Follow-Up Points Arkhangelsk June 4, 2008

Prison Health Expert Group

Sixth Meeting

Oslo, Norway

30 September –

1 October 2008

Reference / PH 6/6/Info
Title / Visit to Arkhangelsk Tuberculosis Control Programme, by LHL
Submitted by / Norwegian Heart and Lung Patients Organisation
Summary / Note / -
Requested action / For information

Visit to Arkhangelsk Tuberculosis Control Programme

Northwest Russia

By LHL – Norwegian Heart and Lung Patients Organisation

Travel Report, May-June 2008

Executive summary

The Health administration, the Northern Medical University and the prison sector in Arkhangelsk oblast (region) in Northwest Russia have collaborated since the 1990s with the Norwegian Heart-and Lung Patients Organisation (LHL) and the Norwegian Institute of Public Health (NIPH) in strengthening the Tuberculosis Control Programme in accordance with international recommendations. The collaboration has changed over the years from first revising the TB program to be in line with international recommendations, then to manage MDR-TB and since 2007 focusing on patient communication and strengthening of the recording and reporting system.

The purpose of the current half-yearly visit was to provide technical support to the TB control programme in the oblast, with special focus on follow-up of MDR-TB information system, psycho social support of patients and training in health communication, follow- up of development of new TB educational materials and follow- up of the external quality control of the TB laboratory. The LHL visiting team consisted of Torunn Hasler ( Consultant health communication and project coordinator), Einar Heldal (LHL consultant, epidemiologist), Eivind Lyche Melvær (computer programme expert). The NIPH visiting team consisted of Turid Mannsåker (microbiologist from the national reference laboratory) and Brita Winje (responsible for TB surveillance in Norway). The visit included meetings with the Regional TB dispensary, the regional prison health administration and the regional prison hospital, and part of the team also visited two prisons in Plesetsk region: Puksa and Colony 8.

Main findings:

The total number of TB cases and the number of new smear and/or culture confirmed TB continued to decrease from 2006 to 2007 both in civil and prison sectors. The proportion of MDR-TB in new cases was still high at 28% in civil sector in 2007 and preliminary data indicate higher proportion in prison.
Culture and DST procedures are centralised to the reference laboratory in the TB dispensary (using both solid and liquid media) and the regional prison laboratory (using solid media). External quality assurance is implemented from Moscow for both sectors. DST is done on solid media on 2.line drugs.
The Russian Health Care Foundation (RHCF) supplied treatment for 200 MDR-TB patients in September 2007 and 300 more treatments arrived in May 2008. Currently there should therefore be enough MDR-TB drugs to cover both the waiting list of patients and newly diagnosed patients both in the civil and prison sector. .So far approximately 40 cases of XDR-TB have been registered in the civil sector and 3 in prison.
The recording and reporting system includes a Foxpro computer system which generates reports required by Order no 50. The MDR-TB recording and reporting is managed with MDR-TB Treatment cards and MDR-TB registers while quarterly reports on MDR case finding and treatment result have been developed but are not yet routinely in use. The computerised system including all TB cases is still not fully operational.
The TB program has implemented several measures to strengthen the support mechanisms for improved adherence. These are support transport to/from the clinics for DOT, food incentives, flexible treatment options (home-dot, ambulatory treatment, day hospital etc), support of social worker and psychologists and a TB school for patients and relatives.
Training of health workers in patient communication : effective health communication and TB peer work methods have resulted in increased involvement of the patients in decision making processes first and foremost during development of new patient-friendly Behaviour Change and Communication ( BCC) materials. TB patients have been involved during the needs assessment process of mapping their information needs and wishes. During the process of pretesting TB patients have given many inputs and suggestions to change the draft BCC materials. Reports and self evaluations of the trainings of health workers in how to communicate effectively suggest stronger awareness of own communication and better listening skills.

Recommendations:

MDR-TB treatment

The TB program should update the projections of MDR-TB cases both in civil and prison sectors to ensure necessary drug supplies from RHCF.
All culture positive MDR-TB patients waiting for treatment in colony 8 should be referred to the regional prison hospital as soon as possible for MDR-TB treatment. The rest of the MDR-TB patients in Colony 8 should be discussed in CVKK and decision taken whether to start treatment or not. New DST should be taken and treatment later modified if indicated.
The infection control measures should be strengthened in the MDR-TB ward in the regional prison hospital, ensuring that staff is strictly following routines.
The TB program should update the list of failures of MDR-TB treatment and XDR cases (both in civil and prison systems), assess the indications for 3.line drugs for these patients and clarify options how to get these drugs. Patients who are not cured with all available drugs, need to be provided for with sufficient living conditions to reduce transmission as much as possible, also respecting minimal requirements for human and patients’ rights
The health authorities both in the civil and prison sectors should ensure that the implementation of the invalidity pension works to promote cure of the disease and not that patients do not want treatment.
The prison health care authorities in Arkhangelsk should ensure that patients on MDR-TB treatment are not moved to other entities or regions in Russia that cannot guarantee completion of the MDR-TB treatment

Recording and reporting of MDR-TB

The TB dispensary should make a new contract with the computer programmer Ivan Druzhinin to complete the computer program by September 2008.
Data from the register needs to be accessible in excel format for routine surveillance and reporting. The TB dispensary should organise training in excel and develop routines for quality assessment of data entry and data completeness
The Foxpro program for MDR-TB could be further developed in Arkhangelsk to include all necessary variables, lists and tables in accordance with revised WHO recommendations and serve as an example for other regions. Regions with hospital based computer programs which also function as TB registers, such as in Arkhangelsk, could use this system as a more complex alternative, providing the same outputs as the Foxpro program.
The civil and prison sectors should update the agreement on the flow of TB reports and data between prison and civil system. The Tb dispensary should assist the TB program staff in prison in updating the handwritten MDR-TB register in prison from the treatment cards, entering smear and culture data, also from Puksa.
The TB dispensary should enter data of all MDR-TB patients since 2004 in the computer program, using the revised definitions of category and date of register as described in the report and update the interim treatment outcome analysis

Treatment adherence, effective communication and peer work.

The LHL team recommends that the:

The TB school should organize pretesting of booklets no 3-6 with patients, pre-test and revise all illustrations. LHL appreciate if results of pretesting and analysis is sent to Torunn Hasler in LHL for further discussions.
The TB school could invite social workers from Puksa and regional prison hospital for training and networking.

LHL could clarify with special hospital in Netherlands working with TB patients with special needs ( Beatrixoord), with view to information sharing and possible visit.

Conclusion and future challenges

The TB program in Arkhangelsk has succeeded in reducing the number of TB patients through strengthening the organisation of case finding and treatment. The levels of MDR-TB are very high but the TB program has gradually started most MDR-TB patients on treatment with 2.line drugs, mainly through the GFATM/RHCF, and has reduced the production of new MDR-TB cases.

The collaboration with Norway continues to focus on two main challenges: One is to ensure treatment completion for all patients with MDR-TB including those who have waited for treatment a long time, who have many social problems and in some cases have strains resistant also to 2.line drugs (XDR-TB). Another challenge is to make the recording and reporting system for MDR-TB fully operational, including the computer program, allowing better capacity for monitoring and analysis of the efforts.

Further development of good examples in Arkhangelsk in these two areas should also be helpful for the process of ensuring effective management of all MDR-TB cases in Russia. The experience in TB control in Arkhangelsk is benefitting other regions in Russia, including through training by the Northern State Medical University in neighbouring regions, including Komi, Karelia and Murmansk.

Although the incidence of TB has been declining in Russia in recent years, and the Russian government has increased budgets for TB control substantially, the TB situation in Russia is of concern, especially regarding MDR-TB, XDR-TB and TB/HIV. It is a challenge to ensure implementation of MDR-TB management in the regions as required by GLC, limiting the capacity to spend the funds available to Russia from The Global Fund. There is concern that if 2.line drugs from RHCF/GFATM are made available to regions without correcting the weaknesses that caused the MDR-TB problem in the first place, it will lead to resistance also to 2.line drugs in the form of so-called XDR. Treatment with GLC drugs have low success rate in XDR-TB patients while so-called 3.line drugs (not supplied by GLC) have some effect. Continued support to this process is also in line with the Berlin declaration on Tuberculosis made by European ministers (of health, etc) in October 2007, including a call for support to the Plan to Stop TB in the high priority countries of the WHO European region 2007-2015

The next visit by the Norwegian partners is planned towards the end of 2008. The LHL consultant may make another visit to Arkhangelsk in late August especially to follow up the process of MDR recording and reporting.

Contents

Background

Three phases of the collaboration

Main findings and recommendations:

Organization and structure of the TB program

Data on case finding, drug susceptibility and treatment outcome

MDR-TB treatment

Recording and reporting system

Registers with MDR-TB patients

Comparison of MDR-TB registers

MDR-TB treatment results

Laboratory issues:

Treatment adherence, effective communication and peer work

Funding and approved budget 2008

Conclusion and future challenges

Acknowledgements

Tables

Attachments:

Attachment 1: Visits to the health services in the prison system in Arkhangelsk:

Attachement 2: Recording and reporting system at the tuberculosis dispensary in Archangelsk 27

Attachment 3:

Availability of data from the tuberculosis register for surveillance, reporting and quality assessment

Background

The visit was part of the collaboration to strengthen TB control in Arkhangelsk oblast (region) between the Health Department of Arkhangelsk oblast, the Northern State Medical Academy in Arkhangelsk, the Prison authorities in Arkhangelsk, the Norwegian Heart and Lung Patients Organisation (LHL) and the Norwegian Institute of Public Health (NIPH). This report includes an overview of the history of the collaboration, main issues from visits since early 2007 and future challenges.

Three phases of the collaboration

The collaboration started when the Health care department in Arkhangelsk in the mid-1990s asked for assistance in TB control within the Euro-Arctic Barents Cooperation. It has mainly consisted of support through twice-yearly visits. LHL has allocated a total funding of 28 million NOK from different Norwegian sources of funding to the collaboration for trainings abroad and locally, supervision – on the job trainings, rebuilding of the reference TB laboratory, infection control in wards, social support measures, establishment of TB school, 2nd line and 3rd line drugs and to cover the consultancy. The total funding to the TB programme in Arkhangelsk has increased during the years mainly because Russian authorities have increased their funding. The external funding from the Russian Health Care Fund (GFATM) is from 2007 covering nearly all expenses from 2nd line drugs. The LHL funding for drugs has in 2007 covered also some 3rd line drugs. The support for 3rd line drugs will be terminated from 2008 because it is anticipated that Russian authorities will have the capacity to take on this financial responsibility and because Norwegian authorities will not support the collaboration if this contain support for drugs. The collaboration has not included permanent Norwegian staff in Arkhangelsk. Most of the Norwegian funding has come from the Barents Health program (provided by Ministry of Foreign Affairs through the Ministry of Health) and LHL and INFIL. Some funding outside the LHL collaboration has been provided by, the Task Force on Communicable Disease Control for infection control in the prison TB hospital. For more details of the Norwegian funding please see page 16.

First phase: 1997-2001

The first phase of the collaboration contributed to the revision of the TB program to be in line with international recommendations. By 2001 the revised programme covered the whole region including prisons. Ambulatory treatment was made available for all patients. Quality assured drug susceptibility testing was established, and it showed very high levels of multidrug resistant tuberculosis (MDR-TB).

Second phase: 2002 - 2007

The collaboration therefore continued in a second phase focusing on prevention, treatment and monitoring of MDR-TB. The health administration had purchased drugs locally for 60-100 MDR-TB patients per year from 2000, but the needs were much higher[1]. The Green Light Committee (GLC), the mechanism established by WHO to give access to cheaper 2.line drugs of ensured quality to treat MDR-TB, approved the TB program in Arkhangelsk in 2003. LHL and the Norwegian government funded the first purchase of drugs through GLC for 100 patients with drugs arriving in June 2005. The Global Fund against AIDS Tuberculosis and Malaria (GFATM) may be used for 2.line drugs but only in projects approved by GLC. Arkhangelsk was one of the first four regions in Russia approved by the GLC and the first to receive drugs through GFATM/ Russian Health Care Foundation (RHCF) for 200 patients in September 2007 after a long delay finally solved partly because LHL brought the issue to the attention of the GFATM, GLC and WHO. The RHCF should therefore in the future supply second line drugs to cover all MDR-TB patients in Arkhangelsk.

Third phase 2007-2010

The collaboration has then moved into a third phase concentrated on two issues: health communication, which is key to ensure high treatment success in MDR-TB patients with many social problems and where LHL has experience from a number of countries, and recording and reporting for MDR-TB, where the LHL consultant has been involved in the development of WHO recommendations, with Arkhangelsk as one of the sites providing input. A well functioning recording and reporting system makes the region more able to monitor the situation, detect problems and measure impact of interventions and also to provide input to the development of the recording and reporting system for MDR-TB in Russia.

The collaboration also promotes the dissemination of the experience in TB control in Arkhangelsk to other regions in Russia. This is mainly taking place through training courses and technical support visits by the Northern State Medical University.

The most recent visits of the Norwegian partners took place in September 2006 (training course in peer work), November 2006 (assessment of the recording and reporting system for MDR-TB, visit funded by WHO), May 2007 (recording and reporting, laboratory, health communication), October 2007 ( course in health communication) and January 2008 (recording and reporting, health communication). Reference is also made to the report of the last GLC monitoring visit by Manfred Danilovits in October 2007, recommending LHL to help improving patients’ adherence to treatment, to finalize the system for recording and monitoring, to take part and coordinate international negotiations to support the program as strong political pressure was needed to overcome delays in drug delivery and to exchange information regarding drug management issues between LHL, TB dispensary and regional health administration.