A Pilot Study Regarding Pharmacy Law Education Across Doctor of Pharmacy Programs

Ettie Rosenberg, PharmD, JD; Erin L. Albert, MBA, PharmD, JD; Geoffrey A. Mospan, PharmD; Shannon Panther, PharmD; James Ruble, PharmD, JD; Robert L. Stein, PharmD, JD


Am J Pharm Educ. 2020;84(2):7172 

In This Article

Abstract and Introduction


Objective: To describe the features of pharmacy law education in Doctor of Pharmacy (PharmD) programs in the United States.

Methods: A review of the literature found no prior published data describing the delivery of pharmacy law education across PharmD programs in the United States. Members of the Pharmacy Law Educators Subcommittee of the American Society for Pharmacy Law (ASPL) developed questions for a survey. The survey was administered electronically to all 139 American Association of Colleges of Pharmacy (AACP) member institutions in the summer of 2016. A link to complete the 32-item online survey was distributed via email to the pharmacy law educator or associate dean at each AACP member institution.

Results: Of the 139 PharmD programs surveyed, 49 completed the survey instrument, yielding a response rate of 35.2%. Variations between programs were found in the professional background of pharmacy law instructors and assessment strategies for pharmacy law courses, as well as in the structure and placement of the main pharmacy law course within the various curricula.

Conclusion: This pilot study represents the first and only known attempt to examine delivery of pharmacy law education across colleges of pharmacy. The variations between programs found in this study highlight the need for further investigation into this area of pharmacy education.


Accreditation standards require Doctor of Pharmacy (PharmD) degree programs to include content on pharmacy law and regulatory affairs "at an appropriate breadth and depth" and explicitly recognize such content to be "central to a contemporary, high-quality pharmacy education."[1] Specifically, the Accreditation Council for Pharmacy Education (ACPE) Standards 2016 provides that PharmD curricula must incorporate critical law content including "federal and appropriate state-specific statutes, regulations, policies, executive orders, and court decisions that regulate the practice of pharmacy, including the mitigation of prescription drug abuse and diversion."[1] Presumably, competency in those content areas lays the foundation for pharmacy graduates to be armed with a working knowledge of the legislative and regulatory boundaries within which pharmacists practice, and the ability to advocate for its expanding scope in the evolving healthcare landscape. However, Standards 2016 provides only a broad overview for the requisite pharmacy law content.

Ideally, there would be published studies to support the recommendations made by ACPE. Instead, there is a remarkable deficiency of literature specifically addressing pharmacy law education, with no published literature related to pedagogic methods for delivery, sequencing, or overall scope of didactic pharmacy law curricula in PharmD programs. Pharmacy law education has been seemingly overlooked in the literature. Thus, the American Society for Pharmacy Law (ASPL) Pharmacy Law Educators Subcommittee sought to highlight that pharmacy law content is an essential component of a PharmD curriculum. Further, the subcommittee recognized that scholarly attention to current pedagogic practices in pharmacy law curricula is warranted. At the federal level, statutes authorizing federal agencies to publish regulations and enforcement provisions directly impact pharmacists and pharmacies, as well as the gamut of players in the pharmaceutical industry and supply chain. Yet other federal statutes exact similar impact, albeit indirectly, through regulation of the drug products handled daily by pharmacists and pharmacies. Moreover, each state has independent jurisdiction over its own pharmacy practice act, regulating the licensing of pharmacists and pharmacies and its own controlled substance statutes. Thus, integrating pharmacy law content into PharmD curricula through robust and evidence-based pedagogic delivery methods should ensure that pharmacy graduates possess a solid foundational understanding of the pervasive federal and state regulatory frameworks impacting pharmacy practice and their application to the profession, and accordingly, that pharmacy graduates are indeed "practice ready."

Accordingly, the Pharmacy Law Educators Subcommittee focused on the observed need to identify strategies and methods for delivery and ultimately assessment of pharmacy law education. The subcommittee's objective was to acquire information through the scholarly collection and evaluation of data on pharmacy law education in the United States. The seminal nature of the subcommittee's exploration guided a probative effort to disseminate a survey with inquiries about demographics of pharmacy law faculty members (who); sequencing of pharmacy law content (when); and teaching-learning strategies (how) for delivery of primary pharmacy law content. The subcommittee reasoned that conducting a pilot study that examined delivery of pharmacy law education, collected and reported demographic information obtained from schools and colleges of pharmacy, the subcommittee could reasonably advise the Academy regarding current practices in pharmacy law education. Likewise, the analysis of data from future studies would afford a longitudinal mechanism by which to identify, develop and recommend evidence-based best practices for delivery of pharmacy law education, while also promoting an exchange of ideas across PharmD programs. As the first step of this initiative, the survey was pilot tested in the summer of 2016. The objective of the pilot survey was to gather preliminary insight about delivery of pharmacy law education in the United States to inform a further and more robust investigation.