(Adapted from the Companion Handbook to the WHO guidelines on programmatic management of drug resistant TB which can be found on the Tools and Resources tab)
In using new medicines for the treatment of MDR-TB patients, health care providers, must be aware of the unique evaluation and monitoring needs of patients taking either bedaquiline or delamanid and companion medicines.
The World Health Organization (WHO) has recommended five conditions for the introduction of new TB medicines (specifically bedaquiline) in countries.
1. Effective treatment and monitoring
Treatment must be closely monitored for effectiveness and safety, using treatment and management protocols approved by relevant national authorities
2. Proper patient inclusion
- Bedaquiline is currently recommended for use in adults (≥ 18 yrs) with pulmonary TB disease
- Use bedaquiline with special caution in the following populations due to limited or unavailable efficacy and safety data under such conditions
3. Informed consent
Health care providers and workers should follow due process for informed consent by ensuring that the patient is “aware of the novel nature of bedaquiline, appreciates the reason why the drug is being proposed for inclusion in their treatment regimen, and recognizes the possible benefits and potential harms as well as the uncertainties that surround the use of bedaquiline.” This informed consent process must be documented and signed by the patient, and applies to all situations where bedaquiline is employed, including under compassionate use programs
4. Adherence to the principles of designing a WHO-recommended MDR-TB regimen
5. Active drug safety surveillance measures and proper management of adverse events.
These measures should be put in place to ensure early detection and proper management of adverse reactions and potential interactions with other drugs.
For more comprehensive technical assistance in developing clinical guidance documents, standard operating procedures, or in preparing clinicians for new TB medicine use, please contact us at newTBdruginfo@msh.org.