Ethical considerations in suspected isotretinoin nonadherence and/or diversion

Isotretinoin is an effective acne therapy but highly regulated due to its potential teratogenicity and serious side effects. Isotretinoin distribution is currently monitored through the Food and Drug Administration- (FDA)-mandated iPLEDGE Risk Evaluation and Mitigation Strategy System (REMS). Safe prescribing depends not only on FDA and physician oversight, but also on patients taking the medication as prescribed and adhering to established safeguards, such as frequent pregnancy tests and routine monitoring. Concerns regarding nonadherence or potential medication diversion in the setting of apparent treatment failures raise ethical tensions, particularly if the provider cannot definitively assess how the medication is being used. We outline the ethical obligations of providers when there is credible suspicion for isotretinoin nonadherence or diversion.