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A Petition to the Board of Pharmaceutical Specialties Requesting Recognition of Pharmacotherapy as a Specialty
A Petition to the Board of Pharmaceutical Specialties
REQUESTING RECOGNITION OF PHARMACOTHERAPY AS A SPECIALTY THE BOARD OF PHARMACEUTICAL SPECIALTIES The Board of Pharmaceutical Specialties (BPS) was ·created in 1976 by the American Pharmaceutical Association (APhA). It was felt that APhA should institute a mechanism within itself to recognize specialties and to certify specialists. A Task Force on Specialties in Pharmacy conducted an analysis of pharmacy practice and concluded that the profession does lend itself to specialization. The BPS is composed of nine members: six pharmacists and three nonpharmacists. The BPS has developed procedures for the recognition of specialties that are designed to both consider the petitions of pharmacists to have their practice recognized as a specialty as well as to provide for input from the public, other pharmacists, and health professionals who would be directly affected by recognition of the proposed specialty. These procedures and the criteria for recognition as a specialty area of pharmacy practice are outlined within the BPS "Petitioners' Guide for Specialty Recognition." Seven criteria must be addressed by those petitioners requesting recognition as a specialty: • Criterion A: Demand. The area of specialization in the practice of pharmacy shall be one in which there exists a significant and clear health demand to provide the necessary public reason for certification. 44
PREPARED AND SUBMITIED BY The American College of · Clinical Pharmacy COORDINATING COMMITTEE John Rodman, PharmD, Co-Chair Robert M. Elenbaas, PharmD, Co-Chair William E. Evans, PharmD Philip P. Gerbino, PharmD Kim L. Kelly, PharmD William J. Kinnard Jr., PhD William A. Miller, PharmD Paul Parker, ScD
As required by BPS procedures, this executive summary is being published in American Pharmacy to give notice of the receipt of apetition to recognize pharmacotherapy as a specialty.
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• Criterion B: Need. The area of specialization shall be one for which specifically trained practitioners are needed to fulfill the responsibilities of the profession of pharmacy in improving the health and welfare of the public, responsibilities which may not otherwise be effectively fulfilled. • Criterion C: Number. The area . of specialization shall include a reasonable number of individuals who devote most of the time of their practice to the specialty area.
• Criterion D: Specialized Knowledge. The area of specialization shall rest on a specialized knowledge of pharmaceutical sciences, which have their basis in the biological, physical, and behavioral sciences, and not solely on the basis of managerial, procedural, or technical services, nor solely on the basis of the environment in which pharmacy is practiced. • Criterion E: Specialized Functions. The area of specialization shall represent an identifiable and distinct field of practice that calls for special knowledge and skills acquired by education and training and/or experience beyond the basic pharmaceutical education and training. • Criterion F: Education and/or Training. The area of specialization shall be one in which schools of pharmacy and/or other organizations offer recognized education and training programs to those seeking advanced knowledge and skills in the area of specialty practice so that they may perform more competently. • Criterion G: Transmission of Knowledge. The area of specialization shall be one in which there is an adequate educational and scientific base to warrant transmission of knowledge through teaching clinics and a body of professional, scientific, and technical literature immediately related to the specialty. Within each of these criteria the BPS has outlined specific informa-
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tion that must be provided and questions that must be answered. This, then, forms the body of the petition for presentation to the Board of Pharmaceutical Specialties.
PHARMACOTHERAPY AS A PHARMACY SPECIALTY The title "pharmacotherapy specialist" identifies an individual . with advanced, unique training, knowledge, and skills in the selection, monitoring, and optimization of drug therapy for patients. The specialist described in this petition is recognized by leaders in the medical community as an important component of the health care team. The number of specialists. recognized by their peers, other health professionals, and the public is substantial and represents an identifiable, distinct segment within the pharmacy profession. Pharmacy's educational and professional response to the need for improved systems for safe and effective drug therapy is shifting the profession from its productlbusiness orientation to a knowledge/patient orientation, and has firmly established clinical pharmacy as a focal point for pharmacy practice. Dr. Paul Parker has stated that clinical pharmacy "represents the most important concept of practice, education, and professional philosophy in the history of our profession. ,,* In addressing the manpower needs of institutional pharmacy practice, the American Society of Hospital Pharmacists (ASHP) identified four categories of professional personnel: generalists, clinical practitioners, specialty practitioners, and administrators and managers. The society further stated that it expects the distinction between a "generalist" and a "clinical practitioner," at least as related to institutional practice, to diminish over time.
Goyan and Day have observed that "there are at least three levels of practicing pharmacists: those with 'no clinical skills; those with intermediate skills; and those with advanced skills." We believe that the pharmacy generalist of the future will be akin to the intermediate group, while the pharmacotherapy specialist is a selected subset of those with advanced skills. Recognition of the pharmacotherapy specialist is consistent with the view held by many individuals that clinical pharmacy is an integral component of the general practice of pharmacy. However, it is also recognized that clinical pharmacy services are now, and will always be, provided with varying scopes and levels of expertise by different practitioners. These pharmacotherapy specialists are highly sophisticated clinical practitioners and are distinguished from the general practitioner of pharmacy by their education, training, knowledge base, skills, and professional responsibilities and attitudes. A very substantial number of the advanced, specialty practitioners defined in this petition now exist. There is thus a continuum as one moves from the large set of general pharmacy practitioners through the smaller subset of general clinical pharmacy practitioners, concluding with the even smaller subset of pharmacotherapy specia:lists described in this petition. As stated by Parker, "The value of a pharmacist's contribution to drug use is directly related to the quality of the pharmacist's knowledge, judgment, and personal skills." However, basic pharmacy licensure does not assure that practitioners are qualified to perform specialized pharmacy functions. Support exists within the profession for "differentiation and specialization in pharmacy practice, and ... [for1 credentialing individuals for specialty practice." It is the pharmacy profession's obligation to provide such quality assurance for those professional obligations that clearly exceed
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those evaluated by the licensing process. As such, this petition is being prepared to meet the quality assurance needs of the profession. It is herein proposed to designate pharmacotherapy as a specialty area of pharmacy practice.
DEFINITION OF PHARMACOTHERAPY The Board of Pharmaceutical Specialties has defined pharmacy practice as "that personal health service that assures safety and efficacy in the procuring, storing, prescribing, compounding, dispensing, delivering, administering and use of drugs and related articles." Pharmacotherapy is herein defined as that area of pharmacy practice whose responsibility is to assure the safe, appropriate, and economical use of drugs in patients through the application of specialized skills, knowledge, and functions in patient care. It requires specialized education and/or structured training and use of judgment in the collection and interpretation of data, patient specific involvement, and direct interprofessional interaction. A pharmacotherapy specialist is a pharnuicy practitioner who devotes the majority of hislher professional practice to the provision of specialized pharmacy services in patient care which includes as a core the defined responsibility to: • Design, recommend, implement, monitor, and alter cost-effective, patient-specific pharmacotherapeutic plans; • Retrieve, evaluate, and apply the drug literature as a means of providing patient-specific drug information to health professionals and patients; • Interpret and apply pharmacokinetic drug data to the design of patient-specific drug dosage regimens; • Educate health professionals, patients, and/or the public in applied pharmacotherapeutics. The ability to effectively provide these specialized functions at the 45
requisite level of sophistication is based on the application of specialized knowledge and skills gained through advanced education and/or structured training. Key among these skills is the abililty to integrate knowledge of the biologic, biomedical, and pharmaceutical sciences with clinical information to make decisions regarding rational drug therapy.
CRITERION A: Demand Statements on Demand BPS guidelines request written statements supporting the demand for specialized services from health professionals other than pharmacists and from pharmacists not practicing in the proposed specialty. The statements provided are notable for their endorsement of the demand for pharmacists specialized as pharmacotherapy experts, and are representative of the widespread support and acceptance that specialists have achieved across the . nation. The following excerpts are provided as a means to concisely relay the level of support documented within the petition: . There is a true need for a professional knowledgeable and skilled in the application ofdrug information to the patient care setting. This professional's ability to guide and counsel the patient, physician, nurse, and other health care practitioners in appropriate drug use not only advances the education of these individuals but improves patient care as well. I believe that the ever increasing complexity of medical care, the importance ofdrug therapy in disease prevention and treatment, and the rapidly expanding knowledge base needed to make optimal drug therapy decisions demand the widespread integration of the [specialist] into the decision making processes of patient care.
E. Grey Dimond, MD Distinguished Professor of Medicine Provost Emeritus University of Missouri-Kansas City 46
There is a need for a substantial number of . .. pharmacists as defined here. These individuals will become the drug therapy specialist in most hospitals and clinics, serving as an essential resource to other health professionals.
Gerhard Levy, PharmD Distinguished Professor State University of New York at Buffalo
Patient Demand Reimbursement for the services of specialists by third party payers demonstrates a public willingness to purchase those services (specialized functions) described in this petition. Prior to indicating approval of practitioner reimbursement for specialized pharmacy services (whether on an individual or institutional basis), the third party payer typically conducts an extensive analysis of data presented to reasonably assure that: (1) the services are indeed cost-effective, and (2) the services are unique from the general practice of pharmacy reimbursed through existing means.
pharmacy services and the need to credential the specialty practitioner through distribution of its "Guidelines for Clinical Pharmacy Specialists." These guidelines describe the requisite education and training, professional responsibilities, functions, and clinical privileges of the v.A. Clinical Pharmacy Specialist, and are consistent with the role of the pharmacotherapy specialist described in this petition.
Health Professions' Demand Stimmel and Adamcik evaluated the attitudes of 60 physicians toward the activities of 36 pharmacy practitioners whose major professional functions included those of the pharmacotherapy specialist. The strength of physician support for these activities varied directly with the amount of prior contact with specialized pharmacy practitioners. Seventy-nine percent of physicians felt a need for certification of the specialty knowledge and skills of the practitioner beyond that provided by basic pharmacy licensure.
Institutional Demand Government Demand Government demand for both specialized services and certified specialists can be found in the actions of state legislatures and Veterans Administration. By California law, certain pharmacists practicing in licensed health care facilities may order or perform drug therapy-related physical assessments, order drug therapy-related laboratory tests, administer drugs and biologicals by injection, and initiate or adjust the drug regimen of a patient. This prescribing authority is restricted to licensed health care facilities (hospitals and skilled nursing facilities); requires written policies, procedures, or protocols developed with physicians; and requires the facility to determine the competence of the pharmacist. The Veterans Administration has affirmed its demand for specialized
Institutional demand for specialized services has been documented through the tabulation of advertised opportunities for specialized practitioners in several selected pharmacy journals. It is apparent that a significant number of opportunities for specialized practitioners exist and that this is a consistent, increasing market. The prerequisite criteria for these professional positions generally require a doctor of pharmacy or clinically oriented master's degree with a residency or equivalent experience. These positions are identified within the job market as unique with respect to responsibilities. This growing de facto categorization and demand for pharmacists with special education, training, and skills provides a strong argument for formalization of criteria to identify practitioners with uniformly high credentials.
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CRITERION B: Need Public Health and Patient Care Needs There are five demonstrable health care needs that the pharmacotherapy specialist is uniquely qualified to address or that cannot be met by other health professionals because they do not (and foreseeably will not) exist in adequately qualified numbers: 1. There exists a need for the safer, more efficacious, and more economical use ofdrugs in health care. The body of drug knowledge and the complexities of its integration and application to successful patient care will continue to grow as technologies advance. It has been estimated that adverse drug reactions cost the U.S. economy as much as $5 billion per year. Drug use expenditures currently account for about 7.5% of US. health care costs. The need for safer, more efficacious, and more economical drug therapy can best be met by the formal identification and widespread incorporation into the drug use process of an expert in pharmacotherapeutics. This specialist offers practical, rational drug therapy consultations and monitors drug therapy so that continuous emphasis is placed on the safe, effective, and economical use of drugs. 2. There exists a need for greater public and ·health professional education about drugs and drug therapy. This education must have at least two focal points: (a) a thrust to change public and professional attitudes and behaviors regarding the total drug use process; and (b) the continuing education of health professionals and the public regarding optimal drug use. The educational role is much more global than that of an educator within a . classroom or clerkship environment, or the specialist practicing in an academic health science center. This role is fulfilled most often as a consultant to physicians, patients, and other health professionals. 3. There exists a need for a highly sophisticated drug information
resource. This resource should have as its primary goal to support the physician's prescribing decisions. The distinguishing characteristic of drug information provided by the specialist is his/her ability to interpret the primary literature, evaluate its applicability to a given patient care situation, and apply it in the synthesis of a solution to a patient-specific drug therapy problem. 4. There exists a need for the advanced application ofpharmacokinetic principles to patient care as a means to maximize the desired outcome ofdrug therapy. This need can best be met by a pharmacotherapeutics expert who applies the principles of pharmacokinetics to individualize the dosage regimen of certain drugs in selected ambulatory and institutional patients. The pharmacotherapy specialist can integrate the multiple influences of changing renal function, hepatic dysfunction, varying organ blood flow, and altered drug protein binding to design a patient-specific drug dosage regimen in complex patients with multi-organ system failure. 5. There exists a need for continued research into the drug use process. This research should have as its general goals the improvement of the safety, efficacy, and economy of drug therapy. Hatoum et al. have prepared an extensive review of pharmacy literature published between 1974 and 1984 that documented the impact of pharmacy services in acute care facilities on the cost and quality of patient care, .and on the attitudes of patients and other health care professionals to these services. When this extensive literature is taken as a whole it provides substantial evidence of the value, justification, beneficial impact, and cost-effectiveness of sophisticated clinical pharmacy services as provided by the specialist in pharmacotherapy. A total of 73 published reports describing the effectiveness of specialists in meeting the public health needs identified above have been summarized
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and keyed to those needs that each function addresses. Perhaps no one function has been more closely associated with this specialist than the direct, sophisticated application of pharmacokinetic principles to patient care. Because this tool in improving drug therapy can be isolated as an activity unique to the specialist in most patient care settings, it allows a less complicated assessment ofits impact on the patient care process and outcome. For example, Bootman et al. have reported the results of studies conducted to determine the impact ofpharmacokinetic-based consultations provided by specialists on the care and outcome of burn patients with gram-negative septicemia. . They found that dosage regimens designed by specialists produced a significant increase in patient survival (63.6% vs 33.3%) and were associated with a benefit to cost ratio of 8.7:1. Several studies have demonstrated that the number of blood levels ordered can be reduced by approximately 40%, effecting a significant reduction in costs.
CRITERION C: Number and Time Whether an individual pharmacy practitioner should be considered a "specialist" or a "generalist" is best based on hislher actual ability to provide specialized services at the level of sophistication and competence outlined in the petition, and not necessarily the actual amount of time spent performing the functions.
Estimate of Practitioners in the Proposed Specialty Data from a survey of ASHP Special Interest Group (SIG) membership has been published, and allow some definition ofthe practice activities of these ASHP individuals. Ofthe more than 20,000 ASHP members at the time of the survey (1984), there were 2,143 individuals enrolled in eight SIGs to which pharmacotherapy specialists are most likely to belong: Adult Clinical, Clinical Pharmacokinetics, 47
Ambulatory Care, Drug and Poison Information, Geriatric, Oncology, Pediatric, and Psychopharmacy. It was possible to identify 455 practitioners who had job titles which would likely identify them as potential specialists. Further data comes from the membership roster of the American College of Clinical Pharmacy. ACCP includes approximately 1,000 individuals who are admitted to membership if their professional practice activities represent that of the pharmacotherapy specialist. Three other national pharmacy organizations also have memberships comprised at least partly of individuals whose professional practice is typified by that ofpharmacotherapy specialists: the American Pharmaceutical Association Clinical Pharmacy Section; the American Association of Colleges of Pharmacy SectIOn of Teachers of Pharmacy Practice; and the American Society of Consultant Pharmacists. Membership rosters of these groups were compared, and duplicate names removed to produce a combined list of approximately 2,400 individuals.
Distribution of Specialty Practice The ASHP SIG survey of 1984 provides data on the proportion of time devoted to various practice activities. Evaluating responses from f'nonadministrative SIG" pharmacists (n = 1,181), 60% (711) reported some participation in patient care activities with the average time spent being 19.5%. However, only 161 reported greater than 50% of their time spent in patient care activities. A survey of ACCP membership done in 1983 (211 respondents; 58% of 1983 membership) indicated the amount of time spent in various activities which closely parallel those listed in the Specialized Functions portion of this document. The majority of the respondents performed the activities of the pharmacotherapy specialist the majority of the time. A subsequent survey of ACCP's membership 48
completed in early 1985 showed that 219 of its then approximately 500 members performed clinical activities more than 75% of the time, and 267 performed these activities over 50% of the time. In summary, from surveys of two major pharmacy organizations it appears a minimum of 400 individuals exist whose "full-time" job is composed of the activities of the pharmacotherapy specialist. It is estimated that an additional 750 individuals from ASHP and ACCP alone perform the activities of the specialist ''part time," averaging about 20% of their practice. Given the continued growth of the specialtysince these data were collected and that specialists belong to organizations other than ASHP and ACCp, it is reasonable to estimate that there are at least 500-1,000 practitioners who could be considered potential full-time pharmacotherapy specialists.
CRITERION D: Specialized Knowledge The concept of pharmacy differentiation and specialization is primarily based upon differences in know ledge and skills among practitioners. Pharmacotherapy specialists have greater scope and depth in their knowledge base of the science of drug therapy, and greater proficiency in the application of that knowledge to patient care than do pharmacy generalists.
Specialized Knowledge Required of Pharmacotherapy Specialists; Basis in the Biological. Physical. and Behavioral Sciences The differentiated knowledge required of the pharmacotherapy specialist is Grawn from the pharmaceutical, biomedical, and behavioral sciences. An important distinguishing characteristic in the knowledge base and skills of specialists is their ability to apply and integrate knowledge of the pharmaceutical and biomedical sciences with the clinical state ofthe patient to optimize care. These skills are
acquired through extensive and intensive supervised training and! or experience. The principal areas in which specialists possess greater depth and scope in their knowledge base than does the pharmacy generalist include: • Pharmaceutical sciences Pharmacology Toxicology Biopharmaceutics Pharmacokinetics and pharmacodynamics • Clinical sciences Pathophysiology Pharmacotherapeutics/clinical pharmacology Drug literature evaluation Clinical pharmacokinetics Physical assessment Clinical laboratory medicine • Behavioral and administrative sciences Psychology and sociology of illness Health care administration Interpersonal communications
CRITERION E: Specialized Functions The functions of pharmacother.a py specialists, in terms of their level of sophistication and knowledge and skill base needed for application, are unique to the profession. It is in the performance of specialized funCtions that specialized knowledge, education, and training culminate to provide the final product: a pharmacy practice specialty with responsibility to assure the safe, appropriate, and economical use of drugs in patients.
Specialized Functions That Differentiate the Pharmacotherapy Specialist from the General Pharmacy Practitioner Six major professional responsibilities and their corresponding functions have been identified, the first four of which are core to the practice of pharmacotherapy: 1. Design, recommend, imple-
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ment, monitor, and alter cost-effective, [Xltient-specific pharmacotherapeutic plans. a. Provide a written and/or oral pharmacotherapeutic consultation which includes a drug therapy regimen that is appropriate in drug selection, dose, dosage schedule and route of administration. h. Generate an expanded patient data base for therapeutic decisions by conducting patient medication histories and, if appropriate, performing selected procedures of physical assessment. c. Select and recommend appropriate subjective and objective monitoring parameters to assess therapeutic and toxic effects of the drugs selected. d. Identify any drugs selected with significant potential for drugdrug, drug-disease, and/or drug-laboratory interactions and notify the prescriber. e. Evaluate and provide assistance in and/or initiate adjustments to drug therapy, given potential therapeutic and adverse drug effects. Develop and recommend appropriate alternative treatment plans should the initially selected regimen fail to produce the desired effect or prove toxic. f. Identify possible drug-induced abnormalities and develop a differential diagnosis to support or negate a drug-induced etiology for disease. 2. Retrieve, evaluate, and apply the drug literature as a means of providing patient-specific drug information to health professionals and [Xltients. a. Serve as an authoritative information source to health professionals. Provide critical analysis of the drug literature applied to patient-specific drug therapy questions. b. Serve as a primary drug information resource for various committees, eg, Pharmacy and Therapeutics Committee, Drug Utilization Committee, Institutional Review Board, etc. c. Provide extemporaneous drug information to professional colleagues and influence decisionmaking processes with literature
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documentation of rational pharmacotherapeutic concepts. d. Author drug information in the form of drug monographs, consultations, and newsletters. Provide drug information in a written form for individual patient care (patient consultations), institutional use (drug monographs), and education of other health professionals (institutional newsletters and articles in professional journals). 3. Interpret and apply pharmacokinetic drug data to the design of patient-specific dosage regimens. a. Design, recommend, and/or prescribe an appropriate dosage regimen for a particular drug, based on the drug's pharmacokinetics, therapeutic index, and patientspecific parameters. -b. -Interpret drug concentrations, correlate these data to patient response and/or toxicity, and utilize the information to design, recommend, and/or prescribe a patientspecific dosage regimen. c. Utilize appropriate pharmacokinetic data to determine, recommend, and/or prescribe drug dosing regimens in patients with renal, hepatic, or other organ disorders. d. Determine, recommend, and/or order the appropriate use of drug assays, including body fluid to be sampled, time of sample collection, and cost-benefit analysis of drug assays. e. Interface with clinicallaboratory personnel in determining analytical procedures for drug concentration determination that produce the most clinically useful results. 4. Educate health professionals, patients, and/or the public in applied pharmacotherapeutics. a. Assume responsibility for the education of all members of the health care team involved in the area of applied pharmacotherapeutics. Responsibilities extend to both students and licensed practitioners, and can occur in all health care settings. h. Participate in continuing education programs concerning pharmacotherapeutics. c. Teach patients about disease
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states and medications through formal patient educational programs and discharge counseling. d. Author original articles that serve to educate a national and international audience of health professionals. 5. Conduct clinical investigations and pursue scholarly activities. a. Conceive a research question, organize and implement a research plan, and evaluate and publish the data in a scholarly journal. h. When unique therapeutic modalities are used in patients, assure that studies are done to evaluate therapy and that the results are published in a clinically oriented journal. c. Participate in collaborative research with other health professionals and/or basic scientists, contributing a unique aspect of applied pharmaceutical sciences to the research. d. Contribute to the practice of pharmacotherapy, clinical pharmacy, and medicine by publishing clinically relevant, original research data and interpretation. 6. Develop treatment protocols and prescribing under such protocols. a. Assist in the development of treatment protocols to be used in patients with specific diagnoses. b. Prescribe drug therapy and other laboratory tests under guidelines of treatment protocols.
Special Skills Required • Effective communication, both verbal and written, with patients, peers, and other professionals about all aspects of drug therapy. • Efficient retrieval of drug literature by use of appropriate indices and computerized techniques of literature retrieval. • Evaluation of drug literature to determine appropriateness of authors' conclusions, including assessment of research methodology, biostatistics, and data manipulation. • Proficiency and understanding in utilizing programmable calculators and computers. 49
• Technical capabilities to perform adequately in both formal and informal education environments. • Effective written communication of treatment or research protocols, application of biostatistics, and familiarity with legal and ethical issues concerning clinical research. • Patient physical assessment skills that enable the specialist to function more independently and contribute to the patient data base. • Integration of baSIC pharmaceutical sciences and clinical data with the application of both used to formulate rational therapeutic plans.
CRITERION F: Education and Training The doctor of pharmacy (PharmD) degree program is now the primary academic curriculum that provides the basic education and training for the pharmacotherapy specialist, and provides "the student with an enhanced core of professional knowledge and skills through enrichment of the biomedical, pharmaceutical, and clinical sciences, as well as through practice experiences. " In addition to a doctor of pharmacy degree, a postgraduate residency is required to provide the further training needed to achieve minimal competency in the specialty. While the PharmD/residency sequence provides the educational framework for specialists of the fut ure, pharmacists of today have acquired the differentiated knowledge and skills required for specialized practice by a variety of methods.
Professional Degree Programs The national utilization of this specialist is clearly supported by the distribution of education and training programs throughout the United States. As of the fall of 1985, there were 36 schools of pharmacy offering the post-baccalaureate doctor of pharmacy degree program, 32 of which were accredited by the American Council on Pharmaceutical Education. The percentage of 50
PharmD degrees to the total of professional degrees was 2.9% in 1960 and 11.9% in 1984.
Postgraduate Training Programs The American Society of Hospital Pharmacists currently accredits pharmacy residency programs in three different categories: general hospital pharmacy, clinical pharmacy practice, and specialized pharmacy practice. Pharmacotherapy specialists would most typically complete a postgraduate residency from one 'o f the latter two categories. A listing of applicable postgraduate residency programs was developed by merging the "1987 ASHP Directory of Accredited Pharmacy Residency Programs" and the "1988 Directory of Residencies and Fellowships Offered by Members of the American College of Clinical Pharmacy." Doing so yielded 90 residency and 93 fellowship training programs.
CRITERION G: Transmission of Knowledge As the number of pharmacists trained as clinical practitioners has increased over the years, the percentage becoming independent investigators has accumulated to a substantial total. A survey of colleges of pharmacy found that 57% of clinical faculty were on tenure tracks. An evaluation of contributions to the journal Clinical Pharmacology & Therapeutics over a la-year period reveals a threefold increase by pharmacist-authors with the greatest proportion of this growth due to individuals with the PharmD degree. The number of publications by a representative group of 50 clinical practitioners increased from 55 to 144 per year from 1978 to 1983. Pharmacokinetic research articles comprised the largest category of publications (33.9%), followed by review articles (19.6%), original clinical drug trials (17.2%), and pharmacy practice articles (13.0%). Journals dealing specifically with the proposed specialty include:
Clinical Pharmacy; Drug Intelligence and Clinical Pharmacy; Pharmacotherapy; Clinical Pharmacology & Therapeutics; Journal of Clinical Pharmacology; and Therapeutic Drug Monitoring. Tenjoumals were reviewed for a single year and all articles of original research, authored or coauthored by a PharmD or an individual known to be active in pharmacotherapy research, were identified. Seventy-eight articles were identified. A breakdown of topics represented reveals that 54% of the articles dealt with pharmacokinetics and 26% would be classified as pharmacodynamic studies. The most common therapeutic categories were the cardiovascular and antimicrobial areas (21 %), but also incl uded were cancer, pulmonary, renal, psychopharmacy, and pediatrics. The publication activities of pharmacists who would likely meet the proposed definition of a pharmacotherapy specialist has been reviewed for the interval 1984-1986. These pharmacists very successfully compete for publication space in the Journal of Clinical Pharmacology and Clinical Pharmacology & Therapeutics with researchers from other disciplines, and authored about 22% and 15% of the articles in these two journals, respectively. Additionally, these pharmacists authored or co-authored approximately 25% of the abstracts presented at the 19841986 annual meetings of the American Society of Clinical Pharmacology and Therapeutics. ®
Comments Invited Members are encouraged to send their comments regarding this petition or the petition for nutritional support pharmacy practice special recognition, published in the March issue (p. 80) to: Clinical' Affairs, American Pharmaceutical Association, 2215 Constitution Avenue, Nw, Washington, DC 20037.
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FROM THE
LITERATURE Brief Abstracts from the MedicalITherapeutics and the Pharmaceutical' Management Literature' of Potential Interest to Pharmacists Editors: Tim R. Covrngton (Therapeutics) Mickey Smith (Economic, Social, and Administrative Sciences) Tim R. Covington, PharmD, is professor and chairman ofthe Pharmacy Practice Department, Samford University School ofP harmacy, Birmingham, AL. Mickey Smith, PhD, is professor of health care administration at the University of Mississippi School of Pharmacy, University, MI, and is editor of The ' Journal of Pharmaceutical Marketing and Management.
EcONOMIC, SOCIAL, AND ADMINISTRATIVE SCIENCES DRUG INFORMATION SEARCHING BY THE ELDERLY This study was sponsored and conducted by the FDA to compare the types of prescription drug information sought by younger and elderly patients. The elderly were more likely to consult mass media sources and less likely to receive counseling from health professionals, according to responses in this telephone survey. Using various statistical techniques, the researchers were able to identify som~ specific factors in differences between the two groups. Older patients felt that trust in the physician lessened the need for information. Younger patients were more likely to see the prescription counter as a barrier to communication. Source: J Health Care Marketing, 7, 5 (1987).
SOCIAL AND ECONOMIC BENEFITS OF DISULFIRAM This review of controlled trials of the use of disulfiram in middle-aged outpatient alcoholic men concluded that: • Disulfiram is unlikely to increase the probability that a middle-aged alcoholic who accepts treatment will abstain for 1 year; the best estimate is that the probability of abstinence , is decreased about 4%. • The drug is expected to decrease the number of drinking days per year by 30. It was suggested that improvements in the health and welfare of alcoholic patients may be realized by using disulfiram, because the number of days that an individual patient is "dry" may be increased. Economic benefits may also accrue from increased productivity. Source: Med Care, 25, 566 (1987 Supplement).
AMBULATORY CARE CENTERS IN THE MARKETPLACE Approximately 400 managers of ambulatory care centers ~cross the United States responded to a mail survey concernIng the pharmaceutical services offered. About one in four of the total number of respondents dispensed prescription drugs as an ancillary service but 95% reported that they did not employ a pharmacist. Other pharmacy-related services pro:'ided by ACCs were blood pressure checks, blood glucose checkIng, and cholesterol screening. The ambulatory care center is
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a present and potential competitor of pharmacists, physicians, and other health care providers. Source: J Health Care Marketing, 7, 27 (1987).
DEMAND FOR PHARMACY CONSULTING SERVICES It seems clear that some, perhaps most, pharmacy customers want more health information, but are they willing to pay for it? This study describes a method for estimating the demand, expressed as a willingness to pay, for pharmacist-provided drug information. Interviews were conducted with nearly 200 patrons. Significant gaps were found in the amount of information pharmacists provided. Data showed that more than 95% of those responding would be willing to pay something for counseling services and that three-fourths would pay as much as $2.50. The authors do not project the cost of such services nor project profitability based on their data. Source: J Heq,lth Care Marketing, 7, 33 (1987).
COST·EFFECTIVENESS COMPARISON OF BUPRENORPHINE/MEPERIDINE Cost-benefit and cost-effectiveness studies are increasingly taking their place with clinical studies in the overall evaluation of both new and old drugs. This study is somewhat different in that cost differences arise, in part, because of differing needs for control procedures. This retrospective study evaluated the cost impact of buprenorphine HCI, a Schedule V injectable analgesic, versus the Schedule II drugs morphine and meperidine HCI in a 694-bed community teaching hospital. The investigators found that using buprenorphine in place of morphine and meperidine for moderate to severe postoperative pain relief was highly cost-effective and resulted in a total analgesic cost avoidance of up to 67% per patient per day. Source: Hosp Formulary, 23, 57 (1988).
P & T COMMITIEE DECISIONS This study identified outcomes related to hospital formulary decision making. The two most important outcomes identified were the effects of a potential drug addition to the formulary on the quality of drug treatments available in the hospital and on hospital costs. Information on the therapeutic advantage of the potential drug addition, the relative adverse effect profile, and cost information were viewed as especially important. Promotional literature was not regarded as important. Source: Hosp Formulary, 23, 174 (1988). 51
WHO ARE THE PHARMACY SHOPPERS? In recent years the pharmacy industry has ,become increasingly competitive largely because of new discount-oriented competitors. To maintain or increase their competitiveness in this market, pharmacies must respond by better understanding the needs of the customer. Based o~ a national survey of pharmacy shoppers, this article assists the industry by providing a comprehensive description of pharmacy shoppers and their experience. Included are a demographic profile of the shopper, consumer evaluation of their pharmacy shopping experience, and a summary of how these shoppers spend their money. Examples of how this information can be used by management are also included. Source: J Pharm Marketing Management, 2, 11 (1987).
, hrombinemic patients had clinically significant hemorrh.age, five required transfusions, and two died. When phytonadIOne was administered, prothrombin times rapidly returned to normal. ' Hypoprothrombinemia appears to be a relatively common complication of cefoperazone therapy although absolute cause and effect can always be questioned in a retrospective assessment. The authors suggest that, unless contraindicated, routIne phytonadione prophylaxis should be used in patients receiving cefoperazone. Cost-effectiveness of such prophylactic therapy far outweighs the cost of managing hemorrhagic complications. Source: So Med J , 80, 1360 (1987).
PHENYLPROPANOLAMINE· INDUCED INTRACRANIAL HEMORRHAGE
THERAPEUTICS ESTROGEN/PROGESTIN THERAPY IN MENOPAUSE The value of cyclic estrogen/progestin replacement therapy in postmenopausal women to relieve complaints such as atrophic vaginitis and vasomotor symptoms and to slow the progression of osteoporosis is well established. Despite these benefits, many women are reluctant to use cyclic replacement therapy because of vaginal bleeding, recurrence of vasomotor symptoms during the week off estrogen, and progestin-related side effects (eg, breast tenderness, abdominal bloating, headache, depression). Because of these complaints, continuous estrogen/progestin therapy was compared with cyclic estrogen/progestin therapy in 26 menopausal women. Group I (N = 16) received continuous conjugated estrogen (0.625 mg/ day) and medroxyprogesterone acetate (2.5 mg/day). Group II (N = 11) received conjugated estrogen (0.625 mg/day) during days 1 through 25 of each cycle and medroxyprogesterone acetate (10 mg/day) during days 16 to 25. At the end of the 9-month treatment period no significant alteration of blood pressure, serum cholesterol, or HDL, LDL, or triglyceride levels occurred in either group. Endometrial biopsy specimens revealed no endometrial proliferation in group I and one proliferative endometrium in group II. Vaginal bleeding was virtually-eliminated in group I whereas 80% of patients in group II continued to have cyclic menses. Short-term continuous estrogen/progestin replacement therapy appears to be a satisfactory method of reducing menopausal symptoms with the add~d benefit of eliminating vaginal bleeding. The apparent lack of side effects and the protective effect on the endometrium increase the attractiveness of this regimen. If long-term studies support the shortterm findings, continuous estrogen/progestin replacement should receive wide acceptance. Source: Am J Obstet Gynecol, 157, 1449 (1987).
CEFOPERAZONE·ASSOCIATED HYPOPROTHROMBINEMIA Cefoperazone, a beta-lactam antibiotic with a methylthiotetrazole side chain, has been associated with hypoprothrombinemic hemorrhage. To determine the incidence of hypoprothrombinemic complications, this study retrospectively analyzed the records of 80 patients who had received cefoperazone for more than 72 hours. Of the 80 subjects evaluated, nine received phytonadione (vitamin Kll ) prophylaxis and there was no evidence of hemorrhage. Prothrombin times were measured in another 32 subjects, of whom 14 were hypoprothrombinemic. Prothrombin times ranged from 14.8 to 97.3 seconds at a mean of 6.2 days after be~nning cefoperazone therapy. Seven of the 14 hypoprot-
The over-the-counter drug Entex contains 5 mg of phenylephrine, 45 mg of phenylpropanolamine (PPA), and 200 mg of guaifenesin per capsule. Approximately 1 hour after ingesting 13 Entex 'capsules, a 27-year-old male patient was seen in an emergency room complaining of severe right temporal parietal headache. He was somnolent and diaphoretic. Blood pressure was 210/110 . mm Hg (supine); pulse rate 62 . beats per minute. During treatment with ipecac syrup and actIvated charcoal, a left-sided weakness of the face evolved into a left hemiparesis. The patient was then admitted to the hospital. Upon admission a CT scan of the brain revealed a right lenticular hemorrhage. A four-vessel cerebral angiogram on the sixth day confirmed the presence of cerebral vasculitis. Dex amethasone phosphate was prescribed for edema shortly after admission. On discharge to a rehabilitation facility, there was a residual mild left hemiparesis, worse in the upper extremity and distally. PPA is available in many OTC decongestant drugs and "diet aids." Physicians and pharmacists should be aware of PPA's adverse effect profile and be cautious in recommending this potentially toxic drug for suicidal patients or those prone to abuse drugs. Source: So Med J, 80, 1584 (1987).
CARDIOVASCULAR EFFECTS OF VERAPAMIL IN ESSENTIAL HYPERTENSION Calcium channel blockers have produced discrepant findings as antihypertensives. The variable responses may be attributed to duration of treatment or different mechanisms of action of calcium channel blockers. As data on the long-term effects of verapamil on norepinephrine-dependent vasoconstriction and body sodium metabolism are lacking, this study evaluated the long-term (8-week) effect of verapamil (348 ± 68 [SD] mg/day) on blood pressure and other factors in 15 patients with essential hypertension. Supine arterial blood pressure decreased from 153/103 ± 19/12 mm Hg to 140/95 ± mm Hg and was unrelated to age. Upright blood pressure did not decrease significantly. Hearl rate, body weight, exchangeable body sodium, and plasma and blood volume were not significantly altered by verapamil. Verapamil did not modify plasma levels of sodium, potassium, calcium, renin, creatinine, uric acid, or glucose. Serum cholesterol and triglycerides were not modified. The antihypertensive effect of verapamil was associated with a decreased cardiovascular pressor responsive to norepinephrine without changes in endogenous nonadrenergic activity. Verapamil was well tolerated; no patient complained of side effects. Verapamil appears to have minimal metabolic adverse effect potential. This, combined with its blood pressure lowering activity, enlarges the therapeutic possibilities for managing hypertension. Source: Clin Pharmacol Ther, 42,485 (1987).
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REQUESTING RECOGNITION OF PHARMACOTHERAPY AS A SPECIALTY THE BOARD OF PHARMACEUTICAL SPECIALTIES The Board of Pharmaceutical Specialties (BPS) was ·created in 1976 by the American Pharmaceutical Association (APhA). It was felt that APhA should institute a mechanism within itself to recognize specialties and to certify specialists. A Task Force on Specialties in Pharmacy conducted an analysis of pharmacy practice and concluded that the profession does lend itself to specialization. The BPS is composed of nine members: six pharmacists and three nonpharmacists. The BPS has developed procedures for the recognition of specialties that are designed to both consider the petitions of pharmacists to have their practice recognized as a specialty as well as to provide for input from the public, other pharmacists, and health professionals who would be directly affected by recognition of the proposed specialty. These procedures and the criteria for recognition as a specialty area of pharmacy practice are outlined within the BPS "Petitioners' Guide for Specialty Recognition." Seven criteria must be addressed by those petitioners requesting recognition as a specialty: • Criterion A: Demand. The area of specialization in the practice of pharmacy shall be one in which there exists a significant and clear health demand to provide the necessary public reason for certification. 44
PREPARED AND SUBMITIED BY The American College of · Clinical Pharmacy COORDINATING COMMITTEE John Rodman, PharmD, Co-Chair Robert M. Elenbaas, PharmD, Co-Chair William E. Evans, PharmD Philip P. Gerbino, PharmD Kim L. Kelly, PharmD William J. Kinnard Jr., PhD William A. Miller, PharmD Paul Parker, ScD
As required by BPS procedures, this executive summary is being published in American Pharmacy to give notice of the receipt of apetition to recognize pharmacotherapy as a specialty.
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• Criterion B: Need. The area of specialization shall be one for which specifically trained practitioners are needed to fulfill the responsibilities of the profession of pharmacy in improving the health and welfare of the public, responsibilities which may not otherwise be effectively fulfilled. • Criterion C: Number. The area . of specialization shall include a reasonable number of individuals who devote most of the time of their practice to the specialty area.
• Criterion D: Specialized Knowledge. The area of specialization shall rest on a specialized knowledge of pharmaceutical sciences, which have their basis in the biological, physical, and behavioral sciences, and not solely on the basis of managerial, procedural, or technical services, nor solely on the basis of the environment in which pharmacy is practiced. • Criterion E: Specialized Functions. The area of specialization shall represent an identifiable and distinct field of practice that calls for special knowledge and skills acquired by education and training and/or experience beyond the basic pharmaceutical education and training. • Criterion F: Education and/or Training. The area of specialization shall be one in which schools of pharmacy and/or other organizations offer recognized education and training programs to those seeking advanced knowledge and skills in the area of specialty practice so that they may perform more competently. • Criterion G: Transmission of Knowledge. The area of specialization shall be one in which there is an adequate educational and scientific base to warrant transmission of knowledge through teaching clinics and a body of professional, scientific, and technical literature immediately related to the specialty. Within each of these criteria the BPS has outlined specific informa-
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tion that must be provided and questions that must be answered. This, then, forms the body of the petition for presentation to the Board of Pharmaceutical Specialties.
PHARMACOTHERAPY AS A PHARMACY SPECIALTY The title "pharmacotherapy specialist" identifies an individual . with advanced, unique training, knowledge, and skills in the selection, monitoring, and optimization of drug therapy for patients. The specialist described in this petition is recognized by leaders in the medical community as an important component of the health care team. The number of specialists. recognized by their peers, other health professionals, and the public is substantial and represents an identifiable, distinct segment within the pharmacy profession. Pharmacy's educational and professional response to the need for improved systems for safe and effective drug therapy is shifting the profession from its productlbusiness orientation to a knowledge/patient orientation, and has firmly established clinical pharmacy as a focal point for pharmacy practice. Dr. Paul Parker has stated that clinical pharmacy "represents the most important concept of practice, education, and professional philosophy in the history of our profession. ,,* In addressing the manpower needs of institutional pharmacy practice, the American Society of Hospital Pharmacists (ASHP) identified four categories of professional personnel: generalists, clinical practitioners, specialty practitioners, and administrators and managers. The society further stated that it expects the distinction between a "generalist" and a "clinical practitioner," at least as related to institutional practice, to diminish over time.
Goyan and Day have observed that "there are at least three levels of practicing pharmacists: those with 'no clinical skills; those with intermediate skills; and those with advanced skills." We believe that the pharmacy generalist of the future will be akin to the intermediate group, while the pharmacotherapy specialist is a selected subset of those with advanced skills. Recognition of the pharmacotherapy specialist is consistent with the view held by many individuals that clinical pharmacy is an integral component of the general practice of pharmacy. However, it is also recognized that clinical pharmacy services are now, and will always be, provided with varying scopes and levels of expertise by different practitioners. These pharmacotherapy specialists are highly sophisticated clinical practitioners and are distinguished from the general practitioner of pharmacy by their education, training, knowledge base, skills, and professional responsibilities and attitudes. A very substantial number of the advanced, specialty practitioners defined in this petition now exist. There is thus a continuum as one moves from the large set of general pharmacy practitioners through the smaller subset of general clinical pharmacy practitioners, concluding with the even smaller subset of pharmacotherapy specia:lists described in this petition. As stated by Parker, "The value of a pharmacist's contribution to drug use is directly related to the quality of the pharmacist's knowledge, judgment, and personal skills." However, basic pharmacy licensure does not assure that practitioners are qualified to perform specialized pharmacy functions. Support exists within the profession for "differentiation and specialization in pharmacy practice, and ... [for1 credentialing individuals for specialty practice." It is the pharmacy profession's obligation to provide such quality assurance for those professional obligations that clearly exceed
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those evaluated by the licensing process. As such, this petition is being prepared to meet the quality assurance needs of the profession. It is herein proposed to designate pharmacotherapy as a specialty area of pharmacy practice.
DEFINITION OF PHARMACOTHERAPY The Board of Pharmaceutical Specialties has defined pharmacy practice as "that personal health service that assures safety and efficacy in the procuring, storing, prescribing, compounding, dispensing, delivering, administering and use of drugs and related articles." Pharmacotherapy is herein defined as that area of pharmacy practice whose responsibility is to assure the safe, appropriate, and economical use of drugs in patients through the application of specialized skills, knowledge, and functions in patient care. It requires specialized education and/or structured training and use of judgment in the collection and interpretation of data, patient specific involvement, and direct interprofessional interaction. A pharmacotherapy specialist is a pharnuicy practitioner who devotes the majority of hislher professional practice to the provision of specialized pharmacy services in patient care which includes as a core the defined responsibility to: • Design, recommend, implement, monitor, and alter cost-effective, patient-specific pharmacotherapeutic plans; • Retrieve, evaluate, and apply the drug literature as a means of providing patient-specific drug information to health professionals and patients; • Interpret and apply pharmacokinetic drug data to the design of patient-specific drug dosage regimens; • Educate health professionals, patients, and/or the public in applied pharmacotherapeutics. The ability to effectively provide these specialized functions at the 45
requisite level of sophistication is based on the application of specialized knowledge and skills gained through advanced education and/or structured training. Key among these skills is the abililty to integrate knowledge of the biologic, biomedical, and pharmaceutical sciences with clinical information to make decisions regarding rational drug therapy.
CRITERION A: Demand Statements on Demand BPS guidelines request written statements supporting the demand for specialized services from health professionals other than pharmacists and from pharmacists not practicing in the proposed specialty. The statements provided are notable for their endorsement of the demand for pharmacists specialized as pharmacotherapy experts, and are representative of the widespread support and acceptance that specialists have achieved across the . nation. The following excerpts are provided as a means to concisely relay the level of support documented within the petition: . There is a true need for a professional knowledgeable and skilled in the application ofdrug information to the patient care setting. This professional's ability to guide and counsel the patient, physician, nurse, and other health care practitioners in appropriate drug use not only advances the education of these individuals but improves patient care as well. I believe that the ever increasing complexity of medical care, the importance ofdrug therapy in disease prevention and treatment, and the rapidly expanding knowledge base needed to make optimal drug therapy decisions demand the widespread integration of the [specialist] into the decision making processes of patient care.
E. Grey Dimond, MD Distinguished Professor of Medicine Provost Emeritus University of Missouri-Kansas City 46
There is a need for a substantial number of . .. pharmacists as defined here. These individuals will become the drug therapy specialist in most hospitals and clinics, serving as an essential resource to other health professionals.
Gerhard Levy, PharmD Distinguished Professor State University of New York at Buffalo
Patient Demand Reimbursement for the services of specialists by third party payers demonstrates a public willingness to purchase those services (specialized functions) described in this petition. Prior to indicating approval of practitioner reimbursement for specialized pharmacy services (whether on an individual or institutional basis), the third party payer typically conducts an extensive analysis of data presented to reasonably assure that: (1) the services are indeed cost-effective, and (2) the services are unique from the general practice of pharmacy reimbursed through existing means.
pharmacy services and the need to credential the specialty practitioner through distribution of its "Guidelines for Clinical Pharmacy Specialists." These guidelines describe the requisite education and training, professional responsibilities, functions, and clinical privileges of the v.A. Clinical Pharmacy Specialist, and are consistent with the role of the pharmacotherapy specialist described in this petition.
Health Professions' Demand Stimmel and Adamcik evaluated the attitudes of 60 physicians toward the activities of 36 pharmacy practitioners whose major professional functions included those of the pharmacotherapy specialist. The strength of physician support for these activities varied directly with the amount of prior contact with specialized pharmacy practitioners. Seventy-nine percent of physicians felt a need for certification of the specialty knowledge and skills of the practitioner beyond that provided by basic pharmacy licensure.
Institutional Demand Government Demand Government demand for both specialized services and certified specialists can be found in the actions of state legislatures and Veterans Administration. By California law, certain pharmacists practicing in licensed health care facilities may order or perform drug therapy-related physical assessments, order drug therapy-related laboratory tests, administer drugs and biologicals by injection, and initiate or adjust the drug regimen of a patient. This prescribing authority is restricted to licensed health care facilities (hospitals and skilled nursing facilities); requires written policies, procedures, or protocols developed with physicians; and requires the facility to determine the competence of the pharmacist. The Veterans Administration has affirmed its demand for specialized
Institutional demand for specialized services has been documented through the tabulation of advertised opportunities for specialized practitioners in several selected pharmacy journals. It is apparent that a significant number of opportunities for specialized practitioners exist and that this is a consistent, increasing market. The prerequisite criteria for these professional positions generally require a doctor of pharmacy or clinically oriented master's degree with a residency or equivalent experience. These positions are identified within the job market as unique with respect to responsibilities. This growing de facto categorization and demand for pharmacists with special education, training, and skills provides a strong argument for formalization of criteria to identify practitioners with uniformly high credentials.
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CRITERION B: Need Public Health and Patient Care Needs There are five demonstrable health care needs that the pharmacotherapy specialist is uniquely qualified to address or that cannot be met by other health professionals because they do not (and foreseeably will not) exist in adequately qualified numbers: 1. There exists a need for the safer, more efficacious, and more economical use ofdrugs in health care. The body of drug knowledge and the complexities of its integration and application to successful patient care will continue to grow as technologies advance. It has been estimated that adverse drug reactions cost the U.S. economy as much as $5 billion per year. Drug use expenditures currently account for about 7.5% of US. health care costs. The need for safer, more efficacious, and more economical drug therapy can best be met by the formal identification and widespread incorporation into the drug use process of an expert in pharmacotherapeutics. This specialist offers practical, rational drug therapy consultations and monitors drug therapy so that continuous emphasis is placed on the safe, effective, and economical use of drugs. 2. There exists a need for greater public and ·health professional education about drugs and drug therapy. This education must have at least two focal points: (a) a thrust to change public and professional attitudes and behaviors regarding the total drug use process; and (b) the continuing education of health professionals and the public regarding optimal drug use. The educational role is much more global than that of an educator within a . classroom or clerkship environment, or the specialist practicing in an academic health science center. This role is fulfilled most often as a consultant to physicians, patients, and other health professionals. 3. There exists a need for a highly sophisticated drug information
resource. This resource should have as its primary goal to support the physician's prescribing decisions. The distinguishing characteristic of drug information provided by the specialist is his/her ability to interpret the primary literature, evaluate its applicability to a given patient care situation, and apply it in the synthesis of a solution to a patient-specific drug therapy problem. 4. There exists a need for the advanced application ofpharmacokinetic principles to patient care as a means to maximize the desired outcome ofdrug therapy. This need can best be met by a pharmacotherapeutics expert who applies the principles of pharmacokinetics to individualize the dosage regimen of certain drugs in selected ambulatory and institutional patients. The pharmacotherapy specialist can integrate the multiple influences of changing renal function, hepatic dysfunction, varying organ blood flow, and altered drug protein binding to design a patient-specific drug dosage regimen in complex patients with multi-organ system failure. 5. There exists a need for continued research into the drug use process. This research should have as its general goals the improvement of the safety, efficacy, and economy of drug therapy. Hatoum et al. have prepared an extensive review of pharmacy literature published between 1974 and 1984 that documented the impact of pharmacy services in acute care facilities on the cost and quality of patient care, .and on the attitudes of patients and other health care professionals to these services. When this extensive literature is taken as a whole it provides substantial evidence of the value, justification, beneficial impact, and cost-effectiveness of sophisticated clinical pharmacy services as provided by the specialist in pharmacotherapy. A total of 73 published reports describing the effectiveness of specialists in meeting the public health needs identified above have been summarized
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and keyed to those needs that each function addresses. Perhaps no one function has been more closely associated with this specialist than the direct, sophisticated application of pharmacokinetic principles to patient care. Because this tool in improving drug therapy can be isolated as an activity unique to the specialist in most patient care settings, it allows a less complicated assessment ofits impact on the patient care process and outcome. For example, Bootman et al. have reported the results of studies conducted to determine the impact ofpharmacokinetic-based consultations provided by specialists on the care and outcome of burn patients with gram-negative septicemia. . They found that dosage regimens designed by specialists produced a significant increase in patient survival (63.6% vs 33.3%) and were associated with a benefit to cost ratio of 8.7:1. Several studies have demonstrated that the number of blood levels ordered can be reduced by approximately 40%, effecting a significant reduction in costs.
CRITERION C: Number and Time Whether an individual pharmacy practitioner should be considered a "specialist" or a "generalist" is best based on hislher actual ability to provide specialized services at the level of sophistication and competence outlined in the petition, and not necessarily the actual amount of time spent performing the functions.
Estimate of Practitioners in the Proposed Specialty Data from a survey of ASHP Special Interest Group (SIG) membership has been published, and allow some definition ofthe practice activities of these ASHP individuals. Ofthe more than 20,000 ASHP members at the time of the survey (1984), there were 2,143 individuals enrolled in eight SIGs to which pharmacotherapy specialists are most likely to belong: Adult Clinical, Clinical Pharmacokinetics, 47
Ambulatory Care, Drug and Poison Information, Geriatric, Oncology, Pediatric, and Psychopharmacy. It was possible to identify 455 practitioners who had job titles which would likely identify them as potential specialists. Further data comes from the membership roster of the American College of Clinical Pharmacy. ACCP includes approximately 1,000 individuals who are admitted to membership if their professional practice activities represent that of the pharmacotherapy specialist. Three other national pharmacy organizations also have memberships comprised at least partly of individuals whose professional practice is typified by that ofpharmacotherapy specialists: the American Pharmaceutical Association Clinical Pharmacy Section; the American Association of Colleges of Pharmacy SectIOn of Teachers of Pharmacy Practice; and the American Society of Consultant Pharmacists. Membership rosters of these groups were compared, and duplicate names removed to produce a combined list of approximately 2,400 individuals.
Distribution of Specialty Practice The ASHP SIG survey of 1984 provides data on the proportion of time devoted to various practice activities. Evaluating responses from f'nonadministrative SIG" pharmacists (n = 1,181), 60% (711) reported some participation in patient care activities with the average time spent being 19.5%. However, only 161 reported greater than 50% of their time spent in patient care activities. A survey of ACCP membership done in 1983 (211 respondents; 58% of 1983 membership) indicated the amount of time spent in various activities which closely parallel those listed in the Specialized Functions portion of this document. The majority of the respondents performed the activities of the pharmacotherapy specialist the majority of the time. A subsequent survey of ACCP's membership 48
completed in early 1985 showed that 219 of its then approximately 500 members performed clinical activities more than 75% of the time, and 267 performed these activities over 50% of the time. In summary, from surveys of two major pharmacy organizations it appears a minimum of 400 individuals exist whose "full-time" job is composed of the activities of the pharmacotherapy specialist. It is estimated that an additional 750 individuals from ASHP and ACCP alone perform the activities of the specialist ''part time," averaging about 20% of their practice. Given the continued growth of the specialtysince these data were collected and that specialists belong to organizations other than ASHP and ACCp, it is reasonable to estimate that there are at least 500-1,000 practitioners who could be considered potential full-time pharmacotherapy specialists.
CRITERION D: Specialized Knowledge The concept of pharmacy differentiation and specialization is primarily based upon differences in know ledge and skills among practitioners. Pharmacotherapy specialists have greater scope and depth in their knowledge base of the science of drug therapy, and greater proficiency in the application of that knowledge to patient care than do pharmacy generalists.
Specialized Knowledge Required of Pharmacotherapy Specialists; Basis in the Biological. Physical. and Behavioral Sciences The differentiated knowledge required of the pharmacotherapy specialist is Grawn from the pharmaceutical, biomedical, and behavioral sciences. An important distinguishing characteristic in the knowledge base and skills of specialists is their ability to apply and integrate knowledge of the pharmaceutical and biomedical sciences with the clinical state ofthe patient to optimize care. These skills are
acquired through extensive and intensive supervised training and! or experience. The principal areas in which specialists possess greater depth and scope in their knowledge base than does the pharmacy generalist include: • Pharmaceutical sciences Pharmacology Toxicology Biopharmaceutics Pharmacokinetics and pharmacodynamics • Clinical sciences Pathophysiology Pharmacotherapeutics/clinical pharmacology Drug literature evaluation Clinical pharmacokinetics Physical assessment Clinical laboratory medicine • Behavioral and administrative sciences Psychology and sociology of illness Health care administration Interpersonal communications
CRITERION E: Specialized Functions The functions of pharmacother.a py specialists, in terms of their level of sophistication and knowledge and skill base needed for application, are unique to the profession. It is in the performance of specialized funCtions that specialized knowledge, education, and training culminate to provide the final product: a pharmacy practice specialty with responsibility to assure the safe, appropriate, and economical use of drugs in patients.
Specialized Functions That Differentiate the Pharmacotherapy Specialist from the General Pharmacy Practitioner Six major professional responsibilities and their corresponding functions have been identified, the first four of which are core to the practice of pharmacotherapy: 1. Design, recommend, imple-
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ment, monitor, and alter cost-effective, [Xltient-specific pharmacotherapeutic plans. a. Provide a written and/or oral pharmacotherapeutic consultation which includes a drug therapy regimen that is appropriate in drug selection, dose, dosage schedule and route of administration. h. Generate an expanded patient data base for therapeutic decisions by conducting patient medication histories and, if appropriate, performing selected procedures of physical assessment. c. Select and recommend appropriate subjective and objective monitoring parameters to assess therapeutic and toxic effects of the drugs selected. d. Identify any drugs selected with significant potential for drugdrug, drug-disease, and/or drug-laboratory interactions and notify the prescriber. e. Evaluate and provide assistance in and/or initiate adjustments to drug therapy, given potential therapeutic and adverse drug effects. Develop and recommend appropriate alternative treatment plans should the initially selected regimen fail to produce the desired effect or prove toxic. f. Identify possible drug-induced abnormalities and develop a differential diagnosis to support or negate a drug-induced etiology for disease. 2. Retrieve, evaluate, and apply the drug literature as a means of providing patient-specific drug information to health professionals and [Xltients. a. Serve as an authoritative information source to health professionals. Provide critical analysis of the drug literature applied to patient-specific drug therapy questions. b. Serve as a primary drug information resource for various committees, eg, Pharmacy and Therapeutics Committee, Drug Utilization Committee, Institutional Review Board, etc. c. Provide extemporaneous drug information to professional colleagues and influence decisionmaking processes with literature
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documentation of rational pharmacotherapeutic concepts. d. Author drug information in the form of drug monographs, consultations, and newsletters. Provide drug information in a written form for individual patient care (patient consultations), institutional use (drug monographs), and education of other health professionals (institutional newsletters and articles in professional journals). 3. Interpret and apply pharmacokinetic drug data to the design of patient-specific dosage regimens. a. Design, recommend, and/or prescribe an appropriate dosage regimen for a particular drug, based on the drug's pharmacokinetics, therapeutic index, and patientspecific parameters. -b. -Interpret drug concentrations, correlate these data to patient response and/or toxicity, and utilize the information to design, recommend, and/or prescribe a patientspecific dosage regimen. c. Utilize appropriate pharmacokinetic data to determine, recommend, and/or prescribe drug dosing regimens in patients with renal, hepatic, or other organ disorders. d. Determine, recommend, and/or order the appropriate use of drug assays, including body fluid to be sampled, time of sample collection, and cost-benefit analysis of drug assays. e. Interface with clinicallaboratory personnel in determining analytical procedures for drug concentration determination that produce the most clinically useful results. 4. Educate health professionals, patients, and/or the public in applied pharmacotherapeutics. a. Assume responsibility for the education of all members of the health care team involved in the area of applied pharmacotherapeutics. Responsibilities extend to both students and licensed practitioners, and can occur in all health care settings. h. Participate in continuing education programs concerning pharmacotherapeutics. c. Teach patients about disease
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states and medications through formal patient educational programs and discharge counseling. d. Author original articles that serve to educate a national and international audience of health professionals. 5. Conduct clinical investigations and pursue scholarly activities. a. Conceive a research question, organize and implement a research plan, and evaluate and publish the data in a scholarly journal. h. When unique therapeutic modalities are used in patients, assure that studies are done to evaluate therapy and that the results are published in a clinically oriented journal. c. Participate in collaborative research with other health professionals and/or basic scientists, contributing a unique aspect of applied pharmaceutical sciences to the research. d. Contribute to the practice of pharmacotherapy, clinical pharmacy, and medicine by publishing clinically relevant, original research data and interpretation. 6. Develop treatment protocols and prescribing under such protocols. a. Assist in the development of treatment protocols to be used in patients with specific diagnoses. b. Prescribe drug therapy and other laboratory tests under guidelines of treatment protocols.
Special Skills Required • Effective communication, both verbal and written, with patients, peers, and other professionals about all aspects of drug therapy. • Efficient retrieval of drug literature by use of appropriate indices and computerized techniques of literature retrieval. • Evaluation of drug literature to determine appropriateness of authors' conclusions, including assessment of research methodology, biostatistics, and data manipulation. • Proficiency and understanding in utilizing programmable calculators and computers. 49
• Technical capabilities to perform adequately in both formal and informal education environments. • Effective written communication of treatment or research protocols, application of biostatistics, and familiarity with legal and ethical issues concerning clinical research. • Patient physical assessment skills that enable the specialist to function more independently and contribute to the patient data base. • Integration of baSIC pharmaceutical sciences and clinical data with the application of both used to formulate rational therapeutic plans.
CRITERION F: Education and Training The doctor of pharmacy (PharmD) degree program is now the primary academic curriculum that provides the basic education and training for the pharmacotherapy specialist, and provides "the student with an enhanced core of professional knowledge and skills through enrichment of the biomedical, pharmaceutical, and clinical sciences, as well as through practice experiences. " In addition to a doctor of pharmacy degree, a postgraduate residency is required to provide the further training needed to achieve minimal competency in the specialty. While the PharmD/residency sequence provides the educational framework for specialists of the fut ure, pharmacists of today have acquired the differentiated knowledge and skills required for specialized practice by a variety of methods.
Professional Degree Programs The national utilization of this specialist is clearly supported by the distribution of education and training programs throughout the United States. As of the fall of 1985, there were 36 schools of pharmacy offering the post-baccalaureate doctor of pharmacy degree program, 32 of which were accredited by the American Council on Pharmaceutical Education. The percentage of 50
PharmD degrees to the total of professional degrees was 2.9% in 1960 and 11.9% in 1984.
Postgraduate Training Programs The American Society of Hospital Pharmacists currently accredits pharmacy residency programs in three different categories: general hospital pharmacy, clinical pharmacy practice, and specialized pharmacy practice. Pharmacotherapy specialists would most typically complete a postgraduate residency from one 'o f the latter two categories. A listing of applicable postgraduate residency programs was developed by merging the "1987 ASHP Directory of Accredited Pharmacy Residency Programs" and the "1988 Directory of Residencies and Fellowships Offered by Members of the American College of Clinical Pharmacy." Doing so yielded 90 residency and 93 fellowship training programs.
CRITERION G: Transmission of Knowledge As the number of pharmacists trained as clinical practitioners has increased over the years, the percentage becoming independent investigators has accumulated to a substantial total. A survey of colleges of pharmacy found that 57% of clinical faculty were on tenure tracks. An evaluation of contributions to the journal Clinical Pharmacology & Therapeutics over a la-year period reveals a threefold increase by pharmacist-authors with the greatest proportion of this growth due to individuals with the PharmD degree. The number of publications by a representative group of 50 clinical practitioners increased from 55 to 144 per year from 1978 to 1983. Pharmacokinetic research articles comprised the largest category of publications (33.9%), followed by review articles (19.6%), original clinical drug trials (17.2%), and pharmacy practice articles (13.0%). Journals dealing specifically with the proposed specialty include:
Clinical Pharmacy; Drug Intelligence and Clinical Pharmacy; Pharmacotherapy; Clinical Pharmacology & Therapeutics; Journal of Clinical Pharmacology; and Therapeutic Drug Monitoring. Tenjoumals were reviewed for a single year and all articles of original research, authored or coauthored by a PharmD or an individual known to be active in pharmacotherapy research, were identified. Seventy-eight articles were identified. A breakdown of topics represented reveals that 54% of the articles dealt with pharmacokinetics and 26% would be classified as pharmacodynamic studies. The most common therapeutic categories were the cardiovascular and antimicrobial areas (21 %), but also incl uded were cancer, pulmonary, renal, psychopharmacy, and pediatrics. The publication activities of pharmacists who would likely meet the proposed definition of a pharmacotherapy specialist has been reviewed for the interval 1984-1986. These pharmacists very successfully compete for publication space in the Journal of Clinical Pharmacology and Clinical Pharmacology & Therapeutics with researchers from other disciplines, and authored about 22% and 15% of the articles in these two journals, respectively. Additionally, these pharmacists authored or co-authored approximately 25% of the abstracts presented at the 19841986 annual meetings of the American Society of Clinical Pharmacology and Therapeutics. ®
Comments Invited Members are encouraged to send their comments regarding this petition or the petition for nutritional support pharmacy practice special recognition, published in the March issue (p. 80) to: Clinical' Affairs, American Pharmaceutical Association, 2215 Constitution Avenue, Nw, Washington, DC 20037.
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FROM THE
LITERATURE Brief Abstracts from the MedicalITherapeutics and the Pharmaceutical' Management Literature' of Potential Interest to Pharmacists Editors: Tim R. Covrngton (Therapeutics) Mickey Smith (Economic, Social, and Administrative Sciences) Tim R. Covington, PharmD, is professor and chairman ofthe Pharmacy Practice Department, Samford University School ofP harmacy, Birmingham, AL. Mickey Smith, PhD, is professor of health care administration at the University of Mississippi School of Pharmacy, University, MI, and is editor of The ' Journal of Pharmaceutical Marketing and Management.
EcONOMIC, SOCIAL, AND ADMINISTRATIVE SCIENCES DRUG INFORMATION SEARCHING BY THE ELDERLY This study was sponsored and conducted by the FDA to compare the types of prescription drug information sought by younger and elderly patients. The elderly were more likely to consult mass media sources and less likely to receive counseling from health professionals, according to responses in this telephone survey. Using various statistical techniques, the researchers were able to identify som~ specific factors in differences between the two groups. Older patients felt that trust in the physician lessened the need for information. Younger patients were more likely to see the prescription counter as a barrier to communication. Source: J Health Care Marketing, 7, 5 (1987).
SOCIAL AND ECONOMIC BENEFITS OF DISULFIRAM This review of controlled trials of the use of disulfiram in middle-aged outpatient alcoholic men concluded that: • Disulfiram is unlikely to increase the probability that a middle-aged alcoholic who accepts treatment will abstain for 1 year; the best estimate is that the probability of abstinence , is decreased about 4%. • The drug is expected to decrease the number of drinking days per year by 30. It was suggested that improvements in the health and welfare of alcoholic patients may be realized by using disulfiram, because the number of days that an individual patient is "dry" may be increased. Economic benefits may also accrue from increased productivity. Source: Med Care, 25, 566 (1987 Supplement).
AMBULATORY CARE CENTERS IN THE MARKETPLACE Approximately 400 managers of ambulatory care centers ~cross the United States responded to a mail survey concernIng the pharmaceutical services offered. About one in four of the total number of respondents dispensed prescription drugs as an ancillary service but 95% reported that they did not employ a pharmacist. Other pharmacy-related services pro:'ided by ACCs were blood pressure checks, blood glucose checkIng, and cholesterol screening. The ambulatory care center is
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a present and potential competitor of pharmacists, physicians, and other health care providers. Source: J Health Care Marketing, 7, 27 (1987).
DEMAND FOR PHARMACY CONSULTING SERVICES It seems clear that some, perhaps most, pharmacy customers want more health information, but are they willing to pay for it? This study describes a method for estimating the demand, expressed as a willingness to pay, for pharmacist-provided drug information. Interviews were conducted with nearly 200 patrons. Significant gaps were found in the amount of information pharmacists provided. Data showed that more than 95% of those responding would be willing to pay something for counseling services and that three-fourths would pay as much as $2.50. The authors do not project the cost of such services nor project profitability based on their data. Source: J Heq,lth Care Marketing, 7, 33 (1987).
COST·EFFECTIVENESS COMPARISON OF BUPRENORPHINE/MEPERIDINE Cost-benefit and cost-effectiveness studies are increasingly taking their place with clinical studies in the overall evaluation of both new and old drugs. This study is somewhat different in that cost differences arise, in part, because of differing needs for control procedures. This retrospective study evaluated the cost impact of buprenorphine HCI, a Schedule V injectable analgesic, versus the Schedule II drugs morphine and meperidine HCI in a 694-bed community teaching hospital. The investigators found that using buprenorphine in place of morphine and meperidine for moderate to severe postoperative pain relief was highly cost-effective and resulted in a total analgesic cost avoidance of up to 67% per patient per day. Source: Hosp Formulary, 23, 57 (1988).
P & T COMMITIEE DECISIONS This study identified outcomes related to hospital formulary decision making. The two most important outcomes identified were the effects of a potential drug addition to the formulary on the quality of drug treatments available in the hospital and on hospital costs. Information on the therapeutic advantage of the potential drug addition, the relative adverse effect profile, and cost information were viewed as especially important. Promotional literature was not regarded as important. Source: Hosp Formulary, 23, 174 (1988). 51
WHO ARE THE PHARMACY SHOPPERS? In recent years the pharmacy industry has ,become increasingly competitive largely because of new discount-oriented competitors. To maintain or increase their competitiveness in this market, pharmacies must respond by better understanding the needs of the customer. Based o~ a national survey of pharmacy shoppers, this article assists the industry by providing a comprehensive description of pharmacy shoppers and their experience. Included are a demographic profile of the shopper, consumer evaluation of their pharmacy shopping experience, and a summary of how these shoppers spend their money. Examples of how this information can be used by management are also included. Source: J Pharm Marketing Management, 2, 11 (1987).
, hrombinemic patients had clinically significant hemorrh.age, five required transfusions, and two died. When phytonadIOne was administered, prothrombin times rapidly returned to normal. ' Hypoprothrombinemia appears to be a relatively common complication of cefoperazone therapy although absolute cause and effect can always be questioned in a retrospective assessment. The authors suggest that, unless contraindicated, routIne phytonadione prophylaxis should be used in patients receiving cefoperazone. Cost-effectiveness of such prophylactic therapy far outweighs the cost of managing hemorrhagic complications. Source: So Med J , 80, 1360 (1987).
PHENYLPROPANOLAMINE· INDUCED INTRACRANIAL HEMORRHAGE
THERAPEUTICS ESTROGEN/PROGESTIN THERAPY IN MENOPAUSE The value of cyclic estrogen/progestin replacement therapy in postmenopausal women to relieve complaints such as atrophic vaginitis and vasomotor symptoms and to slow the progression of osteoporosis is well established. Despite these benefits, many women are reluctant to use cyclic replacement therapy because of vaginal bleeding, recurrence of vasomotor symptoms during the week off estrogen, and progestin-related side effects (eg, breast tenderness, abdominal bloating, headache, depression). Because of these complaints, continuous estrogen/progestin therapy was compared with cyclic estrogen/progestin therapy in 26 menopausal women. Group I (N = 16) received continuous conjugated estrogen (0.625 mg/ day) and medroxyprogesterone acetate (2.5 mg/day). Group II (N = 11) received conjugated estrogen (0.625 mg/day) during days 1 through 25 of each cycle and medroxyprogesterone acetate (10 mg/day) during days 16 to 25. At the end of the 9-month treatment period no significant alteration of blood pressure, serum cholesterol, or HDL, LDL, or triglyceride levels occurred in either group. Endometrial biopsy specimens revealed no endometrial proliferation in group I and one proliferative endometrium in group II. Vaginal bleeding was virtually-eliminated in group I whereas 80% of patients in group II continued to have cyclic menses. Short-term continuous estrogen/progestin replacement therapy appears to be a satisfactory method of reducing menopausal symptoms with the add~d benefit of eliminating vaginal bleeding. The apparent lack of side effects and the protective effect on the endometrium increase the attractiveness of this regimen. If long-term studies support the shortterm findings, continuous estrogen/progestin replacement should receive wide acceptance. Source: Am J Obstet Gynecol, 157, 1449 (1987).
CEFOPERAZONE·ASSOCIATED HYPOPROTHROMBINEMIA Cefoperazone, a beta-lactam antibiotic with a methylthiotetrazole side chain, has been associated with hypoprothrombinemic hemorrhage. To determine the incidence of hypoprothrombinemic complications, this study retrospectively analyzed the records of 80 patients who had received cefoperazone for more than 72 hours. Of the 80 subjects evaluated, nine received phytonadione (vitamin Kll ) prophylaxis and there was no evidence of hemorrhage. Prothrombin times were measured in another 32 subjects, of whom 14 were hypoprothrombinemic. Prothrombin times ranged from 14.8 to 97.3 seconds at a mean of 6.2 days after be~nning cefoperazone therapy. Seven of the 14 hypoprot-
The over-the-counter drug Entex contains 5 mg of phenylephrine, 45 mg of phenylpropanolamine (PPA), and 200 mg of guaifenesin per capsule. Approximately 1 hour after ingesting 13 Entex 'capsules, a 27-year-old male patient was seen in an emergency room complaining of severe right temporal parietal headache. He was somnolent and diaphoretic. Blood pressure was 210/110 . mm Hg (supine); pulse rate 62 . beats per minute. During treatment with ipecac syrup and actIvated charcoal, a left-sided weakness of the face evolved into a left hemiparesis. The patient was then admitted to the hospital. Upon admission a CT scan of the brain revealed a right lenticular hemorrhage. A four-vessel cerebral angiogram on the sixth day confirmed the presence of cerebral vasculitis. Dex amethasone phosphate was prescribed for edema shortly after admission. On discharge to a rehabilitation facility, there was a residual mild left hemiparesis, worse in the upper extremity and distally. PPA is available in many OTC decongestant drugs and "diet aids." Physicians and pharmacists should be aware of PPA's adverse effect profile and be cautious in recommending this potentially toxic drug for suicidal patients or those prone to abuse drugs. Source: So Med J, 80, 1584 (1987).
CARDIOVASCULAR EFFECTS OF VERAPAMIL IN ESSENTIAL HYPERTENSION Calcium channel blockers have produced discrepant findings as antihypertensives. The variable responses may be attributed to duration of treatment or different mechanisms of action of calcium channel blockers. As data on the long-term effects of verapamil on norepinephrine-dependent vasoconstriction and body sodium metabolism are lacking, this study evaluated the long-term (8-week) effect of verapamil (348 ± 68 [SD] mg/day) on blood pressure and other factors in 15 patients with essential hypertension. Supine arterial blood pressure decreased from 153/103 ± 19/12 mm Hg to 140/95 ± mm Hg and was unrelated to age. Upright blood pressure did not decrease significantly. Hearl rate, body weight, exchangeable body sodium, and plasma and blood volume were not significantly altered by verapamil. Verapamil did not modify plasma levels of sodium, potassium, calcium, renin, creatinine, uric acid, or glucose. Serum cholesterol and triglycerides were not modified. The antihypertensive effect of verapamil was associated with a decreased cardiovascular pressor responsive to norepinephrine without changes in endogenous nonadrenergic activity. Verapamil was well tolerated; no patient complained of side effects. Verapamil appears to have minimal metabolic adverse effect potential. This, combined with its blood pressure lowering activity, enlarges the therapeutic possibilities for managing hypertension. Source: Clin Pharmacol Ther, 42,485 (1987).
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