PharmD Accreditation Standards 2007: Much is Implied, Little is Required
- William H Campbell⇑The Accreditation Council for Pharmacy Education (ACPE) recently released revisedAccreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree. The new standards and guidelines (Standards 2007) will be effective July 1, 2007. A 3 year process of stakeholder input and feedback, public hearings, surveys, and extensive “formal and informal interactions [with the] accreditation community” preceded the release of Standards 2007.1 Readers of The Annals are surely among the most actively engaged stakeholders of ACPE and will unite around a goal of optimum accreditation standards for pharmacy education. The intent of this invited commentary is to initiate timely and useful dialog among the readership that may assist the ACPE prior to the scheduled implementation of Standards 2007.
Among the defining characteristics of a profession are the presence of a specialized body of knowledge, the requirement for advanced education by its membership, and the ability to regulate entry (and exit) of professionals to protect the public.2 Accrediting agencies and the educational requirements they promulgate, such as Standards 2007, are therefore important instruments of both public policy and professional self-interest. At risk of stating the obvious, this commentary is not a challenge to the authority of the ACPE. Quite the opposite, it is an affirmation of ACPE's vital role in ensuring a renewable professional resource to advance rational pharmacotherapy in support of public health. As advocates of ACPE, we are obligated to ask, “Will Standards 2007 adequately serve society's needs for rational pharmacotherapy?”
A SOCIAL CONTRACT IS ESSENTIAL
Long before Flexner conducted his study, leading medical educators and practitioners had agreed on the need form change. They advocated bringing scientific breakthroughs into the curriculum, instructing medical students in environments where faculty conducted state-of-the-art research and clinical care, and developing a system whereby graduates of any one program would be comparable to graduates of any other program. Physicians had promoted such reforms in medical education “as a means to increase professional status.”5 Flexner,4 however, redefined the matter as a failed contract between medicine and society. He asserted that social welfare is inextricably linked to the quality of the nation's physicians, and that:
If the sick are to reap the full benefit of recent progress in medicine, a more uniformly arduous and expensive medical education is demanded.
Flexner argued that the profession of medicine must be regarded as a “social instrument” for delivering health and avoiding death and disease, not as a special interest for achieving status or privilege. That both health care and social status were enhanced is beyond argument, but the linchpin that released the forces of change was adoption of a compelling social contract.
TIMIDITY IS THE ENEMY OF CHANGE
The implications of defining medicine as a social instrument responsible for achieving health were monumental. Flexner understood this and did not flinch from the difficult choices to be made. He did not apologize for concluding that, if an environment where faculty engage in state-of-the-art research and clinical care is essential, medical education must take place in university environments where those resources are guaranteed. If “arduous and expensive” medicine education is required, then it is not a “business to be exploited” and proprietary (for-profit) medical schools would not be tolerated. If uniform standards are needed to fulfill the social contract and some medical schools cannot meet these standards, then schools must be closed. In fact, half of the 155 medical schools were closed within a decade of the Flexner Report's release, and a century later we have only 121 medical schools in the US. The lesson we should take from this is that a bold vision, absent the will to make difficult decisions, is indistinguishable from an absence of vision.
DO NOT CONFUSE PROCESS WITH PROGRESS
It is instructive that Flexner did not engage in a “three year revision exercise,” nor did he engage “all stakeholders…and other health professions, and the accreditation community.” Flexner did not hold lengthy hearings or seek counsel from an alphabet soup of professional organizations; he did not pore over white papers, review the musings of futurists or thought leaders (who, after all, bear no responsibility for their prognostications), or rely on anonymous respondents for advice. Nor did he view his task as an incremental change to the status quo. Rather, he understood the need to establish the social purpose of medicine (ie, to produce health), and placed a magnifying glass on the one place where failure could neither be overcome nor success denied: medical education. In what can now be appreciated as a stunning achievement, he found a way for academicians to speak the truth.
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ACPE and Standards 2007
Accreditation of all health professions is in large measure a continuation of the landmark effort of Abraham Flexner. We ignore the lessons of medical education's transformation at our peril, but if we are sufficiently wise, we benefit from its example. With that in mind, it is instructive to describe the changes represented by Standards 2007 since the last revision (1997). The ACPE Board of Directors and staff have summarized these changes as falling within 4 categories:
- Philosophy and Emphasis
- Standards and Guidelines Revision Process Redefined
- Standards: volume and terminology
- Guidelines: volume and terminology
The extant standards and guidelines implemented in 1997 asserted for the first time in the history of pharmacy education accreditation as a social contract between the profession pharmacy and its public. An accredited program was required to6:
Acknowledge pharmaceutical care as an evolving mode of pharmacy practice in which the pharmacist, in concert with other health professionals, takes an active role on behalf of patients in making appropriate drug choice…and by assuming direct responsibilities…to achieve the desired outcomes of drug and related therapy.
This statement established the mission of pharmacy as pharmaceutical care and embraced it as the foundation for accreditation, just as a century earlier Flexner had established scientific medicine as the linchpin for change in medical education. An extensive literature and professional ethos evolved to understand pharmaceutical care and guide pharmacy education into the 21st century.7
The 1997 standards threw down the gauntlet to educate a new generation of practitioners who would take responsibility for the outcomes of pharmacotherapy. Two courses of action were implicit: programs would either choose to accept the challenge or not, and the ACPE would either Choose to enforce its direction or not. bold vision would require the will to make difficult decisions. Fourteen new programs were admitted to full or candidate accreditation status from 1997 to 2006. These programs represent a distinctly different cohort from their established colleagues: predominantly private institutions (12 of the 14) without access to the resources of a comprehensive academic medical center or research university. In such settings, it is certainly possible to provide a pharmacy education experience, but from my experience as a faculty member and administrator in diverse academic settings, it is decidedly more difficult in some settings than in others. Nearly two-thirds of current academic medical centers do not offer a degree in pharmacy and, based on the 1997–2006 cohort of new programs, academic medical centers do not appear to value pharmacy education as a growth opportunity. The converse may also be true: institutions with limited resources and commitments to a health mission find pharmacy education to be an attractive revenue opportunity. In either case, Flexner's words can be paraphrased to warn:
If the sick are to reap the full benefit of recent progress in pharmacotherapy, a more uniformly arduous and expensive pharmacy education is demanded.
Are we demanding a more uniformly arduous and expensive pharmacy education?
It cannot go without notice that Standards 2007 has completely omitted the references to pharmaceutical care that were central to the 1997 standards. The rationale for this exclusion is not clear, although the ACPE states that it is “not a deviation from the vision for pharmacy practice embedded in [the 1997 standards].” The rationale for the change is given as:
By using terms such as “patient-centered care” and “medication therapy management,” the standards and guidelines reflect contemporary terminology regarding the competencies of and services provided by pharmacists. Accordingly, the new wording should not require a fundamental change in the mission and goals of colleges and schools of pharmacy.
The explanation is not adequate. If there is no change implied in the new words, why not use the old words? Was it because the term pharmaceutical care carried connotations that were confusing or unhelpful? If so, those connotations should be described so they can be dealt with in a forthright manner. Was it because the term was too restrictive and needed to be expanded? If so, it is not clear what the areas for expansion might be, since the terms patient centered care, medication therapy management, and pharmacist-delivered patient care are even less descriptive. Was it because the term was too practice-centered and omitted research or other areas? One might draw that conclusion from the added references to postgraduate opportunities, scholarly opportunities, and interdisciplinary activities. However, it is very difficult to know whether this is the case, since all that Standards 2007 requires is support of postgraduate opportunities—that could mean merely acknowledging and encouraging such opportunities. If Standards 2007 intends a significant investment in commitment and resources to new scholarly areas, that can only be conjecture.
A skeptic might view the revision as changing the mission of pharmacy (and pharmacy education) from accepting responsibility for the outcomes of pharmacotherapy (ie, pharmaceutical care) to—well—anything. After all, what is meant by medication therapy management? It can be an ill-defined regulation drafted as part of Medicare Part D implementation; it can be a negotiating strategy for prescription benefit management companies; it can be a memorized (eg, Beers criteria) list of drugs; it can be anything an individual or (more germane to this discussion) an educational institution chooses. The term other scholarly activities is even less descriptive. It is an accreditation in wonderland experience that Alice would appreciate8:
When I use a word, Humpty Dumpty said, in a rather scornful tone, it means just what I choose it to mean–neither more nor less.
The question is, said Alice, whether you can make words mean so many different things.
Removing the requirement for programs to commit to pharmaceutical care without providing a clear alternative is not merely a change in terminology; it represents a fundamental weakness that affects subsequent parts of the standards. The 1997 standards required each program to commit to a mission of pharmaceutical care. From this mandated mission, various elements were to follow: a strategic plan, curriculum, faculty, students, facilities, financial resources, and other enabling factors. However, under Standards 2007, there is no commitment to social contract, merely a statement that the institution must prepare students to do what pharmacists do (ie, pharmacist-delivered care). Since this can be defined as anything, the strategic plan, the curriculum, the faculty, the facilities, financial resources, ad infinitum, can also be defined as anything. This is what is known in research design as a non-nullifiable hypothesis, where the original hypothesis is so vaguely stated that no amount of subsequent data or analysis can confirm or reject the hypothesis. Unfortunately, that is what Standards 2007 could become–a non-nullifiable hypothesis. There is precious little basis for withholding accreditation, because while much is implied, little is required.
On a technical note, the number of standards remains unchanged at 30, with minor editing. The revision process also involved restructuring and reorganizing standards and guidelines. The ACPE describes this as separating the revision process for guidelines from that of standards. Standards will be reviewed approximately every 6–8 years, while guidelines can be refined and improved ad hoc. It is difficult to understand how this can occur, since the standards and guidelines are inextricably linked. In fact, in the current revision some guidelines are described as “musts” (previously a defining feature of standards), and therefore indistinguishable to the reader from a standard. Any change in such guidelines would therefore affect standards and vice versa, rendering independent revision impossible. If the restructuring and reorganization of Standards 2007 are beneficial to the ACPE, then, as advocates of accreditation, we should support their implementation. However, in the scale of important changes in Standards 2007, restructuring and reorganization seem low priorities.
Long-time observers of the ACPE will recognize in Standards 2007 its stubborn insistence on obfuscation over clarity. Should one look for guidance on the financial resources required to deliver quality pharmacy education (Standard 30), the answer would be “the financial resources necessary to accomplish its mission and goals.” In other words, the resources required are the resources required. And if one should ask for guidance on mission and goals? The answer is that the program must “have a published statement of its mission…goals…and values…[and that] the statement must be compatible with the mission of the university.” In other words, there must be a mission, and it must be consistent with the university mission. Hardly a definitive requirement. This circularity of argument permeates Standards 2007 and, combined with the deletion of a guiding philosophy, limits any progress over the 1997 standards.
It is important for The Annals' readers to know that obfuscation is not a required or universal condition of health professions accreditation. A comparison of pharmacy education accreditation (in the form of Standards 2007) and medical education accreditation (in the form of current Liaison Committee on Medical Education version 2005) is instructive. Both pharmacy and medicine have accreditation standards that address the core curriculum.
A single, brief standard describes the core curriculum in pharmacy. It is reproduced in its entirety below.9
Pharmacy Standard (Curricular Core—Total)
To provide the thorough scientific foundation necessary for achievement of the professional competencies, the curriculum of the professional degree program must contain the following:
- biomedical sciences
- pharmaceutical sciences
- social/behavioral sciences
- clinical sciences
That's it. That is the entire statement of required curriculum content. Can any reader imagine a curriculum that would not meet such a vague standard? Could there be a better example of a non-nullifiable hypothesis?
Contrast this with medical education, in which the current accreditation manual for medical schools lists 14 separate standards for curriculum core. For example, one entire standard is on medical ethics and is reproduced below.10
Medicine Standard (Curriculum Core—Medical Ethics)
A medical school must teach medical ethics and human values, and require its students to exhibit scrupulous ethical principles in caring for patients, and in relating to patients' families and to others involved in patient care.
Each school should assure that students receive instruction in appropriate medical ethics, human values, and communication skills before engaging in patient care activities. As students take on increasingly more active roles in patient care during their progression through the curriculum, adherence to ethical principles should be observed and evaluated, and reinforced through formal instructional efforts.
In student–patient interactions there should be a means for identifying possible breaches of ethics in patient care, either through faculty/resident observation of the encounter, patient reporting, or some other appropriate method.
“Scrupulous ethical principles” imply characteristics like honesty, integrity, maintenance of confidentiality, and respect for patients, patients' families, other students, and other health professionals. The school's education objectives may identify additional dimensions of ethical behavior to be exhibited in patient care settings.
The above standard on medical ethics is combined with 13 other standards on topics ranging from basic sciences to behavioral sciences to multidisciplinary instruction. Can there be any doubt which approach provides the clearest guidance for achieving quality education? Clear and measurable standards represent nullifiable hypotheses that allow accreditation to delineate acceptable from unacceptable quality. To be very clear, the point is not that pharmacy education should have an identical statement to medicine about ethics (or any other topic). Rather, the point is that pharmacy accreditation should have clear and measurable standards and need not be consigned to an ineffectual non-nullifiable hypothesis approach. Ineffectual accreditation is a choice—not an inevitability
THE FUNDAMENTAL FLAW IN STANDARDS 2007 IS THE LACK OF A GUIDING PHILOSOPHY FOR PHARMACY EDUCATION AND PRACTICE
This omission cascades into ever-increasing levels of ambiguity. Absent any boundaries on the mission, it becomes impossible to impose boundaries on curriculum, faculty, students, facilities, financial resources, and other quality indicators. The inevitable result is a morass of circular arguments and non-nullifiable hypotheses, all of which are to be found in Standards 2007.
There must not be ambiguity on a matter of this importance. Given the absence of rigorous and measurable standards in the revision, it is difficult to envision a request for accreditation that ACPE could reject after July 1, 2007. More importantly, it is impossible to envision how the profession of pharmacy will contribute to the public's need for rational pharmacotherapy under Standards 2007.
Medicine was transformed only by speaking the truth about medical education. It is time for truth-telling in pharmacy education. What is spoken privately among all faculty and deans should be stated publicly: pharmacy accreditation has become an impenetrable tangle of educationspeak and jargon. None of us understands or can explain what the individual standards and guidelines mean, or their inter-relationships. Our ritual has all the trappings of ancient mystics peering into chicken entrails for hidden meaning. Enormous efforts are expended by faculties and administrators to prepare self-study reports. At best, these tomes gather dust for 6 years before becoming fodder for a new cycle; at worst, they become ammunition for volleys of (misnamed) progress reports. Dedicated, talented, conscientious volunteers form site visit teams and provide useful feedback, but the value of their feedback is inversely related to any linkage to standards. At the end of a school's formal review, a report is drafted that is so thoroughly word-smithed, boiler-plated, and sanitized that it offends—and helps—no one. The process continues year after year, accreditation after accreditation, revision after revision. Some programs get better, some get worse, some stay the same, but any change attributable to accreditation is coincidental. We can do better.
Many words have been changed in Standards 2007, but clarity has not been improved. An optimistic reading of the document might conclude that terms such as fostering innovation through basic and applied research and supports postgraduate professional education and training of pharmacists portend ACPE restoring much-needed rigor to accreditation. A more skeptical reading of the document, noting that hopes for greater rigor rest upon guidelines (which are optional) and vague standards, might just as easily conclude that even less will be required of accredited programs in Standards 2007. It appears that the ACPE has drafted a document that could move pharmacy education in either direction, with the determining factor being the intent and will of the ACPE.
As advocates of rational pharmacotherapy and a strong role for pharmacy accreditation in achieving that goal, we should urge ACPE to take the path demanded by quality and rigor. However, we will only know the path ACPE chooses by observing accreditation decisions made over the next 10 years under Standards 2007. During that period, great progress, or great harm, can take place. In order to tilt the balance of accreditation toward greater rigor and quality, I enlist The Annals' readers to support an agenda composed of 8 items.
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Eight Immediate Steps to Add Rigor to Standards 2007
1. The ACPE has made it clear that Standards 2007 is a final product and will be implemented in July 2007. It is too late to rewrite the standards so they can be understood by everyone. However, there is ample time for the ACPE to prepare a background paper that will prevent confusion. Two areas beg to be clarified: (1) the mission and philosophy of pharmacy practice and education and (2) the requirement (if any) for postgraduate training, graduate education, practice innovation, and research. The ACPE should confirm that each program must describe its vision of pharmacy practice, and the description must include pharmacists accepting responsibility for the outcomes of pharmacotherapy. Accredited programs should be required to describe in detail the characteristics of practice, such as patient population, technology support, information infrastructure, collaborative practice relationships, organizational setting, and other requirements, that each program's graduates will be prepared to enter. The portfolio of services a graduate is required to master must be identified and described in detail, such as, conduct a pharmaceutical care evaluation, develop an evidence-based pharmaceutical care plan, employ all necessary human and capital resources to monitor the plan, and manage the patient's drug therapy to achieve optimum outcomes. These descriptions must be specific to the circumstances and resources of individual settings.
2. Prescription dispensing is the 800 pound gorilla in pharmacy education and practice. It sits silently in the room, dominating every discussion by its mere presence. Standards 2007 continues this unfortunate tradition. We all know many pharmacists are prescriptionists, and many schools of pharmacy exist solely to prepare prescriptionists. All of the grand language in Standards 2007 about problem-solving skills, life-long learning, and patient-centered activities are rendered meaningless when accreditation can be awarded to prescriptionist programs. Yet there is nothing in Standards 2007 that remotely suggests prescription dispensing cannot be the primary mission of the program and its graduates. Only one vague statement addresses prescription dispensing in any form, one sentence in Guideline 12.1 that addresses the competency of “managing medication use systems.” All of the comments about pharmacist-delivered care, patient-centered care, community-based care, and avoidance of medication errors can be accommodated within the role of a pharmacist who exclusively dispenses prescriptions. If product distribution activities are the primary emphasis of an educational program, it should be defined as a pharmacy technician program and not eligible for a PharmD program. Standards 2007 should state this with unmistakable clarity.
3. Programs will be required to conduct continuous evaluation of their goals by monitoring the placement of graduates in professional practice. If less than 51% of the most recent (5 years or less) graduates who are in practice do not have some responsibility for pharmacotherapy outcomes in that setting, this will be considered evidence the program is preparing prescriptionists rather than pharmacists. After 2 years of substandard performance, the school or college of pharmacy will be placed on probationary accreditation status, with loss of accreditation automatic unless the 51% standard is achieved within one year.
A note of explanation may be helpful on this point. If students and graduates are required to accept responsibility for outcomes of care, a dose of the same medicine seems only fair for academicians. If they are supposed to be producing professionals, then placement of graduates is the fairest way to measure performance. If graduates cannot find careers, it must be because either the need does not exist (demonstrably not true) or the training is inadequate. In either case, the academic program is failing to fulfill its social contract. Admittedly, 51% is a low standard, and it should be increased to 90% in the next revision, but it is a starting point. A program that loses accreditation in this manner may still be able to contribute to health manpower by providing pharmacy technician training.
4. For academic programs to provide quality professional instruction, full-time faculty must be actively engaged in research in the pharmaceutical sciences and in delivery of contemporary pharmaceutical care. Faculty who cannot participate in expanding the body of knowledge required by practice and science cannot be expected to provide mastery level instruction to pharmacy students. Demonstration of active engagement in the pharmaceutical sciences must include extramural support, scholarly publication, scientific presentations, and supervision of graduate (Masters, PhD, postdoctoral) students. Faculty in the pharmaceutical sciences must be part of a focused and multidisciplinary effort to advance knowledge in the pharmaceutical sciences. On the postgraduate professional education side, an accredited program must be a primary sponsor of continuing pharmacy education, certificate, and pharmacy residency training for pharmacists. Faculty in the clinical sciences must participate in a focused and multidisciplinary effort to advance knowledge in patient care. Quantitative standards of faculty critical mass should be established by the ACPE. The current situation, in which small postsecondary institutions (it is difficult to use the term “university”) with fewer than 100 faculty can implement a PharmD program by hiring a handful of faculty, is incompatible with ensuring optimum drug therapy outcomes by pharmacists.
5. All accreditation standards and guidelines must be submitted to a linguistic analysis to improve clarity of expression. Private enterprise and state governments are demonstrating that plain-talk initiatives save money and increase productivity. We may not want to adopt rigid standards such as “17 words per sentence maximum,” but 2 people should be able to read the same accreditation standard and agree on its meaning.
6. Lessons learned in medical education (and other professional) accreditation should be reviewed to assist pharmacy education. Precise definitions, detailed explanations, and quantitative standards are preferred when possible. Each standard should be nullifiable; that is, clear in terms of what is accreditable, and equally important, what is not accreditable.
7. A way must be found to bring sunlight into the education and accreditation enterprise. This will perhaps be the most difficult challenge of all. I propose a blue-ribbon panel of pharmacy practitioners who have been recognized for providing state-of-the-art patient care. The membership should be 5–7 people who have been recognized for sustained contributions to patient-care practice and research and who have taught students as full-time faculty in schools of pharmacy. Experience in an administrative appointment (eg, department chair or dean) would not be a disqualifying criterion, but neither would it be helpful. The ideal cohort would be people who have provided innovative patient care in collaborative models of care and who have been recognized for excellence in teaching medical, nursing, and pharmacy students. While readership of The Annalswould not be a requirement for panel membership, it would likely be strongly correlated. The charge to this group would be straightforward: begin the next revision process immediately, by rewriting Standards 2007 to ensure that graduates of accredited programs will be able to accept responsibility for optimum outcomes of pharmaceutical care.
8. Self-study reports will be restricted to 25 pages or fewer. ACPE findings and recommendations will be restricted to 5 pages. Any appendix information will be shredded. All communications related to accreditation (including standards and guidelines) will be written in clear, declarative sentences, using active voice. If 25 pages is sufficient for the National Institutes of Health to dispense billions of dollars in support of the world's most sophisticated biomedical research, 25 pages is enough for a PharmD program accreditation.
- Philosophy and Emphasis
