2004-2007年某三级医院新药选择过程分析

E.R. Alfaro-Lara , M. Galván-Banqueri , E. Prado-Mel , B. Santos-Ramos , J.M. Varela-Aguilar , J. Torelló-Iserte , M.M. Castellano Zurera , F.J. Bautista Paloma
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引用次数: 2

摘要

目的本研究的目的是描述CFyT、药学和治疗学委员会的结构,以及一家三级医院的新药选择过程。材料和方法回顾了2004年至2007年期间在维珍医院Rocío收到的所有PTC年报和新药纳入指南(GINF)。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、管理途径和法律类别)、申请人(负责部门、专业类别和请求类型)和评估结果(最终决定、请求和决定之间的经过时间)有关的变量。结果在申请的72种药物中,有45种(62.5%)获得批准:6种作为等效治疗,36种(80%)具有特定推荐,3种(4.2%)没有限制。12种药物(81.1%)由于与当前治疗相比有效性证据不足而未纳入。最常要求的药物类型是抗肿瘤药物,最常见于肿瘤科和血液科。我们强调的事实是,许多请愿书包括临床试验(97.2%)和涉及成本的数据(84.7%)。结论我们中心对GINF指南的遵守程度很高,这保证了P&TC的最终决定是基于科学证据的。
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Analysis of the selection process for new drugs in a tertiary hospital 2004-2007

Objective

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.

Material and methods

All annals of the PTC 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).

Results

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%).

Conclusions

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.

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