INTRODUCTION OF FDCs: NTP POLICIES, INTERVENTIONS AND EXPERIENCE Shah S' K', Sadiq H', Ahmad N', Sha

1
INTRODUCTION OF FDCs NTP POLICIES, INTERVENTIONS
AND EXPERIENCEShah S. K., Sadiq H., Ahmad N.,
Shaikh U Kazi G. N.National TB Control
Programme, Pakistan.
2
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

3
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.

4
OBJECTIVES

• General 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.

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

• 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

7
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

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
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.
10
Table 1 Cost of treatment for a TB patient
(38-54 KG Wight).
11
Table 2 Comparison of two regimen by weight and
cover space in the store
12
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.

13
Conclusions Recommendations

• Conclusion
• 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.