Adverse Drug Reaction Monitoring in Ethiopia: Analysis of case reports, 2002-2007

Abstract

Abstract

Background: Ensuring the health and safety of the public from adverse reaction of drugs is paramount. Adverse Drug Reactions Monitoring (ADRM) is a system that is put in place to ensure the health and safety of the public from adverse reactions of drugs. It heavily relies on health professionals (HPs) reporting of adverse events of drugs to drug regulators, in Ethiopia to the Drug Administration and Control Authority (DACA). The processed information, based on reported cases, is used to improve evidence based practice and underpins decisions to mitigate drug safety issues by drug regulators. However, the effectiveness of the ongoing ADRM system in Ethiopia in terms of its detection has never been evaluated.

Objective: To explore the magnitude of ADRM and suggest some practical improvement in Ethiopia.

Methods: The study analyzed the number of adverse drug reaction case reports received by DACA in a period of six years (2002 – 2007GC). All cases reported over the study period were included for analysis. Descriptive analysis was carried out to estimate the prevalence of adverse drug reactions and to assess their trend over the study period. To assess the strengths and weakness of the ongoing national ADRM, cases were analyzed by their location, time of occurrence, type of the health professional who made the case reports, drugs implicated, clinical manifestations and age of subjects affected.

Results: A total of 249 ADR cases were reported between 2002 and 2007. An average of 0.5 ADR cases per million populations were reported annually. The majority (36%) of all the cases were for 31 to 40 years of age. Cases were reported mainly (63%) from health facilities in the capital city. Physicians made 76% of all cases reported. Antiretroviral drugs were implicated in 70% of the cases reported. The most widely adverse events reported were dermatological disorders.

Conclusions: The level of ADR case reporting is very low showing the need to address major constraints of ongoing ADR monitoring. Thus, comprehensive measures aimed at improving under-reporting and effectiveness of ADRM should be instituted. [Ethiop. J. Health Dev. 2011;25(2):168-173]