Operational Guide for National Tuberculosis Control Programmes on the Introduction and Use of Fixed-Dose Combination Drugs: 3. FDC DRUG MANAGEMENT: 3.7 Summary checklist for good anti-TB drug management

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

Table of Contents

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

3.7 Summary checklist for good anti-TB drug management

NTP managers are directly involved in a number of TB drug management components, e.g. selection and quantification of FDCs and other TB drugs. Although other aspects of drug management, such as procurement, distribution and monitoring, may not be the direct responsibility of the NTP manager, the manager can be the key player in promoting good drug management practices within the TB control programme. See Table 8 for a checklist of activities.

Table 8: NTP drug manager's checklist

Phase	Activity	Determination
Product planning	Selection of products	• DOTS strategy and existence of standard treatment protocols
	Estimation and quantification of TB drug requirements	• Notification of cases • Availability of locally produced TB drugs
Product procurement	Selection and location of suppliers	• Open and transparent communication with industry • Issue of Request for Expression of Interest to industry • Pre-qualified suppliers • Implementation of review mechanisms
	Assurance of quality of products and sources	• Criteria for manufacturer pre-qualification • Implementation of pre-qualification • system Use of WHO Certification Scheme, inspections and quality testing of samples • Pre-shipment physical inspection with random sampling for laboratory testing • Systems for records and supply monitoring
	Arrangements for purchasing	• Ongoing assessment of purchasing options, including national/regional purchasing • Need for special labelling and packing • Need for reserve/buffer stocks • Management of purchasing arrangements
Distribution, rational use and monitoring	Receipt in country	• Port clearance including availability of funds for payment of duties and taxes • Securing appropriate warehousing at all levels needed • Physical inspection on arrival of each consignment with random sampling for laboratory testing
	In-country distribution	• Logistics system for timely distribution to end users
	Rational use and monitoring	• Providers adequately trained • Systems for monitoring and reporting