The WHO Programme for International Drug Monitoring was set up in 1968 following the thalidomide tragedy, and now plays an important role in global medicines safety monitoring.The programme aims are to: enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
WHO Pharmacovigilance Indicators: A Practical Manual for the Assessment of Pharmacovigilance Systems
Pharmacovigilance as a medical discipline is crucial in preventing medicine-related adverse effects in humans, promoting patient safety, and the rational use of medicines. This manual provides a practical method for determining the pharmacovigilance indices. It is designed to be simple and can be understood by any worker in pharmacovigilance without formal training in monitoring and evaluation.
Safety of medicines is a global responsibility. The WHO Medicines Safety group within Safety and Vigilance (SAV) aim to promote the safe use of medicines at country level by:
- Developing policies, norms, standards and guidelines for pharmacovigilance, with a focus on low and middle income countries
- Facilitating, implementing and monitoring pharmacovigilance best practices
- Providing a platform for Member States to meet and collaborate on pharmacovigilance issues
- Convening a global advisory committee on the safety of medicinal products for strategic and methodological developments in pharmacovigilance
- Communicating regulatory decisions and safety signals for medicinal products at a global level
- Promoting the integration of pharmacovigilance in public health programmes such as TB, HIV and malaria treatment programmes.
- Supporting pharmacovigilance training courses and activities