Patterns of adverse drug reaction reporting in Ethiopia

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.

Characteristics and Trends in Adverse Drug Reactions in Ghana- Evidence of Spontaneous Reports, 2005-2021

“…The demographic details revealed a higher percentage of ADRs occurred in young adults aged 20-44 years (36.7%), followed by older adults aged 45-64 years (1,416, 22.9%) which is similar to a study carried out in Nigeria. 19 The proportion of ADR reports received was higher among men (64.3%) compared to women (35.7%) which is consistent with the ndings from other studies [27,28] and in contrast to previous studies that reported female predominance [29,30,31]. In addition, the age-adjusted report rates revealed a higher ADR reporting increasing trend involving males (19.2%) than females (18.1%) from 2005-2019 (Fig.…”

Profile of adverse drug reaction reports in South Africa: An analysis of VigiBase® for the year 2017

“…Reports in Ethiopia's pharmacovigilance database contain 56.3% for females, compared with males (43.7%). [41] An analysis conducted by Watson et al [42] on more than 18 million ICSRs in VigiBase during 2018 also indicated that women, from puberty and onwards and especially in their reproductive years, report more ADRs than men. This is a known phenomenon attributed to differences in biological, i.e.…”

Incidence and Predictors of Severe Adverse Drug Reactions among Patients on Antiretroviral Drugs in Harari Regional State, Eastern Ethiopia

“…Despite this, the organization collected and documented only a few reports from the health facilities due to diferent reasons. As the case report analysis conducted showed there is a signifcant decrease in ADR reporting from 2016 to 2018 which does not show the absence of ADR, majority of the healthcare professionals were not aware of the existence of the spontaneous ADR reporting system which shows a low response and lack of knowledge at ground level [13][14][15][16][17].…”