Improving Patient Education and Reducing Risk

Marcia L. Buck, Pharm.D., FCCP

Pediatr Pharm. 2001;7(7) 

In This Article

Future Regulatory Changes

The changes taking place in isotretinoin prescribing are not likely to be completed for several years. At their September 2000 meeting, the FDA's Dermatologic and Ophthalmic Drugs Advisory Committee recommended several additional steps, including a mandatory registry for all patients, similar to the one for thalidomide. The program would allow the manufacturer to provide reminders and educational materials to prescribers and patients on a more regular basis, as well as track all pregnancies occurring during treatment.

The details of how the registry will be administered and the impact on prescribers, pharmacists, and patients have not yet been determined. The American Academy of Dermatology and the American Medical Association have voiced opposition to this measure, citing the increased economic and administrative burden the registry might create.[20]