Of the 107 colleges and schools of pharmacy invited to participate in the study, 65 returned questionnaires, yielding a useable response rate of 60.7%. There were random missing data points and it was not possible to record some responses because of skipped questions or problems with legibility. Subsequent analyses were performed using available case methods. The average pharmacy student class size for the respondent schools was 120.7 ± 61.4. The percent of students with a bachelor's degree from the respondent colleges and schools was 49.4%, and the percent of students seeking postgraduate (ie, residencies, fellowships, graduate education) training was 20.7%. Of the respondents, 13.8% and 47.7% of the colleges and schools reported an affiliation with a Center for Education and Research on Therapeutics (CERT) and a medical center, respectively. The respondent schools had an average of 2.6 ± 1.2 departments.
No differences were found in the characteristics of the colleges and schools that responded early vs. late, or in their current teaching of SoS topics. No trends were identified in the type of college or school (eg, public/private, new/old) that responded or to what extent they taught SoS topics.
College and school representatives were asked to indicate whether each listed topic in the 3 SoS domains was currently covered in the curriculum. As mentioned before, the 3 domains were defined as domain 1: product safety from preclinical trials; domain 2: product safety from clinical trials; and domain 3: product safety after drug approval and marketing. As shown in , more than 75% of the responding colleges and schools covered 11 of the 17 topics for all 3 domains. However, less than 75% covered 6 of the topics, most of which were in domains 2 and 3 and related to how drug product safety is monitored and reported. Specifically, this finding suggested that new initiatives of the FDA, such as the Sentinel Initiative, have not been extensively integrated into the pharmacy curricula. Many respondents indicated their college/school is planning to cover these topics in the future.
Science of Safety Topics Covered in US Doctor of Pharmacy Curriculum
College and school representatives’ perceived importance of teaching each of the 17 topics varied substantially (). Eight topics were rated as “very important” by more than 50% of the respondents. Some topics included in the colleges’/schools’ curriculum were not considered “very important” by the college/school representative who completed the questionnaire.
Respondents also were asked to indicate whether an appropriate amount of time was spent on the topics in each domain at their college or school: 64.6% indicated that adequate time was spent on topics in domain 1; 66.2% indicated that adequate time was spent on topics in domain 2; and 63.1% indicated that adequate time was spent on topics in domain 3. No respondent indicated that too much time was spent on any specific topic. Conversely, 24%-31% of the respondents suggested more time should be spent on various topics. The majority of respondents believed that their college/school was devoting adequate time to SoS topics ().
The majority of SoS topics were taught in the required curriculum in the lecture-based part or in both the lecture-based/classroom and experiential parts. For domain 1, the majority of colleges and schools teaching the topics had integrated them into their required coursework, mainly though the classroom lecture portion of the curriculum. Some topics were also covered in the experiential part of the curriculum. For domains 2 and 3, most of the topics were covered in the required classroom lecture curriculum. Almost all of the topics in domain 3 are taught in the classroom lecture portion of the curriculum, but many are covered again during experiential training. For example, the majority of colleges and schools that taught “reporting problems to MedWatch” delivered this content through both lecture-based and experiential coursework.
College and school representatives’ responses to whether the SoS topics for each domain were coordinated and integrated into the curriculum and whether they were taught interprofessionally are summarized in . While colleges and schools of pharmacy were aware of and attempting to incorporate these topics into their PharmD curriculum, few schools reported teaching SoS topics interprofessionally ().
Coordination and Integration of Science of Safety (SoS) Topics in US Colleges and Schools of Pharmacy (N = 65)
College and school representatives indicated that some SoS topics were taught in residency and fellowship training programs, graduate programs, and as continuing education (CE) programs (). Domain 3 topics, which often are covered in the experiential portions of the curriculum, also were covered in practice-related educational experiences such as residency programs, fellowship programs, and CE programs, providing pharmacy graduates with additional knowledge and skills pertaining to the SoS.
Science of Safety Topics Taught Outside Professional Pharmacy Program (n = 65)
Responses as to whether colleges and schools had faculty members with expertise in the SoS domain areas, and whether there was a champion for teaching these topics at the school are provided in . While some colleges and schools reported having faculty members who were considered nationally recognized experts on these topics, more indicated that faculty members conduct research in these domains. However, expertise and curricular advocacy for some of the SoS topics may be lacking at some schools.
Science of Safety Expertise Within US Colleges and Schools of Pharmacy (n = 65)
Fifty respondents indicated that their college or school always or often promoted a culture of safety, and 60 reported that their college or school always or often promoted the role of the pharmacist in minimizing risks associated with medication products. The questionnaire provided a list of 22 abilities () related to the SoS that pharmacy students should be expected to possess upon graduation. Respondents were asked to indicate whether the majority of their graduates possessed each ability. The majority believed that their pharmacy graduates had acquired the abilities that related to product safety in individual patient care. For example, 95.4% of responding schools indicated that a majority of their graduates could identify potential adverse drug reactions, 93.8% indicated graduates could appropriately communicate the risks of medications to patients, 90.8% indicated graduates could communicate with other health care professionals about adverse drug reactions, 89.2% indicated graduates understood causes of medication toxicity, and 87.7% indicated graduates could appropriately respond to medication errors and adverse drug reactions. Most respondents (64% to 77%) indicated that a majority of their graduates could describe how biomarkers are used to identify risk for adverse drug reactions, use technology to manage medication use, and identify risks associated with human subjects research. However, less than 50% of the responding schools indicated that a majority of their graduates could achieve 3 of the listed abilities, 2 of which were specific to FDA-related tasks.
Colleges and Schools of Pharmacy's Perception of Science of Safety Student Outcomes (n = 65)
Thirteen (20%) respondents indicated that their colleges and schools were “very likely” to adopt an FDA-developed SoS curriculum; 44 were somewhat likely; and 7 were not likely to do so. The likelihood of colleges and schools adopting modules for individual domains differed based on domain, with the greatest interest related to adopting a module for the domain 3 SoS topics pertaining to product safety after FDA approval (57; 87.7%).
Though many cross tabulations were conducted, only a few relationships between colleges’ and schools’ characteristics and their SoS curriculum offerings were significant. Responding colleges and schools with a champion or advocate for domain 1 topics were more likely to rate how pre-clinical safety studies inform the conduct of human clinical trials as “very important” compared to those not having a champion or advocate (p = 0.042). Similar associations were observed for some of the topics listed in domains 2 and 3. For example, having a champion or advocate for domain 3 topics was significantly (p = 0.023) associated with respondents indicating topics such as postmarketing surveillance and reporting drug safety issues to MedWatch as “very important.” Whether the college or school has a champion also was significantly associated with the college's/school's teaching of certain topics. Colleges and schools with a champion or advocate to teach domain 3 topics were more likely to report that they covered how the FDA conducts postmarketing surveillance (p = 0.036), FDA's electronic decision support tools for efficient risk management system (p = 0.005), and how the FDA communicates with health care professionals about product safety (p = 0.004). Similarly, colleges and schools of pharmacy with a graduate program appeared to be more likely to offer certain SoS topics. Other school characteristics did not appear to have significant influence on the SoS topics taught.