When patients ask for a pandemic drug

Mr. A comes to your office regularly because of chronic obstructive pulmonary disease with frequent episodes of acute bronchitis. After his current medication is adjusted, he asks you to prescribe a course of oseltamivir (Tamiflu), which he would like to use if and when there's an influenza pandemic.

Ms. B is a patient you have never seen before. She reports that she is healthy and the only reason for her visit is that she would like you to prescribe a course of Tamiflu to be used in case of a pandemic.

Should you provide these patients with the prescriptions?

Reply:

Responding with a simple, unconsidered acceptance or rejection of such patients' requests could be ethically problematic and leave both patient and physician unsatisfied with the encounter. A more nuanced approach is in order. The conflict in this morally complex matter is between the physician's responsibility to his patients and the physician's responsibility for public health.

A physician who accepts a patient for provision of personal health care has primary responsibility to that patient and is expected to act in the patient's best interests.

Moreover, respect for a patient's autonomy requires that the physician support the patient's efforts to contribute to the management of his or her medical condition. This does not mean that physicians have a duty to fulfill every patient's request, but rather that the merit of any explicit request should be examined.

There is no general obligation to provide a prescription for medication in anticipation of a variety of possible future needs, but issuing a prescription for a drug that could be critical in a specific anticipated event is sound practice. A physician may, for example, prescribe an antibiotic to a patient who travels to a risky part of the world or a drug that can be used in the event of a severe allergic reaction. Could the patient's request for Tamiflu have a similar justification?

Educating the patient

As in the dispensing of any prescription, the physician should ascertain what the patient knows about the drug; his or her motivation or reason for the request; the intended consumer of the drug -- the patient or family member; and the intended use -- personal or stockpiling for future black market sale.

If satisfied about the intended use, the physician should supplement the patient's knowledge about the possible benefits and risks. For instance, prophylactic benefits exist only if the drug is taken daily and only while it is being taken; up to one-third of all persons taking the drug during a regular influenza season still could become infected. Notably, it is not at all certain that previously stockpiled drugs will be effective against the new pandemic virus strain.

Therapeutically, oseltamivir reduces the duration of symptoms caused by the common circulating viruses by only one or two days. Little data exist on reduction of flu complications by the drug. The drug has a limited shelf life, and its high cost, probably about $60 for 10 tablets, may not be covered by insurance. Although the drug appears to be tolerated very well, it has been used for only the past six years and never on a large scale, so it is possible that if millions take it, new side effects may emerge, as was the case with COX-2 inhibitors. The patient whose request for the prescription was based on unrealistic or incorrect expectations might retract the request at this point.

Is it medically indicated?

If the patient is still interested in obtaining the antiviral medication, the next step is to consider whether the benefits are likely to be greater than the risks and burdens for this patient. Evidence to date suggests that:

• The drug appears to be very safe, and there are only a few absolute and relative contraindications.
• The drug could be used for general prophylaxis (if influenza starts to spread throughout the community), for postexposure prophylaxis or as a precontact prophylaxis (for a person expected to care for a flu patient). The drug also could be used for treatment, but, to be effective, it must be taken within 48 hours from the onset of symptoms. While staff and patients in health care institutions will have the drug speedily available to them, other groups of people might be at risk of not receiving the drug in a timely fashion because of time lags in obtaining the drug, either through prescription or through a public health distribution initiative. Under such circumstances, it appears prudent for a physician to prescribe in advance of the emergency.
• Before prescribing for some future use, the physician should be reasonably confident that the patient has the ability and motivation to take the drug as instructed at the time of prescribing or at the time of pandemic. Physicians should seek an explicit commitment from the patient to carry out the prescribed regimen.
• Prescribing in advance is more strongly indicated for patients such as Mr. A who are at high risk of developing complications and dying of influenza. High on the recommended national priority group list are people who are immunocompromised and those who live with an underlying chronic condition, so when these patients present themselves to their physician with a request for oseltamivir, they deserve special preference. It must be noted that the system for priority distribution was created to manage the possibility that public stockpiles would be insufficient at the time of pandemic. Hence, it is problematic to attempt to triage patients who request the drug in a personal health care setting during inter-pandemic times.

Taken together, these considerations seem to suggest that in most cases, physicians would be justified in prescribing oseltamivir to their regular, competent and cooperative patients who request it. But the public health consideration might speak against it.

Public health concerns

Physicians also have a responsibility to support public health policies and programs. The departments of health in some jurisdictions have provided guidelines of which physicians must be aware. The New Jersey and Virginia guidelines, for example, list the advantages and disadvantages of prescribing and indicate that "the department ... is not encouraging the practice of writing such prescriptions or the establishment of personal stockpiles. ... However, physicians may wish to consider the special circumstances of the individual patients before making a decision about whether to honor these requests."

Neither the Infectious Diseases Society of America nor the Society for Healthcare Epidemiology supports personal or family stockpiling of oseltamivir. Those who discourage personal possession usually believe that a system of public stockpiles can serve society better, on the whole. But the provision of personal supplies is not likely to threaten the effort to build a public stockpile.

Current concern originates from the worldwide shortage of Tamiflu, but there are indications that the producers of Tamiflu and its generic version will be able to meet the expected demand within the next 12 months. The most serious objection to prescribing is fear that indiscriminate use of oseltamivir will rapidly lead to the emergence of resistant strains of pandemic virus. Securing a commitment from patients to use the drug according to public health instructions could minimize such risk.

If governments or public health authorities were to decide that individual reserves of oseltamivir threaten an important public interest and suspend or restrict prescribing only to certain classes of patients, physicians' hands would be tied. But until such time and without a clear and unequivocal public health guideline, physicians could be remiss to sacrifice the real interest of their patients for the hypothetical interests of public health.

Deciding whether to prescribe

If a physician does decide to prescribe the medication, he or she should take steps to maximize the benefit to the patient and minimize the possible harm or waste. Consider having a pamphlet on hand that provides basic patient education about how the drug should be used. Obtain a promise from the patient that he or she will follow the public health advisory of when and how to utilize the drug. Start a registry of patients who were given the prescription so that they can be contacted with timely instructions. Public health authorities will, one hopes, take into account that many people will have access to an antiviral drug from a personal reserve or from a stockpile created by their employer (e.g., Virgin Airlines), and will provide instructions to the whole population at the time of pandemic.

If a physician decides to not prescribe, he or she should refuse a patient's request in a way that will prevent damaging the patient-physician relationship and will reduce the patient's concern and anxiety.

A truthful and concise but complete explanation of the reasons for the rejection, reassurance and discussion of alternatives are in order. Express empathy for the patient's position, so that he or she knows that you heard and accepted the request and that you have his or her best interest in mind, even if, in this instance, you refused the request.

It would be unfortunate if the patient were to interpret the refusal to prescribe as a rejection of active collaboration on treatment decisions. You even could consider suggesting to the patient that you might prescribe the drug at some future time if you thought it was necessary and that you would contact the patient at that time.

Jaro Kotalik, MD, Centre for Health Care Ethics, Lakehead University, Thunder Bay, Ontario, Canada