病院薬剤部によるＰＭＳへの新しい試み ケイツーＮ注の副作用発生頻度調査の事例

Abstract

With the implementation of amended GPMSP (Good Post-Marketing Surveillance Practice), PMS (Post-Marketing Surveillance) has been assuming increasing importance in clinical practice. On the other hand, hospital pharmacists are in a position to acquire objective clinical information about drugs that are used in medical institutions.We as hospital pharmacists have taken a new approach to PMS by establishing a system whereby objective and reliable information about adverse drug reactions is collected, evaluated, and distributed through direct involvement in PMS and cooperation of prescribing physicians. This communication discusses the results of operation of this system and the direction of its future operation.In this study, clinical experience with Kaytwo N injection (launched in August 1991), a new injectable vitamin K2 preparation free of solubilized HCO-60 which is suspected of causing shock-like symptoms, was investigated for 3 years and 3 months from January 1992 through March 1995, conducting a survey of the incidence of adverse reactions and drugs combined in use with Kaytwo N injection.The investigation was carried out at 29 institutions, with 45 departments in participation, and information was collected from 315 patients with the cooperation of prescribing physicians. The adverse reactions reported consisted of rash, a heavy feeling in the head, and lightheadedness in 2 patients. The incidence of adverse reactions was 0.6%.To enhance the reliability of PMS and promote appropriate use of drugs, it will become increasingly important for hospital pharmacists to actively participate in PMS and in-house clinical studies and the positioning of pharmacists in medical institutions will likewise be important.