Assessment of Medicine Regulatory Performance In South - West Ethiopia: The Case of Ilu-Ababora Zone, Oromia Regional State
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Date
2023
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Addis Ababa University
Abstract
Introduction: The implications of ineffective pharmaceuticals regulation is becoming a
major problem worldwide. Therefore, in order to address this issue and provide access to
high-quality medications, every country should meet the minimum standards of a
functional pharmaceuticals regulation.
Objective: - To assess medicine regulatory performance in Ilu-Ababora zone, Oromia
regional state, south west Ethiopia
Methods: A sequential mixed methods (quantitative method followed by qualitative
research approaches) was conducted from July to September 2022 G.C. in Ilu-Ababora
zone using document review, simulated client visit method and semi-structured
interviews. The study participants were regulatory professionals and healthcare
providers working in Zonal Health Office, selected Woreda Health Offices and both
public and private medicine retail outlets including private clinics. The data was
analyzed using descriptive methods for the quantitative part and thematic analysis for the
qualitative part.
Results: Majority 91.66% of retail outlets from the total 24 issued non prescribed
antibiotics at three distinct demand levels. In Ilu-Ababora zone there were 3,944 human
health related facilities to be inspected by the zonal health department regulatory teams
in collaboration with each woredas regulatory teams. But, at the zonal health
department there were only two inspectors. All the woredas except Mettu City
Administration, which has two inspectors, has one or none inspectors assigned. They
didn’t have separate vehicle as well as no budget breakdown for regulatory activities.
The regulatory performance is currently very poor. Performance influencing factors like
widening of control area, scarcity of resources, capacity building problem, information
iv
leakage, lack of attention from the stakeholders, communication-related issues, and lack
of awareness from the society were identified. Increased circulation of unsafe products,
compromising patient’s quality of care, and monetary costs were reported as major
concerns. As important interventional tactics, sector experts suggested enhancing
capacity building techniques, involving sector stakeholders, and strengthening the
regulatory structure.
Conclusion: Despite the availability of comprehensive medicine regulations in Ethiopia,
the results of this study show that the enforcement of these regulations is weak and the
way regulations are currently being implemented in this area is not very effective and is
still in the early stages of development.
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Keywords
Performance, input, output, outcome, inspection, licensing