chapter 7: state regulation of pharmacy practice

pharmacy self-regulation

• during the 19th century, pharmacists purposely chose to become self-regulating healthcare professionals rather than externally regulated retail merchants

• later, pharmacists chose to organize, self-regulate, seek licensure, and seek state legislation of its standards

approaches to regulation

• although approaches to regulation vary in other countries, most seem to aspire to the U.S. system of regulation where licensed physicians prescribe and licensed pharmacists dispense

• reasons to regulate professions include:

  • to protect the public from unqualified providers

  • to inc quality of health care

  • to reduce the cost of health care

  • to inhibit criminal abuse of drugs

• these reasons to regulate can be challenged

state boards of pharmacy (BOP)

• purpose of the board: to administer state pharmacy practice acts and protect the public

• national association of boards of pharmacy (NABP) performs several functions, including:

  • overseeing the standardized licensure exam process (NAPLEX + MPJE)

  • forum for developing professional policies and standards

  • developing model legislation and regulations for use by member boards

• board composition depends on state law but includes practicing pharmacists and often consumer members

who does the board of pharmacy protect? the profession or the public?

the public

what does NABP stand for?

national association of boards of pharmacy

licensing

• licensing of pharmacists

  • requirements essentially same for each state (MUST GET LICENSE FOR EACH STATE YOU WANT TO WORK IN)

  • foreign pharmacy school graduates may be allowed to take the equivalency exam in order to take the board exam

  • citizenship requirement for licensure is unconstitutional

  • NAPLEX exam administered in every state

  • license transfer generally allowed by every state

  • pharmacist licenses subject to periodic renewal

    • continuing educations (CPE credits)

licensing cont.

CONT

licensing pharmacies

• some states establish different categories of licensure

• ownership requirements exist in many states

  • North Dakota: majority owners must be pharmacists

  • many states prohibit prescribers from owning a pharmacy

  • most states require the owner to name a PIC

  • nonresident pharmacies (a NY medication being shipped into MA)

    • states can require registration but cannot require that they be held to the same requirements as in-state pharmacies

actions against a license

• state boards have broad discretion in the discipline of pharmacists and pharmacies (+ techs and interns)

• state pharmacy boards may not focus on outcomes as much as they should

• boards must comply with administrative procedure laws in any disciplinary action

• revocation of license in one state may serve as the basis for revocation in another state

ancillary pharmacy personnel (techs + interns)

• authorized by state laws to enable pharmacists to perform professional services

• qualifications, licensure requirements, supervision, and ratio requirements vary among states

• national trend toward stricter requirements for qualifications and licensure, including national certification

• some states adopted a tech-check-tech approach in hospital pharmacies

• many states have pharmacist-to-technician ratio requirements, and controversies have existed in some states as to their application

interns

• in most states, pharmacy students are allowed to become interns starting in the first year of pharmacy school

• many states allow interns to perform any function that a pharmacist can perform, under the direct supervision of a pharmacist

automation (technology)

• issue in some states whether Rx must be checked by a pharmacist when dispensed in an automated system

• standards of practice and negligence liability make checking a wise practice

absence of a pharmacist (errors)

• to prevent errors, some state laws require that employers allow pharmacists at least a meal break of usually 30 minutes

• some states now allow the pharmacist (when there is only one pharmacist on duty) to take the break off premises while the pharmacy is left open with ancillary personnel. the pharmacist and PIC remain responsible

continuring pharmacy education (CE)

• required in every state

• most states require 13 hours annually or 30 hours biennially

• states vary in their requirements as to whether any of the hours must be live, must be approved by ACPE, and whether certain hours must be on a specific subject

• most states allow exceptions for hardship

• CPE monitor allows licensees electronic recording and monitoring of CPE credit