Drug safety during pregnancy : can we analyze teratogenic drug prescriptions ?

Objectives: To assess the extent to which teratogenic drugs are prescribed during pregnancy and to investigate. the feasibility of an alert system at the point of prescription, in order to improve drug safety during pregnancy. Methods: We establish a reference list of teratogenic drugs by merging lists of teratogenic drugs published in the literature, extract drug prescriptions to pregnant women from a clinical dataset, and compare the drugs prescribed to pregnant women to the reference list of teratogenic drugs. Finally, we compare the results across drug categories (FDA, FASS and ADEC) and mechanisms of action and count how many alerts would be generated with each reference. Results: A total of 9915 prescriptions of systemic teratogenic drug during pregnancy was identified in our dataset among the 68,699 items prescribed to 89,735 pregnant women. The agreement among sources is limited. The number of potential alerts generated based on FDA, FASS, ADEC is 305, 337 and 1438, respectively. Based on the mechanism of action, 8880 alerts would be generated. Conclusions: It is possible to analyze teratogenic drug prescriptions in a clinical dataset in reference to FDA, FASS and ADEC categories. But the current sources of teratogenicity information cannot effectively support drug safety.