患者・市民からの医薬品副作用報告に関する制度の現状と課題：欧州の状況との比較から

抄録

In the risk management of drugs by regulatory authorities, efforts to utilize information directly from patients and their families have been progressing globally. As one of these efforts, in the adverse drug reaction (ADR) reporting system where the ADR information is reported to regulatory authorities, patients and their families have been newly added as reporters, in addition to pharmaceutical companies and healthcare professionals, who have been the main reporters. In Japan, although the direct reporting system from patients has been launched since 2019 based on the pilot scheme, the number of reports remain low.

In this study, we analyzed and compared the literature available on the European and Japanese direct reporting systems of ADRs from patients to regulatory authorities. Here, we have summarized the current status and challenges of the ADR reporting system from patients in Europe, which precedes Japan's system, and discussed the points of reference and issues specific for Japan. The ADR reporting system needs to be promoted comprehensively in cooperation with patient groups and healthcare professionals. However, some issues need to be addressed while promoting the system, such as lack of active recognition of the risks of drugs, confirmation of the basic principles of reporting and sharing experiences of ADRs, and diversification of the methods of consumer participation and involvement in public risk management schemes. As the importance of collecting information on ADRs after product approval increases, it is necessary to reconsider the functioning of the ADR reporting system and the way of collection and utilization of the information from patients.