Trends in Adherence to a Revised Risk Management Program Designed to Decrease or Eliminate Isotretinoin-Exposed Pregnancies

A risk management program aimed at preventing fetal exposure to isotretinoin: Retrospective cohort study

“…Therefore we could not make comparisons regarding differences in pregnancy testing rates before and after implementation, although there was a dramatic increase in laboratorybased testing that met criteria after April 1, 2002. Similar to our experience, the SMART program failed to meet its goal of reducing fetal exposures to isotretinoin. 2,8,9,15,16 The FDA reported that in the year before implementation of SMART there were 127 spontaneous reports of fetal exposure to isotretinoin and in the year following implementation there were 120 spontaneous reports. 2 Given that there was a 23% decline in the total number of prescriptions dispensed in the United States in the year after implementation of SMART, the FDA concluded that the SMART program had no effect on fetal exposures.…”

The evolution of therapeutic risk management

“…A new risk management programme, the System to Manage AccutaneRelated Teratogenicity (SMART) was initiated in 2002, which was mandatory for prescribers and female patients. Evaluations of effectiveness identifi ed weaknesses that needed addressing -in particular, ongoing cases of pregnancy while exposed to treatment (which remained at approximately three pregnancies per 1000 exposed women) and compliance with the requirements for pregnancy testing and reliable contraception (Brinker et al, 2005;Mitchell et al, 2000). In response, in 2006, Hoffmann-La Roche, manufacturers of generic isotretinoin, and the FDA collaborated to launch a shared Risk Minimisation Action Plan (RiskMAP).…”

Pregnancy and isotretinoin therapy

“…12 An assessment in 2000 concluded that the program was unable to adequately prevent pregnancies during treatment, suggesting the need for improvement. 13 In April 2002, the System to Manage Accutane-Related Teratogenicity (SMART) program began in the US to prevent women from starting isotretinoin therapy during pregnancy and to prevent conception during treatment. In addition to the steps included in the Retinoid Pregnancy Prevention Program, SMART called for 2 consecutive pregnancy tests with negative results before starting treatment and a voluntary registration system.…”

“…Similar to the Retinoid Pregnancy Prevention Program, SMART has also been shown to be ineffective: 34% of women did not receive the required 2 pregnancy tests before starting treatment, and 54% of women of childbearing age did not use 2 methods of birth control in parallel during treatment. 13 In 2006, the FDA implemented iPLEDGE, a program designed to provide more exhaustive guidelines for the safe prescription and use of isotretinoin. This program enforces monthly pregnancy tests, documentation of contraceptive use and patient education to reinforce key safety messages.…”