What's a pharmacist to do?
HJ called a University Hospital Drug Information Center (DIC) to find out how to obtain a medication. She explained to the pharmacist that she had leukemia, presumably secondary to being exposed to low-level radiation as a child. HJ had read about a homeopathic medicine, Cell Saver, that is supposedly an antidote for cancer secondary to radiation exposure. However, her physicians were unable to give her any information regarding the medication.
The pharmacist contacted a local nutritionist and a homeopathic wholesaler to determine the product's contents and availability. The pharmacist discovered that Cell Saver consists of alcohol that "has been exposed to X-rays." The wholesaler indicated the patient should take two tablespoonsful four times a day at a cost of $4.53 per ounce, or about 60 cents a day. The "medicine" is available without a prescription directly from a local homeopathic wholesaler or from a homeopathic physician.
To the pharmacist's knowledge, there is no scientific data regarding either the efficacy or safety of Cell Saver in the treatment of leukemia. Moreover, the pharmacist was concerned that the patient, thinking the medication effective, would be less likely to obtain appropriate medical care.
Should the pharmacist: (1) inform HJ how to order Cell Saver without discussing its therapeutic value, (2) tell HJ that the medication is ineffective and withhold information on how to obtain it, or (3) discuss both its therapeutic uncertainty and provide the ordering information.
Should pharmacists give out information to patients without concern for how it may be used? Or should they regard information as a form of treatment and dispense it according to the patient's "best interests?" An affirmative answer to the first question accords with respect for patient autonomy; an affirmative answer to the second imposes severe restrictions on autonomy. In the case of HJ the best course of action lies somewhere between these two extremes; the pharmacist should both discuss the lack of therapeutic benefit of Cell Saver and provide the requested information. However, the pharmacist must consider several important practical questions and balance obligations to respect autonomy, avoid harm, and provide benefits, before coming to this conclusion.
First, has the patient considered the traditional medical option of chemotherapy? Chemotherapy, while not entirely safe or effective in treating leukemia, might still be more effective than Cell Saver. If HJ did not know about or even try the standard treatment, then the pharmacist should make certain she knows about the potential benefits of this option, since this treatment might help the patient (or at least prevent further harm).
It is likely, however, that the patient knows about chemotherapy and has decided to pursue some alternative form of treatment. The decision to try an alternative form of treatment should be the patient's choice, and the pharmacist should respect her self-determination and autonomy. However, autonomous decisionmaking assumes full information, so the pharmacist should make the patient aware of the lack of scientific data on the safety and efficacy of Cell Saver, since this information may affect her decision.
The pharmacist needs to be concerned with the safety of Cell Saver, but all he or she knows is that there is no scientific data to support a decision either way; it could be harmless, deadly, or mildly toxic. Given this lack of conclusive evidence, the pharmacist might be justified in assuming that Cell Saver is probably safe enough to use, and probably safer than chemotherapy. Cell Saver is just alcohol exposed to X-rays, and presumably won't cause great harm to the patient. Given this assessment, the pharmacist should not refuse to provide information on how to obtain Cell Saver.
However, if the pharmacist had scientific data showing that Cell Saver is unsafe, or at least some good reasons to believe it is not safe, then she should warn HJ about Cell Saver and not tell her how to obtain the medicine. This decision restricts the patient's autonomy, but it would accord with the pharmacist's duty to prevent harm. In circumstances where providing information may result in harm to the patient, the pharmacist could legitimately withhold the requested information.
Assuming that Cell Saver is reasonably safe, the pharmacist also needs to know more about its efficacy. How effective is Cell Saver and how does it work? Suppose that Cell Saver can be effective but that its mechanism of action depends on a strong placebo effect, and that telling the patient about the lack of scientific evidence in favor of Cell Saver will undermine this effect. Furthermore, suppose that HJ is opposed to chemotherapy and will probably opt for no treatment if she cannot obtain Cell Saver. In this situation, the pharmacist should tell the patient how to obtain Cell Saver but should not pass any judgment on its efficacy. This decision would restrict the patient's autonomy, since the patient would be lacking some important information, but it would conform to the pharmacist's duties to help and prevent harm. By refraining from passing judgment on Cell Saver's efficacy, the pharmacist does not undermine its possible placebo effects and by telling the patient how to obtain Cell Saver, the pharmacist allows her to try a reasonably safe and possibly effective treatment rather than choose no treatment at all.
In an ideal scenario, the pharmacist would have answers to the questions we pose above as well as other practical information, such as the patient's economic status and psychological profile. However, lacking definite answers, the pharmacist must rely on probabilities. Given these probabilities, the preferable course is to discuss the lack of therapeutic benefit of Cell Saver and provide information about how to obtain it since this choice respects patient autonomy, as well as the pharmacist's duties to do no harm and to help. The final decision on whether or not to use the medication should be made by the patient.
What role should clinical pharmacists play in providing drug information to consumers? This question has become increasingly relevant as the clinical role of pharmacists has expanded over the last several years. Approximately 150 Drug Information Centers (DICs) exist in the U.S. to provide accurate, unbiased, factual information to health care professionals and/or consumers. In this case a consumer (HJ) called a DIC with a specific question about how to obtain a medication; we shall assume she is competent to make her decision.
Three models of pharmacist-consumer interaction may be used to guide the pharmacist's actions.1 In the "librarian" model, the pharmacist sees his or her role as filling a public need for information. Thus a DIC should respond to all consumer questions unless the information is privileged or could be used for illegal purposes. The goal of the pharmacist is to reply accurately to consumers' questions so that they can make an informed decision.
According to this model, the pharmacist should respond only to the question he or she was asked. HJ did not call for information regarding the medication's efficacy, information about her disease, or an opinion about the use of Cell Saver; thus, for the pharmacist to discuss these matters would be presumptuous.
Most pharmacists, however, would argue that their role consists of more than merely dispensing information, and encompasses determining, in conjunction with the physician, what drug theraphy is best for an individual patient, and acting accordingly. This behavior is analogous to what Robert Veatch designates as the "priestly" model for physician conduct. The American Pharmaceutical Association's Code of Ethics seems to endorse this view for pharmacists, stating that "a pharmacist should never knowingly condone the dispensing, promoting, or distributing of drugs or medical devices, or assist therein, that are not of good quality, that do not meet standards required by law, or that lack therapeutic value for the patient."
Under the "priestly" model, a pharmacist would, after informing HJ about Cell Saver's lack of efficacy and the importance of receiving appropriate care, refuse to tell her how to obtain Cell Saver. The pharmacist may feel it is in the patient's best interest to withhold this information since it may be used inappropriately. By providing this information, a pharmacist would be encouraging the practice of quackery and possibly deterring the patient from seeking suitable medical attention and possible life-saving chemotherapy.
Finally, the pharmacist may choose a "counselor" role that combines attributes of both the "librarian" and "priestly" models. We feel this is the appropriate model in this case. As a "counselor," the pharmacist recognizes the patient's right to make a decision, but also feels responsible for helping the patient make an intelligent, informed decision. The pharmacist must first find out more about HJ's case: for example, the stage of her disease, her previous discussions with her physicians regarding Cell Saver, and whether she is receiving chemotherapy. Then, in addition to providing the requested information, the pharmacist should attempt to convince HJ that it is not in her best interest to take Cell Saver.
If HJ still wishes to take Cell Saver after this discussion, should the pharmacist tell her how to obtain it? The decision to supply this information is fairly straightforward if HJ is receiving standard chemotherapy, has a poor prognosis, and her doctors know of her decision to take Cell Saver. The risk of taking Cell Saver would then probably be minimal since the medication is not likely to be harmful and is not replacing standard therapy. In a more complicated situation where the patient is ambivalent about starting or continuing traditional chemotherapy, will not discuss Cell Saver with her physician, and/or has a potentially curable disease we would still advocate the "counselor" approach and supplying the requested information. Given the risk involved in this decision, the pharmacist must take special care to make sure the patient is aware of Cell Saver's lack of any therapeutic value and that potentially life-saving treatment may be available to her. However, the pharmacist has no insight into HJ's values and goals. It would be excessively paternalistic to define benefit solely in medical terms and thus refuse to tell her how to obtain Cell Saver.
Moreover, patients seeking alternative remedies are often antagonistic toward the medical establishment. Refusing to provide the information will not prevent HJ from obtaining it from another source, probably without the benefit of counseling, and could ultimately prevent her from seeking future or additional help from within the mainstream medical system. Telling HJ how to obtain Cell Saver, on the other hand, may promote trust in the medical system and increase the likehood she will comply with her therapeutic regimen. Thus, if after a thorough discussion, HJ still wishes to obtain the medication, the pharmacist should respect her right to make her own medical decision and tell her how to obtain Cell Saver.
References 1 For analogous models of the physician-patient relationship, see Robert Veatch, "Models for Ethical Medicine in a Revolutionary Age," Hastings Center Report 12:2 (1972), 5-7.
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|Title Annotation:||Case Studies; patient counseling on drug use|
|Author:||Resnik, David B.; Resnik, Susan P.; Arnold, Robert; Nissen, Julia; Haupt, Bridget|
|Publication:||The Hastings Center Report|
|Date:||May 1, 1989|
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