Changes in isotretinoin prescribing before and after implementation of the System to Manage Accutane Related Teratogenicity (SMART) risk management program.
OBJECTIVE
To assess changes in isotretinoin prescribing following the implementation of the System to Manage Accutane Related Teratogenicity (SMART) risk management program.


METHODS
Using nationally representative commercial data resources on prescription drug dispensing patterns, surveys of office-based physician practices, and a large, claims database from a pharmacy benefits manager (PBM), we examined the total number of isotretinoin prescriptions (new and refill), prescriber speciality, and patient characteristics (age, gender, severity of acne indication) in the year before (April 2001-March 2002) and the year following (April 2002-March 2003) implementation of the SMART program.


RESULTS
In the 12-months prior to SMART, 1 508 000 prescriptions were dispensed for isotretinoin, declining approximately 23% to 1 160 000 prescriptions in the year following SMART. There was little or no change in prescriber specialty, severity of acne, and patient age and gender.


CONCLUSIONS
SMART may have lead to a decrease in isotretinoin prescriptions. Further research is needed to determine whether the reduced number of isotretinoin prescriptions reflects appropriate use or inhibited use resulting in loss of access to the product's benefits.
Mendelsohn
Aaron B
AB
Office of Drug Safety, Food and Drug Administration, Rockville, MD, USA.
Governale
Laura
L
Trontell
Anne
A
Seligman
Paul
P
D000293:Adolescent; D000328:Adult; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D016208:Databases, Factual; D011307:Drug Prescriptions / Q000706:statistics & numerical data*; D004363:Drug Utilization; D016568:Drugs, Generic; D005260:Female; D006801:Humans; D007223:Infant; D015474:Isotretinoin / Q000009:adverse effects*; D007641:Keratolytic Agents / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D012308:Risk Management; D013723:Teratogens; D014481:United States / Q000453:epidemiology
D016568:Drugs, Generic; D007641:Keratolytic Agents; D013723:Teratogens; D015474:Isotretinoin