The 2 processes (programme management and drug management) to run concurrently until bridge activites have been finalized

Phase

Programme management

Drug management

Activity

Sub-activity 1

Sub-activity 2

Sub-activity 3

Activity

Sub-activity 1

Sub-activity 2

Decision-making

1

Consider use/introduction of 4-drug FDCs/2-drug FDCs

Calculate and compare costs per regimen per patient

1

Ascertain all dosage forms of drugs presently in use in NTP: regimens/loose/FDCs

Ascertain all dosage forms of drugs presently in use in the private sector

Verify with DRAwhich TB drugs are presently registered in the country

2

Consider blister packs versus loose tablets

Consider feasibility in view of existing practices

Compare efficiency and cost of storage and distribution at all levels

Consult programme staff for suggestions, acceptability

Verify with DRAthe existing registration requirements, enquire about fast track registration and exemptions

3

Set (new) regimens, INN and dosage forms of drugs (size, colour, shape, strength, embossment, loose/blisters) to be used in NTP

Decide how new regimens will be introduced, for all patients at once or gradually for new patients only

Consult programme staff for suggestions, acceptability

4

Estimate quantity and costs of next order including buffer stock

Estimate costs of introduction: seminars, printing forms and manuals

Inform and consult with government and external donors

Secure funds from government/external donors for drugs and introduction activities

Bridge Activity
5

Take the decision to switch overto 4-drug FDCs/2-drug FDCs (ornot)

Preparation

6

Re-examine/adjust present drug stocking, distribution and monitoring systems, including NTP drug ordering system

Consult/verify and confirm with CMS and other government bodies involved

2

Determine present stocks+ no. of patients at all levels

Determine required size of buffer stocks at different levels

7

Make plan for recall of redundant drugs, possible re-distribution or disposal

Arrange extra storage space for recalled drugs

Consult/verify and confirm with CMS and other government bodies involved

3

Calculate size + value of first order of FDCs

8

Print (new) NTP manuals, ordering and distribution stationary

Secure funds for printing

4

Set quality assurance standards and verification methods. i.e.: special QA requirements for R; QA standards for raw materials

9

Inform all stakeholders of introduction of 4-drug FDCs/2-drug FDCs + new/revised systems for ordering, stocking, distribution and monitoring

Organize training and seminars for NTP staff at all levels on DOTS with 4-drug FDCs/2-drug FDCs + changes in drug monitoring and ordering system

Secure funds for training and seminars

Inform DRAof new dosage forms required from now on

5

Determine packing and labelling specifications

10

Calculate expected stock-out date at present consumption rate

Determine lead time for procurement process

Determine first possible arrival date of 4FDCs

6

Determine procurement method (ICB, LCB, direct purchase, donation)

Consult/verify and conform to CMS and other government bodies involved

Assure financing or donation for: goods, (overseas) transport, insurance, QA testing, clearing

11

Calculate no. of loose drugs required for treatment of patients with side-effects

Bridge Activity
12

Set calendar and write change over scenario including dates of arrival of drugs, staff preparation seminars, starting date for DOTS with new FDCs

Bridge Activity
7

Set procurement calendarincluding dates for: floating tender, tenderopening, availability of funds, contract, production, QA, shipment and delivery, and payments

Initial implementation

13

Set eligibility criteria for administrative unit to start using FDCs. For example:- adequate supervision, - a well trained staff, - a well functioning laboratory, - reliable record keeping, etc.

8

Start systematic monitoring of procurement process

14

Set date and standards to determine if introduction was successful:
For example: - improved patient adherence, - reduced workload

9

Float tender/place order

Verify clearing/importation requirements, arrange timely exemptions

Consult/verify and conform to CMS and other government bodies involved

15

Select pilot area(s). Consider possibility of using 2 pilot sites, one rural, one city. Note: Pilot area should comply with the starting criteria and be a good performer, near the central unit

10

Perform QAex factory

Verify and conform to DRA requirements

Assess QA test costs and assure financing

16

Hold introduction seminars

11

Check quantities, contents, packing on arrival

Determine discrepancies, inform manufacturer, insurance agent, verification bureau

Perform QA tests on arrival (when required)

Bridge Activity
17

Receive and store new drugs in pilot area(s)

Bridge Activity
12

Receive, stock new drugs at national stores and distribute to pilot areas

18

Start treatment with 4-drug FDCs/2-drug FDCs

Recall old drugs except for small stock for side-effects

13

Pay invoices

Claim damages (if any)

19

Monitor data for success. Ask for and register reactions of staff and patients. For example: - cure rate; - treatment completed; - patient adherence; - patients' comments; - side effects

20

Make report of findings at end of introduction

Full implementation

21

Adjust, scenario, calendar, manuals, seminar programmes, drug ordering and distribution system to findings from pilot areas

14

Distribute new drugs according to (adjusted) scenario and calendar

22

Inform and hold introduction seminars according to calendar

15

Receive and re-distribute old drugs according to scenario

23

Distribute and store new drugs in respective area

24

Recall old drugs except for small stock for side-effects

25

Start treatment with 4-drug FDCs/2-drug FDCs

26

Monitor data for success. Ask for and register reactions of staff and patients

27

Make report of findings at end of introduction per area

28

Make final report on introduction of FDCs for annual report, publication