Annual Meeting

Clinical Administration PRN Focus Session—Core Measure, Competencies, Black Box Warnings and REMS…Oh My! Activity No. 0217-0000-11-080-L05-P (Knowledge-Based Activity) Monday, October 17 3:45 p.m.–5:45 p.m. Convention Center: Rooms 319 & 320 Moderator: Herbert G. Mathews III, Pharm.D. Pharmacy Operations Manager, Pharmacy Residency Director, Carroll Hospital Center, Westminster, Maryland Agenda 3:45 p.m. How Schools of Pharmacy Are Handling Making Our Students

Competent in BBW, REMS, and Core Measures B. Joseph Guglielmo, Pharm.D. Thomas A. Oliver Chair in Clinical Pharmacy, Professor of Clinical Pharmacy, University of California–San Francisco, San Francisco, California

4:10 p.m. The Role of Pharmacist in Core Measures Compliance—Impact of Clinical Pharmacists and Ways to Document and Present (the Data?) Jean B. Douglas, Pharm.D. Clinical Pharmacy Coordinator, Moses Cone Hospital, Cone Health, Greensboro, North Carolina

4:35 p.m. Thinking Inside the Box: The Black Box

Harminder Sikand, Pharm.D., FCSHP, FASHP Clinical Director/Residency Director, Scripps Mercy Hospital. San Diego, California; Associate Professor, University of California–San Francisco.

5:00 p.m. Thinking Outside of the Box: REMS in the Medical Center—

Assessing REMS Processes and Outcomes and Improving Compliance Juliana Chan, Pharm.D. Clinical Pharmacist, University of Illinois at Chicago, College of Pharmacy; University of Illinois Medical Center, Chicago, Illinois

Faculty Conflict of Interest Disclosures Juliana Chan: no conflicts to disclose. Jean B. Douglas: no conflicts to disclose. B. Joseph Guglielmo: no conflicts to disclose. Harminder Sikand: no conflicts to disclose.

Annual Meeting

Learning Objectives

1. Describe the challenges to pharmacy administrators in preparing competent pharmacist in the fast changing environment.

2. Described various tools and metrics that may be used to survey pharmacy competency. 3. Evaluate the impact accrediting agencies (CMS, TJC) have on the pharmacist role in improving

medical center compliance. 4. Discuss examples of quality initiative projects that may be performed and introduced into the

pharmacist workflow to improve core measure performance. 5. Identify methods for clinical pharmacists to document and present core measure results to C-

Suite. 6. Describe the challenges associated with black box warning for pharmacy administration and

pharmacists. 7. Present examples of (logistical) solutions for solving issues surrounding black box warnings. 8. Review the impact of Risk Evaluation and Mitigation Strategy (REMS) requirements on the

health-system and the medical providers. 9. Identify opportunities and methods for clinical pharmacists to improve compliance rates with

REMS in health care organizations.

Self-Assessment Questions Self-assessment questions are available online at www.accp.com/am

How Schools of Pharmacy are Handling Making our Students 

Competent in BBW REMS and CoreCompetent in BBW, REMS and Core Measures

B. Joseph Guglielmo, Pharm.D.Professor and Chair

Department of Clinical PharmacyDepartment of Clinical PharmacySchool of Pharmacy

University of California San Francisco

Presentation ObjectivesPresentation Objectives

• Highlight current role of pharmacy studentsHighlight current role of pharmacy students toward institutional goals for safe, effective medication managementg

• Review the literature confirming SOP preparation of students for safe medication managementof students for safe medication management

• Suggest next steps toward making our students competent in medication safety (including BBWcompetent in medication safety (including BBW and REMS) and satisfactory compliance with core measures

Google and PubMed Searches for Key fReferences

Search terms: “Schools of Pharmacy, Black Box W i REMS C M ”Warnings, REMS, Core Measures”

Search Results:  

“How Schools of Pharmacy are Handling Making our Students Competent in BBW, REMS and Core Measures” 2011 ACCP Annual Meeting

Background InformationBackground Information

• Defining relationships between SOPs and hostDefining relationships between SOPs and host institutions

• Characterizing perceived and actual role of• Characterizing perceived and actual role of students at host institutions

Boilerplate agreement exists between d hSOP and host institution

31.6%

68.4%

Yes No

All preceptors have volunteer faculty h h h lappointments with the school

38.5%

61.5%

Yes No

Initial orientation is provided for all preceptors

47.1%

52.9%

Yes No

The SOP provides mentoring and l fongoing evaluation of preceptors

26.3%

73.7%

Yes No

For host institutions for multiple SOPs, l l l da single evaluation tool is used

11.1%

88.9%

Yes No

Host institutions considerHost institutions consider

16.7%27.8%

55.6%

students to be an asset toward fulfilling hos... students to be a drain on the efficiency of t...

students to be neutral toward fulfilling host...

SOPs with affiliations with academic medical id P&T C icenters provide support to P&T Committee

28.6%

71.4%

Yes No

Google and PubMed Searches: Trying One More Time

• Search terms: “Schools of Pharmacy and Black Box Warnings” “Schools of Pharmacy andBox Warnings ,  Schools of Pharmacy and REMS”, “Schools of Pharmacy and Core Measures”Measures

Pharmacy Students’ Knowledge of Black Box WarningsBlack Box Warnings

• Cross‐sectional survey administered to pharmacy students in first, second, and third professional years assessing student awareness of medications with BBW

• Classroom instruction on black box warnings occurredClassroom instruction on black box warnings occurred in the 3rd year, consisting of one 2‐hour lecture in the drug information/biostatistics class and 2 examinations in the pharmacy skills laboratory class. The lecturein the pharmacy skills laboratory class. The lecture consists of reviewing the history, definition, FDA criteria, and types of information included in black box warning Additionally the lecture focuses onwarning. Additionally, the lecture focuses on limitations of black box warnings and the use of warnings as a communication tool. (Moeller KE et al Am J Pharm Educ 2010; 74(1): 5)(Moeller KE et al Am J Pharm Educ. 2010; 74(1): 5) 

Pharmacy Students’ Knowledge of l kBlack Box Warnings

• Mean number of correct responses identifying the p y gpresence or absence of a black box warning among the 20 medications were 5.8 ± 3.3, 9.6 ± 4.0, and 14.8 ± 2.8 for the P1 P2 and P3 students respectivelyfor the P1, P2, and P3 students, respectively. 

• Knowledge of black box warning content was variable. • Students were least aware of the warning content forStudents were least aware of the warning content for stavudine and enoxaparin. 

• Students were most familiar with the warning content for paroxetine and estrogen.

(Moeller KE et al Am J Pharm Educ. 2010; 74(1): 5) 

SOPs and BBW Training: Requirements ffrom ACPE

• Currently the study of black box warnings isCurrently the study of black box warnings is not mentioned in the Accreditation Council for Pharmacy Education (ACPE) AccreditationPharmacy Education (ACPE) Accreditation Standards and Procedures

• However this may be assumed under the• However, this may be assumed under the umbrella topic of medication safety. 

Teaching the Science of Safety in US ll d h l f hColleges and Schools of Pharmacy

• Background: collaboration between the FDA, the g ,American Association of Colleges of Pharmacy (AACP), and the Pharmacy Services Support Center (PSSC) at the American Pharmacists Associationthe American Pharmacists Association

• Methods: Literature review, key informant interviews of 30 individuals, and in‐depth case studies of 5 pcolleges and schools of pharmacy ((Temple, University of Arizona, Midwestern University – Chicago College of Pharmacy University of Southern California andPharmacy, University of Southern California, and Virginia Commonwealth University)(Holdford DA et al. Am J Pharm Educ 2011; 75 (4) Article 77)

Teaching the Science of Safety in US ll d h l f hColleges and Schools of Pharmacy

• Results: “Educators believe that they areResults:  Educators believe that they are devoting adequate time to science of safety topics and doing a good job teaching studentstopics and doing a good job teaching students to identify, understand, report, manage, and communicate medication risk ”communicate medication risk.

(Holdford DA et al Am J Pharm Educ 2011; 75 (4) Article 77)(Holdford DA et al. Am J Pharm Educ 2011; 75 (4) Article 77)

Teaching the Science of Safety in US Colleges and Schools of Pharmacy:Colleges and Schools of Pharmacy: 

Recommendations AACP Conference addressing:AACP Conference addressing:

1. Elements of the FDA Science of Safety Model Curriculum that should be a part of theCurriculum that should be a part of the education of all graduates

2 Ed i l l i h i2. Educational outcomes relating to the science of safety and measurements of outcomes

3. Role of academia in promoting the science of safety within the profession

Teaching the Science of Safety in US Colleges and Schools of Pharmacy: g y

Recommendations Studies should be conducted to quantify Studies should be conducted to quantify science of safety outcomes achieved at colleges and schools of pharmacycolleges and schools of pharmacy More education resources should be developed and made available to colleges anddeveloped and made available to colleges and schools of pharmacy (e.g. Educating Pharmacy Students and Pharmacists to Improve Quality p Q y(EPIQ) program available through the PQA (www.pqaalliance.org/)

Teaching the Science of Safety in US Colleges and Schools of Pharmacy:Colleges and Schools of Pharmacy: 

Recommendations

Educational materials should be developed that target pharmacy students’ learning gapsthat target pharmacy students  learning gaps

Interprofessional education and training needed in patient safety and related topicsneeded in patient safety and related topics

UCSF Experience Specific to BBWs, REMS, Core Measures

• Pharmacy Administration class revamped toPharmacy Administration class revamped to address medication safety, including core measures BBWs REMSmeasures, BBWs, REMS

• APPE students engaged in vaccination core measuresmeasures

• Senior student projects include BBW, REMS, CCore measures

ConclusionsConclusions

• Very little is objectively been done by SOPs to e y tt e s object e y bee do e by SO s toprepare graduates for involvement in medication safety and core measures

• The 2011 AJPE paper is a good start regarding recommendations for student education in 

di ti f tmedication safety• Students must be an asset to host institutions, including contributions to safe effectiveincluding contributions to safe, effective medication management (including participation with BBWs, REMS, core measures), , )

PHARMACISTS IN CORE MEASURES COMPLIANCE

I M P A C T A N D D O C U M E N T A T I O N

MEASURES COMPLIANCEI M P A C T A N D D O C U M E N T A T I O N

JEAN BENSON DOUGLAS, B.S., PHARM.D., FASHP

• Clinical Pharmacy Coordinator• Clinical Pharmacy CoordinatorThe Moses H. Cone Memorial HospitalCone Health, Greensboro, NC

• Representing our Pharmacist team’s goals to drive compliance for Core Measures over past 2 years:

Initial phase: memory manual and paper• Initial phase: memory, manual, and paper• Current phase: VigiLanz® Clinical Decision Support• Future phase: EPIC® +/- VigiLanz®

• Project Leadership: Pharmacy Clinical Coordinators and Manager of Medication Safety and Quality for Cone Health

SPEAKER HAS NO CONFLICTS OF INTEREST THAT REQUIRE DISCLOSURE.

CONE HEALTH PHARMACYCONE HEALTH PHARMACY

• The Moses H Cone Memorial Hospital• The Moses H. Cone Memorial Hospital• The Women’s Hospital of Greensboro• Wesley Long Community HospitalWesley Long Community Hospital• Behavioral Health Hospital• Annie Penn Hospital• Ambulatory Care Centers:

• Regional Cancer Center and ClinicsL B H tC C di l Ri k R d ti Cli i• LeBauer HeartCare Cardiovascular Risk Reduction Clinic

• Internal Medicine Outpatient Clinic and Medical Home• Employee Pharmacy• MedCenter High Point Emergency and Oncology

PRACTICE MODELPRACTICE MODEL

• Integrated practice model—pharmacists and g p ptechnicians trained to provide all services

• Each staff member expected and encouraged to have at least one area of specialtyhave at least one area of specialty

• Staff expected to ACTIVELY participate on systemwide pharmacy quality teams and y p y q ymultidisciplinary committees/teams

• All staff assigned annual systemwide pharmacy goals in:goals in:• Quality• Performance• Financial viability• Patient satisfaction

STAFF ACCOUNTABLE FOR:STAFF ACCOUNTABLE FOR:

• Collaborative practice protocols• Medication reconciliation (100% complete)• Evidence-based formulary recommendations• Quality ‘Bus’ teamsQuality Bus teams

• Infectious Disease, Pediatrics, Internal Medicine, Critical Care, Oncology, Nutrition, Neonatal, Surgery, and Distribution

• Core Measures Team Pharmacists for:• Core Measures Team Pharmacists for:• MI, HF, pneumonia, SCIP, VTE, Stroke, and Immunizations

• Precepting residents and students• Response to Code Blue, Code Stroke, Code STEMI, and Code

Sepsis• ED pharmacist patient work-ups• Direct pharmacist care: Critical Care, Pediatrics, Neonatal,

Infectious Disease, Nutrition, and Medication Reconciliation

OBJECTIVESOBJECTIVES

1 Evaluate impact accrediting agencies have on 1. Evaluate impact accrediting agencies have on pharmacist role in Core Measure compliance

2. Discuss examples of quality initiative projects that may be introduced into the pharmacist workflow to improve Core Measure performanceto improve Core Measure performance

3 Identify methods for clinical pharmacists to 3. Identify methods for clinical pharmacists to document and present Core Measure results to the C-Suite

US HEALTHCARE IS RATED AS37TH IN TERMS OF QUALITY WORLDWIDE (OUT OF 190 NATIONS)37 IN TERMS OF QUALITY WORLDWIDE (OUT OF 190 NATIONS)

AND HIGHEST IN SPENDING FOR HEALTH CARE (WHO)

• Core Measures have improved outcomes in CMS ppopulation

• Decreased LOS with AMI and HF• Decreased readmission rate with pneumonia and HFDecreased readmission rate with pneumonia and HF• Decreased mortality with AMI, HF, and pneumonia

• Core Measures have been designed as an i t t limprovement tool

• Evidence-based guidelines to reduce variation • Evidence-based care for better patient outcomes• Tells us what is happening internally, helping focus on ‘why’• Concurrent data collection and analysis: We cannot manage

what we cannot measured f lit t bl t ( i b t d • Reward for quality at reasonable cost (reimbursement and

patient selection of facility)

OUR OUTCOMES ARE PART OF WHOLE TEAM’S SCORE: ONE SCORECARD FOR THE INSTITUTION

• Know the Core Measures: which patients timing • Know the Core Measures: which patients, timing requirements, monitoring parameters, patient education to be provided

• Apply measures to each patient and document as met or as not appropriate, within time frameParticipate in education of patient to influence • Participate in education of patient to influence successful med taking

• Incorporate Core Measures into daily practicep y p• Step up to make the institution successful and

selected by patients

CHANGE AGENTSCHANGE AGENTS

• CMS (Centers for Medicare and Medicaid Services)• Leading the change initiative for quality and reduced variation in

care and costsi i• Processes being used include:

• Evidence -based guidelines (from National Quality Forum)• Measuring outcomes based upon documentation in chart• Sharing outcomes with others and patients• Reducing provider reimbursement (if ‘quality mark’ is missed)

• TJC (The Joint Commission) and NQF (National Quality Forum)• Implementer of Core Measures into surveys• Accreditation status dependent on Core Measures• Reviews data collected and overall quality/patient satisfaction

‘MAJOR’ CHANGE AGENTMAJOR CHANGE AGENT

• Patient Protection and Affordable Care Act• Patient Protection and Affordable Care Act(H.R. 3590)• Established Value-Based Purchasing (VBP)

• Hospital Performance Score • Decision to with hold reimbursement dollars then award based

on performance numbers that meet criteria• This puts some of Medicare reimbursement at risk to institutions

• Medicare Reimbursement Risk (2013)• HCAHPS (30%)• Readmission Rates• Hospital Acquired Conditions (HAC)• Efficiency Measures—Accountability Measures• Healthcare-Associated Infections and Core Measures (70%)

LEADERSHIP GOALLEADERSHIP GOAL

• Identify a systemwide departmental goal for each of our 4 ‘pillars’

• QualityQ y• Patient Satisfaction• Employee Satisfaction• Medication cost per patient dischargeMedication cost per patient discharge

• Systemwide Departmental Quality Goal• Collaborate with quality teams

Lead improvements and hardwire• Lead improvements and hardwire• Attend to the details of our patients• Initiate interventions

I % li f h C M• Improve % compliance for each Core Measure• Teach and learn

CORE MEASURES INCLUDE MEDICATIONSCORE MEASURES INCLUDE MEDICATIONS

• Acute myocardial infarctionAcute myocardial infarction• 6 medication-related measures out of 9

• Heart Failure• 3 medication-related out of 4

• Pneumonia• 6 medication-related out of 9

• SCIP9 f 12• 9 of 12

• Stroke• 6 medication-related out of 8

• Venous thromboembolismVenous thromboembolism4 medication-related out of 6

CMS recognized Pharmacist documentation for:• Pneumonia risk eu o a s • AMI/HF reason for no ACEI/ARB at discharge• AMI bradycardia with beta blocker

OUR APPROACHOUR APPROACH…..

• Pharmacist assigned to each Core Measure team • Learn about Core Measures and metrics• Concurrent inpatient review (find ways to identify patients)• Concurrent inpatient review (find ways to identify patients)• Develop preprinted order sets that ‘hardwire’ and speed up

provision of careEd t th th i t t h t ti• Educate others on these important changes to practice• Share dashboards with Pharmacy Quality Teams & staff

• Form relationships with other providers to allow teamwork, bl l i d t t b ildiproblem-solving, and trust-building

• Brainstorm and find ways to keep improving• Share numbers, research literature for better ways, etc.• Celebrate successes

COMPETENCY PLANCOMPETENCY PLAN

• Educate on 2 Core Measures per monthp• Core team pharmacists to guide learning: data, stats,

processes• Streamed live via Media Site® to each pharmacy• Streamed live via Media Site® to each pharmacy• On-site real-time questions and answers• Presentations made available for off-site review• CBL (computer-based learning tool) questions required a

pass of >80%• Each pharmacist to ‘journal’ 2 interventions for • Each pharmacist to journal 2 interventions for

performance appraisal• Sites shared process improvements with other sites via a

l di i ( di Sit ®)panel discussion (Media Site®)• Complete survey on learning/practice goal

LIVE CORE MEASURES EDUCATION

HARDWIRINGHARDWIRING

• Redesign processes to allow Core Measures to be met ALL THE TIMEE l• Examples:• Preprinted order sheets for Core Measures areas• Vaccine assessment and direct order• Pharmacist documenting ‘reasons’ in chart and signing• Monitoring sheet reworked to capture step of Core Measure

work with handoffs and follow-upwork with handoffs and follow up• VTE process ‘owned’ by pharmacists with approved policies

for ordering baseline INRs, overlap planning, etc.• tPA computer calculation based upon literature etc• tPA computer calculation based upon literature, etc.

PNEUMONIA PHARMACIST RESPONSIBILITIES

T t ED d f tibi ti STAT d d li• Treat ED orders for antibiotics as STAT and deliver• Antibiotics to be given within 6 hours of arrival and after

cultures drawn• Verify vaccinations: Pneumococcal and influenza (nurse

assessment drives automatic order for vaccine to pharmacy). • Non-ICU antibiotics within 24 hoursNon ICU antibiotics within 24 hours

• β-lactam (IV or IM) + macrolide (IV or PO)• β -lactam (IV or IM) + doxycycline (IV-PO)

A ti l i l (IV PO)• Antipneumococcal quinolone (IV or PO)• ICU Antibiotic selection within 24 hours

• β -lactam (IV) + macrolide (IV)β ( ) ( )• β -lactam (IV) + antipneumococcal quinolone (IV)

VTE PHARMACIST RESPONSIBILITIESVTE PHARMACIST RESPONSIBILITIES

• Verify VTE prophylaxis within 12 hours (drug or SCDs • Verify VTE prophylaxis within 12 hours (drug or SCDs, or reason why none ordered); enter SCD as order

• Confirm VTE treatment has a 5-day overlap of y pheparin/warfarin and until INR ≥2• Send patient home with prescriptions if needed and

document in medical recorddocument in medical record• Dose heparin treatment via protocol and write order for or

confirm baseline platelets at baseline, day #2, then every other day while on heparinother day while on heparin

• Look for ‘never events’ (development of VTE after admission, etc.)

• VTE discharge instructions (3 visits with documentation of • VTE discharge instructions (3 visits with documentation of follow-up monitoring—patient to sign as understanding)

HEART FAILURE PHARMACIST RESPONSIBILITIES

• Document left ventricular function• Document left ventricular function• Check ECHO, cath report, transcribed reports of past

admissions/visits• Verify that ACEI or ARB ordered if EF <40% or state reason

why not (e.g., allergy, aortic stenosis, high K, low BP, renal function)

• Order smoking cessation consult/education (if not done)• Document heart failure education and discharge med

instruction (booklets and medication reconciliation)• Beta-blockers ordered or stated why not• If needed, design a medication calendar• If needed, arrange a Care Coordinator consultIf needed, arrange a Care Coordinator consult

MYOCARDIAL INFARCTION PHARMACIST RESPONSIBILITIES

• Check for aspirin within 24 hours before or after • Check for aspirin within 24 hours before or after arrival (may ask if given on ambulance en route); order if not given

• Verify aspirin upon discharge• Verify ACEI or ARB for LVSD; state reason in chart if

not appropriatenot appropriate• Verify B-blocker at discharge; state reason in chart if

not appropriatepp p• Provide thrombolytic or PCI within 90 minutes of

arrival (attend Code STEMI to dose drugs per renal l t )clearance, etc.)

STROKE PHARMACIST RESPONSIBILITIES

• Thrombolytic = tPAThrombolytic tPA• Verify weight, calculate full dose or 2/3 dose, check, deliver to

ED ‘STAT’ with info on IV pump programming• Enter drug into ED computer system for charting• Enter drug into ED computer system for charting• Verify timing for drug: 4.5 hours if >80, INR ≤1.7, NIHSS >25 and

history of both stroke and diabetesVerify ASA given by end of Day #2• Verify ASA given by end of Day #2

• Verify VTE prophylaxis by end day #2• Verify warfarin started in A Fib patients with TIA/stroke and

ti d t di hcontinued at discharge• Allow no therapeutic heparin—only prevention• Verify discharged on antiplatelet or warfarin• Verify statin ordered before discharge• Educate all warfarin patients prior to discharge & teach FAST

SCIP PHARMACIST RESPONSIBILITIESSCIP PHARMACIST RESPONSIBILITIES

• Verify VTE prophylaxis required 24 hours before surgery start time or within 24 hours after anesthesia end time

• Verify antibiotics given within 24 hours before • Verify antibiotics given within 24 hours before incision or 24 hours after anesthesia time (move up antibiotic if needed)

• Document reason for continuing antibiotics• Document reason for vancomycin use (e.g., dialysis,

chronic wound care SNF patient recent admission)chronic wound care, SNF patient, recent admission)• Verify β-blocker given 24 hours prior incision to 6

hours postp• Document reasons for not administering β-blocker

• NPO or ‘hold oral meds’ does not count

EDUCATION PROVIDEDEDUCATION PROVIDED

• Knowledge• Structure and knowing what to do• Importance of the evidence• Checklist, what to document, and when to

intervene• Accountability• Better outcomes for our patients• Confidence that we can accomplish our

department goal

POST-LECTURESPOST-LECTURES

• Each pharmacy department defined processes that could be • Each pharmacy department defined processes that could be changed to drive up % compliance in areas such as:• Patient E-Chart updates

R i i t h i t it i h t/ h t t• Revisions to pharmacist monitoring sheet/chart notes• Handoff process improvements• Better documentation in medical record

• Quality teams led recommendations to change systems/ documentation

• Core Measure abstractors participatedp pin discussions to answer questions perspec manual

• Clinical Coordinators reviewed andencouraged changes to meet goals.

HARDWIRED CHANGESHARDWIRED CHANGES

• Updated all order sets for prophylaxis• Updated all order sets for prophylaxis• Review target list and intervene if no VTE prophylaxis• Document prophylaxis contraindications for OHS

patients• Core Measure reminder forms located in pharmacy and

ready to be placed in chart for pharmacist signatureready to be placed in chart for pharmacist signature• 1st dose antibiotics are STAT or NOWs• Adjust antibiotic start time for post-op dose• Verify aspirin and β-blockers prior to discharge• CAP patients on oral azithromycin, change to IV • Calculated tPA for stroke patients for referral hospital• Calculated tPA for stroke patients for referral hospital• Medication reconciliation discharge process

WE MET OUR 2010 QUALITY GOAL OFCORE MEASURE COMPETENCY TRAINING!

Core Core Core

Core

SiteCore

Measure 1 – Stroke

Measure 2 –VTE and

SCIP-VTE

Core Measure 3 –HF and MI

Measure 4 –Pneumonia and SCIP

APH 100% 100% 100% 100%

BH 100% 100% 100% 50%

Med HP 100% 100% 100% 100%

MCH 95% 90% 90% 90%

Out Pt 100% 100% 86% 86%

RCC 100% 100% 100% 100%

WLCH 90% 90% 90% 100%

WH 100% 100% 100% 100%WH 100% 100% 100% 100%

Systemwide 98% 98% 95% 93%

INTERVENTIONS AT MCHINTERVENTIONS AT MCH

• March 2010 (pre training)• March 2010 (pre training)• 80% interventions documented on monitoring notes

• 1 heart failure met (3%) but no prophylaxis, 1 vaccine met (3%) d t VTE h l i (97%)and rest were VTE prophylaxis (97%)

• September 2010 (post training)• 98% interventions documented (paper)(p p )

• 1 PNA met (3%), SCIP met (20%), 5 HF met (8%), and VTE (99% within 24 hours, 100% 5 day overlap, and 100% education)

• >50% increase in heart failure compliance due to ppharmacists’ documentation of ACEI/ARB/’reason’

• >40% improvement in compliance for pneumonia due to pharmacist work in antibiotic selectionp

OUR IMPACTOUR IMPACTBaseline Current Changeg

Stroke DVT ppx 92%, d/c antithrombotics 100%, warf afib 100%, antithrombotic by day #2 94%, D/C statin 100%, tPA 100% (OVERALL 92%)

DVT ppx 100%, d/c antithrombotics 100%, warf afib 100%, antithrombotic by day #2 92%, D/C statin 100%, tPA 100% (OVERALL

SAME

(OVERALL 92%) statin 100%, tPA 100% (OVERALL 92%)

VTE Prophylaxis 86%, overlap 94%, protocol 98%, D/C 59%, new VTE w/o prophylaxis 31% (OVERALL 31%)

Not measured this quarter

p p y ( )

HF LVD fxn 100%, ACEI 97%, Discharge 82% (OVERALL 82%)

LVD fxn 100%, ACEI 100%, Discharge 94% (OVERALL 94%)

MI ASA arrival 98%, ASA d/c 98%, ACEI and β-blocker 100% for both

ASA arrival 96%, ASA d/c 98%, ACEI and β-blocker 100%

SAMEand β-blocker 100% for both(OVERALL 96%)

ACEI and β-blocker 100% (OVERALL 96% )

SCIP β-Blockers 89%, Abx start 92%, Abx selection 97%, Abx end 96%, VTE 83% (OVERALL 83%)

β-Blockers 97%. Abx start 99%, Abx 100%, Abx end 99%, VTE 98% (OVERALL 97%)

(OVERALL 83%) (OVERALL 97%)

PNA Pneumonia vacc 98%, influenza vacc 96%, 6 hr abx 96%, Abx selection 87% (OVERALL 87%)

Pneumonia vacc 100%, 6 hr abx 97%. Abx selection 96% (OVERALL 96%)

STAFF FEEDBACK ON QUALITY GOALSTAFF FEEDBACK ON QUALITY GOAL

• Suggested:• Suggested:• Reference cards to fit in pocket• Rounds with Clinical Coordinators• Educate hospitalist physicians on PNA treatment• Develop electronic reminders• Find ways to identify patients earlier, before time limitFind ways to identify patients earlier, before time limit• Redo monitoring sheet to last whole admission and provide

space to document• Celebrate the ‘quick’ response times of the technicians • Celebrate the quick response times of the technicians

• tPA, PCI meds, med rec notice of last dose taken, vaccination alerts, and antibiotic removal for recycling

• Change is hard but hardwiring helps• Change is hard, but hardwiring helps

LEARNEDLEARNED

• ‘Everyone loves change, but no one wants to be changed’

• Change takes time• Change takes time• Dashboards created a ‘tension for change’• Can find yourself on the other side of the fence with Can find yourself on the other side of the fence with

physician colleagues who resist imposed change• Leadership may not understand need to talk with

i t ll di l ttresistors personally vs. sending letters• Listen• Attention to the changes captures interest and is • Attention to the changes captures interest and is

worth minimal costs

2010 PAPER PROCESS2010 PAPER PROCESS

• Core Measure forms placed in chartp• Measures spelled out• Place to documentPh i t M it i h t i d t h h t • Pharmacist Monitoring sheet revised to show what was done• Spoke with provider – accepted vs. not accepted• Signed medical record as patient not able to meet

measure • Left instructions with nurse, etc., if certain times of daye s uc o s u se, e c., ce a es o day• Placed discharge information in medical record

• Hard to tabulate what pharmacist did and impact dmade

• Handwriting, pull medical record, assist abstractor, etc.

VIGILANZ®CLINICAL DECISION SUPPORT

• Provides clinicians with knowledge and patient• Provides clinicians with knowledge and patient-specific information (from multiple interfaces)

• Intelligently filtered based upon defined ‘rules’

• Presented to clinician in time to improve health and health care

TOOL DESIGNED TOTOOL DESIGNED TO

• Create clinician work flows• Create clinician work flows• Pharmacists, infectious disease pharmacists, infection

prevention practitioners• Create efficiencies previously unavailable

• Moving from a paper-based process to an electronic workflow; have a patient list at start of shiftp

• Pull data to meet Core Measures timelines• Alerts inform clinician in time to get orders and

documentation completeddocumentation completed• Uncover dangerous or less than ideal clinical

situations related to drug therapy (prevent ADEs)• Help reduce drug costs and duplicate processes

CLINICAL PHARMACIST WORKFLOW

From April 1 2011 to May 31 2011 (Two Months) this rule has fired 170 times – Pharmacist making some form of intervention in 33/170 cases (20%)33/170 cases (20%)

RULES-BASED SOFTWARERULES-BASED SOFTWARE

• Workflow changed to ‘real-time’

• Acknowledgement Status• Not acknowledged

• initial alert status• Acknowledged

• I have completed work on this alert• I have completed work on this alert• Follow-up

• This alert requires further follow up, either by me or another shift

2011 CURRENT EXPERIENCE WITH ELECTRONIC TOOL

ADE avoidance core screens IV to PO• ADE avoidance, core screens, IV to PO• 356 rules

• DVT screenDVT screen• HF screen• IV to PO conversion

D l f ti• Drug-renal function• Duration of therapy

• Infectious DiseaseInfectious Disease• 32 rules

• Infection ControlInfection Control• 16 rules

RESULTS WITH VIGILANZ®RESULTS WITH VIGILANZ

VTE CORE MEASUREVTE CORE MEASURE

DVT PROPHYLAXIS SCREENINGDVT PROPHYLAXIS SCREENING

• Patients at 12 hours post admission who have no prophylaxis ordered (anticoagulant, mechanical DVT prophylaxis or have a DVT check)DVT prophylaxis, or have a DVT check)• Rechecks criteria at 2, 4, and 6 days post admission

• Pharmacists screened 1500 patients in 2 months, with an action being taken in 28% patients

• At 12 hours, 83% patients have DVT prophylaxis• Pharmacist to get orders before the 24 hour windowg

CLINICAL DECISION SUPPORTCLINICAL DECISION SUPPORT

Al t itt t ‘fi ’ h t i it i • Alerts written to ‘fire’ when certain criteria are identified and in ‘real time’

• Pharmacist assigned to units gets electronic notice Pharmacist assigned to units gets electronic notice of alert on laptop, stating need to see patient.

• Pharmacist easily marks results as ‘acknowledged’ ‘ d f f th f ll ’or ‘need for further follow-up’

• Patient information shown to all pharmacists who see patients behind you; visible check-offsee patients behind you; visible check off

• Easier hand-offs• Team can meet patient goals, instead of just one

pharmacist seeing what needs to be done.

COMMUNICATIONCOMMUNICATION

M di ti S f t Ph i t t ith Q lit • Medication Safety Pharmacist meets with Quality team of Board of Trustees

• QLT (Quality Leadership Team) presentations by QLT (Quality Leadership Team) presentations by pharmacists and Medication Safety Pharmacist

• Showcasing work and telling ‘stories’• Physician newsletters, e-mails, service meetings• Nursing Grand Rounds, Shared Governance, Magnet, unit

huddles, staff meetings, etc.• Posters and presentations at national and state meetings• Storyboards with results/outcomes/dashboards• ‘Catch of the Day’Catch of the Day• Culture: ‘pharmacists prevent drug-related problems’

IMPACTIMPACT

• Many ‘new’ situations recognized and acted upon • Recognized as leaders in quality movement landscape• Ability to interpret data allows discussion with physicians

in patient care decisions• Ownership of medication safety improvement• Ownership of medication safety improvement• Quality Department relies heavily on pharmacists• Compliance risen to ‘top box’p p

• AMI 2 %, HF 3%, and PN 1% in last quarter

• Created ‘community’ for quality, strong results, and pride for patient centered carepride for patient-centered care

ON THE QUALITY ROAD….ON THE QUALITY ROAD…..

Ch• Changes• Clinical Paths include Core Measures, with pharmacist

driving medication compliance strategies• Measure progress (i.e., dashboards with leadership

reviewing quality numbers)• Quality Department held accountable for results (new y p (

specialized staff hired to track this work)• Rethinking systems and ‘hardwiring’• Fighting the ‘change monster’ with creative strategies for Fighting the change monster with creative strategies for

buy-in (i.e., magnets )• Data documented before discharge to secure maximum

reimbursementreimbursement• Quality discussion is part of every meeting/initiative

FUTUREFUTURE

• One integrated patient chartOne integrated patient chart• All information to be found in one place• Will allow upfront decision-making to meet Core p g

Measures• Document times of various steps/tests/administrations• Hard-stops vs. defaults vs. alertsHard stops vs. defaults vs. alerts

• Provider easily identified• Robust enough to replace VigiLanz®?

• Pharmacist role changing to ‘designer of Pharmacist role changing to designer of automated processes’ for documentation of quality care, in addition to clinical responsibilities.

SUMMARYSUMMARY

• Accrediting agencies and payers have introduced g g p y‘outcomes measurement’ into daily practice• Right drug and timing of administration for reimbursementW kfl j t h ‘h d i i ’ ti d t• Workflow projects show ‘hardwiring’ expertise due to:

• data management skills, • problem-solving skills, • change management skills, and • expertise in communicating the importance of Core Measures

• Documentation and communication of Core Measure metrics are equally important as ‘pharmacokinetic dosing’ services and other clinical servicesservices.• Core Measures -- a new dimension of pharmacist’s practice.

QUESTIONS?QUESTIONS?

• Jackie.Roh@conehealth.com• Jim.Hasspacher@conehealth.com• Jean.Douglas@conehealth.com

• 336 832 8108• www.jointcommission.orgj g• www.cms.gov/qualitymeasures/03_electronicspecifications• www.hospitalcompare.hhs.gov/hospital_search• www.iqh.org/attachments/219_coremhelpbooklet• Smith Darin On-Demand Webinar: Opportunities • Smith, Darin. On-Demand Webinar: Opportunities

for Improving core measure Performance Through Pharmacist Intervention. 09-15-2010, pharmacyonesource.www vigilanz com• www.vigilanz.com

Think Inside The Box:Think Inside The Box:

The Black BoxThe Black Box

Harminder Sikand Pharm D., FCSHP, FASHPClinical Director Scripps Mercy HospitalClinical Director, Scripps Mercy HospitalAssociate Professor, UCSF School of PharmacyOctober 17, 2011

BackgroundBackgroundBackgroundBackground

As of 2005 14% of the package insert (PI) As of 2005, 14% of the package insert (PI) labeling changes have been due to black box warnings (BBW) revisions or additionsg ( )

~20 million people took at least 1 of the 5 drugs withdrawn from the market between September 1997-September 1998 3 drugs were new (< 2years on market)

Generali, J. Hospital Pharmacy 2008; 43(1): 7Lasser K et al. JAMA 2002; 287 (17):2215-2220

Seven drugs drugs approved since 1993

d th and then withdrawn may have

ibcontributed to 1002 deaths

BackgroundBackgroundBackgroundBackground

1975-1999 548 new chemical entities 1975 1999, 548 new chemical entities 56 (10.2%) received a new

BBW/withdrawn 45 (8.2%) received one or more BBW 16 (2.9%) withdrawn

> 50% of new BBW occurred within first 7 > 50% of new BBW occurred within first 7 yrs of being on the market

Estimated probability based on Kaplan-p y pMeier analysis of acquiring a new BBW or being withdrawn is 20% over 25 yr

Currently >430 medications with BBW Currently >430 medications with BBW

O’Connor et al Am Fam Physician 2010; 81(3):298Lasser K et al. JAMA2002; 287 (17):2215-2220

Harvard investigators

930 000 ti t i 10 i t t d 930,000 patients in 10 integrated health care plans

40% t k di ti ith BBW 40% took medications with BBW Prescriber compliance 0.3-49% Failure frequently associated w/ lab

monitoring ~50% baseline labs not ordered

Wagner, AK et. Drug Saf 2006;15:387-9

What is a Black Box Warning What is a Black Box Warning (BBW) ?(BBW) ?

Strongest medication l t d i i d related warning issued

by the Food and Drug y gAdministration (FDA) for a prescription a prescription medication

U.S. Department of Health and Human Services; January 2006

BBW

Brief concise summary of critical Brief, concise summary of critical information including restrictions on distribution or use of the medication

It can focus on: adverse effects monitoring requirements Drug interactions drug drug disease laboratory

Three Kinds of BBWThree Kinds of BBWThree Kinds of BBWThree Kinds of BBW

1 Serious adverse reaction in comparison to benefit 1. Serious adverse reaction in comparison to benefit (fatal, life-threatening or permanently disabling) that consideration of risk vs benefit is essential

2 Potential for a serious adverse 2. Potential for a serious adverse, prevented/reduced in severity by appropriate prescribingpatient selection /careful monitoringpatient selection /careful monitoringavoiding concomitant therapy /drug interactionsmanaging patients in a specific manner

avoiding use in a specific clinical situationavoiding use in a specific clinical situation3. Approval with mandatory restrictions

Distribution / Certification programDofetilide, Accutane

U.S. Department of Health and Human Services; January 2006

Why Do I Care?Why Do I Care?

Healthcare providers are required to Healthcare providers are required to provide patients with information about the relevant risks of medications

HCP need to evaluate if the benefit HCP need to evaluate if the benefit outweighs the risk with a BBW medication to ensure safe prescribing

HCP d t k h BBW t d HCP need to know how BBW are generated HCP need to know that a large number of

common medications carry BBW Code of Federal Regulations places safe use

of medications under our oversight

Office of Inspector General Report (OIG) November 2010

Evaluated 780 Medicare beneficiaries discharged Evaluated 780 Medicare beneficiaries discharged 10/08

Physicians determined if an ADE occurred, its level of harm & if preventableof harm & if preventable

13.5% experienced an ADE during hospital stay (1:7)

Projected 15 000 patients/month Projected 15,000 patients/month Medication related (n=128)

31%(40)ADE 7/12 deaths due to medication 43%(73) lead to temporary harm 50%(57) were preventable

Problem # 1Problem # 1

NO comprehensive list NO comprehensive list Cheng, Guglielmo et al Evaluated 8 key references at or before 2009y 416 prescription medications found 32 % in all 8 references Sensitivity 42-98% Sensitivity 42 98% NO reference had a boxed warning in

monograph Conclusion Conclusion Imperfect data base Need to cross reference New information subscribe to MedWatchNew information subscribe to MedWatch

Cheng et al. Arch Intern Med 2010,170(9):831-33

lllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllllll

Evaluated consistencies of BBW across Evaluated consistencies of BBW across drug classes

20 top selling drug classes (176 drugs) in 2008 20 categories. 9/20 classes with 15 BBW were not

present on labels of drugs within same class 10/15 BBW were elsewhere on the label or as simple

warnings or text Time lag of 10 drugs with BBW acquiring a warning in

8 t i d f 2 14 8 categories ranged from 2 mo-14 years More transparent and systematic approach to ensure

warnings are consistent across all drugs within the same category and all additions to warnings are done same category and all additions to warnings are done within a reasonable and uniform time period.

Panagiotuou OA et al. Journal of Internal Medicine 2011

Problem # 2Problem # 2

A Awareness Knowledgeg

Study MethodologyStudy Methodology

Two hospital survey Two hospital survey May-August 2011 General knowledge of BBW General knowledge of BBW Survey completed real time Conducted at meetings/ in person Conducted at meetings/ in person Observed

No access to information sources No response to question was considered an

incorrect answer

BBW Education BBW Education

P and T and MEC presentation P and T and MEC presentation Pharmacy Newsletter New physician orientation New physician orientation Physician newsletter Presentation at all Supervisory committees Presentation at all Supervisory committees Pharmacists competency Clinical Pharmacy Practice council Clinical Pharmacy Practice council

discussion

Pilot St d Q estionsPilot Study Questions

1. Discipline2. What does it mean when a medication has a

BBW? (m/c)BBW? (m/c)3. Where would you find information about a

BBW? (m/c)4. Metformin has BBW for lactic acidosis and is

contraindicated with Scr 1.4/1.5 mg/dL (t/f)5 Oxycontin 40 mg can be given to a patient 5. Oxycontin 40 mg can be given to a patient

after two days on oral morphine 60 mg /day (t/f)

Pending publication

ResultsSurvey Demographics

29Rph

RN

29

RN

MD3129

N=89

100%Test Accuracy100%Test Accuracy

70

50

60

70

30

40

50

%

10

20

30

0

Total Rph MD RN N= 89Clinician TypeClinician Type

Distribution of Incorrect Answers by Clinician

*RN < MD/RpH

50

60 *RN < MD/RpH (p = .04)

30

40

MD

RN

%

10

20RN

RpH

0Meaning Metformin Oxycontin

Question # 3 – 100% accurate

Significance of Study findings

Ph i t h b tt k l d Pharmacists have a better knowledge but by a slim margin

Bi t bl di ti Biggest problem area - medication content knowledge related to BBW M tf i ti Metformin > oxycontin

Limitations Pharmacist misunderstanding of the

oxycontin question

Problem # 3 Regulatory Knowledge

3 related to BBW

Title 42 Code of Federal Regulations§482.25 Conditions of Participation: Pharmaceutical §482.25 Conditions of Participation: Pharmaceutical Services

Medicare/Medicaid Program Medicare/Medicaid Program “Hospital must have pharmaceutical services that

meet the needs of the patients. The medical staff is responsible for developing P&P that minimize is responsible for developing P&P that minimize drug errors…”

Interpretative guidelines state “P&P should include: high alert medications dosing P&P should include: high-alert medications- dosing

limits, administration guidelines, packaging, labeling and storage”.

“The should have a means to incorporate external The should have a means to incorporate external alerts and/or recommendations from national associations and governmental agencies for review and facility P&P consideration….”

www.cms.gov/manuals/downloads/SOM107; Personal conversation Loariann DeMartini, CDPH

CDPH Findings Fentanyl Patch

Retrospective analysis Retrospective analysis 8/08-7/10 22 hospitals 22 hospitals 48 patients 96% (46) not opioid tolerant 96% (46) not opioid tolerant 19% treatment of acute pain 12.5% lack of adequate indication 19% initial excessive dose 8% (4) patient harm

Personal Communication- Loriann DeMartini, Chief Pharmaceutical Consultant.,CDPH August 2011

The details… Continued use in non-opioid tolerant Continued use in non opioid tolerant

patients Post C section in PACU 92yr 100mcg patch 200 mcg in 48hr Demise 92yr 100mcg patch, 200 mcg in 48hr. Demise

24 hr after 2nd patch. Pharmacist not available, lives in Tennessee and commutes to CA

Pharmacist intervention in two other cases. a ac st te e t o t o ot e casesDose decreased in one, no change in the other. Dispensed despite contraindication

Pre-printed order form “fentanyl 12.5mcg for i id ï ti t ” H it l h d d th 4 opioid naïve patients”. Hospital had a death 4

months ago related to IV haloperidol and fentanyl patch

CDHP Droperidol findings On preprinted orders without ECG monitoring On preprinted orders without ECG monitoring

requirement ED General Admission orders

In one survey 90 inpatients had an order of droperidol No comment about ECG required

Primary agent for n/v 8 of 13 preprinted orders at one hospital 8 of 13 preprinted orders at one hospital Physician interviewed – use droperidol as it’s the only

antiemetic listed Common comment “we don’t have a problem with

d ope idol as e ha e ne e had an deaths”droperidol as we have never had any deaths” Most hospitals are not monitoring ECG and QTC to

evaluate torsades de points

Personal Communication- Loriann DeMartini, Chief Pharmaceutical Consultant.,CDPH August 2011

The Fines In California May 2010 Droperidol given at Emanuel May 2010. Droperidol given at Emanuel

hospital OR. Anesthesiologist did not evaluate the ECG for QTc prolongation $50 000 fine $50,000 fine Medication removed from formulary Anesthesiologist removed from staff

State legislation as of January 2009 State legislation as of January 2009 $50,000 for first violation ($25,000 in 2007) $75,000 for second

$100 000 f hi d $100,000 for third Can result in loss of certification to participate in

Medicare/Medcaid program

Thompson, CA,. Am J Health Syst Pharm. 2008;65(10) 890-894www.modbee.com/2011

Problem # 4 and 5 Enforcing restrictions and empowerment Enforcing restrictions and empowerment Pharmacist Nurses Physicians

Monitoring and intervention tools System vulnerabilities System vulnerabilities CPOE prompts? Yu et al. Impact of implementing alerts about

medication black-box warnings in electronic health medication black box warnings in electronic health records before and after alert implementation No impact on improvement of BBW adherence

rate

Background on BBWBackground on BBW

Black Box FactsBlack Box FactsBlack Box FactsBlack Box Facts

S f t fil f h i l Safety profile of a new chemical entity is limited by premarketing data Unde po e ed to detect an ADR Underpowered to detect an ADR number of patients Homogenous population Homogenous population Concurrent pharmacotherapy Latent side effects Latent side effects

How are BBW generated?How are BBW generated?How are BBW generated?How are BBW generated?

Pre marketing Pre-marketing Controlled trials prior to medication launch

P t k ti Post-marketing Sentinel event reporting (FDA -

MedWATCH)MedWATCH) Voluntary reporting system overseen by FDA’s Office

of Surveillance and Epidemiology M di ti ti d i k t Medication error prevention and risk management. http://www.fda.gov/safety.medwatch/howtoreport/d

ownloadforms Reports–designation of warning/ BBW/withdrawn

O’Connor et al. Am Fam Physicians 2010; 81(3): 298-303

Regulatory PerspectiveRegulatory PerspectiveRegulatory PerspectiveRegulatory Perspective

Each Department of Health Services Each Department of Health Services (DHS) facility is directed to develop a facility-specific policy describing how BBW facility specific policy describing how BBW are being addressed to safeguard the patients in an INPATIENT and Ambulatory p ysurgical care site

Physician, Nursing, Pharmacist component Regulatory requirement Fines (droperidol)( p )

Medications with BBWMedications with BBW Analgesics CNS Drugsg Anticonvulsants Antidiabetics Anti-Infectives

Aminoglycosides

g Skeletal Muscle Relaxants Antiparkinson Drugs Anesthetics Adjuncts to

Anesthesia Contrast Agentsg y

Antifungals Antituberculins Antivirals Fluoroquinolones

Contrast Agents Dermatologic Agents Gastrointestinal Agents Hematological Agents Hormonesq

Miscellaneous Antineoplastics Cardiovascular Agents CNS Drugs

Sex Hormones Thyroid Hormones

Immunologic Agents and Biologics

Psychiatric Agents g Antihistamines Stimulant Depressants

Psychiatric Agents Renal Agents Respiratory Agents Vaccines Vitamins/Iron

Common reasons for withdrawalCommon reasons for withdrawalCommon reasons for withdrawalCommon reasons for withdrawal

Qt l ti Qt prolongation Grepafloxacin, astemizole, cisapride

C di t Cardiac events rofecoxib, valdecoxib

Hepatic damage Troglitazone, pemoline

Rhadomyolysis Cerivastatin

Medication WITHDRAWALS in US Medication WITHDRAWALS in US 19801980 2007200719801980--20072007

Ticranyfen (1980) Astemizole (1999) Ticranyfen (1980) Benoxaprofen (1982) Zomepirac (1983) Nomifensine (1986)

( ) Alosetron* (2000) Phenylpropanolamine(2000) Troglitazone (2000)( )

Suprofen (1987) Encainide (1991) Temafloxacin (1992)

Cisapride * (2000) Rapacurium (2001) Cerivastatin (2001) Rofecoxib (2004) Flosequinan (1993)

Dexfenfluramine (1997) Fenfluramine (197) Terfenadine (1998)

Rofecoxib (2004) Natalizumab* (2005) Fanolesomab99mTc (2005) Pemoline (2005) Terfenadine (1998)

Mibefradil (1998) Bromfenance (1998) Grepafloxacin (1999)

Pemoline (2005) Valdecoxib (2005) Pergolide (2007) Tegaserod (2007) Grepafloxacin (1999) g ( )

* Currently have restricted access program

BBW designated in 2006BBW designated in 2006BBW designated in 2006BBW designated in 2006

Bevacizumab Methadone Bevacizumab Cetuximab Dextroamphetamin

e sulfate

Natalizumab Nimodipine Pimecrolimuse sulfate

Docetaxel Fluticasone/

salmeterol

Pimecrolimus Tacrolimus Thalidomide Tipranivirsalmeterol

Formoterol Hydromorphone I fli i b

Tipranivir Tolcapone Trastuzumab V l i id Infliximab

Lenalidomide Metformin

Valproic acid /derivatives

Warfarin

http://formularyproductions.com/blackbox

BBW designated in 2007BBW designated in 2007BBW designated in 2007BBW designated in 2007

ACE inhibitors Ketorolac Acitretin Adalimumab Alemtuzumab

Ketorolac Methampethamine Mycophenolate Omalizumab

Antidepressants (SSRIs, TCAs)

Antipsychotics Cetuximab

Perflutren Pioglitazone Protamine

Cetuximab Entecavir ESAs Fentanyl

Raloxifene Rituximab Rosiglitazone Telith om in Fentanyl

Gadolinium contrast agents

idursulfurase

Telithromycin Tenofovir Tinidazole Tolcapone

http://formularyproductions.com/blackbox

Tolcapone

BBW designated in 2008BBW designated in 2008BBW designated in 2008BBW designated in 2008

Abacavir Fluoroquinolones Abacavir Antipyschotics

(conventional) Atomoxetine

Fluoroquinolones Lapatinib Laronidase N i i Atomoxetine

Becalpermin Clindamycin D b ti

Nevirapine Perflutren Tenofovir

Darbepoetin Efalizumab Emtracitabine

Trastuzumab

Entecavir Epoetin

http://formularyproductions.com/blackbox

Recent Medications with BBWRecent Medications with BBWRecent Medications with BBWRecent Medications with BBW

D d Dronaderone Telavancin Tolvaptan Prasugrel Acetaminophen

Key DHS High Priority BBW Key DHS High Priority BBW GuidelinesGuidelines

Drug BBW Pharmacist Action toDrug BBW Pharmacist Action to consider

Amiodarone Pulmonary & √ LFT if > 600 mghepatic toxicity

Carbamazepine Aplastic anemia Agranulocytosis

√ CBC if new orderg y

Enoxaparin Spinal/epidural hematoma risk

• be aware of epidural orders• advise nurses to hold per guidelinesguidelines

Fentanyl patch Respiratory depression. Use in

√ do not use opioid naive• develop and require order formp

opioid tolerant pt.develop and require order form

Haloperidol IV Sudden deathQT l ti

√ EKG monitoring for IV admin.R i di ti f QtQT prolongation • Review medications for Qtc

prolongationwww.socalpatientsafety.org; September 2010 update

Key DHS High Priority BBW Key DHS High Priority BBW GuidelinesGuidelines

Drug BBW Pharmacist Actions toDrug BBW Pharmacist Actions to Consider

Ketorolac Short term use in mod to i M d

√ renal functionsevere pain. Max dose based on age and weight. Risk CV, thrombotic, MI, stroke and GIB

• 48 hours stop date

stroke and GIBMetformin Lactic acidosis Scr

• Contraindicated Scr >1.5 l 1 4 F lmale, >1.4 Female

•Advise MD to hold 48 hr after IV contrast

Warfarin Risk of major bleeding PT/INR• Review D-D interaction• Advise dietician of orderAdvise dietician of order• Follow hospital anticoag policywww.socalpatientsafety.org; September 2010 update

BBW guideline implementation in an BBW guideline implementation in an i i i idi i i idinpatient setting, some ideas…inpatient setting, some ideas…

Clinical pathways/order sets with restrictions Enoxaparin Ketorolac

Automatic discontinuation by pharmacists Metformin Metformin Erythropoeitin

Focused P and T approved interventions at order entry Fentanyl patch, MS Contin, Oxycontin, Haloperidol IV

Registry Clozapine, erythropoeitin

Ongoing monitoring Warfarin, amiodarone, valproic acidWarfarin, amiodarone, valproic acid

Restrictions for use Prasugrel, dronaderone, dabigatran

Pharmacy order entry alerts CPOE??? CPOE???

Opportunities Regulatory guidance Regulatory guidance Focused education Medical, Pharmacy and Nursing Schools, y g Hospital administration

Ownership across all disciplines M di l i d h i ti Medical, nursing and pharmacy associations Boards of Pharmacy etc.. Integrate into our workflow both in the inpatient

and outpatient arena

Recognize it could happen to me and its EVERYONE’s responsibilityEVERYONE s responsibility

What can you do? Be proactive rather than passive Be proactive rather than passive Realize there are no concrete steps. Have discussions

with your staff and clinicians and engage them in the solutionsolution

Review BBW list to determine if there is something that can be done for the most common medications your institution usesy

Make formal recommendations through hospital committees on how you will heed or not heed BBW guidelines for a specific medication

Document benefit vs risk, evidence-based Determine an accountability plan and monitor it both

with Medical and Pharmacy Staff

What’s new on the horizon?

REMS ≠ BBWREMS ≠ BBW

BBW References FDA Medication Safety Sites FDA Medication Safety Sites http://www.fda.gov/medwatch/safety.htm

FDA E email notification FDA E-email notification http://www.fda.gov/medwatch/elist.htm

Bl k B Li t Black Box List http://www.formularyproductions.com/blac

kboxkbox

Generali, J. Black Box Warning. Study Guide 2011 Guide 2011.

Thinking Outside of the Box: REMS in the M di l C t A i REMS P dMedical Center—Assessing REMS Processes and

Outcomes and Improving Compliance

October 17, 2011

Juliana Chan, Pharm.D.Clinical PharmacistClinical Assistant ProfessorClinical Assistant Professor Department of Pharmacy Practice College of Pharmacy and Department of Medicine Section of Digestive Diseases & Nutrition andSection of Digestive Diseases & Nutrition and Section of Hepatology

I have no actual or potential conflict of interest in relation to this presentation or program

Learning Objectives

Review the challenges and identify Review the challenges and identify potential barriers of REMS on the health system pharmacist and medical providerssystem pharmacist and medical providers

Identify practical methods to manage, y p g ,maintain and improve compliance with REMS in a health care systemy

What is REMS?

RRisk EEvaluation and MMitigation SStrategy

The Food and Drug Administration Amendments Act of 2007 gave FDA the authority to require g y qREMS An integral tool used by the FDA to ensure that the

b fit f d bi l i l d t t i h it i kbenefits of a drug or biological product outweigh its risks

BenefitsRisks

Components of REMS: D fi itiDefinitions

• Paper handouts given with prescriptions

May not require the

Paper handouts given with prescriptions• Provides info for patient to prevent

serious adverse eventsMedication GuideMedication Guide

require the provision of all

three components

• Letters to health care providers• Safety info and protocols presented at

professional societies

Communication Plan

Communication Plan professional societies

• Enrollment forms, training materials, , g ,medical procedures or laboratories

• Certification and/or training• Patient enroll in a registry

Elements to Assure Safe Use*

Elements to Assure Safe Use*

*Provide safe access for pts to drugs with known serious risks that would otherwise be unavailable

Implementation System

Elements to AssureSafe Use (ETASU)

Training and certifying of prescribersTraining and certifying of prescribers

• Verify can diagnosis• Understand risks vs. benefits• Know how to treat adverse effects

Certified pharmacies

V if l b h b bt i d• Verify labs have been obtained• Fill Rx from certified prescribers• Dispense drug in certain hospital settingsp g p g

Patient enrollment

• Sign that they acknowledge risks/benefit of drug• Obtain blood as required by ETASU• Have clinic visits

REMS Implementation System

Process to monitor, evaluate and improve ETASU* How products are distributed

H ifi i f di ib d li How certification of distributors ensures delivery to certified settings, and/or to patients who meet certain criteria

Validate database of all certified entities

Audit to ensure ETASU compliance

Audit of distribution systems

*Elements to Assure Safe Use**Elements to Assure Safe Use*

Time Spent with REMS ?

Survey opinions/perceptions on REMS n=601 March to April 2010 March to April 2010

Practicing physicians, advanced practitioners, PA, NP, RN or pharmacists specializing in oncologyg gy

ONS: Oncology Nursing SocietyNCCN: National Comprehensive Cancer Network

Johnson PE, et al. J Natl ComprCancer Netw. 2010;8(Suppl 7):S7-S27.

Estimate Amount of Time Spent on REMS Requirements?Spent on REMS Requirements?

Johnson PE, et al. J Natl ComprCancer Netw. 2010;8(Suppl 7):S7-S27.

Unanswered REMS QuestionsQuestionsMedication Guides Patient

• Are patients receiving these?• Do patients read them?• Do patients understand content?

• Decrease toxicity?• Prevent adverse events?• Improve clinical outcomes?• Access to drugs with known risks

• Do Dear Dr. Letters, certification or training change behavior in prescribing

Communication Plang

that would otherwise be unavailable

Providerg g p gand monitor patient for adverse effects?

Restricted Distribution

• Prescribe drug without REMS?

Overall Medical

• Are there problems with access to drug?

• Do providers find alternate drug

Restricted Distribution

• Increase cost? • Increase workload?

H t i lif k?

Overall Medical System

p gtherapy that may be less effective to avoid obtaining drug from a restricted distribution system?

• How to simplify paperwork? • Integration into electronic medical

records?

“…REMS is a poor substitute for other improvements needed system-wide in drug education, communication, use monitoring, patient access, and delivery of care”

75%: REMS program need a major overhaul 75%: REMS program need a major overhaul

86%: risk/benefit info not well-balanced

22%: REMS is an improvement over the existing risk p gmanagement system

Tufts University. Impact Report. 2011;13:1-4.

University of Illinois Medical Center (UIMC)

450-bed hospital with approximately 40 primary care p pp y p yand specialty outpatient clinics

CPOE (computerized physician order entry) Center of Excellence Center of Excellence

Women’s Health, Solid Organ Transplant, Robotic Surgery, Ophthalmology

Identify Methods to Manage, Maintain and Improve REMS Compliance

ETASUs Requirements

ESA Lenalidomide Bosentan

Package Shorten overall Human birth defects Elevations in ALTPackageInsert, Black Box Warning

• Shorten overall survival

• Increase risk of tumor progression

• Human birth defects • Hematologic toxicity• DVT• PE

• Elevations in ALT and AST

• Animal studies teratogenicity

ETASU Requirement

Prescriber • Complete APPRISE training program

• Obtain prescriber ID

• Complete and be certified in the RevAssist Program

• Telephone survey per Rx

• Each time sign Tracleer Enrollment and Renewal FormObtain prescriber ID Telephone survey per Rx and Renewal Form when prescribe drug

Patient • Review med guide• Sign patient

A t F

• Review medication guide• Sign patient-Physician

A t F

• Review med guide• Sign Enrollment and

R l FAgreement Form Agreement Form• Obtain monthly labs

Renewal Form• Obtain monthly labs

Pharmacy • Select/certify hospital designee to oversee

• Must be certified by Celgene

• Must be certified by Acteliong

• Complete and enroll in the ESA Apprise program

g• Pharmacy completes

RevAssist® Program registration form’

• Restricted network of certified specialty pharmacies

ESAs REMS I l t ti S tImplementation System

ESA APPRISE Oncology Program CenterESA APPRISE Oncology Program Center will audit facilities

Confirm each prescriber for ESAs is certified for CIA patients

Determine that number of acknowledgment forms retained is not less than the number of patients initiating a new course of therapyof patients initiating a new course of therapy

If do not comply with APPRISE programIf do not comply with APPRISE program Suspend access to ESAs

ESA APPRISE Oncology Program gy g

Patient and Healthcare

ProfessionalProfessional Acknowledgement

Form

UIMC ESA ExperienceI t tIntranet

Medication Guides

Acknowledgement Forms

List of ESA Providers at UIMC

Ordering ESAs

Documenting ESAA k l d t FAcknowledgement Forms

Acknowledgement FormsAcknowledgement Forms

Ordering ESAs

Lenalidomide REMS I l t ti S tImplementation System

Celgene will maintain a database ofCelgene will maintain a database of enrolled patients and pharmacies

Celgene will audit dispensing activity

Conduct regular onsite audits

If do not comply with RevAssist programIf do not comply with RevAssist program Suspend access to dispensing lenalidomide

UIMC Lenalidomide Experience

Purpose To determine if lenalidomide was monitored appropriately di h R A i ® REMS iaccording to the RevAssist® REMS requirements

Study design Retrospective chart review

Inclusion Patients who have been prescribed lenalidomide at UIMC criteria

psince July 2006 - February 2011

Exclusion criteria

• Patients not prescribed lenalidomide at UIMC• Patients younger than 18 years of agecriteria Patients younger than 18 years of age• Patients not enrolled in RevAssist® program

Population20

I l d d i t d15 (75%) M l i l

27

Rx lenalidomide

Included in study

Male: 65%

Multiple Mylenoma

5 (25%) Oth /

lenalidomideFemale: 35%

(1 FCBA)Other/

off label

RevAssist Compliance

B li B li

CBC Compliance (n=20)

Pregnancy Compliance (n=1)

Baseline

CBC prior to Tx

n=22/22

100%Baseline

w/in 10-14 d and w/in 24 hrs of Rx pick up

/

50%

Phase 1

CBC Q2 wk x 12 wks 81%

n=1/2

Follow up Q month 44%

12 wks

n=78/97

Phase 2

n=4/9

O erallCBC Q month

n=83/87

95%

*Base on MM

OverallCompliance

Combined (n = 20)compliant non-

compliantBase on MM requirements

Combined (n 20) • CBC w/dif• Pregnancy test

p

Improving Revlimid®

Compliance: Workflow/FlowchartCompliance: Workflow/Flowchart

Revlamid Workflow

UIMC Bosentan Experience: Patient CasePMH Social HistoryType 1 DM, HTN , HL, non-obstr CAD, severe pulmonary arterial hypertension (PAH), hirsutism, microcytic anemia, asthma/COPD, seasonal allergies, diverticulosis and tubular adenoma,

d l d it D d fi i h l i

Smoked 1-2 PPD x 25-30 years; quit 1985 occasional EtOH

M di tiadrenal adenoma, vit D deficiency, hypercalcemia, hyperparathyroidism

StudiesPFTs

MedicationsAlbuterol neb as neededaspirin bosentan 125 mg twice daily (Started in 2005)h l l if lM d % P di t dPFTs cholecalciferol

felodipinefluticasone-salmeterolfurosemide guaifenesin

Measured % PredictedFVC (L) 3.22 116.06FEV1 (L) 1.52 70.55FEV1/FVC (%) 47.11TLC (L) 6.06 107.68 g

hydrochlorothiazide ibuprofen insulin glarginemetformin metoprolol

( )DLCO (ml/min/mm Hg) 3.56 17.38

At the end of 6 min of ambulation the VS were p lse 100 bpm BP 136/77 SPO2 89% on 10 lpm

6 minute walk test

metoprololranitidinesimvastatin tiotropium

pulse 100 bpm, BP 136/77, SPO2 89% on 10 lpm of O2 thru nasal cannula. After 1 min of recovery the VS were pulse 80 bpm BP 144/72 mm Hg and SPO2 91% on room air.

Bosentan Patient Case

Certified Patient Pharmacy called Pulmonary Clinic for Bosentan refill

hospitalized 2nd to Hgb: 5.6g/dL

Bosentan REMSETASU RequirementsETASU Requirements

Enroll patient into Tracleer® Access Program

Counsel patient on risk of bosentan

Di d d b h i titi d h lth

Review baseline LFTs and if applicable, pregnancy test

Dispensed drug by pharmacies, practitioners, and health care settings that are certified by Actelion under

505-1(f)(3)(B)

“Speak with patient, or their prescriber, every month to obtain confirmation that liver function testing and

pregnancy testing was completed”

Bosentan Patient Case

Pharmacist ask:• Pharmacy

called? YES• What is LFT?

DON’T KNOWDON’T KNOW

Certified PharmacyPatient

Certified Pharmacy called Pulmonary Clinic for Bosentan refill

hospitalized 2nd to Hgb: 5.6g/dL

UIMC Bosentan Experience

Purpose To determine if bosentan was monitored appropriately according to the T.A.P. REMS requirements

Study design Retrospective chart reviewStudy design Retrospective chart review

Aug 7, 2009 Mar 3, 2010Apr 1, 2009 -

Apr 19, 2010

• Bosentan REMS approved

• Problem patient identified by Pulmonary Pharm D:

• Identify all bosentan prescriptions

Pharm.D: No LFT in 7 months

Baseline Bosentan

All pts prescribed 16

REMS Compliance Rates*

All pts prescribed bosentan: N = 19

16

On bosentan

Labs to be drawn on a monthly

basisLFT Pregnancy

Tests**

40

117

6

41

Number of actual lab tests drawn

Number of total lab tests

REMS

117

34%

41

15%

should have been drawn

Compliance rates

34% 15%**Female pts of Child Bearing Potential*Analysis: 1 month before REMS approval (8/7/2009); 7/7/09 to 4/19/10

Bosentan Intervention #1:Bosentan Intervention #1: Pharmacy In-service

J l 7 2009 A 27 2010July 7, 2009 -Apr 19, 2010

R i b t

Apr 26, 2010

Ph

Apr 27, 2010 –Aug 3, 2010

I t ti #1• Review bosentancompliance• LFT=34%• Pregnancy test =15%

• Pharmacy In-service to Pulmonary Team

• Intervention #1 analysis of bosentan REMS compliance• Pregnancy test =15% p

Results Post

Apr 27 2010 13

Pharmacy In-service

Apr 27, 2010 -Aug 3, 2010

13 remained on bosentan

Overall REMS compliance

rates

LFT 45%

Only 9 4 4 Only Pulmonary Team had pharmacy

pulmonary clinic

arthritis clinic

p yin-service 63% 17%

No in-serviceIn-service

Bosentan Intervention #2: Dedicated Pharmacy StudentDedicated Pharmacy Student

July 7, 2009 - Apr 27, 2010 – Aug 4, 2010 -y ,Apr 19, 2010

• Baseline; no intervention

p ,Aug 3, 2010

• Pharmacy InservicePulmonary Clinic

g ,present

• Intervention #2 dedicated pharmacyintervention

• LFT=34%• Pregnancy test =

15%

Pulmonary Clinic • Overall LFT: 45%

• Pulmonary: 63%

dedicated pharmacy student monitor REMS requirements

15% Pulmonary: 63%• Arthritis: 17% • Monitor LFTs and

pregnancy tests results• Call patients andCall patients and

remind them to have labs done

• Fill out lab slips and il t ti tmail to patients

• Document in EMR

Results: Dedicated Pharmacy Student

Aug 4, 2010 -Oct 31, 2010

13 13 remained on bosentan

Overall REMS compliance rates

LFT 90%

9 44

Pharmacy student

pulmonary clinic

4 arthritis clinic

monitors LFTs

Aug Sep Oct

100% 100% 96%

Aug Sep Oct

75% 75% 75%

Time Spent and Compliance RatesCompliance Rates

(%)

plia

nce

(M

inuT

Com

putes

LFT

REMS Summary

REMS are here to stay! REMS are here to stay! Many more are to come…

Not easily understood by providers Not easily understood by providers Burdensome, labor intensive, disrupt workflow No payment for extra work No payment for extra work

REMS Summary

Many opportunities for pharmacypharmacy Collaborate with other

health care providers Provides an opportunity for

systematic data collection Education Education

Providers, residents, students

ReactiveProactiveProactive