A qualitative exploration of pharmacovigilance policy implementation in Jordan, Oman, and Kuwait using Matland\u2019s ambiguity-conflict model

Hamza Y Garashi,Douglas T Steinke,Ellen I Schafheutle

doi:10.1186/s12992-021-00751-y

Hamza Y Garashi, Douglas T Steinke + Show 1 more

Open Access

https://doi.org/10.1186/s12992-021-00751-y

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Abstract

BackgroundAs Arab countries seek to implement the ‘Guideline on Good Pharmacovigilance Practice (GVP) for Arab countries’, understanding policy implementation mechanisms and the factors impacting it can inform best implementation practice. This study aimed to explore the mechanisms of and factors influencing pharmacovigilance policy implementation in Arab countries with more established pharmacovigilance systems (Jordan, Oman), to inform policy implementation in a country with a nascent pharmacovigilance system (Kuwait).ResultsMatland’s ambiguity-conflict model served to frame data analysis from 56 face-to-face interviews, which showed that 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”. Factors reducing policy ambiguity in Jordan and Oman included: decision-makers’ guidance to implementors, stakeholder involvement in the policy’s development and implementation, training of policy implementors throughout the implementation process, clearly outlined policy goals and means, and presence of a strategic implementation plan with appropriate timelines as well as a monitoring mechanism. In contrast, policy ambiguity in Kuwait stemmed from the absence or lack of attention to these factors. Factors reducing policy conflict included: the policy’s compliance with internationally recognised standards and the policy’s fit with local capabilities (all three countries), decision-makers’ cooperation with and support of the national centre as well as stakeholders’ agreement on policy goals and means (Jordan and Oman) and adopting a stepwise approach to implementation (Jordan).ConclusionsUsing Matland’s model, both the mechanism of and factors impacting successful pharmacovigilance policy implementation were identified. This informed recommendations for best implementation practice in Arab as well as other countries with nascent pharmacovigilance systems, including increased managerial engagement and support, greater stakeholder involvement in policy development and implementation, and undertaking more detailed implementation planning.

Highlights

As Arab countries seek to implement the ‘Guideline on Good Pharmacovigilance Practice (GVP) for Arab countries’, understanding policy implementation mechanisms and the factors impacting it can inform best implementation practice
Most of the world’s drug safety data originate from the developed world. [8, 9] differences in local factors including drugs’ effects on patients, prescribing patterns, regulation methods, quality, and availability mean that data used in assessing Adverse drug reaction (ADR) may have limited validity or relevance for patients living outside these countries. [10, 11] countries outside the developed world must implement policies aimed at building national pharmacovigilance systems. [12]
Pharmacovigilance Practices (GVP) for Arab Countries’, which is based on the European GVP guideline and was due for implementation by July 2015. [23]

Summary

Introduction

As Arab countries seek to implement the ‘Guideline on Good Pharmacovigilance Practice (GVP) for Arab countries’, understanding policy implementation mechanisms and the factors impacting it can inform best implementation practice. This study aimed to explore the mechanisms of and factors influencing pharmacovigilance policy implementation in Arab countries with more established pharmacovigilance systems (Jordan, Oman), to inform policy implementation in a country with a nascent pharmacovigilance system (Kuwait). As Arab countries seek to implement the Arab GVP guideline; and given pharmacovigilance’s importance as part of a country’s public health policies’ portfolio, understanding the mechanism(s) of policy implementation and the factors influencing it can inform best practice in nascent systems in the region. This paper aims to compare the mechanisms and factors influencing pharmacovigilance policy implementation in Arab countries with established systems to inform pharmacovigilance policy implementation in a country with a nascent system International experience has demonstrated that adopted policies are not always implemented as expected and do not necessarily achieve their intended results. [24, 25] policymakers frequently focus on outputs or outcomes while ignoring the implementation process which could reveal the barriers to effective implementation. [26] learning about the implementation process can assist in gaining a better understanding of the factors impacting policies’ success or failure. [27]

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