Presented by : Amjad Atrash

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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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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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Study Objective

The objective of the study is to characterize national pharmacovigilance systems in place in the Middle East region

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MethodsThe 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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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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Future PlansEstablishing 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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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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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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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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Acknowledgments

This study was part of a larger project supported by the Qatar National Research Fund

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Questions

Thank You

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