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AN OBSERVATIONAL STUDY OF RNTCP & DOTS

STRATEGY IN THREE DISTRICTS


January "98 - March *98

Dr Sunil Kaul

Voluntary Health Association of India


40, Tong Swasthya Bhawan, Institutional Area, South of IIT, New Delhi 110016

Author
Dr Sunil Kaul

Concept & Coordinator


Dr. Mira Shiva

Editing
Dr. Shaloo Puri

Production
Public Policy Division
Development Communications Unit

Cover Painting
Dhiraj Choudhury

Cover Design
Tamal Basu

Page-setting
Print Excel
Subhash Bhaskar

Printed at
VHAI Press

Copyright Voluntary Health Association of India, 1998


Tong Swasthya Bhawan, 40, Institutional Area,
South of I.I.T., New Delhi - 110 016, INDIA.
Phone: 6518071 - 72, 6515018, 6965871, 6962953
Fax: 011-6853708
E-Mail: vhai@del2.vsnl.net.in

RNTCP - A SHORT STUDY


Hie F-ktional Tuberculosis Control Programme was facing problems in its
implementation and for various reasons the case finding, case holding and
cures achieved were far from satisfactory. After studying the deficiencies in
the existing set-up, the programme was revised in 1993.
NGQs working in the field of TB in one of the rare interactions allowed by the
Ministry of Health in 1995 had demanded a visit to the pilot projects to confirm
the announced results of 80% to 95% cure rates. The demand for visits didn't
even materialise in the minutes of the interaction. A visit was out of question.
There have been criticisms by DOTS - busters about the fact that the RNTCP
and DOTS was pushed by the mandarins in Nirman Bhavan under the
influence of WHO and a loan sought from World Bank( IDA) for the same.
Between claims of success made by one party and criticisms on the intentions
and mediodology of tackling TB under RNTCP, the issue of the efficacy of
the DOTS methodology was lost. And since the GOI in its wisdom has gone
ahead any way, it was thought prudent to see if the programme on ground
has been able to go beyond this wrangling and come up with something
better to suit Indian conditions. To study the merits and demerits of the
methodology, and to see if the same could be used by NGOs who are
largely accountable to their society and can suit good ideas to their
communities better than the government can in their areas of work, it
was decided to directly observe for a short while a few of the DOTS
programmes and report back to an NGO group under the aegis of VHAI.
The areas to be focused were to be :

is DOTS really directly observed, because the revision revolves around


this and the investment is being justified on this ground alone ?
what is the universe of patients against which the cure and compliance
rates are being calculated?
what is the detection rate and does it come anywhere near the expected
incidence ofTB (0.2%) in their populations?
is a strict vigil being maintained on the compliance because if not, the
programme would indeed be disastrously increasing the incidence of
MDRTB?
what are the patients reactions?
how strictly are the technical guidelines for case detection and treatment
being met ?

Given the constraints of funds and time, three centres were selected for the
visit:
1. Gulabi Bagh in North Delhi, which is being flaunted as the most successful
pilot project in the entire country.
2. Mahesana district of Gujarat, which was the only rural area chosen
under the pilot phase programme.

3. Jaipur, which was taken up in the second phase and could represent
the BIMAROU (Bihar, MP, Assam, Rajasthan, Orissa, UP) area.
The selection of the centres was made on the basis of proximity and convenience and the fact that these centres have been around long enough to
make corrections necessitated by field conditions.
The study is not going into the comparative efficacy of short course regimens
of RNTCP & NTP, but is only making observations and inferences on the
RNTCP programmes seen at the three programme sites. Neither is at an
inquest. The author has run a TB programme in Urmul Trust and has first
hand experience in using the daily WHO regimens for a long time. The
author attempted to use his experience in digging into data, recording
procedures and regimentation procedures so as to check hi own doubts
about the feasibility and replicability of the project.
Since 'permission' from DDG(TB) didn't arrive in more than a month,
despite our repeated requests and replying all their queries and misgivings,
a direct liaison was established with the three sites and the admittedly honest
and cooperative attitude of the project staff at each place helped the
observational study.
Delhi

Project HQ, Gulabi Bagh


Field Centre, Sarai Rohilla
Field Centre, H Block Ashok Vihar
Field Centre, Shakti Nagar Extn

29Jan&19Feb 1998
31 Jan 1998
19 Feb 1998
19 Feb 1998

Mahesana

Project HQ, Mahesana


PHCs Jagudan & Amabaliyasan
VI11 Baliasana, Vill Akhaj
CHC Lanva & Sander
PHC Ranuj(Patan)

10- 11 Feb 1998

District TB Centre, SMS Hospital


DOTS Centre, Bani Park
TB and Chest Hospital
DOTS Centre, Jaipuriya Hospital
DOTS Centre Gandhi Ngr Dispen.

09&llMarl998
10 Mar 1998
10 Mar 1998
10&11 Mar 1998
11 Mar 1998

Jaipur

11 Feb 1998
12 Feb 1998

There are some queries of mine which remain unanswered and I have
taken the liberty of posing them at the end of the study report. Some
suggestions which come to my mind have also been humbly added for
whatever they are worth.
Note : Data received from the three project areas may not be comparable
as the data sheets handed overto me have been at the discretion of
the projects who have perceptible risks to their careers. "Data from
these projects is the property of the World Bank ", confided one of
tha*project officers.

Background:
It might be worthwhile to mention a few points about the RNTCP and the
DOTS regimen for the uninitiated.
In 1992, a nation wide survey was conducted by the GOI to review the
National Tuberculosis Programme with assistance from WHO and SIDA3.
Their salient findings were :
(i) less dian 30% treatment completion.
(ii) inadequate budgetary outlay and shortage of drugs.
(iii) undue emphasis on X- Ray diagnosis.
(iv) .poor quality of sputum microscopy.
(v) emphasis on case detection rather-than cure.
(vi) poor organisational set up and support for TB.
(vii) multiplicity of treatment regimens.
Revision
RNTCP was launched by the Government of India in 1993 with an emphasis
on DOTS - Directly Observed Treatment - Short Course in pilot projects in 5
different parts of the country. The objectives of die revised strategy were:
a) emphasis on the cure of infectious and seriously ill patients of tuberculosis,
through administration of supervised short course chemotherapy, to
achieve a cure rate of at least 85 %.
b) augmentation of the case finding activities to detect at least 70% of
estimated cases, only after having achieved the desired cure rate.
The strategy involved :

use of sputum testing as the primary method of diagnosis among self reporting patients.
standardise treatment regimens.
augmentation of the penpheral level supervision through the creation of
a sub-district supervisory unit.
ensuring a regular, uninterrupted supply of drugs unto the most penpheral
level.
augmentation of organisational support at central and state levels for
meaningful coordination.
emphasise training IEQ operational research and NGO involvement in
the programme.
increase the budgetary outlay.

Although some of the activities of the strategy formed part of the previous
Strategy also, an emphasis on regular supply of drugs, increased budgetaryoutlays and better supervision is a welcome action.
After the GOI was convinced of the efficacy of the approach through pilot
projects in seven districts, only one of which was rural, the project area

was progressively increased with an aim to cover 271.21 million population


in 102 districts (as per Appendix I) by the end of phase III of the programme,
Le., by 1998.
The successful implementation of the revised strategy4 is expected to achieve:

a cure rate of at least 85%.


case detection of at least 70 % of the expected.
rate of reduction in the annual risk of infection from the current 2 to 2.5
% to 8 to 10 %.
reduction in mortality to about 20 per 1,00,000 population,
reduction in relapse to less than 5% from current figure/of 20 %.

WHO had given its treatment guidelines for national tuberculosis programmes
in 1993 which had four regimens of treatment based on categories of patients
which were:
CAT I

CAT II

CAT III

CAT IV

Sputum positives New cases; but even widespread sputum


negative cases were to be included, e.g., serious TB patients
like TB meningitis etc.
Sputum positive Retreatment cases on account of relapses,
treatment failures or default Even sputum negative cases could
be considered but after exercising a lot of care.
Sputum negative cases and non serious extrapulmonary cases
were to be considered.
Chronic cases.

Treatment was based on the priority for treatment on which basis they were
to be categorised. Sputum positive meant that at least two sputum smear
specimens are detected positive out of three sputum samples which include
at least one overnight sputum. However, one sputum sample positive is
considered sufficient if X-Ray is consistent with active pulmonary TB.
Sputum is the most important aspect of the approach1. Before a diagnosis is
to be made in symptomatic patients, at least three samples of sputum are to
be examined, one of which has to be an overnight sample. Follow up
samples are to be done of overnight samples, once at the end of intensive
phase at the end of two months for Cat I and Cat III patients, and at the
end of three months for Cat II patients and later every two months till the
duration of treatment is completed. For details, please see Appendix A
To further emphasise on the Sputum status, a 1:1 monitoring standard of Sp
positive to Sp negative has been insisted in each project so as to minimise the
X-Ray dependence. Binocular microscopes and training of Lab personnel to
enhance microscopic accuracy have been made part of the Programme.
X-Ray Chest may be done, but is not obligatory for Sputum positive patients.
The idea of DOTS is to ensure that each and every dose is supervised from
a centre close to the patient. This helps the patient to 'remember the intake,

cuts down cost of default, cuts down incidence of MDRTB and is reassuring
to the patient.' By the rime diis study has been conducted, die programme
has already unofficially sanctioned POTS, i.e., Partially Observed Treatment
ShonCourse. During die Intensive Phase(IP), the patient has to come to the
centre for the thrice weekly intake of drugs in single daily dose blister
combi - pack, but during the Continuation Phase(CP) the patient has to
collect the drug only once a week in weekly blister combi - pack dosages
of which s/he has to take only die first of the three doses in front of die TB
worker. In toto, of the 24 IP doses and 18 CP doses, 24 IP and 6 CP doses
require observation.
Weight recordings have to be made at e,ach visit. The first one or two doses
maybe given to the patient before the complete box of drugs for the CAT I
/ll/lll reaches die patients field centre close to his/her house in blister
combi- packs. The dosages are calculated on the basis of die initial weight
recording in accordance widi die following chart:

Drug dosages for RNTCP (thrice weekly): 2


Drug >&me

Children and Adults


<30kg

Adult
30-60 kg

Adult
=60 kg

II if amp kin
INH
Ethambutor

10 mg/kg body weight


5 mg/kg body weight
15 mg/kg body weight
30 mg/kg body weight
15 mg/kg body weight

450 mg
600 mg
1200 mg

600 mg
600 mg
1200 mg
1500 mg
0.75 gm

PyraZinamide
Streptomycin*

1500 mg
0.75 gm

*Ethambutolis not given to children below six years of age.


# Streptomycin is not to be administered to pregnant women.

The DOTS mediodology has been repotted to be very successful in a number


of countries including China and L5. The four/five - drug short course
regimens do not require introduction. However, the changes from daily
regimens to dirice weekly regimens during the Intensive Phase does require
explanations for die medical fraternity of India to understand the basis of
choosing a thrice weekly regimen over a daily regimen in the Intensive
Phase. The flow charts giving die complete RNTCP methodology are given
in appendices A to H,
For effective management, some indicators have been passed down to all
levels so as to allow self evaluation. These are:

Case Finding and Case Management Indicators

Value

Proportion of symptomatic patients who are smear positive


No. of smears taken from suspect cases
Percent smear positives among new TB cases

8-12%
3
50 %

Case Finding and Case Management Indicators

Value

Proportion of new smear positive patients found in the laboratory


Register being on treatment (in TB Register)
Proportion of new smear positive cases placed on DOTS
Sputum conversion for new smear- positive TB cases at
3 months
DOT treatment given in the initial phase
Percent of new smear-positive patients who are cured

>85%
>90 %
585%

Programme management Indicators

Value

TB supervisors and laboratory supervisors in place


Training activities according to plan
Registers, reports, etc. In place
No. Of supervisory visits done by the
Central unit
Number of supervisory visits by the STO
No. of supervisory visits by the DTO
Adequately drugs and laboratory supplies, with stock
at each level
Complete reports received within the quarter

>90%

/>80%
t , >75%
100%
Every site at
least twice
Every site
quarterly
Each microscopy
unit quarterly
>90%
>95%

Integration indicators
Process initiated to enhance integration with other
programmes and other relevant institutions
Delhi Chest Clinic Gulabi Bash
Population of project area
HQ
Field Centres
Microscopy Centres
Project Officer

1 million as of now
Gulabi Bagh
10
1 (HQ) + 2(field)
DrRKMehra

Interviews of Dr RK Mehra, Dr Ghanshyara Singh, Mr Anand, Mr Ajay & Mr


Naresh taken during die course of the visit Visits made from the Hqs to Sarai
Rohilla TB Centre, and the ones at Ashok Vihar Phase I and Shakti Nigar
Extension.

Manpower & Infrastructure


The Chest Clinic, Gulabi Bagh(CCGB) has been running for a long time
and is well known in the area as "TB ka aspatal" even though there are
only a few beds. CCGB started the pilot project in Oct 1993 and established
10 Drug Distribution Centres and 10 Microscopy Centres. The Municipal
Comrftittee of Delhi extended the already existing infrastructure of CCGB

and deputed its manpower for the project. For the field centres, space was
provided for the TB centres within already existing school/ government
buildings. Hie World Bank money coming directly to the project via the
District TB society formed now meets the costs of all consumables (except
drugs and films), laboratory reagents, microscope maintenance, maintenance
of vehicles and vehicle hire, and for contractual staff. OOGB has hardly got
any contractual staff on their rolls.
Funding
When the programme started, the funding was received from SIDAand ten
microscopy centres(MQs) were started along with the drug distribution centres.
But during the switchover from SIDA to World Bank, eight of these have
had to be closed down. All the microscopes of the MCs are centrally used at
GOGB and replacements for the two field microscopy centres are provided
from these on as required basis.
But the funds are clearly not enough to meet the expectations of the staff.
Rumours about motor cycles being given, and cribbing about promised
incentives not being paid for freshly detected sputum positives abound.
Repeated demands for small items like felt pens and tumblers shows that
the project does have to scrounge for money.

Population :
The feeder population of the area varies from the upper & upper middle
class families of posh areas of Pritampura to the migrant labour populations
otjbuggijhopri (shanties) colonies in Shastri Nagar and Sarai Rohilla.
Accessibility
Distances from the farthest point in each locality to the drug distribution
centre range from three to four kilometres. This translates into a maximum
of twelve rupees by rickshaw each way for a patient who cannot walk it to
the centre.
Case Finding
There is only a passive surveillance for newer cases. Initially, there was a
problem in getting patients, and the project resorted to active case finding.
Each case of sputum positive TB attracted an incentive of hundred rupees
and the health workers spent a lot of energy in urging all 'TB looking
people' to cough out their sputum and in making slides on the spot. There
are no official figures available, but around a hundred new cases were
discovered. The scheme fizzled out because finally the promised incentive
was never paid to the workers.
By now, people in the area have heard of the programme, and when they
learn that they have TB, they report to the nearest centre or to the QQGB
usually the latter. All eight patients whom I interviewed had gone for their

cough to some private practitioner- a few to some government hospital as


welland after an X-ray, had been started on ATT. Even according to the
programme staff, about 90% ol patients have already started treatment before
reaching the KNTCP. Yet, it must be said to the credit of the programme that
most of these patients have reached the programme within a month of starting
treatment, i.e., they are within the definition limits of "new case."
Diagnosis
Such patients are given a sputum cup - these are plastic cups with screw-on
lid and have also never been in short supply and asked to go to the
microscopy centre with an overnight sample. The only patient I observed
was sent off with bare minimum instructions, and was not given adequate
instructions to produce sputum as described in the technical'manual.
Since there are only three microscopy centres in the project area, patients
are referred to such centres alone, where a 'spot specimen' is collected
along with the overnight sample. They are asked to come again the next
day and another spot sample is taken. If they come directly to one of the
MGs, as is the case usually because of the "bade doctor sahib GulabiBagh
me baithte hain"knowledge, a spot sample is taken and a cup given to the
patient to get an overnight sample which the patient gives the next day
along with yet another spot sample. The result is given on the nextprogramme
day and the treatment started if required.
Incineration
There are no incineration facilities at the field microscopy centres. This may
have to be looked into. There were a number of sputum cups which were
not yet completely burnt although the staff at the centre had tried to burn
them crudely. The lack of ventilation in the microscopy centre is also
something which may have to be looked into, given the high rates of
MDRTB reported in North India lately.
Registration
Before starting- treatment, patients are asked to show their ration cards or
proof of residence so as to avoid patients outside the project area trying to
get 'good medicines'. Along with, the patients are also required to get a
guarantor, like the local health worker, or anganwadi worker to ensure that
the patient shall visit the centre thrice a week and shall not default. Any
default here, and one doesn't get medicine. Patients diagnosed TB but
failing this 'future compliance test' are asked to approach other TB hospitals
fo r the ir tre atme nt.
Drug Supply
Drug supplies have been regular and have never failed according to the
programme handlers, and to the patients interviewed. This must be one of

the major accomplishments of the programme. Earlier the orders weir to


have a box of drugs per patient, but was given up in between. The 'box'
concept has been reintroduced since the past six months and was seen to
be religiously implemented. The name of each patient has to be written on
the box and the box then reserved for him/her. During the days the system
had been changed, drugs were being given to many patients from the same
box and the logistics of sorting them out in reporting procedures has been a
tiring exercise for the workers. Most field centres reported a lack of storage
space for the 'boxes' concept.
There have been problems with the drugs changing their packaging though.
'Earlier, they were imported, but now they are poor quality from India', said
a worker. Till they are given out of one packet alone, there is no problem
but if the packaging keeps changing, the patients tend to feel that the drugs
have been changed. This doesn't go well with many of them because they
feel that the drug that they were doing well on, has been changed and this
has been the cause of default in a few patients.
Young children have the privilege of getting Rifampicm in syrup form and
small kid tablets of ATT procured specially for the programme. Age specific
doses were found to be accurately entered and adhered to in all the treatment
cards.
DOTS
In both the functioning field TB centres that I visited one had moved in
only the previous day I couldn't find any water source. The patients
had to go out of the centre premises to a roadside hand-pump and then
fetch water in the glasses which had been provided at the centre. The small
room had little space, so all the patients who were given the drugs shelled
out from the combi-pack swallowed the drugs outside the room. Since the
next patients standing at the counter were blocking the health workers view
and attention, the drugs which were swallowed, were not under direct
observation. Worse soil, two relatives came to collect the drugs in my presence
and were given medicine good by my way of thinking but definitely
against the DOTS concept ! I could observe only one patient swallowing
the drug in front of the DOTS worker.
At least four patients in the continuation phase who were asked to eat the
drug then and there questioned the worker to confirm the instruction. "Is it
necessary to eat the drugs now?" This left me to infer that many of such
patients had been allowed earlier to take the drugs away without insisting
on the first dose to be taken under direct observation and my presence
probably was the reason for the insistence of DOTS and the inquiry!
The thrice weekly regimen has been staggered for some centres. Most centres
usually function on Mondays, Wednesdays and Fridays - unless one of
them is a holiday, in which case the routine is changed in anticipation to
Tuesday, Thursday, Saturday for the coming week. This also helps in adjusting

leave and vacations of field staff whereby a shift of duties prevents centres
from closing down on DOTS days.
All the patients whom I interviewed while taking the DOTS dose had taken
at least some kind of food in the last one hour 'to avoid vomiting'. "We
have .been told to take it one hour after food well it is almost an hour,
isn't it?" Given the fact that the centre opened only at nine-thirty and
functioned till twelve noon, one can't blame the patients for not remaining
empty stomach till the drug is swallowed. But it may be a better idea to aim
that these antibiotics have their full effect.

Adverse Drug Reactions


Do patients vomit the medicine often ? " Yes, they do. And see, if they
vomit inside the centre, who will mop the floor? As it is, we get only forty
rupees a month for the sweeper. That is why we avoid patients taking the
drugs inside the centre. But the authorities cannot understand." The staff
hasn't seen any other reactions. However, a few jaundice cases apart from
several temporary gastritis patients have been seen by the medical officers.
Since there are no records maintained nor any attempts to look for druginduced hepatitis, it is difficult to quantify the reactions.

Staff confidence in DOTS


The two medical officers seem to be very enthusiastic about the DOTS
regimen. Having dealt with unending non - compliant patients earlierin the
NIP, they are sure that this is much better. " This requires us to work doubly
hard, but the results are so gratifying!"
Most of the workers were sensitive to the problems faced by the patients
and their relations in attending the DOTS clinic and were strident in their
criticism. Two of them even told me that the doctors also are unhappy
about irbut have to follow the system because of pressure from above. One
teenage girl who was so ill and emaciated that she had to be helped by her
mother in coming to the centre and was accompanied by the father also,
told me that her family had spent twelve rupees for the rickshaw one way
from their home. The father pleaded the worker to hand over the drugs
directly to them as it was costly and very difficult to manage the trip thrice a
week. The latter looked at me for 'permission'. I told him that I was nobody
to give permission, although I would appreciate such a consideration. The
worker, sensing some official problems told them that he can't hand it to
them directly, but will go to their house and personally administer the doses
every alternate day. He was surely Agoing out of his way and it was most
heartening to see a government worker responding from his heart!
Later, he and one of his colleagues who had closed his centre and come
over, vented their frustration. " It is in the first two - three months that these
patients are so weak that they can't work or walk. Coming to the centre
with their relatives is like adding insult to injury. As it is they are poor,
10

the disease period takes away the chance of earning a wage. They do not
mind coming even every day to the centre during the continuation phase. It
is the initial period which is tough and is made tougher because of die
DOTS strategy."
I complimented them for displaying a good heart to the emaciated girl.
How do they handle such cases usually, I inquired. Don't such patients
default ?
" Yes they do." And how do they prevent it ?
" We try and screen out all patients who are likely to default. And do not
start the treatment at all in such patients." And how many patients are left
out on reasons of unlikely compliance'of DOTS ?
" Almost twenty five percent." 'Maybe, even thirty, added the other.'
According to a slogan in the GCGB OPD, it is better not to take anti TB
drugs than to take them irregularly or half way. One agrees with the message.
But you can't leave too many patients out of the programme simply because
they do not fit into the RNTCP system. It would be prudent not to see only
"drop out" rates but also "throw out" rates - a term coined here to see the %
age of patients not put on treatment despite a confirmed diagnosis of active
tuberculosis because of programme conditionalities.

Patient compliance
The patient compliance was generally good. Of the two centres where I
could check out till the closing time of the centre, one had one patient out
of twelve and the other one out of nine patients who were expected to
make their collection that day but hadn't done so. These patients were
supposed to be followed up the next day by the health visitor so as to
ensure that there is no long break between two doses of drugs. Those who
are habitual of missing their turn at the centre are counseled by more senior
members of the staff.
Once started, there seem to be few dropouts. Most of the male patients I
met had leamt to take the disease and the DOTS in their stride and would
drop in at the centre on their way to their work place. It was the women
who faced a bit of a problem, but had adjusted their routine in such a
fashion that they would come to the centre after having dispatched their
husbands and children for the day.
But how many are initial dropouts? Very few. As every health visitor has to
report to the 00GB aftertwelve everyday, he or she can collect the treatment
catd and the drug box of any new patient diagnosed earlier in the day. Such
patients are followed up in their homes if they do not report by the next
DOTS morning. Nb drug is started till the patient reaches the DOTS centre.

Record Maintenance
The record maintenance done is of an exceptionally high quality. The TB
11

treatment cards, which have so many columns and entries to be made,


have few or no lapses at all. Each of the project staff understands the value
of each entry in the card and tries hard to fill up each column. The registers
kept at each centre are updated regularly by die staff who fall back to the
OOGB from their respective field centres after noontime.

Supervision
The supervision by the medical officers and the supervisors has been
reasonably good and has helped not only in keeping the field staff on their
toes, but also in bringing deficiencies to light very early, thus preventing
material/manpower failure.
There is a shortage of laboratory staff however, and it is not possible for the
Lab Supervisor to follow the prescribed norms of checking 10 to 20% of
slides for false positives or false negatives.
Vital Statistics:
(Comments in "Discussion" section)
CHEST CUMC - GULABI BAGH, DELHI
1994

1995

1996

2900
408
2492

1303
758
545

1214
859
355

1177
806
371

127
6350
40.50

73
3650
590

67
3150
590

75
3750
590

Nov 92 - Oct 93

Cases Regd:
Total
Smear -fve
Smear -ve
X - Ray :
Rolls
Total (Rs. )
Compliance
Rate (%)
Cases Registered
Phase

Category Smear-fve. Smear- ve


ExtraTotal
pulmonary
Pul.
Pul.
89
I
I
509
681
83
11
(Oct93 -Nov94)
n
281
5
297
II
i
310
1053
165
1528
(Jan 95 - Mar 97
n
842
807
7
28

304
499
195
m*
i
III
82
351
23
456
291
294
(Apr 97 -Dec 97
n
3
0
149
m
293
145

'started wef 1/2/96


All the categories in the table have a rough genderratio of 2:1.

12

^;u*M4UiaJ|

Results of Sputum positive cases


Total
Cured
Expired
Failed
Tfr out/ Default
Cure Rate

Jan 95 to Dec 95

CAT I
510
440
9
8
53
88%

CAT II
341
263
16
14
48
81%

Treatment Results of Phase I


Total Cure Compliance
Cat I
Pul Sp 4ve
Pul Sp -ve
Extrapulm
CatH
Pul Sp -Hve

Expired Failed

75
87

9
4

222

15

509
83
89

476

281

11

Tfr/ default
18
4
2
33

>B: Results of Phase nhad not been comiled bythe end of Marches forus to makecomparisons
Gujarat Mahesana District RNTCP

Mahesana, Gujarat
Phase I
Phase II
(wef 02 Oct 93)
(wef 15 Aug 95)
5,76,290
14,90,076
4,54,872
11,39,282
1,21,418
3,50,794
252
580

Population of project area


Rural
Urban
No of villages
PHIs used for DOTS
PHC
CHC
Gen Hosp
Dispensary
NGOs
Total
Sub - centres

13
3
1
4
1
23
116

36
5
3
9
5
59
273

The entire project area has 36 microscopic centres and 3 X-Ray centres. 15
more PHCs have been designated Microscopy centres.
Had interviews/ discussions with the DTO, Dr MB. Leuva; the medical
officer who has stayed longest with the project, Dr A .S. Parmar, with the
Supervisor, Mr V S Prajapati, some other staff members and a number of
patients during the course of the visit.
13

Field visits:
1.
2.
3.
4.
5.
6.
7.

PHQJagudan
Vlll. Baliasana, Taluka, Mahesana
PHC Ambaliyasana
Vffl. Akhaj
CHC, Lanva, Chanasma
CHC, Sander
PHQ Ranuj

Population & Infrastructure


The DOTS Project was started in Oct 1993 as a pilot project for the RNTCP.
Although initially it had a feeder population of five lakh*,'it now has fifteen
lakh population under its coverage since Phase II launched in Aug 1995.
Being the only rural area in the pilot project, it is this project which is of
importance to test the feasibility of replicating the DOTS strategy.
The population, except for towns is mainly that of middle class. Those in
lower class are many more in number compared to the number of the elite
class. That there is no kutcha structure in any village that I visited indicates
a general prosperity in comparison to the rural areas of BiMAROU (Bihar,
Madhya Pradesh, Assam, Rajasthan, Orissa, Uttar Pradesh) states.
The entire project has been handled by the existing government health
service and functions through the DTO, CHCs, PHCs, Sub centres,
Anganwadis, etc. by retraining and reorienting the staff to the DOTS and
RNTCP ideology.
Since the DOTS strategy ensures alternate day availability of drugs to the
patients, it is essential that wherever the ANMs/Male health workers aren't
in accessible reach of the TB patients, alternate DOTS workers be appointed.
Forthis, the project has used Anganwadi workers who are offered Rs 175/
- for every patient completing his/her complete treatment. In one of the
villages, the husband of the patient who is a Home Guards personnel is the
alternate DOTS worker. Mien I visited him and his wife Hansaben in
village Baliasan, he was meticulously maintaining the patient record card
and knew exactly how each dose had to be given. Although it cannot be
called DOTS exactly, if the proof of the pudding can be said to be in the
eating, the innovation is creative, patient-friendly, and is effective. The regular
backing and support from the ANM/male health worker and the TB supervisor
ensures that it is functional and the radiance on Hansaben's face affirms
that DOTS or no-DOTS, the system is suiting her.

Case Finding
Initially, the project had difficulty in identifying new cases. But over the
years, the programme has built up a formidable reputation in the rural areas
*and the moment patients come to know that they may have symptoms

14

*i

suggestive of TB, they may even directly report to the PHC \a DTC
for a correct evaluation before starting treatment. Although the majority is
still reaching private practitioners before switching over to the Govt. health
system, the large ratio of Cat I cases to Cat II cases itself speaks of die
accessibility/acceptability and visibility of this project.

Diagnosis
All patients reporting with symptoms of TB are sent to the nearest microscopy
centre. They are asked to give a spot sputum specimen initially and are
given a sputum cup forgetting the next morning's sputum specimen. The
next day, apart from the overnight specimen, a spot specimen is again
collected and the result of the three,are given the next day morning. If
sputum positive, they are registered and treatment started from the DTC/
CHC/PHC, i.e., any part of the system where there is a medical officerpresent
It is anothermatterthatmostpatients stillpreferto get the treatment confirmed
from the DTC and prefer to go to Mahesana for the initial registration.
Ahhough, there is no doubt about the expertise of the microscopists of the
tuberculosis programme at the DTC itself, one cannot say the same about
the CHC/PHC microscopists. The DTO, on his visit to a CHCin my presence
wanted to cross check some sample slides which had been declared ++or
+++positive by the laboratory assistant and treatment authorised accordingly.
After dithering for about fifteen minutes, complaining about the light
adjustment of the binocular micros copes provided in the programme, instead
he was asked to show the same in natural light. Of the two slides which
were marked ++and +++, he could show us the doubts of one single AFB
in high power as the oil immersion lens was not working ! Corrective
action was taken by the DTO immediately by carrying all the slides for cross
- examination at the DTQ but what worried me was die arrogance of the
technician who continued to blame the microscope and continued to be
sure that he had seen the AFBs quite clearly. Having seen DrLeuva's habit
of going into minute details and checking out each and every entry in the
patient treatment cards, I am sure diat this experience must have made him
overhaul the entire lab cross checking procedures which are laid out in die
programme but are not being followed in some programmes where diere is
a shortage of laboratory personnel.
The insistence on die diree sputum specimens before starting treatment is so
conscientiously followed that die transition from multiple x-rays to-rnrx^rays
at all has been easily accepted by die TB patients and by die Project staff.
None of die Sputum Positive patients are x-rayed even once neitherbefore
nor after!

Registration
Once die patient is diagnosed TB, his/her residence is checked and if found
to be within die geographical limits of die district, s/he is put on die RNTCP
regimen. If not, s/rie is given die NIP regimen at dit: DTC or transferred
15


$/t^'^'#^*i^ffl!.!4s^

,
t

f* '

*M

with his/her card to the concerned PHC nearby. Usually, a guarantor in the
form of an Anganwadi worker or local ANM/ MPW is insisted upon.
There is no overlap of regimens in the project area. However, of the patients
taking drugs from the DTC itself, only 50 of the approx. 500 patients are on
the RNTCP regimen. Those reporting for the first time from outside the
district, and those who get transferred from some other district are kept on
NIP regimens.

DOTS
Once the patient is registered, the first DOTS is given immediately. Depending
on the time expected for the drug - box to reach the DOTS/Alternate DOTS
worker, the patient is also given one or two more doses in his or her charge.
However, because an occasional default was found in such patients in the
initial stages of the project, the project has designed a form which is filled
up in triplicate. One copy is given to the patient while another is sent/
handed over to the nearest assigned DOTS worker, who in turn, follows up
the patient at the address given, in case the patient doesn't turn up. This is a
good system by which they have already cut down the initial drop-out to
practically zero.
The drugs are kept in boxes in combi - packs and the name of the patient
prominently displayed on the box. The patient's drugs are thus marked out
and allocated. The change of shape in combi - packs from the Intensive
phase to the Continuation phase also signals the need for a sputum specimen
to be sent to the microscopist. Although the combi - pack drugs for the
programme are still imported, there has been a time when the supply was
interrupted, and the programme had to resort to unpacked loose drugs. But,
luckily the TB drugs supply has never broken down completely. The
flexibility of having Project funds available through the District TB Society,
have also helped.
By and large, the doctors at the CHC and the pharmacist who holds the
drugs and the treatment cards are well conversant with the new changes
in the RNTCP. They also know about the insistence regarding three sputum
specimens before starting treatment It was also good to see that the medical
officers were entirely familiar with the case histories and addresses of those
who have defaulted on the treatment. It could be taken to be an indicator
of the keen interest taken by the doctors in defaulter cases.
Usually, all the adult patients are being given the same dosage of drugs.
One discovered that patients above 60 kgs were also being given 450 mg of
Rifampicin because of oversight, and the same was corrected to 600 mg
when pointed out. The variation in children is being given by dividing the
capsule contents where necessary.
Some of the supervisory staff has been provided with Bajaj-Kawasaki motor
cycles and seem to be making good use of the same. There knowledge
16

about the patients of their respective areas is very good.


The worst area, by their own admission, is the newly added Sami block
which I could not make a visit to.
Record Maintenance
The level of recording accuracy was also very high. There was not a single
entry missing in more than fifty forms that I went through at the various
centres visited. For treatment cards maintained by health workers/ alternate
DOTS workers, there are duplicates maintained at the concerned PHC/CHC
which get updated when the health workers come for the monthly meeting.
Most patients when questioned, were taking their drugs empty stomach first
thing in the morning. However, about thirty percent had problems taking
the Rifampicin and had to resort to taking it after breakfast.
*
Adverse Drug Reactions
Although doctors and the health supervisors did recall seeing quite a few
drug induced gastritis, and even a few cases of jaundice, there is no record
maintained for the same. However, the supervisory staff did not seem to
know how to handle the reactions, because I saw one of the supervisors
advising a patient to take 'Dexona' for a skin rash she was complaining of
after starting the treatment.
Patients who are too weak to walk are admitted in the DTC till they are fit
enough to walk around. They are straightway put on the DOTS regimen
and the same is continued from their respective DOTS centres.
Drug administration directly under observation is not a problem, because
all the centres have only three to five patients staggered over a few hours of
time. The patients have to fetch a glass of water to the pharmacy counter,
the drugs are shelled out from the combi - pack by the pharmacist and the
patient swallows them in front of her/ him. Those in Category II are sent to
the injection room with a Streptomycin vial and on producing the vial an
entry for the directly observed dose is made in the treatment card.

Patient compliance
The general compliance rate was as good as has been reported. Each member
of the staff is very familiar with each case who defaults and the last ditch
attempt to prevent default is almost always made by the medical officer
making a visit to the patient's house.
Although one got the impression that patients are usually compliant, the only
field centre where I could check out till the end of the day at PHC,
Jagudan, two of the three patients expected to collect their medicine dose
didn't report The health supervisor located at the was supposed to take the
drugs down to the concerned guarantor and local health worker the next day.
17

Staff confidence in DOTS


The staff at the DTC and all the medical officers, supervisors and others
who are part of the TB programme directly swore by DOTS. No amount of
provocation could disturb their confidence. In fact, they would rather have
all patients everywhere take only DOTS. They are also very confident of
the futility of x-rays as a rule in the TB programme.
I couldn't make private confidential conversations with the healdi workers
here, but the general feeling palpable was that of enthusiasm about DOTS.
Since they were anyway doing the rounds of the villages quite often, they
didn't find it at all difficult to handle DOTS. Also, the fact that Gujarat at
least Mahesana has more than ninety percent posts of peripheral health
workers filled up, and that there is litde or no absenteeism, one can understand
how the DOTS programme has so successfully been mounted on the
government health system in Gujarat.
In CHCLanva, an attempt was made to see the Medical Officer's dependence
on Sputum for diagnosis vis a vis X- Rays. Of approximately two thousand
OPD patients seen since January '98, an estimated hundred X-Kay screenings
of the chest ( figure given by the technician after consulting his register) had
been done the steel dip tank was rusted and leaking which prevented XRay plates from being developed but the total sputum specimens including
the routine follow up for registered TB patients was not more than thirty
four ! Even at CHC Sander, 8 X- Rays Chest and 65 chest screenings had
taken place although only 12 new sputum specimens were examined since
the beginning of the year.

18

Vital Statistics
(comments in "Discussion" section)

RNT.CP. PILOT PROJECT- MEHSANA


Default-Sate
Period

Type of TB patients
New
Relapse
%
nos.
%
nos.

Others
nos.
%

PHASE I
4th qtr 1993
1st qtr 1994
2nd qtr 1994
3rd qtr 1994
4th qtr 1994
1st qtr 1995
2nd qtr 1995
3rd qtr 1995

Total

n PHASE
3rd qtr 1995
4th qtr 1995
1st qtr 1996
2nd qtr 1996
3rd qtr 1996

Total

Period

35/325
9/68
8/39
11/60
6/30
6/44
11/60
0/17
86/643

10/41
4/16
' 5/21
, 5/15
3/17
5/17
8/30
1/15
41/172

24.4
25
23.8
33.3
17.7
29.4
26.7
6.7
2.4

0/2
3/17
6/11
3/5
0/5
1/6
1/9
0/0
14/55

0
17.6
54.5
60
0
16.6
11.1
0
2.6

10.5
2/49
4.1
12.7
33.3
1/3
16.3
0/2
0
0/2
0
8.8
5.8
0/5
0
10.6
3/61
4.9
Failure-Rate
Type of TB patients
New
Relapse
%
nos.
%
nos.

1/10
13/72
13/77
12/76
8/73
47/308

10.0
1818
16.9
15.8
11
15.3

10.8
13.2
20.5
18.3
20
13.6
18.3
0
13.4

8/76
14/110
13/80
10/114
6/103
51/483

Others
%
nos.

PHASE I

Total

1/325
2/68
1/39
0/60
1/30
0/44
0/60
0/17
5/643

0.3
3.0
2.6
0
3.3
0
0
0
0.8

10/41
0/16
0/21
0/15
0/17
0/17
0/30
0/15
0/172

0
0
0
0
0
0
0
0
0

0/2
0/17
0/11
0/5
0/5
0/6
0/9
0/0
0/55

0
0
0
0
0
0
0
0
0

3rd qtr 1995


4th qtr 1995
1st qtr 1996
2nd qtr 1996
3rd qtr 1996
Total

1/76
2/110
2/80
4/114
2/103
11/483

1.3
1.8
2.5
3.5
1.9
2.3

0/49
0/3
0/2
0/2
0/5
0/61

0
0
0
0
0
0

0/10
2/72
1/77
0/76
1/73
4/308

0
2.8
1.3
0
1.4
1.3

4th qtr 1993


1st qtr 1994
2nd qtr 1994
3rd qtr 1994
4th qtr 1994
1st qtr 1995
2nd qtr 1995
3rd qtr 1995

n PHASE

19

Case Fatality-Rate
Period

Type of TB patients
New
Relapse
%
nos.
%
nos.

Others
nos.

0/2
0/17
2/11
0/5
0/5
1/6
0/9
0/0
3/55

0
0
18.2
0
0
16.7
0
0
5.5

1/10
5/72
6/77
11/76
8/73
31/30

10.0
6.9
7.8
14.5
11.0
10.1

PHASE I
4th qtr 1993
1st qtr 1994
2nd qtr 1994
3rd qtr 1994
4th qtr 1994
1st qtr 1995
2nd qtr 1995
3rd qtr 1995

31/325

Total
PHASE

54/643

3rd qtr 1995


4th qtr 1995
1st qtr 1996
2nd qtr 1996
3rd qtr 1996

6/76
9/110
10/80
5/114
4/103

Total

34/483

Period

10/68
3/39
3/60
2/30
2/44
2/60
1/17

9.5
14.7
7.7
5.0
6.8
4.5
3.3
5.9
8.4

0/21
1/16
4/41
0/15
1/17
1/17
1/30
0/15
8/172

9.8
6.25
0
0
5.8
5.9
3.3 '*
0
4.7

7.9
8.2
12.5
4.4
3.9
7.0

2/49
0/3
0/2
0/2
0/5
2/61

4.1
0
0
0
0
3.3

Treatment Completion Rate


Type of TB patients
New
Relapse
nos.
%
%
nos.

Others

nos.

0/2

0
17.6
9.1
0
20.0
16.7
0
0
10.9

PHASE I
4th qtr 1993
1st qtr 1994
2nd qtr 1994

3rd qtr 1994


4th qtr 1994
1st qtr 1995
2nd qtr 1995
3rd qtr 1995

Total
II PHASE
3rd qtr 1995
4th qtr 1995
1st qtr 1996
2nd qtr 1996
3rd qtr 1996

Total

17/325
3/68
1/39
4/60
1/30
3/44
7/60
0/17
30/643

5.2
4.4
2.6
6.7
3.3
6.8
11.7
0
0.16

3/41
1/16
2/21
1/15
0/17
3/17
4/30
0/15
14/172

7.3
6.25
9.5
6.7
0
17.6
13.3
0
8.1

3/17
1/11
0/5
1/5
1/6
0/9
0/0
6/55

11/76
13/110
2/80
1/114
0/103
27/483

14.5
11.8
2.5
0.9
0
5.6

23/49
0/3
0/2
0/2
1/15
24/61

46.9
0
0
0
20.0
39.3

3/10
9/72
5/77
2/76
1/73
20/308

20

3Q.O
12.5
6.5
2.6
1.4
6.5

Sputum Conversion Rate

Period
PHASE I
4th qtr 1993
1st qtr 1994
2nd qtr 1994
3rd qtr 1994
4th qtr 1994
1st qtr 1995
2nd qtr 1995
3rd qtr 1995
Total
II PHASE
3rd qtr 1995
4th qtr 1995
1st qtr 1996
2nd qtr 1996
3rd qtr 1996
4th qtr 1996
1st qtr 1997
2nd qtr 1997
Total

Type of TB patients
New
%
nos.

Relapse
nos.

272/325
48/68
30/39
46/60
26/30
32/44
48/60
15/17
517/643

83.7
70.59
76.92
76.67
86.67
72.73
80.00
80.4
88.24

10/41
13/16
17/21
10/15
14/17
14/17
24/30
15/15
139/172

78.5
81.25
80.95
66.67
82.35
82.35
80.00
100.00
80.81

60/76
80/110
54/80
94/111
91/103
72/77
78/89
90/100
619/746

78.95
72.73
67.5
84.68
88.35
93.51
87.6
90.0
83.3

42/49
2/3
2/2
2/2
4/5
4/6
15/18
9/16
80/98

85.71
66.67
100.00
100.00
80.00
66.67
83.3
69.2
81.6

T.B. Case Detection


Period of detection

Smear positive

Smear
negative

Total
ExtraPulmonary

New
643
(39.35%)

Relapse
172
(10.53%)

800
(48.96%)

19
(1.16%)

1634
(100%)

PHASE IF*

864
(50.47%)

114
(6.66%)

658
(38.43%)

76
(4.44%)

1712
(100%)

TOTAL

1507
(45.04%)

286
(8.55%)

1458
(43.57%)

95
(2.84%)

3346
(100%)

PHASE I*

* Period 2nd Oct 1993 to Uth August- 1995


"Period - 15th August 1995 to 30th Sept 1995

21

Taipur - District TB Programme CUrban)


Population of project area
HQ
Field Centres
Microscopy Centres
Tuberculosis Units
Project Officer

1.5 million ( Municipal area Jaipur)


Jaipur
12 +l(new)
7 + l(new)
2
DrRNSisodia

Interviews of Dr Sisodia, Mr BL Sharma & Mr Mohammed Khan Bhati


( DOTS workers), and Mr Hardayal Sharma ( Laboratory incharge TB &
Chest Hospital) were taken, apart from other DOTS workers and patients.
Manpower and Infrastructure
Although the programme is working entirely through Government hospitals
and dispensaries, special DOTS workers have been employed forthe project.
Curiously, the Rajasthan Government has decided to employ reared
Government personnel, not necessarily from the health department. One
would have presumed that a programme which requires intensive monitoring,
surveillance and follow-up of defaulters in field would be recruiting young,
energetic people - like those in the Gulabi Bagh project where they had
cleverly taken all new entrants to the Municipal Health Department so as to
avoid those who had become worldly wise and lethargic in the erstwhile
government programmes but in its wisdom, it thought that the contractual
agreements for long periods would lead to unionism and court cases for
permanent absorption in a government job if awarded to younger people.
Hence, this project is saddled by old people who do not have adequate
energy levels to cycle down their areas to follow-up defaulters. Also, many of
these reemployed have little or no background in health, and are unable to
cope with the technical subject, despite an initial training provided.
.The staff for the project is not adequate too, because even the DTC staff
which should have been carrying out Tuberculin Testing at the Centre has
been given field duties and Mantoux's test discontinued.
All Government hospitals and dispensaries have been asked to allot a room
for the DOTS centre. Although the one at Bani Park was as good as a
private doctor's chamber, the others were rather secluded and usually the
last rooms in the back of beyond maybe because of the TB stigma or the
step - motherly attitude of the hospitals to the project. The latter was very
evident at the TB & Chest hospital where the party line is to debunk the
"three month" regimen (since alternate day for six months makes it three
months) and hence the DOTS regimen & RNTCP. In fact, Kanwathiya
Hospital, another one of the many hospitals in Jaipur under the government
which has been constructed by private trusts and are still maintained by
them has refused to comply with the request to set up a DOTS centre. The
* administration threatened to throw out the furniture sent to the hospital after
the government passed a written orderfor the setting up a DOTS centre.
22

'

There is a gross deficiency of laboratory technicians, as many of die vacancies


are yet to be filled up. This is keeping in tune widi die state having a 30 %
deficiency of laboratory technicians. The main reason seems to be a
disinclination to carry out so many sputum smear examinations "for they
do not want to get TB at diis age ". There has also been a radier fast
turnover because diese reared people are unable to keep up with the
dynamism of die DTO, Dr Sisodia and his expectations.

Funding
Since die project started only in 1995, most problems of fund flow seem to
have been sorted out and diere has been no deficiency of funds ever. All
die consumables for die project except drugs and X-Ray films comes directly
to die project via die District TB Committee now formed.

Population:
The population coming to die programme is urban. Since Jaipur has no
slums as yet, die poorest of die TB patients come from die Muslim bastis.
However, most of die twelve patients diat we interviewed belonged to die
middle class.

Accessibility:
All die patients whom I met told me diat diey had come from close-by
areas, i.e., from widiin a two kilometre radius. On record examination, we
did find more dian a few patients coming from long distances who preferred
die centre over some odier ones close to dieir house. This, we were told
were exceptions permitted to suit die doctor and hospital preference of
patients essentially to prevent default on account of this.

Case finding:
As yet, diere is only a passive surveillance. Aldiough DTC Jaipur is one of
die 12 centres functioning from hospitals having more dian a few MOs, it
has provided almost 80 % of all cases registered widi die project last year.
Of a desirable case load in die programme of 135 TB cases - per lakh
population*, die Jaipur project has reached 65 cases last year (981 cases in
15 lakh population), of which die two MOs at die District TB centres have
diagnosed about 53 per lakh population.
Interestingly, die TB & Chest Hospital, which detects an average of 12
sputum positives every day as per die laboratory register which had no
sputum positive till six mondis ago when die DTO intervened - since die
past six mondis, has given only four patients to die DOTS centre in its
premises. The rest of die eighty present and cured patients on its rolls were
transferred to it from die DTC because it was closer for die patients. The
Hospital according to its staff has approximately diree diousand patients on
its rolls at present ! Keeping in mind diat it is a referral hospital for die
23

entire state and many patients would be from outside the municipal limits
of Jaipur, I am sure that the number qualifying for DOTS couldn't be only
two. This has to do with the lack of confidence in DOTS amongst the
doctors at large, despite the DTO's attempts at arranging CMEs and seminars.
In fact we learned that the second medical officer from
the Dist TB Centre was about to be thrashed when he last came for a
monitoring visit and found a lot of DOTS drugs going waste and about to
expire. He was personally warned by the Superintendent not to visit the
hospital again if he valued his personal safety !
Diagnosis:
As mentioned earlier, not many of the microscopy centres are registering
new sputum positives. It is expected that 2% of all general OPD patients are
chestsymptdmatics forTB, and about ten percent of these would be sputum
positives. Most hospitals have not been 'meeting these targets'. At Bani Park
though, the initiative of the young DOTS worker, M K Bhati, brought a
change. With the help of the hospital administration, he has initiated a
register which keeps a record of the number of patients each doctor/OPD
has seen during the month and if the sputum referrals are not unto the 2%
mark, a written counseling is sent to the MO concerned. It has resulted in a
quick 'reaching of targets'. Although the idea is laudable, in a classical case
of overenthusiasm, the targets are enforced onto the ENT surgeons and
Gynaecologists as well
The sputum collection and examination is followed according to the
guidelines at the DTC At the Jaipuriya Hospital, the MO in-charge has
opposed the taking over of the binocular microscope as it does not belong
to the brand that she prefers. Also, she prefers to have her lab collect the
three sputum specimens in a manner different from the guidelines. " Take
these three cups. Take out your sputum after a few hours in the first one.
'Wait for about four hours and then bring out your second sputum in the
second cup. Then, in the morning, take out the last one and bring all of
them tomorrow. We will give you all the results tomorrow itself, " explained
her-lab technician to a patient in front of me.
As per the records of the DTQ the sputum positivity at the DTC jumped from
the pie 1995 level of 0.5% to 20 to 25%positive of all sputum smears examined.
Registration:
Ration Card or proof of residence is required for the registration. This is
necessary because the primary care facilities are poor in the state of Rajasthan,
and a lot of patients from outside Jaipur visit the city looking for treatment.
On specific request, we received figures of initial defaulters for two quarters
of 1997, i.e., difference of number of sputum positives identified and the
number of patients registered.
24

Item

4th qtr 3rd qtr Tolal

1997 1997
Nb. of Chest symptomatics examined for sputum smear 1340 1347 2687
Nb. of sputum positives identified
167 200 367
Nb. of sputum positives put on DOTS
143
170 313
Nb. of sputum positives put on fa other than DOTS
8
8
16
Smear positives not put on any treatment (initial defaulter)
22
15
37
Smear positives of initial defaulters living in project area
11
27
16

Percentage of initial defaulters

37/367=

10%

Patients from outside the district are not given any RNTCP sputum
examination slips and hence do not go onto the register, making it difficult
to judge total patients presenting for.treatment but not given treatment i.e.,
THROW OUT Rate.

DOTS
As most of the sputum positives get identified at the DTQ s/he is sent to the
local DOTS centre closest to the patient's home. When the local DOTS
worker comes to the Dist TB Centre, or the supervisor goes to the DOTS
worker, the patient's details are handed over. Although the procedure
explained to me was that the address is checked by a home visit before
starting the treatment., the only patient starting treatment in front of me was
given the first dose without checking the residential address for proof of
living and a appointment taken for the DOTS worker's home visit.
The drugs as at other places, are kept in boxes marked out for the patients.
The drugs are partially from imported stock and partly from a Pimpri (Pune)
company marketed by Qba - Geigy. All the case records (about sixty at
three different centres) which we went through happened to be of adults
and none less than 30 kg or more than 60 kg, making us wonder if the
paediatric patients are being missed or if the' tall and burly Rajasthani men
are presenting too late to have a weight more than 60 kgs. However, there
was no shortage of drugs ever.
Only one DOTS worker was really diligent ^enough to ensure swallowing
of the doses in front of him. This man also had the best method of explaining
the complete procedure of taking medicines and all that was to be told to a
new patient. All the other four we observed, either asked the patient to go
to the next tap or handed over the complete weekly pack in the hand of
the patient.
Those in Cat II have to purchase syringes on their own as there were none
available with the DOTS workers.
We observed two supervisor visits and both visits appeared extremely cursory.
There was no attempt to check the records or the lab quality. At the TB and
Chest Diseases hospital, the lab incharge complained that there had been
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no sputum cups for the last six months and the DOTS worker confirmed
that he had passed the demand to the STLS but had not got them.
For patients coming from outside the municipal area of Jaipur, Dr Sisodia
has managed to get left over drugs from various districts in his capacity as
the President of the Rajasthan TB Association. As the Government doesn't
supply any non DOTS drugs to districts under the RNTCP, this is the only
recourse for people like Dr Sisodia who have the sensitivity not to send
away patients from other districts.
We learnt that there had been an instance where a DOTS worker had been
caught trying to take a bribe of Rs 50/- so as to allow the patients to take
drugs at home. Similar complaints have been heard about the Delhi projects
also. The system allows money to be made by DOTS workers and since it
makes life less tedious for the worker, and saves a lot of effort and transport
costs on part of the patient, the scope of this practice increasing is enormous.

Record Maintenance
Although the record keeping here too is much better than is expected of
government departments, it is not as good as I found in the other projects.
It was partly due to the high turnover of the newly recruited re-employed
personnel who take time to come to terms with the extensive recording
systems required for a well functioning RNTCP/ DOTS.
In the TB 8tGiest Diseases hospital, the records in the lab register seemed
to be in the same handwriting and pen always'for each of the entries
recorded against specimen I, II and III, raising suspicions of manipulated
records in my mind. As soon as it came to my mind, the lab incharge
confirmed it and told me that he did only one sputum smear examination
and filled the rest of the entries according to that one result.(see statement
of Mr Hardayal Sharma in inset)

Adverse Drug Reactions


Although there are no formal records of Adverse Drug Reactions, Dr Sisodia
recalled seeing a couple of jaundice cases in the last two years. Gastritis to
Rifampkin was quite common, but ione has been so severe so to discontinue
the drug.

Patient Compliance
We didn't get any formal records of compliance and defaulter rates, except
of the initial defaulter ones. However, they seem to be quite high given the
statements of all the interviewees.
During the period of observation on one whole day at the DTQ only one
patient out of eighteen who were to have come for drug ingestion that day
nadn't arrived and was to have been followed up the next day in case he
didn't turn up even the next day.
26

Staff confidence in DOTS:


The confidence of the staff handling DOTS varied from place to place. As
usual it was the highest at the DTG The worst was at the TB and Chest
Diseases Hospital, where the medical staff as well as the lab staff we
interviewed had no faith at all in the DOTS regimen for more reasons than
one.
One DOTS worker who used to be a TB health visitor before his retircment,
was nostalgic about the good old times when there were no follow-ups to
be made. He used to administer Streptomycin, INH and PAS and used to
find them very effective. "Now there are-much more chances that die patient
would have started some treatment earlier and defaulted already. Some of
them do not even respond to Rifarripicin." He was also relieved to see
Thiacetazone out as it used to give a lot of skin rashes. Rifampicin causes a
lot of Gastritis, he feels.
As we were informed, eighteen patients sent from the DTC to the TB and
Qiest Diseases Hospital as it was the nearest DOTS centre were hijacked by
touts standing in the corridors of this hospital. The medical officers and
specialists changed them to other regimens after having warned diem of
dire consequences of taking the DOTS regimen. I also saw a complaint
filed by one such patient giving details of his hijacking and asking for
compensation for not permitting him to get free treatment. [See inset]
As mentioned earlier, there has been a very poor response to the programme
from all die other hospitals where the DOTS centre are running ahhough
one must appreciate that persistent efforts of Dr Sisodia and his team have
started making a dent in the attitudes of these people.

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