From the Editor
It happened so slowly we initially didn’t notice. Soon it declared itself as a nemesis. But by then, it had established itself as a powerful force with which to be reckoned. Today it is a false mythology, designed to wreak misery on any prescribers in the US who want access to all FDA-approved medications to provide the best clinical treatment for their patients. This mythology has constructed numerous obstacles to interfere with a competent medical prescriber’s intent to choose the best dosage of the most appropriate medication to get our patients better. The primary work horse of this mythology is the dreaded medication formularies designed to limit drug prescribing to a subset of available medications. Regrettably, this subset of medications often excludes the preferred medication that competent clinicians would choose as part of a treatment plan that they deem best for their patient.
The false mythology, which remarkably is believed as fact by a minority of prescribers, is that a trained medical professional, duly licensed and with prescribing privileges, CANNOT prescribe a medication off label. This mythology interferes with good clinical practice and often contributes to poor outcomes for patients. There are many corollaries to this false mythology:
1) A drug cannot be prescribed in doses that are outside of the doses listed in that drug’s FDA-approved product insert.
2) A drug cannot be prescribed for an indication for which it is not FDA approved.
3) Some drugs can only be prescribed after numerous failed trials of other drugs, which often include drugs with more adverse effects, poorer tolerability, or with contraindications for a particular patient.
This, of course, is the short list. In my editorial in last month’s issue of Psychiatric Times I focused on all of the clinical facts that render corollary 1 a false mythology.1 This editorial will elaborate on corollary 2, which can be simply restated as the false narrative that a drug is off limits for diagnoses that are off label.
One of my favorite articles, “An Analysis of the High Psychotropic Off-Label Use in Psychiatric Disorders: The Majority of Psychiatric Diagnoses Have No Approved Drugs,” published in 2009, nicely places corollary 2 in its clinical perspective.2 The authors report that only 11.8% of DSM-IV-TR diagnoses have an FDA-approved drug. So, do we not treat the 88.2% of DSM-IV-TR diagnoses that do not have an FDA-approved medication? Also, with the publication of DSM-5 in 2013, it is likely that the percentage of FDA-approved drugs for DSM-5 diagnoses has dropped even further. A good example is the lack of any FDA-approved drugs for the DSM-5 novel diagnosis Disruptive Mood Dysregulation Disorder. Does that mean we cannot treat this disorder with medications?
1. Miller JJ. A drugs journey: from the pill bottle to the toilet. Psychiatric Times. 2019;36(9):11, 18.
2. Devulapalli KK, Nasrallah HA. An analysis of the high psychotropic off-label use in psychiatric disorders: the majority of psychiatric diagnoses have no approved drugs. Asian J Psychiatry. 2:29-36;2009.
3. Furey K, Wilkins K. Prescribing “off-label”: what should a physician disclose? AMA J Ethics. 2016;18:587-593.