Browsing by Author "Endale, Sisay"

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    Pharmacovigilance System in Ethiopia: Implementation Status and Challenges
    (Addis Abeba University, 2021-06) Endale, Sisay; Gedif, Teferi (Professor ); Maraew, Tesfa (M.Pharm)
    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.