Directly Observed Treatment, Short-Course (DOTS)

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1 EDITOR S CHOICE JIACM 2004; 5(2): Abstract Directly Observed Treatment, Short-Course (DOTS) SK Sharma*, A Mohan** Directly observed treatment, short-course (DOTS), is recommended by the World Health Organisation (WHO) globally, for control of tuberculosis (TB). DOTS strategy which aims at detecting at least 70% of the existing cases of sputum smear-positive cases and curing at least 85% of these newly detected cases, has been observed not only to ensure cure but also reduce the number of deaths due to TB. DOTS also results in the reduction of the prevalence of TB by reducing the pool of infectious cases and curtailing the disease transmission. The short-course anti-tuberculosis treatment regimens employed in the DOTS strategy are effective and the supply of drugs is uninterrupted. As regular drug intake is ensured with DOTS strategy by direct observation, drug resistance and relapses develop less frequently. The revised national tuberculosis control programme (RNTCP) of India has adopted the DOTS strategy for the control of TB and has expanded rapidly during the last five years. From a coverage of 18 million in mid-1998, as of June 30, 2003, DOTS coverage has expanded to 712 million of India s population. India s DOTS programme is the second largest in the world. The current expansion is rapidly progressing and the entire country is expected to be covered by The initial experience with DOTS suggests that, in areas of the world where the prevalence of drug-resistant TB is high, modifications such as DOTS-Plus strategy may be required to achieve the desired results. From a public health point of view, the DOTS strategy is indeed one of the most cost-effective health interventions ever conceived. Key words : DOTS, Tuberculosis, Control, DOTS-Plus. Introduction Tuberculosis (TB) has been a major cause of death and suffering since ancient times 1. M.tuberculosis is most often transmitted by the inhalation route as droplet infection. Therefore, interrupting the transmission of TB at the source is of considerable importance in the control of TB. Till the discovery of streptomycin, isoniazid and paraaminosalicylic acid (PAS) in the mid-1940s, it was not possible to cure TB. Subsequently, short-course chemotherapy (SCC) became available with the introduction of rifampicin, pyrazinamide, and ethambutol 2. Even though predictable, curative drug therapy is available, TB continues to plague mankind. Worldwide, TB remains a serious cause of illness and death; so serious as to have been declared a global emergency in 1993 by the World Health Organization (WHO) 3. Thus, it becomes evident that mere availability of anti-tuberculosis drugs is not enough to control TB 4. From a public health point of view, irregular, incomplete treatment of TB is more dangerous than no treatment at all. When patients fail to complete standard treatment regimens, or receive the wrong treatment, they continue to remain infectious, may harbour drug resistant strains that may be passed on to others. For example, in a study conducted in south India 5, it was observed that only 43% of the patients receiving short-course treatment (n = 2,306) and 35% of those receiving standard chemotherapy (n = 1051) completed 80% or more of their treatment 5. Poorly functioning control programmes, use of non-standard treatment regimens with varying drug combinations of doubtful bioavailability for variable periods of time have all been implicated as important causes for the emergence of multidrug-resistant tuberculosis (MDR-TB, defined as M.tuberculosis resistant to rifampicin and isoniazid). As MDR-TB is very difficult to treat, prevention of development of MDR-TB by ensuring cure of new smearpositive patients is a much higher public health priority than its treatment. Directly observed treatment, short-course (DOTS) is an interventional strategy developed by Dr. Karel Styblo and is recommended by the WHO as the strategy that ensures cure of TB 6. Several key concepts underlying the DOTS strategy are : i. domiciliary treatment; ii. need for supervised treatment now called directly observed treatment (DOT); iii. effectiveness of intermittent treatment with the medications administered two or three times a week was effective; and * Department of Medicine, All India Institute of Medical Sciences, New Delhi ** Department of Emergency Medicine, Sri Venkateswara Institute of Medical Sciences, Tirupati , A.P.

2 iv. the crucial contribution of sputum microscopy which is very effective as a case finding tool have their roots in the monumental research work carried out in India 7. DOTS strategy The fundamental principles of the DOTS strategy 2 are listed in Table I. Table I : Fundamental principles of the DOTS strategy. Political will Case-finding primarily by sputum smear microscopy, among patients presenting to health facilities Standardised short-course chemotherapy with firstline anti-tuberculosis drugs given under direct observation Adequate uninterrupted drug supply, and Systematic monitoring and accountability for every patient diagnosed. Political will In many countries, efforts to control TB are poorly funded and supported. Strong political will and government commitment are essential for ensuring communication and collaboration between local health authorities, the primary health care system, hospitals, medical schools, private practitioners, non-governmental organisations (NGOs), and others. Diagnosis by sputum microscopy In the DOTS strategy, diagnosis of TB is based primarily on microscopy rather than clinical examination, chest radiograph or culture, primarily among patients attending health facilities and not by active case-finding in the community. Sputum microscopy is a highly specific test a low-cost, appropriate technology which can be reliably and reproducibly performed even in remote areas 7. It is also useful to monitor the outcome and confirm that a patient with TB is cured. Directly observed standardised short-course treatment Short-course chemotherapy refers to a treatment regimen that uses a combination of anti-tuberculosis drugs and lasts six to eight months. Anti-tuberculosis drugs can only be effective if they are taken 7. Directly observed therapy (DOT) is essential to ensure that the drugs are taken in the right combinations and for the appropriate duration. However, ensuring regular intake of drugs during unsupervised self-administration for prolonged periods is very difficult and may lead to the emergence of MDR- TB. Depending on the local requirements, observation must be done by a person who is accessible and acceptable to the patient and who is accountable to the health system 8,9. There is a chance for TB control only when all patients diagnosed to have TB get treated properly. Thus, there is a need for universal implementation of DOTS strategy. Adequate supply of good quality drugs Ensuring adequate supply of good quality antituberculosis drugs is essential for TB control. In the DOTS strategy, an accurate recording and reporting system provides the information needed to plan and maintain adequate drug stocks. Systematic monitoring and accountability Good record-keeping facilitates easy review and audit. This system not only allows effective programme management but also operational research. DOTS and TB control The revised national tuberculosis control programme (RNTCP) of the Government of India has adopted the DOTS strategy and aims at detecting at least 70% of the existing cases of sputum smear-positive TB and curing at least 85% of these newly detected cases. DOTS strategy has beneficial effects much beyond simply curing the patients with TB (Table II). It reduces the number of deaths due to TB. It also reduces the prevalence of TB by reducing the pool of infectious cases and the disease transmission. Since the treatment regimens are effective, drug supplies are not interrupted and regular drug intake is ensured by direct observation, relapses and drug resistance develop less frequently 5. The DOTS strategy has been implemented successfully world over. The RNTCP of India has expanded rapidly during the last five years 10,11. From a coverage of 18 million 110 Journal, Indian Academy of Clinical Medicine Vol. 5, No. 2 April-June, 2004

3 in mid-1998, as of June 30, 2003, DOTS coverage has expanded to 712 million of India s population 12. India s DOTS programme is the second largest in the world. The current expansion is rapidly progressing and the entire country is expected to be covered by Since its inception, the programme has initiated over 2.5 million patients on treatment, and cure rates are around 85%, while case detection for 2002 was 59% and is moving towards the 70% target 13. Table II : Advantages of DOTS strategy in the control of TB : The Indian experience. DOTS strategy: More than doubles the accuracy of TB diagnosis results in success rates of up to 95% cuts down TB deaths by seven fold doubles the cure rate reduces the incidence and prevalence of TB helps in alleviating poverty by saving lives, reducing the duration of illness and preventing new infectious cases improves the quality of care and overcomes stigma prevents treatment failure and the emergence of MDR- TB. The future Although the DOTS strategy has been widely accepted, many developing countries have been unable to expand coverage as rapidly as required and have failed to achieve the global targets of 70% case detection and 85% cure by the year In March 2000, the Amsterdam Declaration to Stop TB called for increased political commitment and financial resources to reach the targets for global TB control by In May 2000, this call was restated by a resolution of the world health assembly (WHA). In response to these efforts, national tuberculosis programme (NTP) managers of the 22 high-burden countries, technical partners, financial partners, and the global TB network of WHO agreed to develop a global DOTS expansion plan (GDEP) 14. With the aim of development of national DOTS expansion plans and partnership-building to control TB. DOTS-Plus It has been observed that in areas of minimal or no MDR-TB, DOTS achieves cure rates of up to 95%; results in a dramatic reduction in the TB burden and will be able to prevent the emergence of drug-resistant TB However, standard short-course chemotherapy has been found to be inadequate treatment for some patients with drug-resistant TB 19. These observations suggest that although the DOTS strategy is good for TB control, it requires to be modified in some settings. In 1998, WHO and several partners around the world conceived DOTS-Plus strategy for the management of MDR-TB This strategy is under continuous development and testing and is considered to be a supplement to the DOTS strategy. The green light committee, a sub-group of the working group, has been established for this purpose. WHO is a permanent member of the green light committee and houses the Secretariat. The green light committee approves, oversees, and conducts pilot projects for the management of MDR-TB and aims to improve access to second-line anti-tb drugs for DOTS-Plus 21. In the DOTS-Plus strategy 20,21, which has been conceived to work as a supplement to the standard DOTS strategy, certain modifications have been suggested for all five elements of the DOTS strategy such as providing individualised treatment; provision of on-site laboratory facilities for culture and sensitivity testing, reliable supply of second line drugs among others (Table III). In a recently published decision analysis 23, it was observed that fewer TB deaths would occur under DOTS-Plus than under DOTS under conditions of optimal implementation. If, however, implementation of DOTS- Plus were associated with even minimal decreases in the effectiveness of treatment, considerably larger number of patients would die than under DOTS 23. These aspects merit further evaluation. A co-ordinated effort by all concerned is required to ensure that majority of the patients with TB get treated through the RNTCP-DOTS strategy, for this appears to be the only way to control TB. Conservative estimates are that nationwide effective DOTS implementation by 2005 would result in cumulative savings of more than US$ 27 billion through the year Thus, DOTS is indeed one of the most cost-effective health interventions ever conceived 24! Journal, Indian Academy of Clinical Medicine Vol. 5, No. 2 April-June,

4 Table III : DOTS-Plus strategy. DOTS strategy DOTS-Plus strategy Standardised treatment throughout Individualised treatment regimens when mycobacterial culture the duration of treatment and antituberculosis drug sensitivity reports become available. Diagnosis by microscopy Local facilities for mycobacterial culture and anti-tuberculosis drug sensitivity testing. Availability of facilities for second-line antituberculosis drug sensitivity testing. Reliable supply of a limited number Provision of a wide-range of second-line anti-tuberculosis drugs, of reliable first-line drugs laboratory consumables, and prevention of uncontrolled use of second-line drugs. Continuous evaluation of patient notifications, Three monthly culture and anti-tuberculosis drug susceptibility smear results, and outcomes testing and more extensive programmatic reviews. Commitment from the local government Additional support from external governments and agencies. References 1. Mohan A, Sharma SK. History. In: Sharma SK, Mohan A, editors. Tuberculosis. New Delhi: Jaypee Brothers Medical Publicshers; 2001; p Sharma SK, Mohan A. Scientific basis of directly observed treatment, short-course (DOTS). J Indian Med Assoc 2003; 101: 157-8, Grange JM, Zumla A. The global emergency of tuberculosis: what is the cause? J R Soc Health 2002; 122: Grzybowski S. Drugs are not enough. Failure of short-course chemotherapy in a district in India. Tuber Lung Dis 1993; 74: Datta M, Radhamani MP, Selvaraj R, et al. Critical assessment of smear-positive pulmonary tuberculosis patients after chemotherapy under the district tuberculosis programme. Tuber Lung Dis 1993; 74: World Health Organization. Framework for effective tuberculosis control. WHO/TB/ Geneva : World Health Organization; Frieden TR. Directly observed treatment, short-course (DOTS): The strategy that ensures cure of tuberculosis patients. In: Sharma SK, Mohan A, editors. Tuberculosis. New Delhi: Jaypee Brothers Medical Publishers;2001; p World Health Organization. Treatment of tuberculosis. Guidelines for national programmes. 2nd ed. WHO/TB/ Geneva: World Health Organization; Bam DS, Smith IM. Tuberculosis prevention and control. In: Narain JP, editor. Tuberculosis epidemiology and control. New Delhi: World Health Organization Regional Office for South-East Asia; 2002; p Khatri GR, Frieden TR. Controlling tuberculosis in India. N Engl J Med 2002; 347: Khatri GR, Frieden TR. Rapid DOTS expansion in India. Bull World Health Organ 2002; 80: Mohan A, Sharma SK. Medical schools and tuberculosis control: bridging the discordance between what is preached and what is practiced. Indian J Chest Dis Allied Sci 2004; 46: TB India RNTCP Status report. New Delhi: Central TB Division, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India; World Health Organization. Global dots expansion plan. Available at URL: Dots_expansion/index.htm. Accessed on 1 Jan Davies PD, Yew WW. Recent developments in the treatment of tuberculosis. Expert Opin Investig Drugs 2003; 12: Yew WW. Directly observed therapy, short-course: the best way to prevent multidrug-resistant tuberculosis. Chemotherapy 1999; 45 (Suppl 2): Balasubramanian VN, Oommen K, Samuel R. DOT or not? Direct observation of anti-tuberculosis treatment and patient outcomes, Kerala State, India. Int J Tuberc Lung Dis 2000; 4: Mukherjee JS, Joseph JK, Rich ML, et al. Clinical and programmatic considerations in the treatment of MDR-TB in children: a series of 16 patients from Lima, Peru. Int J Tuberc Lung Dis 2003; 7: Espinal MA, Kim SJ, Suarez PG, et al. Standard short-course chemotherapy for drug-resistant tuberculosis: treatment outcomes in 6 countries. JAMA 2000; 283: Bastian I, Rigouts L, Van Deun A, Portaels F. Directly observed treatment, short-course strategy and multidrug-resistant tuberculosis: are any modifications required? Bull World Health Organ 2000; 78: Gupta R, Cegielski JP, Espinal MA, et al. Increasing 112 Journal, Indian Academy of Clinical Medicine Vol. 5, No. 2 April-June, 2004

5 transparency in partnerships for health introducing the green light committee. Trop Med Int Health 2002; 7: Farmer P, Kim JY. Community based approaches to the control of multidrug resistant tuberculosis: introducing DOTS-plus. BMJ 1998; 317: Sterling TR, Lehmann HP, Frieden TR. Impact of DOTS compared with DOTS-plus on multidrug resistant tuberculosis and tuberculosis deaths: decision analysis. BMJ 2003; 326: Frieden TR, Sterling TR, Munsiff SS, et al. Tuberculosis. Lancet 2003; 362: A N N O U N C E M E N T XII Annual Conference of Indian Association of Clinical Medicine Dr. Nitya Nand 3/7J, Medical Enclave, Professor of Medicine, PGIMS, Rohtak Rohtak President-Elect, IACM Phone Chairman, Scientific Committee Dear Colleague, I would like to express my gratitude to you for resposing your faith and confidence in electing me for the post of President-Elect of IACM. I hope to live up to your expectations and assure you of my relentless and untiring efforts in achieving the highest standard of academic activities. As President-Elect, I have the important responsibility of preparing the Scientific Programme and Clinical Medicine Update 2004 for our next annual conference, being held on September 2004, in the city of The Taj Agra (UP). There has been tremendous explosion of knowledge in the field of Medicine during the last 2 decades directed towards providing better health care. The primary aim of any scientific meet is to share this expanding knowledge. Your feedback and suggestions will be of immense importance in preparing the scientific programme, and in the update book. I would therefore, like to take this opportunity to request you to send me your suggestions regarding : 1. The topics for inclusion in the symposia, plenary sessions, workshops, clinical case presentation, CPC, etc. 2. Topics to be covered in the Clinical Update Any other suggestion, which may improve the quality of contents and interaction amongst the members of the association. The important dates for the scientific programmes are : 1. Last date for the suggestions on scientific programme : Last date for receiving free papers : Last date for sending case presentation summary : There would be prizes for the two best papers. I would request the fellows/members to encourage the PG students to actively participate in the conference. The abstract for the Free Papers should not exceed 250 words. The scientific committee is hopeful that scientific programme during the IACMCON-2004 will enable us to enrich ourselves in the field of clinical medicine. I look forward to your early response. Yours sincerely, (Nitya Nand) Journal, Indian Academy of Clinical Medicine Vol. 5, No. 2 April-June,

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