WHO Pharmaceuticals Newsletter 2003, No. 03
(2003; 14 pages) View the PDF document
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Open this folder and view contentsREGULATORY MATTERS
Open this folder and view contentsSAFETY OF MEDICINES
Open this folder and view contentsCURRENT CONCERNS
Open this folder and view contentsDRUGS OF INTEREST
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View the documentWHO Training Workshop on Pharmacovigilance: Basic Introduction and Specifics for Malaria Programmes

WHO Training Workshop on Pharmacovigilance: Basic Introduction and Specifics for Malaria Programmes

24 March - 2 April 2003, Lusaka, Zambia

Because of increasing levels of resistance to antimalarial drugs several endemic countries are in the process of introducing combinations of artemisinin derivatives as 1st-line or 2nd -line treatment of malaria. South Africa has introduced artemether/lumefantrine (Coartemâ) as 1st-line treatment of malaria in 2001 and Zambia has started phased deployment of this drug at the end of 2002, also as 1st-line treatment. Zanzibar and Burundi have adopted artesunate + amodiaquine as 1st-line treatment and the new treatment policy will be implemented in 2003. Mozambique has recently adopted amodiaquine + sulfadoxine/pyrimethamine as 1st-line treatment and artemether/lumefantrine (Coartemâ) as 2nd-line treatment and implementation may start in late 2003. Both the Democratic Republic of Congo and Rwanda are considering a policy change to artemisinin-based combinations in the near future.

As with all newly registered products, there is still limited experience with large-scale operational use and safety of these drugs in special population groups, such as infants, pregnant women, patients with malnutrition and HIV/AIDS. Unfortunately in most malaria endemic countries, particularly in Africa, pharmacovigilance is not yet implemented by the public sector, and post-marketing surveillance by the pharmaceutical sector is not functioning. The introduction of artemisinin combination therapies (ACTs) provides an opportunity to establish pharmacovigilance of antimalarial drugs in these countries. While initially the monitoring activities will focus on antimalarial drugs only, it is expected that over time the system will be strengthened with the support of WHO to include safety monitoring of all drugs.

It was with this background in mind that WHO convened a workshop of malaria managers and officials responsible for pharmacovigilance from five African countries introducing artemisinin-based combination therapies, notably Burundi, Democratic Republic of Congo, Mozambique, Zambia and Zanzibar. A total of 18 participants were exposed to the basic methods and skills for drug safety monitoring, with the aim of introducing a common system of pharmacovigilance of new antimalarial treatments, with access to the WHO database and international expertise, and to initiate plans for early implementation in the respective countries.

The curriculum of the ‘International training course on pharmacovigilance’ developed and regularly conducted by the Uppsala Monitoring Centre was adapted to provide the core introductory course. Several skills-oriented sections of the ‘Adverse events following immunization training course’, conducted by the University of Cape Town, were adapted to the malaria-specific section of the training course. The WHO draft protocol for pharmacovigilance of artemisinin-based combination therapies, with components on monitoring safety in pregnancy and amodiaquine safety monitoring, and the WHO booklet Safety of Medicines: A guide to detecting and reporting adverse drug reactions, was offered for country-specific adaptation.

The programme of the training workshop was divided in two parts:

Part I - Basic introduction to the general principles of pharmacovigilance, based on the best accepted international standards as promoted by WHO (24-28 March 2003); and

Part II - Country-specific adaptation of the general WHO protocol of artemisinin-based combination therapies, practical aspects and planning (29 March - 2 April 2003)

The training workshop was designed by WHO/EDM and WHO/MAL (HQ& AFRO) in close collaboration with the WHO Collaborating Centre for International Drug Monitoring (Uppsala Monitoring Centre). The following tutors were actively engaged in planning and teaching actvities: Mr S. Olsson, Sweden, Dr Ushma Mehta, South Africa, Dr David Coulter, New Zealand, Dr Alex Dodoo, Ghana. The following WHO Secretariat provided facilitation: Dr A. Bosman, WHO/MAL, Dr M. Couper, WHO/EDM, Dr T. Sukwa, AFRO/MAL and Dr F. Masaninga, WHO Office in Zambia. Overall support from the WHO’s Representative Office and the National Malaria Malaria Control Centre of the Central Board of Health of Zambia helped to make the workshop successful.

Each of the five participating countries developed draft guidelines and plans of action for pharmacovigilance which will be presented to the Ministry of Health of the respective countries. WHO will provide technical support to countries for early implementation, monitoring and evaluation.

It is hoped that the workshop can be used as a prototype for other diseases of public health importance.


The third annual meeting of the International Society of Pharmacovigilance (ISoP) will be held in Marrakesh, Morocco, 8-11 October 2003. A wide range of scientific topics will be covered under the conference theme of ‘Pharmacovigilance in Clinical Practice’. Abstracts for both oral and poster presentations are invited. The closing date for submission of abstracts is 15 July 2003. All registrations will have to be made online, through the website: www.isop2003.org. This site provides full details of scientific and social programmes, registration fees, accommodation and other relevant information. Two parallel pre-conference courses will also be offered on ‘Compliance in Pharmacovigilance’ and on ‘How to write a paper for peer-reviewed journals’. Separate registration is required for attending the pre-conference courses.


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