Strengths and Weaknesses of the Pharmacovigilance Systems in Three Arab Countries: A Mixed-Methods Study Using the WHO Pharmacovigilance Indicators

Hamza Garashi,Ellen Schafheutle,Douglas Steinke

doi:10.3390/ijerph19052518

Abstract

Using the WHO pharmacovigilance (PV) indicators as a framework, this study aimed to explore the structures, processes, and outcomes of three Arab countries’ (Jordan, Oman, and Kuwait) PV systems to inform recommendations for countries with nascent PV systems. A mixed-methods design involving document review, semi-structured interviews, and a questionnaire was employed. Fifty-six key informants from the three countries’ national PV centres (NPVCs) and pharmaceutical industry were interviewed. The questionnaire collecting quantitative measures was only completed by Oman and Kuwait’s NPVCs. Using the framework, system strengths were attributed to the presence of “core” structural indicators, including a dedicated and officially recognised NPVC, PV legislation, and a national PV advisory committee, as well as “complementary” structural indicators, e.g., a computerised case-report management system. Contrastingly, 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. Greater governmental prioritisation through the provision of legislative enforcements, resources, and expertise as part of a well-structured system is required. More regional coordination efforts are needed to allow for sharing of expertise in order to bolster nascent systems.

Highlights

Pharmacovigilance (PV) is defined by the World Health Organisation (WHO) as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem” [1] (p. 7) and represents an important element of a country’s public health policies’ portfolio
Questionnaires requesting data on the process and outcome indicators were only completed by the national PV centres (NPVCs) in Oman and Kuwait
The study findings for the three study countries are presented in two sections, namely, WHO “Core Indicators” and “Complementary scores for the six main categories of WHO pharmacovigilance indicators

Summary

Introduction

Pharmacovigilance (PV) is defined by the World Health Organisation (WHO) as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem” [1] (p. 7) and represents an important element of a country’s public health policies’ portfolio. Increased efforts towards addressing public health concerns have led to an unprecedented expansion in global access to healthcare and medicines over the past decades [3]. These efforts have not been met by a proportionate improvement in PV systems in developing countries. A systematic review of developing countries’ PV systems found that overall system performance was poor and varied widely from one country to another [4]. This means that these systems are unable to benefit from local data identifying ADR signals to support regulatory decisions regarding drug safety in the populations they serve [3]

Objectives

Methods

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Discussion

Conclusion