Analysis of Drug Therapeutic Inequivalence Reports in a Hospital

醫院藥物療效不等通報案件之分析

彭姿蓉(Tzu-Rong Peng) ； 吳大圩(Ta-Wei Wu)

《北市醫學雜誌》 15卷4期 (2018/12) Pp. 24-33

https://doi.org/10.6200/TCMJ.201812_15(4).0003

摘要

Objectives: This study evaluated the 2014 to 2017 drug therapeutic inequivalence reports of a regional hospital in northern Taiwan and the establishment of a complete reporting system. Methods: This hospital has collected data on therapeutic equivalence assessment conducted for drug replacements since 2014. The standard records included date of report, sources, reasons and date of drug replacement, patient information, reporting department, drug consumption, and circulate notice before and after drug replacement at the main campus and other branch hospitals. Results: Since 2014, 58 therapeutic inequivalence reports were circulated, in which 36 were related to drugs for nervous system, 10 for metabolism and nutrition, 9 for cardiovascular and renal, and 3 for respiratory tract. Averagely, 10.4% of hospital drugs were switched and 29 notices of drug therapeutic inequivalence were circulated annually. The analysis results showed that only 19% of the reports consisted objective data such as blood pressure and blood lipid levels. Conclusions: There was no correlation between switched drugs and therapeutic inequivalence in this retrospective study. We anticipate reports of drug therapeutic inequivalence and analysis of the underlying reasons help the medical staff to take necessary measures to improve and ensure medication safety.

關鍵字

therapeutic inequivalence ； brand name drug ； generic drug

並列摘要

目的：分析台灣北部某區域醫院2014年至2017年通報療效不等之案例並建立通報藥物療效不等流程。方法：台灣北部某區域醫院於2014年起執行換廠藥品療效不等相關評估，建立完整之通報處理流程，內容包括通報日期、通報來源、換廠原因、換廠日期、病人資料、通報科別、藥品耗用量、換廠前後藥品在院內及其他院區通報情形等。結果：從2014年起接獲58件療效不等的通報，依序為以作用於中樞神經系統的藥物（36件）、代謝和營養劑（10件）、心血管及腎臟藥物（9件）及呼吸道藥物（3件）。院內平均每年有10.4％的藥品異動，及29例報告藥物療效不等的通報。在分析所有通報後，約只有19％有客觀資料能夠顯示療效不等，如血壓和血脂的數值。結論：經回顧案例仍無法證實換廠藥品與療效不等之相關性。我們希望藉藥品療效不等通報作業，彙整通報資訊進行藥品療效不等原因分析，提供醫療人員作參考，必要時採取改善措施，以保障病人用藥安全。

並列關鍵字

療效不等 ； 學名藥 ； 原廠藥