Transcript Oral Presentation 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.
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
.
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.
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.
To 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
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.
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
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.
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 Total
phase
(180 days treatment)
Per patient cost of
treatment
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
Weight
Covering Remarks
space
10,000
tablets
19 Kg
30x22
inches
Enough for 55
patients in
10,000
tablets
10 Kg
16x9
inches
Enough for 83
patients in
Intensive phase
10,000
tablets
10 Kg
15x12.5
inches
Enough for 55
patients in
Intensive phase
10,000
tablets
9 Kg
12x15
inches
Enough for 55
patients in
Intensive phase
10,000
tablets
9 Kg
24x18
inches
Enough for 55
patients in
Intensive phase
Medicine
Quantity
FDCs
Ethumbutol
(400 MG)
Pyrazinamide
(400MG)
Isoniazide
(100MG)
Rifampicin
(150MG)
Intensive phase
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 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.