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Member States Albania Andorra Armenia Austria Azerbaijan Belarus Belgium Bosnia and Herzegovina Bulgaria Croatia Cyprus Czech Republic Denmark Estonia Finland France Georgia Germany Extensive Review of TB Greece Hungary Iceland Prevention, Care and Ireland Edited by: Masoud Dara Israel Italy Zaruhi Mkrtchyan Kazakhstan Control Services in Kyrgyzstan Gayane Ghukasyan Latvia Lithuania Armenia Luxembourg Malta Monaco Montenegro 21 April – 4 May 2011 Netherlands Norway Poland Portugal Republic of Moldova Romania Russian Federation San Marino Serbia Slovakia Slovenia Spain Sweden Switzerland Tajikistan The former Yugoslav Republic of Macedonia Turkey Turkmenistan Ukraine United Kingdom Uzbekistan World Health Organization Regional Office for Europe ISBN Scherfigsvej 8, DK-2100 Copenhagen Ø, Denmark WHOLIS number Tel.: +45 39 17 17 17. Fax: +45 39 17 18 18. E-mail: [email protected] Original: Web site: www.euro.who.int Mission Report Extensive Review of TB Prevention, Care and Control Services in Armenia 21 April – 4 May 2011 ii Address requests about publications of the WHO Regional Office for Europe to: Publications WHO Regional Office for Europe Scherfigsvej 8 DK-2100 Copenhagen Ø, Denmark Alternatively complete online requests form for documentation, health information, or for permission to quote or translate, on the WHO/Europe web site at http://www.euro.who.int/pubrequest. © World Health Organization 2012 All rights reserved. The Regional Office for Europe of the World Health Organization welcomes requests for permission to reproduce or translate its publications, in part or in full. 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Writing Committee Written by Masoud Dara, WHO Regional Office for Europe Andrei Dadu, WHO Regional Office for Europe Smiljka de Lussigny, WHO Regional Office for Europe Brenda van den Bergh, WHO Regional Office for Europe Alejandra Gonzalez Rossetti, WHO Regional Office for Europe Bert Schreuder, KNCV TB Foundation Askar Yedilbayev, Partners in Health Doris Hillemann, Supranational Reference Laboratory, Borstel Kristin Kremer, WHO Regional Office for Europe Nonna Turusbekova, KNCV TB Foundation Andre Zagorski, Management Sciences for Health With contributions from Diana Atajanyan, independent consultant Edited by Masoud Dara, WHO Regional Office for Europe Zaruhi Mkrtchyan, Independent consultant Gayane Ghukasyan, WHO Country Office in Armenia Acknowledgements The members of the mission would like to thank the Minister of Health of Armenia, Professor Kushkyan, for his timely request to the WHO Regional Office for Europe and for facilitating the extensive tuberculosis (TB) programme review. The following organizations and individuals contributed their valuable time, knowledge and experience to the extensive review of TB prevention, control and care in Armenia: − representatives of the Ministry of Health of the Republic of Armenia, acting on behalf of the Minister, Professor Kushkyan, and Deputy Minister, Dr Khachatryan; − heads of marz (provincial) health departments and TB coordinators in Gegharkunik, Kotayk and Lory marzes (provinces); − administration and staff of the Republican TB Dispensary, acting on behalf of Dr Marina Safaryan; − heads and staff of health-care facilities and TB services in Yerevan, Kotayk, Gegharkunik, Lory and Aragatsotn marzes; − heads and staff of the health-care unit of the criminal-executive department of the Ministry of Justice, criminal-executive institutions and the Central Hospital for Detainees; − representatives of the United States Agency for International Development (USAID)/Armenia mission, the Global Fund to Fight AIDS, Tuberculosis and Malaria (GFATM) and World Bank Project Implementation Unit, and Médecins Sans Frontières France. Contents Abbreviations ...................................................................................................................................... i Executive summary ............................................................................................................................ iii Key recommendations ........................................................................................................................ iv Background ......................................................................................................................................... 1 Epidemiology of TB in Armenia ............................................................................................................ 3 Organization and management ............................................................................................................ 6 Findings ....................................................................................................................................................... 7 Accountability, responsibility and institutional capacity......................................................................... 7 Stewardship ............................................................................................................................................. 8 Recommendations ...................................................................................................................................... 8 Financing .......................................................................................................................................... 10 Findings ..................................................................................................................................................... 10 Recommendations .................................................................................................................................... 11 Human resources development ......................................................................................................... 13 Findings ..................................................................................................................................................... 14 Recommendations .................................................................................................................................... 15 Management of TB medicines ........................................................................................................... 16 Findings ..................................................................................................................................................... 16 Selection ................................................................................................................................................ 16 Procurement .......................................................................................................................................... 17 Registration ........................................................................................................................................... 17 Distribution and storage ....................................................................................................................... 18 Recommendations .................................................................................................................................... 19 Diagnosis .......................................................................................................................................... 20 Findings ..................................................................................................................................................... 20 Case detection ....................................................................................................................................... 20 Intensified TB case-finding in people living with HIV ............................................................................ 20 HIV testing and counselling in TB patients and suspects ...................................................................... 21 Recommendations ................................................................................................................................... 22 Laboratory network .......................................................................................................................... 23 Findings ..................................................................................................................................................... 23 Optimization of the laboratory network ............................................................................................... 23 National Reference Laboratory ............................................................................................................. 24 Recommendations .................................................................................................................................... 24 Treatment and care services .............................................................................................................. 25 Findings ..................................................................................................................................................... 26 Magnitude of DR-TB .............................................................................................................................. 26 Management of DR-TB .......................................................................................................................... 27 Management of TB/HIV coinfected patients ........................................................................................ 29 Management of drug dependence ........................................................................................................ 30 Recommendations .................................................................................................................................... 30 Infection control ............................................................................................................................... 32 Findings ..................................................................................................................................................... 32 Infection control in regional TB facilities ............................................................................................... 32 Environmental measures ....................................................................................................................... 33 Personal protection ............................................................................................................................... 33 Recommendations .................................................................................................................................... 35 i Advocacy, communication and social mobilization ............................................................................. 35 Findings ..................................................................................................................................................... 35 Advocacy and social mobilization ......................................................................................................... 36 Recommendations .................................................................................................................................... 36 Penitentiary system .......................................................................................................................... 37 Findings ..................................................................................................................................................... 37 TB Control Programme of the Ministry of Justice ................................................................................. 38 Health information system – continuity of care .................................................................................... 39 Recommendations .................................................................................................................................... 39 Partnership and civil society involvement .......................................................................................... 41 Findings ..................................................................................................................................................... 41 Civil society organizations and patient involvement ............................................................................. 41 Recommendations .................................................................................................................................... 42 Monitoring and evaluation ................................................................................................................ 43 Findings ..................................................................................................................................................... 43 Recommendations .................................................................................................................................... 44 Data collection and reporting ............................................................................................................ 44 Findings ..................................................................................................................................................... 44 Recommendations .................................................................................................................................... 46 Annexes ............................................................................................................................................ 47 Annex 1: Biography of review mission members ..................................................................................... 47 Annex 2: Timetable for the review ........................................................................................................... 50 Annex 3: Background documents ............................................................................................................. 57 Annex 4: People interviewed.................................................................................................................... 59 Annex 5: TB, TB/HIV and MDR-TB country profile ................................................................................... 61 Annex 6: MDR-TB cases estimated, notified, enrolled on treatment and expected to be treated ......... 63 Annex 7: Distribution of TB cases notified in 2010 per marz ................................................................... 64 Annex 8: Findings and recommendations for laboratory facilities visited ............................................... 65 Annex 9: Laboratory network and sputum collection points in marzes .................................................. 71 Annex 10: Treatment outcomes for MDR-TB and PDR-TB patients ......................................................... 72 Annex 11: Observations in TB facilities of the penitentiary system ......................................................... 74 Annex 12: National Health Information Analytical Centre at the National Institute of Health ............... 76 Annex 13: Specific recommendations for revision of the TB performance framework........................... 78 Annex 14: Routine recording and reporting ............................................................................................. 80 ii Abbreviations ACSM advocacy, communication and IEC information, education and social mobilization communication AIDS acquired immunodeficiency IPT isoniazid preventative therapy syndrome IQC internal quality control APEC AIDS Prevention, Education and KAP knowledge, attitude, practice Care (nongovernmental KfW Kreditanstalt für Wiederaufbau – organization) German Development Bank ARCS Armenian Red Cross Society KNCV Royal Netherlands Tuberculosis ART antiretroviral therapy Association ARV antiretroviral LPA lymphocyte proliferation assay AUA American University of Armenia M&E monitoring and evaluation BCG bacillus Calmette-Guerin MDR-TB multidrug-resistant tuberculosis BSC biosafety cabinet (resistant to, at least, isoniazid and CCM country coordination mechanism rifampicin) (for GFTAM grants) MGIT mycobacteria growth indicator CEI criminal-executive institution tube (place of detention) MMR mass miniature radiography CPT cotrimoxazole preventive therapy MoH Ministry of Health DHS Demographic and Health Survey MoJ Ministry of Justice DOT direct observation of treatment MSF-F Médecins Sans Frontières – France DOTS directly observed treatment, MSH Management Sciences for Health short-course – the basic package (USA) that underpins the WHO Stop TB MTEF medium-term expenditure Strategy framework DOTS+ DOTS Plus NCAP National Centre for AIDS DRS drug resistance Prevention surveillance/survey NEML National Essential Medicines List DR-TB drug-resistant TB NGO nongovernmental organization DST drug susceptibility testing NRL National Reference Laboratory for EQA external quality assurance TB EQC external quality control NTP National TB Control Programme FDC fixed dose combination OST opioid substitution therapy FLD first-line drugs PCR polymerase chain reaction GDF Global TB Drug Facility PCTC Patients’ Charter for TB Care GDP gross domestic product PDR-TB polydrug-resistant tuberculosis GFATM Global Fund to Fight AIDS, PHC primary health care Tuberculosis and Malaria PITC provider-initiated testing and GFATM PIU GFATM Project Implementation counselling Unit PLHIV people living with HIV GLC Green Light Committee PMDT programmatic management of HIV human immunodeficiency virus drug-resistant tuberculosis HOTO handover/takeover PPAN Positive People Armenian Network HRD human resources development (nongovernmental organization) IC infection control PPD purified protein derivative ICRC International Committee of the R&R recording and reporting Red Cross RTBD Republican TB Dispensary IDU injecting drug user SCP sputum collection point SLD second-line drug i SM smear microscopy USAID United States Agency for SNRL supranational reference laboratory International Development SOP standard operating procedure WB PIU World Bank Project SS- sputum smear-negative Implementation Unit SS+ sputum smear-positive WHO World Health Organization SHA Armenian State Health Agency XDR-TB extensively drug-resistant TB tuberculosis tuberculosis ToR terms of reference YCTBD Yerevan City TB Dispensary ToT training of trainers Drug abbreviations Am amikacin Cm capreomycin E ethambutol Fq fluoroquinolone H isoniazid Km kanamycin Ofx ofloxacin R rifampicin S streptomycin Z pyrazinamide ii Executive summary Tuberculosis (TB) is one of the major public health problems in Armenia. In 2009, TB incidence in Armenia was reported as high as 45.5 per 100 000 population and TB mortality was 3.9 per 100 000 population. Only 35% of estimated new sputum smear-positive pulmonary TB patients are notified annually. Of 1780 TB cases notified in 2010, only 339 patients were sputum smear-positive. The treatment success rate of new sputum smear-positive pulmonary TB patients in 2009 was 72.9%, which is below the WHO target of 85%. Poor treatment outcome is partially explained by high prevalence of drug-resistant TB forms. Armenia is among the top 10 countries with the highest prevalence rates of multidrug-resistant tuberculosis (MDR-TB). According to the 2007 drug resistance survey, MDR-TB accounted for 9.4% of cases among never treated patients and 43.2% among previously treated cases, with 4% of extensively drug-resistant tuberculosis (XDR-TB) cases. This represents an enormous public health challenge for Armenia. Early identification and effective treatment of patients with MDR-TB are crucial in order to prevent the further spread of the disease. The National TB Control Programme of Armenia (2007-2015) (NTP) is based on the WHO Stop TB Strategy and aims to achieve the global targets for TB control. In 2010, the Minister of Health, recognizing the importance of high-level political will and commitment in ensuring expansion of the Stop TB Strategy, personally took over the management of the National TB Control Programme. Following a request by the Minister of Health of Armenia, the WHO Regional Office for Europe, in collaboration with key partners, organized a comprehensive external review of the National TB Control Programme. The extensive review revealed that, despite the great achievements of the National TB Control Programme, there are several major gaps which require urgent action. The programme has succeeded in reducing the default rate of new sputum smear-positive pulmonary TB patients from 14% to 8% in four years and has embarked on programmatic management of drug resistance. Two projects financed by grants from the Global Fund to Fight AIDS, TB and Malaria (GFATM) are being implemented, and a close collaboration with national and international partners, particularly Médecins Sans Frontières, has been established to address MDR-TB. To advance the achievements of the National TB Control Programme, the Ministry of Health (MoH) needs to maintain its TB control strategy. The structure, mandate and organogram of the National TB Control Programme need to be updated and endorsed by the Ministry. The excessive hospitalization of patients and TB suspects needs to be curbed by rationalizing hospitalization and revising financial mechanisms. New diagnostic methods, including Gene-Xpert MTB/RIF, need to be introduced in a phased manner to improve early diagnosis of MDR-TB. The country needs to revise its national TB strategic plan and ensure universal access to treatment of drug-resistant TB. Diagnosis of TB and MDR-TB needs to be improved by providing a one-stop service for people living with HIV. A continuum of TB treatment needs to be ensured for (ex-) prisoners, strengthening the collaborative mechanism between the civilian and penitentiary services. The programme needs to continue its collaboration with civil society organizations, focusing particularly on injecting drug users (IDU). iii