Influence of the Product Liability Law on the Pharmacy Service for Hospital Pharmaceutical Preparations.

Various pharmaceutical preparations are prepared in hospital pharmacies on a daily basis. The Product Liability (PL) Law has been in effect since July 1995 in Japan. To clarity the influence of the PL Law on the pharmacy service for hospital preparations, the frequency of preparation requests, preparation quantities, and the total preparation time of each hospital preparation were investigated retrospectively for 5 fiscal years (April to next March) from April 1993 to March 1998 at Yamaguchi University Hospital. Hospital preparations were classified into three categories based on the raw materials used. The category I preparations were prepared from the medicines listed in the National Health Insurance price standard for medicine, and were used according to the Pharmaceutical Affairs Law. The category 2 preparations were prepared from the medicine listed on the standard price lists and were used outside the jurisdiction of the Pharmaceutical Affairs Law. The category 3 preparations were prepared from chemical agents not listed in the standard price lists. It is necessary to get the approval of the Institutional Review Board at our hospital before category 2 and 3 preparations can be used. The request frequency and preparation quantity of category 1 preparations gradually decreased during the investigation period, while category 2 preparations remained almost constant. On the other hand, those of category 3 preparations steadily increased from 1993 to 1997. In addition, the total preparation time of the hospital preparations gradually increased year by year, and the preparation times for 1997 reached 110 percent of that for 1993. These results indicate that the pharmacists in our hospital have adequately understood the importance of the hospital preparations and have been adhering to the special preparation orders from each physician. As a result, it appears that the PL Law has not substantially affected the pharmacy service for pharmaceutical preparations in our hospital.