以五年醫學中心資料探討最常見的藥品不良品通報事件

Data Analysis of Frequently Reported Events for Defective Medical Products on Five-year Medical Center Data

本醫院為通過醫學中心評鑑之醫院，為確保病人用藥品質與安全，當發現疑似不良品時，全院醫療人員可透過院內「藥品不良品通報系統」第一時間進行回收通報與評估，用以建立藥品品質內部監控機制。本研究希望分析醫學中心長期通報纪錄，並系統性探討常見不良品之各類型態，以供臨床用藥安全監測追蹤之參考。本研究為回溯型描述性研究，以本醫院藥品不良品通報系統之資料庫為來源。收集時間為2018年1月至2022年12月，蒐集資料有通報來源、劑型、包裝形式、儲存條件與不良品缺陷類型等。本研究共收集205筆通報紀錄，每月平均3.4件，由發現到完成通報約1天時間(0.8天)；通報藥品以Sindine AQ (Povidone iodine) 10% 200mL/Bot的6件最多；通報劑型以錠劑為主(42 .9%)，注射液劑次之(27.8%)；在包裝形式上「瓶裝」通報數近半數(49.3%)；缺陷類型以「產品包裝」最多(47.8%)，外觀異常（非包材）次之(37.1 %)，其中又以「碎裂／破損／缺損」最多(21.1%)。最後，符合高風險不良品定義者共52筆(25.4%)，包含標示錯誤、有雜質異物與顏色異常等。本研究藉由分析醫學中心長時期藥品不良品之通報資料，了解常見問題類型，進而應用於醫療人員教育訓練，減少藥品不良品被誤用且督促藥廠改善藥品原料與製程品質，進而保障病人用藥安全。

Our Hospital is a medical center that has passed accreditation. In order to ensure the quality and safety of medication for patients, all medical staff in the hospital can use the ''Defective Medical Products Reporting System'' to immediately report and evaluate suspected defective products when they are discovered. This is used to establish an internal monitoring mechanism for medication quality. The aim of this study is to analyze the long-term reporting records of the medical center and systematically investigate the various types of common defects for reference in clinical drug safety monitoring and tracking. This is a retrospective descriptive study that uses the database of the hospital's Defective Medical Products Reporting System as the source. The data was collected from January 2018 to December 2022, including information on the source of the report, dosage form, packaging form, storage conditions, and defect type of the defective product. A total of 205 reporting records were collected, with an average of 3.4 cases per month, and it took about 1 day (0.8 days) from discovery to completion of the report. The most reported drug was Sindine AQ (Povidone iodine) 10% 200mL/Bot, with 6 cases reported. Tablet forms were the most commonly reported (42.9%), followed by injection solutions (27.8%). Nearly half of the reports (49.3%) were for products in bottle packaging. The most common defect type was product packaging (47.8%), followed by non-packaging appearance abnormalities (37.1%), with ''cracking/breakage/missing pieces'' being the most common (21.1%). Finally, a total of 52 cases (25.4%) met the definition of high-risk defective medical products, including labeling errors, foreign impurities, and abnormal colors. By analyzing the long-term reporting data of defective medical products in the medical center, this study aims to understand the types of common problems and apply this knowledge to the education and training of medical staff, to reduce the misuse of defective medical products and to urge pharmaceutical companies to improve the quality of raw materials and manufacturing processes, thereby ensuring the medication safety.