ABSTRACT
OBJECTIVES: The surveillance of vaccine safety is an essential requirement in vaccination programmes. Computerized immunization registries such as the Vaccination Information System (SIV) of Valencian Community (Spain) offer the opportunity to estimate the incidence of adverse events according to individual information. The aim of the study was to analyze adverse events following immunization reported through SIV from 2005 to 2011 by age, sex, type of vaccine and dose, and adverse event, and highlight the advantages of this type of reporting. STUDY DESIGN: A retrospective cohort study of subjects vaccinated in the Valencian Community using population health databases was carried out. METHODS: Analysis of vaccinations and reported AEFI via SIV in Valencian Community was carried out. RESULTS: More than 13 million vaccines doses were administered during 2005 through 2011, the reporting rate of adverse events was 12.4/100,000 doses administered with the highest value in 2009 (27.4), with differences by age and sex. DTaP vaccine had the highest reporting in children (96.6/100,000) while influenza A(H1N1)pdm09 in adults (87.7/100,000). An increased reporting of adverse events was seen with DTaP in children 5-6 years of age, detected in real time, drove to swap this vaccine to a low dose Tdap which was followed by a decrease in administration site events. CONCLUSIONS: SIV demonstrates advantages for passive surveillance. Reporting rates by individual characteristics are calculated accurately and it also allows detecting shifts in reporting rate on real time for specific vaccines. The study shows that vaccines included in the routine vaccination schedule for children and adult vaccination programs are safe.
Subject(s)
Adverse Drug Reaction Reporting Systems , Product Surveillance, Postmarketing/methods , Vaccines/adverse effects , Adolescent , Adult , Aged , Child , Child, Preschool , Databases, Factual , Female , Humans , Infant , Male , Middle Aged , Retrospective Studies , Safety , Spain , Young AdultABSTRACT
Las quinolonas en conjunto pueden considerarse como un grupo con un buen balance beneficio/riesgo pues, en general, los derivados quinolónicos son seguros y bien tolerados. Frecuentemente, los efectos adversos disminuyen con la reducción de la dosis y la duración de la terapia. Sólo es necesaria la interrupción del tratamiento en el 1-3 por ciento de los pacientes. Las reacciones adversas más frecuentes son molestias del tracto gastrointestinal, estimulación del sistema nervioso central y alergias. No obstante, algunas quinolonas como el temafloxacino, el grepafloxacino y el trovafloxacino han sido retiradas del mercado por problemas de toxicidad grave. En el presente trabajo se revisa la relación estructura-efectos adversos e interacciones con otros fármacos de estos antibacterianos. El objetivo fundamental es identificar los grupos estructurales que determinan la aparición de reacciones adversas importantes para destacar las configuraciones moleculares exentas de riesgos y que, potencialmente, pueden ser valiosos instrumentos en la terapéutica antiinfecciosa (AU)
