This guide consists of six main sections (see Box 1). The introductory part deals with the objectives of the guide and general considerations to be taken into account when introducing FDCs, and provides the background and rationale for the use of anti-TB FDCs. The second section explains programmatic and managerial requirements, which ministries of health and NTP managers should consider before making certain policy decisions to introduce FDCs. This section reiterates the urgent need for accelerated expansion of DOTS strategy to combat the TB epidemic. It also describes the WHO-recommended FDCs for primary treatment of TB, the different treatment categories and respective regimens. The third section covers drug management issues, including the selection of dosage forms, quantification of drug needs, procurement, stock management and distribution. The fourth section provides useful information on regulatory requirements and proposes approaches for NTP managers and DRAs to address the quality control and bio-availability/bio-equivalence issues of FDCs, in particular FDCs containing rifampicin. The fifth section explains how to introduce and gradually change over to a regimen with 4-drug FDCs/2-drug FDCs. This involves planning, and offers a scenario for changing over to a regimen with 4- drug FDCs. The last section includes annexes of relevant materials and documents referred to in the main text.
Box 1: Main sections
• Introduction: goal and objectives of the guide, background and rationale for using FDCs
• Programmatic and managerial requirements
• Drug supply management
• Quality bio-availability/bio-equivalence and regulatory requirements