[Isotretinoin in childbearing women: compliance with strengthen warnings]

Abstract

Introduction: The recommendations for prescription and dispensing of Roaccutane (isotretinoid) were strengthened in 1997 in order to reduce the number of pregnancies exposed to Roaccutane. The aim of this study was to evaluate the incidence of exposed pregnancies since this time and the compliance with the new recommendations.

Material and methods: All pregnancies exposed to Roaccutane reported to French Regional Drug Monitoring Centers, to Laboratoire Roche or to the Information Center for Teratogenic Agents since the publication of these recommendations for prescription were studied (March 1997-December 1998). In addition, compliance with the new recommendations was evaluated by sampling 169 drug prescriptions dispensed at 105 pharmacies in France.

Results: Thirty-seven pregnancies were exposed to Roaccutane during the risk period because of failure of contraceptive methods (28 p. 100), contraception incorrectly followed (52 p. 100) or not prescribed (20 p. 100). The incidence of pregnancies exposed to Roaccutane during the risk period evaluated at 0.6/1,000 women of child-bearing age [0.4-0.8] is very close to the incidence reported in the earlier study which prompted the new recommendations. Thirty-three percent of the 169 prescriptions studied did not carry all the legal warnings. Roaccutane was correctly prescribed for only 18 p. 100 of women, i.e. with a contraceptive method as recommended by the French Drugs Monitoring Agency and with full, correct information. Although the most important recommendations had been followed, 12 p. 100 of women were treated with Roaccutane without contraception and 16 p. 100 received a contraceptive method not recommended by the French Drugs Monitoring Agency (in particular Diane).

Discussion: The provision of information must be further improved by enforcing the modalities of prescription and dispensing of Roaccutane. However, it appears that there is no way of completely avoiding patient-related failure.