新冠疫情對於臺灣藥品供應鏈之影響   全文下載

The Impact of COVID-19 Pandemic on Drug Supply Chain of Taiwan

藥品穩定供應為確保病人治療品質及用藥安全之重要因素，為保障民眾用藥權益，我國自2012年起逐步健全藥品短缺處理機制，包括建立通報案件評估機制、強化法規管理、建置線上通報及資訊公布網站等，以利臨床端掌握藥品供應狀態及替代藥品資訊，倘藥品確有短缺疑慮，主管機關並啟動公開徵求專案輸入或製造，以確保藥品穩定供應。2019年至2021年共計接獲2,470件通報，多數為重複通報品項、經調查無短缺等案件，有717件（29%）需進一步評估臨床必要性及替代藥品。評估案件中，多數皆有替代藥品，確實有短缺疑慮而需啟動公開徵求專案輸入或製造僅62件（8.6%）。2020年受到新冠肺炎疫情影響，通報案件大幅增加，主要原因包括藥品原料問題（如原料藥短缺）、藥品生產問題（如封城或員工染疫，以致生產力降低）及藥品供應問題（如國內藥品分配不均、國際運輸問題），我國持續採取相關因應作為，包括完善國內藥品分配、強化藥品供應監控及原料藥儲備、加強藥品供應資訊傳遞等，以降低疫情對於我國藥品供應之影響。隨著藥品供應鏈之全球化發展，任一環節皆牽動著藥品供應鏈之穩定性，如何避免藥品短缺仍為各國面臨之重要議題，我國應持續精進藥品短缺處理機制，以保障民眾用藥權益。

Drug supply chain stabilization is important to ensure the treatment quality and medication safety. To protect the rights to obtain essential drugs, the drug shortage management has been developed since 2012 in Taiwan, including establishing an assessment mechanism for shortage cases, strengthening the regulatory management, and building the online shortage reporting system to allow the clinical side to master the supplying status of the shortage drugs and their substitutes. If concerned of any insufficient supply of drugs, the authority may post on a public platform, and grant special permission to manufacture or import the drug to ensure the drug supply. During 2019 to 2021, 2,470 shortage cases were reported, while most of them were repeatedly reported or cases with no shortage after investigation, and 717 (29%) cases needed to be further assessed for their clinical necessities and alternatives. By evaluating the shortage reports, most cases had alternative drugs, and only 62 (8.6%) cases were in shortage and needed to grant special permission for manufacturing or importing the alternatives. Due to the outbreak of the COVID-19 in 2020, the shortage cases were widely increased, the main reasons of the shortages included drug raw material issues (such as shortage of active pharmaceutical ingredients), manufacturing issues (such as city lockdown or employee infection, resulting in reduced productivity), and distribution issues (such as uneven distribution of domestic drugsor international transportation issues). TFDA continued to take relevant actions, including enhancing domestic drug distribution, strengthening drug supply monitoring and active pharmaceutical ingredients storage, and accelerating drug supply information transmission in order to reduce the impact of pandemic on supply chain. With the globalization, many factors could fluctuate drug supply chain. How to avoid drug shortage is still a big issue among countries, and we still need to improve the drug shortage management system to ensure the continuity of patient care.