Impacto de las recomendaciones del Sistema Español de Farmacovigilancia en la publicación de casos de reacciones adversas a medicamentos / Impact of the spanish pharmacovigilance system recommendation son the publication of cases of adverse drug reactions

ABSTRACT

Objective. To assess the impact of therecommendations that, the TechnicalCommittee of the SpanishPharmacovigilance System sent, in 2004,to the editors of Spanish medical journalson the minimum information required forpublication of adverse drug reaction casereports.Design. Observational study.Setting. National suspected adverse drugreactions database (FEDRA).Participants. Published adverse drug reactionreports registered in FEDRA, publishedin the years before (2003) and after (2005)the recommendations were issued.Main measurements. The following dataelements were analysed: sex, age, dose,disease treated with the suspecteddrug, length of treatment and adverse drugreaction, temporal sequence, withdrawaleffect, and alternative causes. The resultsof the 2 years were compared.Results. The information in the case reportspublished between years 2003 and 2005was not significantly different. The dataelements more often incomplete were dose,length of treatment, as well as length ofadverse reaction. Approximately one thirdof the published case reports included fullinformation.Conclusions. There seems to be a needto improve the data elements contentof published adverse drug reactions casereports, so that such documentation can contribute to improve the assessment of alert signals (AU)