Georgia was the first country to receive bedaquiline from the Bedaquiline Donation Program and with the donation needed to focus on strengthening pharmacovigilance (PV) in the country. Because there was no PV system in place at the time, Georgia requested technical assistance from SIAPS to establish an aDSM system as a step in building its overall PV system.
Stakeholder Engagement and Coordination
SIAPS worked with the National Center for TB and Lung Diseases (NCTLD); the National Center for Disease Control and Public Health; the National Drug Regulatory Authority; Médecins Sans Frontières; the USAID-funded TB Prevention Project, implemented by URC LLC Branch in Georgia; and other stakeholders to form a technical working group to draft a coordinated action plan and mobilize all available resources for aDSM development. SIAPS also served as the group’s secretariat.
Information for Decision Making
SIAPS supported the National TB Control Program (NTP) in implementing PViMS, a web-based application used by clinicians, regulatory bodies, and implementing partners to monitor the safety and effectiveness of medicines. Serious adverse event data are collected using paper forms at TB facilities and submitted to the NCTLD, where PViMS is installed and functional. Data are entered regularly into PViMS and analyzed by staff. These data are then reported to the Department of Pharmaceutical Affairs, which is a structural unit of the State Regulation Agency for Medical Affairs at the Ministry of Labor, Health, and Social Affairs.
SIAPS recognized that it was critically important for TB doctors to be trained in the use of bedaquiline through updated standard treatment guidelines and to record and report adverse events in line with the established system. Furthermore, it was important to define the appropriate laboratory tests and examinations for patients on bedaquiline and to ensure that medicine-related adverse events are actively monitored and managed. Therefore, SIAPS conducted countrywide trainings of TB doctors in clinical management and recording and reporting of adverse events.
To date, 275 TB doctors and programmatic management of drug-resistant TB staff have received training on how to conduct active PV, covering 100% of the country’s needs. Prior to the trainings, only 37 serious adverse events from a cohort of 228 patients were reported over a 17-month period. After the trainings, an additional 45 serious adverse events from a cohort of 353 patients were reported over a six-month period.
SIAPS home office staff trained three specialists from the NCTLD on the operation and use of PViMS, ensured that the system met the needs of the country, and deployed it at the national level.
As of July 2017, 268 patients in Georgia have been enrolled on bedaquiline through compassionate use programs (20) and the donation program (248). An additional 85 patients were also enrolled on delamanid, with 12 of those through compassionate use programs.
The Georgia NTP continues to record adverse event data in PViMS.
The lessons learned and country experience on TB patient safety and management in Georgia were presented at the 47th Union World Conference on Lung Health in Liverpool, UK, in October 2016.