患者向け資材における医薬品リスク管理計画の重要な特定されたリスク，重要な潜在的リスクの記載状況の調査

抄録

Objective: The Risk Minimization Plan is developed in the Risk Management Plan (RMP), patient information materials are sometimes prepared as Additional Risk Minimization Activities (ARMA). On the other hand, there are many patient information materials that are not prepared as RMP materials, but are prepared independently by pharmaceutical companies and are actually used to provide information to patients. However, there is no detailed report on the differences between them. Therefore, in this report, we investigated for description of Important Identified Risks (IIRs) and Important Potential Risks (IPRs) in patient information materials.

Methods: The previously published RMP of 588 drugs were obtained on October 1,2020, and used in analysis. We surveyed the description of IIRs and IPRs in patient information materials, and compared patient information materials based on ARMA in the RMP (patient information materials as RMP materials) and patient information materials developed independently by pharmaceutical companies that are not based on ARMA in the RMP (patient information materials as not RMP materials).

Results: Of the 588 drugs, 454 drugs had patient information materials. In addition, 241 drugs had patient information materials as RMP materials. One thousand fifteen of the 1,577 IIRs were listed in the patient information materials as RMP materials (64.4%listing rate). One hundred sixty-six of the 724 IPRs were listed in the patient information materials as RMP materials (22.9%). On the other hand, 700 of the 1,131 IIRs were listed in the patient information materials as not RMP materials (61.9% listing rate). Ninty one of the 447 IPRs were listed in the patient information materials as not RMP materials (20.4%).

Conclusion: It was found that there was no difference in the description of IIRs and IPRs between patient information materials as RMP materials and patient information materials as not RMP materials.