Outcomes of pharmacovigilance training workshop

Pharmacovigilance (PV), defined by WHO as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem”, is a core component of the pharmaceutical management system and represents an arm of patient-oriented care. It aims to ensure the best use of medicines for the prevention and treatment of diseases.

Mindful of the complexity of treatment for multidrug- and extensively drug-resistant tuberculosis (M/XDR-TB), and the additional challenges which programmes will face with the arrival of the new anti-TB drugs which are entering the market ahead of the completion of Phase 3 trials, the first workshop on pharmacovigilance was organized to focus on the specifics of TB and M/XDR-TB care. It successfully brought together drug regulatory and TB control experts from 8 countries in eastern Europe (Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Republic of Moldova, Russian Federation, Ukraine) and Vietnam, as well as experts from WHO/Europe and WHO headquarters (Global TB Programme, Safety and Vigilance Programme), the Global Drug Facility, the WHO Collaborating Centre for International Drug Monitoring in Uppsala, Sweden, and the Green Light Committee (GLC/Europe). The event was supported by USAID in the framework of the WHO-USAID regional platform project for TB control in WHO European Region and was held 3-7 March 2014, in Copenhagen, Denmark.

The meeting was organized in the framework of the "Consolidated Action Plan to Prevent and Combat M/XDR-TB in the WHO European Region, 2011–2015", which aims to contain the spread of drug-resistant tuberculosis by achieving universal access to prevention, diagnosis and treatment of M/XDR-TB in all Member States of the European Region by 2015.

Countries identified the major gaps and challenges for the implementation of PV for anti-TB drugs and developed action plans to address them, in order to strengthen national surveillance networks and improve data recording and reporting. It was concluded that effective pharmacovigilance at national level will require close collaboration between the government structures concerned and other stakeholders for technical assistance and funding.

As an outcome, in the weeks following the workshop, the participants will finalize their plans, identify how to incorporate them into existing strategic documents (e.g. national strategic plans, concept notes for Global Fund support), organize national training within the country, and start to advocate for resources and for actions which will better protect patient safety.

It will be important from now on to advocate for PV in TB care at the country level such as the Ministry of Health and Global Fund, through GLC/Europe and other technical and funding partners.