病院薬剤部から見た医薬品異物混入問題の解析

抄録

  During 1987-1997, Nagoya City University Hospital experienced 22 cases of claim/complaint and recall of the pharmaceutical products. This included 9 cases of abnormality of container and package, 6 cases of contamination, 3 cases of content excess/shortage, and 2 cases of content abnormality and mislabeling. When observing from dosage form, a lot of complaint and recall were the injections of 9, and, next, the external preparations of 7. After enforcing PL law, claims/complains have increased in our hospital. We made the pharmaceutical companies claims of upgrading them and we got the improvement plans as the answer books of how these pharmaceutical companies resolved these problems as follows: contaminations of parts of manufacturing processes, insects, denatured ingredients etc. By using these answers from the companies, each reason of specific and interesting incident was observed and analyzed with the idea of Human Factors. As the results, reasons of most incidents were in the relationship between Liveware and Software.