This research was conducted in response to a RFP published by the American Association of Colleges of Pharmacy. The study is a supported by the

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A Baseline Evaluation of the Integration of the “Science of

Safety” into the Curriculum of the Doctor of Pharmacy Degree

in U.S. Colleges and Schools of Pharmacy

Final Report

Virginia Commonwealth University School of Pharmacy David A. Holdford, PhD, RPh, Principal Investigator University of Arizona School of Pharmacy Terri L. Warholak, PhD, RPh, Co‐Investigator Daniel C. Malone, PhD, RPh John E. Murphy, PharmD University of Mississippi School of Pharmacy Donna Strum‐West, PhD, RPh, Co‐Investigator John P. Bentley, PhD, RPh. Prepared for William G. Lang, MPH VP Policy and Advocacy American Association of Colleges of Pharmacy 1727 King Street Alexandria, VA 22314 (703) 739‐2330 x1038

wlang@aacp.org

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2 This research was conducted in response to a RFP published by the American Association of

Colleges of Pharmacy. The study is a supported by the American Associate of Colleges of Pharmacy (AACP), United States Food & Drug Association (FDA), and Pharmacy Services

Support Center (PSSC) at the American Pharmacists Association.

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Executive Summary

This project provides baseline information on courses and teaching methods relating to the inclusion of Science of Safety in current curriculums in the educational curriculum of professional degree programs at accredited colleges and schools of pharmacy. For the purpose of this report, Science of Safety is defined as the systematic study of the intended and unintended impact of drugs and medical devices on health at all stages of the drug product life cycle. The Science of Safety deals with anything that might be learned about risk in Pre‐Clinical Animal Toxicology and Safety Studies, clinical studies in humans, safety studies needed for FDA approval, and postmarketing epidemiological research. The purpose of Science of Safety is to improve ways of identifying, understanding, reporting, managing, and communicating risk in ways that protect patients. This assessment consists of a literature review, key informant interviews, case studies and a nationwide survey of pharmacy schools in the U.S. The goal of this project is to provide feedback to educators and the pharmacy profession on the teaching of Science of Safety within current pharmacy school curriculums. This report offers direction and recommendations for enhancements to curriculums to educate pharmacy graduates on topics/subjects currently not included. In addition, findings will be used by the Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA) to identify ways to partner with the profession to support implementation of Title IX of the FDA Amendments Act and expand upon the work of HRSA’s Patient Safety & Clinical Pharmacy Services Collaborative. 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 FDA’s concerns regarding the safety of medication use parallel that of the pharmacy profession and pharmacy educators. In general, the product life‐cycle approach used by the FDA to frame the Science of Safety is not an explicit approach to curricular design in pharmacy schools. Rather than viewing safety in terms of FDA’s product approval process where medications progress from pre‐clinical to clinical to post‐marketing phases of their life‐cycle, the pharmacy profession and academics tend to characterize Science of Safety by how it relates to patient care ‐‐ emphasizing domains relevant to post‐marketing stages of the medication product life cycle. The curriculum related to pre‐marketing stages of the product life cycle is not typically framed in terms of medication safety. Nevertheless, the product life‐cycle approach is well‐suited for pharmacy education because much of the coursework in pharmacy schools matches FDA’s model curriculum (See Appendix A). Although earlier phases of the product life‐cycle do not typically come to mind when discussing Science of Safety, they are important elements of a student’s education at most pharmacy schools. 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 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

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6 competencies, like the ability to use databases in pharmacoepidemiology research, are not considered priorities ‐‐ possibly these skills are seen as not often used in pharmacy practice settings. This research found that pharmacy schools 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 support full implementation of new federal laws relative to medication safety and aid pharmacists advocating for greater roles as therapeutic safety management experts. Specifics about some of the findings are detailed below.

Key Findings

This section summarizes the results of this research. Citations, methods and additional details about these key findings can be found in the Methodology and the Results sections of this report.

Literature Review

A literature review found that aspects of Science of Safety are addressed in courses across the pharmacy curriculum by faculty from diverse disciplines. Courses within pharmacy schools are taught across science (e.g., medicinal chemistry, pharmacology) and practice disciplines (e.g., clinical pharmacy). Some education is also provided by departments in schools other than pharmacy (e.g., public health). It is not known how well these topics are integrated across the curricula, the learning outcomes achieved, the level of reinforcement in experiential training, or how comprehensive the coverage is in the curriculum. Gaps in training have been documented and differences of opinion exist about the relative importance of some topics in the curriculum. Specific issues associated with Science of Safety teaching at some pharmacy schools include: • The term “Science of Safety” is not found in the pharmacy literature. • Changes in the pre‐pharmacy curriculum might be beneficial for preparing students for relevant science of safety courses in the curriculum. Differences of opinion exist about what the exact changes should be. • Safety competencies expected of graduates of the nursing, medicine, and pharmacy professions are consistent with those recommended by the “IOM Report on Health Professions Education: A Bridge to Quality.” Common themes among the expected competencies were adopting a safety philosophy, developing the ability to work in teams, incorporating best evidence, applying quality improvement and systems approaches to problems, using technology, managing risk, and refining communication skills. • Science of Safety is associated with a variety of courses across the pharmacy curriculum including Drug Information, Pharmacoepidemiology, Medication Error Instruction, Pharmacogenomics, Pharmacokinetics, Health Policy, Pharmacoeconomics, and Research

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7 Methods. Courses are taught by most science and practice disciplines in pharmacy and in some non‐pharmacy schools. It is not known how well these topics are integrated across the curricula, the learning outcomes achieved, the level of reinforcement in experiential training, or how comprehensive the coverage in the curriculum. • Some of the basics of medication error and adverse drug reactions (ADRs) are not taught consistently to pharmacy students including human factors research, medical errors, medication errors, quality or process improvement, root cause analysis, and failure mode and effects analysis. Safety organizations (e.g., Institute of Safe Medication Practices (ISMP) were not commonly discussed. Didactic instruction was emphasized, but application (e.g., skills labs) was also common. Reinforcing the relevance of ADRs and medication errors to students is an important step for engaging them in the science of safety. • At one time, the depth of training in pharmacogenetics and pharmacogenomics was considered deficient, although it has been improved in recent years. Nevertheless, the depth of training varies across institutions. • Clinical pharmacokinetics is taught extensively at schools of pharmacy across the US but it is not clear to what extent that training supports FDA initiatives. • Most drug information training is didactic, not experiential. The ability to find information, retrieve it, interpret it, and communicate in a relevant manner to professionals and patients are competencies taught at most schools. The quality of that training is not clear. • Epidemiology is taught in most schools of pharmacy but the quality and quantity of training varies. • Educators have a variety of differing opinions on gaps in the SOS curriculum and topics that need greater emphasis. Changes to the curriculum must address these views.

Key Informant

Thirty key informants from academia and outside of academia were asked to comment on what they thought the minimum requirements should be for a pharmacist coming out of school regarding the area of medication safety. Common responses were: the ability to identify errors and the causes of those errors, knowledge concerning how to go about reporting concerns regarding medication safety, and the ability to build/change a system to reduce errors. When asked to describe, “How well you think pharmacy schools are preparing students in the area of medication safety?” most key informants responded, “poorly” or “ok, but could improve.” A possible reason for this downbeat conclusion was a general consensus among key informants that the teaching of Science of Safety was not systematic – indeed, serendipitous ‐‐ and that there is not a set place for it in the curriculum.

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8 Gaps identified in the current pharmacy student’s education were: lack of an acceptance of a “culture of safety”, communication skills, and knowledge of the research and development process. When asked, “How might the education system fill these gaps?” responses varied. Most recommended a dedicated course on medication safety or having the topic threaded throughout the curriculum. Realism in the pedagogy used (case studies, experiential training) was preferable. Key informants stated that some of the existing barriers to improving the Science of Safety curriculum were: • lack of communication between the faculty regarding who is teaching what on the subject • poor student response/engagement • lack of faculty interest in the topic • challenges fitting into the curriculum/finding time to teach it • lack of faculty expertise in the topic Informants were asked about student needs regarding knowledge about risk communication methods (e.g., patient package inserts (PPIs), Medication guides for high risk drugs, FDA website, and verbal counseling). Respondents stated that students need to be exposed to the various methods, understand why they exist, and know what to do with them. Students need to be able to explain them to their patients, and they should have any idea about the strengths and weaknesses of each type of risk communication. When asked about student knowledge about FDA’s advisory committee and FDA Safety Initiatives, respondents answered that they need to be exposed to what they are, how they might benefit patients, and how to build them into system workflow. Most informants had difficulty identifying any specific schools doing a particularly good job in preparing their graduates in the Science of Safety. Of all individuals responding with examples of schools doing a good job, sixteen schools were identified, but only 1 of those sixteen schools got more than one key informant’s vote. In addition, key informants from colleges of pharmacy had more difficulty identifying good Science of Safety teaching than individuals in non‐educational institutions. Most informants stated that pre‐pharmacy requirements were adequate for preparing students for the Science of Safety. Some respondents thought that more training in public health or statistics would benefit students. Some key informants thought that pharmacy employers were part of the problem with some of the issues of medication safety in the United States. Although employers have made steps to improve their dispensing systems, some key informants felt that employers did not emphasize a culture of safety in pharmacy practice. Nevertheless, there was also a belief that pharmacy employers could be part of the solution if they were given the right incentives to change practice toward a greater focus on medication safety. When asked, “What should be the role of professional training in preparing students for graduate education in clinical research?” respondents stated that it should be an option but not an emphasis. A

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9 greater understanding and appreciation for clinical research was desirable, through experiences like conducting some form of research project as part of the professional program. However, the majority of respondents felt that it was not the role of professional education to prepare students to be researchers. When asked about offering tracks that specialize in medication safety, key informant answers varied. Some stated that there should be a core set of standards for all students – supplemented with opportunities to specialize. However, others expressed concern that students have insufficient knowledge about what they want to do professionally and might not be able to make informed decisions regarding specialization. While it was agreed that there are definite gaps in the pharmacy curriculum, key informants felt that much of what FDA defines as the Science of Safety is being taught and integrated into pharmacy curriculums very well. This conclusion contrasts with previous mentioned downbeat responses to, “How well you think pharmacy schools are preparing students in the area of medication safety?” The contrast might have occurred if initial responses were based upon elements of the curriculum (i.e., needs improvement) while the later responses reviewed the entire curriculum (i.e., overall, students are learning what they need). One informant characterized this nicely by saying, “…given that [the FDA’s] definition, the entire curriculum of the College of Pharmacy is probably devoted to [the Science of Safety]…. Probably every discussion we have and every lecture we give has something to do with ensuring or trying to accomplish the safety/effectiveness agenda.” Educators especially felt that students were very well prepared as far as basic knowledge courses and clinical courses such as pharmacology, pharmacotherapeutics, pharmacokinetics, and others. The idea that despite some gaps that need to be addressed, a prevalent response was that the entire pharmacy curriculum is devoted to safety. Some key informants held a strong belief that students should be taught to appreciate the history behind the evolution of safety systems in order to prevent history from repeating itself. For example, one interviewee mentioned that students should know about the advent of unit‐dose packaging and how it came about. The idea is that students need to realize why unit‐dose systems were developed in the first place to fully appreciate what types of errors were occurring at that time. This understanding might provide context for future decisions regarding medication risks in practice.

Case Studies

Five schools of pharmacy were chosen for study based up their geographic diversity, student population, and leadership in teaching the Science of Safety. The schools were Virginia Commonwealth University School of Pharmacy (VCU), Temple University School of Pharmacy (Temple), University of Southern California School of Pharmacy (USC), Midwestern University Chicago College of Pharmacy (Midwestern Chicago), and The University of Arizona College of Pharmacy (Arizona).

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10 Models for teaching the Science of Safety varied among the five schools primarily by how they emphasize it in the professional and graduate curricula. Temple and USC have large graduate programs focusing on safety e.g., regulatory affairs, and quality assurance. USC offers a Ph.D. program, a combined Pharm.D./graduate program, and distance education as an option. Both Temple and USC offer graduate certificate programs and an elective track in medication safety for professional students. Arizona is developing an interprofessional Quality Improvement and Safety track for the Master of Public Health degree. It is anticipated that this internet‐based curriculum will be ready for enrollment in Summer 2010. VCU offers graduate opportunities as part of its pharmaceutical sciences program which includes combined Pharm.D./M.S. and Pharm.D./Ph.D. options. Midwestern Chicago currently offers no graduate program focusing on medication safety but it provides innovative teaching at the professional (i.e., Pharm.D.) level. All five schools have at least one medication safety course serving professional and/or graduate students. Additional courses are being offered to support elective tracks in medication safety and graduate programs. The following are some lessons learned from interviews from individuals at the schools and reviews of school documents: • Explicit learning outcomes associated with the Science of Safety are needed. No clear educational outcomes have been established for students in medication safety by the pharmacy profession or academia. Therefore, training varies significantly from school to school. • Schools should measure their performance on achieving learning outcomes associated with Science of Safety. Otherwise, it will not be a priority. • Faculty time is limited for educating students. Scheduling students and supervising them (e.g., making sure students document patient charts correctly and accurately counsel patients) takes significant time and effort. Commitment by faculty members is needed as well as the support of school leaders. Clear guidance from AACP and other pharmacy organizations can help faculty members make choices on where to spend their time. • Successful faculty members link safety issues with various elements of the School’s mission – education, service, scholarship, and research. Faculty must balance many different responsibilities. The better they are able to link their educational responsibilities with service, research, and scholarship, the more efficient they can be. Expertise in service, scholarship, and research can be leveraged to provide better educational experiences. • Student time is limited. There is a finite amount of time available for students to learn and Science of Safety competes with other topics for student learning time. Sometimes choices are made to include non‐safety topics at the expense of a more comprehensive coverage of medication safety. As with the issue of faculty time, clear guidance is needed on the topic of Science of Safety in the curriculum. In addition, pharmacy employers can reinforce the idea that medication safety is relevant to practice and is a critical skill for success as a pharmacist. • Effective education in medication safety requires teamwork. For instance, a professor who teaches a medication safety course relies on all of the professors teaching pre‐requisites of the

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11 course to adequately prepare students to immediately start without the need to remediate missing skills and knowledge. Mapping the curriculum and open communication between faculty help in ensuring integration of skills development across the curriculum. A product life‐ cycle approach to the Science of Safety can provide a framework for mapping safety across the curriculum. • Faculty members mentoring students in introductory pharmacy practice experiences (IPPE’s) and advanced pharmacy practice experiences (APPE’s) require teamwork at practice sites from pharmacists, technicians, nurses, physicians, and other professionals. Since these practice experiences may be the only opportunity for interprofessional training, the encounters should be positive. The HRSA Pharmacy Services Support Center (PSSC) is promoting student practice rotations at health care sites caring for underserved populations. PSSC health care sites work under team based practice models not typically seen in many community pharmacy practice settings. They can model innovative approaches to incorporating Science of Safety into experiential and interprofessional education. • Champions are needed to promote medication safety. Without champions, many learning opportunities fall between the cracks in the cracks in the curriculum. Champions can advocate for inclusion of patient safety in the curriculum and argue for more than just superficial coverage of the topic. Post‐graduate education including residencies, fellowships, and graduate degrees can develop individuals to champion medication safety in the curriculum. Schools should also seek to identify and support their safety champions. • Learning about real life safety problems is better received by students. Students respond to stories about real people who are exposed to medication risk. Demonstrating concepts using story telling with real life examples provides something that students can remember for the rest of their life. Real life examples also overcome complaints about being given “busy work” and criticisms that what they are learning is not what happens in the real world. In addition, real life safety problems better illustrate the complexity of medication safety problems and their linkages to all parts of the curriculum. Pharmacy employers are essential allies in the teaching of medication safety in IPPEs and APPEs to the extent that they actively promote and support safety in practice. • Relationships are important. Elective tracks, certificate programs, and graduate programs that collaborate with local employers, governmental entities, pharmaceutical companies, and health‐ systems offer more learning opportunities and chances to change the status quo. • Interprofessional education is difficult. All schools in the case studies have difficulty providing interprofessional experiences in a systematic manner to all professional students. Opportunities typically occur in APPEs, but any chances to work in a team based setting depends on a student’s luck in being assigned to the right practice site and faculty mentor. HRSA Pharmacy Services Support Center health care sites providing care for underserved populations provide one model which supports interprofessional education using team based practice models. • Support from administration is essential. All of the schools studied for this report had strong

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12 Safety by offering guidance about the relevance and importance of the topic to pharmacy education.

Survey

A survey was sent to 107 schools of pharmacy and 53 were completed and returned, yielding a useable response rate of 49.5%. A copy of the survey can be found in Appendix B. Of the respondents, 8 of the schools were affiliated with a Center for Education and Research on Therapeutics (CERT), and 25 were affiliated with a medical center. Response bias was not detected ‐‐ i.e. it does not appear that only certain school types (e.g., public/private, new/old) responded or only those schools which teach more or less Science of Safety responded to the survey. However, the results may not be fully representative of all pharmacy school curriculums since only one half of schools responded. In general, most respondents stated that they are devoting adequate time to Science of Safety topics. Approximately two thirds of schools indicated that adequate time was spent on Science of Safety topics addressed in the survey. The majority of topics in the FDA’s model curriculum were a mandatory part of the curriculum. Moreover, some schools provided evidence or comments about how their school excels at teaching certain topics. Nevertheless, some topics of interest to the FDA, such as the Sentinel Initiative, were not addressed very well in the pharmacy curricula. For this research, topics relating to the Science of Safety were divided into the following domains ‐‐ Domain #1: product safety information from pre‐clinical studies; Domain #2: product safety information from clinical trials; and Domain #3: product safety information from post FDA approval. For Domain #1 and Domain #2 topics, the majority of the schools responded that they integrate these topics into their required coursework and cover them in the didactic portion of the curriculum. Some of the topics are also covered in the experiential portion of the curriculum. Most of the Domain #3 topics (product safety after drug approval) were part of the required curriculum and taught in both the didactic and experiential portions of the curriculum. Schools of pharmacy were asked how well Science of Safety topics for each domain were coordinated and integrated into the curriculum or taught interprofessionally. Approximately 80% of respondents indicated that the topics were integrated across the curriculum – being completely or partially included in their curriculum map. Thus, it appears schools of pharmacy are aware of and attempting to incorporate these topics into the curriculum. Integration was greatest in the area of Domain #3 – product safety information from post‐FDA approval. The responses regarding interprofessional education were more discouraging. Few schools were providing interprofessional teaching of Science of Safety in the classroom or via experiential education. Schools of pharmacy indicated varying levels of faculty expertise and leadership in Science of Safety domain areas. Less than one third of schools had faculty members who were nationally recognized experts in any of the Science of Safety Domains. Expertise in terms of scholarship through research and publication was greatest in Domain #1: product safety information from pre‐clinical studies and the least in Domain #2: product safety information from clinical trials. Approximately half of the schools had at least one faculty member to champion or advocate for teaching each domain. Schools with faculty champions were more likely to influence the teaching of some Science of Safety topics. Overall 41 of 53 respondents indicated that their school of pharmacy promotes a culture of safety and 49 indicated that their school promotes the role of the pharmacist in minimizing risk associated with

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13 medication products. It appears that the majority of schools believe their students can accomplish the abilities that relate to individual patient care and product safety in patient care. For example, 96.2% of schools indicated their students could identify potential adverse drug reactions, 94.3% indicated students could appropriately communicate the risks of medications to patients, 92.5% could communicate with other health care professionals about adverse drug reactions, 88.7% indicated students understood causes of medication toxicity, and 88.7% could appropriately respond to medication errors and adverse drug reactions. Fewer schools indicated that the majority of their students 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. There were three listed abilities in which less than 50% of the schools indicated that a majority of their students could accomplish. Those abilities are listed below. • Utilize patient databases to analyze factors affecting the illness of populations • Describe FDA’s Sentinel Initiative • Describe how the FDA communicates risk management strategies to pharmacists Some schools of pharmacy indicated that Science of Safety topics are taught in other places than just the professional pharmacy curriculum. Many schools indicated that it was taught in residency, fellowship, and graduate programs. In addition, some education about the Science of Safety was provided in continuing education (CE) programs. Ten pharmacy schools indicated that they were “very likely” to adopt an FDA‐developed Science of Safety curriculum. Thirty‐five schools were “somewhat likely” and 6 were “not likely” to adopt. Thus, there appears to be some interest in a developed curriculum. Greatest interest was shown in a curriculum for the Domain #3 topics pertaining to product safety after FDA approval. Finally, schools were asked whether their curriculum addressed the topic of safety‐net health care providers for underserved populations. The underserved consist of patients facing potential barriers to care which put them at greater risk of negative health outcomes. Underserved populations in the U.S. include females, children, ethnic minorities, seniors, low‐income groups, people living in rural areas, and individuals with special health care needs. These safety‐net providers can and do provide experiential educational opportunities to students to apply content related to cultural competence and medication risk in the curriculum. Experiences are typically provided using an interprofessional team‐based approach to care. Of the schools asked to whether they are partnering with safety‐net health care providers in providing experiential education, twenty (37.7%) indicated “yes,” while 14 (26.4%) said, “not yet, but they plan to.” Examples of activities in which schools of pharmacy participate include: • Engaging with community partners to decrease the gap in healthcare provision and increase disease awareness and prevention • Offering health education programs for the underserved • Providing experiential education at community health clinics to pharmacy students at: o Charitable medical clinics o Rural clinics in underserved areas o Safety net clinics o 340B clinics o Migrant farm clinics

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14 o Homeless shelters

Summary

In general, most schools of pharmacy believe that they are devoting adequate time to Science of Safety topics. A few topics of interest to FDA were not covered well in the schools of pharmacy, including using clinicaltrials.gov, using electronic decision support tools, and understanding the role of the FDA’s Advisory Committee for Drug Safety and Safety Risk Communication. Several schools indicated that they plan to begin teaching these topics. Some of these topics are relatively new and therefore some faculty may not be as aware or knowledgeable about them. Pharmacy schools appear to be promoting the role of the pharmacist in minimizing risk associated with medication products. They also indicate 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 post‐marketing 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. In addition to ACPE guidelines, a force driving the pharmacy curriculum is employer demand. Pharmacy schools respond to the needs of employers for students with specific training and skills. The pharmacy curriculum will respond if employers demand pharmacy graduates who can utilize patient databases, explain the FDA Sentinel Initiative, complete a MedWatch form, describe FDA’s role in risk management and communication upon graduation, and other competencies associated with the Science of Safety. The Science of Safety curriculum is also influenced by: • The school’s mission • The school’s relative emphasis on developing safety knowledge through research compared to improving the application of that knowledge in practice • The emphasis on preparing generalists (i.e., ability to enter into any field of pharmacy practice) versus preparing specialists (i.e., a concentrated focus of study) • The choice between didactic and experiential education • The choice between offering standalone courses and courses integrated across the curriculum • The ability to provide effective and meaningful interprofessional education Some interest appears to exist for the development of a model Science of Safety curriculum for pharmacy schools. Any curriculum should be modular in nature so schools can adopt portions depending on their needs. There appears to general agreement that pharmacy education should include the following broad topic areas related to Science of Safety: • Educate students in interprofessional teams that are systematically grappling with quality and safety issues • Teach communication skills to help persuade and negotiate

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15 • Teach about computing, data and information, and communication technology; technology’s benefits and limitations; and new evolving disciplines including bioinformatics, genomics, proteomics, and metabiomics • Teach how to best treat and communicate with patients when an error occurs • Provide opportunities for student research in safety that requires application of skills to complex situations • Promote a culture of safety in the minds of students The Science of Safety curriculum needs to consider the interrelationships between pre‐pharmacy, professional pharmacy education, and postgraduate professional residencies. Pharmacy education is a system and requires a systems approach to teaching. Educational experiences build upon and reinforce each other. Furthermore, interprofessional education is needed to promote a systems approach to addressing problems of medication safety. In conclusion, it is hoped that the results of this project will be beneficial for increasing opportunities for collaboration between U.S. schools of pharmacy, FDA, and entities eligible for the 340B drug discount program supported through the Pharmacy Services Support Center. 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. Specific recommendations follow.

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Recommendations

1. AACP should convene a conference to discuss 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 the following: a. What elements of the FDA Science of Safety Model Curriculum should be a part of the education of all graduates of schools of pharmacy in the U.S.? b. What educational outcomes relating to the Science of Safety should be achieved by all graduates of U.S. pharmacy 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? 2. Studies need to be conducted to quantify exactly what Science of Safety outcomes are currently being achieved at schools of pharmacy in the U.S. 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 (e.g., Institute of Safe Medication Practices (ISMP)). A better understanding is needed of the types and extent of gaps in student safety competencies in order to respond with educational interventions. 3. Variation in faculty expertise at some schools was identified. One reason for this variation is that educational materials are not readily available for academics. Resources exist 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 education for faculty is the Educating Pharmacy Students and Pharmacists to Improve Quality (EPIQ) Program available through the Pharmacy Quality Alliance (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 (i.e., 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 (www.ihi.org/IHI/) and the Institute of Safe Medication Practices (www.ismp.org/). The Institute for Healthcare Improvement provides educational tools for improving health care delivery, measures to track improvement, educational materials, and links to professionals with similar interests. The

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17 Institute of Safe Medication Practices provides educational materials, tools, guidelines, newsletters, alerts, and consulting services to promote patient safety. 4. Educational materials should be developed that target learning gaps (e.g., appropriate use of Medication Guides) of pharmacy students in the Science of Safety. FDA could provide the material on their web site or content could be made available at the website of the AACP or other organization. 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 could also be conducted. Modules could be developed for topics including REMS, history of medication risk regulation, clinical pharmacogenomics, and others. 5. 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 (CTSA) could be the presence of plans to implement interprofessional education within an institution’s 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. 6. The HRSA Pharmacy Services Support Center (PSSC) has potential to increase interprofessional education of pharmacy students in medication safety through its support of student practice rotations 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. 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. 7. Studies need to be conducted 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 was also 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 Risk Evaluation and Mitigation Strategies (REMS)? b. What expectations do employers have of pharmacists in the areas of Science of Safety?

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18 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? 8. Funding should be raised to support post‐graduate education in the Science of Safety. Funding can support residencies, fellowships, and graduate degrees in patient safety. 9. The Council of Deans within AACP 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. 10. Pharmacy schools should consider adopting the product life‐cycle approach to teaching the Science of Safety in pharmacy schools. The product life‐cycle approach views the science of medication safety as an interconnected sequence of events that begin 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 life‐cycle 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 life‐cycle 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.

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1. Introduction and Background

Overall Aim

This project provides baseline information on courses and teaching methods relating to the inclusion of Science of Safety in current curriculums at in the educational curriculum of professional degree programs at accredited colleges and schools of pharmacy. For the purpose of this report, Science of Safety is defined as the systematic study of the intended and unintended impact of drugs and medical devices on health at all stages of the drug product life cycle. The Science of Safety deals with anything that might be learned about risk in Pre‐Clinical Animal Toxicology and Safety Studies, clinical studies in humans, safety studies needed for FDA approval, and post marketing epidemiological research. The purpose of Science of Safety is to improve ways of identifying, understanding, reporting, managing, and communicating risk in ways that protect patients. The assessment consists of a literature review, key informant interviews, in‐depth case studies, and a nationwide survey of pharmacy schools in the U.S. The goal of this research is to learn how the concepts of the drug life‐cycle are integrated into the pharmacy curriculum. The purpose will be to identify ways to improve the teaching of the science of safety in pharmacy schools in support of FDA medication safety initiatives to support implementation of Title IX of the FDA Amendments Act. In addition, findings will be used by the Health Resources and Services Administration (HRSA) to identify ways to partner with the profession and expand upon the work of HRSA’s Patient Safety & Clinical Pharmacy Services Collaborative. The results from this project will provide the FDA with the necessary information for planning strategies to accomplish the agency’s strategic goals and legislative mandates. This baseline assessment of the pharmacy curriculum will provide a platform for continued collaboration between AACP and the FDA. Expected benefits to pharmacy academia include the following: • A better understanding of FDA expectations of partners in the Science of Safety • A baseline understanding of how the pharmacy professional curriculum matches the expectations of FDA • Provision of baseline data to guide program development and policy in the area of medication safety • Guidance and recommendations that can support collaboration between pharmacy academia and FDA in promoting the science of safety

Introduction and Background

The public expectations of the FDA have increased substantially over the last decade. These expectations are both a challenge and opportunity for the FDA. The FDA is actively engaged in determining which of its stakeholders can assist the agency in successfully meeting these expectations. The agency has taken the opportunity to address these expectations internally through a variety of

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20 mechanisms including the FDA Strategic Plan and other and initiatives implementing the legislative mandates of the Food and Drug Administration Amendments Act (FDAA). The current FDA strategic plan includes four main goals for which pharmacists might have some role: 1. Strengthen the FDA for Today and Tomorrow: Pharmacy professionals and academic research can collaborate with FDA by participating in programs such as Sentinel Initiative, Critical Path Initiative, and the Adverse Event Reporting System (AERS) 2. Improve Patient and Consumer Safety: Pharmacy faculty and pharmacists can further the science of best methods and development of tools for communicating risk associated with medications, devices and biologics. 3. Increase Access to New Medical and Food Products: Pharmacists can facilitate access to new, safe and effective medical products by improving the monitoring, reporting, and management of risk associated with medications. 4. Improve the Quality and Safety of Manufactured Products and the Supply Chain: Pharmacists can help detect and report sentinel events due to unique accessibility in the community and education – knowledge of pharmacoepidemiology, familiarity with adverse event reporting programs, and effective communication skills. Food and Drug Administration Amendments (FDAA) Act of 2007 directed that new resources and efforts be used for the Science of Safety in order to support FDA’s mission. FDAA Act gave FDA more authority over the regulation of medication safety ‐‐ to require pharmaceutical companies to conduct post‐ marketing studies and trials; make safety related labeling changes; and to develop risk evaluation and mitigation strategies (REMS). The Act directed FDA to develop a systematic plan to better manage the risks versus the benefits of drugs as they progress through their lifecycles, with an explicit focus on post‐ approval safety. The Food and Drug Administration (FDA) wants to better understand how pharmacy professionals are educated in the “Science of Safety.” The purpose is to identify ways FDA can partner with pharmacy professionals in improving medication safety and collaborate in mutually beneficial ways. The FDA is interested in learning how key concepts of the drug life cycle are integrated into the pharmacy curriculum. Advancing the Science of Safety was considered an important part of FDA’s role. This Science combines the growing understanding of disease and its molecular origins (including understanding of adverse events resulting from treatment) with new scientific methods of signal detection, data mining, and analysis. This knowledge will enable researchers to generate hypotheses about, confirm the existence of, and identify causal factors for drug and device safety problems in patient populations. FDA’s life‐ cycle approach to product development and evaluation (i.e., examining drug and device safety from pre‐ marketing to post‐marketing) helps to ensure that safety signals generated at any point in the process can be evaluated along with relevant benefit‐risk data to inform treatment choices and regulatory decision making. New collaborations and the application of a systems approach to monitoring post market medical product safety are critical to helping FDA expand its ability to identify previously unknown risks of medical products, learn about their patterns of use, and assess the outcomes associated with them. FDA collaborations with health professional education and training programs will support these goals.

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21 In 2008, FDA announced its Safety First/Safe Use Initiative. Safety First refers to steps FDA's Center for Drug Evaluation and Research (CDER) can take to strengthen and modernize its internal policies and processes to manage significant drug safety issues. This proposal supports the Safe Use Initiative goal to broaden FDA’s post market mission even further by placing a new emphasis on partnering with health care providers and medical, pharmacy, and nursing associations to promote safe use of drugs. Development of a safety curriculum directed at healthcare professional students was developed to promote Science of Safety in US colleges and professional schools with the goal of expand the pool of health care professionals who can actively participate in FDA initiatives. The totality of the FDA’s initiatives, strategic goals and legislative requirements, many of which are focused on the drug life cycle, can be described as the Science of Safety.

Specific Work Objectives Established for This Study

1. Assess the curricula of accredited U.S. colleges and schools of pharmacy for inclusion of the Science of Safety. 2. Provide a program report summarizing findings, lessons‐learned and recommendations for integrating a proactive Science of Safety program for students. 3. Support HRSA’s Patient Safety and Clinical Pharmacy Services (PSCP) initiative. Dissemination of the project analysis and results are an important component of this project. This results and conclusions will be submitted to peer‐reviewed journals including the American Journal of Pharmaceutical Education (AJPE). In addition, the results of this project will be presented to national audiences. This project consists of both exploratory and quantitative components. The exploratory phase of the project sought to address the following broad research questions: 1. What is the definition of Science of Safety as defined by FDA? 2. How does the Pharmacy Profession and Academia define Science of Safety? 3. What is a working definition of Science of Safety that melds both viewpoints? 4. What issues are fundamental to the provision of a strong Science of Safety Curricula? The quantitative phase of the project sought to summarize the following broad research questions: 1. What topics fall under the area of Science of Safety? 2. What minimum competencies should be expected of all graduates from professional programs? 3. What pedagogy is used in teaching? 4. What are perceived needs and gaps? 5. What organizational factors influence the teaching of Science of Safety?

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Research Domains of This Study

Specific research domains were developed during consultations between representatives of AACP, PSCP, FDA, and the study investigators. A model Science of Safety curriculum developed by FDA (See Appendix A) formed the basis of many of the indentified research domains and questions. The research domains and questions are the following: • The construct of Science of Safety (SOS) ‐‐ Research questions examine how SOS is defined by different parties, the topics covered in pharmacy schools, expected competencies, and who teaches it. • Needs – Research questions examine perceived gaps in the curriculum, leadership, and expertise; future plans; and barriers to teaching. • Pedagogy – Questions about strategies for instruction are asked in this section. Of particular importance are experiential, integrated, and multidisciplinary methods. Another important question addresses how educators collaborate with safety net health care providers for underserved populations. Underserved populations offer exceptional experiential opportunities for students in issues such as medication adherence, the complex nature of managing chronic illness, and patient barriers to care including limited ability to pay and low health literacy. • Organization – Research questions attempt to observe the relationship between organizational factors (e.g., CTSA, CERT) and the teaching of the SOS. • Students – Research questions attempt to observe the relationship between pre‐pharmacy education and post‐graduate plans on the teaching of the SOS. • Outcomes – Research questions examine perceptions that graduating students have achieved desired education in risk understanding/appreciation, identification, management, communication, and reporting. Four different research methods were employed to answer the above questions. Table 1‐1 demonstrates the domains and questions to be examined for each research method. Table 1‐1: Research Domains and Questions and Methodologies Used Lit Review Key informant Case Study Survey Research Domains Research Questions SOS construct How is it defined by different parties? Should we call it the science of medication safety in the survey? x x What topics are covered? x x x x What are the expected competencies in SOS of graduates from pharmacy schools? x x x x Who teaches SOS? (Disciplines, Training) x x Needs What topics need more emphasis? x x x What deficiencies exist in knowledge and application? x x x How satisfied are you with the ability of students to influence the safety of their patients? x x x Is there sufficient leadership (formal and informal) to champion safety initiatives? x x x Is there sufficient faculty expertise to meet the curricular needs of SOS? x x x What plans do you have to address current SOS needs? x x

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23 Is database training to conduct pharmacoepidemiology research required of all students? Elective? x x x x Is database training to conduct pharmacoepidemiology research essential for all pharmacy graduates? x x x Are sufficient rewards and recognition given for promoting safety in the curriculum? x x x What barriers exist to improving the SOS curriculum? x x x Pedagogy What experiential training is offered in SOS? IPPE, APPE x x x Is SOS training multidisciplinary (i.e., with medicine, nursing)? x x x How is SOS fully integrated throughout the curriculum from the basic sciences to pharmacy practice to experiential training? x x x Is SOS mapped across the curriculum? (Has a curricular map been developed that examines medication safety?) x x x What unique training experiences (e.g. Service learning, IPPE/APPE, online, active learning methods) do you provide in SOS? x x x What pre‐pharmacy requirements are needed? x x x What SOS topics are taught in standalone courses at your university? x x Does your pharmacy curriculum address the topic of safety net health care providers for underserved populations? x x x Organization Does your school have a CTSA? (we can get this information from public sources) x x x Does your school have a CERT? (we can get this information from public sources) x x x Is your school associated with a medical center? (we can get this information from public sources) x x x What graduate programs does your school have? MS, PhD, disciplines (we can get this information from public sources) x x x Does your school have a ‐‐‐‐‐‐‐‐‐‐‐‐? x x x How do the above features of your school help in training students about SOS? x x What is the average class size? (we can get this information from public sources) x x x Is medication safety an explicit part of the school's mission/strategic plan? x x x Are students required to complete a research project? x

Students Percentage of students admitted without a prior degree. (Can

AACP supply some of this data?) x x x Percentage of graduating students who go on to post graduate training. x x x Outcomes Can all graduating students do the following: (these can be associated with courses offered) The scale should assess perceived needs for improvement e.g., a strength, meets expectations, some improvement needed, major improvement needed or 5‐Exceptional 4‐Satisfactory 3‐Needs Some Improvement 2‐ Needs Major Improvement 1‐Unacceptable ) Does not address if the topic is considered important 0 ‐ Not considered necessary for graduating students. What should graduating students know to become effective managers of the medication use process? x x x Risk understanding/appreciation Understand the risk associated with medications in underserved populations x x Understand the role of genetics in medication risk x x Understand the importance of a culture of safety in health care institutions x x Understand the risks associated with human subjects research x x

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24 Understand the risks to privacy and confidentiality of patient medication records x x Understand the causes of medication toxicity x x Risk identification Able to recognize human/environmental factors associated with ADRs x x Able to identify potential ADRs from patient medication records x x Can classify ADRs x x Able identify risk of ADRs using biomarkers x x Able to complete a root cause analysis x x Able to distinguish ADRs from natural disease progression x x Able utilize patient databases to analyze the factors affecting the health and illness of populations x x Risk management Able to work in collaborative teams x x Have worked in interdisciplinary teams to manage drug related problems x x Able to apply quality improvement principles to manage medication use x x Able to engage patients in managing their medication use x x Able to use evidence based practice to manage medication use x x Proficient in the use of technology to manage medication use x x Risk communication Ready and willing to advocate for improvements in medication use systems x x Able to clearly communicate with colleagues about medication use issues x x Able to communicate the risks of medications to patients. x x Competent in considering cultural diversity in communicating medication risk to patients. x x Experienced in developing patient education material x x Risk Reporting Can complete a MEDWATCH report x x Competent in recording information in patient medical records x x Understands ethical/professional/legal obligations of risk reporting _x _x Knows how to appropriately respond to medication errors x x

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25 The remainder of this report is organized as follows: Section 2: Methodology: Literature Review, Interviews, Case Studies, and Survey (Also see Appendix B) Section 3: Results: Literature Review, Interviews, Case Studies, and Survey Appendix A: FDA Model Curriculum: Draft Appendix B: Detailed Methodology Appendix C: Bibliography of Publications Reviewed and Detailed Descriptions of Selected Publications Appendix D: Key Informant Interviews