Pharmacovigilance in Public Health Programmes

The UMC is involved closely with WHO HQ in initiatives in promoting pharmacovigilance in HIV/AIDS, malaria and tuberculosis treatment programmes that major donors (Global Fund, Gates Foundation etc) are supporting in countries where only rudimentary systems for pharmacovigilance exist, if at all.

Many of the medicines employed by these public health programmes are new and/or have safety concerns associated with them.

Our work includes collaboration with WHO and others on the establishment and training of a pharmacovigilance field force to actively assemble case information from the programme treatment centres.

Other organisations provide staff to enter this data into country-specific databases, using the UMC's VigiFlow and CemFlow software.

A team of signal reviewers will be trained to analyse the collected case information and to highlight any indication of new patient safety concerns. Such information will be provided to programme managers and regulatory authorities in each country in which the system is operating as well as to the international community where relevant.

UMC has a key role by providing a number of services:
• Training of the field force in the collection of relevant patient and case details
• Access to the VigiFlow software for management of individual case safety reports
• Training for CemFlow users
• Providing tools for data analysis
• Training of staff in case assessment, signal analysis and benefit/harm evaluation
• Communicating results to relevant national authorities and international partners.

The WHO Practical Handbooks on the Pharmacovigilance of Antimalarial Medicines and of Antiretroviral Medicines are available here for download.

For more information about the initiative, please contact Sten Olsson at sten.olsson@who-umc.org

Pharmacovigilance in Public Health Programmes page last updated 20 February 2012