Pharmacovigilance and drug safety 2011 in Calabria (Italy): Adverse events analysis.
J Res Med Sci
; 17(9): 872-5, 2012 Sep.
Article
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| MEDLINE
| ID: mdl-23826016
ABSTRACT
BACKGROUND:
Pharmacovigilance assesses the safety profile of drugs. Its main aim is the increase of spontaneous reporting of adverse drug reactions (ADRs). The Italian Drug Agency (AIFA; Agenzia Italiana del Farmaco) is financing several projects to the aim of increasing reporting, and in Calabria a Pharmacovigilance Information Centre has been created. MATERIALS ANDMETHODS:
We analyzed the AIFA database relatively to Calabria in the year 2011 and we have analyzed ADRs using descriptive statistics. We have also collected a questionnaire-based interview in order to describe the background knowledge in the field.RESULTS:
Regarding the number of AIFA reported ADRs from Calabria, a 38% increase (138 vs. 100) in comparison to 2010 was evidenced. Hospital Doctors represent the main source of signaling (71.7 %). Ketoprofene and the combination amoxicillin/clavulanic acid represent the most frequently reported drugs causing ADRs. Our questionnaires indicated that despite the health professionals have met at least once an ADR only a small percentage of them was reported to the authorities (37%). There is a very good knowledge of the ADR concept and reporting system (90% of interviewed distinguish an ADR and knows how to report it), and there is a strong interest in participating to training courses in the field (95% are interested).CONCLUSIONS:
Despite Calabria has had a positive increase in the number of reported ADRs, the total number is very low and the pharmacovigilance culture is far from being achieved in this region.
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Colección:
01-internacional
Banco de datos:
MEDLINE
Idioma:
En
Revista:
J Res Med Sci
Año:
2012
Tipo del documento:
Article
País de afiliación:
Italia