Operational Guide for National Tuberculosis Control Programmes on the Introduction and Use of Fixed-Dose Combination Drugs: 3. FDC DRUG MANAGEMENT: 3.1 Product selection

Operational Guide for National Tuberculosis Control Programmes on the Introduction and Use of Fixed-Dose Combination Drugs
(2002; 81 pages)

Table des matières

ACKNOWLEDGEMENTS
LIST OF ACRONYMS AND ABBREVIATIONS
PREFACE
KEY POINTS
1. INTRODUCTION
	1.1 Aim and objectives
	1.2 What you can find in this guide
	1.3 Background and rationale
2. PROGRAMMATIC AND MANAGERIAL REQUIREMENTS FOR FDCS
	2.1 DOTS strategy
		2.1.1 Challenges in TB control
		2.1.2 Why switch to FDCs?
		2.1.3 FDCs and adverse effects
		2.1.4 Directly observed treatment and FDCs
	2.2 FDC formulations in the WHO Model List of Essential Medicines
	2.3 Treatment regimens using FDCs
	2.4 Justification for dosage forms and dosage schedules
3. FDC DRUG MANAGEMENT
	3.1 Product selection
	3.2 Procurement
		3.2.1 Quantification of drug needs
		3.2.2 Procurement methods and selection of suppliers
		3.2.3 Procurement and quality assurance
		3.2.4 Minimum product specifications, packaging and labelling requirements to be specified in the contract
	3.3 Distribution and storage
	3.4 Rational use of anti-TB medicines
	3.5 Drug problem reporting system
	3.6 Monitoring and evaluation
	3.7 Summary checklist for good anti-TB drug management
4. ENSURING THE QUALITY OF FDC DRUGS
	4.1 Building a quality assurance system for the national TB programme
		4.1.1 Quality assurance where there is an operational drug regulatory authority
		4.1.2 Quality assurance where there is no national drug regulatory authority or no operational drug registration system
	4.2 Bio-availability and bio-equivalence (interchangeability) data
	4.3 Laboratory testing
	4.4 The WHO Certification Scheme
	4.5 Facilitating the drug registration process
5. HOW TO INTRODUCE AND CHANGE OVER TO A REGIMEN WITH 4-DRUG FDCS/2-DRUG FDCS: PLANNING AND IMPLEMENTING A "SCENARIO"
	5.1 The challenge
	5.2 Planning
	5.3 The process
		5.3.1 Decision-making phase
		5.3.2 Preparation
		5.3.3 Initial implementation
		5.3.4 Full implementation
Annex 1. Glossary and use of terms
Annex 2. WHO Certification Scheme - Model Certificate of a Pharmaceutical Product¹
Annex 3. WHO Certification Scheme - Model Batch Certificate of a Pharmaceutical Product
Annex 4. Example of an order form for anti-TB drugs for treatment facilities
Annex 5. Steps in the quantification of anti-TB drugs using consumption-based information
Annex 6. Suggested reading
Request for feedback on the guide

3.1 Product selection

Selection is the process of establishing a limited list of essential anti-TB drugs to be procured based on the most current acceptable clinical treatment guidelines while defining specifications (see Box 3 and section 3.2.4) and deciding which drugs will be available at different levels of TB facilities. In many national TB control programmes it is difficult to carry out TB drug selection activities independently and managers depend on the information researched and established by WHO with respect to FDCs and drug dosing. In these cases the standard treatment regimens will be the same as those discussed under DOTS strategy above, that is, the treatment regimens recommended by WHO and IUATLD.

Even where there are adequate human resources and experienced personnel to develop national standard treatment guidelines for TB, it is still recommended to use FDCs following the WHO guidelines.

Box 3: Specifications for each drug should include

• Drug description, generic name or INN
• Alocal trade name, if any
• Dosage form e.g. tablet, ampoule for injection
• Strength, e.g. rifampicin 150 mg + isoniazid 75 mg
• Package presentations, quantity of basic units

Once FDC treatment regimens have been selected, the TB programme should preferably use drug formulations which are included in the national essential medicines list and are registered. In case the relevant FDCs are not on this list, or are not registered, the NTP should enter into dialogue with the drug regulatory authority and request FDCs to be put on the list and registered. The advantage of using the essential medicines concept is to enable a health system to limit other more expensive or poor quality drugs from being purchased at local treatment levels in decentralized systems.