[Pharmaco-epidemiology: identification of needs, databases, and study quality criteria]. / Pharmaco-épidémiologie: identification des besoins, bases de données, critères de qualité des études.

Reference data on pathologies, their management, risk factors and the use of drugs in real life is necessary. In France, there are no existing databases of a set of systematically recorded data which associate information on drugs and morbidity/mortality. In contrast, there are a great number of studies focused on pathologies, their management or on drugs. A directory that could identify these databases and a means of accessing them would be desirable. Pharmaco-epidemiology studies must answer epidemiologically specific quality criteria, which must be planned at study conception. The protocol must be developed with a scientific committee on which there are epidemiologically experienced people. It is a prerequisite that a committee of experts with epidemiological competence should give advice on the 'acceptability' of the protocol, that is on the aim and the methodology. Data collection must be the subject of specific quality control of both the study and its aims. Cross-checking with other sources of data is recommended when possible. The coordinator of each study must send a final report to investigators and publish the results.

[Isotretinoin in childbearing women: compliance with strengthen warnings]. / Roaccutane chez la femme en âge de procréer: étude de l'impact du renforcement des recommandations de prescription.

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.