The document summarizes a study that characterized national pharmacovigilance systems in Middle Eastern countries. The study found that while 6 countries had formal pharmacovigilance programs, 5 countries had no active program. Most existing programs are young, formed in the past decade, and have plans to expand capacity and public awareness. The study concludes more countries in the region lack coordinated pharmacovigilance programs, leaving millions without domestic monitoring services, and that regional collaboration could help programs share experiences.

1. Presented by : Amjad Atrash
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2. Background
 Adverse drug reaction (ADR) reporting is the cornerstone of
pharmacovigilance activity
 It has been previously demonstrated that the majority of global
information related to ADRs arises from ‘Western’ nations
 The importance of countries to support their own
pharmacovigilance program cannot be understated
-Citizens may have unique traditions and diets influencing
reactions to medication
-Alternate brands of therapy may be imported or manufactured
and differ in ingredients or production processes
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3. Background
-ADRs may be associated with traditional or herbal remedies
unique to each country
-In some cases, ADRs to certain drugs may only occur in
particular ethnic groups
 While ADR data from other countries is helpful for local
regulatory bodies to make medication safety decisions,
information may not be relevant or applicable to its
population
 The nature of ADR reporting systems and generated data is
not currently readily available for all countries in the
Middle East region
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4. Study Objective
The objective of the study is to characterize national
pharmacovigilance systems in place in the Middle East
region
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5. Methods
 The World Health Organization Uppsala Monitoring
Assessment of Country Pharmacovigilance Situation
(February 2008) questionnaire was adapted and translated
into Arabic
 Questionnaire domains pertained to: general program
overview; resources; information technology support;
suspected ADR reporting and subsequent data use;
pharmacovigilance activity and advocacy
 A comprehensive search was conducted to determine the
existence of a governing body responsible for medication
safety in 13 Arabic speaking Middle Eastern countries
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6. Challenges
Creating a reporting culture for ADRs among health
professionals and the public
Low financial and technical support; lack of adequate
staff
Inability to make independent decisions
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7. Future Plans
 Establishing sentinel sites to build an effective national
system (Iraq)
 Expanding existing staff to build greater capacity and
enhancing public awareness of pharmacovigilance (Egypt)
 Developing electronic services, introducing
pharmacovigilance legislation, enhancing staff training
(Saudi Arabia)
 Including manufacturers into pharmacovigilance activity
(UAE)
 Organizing conferences, generating bulletins and
newsletters, establishing regional pharmacovigilance sites
(Oman)
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8. Results
 Data from 11 countries was obtained: representatives from 2
countries did not respond (Lebanon) or refused to consent to
participation (Syria)
 Six described formal national pharmacovigilance programs
(Egypt, Iraq, Jordan, Oman, Saudi Arabia, and the United Arab
Emirates), while 5 (Bahrain, Kuwait, Palestine, Qatar, Yemen)
reported no active program or designated center
 Data gathered from the public domain indicates a pilot
pharmacovigilance program was launched in Lebanon in 2004,
but at the time included only select hospitals. National
expansion appears to be dormant. There is also some indication
that the Ministry of Health in Syria solicits ADR reports
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9. Results
 All active programs were formed in the past decade (2001-2010 years)
and are overseen by the government
 Only 2 (Jordan, Oman) combine its services with a national drug
information center
 All receive reports pertaining to medications and vaccines; herbal
products (5); medical devices and cosmetics (4 each)
 No program paid reporters for ADR submissions
 All used the information for drug regulatory purposes, but only 3
described classification of causality in ADR report assessment
 Promotion of pharmacovigilance was rarely made by the program to
health professionals in training (2), but did occur at health conferences
(5)
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10. Conclusions
 Several countries in the Middle East lack coordinated
national pharmacovigilance programs
 An estimated 30-40 million people are therefore without
formal domestic services
 Most existing national pharmacovigilance programs in the
Middle East region are in their infancy, but have outlined
plans for growth
 Contemporary technologies could be better exploited to
ease spontaneous reporting and subsequent data
management
 Existing mechanisms for regional collaboration should be
advanced so experience from model programs can be
shared
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11. Acknowledgments
This study was part of a larger project supported by the
Qatar National Research Fund
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12. Questions
 Thank You
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