市販直後調査の効果的な実施方法

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Immediate post-marketing surveillance (IPMS) is a new safety management system in Japan without parrallel in the rest of the world; the effective enforcement of this system is expected in order to minimize the health hazard caused by critical adverse drug reactions (ADR). However, from the medical institution side, there are some problems which need to be resolved in order to carry out IPMS smoothly. To solve these problems, an experimental investigation using a model medicine was conducted in our institution. At the same time, the research on the status of efforts and activities made by pharmaceutical companies toward IPMS was conducted, followed by problem analysis in implementation of IPMS and a review of the countermeasures. The main problems found in the new IPMS operation is the lack of cooperation from medical institutions. In order to obtain cooperation from the medical institutions, some incentives are needed, such as, limiting medical institutions for the use of a new developed medicine or design a contract between the pharmaceutical company and medical institution. Two types of contractual coverage are available; one is to provide the prescriber list to medical representative (MR) in written form, and the other is to provide the ADR information collected in the clinical setting by pharmacists in addition to the prescriber list. And, as a contact point of MR visit, the drug information service center may be considered. Moreover, a model was created based on the contract betweena a pharmaceutical company and medical institution for conducting IPMS effectively and smoothly in the medical institution. This model is characterized by the clear distinction of the pharmacist's role for effective operation of IPMS.

市販直後調査の効果的な実施方法

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