Isotretinoin in childbearing women: compliance with strengthen warnings

Introduction. The recommendations for prescription and dispensing of Roaccu tane(R) (isotretinoid) were strengthened in 1997 in order to reduce the num ber of pregnancies exposed to Roaccutane(R). The aim of this study was to e valuate the incidence of exposed pregnancies since this time and the compli ance with the new recommendations. Material and methods. All pregnancies exposed to Roaccutane(R) reported to French Regional Drug Monitoring Centers, to Laboratoire Roche or to the Inf ormation Center for Teratogenic Agents since the publication of these recom mendations for prescription were studied (March 1997-December 1998) In addi tion, 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(R) during the risk period because of failure of contraceptive methods (28 p.100), contrac eption incorrectly followed (52 p. 100) or not prescribed (20 p. too). The incidence of pregnancies exposed to Roaccutane(R) during the risk period ev aluated 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 recommen dations. Thirty-three percent of the 169 prescriptions studied did not carr y all the legal warnings. Roaccutane(R) was correctly prescribed for only 1 8 p. 100 of women, i.e. with a contraceptive method as recommended by the F rench Drugs Monitoring Agency and with Cull, correct information Although t he most important recommendations had been followed, 12 p. 100 of women wer e treated with Roaccutane(R) without contraception and 16 p, loo received a contraceptive method not recommended by the French Drugs Monitoring Agency (in particular Diane(R)). Discussion. The provision of information must be further improved by enforc ing the modalities of prescription and dispensing of Roaccutane(R). However , it appears that there is no way of completely avoiding patient-related fa ilure.