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": 5.1 The challenge

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

5.1 The challenge

Once the decision to implement and change over to a treatment regimen with 4- drug FDCs is taken, several challenges have to be faced and a process of careful planning has to begin.

Firstly, it is essential that the change-over is flawless, i.e. without interruption in supply and treatment, so as not to endanger the health of patients due to long lead times for delivery of anti-TB drugs. The actual change-over cannot start unless the new drugs are in the country - due to the high cost of the medicines, no programme could afford to buy parallel stocks for the old and new FDC regimens in case the change-over was not successful. This implies that, once the process has started, there is practically no way back. The moment of ordering the new FDCs is the point of no return.

Even a pilot study in one district or dispensary does not have a grace period, since if the study proves a success, it is unthinkable to revert temporarily back to old dosage forms and regimens at the end of the study until the full order of new drugs arrives for the whole programme.

On the other hand, this does not mean that one should not start with one or two areas in order to gain experience, and to adjust the plans as necessary for full implementation throughout the programme.

Therefore it might be best to start in areas where the circumstances are most favourable (see Activity 13 in section 5.3.3). Also, one could start in two places, such as at a dispensary in a large city and another in a rural area.

To make the operation a success, it is essential to win the confidence and full cooperation of health staff at all levels of the programme. Also the support and cooperation of stakeholders outside the programme will have to be assured for the operation to be a success.

The second challenge in changing over to FDCs is to plan and execute two separate processes (see Section 5.4):

1) the process of preparing and introducing the new regimens within the programme, including logistics planning; and

2) the process of ordering and receiving the new drugs. These two processes are linked by bridge activities.

A third challenge is how to handle the stocks of old drugs whilst causing minimum waste of resources (further discussion in Activities 7 and 23 in section 5.3).

These three challenges form quite a unique situation in operational planning and thus proper preparation is essential.

Finally, it is good to bear in mind that the change-over to 4-drug FDC/2-drug FDC dosage forms can also be used as leverage to implement full DOTS coverage throughout the programme.