Introduction of new TB medicines and regimens: An opportunity to strengthen pharmaceutical systems

New medicines and regimens, such as bedaquiline, delamanid, and the newly approved short course regimen, are an exciting development given that first- and second-line TB medicines have limited efficacy and potentially serious adverse effects.

With the introduction of new TB medicines and regimens, some countries may target only the minimum WHO-recommended conditions (i.e., proper patient inclusion, effective treatment and monitoring, designing a WHO-recommended MDR-TB regimen based on established principles, obtaining patient informed consent, and active surveillance)[1]. This is understandable given the urgent need to provide for more treatment options for MDR-TB patients.

However, these global recommendations are only a starting point. Effective and sustainable implementation requires a structured translation of these recommendations into action. For example, National TB Control Programs (NTPs) may focus on training health care workers in the clinical management of patients and general implementation challenges, including how to access the medicines and get them to the end user.

While these steps are necessary, there are many less-obvious aspects of implementation that may be overlooked. This may undermine the implementation efforts and threaten the sustainability of the introduction.

Key concerns that may be overlooked include:

  • Prevention of antimicrobial resistance and misuse of new medicines and regimens
  • Documentation of adverse events and establishing or strengthening pharmacovigilance systems
  • Supply chain challenges that contribute to waste, diversion, or stock-outs
  • Financial implications of medicine procurement and associated costs
  • Governance and stewardship
  • Coordination of multiple TB stakeholders

A 2010 study showed that despite increased financing for TB control, weak health systems are a hindrance to achieving global TB targets. The study authors concluded that a process by which TB care is improved and health care systems are strengthened could be symbiotic[2].

 A systems strengthening framework could be employed to structure implementation activities and ensure that all activities are conducted in a way that ensures sustainability. This framework involves a review of key functional areas of the system (e.g., human resources, supply chain, service delivery, financing, governance and stewardship, stakeholder engagement and coordination, and generating reliable information for decision making) to determine areas of strength and weakness.

What does this mean in practical terms? After review, a country may be found to have a robust and skilled health care workforce (human resources) and an experienced NTP that has oversight over all TB-related activities, including the coordination of multiple TB stakeholders. These strengths could be leveraged to meet TB-related goals.

That same country may have a weak supply chain with inefficient quantification methods or distribution channels. It could also be unable to generate accurate and useful information for decision making, which could hinder forecasting and prevent adequate medicine stock from being maintained. The lack of information may also lead to inadequate budgetary planning (financing) for future stock, ultimately affecting patient outcomes.

Each key functional area works in tandem with all other areas to achieve a common goal. Therefore, if emphasis is placed on a few functional areas and other areas are weak, the overall goal is not achieved and sustainability is less likely.

After areas of strength and weakness are identified, the next step is to determine how to leverage the strengths of each country, establish new systems, or expand existing systems to address weaknesses. This could mean improving reporting systems in the country, such as the pharmacovigilance system (for adverse event monitoring), or monitoring and evaluation to ensure that the NTP has robust data to determine TB epidemiology and the percentages of patients who are experiencing certain adverse events. This knowledge may be used to review and update health care practice standards.

An added advantage of bedaquiline and delamanid is the indication for use in patients who may be experiencing kidney damage, ototoxicity, or psychosis. However, NTPs are hard pressed to quantify the numbers of patients (outside of preXDR-TB and XDR-TB patients) who qualify for bedaquiline and delamanid treatment based on their intolerance without adequate pharmacovigilance systems, reporting, and tracking of adverse events.

New TB medicines and regimens offer many advantages, including the expansion of treatment options for MDR-TB patients and opportunities to improve compliance in patients who have intolerance issues. These are significant steps toward the global goal of ending TB. However, to achieve this goal, strengthening the system in which the medicines and regimens are used is critical to ensuring an efficient implementation and sustainability.

Dumebi O. Mordi, Senior Technical Advisor-TB


[1] Companion Handbook to the WHO guidelines for the programmatic management of drug-resistant tuberculosis. Geneva: World Health Organization; 2014

[2] Atun R, et al. (2010). Health-system strengthening and tuberculosis control. The Lancet, Volume 375 , Issue 9732 , 2169–2178. DOI:10.1016/S0140-6736(10)60493-X.