Interregional training of trainers course on pharmacovigilance and cohort event monitoring for patients on treatment for drug-resistant tuberculosis

3-7 March 2014, Copenhagen, Denmark

The highest proportions of tuberculosis patients infected with multidrug- and extensively drug-resistant tuberculosis (M/XDR-TB) globally are found in countries of the WHO European Region. Mindful of the complexity of treatment for M/XDR TB, and the additional challenges which will be faced by programmes with the arrival of new anti-TB drugs which are entering the market ahead of the completion of Phase 3 trials, the WHO Regional Office for Europe and WHO headquarters (Global TB Programme, Quality Assurance and Safety of Medicines and the Global Drug Facility) are organizing this workshop.

Background

The "Consolidated Action Plan to Prevent and Combat M/XDR-TB in the WHO European Region, 2011–2015" was endorsed by the WHO Regional Committee for Europe in September 2011 and envisages the timely access to quality-assured drugs, their safe and rational use and pharmacovigilance (detection, assessment, prevention and surveillance of adverse drug reactions (ADR)).

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 care. It aims to ensure the best use of medicines for the prevention and treatment of diseases.

Participants

The following countries of the WHO Regions which have sizeable MDR-TB caseloads and are treating MDR-TB patients are targeted: Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, the Republic of Moldova, Russian Federation, Ukraine and Vietnam (provisionally). Two participants from each of the eligible countries will be requested, one being the MDR-TB focal person of NTP and another focal person of the Ministry of Health or National Drug Regulatory Authority for pharmacovigilance.

Objectives and expected outcomes

The general objective is the preparation of high priority TB countries in the WHO European Region for the introduction of pharmacovigilance measures within the monitoring framework for MDR-TB care and control. Overall, the outcome is expected that this interactive 4.5 day workshop will produce outcomes with clear next steps. It is expected that after the workshop each country will organize training at national level by the end of 2014 for the relevant staff. WHO and partners will ensure technical assistance to countries.