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論著名稱: 醫療機構大量預先調製藥品行為之適法性(Legal Analysis on Behavior for Large Quantity Compounding of the Preparations in Advance in Medical Institutions)
編著譯者: 余萬能
出版日期: 2017.03
刊登出處: 台灣/月旦醫事法報告第 5 期 /33-49 頁
頁  數: 10 點閱次數: 715
下載點數: 40 點 銷售明細: 權利金查詢 變更售價
授 權 者: 余萬能
關 鍵 詞: 處方調劑偽藥製劑調製醫療機構
中文摘要: 用於人體治療疾病之藥品,為具有一定劑型及一定劑量之製劑。其製造,係針對所有罹患同一疾病之不特定多數病人;其調配及調製,則是由醫療專業人員針對各個病人作成專業判斷,分別提供使用。製劑之製造,應依藥品優良製造準則之規定,以成分含量之一致性、治療效果之再現性、製造過程之確效及成品之安定性,嚴格要求品質保證,立法者乃以抽象危險定其偽藥罪責。即使同一疾病之人,因體質不同,所需製劑之劑型及劑量各異。依特定病人處方調製所製成之新劑型及新製品,其劑型及劑量與原藥品已非相同,無法適用於其他人。大量預先調製,品質未經保證,無法確保其他病人之使用安全有效,且超出專業人員調劑規範所應負之責任,實已與製造無異。故預先調製成新劑型及新製品之行為,倘超過法規所定調劑之合理範圍,宜回歸製造行為,據以規制。
英文關鍵詞: prescription dispensingcounterfeit drugspreparationscompoundingmedical institutions
英文摘要: Medicine for the treatment of disease should be preparations with specific pharmaceutical form and dosage. Production of medicine is based on non-specific patients with the same disease, but prescription fulfill and compounding are under instructions from medical and pharmaceutical professionals. Productions of preparation should follow the regulations in Good Manufacture Practice(GMP). Medicines must have the consistent contents, the reproducibility of therapeutic effects and validation for manufacturing processes in order to ensure the quality and protect the safety and efficacy. The legislator would determinate the violators as counterfeit drugs. Pharmaceutical forms and dosage of medicine for patients with the same disease should be judged by their constitution. Prescription compounding for a specific patient should not be applied to other patients. Large quantity compounding in advance could not ensure the safety and efficiency, and it is also beyond the responsibility of the professionals. Therefore, it should be a production behavior if compounding new pharmaceutical forms and new products in advance exceeds the range of compounding under the regulations.
目  次: 壹、藥事管理及立法之核心目的
貳、製劑及其製造採許可主義,以抽象危險定其罪責
參、醫療專業人員負擔特定病人處方調劑藥品之品質安全有效責任
肆、製劑之製造與處方調製行為之關聯性
伍、對於醫療機構大量預先調製新製品之行為,實務觀點歧異
陸、本文見解:大量預先調製之危險程度與製造並無不同
柒、超越合理數量之調製宜回歸製造行為-結論

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