Pharmacovigilance System in Ethiopia: Implementation Status and Challenges
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Date
2021-06
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Addis Abeba University
Abstract
Background: Functional pharmacovigilance system is vital to ensure patient safety in the healthcare
system. In the Ethiopian context, there is paucity of information on the organizational functionality
of the pharmacovigilance program.
Objectives: To assess the Pharmacovigilance system and implementation status in Ethiopia
Method: An institution-based mixed study design was used to assess the pharmacovigilance
functionality at hospitals, pharmaceutical companies, and regulatory authority. World health
organization’s pharmacovigilance indicators and key informant interviews were used for data
collection. Quantitative and qualitative data were analyzed using Microsoft excel (2013) and
thematic analysis approach, respectively.
Results: Only 1 (3.3%) of the 30 hospitals had pharmacovigilance unit with dedicated budget, 3
(10%) had staff assigned, and 7 (23.3%) had SOP. Similarly to hospitals, out of 32 pharmaceutical
companies 4 (12.5%) had separate pharmacovigilance unit, 12 (37.5%) had regulatory unit, and 5
(15.6%) had budget for Pharmacovigilance. The national pharmacovigilance center have most of the
structure, process, and outcome level pharmacovigilance practices. As significant challenges,
resource constraints and reporting-related issues were identified. Patient harm, loss of confidence
and trust, increased circulation of unsafe products, and economic costs reported as significant
consequences. Sector experts recommended increasing training, engaging sector stakeholders, and
improving the regulatory system as key interventional strategies.
Conclusion: There are substantial variations in the structures, processes, and outcomes of
pharmacovigilance status among the studied organizations. Most pharmacovigilance system
indicators are absent in the majority of pharmaceutical companies and hospitals. However, most of
the elements of Pharmacovigilance systems are exercised by the national regulatory authority.
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Keywords
Adverse drug events, Pharmacovigilance System, Pharmacovigilance Indicators