Specialization in Pharmacy As drug therapy becomes more complex, pharmacy is following other health professions in developing areas of specialization and accreditation. by Vicki Meade
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pecialization is far from a new idea for health care practitioners. The first medical specialty, ophthalmology, was formally recognized in 1916. Since then, specialization in medicine has grown to a point where today 70% of physicians are certified in one of more than 20 specialties. In fact, it's hard for practicing physicians to advance these days unless they specialize, according to John Gienapp of the Accreditation Council for Graduate Medical Education. Pharmacy has specialties too three of them. But because the evolution of pharmacy specialties is at such an early stage, the public and many pharmacists - are largely unaware that they exist.
The Value of Specialization
Richard Fejka, a radiopharmacist, prepares a radiopharmaceutical drug at the National Institutes of Health. Photo: Bill Branson, NIH
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According to Samuel Kalman, secretary of the Board of Pharmaceutical Specialties (BPS), a specialty is "an area of practice that is underpinned by a very distinctive knowledge base." Specialties tend to emerge, he says, as knowledge grows and technology becomes more complex. In the health care field, specialization goes hand in hand with certification - a process by which a nongovernmental agency grants recognition to individuals who have met predetermined qualifications specified by that agency. The main purpose of providing specialty certification is to ensure
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that a practitioner who offers specialized services meets certain standards - standards that go beyond those necessary to become licensed for general practice. Advocates of specialty certification in phannacy say that although their overriding concern is seeing that the public receives competent services, they also hope that becoming board-certified will bring such personal rewards as an increase in pay, recognition by peers, a competitive edge for professional advancement, and a higher status in the eyes of physicians and others.
Brief History The authority that recognizes pharmacy specialties and oversees certification of practitioners within those specialties is BPS. Among BPS's nine members are pharmacists, other health professionals, and a representative of the public. Although BPS functions as an independent body, it is funded by the American Pharmaceutical Association (APhA) and is housed in APhA headquarters in Washington, D.C. BPS's formation in 1976 was the result of long and careful thought by an APhA task force on specialization, which was created in 1973 at the urging of pharmacy leaders who believed that differentiation of practice areas was inevitable. Members of APhA's nuclear pharmacy section moved quickly to ask the newly created BPS for specialty recognition, and in 1978 nuclear pharmacy became the first pharmacy specialty. Then several years passed without much action in the specialization arena. Things began to move again in 1986 when BPS received a petition requesting that clinical pharmacy become a specialty. It rejected the petition in 1987, stating that "clinical pharmacy practice is too broad and too general to be recognized as a specialty." The sponsoring group - the American College of Clinical Pharmacy (ACCP) - crafted a new petition, presenting more narrowly focused descriptions of the tasks and skills described in the clinical pharmacy petition, and gave the new specialty the name "pharmacotherapy." The pharmacotherapy peti-
tion was submitted in 1988, as was a petition for nutrition support pharmacy, and BPS approved the two later that year. Two months ago, BPS received a petition to recognize psychopharmacy as a specialty. And many other areas are likely to seek specialty status in the next decade, including oncology pharmacy, pediatric pharmacy, and geriatric pharmacy, according to BPS's Kalman.
How a Specialty Is Approved Any individual or group may petition BPS to recognize a specific area of pharmacy practice as a specialty. According to BPS criteria, a petition must provide data and documentation to show that the proposed specialty fulfills each of seven criteria: • The public and the health care system have a clear, significant need for the specialty. • The pharmacy profession needs specially trained practitioners in
• To acquire the special knowledge and skills required in the specialty, one needs education and training beyond the basic level achieved by general pharmacy practitioners. • Pharmacy schools and other organizations offer education and training programs in the specialty. • Scientific and practice-oriented knowledge in the specialty is being transmitted through such mechanisms as books, journals, symposia, and professional meetings. If these criteria are met, BPS seeks comments from the pharmacy profession at large and from other health professionals, and then may choose to interview the sponsors of the petition. Within 270 days of the petition's receipt, BPS must decide whether to recognize the specialty. If recognition is denied, the petition's sponsors can appeal. Of the five petitions BPS has received during its 14-year history, three have been approved, one was denied, and one is pending.
Developing an Exam Because the evolution of pharmacy specialties is at such an early stage, the public - and many pharmacists - are largely unaware that they exist.
this area to improve the health and welfare of the public. These services cannot be provided by pharmacy "generalists" or by other health care professionals, and without these services, the public health and welfare is at risk. • A reasonable number of pharmacists practice in and devote most of their time to the specialty area. • The practice requires specialized knowledge of pharmaceutical sciences that are based in the biological, physical, and behavioral sciences. The area of specialization should not be based solely on the practice environment or on managerial, procedural, or technical services.
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From the day a specialty petition is approved to the day a pharmacist can sit down and take that specialty's certifying exam, a long, rigorous process must be followed. This process is directed by a nine-member specialty council appointed by BPS. Of the nine pharmacists, six are connected with the specialty; the other three are chosen for their know ledge of general pharmacy issues and their ability to question and provide a balanced point of view. First the council has to make sure that the tasks outlined in the petition clearly reflect what a specialist in that area does - and if they don't, the council must define exactly what such specialists do. This can take six months or more and involves extensive literature review, interviews, group discussions of specialty practitioners, and pilot tests. As part of this process, called "role delineation," a questionnaire is developed. The questionnaire, which takes about an hour to complete, is sent to several hundred pharmacists who have been identified as falling within the specialty area. After the questionnaires have been completed, returned, and 25
analyzed, the information is used to create a certification exam. It takes another six months or so to write the exam items, test them, refine them, and put together an examination of about 300 questions that assess whether a pharmacist has the skills and knowledge necessary to practice that specialty at a defined level of competence. Throughout these steps, the council guides and advises, but the actual surveying and test development is done by a professional testing company.
The Oldest Specialty: Nuclear Pharmacy A certifying exam is currently available for nuclear pharmacy only. To be eligible to take the exam, pharmacists must have 4,000 hours of experience in nuclear pharmacy practice, which consists primarily of procuring, compounding, dispensing, and distributing radiopharmaceuticals, or performing related consulting, education, and research. The nuclear pharmacy certifYing
exam was first offered in 1982 when 62 nuclear pharmacists became certified - and has been offered five times since. Today, of roughly 600 nuclear pharmacists in the country, 125 are board certified. Most respondents to a survey conducted in 1988 by James Ponto, a board-certified nuclear pharmacist
with the University of Iowa, reported they are happy with their decision to become certified in nuclear pharmacy. Reasons for their satisfaction include improved feelings of selfworth and confidence, and greater acceptance by peers, health care professionals, and regulatory bodies. Among areas that did not improve
and therefore did not bring satisfaction are monetary compensation, professional responsibilities, and job security, according to the survey. Jeffrey Clanton, clinical director of laboratories at Vanderbilt University's medical imaging division, has been board-certified in nuclear pharmacy since 1982. For him, being
'It assures a level of competency,' says Seifert, 'and other professionals who are board-certified recognize that.' certified is "a matter of pride." One clear advantage to being board certified is that "the Nuclear Regulatory Commission will immediately recognize you as a radiation safety officer," a designation that "makes it easier to get the authority to use radionuclides," Clanton says. Unfortunately "it's meant nothing
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in terms of salary," he adds. However, when asked his opinion of certification, Clanton replies, "I'm glad I'm recognized by my peers; it's very good to know that they see you as competent in the area you're practicing." But he cites the cost of taking the exam, which was $300 in 1982 and is now up to $500, as well as the time it takes to brush up on information the exam covers, as possible deterrents for those considering taking the exam. An enthusiastic proponent of nuclear pharmacy certification is Kathy Seifert, director for professional development at Syncor, a commercial radiopharmacy that employs 250 nuclear pharmacists at 85 locations across the country. In a program she has instituted to encourage Sync or pharmacists to become board-certified, the company will pay candidates' examination fees and give them a bonus if they pass. The reason? "It assures a level of competency," says Seifert, "and other health care professionals who are board-certified in their areas recognize that level of competency."
Seifert says approximately 30 of Syncor's pharmacists are already board-certified, but that in the past the cost of the exam was seen as a barrier. "This is the first year [1990] that we've actively chosen to encourage certification, and we've had a large response of people interested in taking the exam," she says.
Pharmacotherapy Sparks Controversy On August 17, 1991, in Minneapolis, pharmacists will have their first opportunity to become certified in what is surely the most controversial specialty: pharmacotherapy. ACCp, sponsor of the pharmacotherapy petition, defines pharmacotherapy as the area of pharmacy practice that ''has the responsibility for ensuring the safe, appropriate, and economical use of drugs in patient care, through the application of specialized skills, knowledge, and judgments." The debate around pharmacotherapy concerns whether it really re-
quires specialized skills or whether it is simply a definition of what all pharmacists do - or should do. One who argues that the pharmacotherapy specialty should not have been approved is Calvin Knowlton, president of the American College of Apothecaries and owner of a community phannacy that offers compounding, consulting, and counseling. "I'm totally against pharmacotherapy being a specialty," he says. ''This is where the entire profession should be at baseline. We all need to be practicing at this level." But such arguments are moot, according to ACCP Executive Secretary Robert Elenbaas. "BPS has followed a very rigorous procedure that measures the functions of pharmacotherapists against those of general practitioners, and it has validated that this is a specialty," he says. "Those people who ask, 'How can something that one day will become general practice today be a specialty?' aren't considering that it isn't unusual for things initially in the domain of a specialty to become the domain of a generalist." For example, in medicine, he says, "procedures once performed by the gastroenterologist are now performed by the family practitioner, and the gastroenterologist has moved on to higher technologies." The pharmacotherapy validation study, completed last fall, found that pharmacotherapists are involved in these functions: • Collecting and interpreting data so as to design and monitor drug therapies for specific patients. • Interpreting pharmacotherapeutic information for patients, health care professionals, and the public. • Designing and implementing
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policies, in collaboration with 'other practitioners and administrators, that bring about optimal health care. Now, based on the results of that study, questions are being developed and fine-tuned for the August exam. To be eligible to take the pharmacotherapy exam, a pharmacist must have a valid license and have completed a one-year residency, a twoyear fellowship training program, or five years of practice, each with a substantial component of patientcare activities in pharmacotherapy. George Dukes, chairman of the pharmacotherapy specialty council, estimates that between 200 and 400
Sisca hopes that certification will make it easier for pharmacists to be reimbursed for nondispensing services.
pharmacists will apply to take the exam the first time it's offered. Most board-certified pharmacotherapists - at least initially - are expected to be hospital based, says Elenbaas. He predicts that the first cornmunity pharmacists to seek certification will likely be those involved in providing home health care services. Thomas Sisca, one pharmacist who expects to seek phannacotherapy certification, is assistant director for drug information and clinical pharmacy services at a 185-bed hospital in Easton, Md. Among his responsibilities are administering and monitoring therapy according to protocols the hospital has established for about 100 drugs. If, for example, a patient is diagnosed with severe asthma, the physician might write a prescription order for "aminophylline per pharmacy protocol." Under this protocol, Sisca or another pharmacist assesses the patient, calculates the dosage, monitors serum levels of the drug, and adjusts the dosage if
necessary. Sisca's unit also prepares about 300 formal drug information reports a year and consults with physicians seeking to know if a patient has a drug-related problem. Sisca says one reason for taking the exam is "to demonstrate to myself that I have a certain level of competency." He also hopes that eventually certification will make it easier for pharmacists to be reimbursed for nondispensing services by insurance companies. A few years ago he had looked into the possibility of billing patients directly for pharmacy services, the way physicians do, and drawing a reduced salary from the hospital. But Blue Cross/Blue Shield said they couldn't consider reimbursing pharmacists until they received official recognition for their services - such as specialty certification. Ultimately, some observers say, the desire for reimbursement could be a strong driving force for specialization. Specialty certification can also be a plus for pharmacists applying-for positions in his hospital, Sisca adds. "As an administrator looking at hiring, it will tell me something if a candidate is certified." Others have a less positive view of pharmacotherapy certification. Janet p. Engle, ambulatory care clinician at VA Westside Hospital and acting assistant dean at the University of Illinois at Chicago, says she will probably take the exam, but only because she feels it's important in her role as an academician. "I'm not sure [passing the exam] proves anything," Engle says. "You might have a pharmacist who is an excellent clinician but they can't pass the exam because they work in a specialized area, or they may not want to take it," she says. She's concerned about the role that public expectations will play, too. "The public may not understand the legitimate reasons why a pharmacist doesn't have a particular qualification," she says. Engle views the trend toward specialization as a good thing, given the complexity of new therapies and the fast pace at which advances are being made. "I don't necessarily agree that pharmacotherapy is a specialty though," she argues. "It's
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too broad. In my mind, all pharmacists are pharmacotherapists to some degree."
Team Players: Nutrition Support Nutrition support pharmacy practice addresses the care of patients with potential or existing nutritional aberrations. Beverly Holcombe, chairman of the group's specialty council, estimates that there may be 650 nutritional support phannacists in the United States, most practicing in hospitals or home health care companies. Holcombe, a clinical specialist in the nutrition support service at the University of North Carolina Hospitals, says nutrition support pharmacists typically work closely with a team of dietitians, nurses, physicians, respiratory therapists, and sometimes social workers and occupational therapists. Holcombe spends most of her time in direct patient care, which includes determining if a patient risks becoming malnourished, establishing a patient's requirements for vitamins, minerals, electrolytes, and fluids, deciding the best administration route, and looking for potential interactions between nutrients and medications. ''There's a lot of science behind this role, but it takes clinical judgment, too," she explains. Holcombe also monitors the patient to see if her therapy is having the desired impact - for example, is it promoting wound healing, or bringing about a change in weight? Other tasks nutrition support pharmacists may be involved in are compounding, storage, and related areas, Holcombe says. Many are also administrators, preceptors, and researchers. The validation survey for nutrition support pharmacy practice is being conducted now, with final results expected by April 1991. The first exam will be given January 1992, in Orlando, Fla.
Professional Maturation "Specialization is an activity that's going to have a very significant effect toward advancing the entire profession of pharmacy," says
ACCP's Elenbaas, ''because it provides an opportunity to improve the services the profession offers to society." Ray Maddox, BPS chairman, says that specialization "provides evidence of professional maturation." It also raises important questions, he says, such as, How will the different specialties depend on each other? How can the profession best take advantage of specialization? And how will pharmacy specialists be recognized and used by other health care providers? Elenbaas says it's important to guide the emergence of specialties rather than allow them to appear haphazardly. In a recent paper on specialty structure, John Rodman, associate professor of clinical pharmacy at the University of Tennessee, Memphis, points out that because pharmacy specialization is at such
The main purpose of providing specialty certification is to ensure that a practitioner meets certain standards.
an early stage, the profession can learn from the mistakes of medicine and other groups. Heading the list of potential problems is fragmentation of the profession, Rodman writes. And the prolifera tion of specialties and subspecialties could "create unintended voids in meeting the primary health care needs of patients." Several pharmacists have voiced concern that specialization could increase the cost of care, and some spoke of potential "turf battles" between various pharmacy specialties and between pharmacy specialists and practitioners in other disciplines. Some also expressed the importance of avoiding the problems medicine faces now that it has been sliced into tiny pieces - problems such as higher medical school costs
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for operating many specialized programs and frustration for patients who are referred from specialist to specialist. Leonard Fenninger, MD, who served on APhA's 1973 specialization task force, jokes that it's reached the point where physicians say to themselves, "I hope this patient has what I treat." According to Fenninger, it's as if medical specialists have "forgotten that the profession is based on certain bodies of knowledge broadly held in common rather than on separation and difference." Throwing a monkey wrench into the whole business of pharmacy specialization is the fact that nonpharmacy groups are starting to offer certification to pharmacists. In May 1991, the American Board of Clinical Pharmacology - a new, independent medical board that does not fall under the domain of the American Board of Medical Specialties - will give a certifying exam in applied pharmacology that is available to those with a PharmD or PhD.
"Some pharmacists may be tempted to pursue that certification in lieu of a pharmacy-based certification," says Elenbaas. "In some people's minds, to have a medical organization give you a stamp of approval is better." It's too early to know what the impact of overlapping certification among disciplines could be, he says, but cautions the profession against allowing medicine or any group other than pharmacists to take control of assuring the quality of pharmacy services.
Time to Get the Word Out Ponto, one of the small group of pharmacists who can speak from experience as a board-certified specialist, says he is "absolutely in favor" of specialization. "People don't know what to do with pharmacy specialists because there simply haven't been any," says Ponto, who currently serves on the nutrition support specialty council. "It's going to be a good thing. But it's going to take a long time to get the word out." Vicki Meade is managing editor of American Pharmacy.
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