For patients given treatment for self administration at home, there is inherent problem of regularity of intake of drugs particularly if the treatment is long term. It is a common observation that patients with myxoedema, auricular fibrillation, or epilepsy even when their malady is under control are not completely regular. It is just that they take sufficient number of doses of the medicine for successful control of their disease. In leprosy, self administration is rarely relied upon and some form of supervised administration of Diaminodiphenylsulphone (DDS) is devised. This phenomenon is observed even with short term treatment with acute diseases. In 1955, Mohler et al., reported that 32% of 217 patients took less than prescribed doses of one week oral penicillin course for treatment of acute pharyngitis/otitis media. Turning from treatment to prophylaxis, reference may be made to rheumatic fever. WHO expert committee in 1957, stated that unless physician take continuous responsibility, the patient and his family are motivated to take drugs regularly and continuous medical surveillance is done by Public Health Services, the prophylaxis cannot be given successfully. The difficulty in keeping persons who adopt small family norms to observe contraceptive measures is well known. It therefore seems likely from experience in other fields that self administration of drugs may present some problems in TB also.

Experience in Pulmonary TB: Although the effective drug regimen for treatment of TB on mass scale is mandatory, the regularity with which patients will self administer the anti TB drugs for long time is also of fundamental importance. Some amount of information obtained on self administration of anti TB drugs at home from an on going study on “Home Vs Sanitorium treatment” at Tuberculosis Chemotherapy Centre, Madras (Bull WHO 1959, 21, 51-144) is presented here. This will be useful in indicating the problems of self administration of drugs in TB. The regimen used in the study is 12PH (PAS & Isoniazid for 1 year) six to seven cachets (each cachet containing 1.25 gm PAS & 25 mg of Isoniazid) according to body weight. Once a week the patient collects supply of drugs from the centre. They are motivated along with their family about the importance of regularity for the total duration of one year and informed that early disappearance of symptoms may not be considered as cured. Home visits by the field staff are made once a week in the initial 2 months & later on fortnightly basis to collect urine for ferric chloride test for presence of PAS, sputum for culture & sensitivity for Mycobacterium TB (M.tb) and counting of stock of cachets. Some of the visits made are unexpected. The patients are assessed clinically, radiographically and bacteriologically every month.

Preliminary analysis of urine for the presence of PAS was made in a group of 79 patients on home and 81 on sanitorium series. Of the 79 patients on home, 58 patients who completed one year of treatment, 20% gave at least one test negative in the first six months, 14% in the later six months & 9% of the remaining 21 recently admitted patients. In the sanatorium group, 58 of the 81 patients who completed one year of treatment, 4% gave negative results during first six months of treatment and only 0.6% during the second six months. Thus showing the irregularity is high during first six months and the problem of missed treatment is peculiar to the group treated at home, where the patients are not under direct observation. Rregularity by counting cachets is not accurate as the drugs can be sold, given or thrown away; it is best reliable during unexpected visits & can be only complimentary to urine testing. During interviews, reasons for omitting doses were never forthcoming & were obtained by deep probing and suggestions. Thus the questioning indicated the reasons for failure of drug intake as follows: i) Very few patients have minor side effects. ii) Some are unable to satisfy hunger & some attribute-unassociated complaints to the medicine. iii) Few are irregular due to religious reasons. iv) A large group of patients have no explanations, and apparently fail to take their medicine due to forgetfulness or through indolence. In this last group of patients unless the irregularities had been specially looked for, their occurrence would not have been suspected as great majority of them keep up the social side of the relationship with the clinic and attend regularly.

Unfortunately very little is known of the motives, which impel a patient to take medicine and the best way to get him to do so. In essence, in order to make a patient to take medicine regularly morning and night for a year it is necessary to establish a new pattern of behaviour; and this many of the patients find difficult. If the irregularity in self medication is small and does not influence the outcome it does not matter but if the evidence suggest that the irregularity carries serious consequences then i) Find a way to make patient regular in taking their medicine. ii) To alter our out look on the ideal form of home treatment. iii) To study regimen given daily or intermittently under direct observation.

NGOs make a vital contribution to disease control that is increasingly recognized by governments and international development partners. This booklet provides examples of the important contributions NGOs are making to TB control in the region and provides guidelines for NGOs wishing to get involved in the fight against TB.

This is not only a record of success, but also a call for action – a plea for more and more agencies to collaborate and develop partnerships with national TB programmes. And the plea goes out to all organizations – not only those with a historical interest in TB. All organizations – including those working in community development, advocacy, human rights, education – have a role. TB affects us all in one way or another – directly through its impact on the lives of friends and colleagues who have TB, and indirectly through the impoverishment of families and communities. All of us can be, and should be, involved.

The DOTS strategy has been demonstrated to overcome most of the short-comings of self-administered chemotherapy such as low cure rates, high relapse and fatality rates, drug resistance etc. There are several benefits from successful application of the DOTS strategy. The objective of this study was to estimate the direct economic benefits by the reduction in the prevalence of TB and deaths averted on account of DOTS. The methodology adopted has been the comparison of the two scenario “with DOTS” and “without DOTS” and deriving the benefits and calculating the discounted value of the contributions of the DOTS by applying the discount rates ranging from 5% to 16%. The estimates are generated by using the marginal productivity of labour and the deaths averted by DOTS among future workers in each age-sex-area category. The discounted value of the contributions of the future workers among the deaths averted in one year due to DOTS, the remaining years of their productive life are considered as the economic benefits of the deaths averted. The total benefits due to DOTS have been estimated as % of G.D.P. in 1993-94 and annualized benefits due to DOTS as % of G.D.P. The potential benefits are derived by using the most reliable 1993 estimates from survey of causes of deaths.

The potential benefits of successful DOTS in India are divided into two broad categories (I) Pure social welfare increasing effects of DOTS which do not generate direct tangible economic benefits. These would include reduced suffering of TB patients, quick and sure cure from the disease, lives saved, disability reduced for dependents and non-workers suffering from TB, the poverty alleviation, the psychic benefits of living in a more healthy way. (ii) Direct tangible economic benefits by improving the efficiency and productivity due to reduction in prevalence of disease and deaths and release of the hospital beds by averting hospitalization of TB patients.

The method of calculation is based on the estimates of population for the base year 1993-94 by age-sex-area as well as of the workers and sectors. Aggregative macro-economic studies and estimates of productivity differentials are used to calculate rural/urban, adult/child, young adult/old adult and male/female workers output gains. These are applied to two groups ‘with DOTS’ and ‘without DOTS’ and the benefits in the improvements likely to occur ‘with DOTS’ have been estimated.

The benefits are based on twin optimistic assumptions: a) DOTS will succeed in tackling pulmonary TB in India (b) DOTS will reach about 90% of TB patients with full instantaneous coverage. It is envisaged to implement DOTS in a phased manner over a few years. As per the findings of the analysis the potential economic benefits of DOTS to the Indian economy is estimated to be around 4% of GDP in real terms or US $ 8.3 billion during 1993-94. The economy gets a return of more than 16% per annum. Since the present value of all future costs attributable to DOTS is likely to be less than 4% of GDP, DOTS can effectively help step up India’s future economic growth. Phasing in of DOTS over time reduces value of the economic benefits. The longer the period of phasing, the lower is the discounted value of the benefits. Even with 10 years of phasing and 16% of discount rate all future benefits of DOTS turn out to be 2.1% of G.D.P. Projected incremental costs to the government for successful DOTS implementation throughout India are of the order of US $ 200 million per year, compared to the tangible economic benefits of at least US $ 750 million per year exceeding by several folds of the financial costs.

Much of the global strategy for TB control was established in India, but every year, there are an estimated 2 million cases of TB. To describe the policies, initial results and lessons learnt from implementation of a RNTCP using the principles of DOTS is the objective of this study. The RNTCP was designed and implemented starting in 1993. With funding from Government of India, State Governments, the World Bank and bilateral donors, regular supply of drugs and logistics was ensured. Persons with chest symptoms who attend health facilities are referred to microscopy centres for diagnosis. Diagnosed cases are categorized as per WHO guidelines and treatment is given by direct observation. Systematic recording and cohort reporting is done. From October 1993 through mid-1999, 146012 patients were put on treatment in the programme. The quality of diagnosis was improved, with the ratio of smear-positive to smear-negative patients being maintained at 1:1. Case detection rates varied greatly between project sites and correlated with the percentage of patients who were smear-positive among those examined for diagnosis, suggesting heterogeneous disease rates. Treatment success was achieved in 81% of new smear-positive patients, 82% of new smear-negative patients, 89% of patients with extra-pulmonary TB and 70% of re-treatment patients.

The RNTCP has successfully treated approximately 80% of patients in 20 districts of 15 states of India. Treatment success rates are more than double and death rates are less than a seventh those of the previous programme. Starting in late 1998, the programme began to scale up and now covers more than 130 million people. Maintaining the quality of implementation during the expansion phase is the next challenge.

Since chemotherapy first proved efficacious for TB, a significant number of patients have failed to complete an adequate course of therapy. An enormous research performed over the last 40 years has contributed greatly to our understanding of the complex nature of why patients fail to take their medication as prescribed. Despite our increased knowledge of such patient behaviours, modern medical practitioners, to date, have neither the means to identify in advance all patients who will fail to take their medication, nor the means to detect all those who are not taking their medication during the course of their therapy. In the case of a communicable disease such as TB, the well-being of the patient and the interest of the public health overlap. Physicians, in general, and public health officers, in particular, are charged not only with ensuring that individuals are adequately treated so that they may be cured of their disease, but health care professionals are legally obligated to ensure that adequate treatment occurs to protect the public from the threat of TB.

The authors have deduced six steps to optimize patient adherence which is termed as “Denver Model” The principles of using these steps would maximize the efficiency of DOT by eliminating as many barriers as possible and by creating a structure that readily locate the “lost” patient. They are: (i) Know the patient: Initial encounters with the patient should be used to aggressively gather information. The goal of these sessions should be to identify as many points as possible at which the patient connects with the community. (ii) Assign a case manager: Each patient should have one health care professional who is identified as a specific contact. If at all possible, this contact should have fluency in the patient’s first language; if that is not possible, the contact should arrange for an adequate translator to be present for sessions with the patient. Ideally, the case worker and patient will establish a sound and stable therapeutic relationship. (iii) Establish inducements and enablers: Many patients with TB are afflicted with numerous social ills in addition to their disease. Homelessness, hunger, and substance abuse can make TB seem the least of their worries; thus, adherence to medication assumes a low priority. If the TB clinic can meet some of the patient’s other needs, contact with the clinic assumes a higher priority, and the likelihood of adherence to therapy is much greater. The use of “enablers” has also been advocated. Enablers are services that remove barriers to the patient’s participation. For a patient without transportation an enabler might be a bus token or a taxi voucher; for a mother it might be child care so that she can come to the clinic. All of this sounds expensive, but the ultimate total cost of inducements and enablers is far less than the cost of inpatient care in the case of the patient who fails these outpatient efforts, not to mention the cost of caring for the additional cases that will result from failure to treat. (iv) Be flexible: Every attempt should be made to accommodate the patient’s needs and schedule. Whenever possible, reliable contacts in the community should be identified so the patient can get medication 24 hours a day. (v) Involve community workers: Part-time employment of reliable members of the patient’s community can prove invaluable. Ideally, this would be an individual who knows the patient and the patient’s neighbourhood, someone who could quickly locate the patient if he/she failed to show for an appointment and who could determine the reason for the missed appointment as well as administer the missed dose. (vi) Issue an order of quarantine: Patients should clearly understand that their adherence to medical therapy is legally mandated and is offered in lieu of physical quarantine. The patient should receive an order of quarantine that clearly explains this and makes clear that failure to present for medication doses may result in incarceration for the duration of therapy.

Nearly thirty years of experience with the direct observation of antituberculous chemotherapy in Denver have proven these to be effective measures. Each case of TB in Denver County is treated with impartiality. Every patient with TB received DOT and no exceptions are made.

Bangladesh is the most densely populated country in the world, with 122 million people. In spite of many challenges such as poverty, illiteracy, political instability, natural disasters, the national population and health programmes have made significant progress in the recent decades. In 1977, the annual incidence of all TB was 246 / 100,000 population; death due to TB was 68,000 in the whole country. The annual risk of infection was estimated to be 2.2% with an annual decline of 1%. In 1965, the TB services were organized into 44 TB clinics and 12 TB hospitals situated in different districts of the country.

In 1975, the health and population sector, with the international assistance had been successfully implemented, but the philosophy of fourth population and health project (FPHP) was project oriented and had several weaknesses i.e., centralized authority, delays in fund release, etc. In 1998 the GOB changed its policy to sector wide management known as Health and Population sector programme (HPSP). This involves strengthening the management capacity of the Ministry by integrating the two wings of health and population control. The reforms were made to address the inefficient, fragmented and duplicated services provided by the project oriented approach. The essential service package will receive 60% of the total funds. The five areas identified are reproduction, child health care, communicable disease control, curative care and behaviour change communication. TB & leprosy services were identified as important programmes within the communicable diseases.

The NTP organized within the FPHP provided effective TB control services within the existing health care system in Bangladesh. In 1992, Government of Bangladesh (GOB) adopted the WHO recommended World Bank sponsored DOTS programme. Will the integrated approach in fifth HPSP, the priority and commitment given to TB will be sustained? Having reached high cure rates, the NTP needs to reach out to private practitioners and other academic institutions. This needs monitoring of the changed strategy and reformed sectoral approach through indicators such as case detection and cure rates. Many challenges are foreseen in the transition period of implementation of HPSP. The essential programmes should be further integrated for their sustainability and participation by the NGOs, community and the private practitioners should be strengthened.

Several studies have been carried out on the community based DOT in a variety of settings. However, although some have been very large, most of them have been relatively small. The Hlabisa TB Control Programme in rural south Africa has used community-based DOT extensively since mid 1991. A detailed analysis of the data belonging from 1991 to 1996 is done to find out reporting trends in adherence, timing of treatment interruption and risk factors for failing to complete therapy. The study was carried out in a population of 2.1 lakh zulu speaking people who are mostly farmers, labourers and pensioners with middle income and 69% literacy rate. HIV seroprevalence among adult TB patients increased from 36% in 1991 to 66% in 1997 and consequent to that annual case detection increased from 321 to 1250 by 1996. Of the 3610 surviving patients, 629 (17%) failed to complete treatment ranging from 11% in 1991-92 to 22% in 1996. Association of treatment interruption with age, sex, type of TB and HIV status was observed as follows: Age specific frequency distribution for treatment interruption was higher among those aged 25-34 years and significantly greater than among the patients aged 0-14 years and those aged 55 years and over. A similar age specific frequency distribution for treatment interruption was observed each year. Treatment interruption was higher in men than women. The interruption rate was similar among patients with smear positive pulmonary TB, smear negative and extra pulmonary disease. Treatment interruption was more frequent among patients known to be HIV infected (25%) than among those whose HIV status was unknown (17%) and those known to be HIV infected (12%). The pattern was observed each year and was unaffected by age or sex. The interruption of treatment among HIV infected and not tested for HIV patients was high when supervised by health worker. The interruption of treatment increased between 1991/92 – 1996 and was greatest among patients supervised at clinics. The single independent risk factor for treatment interruption was diagnosis between 1994-1996 compared with 1991-93 (odds ratio [OR] 1.9, 95% confidence interval [CI] 1.6-2.4). The second factor was known HIV- positive status versus known HIV-negative status (OR 1.8, 95% CI 1.4-2.4); supervised by village clinic with community worker (OR 1.9) and male versus female (OR 1.3). In conclusion, adherence to therapy in a community with high caseload, migration remains a challenge even with the community based DOTS.

Non-adherence to treatment is an obstacle to the control of TB. Among many reasons mentioned for non-adherence, providers’ attitude, behaviour and knowledge and skill in dealing with TB patients has been cited as an important factor. Few studies also indicate that communication between patient and provider during interaction also plays an important role in the therapeutic process. Hence, this present study on patient-provider interaction was designed to describe some of the factors affecting adherence to TB treatment at LWTDTC, at urban district of Bangalore and its catchment area. The main objectives of the study were to find out the rate of adherence, application of present national control programme, patient perception of DOTS, retrospective elucidation of patient provider interaction and its influence on adherence to treatment. Treatment cards of a total of 602 smear positive patients treated with SCC regimen during Jan to Sept 1997 were analysed. From among them, 11 completed patients and 13 non-adherent patients were selected by systematic random sampling for subsequent interviewing. Further, 10 patients out of 153 patients who were under treatment from April to May 1998 and 15 patients receiving DOTS from 4 Treatment Units were selected by purposive sampling for the interviews. In addition, 23 health care providers (physicians, nurses, health visitors, laboratory technicians and health workers) were interviewed.

Most of the patients interviewed have sought the help of private health services prior to their diagnosis with the belief that their illness is not severe and attributed to cold, fever and viral infections. A majority of the patients were diagnosed within four weeks at the place of treatment. Only some had delay of more than 4 weeks. They were either referred by the initial provider (majority) or by self-motivation. Of the 602 patients, 449 (74.5%) did not complete the treatment. The non-adherence was more significant in the age group of 21-40 years. Defaulting was higher among males than females. The defaulting was early, as 64.3% defaulted within three months. None of the non-adherent patients reported having received a letter or being personally contacted by the staff. The patients put on DOTS had a separate box of anti-TB drugs for him/her and were given drugs in the intensive phase three times a week under direct observation and once a week in the continuation phase and two doses for self-administration. The results were that 74.2% of the patients put on DOTS were cured at the end of treatment. The providers have strong belief that DOTS is the answer to the problem of low adherence.

The most common reasons given for non-adherence by patients, providers and key informants, were lack of family support, providers behaviour, drug side effect, disappearance of symptoms, alcohol and smoking. Adherent patients attributed family support, self-motivation and providers’ assurance as motivating factors for completion of the treatment.

Pulmonary TB is curable when presently available regimens are given to adherent patients under study conditions. Studies show that DOT i.e., a programme in which health care personnel witness patients taking all prescribed TB treatment to be more effective than traditional therapy in which prescribed medications are self-administered by the patients. It reduces the prevalence of chronic bacillary cases, relapse rates, incidence of primary, acquired and Multi Drug Resistant TB. Treatment completion and compliance rates are higher with DOT. This study compares the cost of TB treatment in DOT (it is not widely used; it is perceived to be too expensive) to the traditional therapy. The objective of the study was to directly measure the cost of TB treatment under actual programme conditions. The cost of staff salary, laboratory, outreach, medication and hospitalization were included in the measurement.

The study was a retrospective economic evaluation of all cases reported to the Tarrant County Texas Health Department, USA. The health department serves about 1 million people of greater Fort Worth metropolitan area. The patients who were culture positive, had no history of previous treatment and patients actually managed by traditional or observed therapy were eligible for intake; legally quarantined, lost to therapy, dying from other diseases, were not included for the cost analysis. Eligible patients presenting between Jan 1980 and Dec 1985 were included in the traditional group. Patient treatment costs were followed through 31st Dec 1987, while in the DOT group patients between Jan 1987 and 31st Dec 1992 were included and treatment costs were followed through 31st Dec 1994. Nearly all the patients in either group received their prescribed therapy. Cost estimates were characterized by a cost parameter and a unit rate with cost being determined from the products of the two. Cost parameters describe different elements of treatment i.e., number of X-rays, days hospitalized, physician care time, etc., and are independent of cost which provides a base for comparing the relative costs of each program. Unit rates reflect 1995 pricing for labour, services and materials and representative of costs in Tarrant County Texas. In-patient cost was determined as $600 per day for days hospitalized for TB, out-patient cost parameters included personnel service and travel time, travel mileage, number of laboratory tests, number of X-rays done and medication prescribed.

The Physicians treating TB have three out-patient management options, traditional therapy and universal or selective DOT. The selective DOT suffers from the same flaws as traditional therapy specially the inability to predict, identify and measure non-adherence.

The authors feel that out-patient management with universal DOT should be the standard public health treatment protocol, because it is both more effective and less expensive. A total of 659 patients were studied which included 257 traditional group and 402 in DOT group. The data shows that the treatment cost for traditional therapy is significantly higher ($27630 v/s $11260, P < 0.001). Out patient cost was significantly higher for patients treated with traditional therapy ($2920 v/s $2220) although personnel cost was greater for DOT group. Hospital costs were higher for patients treated with traditional group ($24710 v/s $9040, P < 0.001). The average cost of treatment failures was $94520 in the traditional group and $54350 in the observed group. Relapse or acquired resistance occurred in 10.9% of patients and accounted for 35.7% of the cost with traditional therapy as compared to 1.2% of patient and 6.0% of cost with observed therapy.