目的：藥品回收是保護民眾避免使用到品質不良或潛在具危害人體健康、有安全疑慮藥品之重要機制，近年藥品回收事件頻傳，本研究針對國內藥品回收案件之樣態及趨勢進行回溯分析，供臨床用藥安全監視及藥品管理之參考。
方法：針對2016 年7 月 ~ 2020 年3 月食品藥物管理署網站公告回收藥品案件之風險程度分級、回收原因、回收過程、回收藥品級別、劑型及藥品治療類別等資料，進行分類統計以及分年度之趨勢分析。

結果：研究期間回收案件共計277 件，回收風險程度分級主要為第二級 (89.9%)，藥品回收過程大多為廠商自主通報回收 (89.2%)。藥品回收原因包括未符合安定性試驗規格 (22.0%)，原料藥 (active pharmaceutical ingredients, API) 經檢驗有不純物質或遭汙染 (17.3%)，雜質變色變質 (12.3%)，成分含量檢測不符規格 (11.6%) 等。回收藥品級別多屬處方藥 (76.9%)。藥品劑型為口服劑 (52.3%)、注射劑 (14.4%)、眼藥水 (12.6%) 等。藥品治療類別以胃腸／消化道用藥 (17.0%) 最多，其次如心血管用藥 (15.9%)、眼用藥 (15.9%) 等。

結論：本回溯分析結果研究顯示藥品回收風險程度分級主要為第二級，藥品級別多屬處方藥，藥品治療類別以胃腸／消化道用藥及心血管用藥等為最多，且近年API經檢出有不純物質，或遭受汙染導致藥品回收事件有增加之趨勢，加強藥品回收機制之落實執行，為臨床用藥安全監視及確保民眾用藥安全之重要作為。

Objective: Drug recall is an important mechanism to protect the public from exposure to drugs that are of poor quality or potentially harmful to human health. This study retrospectively analyzed the patterns and trends of drug recall in recent years aiming to provide insightful references for future drug safety monitoring and drug management.
Methods: Drug recall notifications on the Taiwan Food and Drug Administration website from July 2016 to March 2020 were recorded. Data regarding recall risk class, reasons, processes, dosage forms, and treatment categories of recalled drugs were analyzed for patterns and yearly trends.
Results: A total of 277 cases were included during the study period. Most of the drug recalls were class II (89.9%), and the recall processes were mostly voluntary recalls by manufacturers (89.2%). Reasons for drug recall included stability testing fails to meet specification (22.0%), contamination/impurity of active pharmaceutical ingredients (API) (17.3%), impurities/discoloration/deterioration of product (12.3%), etc. Most recalled drugs were prescription drugs (76.9%). The dosage forms were mostly oral (52.3%), injection (14.4%), and ophthalmic preparations (12.6%). The treatment categories of recalled drugs included gastrointestinal/digestive tract medicine (17.0%), followed by cardiovascular medicine (15.9%), and ophthalmic medicine (15.9%).
Conclusions: The results show most of the drug recalls were class II, most recalled drugs were prescription drugs, dosage forms were mostly oral dosage forms, and the treatment categories of recalled drugs included gastrointestinal/digestive tract medicine, followed by cardiovascular medicine. An increasing tendency was noted about the contamination/impurity of API.

Summited for publication: 2020.4.13; Accepted for publication: 2020.7.13