Ethical considerations in suspected isotretinoin nonadherence and/or diversion.

Isotretinoin is an effective acne therapy but is highly regulated due to its potential teratogenicity and serious side effects. Isotretinoin distribution is currently monitored through the Food and Drug Administration-mandated iPLEDGE Risk Evaluation and Mitigation Strategy system. Safe prescribing depends not only on Food and Drug Administration 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 about nonadherence or potential medication diversion in the setting of apparent treatment failures raise ethical tensions, particularly when the provider cannot definitively assess how the medication is being used. We outline providers' ethical obligations when there is credible suspicion of isotretinoin nonadherence or diversion.

Abstract from PubMed