TDR and the Access and Delivery Partnership have been supporting the National Tuberculosis Programme of Indonesia’s efforts to ensure the safety of patients taking new all-oral shorter treatment regimens. Their experience is also being shared with counterparts in West and Central Africa.
Challenge
Indonesia is a high-burden country for tuberculosis (TB) and drug-resistant TB (DR-TB) and adopted all-oral shorter treatment regimens in December 2020. As these new drugs have numerous side effects, active drug safety monitoring and management (aDSM) needs to be fully implemented to ensure the safety of the patients. Although collaborative work with the National Agency of Drug and Food Control (BPOM) had started in 2015, the National TB Programme (NTP) of Indonesia asked for support to review progress towards implementation of aDSM and to develop a plan for strengthening this important component of drug-resistant TB care to maximize patient safety.
Initiative
In 2021, TDR provided technical assistance to the NTP to perform a situational analysis. A team of international and national consultants led the work with technical assistance from TDR. They first performed a desktop review of key documents and information provided by the National TB Programme and the Indonesia Food and Drug Authority (BPOM) about the implementation of aDSM in Indonesia.
To understand the challenges of monitoring and reporting adverse events during DR-TB treatment, an online survey was then conducted across the 34 provinces involving 620 healthcare workers. Virtual meetings with NTP and BPOM were held to discuss systems and processes for aDSM. Interviews of key people at the NTP and BPOM were also conducted by the national consultant. This process helped assess the practical implementation of aDSM in terms of coordination, clinical and laboratory monitoring, training, recording and reporting, data management and analysis.
The NTP of Indonesia shared their experience with aDSM in a virtual workshop attended by NTP managers of 27 countries in West and Central Africa. Findings of the situation analysis were presented at the Regional Greenlight Committee for South-East Asia on 30 June 2021, as lessons learned are also useful for other national TB programmes adopting the all-oral shorter treatment regimens.
Results
The NTP of Indonesia has now a complete situation analysis report with clearly identified challenges and weaknesses in aDSM implementation in terms of health worker knowledge on aDSM, availability of key tools to report safety issues, capacity of health workers to recognize severe adverse events, recording and reporting them (including limitations of digital tools), causality assessment, signal detection and communication, human resources, and monitoring and evaluation. Besides identifying several key elements that will help to strengthen aDSM in Indonesia, a standardized verbal autopsy form specific for MDR-TB patients along with a procedure to complete it were developed. This will allow for better documentation of potentially fatal drug reactions occurring with the new TB drugs.
In July 2021, based on the recommendations, the NTP developed an action plan with a timeline detailing the next steps to overcome the challenges in implementing aDSM, thereby initiating efforts to strengthen TB patient safety in Indonesia.
For more information, please contact Dr Corinne Merle.