Psychiatric medications are often prescribed for conditions for which they have not been approved for by the Food and Drug Administration (FDA), according to a new study published in PLOS ONE.
For this study, researchers aimed to identify the prevalence and predictors of off-label prescribing using data from the 2012 and 2013 National Ambulatory Medical Care Surveys (NAMCS). They looked at all adult outpatient visits to psychiatric practices for chronic care management in which ≥1 psychiatric medication was prescribed; a total of 18.5 million (1.3%) visits of the overall sample of 1.85 billion visits included ≥1 psychiatric drug prescription. An analysis of these prescriptions showed that 12.9% (95% CI: 12.2-15.7) were for off-label uses.
Antidepressants made up the majority of prescriptions for off-label use (52.2%), as they were the most commonly prescribed, but stimulants and antipsychotics were associated with the highest rates of off-label prescription (17.6% and 17.4%, respectively). Manic-depressive psychosis treated with citalopram (75.9% of off-label use) and insomnia treated with trazodone (54.8% of off-label use) were found to be the most common off-label uses.
With regard to the characteristics associated with off-label use, seeing a psychiatrist instead of another type of clinician (P=.03), being in the Western region of the US (P=.02), and having ≥3 chronic non-psychiatric conditions (P=.003) were all positively linked with receiving an off-label prescription. Conversely, having Medicare coverage (P=.04) and receiving payment assistance from a medical charity (rather than a private insurer) (P=.03) were negatively associated with off-label prescribing.
The authors concluded that “examining rates and characteristics of off-label use in specific therapeutic areas, such as psychiatry, and studying predictors of off-label use, can shape future regulatory policy and inform clinical guideline recommendations.” They added that future studies should look at ways to “implement post-market pharmacovigilance in order to minimize adverse drug reactions and ensure patient safety and optimal health outcomes.”
For more information visit Plos.org.