[Impact of the spanish pharmacovigilance system recommendations on the publication of cases of adverse drug reaction].
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.


METHODS
Observational study.


METHODS
National suspected adverse drug reactions database (FEDRA).


METHODS
Published adverse drug reaction reports registered in FEDRA, published in the years before (2003) and after (2005) the recommendations were issued.


METHODS
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.
Esteban Calvo
Carmen
C
Centro de Farmacovigilancia de la Comunidad de Madrid, Madrid, España. carmen.esteban@salud.madrid.org
Ibáñez Ruiz
Carmen
C
Salgueiro Vázquez
Esther
E
Manso Rodríguez
Gloria
G
D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D005260:Female; D017408:Guidelines as Topic; D006801:Humans; D008297:Male; D008875:Middle Aged; D011358:Product Surveillance, Postmarketing; D011643:Publishing / Q000592:standards*; D013030:Spain