Antibacterials: spontaneous report analysis for a six years period in Bulgaria

The pharmacovigilance started in Bulgaria in 1975. The doctors had to send the filled so called "yellow cards" for the suspected Adverse Drug Reactions to the Centre for Drug Safety at the National Drug Institute. In Bulgaria a spontaneous reporting on the adverse drug reactions has been studied during the period 1991-1996 for Antibacterials. The total number of the reports was 2409 and 18% of this number related to the Antibacterials. The reporting rate varied from 0.3 to 1.8 per 100,000 inhabitancy. As a whole 29% of the adverse drug reaction reports concerned the patients in the age groups of 0-5 year old. Amoxicillin is a drug with a majority of reports for the period. This article reveals the limits of the operating spontaneous reporting system in Bulgaria and suggests some possible measures to improve and refine it in a connection to the WHO and EMEA requirements.