[Analysis of the selection process for new drugs in a tertiary hospital 2004-2007]. / Análisis del proceso de selección de nuevos medicamentos en un hospital terciario. Años 2004-07.

ABSTRACT

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 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). 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.