ABSTRACT
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Subject(s)
Humans , Drug Interactions , Valproic Acid , Anti-Bacterial Agents , Information Management/trends , Medication ErrorsABSTRACT
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.
Subject(s)
Adverse Drug Reaction Reporting Systems , Product Surveillance, Postmarketing , Publishing/standards , Aged , Female , Guidelines as Topic , Humans , Male , Middle Aged , SpainABSTRACT
Objetivo. Evaluar el impacto de lasrecomendaciones que el Comité Técnico delSistema Español de Farmacovigilancia envióa los editores de revistas médicas españolasen el año 2004 sobre la información mínimaque deberían contener los casos publicadosde reacciones adversas a medicamentos.Diseño. Estudio observacional.Emplazamiento. Base de datos nacional desospechas de reacciones adversas (FEDRA).Participantes. Notificaciones de publicacionesde sospechas de reacciones adversasregistradas en FEDRA y publicadas enlos años previo (2003) y posterior (2005)al envío de las recomendaciones.Mediciones principales. Información en losapartados: sexo, edad, dosis, motivo de laprescripción, duraciones del tratamiento y dela reacción, secuencia temporal, efecto de laretirada y causas alternativas de laspublicaciones de sospechas de reaccionesadversas registradas en FEDRA. Secompararon los resultados de los 2 años.Resultados. No se observaron diferenciassignificativas en la información contenidaen las publicaciones de casos de reaccionesadversas entre los años 2003 y 2005.Los apartados que con mayor frecuenciapresentaban información incompleta eranlas dosis y duraciones de los tratamientosy de la reacción adversa. Sólo un tercio,aproximadamente, de las publicacionescontenían información completa.Conclusiones. Es necesario mejorarel contenido de la información de laspublicaciones de casos de reacciones adversasa medicamentos para que esta mejordocumentación contribuya a mejorarla evaluación de las señales de alerta
Objective. To assess the impact of therecommendations that, the TechnicalCommittee of the SpanishPharmacovigilance System sent, in 2004,to the editors of Spanish medical journalson the minimum information required forpublication of adverse drug reaction casereports.Design. Observational study.Setting. National suspected adverse drugreactions database (FEDRA).Participants. Published adverse drug reactionreports registered in FEDRA, publishedin the years before (2003) and after (2005)the recommendations were issued.Main measurements. The following dataelements were analysed: sex, age, dose,disease treated with the suspecteddrug, length of treatment and adverse drugreaction, temporal sequence, withdrawaleffect, and alternative causes. The resultsof the 2 years were compared.Results. The information in the case reportspublished between years 2003 and 2005was not significantly different. The dataelements more often incomplete were dose,length of treatment, as well as length ofadverse reaction. Approximately one thirdof the published case reports included fullinformation.Conclusions. There seems to be a needto improve the data elements contentof published adverse drug reactions casereports, so that such documentation can contribute to improve the assessment of alert signals (AU)
