Trends in adherence to a revised risk management program designed to decrease or eliminate isotretinoin-exposed pregnancies: evaluation of the accutane SMART program.
OBJECTIVE
To 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.


METHODS
Observational.


METHODS
A novel pharmacy compliance survey and an ongoing, voluntary survey.


METHODS
Female recipients of isotretinoin.


METHODS
In 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.


METHODS
Use and completion of prescription qualification stickers; changes in pretherapy pregnancy testing and birth control use.


RESULTS
The 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.


CONCLUSIONS
The 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.
Brinker
Allen
A
Food and Drug Administration, Center for Drug Evaluation and Research, Office of Drug Safety, Rockville, MD 20857, USA. brinkera@cder.fda.gov
Kornegay
Cynthia
C
Nourjah
Parivash
P
D000014:Abnormalities, Drug-Induced / Q000517:prevention & control*; D003267:Contraception; D000075202:Contraindications; D004348:Drug Labeling; D005260:Female; D019983:Guideline Adherence; D006801:Humans; D015474:Isotretinoin / Q000009:adverse effects* / Q000627:therapeutic use; D010349:Patient Compliance; D010594:Pharmacies; D011247:Pregnancy; D011258:Pregnancy Tests / Q000639:trends; D012189:Retrospective Studies; D012308:Risk Management / Q000379:methods*; D011795:Surveys and Questionnaires; D013723:Teratogens; D014481:United States; D014486:United States Food and Drug Administration
D013723:Teratogens; D015474:Isotretinoin