Non-psychotic uses for anti-psychotics

Journal of Drugs in Dermatology, March-April, 2004 by Aparche Yang, John Y. Koo

Discussion

It is important to note that prescription of anti-psychotics--or any other drugs--for an indication not approved by the FDA is both ethical and legal (18). In other words, prescription of drugs for off-label indications should not put physicians at risk of litigation. In fact, the off-label prescription of drugs is regulated by the FDA, which lists the requirements for prescribing a drug "for an indication not in the approved labeling" as follows: the physician must "be well informed about the product, |must| base its use on firm scientific rationale and on sound medical evidence, |and| maintain records of the product's use and effects." (5) These requirements are the basic tenets for the prescription for any medication. Physicians should, at the very least, be aware of the drug's mechanism of action [if known] and side effect profile, as well as any possible drug interactions.

Evidence-based prescription of drugs for off-label indications is not only legal, but it is also quite common (15,19-22). Why? First, new discoveries change the standard of care more rapidly than the FDA can approve indications for drugs. Second, standard medical practices are often not enough to meet the challenges of more recalcitrant diseases. Third, the lives of terminal patients often do not last long enough to benefit from FDA approval of drugs. Lastly, "orphan" diseases, like many of the rare diseases found in dermatology, are too rare to validate the expense of FDA required testing for official indication.

Conclusion

Evidence-based prescription of anti-psychotics for non-psychotic indications is both internationally prevalent and well-supported by the literature and authoritative text references. It is an important feature of dermatological practice because of the large number of patients with psycho-dermatologic disorders--including patients with self-injurious tendencies--and the shortage of FDA-proven treatments. It is legally accepted in the United States and is accepted internationally as an appropriate medical practice. Since the physician is legally obliged to do what they can to help the patient, one could argue that the physician is legally obliged to use off-label prescription when other treatments are ineffective or unavailable. Since every physician has sworn a Hippocratic Oath to help their patients, one could argue also that the use of prescription is the physicians ethical responsibility. For these reasons, evidence-based prescription of anti-psychotics for non-psychotic indications should be a medical practice supported, not punished by the government.