Clinical Pharmacy and Clinical Research

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pharmacist learning about and getting involved in clini- cal research. As Hepler .... care-oriented activities and the biological sciences and were especially ...
CLINICAL PHARMACY AND CLINICAL RESEARCH Jean M. Nappi and John A. Bosso

IN THE SUMMER OF 1987, one of the authors (IN) was asked to react to a paper presented by Hepler at the annual meeting of the American Association of Colleges of Pharmacy that involved an overview of the history of pharmacy. I She was specifically asked to address the relationship between clinical pharmacy and clinical research. Those initial considerations plus a major amount of afterthought addressing this issue on a broader basis form the basis for this editorial.

History of Clinical Pharmacy There is no doubt that the clinical pharmacy movement that Hepler described has had a major impact on the curricula in our colleges of pharmacy as well as, and perhaps more importantly, on the practice of pharmacy. In order to discuss the effect of clinical pharmacy on clinical research and the effect of clinical research on clinical pharmacy, a look into the past is necessary. One can start by describing the events that led to the clinical pharmacist learning about and getting involved in clinical research. As Hepler described, once pharmacists found themselves practicing in patient care areas and interacting directly with patients and other health care professionals, the concept of clinical pharmacy began to flourish. At that time, formal drug information centers surfaced and pharmacists' functions expanded to include the active monitoring of drug therapy in addition to traditional drug distribution responsibilities. In the late sixties and early seventies, a new generation of doctor of pharmacy programs was brought into being that provided the basis for a more sophisticated pharmacist clinician. These programs required two or three years of study beyond the baccalaureate degree. A full year of organized and formal lectures in pathophysiology and physical diagnosis, often using medical school faculties and facilities, provided the doctor of pharmacy student with the knowledge needed to fully understand the disease states affecting individual patients and thus better understand the basis for drug selection and therapeutic monitoring. Courses in research design and biostatistics were often required. These courses provided the groundwork for interpretation and evaluation of the literature which the students were then applying to patient care situations. In addition, an active research component was required in some programs. The graduates of these programs were prepared not only to monitor drug therapy, but to advise and teach physicians about the proper use of drugs based on their extended education, ability to critically evaluate and summarize the literature, and JEAN M. NAPPI, Pharm.D., is an Associate Professor of Clinical Pharmacy, College of Pharmacy, and an Adjunct Associate Professor of Medicine, School of Medierne; and JOHN A. BOSSO, Pharm.D., is a Professor of Clinical Pharmacy, College of Pharmacy. and an Adjunct Professor of Pediatrics, School of Medicine, University of Utah. Salt Lake City, UT. Reprints: John A. Bosso, Pharm.D.; Department of Pharmacy Practice, College of Pharmacy, University of Utah Salt Lake City UT 84112. ' ,

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recently acquired clinical experience. Because these students often were educated alongside their medical student counterparts, a comraderie between them developed and has continued to grow. The gap between medicine and pharmacy was, in retrospect, quite easy to close. There was a common goal: the improvement of patient care with each discipline contributing in its own way. As an example, the training in clinical pharmacokinetics that the pharmacist could bring to the patient care area was something that was often unique and valued. Specialization after the attainment of advanced degrees and general clinical training allowed pharmacists to move forward with physicians as professional colleagues. Why was there a place for this new breed of pharmacist in the patient care arena? As can be gleaned from the literature reflecting the medical profession's selfexamination, the discipline of clinical pharmacology has not been adequately attended to through that profession's educational and training programs.' Crout defined clinical pharmacology as "the medical discipline concerned with the action of medicinal drugs in humans, including human metabolism of drugs, their therapeutic effects in sick patients, and the adverse effects and risks that accompany the use of these drugs?' He further defined a clinical pharmacologist as a "medical professional whose career is devoted to teaching and research in clinical pharmacology and to patient care in a relevant medical subspecialty?'3 If one substitutes the words' 'health care discipline" for medical discipline and "health care professional" for medical professional in these definitions, it is our opinion that there are a number of clinical pharmacists who have evolved into clinical pharmacologists. Peck and Crout revealed interesting data from a survey of the current clinical pharmacology programs in the U.S. In the last 20 years, these programs trained fewer than 400 physicians (including U.S. and foreign medical school graduates) as clinical pharmacologists. More than 60 doctor of philosophy recipients also received training in these programs. Although only 17 percent of the physicians abandoned careers in research to go into private medical practice, the total number of clinically trained pharmacologists is not overwhelming." Furthermore, these physicians trained as clinical pharmacologists often are found in the laboratory rather than the patient care area. It is not surprising that a properly trained and educated clinical pharmacist who understands the pathophysiology of disease and pharmacology, and thus the physiological basis for drug selection and use, might help fill the apparent clinical pharmacology gap in patient care. Some physicians apparently agree with this notion.v" Moreover, the inclusion of clinical pharmacists in specific aspects of the pharmacotherapeutics arena has been called for in the medical literature. 7.8 VOL 22

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ClinkalPharmacyasan Academic/Scientific Discipline Since the roots of clinical pharmacy were set in the academic setting, it was inevitable that many doctor of pharmacy graduates would accept academic/clinical practitioner positions that were associated with such institutions. Early clinical pharmacy faculty were largely role-model educators; however, it soon became obvious that in order to meet the traditional responsibilities of university faculty, they would also need to be scholars. Of course, in an academic/tertiary care setting, clinical research overlaps with patient care. Given this scenario, it was not surprising that the initial emphasis on teaching and service would be lessened over time and give way to a greater emphasis in scholarly activity by taking advantage of the many opportunities for involvement in clinical research. With time, pharmacists gained various degrees of independence in their research activities and, as was the case with clinical practice, often specialized in such areas as pharmacokinetics, infectious disease, or cardiovascular research. Because doctor of pharmacy programs do not prepare their graduates for research, new skills were needed by these faculty members. Some pharmacy practice researchers acquired needed skills and knowledge "on the job"; others took advantage of sabbatical opportunities. More recently, graduates of doctor of pharmacy programs have completed postdoctoral research fellowships to help prepare themselves for independent research. Although many clinical pharmacy researchers limit themselves to clinical research, others have also acquired laboratory skills so that they can conduct (and have control over all aspects of) research endeavors that have both clinical and laboratory aspects. In addition to garnering new knowledge and skills and taking advantage of opportunities for research involvement, these fledgling investigators needed to deal with the political realities of research in the academic environment. The basic science faculty of the country's colleges and schools of pharmacy have, for the most part, been both supportive and helpful in the transition of clinical pharmacy from a service- or practice-based discipline to that of an academic one; however, some conflicts were (and continue to be) inevitable. This is not surprising when one considers the differing perspectives and interests of each group. Clinical pharmacy faculty members initially emphasized patient care-oriented activities and the biological sciences and were especially interested in changing the thrust of pharmacy practice, whereas the basic science faculty members often had no experience in the conventional practice of pharmacy, but had been trained and succeeded in the traditional rigors (teaching, scholarship, service) of the academician's pathway. Faculty members trained as basic scientists had difficulty relating to the types of research that clinical pharmacists found interesting. They were skeptical of the clinical pharmacists' training, or rather, lack of it. More pragmatically, there was and still is competition between these groups of faculty members in attracting students interested in furthering their careers through postbaccalaureate education and training. The basic science faculty saw many of the brightest students being drawn away from doctor Drug Intelligence and Clinical Pharmacy

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of philosophy programs and entering postbaccalaureate doctor of pharmacy programs and clinical residency and fellowship programs. Additionally, clinical science and basic science faculty members find themselves in competition for college resources (space and money) and the increasingly elusive research dollars from both federal and private sector funding institutions. Obviously, the support systems and initiative of would-be clinical scientists have outweighed any barriers to this trend as the progress in and contributions to clinical science on the part of clinical pharmacists is quite obvious. It is difficult to quantitate or qualitate the amount of clinical research being done by clinical pharmacists. Most readers are aware of the petition from the Committee on Clinical Pharmacy as a Specialty submitted to the Board of Pharmaceutical Specialties requesting recognition of pharmacotherapy as a specialty area of pharmacy practice. The petition states that the number of pharmacotherapeutic research publications by clinical pharmacists increased by 343 percent from 1978 to 1982. One need only examine the recent abstracts from the American Society of Clinical Pharmacology and Therapeutics and the American College of Clinical Pharmacy annual meetings to appreciate the commitment to the discovery and dissemination of new knowledge on the part of clinical pharmacists. A further reflection of this activity and apparent competence is the fact that a number of clinical pharmacists serve as reviewers for and have appointments to the editorial boards of many nonpharmacy journals. Clinical pharmacy researchers are bringing their research efforts to culmination by publishing their findings in appropriate, peer-reviewed journals. Garnett reported that the number of articles dealing with drug research authored by pharmacists has been steadily increasing. He found that 36.4 percent of articles written by pharmacist researchers appeared in pharmacy journals, 42.9 percent were found in medical journals, and 17.7 percent appeared in pharmacology journals." Clinical pharmacy researchers publish in areas such as pharmacokinetics, clinical efficacy assessment, and the cost effectiveness of various drug regimens. We have also contributed to the entity and evaluation of the discipline of clinical pharmacy itself. We ask what clinical pharmacists do, how well they do it, how much it costs, and how they are perceived by other health care providers. 10 How has the movement to research involvement and productivity affected clinical pharmacy? There is no doubt that involvement in clinical research has had a major impact on clinical pharmacy, especially for certain clinical pharmacy educators. Research has provided another avenue of growth for the discipline of clinical pharmacy. The contributions that clinical pharmacists have made to the body of knowledge has also enhanced our position among our professional colleagues, particularly those in medicine. Vlasses reported that clinical pharmacists have obtained fulltime faculty status in approximately one-third of the colleges of medicine in the U.S. Many of these individuals are involved in clinical research. II In addition, the Food and Drug Administration now accepts individuals holding the doctor of pharmacy degree as principal VOL 22

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investigators in studies involving investigational drugs as long as a person licensed to diagnose and treat disease is formally associated with the study. Those clinical pharmacists who do demonstrate competence in clinical research are also sought by the pharmaceutical industry. It was only 15 years ago that the first clinical pharmacy faculty member left academia to join a pharmaceutical company in a research position. This is a migration that has been repeated many, many times over. In fact, we now have clinical pharmacists as directors of clinical research, at one time a position held only by an individual with a doctor of philosophy or doctor of medicine degree. Future Directions and Needs In order for clinical pharmacy to develop as a scientific discipline, it first has to develop as a true academic discipline within our colleges and schools of pharmacy. Has this happened? Unfortunately, the answer to this question seems to vary considerably from one institution to another. At some, departments of pharmacy practice have attained true academic status by establishing a strong scientific base. In such departments, scholarly productivity is both anticipated and expected. Others have developed into teaching and service departments. Scholarly productivity is neither expected nor required. The latter is a direction that we view as unhealthy for clinical pharmacy. It portrays our discipline as one of lesser importance to our basic science colleagues, our students, and our fellow health care academicians. Moreover, it stifles the scholarly aspirations of young pharmacy practice faculty. In academic units in which teaching and service are stressed and scholarship is minimized, it is obviously difficult for science to exist, let alone flourish. More specifically, it does not provide an environment in which an academician interested in research is likely to succeed. In view of the foregoing discussion, we should expect that many future pharmacists will aspire to careers that involve the discovery and dissemination of new knowledge related to the use of drugs in humans. The academic community must be prepared to meet this need. Within the context of preparing pharmacists for careers that include research, the national movement toward implementation of entry-level doctor of pharmacy programs could be construed as a step in the wrong direction. However, the goal of these professional programs is not to prepare clinical scientists. Furthermore, even the best of our postbaccalaureate doctor of pharmacy programs fall far short of preparing clinicians for research. Therefore, other avenues are necessary and some are already available. In the last five years, the number of post-doctor of pharmacy research fellowships has increased dramatically. However, the educational and training goals of these fellowships are, in some cases, poorly defined. Therefore the prospective fellows and their eventual employers do not really know what to expect in terms of acquired research competence. Further, such fellowships most often depend on external or "soft" funding. Few clinical pharmacy faculty members have the necessary fiscal support and laboratory facilities to carryon a sophisticated research program let alone a 806

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sound fellowship program. It is even more difficult to identify well-trained graduates of doctor of pharmacy programs who wish to pursue fellowship training with the advent of numerous entry-level programs. Some programs have or will have as few as 800 "clinical clerkship" hours required. Secondly, the preceptors of these clerkships frequently are staff pharmacists with considerable dispensing responsibilities who may monitor patients' drug therapy but rarely get involved in the decisionmaking process that initiates such therapy. Most graduates of such programs will require additional clinical experience in the form of residencies to make up for deficiencies (as compared with postbaccalaureate programs) in these entry-level academic programs. Furthermore, very few programs now have courses in study design and biostatistics and even fewer have any kind of research project associated with the program. Other options leading to research competence include traditional doctor of philosophy programs. However, such a path may involve as many as 9-11 years of formal education prior to a potential postdoctoral fellowship. A more time-efficient approach needs to be found. In the final analysis of the relationship of clinical pharmacy and research, it is obvious that a large number of clinical pharmacy educators and practitioners have made a commitment to scientific inquiry. Their contributions to the clinical science literature is already substantial. The profession, and the academic community in particular, are obligated to provide reasonable pathways for future clinical pharmacy researchers to move into this role. This includes formal training programs, the continued cultivation of pharmacy practice or clinical pharmacy departments as credible academic entities, and the provision of settings in which clinical pharmacy educators and researchers can succeed as independent investigators.

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