A Systematic Scoping Review of the State of Pharmacovigilance and Governance in the MENA Region: Challenges and Opportunities

摘要

Abstract Introduction Pharmacovigilance (PV) systems around the world vary in capacity and maturity. Many factors can influence PV. Objectives This systematic scoping review aims to explore the opportunities for effective PV in the Middle East and North Africa (MENA) region by (1) using the pharmacogovernance (PG) framework to evaluate the PV systems and (2) determining the factors influencing PV, including regulatory governance, PG, and international actors influence. Methods In accordance with Cochrane Collaboration guidelines, the STARLITE criteria were used to guide the systematic literature search and review process. The search included English and Arabic language databases, search engines, and grey literature and a supplementary search of the reference lists of included articles. Inclusion criteria were pertinent to the influence of PV, governance and health, PG framework domains, international actors, and MENA countries. Data synthesis followed the meta-aggregation process. Results From the 32 included records, the majority of PV-enhanced actions were from Saudi Arabia, Iran, and Morocco. The ‘policy, law, and regulations’ domain was the strongest in the MENA, whereas public ‘participation and representation’ was lacking. Further, the PG framework allowed the identification of shortcomings, including a lack of public inclusiveness and participation, resource scarcity, misalignment of resource allocation, issues with existing regulations, and deficiencies in ‘accountability and transparency’. Conclusion Most of the existing systems are still in their infancy, and disparities exist at national and regional levels. The operationalization of effective PV systems requires actions that assure (1) the development and enforcement of comprehensive regulations, (2) adequate and equitable aid for core PV processes, and (3) accountability and participation from all stakeholders.