Patients often research psychiatric medications online before trying them, and, if a particular medication has not been approved by the FDA for their particular disorder, may refuse to try the medication, suspecting the psychiatrist of inappropriate guidance in their case, even malpractice.  The resulting suspicion and roadblocks to initiating therapy can be exasperating.

A recent article in Current Psychiatry (Feb. 2009, vol. 8, no. 2) by Douglass Mossman, M.D., director of the Weaver Institute of Law and Psychiatry at Univ. of Cincinnati College of Law, and professor of psychiatry at the Univ. of Cincinnati College of Medicine, entitled, “Why off-label isn’t off base,” dispels much of the confusion over off label use of psychiatric medications.

Dr. Mossman explains a number of things:

a) Off-label use of psychiatric medications is legal.  FDA approval means that drugs may be sold and marketed in certain ways, but the FDA does not tell physicians how they can use approved drugs.  Federal statutes make clear that FDA approval does not “limit or interfere with the authority of a health car practitioner to prescribe” approved drugs or devices “for any condition or disease” (Food, Drug, and Cosmetic Act, 21 USC, 396).

b) Courts endorse off-label prescribing.  One appellate decision says, “Because the pace of medical discovery runs ahead of the FDA’s regulatory machinery, the off-label use of some drugs is frequently considered to be ‘state-of-the-art’ treatment” (Richardson v. Miller, 44 SW3d1, Tenn Ct App. 2000).

c)  Off-label use is not only legal, it is often wise medical practice.  Many drugs now approved by FDA for a particular use were first used off-label for this purpose.

d)  Off-label use does not make the patient into a human guinea pig.  Since the FDA has usually found that a medication has sufficient safety through prior clinical research, the safety factor is not usually an issue — efficacy is the primary issue in off-label uses.  When a physician prescribes a medication which has proven to be safe in order to possibly help a patient, the courts do not view this practice as unreasonable risk.

d)  As a result of the above, off-label use of medications does not require special informed consent.   The general informed consent forms which patients fill out at the beginning of their treatment, usually as part of a general contract for treatment, will suffice for legal purposes.

e)  What is important in off-label use of medications is that:

(1)  the individual physician must keep up with the latest usage of various medications by reading current journals, continuing medical education, collection of articles on current usages, knowing why a certain medication may work for a particular patient;

(2)  the physician must explain to the patient the current usage of a medication, its risks and possible benefits in any off-label use;

(3)  the physician engage in ongoing informed consent at every stage in the off-label use of a medication.  He should have current data and literature available for the patient to read about a possible off-label use of a medication.