某醫學中心藥品安全監視機制執行成效與藥物不良反應通報後續追蹤

The Efficacy of Drug Safety Surveillance Mechanism and Follow-Up of Adverse Drug Reaction in a Medical Center

蔡念慈(Nien-Tzu Tsai) ； 吳奕璋(Yih-Jang Wu)

《臺灣臨床藥學雜誌》 28卷4期 (2020/10) Pp. 287-295

https://doi.org/10.6168/FJCP.202010_28(4).0004

摘要

目的：臺灣的新藥上市通常較歐美國家晚，雖然上市後風險歐美國家大都已偵測，但隨著國產新藥陸續上市與加速審查機制，病人發生未知的藥物不良反應（adverse drug reaction, ADR）可能性隨之提高。ADR通報加上主動監看藥物安全警訊，事先擬定對策，全面性的確保病人用藥安全。方法：本研究調查某醫院ADR通報小組定期開會討論通報，將因果關係明確的案例通報至全國ADR通報中心（Taiwan National ADR Reporting System）並建置於醫令系統。為完善某院藥品安全監視機制，亦主動監看各國發布的藥物安全警訊及國內、外藥物相關安全資訊和新聞輿論，進一步查詢與蒐集資料後，擬定相關對策並建立院內藥物安全警訊資料庫，對於ADR通報案例，評估其後續改善情形，以更完整的確保病人安全。結果：統計2018年，共通報上市後ADR有417件，402例經處置或停藥後改善，15例因未再回診而無法評估，進一步分析未再回診的個案皆屬非嚴重ADR。藥物安全警訊方面，統計2016年1月1日～2018年12月31日共監看國內外警訊147則。結論：藉由ADR通報，進一步分析評估其因果關係後，通報至全國ADR通報中心，評估其後續改善情形，建置更完整的藥物安全資訊。即時掌握國內外各項藥物安全警訊，建立有效風險管理機制，強化藥品安全監視機制，以提升病人用藥安全。

關鍵字

藥品安全監視機制 ； 藥物不良反應 ； 藥物安全警訊 ； 藥物風險評估暨管控計畫 ； 後續追蹤

並列摘要

Objective: Adverse drug reaction (ADR) reporting is an important part of drug risk evaluation. With more novel drugs marketed, it is necessary to monitor drug safety alerts frequently to prevent potential injuries. Through the Risk Evaluation and Mitigation Strategy, it is possible to catch virtually all drug safety alerts as soon as they are posted in order to establish a safe care plan. Methods: We developed a mechanism to communicate drug safety to health care professionals to enhance patient safety. Routine conferences were arranged to discuss patients' ADR cases with apparent causality inferred using the ADR reporting group at our hospital. In the case of an ADR, data is reported to the Taiwan National ADR Reporting System and the specific reaction is noted on the physician order entry system. To establish a certain hospital's drug safety alert database, we monitored domestic and international drug safety alerts and ADRs for follow-ups. Results: From January 1 to December 31, 2018 we reported 417 ADR to the Taiwan National ADR Reporting System and monitored patient response during follow-up appointments. From January 1, 2016 to December 31, 2018 we observed and responded to 147 drug safety alerts. Conclusions: Taiwan's current drug safety surveillance system is relatively passive. In this model, we successfully established a drug safety communication mechanism to monitor drug safety immediately and follow up on those ADRs to safeguard patient health. It is the pharmacist's duty to exercise their professional knowledge and judgment for everyone's health.

並列關鍵字

Drug Safety Surveillance Mechanism ； Adverse Drug Reaction ； Drug Safety Alert ； Risk Evaluation and Mitigation Strategy ； Follow-Up