社團法人臺灣臨床藥學會

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【原著】建立藥品交互作用重點監測指標初探
A Preliminary Study in Development of Potential Monitoring Indicators of Drug-Drug Interactions with Clinical Relevance
藥品交互作用, 監測指標, 實驗檢測值、Drug-drug interactions, monitoring indicators, laboratory test
林珍芳Chen-Fang Lin*1 、白其卉Chyi-Huey Bai2,3 、王春玉Chun-Yu Wang1
1新光醫療財團法人新光吳火獅紀念醫院藥劑部 、2新光醫療財團法人新光吳火獅紀念醫院中央實驗室 、3台北醫學大學 公共衛生學系
目的:目前各醫院所建立的藥品交互作用查核系統或者是國外的商業藥品交互作用查核系統產品,通常以藥品交互作用警示畫面的方式來呈現。在臨床上藥品交互作用的發生,並不一定要更換藥品或停藥,如果這些藥品對病人的疾病治療都是必要的,通常可以對藥品交互作用的資訊提供重點監測指標,進行日後密切的追蹤觀察,以確保病人的用藥安全以及療效。根據MICROMEDEX®在臨床上同時併用spironolactone和ramipril可能會使血鉀升高,甚或造成病人的嚴重心律不整,因此以血鉀濃度作為藥品交互作用的重點監測指標,來確保病人的用藥安全。本研究目的為,以實證為基礎來訂定出本院藥品交互作用之重點監測指標,並呈現這些指標的特性與類型分佈,以供未來建置藥品交互作用重點監測指標系統之可行性做參考。
方法:兩位資深藥師根據本院已建置之1521對藥品交互作用資料,主要以嚴重度為contraindicated或major的藥品交互作用為主,根據實證之藥品資料庫來建立出藥品交互作用重點監測指標。重點監測指標的篩選原則為具臨床相關性以及可與病人的檢驗數值、藥品血中濃度等資訊進行連結,同時我們將重點監測指標依不同屬性分為9類。
結果:經由兩位資深藥師的篩選,針對984對藥品交互作用建立起重點監測指標,佔所有藥品交互作用配對的65% (984/1521)。總共有1074個重點監測指標,佔最大比例的為藥品血中濃度監測32.4% (348/1074),腎功能監測佔11.5% (123/1074),凝血功能監測佔9.4% (101/1074),以及肝功能監測佔1.5% (16/1074)。
結論:為了增進病人用藥的療效與安全性,於臨床決策支援系統建立一個有效以及臨床相關的藥品交互作用重點監測指標是很重要的。藥品交互作用重點監測指標的特性與類型分佈,可供未來建置藥品交互作用重點監測指標系統之可行性做參考。

Objective
Currently, drug-interactions alert system developed by hospital or commercial company is a window-warning system. Discontinuing or changing order is not always necessary or appropriate if these drugs are required regimen for the patient. The combination of spironolactone and ramipril was associated with elevation of plasma potassium level which may yield to severe arrhythmia, so the potential monitoring indicators of this drug-drug interaction is potassium level. The objective of this study is to develop the potential monitoring indicators of drug-drug interaction pairs based on evidence-based drug information database and to examine the characteristics of these indicators. This will help us to evaluate the feasibility of developing a drug-drug interaction system connected with potential monitoring indicators.    
Methods
Based on an established database of 1521 drug-drug interaction pairs with severity characterized as contraindicated or major from the formulary of a medical center. Two senior pharmacists comprehensively identified the drug-drug interaction pairs with potential indicators for monitoring based on evidence-based drug information database. The selection criteria for potential monitoring indicators are clinical relevance, and the possibility of connection to laboratory data or drug levels. Then, we categorized the types of potential monitoring indicators into nine groups.
Results
There were 984 (65%, 984/1521) drug-drug interaction pairs with potential indicators for monitoring to assure their clinical relevance. There were 1074 potential monitoring indicators established in 984 drug-drug interaction pairs. Thirty-two percent of potential monitoring indicators of drug-drug interactions were drug levels monitoring, 11.5% of potential monitoring indicators of drug-drug interactions were renal function check needed, and 9.4% of potential monitoring indicators of drug-drug interactions were coagulation test required.
Conclusion
In order to assure effectiveness and safety of medication use in patients, it is important to develop a clinical decision support system with effective and clinically relevant monitoring indicators of drug-drug interactions. The information regarding to the characteristics and type distribution of potential monitoring indicators will facilitate the development of a drug-drug interaction system connected with potential monitoring indicators in the future.
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