Patterns of adverse drug reaction reporting in Ethiopia: A database analysis of spontaneous reports from 2013 to 2018

ABSTRACT

Objective: To examine the frequency and profile of spontaneous reports of adverse drug reactions (ADRs) sent to Ethiopia's pharmacovigilance (PV) database system. Methods: The descriptive and retrospective study analysed spontaneous ADR complaints reported to the PV database by healthcare professionals between 2013 and 2018. Spontaneous ADR reports that reached the PV center and met the minimum reporting criteria were identified and assessed in terms of reporting rate, patient characteristics, type of ADRs, suspected drugs, report sources, and reporters profession. Results: A total of 657 spontaneous ADR reports were filed to the PV center between 2013 and 2018. During the study period, the reporting pattern of ADRs changed dramatically. The number of reports increased from 2013 (n=12) and peaked in 2015 (n=205), and then declined from 2016 to 2018 (n=144, 142 and 65 in 2016, 2017 and 2018, respectively). Females had a higher percentage of reported cases (56.3%) than males (43.7%). The highest number of ADRs was reported in the age categories of 15-64 years (475, 72.3%), followed by 0-14 years (154, 23.4%), and 65 years and above (21, 3.2%). Pharmacists reported the majority of ADRs (81.7%), followed by health officers (7.2%), nurses (5.8%), and physicians (5.2%). Skin and subcutaneous tissue abnormalities were the most commonly reported ADRs. The anatomical therapeutic chemicals code class "anti-infective for systemic use"was the most usually suspected medication. Trimethoprim with sulfamethoxazole as a combination ADRs was the most commonly reported drug that cause ADRs (14.2%). Conclusions: The number of ADRs reported in Ethiopia was small and unpredictable compared to developed countries, indicating the performance of PV system and level of awareness of health care professionals towards ADR reporting was not satisfactory. In order to increase the frequency of spontaneous reports, more efficient PV methods and public policies must be implemented.