1. INTRODUCTION OF FDCs: NTP POLICIES, INTERVENTIONS AND EXPERIENCE Shah S. K., Sadiq H., Ahmad N., Shaikh U & Kazi G. N. National TB Control Programme, Pakistan.

2. Back Ground
To review the process of translating policy into feasible implementation decisions, a qualitative study has been designed.
To conduct an assessment of the process and the experience of introducing FDCs in national program context.
To study the interventions at all levels i.e. policy, implementation including guidelines and training materials for managers and care providers, etc.
To assess the experiences of managing FDCs at the program, district and community levels and to review the extent of implementation process after adoption of FDCs .

3. INTRODUCTION Fixed dose combination is recommended by WHO, IUATLD
There are a lot of FDCs available in the market, WHO, EDL recommended preparation (FDCs)
While adapting FDCs, sufficient planning be carried out.
Sufficient time will need to be allowed for a transitional phase.

4. OBJECTIVES General Objectives: Specific Objectives:
To review the process of translating policy into feasible implementation decisions, to review the early implementation experience of the program in introducing FDCs and to assess the experiences of the managers, health care providers and patients with FDCs.
Specific Objectives:
To understand perception and practices of service providers for the FDCs.
To assess behavioral changes in the patients for the adaptation of FDCs.
To introduce realistic and feasible policies to achieve efficient DOTs implementation.

5. METHODS A qualitative method was employed in this study
Setting and Population:
National and the provincial levels (two provinces).
Four districts of Pakistan
Subjects:
4 Managers at National and Provincial levels, 6 mid-level District Managers, 10 doctor and 10 patients
Data collection method:
Focus group and individual interviews.
Data analysis:
Collected data is transcribed and coded and classified in categories.
A cross-interview analysis was employed in this study. Each interview was taken as an individual case (Patton, 1990).
Finally, categorisation strategies (coding and thematic analysis) were employed to narrow down broad categories into more focused concepts.
Data have been sorted out in broader themes and issues.

6. Results Less price in the market (Please see table 1)
Cost-effectiveness
Less price in the market (Please see table 1)
Less Transport charges (Less Labor on loading and unloading
Less shelf space and span (almost 82% less)
(Less weight and mass, please see table 2)
Prescription and patient counseling
less time and efforts on dose calculation (weighing patient etc.)
Less efforts on guiding and counseling patients
Less questions by the patient
Compatible with the usual private practice
Inventory/record keeping
Less efforts on inventory, record keeping and dose
management at supply and final distribution levels
Patient’s experience
Easy to swallow three tablets rather 11 tablets. Physical appearance of drugs (Blister pack), size of tablet, less number of tablets all contributed to in building confidence of patients.

7. Results Complexities in introduction of FDCs:
Doctors relying only on FDCs, are facing difficulties in adjusting dose of patients in the range of Kg weight
Care providers are advising to divide the tablet into halves or crush the tablet or to take tablet on alternate days.
High chances of side effects and multi-drug resistance

8. RESULTS Switching on FDCs: deficient groundwork
Abrupt introduction of Fixed Dose Combination drugs
Deficient guidelines on the management of Fixed Dose Combination drugs
Confusion in the understanding management of new regimen during the transitional period
Misinterpretation of information conveyed mainly through inter-personal communication
Training modules were not revised
Retraining of care providers were not carried out
Lack of uniform implementation of FDCs
Lack of appropriate counseling to patients while swapping from separate dose regimen to FDCs created concern among patients regarding their cure.
Wastage of separate drugs already lying in the stores

9. Summary The study revealed that:
Introduction of FDCs in the programme proved enormous advantages for the patients and care providers.
To achieve the desired results of DOTS, switching on Fixed Dose Combination Drugs needed crucial interventions (groundwork).
Module modification, trainings for the managers, care providers, and counseling strategies for the patients were very important interventions which needed consideration.
The introduction of FDCs was associated with various complexities due to deficient prior groundwork.

10. Individual
A patient receiving 90 tablets for a month in intensive phase
F D Cs
A patient receiving 330 tablets for a month in intensive phase.

11. Table 1: Cost of treatment for a TB patient (38-54 KG Wight).
Drug regimen
Intensive phase
(60 days treatment)
Per patient cost of treatment
Continuation phase
(180 days treatment)
Total
FDCs (RHEZ)
$13.06
$13.13
$26.19
Separate drugs
$18.87
$11.21
$30.08

12. Table 2: Comparison of two regimen by weight and cover space in the store
Medicine
Quantity
Weight
Covering space
Remarks
FDCs
10,000 tablets
19 Kg
30x22 inches
Enough for 55 patients in Intensive phase
Ethumbutol
(400 MG)
10 Kg
16x9 inches
Enough for 83 patients in Intensive phase
Pyrazinamide
(400MG)
15x12.5 inches
Isoniazide
(100MG)
9 Kg
12x15 inches
Rifampicin
(150MG)
24x18 inches

13. Conclusions & Recommendations
Introduction of FDCs with less consideration to the prior groundwork has produced enormous complexities for the health care providers and patients.
Since long separate doses were in use for the treatment of TB, abrupt change from this traditional regimen to FDCs needed crucial interventions.
Training on introduction of FDCs was not carried out which created confusion/misinterpretation of information particularly among dispensers who serve as a first level contact in public sector.
Pediatric FDCs are not available. Adjustment of dose for certain age groups was carried out by dividing or crushing of tablets or advising taking tablet on alternate days.
Such practices may lead to under or over dosage and ultimately causing side effect or multi drug resistance.
Recommendations:
Sufficient planning, regarding training of personnel, revision of training modules and inclusion of information on FDCs and adjustment of procurement plan
Assured and sustained supply of FDCs to avoid interruption in treatment and efficient supervision to prevent multi drug resistance.
Referral mechanism for patients with drug reaction
Pediatric FDCs need to be introduced or a limited stock of single drugs should be made available in the stock.