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.

ABSTRACT Fixed dose combination drugs were introduced in National TB control Programme, Pakistan in early 2003. To review the process of translating policy into feasible implementation decisions, a qualitative study has been designed. Purpose of study was to conduct an assessment of the process and the experience of introducing FDCs in national program context. The change in program policy from individual to fixed dose combination required interventions at all levels i.e. policy, implementation including guidelines and trainings materials for managers and care providers, etc. Thus it became imperative 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 . Sponsored by WHO

INTRODUCTION Fixed dose combination is recommended by WHO, IUATLD and their partners, as one further step towards effective implementation of the DOTS strategy. There are a lot of FDCs available in the market, WHO, EDL recommended preparation (FDCs) should be used by the National TB Control Programmes. While adapting FDCs, sufficient planning be carried out. Sufficient time will need to be allowed for a transitional phase.

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. On the basis of the results, introduce realistic and feasible policies to achieve efficient DOTs implementation.

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.

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. Patients are experiencing less side effects particularly nausea, vomiting and abdominal cramps

Results Complexities in introduction of FDCs: Doctors relying only on FDCs, are facing difficulties in adjusting dose of patients in the range of 20-30 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

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

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.

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

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

Summary This study was based on a qualitative assessment of the perception and practices of care providers and patients. 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.

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 personals, 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.