Operational Guide for National Tuberculosis Control Programmes on the Introduction and Use of Fixed-Dose Combination Drugs: 3. FDC DRUG MANAGEMENT: 3.2 Procurement: 3.2.2 Procurement methods and selection of suppliers

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

3.2.2 Procurement methods and selection of suppliers

Many procurement methods are used by governments and NGOs, including open tender, restricted tender, competitive negotiation, and direct procurement. National TB programmes may use one or a combination of these methods to procure anti-TB drugs. For more information on different procurement methods and selection and location of suppliers, please refer to Managing Drug Supply⁴. The overall goal is to identify good quality anti-TB drugs at competitive prices from quality assured suppliers. NTPs should strive to be self-sufficient in procuring drugs for their programmes. However, in countries without available resources and experience, it may be advantageous to obtain anti-TB drugs, including FDCs, through global initiatives such as the GDF.

⁴ Quick JD, Rankin JR, Laing RO, O'Connor RW, Hogerzeil HV, Dukes MNG, Garnett A. (editors) Managing Drug Supply, 2nd ed.West Hartford, Kumarian Press; 1997.

The GDF is an initiative of the Global Partnership to Stop TB. The GDF provides a mechanism for expanding access to high-quality TB drugs to facilitate global DOTS expansion. The advantages of using the GDF include:

• competitive prices;

• procurement is done by others;

• timely deliveries are made to country port of entry;

• ongoing development of packaging, e.g. blisters, to promote patient compliance;

• appropriate linkage exists with the DOTS expansion programmes of WHO Member States and Stop TB partners for the benefit of drug use within the country;

• quality of products is controlled.

The GDF has a grants-in-kind mechanism to fill the gap in TB resources of DOTS countries, and in 2002, the GDF established a direct procurement mechanism. To use this direct procurement mechanism, countries must meet specific criteria that permit the sale of drugs only to those organizations and countries that follow DOTS guidelines and are committed to only using TB drugs procured through the GDF in DOTS patients. To continue purchasing from the GDF, countries must submit routine annual DOTS programme performance reports to WHO⁵.

⁵ See the Stop TB website for more information: http://www.stoptb.org/GDF/drugsupply/Direct_procurement_process.html.