Operational Guide for National Tuberculosis Control Programmes on the Introduction and Use of Fixed-Dose Combination Drugs
(2002; 81 pages) Voir le document au format PDF
Table des matières
Afficher le documentACKNOWLEDGEMENTS
Afficher le documentLIST OF ACRONYMS AND ABBREVIATIONS
Afficher le documentPREFACE
Afficher le documentKEY POINTS
Ouvrir ce répertoire et afficher son contenu1. INTRODUCTION
Fermer ce répertoire2. PROGRAMMATIC AND MANAGERIAL REQUIREMENTS FOR FDCS
Ouvrir ce répertoire et afficher son contenu2.1 DOTS strategy
Afficher le document2.2 FDC formulations in the WHO Model List of Essential Medicines
Afficher le document2.3 Treatment regimens using FDCs
Afficher le document2.4 Justification for dosage forms and dosage schedules
Ouvrir ce répertoire et afficher son contenu3. FDC DRUG MANAGEMENT
Ouvrir ce répertoire et afficher son contenu4. ENSURING THE QUALITY OF FDC DRUGS
Ouvrir ce répertoire et afficher son contenu5. HOW TO INTRODUCE AND CHANGE OVER TO A REGIMEN WITH 4-DRUG FDCS/2-DRUG FDCS: PLANNING AND IMPLEMENTING A "SCENARIO"
Afficher le documentAnnex 1. Glossary and use of terms
Afficher le documentAnnex 2. WHO Certification Scheme - Model Certificate of a Pharmaceutical Product1
Afficher le documentAnnex 3. WHO Certification Scheme - Model Batch Certificate of a Pharmaceutical Product
Afficher le documentAnnex 4. Example of an order form for anti-TB drugs for treatment facilities
Afficher le documentAnnex 5. Steps in the quantification of anti-TB drugs using consumption-based information
Afficher le documentAnnex 6. Suggested reading
Afficher le documentRequest for feedback on the guide
 

2. PROGRAMMATIC AND MANAGERIAL REQUIREMENTS FOR FDCS

TB regimens and anti-TB drug formulations have changed regularly in the past in response to new insights and circumstances in TB control. The introduction of rifampicin in the 1970s shortened the regimen from 12-18 months to 6-8 months (short course chemotherapy: SCC). In the 1990s, SCC was expanded worldwide together with the expansion of DOTS strategy. More recently, the majority of countries using DOTS strategy have replaced rifampicin and isoniazid loose tablets with combination tablets (2-drug FDCs [RH]) as recommended by WHO and IUATLD since 1994. Since the early 1990s, many high HIV prevalence countries have replaced thioacetazone with ethambutol or rifampicin in the continuation phase and some countries have also changed from a daily to intermittent treatment regimen. The 1997 WHO Model List of Essential Medicines recommended the use of rifampicin 150 mg + isoniazid 75 mg (R150 mg + H75 mg) instead of the previously recommended rifampicin 150 mg + isoniazid 100 mg (R150 mg + H100 mg) and pyrazinamide 400 mg (Z400 mg) instead of pyrazinamide 500 mg (Z500 mg). All these changes were included in guidelines and training, and have been implemented at local level, resulting in increased DOTS efficiency.

Since 1999, 4-drug FDCs have been proposed for the initial phase of treatment of category 1 and 2 patients. Availability on the international market, quality and price no longer represent an obstacle. Considering the advantages, e.g. simpler prescription, decreased chance to select resistant strains, and increased patient and health worker acceptance, it is expected that 4-drug FDCs will become the standard formulation for TB regimens in the very near future.

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Dernière mise à jour: le 3 mai 2013