A strategy for the implementation of of the 'guideline on good pharmacovigilance practices (GVP) for Arab countries' in countries with nascent pharmacovigilance systems: the case of Kuwait

Abstract

Background - Pharmacovigilance (PV) plays a vital role in ensuring medicines' safety. Differences among countries in the incidence, pattern, and severity of adverse drug reactions (ADRs) mean that it is essential for each country to have a PV system. Although PV is generally well established in developed nations, it remains underdeveloped in a number of countries, including the Arab World and Kuwait in particular. To unify PV practice across the Arab World, the Arab League developed the guideline on good PV practices (GVP) for Arab countries. As Arab countries seek to implement the guideline, understanding what helps and hinders implementation in Arab countries with more or less developed systems can inform improved PV system performance as well as policy development and implementation. This study aimed to explore and identify the key factors impacting PV system performance and policy implementation in Kuwait and other Arab countries with more established PV systems to inform recommendations for strengthening PV in Kuwait. Method - Three studies were undertaken to address the above aim. Informed by the World Health Organisation (WHO) PV indicators, Study One systematically reviewed literature evaluating PV systems' performance in developing countries. Using the WHO PV indicators as a framework, Study Two employed a mixed-methods approach involving document review, semi-structured interviews, and a survey to explore PV systems' structures, processes, and outcomes, and to offer in-depth understanding of strengths and limitations in Jordan, Oman, and Kuwait. In Study Three, Matland's ambiguity-conflict model of policy implementation served to frame semi-structured interviews exploring the mechanisms of and factors influencing PV policy implementation in Jordan, Oman, and Kuwait. Results - Study One revealed that overall system performance was poor and varied widely from one country to another. Moreover, it highlighted the scarcity of research providing an in-depth exploration of countries' PV systems' performance and policy implementation as well as the factors impacting them. In Study Two, system strengths were attributed to the presence of "core" structural indicators including a dedicated and officially recognised PV centre, PV legislation, and a national PV advisory committee, as well as "complementary" structural indicators e.g. a computerised case-report management system. Weaknesses were attributed to the absence of these indicators plus other "core" structural indicators, namely regular financial provision, and adequate staff. Other weaknesses were attributed to low performance in "core" process and outcome indicators including reporting rates, reporter awareness, and signal detection. Study Three found that PV policy ambiguity and conflict were low in Jordan and Oman suggesting an "administrative implementation" pathway. In Kuwait, policy ambiguity was high while sentiments about policy conflict were varied suggesting a mixture between "experimental implementation" and "symbolic implementation". Conclusion - This programme of research highlighted the need for applying a holistic and stepwise approach to strengthening PV policy implementation and subsequent system performance that considers countries' resources and infrastructure. Informed by insight gained from the three studies, recommendations for strengthening PV policy implementation and subsequent system performance in Kuwait and other Arab countries with nascent systems were made.

Date of Award	31 Dec 2022
Original language	English
Awarding Institution	The University of Manchester
Supervisor	Ellen Schafheutle (Supervisor) & Douglas Steinke (Supervisor)