頁籤選單縮合
題名 | 物流商與藥品管理的風險相關性=Risk Correlation between Medical Distributors and Hospital Drug Inventory Management |
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作者 | 蔡美琦; 林子舜; Tsai, Mei-chi; Lin, Tzu-shun; |
期刊 | 藥學雜誌 |
出版日期 | 20191200 |
卷期 | 35:4=141 2019.12[民108.12] |
頁次 | 頁140-146 |
分類號 | 412.24 |
語文 | chi |
關鍵詞 | 優良藥品運銷規範; 效期短者優先出庫; Good distribution practice; GDP; First expired/first out; FEFO; |
中文摘要 | 我國自2016 年7 月1 日開始執行 GDP 查核,2019 年1 月1 日起未通過查核者不得 從事相關業務。世界衛生組織 (WHO) 在2010年;歐盟在2013年都訂定優良藥品運銷 規範,其中也針對庫存的出庫原則明確規範,即採「效期短者優先出庫 (first expiry/ first out;FEFO)」,即俗稱的「先進先出」原則,有任何特例則必須加以記錄並留存 相關文獻。 目的:我國確保藥物物流品質的品質保證制度 ( 優良藥品運銷規範) 早已上路, 多數醫療院所總是在相信 GDP 的執行有其一定品質的認知下,理所當然著重在自己 院所的管控機制,本院在檢討先進先出作業常規的異常時,發現部分異常可能非醫院 內部管理的因素,故著手相關研究。 方法:原有的收貨檢核表上,加註該藥品品項的上一批採購效期,並自2018 年 12 月至2019 年3 月期間開始統計分析,請收貨人員驗收時,務必記錄當次收貨效期 小於前一批效期之品項,並由筆者針對資訊系統的記錄與人工登錄結果進行雙重核對 來加以確認,不論物流商的規模及屬性 ( 跨國性或是台灣地區),就所有效期短於前 次收貨之品項數來加以統計分析。 結果:經過4 個月的統計 (2018 年12 月至2019 年3 月),有入庫之145 家物流商總 驗收入庫數為2770 項,曾出現異常的15 家物流商中總驗收入庫數為1624 項,標的的 異常項次有24 項,以項次而言,占該期間總驗收入庫及曾出現異常物流商總入庫項 次的百分比分別為0.87%及1.48%。 討論與建議:藥品物流廠商對效期管控應包括 FEFO 原則並納入品質保證的稽核 條件,而醫療院所也應重視此類外部因素造成的藥品管理風險,FEFO 的原則必須從 製造廠至最終零售調劑的藥局都嚴格遵守,才能確保藥物管理的品質。 |
英文摘要 | Taiwan has implemented GDP inspection since July 1, 2016. Those who fail to pass the inspection on January 1, 2019 may not engage in related business. The World Health Organization (WHO) and the European Union has set the quidelines for good drug delivery in 2010 and in 2013 respectively, which also clearly regulates the principles of inventory control, including the principle of first expiry/first out (FEFO), which is commonly known as the "first in, first out (FIFO)" principle. Any special event must be recorded and retained. OBJECTIVE: Taiwan's quality assurance system for ensuring the quality of pharmaceutical products has been on the road for years. Most medical institutions suppose that the implementation of GDP exhibit certain quality, and just focus on the control mechanism of their own institutions. When reviewing the anomalies of the FIFO practices, we found that some of the abnormalities may not be internal factors of the hospital inventory control system, so the relevant research was initiated. METHOD: We modified the original receipt checklist by adding the column of expired day validation of each drug item, and start to collect the data from December, 2007 to March, 108, and ask the inspection personnel to record if the expired day is earlier than previous one of the inspected items as abnormalities, and we would confirms the record of information system with the manual record for double check subsequently, regardless of the properties of distributors (international or Taiwan locally), statistical analysis is carried out based on the number of items the expired day is earlier than previous one of the inspected items versus all items. RESULT: After 4 months of inspection (December 2018 to March 2019), there were 2,770 inspection revenues from total 145 distributors, and 1,624 total revenues from 15 distributors with target abnormalities. There were 24 target items detected, which accounted for 0.87% and 1.48% of the total inspection of all distributors and the total number of targeted distributors respectively during the period. DISSCUSSION and SUGGESTION: the GDP for Drug distributors should include FEFO principles in their quality assurance auditing system, and medical institutions should also pay attention to drug management risks caused by such external factors. FEFO principles must be strictly confirmed from manufacturing to final retail processes, then the pharmacy is able to ensure the quality of drug management. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。