Multidrug-resistant Tuberculosis

Transcription

1

2 SEA-TB-362 Distribution: General Multidrug-resistant Tuberculosis Report of the Seventh Meeting of the Regional Advisory Committee on MDR-TB (r-glc SEAR) Mandalay, Myanmar, August 2015

3 World Health Organization 2016 All rights reserved. Requests for publications, or for permission to reproduce or translate WHO publications whether for sale or for noncommercial distribution can be obtained from SEARO Library, World Health Organization, Regional Office for South-East Asia, Indraprastha Estate, Mahatma Gandhi Marg, New Delhi , India (fax: ; The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use. This publication does not necessarily represent the decisions or policies of the World Health Organization. Printed in India

4 Contents Page Acronyms... v 1. Background Objectives Opening session Endorsement of the report of the Sixth MDR-TB Advisory Meeting Field visit Challenges and opportunities in controlling drug-resistant TB in the South- East Asia Region Recommendations from the regional workshop on combating drug-resistant TB Review of country mission reports Discussion on renewed memorandum of understanding between WHO and TGF and revision of PMDT mission report format Report of the Joint GLI/GDI Meeting Active pharmacovigilance for new drugs and novel regimens for the treatment of MDR-TB Universal access to MDR-TB services Next steps Annexure Agenda List of participants iii

5

6 Acronyms BAL BRAC BDQ CSF CSO DOTS DRS DST EQA GDF GDI GLI FQ IOM KNCV LNs MDR-TB MoU 3MDG Fund MSH bronchoalveolar lavage Bangladesh Rural Advancement Committee bedaquiline cerebral spinal fluid Civil Society Organization directly observed treatment, short-course Drug-resistant survey drug susceptibility test external quality assessment Global Drug Facility Global Drug-Resistant Tuberculosis Initiative Global Laboratory Initiative fluoroquinolone International Organization for Migration Royal Dutch Tuberculosis Association lymph nodes multidrug-resistant tuberculosis memorandum of understanding Three Millennium Development Goals Fund Management Sciences for Health v

7 NSP NTP NTRL PMDT PPM PV rglc R&R RR TB SEA SLD SLI SRL TA TB TGF TWG UHC XDR-TB national strategic plan national tuberculosis programme national tuberculosis research laboratory(ies) programmatic management of drug-resistant tuberculosis public private mix pharmocovigilance regional Green Light Committee recording & reporting rifampicin-resistant tuberculosis South-East Asia second-line drugs second-line injectables Supranational Reference Laboratory Technical Assistant tuberculosis The Global Fund technical working group universal health coverage extensively drug-resistant tuberculosis vi

8 1. Background It is estimated that people developed multidrug-resistant tuberculosis (MDR-TB) in 2013 in the WHO South-East Asia (SEA) Region. MDR-TB is a form of TB that is difficult to treat with standard first-line anti- TB drugs because of resistance to isoniazid and rifampicin, the most efficacious drugs developed so far. At the Sixty-second World Health Assembly in May 2009, resolution WHA62.15 urged Member States to develop and implement long-term plans for TB, including prevention and control of MDR-TB and extensively drug-resistant tuberculosis (XDR-TB), in line with the Global Plan to Stop TB One of the actions taken to implement this resolution was the establishment of the Green Light Committee (GLC) Initiative to help countries gain access to high-quality second-line anti-tb drugs. This would 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 drugresistant tuberculosis (PMDT) in the WHO South-East Asia Region, a Regional Advisory Committee on MDR-TB, also known as the regional Green Light Committee (rglc SEAR), was established in The rglc functions as the advisory committee to the WHO Regional Office for South- East Asia, Member States of the South-East Asia Region, and donors and partners. The first and second meetings of the committee were held in May and December 2012 at the WHO Regional Office for South-East Asia, New Delhi, India. The third and fourth meetings were held in April and November 2013 in Thimphu, Bhutan, and Jakarta, Indonesia, respectively. The fifth and sixth meetings in May 2014 and February 2015 were in Mumbai, India, and Dhaka, Bangladesh, respectively. During these meetings, the committee reviewed and endorsed the country mission reports on PMDT and extensively discussed issues related to the scale-up and implementation of PMDT in countries of the Region. 1

9 Report of the Seventh Meeting of the Regional Advisory Committee on MDR-TB (r-glc SEAR) The seventh meeting of the rglc was held in Mandalay, Myanmar, from August Objectives Dr Md Khurshid Alam Hyder, Regional Adviser (TB), WHO SEA Region, outlined the objectives of the meeting. The overall objective of the meeting was to provide guidance on PMDT to the rglc SEAR. Specific objectives of the seventh meeting were to: (1) organize a field visit to provide an opportunity to the rglc SEAR to review current progress and provide further guidance on the planned scale up of PMDT in Myanmar; (2) review activities planned and progress made based on recommendations of the sixth MDR-TB Advisory Committee meeting; (3) share and discuss new technical updates on PMDT and pharmacovigilance for new drugs and regimens in the countries (bedaquiline and delamanid); (4) set the way forward on PMDT scale-up in countries of the Region for the next six months. (See Annex 1 for agenda of the meeting.) 3. Opening session Dr Win Hlaing, Minister of Social Welfare, Mandalay Region, Union of Myanmar, chaired the opening session of the Seventh meeting of the Regional Advisory Committee on MDR-TB. Indicating that Myanmar is one of the high MDR-TB burden countries in the world, he highlighted strong government commitment towards the PMDT programme of the country. This is reflected by the allocation of substantial domestic resources. He outlined the successful implementation of the TB programme in Myanmar, including features such as the: 2

10 Multidrug-resistant Tuberculosis introduction of the directly observed treatment, short-course (DOTS) programme in 1997; completion of national DOTS coverage in 2013; MDR-TB programme set in place since The PMDT programme is moving forward in Myanmar, and its scaleup featured an update on the national guidelines on MDR-TB in He mentioned some of the challenges faced in the Region for the PMDT scaleup. These included shortage of human resources, need for laboratory capacity strengthening, and lack of community engagement. This meeting would provide a great opportunity to improve PMDT scale-up in the country as well as in the Region, he observed. Dr Jorge M Luna, WHO Representative to Myanmar, also welcomed participants to the meeting. 4. Endorsement of the report of the Sixth MDR-TB Advisory Meeting Dr Rohit Sarin, Chair of the MDR-TB Advisory Committee in the SEA Region, briefly presented the summary and recommendations of the sixth meeting along with progress made in the countries in implementing its recommendations. He mentioned several key recommendations made to the National TB Programme (NTP) of Bangladesh during the field visit in Dhaka. NTP Bangladesh had shared with the Committee its progress with most of the recommendations. The recommendations made to all countries in general were presented, and several follow-up actions taken by the Secretariat and Member countries based on their recommendations were also enumerated. The Committee members discussed the implementation of recommendations of the meeting. It was observed that some country PMDT monitoring mission reports had omitted the section on community engagement. Committee members reiterated the need to strengthen the Secretariat, and compared their situation with that of other regions where a designated medical officer for DR-TB is available for full-time support. The Secretariat clarified that, due to funding constraints, the Medical Officer for TB in the WHO Regional Office for South-East Asia (SEARO) is the 3

11 Report of the Seventh Meeting of the Regional Advisory Committee on MDR-TB (r-glc SEAR) designated focal point for the work of the rglc Secretariat. Members also suggested that countries raise this issue with the The Global Fund (TGF) to strengthen the Secretariat s role in future. Countries are benefiting from rglc technical support, and this should be sustained. Committee members also discussed the timely review of the country PMDT mission report. It was explained that the new MoU signed with the Global Fund in May 2015 stipulated that mission reports should be reviewed primarily by the rglc Secretariat and committee members if needed and submitted within two months of review. Accordingly two mission reports undertaken in 2015 were reviewed by the Secretariat and select committee members. The following recommendations were also made: The rglc members were called upon to review recommendations of the Sixth rglc meeting in Dhaka along with progress reported from some countries, and endorse the meeting report. The rglc Secretariat should coordinate review of the country PMDT mission report involving rglc members. This can be done through s/review meetings in WHO-SEARO or by inviting mission members and rglc Committee members for the review via Skype or webinar. The Secretariat needs to be bolstered with a designated Medical Officer for drug-resistance TB supported by the Global Fund to continue collaboration with Member States on PMDT. Funding support may be sought from the Global Fund as is the case with other regions. 5. Field visit A field visit was organized on the first day of the meeting to enable committee members to review current progress and provide further guidance on planning scale up of PMDT in the Mandalay Region of Myanmar. Members visited the Mandalay Regional TB Laboratory, Upper Myanmar TB Centre, Patheingyi TB Hospital and the Maharaungmyae township clinic. At the Mandalay Regional TB Laboratory and Upper Myanmar TB Centre, the majority of patients were referred from different 4

12 Multidrug-resistant Tuberculosis parts of the country. Committee members studied the management of MDR-TB patients here. At the regional TB centre members observed activities at various stages of diagnosis and follow-up. The Upper Myanmar TB Centre is functioning well as a regional reference laboratory, they observed. It has been upgraded to Bio Safety Lab (BSL) 3, granted accreditation, and has the capacity for routine culture and drug susceptibility testing, rapid-line probe assay and external quality assurance mechanism under the supervision of national tuberculosis research laboratory (NTRL) Yangon and Supranational Reference Laboratory (SRL) Bangkok. The team also observed a patient support system, wherein monetary support to MDR-TB patients during treatment was provided by the bank collaborating with the programme through the 3MDG support initiative. The team later visited Patheingyi TB Hospital, which is equipped with 200 beds that support both TB and MDR-TB patients. In addition, this hospital manages complicated cases, including adverse reactions by second-line drugs. Within the purview of airborne infection control measures, records and reports and drug supplies are well maintained. This hospital acts as a basic health centre, providing diagnosis and referral of patients as well as diagnosis and treatment of TB and MDR-TB cases. Finally, the team visited Maharaungmyae township and studied its collaboration with the National TB Control Programme. Health-care workers who also function as trained DOT providers for TB patients were interviewed. The MDR-TB patients interviewed expressed satisfaction with the services provided by the township. The MDR-TB Advisory Committee had the opportunity to review current progress and provide guidance on planning the scale up of PMDT during its field visit on the first day. Dr Saw Thein, Mandalay Regional TB Officer, and his team accompanied members and provided necessary clarifications during the field visit. Presentations were made at each place visited, contributions were made to the NTP, and fruitful discussions held. The discussions mainly focused on two aspects: PMDT including patient support, and laboratory management. Several observations were made during the field visit, and committee members discussed them extensively. It was observed that GeneXpert use is optimized, but standardized sputum sample transportation system is required. It seems that in the Yangon Region, a transborder approach to 5

13 Report of the Seventh Meeting of the Regional Advisory Committee on MDR-TB (r-glc SEAR) improve access of MDR-TB services is being implemented. This could be applied to other regions of the country. It was observed that community-based activities, including patient support, are undertaken with the support of various projects. But these need coordination to ensure equity across the Region as well as in the whole country. Various patient support and incentive mechanisms are based on donor support. This raised concerns on sustainability in the long term, particularly in the context of the government s willingness and capacity to take over and sustain these initiatives. There was concern in relation to reconfirming results of GeneXpert tests among new cases, considering the low PPV (positive predictive value) of the GeneXpert machine in the context of low DR-TB prevalence. Drug-resistant survey (DRS) done in the country thus far did not portray the overall national situation. Further national representative surveys may be required to reflect the situation of DR-TB prevalence in Myanmar. There was also concern that retesting with DST in new cases may have cost implications. Moving to SL drug susceptibility testing (DST) (at least of fluoroquinolone (FQ) and second-line injectables (SLI) is essential as the country is planning to move towards a newer and shorter regimen. Alternatively, testing the existing cultures for SL DST can be undertaken to establish the baseline resistance levels of FQ and SLI. Moving towards an electronic recording & reporting system is necessary with the scale-up. With regard to programmatic management of MDR/XDR-TB, the regimens being used in the country in terms of designing, selecting appropriate drugs, rational use, pharmacovigilance, and the addition of new drugs (such as bedaquiline, which had proven to be efficacious with interim guidelines issued by WHO) were discussed. The need for compassionate use of newer drugs for severe cases was also discussed. Members elaborated on steps taken in India and Indonesia on controlled introduction of bedaquiline. Higher treatment success rates of the shorter regimen were noted and the need for early implementation of the proposed operational research on the shorter regimen in conformity with WHO recommendations, was underscored. An analysis of the impact of the regimen in terms of efficacy and effectiveness, safety and need for dissemination of research results was also made. 6

14 Multidrug-resistant Tuberculosis Committee members were informed about Dr Hyder s request to the Minister of Social Welfare to consider expanding nutritional and other patient support systems and take them over from the TGF. Programme expansion in the non-tb township areas and the opportunity of the national strategic plan (NSP) to include all these areas was also discussed. With regard to the deliberations based on the result of the field visit, the following recommendations were made: The rglc will request the Member State for a brief presentation by the NTP on country PMDT status and plan as an overview on the first day s visit. Transition/exit plans from project to scale-up interventions that have demonstated results in project mode must be funded in the national strategic plan (over the next five years) to sustain the benefits. The experience of Yangon in scaling up DST to new cases that resulted in rapid diagnosis of a large number of rifampicinresistant TB cases, while balancing the treatment capacity need, must be systematically shared with Mandalay and other regions. This can be considered by the NTP manager in the upcoming meetings on the National Strategic Plan. Expanding nutritional and other patient support systems and transition from the Global Fund to domestic sources must be considered. Programme expansion in the non-tb township areas should be accelerated. The revision of the NSP should factor in all these aspects. 6. Challenges and opportunities in controlling drugresistant TB in the South-East Asia Region Dr Khurshid Hyder made a presentation on the drug-resistant TB situation, covering the challenges, opportunities and priority issues in addressing DR-TB in the SEA Region. He emphasized that the SEA Region accounts for almost 30% of the global MDR-TB burden. XDR-TB was reported from six countries of the Region. There is also less than 50% of MDR-TB case detection. The gap between detection and enrolment for treatment is 7

15 Report of the Seventh Meeting of the Regional Advisory Committee on MDR-TB (r-glc SEAR) widening, with only 59% of cases detected being enrolled for treatment in Challenges faced by countries of the Region include the need for sufficient prevention measures and more efforts towards sustaining basic TB control measures. Low case detection and treatment outcomes are also a challenge. However, he also highlighted several opportunities such as increasing global attention and commitment on TB elimination and MDR- TB; increased domestic funding on TB including MDR-TB in many highburden countries; strong partnerships with CSOs and the private sectors. Priority actions to be taken by countries in addressing the MDR-TB crisis were reiterated. Committee members discussed some issues in addressing MDR-TB in the Region. It was suggested that various operational research in countries should be encouraged to identify gaps and ways to address DR-TB issues. Regarding procurement of second-line drugs (SLD), Dr Rim Kwang IL, Medical Officer for TB, WHO SEA Region, informed that 10 out of the 11 states of the Region send procurement request forms (PRF) to the Global Drugs Facility (GDF). GDF then invites comments from the rglc SEAR Secretariat. The rglc Secretariat checks only regimens and treatment enrolment plans. This is by cross-checking with the PMDT mission report for the particular country from which the form was submitted. In case of discrepancies, this is sent to the rglc SEAR chair or select members or to WHO headquarters. It was also mentioned that greater priority be given to engagement by the private sector. Decentralized treatment for MDR-TB was considered to be a major achievement in many countries although it varies across countries. A quality control mechanism should be put in place for treatment services. As we move to more community-based care for PMDT, it would be worthwhile for the Committee to provide guidelines/checklist for maintaining the quality of decentralized services. Training quality at the district and ground levels also need to be maintained. Dr Malik Parmar, MDR-TB focal point in the WHO Country Office for India, informed that a prerequisite checklist for decentralizing district-level treatment centres has been established in India. In India states assess the preparedness level and keep the Centre informed about it. Also, systematic participatory planning for phased expansion to universal DST and baseline 8

16 Multidrug-resistant Tuberculosis SL DST is being undertaken in India in every province. This plan would offer a benchmark for monitoring progress. The issue of a centre of excellence on MDR-TB was discussed and members highlighted the importance of moving aggressively towards establishing such a centre in all Member countries. It was stated that even the provinces may consider a provincial-level centre of excellence based on case load, and that this may undertake training of community providers. The following recommendations were made: The rglc encourages Member countries to undertake operational research to identify gaps in PMDT service delivery and ways to address them. The GDF second-line drugs procurement form submitted by countries should be circulated to all members for comment. The rglc continues to support countries to establish centres of excellence on PMDT, including clinical management of MDR-TB cases, as and when requested by countries. 7. Recommendations from the regional workshop on combating drug-resistant TB Dr Rim Kwang IL, Medical Officer (Tuberculosis), WHO SEA Region, presented the recommendations of the regional workshop on combating DR-TB held in Bangkok, Thailand, on April The workshop was held primarily to review DR-TB status and national responses to its prevention and management. It also sought to identify challenges in ensuring universal access to high-quality care to all patients with DR-TB, and identify the way forward in Member States and possible support from international partners. The workshop was attended by Member State representatives of all 11 countries along with several country partners such as BRAC Centre Bangladesh, KNCV Indonesia and IOM Myanmar, among others. The sessions presented included: global and regional response on DR-TB 9

17 Report of the Seventh Meeting of the Regional Advisory Committee on MDR-TB (r-glc SEAR) country PMDT expansion plans policy and strategy update on MDR-TB universal access to MDR-TB services supporting scale-up of MDR-TB assessing impact of TA and monitoring missions scaling-up treatment and care of drug-resistant TB. Each session had recommendations for NTPs and in-country partners as well as for WHO and international partners. These were relevant for efficiently addressing issues and challenges faced in countries of the Region during their implementation and scale up of PMDT programmes. The following recommendations were made: The rglc must encourage countries to participate in research on newer drugs and shorter regimens. If countries need support in developing protocol or reviewing existing protocols, it can be provided by rglc on request. The rglc suggested that each country may need to establish a DR-TB surveillance system for periodic data collection. This is for an epidemiological analysis of DR-TB and to identify hot-spots (defined with clear parameters) to address specific situations using treatment approaches guided by DST results. 8. Review of country mission reports Mission reports for Indonesia, Myanmar and Thailand were reviewed and discussed by the committee. The committee suggested minor changes to be incorporated in the final report. This was communicated to the countries, and the three country mission reports were endorsed in principle. 10

18 Multidrug-resistant Tuberculosis 9. Discussion on renewed memorandum of understanding between WHO and TGF and revision of PMDT mission report format Dr Rim Kwang IL discussed new issues and those that have implications for the future functioning of the rglc SEAR in the memorandum of understanding (MoU) between WHO and the TGF to support a decentralized GLC mechanism to be renewed at the end of May In particular, a performance-based disbursement mechanism where Annual GLC fees in two tranches (the first tranche of US$ for an enhanced package and US$ for a core service package and the remaining through a second tranche) are to be paid was discussed. The second tranche is due on the Global Fund s review and acceptance of the peer-reviewed rglc mission report. It was further explained that the rglc mission reports are to be reviewed primarily by the respective rglc Secretariat and rglc members if needed. Peer-reviewed mission reports are to be submitted to the GFATM Secretariat within two months of the mission s completion. It was emphasized that planning of in-country missions should be done in consultation with principal recipients (PRs), NTPs, relevant partners and the GF Secretariat and country teams. A need for bolstered communication through quarterly teleconferences with the Global Funds TB adviser and regular communication with the Global Fund country team by the rglc Secretariat was highlighted. Dr Sarabjit S. Chadha, member of MDR Advisory Committee presented the format for the PMDT monitoring mission report, which has been slightly revised using the previous format. Some aspects as required by the renewed MoU (such as overall description of the PMDT programme in the country visited, diagnostic algorithm, analysis of country capacity in terms of technical, managerial and resource availability, etc.) were added. The Committee reviewed the revised format and endorsed it. 10. Report of the Joint GLI/GDI Meeting Dr K.S. Sachdeva, Vice-Chair of the rglc SEAR, presented the report on the Joint Partners Forum for Strengthening and Aligning TB Diagnosis and 11

19 Report of the Seventh Meeting of the Regional Advisory Committee on MDR-TB (r-glc SEAR) Treatment, held on April 2015 in Geneva. He presented highlights of topics discussed daily and on GLI/GDI achievements and priorities for The meeting had provided participants with an overview of the WHO End TB Strategy on the global TB epidemic post It also presented priorities and achievements of the Global Laboratory Initiative and Global Drug-Resistant TB Initiative. The meeting had disseminated developments in WHO policy guidance on TB diagnostics and new drugs, and provided updates on the TB diagnostics pipeline and clinical trials for new drugs and regimens. This included shared lessons learned and challenges for widescale implementation of GeneXpert MTB/RIF and other rapid diagnostic tests to ensure effective use of resources and identify synergies with TB/HIV integrated activities. The meeting also reviewed the SRL network and its activities. Best practices for the alignment of diagnosis and treatment for the programmatic management of drug-resistant TB (PMDT), were shared and progress of regional initiatives for the scale-up of laboratory strengthening and PMDT. Dr Sachdeva shared the experience of the use of GeneXpert in the diagnosis of TB among children in four pilot sites in India. This included sputum samples: direct, induced, BAL, gastric aspirates, and samples from extrapulmonary sites. The yield in extrapulmonary samples such as CSF, gastric aspirate, and LNs is much higher than sputum samples. This intervention has increased the case detection of TB and rifampicin-resistant TB by 3 4 times in children: 8 to 10% of TB cases had RR TB in children. Decentralization beyond district or block-level hospitals will be a challenge for getting skilled staff to collect appropriate samples from EP sites. An additional challenge will be the availability of pediatricians. The issue related to TB drug forecasting and management was raised during the discussion. Myanmar successfully used QuanTB with support from MSH. Bangladesh reported many challenges with QuanTB over its lack of user-friendliness. India shared the experience of in-country customization of the procurement forecasting and quantification tools with adjustments dynamically made annually based on assumption implementation experiences. On logistics management, it was observed that sharing of technical expertise could be undertaken by the rglc for countries in the Region. Different e-health models such as GxAlert, QuanTB, Open MIS, etc. are 12

20 Multidrug-resistant Tuberculosis standalone. There needs to be a collaborative, collective pooling of data to enable NTPs to have a clear view on its usage. Indonesia is also planning to use Open MIS. In this regard, the Committee recommended that the rglc encourage and may assist intercountry experience sharing on use of particular software, including QuanTB, for effective forecasting and management of SLDs. 11. Active pharmacovigilance for new drugs and novel regimens for the treatment of MDR-TB Dr Rohit Sarin, Chair of the rglc SEA Region, made a brief presentation on active pharmacovigilance for new drugs and novel regimens for the treatment of MDR-TB, especially in the context of introduction of bedaquiline and delamanid in countries. The presentation was followed by discussions. A manual for pharmacovigilance was developed for active PV in the roll-out of BDQ in Indonesia. Compassionate use of new TB drugs was also discussed. It was discussed that national pharmacovigilance (NPV) and TB programmes (NTP) should closely collaborate for an active PV system. However, if NTP endorses the introduction of these drugs, the PV would not be available for compassionate use. However, this is collected by the pharmaceutical company from the physician treating such cases under compassionate use. It was explained that compassionate use allows access under conditional approval from drug controllers in countries until the NTP introduces a drug after establishing the active PV systems. Delays by the NTP would lead to more calls for compassionate use under the private sector. The rglc can reiterate the encouragement to countries to take up and expedite the introduction of newer drugs and set up active PV systems. NTP s must take the lead in establishing the PV systems with the drug authority. There is a session to sensitize the NTP managers meeting planned for October 2015 to set up active PV systems as well as the regulation of drug sale in the private sector. Following the discussion, the Committee made the following recommendation: The rglc must encourage countries to establish an active pharmocovigilance system to introduce new TB drugs and regimens in collaboration with national drug regulatory 13

21 Report of the Seventh Meeting of the Regional Advisory Committee on MDR-TB (r-glc SEAR) authorities and national pharmacovigilance programmes in countries. 12. Universal access to MDR-TB services The committee discussed how the rglc can support to ensure universal access to MDR-TB services in countries of the Region. In Indonesia, for regular TB, universal access to TB care is a policy, but for MDR TB, it is not yet in place. Government funding for universal access to DST and drugs has not yet been completely secured. Indonesia is yet to complete geographical coverage of PMDT services. This needs to be negotiated with Challenge TB and TGF by NTP. In India, it is essential to define universal access, which should include reimbursement of services given by the private sector. UHC comes as a larger health system package that includes some baseline insurance. GeneXpert can be used for presumptive TB in key populations. The next step planned is to offer DST to all TB cases, gradually and progressively, as more DST facilities are scaled up. For 2015, 300 machines were installed and universal DST will be possible in a phased manner during the next three to five years. With scale-up of DST and other laboratory technologies for expanded resistance profiling and follow-up culture, there is a plan for decentralized scale-up of treatment centres, built-in PV, support systems, enablers and adverse drug reaction (ADR) management. The National Laboratory and PMDT scale-up Plan ( ) have been developed, and policy articulated in line with the National Strategic Plan. The discussion was followed by several recommendations: Countries must be encouraged to expedite coverage of PMDT services with necessary capacity strengthening. Countries must undertake demand forecasting for laboratories and treatment services keeping in focus universal access to PMDT services; and revise the National laboratory and PMDT scale-up plans aiming towards universal DST that are aligned with the National Strategic Plan. 14

22 Multidrug-resistant Tuberculosis 13. Next steps The Committee proposed the next steps of PMDT monitoring missions and other technical support as required by countries in consultation with NTP, WHO country offices and the rglc Secretariat in the WHO Regional Office. The current Committee has served for three years since its establishment in May 2012 and is due for renewal as per the terms of the initial agreement. It was agreed for the rglc Secretariat to go ahead with a call for applications to invite applicants widely across the Region and globally. It was further agreed that until the next committee is established, the current committee will continue to discharge its functions. 15

23 Report of the Seventh Meeting of the Regional Advisory Committee on MDR-TB (r-glc SEAR) Annex 1 Agenda (1) Endorsement of the Sixth MDR-TB Advisory Meeting Report (2) Field visit (3) Challenges and opportunities in controlling DR-TB in the SEA Region (4) Recommendations from Regional Workshop on combating DR-TB (5) Review of country mission reports (6) Discussion on renewed MoU between WHO and TGF and revision of PMDT mission report format (7) Report from GLI/GDI meeting (8) Active pharmacovigilance for new drugs and novel regimens for treatment of MDR-TB (9) Universal access to MDR-TB services (10) Supporting the scale-up of MDR-TB (11) Next steps (12) Conclusions and recommendations 16

24 Report of the Seventh Meeting of the Regional Advisory Committee on MDR-TB (r-glc SEAR) Annex 2 List of participants Dr Rohit Sarin Chair of MDR Advisory Committee D-112 East of Kailash New Delhi, India Dr Kuldeep Singh Sachdeva 36 Munirka Vihar New Delhi, India Dr Sarabjit S. Chadha Member of MDR Advisory Committee The Union South-East Asia Office International union Against Tuberculosis and Lung Disease (The Union), C-6, Qutub Institutional Area New Delhi, India Dr Erlina Burhan JI. Perhubungan XI no 77 Kompleks Perhubungam Rawamangun, Jakarta Timur Indonesia Mr Somsak Rienthong 21 Tesaban, 27 Street Sukhumvit Road, Samutprakarn Thailand Ms Thandar Lwin Deputy Director (TB) National TB Control Programme Department of Health Naypitaw, Myanmar Dr Camila Rodriques P.D. Hinduja Hospital and Research Centre Mumbai Ms Blessina Kumar TB/HIV Activist & Public Health Consultant, India New Delhi MoH Myanmar Participants Dr Si Thu Aung Programme Manager National TB Control Programme Department of Health Ministry of Health Nay Pyi Taw Dr Tin Mi Mi Khine Regional TB Officer - Yangon Department of Health Ministry of Health Nay Pyi Taw Dr Wint Wint Nyunt Microbiologist Yangon Department of Health Ministry of Health Nay Pyi Taw Prof Tin Maung Cho Chairman MDR Expert Committee Myanmar Partner Dr Catharina Van Weezenbeek Executive Director KNCV TB Foundation Netherlands WHO Secretariat Dr Jorge M Luna WHO Representative Myanmar Dr Malik Parmar National Professional Officer for Drug-Resistant TB WHO Country Office for India New Delhi 17

25 Report of the Seventh Meeting of the Regional Advisory Committee on MDR-TB (r-glc SEAR) Dr Giampaolo Mezzabota Technical Officer WHO Country Office Myanmar Yangon Dr Win Maung National Technical Officer (TB Human Resources) WHO Country Office Myanmar Dr Md Khurshid Alam Hyder Regional Adviser, Tuberculosis Department of Communicable Diseases SEARO, New Delhi Dr Rim Kwang IL Medical Officer TB Department of Communicable Diseases SEARO, New Delhi Ms Tanushri Mitra Executive Assistant Department of Communicable Diseases SEARO, New Delhi Mr Thuyain Tun Tun Executive Assistant TB Unit WHO Country Office for Myanmar 18

26