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

Abstract

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.

INTRODUCTION

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.

METHODS

This was a cross-sectional survey which studied the delivery of pharmacy law education in the United States. An online survey approach was used to collect information on current practices in pharmacy law education. The study was deemed exempt by the Washington State University Institutional Review Board (IRB) Office of Research Assurances.

Members of the ASPL Pharmacy Law Educators Subcommittee identified and developed the framework of inquiry and the survey questions on pharmacy law pedagogy. The survey tool contained 32 questions on delivery of pharmacy law education, including: faculty demographics (who delivers the pharmacy law content); scope (what pharmacy law content is delivered); sequencing (when primary pharmacy law content is delivered); and teaching-learning strategies (how primary pharmacy law content is delivered). A list of the 32 items comprising the pilot survey is presented in Appendix 1.

The SurveyMonkey platform (SurveyMonkey Inc., San Mateo, CA) was used for data collection. The survey was conducted during the narrow period between June 22, 2016 and July 31, 2016. ACPE Standards 2016 became effective July 1, 2016. At the start of the data collection period, an email was sent to the pharmacy law educator or associate dean at each PharmD program that explained the survey’s purpose, provided a link to the survey, and specified a deadline of July 31, 2016, for the survey’s target completion. A reminder e-mail was sent to nonresponders on July 8, 2016, and the survey link was inactivated on August 8, 2016. Descriptive data analyses (i.e., frequency and percentage) were performed to identify the characteristics associated with the current delivery of pharmacy law education in the United States.

RESULTS

Of the 139 AACP member institutions in 2016, 49 responded to the pilot survey, yielding a response rate of 35.2%.² The demographics of the responding schools and colleges of pharmacy can be found in Table 1. The majority (n=27, 55%) of schools that responded were public institutions. Most of the responding schools (n=28, 57%) had an average class size of 51-100 students.

Table 1.

Demographic Data for US Doctor of Pharmacy Programs Responding to a Survey on Pharmacy Law Education (N=49)

The professional and employment characteristics of pharmacy law educators at the responding schools are listed in Table 2. Nearly all of the pharmacy law educators were pharmacists, attorneys, or both. The academic and professional backgrounds of the pharmacy law professors varied significantly, with pharmacists being the most common (n=25), followed by pharmacist-attorneys (n=23), non-pharmacist attorneys (n=6), PhD pharmaceutical scientists (n=4), and one professor with a doctorate in social and administrative sciences. Most (n=37, 76%) of the programs that responded employed a full-time pharmacy law faculty member (n=37, 76%). Only five programs reported using a teaching assistant or graduate student in the pharmacy law course.

Table 2.

Characteristics of Pharmacy Law Educators in US Doctor of Pharmacy Programs (N=49)

Data describing the delivery of pharmacy law content is reported in Table 3, with programs indicating that a majority of pharmacy law content was taught in one semester (n=43, 88%) and within a standalone course (n=45, 92%). Most (n=34, 69%) institutions maintained only a single primary pharmacy law course that incorporated all pharmacy law content delivered within the PharmD curriculum. The number of credit hours, the number of educators teaching the primary pharmacy law course, and its professional year (P1, P2, or P3) placement (varied widely (Table 3). While two (n=23, 47%) or three (n=20, 41%) courses were among the most common models by which the primary pharmacy law content was delivered, its placement within the PharmD curriculum varied: P1 (n=24), P2 (n=16), and P3 (n=31).

Table 3.

Details of Pharmacy Law Content Delivery Within the Curriculum of US Doctor of Pharmacy Programs (N=49)

Table 4 presents the data on assessment methods used in pharmacy law courses, which encompassed traditional summative assessments and formative assessments involving active-learning techniques. Of the traditional summative assessment methods, almost all (n=44, 90%) programs used multiple-choice examinations, which are comparable to the Multistate Pharmacy Jurisprudence Examination (MPJE) or state-specific jurisprudence licensing examinations; 29% (n=14) used short-answer questions; and 18% (n= 9) used essays as an assessment tool. With respect to formative assessments using active learning, 31% (n=15) of responding programs reported using team or group projects, and 10% (n=5) reported mock trials or mock board of pharmacy meetings to assess student learning (ie, students role-played parties in mock trials, board meetings, or administrative hearings). All 18 programs used more than one of these assessment methods. Various other assessments that the programs reported using included weekly quizzes, clicker quizzes/class participation, attendance at a board of pharmacy meeting, and self-directed learning modules.

Table 4.

Assessment Methods Used in Pharmacy Law Courses Within the Curriculum of US Doctor of Pharmacy Programs (N= 49)

A substantial majority of the responding programs (n=39, 89%) identified the MPJE as the pharmacy law licensing examination in their respective states, and specified their respective pharmacy law curricula were deliberately designed to prepare students for the MPJE. Five programs (11%) acknowledged a state-specific or territory-specific examination requirement, and similarly reported that their program’s primary law course targeted the respective state/territorial licensing board examination rather than focusing on the MPJE.

DISCUSSION

The ACPE Standards 2016 focus on concepts “central to a contemporary, high quality pharmacy education” and “essential for pharmacists to master” with a stated goal “to ensure that critical areas of learning are included in the curricula of all programs.”¹ ACPE Standards do not dictate how lessons are structured or how content is delivered.¹ In other words, while all PharmD programs must satisfy the broadly framed accreditation standards for pharmacy education, individual programs retain the latitude to determine when and how pharmacy law content is delivered and which additional topics are covered. Consistent with the latitude afforded by ACPE, this pilot study data noted variations in delivery (how), sequencing of pharmacy law courses (when), and pharmacy law topics and course offerings (what) across the 49 programs that responded. Differences in the delivery, sequencing, and scope of pharmacy law content in a PharmD program may serve to distinguish one PharmD program from others in the academy and can be a deliberate or desirable result. Given that this was a pilot survey, the rationale for placement or sequencing of the pharmacy law content within a curriculum was not explored with this foray, though admittedly that could be a line of inquiry in a future survey.

We identified a historic paucity of literature on pharmacy law education, which is what motivated us to conduct the survey. The pilot survey attracted responses from only 49 programs, which means the data collected represents only 35% of AACP member institutions in 2016 (N=139).² Accordingly, these results may not be generalizable to the remaining non-reporting programs because of statistical limitations imposed by the relatively low response rate.

Nonetheless, these data provide a relevant starting point for future studies. Indeed, the results of this pilot initiative underscore the necessity for further investigation and a longitudinal study to bridge the considerable information gap concerning delivery of pharmacy law education. Anecdotally, we do not believe that delivery of pharmacy law education has changed significantly since the 2016 pilot survey. Moreover, ACPE Standards 2016 became effective on July 1, 2016, precisely in the middle of the data collection period (June 22, 2016, to July 31, 2016) for the pilot survey.¹ Therefore, in the absence of any prior literature, the data from this pilot survey provide an invaluable baseline examination and offer relevant and instructive insight about trends in the delivery of pharmacy law education.¹

CONCLUSION

Results of this pilot study illustrate wide variations in delivery of pharmacy law curricula as reported by the responding PharmD programs. Variations encompass how primary pharmacy law content is delivered (teaching-learning strategies); when primary pharmacy law content is delivered (sequencing); and what pharmacy law topics and course offerings are delivered (content) across the 49 programs that responded. Because of the current limited data set and the importance of pharmacy law education to a pharmacy career, there is clearly need for further investigation in this area. Armed with the lessons learned from these pilot study results, we have planned a revised and improved survey of pharmacy law education which will include additional items inquiring about delivery of pharmacy ethics content in PharmD curricula.

Appendix 1.

2016 ASPL Pilot Survey: Delivery of Pharmacy Law Education (Item options appear in parentheses)