Biomedical Ethics & Pharmacy Issues in Long-Term Care Facilities

by Jonathan Evans, MD, CMD
Associate Professor of Medicine
Chief, Section of Geriatric Medicine
University of Virginia
Charlottesville, VA

Consultant pharmacists play a critically important role in promoting and assuring quality of care for long-term care facility residents. In addition to serving as an important resource for drug prescribers, they offer valuable assistance to nursing home staff with regard to drug administration issues, and perform an essential auditing and oversight role by periodically reviewing the medications and diagnoses of all facility residents. In addition, they assist facility staff with regulatory compliance, and their knowledge of medication costs helps control expenses for residents, facilities, and third party payers alike.

Despite the obvious importance and value of consultant pharmacists to facility residents and staff, however, economic forces aimed at reducing overall long-term care costs have contributed to change the role of consultant pharmacists in ways that have the potential to undermine their effectiveness as well as their credibility. As a consequence, quality of care may ultimately be threatened, along with the professional respect and esteem that consultant pharmacists are accorded.

Oversight & Quality of Care

The discovery and development of new drug therapies over the last century represent some of the most significant achievements in public health in modern history, and have substantially contributed to impressive increases in life expectancy. Nevertheless, drug therapies are associated with substantial health risks, particularly among the elderly. In addition, drug therapies are increasingly associated with substantial financial outlays by patients, third-party payers, and governments. Concerns about drug safety as well as rising drug costs have prompted changes in public policy as well as changes in health care financing.

The Nursing Home Reform Act (often referred to as OBRA '87) required all nursing facilities participating in Medicare or Medicaid to ensure that the medications of all facility residents are periodically reviewed by a consultant pharmacist. The purpose of this regulation was to improve the quality of care for residents by creating a mechanism for medication oversight. The intent was to reduce unnecessary drug use as well as to assure that all medications administered had appropriate indications, were administered in proper dosages, via appropriate routes, for appropriate duration of therapy, with appropriate monitoring. This is especially important given that older residents are especially vulnerable to the harmful side effects of medications, and may be unable to communicate symptoms or problems when they develop.

The effectiveness of consultant pharmacist oversight in nursing facilities is supported by data that demonstrate substantial reductions in psychotropic drug and chemical restraints use. Moreover, consultant pharmacists are uniquely qualified, by virtue of their training and experience, to evaluate drug-drug interactions and other issues related to drug administration, such as which medications can be crushed for ease of oral or enteral administration without compromising drug efficacy or safety.

Independence vs. PPS

The traditional role of consultant pharmacists has been to support the quality of care through oversight and auditing of medication prescribing and administration, as well as review of facility policies and procedures concerned with medication and pharmacy issues.

Until recently, these services typically were provided by independent consultant pharmacists, working part-time for individual facilities, whose services were paid for directly by the facility itself--not passed on to residents, and not reimbursed by third party payers. Thus, consultant pharmacists represented an expense for nursing facilities. However, the expense of medications was not borne by the facility--rather, this was an expense borne by residents and third party payers.

When Medicare began the prospective payment system (PPS) for skilled care in nursing facilities, it did so with the intention of controlling the cost of long-term care by limiting payments to facilities and by shifting the burden of expense management away from the government and onto the facilities.

In the past, when facility staff were responsible for procuring and administering medications--but not for paying for them--they generally chose nearby pharmacies on the basis of their ability to provide medications quickly, reliably, and conveniently. This changed somewhat as many facilities shifted toward providing more skilled care, which resulted in a greater dependency on pharmacy services and contributed to the growth of large-scale pharmacy providers across the country.

Once facilities bore responsibility for the cost of medications, it became a matter of economic necessity to seek lower-cost sources of medications and other biologicals. Consequently, facility staff searched further afield for better prices, and corporate parents of individual facilities often negotiated with large-scale pharmacy distributors for exclusive contracts securing lower prices for all of their facilities. Consultant pharmacy services were included free of charge or at a reduced cost as part of the overall pharmacy contract.

On the positive side, larger-scale pharmacy providers did help to improve and streamline drug administration processes within facilities, which helped to improve the quality and efficiency of care; this, in turn, contributed to lower costs.

Despite the obvious benefits of this new model, however, consultant pharmacists were no longer unaffiliated, independent contractors whose primary function was to provide quality assurance by helping to identify and discontinue unnecessary or inappropriate medications. They were now employees of corporate pharmacy service providers whose profits were derived from the sale of medications in general, and whose profit margins in some cases were favored by the sale of certain drugs in particular.

As a consequence of the "new economy" of pharmacy services, the primary and historical role of consultant pharmacists, once separate and independent, has now become married to large pharmacy providers; their financial performance may be tied to their ability to sell drugs, and to sell certain drugs especially.

Within the last two years, at least one national pharmacy provider faxed virtually identical prescriptions to physicians across the country--for their "convenience" and requiring only their signature--in order to begin their patients on lipid-lowering therapy with a particular brand of statin drug.

Although some might view this as a public health measure, based upon guidelines for lipid-lowering therapy in younger patients, many physicians who received these faxes reacted with justifiable concern, both because of the lack of demonstrable benefit and unknown safety among older nursing home residents, as well as the considerable expense of these medications. That a single brand-name drug was being recommended out of an entire class was also of concern, and raised obvious concerns about a profit motive for the pharmacy provider.

Shades of Enron?

For much of this year, the national news has been dominated by corporate scandals characterized by greed, dishonesty, and conflicts of interest. These scandals are threatening to affect the entire national economy, as well as the nation's trust in public and private institutions.

Emblematic of these corporate scandals is the scandal involving Enron and Arthur Andersen, for which Andersen was found guilty of fraud. Enron was notable at the time for being the largest corporate bankruptcy in American history, an event brought about by unethical business and accounting practices that destroyed investors' trust in the company.

Enron's wrongdoing occurred under the supposedly "watchful eye" of Arthur Andersen, among the nation's oldest and most prestigious public accounting firms, whose very name had symbolized honesty and integrity for nearly a century.

Andersen earned its reputation for integrity as an independent auditor. In recent years, however, its independent auditor function became dependent upon its larger business as corporate consultant--a business with different interests altogether. These interests came into conflict in situations such as Enron, in which improper accounting practices were not only approved of by the "independent" auditor--but, also, the auditor had been instrumental in helping to invent those improper practices in its capacity of corporate consultant.

Meanwhile, analysts at brokerage firms with their own conflicts of interest continued to recommend the stock.

Consultant pharmacists stand at a similar crossroads. They have tremendous potential to positively influence the quality of care, and the health of millions of people. That potential is based not only on their knowledge and skill, but on the faith and trust that prescribers and patients place in their hands. High standards of professional integrity are essential to support and maintain the profession of pharmacist. Consequently, the profession has the most to lose if consultant pharmacists come to be viewed as marketers and sales agents.

Long-term care facilities have their own public image to contend with. In order to maintain their legitimate role as patient advocates, facility administrators and staff should strongly consider hiring their own independent consultant pharmacists to perform the auditing and oversight function required by federal regulations.

Physicians and others caring for residents in long-term care are expected to act in the best interest of the patient. Although physicians prescribe medications, the ethical tradition in the field of medicine generally holds that it is unethical for physicians to sell medications to patients, because of the potential for patients to suffer as a result of this potential conflict of interest. In that same moral and ethical tradition, it is best for the patient, and therefore best for long-term care in general, if consultant pharmacists remain truly independent from pharmacy providers, in order to avoid even the appearance of a conflict of interest.

Complicating the role of consultant pharmacist by coupling the auditing and oversight role with marketing and formulary management is likely to alienate physicians, who may come to view consultant pharmacists with distrust. The result will be to diminish the positive impact of consultant pharmacists on the quality of care.

The opinions expressed by Dr. Evans are his own and not necessarily those of the American Medical Directors Association.

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