Drug safety and monitoring are key as bedaquiline donation program launches in Georgia

In April 2015, USAID and Janssen Therapeutics officially launched the bedaquiline donation initiative, under which Janssen committed to providing free bedaquiline to 30,000 patients with multidrug-resistant tuberculosis (MDR-TB) over a four-year period. Bedaquiline is the first anti-TB medicine to be approved by the U.S. Food and Drug Administration in more than 40 years, and is considered a particularly significant development to aid in the fight against MDR-TB. The public-private partnership between USAID and Janssen Therapeutics will ensure that countries in need can request bedaquiline through the Global Drug Facility at no cost.

Today USAID delivered the first doses of bedaquiline to the National Center for TB and Lung Diseases in Georgia—the first country to start MDR-TB patients on treatment through the program.

SIAPS Program is providing technical assistance to Georgia and other countries requesting aid through the donation program, working with national TB programs and partners in those countries to ensure patient safety in accordance with WHO recommendations. SIAPS is helping the government of Georgia to establish a system for active drug safety monitoring and management. The system will ensure that adverse drug reactions (ADR) to bedaquiline and other anti-TB medicines are monitored and managed appropriately to achieve better health outcomes for MDR-TB patients.

SIAPS is working with national and international stakeholders, such as the National Center for TB and Lung Diseases, the National Center for Disease Control and Public Health, the National Drug Regulatory Authority, Médecins Sans Frontières  (MSF), and the USAID-funded TB Prevention Project to mobilize all available resources and develop active an drug safety monitoring and management system. As a result of this coordination and collaboration, the protocol for monitoring ADRs to bedaquiline has been developed and is now an integral part of the Georgian National TB treatment guidelines. Data collection forms and processes have been established, and doctors are being trained in the use of bedaquiline and the management of ADRs. SIAPS will continue coordinating domestic and international efforts and providing technical assistance to implement a sustainable system for proper implementation of the drug safety and monitoring system, which will help to ensure the effective and safe use of bedaquiline and other anti-TB medicines.