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ACCP Report

Washington Report: Medication Therapy Decision-Makers Should Not “Own” or “Sell” the Medications They Select

Written by C. Edwin Webb, Pharm.D., M.P.H. Director, Government and Professional Affairs

Washington Report

The pharmacy profession, through both individual and joint pronouncements of several of its national organizations during the past 4 years, has published bold expressions of the appropriate and necessary transformation of the pharmacist’s role in patient care to promote and achieve higher quality medication decision-making, use, and outcomes. For example, from the Joint Commission of Pharmacy Practitioners “Vision Statement for 2015” (2005) comes the following regarding the role of pharmacists:

Pharmacists will have the authority and autonomy to manage medication therapy and will be accountable for patients’ therapeutic outcomes.
As experts regarding medication use, pharmacists will be responsible for rational use of medications, including the measurement and assurance of medication therapy outcomes.

From the consensus definition of “medication therapy management,” developed and approved by 11 national pharmacist/pharmacy organizations in 2004, comes the following elements of practice activity of health professionals performing medication therapy management:

Selecting, initiating, modifying, or administering medication therapy;

From the ACCP statement to the Institute of Medicine Committee on Identifying and Preventing Medication Errors (2005) comes the following on the need for change in the processes of medication decision-making:

Substantial change in provider responsibilities, care processes, and the systems and procedures that constitute the current medication use process must occur if meaningful improvement in the quality of medication use, including the prevention of avoidable medication errors, is to be achieved.
Why should we not expect pharmacotherapy to be provided by and be the responsibility of a health care professional with specific and comprehensive education, training, and expertise in that area of clinical care?

Inherent in these and similar pronouncements for the past several years is the belief that the contemporary pharmacist is the health care professional best prepared by formal education, clinical training, and professional commitment to make medication use decisions (dare we call it “prescribing?”). Whether in the context of a collaborative practice model of care or, as suggested by some, in an autonomous practice structure, if this is the profession’s future, what elements of the current practice model and structures must be changed to effectively achieve it?

Extensive discussion has occurred regarding pharmacists’ education and clinical competence, credentialing requirements, models of collaborative practice, payment for professional services, and roles and responsibilities of pharmacy technicians. But a much more fundamental issue has received virtually no attention during this period of strategic thinking and planning. That issue is the fundamental question of the conflict of interest, whether real or perceived, that would exist in continuing to “own” and “sell” for some level of profit (i.e., the dominant current economic model of most pharmacy practices) prescription medications, which, in the envisioned model, pharmacists would be responsible for “selecting” when initiating and managing patients’ pharmacotherapy.

Such a conflict of interest has long been appreciated and addressed in the traditional system of prescribing by physicians. For more than 20 years, the active policy of the Council on Ethical and Judicial Affairs (CEJA) of the American Medical Association has stated that:

Although there are circumstances in which physicians may ethically engage in the dispensing of drugs, devices, or other products, physicians are urged to avoid regular dispensing and retail sale of drug, devices, or other products when the needs of patients can be adequately met by local ethical pharmacies.1

Subsequent reports of the CEJA have provided additional guidance on the sale of other health-related products (other than prescription medications) from physicians’ offices as well as non–health-related products. In almost all cases, such activities are discouraged because they “present a financial conflict of interest, risk placing undue pressure on the patient, and threaten to erode patient trust and the primary obligation of physicians to serve the interests of their patients before their own.”2

The JCPP Practice Model

The practice model articulated in the “JCPP [Joint Commission of Pharmacy Practitioners] Vision for Pharmacy Practice in 2015” is constructed around a “three-legged stool” framework consisting of:

  • Direct patient care services that assist patients in achieving effective and safe medication therapy outcomes (ACCP members would likely call this “clinical pharmacy practice”);
  • Supervised systems that provide safe, accurate, and efficient medication distribution; and
  • Services (and products) for promotion of wellness, disease prevention, and health improvement.

The model anticipates that pharmacy practice in 2015 will ideally provide this full scope of activity regardless of the setting in which the services are delivered, although there will probably be practice settings that choose to limit their scope of activity to only one or two of these elements, just as any health care setting may consciously choose to limit its scope of services. Regardless of scope, however, it is essential that the profession’s leadership begin to think strategically about its desired economic future and to identify appropriate, and legal, mechanisms to engage a range of other stakeholders in examining the changes in the economic model of pharmacy practice that are necessary to align it with the practice vision on which the profession has staked its future success.

The Imperative for a Strategic Examination of Pharmacy’s Existing Economic Model,

Although the “conflict of interest” question may be among the most fundamental of economic challenges affecting pharmacy’s transition to a patient services–centered practice model, there are other, related economic issues that, if explored and addressed, could conceivably contribute to a more rational, defensible, and publicly understood paradigm for the economics of medication use in patient care. These could include:

  • The desirability for all pharmacy practices to generate appropriate and fair revenues from the provision of patient care services that enhance medication use quality and outcomes;
  • The development and implementation of “firewalls” between practice activities and economic/accounting procedures that would prevent conflicts of interest between the core elements of the JCPP-envisioned practice model;
  • The opportunity to manage, or perhaps eliminate, the large and growing burden of acquisition and inventory costs of medications on pharmacy practices, particularly current and future high-cost medications and biotechnology products. This could be accomplished through conversion to a system of product consignment, with ownership of product retained by the manufacturer or wholesaler until its distribution to the patient;
  • As a result of a “consignment approach,” the opportunity to invest more of the limited capital resources of pharmacy practices in patient care services and the facility reconfiguration that would support these services;
  • The opportunity to develop, promote, and justify a transparent fee structure for the order processing and medication distribution components of the practice model that accurately reflects the costs of such activities;
  • Placement on the manufacturer and/or wholesaler the responsibility (and eventual economic impact) for negotiating with payers the value of (i.e., level of reimbursement for) prescription medications within health benefit plans.

The legal prohibition against anticompetitive activities does, undoubtedly, present substantial barriers to a purely intraprofessional and intrapharmaceutical industry discussion of many of these issues. Consequently, the profession and the pharmaceutical industry could seek, perhaps together, to engage appropriate national leaders in the health policy community who might agree to facilitate the type of “out-of-the-box” thinking on economic reforms that would more effectively support the envisioned practice model.

ACCP President-Elect John Murphy will soon be impaneling a special task force of past presidents to assist the College leadership in exploring the specific issue of addressing conflicts of interest that arise between ownership and sales of prescription medications and the pharmacist’s scope of practice as a pharmacotherapy decision-maker. As a part of that process, the College will be engaging other organizations and interested parties in a discussion of this issue. We welcome the input and ideas of ACCP members on this subject. Comments can be directed to [email protected].


References
  1. AMA Council on Ethical and Judicial Affairs. In: Proceedings of the House of Delegates of the American Medical Association, 4th Interim Meeting. Chicago: AMA, 1986.
  2. AMA Council on Ethical and Judicial Affairs. Report 1-A-99. Chicago: AMA, 1999.