| 摘要: | 中藥係以其性味、歸經為分類，歷代中醫根據病情之需要，運用藥品及丸、散、湯、膏等劑型，然市售中藥之品項及劑型不敷臨床之需求，故中醫醫療機構須預先調製丸、散、膏、丹及水煎藥液等中藥藥品，供診療後病患使用。但有關中醫醫療機構自行調製藥品之規定，歷年來衛生福利部（行政院衛生署）多次以函釋從嚴規範或甚至禁止，造成中藥院內製劑發展受到限制。
本論文先就歷代中藥製劑之沿革加以說明，並比較分析相關制度，說明中藥之院內製劑有其必要性。此外，本文亦認為衛生福利部誤解調劑與製造之概念，預製為調劑之範圍，與製造之概念不同，藥事法亦未授權中央主管機關就製造之刑罰構成要件為補充，是衛生福利部函釋內容顯有逾越藥事法授權範圍。
另中醫醫療機構有預製藥品之需求，然可能因醫療機構內設施有限，故有委託調製之需求，藥事法規定中醫師本有監督中藥調劑之權，且無規定僅可在醫療機構內監督調劑，故中醫師委託他人並依照藥事法進行監督調劑，其並無違反藥事法。是以本論文依照藥事法第37條第1項之規定，草擬「中醫醫療機構中藥製劑委託調製管理辦法」草案供日後法規增訂之參考。
Traditional Chinese medicine preparations are categorized by their nature, flavor and meridian tropism (channel of entry). Depending on the needs of response to different symptoms, traditional Chinese medicine practitioners may choose the medicine preparations in the form of pills, powder, soup or paste. However, the commercialized items and forms of traditional Chinese medicine preparations do not meet the needs and requirements for clinical use. As a result, medical institutions practicing traditional Chinese medicine must prepared the pills, powder, paste, balls and decoction of traditional Chinese medicine for patients to use after consultation. Yet the Ministry of Health and Welfare (the Department of Health, Executive Yuan) has repeatedly issued instructions to strictly regulate or even prohibit such practice over the years in terms of the regulations governing the traditional Chinese medicine preparations prepared by medical institutions practicing traditional Chinese medicine, which limits the development of traditional Chinese medicine hospital preparations.
The study first introduced the history of traditional Chinese medicine preparations. A comparative analysis of the related systems was conducted, which explained the necessity of preparing traditional Chinese medicine hospital preparations. In addition, it was considered that the Ministry of Health and Welfare has misunderstood the concept of preparation and manufacturing. Preparation belongs to the scope of dispensing, which is different from manufacturing in the aspect of concept. The Pharmaceutical Affairs Law does not authorized any central competent authority to provide supplement for the legal element of the offense for the criminal penalty of manufacturing. It was the interpretation in the issued instructions of the Ministry of Health and Welfare that surpassed the scope of authorization provided in the Pharmaceutical Affairs Law.
On the other hand, there are needs of pre-prepared traditional Chinese medicine preparations in related medical institutions, but probably due to the limited facilities in the institutions, the task of preparation is needed to be entrusted to a third party. It is stated in the Pharmaceutical Affairs Law that traditional Chinese medicine practitioners have the right to supervise the preparation of traditional Chinese medicine preparations, and there is no regulation which regulates that the supervision of preparation can only be performed in a medical institution. Therefore, having the preparation entrusted to a third party and having a traditional Chinese medicine practitioner supervising the preparation do not violate the Pharmaceutical Affairs Law. Based on Paragraph 1, Article 37 of the Pharmaceutical Affairs Law, the study provided the draft of the “Regulations on the Preparation and Management of Traditional Chinese Medicine Preparations Entrusted to Third Parties by Medical Institutions Practicing Traditional Chinese Medicine” as the reference for the possible addition or amendment of laws and regulations in the future. |
