This study investigated how Japanese physicians make decisions about prescribing medications during pregnancy, based on safety information provided in drug package inserts. An online questionnaire survey targeted physicians working at pregnancy hub hospitals with expertise in drug treatment during pregnancy and physicians in general hospitals without such specialization. The findings revealed significant differences in prescribing behavior and perceptions of safety. Physicians at hub hospitals were more likely to view certain medications as safe for pregnant individuals when supported by epidemiological data, even if such drugs were contraindicated based on preclinical studies. In contrast, physicians in general hospitals followed the wording in the package inserts more strictly and often avoided prescribing. Physicians from both groups strongly needed more detailed descriptions of therapeutic benefits and epidemiological evidence in the pregnancy sections of package inserts. The results suggest that current drug labeling in Japan does not provide sufficient information for evidence-based risk-benefit decision-making in pregnancy care. Differences in prescribing behavior were attributed to disparities in training and access to specialized information. The study highlights the importance of revising Japanese package inserts to include more precise descriptions of clinical benefit and human data to improve the quality of medication decision-making during pregnancy and reduce unnecessary contraindications. Improved access to training and updated information may help close the gap between general and specialized physicians and promote more consistent and appropriate care for pregnant individuals across healthcare settings.
Goto et al. (Mon,) studied this question.