Multidrug-resistant tuberculosis. Report of the sixth meeting of the Regional Advisory Committee (r-glc SEAR) Dhaka, Bangladesh, February 2015

Transcription

1 Multidrug-resistant tuberculosis Report of the sixth meeting of the Regional Advisory Commiee (r-glc SEAR) Dhaka, Bangladesh, February 2015

2 SEA-TB-360 Multidrug-resistant tuberculosis Report of the sixth meeting of the Regional Advisory Commiee (r-glc SEAR) Dhaka, Bangladesh, February 2015

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4 Contents Acronyms...iv 1. Background Opening session Objectives Progress report on the fifth meeting of rglc SEAR Field visit Regional issues and challenges on PMDT Recommendations from the Fifth Meeting Review of country mission reports Major country issues and challenges Operational research on shorter regimen on MDR-TB Improving efficiency and efficacy of rglc and establishment of Regional Centre of Excellence Next steps Annexes 1. Agenda List of participants Multidrug-resistant tuberculosis iii

5 Acronyms DST EQA GF GDF GDI drug susceptibility test external quality assessment Global Fund Global Drug Facility Global Drug-Resistant Tuberculosis Initiative ICDDR,B Dhaka International Centre for Diarrhoeal Diseases, Research- Bangladesh MDR-TB MoU NSP NTP NTRL PMDT PPM rglc SEAR SLD TB TWG XDR-TB multidrug-resistant tuberculosis memorandum of understanding national strategic plan national tuberculosis programme national tuberculosis research laboratory (ies) programmatic management of drug-resistant tuberculosis public private mix regional Green Light Commiee WHO South-East Asia Region second-line drugs tuberculosis technical working group extremely drug-resistant tuberculosis iv Multidrug-resistant tuberculosis

6 1. Background It is estimated that in 2013, people developed multidrug-resistant tuberculosis (MDR-TB) in SEAR, a form of tuberculosis (TB) that is difficult to treat with standard drugs because of resistance to isoniazid and rifampicin, the most efficacious first-line anti-tb drugs developed so far. Resolution WHA62.15 adopted by the Sixty-Second World Health Assembly in May 2009 urged Member States to develop and implement long-term plans for TB, including MDR-TB and extremely drug-resistant tuberculosis (XDR-TB) prevention and control, in line with the Global Plan to Stop TB One of the actions taken to implement this resolution was to establish the Green Light Commiee Initiative to help countries gain access to highquality second-line anti-tb drugs, to enable them to provide treatment for people with MDR-TB in line with WHO guidelines, the latest scientific evidence and country experiences. In response to the need for scaling up the programmatic management of drug-resistant tuberculosis (PMDT) in the WHO South-East Asia Region, a Regional Advisory Commiee on MDR-TB, also known as the regional Green Light Commiee (rglc SEAR) was established in 2012, which functions as an advisory commiee to the WHO Regional Office for South-East Asia, WHO Member States in the South-East Asia Region (SEAR), as well as donors and partners. The first and second meetings of the Commiee were held in May and December 2012 at the WHO Regional Office for South-East Asia, New Delhi, India; the third and fourth meetings in April and November 2013 in Thimphu, Bhutan and in Jakarta, Indonesia; and the fifth in May 2014 in Mumbai, India, respectively. During these meetings, the Commiee reviewed and endorsed the country mission reports on PMDT undertaken in 2013 and the first half of 2014 and extensively discussed issues related to the scale-up and implementation of PMDT in the countries of the Region. The sixth meeting of the rglc was held in Dhaka, Bangladesh from February Multidrug-resistant tuberculosis 1

7 2. Opening session Dr Navaratnasamy Paranietharan, WHO Representative to Bangladesh, inaugurated the Sixth Regional MDR-TB Advisory Commiee meeting. Welcoming the Commiee members, he highlighted the TB burden in Bangladesh and concerns for TB from the health system perspective, including the funding situation driven by donors and the financial gap between the existing and required funding identified in the national strategic plan (NSP). Noting the vertical nature and approach of the TB programme, he emphasized the need for delivery of quality-assured services to the people as an integral part of the health system. He also stressed the importance of making recommendations that matched the available resources. (See Annex 2 for list of participants). 2 Multidrug-resistant tuberculosis

8 3. Objectives Dr Md Khurshid Alam Hyder, Regional Adviser (TB), WHO Regional Office for South-East Asia, presented the objectives of the meeting. As stated, the overall objective of the meeting was to provide guidance on PMDT to rglc. The specific objectives of the sixth meeting were to: (1) organize a field visit to provide an opportunity to rglc SEAR to review the current progress and further guide on planning scale up of PMDT in the operational sites; (2) review the activities planned and progress made based on the recommendations of the fifth meeting of rglc SEAR; (3) share and discuss new technical updates on PMDT; and (4) set the way forward on PMDT scale-up in the countries of the Region for the next six months. (See Annex 1 for agenda of the meeting.) Multidrug-resistant tuberculosis 3

9 4. Progress report on the fifth meeting of rglc SEAR Dr Rohit Sarin, Chair MDR-TB Advisory Commiee SEAR, briefly presented the summary and recommendations of the fifth meeting, especially with regard to the usefulness of the field visit to understand issues faced in the countries. He said that this gave the opportunity to provide practical inputs on the spot to improve the performance of PMDT services; active country-focused support from the rglc Commiee including review of country mission report; face-to-face interaction by the members of the Advisory Commiee; deliberations on practical issues faced by the country PMDT services such as PMDT expansion plan; national capacity-building on laboratory services; clinical management and PMDT; human resource development; and strengthening the involvement of all care providers, especially in the private sector and effectively linking patients to available patient support systems and social welfare schemes. The Chair also acknowledged the useful technical guidance provided by the Global Drugresistant Tuberculosis Initiative (GDI) to the rglc, especially referring to the six priority recommendations from the first GDI meeting, including development of targeted advocacy strategies, resource mobilization for DR- TB management scale-up, facilitating integration and ensuring coordinated efforts to align diagnostic services for patients with access to high-quality treatment and care. He noted the major issues and challenges faced by the countries in scaling up PMDT, which were identified through PMDT monitoring missions and during the deliberations of the meeting, and emphasized strengthening the capacity of NTP to ensure involvement of all care providers for PMDT scale-up and continuous capacity-building for PMDT at the regional and country levels, including establishment of centres of excellence for PMDT. 4 Multidrug-resistant tuberculosis

10 5. Field visit A field visit was organized on the first day of the meeting to provide an opportunity for Commiee members to review the current progress and further guide on planning scale up of PMDT in Dhaka. Members visited the National Institute of Diseases of Chest and Hospital, National TB Reference Laboratory, Urban Centre and International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh. The Director, Mycobacterial Diseases, Line Director TB/LEP, DGHS and his team accompanied the members and provided necessary explanation and inputs during the field visit. Presentations were made at each place visited about their work and contributions made to NTP and fruitful discussions held. The discussions mainly streamed in two aspects: one was on PMDT and the other on laboratory management. For programmatic management of MDR- and XDR-TB, the regimens being used in the country in terms of designing, selecting appropriate drugs, rational use, pharmacovigilance and addition of new drugs like bedaquiline which had proven to be very efficacious and recommended by WHO, were discussed. The need for compassionate use of newer drugs for severe cases was also discussed. The steps taken in India and Indonesia on controlled introduction of bedaquiline were elaborated. Higher treatment success rate of the shorter regimen was noted and the need for early implementation of the proposed operational research on the shorter regimen in conformity with WHO recommendations underscored. Analysis of the impact of the regimen in terms of efficacy and effectiveness, safety and need for dissemination of the research results was discussed. With regard to community engagement and participation, it was recommended that community engagement should not only be for treatment delivery and follow-up, but cover all dimensions of public health from health promotion, prevention efforts and advocacy to case-finding and treatment delivery, including psychosocial support. With regard to the various guidelines developed by NTP Bangladesh as policy documents, the members noted that there was a gap in implementing these policies. Multidrug-resistant tuberculosis 5

11 For laboratory management, the Commiee member representing the supranational laboratory in Bangkok observed that external quality assessment (EQA) should be improved for smear microscopy. Monitoring and supervision by the national tuberculosis research laboratories (NTRL) of culture and drug susceptibility test (DST) in other laboratories should be strengthened. It was further noted that regular maintenance of laboratory equipment including microscopes was inadequate. The issue of on-site evaluation of the laboratory certification was raised and necessary supports were sought. The following observations were made on laboratory performance and maintenance. Appropriate fixation slide from pellet after centrifuge should be considered for prevention of false negative result due to slough off from slide during staining procedure, and a loop should be used instead of stick to make a smear from pellet samples. The user must clean the filter of the Gene-Xpert machine frequently for good results and prevention of error. It has been reported by NTP that there have always been delays in geing response from Cepheid in maintenance and repair of the module. The urban centre needs a supervisor from NTRL for monitoring and evaluation of laboratory performance including microscope, staining solution, procedure and EQA slide as well. Follow-up smear positivity rate at NTRL was observed to be increasing in 2013 and 2014 as DR-TB patients are offered weekly follow-up smears with LED FM to check for early conversion. This was beyond the stated programme policy and would unnecessarily burden the NTRL. From the observations during the field visit, the following recommendations were drawn up. PMDT management The Commiee suggested that two rglc members (Drs Chadha and Asif) review the current XDR regimens in Bangladesh and provide advice for appropriate drugs for treatment which would be recommended to PMDT Commiee of NTP Bangladesh for endorsement. 6 Multidrug-resistant tuberculosis

12 Countries of the Region, including Bangladesh, need to develop a system or policy for systematic controlled introduction of new drugs like bedaquiline, keeping WHO interim guidelines in view, and learning from the experience of India and Indonesia. (Action: NTP Bangladesh). The community PMDT (c-pmdt) model in Bangladesh could be reviewed, considering all dimensions of community engagement and implementation barriers. Modalities and lessons learnt through this can be shared with other countries in order for them to identify similar mechanisms in their own context. (Action: NTP Bangladesh) Investment proposed for a larger DR-TB ward needed to be done with caution, based on need assessment. Greater focus is needed in a decentralized community-based approach engaging community clinics in Bangladesh in PMDT, to improve access to quality care. (Action: NTP Bangladesh) The national policy should be revisited, based on the results of national DRS, m-health, e-tb manager as well as surveillance data and other research on public private mix (PPM) like use of digital X-ray, prison interventions, c-pmdt evaluation, shared by ICDDR,B, Dhaka, to translate research to policy, and policy to actions with controlled scale-up of the best practices monitored closely by programme managers at national and district levels. (Action: NTP and PMDT commiee, Bangladesh) While revising policy, planning should be initiated simultaneously to lay down the road map for further PMDT scale-up with service delivery level, capacity issues, stakeholder mapping, resource mapping, exit strategies and for uninterrupted transition and sustainability of project interventions. (Action: NTP and PMDT Commiee, Bangladesh) The following steps may be considered: With 39 GeneXpert sites and relatively low proportions of retreatment TB cases, provinces and districts may initiate phased scale-up towards universal DST. Multidrug-resistant tuberculosis 7

13 Proficiency testing of NTRL and strengthening of DST laboratories with second-line drugs in liquid culture may be expedited. Existing DR-TB centres may be strengthened with enhanced capacity to manage XDR and seriously ill cases while engaging physicians at district-level hospitals to manage ambulatory, not seriously ill cases. Laboratory management NTRL should ensure that EQA is improved for smear microscopy, and monitoring and supervision for culture and DST provided to other laboratories. (Action: NTP and NTRL Bangladesh) It is important to ensure regular maintenance of laboratory equipment including microscopes. (Action: NTP and NTRL Bangladesh) The practice of weekly follow-up smears at NTRL LED FM beyond the stated national policy is unnecessary and may be discontinued. However, a retrospective correlation analysis between FM smear results and culture conversion may be undertaken as an operational research to guide policy. (Action: NTP and NTRL Bangladesh) NTP should engage the BSL III level laboratory at ICDDR,B Dhaka for PMDT service delivery under an appropriate Memorandum of Understanding mechanism. NTP should take regular updates of best practices demonstrated in their research findings from the institute for application to the national policy/guidelines. ICDDR,B could be a good collaborating partner for research to strengthen the third pillar of the End TB Strategy and share the workload of the ongoing prevalence survey. (Action: NTP and NTRL Bangladesh) t t NTP should strengthen the surveillance system for TB and DR-TB established by ICDDR,B through a collaborative mechanism. The sites may be expanded beyond tertiary care centres to include a representation of secondary- and primary-level public health centres that may be able to monitor trends of emergence of DR-TB of various types including INH mono, poly-resistance and fluoroquinolone resistance to guide policy refinements. (Action: NTP and NTRL Bangladesh). 8 Multidrug-resistant tuberculosis

14 6. Regional issues and challenges on PMDT Dr Md Khurshid Alam Hyder presented the issues and challenges faced in SEAR from the regional perspective. He briefed participants on the epidemiological situation of DR-TB at the global level and in SEAR and the current status of progress and achievements made towards the global targets set out for implementation of resolution WHA62.15 to achieve universal access to diagnosis and treatment of multidrugresistant and extensively drug-resistant tuberculosis. It was noted that substantial progress has been made in case detection of the DR-TB cases and subsequent enrolment for treatment of the detected cases with successful scale-up of PMDT in the countries of the Region. However, it is of concern that progress made is not sufficient in respect to targets set in the countries by the end of Efforts should be made to strengthen diagnostic capacity in the countries including introduction of Gene-Xpert and training on clinical management and PMDT. Various approaches including PPM to increase case detection and quality-assured treatment delivery was also highlighted. Multidrug-resistant tuberculosis 9

15 7. Recommendations from the Fifth Meeting Dr Rim Kwang IL, Medical Officer (TB), WHO Regional Office for South- East Asia, disseminated the recommendations from the fifth meeting of NTP managers and partners held on November 2014 in New Delhi, India. He also highlighted the substantial progress being made in the countries of the Region in detecting DR-TB cases and enrolling them on second-line drugs (SLD) treatment. However, he emphasized the need for urgent and significant expansion within the scope of TB control activities in preventing and controlling MDR-TB and XDR-TB in the countries. He referred to the activities to scale up the PMDT at the global and regional levels, including the activities of GDI and rglc as well as the recommendations on PMDT implementation from the meeting. He stressed the importance of underpinning and sustaining the MDR-TB response through high-level political commitment, strong leadership across multiple governmental sectors, ever-broadening partnerships including the community and civil society, and financing for care and research. 10 Multidrug-resistant tuberculosis

16 8. Review of country mission reports Mission reports for Bangladesh, Bhutan, India and Timor-Leste were reviewed and discussed by the Commiee. The Commiee requested rglc to communicate with respective consultants for their clarification or revisions, if necessary, on the four country mission reports. Multidrug-resistant tuberculosis 11

17 9. Major country issues and challenges Major issues and challenges faced in the countries, such as adaptation of PMDT training modules, sustainability of Expand TB project and SLD forecasting and management were discussed at length. WHO published a generic training module on PMDT in 2014 which can either be adapted for use in country training in line with the WHO PMDT guidelines, or may be used as examples to modify as per country context. This training module was been circulated to the Commiee members well before the meeting for their information and any suggestion for future actions. The Commiee members opined that the training module was comprehensive and could be adapted in the countries as per the need of the countries. Some members suggested that countries may hold a national workshop on PMDT where they can discuss and decide how they can adapt the training modules to their context and may request rglc secretariat to support resource persons to facilitate the training using these modules. Few Commiee members opined that the rglc Secretariat may support countries exploring for funds to conduct the training. With regard to sustaining the Expand TB Project in Bangladesh, India, Indonesia and Myanmar, Bangladesh expressed its requirement of a medical microbiologist to sustain the project in the country. The Commiee sought any possibility that NTP might consider deputing one medical microbiologist to the NTRL to sustain the project. The Commiee members discussed with the rglc Secretariat on forecasting and managing SLD in the countries. The countries informed that QuanTB introduced by MSH was not user-friendly and felt that simple country-specific spreadsheet was preferable to QuanTB software. It was noticed that most of the countries were not using QuanTB and using their own software or simple spreadsheet. The Commiee suggested that rglc may raise this issue with GDF/GDI on how to support countries in addressing the issues faced in introducing QuanTB for forecasting and managing SLD. 12 Multidrug-resistant tuberculosis

18 In view of the above discussions, the Commiee recommended the following. PMDT training General PMDT training material should be looked into as per country context for adaptation in the countries. Countries could plan national workshop on PMDT and request rglc to support resource persons and funding if required, through WHO country offices. The rglc Secretariat may explore possible funding sources. (Action: NTP in SEAR) Sustainability of Expand TB Project NTP may consider supporting one medical microbiologist to NTRL in Bangladesh to sustain the Expand TB Project. (Action: NTP Bangladesh) SLD forecasting and management rglc can coordinate necessary technical support in SLD forecasting and management with GDF as per the need of the country. rglc can communicate with GDF/GDI on the issues faced by countries using QuanTB for necessary support. (Action: rglc Secretariat) Multidrug-resistant tuberculosis 13

19 10. Operational research on shorter regimen for MDR-TB Dr Hyder briefed on WHO support to facilitate operational research on shorter regimen including development of research protocol to countries, specifically for Bangladesh, as requested by the country. He explained procedures followed to provide necessary support to the countries, keeping feasibility, efficacy and pharmocovigilance in mind. Commiee members were informed that research proposals had to be approved by the Ministry of Health. Once approved, the Ethical Review Commiee (ERC) reviewed the proposal from the Commiee s perspective. Some Commiee members opined that it might be useful if the countries share the proposals with the MDR-TB Advisers of rglc Secretariat for technical review, whereas some others expressed concern that review of individual research carried out by the countries did not fall within the terms of reference of the rglc Commiee. Ultimately, the Commiee reached a consensus that countries may share the information on country efforts and issues, including research on shorter regimen, with the rglc Secretariat for the Commiee s information, and in case a particular researcher required technical inputs from the Commiee, necessary technical support may be requested through the rgcl Secretariat. From the above discussion, the Commiee recommended the following. Countries can share information on country efforts and issues including shorter regimen with rglc for the information of the Commiee. In case a particular researcher requires the technical input of the Commiee, s/he can request them through the rglc Secretariat. (Action: NTP in SEAR) 14 Multidrug-resistant tuberculosis

20 11. Improving efficiency and efficacy of rglc and establishment of Regional Centre of Excellence Improving efficiency and efficacy of rglc Dr Rim Kwang IL presented to the Commiee the findings and recommendations of a review mission of the Green Light Commiee Agreement between the Global Fund and WHO which was carried out by the KNCV TB Foundation in the second half of The overall aim of the review was to assess whether the GLC mechanism had been functioning as per agreement and if countries had been receiving the agreed package of services. A brief history of the GLC mechanism based on MoU between GF and WHO and the methodologies were explained to the forum. The purpose of presenting the mission report was to discuss the issue of improving the efficiency and efficacy of rglc, on the basis of the findings and recommendations of the review mission. Recommendations made to GF, WHO, GDI and rglc Secretariat respectively were presented, highlighting important issues pertaining to the functions and operations of rglc and its Secretariat to provide efficient and effective technical support to the countries in the Region for their continuous efforts to scale up PMDT services. The strengths and weaknesses of the current mechanism in delivering necessary and timely support to the countries, based on timely identification of the issues and challenges faced, were also discussed. The Commiee members agreed on the findings and recommendations of the meeting and appreciated the achievements made so far in running the Secretariat. The Commiee also agreed to learn and share experiences from and with other regions in the future. Establishment of Centre of Excellence Dr Rohit Sarin, Director, National Institute of TB and Respiratory Diseases, New Delhi, India, and Chair of rglc informed that the Institute had been recently designated as WHO Collaborating Centre for TB Training and Research. Dr Sarin extended his firm commitment to human resource development and dissemination of knowledge and skills in TB control based Multidrug-resistant tuberculosis 15

21 on the vast experience and knowledge accumulated over the decades by the Institute in close collaboration with WHO. The Institute offered training on PMDT and technical support on development of guidelines on different aspects of TB control and care to the Member States. The Commiee expressed a strong need to avail the opportunities offered by the Institute. The Commiee also acknowledged the importance of continuing efforts to establish more centres of excellence in the countries of the Region. The Commiee made the following recommendations on these two aspects. The rglc Secretariat should be strengthened by ensuring deployment of one full-time professional staff at the WHO Regional Office devoted to MDR-TB. The rglc Secretariat may provide a format on the issues to be discussed in the following r-glc Commiee meetings; and facilitate the process of using opportunities like establishment of a new WHO collaborating centre. (Action: rglc Secretariat) 16 Multidrug-resistant tuberculosis

22 12. Next steps The Commiee proposed the next steps of PMDT monitoring missions for the first half of the year 2015 and other technical support as required by the countries in consultation with NTP, WHO country offices and rglc Secretariat in the WHO Regional Office. The following recommendations were made for future meetings. Recent updates on PMDT and associated areas (e.g. research) from all countries in the Region will be presented henceforth in the advisory group meetings. The collection, compilation and presentation of the updates will be facilitated by the rglc Secretariat. The Commiee decided to include a technical session in all future meetings in which the recent evidence and newer developments related to DR-TB will be discussed. The topics and facilitators will be decided in consultation with the members while finalizing the agenda. (Action: rglc Secretariat) Multidrug-resistant tuberculosis 17

23 Annex 1 Agenda 1. Report of the fourth meeting of rglc and progress made 2. Field visit 3. Regional issues and challenges on PMDT 4. Recommendations from fifth meeting of NTP managers and partners 5. Review of country mission reports 6. Country issues 7. OR shorter regimen MDR-TB 8. Improving efficiency and efficacy of rglc and establishment of Regional Centre of Excellence 9. Next steps 10. Conclusions and recommendations 18 Multidrug-resistant tuberculosis

24 Annex 2 List of participants Members Dr Rohit Sarin Chair of MDR Advisory Commiee D-112 East of Kailash New Delhi, India Dr Asif Mujtaba Mahmud Apt. A6, House-95 Road-13, Block-E, Banani, Dhaka, Bangladesh Dr Kuldeep Singh Sachdeva 36 Munirka Vihar New Delhi, India Dr Sarabjit S. Chadha The Union South-East Asia Office International Union Against Tuberculosis and Lung Disease (The Union) New Delhi, India Dr Erlina Burhan JI. Perhubungan XI no 77 Kompleks Perhubungam Rawamangun, Jakarta Timur, Indonesia Mr Somsak Rienthong National TB Reference Laboratory Bureau of Tuberculosis 116 Street Sudprasert Rd, Bangkok, Thailand Ms Blessina Kumar TB/HIV Activist & Public Health Consultant New Delhi, India Bangladesh Dr Ahmed Hussain Khan Director, MBDC and Line Director (TB-Leprosy) DGHS, Dhaka Dr Mirza Nizamuddin Deputy Programme Manager Administration and Finance Focal person for MDR-TB, TB/HIV and TB Team NTP, DGHS, Dhaka Observers Dr Kausari Jahan Deputy Programme Manager Training NTP, DGHS, Dhaka Dr Nazis Arefin Saki Medical Officer- MDR TB NTP, DGHS, Dhaka WHO Regional Office for South- East Asia, New Delhi Dr Md Khurshid Alam Hyder Regional Adviser, Tuberculosis Department of Communicable Diseases Dr Rim Kwang IL Medical Officer Tuberculosis Department of Communicable Diseases Multidrug-resistant tuberculosis 19

25 WHO Country Office for Bangladesh, Dhaka Dr Vikarunnessa Begum National Professional Officer TBC Dr Sabera Sultana National Professional Officer DR-TB WHO Country Office for India, New Delhi Dr Malik Parmar National Professional Officer - TB WHO Country Office for Indonesia, Jakarta Dr Muhammad Akhtar Medical Officer TB WHO Country Office for Myanmar, Yangon Dr Erwin Cooreman Medical Officer - TB 20 Multidrug-resistant tuberculosis

26 In response to the need for scaling up the programmatic management of drugresistant tuberculosis in the WHO South-East Asia Region, a Regional Advisory Commiee on MDR-TB, also known as the regional Green Light Commiee (r-glc), was established in May, 2012, which functions as an advisory commiee to the WHO Regional Office for South-East Asia, WHO Member States in the South-East Asia Region, as well as donors and partners. The sixth meeting of the r-glc SEAR was held in Dhaka, Bangladesh, February The Commiee reviewed and endorsed the country mission reports on the programmatic management of drug-resistant tuberculosis (PMDT) undertaken during 2014 and extensively discussed technical issues related to the scale-up and implementation of PMDT in the countries of the Region. The Commiee also discussed the next steps in PMDT implementation. World Health House Indraprastha Estate, Mahatma Gandhi Marg, New Delhi , India SEA-TB-360