Off-Label Drug Use in Ambulatory Settings: Is Utilization Increasing or Decreasing? :

With legislative measures since the start of the 21st century to foster research in pediatric drug development, one would think that the use of off-label drugs in children would decrease thanks to increased labeling. Hoon et al. (10.1542/peds.2019-0896) shares with us the trends, frequencies, and reasons for off-label use of drugs in children from 2006-15 using data obtained from the National Ambulatory Medical Care Surveys. The authors found that the rate of off-label drug use over the time period studied did not decrease but actually increased, especially in neonates and adolescents. The authors evaluate off-label drug use by treated condition, by biological sex, geographic location, specialists vs. primary care physicians.  While there is plenty to learn about from reading this study, it was interesting to see that at least off-label antibiotics were not the culprit, however, antihistamines and several psychotropic drugs showed upticks in off-label utilization.  So why is this and what might be the reasons for the increase in off-label medication usage in children? To answer that we invited Drs. Katelyn Yackey and Rachel Stanley (10.1542/peds.2019-1571) to share their thoughts in an accompanying commentary.  The authors remind us that just because a drug is off-label doesn’t mean there has not been sufficient research on the adult usage of the drug to support that off-label drug from being prescribed for a pediatric medical condition.  There is a lot more to learn from both the article and commentary, so I prescribe a good dose of both for you to read and then reflect upon regarding your own use of off-label drugs and the rationale for such use.  Are your rates of off-label drug use prescribing to your patients also going up?  Feel free to share your thoughts about this study and commentary with us by posting a response to this blog, the article itself, or on our social media pages.