New drugs approved by regulatory authorities, notably bedaquiline and delamanid, as well as re-purposed drugs classified as Group 5 in the WHO Companion Handbook to the 2011 Guidelines for Programmatic Management of Drug-resistant Tuberculosis (PMDT) are increasingly being introduced in the treatment regimens for MDR-TB and XDR-TB patients. The WHO's Global TB Programme issued interim policy guidance on the use of bedaquiline in the treatment of MDR-TB in mid-2013 and on the use of Delamanid in October 2014. However limited data, particularly on safety, are currently available on these new drugs, and also on the safety and efficacy of the re-purposed drugs listed under Group 5. It is therefore imperative that adequate provisions for safe, rational and effective use of these drugs be put in place, specifically ensuring appropriate selection of eligible patients, informed consent, design of effective regimens, and close patient monitoring and evaluation. Both drug stock-outs and overstocking should be avoided and orders aligned to treatment regimens recommended by WHO. Furthermore, WHO/GTB is recommending that countries introducing new and re-purposed Group 5 drugs establish active pharmacovigilance to rapidly detect potential drug adverse events.
Given the essential role of the regional Green Light Committees (rGLCs) as the primary point of contact for country guidance and advice on PMDT, it is very important that rGLC members and PMDT consultants are fully au fait with current WHO policy recommendations on the use of new drugs, as well as those in Group 5. Therefore a series of workshops have been planned by the WHO for the rGLC members and their respective rGLC Secretariat Focal Points, whilst encouraging countries and partners to make use of the rGLC mechanism to ensure that treatment principles and drug orders are aligned with WHO guidelines.
Workshops held as yet are as follows:
- For the members of the rGLC for the European Region, the rGLC Secretariat Focal Point, and representatives of partner organizations - Copenhagen, Denmark, 22-23 September 2015.
- For the members of the rGLCs for the African and Eastern Mediterranean Regions, the rGLC Secretariat Focal Points, and representatives of partner organizations - Nairobi, Kenya, 4-5 November 2015.
- For the members of the rGLCs for the South East Asia and Western Pacific Regions, and representatives of partner organizations - Bangkok, Thailand, 24-25 February, 2016
- For the members of the rGLCs for the Americas Region, the rGLC Secretariat Focal Points, and representatives of partner organizations - Panama City, Panama, 18-19 April 2016.
The reports of these workshops are available here
Report of workshop on new DR-TB drugs for AFR and EMR, Nairobi, Kenya, 4-5 Nov 2015.
WHO HQ-EURO experience sharing workshop on new drugs for DRTB report 22-23 Sept 2015.
Report of workshop on new DR-TB drugs for SEAR and WPR, Bangkok, Thailand, 24-25 February , 2016.