医薬品の回収における医療機関側の対応とその業務量

抄録

Over 100 pharmaceutical products are withdrawn from the market in Japan each year. Nonetheless, there has so far been no report consisting of a specific survey of the volume of work borne by the medical organizations related to such with drawals. As are sult, a survey of the response of medical organizations and the volume of work have been made regarding the withdrawal of Maalox ^®in August 2000.
Our findings revealed that a considerable amount of time, namely 4, 502 minutes was expended regarding the withdrawal of this product at Kitasato University East Hospital. A total of 2, 770 minutes, or 62% of the total time was spent within 24 hours after receiving the announcement of the drug's removal from the market. When the total time was broken down by job type, 3, 188 minutes, or 71% of the total, were spent by pharmacists A further, 2, 315 minutes, or 52% of the total, were used to determine how to best respond to the matter.
In order to efficiently recall pharmaceutical products, an operation was established which was thereafter distributed to all concemed staff members.
The total time spent on the withdrawal of Maalox ^® was estimated to have utilized approximately ¥285, 000of labor cost, based on the average wages of the employees. As a result, hospitals are forced to bear a significant economic burden whenever such products are withdrawn.
Finally, pharmaceutical manufacturers should be equipped with the systems for manufacture and supply as much as possible to minimize such recall incidents. When drug are unavoidably withdrawn, however, the manufacturers should nevertheless provide all appropriate information as quickly as possible to the related medical organizations while carefully taking the economic burden that such organizations must bear into consideration.