[Impact of the spanish pharmacovigilance system recommendations on the publication of cases of adverse drug reaction]. / Impacto de las recomendaciones del Sistema Español de Farmacovigilancia en la publicación de casos de reacciones adversas a medicamentos.

OBJECTIVE: To assess the impact of the recommendations that, the Technical Committee of the Spanish Pharmacovigilance System sent, in 2004, to the editors of Spanish medical journals on the minimum information required for publication of adverse drug reaction case reports. DESIGN: Observational study. SETTING: National suspected adverse drug reactions database (FEDRA). PARTICIPANTS: Published adverse drug reaction reports registered in FEDRA, published in the years before (2003) and after (2005) the recommendations were issued. MAIN MEASUREMENTS: The following data elements were analysed: sex, age, dose, disease treated with the suspected drug, length of treatment and adverse drug reaction, temporal sequence, withdrawal effect, and alternative causes. The results of the 2 years were compared. RESULTS: The information in the case reports published between years 2003 and 2005 was not significantly different. The data elements more often incomplete were dose, length of treatment, as well as length of adverse reaction. Approximately one third of the published case reports included full information. CONCLUSIONS: There seems to be a need to improve the data elements content of published adverse drug reactions case reports, so that such documentation can contribute to improve the assessment of alert signals.