Operational Guide for National Tuberculosis Control Programmes on the Introduction and Use of Fixed-Dose Combination Drugs
(2002; 81 pages) View the PDF document
Table of Contents
View the documentACKNOWLEDGEMENTS
View the documentLIST OF ACRONYMS AND ABBREVIATIONS
View the documentPREFACE
View the documentKEY POINTS
Open this folder and view contents1. INTRODUCTION
Close this folder2. PROGRAMMATIC AND MANAGERIAL REQUIREMENTS FOR FDCS
Close this folder2.1 DOTS strategy
View the document2.1.1 Challenges in TB control
View the document2.1.2 Why switch to FDCs?
View the document2.1.3 FDCs and adverse effects
View the document2.1.4 Directly observed treatment and FDCs
View the document2.2 FDC formulations in the WHO Model List of Essential Medicines
View the document2.3 Treatment regimens using FDCs
View the document2.4 Justification for dosage forms and dosage schedules
Open this folder and view contents3. FDC DRUG MANAGEMENT
Open this folder and view contents4. ENSURING THE QUALITY OF FDC DRUGS
Open this folder and view contents5. HOW TO INTRODUCE AND CHANGE OVER TO A REGIMEN WITH 4-DRUG FDCS/2-DRUG FDCS: PLANNING AND IMPLEMENTING A "SCENARIO"
View the documentAnnex 1. Glossary and use of terms
View the documentAnnex 2. WHO Certification Scheme - Model Certificate of a Pharmaceutical Product1
View the documentAnnex 3. WHO Certification Scheme - Model Batch Certificate of a Pharmaceutical Product
View the documentAnnex 4. Example of an order form for anti-TB drugs for treatment facilities
View the documentAnnex 5. Steps in the quantification of anti-TB drugs using consumption-based information
View the documentAnnex 6. Suggested reading
View the documentRequest for feedback on the guide
 

2.1.2 Why switch to FDCs?

Use of 2-, 3- and 4-drug FDCs does not replace proper case management and directly observed treatment (DOT), which ensure adherence to treatment and ultimately the cure of a patient.

In some countries, the use of 4-drug FDC tablets might not (yet) be allowed by the DRAs for various reasons, e.g. they may not yet be registered or licensed for marketing.

Besides the potential advantages described above (section 1.3), FDC tablets will contribute tremendously to DOTS expansion in several ways:

• there will be no more monotherapy with one medicine or an insufficient number of different loose drugs, reducing the chance of development of resistant strains of TB;

• the 4-drug FDC regimen decreases the risk of treatment failure and relapse;

• patients will have fewer tablets to swallow, which will help improve compliance;

• having fewer tablets to handle, supervision of drug intake will be quicker, so greatly reducing the workload and potential prescription errors of health workers administering DOTS;

• drug ordering, storage and stock control will be simpler and time will be saved, while errors are less likely to occur (fewer items to handle with the same expiry date);

• from the programme management point of view, calculation of drug needs, procurement, distribution and stocking throughout the programme will become simpler and, in some instances, even cheaper (e.g. due to less volume and storage capacity needed); and

• it will be easier to adjust dosages by body weight (see Tables 4 and 5).

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Last updated: May 3, 2013