Chapter 21: Drug Information Education and Training

After completing this chapter, the reader will be able to

• Determine fundamental drug information skills for all pharmacy students.

• Identify settings in which student drug information skills can be developed and refined.

• Define the recommended training path for drug information specialists.

• Describe job responsibilities of contemporary drug information specialists.

• Formulate a strategy by which interested candidates can learn about available drug information residencies and fellowships.

1. Information retrieval, evaluation, and application skills represent a significant component of the core skill set each pharmacist must possess.

2. Drug information skills are core concepts that must be incorporated in pharmacy curricula.

3. The majority of foundational skill development should occur prior to student participation in advanced pharmacy practice experiences (APPEs).

4. Drug information rotations may also occur in nontraditional settings (e.g., pharmaceutical industry, managed care, group purchasing organization), a reflection of the expanding role of drug information in contemporary pharmacy practice.

5. Activities identified by the Accreditation Council for Pharmaceutical Education (ACPE) in which students should engage to foster their skill development range from responding to drug information requests to preparing materials for consideration by a pharmacy and therapeutics committee.

6. Pharmacy residency training standards include core drug information retrieval and evaluation skills for both postgraduate year one (PGY1) and postgraduate year two (PGY2) programs.

7. Consistent with the profession-wide model for specialist training, the preferred training model for a drug information specialist is a PGY1 residency program, followed by completion of a PGY2 residency in drug information.

8. The American Society of Health-System Pharmacists (ASHP), the organization charged with accrediting pharmacy residency programs, has developed outcomes, goals, and objectives that must be incorporated into ASHP-accredited PGY2 residency programs.

9. PGY2 programs in drug information are not limited to health systems, as programs exist in academic, pharmaceutical industry, and managed care settings.

10. Fellowship programs build research skills beyond those provided during residency training programs.

❶ Information retrieval, evaluation, and application skills represent a significant component of the core skill set each pharmacist must possess. Combined with other practice responsibilities that have traditionally been linked to the practice of drug information (e.g., medication use policy), developing and maintaining practitioners with expertise in such activities is critically important. This chapter will focus on key models of education and training for all pharmacists, as well as those specializing in drug information practice.

Building basic drug information skills, a signature feature of early doctor of pharmacy degree programs, remains an essential component of contemporary entry-level doctor of pharmacy education.^1-3 Skills are developed by both didactic and experiential methods. Didactic drug information education is provided through stand-alone courses as well as being integrated within other courses or throughout the professional curriculum.

❷ Drug information skills are core concepts that must be incorporated in pharmacy curricula. Pharmacy curricula must be designed to prepare program graduates with entry-level professional competencies to ensure optimal medication therapy outcomes and patient safety in any pharmacy practice setting and incorporate core drug information skills. To meet the profession’s broader needs, the scope of drug information practice has evolved beyond a focus on literature retrieval, evaluation, and application to specific organizational needs and patient care situations such as therapeutic policy management, oversight of safe medication practices including information systems, and promotion of health and wellness.⁴ The accreditation standards for professional degree programs include the broad set of related concepts that must be taught and evaluated (e.g., professional communication, practice management, biostatistics).² Those that are readily identifiable as connected to drug information are broadly categorized as drug information, literature and research design evaluation (see Chapters 4 and 5), biostatistics (see Chapter 8), economics/pharmacoeconomics (see Chapter 6), pharmacoepidemiology, pharmacogenomics, and medication safety (see Chapter 16). However, a number of foundational elements relevant to drug information practice are integrated into other categories of the Accreditation Council for Pharmacy Education (ACPE) accreditation standards.² Those elements include:

• Interpretation of drug screens (e.g., urine toxicology)

• Pharmacist’s role in poison control centers

• Dietary Health Supplement and Education Act and impact on regulation of dietary supplements and herbal products

• Drug-herbal interaction

• Indigent care programs

• Incidence of and problems associated with drug overuse, underuse, and misuse in the health care system

• Tools, including informatics, needed to assess and address change, increase competitiveness, improve quality, and optimize patient services

• Managing and improving the medication use process

• Ethical issues related to the development, promotion, sales, prescription, and use of drugs

• Conflict of interest

• Effective verbal and written interpersonal communication

• Health literacy

• Use of data in continuous quality improvement initiatives

• Systematic processing of data, information, and knowledge in health care

• Identifying pharmacotherapeutic knowledge gaps in the professional literature

• Evidence-based practice and decisions

• Assurance of safety in the medication use process

• Medication error identification and prevention programs

• Identification and prevention of drug toxicity

• Role of automation and technology in workload efficiency and patient safety

• Continuous quality improvement programs

• Evaluation of clinical trials that validate treatment usefulness

The American College of Clinical Pharmacy (ACCP) Drug Information Practice and Research Network (PRN) published an opinion paper to ensure that drug information education and practice is designed to meet the needs of the changing health care environment. This paper recommended core specific drug information concepts that should be formally taught and evaluated in all colleges of pharmacy (see Table 21–1).⁴ Other topic areas closely aligned with drug information practice include alternative medicine, adverse drug event (medication misadventure) surveillance, drug shortage management and mitigation, safety monitoring during clinical trials, risk evaluation mitigation strategies (REMS), and managing investigational drug services.

A number of pedagogical approaches may be used to build drug information associated skills in the didactic setting. A 2012 survey conducted by the ACCP Drug Information PRN summarized the methods by which colleges of pharmacy include drug information, literature evaluation, and biostatics content into the curricula. Survey responses represented 50% of the pharmacy schools listed in the American Association of Colleges of Pharmacy (AACP) online directory. Instructional methodology used included didactic lectures, small group learning, Internet-based learning, and other formats. Survey respondents indicated using online course management programs, audience response systems, YouTube, online blogs, tweets, and wikis to teach drug information, literature evaluation, and biostatistics content.⁵ The availability of instructional technologies and focus on active learning components in the professional program provide many opportunities for instructors to engage learners through incorporation of practical, practice-oriented scenarios.

❸ The majority of foundational skill development should occur prior to student participation in advanced pharmacy practice experiences (APPEs). Integration of practice-related activities in the introductory pharmacy practice experiences (IPPEs) are also important activities supported by the ACPE.² Once a student reaches the final year in the professional curriculum, he or she can benefit greatly from a practice experience devoted to drug information practice. Having the opportunity to provide responses to drug information requests following completion of didactic coursework and complete other drug-information-related projects (e.g., medication use evaluation, formulary class review or monograph, evaluation of adverse drug events) provides students even greater opportunities to apply pharmacotherapeutic, pharmacokinetic, legal, and ethical principles to their approach to providing drug information. Drug information historically was a required learning experience for each doctor of the pharmacy student. The growth in the number of colleges of pharmacy and pharmacy student population and reductions in the number of formal drug information centers has resulted in an inadequate number of teaching sites to support a required drug information APPE for every student.⁶ While some colleges have developed their own formalized centers, others provide only elective drug information advanced practice experiences.^1,6 ❹ Drug information rotations may also occur in nontraditional settings (e.g., pharmaceutical industry, managed care, group purchasing organization), a reflection of the expanding role of drug information in contemporary pharmacy practice.

❺ Activities identified by ACPE in which students should engage to foster their skill development range from responding to drug information requests to preparing materials for consideration by a pharmacy and therapeutics committee. Table 21–2 provides a comprehensive list of suggested drug information skill building activities to incorporate into APPEs.² Students require adequate supervision and oversight to ensure the quality of service they provide, as well as to provide them valuable feedback to subsequently improve their performance. Sites often realize that incorporation of students into the practice site may expand the capacity of services provided, including responding to more drug information requests, preparing analyses of drug policy issues for consideration by the pharmacy and therapeutics committee, and conducting medication use evaluations or adverse drug reaction surveillance. Other APPE experiences beyond those labeled as drug information (e.g., pharmacy management, informatics, and medication safety) also provide opportunities that are beneficial to building skills in drug information.

Drug information skills are a core skill set for all pharmacists, regardless of their practice setting, area of therapeutic focus, or declared area of specialty. ❻ Pharmacy residency training standards include core drug information retrieval and evaluation skills for both postgraduate year one (PGY1) and postgraduate year two (PGY2) programs.^7,8 As early as 1966, the need for pharmacists with specialized skills in drug information was documented.⁹ The focus of doctor of pharmacy degree programs has evolved to the current model of postgraduate training, specifically through residency programs, to train drug information specialists. ❼ Consistent with the profession-wide model for specialist training, the preferred training model for a drug information specialist is a PGY1 residency program, followed by completion of a PGY2 residency in drug information. This training model is also supported by drug information specialist members of ACCP.⁴

Although there is long-standing recognition regarding the importance of advanced training, one survey identified that 40% of drug information pharmacists have completed such training and the remaining 60% developed skill in their position responsibilities through on-the-job training.¹⁰ This may reflect an imbalance in pharmacists with advanced trained and available job openings. A relative lack of popularity or desirability of the specialty to students and new trainees, or pressures on employers to fill positions with applicants who lack the desired formal training, may have contributed to this imbalance; no formal assessment of these or other factors has been conducted. One theory for the decreasing numbers of available PGY2 drug information residency programs is the misconception regarding the activities of drug information residents and specialists. Drug information is evolving from merely providing responses to drug information queries to serving as organizational leaders in medication use policy and safety.^11,12 The number of available positions for individuals with advanced training in drug information often exceeds the number of candidates who have completed advanced training. This imbalance is cause for concern and may result in a shortage of qualified candidates to meet the drug information needs of the changing health care environment.^4,11

A 2006 survey of United States (U.S.) pharmacists with presumed drug information practices was conducted to determine the perceptions regarding drug information practice and training.¹⁰ The survey was sent to members of the ACCP DI PRN, participants of a drug information practice listserv, and pharmacists employed by drug information centers; because of this methodology, the sample may not reflect all pharmacists with drug information responsibilities. The most common job responsibilities of those surveyed were instructing pharmacy students and staff (64%), maintaining formal drug information center operations (63%), responding to drug information queries (59%), conducting original research (53%), providing pharmacy and therapeutics committee support (46%), providing medication safety support, publishing pharmacy-related newsletters (38%), and developing medication use policy (35%). Respondents generally felt prepared to undertake their responsibilities in relation to the extent of postgraduate training they received. However, areas in which pharmacists felt less prepared included information systems support (41%), pharmacoeconomic evaluations (32%), and clinical outcomes research (19%). Approximately 80% of those who had completed postgraduate training felt adequately prepared overall for their job roles. Preparing for practice changes and innovations is a focus of residency training, and perhaps was reflected in the greater sense of preparedness reported by residency-trained pharmacists.¹⁰ A 2011 survey of pharmacy residents and fellows identified that a new motivator of pharmacy students to pursue residency and fellowship training is that these additional training programs are prerequisites for certain jobs.¹³

❽ The American Society of Health-System Pharmacists (ASHP), the organization charged with accrediting pharmacy residency programs, has developed outcomes, goals, and objectives that must be incorporated into ASHP-accredited PGY2 residency programs.⁷ Required outcomes of PGY2 drug information residencies are to demonstrate excellence in the provision of education, training, and evidence-based information for health care professionals and health care professionals in training; contribute to the management of the organization’s medication use policies processes; exercise leadership and practice management skills; conduct drug-information-practice-related projects; and contribute to the management of the organization’s budget. There are additional outcomes suggested for those residencies conducted in formal drug information centers and hospitals or health systems. PGY2 drug information residencies are designed to “transition PGY1 residency graduates from generalist practice to a specialized role as an organizational leader in the development of safe and effective medication use policies and/or processes and in the expert analysis of medication-related information.”⁷ As noted in the 2006 survey, contemporary drug information specialists should be prepared to utilize technology and advance population-based approaches (e.g., data mining, pharmacoepidemiology, pharmacovigilance) to support a safe and effective medication use process.¹⁰ These tools and approaches may include information systems support, clinical outcomes research, pharmacoeconomic evaluations, and other such techniques are also consistent with the Institute of Medicine’s (IOM) focus on evidence-based medicine, technology, and quality assurance as core competencies for health care practitioners.¹⁴

❾ PGY2 programs in drug information are not limited to health systems, as programs exist in academic, pharmaceutical industry, and managed care settings. The ASHP required outcomes, goals, and objectives of PGY2 drug information residency programs provide opportunity for development of an advanced skill set that can be applied to many practice settings. Residency graduates who are actively engaged in the practice environment of their training program and then become employed in the same type of practice environment should be well equipped to effectively contribute to the drug information needs of their new organization, and the time to effectively transition from resident to independent practitioner may be shortened. For example, a graduate of an ASHP-accredited PGY2 drug information residency in an academic medical center would likely be a highly desirable candidate for drug information specialist positions within other hospitals and health systems. However, the skills afforded by advanced drug information training in any setting are transferable and beneficial to other settings since having a greater understanding of the operations of an alternate setting may improve decision making in the new environment. For example, training in pharmaceutical industry can better inform a pharmacist of the Food and Drug Administration (FDA) about regulations and internal policies that may shape the manner in which a manufacturer can provide information about an investigational drug or suspected adverse effects of a marketed drug.

❿ Fellowship programs build research skills beyond those provided during residency training programs. These fellowships have focus in a number of subspecialty areas including evidence-based practice, medical communications, medication use policy, medication safety, pharmacoepidemiology, and pharmacoeconomics. As with therapeutic specialties, fellowship training in drug information should focus on expanding the fellow’s research abilities. There are no accreditation standards for fellowship programs, so their structure, duration, and delivery are guided by the program director.¹⁵ Given the growing complexity and cost of health care, the need for practice-focused researchers has grown more vital. Drug information fellowships that focus on research skills in pharmacoepidemiology, pharmacoeconomics, and comparative effectiveness, or the role of informatics to support a safe and effective medication use system, would be well suited to fill this need.^4,10,13

Identifying potential residency or fellowship programs that may meet an individual’s training needs should begin with a search of available training directories such as the ASHP online residency directory and the ACCP Directory of Residencies and Fellowships.^15,16 Different factors may be important to individual applicants as they evaluate available programs. Beyond traditional drug information activities like responding to queries and providing formulary management, factors that may be important to individual candidates include the ability to gain experience working with students or PGY1 residents, performing contract work, extensive opportunities to manage drug policy across a health system, and intensive training in medical writing. Regardless of the special features or characteristics, there should be opportunities that will prepare the individual for the type of practice they envision. In addition to being prepared for a position as a drug information specialist, graduates of PGY2 drug information residencies may pursue positions in medication safety (see Chapter 16), regulatory/quality pharmacists (see Chapter 22), drug policy (see Chapter 18), and medical writing (see Chapter 9). Settings in which positions may be available include hospitals and health systems, managed care organizations, government organizations, pharmaceutical industry, and academia. A directory of accredited or accreditation-pending residency programs can easily be accessed from the ASHP Online Residency Directory (http://accred.ashp.org/aps/pages/directory/residencyProgramSearch.aspx).¹⁶ In addition to employment (e.g., salary, benefits) and contact (e.g., program director) information, each program’s listing includes a description of the practice site, key program features, application information, and a hyperlink to the provider’s Web site. More detailed information such as schedules, learning experience descriptions, and accomplishments of program graduates may be found on the Web sites of the individual programs. Residency programs, including those that are not accredited, may also be identified through a review of the Directory of Residencies, Fellowships, and Graduate Programs hosted on the ACCP Web site (http://www.accp.com/resandfel/).¹⁵ This directory is also the primary catalog of possible fellowship options. Fellowship programs may be identified by searching drug information as well as the heading of the research focus (e.g., pharmacoeconomics, pharmacoepidemiology, outcomes research, medication safety). The program listings also provide descriptions of secondary specialty, which include evidence-based medicine or practice, medical communications, and medication use policy. These secondary specialty descriptions may continue to evolve as program’s morph to meet the demands of the changing health care environment.

All pharmacists, regardless of practice setting, require drug information skills in order to provide evidence-based patient-centered care and appropriately support other health care professionals. Equipping pharmacists with those skills begins in professional degree programs, continues into residency training, and may extend into fellowship programs. Additionally, pharmacists may continue to expand drug information skill development throughout their careers by involvement in continuing professional development and on-the-job training. Each of these important elements of education and training should continue to evolve to meet contemporary practice and research needs and to prepare future practitioners to provide innovative services grounded in principles of evidence-based medicine.

The author acknowledges Kelly M. Smith, PharmD, BCPS, FASHP, FCCP, who wrote this chapter in the previous edition.