Even though validated by certain trials, this new thrice weekly (3/7) concept is still in its infancy; it has yet to pass the ultimate test – the test of time. Till then, caution ought to be exercised. Several nations aboard WHO-operated DOTS bandwagon and even some which are supplied anti-TB drugs by Global Drug Facility, have chosen to stick to the traditional time tested daily regime.
Total number of doses having been drastically slashed, each dose assumes magnified significance. Now, a patient just can’t afford to miss even a single dose, making ‘supervision’ indispensable. In other words, non-enforcement of impeccable supervision over thrice-weekly regime can prove catastrophic.
The patient takes his doses on, say, Monday, Wednesday and Friday. Suppose, he duly takes his Friday dose, but somehow misses the Monday dose, and then is able to take it only on the next appointed day i.e. Wednesday. A miss thus occurs. This single ‘trivial looking’ miss is able to cause a prolonged 5-day gap – hardly compatible with cure. Therefore, this 2-day risky gap in design, kept to accommodate a weekend, must be eliminated forthwith and we must adopt five-doses-per-week regime.
Ever since anti-TB drugs were discovered, a TB patient has been required to take medicines every day; not a single day to be missed; daily dose considered imperative.
Not any more!
In a drastic change, under RNTCP, the patient is required to ingest medicines on alternate days – mere 3 doses per week (3/7)!
‘Given just thrice a week, TB medicines are equally effective’ claim some studies; the cure rates and duration of treatment remain unaffected – same as with daily medication.
Sheer scale of compliance failure (60%) makes supervision an absolute necessity.
And supervision can become feasible only in case a thrice-weekly regime is employed since patient can practically visit no more than three times a week. Daily regime is unsuitable for the purposes of supervision, since it is impractical for a patient to physically attend the clinic every single day and be observed while taking his dose.
Besides, there is yet another irresistible feature of thrice-weekly regime – the cost gets reduced to nearly half since, overall, less drugging is involved. In simple terms:
• With the same resources, we could benefit twice as many humans.
• In less than half the estimated cost, we could rid the entire world of TB.
However, even though authenticated by scientific trials, this new thrice weekly (3/7) concept is still in its infancy. Not much time has elapsed since its practice began. It has yet to pass the ultimate test – the test of time.
In the meanwhile, we must ponder over 2 main controversies of the new program:
A. Are health workers truly supervising the patients in our villages and towns?
Total number of doses having been drastically slashed in an intermittent (3/7) regime, each dose assumes huge significance; the patient simply can’t afford now to miss even a single dose. That makes supervision – the tool that ensures drug delivery – absolutely indispensable in the current intermittent regime.
Patients treated without direct observation have a substantially higher risk of adverse outcome than those treated under it, concluded a Kerela study* (13).
When success of an intermittent regime so critically depends on foolproof supervision, we must ask ourselves – is DOTS really well supervised on the ground in India?
a. Extent & scope of ‘supervision’ was minimized in the Indian design itself:
• While knitting the original design, the Indian architects clandestinely diluted the element of supervision – by about 50%.
• Of the 78 intermittent doses given with in 6 months in order to cure a category I patient, only 42 doses are supposed to be directly supervised. The remaining 36 doses are to be handed over to the patient who carries them home and ingests them unobserved there.
• 36 power-packed, precious doses have thus been quietly set aside & kept outside of purview of supervision – a substantial compromise that makes the name DOT a misnomer; POT (Partially Observed Treatment) sounds more appropriate.
• ‘Minimizing supervision to such a sizeable extent’, is this compatible with success in thrice-weekly regime?
b. Human inefficiency not factored in to the current design:
Moreover, divorcing bulk of ‘supervision’ in the design itself leaves little scope for any further lapses of supervision by human element in the next tedious stage – practical implementation in the field. Supervision stands curtailed at source – as if on the assumption that no irregularity in supervision will occur subsequently – during 6 months of treatment. It is hoped that neither the patient nor the health worker will falter. DOTS being such a highly labor-intensive operation, failing to retain an adequate cushion for human inefficiency – so glaringly inevitable in India – makes it a utopian blueprint.
It appears that human inefficiency, the hallmark of a government employee, scandalously escaped being factored in to the current design. Government files and records being completely out of reach of a common man like the petitioner, the reason can only be construed to be either gross ignorance of the grass roots realities on the part of elite Indian architects or their fascination with things foreign and the awe of the WHO officials who not only recommended, aggressively promoted, technically supported but also intimately presided over the finalization of each and every facet of the strategy. Further, they enjoyed immense leverage over the proceedings since they held the purse strings; their verdict alone would throw open the floodgates for the inflow of massive international funding – to the famished Ministry of Health in the 1990s.
India’s multipurpose health worker is simply too busy, perpetually on the move.
He is burdened with a multitude of vague, overlapping duties concerning 18 national programs ongoing at a snail’s pace – e.g. family planning, polio, malaria, immunization etc. And then, with numerous holidays and meetings, he is frequently ‘not on seat’ – leading to several supervision lapses and interruptions in treatment. A fortnight is invariably washed away around each ‘Pulse Polio’ campaign. Malaria season too is pretty hectic. Further, he might accept bribe and give away extra strips (or even the entire box) of medicines, further mocking and diluting ‘supervision’. Anecdotal evidence suggests that workers hardly understand, appreciate or respect the concept of supervision and which carries little conviction around. Left unobserved, patients indulge in all sorts of irregularities; they skip or divide a dose or pop pills at will – incompatible with cure – more so in an intermittent regime.
Further, to be maximally effective, the program must be both confidential and convenient* (14). The patient must be provided DOT from a nearby clinic – at the time and place that is convenient and acceptable to him, which is hardly feasible in India where health services are understaffed and bursting at the seams. Patient-numbers, logistics and expanse of operation simply overwhelm the system.
Curiously, govt. has not undertaken a systematic evaluation of the levels of supervision. Whatever tiny research has been invested on the subject points to an ominous prognosis:
• Balasubramaniam* (15) found that 26.5% patients were in reality not supervised though recorded as having been directly observed.
• In 40 visits to health centers, investigators in Sonipat* (16) never saw even a single patient taking medicine in front of any health workers. Besides, medicine boxes were spotted in the patients’ houses.
Non-enforcement of strict supervision over thrice-weekly concept can prove suicidal for a nation. Paradoxically, the most glaring drawback today appears to be what was professed the most powerful and essential element in this new technology – namely supervision. The main strength has turned its crippling weakness.
The most compelling advantage cited in favor of intermittent regime (over the time tested daily regime) had been that it makes supervision feasible. However, supervision it is that is in shambles; unacceptably compromised – in design as well as in practice. Hence, the very basis of selecting thrice-weekly regime over daily regime is rendered null and void.
B. The Dangerous weekend ‘Miss':
In ‘thrice weekly’ regime, a patient is administered a dose each on three days, say Monday, Wednesday and Friday. Suppose, he duly takes his dose on Friday, but somehow misses it on Monday and then swallows it on the next appointed day i.e. Wednesday – a single trivial looking miss has occurred. But it causes a menacing 5-day gap – hardly compatible with cure, hence unacceptable. There are no studies that document as to how many such interruptions are permissible, anyway?
Prayer No. 5
The two-day gap in design, kept to accommodate the weekend, is risky and must be eliminated forthwith so that no single miss has the potential to create so long an interruption. Dispensing an extra take-home dose for Sunday can neutralize this risk.
However, it is prayed that the program be made 5/7 (five doses per week), instead of the current 3/7 without increasing the number of weekly visits by the patient (three during intensive and one during continuation phase).
During the first two months (Intensive phase), the patient comes to the clinic on Monday, swallows his dose and pockets a dose for Tuesday to take it unobserved at home. On Wednesday, he simply comes and swallows a dose and goes home. On Friday, he comes, takes his dose and carries home a dose for Sunday.
During the next four months (Continuation phase), he just visits once a week, say on Monday, swallows his dose and carries home a strip containing four more doses that he will take by himself at home on Tuesday, Wednesday, Friday and Sunday.
This will obviate the risk of a prolonged gap at any point in time even if an interruption does occur for any reason – be it due to unavailability of the health worker or inability on the part of the patient to visit.
Moreover, this will introduce some desperately needed margin of error for absorbing inevitable human inefficiency so rampant in India and which curiously escaped being factored in to the design.
Weight of various drugs for the doses of 5/7 schedule can be readjusted appropriately