医療機関における市販直後調査への対応と課題 : 調査への薬剤師の介入効果と労力・費用について

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On December 27, 2000, the Ministerial Ordinance No. 151, and the Notification from Pharmaceutical and Medical Safety Bureau Director of the Ministry of Health and Welfare (No. 1324) were issued. As a result, the requirement to collect up to 3,000 examples for PMS (Post Marketing Surveillance) became unnecessary, and intensive investigations for six months right after sale will instead be conducted. Although conducting such investigations right after marketing is necessary in order to complete a "side effects and an infection report", various problems are still remain. In view of these situations, the pharmacists at our hospital took the lead in implementing the investigation right after marketing in order to identify the effects and estimate the man power and cost for medical institutions. This paper also compares the efficiency of various methods to collect adverse events between pharmacists and MR individuals. Moreover, some future subjects identified from the present investigation process are discussed on. Investigations right after marketing was conducted by collecting institutional questionnaires issued to physicians with four medicines for two or three months this time. The effect of such investigations (influence to the rapidity and certainty with collecting of adverse events) regarding intervention by the pharmacists was found to be large. In particular, the effect remarkably increase as a large number of questionnaires issued. It became clear that man power and cost were largely proportional to the number of collected questionnaires rather than the frequency of adverse events. Calculating the cost as a means of evaluating the value equivalent to these new jobs on monitoring adverse events from now on is indispensable. If the route for an adverse event and/or side effect with a new medicine could be monitored and coped with is not made promptly, then, the reliability of a medical institution could be greatly affected. In this meaning, pharmacists have to accumulate the implementation results of these investigations in their own medical institution.
日本医療薬学会の論文
2003-06-10

医療機関における市販直後調査への対応と課題 : 調査への薬剤師の介入効果と労力・費用について

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