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1 Michael D. Bullek BSP R.Ph. Administrator/Chief of Compliance New Hampshire Board of Pharmacy
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Page 1: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

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Michael D. Bullek BSP R.Ph.Administrator/Chief of ComplianceNew Hampshire Board of Pharmacy

Page 2: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Today’s discussion:

New rules and rules changes

Pharmacy practice and ethics

Legislative issues

Prescription Monitoring Program update

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Page 3: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Statement of Disclosure

I have nothing to declare

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Page 4: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

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Page 5: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Rules:

Rules currently in legislative process

Rules in Review

Pending rules issues

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Page 6: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

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Page 7: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Naturopaths are providers….. Have prescriptive authority for whole range of FDA

approved medications………

Formulary on Pharmacy Board website

DO NOT need a DEA or NPI number to prescribe!!!!

Compliance required by statute to create inspection rules………

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Page 8: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Dental Hygienists are too……

SB 377-FN (2018 Dental cleanup bill)

Relative to the regulation of dentists and dental hygienists by the board of dental examiners.

316:13 (g)

The administration, prescription, and dispensing of a fluoride supplement, topically applied fluoride and chlorhexidine gluconate oral rinse.

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Page 9: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

HB615 Pharmacy cleanup bill

6. New Subparagraph; Dealing in or Possessing Prescription Drugs; Dental Hygienists. Amend RSA 318:42, II by inserting after subparagraph (b) the following new subparagraph:

(c) Nothing in this section shall prohibit a dental hygienist from possessing, administering, dispensing, or prescribing of a fluoride supplement, topically applied fluoride, and chlorhexidine gluconate oral rinse pursuant to RSA 317-A:21-c, I(g).

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Page 10: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

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Page 11: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Licensing updates

All CPE monitors and CE certificates not posted to monitor shall be uploaded during pharmacists renewal

All demographic/employment updates/changes must be submitted online using Board forms and process

Technicians can apply online for initial registrations and reinstatements. Instructions posted on website. Pharmacists to follow shortly.

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Page 12: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

pseudoephedrine SB376-FN Relative to the sale of certain cold

medications

Regulates the sale and possession of products containing ephedrine and pseudoephedrine

Allows for sale, providing follows federal reporting guidelines in any retail establishment.

New national reporting program via APPRISS HEALTH

Located in RSA318, under Board control? Inspections?

Very popular with local police departments……..

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Page 13: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Board approved Rules in Legislative Process:

Cleanup/update rules: Ph103.04 meetings

Ph103.05 financial disclosure

Ph403.02 CE requirements- add law

Ph 104 Public information requests

Ph 1607 Intern immunization rules update

Ph 2200 investigation rules and forms

Ph 2100 inspection rules and forms

Ph 2400 contraceptive rules/protocol (HB1822)

Ph 900 mail order pharmacies

Ph 2500 drug/device distribution/virtuals (HB615)

Biennial licensing (HB615)

HB627 Veterinarians exception to USP

HB359 warning labels on RX’s containing opioids

HB 463 advanced practice technicians

SB120 move PDMP to stand alone program

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Page 14: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Statute review 15. Repeals. The following are repealed:

318:45 Sales Permitted. – This chapter shall not prevent the sale of the following: alum, blue vitriol, borax, camphor gum, copperas, epsom salts, glauber salts, castor oil, oil of turpentine, sulphur, cottonseed oil, saltpetre, househol ammonia, flavoring extracts, and unofficial chlorinated solutions.

Source. 1921, 122:28. PL 210:46. 1931, 123:7. RL 256:46.

318:46 Record Book. – The pharmacist in charge of a pharmacy shall at all times keep in the pharmacy a record book in which shall be entered all sales of the following, other than sales to physicians, dentists and veterinarians, and sales made upon a prescription of a physician, dentist, veterinarian, or advanced practice registered nurse: arsenous acid (arsenic trioxide), mercuric chloride, hydrocyanic acid, potassium cyanide, cyanide mixture, strychnine and its salts except in proper dosage in pill or tablet form.

Source. 1921, 122:29. PL 210:47. RL 256:47. RSA 318:46. 1973, 453:11. 1994, 333:11. 2009, 54:5, eff. July 21, 2009.

318:47 Keeping and Inspection of Record. – The record required by RSA 318:46 Source. 1921, 122:29. PL 210:48. RL 256:48. RSA 318:47. 1981, 484:18, eff. July 1, 1981.

318:47-e Procedures for Dispensing Emergency Contraception. –Source. 2005, 131:3, eff. Aug. 15, 2005.

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Page 15: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Rules in final Board Review:Reorganization of existing and updating rules

Ph300 new rules specific to pharmacists

Ph400 new rules specific to institutional practice and compounding

Ph700 (audit revisions) standards of practice

Ph1900 new rules specific to pharmacies

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Page 16: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Ph 2100: Draft Inspection Rules

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Currently no rules regarding the inspection process

Board current responsibilities to inspect every place there are drugs in state…......

Cited in Legislative Audit of 2008 and 2015 as an issue.

Board inspections do not hold permit holders accountable to rules

A need to develop a risk-based inspection process.

Required to include PDMP program in inspection process

Page 17: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Ph 2100: DRAFT Inspection Rules

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Inspections shall be for the following registrants licensee’s as follows: Retail pharmacies- annually or based on risk assessment

low, medium, high risk

Institution pharmacies (hospitals, stand-alone emergency departments and long term care facilities) –annually

Compounding pharmacies –annually

Public Health and Methadone Clinics- annually

Practitioner/Clinic inspections – every 5 years

Veterinarians/veterinary clinics- every 3 years

Manufacturer/Wholesaler- every 3 years

Limited Retail Drug Distributor- every 3 years

Page 18: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Ph 2100: DRAFT Inspection Rules

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The following facilities possessing control substances shall be inspected every two years:

Practitioner/Clinics

Veterinarians/veterinary clinics

Inspections with past issues or disciplinary actions will be conducted annually until compliance deems issues resolved or at request of Administrator/Chief of Compliance.

Compliance staff will review pharmacies annually to assess risk and make recommendations to the board.

Currently 93 pharmacies identified as “low risk”. All will receive inspection this year, self inspection 2021.

Page 19: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Ph 2200 Investigations

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Another audit issue that stated we needed to have the investigation process in rules

QRE report – pharmacists OWN words of issue, NOT corporates!! Will be in rule and will be enforced Corporate will have opportunity to file separate

QRE report

Investigations involve professional misconduct and standards of practice issues. Are reviewed by the Board and can result in actions

against your license. Result can be dismissal, letter of concern,

disciplinary actions

Page 20: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Violation notices

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A violation notice shall be given as a notification of non-compliance with Federal, State, or local laws.

Minor violations will be administrative in nature.

Example: Nametags, paperwork issues etc.

Minor violations shall be issued as a needs improvement, verbal warning, or violation with fine.

Repeat minor violations will result in Board review with consideration for further disciplinary action.

Page 21: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Major Violations

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Major violations will be administrative in nature.

Example administrative- refrigerator temperature logs

The Pharmacist-in-charge and/or the pharmacist on duty at time of violation is responsible for completing violation notice within 15 days of issue.

ALL Violation notices shall be returned to the Board investigator/inspector in writing with corrected action noted.

Subsequent or multiple violations may result in further action by the board

Investigators/inspectors shall follow up written violation notices no later than 60 days after action noted.

Major violations, after board review, shall be maintained in pharmacist and permit holders permanent file.

Page 22: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Major Violations cont…

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Violation notices for practitioners shall be forwarded to respective Boards

Violation notices of RSA 318(b) under pharmacy statutes may result in a fine by Board of Pharmacy

Follow up for violation notices shall be responsibility of Board of pharmacy.

Regulatory boards may make a request of pharmacy board investigators/inspectors for follow up on board actions.

Page 23: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Actions that result in professional misconduct are reported to national databases and affect your license status.

Regardless of violation or investigation you have the right to a hearing before the Board!

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Page 24: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Collaborative Practice:

Approved final review JLCAR 11/16/17

Final Board approval 12/11/17

Rules approved 1/17/18

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There will be no practice site restrictions with updated rules.

Page 25: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Collaborative practice: 318:16-a Standards for Collaborative Pharmacy Practice. –

I. Pharmacist participation ;

(a) Hold an unrestricted and current license to practice as a pharmacist in New Hampshire.

(b) Have at least $1,000,000 of professional liability insurance coverage.

(e) In order to administer drugs by injection, have completed training that includes programs approved by the Accreditation Council for Pharmacy Education (ACPE) or curriculum-based programs from an ACPE-accredited college of pharmacy or state or local health department programs or programs recognized by the board.

The agreement is between the provider and the pharmacist. The provider will set all the requirements of the collaborative practice.

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Page 26: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

DPH/DHHS CDC grants

State grant over the next five years through a cooperative agreement with The Centers for Disease Control and Prevention (CDC) titled “Improving the Health of Americans through Prevention and Management of Diabetes and Heart Disease and Stroke (CDCRFA-DP18-1815)”.

Only state to receive this grant where pharmacists are participating as primary professional

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Page 27: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

February 25- May 2, 2019

728 Responses (28% response rate): including 24 retired or non-practicing pharmacists.Results presented include only responses from currently licensed NH pharmacists (non-retired).

Overview:

34 question, anonymous, online survey developed in partnership between:• NH Division of Public Health Services• NH Board of Pharmacy• NH Pharmacy Association• NH Society of Health-Systems Pharmacists

Page 28: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

February 25- May 2, 2019

Purpose:1. Define Medication Therapy Management (MTM), Diabetes Self-Management

Education Support (DSMES), and Collaborative Practice Agreement (CPA) for

practicing pharmacists

2. Collect anonymous, baseline data to understand awareness of, current integration

of, and needs for integration of MTM, DSMES and CPA directly from pharmacists

licensed and practicing in NH.

3. Determine areas where more outreach and/or continuing education and training

are needed.

4. Gather data needed to report on performance measures required by CDC grant

related to increasing engagement of pharmacists in the provision of MTM or

DSMES for people with diabetes (i.e. number of pharmacy locations/pharmacists

using patient care processes that promote medication management or DSMES for

people with diabetes

Page 29: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

February 25- May 2, 2019

Funding for this survey came through a five-year cooperative agreement with

the Centers for Disease Control and Prevention (CDC) titled Improving the

Health of Americans through Prevention and Management of Diabetes and

Heart Disease and Stroke (CDCRFA-DP18-1815).

Surveys, like the one, provide insight on the most effective areas to allocate

CDC funding toward building awareness of and successfully integrating MTM,

DSMES, and CPA in pharmacy practices across the state.

Page 30: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Demographics of Survey Respondents

Pharmacy Supervisor / Manager / Director 30%

Clinical Pharmacist 27%

Operations Pharmacist 26%

Staff / Retail / Informatics Pharmacist 14%

Pharmacist Consultant 2%

Educator / Professor of Pharmacy 1%

Pharmacists’ Titles (n=699) Current Practice Setting (n=717)

Pharmacists’ Years in Practice (n=699)

Page 31: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Pharmacists’ MTM Awareness

715 individuals responded to their level of awareness of their ability to

provide Medication Therapy Management (MTM) services to patients.*

79% reported being aware of their ability to practice MTM.

Of the 5% who reported “very little” or “no” awareness, the majority of those respondents represented Home Health Care, Community Chain or Hospital / Health Systems.

* MTM as defined by the American Pharmacists Association

Page 32: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

MTM in Practice686 pharmacists reported the frequency in which they practice MTM defined as:

61% report they “Often” or “Always” provide MTM in the form of education and

training (verbal, online, or written) designed to enhance patient understanding and appropriate use of his/her medications.

Other MTM activities were reported to be rarely if ever implemented by pharmacists.

• Administration of medication therapy (not including immunizations)

• Initiation of medication therapy• Formulation of a medication treatment plan • Coordination and integration of medication

therapy management services within the broader health care management services being provided to the patient

• Promotion of self-management and lifestyle modification for high blood pressure and high blood cholesterol

• Modification of medication therapy

• Provision of information (verbal, online or written) including referrals to support services and resources designed to enhance patient adherence with his/her therapeutic regimens

• Monitoring and evaluation of the patient’s response to therapy, including safety and effectiveness

• Performing or obtaining necessary assessments of the patient’s health status

• Performing a comprehensive medication review to identify, resolve, and prevent medication-related problems, including adverse drug events

Page 33: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

MTM in Practice (cont.)

Of the 61% who provide education and training (verbal, online, or written) designed to enhance patient understanding and appropriate use of his/her medications:

Page 34: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Barriers to Practicing MTM

Despite the high level of awareness of MTM in pharmacy practice, there remains a low level of MTM implementation across pharmacy types. To understand why this may be, respondents identified barriers to incorporating MTM in their practices. Top-ranked barriers include:

61% Lack in staffing capacity (n=350)

54% Difficulty in integrating MTM in to current workflow (n=312)

50%Lack in flexibility with time spent dispensing medications versus

counseling patients (n=287)

30% Lack of private / consultation space in practice setting (n=172)

30% Obstacles to billing / collecting payment for services (n=172)

22% Lack in professional training / skill in providing MTM (n=124)

9% Lack in understanding of MTM services (n=53)

6% Lack of evidence to support MTM integration in my practice (n=36)

Page 35: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Full Report: November 2019

NH Pharmacist Survey

More in-depth analysis will be provided and include pharmacists’ responses to their level of awareness, perceived importance, and current practice of Diabetes Self-Management Education and Support (DSMES) for patients with diabetes.

Additional analysis of pharmacists’ awareness, perceived importance, and implementation of Collaborative Practice Agreements.

Page 36: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Quality Assurance:

HB 469 and Ph1700 Establishing a continuous quality improvement program

for pharmacies

assess errors that occur in the pharmacy in dispensing or furnishing prescription medications so that the pharmacy shall take appropriate action to prevent a recurrence. The purpose of the program is non-punitive and seeks to identify weaknesses in workflow and make appropriate corrections to improve.

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Page 37: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Quality Assurance:

Each pharmacy’s continuous quality improvement program shall meet the following minimum requirements:

Meet at least once each quarter each calendar year; Have the pharmacy’s pharmacist in charge in attendance at each

meeting; and Perform the following during each meeting:

Review all incident reports generated for each reportable event associated with that pharmacy since the last quarterly meeting;

For each incident report reviewed establish the steps taken or to be taken to prevent a recurrence of the incident; and

Create a report of the meeting including at least the following information; A list of persons in attendance; A list of the incident reports reviewed; and A description of the steps taken or to be taken to prevent

recurrence of each incident reviewed.37

Page 38: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Quality Assurance:

The Board will be looking for: Policy and procedures

Meeting attendance

Summary

Starting September 2019, first meeting January 2020

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Page 39: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Upcoming rules changes

RENEWAL AND REPLACEMENT LICENSES

Now on line registrations for renewals

Will ask for additional information!!

Biennial licensing

CONTINUING EDUCATION REQUIREMENTS

Addition of 2 credits Law

Annual requirements

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Page 40: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Proposed Ph 700 Changes CHAPTER Ph 700 STANDARDS OF PRACTICEMany changes to this chapter. Moving rules specific to “pharmacists” and “pharmacies” to chapters 300 and 1900

PH 702.01 Area, Space and Fixtures Designated area for vaccinations of adequate size and design

to ensure patient confidentiality.

Ph 702.05 Limitations on Access.

(d) The pharmacy permit shall be issued to the pharmacy in the name of the pharmacist-in-charge, who along with the permit holder shall have sole control and responsibility for the operation of the pharmacy in accordance with all laws and rules pertaining to the practice of pharmacy in this state and always in the best interest of public health and safety.

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Page 41: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Proposed Ph 700 Changes Ph 704.04 Transfer of Prescriptions.

(1) New or on hold prescription orders for ELECTRONIC PRESCRIPTIONS FOR CONTROLLED SUBSTANCES (EPCS) may transfer an original unfilled prescription from hold.

Ph 704.08 Prescription Pick-up and Delivery (SB483) (1) All schedule medications dropped off shall present picture

identification and noted on hard copy of prescription.

(2) All schedule II medications picked shall present picture identification to pharmacy staff. Verification shall be noted in readily retrievable fashion or noted on hard copy prescription.

(3) Mail order pharmacies dispensing new schedule II medications to the patient shall have a “face-to-face” counseling or electronic equivalent and documentation readily retrievable on request by Board.

(a) Patients receiving greater than 100 morphine equivalent dose shall be counseled on availability and use of naloxone.

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Page 42: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Proposed Ph 700 Changes Ph 704.10 Out-of-State Prescriptions.

Prescriptions written by physicians for controlled substances in a state other than New Hampshire may be dispensed to a patient only when the traditional physician-pharmacist-patient relationship exists.

Physicians Prescriptions for controlled substances in Schedule III-IV may be filled for no more than a 34 day supply.

Physicians Prescriptions for controlled substances in Schedule II may be filled if originating from border states, Rhode Island, and Connecticut for no more than a 34 day supply.

This will require a statute change (legislation) Don’t think this one will fly….snowbirds!!!!

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Page 43: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Proposed Ph 700 Changes Ph 706.03 Patient Counseling.

Removing mandatory counseling requirement?

Addition of counseling on opioids?

Mail order pharmacy increased requirements?

????? Lots of discussion, need pharmacist involvement!!!!

(i) A pharmacist shall make a reasonable attempt to verify all Control Drug Medication information with the Prescription Drug Monitoring Program.

(1) Pharmacy shall develop and have readily retrievable a policy for verification with Prescription Drug Monitoring Program.

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Page 44: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

703.04 – Controlled Drug Losses

(d) A pharmacy shall consider a controlled drug loss to be significant when:

1.The percentage of dosage units of a specific drug exceeds 2% of monthly dispensing volume; or

2.Fifteen or more dosage units are not accounted for.

Attached to PIC and pharmacy permit. Excessive number of losses reported to Board. (Again….Audit)

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Page 45: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Control drug loss data 211 reports of Controlled Substances were reported lost in 2018

97/211 or 45.9 % of the C/S reported loss are opioid or synthetic opioid

91% of all stimulants that were C/S loss were BRAND NAME!

12 reports came from Hospitals

5.6% of the reports came from Hospitals

41.6% of the Hospital reports (5 of 12) came from Mary Hitchcock / Dartmouth

199 Reports came from community (retail) pharmacies

39.8% of the reports came from Rite-Aid

30% of the reports came from CVS

6.6 % of the reports came from Shaw’s / Osco

5.2% of the reports came from Walgreens

2.84% of the reports came from Omnicare

1.42% of the reports came from Hannaford

1.42 % of the reports came from Wal-Mart

Still a lot of reporting of less than 15 dosage units!!

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Page 46: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

REASON FOR LOSS

41.22 % Unknown THIS WILL BE A RED FLAG!!!!! 30.33% Miscounting & Overfill

2.84 % C/S was thrown out

2.84 % Diversion

1.42% Armed Robbery

DRUG CATEGORY LOSS Opioid CII 37.9%

Stimulants CII 16.8%

Benzodiazepines 15.8%

Tramadol 4.32%

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Page 47: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

703.04 – Controlled Drug Losses

NEW!!! On line drug loss reporting replace New Hampshire Control Drug Loss form

Sign in with same information used for licensing

Print and upload or use on line form to submit

Testing currently underway

Target date is January 1st, 2019

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Page 48: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Break Policy

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Page 49: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Break Policy

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Ph 704.01 Presence of Pharmacists.

(a) No pharmacist shall work more than 8 hours without a rest break of 30 minutes. Breaks shall be scheduled as close as possible to the same time each day so that patients may become familiar with the approximate break times.

(b) Whenever the prescription department is staffed by a single pharmacist, the pharmacist may take a rest break of a period of 30 minutes without closing the pharmacy an removing support personnel from the pharmacy, provide that the pharmacist reasonably believes that the security o the prescription drugs will be maintained in the pharmacist’s absence.

Page 50: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Break Policy

How many of you take a 30 minute uninterruptedbreak?

What are the barriers?

How to we fix?

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Page 51: Michael D. Bullek BSP R.Ph. Administrator/Chief of ... Presentations/2019/20… · Board approved Rules in Legislative Process: Cleanup/update rules: Ph103.04 meetings Ph103.05 financial

Pharmacy Technicians

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(a) “Registered pharmacy technician” means a person employed by a pharmacy who can assist in performing, under the supervision of a licensed pharmacist, manipulative, nondiscretionary functions associated with the practice of pharmacy and other such duties and subject to such restrictions as the board has specified; and

(b)Certified pharmacy technician” means a registered pharmacy technician who has become and who maintains national certification by taking and passing an exam recognized by the board for the purpose of certifying technicians.

(c) Advanced practice pharmacy technician (HB463) new license approved by legislature this year.

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Registered Pharmacy Technician

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Registered Pharmacy technician:

All personnel working within the pharmacy are to be licensed as “registered pharmacy technicians”

Cashiers

Delivery personnel (NOT Required if specific)

Billing/data entry

Registered Pharmacy technicians with duties that include data entry of prescriptions without direct supervision

Need to take and update annually of board approved competencies in data entry

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Register Technician Duties

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Ph807.02 Registered Pharmacy Technician duties.

(a) Non-discretionary functions within the pharmacy concerning cashier, stocking, delivery, and other non-clinical functions necessary for pharmacy operation under the supervision of a licensed pharmacist or certified pharmacy technician;

(b)The counting, weighing, measuring, pouring, and reconstitution of non-parenteral prescription medication or stock legend drugs and controlled substances;

(c) Performing stocking or replenishment of automated dispensing machine, other automated dispensing equipment or other stock locations. Products shall be verified by a pharmacist or certified pharmacy technician.

(d) Registered pharmacy technicians in training to become certified may perform the duties of a certified pharmacy technician under the direct supervision of a pharmacist or certified pharmacy technician.

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Ph 808.01 Certified Pharmacy Technician Qualifications.

(b) A registered pharmacy technician seeking certified status shall obtain and maintain certification from a nationally recognized certifying organization, such as the PTCB or the NHA, within one year of entering into a certified pharmacy program.

Ph 805.01 Change in Registration Information for Registered Pharmacy Technicians.

(a) The person to whom a pharmacy technician registration has been issued shall, within 15 days of a change of address or location of employment, notify the board of such changes.

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Certified Pharmacy Technicians

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Ph 808.01 Certified Pharmacy Technician Qualifications.

(a) An applicant for a certified pharmacy technician shall:

(1) Be at least 18 years of age;

(2) Have a high school or equivalent diploma;

(4) Not have been convicted of a drug related felony or admitted to sufficient facts to warrant such a finding; and

(5) Seek certification from the board within 15 days of the start date of employment as a Certified Pharmacy technician, and be verified by the pharmacist-in-charge within 30 days.

(b) A registered pharmacy technician seeking certified status shall obtain and maintain certification from a nationally recognized certifying organization, such as the PTCB or the NHA, within one year of entering into a certified pharmacy program.

(c) A certified pharmacy technician with duties involving sterile and non-sterile compounding, shall complete a board approved training program before participating in those duties.

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Ph 812.01 Determination of a Certified Pharmacy Technician’s Duties.

(a) Any certified pharmacy technician who does not maintain national certification shall notify the board and the pharmacist–in-charge immediately of the lapse of certification. Those whose certification has lapsed shall be permitted to perform the duties of a registered pharmacy technician, but shall no longer perform the additional duties of a certified pharmacy technician.

(b) A certified pharmacy technician shall only perform such tasks and duties which are prescribed by the permit holder or pharmacist-in-charge based upon the needs of the pharmacy.

(c) A certified pharmacy technician’s duties may be further limited by the pharmacist on duty or the supervising pharmacist.

(d) Any training given under the direction of a pharmacist shall be documented by the pharmacist-in-charge and be retrievable upon inspection.

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Certified Technician Duties

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(1) Any duties performed by registered pharmacy technicians under Ph 807.02;

(2) Accepting a new oral telephone order;

(3) Accepting an oral refill authorization from a provider;

(4) Communicating a prescription transfer for a non-control medication to or from another pharmacy that does not maintain a common database;

(5) Communicating orally or in writing, any medical, therapeutic, clinical, or drug information, or any information recorded on a patient profile that does not require professional judgment;

(6) Performing the data entry of a prescription or medication order into the computer without supervision;

(7) The task of reducing to writing a prescription left on a recording or message line;

(8) Preparing or compounding sterile and non-sterile compounds;

(9) Verifying stock replenishment medications against the stocking/replenishment system, report or label prior to the stocking/replenishment of the automated dispensing machine, other automated dispensing equipment, or other stock location provided that bar-coding, radio frequency identification or another form of electronic verification is used at the time of stocking/replenishment, or a licensed health professional checks the medication before administration to the patient;

(10) Clarification of an original prescription or drug order with a practitioner or authorized agent of the practitioner; and

(11) Preparation, verification, and sealing of an emergency kit.

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Continuing Education-Certified

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Ph 810.02 Continuing Education Requirements for Certified Pharmacy Technicians.

(a) Certified pharmacy technicians shall maintain their nationally certified status and stay up to date with all continuing education requirements such certification demands.

(c) Certified pharmacy technicians with duties involving sterile and non-sterile compounding shall complete a minimum of 0.4 CEU’s in the area of compounding.

(d) Not less than 10% of certified pharmacy technicians shall be randomly selected each year by the board for determinations of compliance. ???????? Issues here!!

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Ph 1800: Advanced Practice Pharmacy Technicians

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(a) “Advanced pharmacy practice technician” means a person employed by a pharmacy who can assist in performing, under the supervision of a licensed pharmacist, manipulative, nondiscretionary functions associated with the practice of pharmacy and other such duties including product verification of a prescription refill in which no changes have occurred as well as verification of automation machine refilling or repackaging unit -dose.

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So…….what do you think a marriage of

“central fill processing/workflow

balancing” and advanced practice

technicians is going to do?

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Vaccines

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NOTE: You cannot administer tetanus vaccine just because it is included in Tdap!!!

You cannot advertise a measles vaccine!! It is a combination product (MMR)!!

You can administer hepatitis A and B combination products!!

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Vaccines and standing orders Board notice of August 16th, 2018

318:16-b Pharmacist Administration of Vaccines. – A pharmacist or pharmacy intern under the direct supervision of an immunizing pharmacist may administer influenza vaccines to the general public and a pharmacist or pharmacy intern under direct supervision of a immunizing pharmacist may administer pneumococcal and varicella zoster vaccines to individuals 18 years of age or older, provided all of the criteria in this section have been met

Pharmacists have the ability to administer vaccines, the statutes do not give us prescriptive authority. All vaccines must have a provider associated with the collaborative practice agreement, standing order or written/verbal prescription.

Open for interpretation………….

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SB179-relative to pharmacy administration of vaccines Referenced adult immunization schedule of 11 vaccines

Hib, HPV, TD added to current list

Not requested by any pharmacy organizations?

Board not in favor of adding any additional vaccines due to provider backlash over paperwork transmissions

Referred for more study

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How many have issues with vaccination quotas?

Business issue vs. practice????

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Pharmacist “Report Cards”

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More good news from the audit……..stated we needed to inspect “pharmacists” as well as “pharmacies”…..haven’t figured out how to do that yet…….leads us too;

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Pharmacist credentialing

Maintain file for each individual pharmacist

All CE’s will be downloaded as part of this process, effective with 2020 licensing process. Should simplify the audit procedure

We need correct data in system!! 318:26-a Change in Name, Employment, or Residence. –

Any pharmacist or pharmacy technician who changes his or her name, place or status of employment, or residence shall notify the board in writing within 15 days. For failure to report such a change within 15 days, the board may suspend the pharmacist's license or the pharmacy technician's registration. Reinstatement shall be made only upon payment of a reasonable fee as established by the board.

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Credentialing

HB 591-FN and HB1746-FN

2018-Prohibited PBM’s from requiring accreditation of providers. Bills were defeated. A sunset clause was in place that was removed in 2019.

Pharmacy board has all the information necessary for credentialing process.

Will be required for insurance billing for contraceptives!!!

Any future provider status billing!!!

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Medicaid Dispensing Issue

If a patient has current Medicaid eligibility, there prescriptions must be filled using the proper insurance!!!!

No filling for cash allowed under Medicaid contracts!!

This is a PDMP and diversion issue!!

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ETHICS

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Corresponding responsibility

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Time for a discussion…….

……….Where do we draw the line????

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21 CFR 1306.04(a)

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§1306.04 Purpose of issue of prescription. (a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances.

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Two Pharmacy Chains Pay Civil Monetary Penalties to Resolve Alleged Violations of the Controlled Substances Act CONCORD - Two national pharmacy chains agreed to pay civil monetary penalties to resolve

allegations that they violated the Controlled Substances Act by filling fraudulent prescriptions,

United States Attorney Scott W. Murray announced today.

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“Pharmacies and health care professionals must comply with their legal obligations in order to

ensure that controlled substances do not end up in the wrong hands,” said U.S. Attorney

Murray. “When businesses or individuals fail to fulfill these obligations, drugs can be diverted into

the black market or otherwise misused. We will not hesitate to use federal enforcement tools to

ensure that members of the health care industry follow the law.”

“DEA registrants like Osco and Rite Aid have a corresponding responsibility to dispense controlled substances in accordance with the Controlled Substances Act. When these responsibilities are not adhered to it allows for the diversion of prescription pain medication which contributes to the widespread abuse of opiates that are devastating our communities,” said DEA Special Agent in Charge Brian D. Boyle. “Today’s settlements demonstrate DEA’s commitment to improve public safety and public health in New Hampshire.”

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Ethics

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Board receiving too many inquires and complaints from providers and patients

Legislators threatening action…..current system not in best interests of patients

Board meetings with stakeholders on pain issues

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Who can prescribe Buprenorphine?

Any physician with a special "X" number issued by the DEA. The way the law is written, any doctor can prescribe Suboxone for treating pain, however the FDA has not granted approval for Suboxone to be used for pain, so it would be an off-label prescription.

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Subutex-suboxone difference

?????reasons why so much being dispense??????

Cost?

Allergies?????

Remember………corresponding responsibility!!!!

Buprenorphine investigations

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Ethics

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Due Diligence

DOCUMENT!!!!!

What is in the best interest of the patient?

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Provider issues-BOM meeting of September 2019……..

Scope of practice

Questioning/refusing of prescriptions

Buprenorphine SL tablets

pain vs MAT

Quantity

dose

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While we are on topic of what we do wrong……..

Who is dispensing syringes without an prescription??? Noted at August meeting of Governor's commission on

alcohol and other drugs………2 out of 18 pharmacies in Manchester will not dispense without prescription……..

Pharmacists choice………

Board memo of Feb 13th, 2018 concerning RSA 318:52 (c) ; sale of hyper dermic syringes and needles

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RSA 318 – B:15

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318-B:15 Persons and Corporations Exempted. – The provisions of this chapter restricting the possession and having control of controlled drugs shall not apply to:IV. (a) A health care professional authorized to prescribe an opioid antagonist may prescribe, dispense, or distribute, directly or by standing order, an opioid antagonist to a person at risk of experiencing an opioid-related overdose or a family member, friend, or other person in a position to assist a person at risk of experiencing an opioid-related overdose. Any such prescription shall be regarded as being issued for a legitimate medical purpose in the usual course of professional practice.

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Naloxone

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Naloxone survey results for DHHS

Access better than anticipated

Usage numbers poor

215 pharmacies responded to survey. Excellent response!!!!!!

Available for free as part of state “hub and spoke” program

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Veternarians

Seeing issues with multiple visits to providers using different animal names.

Buprenorphine and tramadol issues.

Due diligence!!!

Verify RX’s!!!!

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The case of cannabis…..

CBD oil an issue……….

Agriculture has control…..out of pharmacies hands…..at the moment……..

Much more to come on this topic….

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HB 359 relative to warning labels on prescription drugs containing opiates. “red cap” bill” This bill requires any drug which contains an opiate dispensed

by a health care provider or pharmacy to have an orange sticker on the cap or dispenser and a warning label regarding the risks of the drug.

This bill also requires the governor's commission on alcohol and drug abuse prevention, treatment, and recovery to develop a handout on the risks of opioids and how to mitigate them for persons who are receiving prescriptions for opioids.

HB615 Pharmacy “cleanup bill” This bill makes various changes to the regulation of

pharmacies and pharmacists by the board of pharmacy, including procedures of the board, exceptions to possessing prescription drugs, license expirations and renewals, and establishing the licensure of drug distribution agents.

Legislative Issues Affecting Pharmacy from 2019 session

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HB670-FN- relative to cost of prescription drugs

HB703-FN – relative to providing notice of introduction of new high-cost prescription drugs

HB671-FN -relative to PBM business practices, licensure and transparency.

SB222-FN- relative to licensure of PBM’s.

Others affecting impact on insurance premiums

SB226-FN-relative to registration of pharmacy benefit managers, and reestablishing the commission to study greater transparency in pharmaceutical costs and drug rebate programs.

Legislation- discussion on PBM’s

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HB1822-FN making hormonal contraceptives available directly from pharmacists by means of a standing order.

Result of study commission established in 2017.

Was our best chance for provider status.

Allows pharmacist to charge for an initial screening and payment by insurance carrier.

Standing order an issue, DHMC OB/GYN department head to sign blanket order.

Specific education requirements, will begin this winter.

Don’t expect program until next year.

Legislation- contraceptives??

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Changes proposed this session

4 Amend RSA 318:16-a by adding: (a) The commissioner shall employ a managed care model for

administering the Medicaid program and its enrollees to provide for managed care services for all Medicaid populations throughout New Hampshire consistent with the provisions of 42 U.S.C. 1396u-2, …………pharmacy benefit management, provider network management, quality management, and customer services. The model shall reimburse pharmacists for cognitive services enumerated in RSA 126-A:3 III-a.

4 Amend RSA 318:16-a by adding: VII. Pharmacists dispensing hormonal contraceptives via standing

order pursuant to RSA 318:47-l II and pharmacists dispensing smoking cessation therapy via standing order pursuant to RSA 318:47-m II shall be considered to be in a collaborative practice agreement with the physician or APRN who signed the standing order.

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Next legislative initiatives E-prescribing (associated with PDMP changes on who is required to

register with program, and data sharing)

Medicaid provider status for contraceptive billing Addition of smoking cessation standing order to contraceptive bill

Statute and rules cleanup RSA 318-B:9 III (f) Sale by Pharmacists. Partial fill of CII’s (2009)

“no refills shall be authorized for controlled drugs in schedule II of the current chapter 21, Code of Federal Regulations”

Will be others

318-B:7 Written Orders. – An official written order for any controlled drug in schedule II shall be signed in triplicate by the person giving said order or by his duly authorized agent. (1985)

Will be more……….

Insulin price protections and limits94

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318-B:9 Sale by Pharmacists

21 U.S.C. 829 – control substances act

B (f) Partial fills of Schedule II control substances.

1. Partial fills- a prescription may be partially filled if;

A. it is not prohibited by state law

B. written in accordance with this subchapter

C. partial fill requested by patient or practitioner who wrote the prescription

D. total quantity dispensed does not exceed total prescribed

Remaining portions

A (1) may be filled; and

A (2) shall be filled not later than 30 days after date the prescription is written.

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Tele-pharmacy:

Tele pharmacy rules will be developed in near future.

Current rules proposal (Ph900 update):

Pharmacist in charge of all pharmacies doing business in state to be licensed by the Board

Pharmacist’s involved in clinical duties shall be licensed by the Board. (same as tele medicine rules)

Where does tele-pharmacy lead us?

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329:1-d Telemedicine. –I. "Telemedicine" means the use of audio, video, or other electronic media for the purpose of diagnosis, consultation, or treatment. "Telemedicine" shall not include the use of audio-only telephone or facsimile. II. An out-of-state physician providing services by means of telemedicine shall be deemed to be in the practice of medicine and shall be required to be licensed under this chapter. This paragraph shall not apply to out-of-state physicians who provide consultation services pursuant to RSA 329:21, II. III. It shall be unlawful for any person to prescribe by means of telemedicine a controlled drug classified in schedule II through IV. IV. (a) The prescribing of a non-opioid controlled drug classified in schedule II through IV by means of telemedicine shall be limited to prescribers as defined in RSA 329:1-d, I and RSA 326-B:2, XII(a), who are treating a patient with whom the prescriber has an in-person practitioner-patient relationship, for purposes of monitoring or follow-up care, or who are treating patients at a state designated community mental health center pursuant to RSA 135-C or at a Substance Abuse and Mental Health Services Administration (SAMHSA)-certified state opioid treatment program, and shall require an initial in-person exam by a practitioner licensed to prescribe the drug. Subsequent in-person exams shall be by a practitioner licensed to prescribe the drug at intervals appropriate for the patient, medical condition, and drug, but not less than annually. (b) The prescribing of an opioid controlled drug classified in schedule II through IV by

means of telemedicine shall be limited to prescribers as defined in RSA 329:1-d, I and RSA 326-B:2, XII(a), who are treating patients at a SAMHSA-certified state opioid treatment program. Such prescription authority shall require an initial in-person exam by a practitioner licensed to prescribe the drug and subsequent in-person exams shall be by a practitioner licensed to prescribe the drug at intervals appropriate for the patient, medical condition, and opioid, but not less than annually. Source. 2015, 246:6. 2016, 221:3, eff. Aug. 8, 2016.

Telemedicine issue

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DEA inspections……….

Control drug prescription requirements for ALL prescriptions!!!

III. Prescriptions issued by practitioners for controlled drugs shall be executed in clear, concise,

readable form. Each prescription shall contain the following information and comply with the

following requirements:

(a) The full name and complete address of the patient or of the owner of the animal for which

the drug is prescribed.

(b) The day, month, and year the prescription is issued.

(c) The name of the controlled drug prescribed. Only one controlled drug shall appear on a

prescription blank.

(d) The strength of the controlled drug prescribed.

(e) The specific directions for use of the controlled drug by the patient.

(f) No refills shall be authorized for controlled drugs in schedule II of the current chapter 21,

Code of Federal Regulations.

(g) The federal Drug Enforcement Administration registration number of the practitioner.

(h) The practitioner shall manually or electronically sign the prescription on the date of

issuance.

(i) The practitioner's full name shall be printed, rubber stamped, or typewritten above or

below the manual or electronic signature.98

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How is NH PDMP used?

NH PDMP is a clinical tool that exists to promote the appropriate use of controlled medications for legitimate medical purposes, while deterring the misuse and diversion of controlled medications.

NH PDMP also serves as a surveillance tool that is used to monitor statewide trends in the prescribing, dispensing, and use of controlled medications.

DATA LIMITATION: Opioid addiction treatment programs (OTPs) that dispense methadone and buprenorphine do not upload into the NH PDMP - (CFR 42 part 2 – confidentiality).

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Who has ACCESS?

Dispensers

Prescribers incl. Federal

Medical Examiner

Law Enforcement

w/Court Order

Professional Licensing Agencies

Patients

Pharmacists incl. Federal

State PDMP

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NH PDMP

LAWS

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2019 Legislative Changes

HB 369 SB 120

Requires prescribers who write an opioid when treating a patient for an substance use disorder to query the PDMP.

This is similar to the mandate that requires a prescriber to query the PDMP when prescribing an opioid to a patient for the treatment and management of pain from HB 1426.

Moves the PDMP out from under the authority of the Board of Pharmacy to under the authority of the Office of Professional Licensure and Certification. It also re-designs the focus of the Advisory Council and allows the impaired practitioner program to review PDMP information when retained by OPLC or referral who has agreed to be evaluated has separately agreed in writing.

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Practitioner Registration and Patient Query Activity Report (2017 – 2018)

User Role2018 Registered

Users

% change from

2017

Physician (MD, PA, DO, Res) 5,784 18%

Delegates ** 3,551 56%

Pharmacists 3,145 15%

Nurse Practitioner / Clinical Nurse Specialist 2,181 20%

Dentist 1,090 12%Optometrist/Podiatrist (DPM)/Naturopathic Physisican 365 21%

Veterinarian 341 20%

Totals 16,457 24%

User Role2018 Patient Info

Requests

% change from

2017

Physician (MD, PA, DO, Res) 115,056 91%

Delegates 408,857 171%

Pharmacists 232,095 173%

Nurse Practitioner / Clinical Nurse Specialist 66,547 137%

Dentist 23,343 149%

Optometrist/Podiatrist (DPM)/Naturopathic Physisican 1,677 158%

Veterinarian 146 -3%

Totals 847,721 153%

Registration Query Requests

Registration is required. The PDMP will be conducting an audit of the of the registrations to identify those licensees who are required to be registered and are not.

PDMP queries increased by over 153% between 2017 and 2018. Queries by delegates (171%) and pharmacists (173%) increased dramatically between 2017 and 2018

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PDMP usage by pharmacy……

Pharmacy Chain (grouping)Sum of Total RX Filled

Sum of Search Count

Ratio RX dispensed to Searches conducted

Clinics (Martin's Point, Harbor Homes, etc.) 6,546 1,495 4

Costco 1,786 1,032 2

CVS 245,565 8,406 29

Misc. pharmacies (PillPak, Pharmerica, etc.) 32,648 63 518

Genoa 7,990 42 190

Hannaford 72,983 8,830 8

Hospitals 28,269 10,816 3

Independents 57,912 3,947 15

Rite Aid 278,669 20,097 14

Sam's Club 2,183 3,239 <1

Shaws/Osco 26,097 1,222 21

Walgreens 168,835 9,059 19

Walmart 80,472 42,324 2

Grand Total 1,011,839 111,768 9

107

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User RoleActive users Jul 1, 2017

thru Dec 31, 2017 *

Active users Jan 1, 2018

thru Jun 30, 2018 *

%

Change

Physician (MD, PA, DO, Res) 1,920 1,978 3.0%

Delegates 1,405 1,697 20.8%

Pharmacists 768 830 8.1%

Nurse Practitioner / Clinical Nurse Specialist 617 680 10.2%

Dentist 201 272 35.3%

Optometrist/Podiatrist (DPM)/Naturopathic Physisican 27 29 7.4%

Veterinarian 10 6 -40.0%

Totals 4,948 5,492 11.0%

0

5,000

10,000

15,000

20,000

25,000

30,000

35,000

40,000

Prescribers Pharmacists Delegates

Figure 5

Although prescribers (MD,PA,DO,Res) represent the highest number of registered users, Delegates account for almost twice as many patient inquiries.This was probably caused by clinicians delegating PDMP use to other staff in their practices.Another trend in SFY 2018 utilization data was an increase in active system users. In short, the PDMP is being used more.

Overall, the number of active PDMP users increased by 11% during from the previous two quarters of 2017 to the end of 2018. The largest distribution of the increase was for delegates, followed by pharmacists and then prescribers as a combined group.

PDMP UTLIZATION- Patient Inquiries by Active Users

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Prescription Drug Use in New Hampshire

Background: How PDMP tracks prescriptions The information in the PDMP comes from pharmacies. By law, all pharmacies in New Hampshire, including veterinarians, are required to report the controlled substances they dispense to the PDMP. Controlled substances are drugs that can be misused, diverted and may lead to a substance use disorder. Hospitals that administer drugs to patients in their facility are exempt, and do not have to report to the PDMP, as well as wholesale pharmacies. An additional exemption is when a patient is dispensed less than a 48 hour supply of a controlled medication in an ER.

This chart shows that for each of SFY 2017 and SFY 2018, prescription counts declined, overall by 7.6%. We attribute this to the timely information prescribers can get from the PDMP, using it as another tool for prescribing decisions.

SFY Q1 SFY Q2 SFY Q3 SFY Q4

SFY 2017 536,571 534,881 516,825 514,739

SFY 2018 506,942 504,728 495,014 495,904

SFY 2017

SFY 2018

470,000

480,000

490,000

500,000

510,000

520,000

530,000

540,000

Co

un

t o

f R

X

Prescription Count by SFY QuarterSFY 2017 – SFY 2018

Figure 7

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Prescription Drug Use in New Hampshire

Comparison of Prescription Counts of Opioids to Non-Opioids

Q1 2017 Q2 2017 Q3 2017 Q4 2017 Q1 2018 Q2 2018 Q3 2018 Q4 2018

Opioid 201,247 193,557 178,739 174,311 169,926 165,134 156,889 153,961

100,000

120,000

140,000

160,000

180,000

200,000

220,000

Opioids

Q1 2017 Q2 2017 Q3 2017 Q4 2017 Q1 2018 Q2 2018 Q3 2018 Q4 2018

Non-Opioid 285,954 288,239 284,636 288,385 285,228 285,810 282,507 287,480

250,000

255,000

260,000

265,000

270,000

275,000

280,000

285,000

290,000

295,000

300,000

Non-Opioids

Non-Opioid RX quarterly counts show a variation of less than 6,000 from quarter to quarter. The trend line over two years is essentially flat with minimal change in RX count.

Opioid RX quarterly counts show a steep decline over the 24 months. Therefore the decrease in total RX (shown previously) is driven almost entirely by a decrease in opioid RX.

Figure 8

Figure 9

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Prescription Drug Use in New HampshireAverage Number of Units and Average Days Supply per Prescription – Opioids only

Q1 2017 Q2 2017 Q3 2017 Q4 2017 Q1 2018 Q2 2018 Q3 2018 Q4 2018

Ave Nbr Units 61.6 62.2 63.8 64.9 64.6 64.3 63.8 64.2

Ave Days Supply 16.4 16.6 17.1 17.5 17.6 17.5 17.5 17.7

Ave Nbr Units, 61.6

Ave Nbr Units, 64.2

Ave Days Supply, 16.4

Ave Days Supply, 17.7

15.5

16.0

16.5

17.0

17.5

18.0

60.0

61.0

62.0

63.0

64.0

65.0

66.0

Ave Days SupplyAve Nbr units

Ave Days Supply, 16.4

Figure 12

Ave Days Supply, 17.7

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Prescription Drug Use in New Hampshire

The percentage of all controlled substance prescriptions by age range compared to the percentage of opioid only prescriptions. SFY 2017 and 2018 combined.

New Hampshire’s 55 and older population are prescribed over half (54.7%) of all opioid prescriptions. The 34 to 54 age range account for makes up a third of all opioid prescriptions.

In essence, as the age of patients increase, the prescribing of Controlled Substances increases.

Under 18 18-34 35-44 45-54 55-64 65 and older

% of All CS RX 6.2% 16.4% 13.5% 17.1% 21.8% 25.1%

Under 18

18-34

35-44

45-54

55-64

65 and older

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

% of All CS RX

Under18

18-34 35-44 45-54 55-6465 andolder

% of Opioid RX 1.5% 13.3% 13.1% 17.4% 24.3% 30.4%

Under 18

18-34 35-44

45-54

55-64

65 and older

0.0%

5.0%

10.0%

15.0%

20.0%

25.0%

30.0%

35.0%

% of Opioid RX

Figure 10

Figure 11

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Number of Opioid RX per 1,000 residents, where the RX indicated both the prescriberand the pharmacy had an NH address.The data show that half of NH Counties are above the statewide value and half are below.

598

521

456

454

447

435

410

389

371

339

289

0 100 200 300 400 500 600 700

Merrimack

Strafford

Coos

Carroll

Rockingham

All of NH

Belknap

Hillsborough

Cheshire

Grafton

Sullivan

Prescription Drug Use in New HampshireBy County – Opioids Only SFY 2018 only

Population Estimate from US Census, July 2017Figure 13

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Prescription Drug Use in New HampshirePercent of Rx Greater than 100 MMEOpioid Rx only; SFY 2017 – SFY 2018 (Excludes Buprenorphine & Naloxone).Morphine Milligram Equivalent (MME) is the amount of morphine equivalent to the strength of the opioid dose prescribed. Using MME allows comparison between types and strengths of opioids.

19.0%

18.1% 18.3%17.7%

15.9% 15.8%

17.6%17.2%

10%

11%

12%

13%

14%

15%

16%

17%

18%

19%

20%

All Prescribers

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Prescription Drug Use in New HampshirePercent of patients prescribed long-acting/extended release opioids who were opioid-naïve.Measured using all controlled substance prescriptions.Opioid-naïve is defined as a patient who had not received an opioid prescription in the prior 90 days.

9.9%10.5%

11.7%10.5%

8.7%

16.8%

12.0%

15.5%

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

20%

All Prescribers

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Prescription Drug Use in New HampshirePercent of prescribed opioid days that overlap with benzodiazepine prescriptions.

Patients with combined prescription use of both drugs may be more at risk to become addicted or to die from an overdose. (Source: CDC)

19.0% 18.5% 18.2% 18.5%19.8% 18.6%

17.4%16.6%

0%

2%

4%

6%

8%

10%

12%

14%

16%

18%

20%

22%

24% All Prescribers

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Program & System Upgrades

• On-Staff Program Analyst• Data Sharing Agreements• Clinical Alerts (data collection at first)

• Prescriber Report Cards – Oral Health Grant• Tool to better monitor utilization of PDMP - CDC

Grant• Hiring of Audit/Compliance staff to review and ensure

PDMP data is being uploaded & uploaded accurately in accordance to the law and rules – CDC Grant.

• NO LONGER responsibility of Board of Pharmacy effective September 27th, 2019!!!

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PDMP Data Audit & Compliance Project

To assist with improving data and making better linkages – the PDMP will receive CDC funds to hire temporary staff to implement a PDMP Audit:

Determine New Hampshire’s PMP data accuracy by: Implementing a standardized process for evaluating its

accuracy

Taking the necessary steps to correct the data if errors are identified

Prevent incidences of errors

Started June 1st, 2019

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Audit Process

PDMP Auditor sends audit Notice to PIC with 8 pre-chosen

prescription numbers asking to

prepare

documents

PIC prepares the filling tag, back tag, copy of the prescription, and

make original prescription

readily retrievable

BOP Compliance Inspectors visit pharmacy and look at documents, comparing back tag/filling tag with original and marking on form.

• They then pull 2 additional prescriptions randomly for the audit

BOP Compliance Inspectors bring form

and prescriptions

back to PDMP office

PDMP auditor compares

information to PDMP

• Any errors are reported to administrator

• Severe errors may be further reported to the BOP for further review

Pharmacies that pass audit are provided notice and nothing further needs to be done.

Pharmacies that fail the audit: PDMP auditor informs these pharmacies of errors, and provides 72 hours to correct errors

•Corrected errors within 72 hours = good job

•Not corrected within 72 hours = reported to BOP

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Audit Executive Summary(Human Prescriptions Only)

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Audit Executive Summary(Animal Prescriptions Only)

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Breakdown of TOP Districts (Human Prescriptions Only)

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Breakdown of TOP Chains (Human Prescriptions Only)

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Most Common Errors(Animal Prescriptions Only)

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Most Common Errors(Days Supply)

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Most Common Errors(Date Filled vs Date Written)

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Most Common Errors(X DEA # of Prescriber)

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Most Common Errors(Patient Address & DOB)

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Most Common Errors(Different DEA # for Prescribers)

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Most Common Errors(Prescriber Full Name, Address & DEA)

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Electronic Rx Error Analysis

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NON-Electronic Rx Error Analysis

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Questions or Comments

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134

Pharmacists questions By current rule, how often should a pharmacist check the Prescription Drug

Monitoring Program? a. Every time they fill a prescription for Tramadol b. Make a reasonable attempt to verify all control drug medications c. When time permits d. Not required to check at any time

Dental Hygienists have prescriptive authority from the dental board to prescribe which of the following:

a. oral and topical antibiotics b. triamcinolone in orabase c. Chlorhexedine gluconate oral rinse d. None, pharmacy statutes do not address Dental Hygienists prescriptive

authority.

What current information is required by the Board for a pharmacist to participate in a collaborative practice?

a. a signed agreement on pharmacists duties with a single provider. b. 20 additional hours of continuing education in specialty annually. c. pass a Board approved exam on specialty of practice. d. no requirements necessary.

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135

Technicians questions 1. Advanced practice pharmacy technicians can perform which of the following duties?

a. Data entry of a new prescription without direct supervision by the pharmacist b. Transfer a non-controlled prescription to another pharmacy. c. Product verification of a prescription refill when no changes have occurred. d. All of the above

2. What is the length of time a pharmacist shall take a break in an 8 hour work day? a. 15 minutes b. 30 minutes c. pharmacists are not allowed to take rest breaks. d. The pharmacy is too busy for the pharmacist to take a break.

3. How many continuing education credits does a registered pharmacy technician need to maintain their registration? a. 10 credits of which 1 credit is “live programming” annually. b. 2 credits of pharmacy law. c. 2 credits of sterile or non-sterile compounding. d. none.


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