PHARMACEUTICS, ISSUES IN PRESCRIBING

During much of the fourth quarter of the twentieth century, discussions of ethics in prescribing tended to focus on the physician–patient relationship, the quality of patient care, and on patient rights. By the turn of the century, another set of considerations began receiving consistent attention in the United States: issues raised for the prescribing clinician by some healthcare business practices. Most of the ethical issues related to prescribing decisions and behavior fit into one of these two, sometimes overlapping, categories.

Prescribing and the Clinician–Patient Relationship

In the traditional medical model of rational prescribing, the patient presents challenging symptoms that the physician investigates and then diagnoses a disease. Based on this diagnosis, the appropriate drug and/or non-drug treatment is prescribed. Emphasis is placed on accurate diagnosis and application of pharmacologic principles, which govern the use of safe and effective drugs to treat a disease (O'Hagan).

The prescribing of medication, which occurs in most physician–patient encounters, does not, however, always occur through the application of this rational model. Many prescriptions are written on the basis of careful diagnosis and assessment, but sometimes other factors are involved as well.

Patients often expect prescriptions. A friend or a family member may have experienced some benefit from a medication given for a similar symptom. Direct-to-consumer advertising has raised patient expectations, both that prescribed medications are needed and that they will be beneficial. The public is led to accept the principle that there is a pill for every ill (Morgan and Weintraub; O'Hagan). The physician is expected to "do something" for the patient. Patients may feel confident that something concrete has been offered when given a prescription. Regardless of how trivial the complaint may be, the patient's sick role is legitimated by a prescription. It validates the doctor visit and allows future visits for vague symptoms (Stimson; O'Hagan). It is quite possible, however, that physicians may be overestimating the extent to which patients actually desire medications (Frølund).

Physicians are regularly exposed to education and marketing that highlights the use of medications in patient care. Physicians frequently have little time to spend speaking with patients about non-drug regimens, which may contribute to the frequency of prescription writing. Many physicians, like many patients, expect that something will be done in a patient–doctor encounter. Prescribing is a common way for the physician to intervene. It also allays the physician concern that the patient may be unhappy if not given a prescription and go elsewhere for the medicine believed to be necessary (Schwartz, Soumerai, and Avorn).

Some have suggested that a prescription may even help the physician define the disease in situations where the diagnosis is uncertain (O'Hagan). "I prescribe an antibiotic, therefore the patient has a bacterial infection." Or "I prescribe a tranquilizer, so the symptoms must be due to anxiety." Reimbursement requirements of insurers may reinforce this attitude, since often a diagnosis is expected even if the physician is uncertain.

Clearly, it is more difficult not to prescribe than to prescribe. Medicines are generally viewed as good, and prescribing as a beneficent act. Nevertheless, there are some developments in American medicine in the beginning of the twenty-first century that place more emphasis on the risks associated with medications and on the importance of prescribing medications only when there is a good medical reason for do so. The Institute of Medicine in 1998 identified misuse (interventions causing preventable complications) and overuse (unnecessary interventions or treatment for clearly inappropriate indications) as healthcare quality problems, in addition to under-use (failure to provide proven effective interventions). The movement toward "evidence-based" healthcare, which stresses the importance of having a foundation in medical experience and research for interventions, discourages treatment that cannot be supported scientifically. The growing recognition of the risks of "polypharmacy" means that more emphasis is being placed on the harm done by multiple medications and their interactions (Colley and Lucas).

These and related developments have supported the efforts of some physicians (and others in healthcare) to highlight the ethical importance of avoiding unnecessary prescribing.

Placebos

The question of whether, or when, the prescribing of placebos is ethically acceptable has received considerable attention at least since the 1970s. Placebos can relieve symptoms and they are one way that physicians can please patients who expect a medication without prescribing unnecessary drugs. The use of placebos might appear, therefore, to benefit patients without much risk of harm (Schwartz et al.). The major objection to the use of placebos is based on the conviction that, however well they might work, prescribing placebos is a deception of patients and is a basic violation of their right to be informed about the diagnosis and the treatment (Bok). Long-term placebo treatment might divert attention from the cause of a patient's complaints, possibly resulting in a serious medical problem going unrecognized and untreated. In addition, the patient may lose trust in the physician upon recognizing the deception (Schwartz et al.).

The use of placebos received renewed attention near the end of the twentieth century in the United States with the movement to improve the management of patient pain. The use of placebos in response to patient request for pain relief became a focus of special concern. For many, prescribing placebos for pain relief is, in effect, a refusal to accept the patient's own perception of pain and was incompatible with a pain management program based on taking patient reports of pain seriously. Some hospitals developed policies prohibiting the use of placebos for symptoms of pain or for all treatment purposes, permitting placebos only as part of a clinical study approved by an institutional review board (IRB).

Healthcare Business Practices and the Writing of Prescriptions

As discussed above, some of the enduring concerns about ethics in prescribing focus on the quality of patient care and on the nature of the clinician–patient relationship. A commitment to professional competence and to professional integrity requires that these concerns continue to receive careful attention. In recent years, however, there has been a growing concern about another aspect of ethics in prescribing: the potential impact of different healthcare business practices on prescribing decisions and behavior. The practices of pharmaceutical companies and of health insurance plans are of particular interest in this regard.

Pharmaceutical companies invest heavily in marketing and most heavily of all in marketing to physicians (Johnson; Relman and Angell). Drug company representatives visit physician offices regularly and frequently, bringing information on their company's products, free samples, and gifts for the physician and staff. The sales representatives often have information on the physician's individual prescribing habits and are prepared to influence specific prescribing decisions (Kowalczyk).

As studies have demonstrated, physician prescribing is often affected by interactions with drug company representatives (Wazana). Drug companies market their products to provide patients with good and needed medicines, but they are also highly focused on profit and on market share. Physicians acquire some useful and important information from sales representatives, but they are at some risk of compromising their professional judgment by participating in these interactions. To protect the quality of healthcare, it is important to minimize the influence of (potentially) biased information and the influence of the personal interactions with sales representatives.

Influences can be present even when they are not recognized, when the individual is not aware of what is affecting a particular decision or action. Some physicians have decided that the best way of interacting with drug company representatives is not to see them at all (Griffith). While much of the concern about physician relationships with drug companies has been focused on the acceptance of gifts (American Medical Association; Coyle), the issue is more extensive than that. Marketing and objective education simply may be two quite different things.

The acceptance of free samples of medicines is also being questioned by some bioethicists. These medications are often used for patients with limited resources or to test whether a particular medication is effective for a specific patient. Once started, however, a medication is often difficult to change, even when it may not be the best for the patient or when the cost cannot be justified. Free samples are especially problematic when the sales representative rather then the physician decides which medications will be provided as samples.

Ethical challenges in prescribing are also raised by healthcare insurance industry practices. The use of formularies and a tiered schedule of pharmacy co-pays are two such practices. Healthcare plans publish lists of covered and of recommended medications for specific symptoms or diagnoses and provide physicians with clinical guidelines for recommended treatment. The insured are often charged different co-pays for different medications (for example, a lower out-of-pocket cost for generics, higher for recommended brand drugs, and highest for nonrecommended brand-name drugs).

Insurance plans are seeking to control costs through these practices. They are encouraging the use of the lowest cost medications or treatments appropriate. Physicians are free to prescribe whatever they think best, but they risk being identified as providers who are not following the plan's guidelines. In addition, their prescribing decisions have a direct impact on the patient's personal pharmacy expenses.

These practices raise the question of the clinicians' responsibility in regard to the cost of the medications they prescribe. Many physicians, at least until recently, have not routinely considered the cost when making medication decisions. In fact, based on the belief that the physician's responsibility is to do what is best for the individual patient under care, it has often been considered inappropriate to allow the cost of the treatment to play a significant role in the recommendation for medical treatment. This understanding of the meaning of patient advocacy was widely challenged at the beginning of the twenty-first century.

In a statement that has received considerable attention and support, James Sabin argued that physicians do have an ethical responsibility to act as stewards of society's healthcare resources. "As a clinician I believe it is ethically mandatory to recommend the least costly treatment unless I have substantial evidence that a more costly intervention is likely to yield a superior outcome" (Sabin, p. 859). If a physician's responsibility to patients includes taking cost into account, it makes good ethical sense to conform to an insurer's practice that promotes lower cost medications, whenever that "substantial evidence" of a more expensive medication being more effective does not exist.

Wise use of available medical resources is one rationale for physician attention to the cost of the medications prescribed. Another reason is respect for the patient role in making informed consent decisions. If patient out-of-pocket expenses are greater for one medication than another (because of lack of healthcare insurance coverage or because of a tiered co-pay system), the patient needs to know, in advance, the relative difference in price. The patient needs to know, as well, the prescriber's rationale for recommending a higher-cost drug, when that is the case. Without both pieces of information, the patient does not have all the information necessary to determine whether to consent to the recommended treatment.

Some cost-driven insurance company practices support (or are compatible with) high-quality prescribing decisions and some do not. The physician needs to distinguish between the two and act to protect the patients' best interests and their own professional integrity. Knowledge of the general costs of the medications that one prescribes is, it seems, an essential component of responsible practice.

The ethical considerations related to prescribing treatment, especially prescribing medications, can be expected to receive continuing attention—and perhaps significantly increased attention—in the early part of the twenty-first century.

david t. lowenthal

george j. caranasos (1995)

revised by leonard j. weber

SEE ALSO: Addiction and Dependence; Conflict of Interest; Informed Consent; Life, Quality of; Placebo; Pharmaceutical Industry; Psychopharmacology

BIBLIOGRAPHY

Bok, Sissela. 1974. "The Ethics of Giving Placebos." Scientific American 231: 17–23.

Colley, C.A., and Lucas, L.M. 1993. "Polypharmacy: The Cure Becomes the Disease." Journal of General Internal Medicine 8: 278–283.

Coyle, Susan L., for the Ethics and Human Rights Committee, American College of Physicians—American Society of Internal Medicine. 2002. "Physician-Industry Relations." Annals of Internal Medicine 136: 396–406.

Frølund, Fleming. 1978. "Better Prescribing." British Medical Journal 2(6139): 741.

Griffith, David. 1999. "Reasons for Not Seeing Drug Representatives." British Medical Journal 319: 69–70.

Institute of Medicine National Roundtable on Healthcare Quality. 1998. "The Urgent Need to Improve Health Care Quality." The Journal of the American Medical Association 280: 1000–1005.

Johnson, Linda. 2003. "Drug Makers Continue to Bolster Sales Legions." Associated Press June 2, 2003.

Kowalczyk, Liz. 2003. "Drug Companies' Secret Reports Outrage Doctors." The Boston Globe May 25, 2003: A1.

Lowenthal, David T.; Levy, G.; Lavy, N. W.; McMahon, F. Gilbert; et al. 1990. "That None Should Be Denied." Clinical Pharmacology and Therapeutics 47(3): 422–423.

Morgan, John P., and Weintraub, Michael. 1974. "A Course on the Social Functions of Prescription Drugs: Seminar Syllabus and Bibliography." Annals of Internal Medicine 77(2): 217–222.

O'Hagan, J. J. 1984. "What Influences Our Prescribing?—Some Nonpharmacological Issues." New Zealand Medical Journal 97(756): 331–332.

Relman, Arnold S., and Angell, Marcia. 2002. "America's Other Drug Problem." The New Republic December 16, 2002: 27–41.

Ryde, David. 1976. "Does the Patient Really Need a Prescription?" Practitioner 216(1295): 557–559.

Sabin, James. 1994. "A Credo for Ethical Managed Care in Mental Health Practice." Hospital and Community Psychiatry 45(9): 859.

Schwartz, R. K.; Soumerai, S. B.; and Avorn, J. 1989. "Physician Motivations for Nonscientific Drug Prescribing." Social Science and Medicine 28(6): 577–582.

Stimson, G. V. 1976. "Doctor-Patient Interaction and Some Problems for Prescribing." Journal of the Royal College of General Practitioners 26(Suppl. 1): 88–96.

Wazana, Ashley. 2000. "Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?" The Journal of the American Medical Association 283: 373–380.

INTERNET RESOURCE

American Medical Association. 2003. "Gifts to Physicians from Industry." Available from <http://www.ama-assn.org>.