Current state of pharmacovigilance in the Arab and Eastern Mediterranean region: results of a 2015 survey

Qato, Dima M.

doi:10.1111/ijpp.12372

Cited by 21 publications

(50 citation statements)

References 10 publications

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“…To inform pharmacovigilance policy implementation in a nascent country (Kuwait), two other countries at more advanced levels of performance and implementation of the GVP for Arab countries (Jordan and Oman) were selected. (11,20) As previously stated, Jordan possessed a pharmacovigilance system which is among the highest performing systems in the region. (20) Kuwait is one of the Arab countries without an o cially recognised pharmacovigilance system.…”

Section: Methodsmentioning

confidence: 94%

“…Morocco, Egypt, Jordan, and Saudi Arabia) have systems comparable to those in developed countries. (11,(20)(21)(22) To harmonise pharmacovigilance practices in the Arab World, the Arab League developed the 'Guideline on Good Pharmacovigilance Practices (GVP) for Arab Countries', which is based on the European GVP guideline and was due for implementation in July 2015. (23) 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 in uencing it can inform best practice in nascent systems in the region.…”

Section: Introductionmentioning

confidence: 99%

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

Garashi

Steinke

Schafheutle

2021

Preprint

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Background 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). Results Matland's ambiguity-conflict model served to frame data analysis from 55 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 “political 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). Conclusion Using 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.

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Section: Methodsmentioning

confidence: 94%

Section: Introductionmentioning

confidence: 99%

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

Garashi

Steinke

Schafheutle

2021

Preprint

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“…All respondents of this assessment confirmed the existence of a national program, except in Kuwait, where no official program has been established. Eight out of the fifteen countries launched their national PV programs in the past decade (2008‐2018), showing that PV programs in Arab countries are still in their infancy stages, wherein stakeholder support and enforcement are needed . The need by all countries for efficient governmental guidelines that are used to plan, to establish, and to sustain a strong PV program was discussed in several conferences on PV strategies …”

Section: Discussionmentioning

confidence: 99%

National pharmacovigilance programs in Arab countries: A quantitative assessment study

Alshammari

Alenzi

Ata

2020

Pharmacoepidemiology and Drug

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Purposes The aim of the pharmacovigilance (PV) process is to bring together all the much‐needed information about various aspects of product safety or, in particular, the safety and vigilance of drugs as pharmaceutical products. This study aimed to investigate and provide an overview on the current situation and activities of the national PV centers in Arab countries. Methods A cross sectional study was conducted between March and May in 2018. The current survey was adopted and modified from a study that used the questionnaire designed by the World Health Organization Collaborating Centre for International Drug Monitoring. The national PV centers of 22 Arab countries were invited to participate in this study. Descriptive analyses were conducted utilizing the analysis services provided by SurveyMonkey. Results In total of, 15 countries responded to our invitation (response rate: 68%). Most Arab countries started their PV program in the last decade, with Palestine implementing its program in 2017. Among the respondents, nine (60%) were members of the WHO International Drug Monitoring Program and were all users of the software provided by the WHO Uppsala Monitoring Center (VigiFlow or VigiBase), except Sudan. In 2017, a total of 27 502 reports were received by the centers in the studied countries, ranging from three reports received in Lebanon to a total of 7362 reports received by the national program of Algeria. Conclusions An improvement was noticed among the national PV programs in the Arab countries. However, a considerable difference still exists among the countries in terms of the implementation and practice of PV.

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“…In 2012, the LAS assigned Egypt to lead the committee responsible for establishing guidelines on GVP for Arab countries, which were completed in March 2014 and became effective on 1 July 2015 [8,11,25,27]. Pharmaceutical companies are required to report both domestic serious and domestic non-serious adverse events to the EPVC through ICSRs as per the E2B guidelines.…”

Section: Pharmacovigilance Regulationsmentioning

confidence: 99%

“…The number of submitted reports has varied over the years, with 42 reports submitted in 2009, 94 reports submitted in 2013, and 180 reports submitted in 2014. Moreover, the yellow card system (reporting form) for reporting ADRs was adopted[1,2,27].…”

mentioning

confidence: 99%

Pharmacovigilance Systems in Arab Countries: Overview of 22 Arab Countries

Alshammari

Mendi²,

Alenzi

et al. 2019

Drug Saf

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Pharmacovigilance has received much attention in Arab countries recently due to the development of new regulations. However, there are differences in the progression of pharmacovigilance systems by regulatory agencies in these countries because only some are able to meet the requirements for conducting pharmacovigilance activities. Only 45% of Arab countries are official members of the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring. Countries such as Morocco, Tunisia, Saudi Arabia, Egypt, and Jordan are considered to be advanced pharmacovigilance countries, whereas other countries such as Libya, Yemen, and Palestine remain in the very early stages of implementing and developing pharmacovigilance systems. Countries such as Somalia, Djibouti, Mauritania, and Comoros Island have no pharmacovigilance system or culture. Asian Arab countries have some advantages over those in Africa because 50% of them are a part of the Gulf Cooperation Council (GCC), meaning that most of them can utilize similar approaches for the application of the majority of activities related to the healthcare system, including pharmacovigilance. Thus, participating in the GCC enables increased connections among these countries. However, one of the strengths in Africa is that Morocco is partnering with the WHO through the WHO Collaborating Center to enhance and strengthen pharmacovigilance across the Eastern Mediterranean Region and the Francophone and Arab countries. This partnership could have a role in enhancing the pharmacovigilance culture among African Arab countries. This review provides a general overview of the current situation regarding regulatory agencies related to pharmacovigilance in Arab countries. This article was produced as an activity of the International Society of Pharmacovigilance Middle East Chapter.

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Current state of pharmacovigilance in the Arab and Eastern Mediterranean region: results of a 2015 survey

Cited by 21 publications

References 10 publications

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

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

National pharmacovigilance programs in Arab countries: A quantitative assessment study

Pharmacovigilance Systems in Arab Countries: Overview of 22 Arab Countries

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