Alfaro-Lara E R, Galván-Banqueri M, Prado-Mel E, Santos-Ramos B, Varela-Aguilar J M, Torelló-Iserte J, Castellano Zurera M M, Bautista Paloma F J
Servicio de Farmacia, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
Farm Hosp. 2010 Mar-Apr;34(2):76-84. doi: 10.1016/j.farma.2009.09.004. Epub 2010 Jan 25.
The purpose of this study is to describe the structure of the CFyT, the Pharmacy and Therapeutics Committee, and a tertiary hospital's selection process for new drugs.
All annals of the P&TC and the New Drug Incorporation Guides (GINF) to incorporate new drugs received at Hospital Virgen del Rocío between 2004 and 2007 were reviewed. We carried out a descriptive study which collected variables having to do with the drug (drug type, type of register, route of administration and legal category), the petitioner (responsible division, professional category and request type) and the result of the evaluation (final decision, elapsed time between the request and the decision).
Of the 72 requested drugs, 45 (62.5%) were approved: six as equivalent treatments, 36 (80%) with specific recommendations, and three (4.2%) with no restrictions. Twelve drugs (81.1%) were not included due to insufficient evidence of their effectiveness compared with the current treatment. The most frequently-requested drug type was the antineoplastics, most commonly requested by Oncology and Haematology divisions. We highlight the fact that many of the petitioners included clinical trials (97.2%) and data referring to costs (84.7%).
There is a high level of compliance with the GINF guide in our centre, which guarantees that the P&TC's final decision is based on scientific evidence.
本研究旨在描述临床药学与治疗学委员会（CFyT）的结构、药学与治疗学委员会以及三级医院新药的遴选过程。
回顾了2004年至2007年期间维根德埃尔罗西奥医院收到的所有药学与治疗学委员会记录以及新药纳入指南（GINF）中有关新药纳入的内容。我们进行了一项描述性研究，收集了与药物（药物类型、注册类型、给药途径和法律类别）、申请人（责任科室、专业类别和申请类型）以及评估结果（最终决定、申请与决定之间的时间间隔）相关的变量。
在72种申请的药物中，45种（62.5%）获得批准：6种作为等效治疗药物，36种（80%）有具体推荐意见，3种（4.2%）无限制。12种药物（81.1%）因与现有治疗相比有效性证据不足而未被纳入。最常申请的药物类型是抗肿瘤药, 肿瘤学和血液学科室申请最为常见。我们强调许多申请人提供了临床试验（97.2%）和成本数据（84.7%）这一事实。
我们中心对GINF指南的依从性很高，这确保了药学与治疗学委员会的最终决定基于科学证据。
