World Report
Pharmacovigilance bolstered in the Arab world Several developments this year could mark a turning point for drug use and safety monitoring in the WHO Eastern Mediterranean Region. Syed Rizwanuddin Ahmad reports.
www.thelancet.com Vol 384 December 13, 2014
reporting rates and signal detection. It will also help some Arab countries to develop in the area of regulatory pharmacovigilance.” Saleh Bawazir, currently adviser to the president of the Saudi Food and Drug Authority, said that the “Arab guideline is a step forward to help countries to look seriously at pharmacovigilance and this initiative allows common training programmes between Arab countries.”
“‘...political will...in the region will play an important role in planning, establishing, and sustaining a successful pharmacovigilance system’...” The second major event was the Conference on Pharmacovigilance Strategies that was held in Kuwait in May. This event organised by Kuwait Advancement for Conference & Exhibition in collaboration with the Executive Board of Health Ministers’ Council of the Gulf Cooperation Council (GCC) States brought together delegates and speakers from the GCC region, WHO, and around the world. The Kuwait conference emphasised the role of national medicines regulatory authorities in monitoring the postmarketing assessment of medical products and identified strategies for establishment, growth, and development of pharmacovigilance systems in the region. “Pharmacovigilance has become a global effort that is constantly gaining momentum. A strong governmental and political will in Kuwait and elsewhere in the region will play an important role in planning, establishing, and sustaining a successful pharmacovigilance system”, said Reem Al-Essa, conference head and formerly with the Kuwait Ministry of Health.
One of the key recommendations that came out of this meeting was the establishment of a single pharmacovigilance database for all GCC countries, which will optimise human and financial resources, enhance adverse event reporting, and centralise decisions and actions. The final event to bolster pharmacovigilance in the region in late September was the first EMRO/Arab countries meeting on pharmacovigilance organised by the Centre Anti Poison et de Pharmacovigilance du Maroc (CAPM), a WHO Collaborating Centre for Pharmacovigilance, in collaboration with WHO in Rabat, Morocco. The purpose of this meeting was to interact, exchange information, and implement and reinforce national pharmacovigilance activities in the region. The conference was attended by 183 participants and experts from the region, WHO, and the Council for International Organizations of Medical Sciences. Attendees discussed important issues including risk minimisation; training and capacity building; sharing of databases; and harmonising terminologies. “Overall, the state of pharmacovigilance in the EMRO/Arab region is very limited and there is a need for governments in the region to provide infrastructure and human and financial resources, and to enact laws to develop an integrated system of pharmacovigilance. International agencies such as WHO and others should provide moral and material support for awareness programmes, training, and organising seminars and conferences in this region”, said Rachida Soulaymani Bencheikh, director of CAPM and president of the meeting.
Tek Image/Science Photo Library
Pharmacovigilance is rapidly gaining momentum in the Eastern Mediterranean Region of WHO (EMRO) some 50 years after the thalidomide disaster. Several countries from the region, namely Sudan, Saudi Arabia, Egypt, and the United Arab Emirates, have become full members of the WHO programme for International Drug Monitoring in the past few years. Ten (45%) of 22 countries in EMRO are full members of the WHO programme with an active pharmacovigilance centre. However, in the rest of the countries, including Bahrain, Kuwait, Qatar, and Yemen, adverse event monitoring is either in its infancy or non-existent. Only 0·6% of the 9 million individual safety case reports submitted to the WHO programme’s Vigibase—a spontaneous reporting database—are submitted by the countries in the region. Three major events happened this year, which have the potential to change the poor status of pharmacovigilance in the region. The first was the development of the Arab pharmacovigilance guidelines under the aegis of the Higher Technical Committee for Medicines (HTCM) of the Arab League, which aims to create a unified Arab pharmacovigilance guideline. In March, 2014, the final draft of the common guidelines was approved by Arab ministers of health. The new guidelines are largely adapted from the European Good Pharmacovigilance Practices and come into effect on July 1, 2015. According to Amr Saad, the head of the Egyptian Pharmaceutical Vigilance Centre and head of the HTCM of the Arab League, “It is expected that these guidelines will significantly influence pharmacovigilance practice in general in the whole Arab world, and will enhance such activities including
Syed Rizwanuddin Ahmad e63
Pharmacovigilance bolstered in the Arab world Several developments this year could mark a turning point for drug use and safety monitoring in the WHO Eastern Mediterranean Region. Syed Rizwanuddin Ahmad reports.
www.thelancet.com Vol 384 December 13, 2014
reporting rates and signal detection. It will also help some Arab countries to develop in the area of regulatory pharmacovigilance.” Saleh Bawazir, currently adviser to the president of the Saudi Food and Drug Authority, said that the “Arab guideline is a step forward to help countries to look seriously at pharmacovigilance and this initiative allows common training programmes between Arab countries.”
“‘...political will...in the region will play an important role in planning, establishing, and sustaining a successful pharmacovigilance system’...” The second major event was the Conference on Pharmacovigilance Strategies that was held in Kuwait in May. This event organised by Kuwait Advancement for Conference & Exhibition in collaboration with the Executive Board of Health Ministers’ Council of the Gulf Cooperation Council (GCC) States brought together delegates and speakers from the GCC region, WHO, and around the world. The Kuwait conference emphasised the role of national medicines regulatory authorities in monitoring the postmarketing assessment of medical products and identified strategies for establishment, growth, and development of pharmacovigilance systems in the region. “Pharmacovigilance has become a global effort that is constantly gaining momentum. A strong governmental and political will in Kuwait and elsewhere in the region will play an important role in planning, establishing, and sustaining a successful pharmacovigilance system”, said Reem Al-Essa, conference head and formerly with the Kuwait Ministry of Health.
One of the key recommendations that came out of this meeting was the establishment of a single pharmacovigilance database for all GCC countries, which will optimise human and financial resources, enhance adverse event reporting, and centralise decisions and actions. The final event to bolster pharmacovigilance in the region in late September was the first EMRO/Arab countries meeting on pharmacovigilance organised by the Centre Anti Poison et de Pharmacovigilance du Maroc (CAPM), a WHO Collaborating Centre for Pharmacovigilance, in collaboration with WHO in Rabat, Morocco. The purpose of this meeting was to interact, exchange information, and implement and reinforce national pharmacovigilance activities in the region. The conference was attended by 183 participants and experts from the region, WHO, and the Council for International Organizations of Medical Sciences. Attendees discussed important issues including risk minimisation; training and capacity building; sharing of databases; and harmonising terminologies. “Overall, the state of pharmacovigilance in the EMRO/Arab region is very limited and there is a need for governments in the region to provide infrastructure and human and financial resources, and to enact laws to develop an integrated system of pharmacovigilance. International agencies such as WHO and others should provide moral and material support for awareness programmes, training, and organising seminars and conferences in this region”, said Rachida Soulaymani Bencheikh, director of CAPM and president of the meeting.
Tek Image/Science Photo Library
Pharmacovigilance is rapidly gaining momentum in the Eastern Mediterranean Region of WHO (EMRO) some 50 years after the thalidomide disaster. Several countries from the region, namely Sudan, Saudi Arabia, Egypt, and the United Arab Emirates, have become full members of the WHO programme for International Drug Monitoring in the past few years. Ten (45%) of 22 countries in EMRO are full members of the WHO programme with an active pharmacovigilance centre. However, in the rest of the countries, including Bahrain, Kuwait, Qatar, and Yemen, adverse event monitoring is either in its infancy or non-existent. Only 0·6% of the 9 million individual safety case reports submitted to the WHO programme’s Vigibase—a spontaneous reporting database—are submitted by the countries in the region. Three major events happened this year, which have the potential to change the poor status of pharmacovigilance in the region. The first was the development of the Arab pharmacovigilance guidelines under the aegis of the Higher Technical Committee for Medicines (HTCM) of the Arab League, which aims to create a unified Arab pharmacovigilance guideline. In March, 2014, the final draft of the common guidelines was approved by Arab ministers of health. The new guidelines are largely adapted from the European Good Pharmacovigilance Practices and come into effect on July 1, 2015. According to Amr Saad, the head of the Egyptian Pharmaceutical Vigilance Centre and head of the HTCM of the Arab League, “It is expected that these guidelines will significantly influence pharmacovigilance practice in general in the whole Arab world, and will enhance such activities including
Syed Rizwanuddin Ahmad e63
