This document is intended to promote the use of fixed-dose combination (FDC) anti-TB drugs in the treatment of tuberculosis (TB). It is directed to national TB programme (NTP) managers to assist them in the process of making policy decisions and planning for the introduction of 2-, 3-, and 4-drug FDCs.
For effective planning of the implementation of FDC drugs in a country's TB control programme, it is advisable that policy-developers and decision-makers, and the NTP managers in particular, study this guide before making any policy decision regarding programme and drug management. This is especially true if a country has never used 2-, 3- or 4-drug FDCs.
This publication provides easy-to-follow guidance on programmatic, managerial, quality and regulatory matters, with some practical approaches to facilitating the use of FDCs in a TB control programme. The guide contains minimum requirements and is not intended to replace existing requirements and practices in countries achieving high quality Directly Observed Treatment, Short-course (DOTS) implementation. Approaches other than those set out in this guide may be applicable and acceptable. It is the responsibility of the NTP manager and key stakeholders to choose the most suitable approach for their national and local settings to introduce FDCs. FDCs should be considered as part of the overall DOTS strategy implementation and should definitely not be seen as an alternative.
Policy-makers and national TB programme managers deciding to use FDCs should develop a clear strategy and detailed plan for replacing single drug formulations by FDCs. The implementation process should be carefully introduced and, if necessary, gradually expanded.
National drug regulatory authorities (DRAs) and NTP managers should ensure that all anti-TB drugs, including FDCs, meet acceptable standards of quality, safety and efficacy, and that they are accessible to the whole population. Anti-TB drugs should be used rationally in accordance with the current standardized treatment guidelines for effective treatment outcomes in both the public and private sectors. It is crucial for NTP managers to ensure that all TB patients have uninterrupted access to anti-TB drugs, and that the right drugs of the right quantity and in the right dosage form are delivered to the right patient at the right time.
Assuring the quality of both locally produced and imported FDCs may present a problem for many DRAs and NTP managers with limited technical capacity and resources. In that case, for imported FDCs, managers must rely on quality information from the DRA of the exporting country. For locally manufactured products, managers must establish their own quality assurance system and demand that suppliers provide the quality documents described in the WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International