Changes in Registration Status of Identification Codes on PMDA’s Information Search Site of Pharmaceuticals for Prescription / 医薬品情報学

The identification code of a drug is defined as “a code for identifying tablets, etc.” and is described in the “Composition/Properties” section of the package insert. We investigated whether the Pharmaceuticals and Medical Devices Agency (PMDA) website, which allows users to search package insert information, can be used for drug identification using identification codes in 2019 before the new package insert guidelines were implemented, and in 2022, during the revision period. Approximately 30% of the investigated high-risk drugs were unidentifiable in both years. The most common reason was that images were used to register identification codes on the PMDA website, and character strings were not searchable. We then conducted a questionnaire survey of pharmaceutical companies, and only approximately half of the respondents opined that it would be preferable if the registration format for identification codes was established within the pharmaceutical industry. However, hospital pharmacists urged for more simplified identification of drugs on the PMDA website.

Survey on Timing Related to Preparation and Publishing of Risk Management Plans / 医薬品情報学

Objective: Risk Management Plan (RMP) is created and submitted by a pharmaceutical company while applying for new drug approval; it is published to be used by healthcare professionals. For example, healthcare professionals utilize RMP when considering whether to adopt a drug. However, there is no stipulation for the release date of RMPs; moreover, surveys regarding this are limited. We conducted a cross-sectional survey on the relationship between RMP-related timing and regulatory affairs-related timing.Methods: The surveyed drugs were those for which the first version of RMP was notified by PMDA Medinavi (mail delivery service) in FY2014 and FY2018. We examined regulatory affairs-related timing (i.e., “manufacturing and marketing approval date,” “drugprice standards listing date,” and “release date”) and RMP-related timing (i.e., “RMP creation date” and “Medinavi delivery date”).Results: For 7 of 43 items in FY2014 and 5 of 41 items in FY2018, the “RMP creation date” occurred later than the “drug-price standards listing date.” For one item in FY2014, the “RMP creation date” occurred later than the “release date.” For 12 items in FY2014 and 13 items in FY2018, the “Medinavi delivery date” occurred later than the “release date.”Conclusion: No considerable difference was confirmed between FY2014 and FY2018 regarding RMP-related timing and regulatory affairs timing. It was confirmed that there were several items for which the RMP creation occurred later than drug-price standard listing and items for which the publishing notice by Medinavi was delayed for drug marketing release. To promote the utilization of RMPs by healthcare professionals, RMPs must be created and published without delay.