| Abstract | 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. |
