從藥害救濟案例探討藥品仿單標示外使用

背景及目的：「藥品仿單標示外使用（Off-Label Use）」，是已被認為普遍存在的醫療現象，世界各國雖無法令規範或禁止，但在我國藥害救濟法中，原明文規定為不得申請藥害救濟之情事之一，也是近年來醫學界熱烈討論的議題。本研究目的為藉由嚴重藥害案件，瞭解台灣地區仿單標示外使用之處方情形及不良反應之型態。方法：本研究彙整1999年1月至2011年6月30日間所有申請藥害救濟案件，並經衛生署藥害救濟審議委員會審定完成資料。包含個案基本資料、處方藥品名稱、疾病診斷名稱、以及案件審議結果等，所有資料分別以Microsoft Excel匯集資料並以PASW 16.0版本進行統計分析。結果：彙整研究期間內經審議完成之藥害救濟申請案共1,296例，平均獲救濟給付率為51.1%。在所有不予救濟案件中，屬藥品仿單標示外使用之案件佔29.3%；案件基本資料顯示off-label use之情形並無性別差異，且各年齡層均可能被處方，平均年齡為52.6±16.2。進一步分析前述案件，常見用於off-label use而致藥害發生之前三名藥品分別為carbamazepine（51.5%）、allopurinol（14.8%）、及azathioprine（3.6%）；而此三項藥品最常見被用於適應症外之處方目的則分別為神經痛（44次）、無症狀之高尿酸血症（16次）及多發性硬化症（3次）。將所有經審議屬off-label use案件，以藥物不良反應器官分類代碼（System Organ Classes, SOC）分類，以發生皮膚黏膜方面的不良反應者為最多，佔76.9%，其次為免疫系統不良反應，佔10.2%。結論：綜觀歷年藥害救濟審議案例，臨床治療上藥品仿單標示外使用之情形甚多，然而造成藥品仿單標示外使用的原因以及開立此類處方時之正當性與合理性，皆存在極大之可討論空間。藥害救濟法在各界綜合考量醫療實務現況與受藥害者權益下，2011年5月業已修正藥害救濟法相關條文，將有條件地適度准予藥品仿單標示外使用時之救濟可能，本文提供醫事人員執業時之參考。

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Background: Off-label use of prescription medicine is a common medical practice. Although the practice is generally not prohibited by regulation, it is one of the exclusion criteria for drug relief in the Taiwan Drug Hazard Relief Act. Objectives: Our aim was to analyze cases from the drug hazard relief applications in order to understand the patterns of the prescription of and the adverse drug reactions (ADRs) from the use of off-label medications in Taiwan. Methods: We reviewed all drug hazard relief applications which had been evaluated by the Drug Hazard Relief Committee during the period of January 1999 to June 2011. Data were collected by chart review to determine basic demographic data, prescription medications used, diagnoses, and Committee evaluations. Source data were pooled by Microsoft Excel software and analyzed by PASW, version 16.0. Results: Of the 1,296 cases reviewed, the average approval rate for relief payment was 51.1% over the 12 years. Of the non-approved cases, 29.3% were categorized as ”off-label use”. Data from the cases of off-label use showed no difference in gender and included all age groups. The top three medications leading to serious ADRs in cases of off-label use were carbamazepine (51.5%), allopurinol (14.8%), and azathioprine (3.6%). The recorded indications for prescribing the aforementioned medications were neuralgia (44), asyptomatic hyperuricemia (16), and multiple sclerosis (3), respectively. According to the System Organ Classes (SOC) classification, the most frequently reported serious ADRs were skin and subcutaneous tissue disorders (76.9%) and immune system disorders (10.2%). Conclusions: Off-label prescription is common in clinical practice. Many important issues are worth discussing. These include the reasons for off-label use and the appropriateness of such prescriptions. Accordingly, the Taiwan Drug Hazard Relief Act was amended in May 2011 so that cases of off-label use could be conditionally approved in the future. This review may provide appropriate information to health care professionals about the issues raised by off-label use.