用藥安全體系的環境建構   全文下載

From Pharmacovigilance to Pharmacovigilance Planning--The System Building for Safe Medication

歐盟、美國及日本等先進國家在用藥安全的思維上，已從被動式藥品安全監控（pharmacovigilance）轉型為知識性預防風險的環境建構（pharmacovigilance planning）。本文介紹(1) 國際協合組織（iCh）在用藥安全體系之環境建構的宣示及指引；(2) 從科學文獻歸納藥物與食品交互作用的評估用藥風險的科學基礎，並闡述實証藥學（evidence-based medicine）針對藥品與身體間夥伴關係的風險評估在中、西醫學理論上是契合的；(3)從健康保險資料庫及政府出版品，歸納台灣地區民眾缺乏用藥知識判斷及風險意識所造成的藥品過度消費、中草藥及健康食品盛行、廣告氾濫以及腎病盛行的現況，以及分析中藥、西藥獨立管理所形成的用藥風險的盲點；(4)在品質、療效及安全是用藥安全的準則下闡述台灣建構用藥安全體系。

The concept of pharmacovigilance planning (PVP) was initiated by the International Conference on Harmonization (ICH) in 2004 and followed by the publication of Topic ICH E2E Guideline. However, the implementation of PVP in societies like Taiwan where irrational medication or co-medication of conventional medicine with complementary/alternative medicine (CAM) is prevalent, became a challenge. This report aimed to (1) introduce the concept of PVP and the importance of evidence-based justification of medicinal products for risk prevention and minimization, (2) summarize the scientific evidence regarding the sites and mechanisms of drug–drug or drug-CAM interactions along the biological processing of xenobiotics and identify potential risks in relation to co-medication of conventional medicine with CAM by reviewing literatures, (3) employ public information to analyze potential risk underlying irrational medication of registered medicine, registered traditional Chinese medicine (TCM) and un-registered CAM in Taiwan, and (4) address the importance of conceptual change from individual product-oriented pharmacovigilance to a proactive system-based risk management of pharmacovigilance planning.