A Vision of Pharmacy's Future Roles, Responsibilities, and Manpower Needs in the United States

This paper was prepared by the 1997-1999 ACCP Clinical Practice Affairs Subcommittee A: Michael S. Maddux, PharmD, FCCP, Chair; Betty J. Dong, PharmD; William A. Miller, PharmD, FCCP; Kent M. Nelson, PharmD, BCPS; Marsha A. Raebel, PharmD, FCCP, BCPS; Cynthia L. Raehl, PharmD; and William E. Smith, PharmD, PhD

Pharmacotherapy. 2000;20(8) 

In This Article

Qualifications for Pharmacy Practice

Students prepared at the entry level are general practitioners who coordinate and render pharmaceutical care. A system of pharmaceutical care requires the participation of both generalists and specialists.
The Commission to Implement Change in Pharmaceutical Education, 1991 [94]

The issue of credentialing in pharmacy is of critical importance because it has the potential to elevate the profession to new levels or to mire it in divisiveness.
Bertin, 1999 [95]

Any system that assesses and recognizes practitioner competence must be based on a valid and reliable method of assessing capability. That such systems are possible is verified by the existence of specialty certification mechanisms which use experience and examinations as assessment tools.
The Commission to Implement Change in Pharmaceutical Education, 1993 [96]

Requisite education and credentialing of pharmacists will be important issues as the profession pursues patient-centered practice roles. As recounted earlier, the debate surrounding the most appropriate degree for entry into the profession has been resolved as we begin a new century. However, emerging controversies surrounding postgraduate credentialing processes now threaten to embroil the profession in renewed debate. We believe that the credentialing issue -- in particular the controversy associated with certification -- has the potential to spark the same level of discussion that occurred during the "B.S. versus Pharm.D." controversy. Certainly one must hope that the credentialing/certification issue will not result in the marked polarization that was spawned by the entry-level degree controversy. Because there is still confusion within the profession concerning contemporary education and credentialing, we have taken the liberty of summarizing the current status of each below (Figure 1) and then concluding with an editorial viewpoint on credentialing.

Curriculum Standards and Guidelines. "Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree" (Standards 2000) were adopted by the American Council on Pharmaceutical Education (ACPE) in 1997, setting the stage for the final steps of a 10-year accreditation revision process that resulted in implementation of the doctor of pharmacy as the sole professional degree.[97] Standards 2000 state as follows:

"The professional program in pharmacy should promote the knowledge, skills, abilities, attitudes, and values necessary to the provision of pharmaceutical care for the general practice of pharmacy in any setting." [97]

Colleges of pharmacy are expected to prepare

generalist practitioners of pharmacy

for both contemporary practice and for emerging practice roles. The ACPE standards acknowledge that colleges should educate and train pharmacists for both patient-specific and population-based pharmaceutical care. Contained within Standards 2000 are 18 professional competencies that graduates should achieve through the professional curriculum. Outcome expectations for student performance in these professional competencies are expected to be determined and assessed by each institution.

Disease state management is one of the professional practice competencies included in Standards 2000, although no specific disease states are required for inclusion in the curriculum. With respect to experiential education, introductory practice experiences are to be offered to all students during the "early sequencing" of the curriculum. This expansion of the experiential curricula will provide students with an early exposure to practice environments that is likely to reinforce the relevance of didactic content and also to set the stage for early professionalization. Institutions also are expected to provide advanced pharmacy practice experiences in both ambulatory and inpatient settings including primary, acute, chronic, and preventative care among patients of all ages. The guidelines further call for core (required) advanced practice experiences that provide substantial experience in the community pharmacy setting, hospital/institutional practice, and acute care of general medicine patients.

Licensure. Licensure is the national, uniform, mandatory process whereby regulatory and governmental bodies (the National Association of Boards of Pharmacy [NABP] and the respective individual state boards of pharmacy) determine by examination (e.g., NAPLEX) whether an individual has the required education and skill to practice pharmacy. The boards of pharmacy in turn rely on ACPE to review and accredit the curricula offered by schools and colleges of pharmacy. The professional degree programs in pharmacy provide sufficient knowledge, skills, and practice experience for graduates to fulfill the professional competencies required of general practice.[94] Thus, these professional curricula satisfy the educational requirements for licensure of pharmacists. Professional degree programs, by themselves, do not provide graduates with the skills and experience needed to deliver specialty practice-based care, thus creating a need for post-licensure credentialing options.[94] In addition, it appears to us that current licensure examinations are not adequately directed toward the clinical competencies needed to provide care and conduct collaborative drug therapy management.[98] Hence, continued revision and updating of licensure examinations will be necessary to ensure that future graduates are sufficiently competent to fulfill evolving practice roles. As the profession examines future means to ensure professional competence in evolving clinical roles, it also should assess the need for periodic re-licensure.

Lack of understanding of the terminology associated with the credentialing process has contributed to significant confusion regarding credentialing.[95] A credential is evidence of an achievement, including documentation of licensure to practice; residency or fellowship training; or completion of specific training courses. Credentialing commonly refers to the review of an individual's credentials, often for the purpose of determining practice privileges; this term also may be used to describe simply the process of awarding a credential. Licensure is a form of mandatory credentialing. Certification is a voluntary process, usually established by a professional, nongovernmental agency, that is designed to evaluate an individual's training, experience, knowledge, and skill level beyond that required for licensure. Certification usually is focused in an area of practice that is defined more narrowly than the domain(s) tested during initial licensure. Certificate programs are defined by ACPE as "...structured and systematic postgraduate continuing education experiences for pharmacists that are generally smaller in magnitude and shorter in time than degree programs, and that impart knowledge, skills, attitudes, and performance behaviors designed to meet specific pharmacy practice objectives."[99]

Credentialing Options. Excluding pharmacist licensure, postgraduate credentials are obtained on a strictly voluntary basis. Pharmacists may elect to obtain credentials at the disease, generalist, or specialist levels. Post-licensure credentialing programs should be subject to national standards. Training programs also may be guided by national standards, such as those used in the accreditation of residency programs. Although pharmacy has a national accrediting body for pharmacy residencies (The Commission on Credentialing within the American Society of Health-System Pharmacists [ASHP]), many pharmacy residency training programs are not accredited; therefore, they do not undergo national peer review.[100,101] Whereas some pharmacy fellowship programs are subjected to voluntary peer review through ACCP, most pharmacy fellowship programs do not undergo national peer review.[101] The recent proliferation of post-licensure disease-specific credentialing programs, often not subject to national standards, has created concern about program quality, consistency, and value. Confusion is rampant, as neither pharmacists nor the public clearly can define the minimal standards for these programs.

General Elements of Post-Licensure Certification.Voluntary certification has emerged as the highest demonstrated professional level of achievement in pharmacy practice. Certification provides public identity for those pharmacists who have demonstrated knowledge deemed important by professional peers. Pharmacy, like all professions, endorses certification as a means of elevating professional standards. Certification can be used both to expand the professional influence of pharmacy within health care systems and to protect professional boundaries. Certification of licensed pharmacists may be a means of verifying advanced professional knowledge and skills. Certification processes usually are established by professional, nongovernmental agencies.[99] In addition to evaluating an individual's knowledge, the certification process also should document the individual's formal training, professional experience, and clinical skills. The individual seeking certification usually is assessed using a national standard that is more rigorous than that required for entry into the profession by licensure. Certification bodies should not provide the training or education required for certification examinations. Instead, independent professional, academic, or corporate entities are best suited to provide preparatory materials and courses.

Specialist Pharmacist Certification. In 1976, the APhA established the Board of Pharma-ceutical Specialties (BPS) to recognize specialty practice areas, define knowledge and skill standards for recognized specialties, evaluate the knowledge and skills of individual pharmacist specialists, and serve as a source of information and coordination for pharmacy specialties.[102] The BPS has recognized five specialty practice areas: nuclear pharmacy, nutrition support pharmacy, oncology pharmacy, pharmacotherapy, and psychiatric pharmacy. Board certification by the BPS indicates that a pharmacist has demonstrated an advanced level of education, experience, knowledge, and skills -- beyond that required for licensure -- in a specialty practice area. Board of Pharmaceutical Specialties certification is the only such designation within pharmacy that recognizes advanced, specialized skills and knowledge against an established national standard. Four eligibility criteria are defined for BPS recognized specialties: an entry-level pharmacy degree, an active pharmacy license, additional training within the respective specialty area, and successful completion of the specialty certification examination.[102] Whereas the specialized education or experience required for certification varies among the BPS specialties, all require either several years of prior specialty practice experience or completion of specialty residency or fellowship training. The BPS requires recertification every 7 years, with each specialty having separate requirements for the recertification process. As of January 2000, more than 2900 pharmacists have been certified by the BPS.[102]

Added Qualifications within a Recognized Pharmacy Specialty. The BPS also recognizes focused areas within established pharmacy specialties. Demonstration of enhanced training and experience within one segment of a BPS-sanctioned specialty practice area is recognized by the designation "Added Qualifications."[102] This designation denotes further differentiation within a specialty. Unlike the medical profession, pharmacy does not require such subspecialty differentiation through separate board examinations. To establish a new area of Added Qualifications, a group first must petition the BPS to recognize the desired subspecialty. If this petition is approved, individuals wishing to be considered for Added Qualifications must submit a portfolio that documents their enhanced experience and training. If the committee of the Specialty Council believes the portfolio meets established requirements, individuals receive a new BPS Certificate recognizing their status as "Board Certified with Added Qualifications." The Added Qualifications practice area first recognized by the BPS was Infectious Diseases within the specialty of Pharmacotherapy, approved by the Board in 1999.

Generalist Pharmacist Certification. The APhA proposed a certification program in "pharmaceutical care" in the late 1990s, although the program has not yet been developed. This was intended to be an advanced generalist designation but not as intensive as the pharmacotherapy specialty or other specialty certification processes performed by the BPS. Another generalist certification program was developed for pharmacists in geriatric pharmacy practice. The Commission for Certification in Geriatric Pharmacy (CCGP) was established by the American Society of Consultant Pharmacists (ASCP) in 1997.[103] This national voluntary certification program requires successful completion of a written examination. To be eligible to take the CCGP certification examination, the pharmacist must hold a current license and possess a minimum of 2 years of practice experience. According to CCGP, no special training or clinical experience in geriatrics is required, although a review course is available on the ASCP Web site, and numerous continuing education programs can help pharmacists prepare for the exam.[103,104] Domains included in the geriatric pharmacy practice exam are patient-specific activities, disease-specific activities, and quality improvement and utilization management activities.[103]

Interdisciplinary Certification. Most certification processes in health care emerged within individual health care disciplines. This is also true for pharmacy. During the past 2 decades, however, interdisciplinary certification involving two or more health care disciplines emerged. The American Academy of Pain Management provides voluntary certification for inter-disciplinary pain practitioners.[105] Practitioners from medicine, pharmacy, nursing, psychology, counseling, physical therapy, chiropractic, and social work have been accorded voluntary certification as interdisciplinary pain managers. The National Certification Board for Diabetes Educators designates qualifying health care practitioners as Certified Diabetes Educators (CDE).[106] The CDE designation assures the public that the individual demonstrated excellence in diabetes education. The American Board of Applied Toxicology (ABAT) provides voluntary certification of nonphysician specialists in applied clinical toxicology.[107] Certified individuals are designated as ABAT Diplomates (DBAT). The American Board of Clinical Pharmacology (ABCP) provides voluntary certification for nonphysicians in applied pharmacology.[108] On successful completion of professional requirements and certification exams, the ABCP issues a certificate that designates the individual as "Accredited in Applied Pharmacology."

Disease-Specific Credentialing. Disease-specific credentialing is designed to document a pharmacist's ability to provide disease-specific care beyond the dispensing of medications.[109] The National Institute for Standards in Pharmacist Credentialing (NISPC) serves as the credentialing body for this process. The NISPC was formed by NABP, NCPA, and NACDS in June 1998; the APhA joined the group in 1999. Pharmacists who desire to be credentialed voluntarily in one of four disease states must pass an NABP disease state management exam. Currently, disease state management exams are available for anti-coagulation, asthma, diabetes, and dyslipidemia. The exams are designed to serve as standardized assessment tools that measure the application of knowledge and judgment of pharmacists providing disease state management. The NABP creates and administers the disease state management exams, which were offered in more than 20 states in 1999. Pharmacists may elect to become credentialed in more than one disease state and combine disease-specific credentialing with other continuing education activities. Whereas disease state management exams assess knowledge and skills related to management of each respective disease state, they cannot assess clinical training or experience. Because training and experience are certainly important prerequisites for the provision of patient care, other certification processes (e.g., BPS certification) require validation of these prerequisites. The NABP maintains a database on its Web site that allows the public and third-party payers to verify pharmacists' disease-specific credentials obtained through NISPC.[110] Successful completion of a disease state management exam qualifies the pharmacist to apply for a provider number and receive payment for disease-specific clinical services in a pilot Medicaid waiver program in Mississippi. Eligibility to sit for any of the disease state management examinations is limited to possession of an active license issued by a board of pharmacy in a jurisdiction that administers the exam; no prior clinical experience is required. The NABP disease state management exam qualifications do not require additional preparation beyond the education required for licensure; although, review courses are offered by professional organizations and schools and colleges of pharmacy. The disease state management objectives and standards, available on the NABP Web site, include collection of patient data and documentation of care.[110]

To obtain input on disease management certification value and process, NISPC convenes a Payer Advisory Panel and a Standards Board.[110] According to the NISPC, both advisory groups have affirmed the value of pharmacist credentialing in "high-cost clinical conditions." The Payer Panel recognized the importance of outcomes assessment and the need for a clearly defined menu of services to be provided by credentialed pharmacists. They also recom-mended creation of a credentials database accessible to payers, physicians, and other collaborating health care providers as previously described.

Certificate Programs. In late 1998, national professional organizations and the NABP asked the ACPE to assume overall responsibility for developing guidelines for certificate programs and their providers. The "Standards and Quality Assurance Procedure for ACPE-Approved Providers of Continuing Pharmaceutical Education Offering Certificate Programs in Pharmacy" were adopted by the ACPE Board of Directors in June 1999 and became effective in January 2000, following an implementation/transition period.[99] Thus, the ACPE extended its purview to include oversight of providers of all voluntary pharmacy certificate programs in addition to providers of general pharmacy continuing education programs. These new ACPE standards provide a list of 24 professional competencies that may be used for guiding the organization and for development of certificate program content. The standards also require the certificate program to include practice experiences, simulations, and/or innovative activities to ensure demonstration of the stated professional competencies. Unlike traditional continuing education provider standards, ACPE certificate program provider standards require that providers of certificate programs conduct summative evaluations of participant learning. Generally, certificate programs are expected to require a minimum program length of 15 contact hours or 1.5 CEUs. A special ACPE certificate program logo identifies certificate programs that are delivered by ACPE-approved providers. Because ACPE approves the provider of the program and not individual participants, each participant is awarded a certificate of completion. The certificate of program completion does not imply certification of the individual. This is analogous to the recognition of residency program graduates; residents are awarded certificates of completion, but the individual resident practitioner is not certified.

The Council on Credentialing in Pharmacy (CCP) was formed in 1998 by a consortium of organizations dedicated to providing leadership, standards, public information, and coordination of voluntary pharmacy credentialing programs.[111] The CCP was established by 11 founding member organizations: the Academy of Managed Care Pharmacy, the American Association of Colleges of Pharmacy, the American College of Apothecaries, ACCP, ACPE, APhA, ASCP, ASHP, BPS, CCGP, and the Pharmacy Technician Certification Board. The Council is dedicated to ensuring that pharmacist credentialing is a credible process that is understood by all stakeholders, including patients, payers, other health professionals, and the quality assurance leadership in hospitals and health systems.[112] The CCP is attempting to establish a more coordinated approach to guide the profession through the development of new, voluntary, post-licensure certification processes. The Council also hopes to determine and clarify the relationships among the profession's various credentialing activities.[111]

A coordinated national strategy to clarify pharmacist credentialing processes clearly is needed. The proliferation of credentialing processes and certification programs that do not undergo rigorous review and assessment and that may not require prior training or experience could undermine pharmacists' credibility with providers, the public, and payers. We strongly support the continued evolution of post-licensure pharmacist credentialing. However, we believe that credentialing within the pharmacy profession should meet rigorous national standards. Therefore, pharmacist certification would be administered best through a coordinated national certification board that assures assessment of knowledge and skills while also validating the appropriate level of training or experience. Logically, this certification board would include BPS to conduct specialist certification and an analogous body to carry out nonspecialist certification. We further suggest that the entire voluntary pharmacist credentialing process (including certification and perhaps postgraduate training) should be coordinated by a national, broad-based credentialing coalition, such as the CCP (should it choose to assume this role) or an alternate governing body as depicted in Figure 2. We recommend that this proposed model for pharmacist credentialing be explored further in a future ACCP thought paper. Finally, the subcommittee also endorses pharmacist participation in national interdisciplinary certification processes as previously described (e.g., CDE).

It is important to recognize that many of the newly emerging credentialing mechanisms are intended to serve primarily as a temporary "bridge" to the future. That is, effective retraining processes will be required by many of today's pharmacists as they prepare to "retool" to assume new patient care roles. However, it is reasonable to expect that future doctor of pharmacy graduates will possess the abilities necessary to enter the profession as effective generalist practitioners and should not require retooling. The profession should be prudent in its approach to developing and managing these retraining processes; creating a plethora of "extra" postgraduate certificates that all pharmacists would be required to complete to engage in clinical practice should be avoided. Structured and systematic postgraduate education experiences (i.e., certificate programs) should provide much of the retraining that will be needed by the current pharmacist workforce. Therefore, we favor development of well-designed certificate programs that pharmacists can complete as part of a nonspecialist certification process (as discussed previously). Such nonspecialist certification could serve as a basis for the credentialing of today's nonspecialist pharmacists who desire access to particular practice privileges or reimbursement. More importantly, we hope that this process might help the profession to establish new and more appropriate domains of the professional knowledge, skill, and experience to be tested in future licensing exams.

We view disease-specific credentialing processes (such as those administered by NISPC), as currently constituted, in a mixed light. On the positive side, such programs can improve the practitioner's knowledge base, may allow pharmacists to have increased impact on patient care outcomes, and may provide a basis on which to qualify for reimbursement from some payers. On the negative side, these programs are limited in scope, require no clinical training or clinical experience, and may fragment patient care. Furthermore, if a pharmacist's disease management abilities are limited to only selected diseases, he or she may not be able to impact fully the number of patients that health care payers expect. We also are concerned that a pharmacy practitioner could be credentialed in an area of disease management without having acquired any prior clinical patient care experience. In our view, this could compromise patient care.

The role of generalist pharmacist certification remains to be determined. As it has not yet been developed, a pharmaceutical care certification cannot be evaluated. However, pharmaceutical care is a philosophy of practice that the Commission to Implement Change in Pharmaceutical Education characterized as follows:

"Pharmaceutical care focuses pharmacists' attitudes, behaviors, commitments, concerns, ethics, functions, knowledge, responsibilities, and skills on the provision of drug therapy with the goal of achieving definite outcomes toward the improvement of a patient's quality of life. These outcomes of drug use are: (1) cure of a disease; (2) elimination or reduction of symptoms; (3) arresting or slowing a disease process, (4) prevention of disease; and (5) desired alterations in physiological processes, all with minimum risk to patients. Just as it is generally assumed that physicians are primarily involved in medical care and nurses in nursing care, pharmacists are the primary providers of pharmaceutical care."[13]

It appears that it would be virtually impossible to describe a unique set of knowledge and skills that would encompass the domains for certification of pharmaceutical care. Even if such a set of domains were defined, the breadth of such a certification program would be enormous, presumably approaching the outcome expectations for the doctor of pharmacy degree. Furthermore, it is inconceivable to us that the profession or public would find value in certifying a philosophy of practice -- to follow the analogies from the previous quotation, medicine has no "medical care" certification and nursing does not certify "nursing care." On the other hand, if it is clinical skills and selected drug- and disease-specific knowledge that are desired, it is conceivable that appropriately focused and standardized certificate or training programs could be designed to meet practitioner needs effectively.

Our impression is that the CCGP certification process involves pharmacists actively practicing in geriatric and long-term care settings. However, we still view the absence of any explicit requirement for prior clinical training or clinical practice experience as a potential weakness of this certification process, as noted for the disease-specific programs.

As a final caveat, we encourage those involved in current and future pharmacy certification processes to study and assess the value of certification. While acknowledging the potential benefits of certification, we are aware of no published data that have examined the effects of any pharmacy certification process on patient outcomes, including technician certification, specialist pharmacist certification, or generalist pharmacist certification. Until such data are available, it may be difficult to convince pharmacists, other health professionals, payers, or the public of the benefits of certification. In this regard, we believe that mechanisms should be explored to include BPS-certified clinical specialists in the national NABP database (or analogous credentialing directory) that currently catalogs pharmacists who have been credentialed in disease management. This would allow ready identification of those specialty-certified and disease-certified practitioners who could be available to participate in patient outcomes studies or pilot reimbursement programs (e.g., Mississippi Medicaid waiver program).

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