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標題: 獸醫藥品標籤外使用機制及資料之建立-次要動物標籤外使用機制及停藥期資料
Establishment of Extra-Label Use of Drugs in Minor Species
作者: 周濟眾
關鍵字: 畜牧獸醫類;應用研究
錯誤的標籤指示外用藥(Extra-Label Use of Drug,ELUD)是造成藥物殘留的重要主因之一。各國在新藥核准上市時,對於各適用動物之用法規範,常明顯無法跟上現實的需要,為解決此問題,擬利用FDA支持成立食用動物避免殘留資料庫(Food Animal Residue Avoidance Databank,FARAD)之資料,以促進藥物的合理使用與藥物殘留的預防及減量。本計畫目標有 1. 調查與整理國內與美國現行己核可使用於山羊、鹿、鴨、鵝及水產等食用動物之藥品使用資訊及現場用藥習慣,再利用FARAD資料庫,就選定之台灣常見標籤外使用藥物,提供標籤指示外用藥之用法、用量及停藥期建議。 2. 研析歐美日各國對次要及水產動物用藥之管理制度。 3. 研析美國 FDA對動物用藥品採行標籤外使用制度之相關配套措施。 4. 匯集美國FDA訂定「次要用藥與次要動物健康法(MUMS)」及「動物用藥物使用說明法(AMDUCA)」之法規內容及沿革。 5. 搜集瞭解各國准許人用藥品使用於伴侶動物及動物園動物之法規及管理架構。 6. 研析並翻譯WHO使用之ATCvet動物用藥品分類系統並應用於國內已核准之獸醫藥品許可證。本計畫之長期目標在促使台灣加入成為全球FARAD (global FARAD)之一員,提高動物來源食品之安全性。此過程並可促進台灣與美國院士,以及與世界著名藥物殘留監測機構專家間之合作與交流。

Extra-label use of drug (ELUD) is one of the most important causative reasons for drug residues in edible tissues, yet ELUD happened everyday beyond the regulatory control. To reduce drug residues resulted from ELUD, US FDA established a computer-based decision support system, the Food Animal Residue Avoidance Databank (FARAD) in 1982, designed to provide practical information on how to avoid drug residue problems. The purposes of this study are: 1. to investigate current ELUD status in Taiwan for minor species and to utilize the FARAD database to provide scientific-based proper instructions on antibiotic uses; 2. to study the management system of extra label use of veterinary drugs in EU, USA and Japan, as well as Minor Use/Minor Species system in USA; 3. to study the regulatory issues of MUMS and AMDUCA; and 4. to study the veterinary drugs with regard to use in aquatic animals, companion animals and zoo animals with focus on investigation of management and regulation framework; finally, 5. to introduce the ATCvet drug classification system and apply to the current veterinary drug registries in Taiwan. The completion of the study should provide useful information regarding the proper dosage, usage and withdrawal times on drugs most frequently misused in Taiwan. The long-term goal of the study is to promote Taiwan as a member of the global FARAD family and to further improve food safety through education and easy-accessed information system rather than purely rely on law enforcement. The study could also promote academic and governmental collaborations between food safety agencies in Taiwan and the United States.
其他識別: 97農科-14.2.2-檢-B2(2)
Appears in Collections:獸醫學系所

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