Pharmacovigilance in the Middle East: a survey of 13 arabic-speaking countries.

BACKGROUND

The importance of countries to support their own national pharmacovigilance cannot be understated. While adverse drug reaction (ADR) data from other countries is helpful in making medication safety decisions, information may not be relevant or applicable to domestic populations.

OBJECTIVE

The aim of this study was to inventory national pharmacovigilance systems in place in the Middle East region.

MATERIALS AND METHODS

The Uppsala Monitoring Centre Assessment of Country Pharmacovigilance Situation questionnaire (February 2008) was adapted and translated into Arabic and administered to the head of the identified centres responsible for medication safety in 13 Arabic-speaking Middle Eastern countries. This survey contains domains pertaining to general programme information; overview of technology and personnel support; suspected ADR reporting and subsequent data use; and pharmacovigilance activity and advocacy.

RESULTS

Data for 11 countries were obtained: representatives from two countries did not participate (Lebanon, Syria). Six described formal national pharmacovigilance programmes (Egypt, Iraq, Jordan, Oman, Kingdom of Saudi Arabia and the United Arab Emirates), while five (Bahrain, Kuwait, Palestine, Qatar and Yemen) reported no active programme or designated centre. The majority are government funded, but staff resources are constrained, ranging from two to ten people. Sixty-seven percent of programmes facilitated submission of spontaneous ADRs to the centre by email, but none directly through a web-based platform. All used the information for drug regulatory purposes and five reported dissemination of safety information to the public.

CONCLUSIONS

This is the first survey to inventory the status of pharmacovigilance in the Middle East. While a number of countries participate in suspected ADR reporting activities, an estimated population of 30-50 million is without formal domestic programmes. Current emphasis of drug safety in the region is on detection and prevention of counterfeit products reaching the consumer. Existing mechanisms for regional collaboration should be advanced so experience from model programmes can be shared. Technology must be exploited to enhance ease of spontaneous reporting and subsequent data management.