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National pharmacovigilance programs in Arab countries: A quantitative assessment study
Thamir M Alshammari1,2, Khalidah A Alenzi3, Sondus I Ata4
1Saudi Food and Drug Authority, Riyadh, Saudi Arabia.
Pharmacoepidemiology and Drug Safety
|March 18, 2020
Summary
Pharmacovigilance programs in Arab countries show improvement but vary in implementation. This study surveyed national pharmacovigilance centers to assess current activities and identify disparities in drug safety monitoring.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Pharmaceutical Sciences
Background:
- Pharmacovigilance (PV) is crucial for monitoring drug safety and vigilance.
- Assessing the current state of national PV centers in Arab countries is essential for understanding regional drug safety practices.
Purpose of the Study:
- To investigate and provide an overview of the current situation and activities of national PV centers in Arab countries.
- To identify the level of implementation and practice of pharmacovigilance across the region.
Main Methods:
- A cross-sectional study was conducted in March-May 2018.
- A modified questionnaire, based on WHO standards, was used to survey national PV centers in 22 Arab countries.
- Descriptive analyses were performed using SurveyMonkey.
Main Results:
- 15 out of 22 Arab countries participated (68% response rate).
- Most PV programs were established in the last decade, with Palestine in 2017.
- Nine countries (60%) were members of the WHO International Drug Monitoring Program, utilizing VigiFlow or VigiBase software.
Conclusions:
- National PV programs in Arab countries have shown improvement.
- Significant differences persist among countries regarding the implementation and practice of pharmacovigilance.
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