Academic journal article American Journal of Pharmaceutical Education

Science of Safety Topic Coverage in Experiential Education in US and Taiwan Colleges and Schools of Pharmacy

Academic journal article American Journal of Pharmaceutical Education

Science of Safety Topic Coverage in Experiential Education in US and Taiwan Colleges and Schools of Pharmacy

Article excerpt


Drug safety encompasses many activities across a range of disciplines and approaches, and pharmacists play a key role in ensuring the public's safety as a member of the healthcare team. Because of well-publicized drug safety issues, the US Food and Drug Administration (FDA) instituted a number of activities to increase awareness of and ultimately improve medication safety. In its 2008 Sentinel Initiative Report, the FDA defined the science of safety (SoS) as a broad concept that focuses on a lifecycle approach to drug safety. (1) This broad perspective on SoS allows formany opportunities for pharmacists to impact patient safety with medication use. (2) Using the drug lifecycle approach ensures that safety concerns raised at any point in the drug development/marketing process "can be evaluated along with relevant benefit-risk data to inform treatment choices and regulatory decision making." (1) Analyses with respect to risk vs. benefit or safety vs. access were regarded as important areas within the SoS that the FDA seeks to improve. (1) Specifically, FDA seeks to understand how pharmacy students are educated in the SoS in order to identify how the agency can partner with pharmacy professionals to improve medication safety.

Topics related to the SoS are taught in various courses in US colleges and schools of pharmacy. (2) In fact, when defined by the FDA's lifecycle approach, some US faculty members pointed out that the entire pharmacy curriculum relates to the SoS. (2) However, the quality and quantity of curricula associated with the SoS, such as medication error instruction, varies widely among colleges and schools of pharmacy. (3) Only 12% of respondents to a survey conducted by Johnson and colleagues indicated that medication error information was taught during pharmacy practice experiences (PPEs). This raises the concern that other critical safety-related teaching may be lacking during PPEs.

Although medication safety remains a global issue, there is a dearth of current studies describing curriculum devoted to the SoS in Taiwan. Moreover, fundamental differences in pharmacy education exist between the United States and Taiwan with respect to experiential education. A 4- to 5-year baccalaureate pharmacy degree program is the prevalent program offered in Taiwan. Upon graduation, baccalaureate pharmacy students are eligible to take the national pharmacist licensure examination to become a pharmacist. The required portion of pharmacy experiential education in Taiwan is composed of multiple hospital pharmacy experiences lasting for approximately half a year and are roughly analogous to the advanced pharmacy practice experiences (APPEs) offered in US doctor of pharmacy (PharmD) programs.

However, Taiwanese students are not obliged to participate in community pharmacy or other experiences in other practice settings during the experiential curricula. Investigating SoS-related curricula in Taiwan and comparing it with that taught in the United States could identify for pharmacy educators, practitioners, and administrators in the 2 countries the differences in, similarities of, and improvements needed for the current curricula to effectively provide SoS education during PPEs. This mixed-method study attempted to obtain, compare, and contrast pharmacy faculty perceptions in the United States and Taiwan on experiential education SoS curricula for pharmacy students by conducting key informant interviews and an Internet-based survey.


For this study, the SoS was defined as: "the systematic search for knowledge about risks of exposure to drugs and methods to protect individuals from drug-related problems. The SoS encompasses the study of adverse events any place within the product life cycle from preclinical safety testing in animals to post-marketing surveillance in the general population." (1) This study used a series of key informant interviews to gather qualitative data on perceptions of experiential SoS coverage and gaps, followed by an Internet-based survey instrument to gather quantitative data on SoS topic coverage in experiential education and perceptions of student SoS skills. …

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