Spontaneous and timely reporting of adverse drug reactions: a necessary custom

Abstract

Objective: the purpose of the present study was to identify the number of adverse drug reactions in hospitalized patients, through active search for prescription of antihistamines, biperiden and vitamin K.

Methods: we conducted an observational, descriptive study from July 2008-June 2009, by the search in medical records in the Clinica Universitaria Bolivariana, n=143. We estimated the frequency of probable or possible adverse drug reactions and spontaneous medical report.

Results: we assessed 892 inpatient cases with antihistamines, biperiden or vitamin K prescription; 143 cases were included in the study for their relationship with treatment of possible or probable adverse drug reactions. We found a frequency of cases with no spontaneous medical report in 72.7% (n=104), the time for presentation of the latter was with a mean of 8.1 days, a median of 4 days, IQR (1-11) and a range in days of 0-37.

Conclusion: we observed a low frequency of adverse drug reactions with spontaneous medical report and an average of eight days for notification when it was reported. Therefore, it is necessary to promote spontaneous and timely reporting that can help improve the safety in administered drugs.