Preparation begins once the decision to switch over to a new regimen has been taken.
Programme management:
Activity 6 |
Arrange for the new NTP manuals on FDCs and reporting forms to be printed. Before the manuals are printed (this being a long process), provide a circular containing details of the new regimens and FDCs to all NTP staff. If possible, check and adjust, if necessary, the drug stock distribution and monitoring system, and verify if the current text in the manual is still valid. |
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Activity 7 |
Introducing the new dosage forms will mean that some old stocks will have to be recalled or re-distributed to specialized hospitals where the drugs can be used. A recall plan has to be made and additional storage space reserved. In general, it is easiest to recall all redundant drugs to one point, preferably the central stores, and to redistribute from there. At this stage, an estimate will have to be made of how many drugs are concerned and what can best be done with them. In some cases, NTP managers may negotiate with the supply companies to collect the old redundant stocks and replace them with FDCs, with or without extra charges. The outputs of activity 6 (the new NTP manual, the circular, the recall plan, data on old stock) will have to be verified with the central medical stores and other government bodies involved. [Note: In the transitional period it is better to be left with some additional stocks of single drug tablets than to run out of single drugs before the FDCs arrive]. |
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Activity 8 |
Secure funds and print the new, adjusted manuals. |
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Activity 9 |
As soon as the manuals are ready, or when preliminary circulars have been issued, all stakeholders (including, in some cases, the private sector) can now be informed of the upcoming changes. Training and seminars for NTP staff, to introduce them to the new regimens and changes in the drug monitoring and distribution system, if any, can now be planned and can start once the necessary funds have been secured. |
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Activity 10 |
Determine the first possible arrival date of the new FDCs, and the actual starting date when the first patients will receive the new regimens. This can be calculated based on the expected stock-out date of present stocks, and the lead time for procurement of the new FDCs. |
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Activity 11 |
Calculate the amount of loose single medicines that need to be kept in referral centres for the treatment of patients with severe adverse drug reactions. These patients should be treated in specialist units only. |
Drug management:
Activity 2 |
Hold an audit to determine the present stock of all TB drugs at all levels in the programme, the exact number of patients on register, and the size of the required buffer stocks. |
Activity 3 |
Calculate the size and value of the first order of FDCs. |
Activity 4 |
Re-examine the quality standards in use and/or set for FDCs. Special attention should be paid to bio-availability tests for the rifampicin in FDCs, and to the quality and source of the rifampicin raw material. |
Activity 5 |
Set specifications for labelling and packing, according to the outcome of activity 3 of programme management. |
Activity 6 |
Determine the procurement method according to the value of the order (usually LCB from pre-qualified suppliers), and secure the necessary funds. |
The preparation phase now culminates in two scenarios, one for the programme management process and one for the drug management process:
Bridge activity 12
Programme management (set calendar and write change-over scenario which includes date of drug arrival, staff preparation seminars, starting date for DOTS with new FDCs).
Bridge activity 7
Drug management (set procurement calendar including dates for floating tender, tender opening, availability of funds, contract date, production duration, QA and shipment, delivery and payment).
Each of these scenarios can be summarized on a planning calendar.
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