[Safety of meningococcal A and C vaccine. Data from the Spanish drug surveillance system. Meningococcal Vaccine Research Group of the Spanish System of Drug Surveillance]. / Seguridad de la vacuna antimeningocócica A+C. Datos recogidos por el Sistema Español de Farmacovigilancia. Grupo de Investigación sobre la vacuna antimeningocócica del Sistema Español de Farmacogigilancia.

OBJECTIVE: Data on meningococcal vaccines safety are scanty. In 1997 several vaccination campaign took place in Spain. Thus, this situation was used to improve our knowledge about the safety profile of this vaccine. METHODS: An inquiry was carried out to the Regional Centers of the Spanish Pharmacovigilance System to know the number of vaccinated people and the type and number of suspected cases of adverse reactions. RESULTS: There were 133 identified cases of suspected adverse reactions associated with meningococcal A and C vaccine until June 1st, 1998. Most of them affected the skin (25,3%) or nervous system (similar proportion). Those of allergic reactions accounted for 35,2%. Two cases were considered as severe, although they were resolved without secuelae. CONCLUSIONS: Serious risks were not detected. The Spanish Pharmacosurveillance System as an epidemiological surveillance resource has been useful to know the safety problems associated with antimeningococcal vaccine in the community.

[Adverse drug reactions and a program of voluntary notification: an opinion survey of primary care physicians]. / Reacciones adversas a medicamentos y programa de notificación espontánea: una encuesta de opinión a médicos de atención primaria.

OBJECTIVES: To discover the view of primary care doctors on aspects of the safety of medicines, their knowledge of the programme of automatic notification of negative side-effects of medicines (NSEM), their opinion of the programme and factors affecting low notification. DESIGN: A survey of views. SETTING: Madrid's Health Area 1. PARTICIPANTS: General practitioners and paediatricians (n = 417). MEASUREMENTS AND RESULTS: 281 doctors (67.4%) replied. 88.4% (48 + 40.4%) said they included questions on possible side-effects in the case history interview (always or almost always). 58.2% suspected at least one negative side-effect each month. CONCLUSIONS: Doctors are very interested in detecting and identifying the NSEM of their patients, and therefore believe that a centralised system to record NSEM should be set up.