Abstract

BackgroundBurden of adverse drug reactions (ADRs), in home-environment and domestic settings, is unknown.ObjectiveTo discuss the epidemiology of reported ADRs to 13-Aban drug and poison information center (DPIC) and to discuss the burden of hospitalization caused by these ADRs from commonly implicated therapeutic groups.MethodsA retrospective analysis of the yellow card schemes of suspected ADRs reported to the 13-Aban DPIC was conducted from 21 March 2013 to 21 November 2016 inclusive.Main outcome measuresCharacteristics of the ADRs, such as the sex and age of the patient, the therapeutic group involved, and the medical outcome of the exposure, were examined. ADR Hospitalization (ADRH) index was calculated for each drug group by dividing the number of ADR-related hospitalizations with total number of reported ADR cases (n = 748), and then multiplying by 100.ResultsADRs were reported for 748 patients representing 5 cases per 1000 enquiries to the 13-Aban DPIC over almost 4-years of the study period. Public were responsible for reporting every 4 out of 5 ADR cases (n = 651, 87%) and the remaining 1 out of 5 ADR cases was reported by the health care professionals (n = 97, 13%). Most of the ADRs had a medical outcome documented as having a minor effect or were minimally bothersome to the patients (n = 509, 68%), and less than 4.9% (n = 37) were documented as having a major effect or were life-threatening. Overall, 7.4% (n = 55) of ADRs were resulted in hospitalization. Antibacterials for systemic use represented the therapeutic group with the highest hospitalization index (1.7%).ConclusionsThe study concluded that ADRs to antibiotics are common and some of them resulted in hospitalization.

Highlights

  • Adverse drug reactions (ADRs) represent a major burden on healthcare systems and are a common cause of hospital admissions as well as of in-hospital morbidity and mortality [1,2,3]

  • adverse drug reaction (ADR) were reported for 748 patients representing 5 cases per 1000 enquiries to the 13Aban drug and poison information center (DPIC) over almost 4-years of the study period

  • Most of the ADRs had a medical outcome documented as having a minor effect or were minimally bothersome to the patients (n = 509, 68%), and less than 4.9% (n = 37) were documented as having a major effect or were life-threatening

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Summary

Introduction

Adverse drug reactions (ADRs) represent a major burden on healthcare systems and are a common cause of hospital admissions as well as of in-hospital morbidity and mortality [1,2,3]. In Iran this is managed through the yellow card scheme which is operated by the Iranian Adverse Drug Reaction Monitoring Center (IADRMC) at the Ministry of Health [4]. Information in these cards is the main source of data for the IADRMC and is mostly supplied by health professionals such as physicians, nurses, and pharmacists [4]. Direct reporting of suspected ADRs by public, which is already well established in other countries [5,6,7], has shown to have many potential benefits.

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