Drug Evaluation Committee Detailed Questionnaire for Adverse Reaction Surveillance (Pharmaceutical Cooperative 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 Pharmaceuticals Evaluation Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) has decided to standardize the detailed survey forms of the pharmaceutical companies that request surveys in order to make them as consistent as possible, make them easier to fill out, make them mutually usable for adverse reaction surveys by multiple companies, and reduce the burden on 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 based on the Pharmaceutical Affairs Law were commonly included, although the order and layout of each item, item expressions and entry methods were different, and no significant differences in the survey items were found. No significant differences were found in the survey items. Based on the above, we have considered the standardization of the detailed survey form and compiled a detailed survey form (Pharmaceutical Cooperative Association model) for use in adverse drug reaction surveys as a subcommittee document.
We presented these results at the 14th Annual Meeting of the Japanese Society for Drug Information Research (held in July 2011), where we received support for standardizing the detailed questionnaire as much as possible, and received requests from pharmaceutical companies and medical institutions other than PMS Subcommittee member companies to make the detailed questionnaire (Pharmaceutical Cooperative 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.
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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