適應症外使用藥品——三個藥害救濟案例給我們的提醒【本期企劃】 試閱
Perspective on Off-Label Drug Use–Lessons from Three Drug-injury Relief Cases
藥害救濟法第13條第8款於2011年修正，新增但書規定，將「適應症外使用藥品」有條件放寬納入藥害救濟範疇。惟臨床醫師「適應症外使用藥品」時，仍應遵守「基於正當理由」、「合理使用」、「未違反藥品使用當時已知的具公信力的醫學文獻」及「據實告知病人」等原則，以確保病人用藥安全，進而避免可能的醫療爭議。
Article 13, Paragraph 8 of the Drug Injury Relief Act was amended in 2021, adding a provision that conditionally expands the scope of drug injury relief to include “off-label drug use.” Nevertheless, when physicians deem it necessary to prescribe off-label drugs, they should still adhere to principles such as “for legitimate reasons,” “reasonable use,” “not contravening the credible medical literature available at the time,” and “truthfully informing patients” to ensure patient safety in drug usage, thereby mitigating potential medical disputes.
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