藥品療效不等線上通報系統之建置與成效

Establishment of a Reporting System for Therapeutic Inequivalence and Analysis of Effectiveness

李佳玲(Chia-Ling Li) ； 葉子慧(Tzu-Hui Yeh) ； 王明賢(Ming-Shyan Wang) ； 孫淑慧(Shu-Hui Sun)

《臺灣臨床藥學雜誌》 29卷2期 (2021/04) Pp. 93-100

https://doi.org/10.6168/FJCP.202104_29(2).0003

摘要

目的：建置獨立的療效不等通報介面與評估系統，並設置獎勵機制，期能藉此提升臨床醫師通報意願，以確保病人的用藥品質與安全。方法：從2012年5月1日至2019年12月31日，擷取某醫學中心藥品療效不等通報系統資料庫中符合藥品療效不等定義之案件，若有不良反應則再使用Naranjo score與世界衛生組織合作中心國際藥物監測的成因相關性評分（World Health Organization-Uppsala Monitoring Center [WHO-UMC] causality criteria）評估藥品相關性，以Microsoft Excel彙整資料並進行統計分析。若成立案件達到藥事委員會制定的案件數則啟動專案機制，請供應商提供相關資料，再提至藥事委員會會議進行討論。結果：共收入204件通報案件，經評估後不成立案件共49件，成立的療效減弱案件共129件，不良反應案件共21件，同時併有療效減弱及不良反應案件共5件。藥物類別前三名為神經系統用藥共59件、消化系統和代謝用藥共40件與荷爾蒙類用藥共29件，占62.7％。經評估，共有4個藥品品項啟動專案機制，其中有2個品項更換廠牌。結論：建置藥品療效不等通報系統並追蹤通報案件，可讓臨床醫師快速反應病人更換藥物後的臨床狀況與影響，顯著提高通報意願；專責藥師依評估結果進行後續處理，可提升病人的用藥品質與安全。

關鍵字

藥品療效不等 ； 通報系統 ； 用藥品質

並列摘要

Objective: This paper aims to establish an independent reporting interface and evaluation system for therapeutic inequivalence, and the corresponding reward system to help to increase the willingness of clinicians to report therapeutic inequivalence to ensure quality. Methods: From May 1, 2012 to December 31, 2019, we extracted information from the database of a medical center’s drug therapeutic inequivalence reporting system that meets the definition of drug efficacy. If the number of established reports reaches the number of reports set by the Pharmaceutical Affairs Committee, the special reports mechanism will be activated. Suppliers are requested to provide relevant information before they are brought to the Pharmaceutical Committee meeting for discussion. Results: A total of 204 reports were collected, and 49 reports were excluded, 129 reports of therapeutic inequivalence, 21 reports of adverse reactions, and 5 reports of therapeutic inequivalence and adverse reactions. The top three categories for therapeutic inequivalence are medications for nervous system (n = 59), digestive system and metabolism (n = 40), and hormone (n = 29). After evaluation, a total of 4 medications have activated the special case mechanism, of which 2 items have changed their generic brands due to therapeutic inequivalence. Conclusions: Establishing a reporting system for therapeutic inequivalence and tracking reporting cases can allow clinicians to quickly respond to the clinical status and impact of patients after drug replacement, and significantly increase the willingness to report. Dedicated pharmacists can follow-up treatment based on the evaluation results, which can improve patient's medication quality and safety.

並列關鍵字

Therapeutic Inequivalence ； Reporting System ； Medication Quality