Drug Evaluation Committee Detailed Questionnaire for Adverse Reaction Surveillance (JPMA Model)

Pharmacovigilance Subcommittee

February 2012

When a pharmaceutical company receives a report of an adverse drug reaction from a medical professional, it may ask the medical professional to fill out a detailed survey form. In order to improve this situation as much as possible, the PMS Subcommittee of the Drug Evaluation Committee of the JPMA has decided to standardize the detailed survey forms of each JPMA company as much as possible, so that they can be filled out easily, can be used mutually by multiple companies for adverse reaction surveys, and can reduce the burden on the medical professionals who cooperate in adverse reaction surveys. We have been studying the standardization of the detailed survey forms.
As a result of our study, although there were some special items in the detailed survey forms for some special drugs and limited departments, the items required for evaluation and reporting to the regulatory authorities under the Pharmaceutical Affairs Law were commonly included, and no significant differences were found in the survey items, although the order and layout of items, item expressions and entry methods, etc. were different. No significant differences were found in the survey items. Based on these findings, the standardization of the detailed survey form was discussed, and a detailed survey form (JPMA model) for use in adverse drug reaction surveys was compiled in the form of a subcommittee document.
When we presented these results at the 14th Annual Meeting of the Japanese Society for Drug Information Research (held in July 2011), we received support for standardizing the detailed questionnaire as much as possible from each company, and received requests from pharmaceutical companies and medical institutions other than PMS Subcommittee member companies to make the detailed questionnaire (JPMA model) available to the public. We have received requests from pharmaceutical companies and doctors of medical institutions other than PMS subcommittee member companies to release the detailed survey form (Pharmaceutical Cooperative Association model). In particular, we received feedback from doctors at medical institutions that the model would make it possible to streamline the provision of necessary information, including the establishment of a system that automatically extracts necessary information from electronic medical records, thereby facilitating their cooperation in the survey.
We believe that the wide adoption of this model will make it easier for multiple companies to utilize each other when they receive requests for adverse drug reaction investigations, and will also help reduce the burden on medical personnel, so we have decided to make this information widely available through the JPMA website, rather than stopping at the PMS subcommittee members' internal documents.
We hope that pharmaceutical companies will understand the purpose of the release of this document, adopt this model in their detailed survey forms, and cooperate with us in streamlining the work of healthcare professionals involved in detailed surveys.
In particular, the PMS Subcommittee recommends the use of this model in the next two years until March 2014, and we would appreciate your cooperation.

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