社團法人臺灣臨床藥學會

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【原著】藥品供應短缺通報案件之現況分析
Current Situation of Drug Shortage Reports
藥品供應短缺、通報平台、替代藥品、回溯分析、Drug Shortage, Reporting Platform, Alternative Drugs, Retrospective Analysis
陳立奇Lih-Chi Chen1,*
1臺北市立聯合醫院教學研究部
目的:藥品供應短缺影響臨床作業及藥物治療醫療照護品質,是目前全球共同面臨之重要公共衛生議題,本研究針對國內近年藥品短缺案件之現況進行回溯分析,供臨床藥品供應管理之參考。
方法:針對2016 年3 月至2020 年10 月食品藥物管理署藥品供應資訊平台網站公告藥品供應短缺案件之短缺原因、有無替代品項及短缺藥品類別、劑型、藥理分類、治療類別等相關資訊,進行單一變項之敘述性統計及相關變項之交叉分析。
結果:研究期間藥品供應短缺案件共計210 件,大部分(93.3%)尚有替代藥品可建議使用,短缺原因主要為原料問題(36.2%)、生產問題(23.3%),餘包含停止生產、供應問題等。短缺藥品劑型主要為口服劑(50.0%)及注射劑(36.2%),餘包含外用、鼻用、眼用製劑等。短缺藥品藥理分類主要為全身性抗感染藥(13.8%)、心血管系統用藥(12.9%)、消化道及新陳代謝用藥(11.0%)、神經系統用藥(10.5%)、抗腫瘤及免疫抑制劑等。藥物治療類別主要為降血壓劑(9.0%)、抗腫瘤劑(8.6%)、解毒劑(5.7%)、疫苗(5.7%)等。
結論:藥品短缺由許多因素引起,影響臨床作業,必須及時採取適當因應行動,建立可持續的管理策略,包括相關資訊之通報收集,決策和及時溝通,以便有效及快速地因應藥物短缺問題,避免及減低藥物短缺對臨床作業之影響及衝擊,確保臨床作業品質及病人用藥權益。

Objective: Drug shortage affects clinical operations and the quality of drug treatment. It is an important public health issue at present. This study retrospectively analyzed the reports of drug shortage in recent years for reference for clinical drug supply management.
Methods: Drug shortage reports announced on the website of Taiwan Food and Drug Administration’s Drug Supply Information Platform from March 2016 to October 2020 were recorded. Data regarding the shortage reasons, whether there are
alternatives, and the shortage drug categories, dosage forms, pharmacological, and therapeutic classifications were analyzed.
Results: A total of 210 cases of drug shortage during the study period, most of which have alternative drugs. The reasons for the shortage include raw material problems, manufacturing problems, discontinued production, supply problems, etc. The dosage forms of the shortage drugs are mainly oral preparation and injections, and the rest include topical, nasal, and ophthalmic preparations. The pharmacological classifications of shortage drugs are mainly systemic anti-infective drugs, cardiovascular system drugs, alimentary tract, and metabolism drugs, nervous system drugs, antineoplastic and immunomodulating agents, etc. The main therapeutic classifications are antihypertensives, antineoplastic agents, antidote, vaccines, antiallergic agents, antidiabetics, antiviral agents, etc.
Conclusions: Appropriate actions must be taken in time to establish a sustainable management strategy, including collection and notification of relevant information, decision-making, collaboration, and timely communication, so as to effectively and quickly respond to drug shortages, to reduce the impact of drug shortage on clinical operations, and to ensure the quality of clinical drug therapy and the rights of patients.

Summited for publication: 2020.11.11; Accepted for publication: 2021.1.4
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