[Official systems of pharmacovigilance in France and in Spain. Comparison of spontaneous reporting in two regional centers: Pays Basque and Bordeaux].
This report compares the drug surveillance systems in France and Spain. The Spanish causality assessment method is explained. The Spanish and French drug surveillance systems are rather similar, but with some variations in the data analysis and differences between causality algorithms used. Spontaneous reporting in two drug surveillance centres, Aquitaine (Bordeaux, France) and in the Spanish Basque Country (SBC) (type of reports, reporting form) is compared. Reports received by the two centres during the year 1992 are presented. The SBC Centre has received more reports and differences in the source and type of effects were observed.
Aguirre
C
C
Centre de Pharmacovigilance du Pays Basque, Hospital de Galdakao, España.
Haramburu
F
F
D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration*; D000465:Algorithms; D016208:Databases, Factual; D005602:France; D006801:Humans; D011358:Product Surveillance, Postmarketing; D013030:Spain
Les systèmes officiels de pharmacovigilance en France et en Espagne. Comparaison de la notification spontanée dans deux centres regionaux Pays Basque et Bordeaux.