The National Tuberculosis Programme (NTP)

 

India's National Tuberculosis Programme (NTP) was established in 1962 and provided a system 446 District TB Centres, 330 TB clinics, and more than -47,000 hospital beds – for TB control throughout the country. After more than three decades of operation, the NTP can justly claim to have established an infrastructure for tuberculosis treatment in India. However, with a treatment completion rate of only 30 percent, the programme did not make a significant dent in the problem.

Part of the difficulty undoubtedly lies in the perceived priority of tuberculosis in India. One study of the problem from the Indian Institute of Management, Ahmedabad found that tuberculosis had a low priority compared to other diseases; funding was disproportionately low; senior programme leaders did not remain in place for long: health staff were pressured by non-TB activities; patients experienced indifferent programme delivery; and the visibility of TB in the media was low.

Until recently, tuberculosis has had a smaller central budget than malaria, leprosy, blindness, or AIDS. Only guinea worm, among the priority communicable diseases, received less. Negative expectations about the TB programme have tended to become self-fulfilling.

In 1992, a review of the National Tuberculosis Programme by national and international experts - in coordination with the World Health Organization and the Swedish International Development Association - determined that the programme had not had the desired impact on tuberculosis in India. The review noted inadequate budgets, a lack of coverage in some parts of the country, shortages of essential drugs, poor administration, varying standards of care at the district centres, unmotivated and unevenly trained staff, lack of equipment, poor quality of sputum microscopy, and focus on case detection without an accompanying emphasis on treatment outcomes. There was a general consensus that, in a revised tuberculosis control programme, the patient would have to be both the starting point and the focus, It is therefore essential to understand the patterns of diagnosis and treatment from the patient's perspective.

 "Health-Seeking Behaviour of Chest Symptomatics"

 

In India, the vast majority of patients with active tuberculosis seek treatment for their disease, and do so promptly. However, many patients spend a great deal of time and money "shopping for health" before they begin treatment, and, all too often, they do not receive either accurate diagnosis or effective treatment, despite spending considerable resources. In a community-based systematic survey in Karnataka, cough for three weeks or more was present in 1.4% of people; rates increased with age, and were higher among males than among females (See figure). Patients usually visit a number of health providers - from general practitioners and general hospitals to practitioners of indigenous medicines and even quacks. Unqualified rural practitioners are the first point of contact for many TB patients.

This study also found that patients almost always seek care promptly. The average time it takes for a patient to visit a health facility after the appearance of symptoms was less than 2 weeks. Virtually all symptomatic patients who sought care did so within one month of the onset of symptoms. In areas with better performing health systems, patients sought care even more promptly. The only sub-group which did not seek care promptly was elderly, non-literate males.

 

Delay between the onset of symptoms and the start of effective treatment is important in the control of tuberculosis because during this rime patients are most infectious. Most delay in diagnosis is on the part of the health system, not patients.

 

One barrier to treatment is the stigma that is still associated with tuberculosis. In many parts of India, this remains a serious problem.

 In one recent study, researchers interviewed several hundred patients and their families and found that most patients felt uncomfortable talking about tuberculosis. Several patients denied that they were suffering from the disease or taking treatment for it, and some even refused to mention tuberculosis by name. Patients frequently attempted to hide their disease from their family and community by registering under false names at tuberculosis clinics or by denying their identity when confronted by interviewers.

 Similarly a study by the Indian institute of Management found that most patients were reluctant to admit that they had TB because they feared stigma, and they preferred not to discuss the disease in the presence of family or neighbors. This was more so in urban than in rural areas. Family support for treatment was more frequent among cured patients than among those who had defaulted.

 

First action taken by chest symptomatics
		Mysore district		Raichur district		Tamil Nadu		Delhi   %	Average   %
		Rural %	Urban %	Rural %	Urban %	Rural %	Urban %
Private provider	48		76	93	74	48	57	55	64
Government facility	51		22	5	25	46	32	21	29
Self-medication	--		--	--	--	4	8	10	3
Home remedies	--		--	--	--	1	2	6	1
Others	1		2	2	1	1	1	8	2
Total taking action	83		85	90	85	63	80	82	81
No action prior to interview	17		15	10	15	37	20	18	19

 

The majority of TB patients in India who seek help first consult one of India's 10 million private medical practitioners (See previous tables). In studies that assessed the health-seeking behaviour of chest symptomatics in rural Karnataka and Tamil Nadu, and in urban Karnataka, Tamil Nadu and Delhi, researchers found that 64 percent first sought help from a private provider Only 29 percent went to a government facility on the first visit. Ramana et al. found that 80 percent of all private practitioners in their study areas in rural and urban Andhra Pradesh were treating tuberculosis.

The major causes patients gave for seeking private providers were proximity and convenient working hours; while the main reason for going to government facilities was free treatment.

Studies have shown that, despite having limited resources, most patients are not promptly diagnosed and treated, and therefore go from one doctor to the next before a diagnosis is firmly established and treatment begins.

In one study, the average number of health providers visited by patients from the time they developed symptoms to the time they registered at a TB clinic was 2.5 for urban patients and 4.0 for rural patients. Not only did this increase the cost of treatment, increasing debt, but it also delayed prompt initiation of treatment, thus avowing disease to spread further in the community.

 The total cost incurred by patients shopping for care was about Rs 1000 ($30) in urban and Rs 630 ($18) in rural Karnataka, and about Rs 550 ($16) and Rs 400 ($11) in urban and rural Tamil Nadu.

 All too often, health providers fail to diagnose the disease correctly, thereby delaying the start of treatment and perpetuating the chain of infection in the community

 

Provider consulted first by patients with tuberculosis
Provider Consulted First	Medak (rursal)%	Hyderabad (urban)%
Unqualified neighborhood doctor	7.1	1.5
Qualified neighborhood doctor	25.7	55.2
Doctor (not aware of qualifications)	41.5	20.9
Specialist in TB/Chest Diseases	0	.7
Specialty Hospital	8.6	0
Clinic/Dispensary/PHC	4.3	3
Hospital	1.4	14.9
TB Clinic/Hospital	11.4	3.8

              Source: Mapping of TB Treatment Providers at Selected Sites in Andhra Praradesh State,

 

Many providers do not confirm their diagnosis of pulmonary tuberculosis by sputum examination, relying instead on chest radiographs and thus often incorrectly diagnosing patients to have tuberculosis, in one study in Bombay, only 39 percent of doctors used sputum examination to confirm the diagnosis of tuberculosis. Studies in Delhi, Karnataka, and Tamil Nadu revealed that, even after multiple visits, less than one third of patients underwent sputum smear examination. In one study, even after 8 encounters with the health system, less than one third of patients had undergone even a single sputum examination, despite spending 1-6 months of their income, in rural areas, lack of access to effective diagnosis and treatment was even more pronounced (See figure).

 

 

 

Even when tuberculosis is diagnosed by private practitioners, prescribing practices vary widely. A study of 100 private doctors in Bombay, found that there were 80 different regimens, most of which were either inappropriate or expensive, or both. In a similar survey in Pune, 113 doctors prescribed 90 different regimens. Private doctors seldom felt that it was their duty to educate the patients about TB and never made attempts to contact or trace patients who had interrupted treatment. Virtually no individual patient records are maintained by private physicians.

 

Even when patients are eventually diagnosed and then prescribed the correct treatment regimen, many discontinue it if they are not supported and monitored throughout the treatment period. The two main reasons offered by the majority of those who stopped treatment were that they felt better and had therefore discontinued their drugs, and that there was too much cost and trouble associated with getting an uninterrupted supply of drugs.

Estimates in India indicate that, of every 100 infectious tuberculosis cases in the community, about 30 are identified in the public sector, of which at most 10 are cured; similarly, about 30 are identified in the private sector, of which at most 10 are cured. Hence, not more than 20 percent of patients who develop tuberculosis in India each year are cured. Many of the remaining patients remain chronically ill or die slowly from the disease, infecting others with strains of the disease which may have developed drug resistance.

Despite these serious shortcomings, there are signs of hope. Most practicing physicians reported that they would be interested in receiving training on DOTS, and most were willing to have their offices used as centres for treatment observation for their patients, free of charge.

 How is TB disease treated in India?

 There are many possible anti-TB treatment regimens. The World Health Organization (WHO) and the International Union against Tuberculosis and Lung Disease (IUATLD) recommend standardized TB treatment regimens.

The most common drugs used to fight TB (when used in combination of more than one drug, called a "regimen") are:

·       isoniazid (INH or H)

·       rifampicin (R)

·       pyrazinamide (Z)

·       ethambutol (E)

·       streptomycin (S)

Based on case- definition, a TB patient may fall into any one of the following four categories for treatment. The categories are numbered in order of priority. The highest priority for treatment is Category 1 patients and the lowest priority is Category 4:

Category 1: New cases who are smear-positive, or seriously ill patients who are smear-negative or who have extra-pulmonary disease.

Category 2: Re-treatment cases including patients with relapse, treatment failure and those who return to treatment after default. Such patients are generally sputum-positive.

Category 3: Patients who are sputum-negative, or who have extra-pulmonary TB and are not seriously ill.

Category 4: Chronic cases, still sputum-positive after supervised re-treatment

 Treatment regimens usually comprise two phases: the Intensive phase and the continuation phase. There are several possible regimens for treating each category of TB. Suggested alternatives are given in the following table.

However, it is important to stress that in a given country, the regimen recommended by the National TB Programme, which is described in the NTP Manual, should be followed.

Table 1 Possible alternate treatment regimens for each treatment category

TB treatment category	Alternative TB treatment Regimens
	Initial Phase (daily or 3 times a week)	Continuatioin phase
I	2 EHRZ (SHRZ)* 2 EHRZ (SHRZ) 2 EHRZ (SHRZ)	6 HE* 4 HR 4 H2R3
II	2 EHRZ (SHRZ)/ 1 HRZE 2 EHRZ (SHRZ)/ 1 HRZE	5 H3R3E3 5 HRE
III	2 HRZ 2 HRZ 2 HRZ	6 HE 4 HR 4 H3R3
IV	Not Applicable (Refer to WHO guidelines for use of second-line drugs in specialized centres )

 

 

* A standard code is used for each drug. For example, the regimen of 2HRZE(S)/4HR has two phases

 

·       The intensive phase (2HRZE) means daily treatment with a combination of four drugs for two months: isoniazid (H), rifampicin (R), pyrazinamide (Z) and ethambutol (E). The last drug (E) and streptornycin (S) can be interchanged where either one or the other of the two drugs is available.

·       The continuation phase (4HR) means daily treatment with isoniazid (H) and rifampicin (R) for four months

 

For the regimen 2HRZE(S)/4H3,R3, the abbreviation H3R3 means a treatment three times a week with both isoniazid and rifampicin.

Anti-TB Drug (Abbreviation)	Recommended Dose (mg/ kg)
	Daily	Intermittent 3x /wk
Isoniazid(H)	5(4-6)	10(8-12)
Rifampicin (R)	10(8-12)	10(8-12)
Pyrazinamide (Z)	25(20-30)	35(30-40)
Streptornycin (S)	15(12-18)	15(12-18)
Ethambutol (E)	15(15-20)	30(25-35)
Thiacetazone(T)	2.5	Not Applicable

 

 All these anti-TB drugs should be given as as a single daily dose. Direct observation is recommended for all patients and is particularly essential when intermittent regimens are used. Thiacetazone is not effective when given intermittently and is not recommended for use in high HIV prevalence areas.

 The side-effects of anti-TB drugs

 The side effects of individual anti-TB drugs are shown in the table below. They are classified as minor or major. In general, a patient who develops minor side effects should continue the anti-TB treatment, usually at the same dose or if necessary at a reduced dose. The patient should also receive symptomatic treatment. If a patient develops a major side effect, the treatment or the offending drug should be stopped.

Table 2 Side-effect of anti-TB drugs
Side-effects	Drug(s) probably responsible
Minor
1 anorexia, nausea, abdominal pain 2 joint pain 3 burning sensation in the feet 4 orange/ red urine	rifampicin pyrazinamide isoniazid rifampicin
Major
1 itching of skin, skin rash 2 deafness 3 dizziness 4 jaundice 5 vomiting and confusion 6 visual impairment 7 shock, purpura, acute renal failure	thiacetazone (streptomycin) streptomycin streptomycin most anti-TB drugs (esp. H,Z,R) most anti-TB drugs ethambutol rifampicin

 

Are the side-effects or toxicity due to anti-TB drugs more common in HIV-positive Individuals?

 

Adverse reactions are generally more common in HIV-positive than in HIV-negative TB patients. Most reactions occur in the first two months of treatment. Skin rash and hepatitis are more common and most often attributed to rifampicin. The usual drug responsible for fatal skin reaction such as exfoliative dermatitis, Steven-Johnson syndrome, and toxic epidermal necrolysis is thiacetazone. Therefore, thiacetazone should never be given to HIV-positive TB patients. From a programmatic point of view, thiacetazone should not be prescribed in areas where HIV prevalence is shown to be high.

 Key Findings and implications for Action

Patients with symptoms of TB seek care promptly - but in both the public and the private system, they are neither reliably diagnosed nor effectively treated. Where services are better people use them more promptly and more often despite 8 encounters with the health system and the expenditure of 1-6 months' wages, less than one third of patients with symptoms of TB had undergone even a single sputum examination for AFB! in both public and private sectors, successful treatment of tuberculosis is the exception rather than the norm.

•   The behavior of patients does not need to be changed - the health system's response to this behavior must improve.

•   Diagnostic practices need to be strengthened urgently. In both public and private primary health care systems health workers need to "Think TB" and ensure that all adult patients are asked whether or not they have cough for 3 weeks, and, if they do, that they undergo 3 sputum examinations in a good quality laboratory.

•  Programme managers need to publicize the location and availability of free sputum microscopy centres, and the fact that 3 sputum samples should be examined if patients have cough for 3 weeks or more.

 •  Programme managers need to involve both qualified and unqualified practitioners to refer patients for diagnosis.

•  Practicing physicians should ensure that every patient with symptoms of TB undergoes 3 sputum examinations in a quality-controlled laboratory, preferably by referring such patients to an RNTCP microscopy centre.

•  In public and private sectors, improved interpersonal communication, standardized treatment, direct observation at a time and place convenient to patients, and systematic monitoring and accountability are needed urgently.