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題名 | 上市後藥品療效相等性監控機制之現況與展望=The Current Status and Prospect of Therapeutic Equivalence Surveillance of Post-Marketing Pharmaceutical Products |
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作 者 | 詹孟儒; 楊博文; 陳可欣; 戴雪詠; 鄒玫君; | 書刊名 | 食品藥物研究年報 |
卷期 | 3 2012.11[民101.11] |
頁次 | 頁198-203 |
分類號 | 412.24 |
關鍵詞 | 藥品療效不等; 學名藥; 藥品生體可用率及生體相等性試驗基準; Therapeutic equivalence of pharmaceutical products; Generic drug; Bioavailability and bioequivalence trail of pharmaceutical products act; |
語文 | 中文(Chinese) |
中文摘要 | 學名藥品於上市前雖經審查及確認其生體可用率及生體相等性情形,惟部分醫療人員或病患仍對於學名藥品之療效存有疑慮,因此,衛生署自98年起逐步建立藥品療效不等評估機制,包括建立藥品療效不等通報系統,並透過專家會議協助通報案件之評估,必要時針對疑似療效不等之藥品採取風險管控措施,以確保民眾用藥安全。自98至100年總計接獲疑似藥品療效不等之通報案件共計124件,通報藥品以中樞神經系統類藥品(約46%)及內分泌及代謝系統用藥(約19%)為主,藥品更換情形大部分為原廠藥品更換為學名藥品(約47%)。經評估該等通報案件,其中僅1項藥品因屬治療指數狹小藥品,少部分病患於更換藥品後有較明顯之臨床治療差異,對此已採取相關風險管控措施。有鑑於大部分通報案件多為零星通報個案,且常常缺乏臨床數據,尚難評估是否確實有療效不等之情形,因此未來除持續鼓勵醫療人員通報外,將與醫療機構合作,配合院內換藥之系統性分析機制,鼓勵其提供分析結果資料,以利政府有效掌握藥品療效相等性之情形,以確保民眾用藥安全。 |
英文摘要 | Although TFDA has already reviewed and confirmed the bioavailability and bioequivalence data at the premarketing stage, some health providers or patients may still doubt about the efficacy of generic drugs. Therefore, TFDA has established the therapeutic equivalence surveillance mechanism of post-marketing pharmaceutical products since 2009, including founding the "National Drug Therapeutic Inequivalence Reporting System" and organizing the therapeutic equivalence assessment expert committee. From 2009 to 2011, TFDA received 124 cases via the "National Drug Therapeutic Inequivalence Reporting System". Among those reported cases, more than half were central nervous system drugs (approximately 46%) and endocrine/metabolic system drugs (approximately 19%). Besides, most of the cases (47%) were due to replacement of brand name drugs to generic drugs. After assessing all the reported cases, only one case was found related to the drug with narrow therapeutic index. In this case, a small number of the patients had obvious difference in clinical outcome after drug replacement, and TFDA has already taken the corresponding risk managements. Reviewing those reported cases, most of them were single cases and lack of clinical data to support the therapeutic inequivalence status. In order to effectively control the situation of therapeutic equivalence of pharmaceutical products and ensure public health, TFDA will not only keep working to enhance the number of reported cases but also encourage medical institutions to provide their analytical data for reference. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。