Drug Evaluation Committee Guidance for Conducting Post-Marketing Database Surveys - January 2024 Edition
January 2024
In a post-marketing database survey, if the data necessary for the review has already been accumulated in the medical information database, it is expected to lead to efficient drug safety surveillance in terms of time, cost, and human resources, because, unlike a use-results survey using questionnaires, it is not necessary to collect information for each patient on a case-by-case basis. The use of the same drug for the same purpose is also expected to be more efficient. In addition, since the frequency of occurrence of the targeted event can be compared with that of the same drug, it is possible to consider whether the occurrence of the event is caused by the drug or the underlying disease.
On the other hand, the medical information DBs used in the post-marketing DB survey include medical fee and dispensing fee statements, electronic medical record data, diagnosis group classification comprehensive evaluation (DPC) data, disease registry data, and other medical information, each of which has different characteristics and limitations. Therefore, after understanding the characteristics and limitations of each medical information DB, a reliable medical information DB should be selected according to the purpose, and an appropriate plan should be formulated and implemented.
Based on the above background, we are pleased to publish this document, "Guide to Conducting Post-Marketing Database Surveys," with the aim of further expanding and promoting post-marketing DB surveys. In this document, we have tried to explain the procedures for conducting post-marketing database surveys based on relevant notifications and the experience of each company. We hope that it will be of assistance to companies involved in post-marketing database surveys in their operations and in the preparation of documents.
Drug Evaluation Committee, Japan Pharmaceutical Manufacturers Association
Pharmacovigilance Subcommittee, Ongoing Issues Team 6
Guidance for Conducting Post-Marketing Database Surveys - January 2024 Edition - (2.9MB)