Operational Handbooks

This operational handbook was prepared by Sabine Verkuijl, Annemieke Brands, Kerri Viney and Tiziana Masini, under the guidance of Farai Mavhunga and the overall direction of Tereza Kasaeva, Director of the World Health Organization (WHO) Global Tuberculosis (TB) Programme.

The WHO Global TB Programme gratefully acknowledges the contributions of all experts who were involved in the production of the operational handbook. Unless otherwise specified, those listed below work in the WHO Global TB Programme.

Targeted NGS tests couple amplification of selected genes with NGS technology to detect resistance to many drugs with a single test. Because targeted NGS tests can interrogate entire genes to identify specific mutations associated with resistance, targeted NGS tests may provide improved accuracy compared with other WRDs. In addition, new targeted NGS tests can detect resistance to new and repurposed drugs not currently included in any other molecular assays.

Policy and operational documents that govern the main components of the programme will need to be revised. Such documents include the national strategic plan for TB, treatment guidelines and algorithms, diagnostic algorithms, the essential medicines list, regulations (e.g. importation of clofazimine and pretomanid), drug orders and training material. Ideally, the type of regimen used by the patient would be indicated in the register and could be summarized for reporting.

A national MDR-TB expert committee or technical working group (the consilium or its equivalent structure within the NTP) will assist health care providers as early as possible to:

There is a need to improve the quality of patient data using standardized variables, such as data on DST patterns, prescribed treatment, treatment outcomes and adverse drug reactions. The collection and utility of these data are important for future evidence-based recommendations, especially given the lack of RCTs on the management of DR-TB (126). If digital patient records do not already exist, it is important that the programme managers consider their introduction, at least for surveillance and possibly also for case management (146).

Estimates are needed by the NTP and other health care providers, to determine the number of MDR/RR-TB patients eligible for the longer and shorter MDR-TB regimens, to revise the budget accordingly, and to submit the corresponding requests for drug orders, taking into account the existing stock of medicines. These estimates of MDR/RR-TB patients likely to be enrolled are based on current notification trends and an expected increase in line with national and subnational plans.

Management of the supply chain and storage conditions for pharmaceuticals should be reviewed to ensure that TB drug orders are made in good time and are correctly quantified to avoid overstocking or shortages. The NTP must ensure an uninterrupted supply of TB medicines through proper quantification, supply planning and rigorous quarterly monitoring, with a functional early warning system to avoid stock-outs and subsequent treatment interruptions. Similarly, other consumables (e.g.

In November 2020, WHO/GTB convened an online consultation and released new definitions of TB treatment outcomes, which were the same for DS-TB and DR-TB (150, 151).

The principles guiding the update of the definitions were: