Selmin Francesca, Casiraghi Antonella, Musazzi Umberto M, Fortini Marco, Minghetti Paola
Università degli Studi di Milano, Department of Pharmaceutical Sciences, Milano, Italy.
Farmacia Nuova Fortini, Seriate, Italy.
Int J Pharm Compd. 2019 Jan-Feb;23(1):6-12.
Pharmaceutical compounded medicinal preparations are aimed to fulfill the special needs of a subpopulation of patients for whom a medicinal product is not commercially available. Nowadays, this activity remains an important component of pharmacy practice and an integral part of the modern healthcare system. In 2011, the Committee of Ministers of the Council of Europe adopted a resolution to harmonize quality assurance and safety standards for medicinal products prepared in pharmacies for the special needs of patients in European countries. This article discusses the actual rules and technical norms that regulate the compounding activity in Italy in the light of the new European laws.
药物配制制剂旨在满足特定患者亚群体的特殊需求，这些患者所需的药品尚无商业供应。如今，这项活动仍是药学实践的重要组成部分，也是现代医疗保健系统不可或缺的一部分。2011年，欧洲委员会部长委员会通过了一项决议，以协调欧洲各国药房为满足患者特殊需求而配制的药品的质量保证和安全标准。本文根据欧洲新法律，探讨了意大利规范配制活动的实际规则和技术规范。
