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.