製造販売後調査における調査票の現状と標準化の提案
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概要
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Post Marketing Surveillance (PMS) is conducted to obtain information on the frequency of adverse events, quality, efficacy, and safety of medicines when used in medical care. Rules for PMS are established in GPSP (Good Post marketing Study Practice) departmental regulations, and companies are required to determine the design of the survey sheets and survey items as well as the procedures for PMS in compliance with them. However, there are no rules for the design of the survey sheets and survey items. With this in mind, we studied the standardization of survey sheets by investigating the information items and response choices used by pharmaceutical companies for PMS. The results of our investigation revealed that survey sheets lacked unity; for example, the types and titles of survey items and the number of choices varied among companies. There was also variation among companies as regards the format of survey sheets (layout of information items and coloration). We felt that there would be benefits from standardizing sheets by eliminating these variations. First of all, there would no longer be the need to conform to a particular survey sheet for each company which would decrease mistakes in filling them out as well as the time required, enabling more safety-and efficacy-related information to be collected. In addition, the cooperation of physicians with PMS would be likely to increase. The extra information obtained would contribute to further raising the quality of medical care provided to patients.
- 2008-12-10
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