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This paper provides baseline information on integrating the science of safety into the professional degree curriculum at colleges and schools of pharmacy. A multi-method examination was conducted that included a literature review, key informant interviews of 30 individuals, and in-depth case studies of 5 colleges and schools of pharmacy. Educators believe that they are devoting adequate time to science of safety topics and doing a good job teaching students to identify, understand, report, manage, and communicate medication risk. Areas perceived to be in need of improvement include educating pharmacy students about the Food and Drug Administration's (FDA's) role in product safety, how to work with the FDA in post-marketing surveillance and other FDA safety initiatives, teaching students methods to improve safety, and educating students to practice in interprofessional teams. The report makes 10 recommendations to help pharmacy school graduates be more effective in protecting patients from preventable drug-related problems.
Since 2000, a series of publications have argued for change in healthcare and healthcare education. These include the Institute of Medicine's (IOM's) report “To Err Is Human: Building a Safer Health System,” which defined the economic and clinical consequences of medication error and misuse1; “Crossing the Quality Chasm: A New Health System for the 21st Century,” which called for fundamental changes in the structure and provision of healthcare2; and “Health Professions Education: A Bridge to Quality,” which identified gaps in healthcare education and general recommendations for change.3 “Roadmap to 2015: Preparing Competent Pharmacists and Pharmacy Faculty for the Future,”4 made an argument for pharmacy education to serve as a resource and catalyst for furthering research in the areas of patient safety and quality. In 2006, IOM released “The Future of Drug Safety — Promoting and Protecting the Health of the Public,” which recommended how the FDA might improve the nation's drug safety and how other elements of the federal government might help ensure the safe use of medical products.5 One key recommendation in this report was an appeal to improve the science of safety.
This paper presents the findings of the report “A Baseline Evaluation of the Integration of the ‘Science of Safety’ into the Curriculum of the Doctor of Pharmacy Degree in US Colleges and Schools of Pharmacy.” The concept of science of safety is introduced and recommendations are presented for improving the science of safety curricula in US colleges and schools of pharmacy. Detailed description of the methodology used to develop the report is presented in the final report.6
The FDA describes the science of safety as an emerging discipline that seeks to understand and prevent adverse events.7 This explicit definition should have a common meaning for various disciplines within the field of pharmacy. However, initial discussions with educators and others did not find this to be the case. One reason was because pharmacists and scientists/health science professionals tend to view the construct, science of safety, within the framework of their own discipline. Therefore, toxicologists commonly view science of safety as the study of toxic substances in animals, pharmacoepidemiologists see it as exploring the risk of drugs used in populations, and clinicians perceive it as identifying and preventing adverse drug events in practice settings. The concept of science of safety also can be confused with issues like equipment safety, laboratory safety, occupational safety, and consumer product safety. Because the science of safety can mean many things, it was important to clearly define the term for educators.
This research defines science of safety as the systematic study of the negative impact of drugs and devices on humans at all stages of the drug product lifecycle (Figure (Figure1).1). This definition is based on source documents from the IOM 7 and FDA.8 Key elements of science of safety include the following:
Thus, science of safety can refer to knowledge learned at any step of the product development and marketing process including in preclinical animal toxicology and safety studies, clinical studies in humans, safety studies needed for FDA approval, and postmarketing epidemiological research. It includes translational research enabling healthcare professionals and other individuals to better identify, understand, report, manage, and communicate the risk of drugs and devices in patient populations. It also includes advances in the molecular origins and progression of disease, adverse consequences of treatments, and patient-specific and population-specific causes and responses. Figure Figure22 presents subject matter potentially associated with science of safety.9
In September 2007, the Food and Drug Administration Amendments Act (FDAAA), HR 3580, was signed into law giving the FDA greater authority over regulation of medication safety.10 The FDAAA gave the FDA more authority to require pharmaceutical companies to conduct postmarketing studies and trials, make safety-related medication labeling changes, and develop risk evaluation and mitigation strategies (REMS). In addition, the act instructed the FDA to develop a systematic plan to better manage the risks versus the benefits of drugs as they progress through their lifecycles.
The FDA's strategic plan had objectives to strengthen the science and systems that support medication and device safety.11 Part of that plan was to develop collaborations with bodies involved in maximizing patient and consumer safety. Colleges and schools of pharmacy and faculty members were identified as important partners in the science of safety because of their contributions to the science and to the teaching of that science to students.
The FDA strategic plan included 4 main goals in which pharmacists might have some role:
To achieve the goals of the strategic plan, the FDA wanted to better understand how pharmacists are educated in the science of safety in order to identify ways to partner with pharmacy professionals in improving medication safety. That interest led to a collaboration between the FDA, the American Association of Colleges of Pharmacy (AACP), and the Pharmacy Services Support Center (PSSC) at the American Pharmacists Association to conduct this research. The purpose of the collaboration was to conduct a baseline assessment to identify ways to improve the teaching of the science of safety in colleges and schools of pharmacy in support of FDA medication safety initiatives to support implementation of Title IX of the FDA Amendments Act. The results from this project provided the FDA with information necessary to construct a plan to accomplish the agency's strategic goals and legislative mandates. In addition, this baseline assessment of the pharmacy curriculum provides a platform for continued collaboration between the AACP and the FDA. Expected benefits of this collaboration to pharmacy academia include the following:
Specific research domains were developed during consultations between representatives of the AACP, PSSC, and FDA, and the study investigators (Table (Table1).1). A model science of safety curriculum developed by the FDA9 formed the basis of many of the identified research domains and questions.
This project consists of a literature review, key informant interviews, in-depth case studies, and a nationwide survey. A multi-method approach to data analysis was used to synthesize data collected by qualitative and quantitative methods. Multiple methods allowed triangulation of results (ie, cross-checking findings for consistency and contrast) and offered greater potential for insight and understanding. The project was conducted by a team of researchers from colleges and schools of pharmacy at Virginia Commonwealth University, the University of Arizona, and the University of Mississippi. Methods and design were approved by the institutional review board of each university. A brief overview of the literature review, key informant interviews, and in-depth case studies is provided here as background. A detailed description of the methodology for all 4 research approaches is described in the final report.6
Prior to primary data collection, a review of the current literature on the education of the science of safety in US colleges and schools of pharmacy was conducted. Investigators reviewed published and unpublished literature relating to pharmacy education and safety-related topics. Scans were conducted of the PubMed and International Pharmaceutical Abstract databases of biomedical and life sciences literature and of pharmacy organization and association Web sites (eg, Institute for Safe Medication Practices, National Association of Boards of Pharmacy). Titles and abstracts of articles in the American Journal of Pharmaceutical Education also were reviewed for relevance to science of safety.
Keyword searches were used to link the terms pharmacy education, pharmacy teaching and pharmacy curriculum with other keywords including safety studies, toxicity, biomarkers, institutional review boards (IRB), Protection of Human Subjects, drug interactions, pharmacokinetics, pharmacology, pharmacogenomics, personalized medicine, adverse events, Physician Labeling Rule, ClinicalTrials.gov, quality improvement / assurance, Titles VIII and IX of FDA Amendments Act (FDAAA), post-marketing safety, pharmacovigilence, MedWatch, sentinel events, medication safety / patient safety, FDA Advisory Committee for Drug Safety and Safety Risk Communication, market withdrawal, and risk communication. Titles and abstracts of articles generated from the search were reviewed for relevance to the proposal objectives. English-language papers from January 1, 2000, to March 31, 2010, were reviewed. References of key articles also were searched for seminal papers prior to 2000, allowing the inclusion of earlier papers. More than 100 articles were read in the first review of the literature.
Of these articles, further analysis was done to identify papers that surveyed pharmacy school curricula, provided key commentaries and reports relating to the teaching of safety within a curriculum, or provided detailed descriptions of courses or educational experiences in the teaching of science of safety topics. Twenty-six papers were analyzed and used to provide support for the findings of the literature review.
Thirty key informant interviews were conducted with individuals by study investigators. The purpose was to understand current thinking and practices in pharmacy education about the science of safety from the perspective of educators and safety experts. In-depth interviews were conducted with educators at pharmacy colleges/schools across the United States from a mix of small and large institutions and safety experts from institutions and associations engaged in safety-related topics [eg, Institute for Safe Medication Practices (ISMP), Pharmacy Quality Alliance (PQA), AACP].
An interview protocol was created and used to collect descriptive information and obtain viewpoints about the topic. When relevant, findings from the literature were used to guide the interview. Trained investigators conducted the interviews via phone or e-mail. Interviewers took notes during interviews or afterwards from recordings of interviews. Content analyses of interview summaries were conducted to assess and organize themes, ideas, and practices. These content analyses were used to summarize the findings of the interviews.
Colleges/schools of pharmacy at 5 universities (Temple, University of Arizona, Midwestern University – Chicago College of Pharmacy, University of Southern California, and Virginia Commonwealth University) were identified for case studies and asked to provide in-depth insight into curriculum development and effective processes that integrate and elevate the science of safety in pharmacy education. Case studies consisted of review of the college's/school's Web site and telephone interviews with faculty members. Supplemental documents not available on the Web, like course syllabi, also were requested and reviewed. Specific questions of interest include the following:
This section provides a brief summary of the results from the literature review, key informant interviews, case studies, and survey. A detailed summary of the findings of this research is in the final report.6
There appears to be general agreement from the various methods that pharmacy education should include the following broad topic areas related to science of safety:
In general, respondents at colleges and schools of pharmacy believe that they are devoting adequate time to science of safety topics. A few topics that are of interest to the FDA but were not covered well included the colleges’/schools’ use of clinicaltrials.gov, use of electronic decision support tools, teaching of methods to improve safety, and understanding of the role of the FDA's Advisory Committee for Drug Safety and Safety Risk Communication. Several respondents indicated that they plan to begin teaching these topics.
Similarly, respondents believed that their college/school was promoting the role of pharmacists in minimizing risks associated with medication products. Individuals indicated that their graduates are able to accomplish many of the abilities associated with the science of safety. However, there is some room for improvement in educating pharmacy students about the FDA's role in product safety and the future of postmarketing surveillance, pharmacoepidemiology, and other population-based safety efforts. The new Accreditation Council for Pharmacy Education (ACPE) guidelines include more requirements related to population-focused care, informatics, pharmacoepidemiology, and research processes and future curricula likely will reflect many of these changes.
There were various opinions among respondents about how to best teach science of safety topics and how to integrate science of safety topics into the curriculum. There was some interest in the development of a model science of safety curriculum for colleges and schools of pharmacy that is modular in nature so colleges and schools can adopt portions depending on their needs.
Finally, few respondents indicated that their college or school of pharmacy was interprofessional in its approach to teaching the science of safety. Given that medication safety requires teamwork between pharmacists, technicians, nurses, physicians, and other professionals, this finding was disappointing. Some interprofessional education is provided in many schools, but it is not done in a systematic manner for all professional students. Opportunities typically occur in advanced practice experiences, but chances to work in team-based settings depend on a student's luck in being assigned to the right practice site and faculty mentor.
Both the FDA and the pharmacy profession seek to positively impact patient health by ensuring appropriate use of medications toward a goal of achieving desired health outcomes. The FDA and pharmacy professionals seek to minimize risk to patients by identifying, understanding, reporting, managing, and communicating risk. Consequently, many of the FDA's concerns regarding the safety of medication use parallel those of the pharmacy profession and pharmacy educators.
In general, the product lifecycle approach used by the FDA to frame the science of safety is not an explicit approach to curricular design in colleges and schools of pharmacy. Rather than viewing safety in terms of the FDA's product approval process where medications progress from preclinical to clinical to postmarketing phases of their lifecycle, the pharmacy profession and academics tend to characterize science of safety by how it relates to patient care, emphasizing domains relevant to postmarketing stages of the medication product lifecycle. The curriculum related to premarketing stages of the product lifecycle is not typically framed in terms of medication safety.
Nevertheless, the product lifecycle approach is well-suited for pharmacy education because much of the coursework in colleges and schools of pharmacy matches the FDA's model curriculum.9 Although earlier phases of the product lifecycle do not typically come to mind when discussing science of safety, they are important elements of a student's education at most colleges and schools of pharmacy.
Most safety competencies expected of pharmacy graduates are consistent with those recommended by the “IOM Report on Health Professions Education: A Bridge to Quality.” Competencies expected of graduates include the adopting of a safety philosophy, developing the ability to work in teams, incorporating best evidence in decision making, applying quality improvement and systems approaches to problems, using technology, managing risk, and refining communication skills. Some safety competencies, like the ability to use databases in pharmacoepidemiology research, are not considered priorities; possibly, these skills are not often used in pharmacy practice settings.
Colleges and schools of pharmacy are exerting significant time and effort toward the teaching of science of safety topics. Even so, there appears to be gaps in content and competencies achieved. Some schools are already taking action to address these gaps while others are not. Addressing these gaps may help support full implementation of new federal laws relative to medication safety and aid pharmacists advocating for greater roles as therapeutic safety management experts.
Based upon the findings of the report, a list of 10 recommendations is provided to guide the FDA and the pharmacy profession. These recommendations are intended to encourage dialogue and action inside and outside of academia about pharmacy's role in science of safety and its needs. In addition, we desire/hope that the results of this research will provide opportunities for collaboration between US colleges and schools of pharmacy and the FDA. These opportunities include improving the teaching of the science of safety to improve our healthcare delivery system in all practice settings including those sites serving underserved and underinsured populations.
This paper summarizes the findings of a report providing baseline information on how the science of safety is taught in professional programs at US colleges and schools of pharmacy. The report indicates some room for improvement in teaching students to identify, understand, report, manage, and communicate medication risk. Many of the deficiencies revolve around areas of interest to the FDA. Another concern surrounds the need for improving interprofessional training with physicians and other health professionals. Ten recommendations are provided to encourage future discussions about helping pharmacy graduates be more effective in protecting patients from preventable drug-related problems.