原廠藥品品質優於學名藥品？臺灣某醫學中心之研究   全文下載

Are Brand-Name Drugs of Better Quality than Generics? Research at a Medical Center in Taiwan

書面藥品製造相關文件審查及藥品外觀檢視通常是醫療機構確認藥品品質的方式，然而這些審查的機制可能無法完全保障使用的藥品品質。為評估臺灣某醫學中心藥品的品質，於2004年4月到2010年6月，共抽驗使用中之藥品及新進藥品共190品項，進行437次檢驗，依藥典或廠規規定，檢驗項目依劑型及臨床需求由規格中選擇1項以上進行檢驗。所有190個受檢藥品中，有11個藥品檢查結果與其規格不符，不合格率約為5.8%。特殊劑型藥品及療效存疑藥品的有較高的不合格率，分別為12.5%及7.7%。雖然臺製原廠藥品（9.1%, 2/22）與進口學名藥品（16.7%, 1/6）之失敗率看起來高於進口之原廠藥品（0%, 0/29）及臺製學名藥品（6.0%, 8/133），但由於樣本數少，依據Fisher’s exact test，在各組間沒有統計上的差異。由本研究之結果顯示，市面上仍有不合標準的藥品（substandard medicines）。進口原廠藥的品質無庸置疑，臺製學名藥的品質不比臺製原廠藥或進口學名藥來得差。醫療機構自行化驗藥品可以協助書面文件審查，確保機構內所使用藥品之品質。"

Medical institutions usually ensure the quality of medications by reviewing manufacturing documents and examining the appear-ance of the drugs. However, these mechanisms may not be robust enough to confirm the quality of the medications used. To evaluate the quality of medicines used at a medical center in Taiwan, a total of 190 new or formulary drugs were analyzed in a period from April 2004 to June 2010. For each medication, at least one test in the pharmacopeia or pharmaceutical manufacturers’ specifications was chosen according to the dosage form or clinical requirement. A total of 437 tests were conducted. The overall failure rate was 5.8% (11/190) among all the drug products tested. Higher failure rates were seen in drugs with special dosage forms (12.5%) or dubious quality (7.7%). Although the failure rates of domestic brand-name drugs (9.1%, 2/22) and imported generic drugs (16.7%, 1/6) appeared to be higher than those of imported brand-name drugs (0%, 0/29) and domestic generic drugs (6.0%, 8/133), there was no significant difference among the various groups by Fisher’s exact test due to the small sample size. Nevertheless, this study shows that there are still some substandard medicines in the market. The quality of imported brand-name drugs was shown to be unquestionable. The quality of domestic generic drugs was found to be equivalent to that of domestic brand-name or imported generic drugs. In-house laboratory analysis is an effective method that can be used together with the review of manufacturing documents to ensure the quality of drugs used at health-care institutions.