• Allen Brinker, Cynthia Kornegay, and Parivash Nourjah.
• Food and Drug Administration, Center for Drug Evaluation and Research, Office of Drug Safety, Rockville, MD 20857, USA. brinkera@cder.fda.gov
• Arch Dermatol. 2005 May 1;141(5):563-9.

ObjectiveTo review adherence to selected procedures outlined in the System to Manage Accutane-Related Teratogenicity (SMART) program during the first year of implementation vs the procedures in effect in the year prior to initiation of the SMART program.DesignObservational.SettingA novel pharmacy compliance survey and an ongoing, voluntary survey.PatientsFemale recipients of isotretinoin.InterventionIn April 2002, Hoffmann-La Roche Inc, Nutley, NJ, manufacturer of Accutane brand isotretinoin and at that time the sole source of isotretinoin, revised earlier guidelines and instituted the SMART risk management program, which included the use of qualification stickers to affix to all prescriptions for Accutane to indicate, among other things, a negative pregnancy test just before the prescription was written. The goal of the SMART program was to decrease or eliminate isotretinoin-exposed pregnancies.Main Outcome MeasuresUse and completion of prescription qualification stickers; changes in pretherapy pregnancy testing and birth control use.ResultsThe results of the pharmacy compliance survey indicated high (>90%) use of prescription qualification stickers. Results of the patient survey suggested that 9% of prescription qualification stickers within the observed user cohort were issued without a pregnancy test. Furthermore, the pregnancy rate for patients participating in the survey was similar to that reported for cohorts recruited before the SMART program.ConclusionsThe usefulness of the results derived from 2 surveys designed to evaluate the SMART program is limited by the lack of reliability and validity of the survey instruments and by questionable generalizability to all female recipients of isotretinoin. The presence of a qualification sticker may not have an impact on pregnancy testing or compliance with effective birth control behavior as outlined in the SMART program.

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