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Members Academy News: May 2004
Personal use of sample medications
By Mitchell H. Grayson, MD, FAAAAI, AAAAI Ethics Committee memberDr. E has a chronic medical condition for which she takes Zoomamax, originally prescribed by her personal physician. In an effort to reduce her medication costs, Dr. E has been obtaining her Zoomamax from her drug sample closet. One day she finds no samples in her office, so she calls the representative of the pharmaceutical company that makes Zoomamax and asks him if it would be possible to get additional samples. He promptly comes to her office and restocks the closet. As he is leaving, Dr. E asks him if it would be possible to get samples for her own personal use.
Are Dr. E’s actions appropriate? When is it appropriate for a physician to take medication samples to treat their own illnesses? This case illustrates issues related to the use of sample medications. While the American Medical Association (AMA) Code of Ethics clearly states that it is generally inappropriate for physicians to “treat themselves or members of their immediate families,”1 it is less clear cut in its discussion on the use of sample medications. In this discussion we will look more closely at these principles and guidelines.
First and foremost in medical ethics we are to do what is right for the patient. In this vein, the AMA Code of Ethics discusses the use of sample medications in the section on gifts to physicians from industry.2 In particular, the Code states that “the use of drug samples for personal or family use is permissible as long as these practices do not interfere with patient access to drug samples.” In other words, as long as the use of the samples will not deprive patients of them, it is acceptable.
The guideline continues with a somewhat unusual comment, “it would not be acceptable for non-retired physicians to request free pharmaceuticals for personal use or use by family members.” Interestingly, the AMA Code makes a distinction between retired and practicing (or “non-retired”) physicians. This distinction is not made at any other point in the Code except when discussing the additional responsibilities of the retiring physician with respect to patient records and encouragement of former patients to find a new care giver.3 Why this distinction would be made is not entirely clear. The Code and associated annotations do not discuss this issue, nor have any recent ethical discussions in AMA publications dealt with this issue. Perhaps this is simply a reflection of the concern that a practicing physician might demand samples with the implied threat that failure to provide would lead to a change in prescribing patterns to the pharmaceutical representatives disadvantage.
The assumption here is that retired physicians do not prescribe medications and therefore would not represent a quid pro quo threat. Another explanation for the distinction is based on the assumption that medical ethics no longer apply to someone who does not practice the art of medicine. This seems unlikely, as medical ethics clearly apply to physicians who are involved entirely in basic research. They are not practicing in terms of patient care, but still are considered bound by medical ethics. Furthermore, if retirement excused a physician from the primary principle of doing what is right for the patient, then why would an entire opinion in the Code be directed at additional responsibilities of retired physicians. Indeed, if asked, it is likely most retired physicians would indicate that they believe they continue to be bound by the ethical considerations embodied in the AMA Code.
Let’s return to the issue of the appropriateness of taking medicines directly from the sample closet. In an annotated commentary on gifts to physicians from industry, the guidelines are more clearly explained. In particular, it is made clear that personal or family use of sample medications is acceptable: “(i) in emergencies and other cases where the immediate use of a drug is indicated, (ii) on a trial basis to assess tolerance, and (iii) for the treatment of acute conditions requiring short courses of inexpensive therapy. …”4 How long a trial may last or the definitions of acute and short are not discussed. These are issues that are left to the individual physician to determine their level of comfort. Nonetheless, we are left with the prohibition of practicing physicians requesting samples for personal use.
This concept, however, is problematic since a crafty physician who wanted samples for personal use, would simply ask the pharmaceutical representative to provide sample medications for all of his/her patients. While this is a noble idea, it may lead to overstocking of samples, which the physician can then ethically take for personal use to “assess tolerance” or for a “short course” of therapy.
Some physicians could even justify this by stating that they are testing the drug so that they will know what to tell patients when asked about the drug’s tolerability. If this were considered ethically sound, then retired physicians should be forbidden to ask for samples, as the samples would never benefit a patient (other than the physician). Further, the quid pro quo threat would be even more concerning. Imagine the disclosure issues that would result. Should physicians tell their patients that they are taking a given drug so that the patient can decide if a conflict has arisen in choosing the best medication for them?
These are issues that are not clearly defined in the Code and for good reason. Determining what is ethically sound when it comes to the use of sample medications by practicing or retired physicians must be determined on a physician-by-physician basis. What is acceptable then becomes what the physician feels is appropriate. That sneaking suspicion that we are doing something wrong is probably the best guide that our actions are inappropriate. Turning back to our vignette, the question is yours to answer. Was Dr. E acting in an ethically acceptable manner?
References
- Opinion 8.19. Self-treatment or treatment of immediate family members. Code of Medical Ethics: Current Opinions with Annotations. American Medical Association. Council on Ethical and Judicial Affairs. 2002. p. 237.
- Opinion 8.061. Gifts to physicians from industry. Code of Medical Ethics: Current Opinions with Annotations. American Medical Association. Council on Ethical and Judicial Affairs. 2002. p. 192.
- Opinion 7.03. Records of physicians upon retirement or departure from a group. Code of Medical Ethics: Current Opinions with Annotations. American Medical Association. Council on Ethical and Judicial Affairs. 2002. p. 160.
- Clarification of Opinion 8.061, Guideline 1(h). Code of Medical Ethics: Current Opinions with Annotations. American Medical Association. Council on Ethical and Judicial Affairs. 2002. p. 197.
The Ethics Committee provides these discussions as a way to open a dialogue on the various ethical issues that confront our specialty on a daily basis. These issues are often quite complex and do not have simple “right” or “wrong” solutions. The articles are meant as a way to highlight the various issues that are involved in these ethical dilemmas. They should not be viewed as the Ethics Committee’s or the AAAAI’s particular stance on an issue.
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