1.9 Effective TB Control: WHO Strategy for Controlling Tuberculosis

Home , Oblast, Raion

The work upon which this publication is based was performed in part under Grant Agreement 118-G-00-99-00112 (WHO) and PASA 118-P-00-98-00165 (DHHS/CDC) funded by the U.S. Agency for International Development. The opinions expressed herein are those of the author(s) and do not necessarily reflect the views of the U.S. Agency for International Development.

Additional funding was provided by the World Health Organization and the Centers for Disease Control and Prevention.

2003

1 Introduction: Managing TB at the Raion Level

Module 1 – Table of Contents

1.1 Purpose of the Course ...... 1 1.2 Target Audience...... 1 1.3 Organization of the Course ...... 1 1.3.1 Course Materials To Be Used...... 1 1.3.2 The Role of a Facilitator...... 3 1.4 Course Goal and Objectives...... 3 1.5 TB Transmission ...... 5 1.6 Global and Regional Burden of TB...... 5 1.7 TB Burden in Russia ...... 6 1.8 Factors Contributing to The Rise of TB in Russia...... 7 1.9 Effective TB Control: WHO Strategy for Controlling Tuberculosis ...... 9 1.10 Aim of a National Tuberculosis Program ...... 12 1.11 The Structure of the TB Health Care Delivery Program in Russia...... 13 1.11.1 The Central Level ...... 15 1.11.2 The Oblast Level ...... 16 1.11.3 The Raion Level ...... 17 1.11.4 General Medical Services Level...... 18 1.12 Summary ...... 19 Annex A...... 21 Annex B ...... 41

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1 Introduction: Managing TB at the Raion Level

1.1 Purpose of the Course The tuberculosis (TB) training modules entitled Managing Tuberculosis at the Raion Level are a series of educational modules designed to provide the technical knowledge and skills essential for TB control at the Raion (district) level in Russia. The course has been developed by the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), in collaboration with the Central Tuberculosis Research Institute (CTRI) in Moscow, and TB specialists from Oblasts implementing the WHO’s strategy for controlling TB.

The information presented in this course is based on experiences of the implementation of the WHO’s proven and cost-effective TB treatment strategy known as directly observed treatment short-course. This course provides an overview of the technical knowledge and skills needed to implement the WHO’s strategy for TB control in the context of the health care delivery system in Russia.

1.2 Target Audience The target audience for this course is the TB Specialist or TB Coordinator at the raion level, as well as other raion-level staff who are responsible for planning, organizing, delivering, and supervising TB control activities at the raion level. Although the principal target audience is raion-level staff, the information in this course may also be relevant for oblast level staff who supervise TB activities at the raion-level.

1.3 Organization of the Course

1.3.1 Course Materials To Be Used This course consists of 11 instructional booklets called modules, which serve as the main resource for this course, a workbook to complete the exercises found within the modules, and an answer book. The modules review the technical knowledge and skills essential for TB control at the raion level. Within the modules are exercises that allow the course participant to practice important skills for planning, organizing, delivering, and supervising TB control at the raion level. The course Workbook is essentially consists of copies of the TB Patient Register (TB 03), and is used for all exercises that involve working with a TB Patient Register (TB 03).

Each module is based on a major task that makes up a raion TB Coordinator’s job.

1 1 Introduction: Managing TB at the Raion Level

These major tasks are: Module 1: Introduction to managing TB at the Raion level Module 2: Identification of tuberculosis suspects Module 3: Administering treatment Module 4: Registering cases Module 5: Monitoring treatment outcomes Module 6: Completing quarterly reports on new cases and relapses of tuberculosis Module 7: Completing quarterly reports on treatment results of pulmonary patients Module 8: Maintaining regular drug supplies and other materials Module 9: Supporting laboratory services Module 10: Conducting supervisory visits Module 11: Patient education

Each module contains the following sections: • Introduction: Background information to help the reader understand the purpose of the module. • Objectives: A guide to the information included in the module. • Reading material: The reading material for the module, including forms. • Study exercises: Sets of exercises, spread throughout the reading material, designed to help the reader apply the knowledge learned during the course. These will either be individual or group exercises. • Summary: A description of key points in the module.

Before each individual exercise, the following picture will appear:

For the group exercises, course participants will be asked to work with other participants to discuss answers to a given situation or to participate in a role-play exercise. A facilitator will lead the small group discussions and observe and comment on each role-play exercise.

Before each group exercise, the following picture will appear:

2 1 Introduction: Managing TB at the Raion Level

1.3.2 The Role of a Facilitator Although the course modules can be used on their own, the course is designed to be facilitated in a classroom setting by a course facilitator. The facilitator should be an expert in the WHO’s strategy for controlling TB and could be from the raion, oblast, national, or international level. The facilitator should give an overview of the content in each module. The participants should then read the module and work through the individual exercises at their own pace. The facilitator should also lead group exercises and summarize each module.

The facilitator should • introduce each module; • answer questions whenever they arise, or find the appropriate answer; • facilitate group discussions; • summarize each module.

1.4 Course Goal and Objectives The goal of this course is to increase the technical knowledge and skills of staff at the raion level and to improve their ability to implement the proven and cost- effective WHO’s strategy for controlling TB.

The course provides the knowledge and needed skills to identify TB suspects, diagnose TB disease, treat patients effectively, monitor the patients during treatment, and evaluate treatment outcomes at the end of chemotherapy. The WHO strategy for controlling TB requires the completion of several cards, forms and registers. This course provides an overview of the procedures for completing these documents. An explanation and example of each card, form, and register can be found in Appendix A of this introduction module.

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Table 1.1 Names of Cards, Forms, and Registers used in WHO Strategy for Controlling TB TB Patient Treatment Card (TB 01) TB Patient Register (TB 03) Tuberculosis Laboratory Register (TB 04) Request For Sputum Microscopy Examination (TB 05) Request for Culture/Drug Sensitivity Testing Form (TB 06) Quarterly Report on New Cases and Relapses of Tuberculosis (TB 07) Quarterly Report on the Results of Treatment of Pulmonary Tuberculosis Patients Registered 12-15 Months Earlier (TB 08) Tuberculosis Referral/Transfer Form (TB 09) Quarterly Report on Sputum Conversion (TB 10)

Course Objectives By the end of the course, participants should be able to perform the following objectives: • Complete TB Patient Treatment Card (TB 01); • Ensure the proper prescription and administration of drugs during the entire course of treatment, and document patient adherence; • Provide health education to patients and train health workers to do the same; • Register patients in the TB Patient Register (TB 03); • Verify that patients’ sputum specimens have been examined at the correct intervals and record the results in the TB Patient Register (TB 03); • Review the TB Patient Treatment Card (TB 01) to identify treatment outcomes and record the treatment outcomes in the TB Patient Register (TB 03); • Control data entry into Tuberculosis Laboratory Register (TB 04) • Complete the Request For Sputum Examination (TB 05) and Tuberculosis Culture/Sensitivity Test Request/Report Form (TB 06;) • Complete the quarterly reports: on case-finding, sputum conversion, and treatment outcomes: Quarterly Report on New Cases and Relapses of Tuberculosis (TB 07); Quarterly Report on the Results of Treatment of Pulmonary Tuberculosis Patients Registered 12-15 Months Earlier (TB 08); and the Quarterly Report on Sputum Conversion (TB 10). • Train health workers to properly identify suspect patients of tuberculosis; • Train health workers to properly collect and transport sputum specimens; • Train health workers to refer suspect patients for future diagnosis to raion or oblast level TB dispensary;

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• Work with oblast level staff to ensure that an adequate supply of drugs and other materials for the raion are maintained; • Monitor the Tuberculosis Laboratory Register (TB 04); • Monitor the documentation related to microscopy and culture examinations; and • Conduct supervisory visits to the health units.

1.5 TB Transmission TB is a contagious disease that is caused by the organism Mycobacterium tuberculosis. Like the common cold, it is spread mainly through the air. However, only people who are sick with pulmonary TB are infectious. When infectious people cough, sneeze, talk, or spit, they propel TB germs, known as bacilli, into the air. A person needs only to inhale a small number of bacilli to be infected. It is also possible to get infected with Mycobacterium bovis by drinking unpasteurized milk from cows with bovine TB. However, this is a rare event and such infection usually develops into a nonpulmonary form of the disease, which is noninfectious and does not spread from person to person.

Left untreated, each person with active TB will infect on average, between 10 and 15 people every year. But people infected with TB germs will not necessarily get sick with the disease. Only 5%-10 % of people who are infected with TB become sick or infectious at some time during their life. The immune system stops and contains the TB bacilli, which can lie dormant for years. When someone’s immune system is weakened, the chances of getting sick increase. • Someone in the world is newly infected with TB every second. • Nearly 1% of the world’s population is newly infected with TB each year. • Overall, one third of the world’s population is currently infected with the TB bacillus.

1.6 Global and Regional Burden of TB Tuberculosis (TB) kills about 2 million people each year, and around 8 million people become sick with TB disease. The global epidemic is growing and becoming more dangerous. The breakdown in health services, the spread of HIV/AIDS, and the emergence of multidrug-resistant TB are contributing to the worsening impact of this disease.

In 1993, concern about the TB epidemic was so great, that the WHO took an unprecedented step and declared TB a global emergency.

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It is estimated that between the years 2000 and 2020, nearly one billion people will be newly infected, 200 million people will get sick, and approximately 40 million will die from TB if control is not further strengthened.

Globally, each year, more people are dying of TB. The TB burden is also increasing in Eastern Europe and the former Soviet Union, where TB deaths are increasing after almost 40 years of steady decline. • Over 1.5 million TB cases per year occur in sub-Saharan Africa. This number is rising rapidly as a result of the HIV/AIDS epidemic. • Nearly 3 million TB cases per year occur in Southeast Asia. • Over a quarter million TB cases per year occur in Eastern Europe.

1.7 TB Burden in Russia The number of TB cases reported in the Russian Federation has more than doubled since the early 1990s (see Figure 1.1) (Russian Ministry of Health, 2000). With the number of new cases exceeding 130,000 in 2000 (for a case rate of 90/100.000), Russia ranks 11 among 22 highest burden TB countries in the world, and has one of the highest TB case rates among developed countries. The TB mortality rate was about 20 per 100,000 population in 1999, which is the highest TB mortality rate in Europe. Figure 1.1 Number of Cases Reported, 1981-1990 ,

140000 120000 100000 80000 60000 40000 20000 No. of TB Cases Notified 0 1981 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999

Year

There is a serious TB epidemic occurring in the prison system in Russia. TB rates in Russian prisons are rising significantly and these prisoners threaten to become a continuous source of infection for the civilian population, especially the prisoners with multidrug resistant (MDR) TB. Every year, there are about 100,000 prisoners with active forms of TB in detention centers, and the TB case rate is estimated to be about 50 times higher than in the civilian population. Similarly, the TB mortality rate in Russian prisons is estimated to be nearly 30 times higher than in the civilian population.

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The lack of anti-TB drugs and the use of nonstandardized and suboptimal therapies have resulted in alarmingly high numbers of MDR TB cases, both in the civilian and prison populations. Surveillance of drug resistance in some oblasts showed MDR TB among approximately 9% of new cases (from a survey conducted between 1996 and 1999). A survey carried out in one prison in Siberia has documented a rate of almost 17% rate of primary MDR TB, which is one of the highest ever reported in the world. Today in Russia, it is extremely difficult to cure patients with MDR TB due to the lack of second-line drugs, sufficient laboratory support, and adequately trained staff.

1.8 Factors Contributing to The Rise of TB in Russia The following factors have contributed to the rise of TB in Russia: • Cuts in health care expenditures resulting in inadequate budgets for case finding and treatment; • Limited access to health care, especially for vulnerable groups (i.e., ex- prisoners, homeless persons, migrants, people living in far distances from health care facilities); • Increase of TB and MDR TB in prisons; • Migration from former USSR countries with a high TB burden (i.e., central Asian republics and the Caucasus); • Social crises (unemployment, substance abuse, poverty and stress); • A lack of ability of health care workers within the general medical services to and properly identify patients suspected of having TB; • The increasing HIV and TB coepidemics.

In the early 1990s, Russia underwent a revolutionary transition from a centralized into a market-oriented economy. Unprecedented in terms of scale, scope, and speed, this change resulted in the deterioration of internal and external trade and a rapid rise in the fiscal deficit, which resulted in major cuts in public health expenditures, including health care. Economic difficulties, the deterioration of the public health infrastructure, and unhealthy behaviors (i.e., smoking, alcohol and drug abuse, and unbalanced diet), resulted in the decline of the health status of the population.

Due to the political and economic transition, the decentralization of the health care system, and reductions in the overall health budget, the TB control network is finding it difficult to address the increasing TB burden. In addition, high rates of TB among marginalized population groups (e.g., prisoners, migrants, and homeless persons) provide further challenges to controlling TB.

7 1 Introduction: Managing TB at the Raion Level

The TB health care delivery system in Russia is undergoing reorganization to adjust to both budgetary restrictions and an increase in the TB caseload. Access to health care, especially for marginalized groups, must be taken into consideration during this process. In particular, the primary (general) health facilities will need to be involved in case finding and initial diagnosis of TB.

The biggest challenge to controlling TB in Russia is the increasing problem of MDR TB. Drug-resistant TB is caused by inconsistent or partial treatment. It develops when patients do not take all their drugs regularly for the required period because they start to feel better, when doctors and health workers prescribe the wrong treatment regimens, or when the drug supply is unreliable.

MDR TB is a type of TB disease caused by TB bacilli that are resistant to at least isoniazid and rifampicin—the two most powerful anti-TB drugs. MDR TB is rising at alarming rates in former Soviet Union.

Poorly supervised or incomplete treatment of TB is the cause of MDR TB. When people fail to complete standard treatment regimens, or are given the wrong treatment regimen, they may remain infectious. The bacilli in their lungs may develop resistance to anti-TB drugs. People they infect will have the same drug-resistant strain. While drug-resistant TB is treatable, it requires extensive chemotherapy (up to two years of treatment) that is often prohibitively expensive (often more than 100 times more expensive than treatment of drug-susceptible TB), and is also more toxic to patients.

Another factor affecting the TB problem in Russia is HIV infection. HIV accelerates the spread of TB by weakening the immune system. HIV and TB form a lethal combination, each speeding the other’s progress. A person who is HIV- positive and infected with TB is many times more likely to become sick with TB than someone infected with TB who is HIV-negative. TB is a leading cause of death among people who are HIV-positive, accounting for about 15% of AIDS deaths worldwide. HIV is increasingly becoming a significant health care issue in Eastern Europe and the former Soviet Union, especially in Russia (see Figure 1.2).

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Figure 1.2 Number of Newly Diagnosed HIV Infections in Belarus, Russia, and Ukraine, 1993-1999

22000 Russia 20000 18000 16000 14000 12000 10000 8000

Number of HIV cases Ukraine 6000 4000 2000 Belarus 0 1993 1994 1995 1996 1997 1998 1999

Source: Euro-AIDS, 2000.

1.9 Effective TB Control: WHO Strategy for Controlling Tuberculosis For more than 100 years, microscopes have been able to detect the bacterium that causes TB. For almost 50 years there have been effective anti-TB drugs.

Methods and tools exist for detecting and curing TB patients. However, the problem has been the lack of organized services that ensure widespread detection and treatment of TB patients, particularly the infectious ones. Today, however, there is a proven, cost-effective TB treatment strategy known as DOTS (directly observed treatment), which is recommended by the WHO and the International Union Against TB and Lung Disease (IUATLD).

The WHO strategy for controlling TB is a combination of technical and managerial components. This strategy quickly makes the infectious cases noninfectious and breaks the cycle of transmission. The WHO strategy also prevents the development of drug-resistant TB, which is often fatal and always more expensive to cure.

The WHO strategy for controlling TB is the most effective strategy available for controlling the TB epidemic today. It has five key components:

9 1 Introduction: Managing TB at the Raion Level

The Five Components of the WHO Strategy for Controlling TB 1. Government commitment to sustained TB control activities. 2. Case detection by sputum smear microscopy among symptomatic patients self-reporting to health services. 3. Standardized treatment regimen of six to eight months for at least all confirmed sputum smear positive cases, with directly observed treatment (DOT). 4. A regular, uninterrupted supply of all essential anti-TB drugs. 5. A standardized recording and reporting system that allows assessment of treatment results for each patient and of the TB control program overall.

The WHO strategy combines five elements: political commitment, microscopy services, drug supplies, surveillance and monitoring systems and use of highly efficacious drug regimens with direct observation of treatment.

This cost-effective strategy was developed from the collective best practices, clinical trials, and programmatic operations of a number of TB control programs over the past two decades. When implemented correctly, this strategy: • produces cure rates of up to 95% even in the poorest countries; • prevents new infections by curing infectious patients; and • prevents the development of MDR TB by ensuring the full course of treatment is followed.

Once patients with TB have been identified using microscopy services, health and community workers and trained volunteers observe and record patients swallowing the full course of the correct dosage of anti-TB medicines throughout the duration of treatment (treatment lasts 6 to 8 months). The most common, first-line drugs are isoniazid, rifampicin, pyrazinamide, ethambutol, and streptomycin.

Sputum smear testing is repeated after 2 months and during the course of treatment to check progress, and again at the end of treatment to determine treatment outcome. A recording and reporting system documents patients’ progress and the final outcome of treatment.

Since the WHO TB strategy was introduced on a global scale, millions of infectious patients have received treatment. The strategy has been successful in large and small countries, both rich and poor; some examples include the United States, Peru, China, the Netherlands, the Czech Republic and Vietnam.

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The WHO-recommended TB control strategy, when properly conducted, can have a profound impact on the TB program in the areas of Russia where it is implemented. The implementation of WHO recommendations in Ivanovo and Tomsk oblasts yielded positive results. In October 1999, a TB project based on the WHO Tuberculosis control strategy was initiated in the Orel Oblast. Case finding followed national Russian recommendations, which include TB detection among symptomatic cases referring to health care facilities, active case finding among household contacts, and regular screening among groups considered to be at risk (e.g., prisoners, health care workers, teachers, etc. Smear microscopy and mycobacterial culture, in addition to chest radiograph, were used by the clinicians to diagnose TB. Standard course chemotherapy (6 months for new cases and 8 months for re-treatment cases) was administered under direct observation to each patient. A sustained supply of anti-TB drugs was ensured. In addition, the local government and the Russian Red Cross provided social support to vulnerable patient groups (free public transportation, food packages, home treatment administration for those with limited access to health facilities).

The initial quarterly cohort analysis was conducted for the evaluation of treatment outcomes. Treatment success (i.e., patients with bacteriologically documented cure and those who completed treatment) was attained for 88% of new and 60% of retreatment TB patients. Cure and completion rates among prisoners were high (97%), with no prison patients defaulting. This demonstration project demonstrates that the WHO TB control strategy can be successfully adapted to the Russian TB health care delivery system.

The WHO TB control strategy can prevent deaths and disabilities among the most productive age groups, and, at the same time, make more effective use of scarce resources by reducing length of hospitalization, number of beds occupied, and other costly interventions. The benefits should be a reduction of TB prevalence from current levels and a decline in the annual risk of tuberculosis infection. In addition, mortality from TB should decline within a few years. Eventually, a decline in the annual number of new cases due to reduced transmission of tubercle bacilli in the community will follow. The final effect should be a permanent reduction of incidence rates.

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1.10 Aim of a National Tuberculosis Program In countries with a high TB burden, the fight against TB can be successfully conducted within the setting of a National Tuberculosis Program utilizing the WHO recommended DOTS strategy. The WHO TB strategy should be integrated into the country’s general health service.

The overall objectives of TB control are to • reduce mortality, morbidity, and disease transmission, and • prevent the development of drug resistance.

The target cure rate is at least 85%. (In some countries with primary drug resistance this target may not be attainable at the beginning of program implementation.)

Target: Cure At Least 85% of New Smear-Positive Patients

To achieve at least an 85% cure rate in new smear-positive patients, a National Tuberculosis Program must (1) Introduce standard treatment for all diagnosed TB cases. The aims of treatment of TB are to: • cure the patient of TB, • prevent death from TB or its late effects, • prevent relapse of TB, and • decrease transmission of TB to others. It is vital to achieve these aims while preventing the growth of resistant bacilli in infectious patients. (2) Improve management of the treatment system. Some key components for an improved management system are • well-trained and motivated staff; • regular anti-TB drug supplies at treatment centers; and • analysis of treatment outcomes of all bacteriologically confirmed patients at treatment centers to (1) help health workers see how well or poorly they are implementing treatment activities and (2) help the National Tuberculosis Program identify areas that require attention.

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Another objective for a country’s National Tuberculosis Program is to expand case- finding by targeting high-risk groups, including • contacts of smear-positive TB cases, • prisoners, • homeless persons, • HIV-infected persons, and • migrants from countries or oblasts with a high incidence of TB.

1.11 The Structure of the TB Health Care Delivery Program in Russia TB care in Russia is delivered through a specialized network of anti-TB facilities distributed throughout the country. This network reports to the Ministry of Health at the federal level and to local governments at the oblast level. In addition, TB care is provided in health units of the Ministry of Justice (prison hospitals, colonies and ambulatory care for the detained population), Ministry of Defense (hospitals and ambulatory care for the military service and their families) and Ministry of Transportation (for the railway employees and their families). Ultimately, effective TB control will depend on coordination among ministerial level organizations.

The structure of the TB network consists of a central (federal level), oblast level, raion Level and general medical services level (see Figure 1.3).

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Figure 1.3 Organization of TB Health Care Delivery in Russia

Central Level-Ministry of Health Responsible for the coordination of TB care in Russia.

In addition, at the central level, there is coordination among the TB Institutes which are responsible for conducting TB research, treating difficult cases, and providing postgraduate training of TB specialists.

Oblast Level1 Within each oblast there is an oblast TB dispensary responsible for overall organization and TB care within the entire oblast.

Raion Level At the raion level, there is coordination with the oblast and the general medical services for the referral and monitoring of TB patients. Typically, within each raion, the central raion hospital is the main health facility. There is usually a TB cabinet and a TB specialist at the raion level. In larger raions, there may also be a raion TB dispensary.

General Medical Services At the general medical services level, there are polyclinics, general and rural hospitals, feldsher and midwife posts, and other primary care facilities. The general medical services are where most patients with symptoms of TB are first seen and often where patients with TB disease may finish treatment.

1 The oblast level can also refer to the republic or regional level as well.

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1.11.1 The Central Level A special unit (or a designated person) at the Ministry of Health is responsible for the coordination of TB care in Russia1. There is also coordination among the TB research institutes responsible for conducting TB research, treating difficult cases, providing post-graduate training for TB specialists, and advising the Ministry of Health on different issues of TB control. Currently, there are six TB Institutes in the country, of which five report to the MOH. One, the Central TB Research Institute (CTRI), reports to the Russian Academy of Medical Sciences and is the WHO Collaborating Center in TB Control. An additional responsibility of the CTRI is assisting the Oblasts that have implemented or are planning to implement the WHO-recommended TB control strategy.

CTRI and any other TB research institute (determined by MOH) are designated as a central TB unit and have the following functions: 1. Plan the operational steps in implementing, monitoring, and evaluating the WHO recommended TB control strategy and its expansion; 2. Coordinate and monitor the program; 3. Collect and analyze TB surveillance data; 4. Train the personnel involved in the program; 5. Perform quality control of sputum smear microscopy, culture and drug sensitivity testing; 6. Perform sensitivity testing of second line anti-TB drugs; 7. Supervise and support the oblast TB programs, including the network of laboratories; 8. Coordinate with other ministries that diagnose and treat TB patients; 9. Link with donors and NGOs supporting TB control in Russia; and 10. Evaluate performance of the oblasts’ TB programs and propose appropriate recommendations to the Ministry of Health in order to update and improve TB control in Russia.

1 The central unit within in the Ministry of Health should also collaborate with other Ministries within the government, specifically the Ministry of Justice.

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1.11.2 The Oblast Level Within each oblast, there is a TB dispensary responsible for the overall organization of TB care within the entire oblast. In some oblasts, there are also specialized TB hospitals and TB sanatoria (for adults and children). The oblast level staff typically coordinate TB care among all of the individual raions within the oblast. Depending on the organization of TB health care delivery in an oblast, some oblasts have a centralized TB care system, with all patients eventually diagnosed and treated at the oblast level. In oblasts characterized by a decentralized health care delivery system, there may be several specialized TB hospitals and TB sanatoria at the raion level located throughout the oblast. The oblast TB dispensary reports to the oblast health department. The director of the TB dispensary has a team in the dispensary responsible for TB care, TB surveillance (data collection, analysis, and reporting), training and education, monitoring and supervision, drug supply, and other activities. In the oblasts implementing the WHO TB control strategy, the director of the dispensary or a designated team member, is appointed the oblast TB Coordinator. The oblast director and team are responsible for coordinating all TB diagnosis and care activities with raions within the oblast.

The functions of the oblast level staff are as follows: 1. Work closely with the central level in implementing, monitoring, and evaluating the program; 2. Coordinate TB control in the raions and supervise the personnel involved in case finding and treatment of TB. A supervisory visit will be made to each raion (at least once every 3 months). The frequency of supervisory visit to the raions should depend on the success of raion TB programs implementing successful TB control programs, and will vary by raion. 3. Verify diagnosis and treatment of TB cases diagnosed in the raions; 4. Provide reference laboratory services that include culture and drug sensitivity testing of specimens collected before and during treatment. The laboratory will notify the raion level of results in a timely manner and record culture and drug sensitivity results in the oblast laboratory register; 5. Organize and perform laboratory quality control of smear microscopy examinations performed at the raion level; 6. Organize training programs in raions and provide on-the-job training to health workers in the general medical and specialized TB services; 7. Maintain the oblast TB Patient Register (TB 03) and ensure that all relevant information, such as smear, culture, and drug sensitivity results and final treatment outcome for each patient are properly recorded; 8. Ensure that quarterly reports on case finding, sputum conversion, and outcome of chemotherapy are made in each raion and sent to the oblast level;

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9. Check the quarterly reports for accuracy, perform data analyses, and send the reports to the central Level; 10. Acquire and distribute supplies needed in the program such as anti-TB drugs (check whether drugs are ordered, delivered, stored, and distributed to the oblast and raion units), laboratory equipment and supplies, forms, registers, and manuals; 11. Coordinate anti-TB activities with general hospitals, clinics, and TB facilities as well as the penitentiary system, and nongovernmental organizations; 12. Develop and implement health education and health promotion materials for TB patients and the general public in cooperation with the oblast Health department, raion and nongovernmental organizations (such as Red Cross and other).

1.11.3 The Raion Level Although in most areas, the overall organization of TB care takes place at the oblast level, TB diagnosis and care at the raion level is a critical. Typically, TB patients are initially diagnosed at the raion level and may often complete their TB treatment within the raion as well. At the raion level, there is coordination with the general primary health services as patients initially present at polyclinics, general and rural hospitals, feldsher and midwife posts, and other primary health facilities. In addition, there is coordination with the oblast level with the referral and monitoring of suspected TB patients. Typically, within each raion, The Central Raion Hospital (CRH) is the main health facility. There is usually a TB cabinet located at the CRH, with a raion TB specialist. In larger raions, there may also be a raion TB dispensary with or without TB beds for inpatient treatment. The deputy director of the CRH or the TB Raion Specialist (be it the doctor at the TB Cabinet or at the raion TB dispensary) is nominated as the raion TB Coordinator. The TB Coordinator will, among other duties, have responsibility to maintain the raion tuberculosis register and ensure coordination between the general primary health services and the specialized TB services at the raion and oblast levels.

The raion TB Coordinator has the following responsibilities and tasks: 1. Implement the WHO TB control strategy at the raion level through the TB control service together with the primary health care facilities; 2. Introduce and maintain (or supervise the accurate maintenance of) the TB Patient Register (TB 03). Verify that the appropriate initial and treatment monitoring smears and cultures are done and results are properly recorded.

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3. Supervise treatment throughout the raion to ensure that a. recommended regimens are prescribed; b. health care workers observe patients ingesting medicines for the entire course of treatment; c. regimens are given for the required period and patients who have completed the prescribed course of chemotherapy are discharged from treatment after consultation with oblast-level staff to determine final outcome of chemotherapy; and d. sputum is examined for tubercle bacilli and specimens are sent to the oblast reference laboratory for cultures at given intervals. For patients living far from the general hospital or who have difficulties in traveling, the raion TB Coordinator must instruct feldshers, nurses, or other peripheral health workers on how to collect sputum and transport it to the nearest laboratory for follow-up examinations and make sure that this occurs. 4. Assist health workers in the expansion of TB case-finding in all designated health facilities of the raion (TB and PHC); 5. Monitor the inventory of the supply system for anti-TB drugs, laboratory reagents, sputum containers and slides, and forms for the raion; 6. Develop and implement health education and health promotion materials for TB patients and general public in cooperation with the oblast level and nongovernmental organizations. 7. Conduct outbreak control activities, with a focus on rural areas where there may be an increased likelihood of delayed diagnosis of TB, primary drug resistance, and high rates of TB mortality.

1.11.4 General Medical Services Level Nearly every patient with respiratory symptoms will initially present to a primary (general) health facility. The primary (general) health care level is where patients are first seen and in most cases receive the continuation phase of their treatment. At this level, there are polyclinics in towns, general and rural hospitals, and other general medical health facilities like feldsher and midwife posts. The general medical services health care worker may refer suspected TB patients to the specialized TB services within the raion for diagnosis. Some general health care facilities may have the capability to perform initial diagnostic activities. If TB is suspected, after the initial examinations, including chest x-ray and 3 sputum smears, the patient is referred to a TB specialist (at the raion or oblast level) for confirmation of diagnosis.

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The main responsibilities of staff within the general medical services are as follows: 1. Be aware of TB symptoms and recognize symptoms among patients; 2. Refer TB suspects or send their sputum specimens to microscopy laboratories for examination for diagnosis; 3. Carry out treatment services, including administering drugs to patients under direct observation (usually in the continuation phase of treatment); 4. Provide health education to patients and their families on a regular basis; 5. Locate patients who do not come for treatment; 6. Maintain TB Patient Treatment Cards (TB 01) and records and make them available for the raion TB coordinator during supervisory visits to the health unit; 7. Refer patients on treatment (or send their sputum samples) for follow-up examinations; and 8. Report to the raion TB Coordinator if the patient has come to an end of prescribed chemotherapy.

1.12 Summary

• The TB training modules entitled, Managing Tuberculosis at the Raion Level are a series of educational modules designed to provide the technical knowledge and skills essential for TB control at the raion (district) level in Russia. • The target audience for this course is the TB Specialist or TB Coordinator at the raion level, as well as other raion-level staff who are responsible for planning, organizing, delivering, and supervising TB control activities at the raion level. • The goal of this course is to increase the technical knowledge and skills of staff at the raion level to implement the proven and cost-effective World Health Organization’s strategy for controlling TB. • Left untreated, each person with active TB will infect, on average, between 10 and 15 people every year. • The number of TB cases reported in the Russian Federation has more than doubled since the early 1990s. • The biggest challenge to controlling TB in Russia is the increasing problem of MDRTB. Drug-resistant TB is caused by inconsistent or partial treatment. • There is a proven, cost-effective TB treatment strategy known as DOTS (Directly Observed Treatment), which is recommended by the WHO and the International Union Against TB and Lung Disease (IUATLD). The WHO strategy combines five elements: political commitment, microscopy services,

19 1 Introduction: Managing TB at the Raion Level

drug supplies, surveillance and monitoring systems, and use of highly efficacious drug regimens with direct observation of treatment. • The WHO-recommended TB control strategy, when properly conducted, can have a profound impact on the TB program in the areas of Russia where it is implemented • The structure of the TB network in Russia consists of a central (federal level), oblast level, raion level and the general medical services level. • At the central level, the Ministry of Health is responsible for the coordination of TB care in Russia. There is also coordination among the TB research institutes responsible for conducting TB research, treating difficult cases, providing postgraduate training of TB specialists, and advising the Ministry of Health on different issues of TB control. • At the oblast Level there is a TB dispensary responsible for the overall organization of TB care within the entire oblast. • At the raion level, there is coordination with the oblast and the general medical services for the referral and monitoring of TB patients. Typically, within each raion, The Central Raion Hospital is the main health facility. There is usually a TB cabinet and a TB specialist at the raion level. In larger raions, there may also be a raion TB dispensary. • At the general medical services level, there are polyclinics, general and rural hospitals, feldsher and midwife posts, and other primary care facilities. The general medical service is where most patients with symptoms of TB are first seen and where TB cases are detected, and in most cases where the continuation phase of treatment is performed.

20 1 Annex A

Annex A TB Treatment Cards, Forms, and Registers Used in WHO Russian Collaborative Programs TB Patient Treatment Card (TB 01) The TB Patient Treatment Card (TB 01) contains important information about a patient, including: • patient registration number • patient demographics and locating information • disease classification and type of patient • treatment category and prescribed regimen • results of sputum examination (smear and culture) and chest x-ray before and during treatment • results of drug sensitivity testing • patient’s weight before and during the treatment • record of daily drug doses administered during the intensive and continuation phases of treatment • treatment outcome

A TB Patient Treatment Card (TB 01) assists health workers in ensuring that patients: • are correctly classified as having either pulmonary or extra-pulmonary tuberculosis • are prescribed the correct regimen and dosages • have sputum examinations at the scheduled times (smear and culture) • are regularly taking drugs during the initial and continuation phase

Typically the TB Patient Treatment Card (TB 01) is kept in the health facility where the patient is receiving treatment.

Registration number (from TB 03)______Year ______Quarter ______Site of registration: ______TB Patient Treatment Card (TB 01) 1. Name 2. Address and tel.: ______7. Date of symptom onset: ______3. Name, address and tel. of the next of kin: 8. Date when presented to physician ______with these symptoms: ______4. Sex: M F 9. Date when diagnosis was established: ______5. Date of birth: ______6. Age (______) 1.1 Disease Classification 1.4 Categories and standard treatment regimens in the intensive phase Pulmonary TB Extrapulmonary TB Category 1 Category 2 Category 3 Organ(s)______2HRZE(S) 2А – 2 HRZES + 1 HRZE 2 HRZE Clinical form of pulmonary TB Tuberculous pleuritis, upper respiratory TB 2B* – 3 HRZE+Pt+Cap/K+[Fq] ______or intrathoracic lymph node TB 1.2 Patient Type 1.5 Intensive phase. Treatment regimen and TB drug dosage** NEW CASE TREATMENT AFTER FAILURE (indicate the daily dose in g) RETURN AFTER DEFAULT Prescription Date H R Z E S Fq* Cap* TRANSFERRED IN RELAPSE OTHERS

* To be used only in specialized oblast-level centers. ** Drugs: Isoniazid (Н); Rifampicin (R); Pyrazinamide (Z); Streptomycin (S); Ethambutol (E); Fluoroquinolones (Fq); Capreomycin (Cap).

1.3 Examination results Results of sputum examinations X-ray (lung cavitation) Weight Drug sensitivity (S/R) Month/treatment phase Lab # Test date Smear Culture (kg) H R S E Date Result (+/-) 0*/GMS 0**/TB Service 2/3/ intensive phase 3/4/ intensive phase extension 5/ continuation phase

At the end of treatment

1.6 Intake of daily doses Day Number 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 of doses Month taken

Instructions for recording drug intake: Observed drug intake: nurse’s initials; Non-observed drug intake: Х – Х; Drugs not taken: leave the cell empty Number of daily doses taken in the intensive phase: _____

1.7 Categories and standard treatment regimens in the continuation phase 1.8 Continuation phase. Treatment regimen and TB drug dosage** Category 1 Category 2 Category 3 (indicate the daily drug dose in g).

4 HR or 4 Н3R3 or 6 HE 2А: 5 HRE or 5 H3R3E3 4 HR or 4H3R3 or 6 HE Prescription 2B: Depends upon Drug Date H R E Sensitivity Testing

1.9 Intake of daily doses Day Number 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 of doses Month taken

Instruction for recording drug intake: Observed drug intake: nurse’s initials; Non-observed drug intake: Х – Х; Drugs not taken: leave the cell empty Number of daily doses taken in the continuation phase: _____

1.10 Treatment outcome Date 1.11 Comments CURED (CONFIRMED BY SMEAR) ______CURED (CONFIRMED BY CULTURE) TREATMENT COMPLETED ______FAILURE (CONFIRMED BY SMEAR) ______FAILURE (CONFIRMED BY CULTURE) DEFAULT ______TRANSFERRED OUT ______DIED

23 1 Annex A

TB Patient Register (TB 03) The TB Patient Register (TB 03) is used to keep track of all the tuberculosis patients in a Raion. Maintaining an accurate TB Patient Register (TB 03) is critical to managing an effective TB program, as well as determining TB program success. The data on the TB Patient Register (TB 03) is used to conduct quarterly reviews of cohorts of patients to assess the number and type of new cases registered in a quarter, as well as the treatment outcome for patients who were on treatment.

The TB Patient Register (TB 03) is used to document • The number of TB cases • Demographic data on each patient • Treatment category • Disease Classification • Patient Type • Clinical Examinations (X-ray, Sputum, and Culture) • Treatment Outcomes

The TB Patient Register (TB 03) is a snapshot or a summary of the TB patient’s progress on treatment. It can be an effective tool for TB Coordinator’s to evaluate TB program activities

24 TB Patient Register (TB 03)

Treatment Patient type start date Date of Regis- Date of birth Medical institution Disease Serial Sex Regis- tration Full name (Age at Full address where the patient is classification Number M/F Treatment Transferred Treatment after tration number registration) registered (P/EP) New Relapse after Other Category in default failure

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15

Year ______

Clinical Examinations: write the lab number in the lower part of the cell, the result, in the upper. Treatment outcomes Treatment Before treatment End of 2nd month End of 3rd month Cured Failure (new cases) (new cases) Month 5 End of treatment out out End of 3rd month End of 4th month Smear – Culture – Smear – Culture – Died GMS TB Service (retreatment cases) (retreatment cases) confirmed confirmed confirmed confirmed Default

Treatment Treatment Comments Completed Transferred

16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43

Smear Smear Cult. X-ray Smear Cult. X-ray Smear Cult. X-ray Smear Cult. X-ray Smear Cult. X-ray Smear Cult. X-ray

26 1 Annex A

TB Laboratory Register (TB 04) The TB Laboratory Register (TB 04) contains the results of sputum examinations conducted by the laboratory for diagnosis and for follow-up examinations for treatment monitoring. For the diagnosis of a patient, the sputum examination results on this register are used to determine whether the patient is sputum smear- positive or smear-negative. For follow-up examinations, the sputum examination results are examined to determine whether the patient has converted from smear- positive to smear-negative or has remained smear-negative, and afterwards to determine treatment outcome.

TB Laboratory Register (TB 04)

Results of Name of Address Reason for examination Name specimen Signature Remarks

Date Treatment Unit (for new patients) Sex M/F Date of Birth Lab. serial No. No. serial Lab. Diagnosis* Follow up** 1 2 3

28 1 Annex A

Request for Sputum Microscopy Examination Form (TB 05) The Request for Sputum Examination Form (TB 05) is the form used to request a sputum examination from the laboratory. The form is included with the patient's sputum specimens when they are transported to the microscopy laboratory for examination.

The health worker who collects the patient’s sputum completes the top half of this form. The “Results” section, located on the bottom half of this form is completed by laboratory staff at the microscopy laboratory after the sputum is examined. Exam results should be taken from the Request for Sputum Examination Form (TB 05) and transferred to the TB Patient Treatment Card (TB 01) and the TB Patient Register (TB 03).

29 1 Annex A

Request for Sputum Microscopy Examination (TB 05)

1) Date ______2) Name and address of the treatment unit ______3) Patient’s full name ______4) Address (in full) ______5) Raion ______6) Date of birth ______7) Sex: M F 8) Reason for examination: Diagnosis Treatment Monitoring Follow-up, month _____ Other 9) Specimen identification numbers*: 1. ______2. ______3. ______10) Patient’s registration number** ______11) Specimen collection dates: 1. ______2. ______3. ______12) Signature of medical worker who collected sputum: ______*3 sputum samples should be collected for diagnosis purposes. 2 sputum samples should be collected for treatment monitoring follow-up purposes. **Enter the patient’s TB Registration number for registered patients on treatment.

Results of Smear Microscopy Examination (for laboratory use) Lab serial number: ______Sputum Appearance of the Result Positive

collection specimen* (Neg/ (grading) Specimen date M-P Bl S Pos) Scanty 1+ 2+ 3+ 1 ___AFB**

2 ___AFB**

3 ___AFB** *Visual appearance of the specimen: M-P – muco-purulent, Bl – blood-stained, S – saliva (If saliva, do not process). **Indicate number of AFB per high-power field.

Date Results Reported: ______Signature of Lab Technician: ______

30 1 Annex A

Request for Culture/Drug Sensitivity Testing Form (TB 06) The Request for Culture/Drug Sensitivity Testing Form (TB 06) is the form used to request culture examinations and drug sensitivity testing. The health worker who collects the patient’s sputum completes the top half of this form. The “Results” section, located on the bottom half of the form, is completed by the laboratory after the sputum is examined. Exam results should be taken from the Request for Culture/Drug Sensitivity Testing Form (TB 06) and transferred to the TB Patient Treatment Card (TB 01) and the TB Patient Register (TB 03).

31 1 Annex A

Request for Culture/Drug Sensitivity Testing Form (TB 06)

1) Date: ______2) Name Treatment Unit: ______3) Patient’s Full Name: ______4) Address (in full): ______5) Raion: ______6) Date of Birth: ______7) Sex: M F 8) Reason for Examination Diagnosis Treatment Monitoring Follow-up, Month:______ Other 9) Specimen Identification Number: ______10) Patient’s Registration Number*: ______11) Specimen collection date: ______12) Signature of health worker: ______*Enter the patient’s TB Registration number for registered patients on treatment.

Culture Examination Results (for laboratory use)

Grading Date culture Date culture + = 1-20 colonies Lab specimen Results (POS or examination examination ++ = 21-100 Colonies number NEG) initiated reported +++ =>100 colonies + ++ +++

Drug Sensitivity Test Results Drug Sensitive Resistant Isoniazid Streptomycin Rifampin Ethambutol Other

Date Results Reported: ______Signature of Lab Technician:______

32 1 Annex A

Quarterly Report on New Cases and Relapses of Tuberculosis (TB 07)

The Quarterly Report on New Cases and Relapses of Tuberculosis (TB 07) provides a summary of number of new pulmonary smear-positive cases, relapse smear- positive cases, new pulmonary smear-negative cases, relapse smear-negative cases, new extra-pulmonary cases, and relapse extra-pulmonary cases registered in the Raion during the previous quarter. This form essentially characterizes the case finding of the Raion each quarter. It also contains an age breakdown of new pulmonary smear-positive cases by age and sex.

Quarterly Report on New Cases and Relapses of Tuberculosis (ТB 07)

1. Administrative territory:______

3. Patients registered in ___ 4. Date when report is 2. Raion/Raion code: Quarter of the Year 20___ filled: ___/___/___

5. Raion TB Coordinator Name/Signature: ______

6. Table 1 Pulmonary TB Extrapulmonary TB Positive smear Negative smear Total New cases Relapses New cases Relapses New cases Relapses 1 2 3 4 5 6 7

M F Total M F M F M F M F M F M F Total

7. Table 2. Age and sex distribution of sputum smear-positive new cases Age groups Total 0-14 15-24 25-34 35-44 45-54 55-64 > 65 M F M F M F M F M F M F M F M F Total

Comments:

34 1 Annex A

Quarterly Report on the Results of Treatment of Pulmonary Tuberculosis Patients Registered 12-15 Months Earlier (TB 08)

The Quarterly Report on the Results of Treatment of Pulmonary Tuberculosis Patients Registered 12-15 Months Earlier (TB 08) contains the treatment outcome for every pulmonary tuberculosis patient who was registered 12 to 15 months earlier. A patient's treatment outcome can be recorded as cured, treatment completed, died, failure, defaulted or transferred.

Quarterly Report on the Results of Treatment of Pulmonary Tuberculosis Patients Registered 12-15 Months Earlier (ТB 08)

1. Administrative territory:______

3. Patients registered in ___ 4 Date when report is 2. Raion/Raion code: Quarter of the Year 20___ filled: ___/___/___

5. Raion TB Coordinator Name/Signature: ______

6. Table 1 (7) Total No. of Pulmonary (1) (2) (4) (6) Total number (3) (5) evaluated Patients reported Patient type Cured (conf. Treatment Failure (conf. Transferred Died Default (sum of during above quarter by smear) completed by smear) out columns 1 to 6) New pulmonary TB cases 1. New cases M F Total* 1.1 Smear + 1.2 Smear – Relapses 2. Re-treatment cases M F Total**

2.1 Relapses S+ 2.2 Other types S+*** *Of all the new pulmonary TB cases ______(number) were excluded from evaluation for the following reasons: ______

** Of all the relapse TB cases ______(number) were excluded from evaluation for the following reasons ______

*** “Other types” of smear positive retreatment cases, including “treatment after failure,” “treatment after default” and “other” ______

36 1 Annex A

Tuberculosis Referral/Transfer Form (TB 09)

The Tuberculosis Referral/Transfer Form (TB 09) is completed by a health worker when a patient is transferred or is referred to a health unit in a Raion in another territory or to another agency. It contains basic information about a patient and his treatment.

Once a patient reports to a new Raion and is registered, the bottom portion of this form is mailed back (or sent by other means) to the referring unit. When the referring unit receives this portion of the form, they will know that the patient's treatment is being continued.

37 1 Annex A

Referral/transfer Form (ТB 09)

1. Name of referring/transferring unit: ______2. Name and address of unit to which patient is referred: ______

3. Full name of patient ______4. Full address______

5. Date of birth: ___/___/___ 6. Sex: M F 7. Registration number: ______8. Date of treatment start: ___/___/___ 9. Treatment category: Cat. 1 Cat. 2А Cat. 2B Cat. 3 10. Treatment regimen: ______11. Phase: intensive continuation 12. Number of doses received 13. Number of doses received 14. Number of doses in the intensive phase: _____ in the intensive phase: _____ missed: ______15. Diagnosis: ______16. Remarks: ______17. Signature______18. Position: ______19. Date of referral/transferral: ___/___/___

For use by Treatment Unit where patient has been referred

1. Name and address of unit to which patient is referred: ______2. Full name of patient: ______3. Date of birth: ___/___/___ 4. Sex: M F 5. Registration number: ______6. Date of treatment start: ___/___/___

7. Signature______8. Position: ______9. Date of referral/transferral: ___/___/___ Send this part back to the Referring Unit as soon as patient has reported and been registered

38 1 Annex A

Quarterly Report on Sputum Conversion after initial phase of treatment (TB 10)

Quarterly Report on Sputum after initial phase of treatment. (TB 10) is the quarterly report to record sputum conversions. It contains the sputum conversion result taken at the end of the initial phase of treatment for every TB patient who was registered 6 months earlier.

Quarterly Report on Sputum Conversion After Completion of Intensive Phase Treatment (TB 10)

1. Administrative territory:______

3. Patients registered in ___ 4. Date when report is 2. Raion/Raion code: Quarter of the Year 20___ filled: ___/___/___

5. Name/Signature of the Raion TB Coordinator: ______

6. Table 1

Sputum conversion Number of s+ No smear Smear remained Patient types After 2 mths. After 3 mths. After 4 mths. Total patients registered available positive N % N % N % N %

New cases

Relapses All other retreatment cases

Comments:

40 1 Annex B

Annex B Glossary Basic (first-line) Drugs that are most effective against the tubercle bacilli. TB drugs They include isoniazid (H), rifampicin (R), pirazinamide (P), ethambutol (E), and streptomycin (S).

Chemotherapy Use of an antituberculous drug combination able to kill of TB mycobacteria in the patient’s body and prevent the development of drug resistance.

Cure (confirmed by At the end of a course of treatment, a patient who meets smear or culture) the following criteria: (treatment • was initially smear-or culture-positive, outcome) • received all drug doses prescribed and • has at least 2 negative smears or cultures at both month 5 and the end of treatment.

Died A patient who dies from TB or any other cause during the (treatment course of treatment for TB. outcome)

Extrapulmonary TB TB involving any organ other than lung parenchyma. According to WHO definitions, extrapulmonary TB also includes tuberculous pleuritis, upper respiratory TB, and intrathoracic lymph node TB. A combination of pulmonary and extrapulmonary TB is classified as pulmonary TB.

Incidence Number of new cases of disease per 100,000 population per year.

Multidrug-resistant Strains of M. tuberculosis resistant to at least isoniazid tuberculosis and rifampicin, considered the two most efficacious (MDRTB) antituberculous drugs.

New case A newly detected patient who has never had treatment for (patient type) TB or who has taken anti-tuberculosis drugs for less than one month.

41 1 Annex B

Other All active TB cases, which start treatment in the WHO (patient type) program and do not fit the definition for any type.

Prevalence Total number of diseased persons per 100’000 population at a given time.

Preventive The treatment of persons with a high risk of developing chemotherapy tuberculosis who have no signs or symptoms of bacteriologically, clinically or radiologically active tuberculosis, in order to prevent them from developing the disease.

Pulmonary TB TB involving lung parenchyma. A combination of pulmonary and extrapulmonary TB is diagnosed as pulmonary TB.

Relapse A patient previously treated for tuberculosis who has been (patient type) declared cured or treatment completed, and is diagnosed again with bacteriologically positive (smear or culture) tuberculosis.

Reserve stock An extra supply of stock kept at the central, regional and district level to ensure that all patients under treatment in the entire country always receive the prescribed drugs during the treatment.

Return after default A patient who returns to treatment after an interruption of (patient type) treatment for 2 months or more.

Sputum smear Negative result of sputum smear microscopy at the end of conversion the initial phase of treatment in patients with initially sputum smear positive TB

42 1 Annex B

Standard Chemotherapy for 6-8 months based on the combination chemotherapy of at least four major drugs (isoniazid, rifampicin, pyrazinamide and ethambutol [streptomycin]) given for 2 to 3 months during the initial intensive phase of treatment and followed by a combination of at least 2 drugs given for 4 to 6 months during the continuation phase of treatment.

Sputum A patient with smear-negative 1. at least three sputum specimens negative for AFB1 and pulmonary TB 2. radiographic abnormalities consistent with active pulmonary tuberculosis, and 3. no response to a course of broad spectrum antibiotics, and 4. there is a decision by a clinician to treat with a full course of anti-tuberculosis chemotherapy.

Sputum smear- A patient with positive pulmonary 1. at least 2 or more sputum examination specimens TB positive for AFB by microscopy, or 2. 1 sputum specimen positive for AFB and radiographic abnormalities consistent with active pulmonary tuberculosis determined by clinician, or 3. one sputum smear positive for AFB plus sputum culture positive for M. tuberculosis.

Supervision The process of helping people improve their own work performance.

Transfer in A patient who has been transferred from another TB (patient type) register (another Oblast or another agency, e.g., the Ministry of Justice) to continue treatment.

Transfer out A patient who was transferred to another administrative (treatment territory or to another agency (with a different TB outcome) register) and the final treatment outcome is not known.

1 Cases, which are sputum-negative by smear microscopy but sputum-positive by culture are registered as sputum smear-negative pulmonary TB.

43 1 Annex B

Treatment after Patient who is started on retreatment regimen after having failure failed previous treatment.

(patient type)

Treatment completed At the end of a course of treatment, a patient who meets (treatment the following criteria: outcome) • Initial smear (or culture) negative • Received all drugs prescribed • Consistently sputum negative at all stages of treatment. • Also, initially smear or culture-positive patients who have completed treatment but lack the necessary number of negative smears/cultures at 5 months or thereafter.

Treatment Default The patient interrupted treatment for two months or more. (treatment outcome)

Treatment failure A patient with persistently or newly positive sputum (by (confirmed by smear smear or culture) at 5 months of treatment or thereafter. or culture) (treatment outcome)

Tuberculosis (TB) Infectious disease caused by M. tuberculosis, which is transmitted through the airborne mode.

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