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Related Experiment Videos

Trends in adherence to a revised risk management program designed to decrease or eliminate isotretinoin-exposed

Allen Brinker1, Cynthia Kornegay, Parivash Nourjah

  • 1Food and Drug Administration, Center for Drug Evaluation and Research, Office of Drug Safety, Rockville, MD 20857, USA. brinkera@cder.fda.gov

Archives of Dermatology
|May 18, 2005
PubMed
Summary

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The System to Manage Accutane-Related Teratogenicity (SMART) program showed high sticker use but didn't significantly improve pregnancy testing or birth control compliance. Its effectiveness in reducing isotretinoin-exposed pregnancies remains uncertain due to survey limitations.

Area of Science:

  • Pharmacovigilance
  • Risk Management Programs
  • Drug Safety

Background:

  • Isotretinoin, a potent teratogen, necessitates strict risk management.
  • The System to Manage Accutane-Related Teratogenicity (SMART) program was implemented to mitigate risks.
  • Accutane prescriptions required qualification stickers indicating a negative pregnancy test.

Purpose of the Study:

  • To assess adherence to SMART program procedures.
  • To compare adherence in the first year of SMART implementation versus the prior year.
  • To evaluate the impact of the SMART program on pregnancy testing and birth control use.

Main Methods:

  • Observational study design.
  • Utilized a novel pharmacy compliance survey and a voluntary patient survey.

Related Experiment Videos

  • Focused on female isotretinoin recipients.

    • Main Results:

    • Pharmacy compliance surveys showed over 90% use of qualification stickers.
    • Patient surveys indicated 9% of stickers were issued without a pregnancy test.
    • Pregnancy rates remained similar to pre-SMART program levels.

    Conclusions:

    • Survey reliability and validity raise concerns about generalizability.
    • The qualification sticker's impact on pregnancy testing and birth control compliance is questionable.
    • The SMART program's effectiveness in reducing isotretinoin-exposed pregnancies requires further investigation.