The first meeting of the WHO Advisory Committee (AC) on Safety of Medicinal Products took place in Geneva, Switzerland on October 20 - 22, 2003. The meeting was organized by staff in the Essential Drugs and Medicines Policy Directorate, Quality Assurance and Safety of Medicines (QSM). With the assistance of Dr. Mary Couper, Dr. Lembit Rago, Coordinator of QSM, welcomed the AC members and emphasized the importance of the new AC. At the May 2002 meeting of the World Health Assembly, resolution WHA55.18 "Quality of care: Patient Safety" was passed which addresses the importance of patient safety. The need for all partners, including WHO Headquarters, the Uppsala Monitoring Center (UMC), and the 72 National Centers, to work in partnership was emphasized by Drs. Couper and Rago. It was particularly noted that in light of increasing numbers of clinical trials being conducted in African countries, having more active participation in UMC's programs by these countries would be of paramount value.

Dr. Vladimir Lepakhin, newly appointed Assistant Director-General, Health Technology and Pharmaceuticals also participated. He emphasized that rather than representing national agencies or institutions, members of the AC participate as individuals with expertise in medicinal product safety who represent a broad range of geographical and professional backgrounds. The AC convened under a set of terms of reference that defined its function, composition, and principles of operation, stipulating that it work independently and in a transparent manner by wide consultation. While the principal role for the AC is in pharmacovigilance advocacy and policy recommendations, there is an essential role in advising national authorities on specific drug safety issues, recognizing that ultimately the national authorities must make their own determinations on such issues. Most importantly, the terms of reference includes language stating that the AC will advance and promote the future developments of pharmacovigilance as a discipline.

In the course of discussion, several prominent themes emerged:

• The need to inform policy makers about the considerable global economic consequences of adverse drug reactions and the positive benefit/cost ratio of implementing appropriate risk management programs.
• The need for building linkages between academic institutions and regulatory authorities throughout the world.
• The need to build synergies rather than parallel structures. In particular, it was noted that certain ICH initiatives have a global impact on pharmacovigilance practices and yet involve only the participation of certain regions.
• The need to integrate work throughout WHO programs.
• The essential need for training in the discipline of pharmacovigilance for public health program providers both within the WHO's existing National Centers and for extension to countries not yet participating in the collaborative monitoring program.
• The importance of monitoring all medicines, old as well as new.
• The increasing significance of managing the risks of herbals and traditional medicine products, including the need to address interactions with allopathics.
• The inclusion of medication errors in the routine practice of pharmacovigilance.
• The increasingly important role of consumers in post-approval drug safety, and the need for appropriate risk communication to policy makers.

A set of recommendations from the first meeting are available at the WHO website and include:

• Setting priorities in the promotion of drug safety activities through WHO's International Drug Monitoring Program.
• The increasingly important role of pharmacovigilance in public health programs and the need to recount and model upon topical success stories, such as the incorporation of pharmacovigilance into the antimalarial program in several African countries. In this program safety monitoring is to begin with the antimalarials and eventually extend to all medicinal products.
• The importance of the safety of medicines and the acceptance and continued support of public health programs by local communities.
• Pharmacovigilance for antiretrovirals: practical recommendations to integrate patient safety into the WHO's 3 x 5 initiative.
• Specific safety issues of current interest included isotretinoin teratogenicity and thalidomide current registration status.

The AC on Safety of Medicinal Products will meet at least once per year, with additional meetings, including teleconferences and videoconferences, to be held on an ad hoc basis.

Return to table of contents