Assessment of new drugs in a tertiary hospital using a standardized tool

• Published in: Farmacia hospitalaria : organo oficial de expresion cientifica de la Sociedad Espanola de Farmacia Hospitalaria Vol. 37; no. 5; p. 388
• Main Authors: González-Bueno, J, Chamorro-de-Vega, E, Alfaro-Lara, E R, Galván-Banqueri, M, Santos-Ramos, B
• Format: Journal Article
• Language: English
• Published: Spain 01-09-2013
• Subjects: Cost-Benefit Analysis; Decision Support Techniques; Drug Approval; Drug Costs; Drugs, Investigational - economics; Drugs, Investigational - therapeutic use; Evidence-Based Medicine; Forms and Records Control; Formularies, Hospital; Guideline Adherence; Guidelines as Topic; Hospital Departments; Hospitals, Teaching - economics; Hospitals, Teaching - organization & administration; Humans; Pharmaceutical Preparations - classification; Pharmacy and Therapeutics Committee; Retrospective Studies; Spain; Tertiary Care Centers - economics; Tertiary Care Centers - organization & administration; Therapeutic Equivalency; Spain
• ISSN: 0214-753X

To describe the profile of new drugs evaluated by the Pharmacy and Therapeutics committee in a tertiary hospital using a standardized tool, the Guideline for the Introduction of New Drugs in the Formulary (GINF form), as main objective.
Retrospective observational study of drugs was assessed during 2008-2011. Variables related to the drug, the request, and the result of the evaluation were collected based on information contained in the GINF form and in the assessment reports.
63 of 75 assessed drugs (84%) were included in the hospital formulary. Only one drug (1%) was included without any restrictions. The rest of them were included as therapeutic equivalents (23%) or under specific recommendations (61%). Half of the drugs (6) not included had insufficient evidence of effectiveness compared with current treatments. Haematology and Medical Oncology were found to be the most active medical services in the application process. There was a high prevalence of drugs that had more than one advanced clinical trial (phase III and/or phase IV). Furthermore, 28% of assessed drugs were associated with a financial burden of more than ?10,000 per year for our hospital. Highquality information was provided by applicants to the P&T committee for drugs that were finally included. However, the relationship between the information provided to the P&T committee and its decision was not statistical significance.
The requests received were primarily related to drugs intended for parenteral use and most of them were antineoplastic drugs. The medical departments most heavily represented were Haematology and Oncology.