________ Date/Time: ________________ Nurse: ______________________ Date/Time: _____________

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RICHMOND AGITATION SEDATION SCALE

Richmond Agitation Sedation Scale (RASS)

Score Description

RASS Target Sedation = 0 to -3

+4 Combative Overtly combative, violent, immediate danger to staff

+3 Very Agitated Pulls or removes tube(s) or catheter(s); aggressive

+2 Agitated Frequent non-purposeful movement, fights ventilator

+1 Restless Anxious but movements not aggressive vigorous

00 AAlleerrtt aanndd CCaallmm

-1 Drowsy Not fully alert, but has sustained awakening (>10 seconds) (eye-opening/eye contact) to voice

-2 Light Sedation Briefly awakens with eye contact to voice (<10 seconds)

-3 Moderate Sedation Movement or eye opening to voice (but no eye contact)

-4 Deep Sedation No response to voice, but movement or eye opening to physical stimulation

-5 Unarousable No response to voice or physical stimulation

Procedure for RASS Assessment: The basis of the RASS assessment is to see what amount of stimulation is necessary to evoke a response and evaluate sedation.

• Observe patient.

a. Patient is alert, restless, or agitated. (Score 0 to +4)

• If not alert, state patient’s name and say “open eyes and look at (speaker).”

b. Patient awakens with sustained eye opening and eye contact. (Score –1)

c. Patient awakens with eye opening and eye contact, but not sustained. (Score –2)

d. Patient has any movement in response to voice but no eye contact. (Score –3)

• When no response to verbal stimulation, physically stimulate patient by shaking shoulder and/or rubbing sternum.

e. Patient has any movement to physical stimulation. (Score –4)

f. Patient has no response to any stimulation. (Score –5)

Sessler CN, et al. (2002). The Richmond Agitation-Sedation Scale: validity and reliability in adult intensive care patients. Am J Respir Crit Care Med. Vol. 166. pp. 1338-1344.

Ely EW, et al. (2003). Monitoring sedation status over time in ICU patients: the reliability and validity of the Richmond Agitation Sedation Scale (RASS). JAMA ; Vol. 289. pp. 2983-2991

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RIKER SEDATION-AGITATION SCALE (SAS)

Riker Sedation-Agitation Scale (SAS)

Score Term Descriptor

SAS Target Sedation = 3 to 4

7 Dangerous Agitation Pulling at ET tube, trying to remove catheters, climbing over bedrail, striking at staff, thrashing side-to-side

6 Very Agitated Requiring restraint and frequent verbal reminding of limits, biting ETT

5 Agitated Anxious or physically agitated, calms to verbal instructions

4 Calm and Cooperative Calm, easily arousable, follows commands

3 Sedated Difficult to arouse but awakens to verbal stimuli or gentle shaking, follows simple commands but drifts off again

2 Very Sedated Arouses to physical stimuli but does not communicate or follow commands, may move spontaneously

1 Unarousable Minimal or no response to noxious stimuli, does not communicate or follow commands

Jacobi J, Fraser GL, Coursin DB, et al. (2002). Clinical practice guidelines for the sustained use of sedatives and analgesics in the

critically ill adult. Crit Care Med. Vol. 30, No. 1

Guidelines for SAS Assessment

1) Agitated patients are scored by their most severe degree of agitation as described

2) If patient is awake or awakens easily to voice (“awaken” means responds with voice or head shaking to a question or follows commands), that is a SAS 4 (same as calm and appropriate – might even be napping).

3) If more stimuli such as shaking is required but patient eventually does awaken, that is SAS 3.

4) If patient arouses to stronger physical stimuli (may be noxious) but never awakens to the point of responding yes/no or following commands, that is a SAS 2.

5) Little or no response to noxious physical stimuli represents SAS 1

This helps separate sedated patients into those you can eventually wake up (SAS 3), those you can't awaken, but can arouse (SAS 2), and those you can’t arouse (SAS 1).

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ADULT ICU DELIRIUM ORDERS

���� Assess for Delirium using standardized scale (e.g., CAM-ICU or ICDSC)

NOTE: Provided dosing ranges are general guidelines and are not intended to supersede clinical judgment of prescriber.

FOR BREAKTHROUGH AGITATION - check box to select agent(s):

HALOPERIDOL (HALDOL®) BOLUSES

• Haloperidol _________ mg (e.g., 2.5-5 mg) IV every 15 min prn agitation/delirium.

• Maximum daily dose = _________ mg/day (Suggested max total daily dose is 35 mg/day)

• Monitor for Qtc prolongation ________

MAINTENANCE TREATMENT FOR AGITATION/DELIRIUM - check box to select agent(s):

HALOPERIDOL (HALDOL®)

• Haloperidol _________ mg (e.g., 2.5-5 mg) PO every _________ hours (e.g., 6 hours).

• Maximum daily dose (including PRN doses) = _________ mg/day (Suggested max daily dose is 35 mg/day)

• Monitor for QTc prolongation ________

RISPERIDONE (RISPERDAL®) TABLET OR ORALLY DISINTEGRATING TABLET (ODT)

• Risperidone _________ mg (e.g., 1 – 2 mg) PO every _________ hours (e.g,. 12 hours).

• Maximum daily recommended dose is 4 mg/day

• Monitor for QTc prolongation ________

ARIPIPRAZOLE (ABILIFY®)

• Aripiprazole _________ mg (e.g., 5 – 10 mg) PO daily OR _________mg (e.g., 9.75 mg) IM daily.

• Maximum daily recommended dose is 30 mg/day

• Monitor for QTc prolongation ________

QUETIAPINE (SEROQUEL®)

• Quetiapine _________ mg (e.g., 50 mg) PO every _________hours (e.g., 12 hours).

• Maximum daily recommended dose is 200 mg q12h.

• Monitor for QTc prolongation ________

DEXMEDETOMIDINE (PRECEDEX®) (Consider in patients failing spontaneous breathing trials secondary to agitation)

Loading dose _________ mcg (1 mcg/kg) over 20 min (not recommended due to risk of hypotension).

• Start dexmedetomidine infusion at _________ mcg/kg/hr (e.g., 0.2 – 0.7 mcg/kg/hr).

• Titrate dexmedetomidine by _________mcg/kg/hr (e.g., 0.1 – 0.2 mcg/kg/hr) every hour until target sedation score achieved.

• Maximum rate = _________ mcg/kg/hr (e.g., 1 – 1.5 mcg/kg/hr).

• Notify physician if patient has hemodynamic instability or if target sedation score not achieved at maximum dosages.

Prescriber / PID: _____________________ Date/Time: ________________ Nurse: ______________________ Date/Time: _____________

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CONFUSION ASSESSMENT METHOD IN THE ICU (CAM-ICU)

Directions: If patient’s RASS is above -4 (-3 through +4), refer to the following chart and assess for delirium using the Confusion Assessment Method in the ICU (CAM-ICU) on the next page.

Harvard CAM-ICU Flowsheet (by Houman Amirfarzan, M.D., Wes Ely, M.D.) Copyright © 2003, Vanderbilt Medical Center

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CONFUSION ASSESSMENT METHOD FOR THE INTENSIVE CARE UNIT (CAM-ICU)

Table 3: Confusion Assessment Method for the Intensive Care Unit (CAM-ICU)

FEATURE 1: Acute Onset or Fluctuating Course Positive, if answer ‘yes’ to either 1A or 1B. YES NO

1A: Is the patient different than his/her baseline mental status?

OR

1B: Has the patient had any fluctuation in mental status in the past 24 hours as evidenced by fluctuation on a sedation scale (e.g. RASS), GCS, or previous delirium assessment?

FEATURE 2: Inattention Positive, if either score for 2A or 2B is less than 8 Positive Negative

First, attempt the Letters (ASE). If patient is able to perform this test and the score is clear, record this score and move to Feature 3. If patient is unable to perform this test or the score is unclear, then perform the Pictures ASE. If you perform both tests, use the ASE Pictures’ results to score this Feature.

2A: AUDITORY (Letter – ASE) Record score (enter NT for not tested) Score (out of 10):

Directions: Say to the patient, “I am going to read you a series of 10 letters. Whenever you hear the letter ‘A’ indicate by squeezing my hand.” Read letters from the following letter list in a normal tone:

____

S A V E A H A A R T

Scoring: Errors are counted when patient fails to squeeze on the letter “A” and when the patient squeezes on any letter other than “A.”

2B: VISUAL (Pictures - ASE) Record score (enter NT for not tested)

Directions: Use the Picture Packets (A and B) on the next page. Score (out of 10):

____

FEATURE 3: Disorganized Thinking Positive, if the combined score isles than 4 Positive Negative

3A: Yes/No Questions

(Use either Set A or B, alternate on consecutive days if necessary):

Combined Score

(3A + 3B):

Set A Set B ____ (out of 5)

1. Will a stone float on water?

2. Are there fish in the sea?

3. Does one pound weigh more than two pounds?

4. Can you use a hammer to pound a nail?

1. Will a leaf float on water?

2. Are there elephants in the sea?

3. Do two pounds weigh more than one pound?

4. Can you use a hammer to cut wood?

(Patient earns 1 point for each correct answer out of 4) 3A Score ____

3B: Command

Say to patient: “Hold up this many fingers: (Examiner holds two fingers in front of patient) “Now do the same thing with the other hand: (Not repeating the number of fingers). *If patient is unable to move both arms, for the second part of the command ask patient to “Add one more finger”)

(Patient earns 1 point if able to successfully complete the entire command) 3B Score ____

FEATURE 4: Altered level of Consciousness Positive if the actual RASS score is anything other than “0” (zero)

Positive Negative

Is the patient’s current level of consciousness anything other than alert such as vigilant, lethargic, or stupor (e.g.,

score on Richmond Agitation Sedation Scale other than 0 at time of assessment)?

Alert Spontaneously fully aware of environment and interacts appropriately

Vigilant Hyper alert

Lethargic

Drowsy but easily aroused, unaware of some elements in the environment, or not spontaneously interacting appropriately with the interviewer; becomes fully aware and appropriately interactive when prodded minimally

Stupor Becomes incompletely aware when prodded strongly; can be aroused only by vigorous and repeated

stimuli, and as soon as the stimulus ceases, stuporous subject lapses back into the unresponsive state.

(Features 1 and 2 and either Feature 3 or 4): Overall CAM-ICU: Positive Negative

Copyright © 2002, E. Wesley Ely, MD, MPH and Vanderbilt University, all rights reserved.

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2B: VISUAL (Pictures - ASE)

Step 1: 5 pictures

Directions: Say to the patient, “Mr. or Mrs. _________, I am going to show you pictures of some common objects. Watch carefully and try to remember each picture, because I will ask what pictures you have seen.” Then show Step 1 of either Packet A or Packet B, alternating daily if repeat measures are taken. Show the first 5 pictures for 3 seconds each.

Packet A

Packet B

Directions: Say to the patient, “Now I am going to show you some more pictures. Some of these you have already seen and some are new. Let me know whether or not you saw the picture before by nodding your head yes (demonstrate) or no (demonstrate).” Then show 10 pictures (5 new, 5 repeat) for 3 seconds each (Step 2 of Packet A or B, depending upon which form was used in Step 1 above).

Scoring: This test is scored by the number of correct “yes” or “no” answers during the second step (out of a possible 10). To improve the visibility for elderly patients, the images are printed on 6”x10” buff colored paper and laminated with a matte finish. Note: If a patient wears glasses, make sure he/she has them on when attempting the Visual ASE.

Packet A

Packet B

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INTENSIVE CARE DELIRIUM SCREENING CHECKLIST (ICDSC)

Intensive Care Delirium Screening Checklist SCORE

1. Altered level of consciousness. Choose ONE from A-E.

Note: May need to reassess patient if recent administration of sedation therapy

A. Exaggerated response to normal stimulation SAS = 5, 6, or 7 Score 1 point

B. Normal wakefulness SAS = 4 Score 0 point

C. Response to mild or moderate stimulation SAS = 3 Score 1 point

(follows commands) If LOC related to recent sedation/analgesia, score 0

D. Response only to intense and repeated stimulation (e.g., loud voice and pain)

SAS = 2 **Stop assessment

E. No response SAS = 1 **Stop assessment

2. Inattention. Score 1 point for any of the following abnormalities:

A. Difficulty in following commands OR

B. Easily distracted by external stimuli OR

C. Difficulty in shifting focus

Does the patient follow you with their eyes?

3. Disorientation. Score 1 point for any of the following abnormality:

A. Mistake in either time, place, or person

Does the patient recognize ICU caregivers who have cared for him/her and not recognize those that have not? What kind of place are you in? (list examples)

4. Hallucinations or Delusions. Score 1 point for either:

A. Equivocal evidence of hallucinations or a behavior due to hallucinations (Hallucination = perception of something that is not there with NO stimulus) OR

B. Delusions or gross impairment of reality testing (Delusion = false belief that is fixed/unchanging)

Any hallucinations over past 24 hrs? Are you afraid of the people or things around you? (fear that is inappropriate to clinical situation)

5. Psychomotor Agitation or Retardation. Score 1 point for either:

A. Hyperactivity requiring the use of additional sedative drugs or restraints in order to control potential danger (e.g., pulling IV lines out or hitting staff) OR

B. Hypoactive or clinically noticeable psychomotor slowing or retardation

Based on documentation and observation over shift by primary caregiver

6. Inappropriate Speech or Mood. Score 1 point for either:

A. Inappropriate disorganized or incoherent speech OR

B. Inappropriate mood related to events or situation

Is the patient apathetic to current clinical situation (i.e., lack of emotion)?

Any gross abnormalities in speech or mood? Is patient inappropriately demanding?

7. Sleep/Wake Cycle Disturbance. Score 1 point for either:

A. Sleeping less than four hours at night OR

B. Waking frequently at night (do not include wakefulness initiated by medical staff or loud environment) OR

C. Sleep ≥ 4 hours during day Based on primary caregiver assessment

8. Symptom Fluctuation. Score 1 point for:

Fluctuation of any of the above items (i.e., 1–7) over 24 hours (e.g., from one shift to another)

Based on primary caregiver assessment

TOTAL ICDSC SCORE (Add 1 – 8)

A total ICDSC score ≥ has a 99 percentage sensitivity correlation for a psychiatric diagnosis of delirium

Source: Bergeron N et al. (2001). Intensive Care Med. Vol. 27. pp. 869-64 - Revised July 22, 2005

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ICU Sedation 2009

AGENTS FOR ANALGESIA

Approximate

Equivalent Single IV

Dose b 1,2

Typical

Infusion

Rate b 1,2

Onset to

Peak Effect1

Duration1 Average

Price/Daya

Comments

Opioids

FentaNYL 100-200 mcg 50-200 mcg/hr 2-5 min 0.5-2 hours

$26/day

at a rate of

100 mcg/hr

Fastest onset and shortest duration.

HYDROmorphone (Dilaudid

®)

1.5-2 mg 0.2-3 mg/hr 20-30 min 3-4 hours

$23/day

at a rate of

1.6 mg/hr

5-10x more potent than morphine.

Morphine 10 mg 2-10 mg/hr 20-30 min 3-4 hours

$20/day

at a rate of

10 mg/hr

Avoid in hypotension. Active metabolite accumulates in renal dysfunction. May cause itching due to histamine release (not a true allergy). Decreases preload, which may be beneficial in pulmonary edema.

NSAIDs (Parenteral)

Ibuprofen (Caldolor

®)

400-800 mg IVPB over 30 mg Not

reported 6 hours

$7 per 400mg dose

Infuse over 30 minutes. Not to exceed 3200 mg/day. Black box warnings: Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular thrombotic events. Risk may increase with duration of use. Contraindicated in setting of CABG. NSAIDs increase the risk of gastrointestinal adverse effects.

Ketorolac

(Toradol®)

15-60 mg IV push 1-2 hours 4-6 hours

$0.50-0.80 per

15 mg dose

Max adult dose 120 mg/day (60 mg/d in elderly or weight <50 kg). Do not use for >5 days. Avoid use in renal dysfunction. Monitor for gastrointestinal adverse effects. Black box warning: Nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular thrombotic events. Contraindicated in setting of CABG.

a Equivalent prices and doses are approximations and may vary due by institution and due to patient-specific differences in onset and duration of effect.

b Doses higher than recommended in the chart above may be required. Weight-based doses are reported for the following agents, but use may result in high infusion

rates (fentaNYL 0.7-10 mcg/kg/hr, HYDROmorphone 7-15 mcg/kg/hr, morphine 0.07-0.5 mg/kg/hr). Based on clinical experience, more typical infusion rates are included in the table.

References:

1. Crit Care Med. 2008. Vol. 36. pp. 953-963.

2. Crit Care Med. 2002. Vol. 30: pp. 122-123.

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ICU Sedation Guidelines of Care

ICU Sedation 2009

AGENTS FOR SEDATION

Drug Typical IV

Bolus Dose1

Typical

Infusion Rate 1,2

Onset to

Peak 1 Duration1

Average

Price/Daya

Comments

Propofol (Diprivan

®)

0.03-0.15 mg/kg

(max 20 mg)

5-80 mcg/kg/min

1-2 min <20 min

$36/day

at a rate of

50 mcg/kg/min

Fastest onset and shortest duration. Avoid in hypotension. Dose/rate related hypotension/ bradycardia. Avoid IV push bolus due to increased risk of hypotension (if bolus required and low risk of hypotension, limit dose to 10-20 mg). Monitor triglycerides. Provides 1.1 kcal/mL. Monitor for propofol-related infusion syndrome

Midazolam b

(Versed®)

1-6 mg 1-10 mg/hr 5-10 min 1.5-2 hours

$70/day

at a rate of

8 mg/hr

Fast onset - good for acute agitation/anxiety. Active metabolite accumulates in renal dysfunction. Midazolam 2-3 mg is approximately equivalent to 1 mg LORazepam. Midazolam is associated with increased incidents of delirium.

LORazepam b 6

(Ativan®)

1-3 mg 1-5 mg/hr 15-20 min6 2-4 hours

$38/day

at a rate of

4 mg/hr

Slower onset but longer duration. Risk of propylene glycol toxicity with high doses (anion-gap acidosis, ↑ Serum Creatinine, ↑ Lactate). Monitor serum osmolality if rate > 6 mg/hour and consider possible PG toxicity if osmol gap >10-15 3-5

LORazepam is associated with increased incidents of delirium.

Dexmedetomidine (Precedex

®)

1 mcg/kg over 20 min (not

recommended)

0.2-1.5 mcg/kg/hr

30 min 2-4 hours

$408/day

at a rate of

0.8 mcg/kg/hr

Limited data for use as a 1st line agent. FDA approved for use <24 hrs (studied up to 7 days in literature). FDA approved max dose = 0.7 mcg/kg/hr (studied up to 1.5 mcg/kg/hr). No respiratory depression - consider for patient failing spontaneous breathing trial due to agitation/anxiety. Dose/rate related hypotension and bradycardia–bolus not recommended. May cause hyper/hypotension. Consider higher starting dose if used as monotherapy. Expensive.

a Equivalent prices and doses are approximations and may vary due by institution and due to patient-specific differences in onset and duration of effect.

b Midazolam and LORazapem doses higher than recommended in the chart above may be required. Weight-based doses are reported for the following agents, but use

may result in high bolus doses and infusion rates (Midazolam bolus 0.02-0.08 mg/kg and infusion 0.04-0.2 mg/kg/hr; LORazepam bolus 0.02-0.06 mg/kg and infusion 0.01-0.1 mg/kg/hr). Based on clinical experience, more typical bolus doses and infusion rates are included in the table.

References:

1. Crit Care Med. (2008). Vol. 36: pp. 953-963. (for all references unless indicated otherwise)

2. Crit Care Med. (2002). Vol. 30: pp. 122-123.

3. Yahwak. Chest. (2003). Vol. 124. pp. 178S.

4. Arroliga. CCM. (2004). Vol. 32: pp. 1709.

5. Barnes. Pharmacotherap. (2006). Vol. 26: pp. 23.

6. Micromedex. LORazepam monograph. (Oct 2009).

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ICU Sedation Guidelines of Care

IC

U S

edation 2

009

AGENTS FOR D

ELIRIUM

Adverse Effects

Antipsychotic

Agent

Dosage

Form

Metabolism

Metabolizing

Enzyme

Equiv.

Dosages

(approx)

(mg)

Max Dose

(mg/day)

QTc

Pro

longation

Pote

ntial D

ose

Rela

ted E

ffecta

Sedation

Dopam

inerg

ic2

Recepto

r Affin

ity/

Extr

apyra

mid

al

Sym

pto

ms

b

Anticholinerg

ic

Effects

O

rthosta

tic

Hypote

nsio

n

Black Box Warning: Increased mortality seen when used in elderly patients with dementia-related psychosis due to cardiovascular or infectious complications.

The use of these agents for delirium in ICU patients has not been tested in large, randomized, placebo-controlled trials.

Haloperidol

(Haldol)

Tab, IV

injection

T½:: 21 hrs

Hepatic

CYP3A4, 2D6

2

35*

Low

Low

High

Low

Low b

* Use heightened caution and be aware that there is a dose related QT interval prolongation and torsades de pointes (TdP) risk when using in excess of >20 mg per day.

QUEtiapine c

(SEROquel)

Tab

T½:: 6 hrs

Hepatic

CYP3A4

125

400

Moderate

Moderate

Low

Moderate

High

Risperidone

(Risperdal)

Tab, ODT

tab, solution

(1 m

g/ml)

T½:: 3 hrs

Hepatic

CYP2D6, 3A4

1

4

Moderate

Low

High

Low

Moderate

Aripiprazole

(Abilify)

Tab,

solution

(5mg/m

l),

IM injection

T½:: 75 hrs

Hepatic

CYP2D6, 3A4

5

30

Low

Low

Low

Low

Low

The following agents are NOT recommended for ICU use.

Ziprasidone d

(Geodon)

Capsule

T½:: 7 hrs

Hepatic

CYP3A4, 1A2

40

160

High

Low

High

Low

Moderate

OLANZapine e

(ZyPREXA)

Tab, ODT

tab, IM

injection

T½:: 30 hrs

Hepatic

CYP1A2

5

20

Low

Moderate

Low

Moderate

Low

a Low: 3-10 m

sec, Medium: 10-15 m

sec, High: > 15 m

sec

b Increased with IV form

ulation

c Caution: Bone m

arrow suppression; blood dyscrasias

d Secondary to high risk for QT prolongation

e Secondary to high risk for metabolic syndrome

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SBT Termination Criteria:

� Respiration Rate >35/minute for >5 minutes

� SpO2 < 90% for > 2 minutes

� New Ectopy

� Heart Rate change 20% from baseline

� Blood Pressure change 20% from baseline

� Accessory muscle use

� Increased anxiety/diaphoresis

__________________

����Return patients who fail a SBT to their previous

ventilator settings and re-screen in 24 hours

����Discuss with MD prn vs. continuous sedation/pain

DAILY AWAKENING TRIAL PROTOCOL SHEET (TEMPLATE) The following protocol sheet contains recommendations from the San Diego Patient Safety Council. Elements may vary based on

your patient population and unit needs.

1. Assess for Daily Awakening

Exclusions:

� Increased Intracranial pressure issues

� Neuromuscular blockade

� Significant ventilation support required, such as very high PEEP (____), FiO2 (____)

� CABG immediate post-op

� Other site specific exclusionary criteria:

•

•

2. Perform Daily Awakening

� Wean / Stop sedation

� Consider decreasing narcotics infusion by 25-50%

3. Is Patient Awake and Calm? Use sedation scale (SAS 3-4 or RASS 0 to -1)?

- Take opportunity to assess patient’s pain

- Titrate narcotics as needed for pain

���� If no, Restart Sedation at ½ previous dose (No Rapid Shallow Breathing Index)

���� If yes, proceed to Spontaneous Breathing Trial

4. Assess for Spontaneous Breathing Trial (SBT) (performed by RN and RCP)

*** Patient must meet all criteria to proceed to conduct SBT***

� Calm and co-operative (SAS score of 3 to 4; RASS 0 to -1)

� Hemodynamically stable

� PEEP < 8

� FiO2 < 0.60

� PH > 7.34

� SpO2 > 90%

5. Conduct SBT for 1 Minute

� Mode CPAP

� PEEP = 0

� Pressure support vent. at least 5 - 10

� FIO2 unchanged

After 1 minute, calculate Rapid Shallow

Breathing Index (RSBI):

RSBI = Respiratory Rate/Tidal Volume in liters

<105 = 80% success

>105 = 95% failure

���� If RSBI successful, continue to conduct SBT for up to 2 hours

���� If RSBI failure, return to previous ventilator settings

6. Conduct SBT for up to 2 hours and Continuously Reassess

~~~ Successful Completion SBT ~~~

� Discuss Arterial Blood Gases and Extubation Plan with Physician

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1

Lori Woolsey

Subject: FW: Special request from the U.S. Department of Health and Human Services' Agency for Healthcare Research and Quality

From: Isquith, Bob (AHRQ) To: Jan Emerson Cc: Isquith, Bob (AHRQ) ; Godfrey, Leslie (AHRQ/OCKT) Sent: Thu Mar 04 06:57:06 2010 Subject: Special request from the U.S. Department of Health and Human Services' Agency for Healthcare Research and Quality Dear Ms. Emerson: Could you please tell California hospitals and health systems that the Agency for Healthcare Research and Quality would be happy to supply them with free bulk copies of our patient education publications and audiovisual products. We also have free guides for clinicians. Our comparative effectiveness research-based patient and clinician guides make head-to-head comparisons of the benefits and risks of medications or other therapies used for treating conditions such as gestational diabetes, type 2 diabetes, high blood pressure, osteoarthritis, depression, prostate cancer, and induced labor. To see our full current list of AHRQ patient guides and clinician guides, your members should go to http://effectivehealthcare.ahrq.gov/ and click on “Guides for Patients and Consumers” and Guides for Clinicians.” We can also supply California hospitals and healthcare systems with other free AHRQ patient information of their choosing. For example, we recently produced a 10-minute video to help clinicians educate patients for whom they’ve prescribed an anticoagulant. In addition, the DVD will help your members meet the Joint Commission Patient Safety Goal of educating patients and families about anticoagulants. To view the video, which can be seen in English or Spanish, and our bilingual pamphlet, your members should go to http://www.ahrq.gov/consumer/btpills.htm To see all our free patient and consumer health education publications audiovisual products, hospitals should go to http://www.ahrq.gov/consumer/. For Spanish, click on the link at the bottom of the Web page. Products can be ordered singly or in quantity from the AHRQ Publications Clearinghouse at 1-(800) 358-9295 or by e-mail to ahrqpubs@ahrq.gov Thank you for your attention. I hope to hear from you soon. Bob Isquith Office of Communications and Knowledge Transfer Agency for Healthcare Research and Quality Public Health Service U.S. Department of Health and Human Services 540 Gaither Road Rockville, Maryland 20850 (301) 427-1539

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February 19, 2010 TO: Medication Safety Committee Members FROM: Dorel Harms, MS, RN

Senior Vice President, Clinical Services SUBJECT: Updated 2010 Meeting Schedule Following is the updated meeting schedule for 2010 Medication Safety Committee in-person meetings:

FEBRUARY 17, 2010 Welcome Reception, Hyatt’s Capitol Room (5:30–7:00) FEBRUARY 18, 2010 General Session (9:00–Noon), Committee Meeting (1:30-4:30)

APRIL 20, 2010 SACRAMENTO, CHA OFFICES BOARD ROOM AUGUST 18, 2010 SACRAMENTO, CHA OFFICES BOARD ROOM DECEMBER 15, 2010 SACRAMENTO, CHA OFFICES BOARD ROOM

You will receive an official call approximately one month prior to each meeting indicating the exact location. Thank you and if you have any questions, please feel free to call me directly at (916) 552-7574. DFH:lw

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