Operational Guide for National Tuberculosis Control Programmes on the Introduction and Use of Fixed-Dose Combination Drugs: 5. HOW TO INTRODUCE AND CHANGE OVER TO A REGIMEN WITH 4-DRUG FDCS/2-DRUG FDCS: PLANNING AND IMPLEMENTING A "SCENARIO": 5.3 The process: 5.3.1 Decision-making phase

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

5.3.1 Decision-making phase

Before the decision can be taken, a number of activities have to be performed, and certain information has to be available. This information is crucial to making a well-founded decision, and to explaining to all parties concerned, both within and outside the programme, e.g. staff responsible for financing and planning, why it is desirable to make the change.

Programme management:

Activity 1	Find out what the cost per patient will be compared to the present cost.

Activity 2	Especially consider the use of 4-drug FDCs for the intensive phase of treatment and base calculations on loose tablets or blisters depending on which package you intend to use in the NTP. You may want to consider the opinion of staff at the dispensaries as well.

Activity	3 Reconsider the shape, colour embossment etc. for the tablets. When the drugs are purchased specially for the programme, this is possible and manufacturers may be willing to oblige, as long as they are informed of what is expected in good time. Also, the opinion of the staff handling the drugs could be sought in good time.

Activity 4	Calculate the value of the next drug order, and also what the changeover itself is going to cost.

Drug management:

Activity 1

Make an inventory of all the different dosage forms presently in use in the programme and whole country, including the private sector. Also, it is important to know which TB-drugs are actually registered for use by the DRA.

Once the FDCs have been selected, verify with the DRA their requirements for registration and whether exemptions and/or fast track registration is possible. Generally, it remains advisable to adhere as much as possible to normal registration policies so as not to create problems for the future.

Bridge activity 5

With the information from both programme management and drug management, take a well-founded decision to switch over to 4-drug FDCs/2-drug FDCs.