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.
- The AACP should convene a conference to discuss the findings of this report. Attendees should comprise a diverse group including educators, scientists, clinicians, practitioners, pharmacist employers, and FDA representatives. Participants at the conference should confer and seek agreement on various questions including:
- (a) What elements of the FDA Science of Safety Model Curriculum should be a part of the education of all graduates of colleges and schools of pharmacy in the United States?
- (b) What educational outcomes relating to the science of safety should be achieved by all graduates of US pharmacy colleges and schools, and how would these outcomes be measured?
- (c) What steps should be taken to achieve the educational outcomes in science of safety identified in the conference?
- (d) What is the role of academia in promoting the science of safety within the profession?
- Studies need to be conducted to quantify exactly what science of safety outcomes are being achieved at colleges and schools of pharmacy in the United States. This report highlights some potential gaps in basic student safety competencies including those relating to human factors research, medical errors, medication errors, quality or process improvement, root cause analysis, failure mode and effects analysis, and safety organizations (eg, ISMP). A better understanding is needed of the types and extent of gaps in student safety competencies in order to respond with educational interventions.
- More education resources should be developed and made available to colleges and schools of pharmacy to address faculty needs in the science of safety. Resources exist for faculty members but may only address pieces of the medication safety puzzle. No comprehensive works exist on the subject where science of safety experts share their expertise with fellow educators. One model of training for faculty members is the Educating Pharmacy Students and Pharmacists to Improve Quality (EPIQ) program available through the PQA (www.pqaalliance.org/). The EPIQ program is a complete educational curriculum that can educate pharmacy students, pharmacists, and other stakeholders about measuring, reporting, and improving quality in pharmacy practice. It contains PowerPoint slide sets with lecture notes, case studies, student-centered activities, student readings, faculty readings (ie, a list of suggested readings to hone faculty knowledge of core content), class discussion questions, examples of outside-of-class projects for additional hands-on experience, an example syllabus, recommendations for achieving differing levels of knowledge and skill development for various audiences, and more. Other models are offered by the Institute for Healthcare Improvement (IHI) (www.ihi.org/IHI/) and the ISMP (www.ismp.org/). The IHI provides educational tools for improving health care delivery, measures to track improvement, educational materials, and links to professionals with similar interests. The ISMP provides educational materials, tools, guidelines, newsletters, alerts, and consulting services to promote patient safety.
- Educational materials should be developed that target pharmacy students’ learning gaps (eg, appropriate use of medication guides) related to the science of safety. The FDA could provide the material on their Web site or content could be made available on the Web sites of the AACP and other organizations. For instance, modules might be designed to educate students either in the classroom or in an e-learning format via the Web. Testing achievement of defined learning outcomes also could be conducted. Modules could be developed for topics including REMS, history of medication risk regulation, clinical pharmacogenomics, and others.
- Interprofessional education and training in patient safety and related topics should be encouraged at schools of medicine, nursing, pharmacy, and other health professions. One way would be to link some federal research funding to efforts to provide interprofessional education at schools. For instance, one criterion for funding Clinical and Translational Science Awards could be that the institution has plans to implement interprofessional education within its curriculum. Certain skills and topics are better learned using an interprofessional teaching approach, especially adopting a safety philosophy, developing the ability to work in teams, applying quality improvement and systems approaches to medication safety issues, and communication. Not all pharmacy schools are located on medical center campuses; therefore, interprofessional education may require innovative teaching approaches. For example, didactic training could be provided online, mixing professions in case-based exercises or via telemedicine conferences.
- Support should be provided by HRSA to expand the number of PSSC experiential learning sites for pharmacy students with the goal of providing patient-centered, team-based approaches to identifying, understanding, reporting, managing, and communicating medication risk. The Health Resources and Services Administration (HRSA) Pharmacy Services Support Center (PSSC) has the potential to increase interprofessional education of pharmacy students in medication safety through its support of student practice experiences at health care sites caring for underserved populations. PSSC healthcare sites work under team-based practice models not typically seen in many community pharmacy practice settings.
- Institutions, associations, and/or organizations should conduct studies that examine the role of pharmacy employers on the science of safety. This research illuminated some assumptions in academia that the current pharmacy practice environment may lower expectations in students about the relevance of some science of safety topics. Concern also was expressed that the work environment in some pharmacy practice settings did not promote a culture of safety. There is little evidence to support or counter these opinions. Research needs to be conducted to better understand this issue. Some questions that might be answered by this research include:
- (a) To what extent do pharmacists in practice settings deviate from standards of practice that put patients at unreasonable safety risks? For example, are pharmacists adequately fulfilling their roles in REMS?
- (b) What expectations do employers have of pharmacists in the areas of science of safety?
- (c) What kind of socialization occurs in practice settings to encourage or discourage safe medication practices? How do organizational norms influence the adoption of safe medication use?
- (d) To what extent does the socialization of pharmacy students in practice settings influence their commitment to medication safety?
- (e) To what degree do employers establish and maintain a culture of safety in workplaces?
- (f) What technology and management systems are in place to identify, understand, report, manage, and communicate medication risk?
- (g) How can employers support the teaching of science of safety in the curriculum? What real life experience can they provide to encourage student commitment to medication safety?
- (h) To what extent do employers incentivize or sanction practices related to safety? Are these approaches effective?
- (i) What occurs when a pharmacist's professional norms with respect to safety are in conflict with organizational norms?
- Funding should be raised to support postgraduate training in the science of safety. This funding could support residencies, fellowships, and graduate degrees in patient safety.
- The AACP Council of Deans should address the issue of science of safety. At minimum, the Council should make a statement about their assessment of the relevance and importance of the topic to pharmacy education. A statement from the Council of Deans would provide some leadership to educators about where science of safety should fit within the pharmacy curriculum.
- Colleges and schools of pharmacy should consider adopting the product lifecycle approach to teaching the science of safety. The product lifecycle approach views the science of medication safety as an interconnected sequence of events that begins with the creation of a drug; continues with its development, testing, and introduction to the market; and ends when the drug is removed from the market. The lifecycle approach views problems of medication safety using an interdisciplinary and interprofessional approach instead of a compartmentalized method that is dealt with by separate scientific disciplines or professions. This systems approach to medication safety can harmonize all of the disciplines toward a single conceptual framework and provide explicit linkages between basic and applied sciences. The lifecycle can be used to coordinate the various sciences associated with pharmacy – medicinal chemistry, pharmacology, pharmaceutics, clinical sciences, social/behavioral/administrative sciences, and others – with the common goal of better identifying, understanding, reporting, managing, and communicating risk in a way that protects patients.