Análisis de las notificaciones de reacciones adversas a medicamentos tras la informatización de las consultas de atención primaria en Aragón / Adverse drug reaction report analysis after computerizing primary

Las reacciones adversas a medicamentos son una de las principales causas de morbimortalidad en los países desarrollados. La Farmacovigilancia se encarga de la detección, registro y evaluación de estas reacciones. El conocimiento de los efectos adversos observados en la práctica clínica diaria y su cuantificación se ha realizado tradicionalmente mediante el Programa de Notificación Espontánea a través de la Tarjeta Amarill. Actualmente la informatización progresiva de las consultas de AP a través del programa informático OMI-AP, ha facilitado el proceso de notificación mejorando la calidad y precisión de la información recogida. El objetivo de este trabajo ha sido comparar la cantidad y calidad de las notificaciones obtenidas antes y después de la informatización (durante 2004) en cuatro Centros de Salud de la regios: Delicias Sur, Valdefierro, Oliver y Monzón

Adverse drug reactions are one of the main morbimortality causes in developed countries. Pharmacovigilance is charge of detection registry and evaluation of these reactions. The knowledge and quantification of the observed adverse effects in clinical practice have been made traditionally by the Spontaneous Notification Program through the yellow card. At the moment, the progressive primary health care computerization through OMI-AP program, has facilitated the notification process improving the quality and precision of yellow card. The aim of this work has been to compare the amount and the quality of the spontaneous notifications obtained before and agter comuterization (during year 2004) in four regional Health Centres: Delicias Sur, Valdefierro, Oliver and Monzon

From pharmacovigilance to pharmacoperformance.

The pharmaceutical industry is going through a period of enormous upheaval, as new sciences, technologies and commercial pressures reshape the way in which it performs research and development. PwC Consulting estimates that the top 20 companies will each need to launch between four and six times the number of drugs they currently produce, as well as improving the quality of those drugs, merely to maintain shareholder returns. This has huge implications for pharmacovigilance departments. More drugs means more trials, more patients and -- of course -- more safety reports for evaluation. The pharmacovigilance teams in most big companies are ill prepared for this transition being already stretched to the limit. But as demand for patients to participate in clinical trials increases -- with shorter development times, higher success rates in discovery and greater productivity -- so companies with a poor reputation for safety will suffer. What is it then that companies should be doing to remain compliant and be seen to be safe in the eyes of the consumer? Can pharmacoepidemiology support both molecules in the marketplace as well as those in research and development and what is really needed to enable this? Key to success will be the ability to capture, analyse and evaluate data (from disparate sources) in real time and to make rapid decisions on the appropriate course of action. Putting better structures, processes and technological platforms in place to cope with a big increase in throughput is only a short-term solution yet is it enough to fulfil the objective in the long-term of ensuring compliance and patient safety?