(2002; 166 pages)
There have been major advances in the area of pharmacovigilance and drug monitoring since WHO established its Programme for International Drug Monitoring in 1968 as the global standard for drug safety. These recommendations highlight important issues for action by regulatory authorities and WHO.
1. Regulatory authorities should expand the scope of their activities to include surveillance of medication errors, medical devices, homeopathic products, herbal medicines, natural health products and identify reports that may point to quality defects or to counterfeit products.
2. Regulatory authorities should improve efforts to evaluate the effectiveness of the various reporting mechanisms in operation in their countries.
3. Regulatory authorities should improve communication of emerging safety concerns. To assist in this and to ensure that confidentiality and security of shared data is maintained, WHO should develop a secure web-based communication system.
4. Regulatory authorities should be encouraged to develop postmarketing risk management strategies for products identified as posing a significant risk.
5. WHO should finalize and distribute its crisis management plan to Member States. This should be tested periodically. WHO should provide professional assistance and resources in crisis management, communications and research to Member States.
6. The WHO adverse reactions database utility should be strengthened by:
• Use of best methods to ensure timely reporting to WHO of case information, and by taking steps to increase national reporting rates.
• Assigning unique case identification codes to avoid duplication to all case-report recipients.
• Opening access to the WHO database to all stakeholders with a genuine public health interest and the ability to evaluate such case information.
7. The current WHO Programme for International Drug Monitoring should be supported by:
• Encouraging all WHO Member States including ICH member countries to participate actively in the WHO Programme, and contribute to its development.
• Periodically and regularly reviewing definitions, tools, and procedures in the light of developments in safety in medicine.
• Strengthening WHO’s role as the mandated global pharmacovigilance system and recognizing WHO definitions, tools and practices for pharmacovigilance and drug monitoring as world standards.
8. WHO should convene an expert group to examine the special needs for assessing the safety and risk of medicines used in the treatment of HIV/AIDS, particularly in developing countries.
9. Progress should be reported back to the ICDRA.