Evaluation of the Pharmacovigilance System in Qatar: A Mixed Method Study on Structure Process, And Outcome

Introduction: It is evident that pharmacovigilance (PV) centers are the entities required to ensure medication safety and protect public health from drug related morbidity and mortality. In many developing countries PV systems are mostly immature or non-existent. In Qatar, a centralized PV center does not exist. Therefore, this research aimed to conduct a comprehensive system assessment by evaluating the current state of PV in Qatar in order to establish a baseline understanding of PV situation and to identify weaknesses and improvement opportunities for PV. Methodology: This mixed-method case study (i.e., concurrent) provided multiple case evaluation for: a) in-depth subnational PV systems case evaluation, b) comparative case analysis, and c) evaluation of the overall national PV system. Quantitative approach included a cross-sectional descriptive study utilizing the World Health Organization (WHO) PV indicators (i.e., structure, process, and outcome). It included the Ministry of Public Health (MOPH); public sector; private sector; academic institutions; pharmaceutical industry. Descriptive statistics were used to describe systems' performance based on a scoring scheme. Qualitative approaches included semi-structured interviews, document review and field observation. Deductive content analysis was used to analyze qualitative data. Additionally, the WHO minimum requirements for a functional PV system were employed in the evaluation. Findings: The WHO five minimum requirements for an operational PV system are not available in Qatar. The overall national PV system achieved a good total system performance status. Most subnational PV systems obtained good total system performance. The MOPH system revealed weak performance status. However, MOPH plans to establish a medication safety program and patient safety reporting system. The highest scores were for structural indicators with most subnational PV systems demonstrating excellent performance. MOPH structural shortfalls included the lack of PV specific legislation, national reporting system, and a dedicated budget for PV. Process indicators revealed good performance status for the public and private sectors. However, existing PV processes are mostly at an early stage of advancement. Outcome indicators showed the weakest performance across the subnational PV systems. Conclusion: Subnational PV systems strengthening is required to address the identified challenges to effective PV and performance disparities between systems. The overall performance of the country needs to be improved following a system-based approach. It is recommended to: 1) improve PV prioritization in the regulatory, practice and academic agendas; 2) establish effective PV structures, especially PV specific legislation and PV center; 3) target efforts to improve and coordinate PV between national stakeholders; 4) build the national PV system capacity to meet the minimum requirements of WHO. Finally, future research can focus on aspects related to the governance of the PV system and the feasibility of establishing the proposed PV center organizational structure