Pennsylvania State Board of

Pharmacy Regulations and Update

Gayle A Cotchen, RPh, MBA PharmD

Disclosure

I have no relevant financial disclosures in relation to this activity

Learning Objectives

• At the end of this presentation, the CE participants will be able to:▫ Describe the structure and purpose of the

Pennsylvania State Board of Pharmacy (SBOP)

▫ Discuss the regulatory process in the Commonwealth of Pennsylvania

▫ Discuss recent and pending changes in pharmacy regulations in the Commonwealth of Pennsylvania

State Board of Pharmacy Background

• Established by the Pharmacy Act

• Pharmacy Act gives powers and duties to the Board

• Current makeup of the Board dictated by amendment to the Pharmacy Act in 1985

• Professional and Public members are appointed by the Governor with approval by the State Senate for 6 year terms

Test Your Knowledge

• How many professional members represent institutional pharmacy on the board?

• How many public members are on the board?

• True or false—The Department of Health (DOH) has a member who serves on the board

State Board of Pharmacy

• Five Pharmacists (2 Independent Retail Pharmacists, 2 Chain Retail Pharmacists, 1 Institutional Pharmacist)

• Two Public Members• One Representative of the Attorney General’s

Office• The Commissioner of the Bureau of Professional

and Occupational Affairs (BPOA)

Executive Secretary

• By law, the Executive Secretary must be a Registered Pharmacist

• Responsible for the day to day operations of the Board office: processing applications, maintaining license database, handling licensee and consumer questions

• May not give legal advice

Test your Knowledge

• What is the role of the State Board of Pharmacy?

The Role of the State Board

Like all professional licensing boards, the State Board of Pharmacy protects the health, safety and welfare of the public from fraudulent and unethical practitioners

Mission StatementThe State Board of Pharmacy regulates the practice

of pharmacy in Pennsylvania. The Board registerspharmacy interns and licenses pharmacists andpharmacies. The Board is charged with passing uponinitial qualifications for licensure and with imposingsanctions against persons and businesses who violate thePharmacy Act. The Board’s regulations govern practicestandards; drug storage; security and dispensingrequirements; facility requirements; licensurerequirements; internships; and continuing education

Regulations

• Why does it take so long to promulgate regulations??

Process for New Regulations

• 1. Idea for a new regulation could come from the Board, the Legislature (i.e. new law), members of the profession, concerned citizens

• 2. Draft regulation developed and reviewed within BPOA, the Department of State and Governor’s Policy Office

• 3. Draft regulation distributed to identified “Stakeholders” for comment

Process for New Regulations

4. Back to Board for review of comments, changes may be made

5. Reviewed again within BPOA, the Department of State and Governor’s Policy Office

6. Published as Proposed Regulation in Pennsylvania Bulletin with a 30-day comment period

7. Board reviews comments and may make changes based on the comments

Process for New Regulations

8. Again, reviewed within BPOA, the Department of State and Governor’s Policy Office

9. Submitted to House and Senate Professional Licensure Committees for approval

10. Submitted to Independent Regulatory Review Commission (IRRC) for approval

11. Reviewed by Attorney General12. Published as Final in the Pennsylvania Bulletin

Statutes and Drafted Regulations

• Domestic Relations Code – Education and Training Act No. 2014-31 amending Title 23 of the Pennsylvania Consolidated Statutes

• Drug Overdose Response Immunity Act No. 2014-139 amending the Controlled Substance, Drug, Device and Cosmetic Act

• Achieving Better Care-Monitoring All Prescriptions (ABC-MAP) Act No. 2014-191

• Authority to Administer Injectable Medications, Biologicals and Immunizations Act No. 2015-8 amending the Pharmacy Act -> Necessitates Immunization revisions to Chapter 27. State Board of Pharmacy (regulations)

• Medical Marijuana Act No. 2016-16• Achieving Better Care-Monitoring All Prescriptions (ABC-MAP)

Act – Omnibus Amendments No. 2016-124• SBOP proposes adding Compounding regulations to

Chapter 27. State Board of Pharmacy (regulations)• SBOP proposes General Revisions to Chapter 27. State

Board of Pharmacy (regulations)

Domestic Relations Code amended

• Mandates reporting of child abuse

• As a condition of licensure, requires professional licensees identified as mandated reporters to complete a course about child abuse recognition and reporting

▫ Initial licensees must complete a 3 hour course

▫ Renewing licensees must complete a 2 hour course every renewal cycle

Domestic Relations Code amended

• Continuing education (CE) course for license renewal must have been approved by BPOA, but it does not have to have been accredited by the Accreditation Council for Pharmacy Education (ACPE)

BPOA-approved courses are identified on the board’s website(http://www.dos.pa.gov/ProfessionalLicensing/BoardsCommissions/Pages/Act-31-Mandated-Child-Abuse-Recognition-and-Reporting-Continuing-Education-Providers.aspx)

• CE providers upload the data to BPOA

• Unless the completed CE was an ACPE-approved course, child abuse recognition CE credit does not appear on the Continuing Pharmacy Education transcript from CPE Monitor, the CE monitoring program of the National Association of Boards of Pharmacy (NABP)

• Two-hour or three-hour CE course may be used for license renewal; hours count toward the 30-hour CE requirement

Drug Overdose Response

• Pharmacies in Pennsylvania may be requested to fill naloxone standing orders or prescriptions for first responder agencies or friends/family members under the direction of a health care provider authorized to prescribe naloxone.

• Statewide naloxone standing order issued by physician general on 10/28/15

• All pharmacists in the state may use this protocol or collaborate with another physician

• Provides civil, criminal and licensure discipline immunities

PDMP—test your knowledge

• True or false—Pennsylvania currently has a Prescription Drug Monitoring Program (PDMP)

• True or false—Pharmacists have access to the PDMP

• True or false—All controlled substances must be reported to the PDMP on a weekly basis under the new regulations

PDMP, known as ABC-MAP program

• Requires data submission to PDMP within 1 business day of dispensing of controlled substance

• All controlled substances are reported to the program…not just C-II

• Prescribers must check the PDMP:▫ Before initial prescription of controlled substance▫ If the prescriber believes or has reason to believe,

using sound clinical judgment, that a patient may be abusing or diverting drugs

PDMP, known as ABC-MAP program

• Is administered by Department of Health; more information at http://www.health.pa.gov

• Is part of the National Association of Boards of Pharmacy’s PMP InterConnect

• Pharmacists may query system, but it is only mandatory before dispensing an opioid drug product or a benzodiazepine prescribed to a patient if the patient: ▫ Is a new patient of the dispenser; ▫ Pays cash when they have insurance; ▫ Requests a refill early; or, ▫ Is getting opioid drug products or benzodiazepine

from more than one prescriber

Test Your Knowledge—

Immunizations• Pharmacists can now administer any vaccine to

anyone under the age of 18.

• Pharmacy interns can administer vaccines under the direct supervision of the pharmacist if they have been trained to do so.

Immunizations

• Allows for influenza vaccine for children between 9 and 18 (either nasal or injected)

• Mandates liability insurance for all immunizers

• Authorizes the board to create regulations to allow for interns who are properly educated and certified to immunize

• Regulation status update

Medical Marijuana—

Test your knowledge

• True or False—any pharmacist can dispense medical marijuana

• True or False—the Board of Pharmacy is responsible for licensing dispensaries

• True or False—the products dispensed will include product that may be smoked

Medical Marijuana

• Signed 4/17/16 with an effective date of 5/17/16

• Established a program for use of medical marijuana by patients with “serious medical conditions”— patients will need to obtain certificates from their prescribers that they qualify.

• Regulations posted on DOH website

ABC-MAP program: education requirement

• Effective date 1/1/2017• Requirements:

▫ require initial and continuing education in pain management, identification of addiction and the practices of prescribing or dispensing of opioids. Renewal – Dispensers must complete at least 2 hours of

continuing education in this area as part of license renewal. Initial License - Within 12 months of obtaining an initial license,

dispensers must submit documents showing completion of at least 2 hours of education in pain management or identification of addiction, and at least 2 hours of education in the practices of prescribing or dispensing of opioids. This education may be part of the individual’s professional degree program.

• Program must be approved by the SBOP in consultation with DOH—hopefully will be ACPE-accredited…stay tuned for details

Compounding Regulations

• Following the New England Compounding Center case in 2012, the board drafted compounding regulations with input from stakeholders

• “The compounding of sterile and non-sterile preparations shall be done in accordance with the current version of the United States Pharmacopeia (USP) chapters...”

• Proposed regulations submitted by the board in 2014 came back from the Independent Regulatory Review Commission with comments

• Update

General Revisions

• SBOP began working on general regulation revisions in 2010

• Other “more urgent” regulations took priority and the general revisions were put on hold until 2014

• SBOP with stakeholder input reviewed all regulations

• Drafted revisions totalling 35 pages were proposed January, 2017 and started through the regulatory process

Pennsylvania Board of Pharmacy

Contact Information

• Phone: 717-783-7156

• Email: ST-PHARMACY@state.pa.gov

• Board Website: http://www.dos.pa.gov/ProfessionalLicensing/BoardsCommissions/Pharmacy