Evaluación de medicamentos a nivel hospitalario: de la selección a la práctica clínica
- Autores: Amaya Echeverría Gorriti
- Directores de la Tesis: Ana Ortega Eslava (dir. tes.)
- Lectura: En la Universidad de Navarra ( España ) en 2018
- Idioma: español
- Tribunal Calificador de la Tesis: Pilar Modamio Charles (presid.), Azucena Aldaz Pastor (secret.), Ana Clopés Estela (voc.), Antonio Joaquín Idoate García (voc.), Vicente Arocas Casañ (voc.)
- Programa de doctorado: Programa de Doctorado en Medicamentos y Salud por la Universidad de Navarra
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- Resumen
Drug selection is a continuous and multidisciplinary task. At hospital level, it is conducted by Pharmacy and Therapeutics Committees based on drug evaluation reports. These reports are mostly done by hospital pharmacists, include comparative pharmacological characteristics, efficacy, safety and economic data, and are based on the information available at that moment, mainly clinical trials. Real world data are generally not available at that point. However, outcomes in clinical practice can differ from those in trials, and real world results could condition drug selection.
The aim of this study was to evaluate in clinical practice the use, effectiveness, safety and costs of new drugs approved in our hospital, to compare them with the expected results according to the drug evaluation report and to analyze which factors could contribute to the observed differences.
A retrospective observational study of electronic patient records was conducted. We reviewed data of patients that received new drugs with a full drug evaluation report and that were included in the hospital drug formulary from 2011 to 2015.
Mostly, drugs were generally used for approved indications. Effectiveness in clinical practice was higher than in clinical trials in 60% of the drugs, while costs were lower than estimated in 64% of them. However, variability in these outcome deviations was wide and it was not possible to predict these deviations according to some general criteria. Although drugs with restricted criteria for use and non-cancer drugs seem to be associated with higher effectiveness than efficacy data, and ambulatory drugs with higher deviation percent. Some reasons for deviation in effectiveness were patient performance status, patient age, concomitant drugs, previous therapies, etc; and for deviation in costs included lower treatment durations, or dosing optimization. Less adverse effects were registered in patients records comparing to those recorded in clinical trials, however under-reporting could contribute to this fact. The main study limitation was the single center and retrospective design.
Real world outcomes may be different from those obtained in clinical trials and deviance is difficult to predict according to general criteria. Therefore, multicenter observational studies and continuous drug evaluation are necessary in order to improve drug selection and patient outcomes.
