Objective: The package inserts are official clinical decision-making documents that provide pharmacological treatment information. However, it has been noted that package inserts on perinatal drug usage differ greatly from expert opinions. This study identified Japanese package insert drugs that are contraindicated for pregnant women and compared them to foreign risk categories.Methods: The survey included 19,022 drugs on the drug pricing list as of April 2022, with package inserts available on the Pharmaceuticals and Medical Devices Agency website. We retrieved the package inserts with the word “pregnant” in the “Contraindications” section and reviewed the descriptions to exclude those that satisfied the exclusion criteria. We also checked the foreign risk categories of contraindicated ingredients for pregnant women. This study used the Australian Therapeutic Goods Administration’s categorization for prescribing medicines in pregnancy (the TGA classification).Results: Of the 19,022 medicines studied, 4,111 (21.6%) were contraindicated for pregnant women. Conversely, 19 (5.1%) ingredients categorized under the relatively safe TGA classifications A, B1, and B2 were also contraindicated for pregnant Japanese women.Conclusion: This study revealed that Japanese package inserts contraindicate over 20% of drugs for pregnant women. On the other hand, some forbidden ingredients did not match the foreign risk categories. Therefore, healthcare professionals should be aware of the limitations of Japanese package inserts concerning pregnant women and make careful decisions based on both package inserts and additional drug information.

Objective: The collection and utilization of adverse drug reaction (ADR) reports are essential in pharmacovigilance activities. Healthcare professionals, especially pharmacists, are required to report ADRs to the regulatory authorities in Japan. The ability of pharmacists to identify ADRs, assess causality and severity, and submit ADR reports is of utmost importance. This study aimed to investigate the current status and challenges of education regarding ADR reporting in pharmacy schools in Japan. Design: A cross-sectional survey. Methods: A self-reported questionnaire was conducted among faculty members of 77 pharmacy schools in Japan to assess the implementation of ADR reporting system education. A separate survey was conducted among hospital and community pharmacists to understand ADR reporting-related training provided during practical training. The questionnaire included items on implementing ADR-related lectures and practical training, characteristics and innovations in such education, and opinions on ADR reporting education. Results: Responses were obtained from 48 pharmacy schools (response rate: 62%). The implementation rates for lectures on the ADR reporting system and ADR causality assessment were 94 and 83%, respectively, typically conducted in the 3rd or 4th year. However, the implementation rate for training on completing ADR reporting forms was only 38%, with 61% of these schools providing practical exercises. The survey of hospital and community pharmacists (n=22) revealed that 82% provided training on completing ADR reporting forms, often using case studies or simulated scenarios. Conclusion: The survey found that pharmacy schools offer lectures on ADR reporting, but there isa need for practical training to improve pharmacists’ ability to report ADRs. To enhance pharmacists’ skills in this area, there should be more collaboration between schools and training sites, and comprehensive educational programs and lifelong learning opportunities should be developed.