ATTACHMENT 16 A Health Systems Approach to Tb Control in Central Asia.doc

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Conceptual Paper

A Health Systems Approach to TB Control in Central Asia

Authors

Michael Borowitz

Sheila O’Dougherty

Sergei Muratov

Marat Turgunbaev

Aziz Jafarov

Jason Maddix

Jessica Pickett

December 2008

Almaty, Kazakhstan

I. Introduction………………………………………………………….………… II. The International Context of TB Control in the Former Soviet Union…………… III. Broad Health Systems Approach in Central Asia……………….………………

IV. Assessment of TB Control in Central Asia Using STOP TB Strategy

1. Pursue High-Quality DOTS Expansion and Enhancement………………………

a. Political Commitment with Increased and Sustained Financing……………… …

b. Case Detection Through Quality-Assured Bacteriology……………………… …

c. Standardized Treatment, with Supervision and Patient Support…………..…. …..…

d. Effective Drug Supply and Management System…………………………...... …...…...14

e. Monitoring and Evaluation System, Impact Measurement……………….……...…

2. Address TB/HIV, MDR-TB, and Other Challenges………………………..…...……18

a. Implement Collaborative TB/HIV Activities……………………………...….. …..…...18

b. Prevent and Control Multidrug-Resistant TB (MDR TB)………………...…… .…

c. Address Prisoners, Refugees, and Other High-Risk Groups and Special Situations...…21

3. Contribute to Health systems Strengthening………………………………………... …23

a. Actively Participate in Efforts to Improve System-Wide Policy, Human Resources, Financing, Management, Service Delivery, and Information systems.....……...…...………...23

1. Political Commitment, Policy, Stewardship/Governance…………………….………….23

2. Legal/Regulatory Framework…………………………………………………...… …

3. Human Resources…………………………………………………………...….……

4. Financing……………………………………………………………………….………26

5. Management………………………………………………………………….….... …..29

6. Service Delivery…………………………………………………………...……………29

7. Information Systems………………………………………………………..…………32

8. Health systems Strengthening Guidance from WHO and Other Sources……..…….…33

b. Share Innovations that Strengthen Systems, Practical Approach to Lunch Health (PAL)..33

c. Adapt Innovations from Other Fields…………………………………………….…….34

4. Engage All Care Providers…………………………………………………………

a. Public-Private and Public-Private Mix (PPM) Approaches…………………………

b. International Standards for Tuberculosis Care………………………………………….34

5. Empower People with TB, and Communities……………………………...……..…….35

a. Advocacy, Communication, and Social Mobilization……………………....……....…

b. Community Participation in TB Care………………………………………...….……...35

c. Patients’ Charter for Tuberculosis Control…………………………………...…….…...35

6. Enable and Promote Research……………………………………………..…….….….35

a. Programme-Based Operational Research…………………………………..………..….35

b. Research to Develop New Diagnostics, Drugs, and Vaccines………………. …..……36 VI. Conclusions and Next Steps……………………………………………….….....……36 Appendix A…………………………………………………………...…………… I. Introduction The basic intent of this Conceptual Paper is to establish a conceptual foundation for assessment of TB control in Central Asia bridging international approaches to TB, international health system strengthening approaches, and the health systems strengthening approach developed for the unique post Soviet Central Asian environment. Its starting point is the emerging global consensus on TB control set out in the new framework from the WHO STOP TB Partnership.

The underlying framework and organization is the six components in the new STOP TB strategy as well as accompanying guidance on health system strengthening.

I. The International Context of TB Control in the Former Soviet Union

A. Background

Political Commitment to DOTS in the Former Soviet Union In the 1990s, after the collapse of the former Soviet Union (FSU), there was a dramatic doubling of TB incidence. In 1994, DOTS implementation began in Central Asia. The importation of DOTS into the post-Soviet context has faced many challenges. There was and remains an old guard of Soviet TB specialists who continue to believe that the Soviet Union had an excellent system of TB control and the only reason it does not work now is lack of money. These TB specialists were not part of the international mainstream of TB control.

A good way to understand Soviet TB specialists is to read Thomas Mann’s novel, Magic Mountain, set in the 1920s in a tuberculosis sanatorium where people sit outside all day in the fresh air, there are frequent x-rays, and doctors still perform lung surgery. This world disappeared in Europe in the 1950-1970s with the triumph of standardized chemotherapy and good public health surveillance. It is interesting to speculate why TB disappeared in the West, but persisted in the Soviet Union including Central Asia. In the 1980s, the Soviet Union still had a significant TB problem with incidence in the range of 50 per 100,000, which has subsequently doubled in the post-Soviet period.

The differences in opinion between Western experts and Soviet TB doctors are fascinating. Soviet TB doctors could never really understand what the fuss was all about concerning DOTS. The main focus of the WHO DOTS approach was on “Directly Observed Therapy,” and in the Soviet system not only did they observe them, patients were kept virtually incarcerated in TB hospitals that functioned largely as prisons. So what was the difference? Some aspects of TB treatment in Central Asia and the FSU have changed and some aspects have not. Although TB doctors will tell you that they have implemented DOTS, it remains an open question whether it has only been implemented partially and is overlaid on the substrate of the old vertical system of TB hospitals, sanatoria, etc. to create a new hybrid post-Soviet DOTS.

It is not surprising that post-Soviet TB physicians still think differently about TB. The WHO framework changed the classification of patients. It also recommended replacing mass screening using x-rays with diagnosis through sputum microscopy and also microbiological culture. This Soviet reliance on x-rays and radiological methods for diagnosis and treatment is one of the most important differences between Soviet and international best practice. There was little emphasis on microbiological laboratories carrying out smears and cultures. Soviet TB physicians used different drugs and treatments including surgery.

Few of the older generation read or speak English and so they have not had close contact with latest international guidelines. They do not have continuing medical education. Many trained in prestigious institutes in Moscow. There is a strong persistence of Soviet traditions in the Central Asian vertical TB system, particularly since there have been few new graduates going into TB medicine for more than a decade. The field is still dominated by those who were trained and practiced in the Soviet period. There was and remains a wide gulf in understanding between “pthysiotrists” and TB practice. This is borne out by the remaining high rates of TB surgery that still occur in the peak TB institutes and the persistence of sanatoria.

Experience with DOTS in Russia Given that both the Central Asian vertical TB systems and individual health professionals still look to Russia, the history of DOTS implementation in Russia is relevant to DOTS implementation in Central Asia. When WHO first began to implement DOTS in Russia there was a substantial confrontation. There was a long-standing negotiation between the Russian Government and WHO, World Bank, USAID, DFID over a large World Bank project. Eventually, the loan was abandoned because the international tender process required by the World Bank would exclude Russian manufacturers that were not GMP certified by WHO. Interestingly, the prison sector was the most open to collaboration with international organizations. They were desperately in need of support but could not borrow directly from the WB and needed to be part of a wider loan.

Although there was no progress at the Federal level in Russia, there was progress at the Oblast level. There were a series of pilot projects in many Russian oblasts sponsored by different donors. The most famous was Tomsk, which had the support of Partners in Health and Merlin. There were also DOTS Plus pilots in Ivanovo and a number of other oblasts. Reform in the Baltic Countries showed that treating MDR TB was indeed possible.

In Russia, with the collapse of the World Bank loan, the compromise brokered was to establish a high level working group that included Russian and international experts. There were sub-groups on all the key technical issues including labs, surveillance, treatment guidelines, etc. The working groups functioned largely on consensus which formed the basis for prekaz/administrative orders setting policy for TB control. The key to the success of the high level working group in Russia was that WHO served as the Secretariat to the working group with a very competent staff supported from technical staff in Geneva. The result has been a slow and steady transformation of the Soviet TB establishment in Russia.

The Soviet Vertical TB System It is important to remember that the Soviet Union had one of the strongest vertical systems for TB control in the world and the influence of this system is still obvious in Central Asia today. It is an open question whether to try to “de-verticalize” the system and shift its functions into the general health system or strengthen the vertical system in the face of a growing TB burden. There are many cross-cutting issues such as laboratories, information systems, surveillance etc., so it may not be productive to view it as all or nothing, but rather a wider continuum of relationships. The broader current of health reform in Central Asia has been to move towards greater integration. The goal is to create an effective platform of PHC that can deliver many of the services provided by vertical systems or vertical programs during Soviet times. This conceptual paper will address the question of integration throughout as it is the most fundamental issue from a health systems perspective.

In the FSU, there existed a strong vertical system for TB control based on an extensive system of TB hospitals controlled by a peak national hospital/research institute. At the heart of system is generally a large TB hospital outside of town. They also had their own supply chain with vehicles. They were responsible for national clinical guidelines and had their own information system. Microbiology labs were the province of the SES during Soviet times. In addition, some of the vertical systems or programs had some specialized laboratories. After the break-up of the FSU, bacteriological laboratories developed in some hospitals.

The collapse of the FSU led to a collapse in health financing and the remaining health budget could no longer support the extensive health infrastructure with more hospitals and hospital beds than any other system in the world. Health financing decreased dramatically with real funding declining by more than 40%. Extensive reform was required in the health system particularly the move from a hospital oriented system based on inputs towards a PHC system that could diagnosis and treat the majority of clinical conditions. This required inverting the health delivery system pyramid, shifting financing and service delivery care into a newly restructured PHC system based on family medicine. The vertical TB system remained isolated from the broad currents of health reform as did other FSU vertical systems including dermato-venerology (for sexually transmitted illnesses), oncology, narcology (for alcohol and drug abuse), mental health, and the emerging HIV/AIDS system. While the rest of the system was moving towards new methods of financing and organization, the TB system remained virtually unchanged.

The vertical TB system was part of a much wider system of social controls in the Soviet Union. There was strong control over the movement of people and a strong system of police surveillance to monitor movement. One could not move to different parts of the country without a propiska and registering with the police. As a consequence of the break-up of the Soviet Union and the move towards a more open society, there was a breakdown in the system of tight social control that made the TB system effective. The most serious breakdown occurred in the prison sector. The dramatic decline in funding led to collapse of prison health services, and the rise of TB in prisons. Post-soviet countries had very high rates of incarceration and the extensive prison system was even more underfinanced than the health system. Prisons and pre-trial detention centers became incubators for TB with poor nutrition, overcrowding, and health services. Regular amnesties of prisoners created an epidemiological pump increasing TB in the communities. In addition, the coordination between the prison and civilian sector deteriorated with the collapse of the system of social controls including strong controls on where people could live. Prisoners who had started TB treatment were often released and then lost to follow-up.

WHO has identified a need for greater coordination of TB programs with primary care and civil society. The rapid scaling up globally of HIV, TB, malaria, and immunization programs has reinforced awareness of the well-known weaknesses in the health systems and the need to develop new strategies with availability of new funds to support a broader strengthening of health systems. There is consensus that strengthening health systems is essential to achieving not only improved TB results but broader health goals including progress on child and maternal mortality. WHO STOP TB has explicitly included health systems in their latest strategy under the belief that sustainable TB control relies on the general health system especially on well functioning PHC. In Central Asia, the home of the Alma-Ata declaration, it’s not yet possible to say that TB diagnosis and treatment are well integrated into PHC in any of the five countries.

B. Basic Hypothesis of Conceptual Paper

Although the context is evolving in Central Asia today, ZdravPlus initial interviews with country partners showed that the level of acceptance of DOTS by the vertical TB system remains an open question.

II. Broad Health Systems Approach in Central Asia

A. Background and Options

This section discusses a very broad health systems approach for TB services. As reflected in the chart below, the FSU TB system consisted of closed institutions linked by a strong system of control and characterized as follows:

· Complete separation of the general health system and the vertical TB system

· Strong walls around the prisons and vertical TB systems controlling the location and treatment of TB patients

· Strong administrative controls moving TB patients released from prison to the civilian vertical TB system and TB cases identified in the community or general health system to the vertical TB system.

After independence, the situation in Central Asia is reflected in the chart below and characterized as follows:

· Budget collapse, weaker administrative controls and increased human rights resulted in leakage of patients and health system functions from the walls of the prisons and vertical TB systems into open society (the walls started to crumble).

· No broad governance/stewardship or institutional roles and relationships existed to manage this leakage from the prisons and the vertical TB systems resulting in significant and substantial gaps in the overall system conducive to TB transmission

· Initial steps to integrate the vertical TB system into the general health system

A broad health systems approach produces three main options to address TB service problems including high incidence of MDR-TB:

Option 1: Rebuild the Soviet vertical TB system but move diagnosis and treatment protocols towards international standards of clinical practice.

Over the last decade, the donors have largely supported this first option. The focus of funding has been the vertical TB system. Reforms have worked on changing clinical protocols to align with DOTS and regular supply of key first line medications. There have also been deeper changes such as the adoption of the WHO classification for TB cases and the introduction of bacteriologic diagnosis. There has been only limited reform in the structure and organization of TB control which is still dominated by specialized TB institutions separate from the general health care system.

It’s possible to continue to support and expand this system. This idea would be to return to the strong system of control of the earlier Soviet period, with what was called the “dispensarization” function. This system and its functions could be strengthened by extending it beyond the Oblast TB hospital into Central Rayon Hospitals and urban polyclinics. The TB vertical program could second personnel to these institutions, extending the reach of the system and carrying out coordination with primary care and public health surveillance.

This option has two main disadvantages. First, the structure of the current vertical TB system is massive with enormous excess capacity, unsustainable fixed costs, and very little financing to invest in variable costs or direct patient care. A further extension of infrastructure will only exacerbate this problem. Secondly, given the extent of leakage of functions creating gaps as well as reductions in administrative controls or increases in human rights with a more open society, it is very difficult to imagine how to put the system completely back into the bottle. Mechanisms and processes will be required to coordinate care across a variety of settings and the community even if attempts to strengthen the old vertical TB system continue. A related issue is the inability of the vertical TB system to perform some functions such as overall governance/stewardship or some broader public health functions which may conflict with their desire to provide curative services which are more financially lucrative. As discussed in Section II, it is an open question whether the vertical TB system is willing or able to serve a leadership role in coordinating TB services at the PHC level or in the community.

Option 2: Complete integration of the vertical TB system into the general health system

Integration is the buzz word and the presumption is that Central Asia should move towards some type of meaningful integration of TB services. A radical vision of integration would be to abolish the vertical TB system and absorb its functions into the general health system.

Complete integration of the vertical TB system and core TB service functions into the general health system would require at least the following:

· Free-standing TB hospitals are integrated into an oblast, city, or rayon general hospital department, affiliate, or hospital network

· PHC (family group practices/polyclinics) provide the core diagnosis and treatment in the community with the support of specialists located in the general hospitals

· Surveillance and contact tracing is integrated into the SES

The most critical discrete or one-time step in complete integration of the vertical TB system into the general health system is integrating free-standing TB hospitals into an oblast, city, or rayon hospital department, affiliate, or network. TB could be integrated into general hospitals as only TB, a sub-set of infectious diseases or a sub-set of pulmonary medicine. Until general infrastructure is improved including better ventilation, the TB department would probably need to be in a separate building. There are a variety of organizational models possible providing a range of flexibility for the TB entity under a general hospital. Complete integration could be established by creating a department under the general hospitals and less complete integration (more flexibility for the TB entity) through establishing an affiliate or type of network. The general objectives would be to: 1.) Increase efficiency through reduction in excess capacity especially given continually rising utility costs; 2.) Create economies of scale through shared functions including administration, support, and some clinical services; 3.) Reallocate some savings to PHC to strengthen TB services, some savings to general hospitals to strengthen TB services, especially MDR TB services, and also reduce patient informal payment, and the remainder of the savings to address the leakage or gaps in the TB system described above; 4.) Improve overall health sector prioritization given extremely limited resources; and, 5.) Remove any conflicts of interest or inherent tendencies of the vertical TB system to not fully address all TB control functions which might result in their own “sunset” clause.

The most critical continuous or ongoing step in the complete integration of the vertical TB system into the general TB system is strengthening the integration of TB prevention and treatment into PHC including establishing appropriate roles for TB specialists in coordination and supportive supervision. This requires a comprehensive and high priority strategy to improve the capacity of PHC providers to diagnosis and treat TB. Another continuous step would be integrating laboratories into the hospital or SES bacteriological laboratories and ensuring good access to high quality laboratory services for PHC providers. Transportation of laboratory specimens is a problem long discussed in Central Asia with little result, it would also need to be addressed.

The public health functions would shift to the entity responsible for public health, the SES. They would be responsible for the TB database across all parts of government including civilian and prison sector. SES would carry out epidemiological analysis including regular studies of drug resistance along with wider studies of antibiotic resistance. Most importantly, they would carry out contact tracing of all MDR TB patients and ensure access to diagnosis and treatment for all those who were exposed.

Restructuring and rationalizing the massive vertical TB system infrastructure would create savings which could be reallocated to address critical TB problems. In addition, any problems with the vertical TB system lack of desire to support integration into PHC and provide appropriate specialist supervision would also be resolved. In many ways, choosing this option would resemble the decisions made on restructuring the PHC sector early in the health system reform process. It was believed the old specialist-oriented polyclinic structure with its separation of services for adults, women, and children, domination by narrow outpatient specialists relegating first point of contact or PHC professionals to a dispatcher role did not include an organization structure or culture conducive to developing and expanding the scope of services in PHC. So, a new PHC sector structure was created in many Central Asian countries to establish an organizational structure consistent with the development of PHC. It is likely that Option #2 would eventually provide the same outcome, a general health system approach motivated to reduce TB incidence, strengthen the role of cost-effective PHC, and ensure appropriate access to specialists in departments of general hospitals.

Kyrgyzstan has the most advanced health reforms in Central Asia and two aspects of the Kyrgyz health reform experience shed some light on Option 2 and will be further analyzed in the country specific assessment. One is experience in merging the vertical TB system free-standing TB hospitals and the second is the collapse and integration of the vertical Dermato-Venerology (DV) system which largely treated STIs. Kyrgyzstan merged free-standing TB hospitals into an Oblast Merged Hospital. It is hard to fully evaluate this experience due to conflicting stories, the short-time period before they were again unmerged, and the lack of concrete, objective data available. However, two conclusions have generally been agreed upon by observers: 1.) it appeared to work better in oblasts who had accomplished more general health reform and health system restructuring; and, 2.) there was some time correlation between unmerging the TB hospitals and strengthening of the political position of the vertical TB system due to their being the principle recipient of Global Fund grants.

A more comparable precedent may be the fate of the vertical DV system in Kyrgyzstan. This was once a powerful Soviet vertical system with police powers for carrying out surveillance and treatment of sexually transmitted illnesses. The DV system has disappeared as a separate vertical structure and has been fully integrated into the health system. Although at times the health reforms have been blamed for the collapse of the vertical DV system, it is hard to make that case given other factors contributing to its demise including the system was collapsing under its own weight and the continuous budget reductions, international best practice is generally outpatient treatment of STIs, and it lost out on the large increase in donor funds for HIV/AIDS although treatment of STIs is critically important for HIV/AIDS prevention. The system was needlessly fragmented with the arrival of HIV/AIDS and the development of a new separate vertical HIV/AIDS system structure. The vertical HIV/AIDS system has garnered the lion’s share of funding including development of a new vertical laboratory structure doing AIDS testing. Much work would be needed to improve STI treatment either in the old vertical system or the general health system but general health reform and savings from reduced excess physical infrastructure and increased efficiency should enable STI service improvement over time.

The main disadvantage of the complete integration option is this radical step could further disrupt DOTS implementation and a response to MDR TB in the short-term or transition period. However, even here there is an argument for the integration option. The unfortunate status of Central Asia as a world-wide MDR TB hotspot provides some evidence (correlation if not causation) concerning the validity of the charts above which hypothesize that the walls crumbling in the vertical TB system and people and functions “leaking” from both the civilian and prison sectors creates gaps which contribute to the very high MDR TB rates. If this is true, it can also be hypothesized that the radical option is needed to solve the problem.

Option 3: Gradual Integration and Push Out/Pull In

Option 3 consists of two parts:

1. Continue the gradual integration of the vertical TB system which is occurring to a greater or lesser extent in each Central Asian country

2. A push out/pull in or Push/Pull strategy consisting of:

· Push-out all or most diagnosis and treatment for primary non-MDR TB into the general health system.

· Pull-in MDR/XDR TB into the vertical TB control system.

Continuing the gradual integration of the vertical TB system would allow development of a step-by-step implementation strategy and plans. This step-by-step approach is consistent with the general health reform process that has been successful in much of Central Asia. It avoids the risks of the radical complete integration option and may help mitigate any further decline in TB services or increases in MDR TB while also recognizing that the existing structure of the vertical TB system is unaffordable and unsustainable in the long-term. It also enables the step-by-step integration and improvement of referrals between the civilian and prison sectors.

Under the Push/Pull strategy, primary TB would be largely treated in PHC and the general health system, and the vertical TB system free-standing hospitals would almost exclusively treat MDR/XDR TB cases. Initiating restructuring and rationalization of the enormous excess capacity and high fixed costs contained in these free-standing hospitals would also help increase the variable cost per case required to appropriately treat MDR TB cases by reallocating savings from fixed costs to direct patient care.

The advantages of the Push/Pull strategy are as follows:

· Enables continuing gradual movement toward the long-term objective of integration of the vertical TB system into the general health system

· Addresses the critical MDR TB problem while avoiding further expansion and strengthening of the vertical TB system which would make it harder to integrate in the long-term.

· Enables a potentially major impact on facility level TB infection control by taking a more radical step to separate primary TB and MDR TB cases inside hospitals. Push-out primary TB and pull-in MDR TB will result in infection control and patient separation (which should be occurring but ZdravPlus initial interviews found remains an open question).

· A clear timeframe and plans for full integration of the vertical TB system can be developed as the system is fully integrated at the time the MDR TB problem is largely solved.

· It may create opportunities for further integration of TB and HIV/AIDS services

· An improved referral system from prisons to the civilian sector could be built around the Push/Pull strategy by referring released prisons with primary TB to PHC and released prisoners with MDR TB to free-standing TB hospitals with an appropriate balance of pubic health and human rights concerns.

There is a large cohort of patients that already have chronic MDR TB and are unlikely to be successfully treated. Given that they are infectious, they cannot be released into the community. Notwithstanding human rights concerns, there is a compelling state interest for providing compulsory treatment segregated from the wider community. Whether they choose to accept treatment or not, people need to be treated with dignity with assess to good palliative care in good settings.

The full integration of services might be a long-term vision, but at the moment, the key priority is to solve the MDR TB crisis. This requires scale-up of treatment in the civilian sector and this is most simply accomplished by using the existing hospital capacity in the TB vertical system for treating MDR TB cases. It also requires strengthening of first line treatment of patients identified with sputum positive tuberculosis (the core of DOTS). For community acquired infections of non-MDR TB, there can be a greater role for community-based treatment in PHC and social support. This system would be much less expensive and probably more effective then the current system of hospitalizing everyone in TB hospitals.

Accomplish these objectives requires rectifying long-standing problems in the implementation of DOTS in the post Soviet countries of Central Asia. There has never been meaningful integration of TB services into urban and rural PHC. Real integration requires some form of financial incentives to shift care from the vertical TB system into PHC. To date, treatment functions have been shifted to PHC but corresponding financing has not accompanied this shift in functions. The incentives need to be complemented by an improved infrastructure for bacteriological diagnosis requiring funding. It also requires on-going professional training, continuing medical education, to doctors, nurses, and laboratory workers on methods and guidelines. On the demand side, there needs to more direct work with patients, providing them with greater social support so that they can complete their treatment in the community.

This is the unfinished agenda that should be the backbone of long-term TB infection control in Central Asia. This approach would prevent new cases from appearing and eventually driven down the rate of MDR TB.

B. Basic Hypothesis of Conceptual Paper

The extreme option of moving back to the old FSU vertical TB system with its accompanying administrative controls is not conceptually or operationally viable or optimal. The other extreme option of substantially accelerated or complete integration of the vertical TB system into the general health system is conceptually the best option but operationally difficult or impossible.

The option of continuing the gradual integration of the vertical TB system into the general health system including a step-by-step implementation strategy and plans is the most viable option. In addition, the Push/Pull strategy could be both a long-term integration strategy (the vertical TB system gradually dissolves with the resolution of the MDR TB problem) and a short-term infection control strategy to ensure separation of patients. Potential to realize this strategy will also be very politically difficult but will be assessed on a country specific level.

The gaps in governance/stewardship and system management across the entire span of TB services that resulted when the walls of the vertical TB system and prisons started to crumble are likely a major contributor to poor TB infection control and increases in MDR-TB transmission. Improving governance/stewardship across the entire universe of TB services and strengthening institutional structure, roles, and relationships to reduce the gaps in system management at all levels will be a priority.

IV. Assessment of TB Infection Control in Central Asia Using STOP TB Strategy

The following sections describe background, general hypotheses for country assessments, and key questions for country assessment for each of the six components of the WHO STOP TB strategy. The sections are ordered exactly as in the STOP TB Strategy.

1. Pursue High-Quality DOTS Expansion and Enhancement

This component of the STOP TB strategy includes five subcomponents which are discussed in the sections below.

a. Political Commitment with Increased and Sustained Financing

As political commitment and financing apply not only to DOTS expansion and enhancement, they are discussed in the Health Systems Strengthening Component and the Prison Subcomponent of the Address TB/HIV, MDR-TB, and Other Challenges Component.

b. Case Detection Through Quality-Assured Bacteriology

A. Background

As mentioned earlier, one of the critical differences between Soviet and WHO/ International best practice was/is the importance of microbiologic diagnosis through microscopy and culture. One of the central changes in DOTS from Soviet clinical practice was to base diagnosis and treatment on sputum microscopy and bacteriologic culture rather than through x-rays. This requires the introduction of good microscopes and good standard methods in PHC. It also requires strengthening the laboratory network for culturing mycobacterium and carrying out drug resistance testing.

Accurate and timely diagnosis of resistance is key to combating the growth of resistance because drug resistant TB must be diagnosed correctly before it can be treated effectively. Case finding strategies depend on level of drug resistance in the community. This all depends on the ability to culture mycobacterium tuberculosis and test it for resistance in a quality assured laboratory.

There are three core competencies needed for DOTS and DOTS Plus:

· sputum smear microscopy,

· microbiologic culture of TB,

· Drug Susceptibility Testing (DST)

Unfortunately, none of these three areas is working well in Central Asia. It is important to emphasize that DST was always important, but it became critical with DOTS Plus and new pilot projects to treat MDR TB. In these cases, it is critical to test for resistance to develop meaningful therapy for drug resistant patients.

In general, donor support to build laboratory capacity has largely focused on the laboratories in the vertical TB system, largely TB hospitals. There has also been focused support to develop a national reference laboratory as part of the Republican TB Institute that can do DST and participate in the global network. There are many additional possibilities for developing bacteriology as part of a wider emphasis on health system strengthening and this will be addressed later in the report.

National Reference Laboratory

It is a bit disheartening to read of the continuing problems in the key peak laboratories in all of the Central Asian countries. As early as 1995, donors identified bacteriological laboratories as central plank for the implementation of DOTS. There has been long-standing and significant donor support through Global Fund, USAID (CDC/Project Hope), World Bank and others and yet the reference labs all still seem to be functioning very poorly. Information about the Kyrgyz National Laboratory in reports from ICRC and Project Hope is particularly troubling. They seem to have virtually no equipment and do not even have an uninterrupted power supply. Is this model working or would other institutional arrangements be more effective?

Laboratory Rationalization

Report after report details problems in the laboratory network. There is overlapping responsibility in the civilian sector between the vertical TB system and the general health care system (oblast and rayon hospitals and polyclinics). A recent report by Project Hope documented many issues in the overall laboratory network with far too many facilities, lack of quality control, and inadequate caseload. There is a need for a more systematic approach to laboratory rationalization. However, if this is not accompanied by changes in payment methods, there is unlikely to be significant progress. Transportation is a critical issue. Over the last ten years, there has been consistent dialogue on the need to establish a reliable laboratory specimen transportation system, not just for TB services but for the entire health system. How to balance ensuring access in rural areas and ensuring laboratories have enough volume to produce high quality results remains an issue. A reliable laboratory specimen transportation system seems to be the answer but it has never progressed beyond dialogue in Central Asia. Establishing a pilot laboratory specimen transportation system is one option.

Case Detection in Primary Health Care

WHO recommends that the primary system of case detection in post-Soviet countries should be based on passive detection of cases through symptoms presenting in PHC. All studies suggest that there are relative low levels of case detection in Central Asia. The capacity of the laboratories that service PHC in the Central Rayon Hospitals and Family Medicine Centers/Urban polyclinics are low. There is very limited capacity and competence for sputum microscopy and bacteriological culture. There has been little investment in training or infrastructure. The labs are often unsafe and of poor quality. There has been little training of microscopists and high staff turnover.

There seems to be a lack of adequate understanding of the importance of diagnosing TB in the civilian sector. Although there has been some limited training, there are clearly deeper issues at work. Given the large extensive TB structure staffed with TB specialists, PHC providers have a strong incentive to refer any suspected case to TB specialist facilities. Similarly, the poor condition and training of PHC laboratories means that there have limited incentive to carry out sputum microscopy. If passive case detection rates are to increase, this will require rethinking how to integrate TB diagnosis and treatment into PHC.

In the short-run, this may require providing incentives for diagnosing sputum positive cases. Ideally, it would also include improving the diagnostic capacity of polyclinics/family medicine centers. One of the simplest approaches would be to shift TB specialists from TB dispensaries to polyclinics. In theory, they could serve as a resource to the all physicians in the polyclinic similar to other polyclinic specialists.

B. Basic Hypothesis of Conceptual Paper

The whole laboratory backbone of TB sputum collection, microscopy, bacteriology, and drug resistance testing is not functioning well for either DOTS or DOTS plus and this is a critical health system roadblock for controlling MDR TB. The system gap between the vertical TB system and PHC could be particularly significant in this program element. The vertical TB system has no incentive to support development of sputum microscopy capacity in PHC, and PHC has incentives to refer everyone to the vertical TB system and no incentive to develop sputum microscopy capacity. Low case detection in PHC and losing patients presenting with symptoms in PHC could be the result of this system gap.

c. Standardized Treatment, with Supervision and Patient Support A. Background

Standardized treatment

One of the key differences between Soviet TB clinical practice and WHO/International best practice was standardized regimens. The Soviet tradition of clinical medicine had less standardized regimens and often used up to 8 drugs tailoring the regimen to individual patient characteristics. There were also differences in the drugs used. The old drug supply system collapsed with the collapse of the FSU. Since many of the drugs were now imported, with strong technical support by WHO and others the countries shifted their clinical protocols to standard WHO practice for first line therapy.

However, many Soviet TB clinical practices may or may not have disappeared. Many TB specialists still believe that patients should receive adjuvant TB drugs, even after technically cured by WHO standards, especially if there is still any radiological evidence of TB. The main difference remains the reliance of radiology as the principal means of diagnosis. Although clinicians will use smear microscopy, it is often done in parallel with radiology. Interestingly, radiology was one pathway for becoming a TB specialist in the Soviet medical education system.

The Central Asian republics continue to rely on ineffective x-ray screening as a method of case finding. Instead they should rely more on identifying the majority of cases through PHC, where the patient presents with cough and fever. With confirmed cases, there should be systematic contact tracing, since the highest risk groups are those who have been in close contact with the incident case. For complex reasons, the system of contact tracing has disappeared and this is one of the key health system problems to be addressed.

Evidence-Based Medicine (EBM) There are numerous examples of the need for promotion of evidence-based medicine (EBM) in improving TB services. One way to understand the need for a larger role for EBM is to look at the example of continued use of TB surgery. ZdravPlus staff have met physician after physician that was not convinced about the new WHO approach. They still used mainly x-rays for diagnosis (as the sputum microscopy labs remain weak there may be good cause to continue to rely on x-rays). They still use x-ray to monitor the course of treatment. Many still believe in general relapse treatment with several drugs even after cure by WHO definition.

Convincing physicians on the right diagnosis and treatment will not likely be accomplished through diktat but through continuing dialogue on evidence-based approaches to diagnosis and treatment of TB. Although the doctors talk the talk, it is not clear whether their hearts and minds have been won. Engaging with physicians about what works using data from studies and encouraging them to read the new literature (in Russian) is an important step. A more strategic approach is required including strengthening TB professional standards through developing profession organizations, development of evidence-based standards, and CME for TB professionals with new literature.

Part of the problem is a generational issue. The old guard of Soviet phtysiatrists will continue to believe in Soviet clinical practice. A new generation of TB doctors is needed with broader general practice and pulmonary education, trained in lung disease but also epidemiology, and who know the latest literature on best international clinical practice.

Patient Support Patient support is one of the most neglected areas of TB control in Central Asia. It is a critical transition issue from the old closed system of TB control (which had many merits from a public health standpoint) to a more open society where people are allowed to move about more freely. The presumption of the old system was that patients would not be compliant and therefore they should be incarcerated. However, with strong social support it becomes much more possible to treat people in the community.

There are many different models of social support including enablers and incentives and there are lessons to be learned from FSU experiences. The patient must come in to have treatment observed and this requirement can be linked to social support. One of the incentives used for patients is food baskets. Another possibility is to involve community volunteers. In Russia, nurses have been used to follow patients. Some have argued this is stigmatizing behavior since TB patients can be identified. Ideally, it might be possible to integrate social support and PHC for a wide variety of conditions. In rural areas, it may be possible to have feldshers supported by community workers similar to the model developed by Partners in Health in Peru.

A major problem is that there is limited funding for TB services in general and patient support is often one of the first program areas to go. A critical task is to ensure funding of social support. Patient support could be an important place for international donor assistance using NGOs such as the Red Cross and Red Crescent Society. Ideally, some of this funding could be provided by local governments but experience to date has been limited. There may be an important role for sustained donor assistance with matching funds from government to ensure funding for social support. In addition, there is an urgent need to develop models of social support adapted for each country. The introduction of pilot projects showing much higher rates of adherence would help justify this investment.

B. Basic Hypothesis of Conceptual Paper

Changes vary by country and region but TB treatment is not yet standardized, evidence-based medicine is not yet accepted, continuing professional development including access to Western literature is not yet wide-spread, and patient social support is not valued, funded or provided well.

d. Effective Drug Supply and Management System

A. Background

In the Central Asian context with high rates of MDR TB, short-course chemotherapy for patients infected with drug resistant strains may create even more resistance to the drugs in use. This has been termed the amplifier effect of short course chemotherapy. Ongoing transmission of established drug resistance is most likely to be the major cause of increasing drug resistance in Central Asia. Unfortunately, a good understanding does not exist of the relative importance of the key drivers of resistance in the Central Asian context.

Drug Resistance—Primary Use by Population without Prescription In the crisis period of 1990-1998 the TB drug supply system collapsed. The impact of the crisis was much wider than just TB drugs as a precipitous decline in health financing resulted in a general collapse of the old health system. For TB services, a major consequence of the collapse was that drugs were no longer provided free of charge in the hospital. This, in turn, led to a collapse of the system of controls for drug prescriptions and people were able to buy drugs directly from pharmacies which were largely privatized in the mid-1990s.

People can access first and second line drugs for TB without prescription. For many of the first line drugs, there is unlikely to be that much use outside suspected TB. The one exception is rifampicin which is widely used for other types of infections. There is an urgent need to stop people from using these drugs except for TB in order to protect the use of cheap first line drugs. There is absolutely no need to use rifampicin except for cleared specified conditions and the same holds true of isonizaid (H) and streptomycin (S).

Ideally, these should be controlled drugs handled similar to opiates and other psycho-active substances. The Central Asian Republics all have controlled drug regulations that are still functioning. Other intermediate steps could be the MOH Drug Department approving and enforcing new regulations on these medications or more widely on antibiotics in general. This would be a simple and cheap solution to part of the problem of antibiotic resistance for TB. In principle, this is a problem with a relatively easy solution and it will be a priority of country assessments to recommend options for regulating access to use of first line TB drugs for other purposes.

Separate Drug Supply System for TB Drugs

The TB institute has developed its own vertical drug distribution system. In general, drugs are procured by the Republican TB Institute and distributed throughout the TB system using their own separate supply chain and information system. On average, this has meant that drugs are less available throughout the periphery as in a resource constrained environment the periphery tends to be a lower priority. Also each level is expected to come and get their drugs.

In Kyrgyzstan, the Republican TB institute has its own warehouses for drugs and laboratory supplies. Oblast TB facilities are expected to get their drugs and supplies by driving to the warehouse and picking them up. Similarly, each level is expected to pick-up their own drugs and supplies. This burden becomes greater at the lower levels of the system and is especially problematic for PHC. Although currently there is, in theory, adequate drugs and supplies, there is no real supply chain delivering drugs to the facilities particularly PHC. The likely consequence is inadequate supply particularly at the PHC level. Per USAID TB Control Project reports (Project HOPE/JSI), there have been some improvements in the logistical information management system (LIMS).