Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Special needs dentistry wikipedia , lookup
Health equity wikipedia , lookup
Reproductive health wikipedia , lookup
Preventive healthcare wikipedia , lookup
Harm reduction wikipedia , lookup
Infection control wikipedia , lookup
International Association of National Public Health Institutes wikipedia , lookup
CONSOLIDATED ACTION PLAN TO PREVENT AND COMBAT MULTIDRUG-RESISTANT AND EXTENSIVELY DRUG RESISTANT TUBERCULOSIS (EXTENSIVE VERSION) 2011-2015 DRAFT V.5 MARCH 2011 FOR CONSULTATION WITH THE MEMBER STATES, CIVIL SOCIETIES AND PUBLIC WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR EUROPE The Consolidated Action Plan to Prevent and Combat Multidrug and Extensively-drug tuberculosis (TB) in WHO European Region 2011-2015 is a roadmap to strengthen and intensify efforts to address the alarming problem of drug resistant TB in the Region. The Plan is being prepared in region-wide consultation with experts, patients and communities suffering from the disease. The participatory process of developing the Plan is led under the initiative of Special Project of WHO/Europe Regional Director to Prevent and Combat M/XDR-TB and is overseen by an independent Steering Group composed of key technical and bilateral agencies, representatives of Member States and civil society organizations. Following a detailed assessment of TB and MDR-TB interventions in WHO European Region, and considering the Member States’ response to Regional Director’s solicitation for inputs and feedback of the Eighteenth Standing Committee of the Regional Committee for Europe in Andorra, from 18 to 19 November 2010, the first draft of Consolidated Action Plan to Prevent and Combat M/XDR-TB 20112015 was drafted. WHO/Europe organized a three day workshop in Copenhagen from 6 to 8 December 2010 and finalized the second draft of the Plan with participation of country representatives and key experts in the field. The Plan is posted on the internet for public and civil society consultation and simultaneously sent to Member States for their review by 25 March 2011. Targets and objectives of the Consolidated Action Plan to Prevent and Combat M/XDR-TB in WHO European Region are aligned with those of the MDR-TB section of the Global Plan to Stop TB 2011-2015 and World Health Assembly Resolution 62.15 urging all Member States to achieve Universal access to diagnosis and treatment of MDR-TB by 2015. The Consolidated Action Plan to Prevent and Combat M/XDR-TB 2011-2015 is built upon the core principles of Health 2020 Strategy with the vision of equitable access to health. The Consolidated Action Plan to Prevent and Combat M/XDR-TB 2011-2015 will be submitted for endorsement by the WHO Regional Committee for Europe in Baku, Azerbaijan, in September 2011 along with an accompanying resolution. 1 Contents Acronyms and abbreviations........................................................................................................ 2 Target Audiences ......................................................................................................................... 3 Executive Summary ..................................................................................................................... 4 Introduction .................................................................................................................................. 5 Outline.......................................................................................................................................... 8 Goal .......................................................................................................................................... 8 Targets...................................................................................................................................... 8 Strategic directions................................................................................................................... 8 Areas of intervention................................................................................................................ 9 Milestones ................................................................................................................................ 9 Expected Achievements ......................................................................................................... 10 Regional SWOT analysis in relation to M/XDR-TB ................................................................. 11 Strengths ................................................................................................................................ 11 Weakness ............................................................................................................................... 11 Opportunities.......................................................................................................................... 13 Threats.................................................................................................................................... 13 Areas of Intervention (adapted from Objectives of Global Plan 2011-2015) ........................... 14 1. Prevent development of M/XDR-TB cases .................................................................... 14 2. Scale up access to testing for resistance to first-line and second line anti-TB drugs and HIV testing among TB patients ............................................................................................. 17 3. Scale up access to effective treatment for drug resistant TB .......................................... 19 4. Scale up TB infection control ......................................................................................... 22 5. Strengthen surveillance, including recording and reporting, of drug-resistant TB......... 24 6. Expand country capacity to scale up the management of drug-resistant TB including advocacy, partnership and policy guidance ........................................................................... 26 7. Address the needs of special populations ....................................................................... 35 Annex I: Overview of major activities....................................Error! Bookmark not defined. Annex II: References ............................................................................................................. 37 1 Acronyms and abbreviations ACSM AIDS BCG CSO DOT DOTS EEA EU EQA GLC GFATM GDF HIV HPC HRD HRH IUATLD MDR-TB MDR HBC MOH MOJ NGO NTP PHC PMDT PSM SLD SNRL WHO XDR-TB Advocacy, Communication and Social Mobilization Acquired Immuno-deficiency Syndrome Bacille Calmette Guérin (Tuberculosis vaccine) Civil Society Organization Directly Observed Treatment The WHO-recommended essential strategy for TB control European Economic Area European Union External Quality Assurance Green Light Committee GFATM, Global Fund for AIDS, Tuberculosis and Malaria Global Drug Facility (for Tuberculosis Programmes) Human Immunodeficiency Virus High (TB) Priority Countries Human Resources Development Human Resources for Health International Union Against TB and Lung Diseases Multi Drug Resistant Tuberculosis (resistance to at least isoniazid and Rifampicin, the two most effective drugs available) MDR high burden country, incidence > 4000 cases or >10% of the new TB cases with MDR. Ministry of Health Ministry of Justice Non-Governmental Organization National Tuberculosis Programme Primary health care Programmatic Management of Drug-resistant Tuberculosis Procurement and supply management Second line anti-TB drugs Supra-national Tuberculosis Reference Laboratory World Health Organization MDR-TB resistant also to a fluoroquinolone and a second line injectable agent 2 Target Audiences The primary audience of this Action Plan is the national authorities in the Member States of the WHO European Region, responsible for tuberculosis control in the health Ministries as well as other government bodies responsible for health in penitentiary services, health financing, health education and social services. The Plan urges intensified involvement of civil society, communities affected by the disease, professional societies and national and international technical agencies and donors. The MDR-TB Action Plan calls for consolidated and coordinated action by the World Health Organization Regional Office for Europe and all stakeholders engaged in TB control in the Region. 3 Executive Summary In response to the alarming problem of Multidrug resistant tuberculosis (MDR-TB) and Extensively drug resistant Tuberculosis (XDR-TB) in WHO European Region, the Regional Director has established a Special Project to Prevent and Combat M/XDR-TB in the region. In order to scale up comprehensive response and prevent and control M/XDR-TB, a Consolidated Action Plan has been developed for 2011 to 2015 to function as a road map for the Member States, WHO/Europe and partners. The Consolidated Action Plan to Prevent and Combat M/XDR-TB in WHO European Region 2011-2015 has six strategic directions and seven areas of intervention. The strategic directions are crosscutting and are to safeguard the values of Health2020 Strategy and highlight the priorities of the WHO European Region and the Member States. The areas of interventions are aligned with the Global Plan to StopTB 20112015 and follow the same targets as set by the Global Plan and World Health Assembly 62.15 to provide Universal Access to diagnosis and treatment of MDR-TB. A more concise version of the Consolidated Action Plan to Prevent and Combat M/XDR-TB in WHO European Region 2011-2015 is developed for endorsement by the Member States along with a resolution. WHO/Europe has assisted Member States with high MDR-TB burden countries in the WHO European Region to develop national MDR-TB response Plans based on the Beijing Commitment. The Consolidated Action Plan to Prevent and Combat M/XDR-TB in WHO European Region 2011-2015 will lead the Member States for further elaboration and integration of national MDR-TB response plans in the national TB and/or national health strategy plans. With implementation of the Consolidated Action Plan to Prevent and Combat M/XDRTB in WHO European Region 2011-2015, the emergence of 10,000 new MDR-TB patients and 1500 XDR-TB patients would be averted yearly and an estimated 60,000 MDR-TB patients would be diagnosed and at least 40,000 of them would successfully be treated and hence interrupting transmission of MDR-TB (a detailed modelling is being worked out along with the cost of implementation and savings by cutting transmission which will be ready in April 2011) 4 Introduction Of 440 000 estimated multidrug-resistant TB (MDR-TB) patients in the world, 81 000 MDR-TB prevalent cases are estimated to be in WHO European region (20% of the global burden). The top nine countries in the world with MDR-TB exceeding 12% among new TB cases, and the top six exceeding 50% among previously-treated TB cases, are in the WHO European Region. A high correlation of MDR TB among HIV-positive patients and downstream and upstream determinants of health, such as imprisonment, migration and low socio-economic status have been documented in several Member States. MDR-TB is the result of inadequate treatment of tuberculosis which can then be transmitted within the community and/or due to poor airborne infection control in health care facilities and congregate settings. While the WHO European Region comprises only 5.6% of newly detected and relapsed TB cases in the world, it reported 329,391 new episodes of TB and 46,241 deaths from TB in 2009, the majority of them in the 18 high priority countries (HPC) of the Region1. The trend in TB notifications has been decreasing since 2005. In spite of this encouraging trend, notification rates of the newly-detected and relapse TB cases in the 18 HPC remained almost eight times higher (73.0 per 100 00 population) than in the rest of the Region (9.2 per 100 000) and double the Regional average (36.8 per 100 000 population). The rates of MDR-TB throughout the Region remain very alarming. The proportion of MDR among new TB cases and previously treated TB patients in 2009 was 11.1% and 36.7% respectively. Many countries in the region have reported extensively drug-resistant TB (XDRTB). In spite of still very low coverage of drug susceptibility testing on second-line drugs in non-European Union (EU)/ (European Economic Area (EEA)2 countries the total number of such patients with extensively drug-resistant TB (XDR-TB) notified in the Region almost tripled from 132 in 2008 to 344 in 2009, the vast majority of them (80%) were notified in nonEU/EEA sub-region. In order to diagnose the extensively drug resistant TB (XDR-TB), there is a need to have access to second line drug susceptibility testing which is not readily available for all patients. In 2009, from estimated 81,000 MDR-TB patients, only 27,760 cases (34.2%) were notified3 due to low availability of bacteriological culture and drug susceptibility testing (Table 1). From this number of MDR-TB patients only 36.4% (10,107 patients) received adequate treatment with quality second-line drugs (SLD)4. Currently, treatment of MDR-TB patients is lengthy and takes up to 24 months with the use of SLD and/or surgery, often accompanied by adverse effects, which cause further burden to the patients and their families. The latest available data indicates that the treatment success rate of MDR-TB patients in WHO European Region receiving quality assured second line medicines is 62%. The other two third of notified MDR-TB patients have no access to quality treatment or are not reported so and may die after few years. Access to quality SLD and TLD 1 High Priority countries are: Armenia, Azerbaijan, Belarus, Bulgaria, Estonia, Georgia, Kazakhstan, Kyrgyzstan, Latvia, Lithuania, Moldova, Romania, Russia, Tajikistan, Turkey, Turkmenistan, Ukraine and Uzbekistan. 2 The 30 EU and EEA countries are: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom. The 24 countries in the rest of the European Region (‘non-EU/EEA’) are: Albania, Andorra, Armenia, Azerbaijan, Belarus, Bosnia and Herzegovina, Croatia, Georgia, Israel, Kazakhstan, Kyrgyzstan, the former Yugoslav Republic of Macedonia, Moldova, Monaco, Montenegro, Russia, San Marino, Serbia, Switzerland, Tajikistan, Turkey, Turkmenistan, Ukraine and Uzbekistan. 3 WHO report 2010, table 7; WHO/HTM/TB/2010.7 4 5738 in non-EU/EEA under GLC projects and 4368 in the EU/EEA countries assuming a 100% access to the proper treatment. 5 medicines for treatment of M/XDR-TB is limited in many Member States. Some of the SLD and TLD are too expensive and/or not available for all the patients. Despite good progress in several countries, in others the TB control network, especially regarding diagnosis and treatment of MDR has not yet included the prison system. Currently, a recommended package of airborne infection control measures is missing in most of the hospital wards and outpatient clinics where patients with MDR-TB are treated. The latest available data from MDR-TB HBCs indicates that TB IC is still in a preliminary implementation phase in most of these countries. TB IC national situation assessment has been done so far in ten MDR-TB HBC. TB IC National action plan exists in four countries and six notified that there were preparing it.WHO/Europe in collaboration and coordination with other partners has provided guidance and technical assistance to Member States to improve TB, MDR-TB and TB/HIV prevention, control and care, including planning and programme management, airborne infection control, surveillance, monitoring and evaluation, human resources capacity-building, quality assured laboratory diagnosis, guidelines and policy development, provision of quality medicines through the Global Drug Facility (GDF) and Green Light Committee (GLC), advocacy, communication and social mobilization. Concerning vaccination, the Bacille Calmette Guerin (BCG) is the only vaccine available against TB which was first used in 1921. BCG has limited efficacy for protection against the disease and can’t be administered for people living with HIV, however it can to some extent protect against the severe form of TB in children. The most effective drugs against TB were discovered in 50s and since then other agents are being introduced with often more adverse effects. There is an urgent need for more effective medicines and vaccines and the European scientific institutes can play an important role in research and development for new medicines and vaccine. Recently several molecular techniques including Gene Xpert was endorsed by World Health Organization (WHO) as a rapid method of diagnosing of tuberculosis and Rifampicin resistance; however the technology has not been introduced in most MDR-TB high burden countries of the Region. The Berlin Declaration on Tuberculosis, endorsed in 2007, binds all Member States to fight against TB and properly address M/XDR TB. Adequate interventions addressing drug resistant TB require proper national planning and effective implementation, comprehensive approaches in and across countries as well as strong support from national and international partners. Ministers from the 27 M/XDR-TB high burden countries of the world met in Beijing, China, from 1 to 3 April 2009 to urgently address the alarming threat of MDR-TB. This was reflected in a Call for Action on M/XDR-TB to help strengthen health agendas and ensure that urgent and necessary commitments for action and funding are made to prevent this impending epidemic. In the same year, the World Health Assembly Resolution 62.15 urged all Member States to achieve universal access to diagnosis and treatment of MDR-TB. High MDR-TB burden countries in Europe have already developed their national M/XDR TB response plan 201l-2015. European high TB priority countries in Europe need to align their approved national TB plan with the new commitments in preventing and controlling M/XDR TB. Based on the above, the WHO Regional Director for Europe confirmed the strong commitment of WHO to fight against TB and to develop an action plan to prevent and combat M/XDR TB in the Region. The Consolidated Action Plan to Prevent and Combat M/XDR-TB 2011-2015 is developed under the leadership of WHO Regional Office for Europe and the guidance of an 6 independent steering group5 with inputs of the Member States, technical agencies and civil societies involved in TB control in Europe. The Consolidated Action plan follows the Beijing call for Action and Berlin Declaration. Countries with high burden or high incidence of MDR-TB in the WHO European Region, 2009 in alphabetic order Country Estimated MDR-TB annual incidence Estimated MDR-TB among new TB cases (%) Reported MDR-TB in 2009 480 (380-580) 9.4 (7.3-12.1) 156 4,000 (3,300-4,700) 22.3 (19.0-26.0) -- Belarus 800 (260-1,300) 12.5 (0.0-25.3) 867 Bulgaria 460 (99-810) 12.5 (0.0-25.3) 43 Estonia 94 (71-120) 15.4 (11.6-20.1) 86 Georgia 670 (550-780) 6.8 (5.2-8.7) 369 Kazakhstan 8,100 (6,400-9,700) 14.2 (11.0-18.2) 3644 Kyrgyzstan 1,400 (350-2,400) 12.5 (0.0-25.3) 785 Latvia 170 (140-200) 12.1 (9.9-14.8) 131 Lithuania 330 (270-390) 9.0 (7.5-10.7) 322 2,100 (1,700-2,400) 19.4 (16.8-22.2) 1069 38,000 (30,000-45,000) 15.8 (11.9-19.7) 14686 Tajikistan 4,000 (2,900-5,100) 16.5 (11.3-23.6) 319 Ukraine 8,700 (6,800-11,000) 16.0 (13.8-18.3) 3482 Uzbekistan 8,700 (6,500-11,000) 14.2 (10.4-18.1) 654 Armenia Azerbaijan Republic of Moldova Russian Federation Estimated annual incidence over 4000 MDR-TB cases and/or at least 10% newly registered cases with MDRTB. Source: Multidrug and extensively drug-resistant TB (M/XDR-TB). 2010 global report on surveillance and resistance. WHO/HTM/TB/2010.3 Steering group included European Centre for Disease Prevention and Control (ECDC), European Commission, European Respiratory Society, Global Fund to fight Against AIDS, TB and Malaria, International Union Against Tuberculosis and Lung Disease, KNCV Tuberculosis Foundation, Partners in Health, United States Agency for International Development (USAID), WHO headquarters and WHO/Europe. In October 2010 the Steering Group was expanded to include civil society representatives and English-speaking TB focal points from the following Member States were invited to the Group: Germany, Netherlands, Romania, Russian Federation, Slovakia and Uzbekistan 5 7 Outline Goal To contain the spread of drug resistant tuberculosis by achieving Universal Access6 to prevention, diagnosis and treatment of M/XDR-TB in all Member States of the WHO European Region7 by 2015. Targets 1. To decrease by 20 percentage points MDR-TB proportion among previously treated patients by end 20158 2. To diagnose at least 80% of estimated MDR-TB patients by 20159 3. To successfully treat at least 75% of estimated number of patients suffering from MDRTB by 2015 Strategic directions 1. Identifying and addressing determinants contributing to the emergence and spread of drug resistant TB; (areas of intervention 1, 4, 6 and 7) 2. Strengthening health system response in providing accessible, affordable and acceptable services with patient-centred approaches. (areas of intervention 1, 2, 3, 4, 5, 6 and 7) In order to reach the most vulnerable population, it is important that services remain free of charge for patients; 3. Working in national, regional and international partnerships in TB prevention, control and care; (areas of intervention 6) 4. Promoting the rational use of existing resources, identifying gaps, and mobilizing additional resources to fill the gaps; (areas of intervention 6) 5. Fostering regional and international collaboration for the development of new diagnostic tools, medicines and vaccines against tuberculosis; (areas of intervention 3 and 6) 6. Monitoring the trends of M/XDR-TB in the region and measuring the impact of interventions. (areas of intervention 5) 6 Universal Access is defined as evidence-based practices and quality services which are available, accessible, affordable and acceptable by people irrespective of their age, sex, sexual orientation, religion, origin, nationality, socioeconomic status or geographic background. 7 The 62nd World Health Assembly on May 2009 has adopted a resolution on MDR-TB and XDR-TB (Agenda item 12.9): to achieve universal access to diagnosis and treatment of multidrug-resistant and extensively drug-resistant tuberculosis as part of the transition to universal health coverage, thereby saving lives and protecting communities 8 It is a common understanding that within the time span of this Action Plan, it would be difficult if at all possible to decrease primary MDR-TB significantly enough and attribute it to interventions of this Action Plan. Apart from improving airborne infection control in health care facilities and congregate settings, many of primary MDR-TB patients who have been infected in the community may develop MDR-TB in the near future, however proportion of MDR-TB among previously treated patients would be a more sensitive indication of improvement in case holding and appropriate treatment of patients and hence preventing further development of MDR-TB 9 In 2009 only 34.5% of estimated MDR-TB patients were notified. With Universal Access to diagnosis, one would expect most sputum culture positive patients be identified, notified and reported, while still many culture negative TB patients may not be detected. 8 Areas of intervention (Based on MDR-TB Objectives of the Global Plan to StopTB 2011-201510) 1. Prevent the development of M/XDR-TB cases 2. Scale up access to testing for resistance to first-line and second line anti-TB drugs and HIV testing among TB patients 3. Scale up access to effective treatment for all drug resistant TB 4. Scale up TB infection control 5. Strengthen surveillance, including recording and reporting of drug-resistant TB and treatment outcome monitoring 6. Expand country capacity to scale up the management of drug-resistant TB including advocacy, partnership and policy guidance 7. Address the needs of special populations Milestones 1. Rapid molecular diagnostic tests of MDR-TB11 are available for all eligible TB suspects in the Member States by 2013 2. All high MDR-TB burden countries introduced electronic case-based database for notification and treatment outcome of MDR-TB patients at national level by 2013 3. All high MDR-TB burden countries reporting more than 50% of the estimated MDRTB cases by 2013 4. All 18 European high TB priority countries have adopted and budgeted national M/XDR-TB action plans embedded in their national TB strategic plans by 2012 5. All Member States have ensured uninterrupted supply and rational use of quality first and second line drugs for treatment of TB and M/XDR-TB patients by 2013 6. All Member States monitor and report treatment outcome of M/XDR.TB patients according to internationally recommended methodologies by 2013 7. All MDR-TB patients including previously treated tested for resistance to second-line drugs by 2014 at least in all European high burden countries to define the level of XDR-TB 8. All previously treated TB patients tested for resistance to first-line and second-line drugs by 2012 9. At least one new medicine with more effective and shorter treatment regimen for M/XDR-TB patients is available by 2014 10 It has been decided to refer to Objectives as Areas of Interventions and define specific objectives under each of these areas to ensure they are SMART (Specific, Measurable, Achievable, Realistic and Time-bound) to be able to call the Objectives 11 A rapid test is defined as one which provides diagnosis within 48 hours of processing the specimen and can therefore accelerate the initiation of appropriate treatment 9 Expected Achievements (We are working on this section from epidemiological and modelling perspective) - Xxx number of MDR-TB patients diagnosed within three days of presenting with TB symptoms to the health care services - Yyy number of MDR-TB patients treated successfully - Zzz number of primary and ddd number of acquired MDR-TB averted - Uuu number of XDR-TB averted - Implementation of this plan would save ttt number of lives - With implementation of this plan Member States would save xxxxx USD due to M/XDR-TB averted 10 Regional SWOT analysis in relation to M/XDR-TB Strengths - - - There is a strong political commitment of the Member States to address the problem of tuberculosis. The Member States have shown their commitments with their endorsement of the Berlin declaration, Beijing meeting of high MDR-TB burden countries and the World Health Assembly resolutions. Member States have skilled health care staff involved in TB prevention and control. The World Health Organization Regional Office for Europe and partners have intensified their support to the Member States to prevent and control TB and M/XDRTB. Increasing number of national and international organizations are willing to strengthen partnership and coordination GFATM has been instrumental in pilot implementation of MDR/TB control projects; Under the Green light Committee mechanism, 19 countries of the region have set up MDR-TB control projects WHO Europe Regional Director has established a Special Project to prevent and combat M/XDR-TB in the Region WHO/Europe, headquarters and other technical agencies have been providing technical assistance to Member States Strong WHO Collaborative Centres and Centres of Excellence for MDR-TB control are established in the Region WHO/Europe and WHO headquarters have assisted high MDR-TB burden countries prepare national MDR-TB response plans. All 15 high MDR-TB burden countries have finalized their national MDR-TB response plans Several pharmaceutical manufacturers in non-EU countries have initiated a process for pre-qualifying their TB drug products through the WHO Pre-qualification mechanism Some counties (at least two countries) in the region are participating in the WHO Good Governance for Medicines program Two Medicines Quality Control laboratories in non-EU region have been pre-qualified by WHO Weakness - Poor quality of DOTS implementation in some countries Limited coverage of culture and drug susceptibility testing leading to only 34.2% of estimated MDR-TB detected in 2009 Only 36.7% of diagnosed MDR-TB patients could benefit from adequate treatment in 2009 due to the limitation of Member States to procure quality second line drugs Limited involvement of civil society in TB prevention, control and care Weak coordination of different health authorities involved in TB control between the civilian and penitentiary services Limited diagnostic capacity for early detection of TB and M/XDR-TB in most Member States External quality assurance of culture and DST has not yet covered all patients 11 - - - - - - - EQA DST for SL TB drugs, especially SL injectables and FQ’s is largely unavailable Vertical structure of TB control programme with limited interaction with other levels of health systems including primary health care services Lack of or insufficient collaboration mechanisms for continuum of care between the countries (cross border TB control) Limited involvement of other sectors (private health sector, social services among others) Poor coordination among TB and other programmes for collaborative activities (HIV, alcohol, drug users and tobacco and other communicable and non communicable diseases) Outdated TB policy and guidelines in some of the countries of the Region Weakening of TB clinical expertise in low prevalence countries Lack of novel medicines for shorter and more effective treatment regimen Patient-centered approaches not fully established in most high MDR-TB burden countries with lack of mechanisms/initiatives for community-based treatment Lack of or limited involvement of national TB control programmes in strengthening the outpatient treatment in some settings Poor reporting and information sharing among international technical agencies and bilateral donors Insufficient engagement of national TB control programmes in health systems reforms (with both national and international institutions); AntiTB medicines and antibiotics are sold over the counter in some of the Member States In some settings, financing mechanisms that are disincentive. For example financing based on bed occupancy rather than performance of services, resulting in large bed capacity and long hospitalization. Poor airborne infection control in most inpatient facilities and laboratories Poor infrastructure of many TB inpatient and outpatient facilities Poor contact tracing in some settings Overburdened human resources (TB services are understaffed, motivation is poor, underpaid, overloaded with state reporting) Weak or nonexistent default prevention and retrieval in most settings Inadequate public health education and prevailing stigma Lack of multidisciplinary approaches to patients’ problem in most countries (socioeconomic status and poverty, unemployment, psychiatric disorders, alcoholism and drug addiction). Lack of palliative care for patients who fail M/XDR-TB treatment Outdated management of TB in children in some countries. Pharmaceutical regulations and inspection in many non-EU countries are weak and lack enforcement mechanisms to ensure drug quality throughout and prevent over-thecounter sales of antimicrobials Weak pharmacovigilance mechanisms and lack of unbiased drug information for prescribers and patients in most high MDR-TB burden countries are possible contributors to irrational (improper) use of TB medicines Most countries in the region do not have a Law on Procurement of Medicines that would define medicines as products requiring unique specifications and actions to ensure their quality Inappropriate treatment regimen in some settings Shortage of quality assured second line drugs in some countries 12 Opportunities - - Inter-country cooperation to address cross border TB control and care, improve second line drug availability Twining of cities or institutes responsible for TB control A new diagnostic test (Xpert MTB/Rif) is endorsed by WHO which can confirm tuberculosis and rifampicin resistance tuberculosis with high sensitivity and specificity within 90 minutes. Involvement of private sector, health insurance services and University health care services out of the Ministry of Health Increased involvement of bilateral agencies, GFATM , UNITAID, TB REACH and other funding mechanism to fill in the financial gaps Increased involvement of civil society, patients association and professional societies Involvement of good will ambassadors and private entrepreneurs in TB control Threats - Poor quality of DOTS implementation and MDR-TB management seriously contributing to increase of M/XDR-TB Upstream and downstream social determinants and health system factors contributing to increase of MDR-TB Interventions initiated under GFATM grant will not be taken over by the national health authorities due to shortage of funds and financial crisis GFATM eligibility criteria are modified and as a result some high MDR-TB burden countries of the region may become ineligible for GFTAM grants Financial crisis and budget cuts lead to decreased resources available for TB and M/XDR-TB control HIV infection and other co-morbidities continues to rise particularly among vulnerable groups Lack of funds to scale up MDR-TB prevention, diagnosis and treatment Existing pharmaceutical policies, regulations, and practices may not support a rapid introduction, adoption, and implementation of new TB tools, and proper utilization 13 Areas of Intervention (adapted from Objectives of Global Plan 2011-2015) 1. Prevent development of M/XDR-TB cases In order to decrease the burden of the disease, all efforts should be made to prevent development of drug resistant TB and particularly MDR-TB. Among the main causes of emergence of MDR-TB is inadequate and inappropriate treatment. TB patients diagnosed should be put on appropriate treatment regimen as early as possible. The patients need to receive counselling and support throughout the treatment course in order to increase their adherence to treatment. Some of the intervention areas related to this objective are discussed under scale up the management of drug-resistant TB (area of intervention 6) and TB infection control (area of intervention 4). In this area of intervention two distinctly relevant areas to prevent the emergence of M/XDR-TB are addressed: improved patient adherence and chemoprophylaxis. 1.1 Identify and address social determinants related to M/XDR-TB Activity 1.1.1 WHO/Europe and partners in collaboration with the Member States conduct studies on social determinants of M/XDR-TB by end 2012. Activity 1.1.2 Member States include actions in their national health strategies to address social determinants of M/XDR-TB by end 2013. Activity 1.1.3 Member States define measures to engage national and local governments in provision of the psychosocial support for TB and M/XDR-TB patients by end 2013. 1.2 Improve patient adherence to treatment Activity 1.2.1 WHO in collaboration with partners document the best practices for models of care (inpatient, outpatient, home/community-based treatment) in different settings and provide a compendium of models of care and minimum packages of interventions to prevent and retrieve treatment interruptions and default by 2012. Activity 1.2.2 WHO in collaboration with partners provide technical assistance to Member States on health system aspects and patient-centered approaches on a continuous basis. Activity 1.2.3 All Member States will strengthen and/or establish measures to improve default prevention and retrieval by end 2012. These efforts and their impacts are to be reported during NTP managers meeting in 2013. Activity 1.2.4 WHO/Europe and other partners to analyze every other year the options of models of care, and case holding for NTP managers and health authorities from 2012 onwards. Activity 1.2.5 Member States to specify the strategies and mechanisms for expanding ambulatory treatment and social support, and their linkages with the national health plans, and measures to engage national and local governments in provision of the psychosocial support for TB and M/XDR-TB patients. 14 1.3 Apply the full capacity of Primary health care services in TB prevention, control and care Activity 1.3.1 Member States will specify the strategies and mechanisms for integrating ambulatory treatment in primary health care (PHC) services by end 2012. Activity 1.3.2 WHO/Europe and partners will provide technical assistance to Member States on measures to strengthen PHC involvement in TB prevention and control. 1.4 Increase efficiency of health financing for TB control Activity 1.4.1 WHO/Europe and partners in collaboration with the Member States will conduct an in-depth analysis of existing health financing mechanisms for TB control and recommend measures to improve efficiency of health financing for TB prevention and control by end 2013. Activity 1.4.2 WHO in collaboration with other international donors will conduct an operational cost effectiveness study on the advantages of different models of care focused on strengthening case holding by end 2013. 1.5 Consider prophylactic treatment for M/XDR-TB contacts Currently, there is no prophylactic treatment available for individuals who have been recently infected with/exposed to M/XDR-TB strains. Activity 1.5.1 WHO/Europe and partners will conduct a study on prophylactic treatment for M/XDR-TB contacts by end 2012. Activity 1.5.2 WHO/Europe in collaboration with other partners will put forward a set of recommendations for prophylactic treatment of M/XDR-TB contacts by mid 2013. Activity 1.5.3 Member States will introduce new recommendations on prophylactic treatment of M/XDR-TB contacts by beginning 2014. Key indicators and targets Less than 5% default rate for new cases, less than 8% for retreatment patient and less than 10% for MDR-TB cohorts. Percentage of patients who have missed more than 10% of their monthly treatment doses less than 5% for new patients, less than 8% for retreatment and less than 10% for M/XDR-TB patients Best practices Patient-centred approach used in Tomsk Oblast TB Program of Russia has been introduced with technical support from PIH and financing from GFATM in 2004. Various strategies to address TB and MDR-TB patients’ non-adherence resulted in the overall decrease of default rate from almost 28% to 8.9%. These strategies include enhanced social and psychological support during the whole duration of chemotherapy, development and introduction of various models of community-based treatment. The experience from Tomsk has been replicated in the neighbouring territories of Russia and Kazakhstan. 15 . 16 2. Scale up access to testing for resistance to first-line and second line anti-TB drugs and HIV testing among TB patients Despite improvement in coverage of mycobacteriological culture and drug susceptibility testing, only 34.2% of estimated MDR-TB patients were notified in 2009. The Member States need urgent investment in human resources, infrastructure and technology to scale up capacity and access to diagnose MDR-TB and monitor response to treatment. The Global Laboratory Initiative (GLI), under WHO guidance, has developed a Roadmap for TB Laboratory Strengthening aimed at ensuring quality TB diagnostics in appropriate laboratory services within the context of national laboratory strategic plans. WHO has developed a Policy Framework for Implementing TB Diagnostics to facilitate implementation at country level. The GLI, under WHO guidance, has developed a Laboratory Tool Set to standardise laboratory methods, including standard operating procedures, equipment specifications, guidelines for procurement of laboratory equipment and supplies, training packages for microscopy and culture, and a costing/budgeting tool to facilitate supply chain management and stock control at country level12. 2.1 Strengthen TB laboratory network Activity 2.1.2 WHO Regional Office for Europe to support the development of formal collaboration agreements between TB Supranational Reference Laboratory (SRL) Network and National TB Reference Laboratories (NRL) in the region. The collaboration agreements will form the basis for a strong partnership between SRLs and NRL for the development of medium and long term National TB Laboratory Strategic Plans for strengthening laboratory capacity for the diagnosis of MDR-TB and monitoring response to therapy in each of the 18 high TB priority countries by 2012 Activity 2.1.2 WHO Regional Office for Europe in collaboration with supranational reference laboratories to prepare a regional roadmap for expanded and accelerated quality assured new diagnostic technologies including Xpert MTB/RIF and TB laboratory network for diagnosis and treatment monitoring of TB by 2012 Activity 2.1.3 WHO and supranational TB reference laboratories in collaboration with national TB reference laboratories, develop a three year TB laboratory development plan for each of the 18 high TB priority countries by 2013 Activity 2.1.4 WHO Regional Office for Europe to support the Supranational Reference Laboratories in the provision of technical assistance to NRLs to help accelerated uptake of quality assured WHO diagnostic technologies through new and existing funding mechanisms including the EXPAND-TB project and Global Funds by 2012. Activity 2.1.5 WHO to support the TB Supranational Reference Laboratory Network to build human resource capacity through regular county visits to monitor the performance of laboratory networks and in the provision of technical assistance both in-country and through internships of one to two months in their supranational reference laboratories 12 These tools are available at http://www.stoptb.org/wg/gli and at http://www.who.int/tb/laboratory/policy/en . 17 Activity 2.1.6 Member States and donors prioritize funding for introduction of new techniques for diagnosis of M/XDR-TB including Xpert MTB/RIF Activity 2.1.7 Member States to ensure quality assurance schemes are in place for all levels of diagnostic testing in TB laboratory facilities which meet at least the minimum WHO biosafety requirements by 2013. Activity 2.1.8 All high TB priority countries ensure availability of Xpert MTB/RIF using national resources as well as GFATM, UNITAID and other funds from development and technical agencies including USAID. Best practices The EXPAND-TB project (EXPanding Access to New Diagnostics for TB) established in 2008 aims to accelerate uptake of new TB diagnostic technologies (commercial liquid culture systems, rapid speciation and molecular line probe assays, recently endorsed by WHO 1) into adequate laboratory services in 27 recipient countries (Figure X). Project partners include WHO, GLI, the Foundation for Innovative New Diagnostics (FIND)2 and the Stop TB Partnership’s Global Drug Facility (GDF)3, with funding provided by UNITAID and other donors. During the first 18 months of the EXPAND- project, a wide range of activities was initiated in 23 of the 27 recipient countries. These include laboratory needs assessment and gaps analyses, upgrades and renovation of laboratory infrastructure, training of staff, diagnostic policy reform and country validation of new technologies. In the European Region, this technology transfer has commenced in 8 MDR-TB priority countries including Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgzstan, Moldova, Tajikistan and Uzbekistan. The project will support countries the routine diagnosing MDR-TB patients and also pave the way for eventual routine surveillance of drug resistance. 2.2 Diagnostic counselling and testing for HIV of all TB patients Activity 2.2.1 Member States ensure personnel responsible for TB and M/XDR-TB are trained on HIV counselling and testing by 2012 Activity 2.2.2 Member States ensure HIV diagnostic counselling and testing are offered to all TB patients on provider initiated and opt-out basis by 2012. Activity 2.2.3 WHO and other partners provide technical assistance to high TB priority countries on collaborative TB/HIV activities based on a needs assessment on a continuous basis. Best practices one paragraph with reference from published source preferably 18 3. Scale up access to effective treatment for drug resistant TB Currently only one third of diagnosed M/XDR-TB patients are reported to have access to appropriate treatment in WHO European Region. Lack of appropriate treatment of MDR-TB patients, in addition to possible death and the burden on families and society, can lead to a spread of MDR-TB and eventual amplification and emergence of XDR-TB. 3.1 Ensure uninterrupted supply and rational use of quality medicines Activity 3.1.1 WHO and other partners provide reliable estimates of SLD needs in the region, and expansion trends by 2011. Activity 3.1.2 WHO to introduce to countries a generic indicator-based tool for conducting an ongoing drug utilization review as part of routine program performance monitoring by 2012. Activity 3.1.3 WHO and partners promote WHO Pre-qualification program mechanism as interim measure to ensure regional prequalification by 2012. Activity 3.1.4 WHO to assist countries in the development of legislation, procedures, and model standard bidding documents for the procurement of medicines, vaccines and medical supplies with an emphasis on quality assurance (with TB medicines specifications, by 2014) Activity 3.1.5 WHO and partners conduct gap analysis of pharmaceutical legislation and regulations and adapt for the region Stop TB Framework for adoption, introduction, and implementation of new technologies for tuberculosis control by 2012 (countries to develop country frameworks and plans by 2013) Activity 3.1.6 WHO and partners to engage countries in the WHO Good Governance for Medicines (GGM) program (five countries by 2014) Activity 3.1.7 Member States to expand use of fixed dose combinations where applicable. Activity 3.1.8 Member States ensure capacity building in procurement and supply management of anti-TB medicines at all levels of the healthcare system according to the best PSM practices and WHO recommendations by 2012 3.2 Management of adverse events Activity 3.2.1 WHO to develop a regional generic guide for managing and reporting side effects and adverse reactions by 2012 Activity 3.2.2 WHO to develop regional sources of unbiased drug information for prescribers and patients by 2013 Activity 3.2.3 Member States to ensure measures to screen and/or diagnosis and prevent or treat side effects are available for all TB patients by 2011. 19 3.3 Management of adverse events Activity 3.3.1 WHO to develop a regional generic guide for managing side effects and adverse reactions by 2012 Activity 3.3.2 WHO to develop regional guidelines for NTPs on reporting side effects and adverse reactions by 2012 Activity 3.3.3 Member States to ensure measures are available for screening and/or diagnosis; preventing or treating side effects for all TB patients by 2011. 3.4 Development of new medicines Activity 3.4.1 WHO/Europe in collaboration with StopTB partnership and Global TB Alliance and partners to develop a long-term regional strategy for the development of TB medicines market by 2012. Activity 3.4.2 WHO Europe and Member States to facilitate research and development of new medicines for TB on a continuous basis and report its progress at the annual Regional Committee meetings from 2012 onwards. 3.5 Scale up access to treatment Activity 3.5.1 WHO and partners, including WHO collaborating centers in close consultation with Member States to develop a joint technical assistance plan to Member States in reaching Universal Access to treatment (including treatment of children) by 2012. Activity 3.5.2 Member States ensure availability of resources for Universal Access to treatment by 2012 and report the progress during the Regional Committee meetings from 2012 onwards. Activity 3.5.3 Member States ensure that by 2012 their treatment guidelines are updated according to the latest available evidences and WHO recommendations. Activity 3.5.3 Member States procure and make available adequate quality medicines for TB and M/XDR-TB treatment under direct observation of treatment (DOT) by 2012. Activity 3.5.4 Member States ensure adequate training, coaching and support of health care staff for scale up of treatment of M/XDR-TB patients by 2011. Activity 3.5.5 WHO in collaboration with the Member States and other partners develop a set of evidence-based criteria for surgery for M/XDR-TB patients Activity 3.5.6 Member States ensure availability of surgery for eligible M/XDR-TB patients Best Practices Republic of Georgia launched its MDR-TB control project in 2007 with the Global Fund support. World Health Organization provided technical support in the framework of Green Light Committee mechanism. With high commitment of authorities, full engagement of highly motivated staff in the country and WHO continuous support, Georgia moved towards integrated programmatic management of drug resistant TB. Within a two year period of time, 20 the successful project was expanded nation-wide and the country reached universal access for MDR TB treatment. WHO/Europe along with other partners including KNCV Tuberculosis Foundation trained health care staff on MDR-TB management and provided advice and technical support in between the country visits. TB and MDR-TB clinical guidelines and operation manuals were updated. A regional training centre was established. Leadership of national TB control programme played a key role in empowering health care staff and involving them in each step of the decision making. This created a supportive environment. A well-planned and implemented advocacy activities as well as the involvement of the First Lady in the TB control made it possible to attract a high level attention to MDR TB and it became the priority for the Ministry of health as well as for the government as a whole. The Government fully funded the construction work of a new TB hospital with state of the art infection control measures. An outreach programme established to address the needs of special population. With technical support of supranational reference laboratory, WHO and Emory University, Georgia was among the first high MDR-TB burden countries in the region to put molecular diagnosis of MDR-TB into full operation. Since 2007, 1740 DR-TB patients were enrolled into treatment with quality second line drugs. In February 2011, 950 DR-TB patients were simultaneously under treatment. 21 4. Scale up TB infection control Importance of TB infection control can’t be overemphasized. Several European High Priority Countries have not yet finalized their national TB IC plans. Many inpatient and outpatient facilities dedicated to tuberculosis care in European High Priority Countries have poor infection control. Evidence of nosocomial transmission has been documented and risk of developing TB among health care staff is often multiple times higher than in the general population. The risk of TB transmission in congregate settings (such as penitentiary services) is even higher due to overcrowding and poor ventilation. In many Member States, health care workers are often not fully aware of airborne infection control measures. 4.1 Improve administrative and managerial aspects of TB-IC Activity 4.1.1 WHO and other partners provide technical assistance to Member States to finalize national TB-IC action plans integrated in their national TB strategic plans or national infection control or health strategies by end 2012. Activity 4.1.2 WHO and other partners develop a joint technical assistance plan to Member States to improve TB-IC by end 2012 including country visits, TB-IC risk assessments and training of staff. Activity 4.1.3 Member States introduce or strengthen surveillance of TB infection and disease among health-care workers by end 2012. Activity 4.1.4 Member States ensure all health care facilities serving TB or suspect TB patients have a sound infection control standard operating procedure by end 2013. Activity 4.1.5 Member States develop and disseminate educational messages and materials for patients and health-care workers by end 2011. Activity 4.1.6 Member States ensure contact tracing of TB patients for early diagnosis of infection and disease by end 2012. Activity 4.1.7 Member States include in-service and pre-service training of health care staff on TB infection control by 2012. 4.2 Strengthen environmental measures of TB-IC Activity 4.2.1 WHO and partners organize training of trainers on environmental measures, including engineering and facility design for airborne infection control by 2012. Activity 4.2.2 Member States conduct cascade training of responsible staff for environmental aspects of airborne infection control by 2013. 4.3 Ensure accessibility to personal protection measures Activity 4.3.1 WHO to share with the Member States procurement specifications for TBIC equipment. Activity 4.3.2 Member States ensure respiratory protection programmes are in place for TB and M/XDR-TB services by 2012. Best practices 22 Vladimir one paragraph with reference from published source preferably 23 5. Strengthen surveillance, including recording and reporting, of drug-resistant TB Since 1 January 2008, the WHO Regional Office for Europe and the European Centre for Disease Prevention and Control (ECDC) have jointly coordinated the collection of tuberculosis (TB) surveillance data in Europe. Their aim is to ensure a high quality of standardised TB data covering all 53 countries of the WHO European Region. While much information has been collected in many countries, available data for certain countries are still patchy and/or outdated. 5.1 Strengthen surveillance Activity 5.1.1 Member States to strengthen data collection for surveillance and monitoring of programme activities on a continuous basis. Activity 5.1.2 WHO to assist HPCs establish surveillance of drug resistant TB including second line medicines by 2013 Activity 5.1.3 WHO/Europe organize training and support surveillance staff and programme managers on minimum MDR-TB indicators13 5.2 Improve recording and reporting Activity 5.2.1 WHO/Europe and partners to develop further electronic tools for recording and reporting (R&R) including the use of modern techniques of data transmission (web, handheld devices and satellite) by 2012. Activity 5.2,2 WHO/Europe prepare a monitoring framework for follow-up of the Berlin declaration by 2012. Activity 5.2.3 WHO/Europe and partners to conduct training and coaching of national programme managers of HPCs in monitoring and evaluation and using data for improving programmes’ performance by 2012. Activity 5.2,4 In the context of scaling up of diagnostics and treatment, Member States ensure categorization of TB cases based on drug susceptibility testing to facilitate appropriate treatment and cohort reporting. Activity 5.2.5 WHO/Europe, ECDC and partners to include other country representatives and civil society representatives in national programme reviews to facilitate exchange of experience and transparency of programme evaluations by 2011. Activity 5.2,6 WHO/Europe in collaboration with partners to assist Member States in development of electronic systems to enhance R&R systems (e.g. use of open source solutions, "indicator dashboards") Activity 5.2,7 WHO and ECDC conduct coordination meeting of TB surveillance and meeting of country TB surveillance focal points on annual basis. 13 Multidrug-resistant tuberculosis (MDR-TB) Indicators. A minimum set of indicators for the programmatic management of MDR-TB in national tuberculosis control programmes. WHO/HTM/TB/2010.11. (whqlibdoc.who.int/hq/2010/WHO_HTM_TB_2010.11_eng.pdf) 24 Best practices: - Belarus, Bulgaria, Uzbekistan : conduction of recent DR surveys to quality recommendations - Georgia, Moldova Rep. of, Kazakhstan, Russian Fed (certain oblasts) : move towards routine drug resistance surveillance - Romania : second line drug resistance testing as part of anti-TB DRS - Armenia, Kazakhstan, Latvia, Turkey, Uzbekistan : reporting success for at least 55% among >50 MDR patients treated in 2007 - Ukraine since 2009 is implementing a comprehensive web-based management application for surveillance and reporting and recording TB and DR TB cases, diagnostic laboratory results, and TB medicines supply and utilization. 25 6. Expand country capacity to scale up the management of drugresistant TB including advocacy, partnership and policy guidance In order to use human and financial resources in an efficient manner, it is essential to ensure optimal management of TB control programme/interventions. There are huge opportunities of improving partnership and coordination and engaging national and international organizations including civil society in TB control. Care and management of patients who are not responding to any treatment has not been addressed in many settings. All high MDR-TB burden countries have finalized their summary MDR-TB response plan however these plans need to be updated, endorsed and implemented by the Member States. 6.1 Efficient programme management Activity 6.1.1 All high TB priority countries develop, endorse and start implementation of their National MDR-TB Response Plan by 2012 Activity 6.1.2 WHO/Europe assists high TB priority countries update and finalize their National MDR-TB Response Plan by end 2011. Activity 6.1.3 Member States to ensure external review of their national TB programme/intervention every three to five years led by WHO/Europe for a transparent and objective assessment of programmatic gaps. Activity 6.1.4 WHO in coordination with Member States to formalize the twinning of cities and TB and lung diseases programmes across the Region and facilitate collaboration and coordination among Member States by 2013 Activity 6.1.5 WHO/Europe develop and share a programmatic assessment check list for health authorities of Member States and advise Member States on measures to improve programmatic aspects of TB prevention, control and care by 2012 Activity 6.1.6 Member States ensure representatives of patients and/or communities affected by the disease are included in programme planning and assessment of quality of services by end 2012. Activity 6.1.7 WHO/Europe and WHO Country offices, in cooperation with partners, to provide operational guidelines for implementing the high level political statements into action and measure progress on a regular basis. Activity 6.1.8 WHO and other partners improve programme management capacity (both civilian and prison services) with modern training and coaching particularly on efficient use of resources, recording and reporting and applying new diagnostic and programme tools on a regular basis. Activity 6.1.9 Member States to ensure transparency in programme management with selection and recruitment of dynamic and competent staff on a continuous basis. Activity 6.1.10 Member States to use internet and other media to increase public awareness on TB and M/XDR-TB and availability of treatment from 2011 onwards. Activity 6.1.11 WHO/Europe analyze successful models of program management and draw recommendations to be included as criteria in the forthcoming “program certification” exercise by WHO including ISO 9001 certified project management standards by 2012. 26 Activity 6.1.12 Member States tie readiness of the health systems to uptake program implementation (to implement case holding) with GF financing Activity 6.1.13 WHO/Europe and key partners offer mentorship for poorly performing national TB control programmes from 2012 onwards Activity 6.1.14 Health authorities engage TB provider network and/or program in health system reform initiatives on a continuous basis. Activity 6.1.15 Member States to establish palliative care mechanism for M/XDR-TB patients who fail treatment by 2012. Best practices 6.2 Human Resources Development (HRD) Most Member States lack strategic HRD plans for TB and M/XDR-TB control. In order to effectively prevent and control M/XDR-TB there is a need to have motivated and trained staff who are protected against tuberculosis infection and are supported by a modern management mechanism. In some Member States, there is an uneven distribution of health care staff at different levels of service delivery. Most in-service training courses have not been based on practical needs or accompanied with on-the-job coaching to acquire knowledge and skills and practical application. Activity 6.2.1 Member States prepare and implement strategic plans for HRD for the implementation of all components of the Stop TB strategy (using the framework for HRD needs for scaling up management of DR-TB and the handbook “planning the development of human resources for health for implementation of the Stop TB Strategy”).. The strategic plans include the following elements: a. Policy: The need for policy changes to allow task shifting, creation of new cadres of staff, additional recruitment, special incentive packages for postings in rural and remote areas etc. Develop a standard set of terms of references for labs (I-III) level) with list of staff needed, competences, workload and core equipment b. Finance: Ensure donor coordination for use of funds for in service training. c. Education: Need to develop new competency based training programmes for all aspects of management of MDR-TB – clinical and managerial; need to coordinate current trainings by academic institutions with practical on the job training; need to revise SOPs for lab to enable revision of training programmes; need to revise basic training curricula for all cadres involved in TB control. Regional Centres of excellence: sustainability of training courses funded by external donors d. Leadership: collaboration and coordination between NTPs and HRH departments. e. Human resource management: revise/develop job descriptions, workload assessment; determine staff needs, supervision and monitoring. Activity 6.2.2 WHO/Europe and partners to establish and/or improve the capacity of existing centres of excellences WHO to establish accreditation of WHO collaborating centres by 2012 27 WHO and partners to provide technical assistance to centres of excellence and enable them to provide technical assistance to provinces and countries they are to support. Activity 6.2.3 WHO/Europe will finalize adaptation and translation of training modules developed by HQ “Management of drug-resistant tuberculosis. Training for MDR-TB referral centre staff” by end 2011 Activity 6.2.4 WHO/Europe to ensure virtual TB library and training materials in Russian are available and updated from 2011 onwards. 6.3 Policy Guidance Activity 6.3.1 Member States ensure they have adopted/adapted the latest available evidence in their national TB control policies by 2012. Activity 6.3.2 WHO in collaboration with partners to assist Member States in adopting/adapting international TB policies. Activity 6.3.3 Member States ensure the results of operational research and other studies are included in development of TB control policies on a continuous basis. 6.4 Partnership and Coordination Activity 6.4.1 Member States in HPC to establish national STOP TB Partnership to ensure due coordination and concerted action of all stakeholders including civil society, charities by 2013. This partnership should be given legal status in order for it to be effective and stimulate policy change (clarify the terms of reference and interaction mechanisms among Ministry of Health, professional medical associations, academia, NTP, WHO and other technical agencies in the TB control efforts) Activity 6.4.2 WHO and partners to assist Member States establish and strengthen their national StopTB Partnership. Activity 6.4.3 Member States ensure sound collaborative mechanisms for improved diagnosis and treatment of TB and M/XDR-TB patients in prison services, refugee camps or other relevant settings and a continuum of care and services between health services are in place by 2013. Activity 6.4.4 WHO/Europe using the successful model of Health in Prison Project14 assist Member States improve TB control in penitentiary services. Activity 6.4.5 WHO/Europe to establish a mechanism of coordination and collaboration among national and international partners including IUATLD, KNCV Tuberculosis Foundation, USAID funded projects, European Respiratory Society, ICRC; IFRC among others by 2012. Activity 6.4.6 Establish the role of different partners - technical and civil society -and formalize them if possible through MoU with MoH Best practices 14 HIPP website 28 one paragraph with reference from published source preferably 6.5 ACSM/Civil Society Involvement While the potential value of Advocacy, Communication and Social Mobilization (ACSM) is generally well understood by national TB programmes (NTPs), there is frequently a lack of capacity to implement ACSM activities. The first set of recommendations for enhancing TB action to confront the challenge of MDR-TB, therefore, relate to increasing the capacity of NTPs and their partners to implement ACSM action. NTPs should, with advice from WHO-Europe: Activity 6.5.1 Arrange for Knowledge, Attitude, Practice (KAP) Surveys and needs assessments with a focus on MDR to be undertaken – in each country or sub-national region to determine behaviour change objectives, target groups, advocacy needs, and foci for ACSM interventions. Target: Each MDR priority country that has not yet done so, will have arranged for and completed a KAP survey by the end of 2012. Activity 6.5.2 High TB priority countries to develop a national ACSM Strategy and Workplan if one does not yet exist, ensuring particular reference to the challenges of MDR-TB. It should be supportive of and incorporated within the overall national TB plan. If an ACSM Strategy already exists, it should be reviewed and amended to take account of the particular challenges of MDR-TB. The KAP survey results should feed into such strategies and indicate directions for priority action. Activity 6.5.3 High TB priority countries to review ACSM focal staff needs within the NTP in line with the ACSM workplan. Little action will take place without at least a small team of people with a mix of ACSM-related skills. Target: By mid 2013, each NTP in the MDR priority countries of the Region will have developed an ACSM Strategy and Workplan; and have reviewed NTP ACSM staff needs with a view to there being at least one staff member, and preferably a full team - possibly organised as a partnership with civil society organisations (CSOs) - with between them the skills and responsibility to stimulate and manage advocacy, communications and social mobilisation activities. Activity 6.5.4 Organise Training Workshops for CSO and NTP ACSM staff on MDR aspects of TB and consequential ACSM needs – at national and sub-national region levels. While the primary purpose of such training is to increase the number of people capable of undertaking ACSM activities, such events have the additional impact of being useful consultation opportunities in the development of ACSM strategies and in building co-operative 29 links between CSO and NTP staff. Resources and trainers for workshops are available through Stop TB Partnership Geneva (TBTEAM roster) and PATH. Target: That each country in the Region, if they have not already undertaken such training, shall have completed at least one ACSM Training Workshop by the end of 2012; and will have made arrangements for there to be a continuous rolling programme of such training throughout the period of this Plan. Activity 6.5.5 Identify and bring together for common planning of ACSM and MDR-TB activity, all CSOs with an interest in TB. This will certainly include HIV organisations but may well also mean many other agencies with social welfare and human rights aims, including professional associations of doctors, nurses, pharmacists, etc. Faith-based organisations (FBOs) should also be included; church and mosque-based initiatives can be very powerful. In larger countries, this process needs to be replicated at sub-national regional level (i.e. Oblasts, Provinces, Counties, etc). Activity 6.5.6 Especially support the development and engagement of patient advocates. Their personal experience of the disease is invaluable in getting messages across within the wider community, helping new patients understand what happens during treatment, helping healthcare staff understand the importance of patient-centred approaches, and acting as DOTS providers. The use in the HIV world of trained patients, known as ‘expert’ patients, is a helpful example. In former Soviet Union countries it may be helpful to ensure sustainability of patient engagement by including reference to them in the formal regulations (prikaz). Activity 6.5.7 WHO-Europe should facilitate the development of ACSM advisory materials appropriate to the Region and available in at least Russian and English as the main lingua franca. Advocacy: Activity 6.5.8 Member States develop national plans to explain M/XDR-TB and its dangers to decision-makers, notably politicians at national and sub-national levels, with the aim of initiating policy changes and sustaining political and financial commitment. These should be sustained over time, not just one-off events. Such programmes are likely to include formation of forums of parliamentarians to advocate for TB action. Members of Parliament willing to be ‘champions’ for TB action can be very helpful. The specific format for such fora will depend on the procedures of each national parliament. A good current example is the All Party Parliamentary Group on Global TB in the British Parliament. Sustained advocacy action will also require good information and data on TB and MDR realities in the country or area concerned, including operational research, surveillance and monitoring and evaluation. Communications: Using media in all its forms to inform, persuade and generate action among the whole population about TB; and to generate awareness of the challenge of M/XDR-TB and thus the importance of prevention, increased and speedy detection and completion of treatment. 30 Following KAP surveys, decide the sections of society to be targeted and develop messages to be used that will increase public understanding without raising undue fear. Then develop clear Work plans indicating who is going to do what in line with the country health communications strategy. Once messages, target audiences and knowledge of existing organized and interested groups are clear, develop appropriate campaigns with all stakeholders, making good use of media - Always aiming to move people from simple knowledge of TB to appropriate action such as self-referral for diagnosis if suggestive symptoms occur, and full completion of treatment even when it is a matter of years for MDR-TB. Activity 6.5.9 Member States train healthcare staff in patient-centred care and communication on a regular basis. Patients need to feel trust in and support from healthcare staff through the long period of M/XDR-TB treatment. Staff should develop appropriate interpersonal skills and attitudes. Experience of the International Council of Nurses TB initiative indicates that, once encouraged, nurses become enthusiastic participants in developing locally-appropriate approaches. Another useful tool is Interpersonal Communication and Counselling (IPCC) training. Activity 6.5.9 Member States develop materials such as roadside and health clinic posters to be widely used by 2013 [Beware: This is only one part of an ACSM strategy. There is too often a tendency to limit action just to this kind of informational work.] In messaging, avoid stigmatisation of and discrimination against vulnerable communities, such as injecting drug users, homeless and migrants. Individuals who believe there will be action against them if they present themselves with TB at a clinic, will not come forward for diagnosis and treatment, and thereby continue transmission. There are staff in Ministries of Health and in TB Dispensaries in former Soviet Union countries whose status under formal regulations (prikaz) include communications responsibilities which could be expanded to undertake TB health education communications activity. Social Mobilisation: Actively engage communities and affected individuals in the fight against TB and of MDR-TB, and also in speeding up detection and supporting patients through the long treatment periods, thus reducing the current high default rates in MDR-TB patients. Support, encourage, and link into national programmes both national and local CSOs, and also local community traditional networks such as the Makhalyas that exist in a number of central Asian countries. Activity 6.5.10 Member States with technical support of partners develop action plans based on the messages and target communities and areas identified by the KAP studies and mutual debate by 2013. Activity 6.5.11 Member States map the presence of CSOs at national, sub-national and local levels by seeking out organisations that are or might become TB-interested, and then reach out to build working relations with those that appear the most active and relevant. Activity 6.5.12 Member States assist local CSOs to work with their NTP in devising and implementing effective plans, and ensuring that in their own activities they act in alignment with NTP policies and priorities, for: 31 Engaging in planning, decision-making, implementation and monitoring and evaluation processes Working on the social determinants that increase vulnerability to TB such as poor quality housing, inadequate nutrition, drug and substance misuse, discrimination and unemployment. Increasing community awareness and mobilization of TB in general and MDR-TB in particular. Referring individuals with suspect symptoms to TB clinics for diagnosis. Providing social support to patients through the long months (commonly 2 years or more for MDR patients) of treatment. In the context of high default rates in MDR TB treatment, providing support to CSOs and health staff in the development of empowered patients who understand and accept the need to take treatment for two years or more. Close collaboration between welfare service provision including probation, rehabilitation and housing services and healthcare providers Improving skills throughout civil society with knowledge and information about TB, especially organisations working within communities at risk of TB. Activity 6.5.13 Member States Support and encourage creation of associations of current and past patients. Individuals with personal experience of the disease are especially effective at increasing awareness of TB and stimulating good practice within communities. Activity 6.5.14 Member States in collaboration with partners to assist with cross-border TB care, encourage creation of CSOs within migrant communities and support those that already exist. They can do much to help increase awareness of TB and knowledge of local health services so that symptomatic individuals appropriately self-refer. Activity 6.5.15 Member States to reach the hard-to-reach, especially those with difficult lifestyles such as alcoholics and injecting drug users, develop outreach programmes using patient activists, CSOs and community healthcare staff, as appropriate, to link with patients in their own social contexts and support them through both the diagnostic and treatment processes. Best practices A good current example is the Find and Treat programme in London, United Kingdom Find and Treat, London, United Kingdom www.findandtreat.com Metropolitan TB cannot be effectively controlled unless specific provision is made to find and treat the most vulnerable and socially excluded cases. The assumption that all patients will present promptly and complete treatment lasting a minimum of six months is no longer a basis for effective TB control [1]. Rates of TB continue to rise across London with one in six cases occurring among hard-to-reach groups; homeless people, problem drug and alcohol users and prisoners. These groups are at high risk of infectious drug resistant forms of TB, delayed presentation, onward transmission and death [2]. 32 Find&Treat was established in October 2007 by the UK Department of Health to implement the recommendations of the Health Protection Agency's evaluation of the Mobile X-ray Unit (MXU) [3] and strengthen TB control in London among hard-to-reach groups. A small multi-disciplinary health and social care team, working alongside trained recent patients with personal experience of tuberculosis and homelessness, links the 30 TB treatment centres in London with the most patients. Homelessness is recognised as an independent risk factor for MDR-TB. One third of active cases with which Find and Treat works are at least mono-resistant and 11% of these have MDR-TB. In the last three years, Find and Treat has been asked to trace over 225 active TB cases lost to mainline services, and has managed to find 75% of them and link them back into treatment. Find and Treat also screens almost 10,000 homeless people and drug users for TB every year, using the MXU van. For the past 6 years the MXU has consistently detected a pulmonary TB rate of 250 per 100,000; with such cases being significantly less likely to be infectious at diagnosis than comparable controls who present passively to mainline TB services. The multidisciplinary model of care that has been developed, spanning traditional administrative and geographic boundaries, and working with over 200 different government and civil society units, is now an essential component of TB control in London. 1. Story A, van Hest R, Hayward A. Tuberculosis and social exclusion. BMJ. 2006 Jul 8;333(7558):57-8. 2. Story A, Murad S, Roberts W, Verheyen M, Hayward AC; London Tuberculosis Nurses Network. Tuberculosis in London: the importance of homelessness, problem drug use and prison. Thorax. 2007 Aug;62(8):667-71. 3. Health Protection Agency 2007. Mobile targeted digital chest radiography in the control of tuberculosis among hard to reach groups - Key Findings: http://www.findandtreat.com/TB_Find_%26_Treat/How_we_find_files/MXU_Final%20 Evaluation_Report_November_2007.pdf (accessed 16 Feb 2011) 6.6 Ethics and human rights There are several opportunities identified where attention to human rights in TB care will also aid the scale up of effective MDR TB treatment.. Activity 6.6.1 WHO provide guidance to Member States in revising the frameworks for ethics and Human Rights for TB and other infectious diseases by 2012 Activity 6.6.2 Member States, WHO and partners to included ethics and human rights in academic curricula of TB/MDR-TB training for all health staff by 2014. Activity 6.6.3 Member States strengthen their capacity for palliative care for eligible M/XDR-TB patients by 2013. Activity 6.6.4 WHO and partners to conduct operational research on service models (needs of patients, cost and resources) for provision of palliative care by 2012 33 Activity 6.6.5 WHO to provide guidance to Member States for Palliative care including home based models by 2013 Activity 6.6.6 WHO in collaboration with partners to develop indicators for patient centred care by 2012 Activity 6.6.7 Member States to involve CSOs in performing client satisfaction assessments within TB services Activity 6.6.8 Member States to ensure mechanisms to hear complaints or to sanction when corruption or unethical practices are occurring by 2013 Activity 6.6.9 WHO to issue guidance for Member States to develop their frameworks for compassionate use of medicines by 2012 Activity 6.6.10 WHO and other partners to organize a regional conference on patientcantered care and human rights in TB and HIV Best practices one paragraph with reference from published source preferably 34 7. Address the needs of special populations WHO and other partners advocate for Universal Access to M/XDR-TB diagnosis and treatment including socially-disadvantaged populations like migrants, homeless, drug addicts, alcoholics among others. Countries should include actions for removing barriers to access health care for these population groups. 7.1 Improve collaborative TB/HIV activities Activity 7.1.1 Ministries of Health to establish functional TB/HIV coordinating bodies to facilitate the delivery of integrated TB, HIV (and drug use/narcology) services within the same facility, including in prisons. Activity 7.1.2 Ministries of Health of countries where there is no delivery of antiretroviral therapy in TB dispensaries and TB treatment in AIDS dispensaries to urgently develop directives to do so. Activity 7.1.3 All authorities of the Ministries of Health and Justice in the countries to expand access to evidence based harm reduction services, which include TB and HIV prevention, diagnosis and treatment services to people living with or at risk of HIV in the region, particular people who use or inject drugs. Activity 7.1.4 Scaling up of the provision of prophylactic treatment in all AIDS dispensaries as a core HIV care intervention in line with internationally recommended evidence based policies. Activity 7.1.5 Ministries of Health to ensure the availability of INH in AIDS dispensaries as part of HIV care intervention. Activity 7.1.6 NGOs working on TB or HIV in the region to embrace collaborative TB/HIV activities as their core business. Activity 7.1.7 National TB and HIV programmes and dispensaries to actively engage with civil society partners to improve access to integrated TB/HIV and where appropriate harm reduction services for the most at risk and vulnerable populations. Activity 7.1.8 WHO to document best practices and experiences on effective integration and service delivery models (i.e. “one-stop-shops” for TB/HIV/harm reduction services) Activity 7.1.9 WHO and other partners to support training and education of HIV and TB healthcare professionals. Activity 7.1.10 WHO and other partners to support revision of national TB/HIV policies. Best practices Collaborative TB/HIV activities are being implemented in Estonia such as HIV testing of TB patients and TB screening among people living with HIV, co-treatment with anti-TB drugs, antiretroviral therapy and opioid substitution therapy if indicated, information to patients and training of medical doctors. These resulted in earlier detection of both TB disease and HIV infection, decreased default rate among HIV-infected TB patients and increased TB awareness among people living with HIV. Meeting report “Accelerating the implementation of collaborative TB/HIV activities in the WHO European Region, 16-17 July 2010, Vienna, Austria World Health Organization, 2010. WHO/HTM/TB/2010.9 35 7.2 Strengthen MDR-TB control in prisons Activity 7.2.1 Early diagnosis and effective treatment of M/XDR-TB to be available in all penitentiary services across the region by 2014 Activity 7.2.2 Continuum of care to be ensured for released prisoners on TB treatment (85% of released prisoners while on TB treatment receive treatment in the civilian services) by 2014 7.3 Improve access for hard-to-reach population Activity 7.3.1 Member States will improve access to TB prevention, control and care for the hard-to-reach population, especially those with difficult lifestyles such as alcoholics and injecting drug users with developing outreach programmes. Activity 7.3.2 WHO/Europe and Member States establish a mechanism for cross-border TB control and care. Best practices one paragraph with reference from published source preferably 36 Annex I: References - - - - - - - Plan to stop TB in 18 high priority countries in WHO European Region 2007-2015 Berlin declaration October 2007 Multidrug and extensively drug resistant TB (M/XDR-TB) 2010 global report on surveillance & response WHO Global Code of Practice on the International Recruitment of Health Personnel; 21-05-2010 WHA 63.16 Euro Observer capacity planning in health care: reviewing the international experience spring 2007, volume 9 number 1 Stefanie Ettelt and all Classifying health workers, WHO Geneva Assessing future health workforce needs; Gilles Dussault and all (policy summary prepared for the Belgian EU presidency Conference on investing in Europe’s health workforce of tomorrow 9-10 September 2010 Quality and accreditation in Health Care Services; a global review WHO 2003 Working together for Health; WHO report 2006 Handbook “planning the development of human resources for health for implementation of the Stop TB Strategy Report from the meeting: “Accelerating the implementation of collaborative TB/HIV activities in the WHO European Region”, July 2010, Vienna http://www.stoptb.org/wg/tb_hiv/assets/documents/euro_meeting%20report.pdf Report of the 16th TB/HIV Core Group meeting, May 2010, Almaty, Kazakhstan http://www.stoptb.org/wg/tb_hiv/assets/documents/Final%20Report16CG%20meeting.pdf WHO, UNODC, UNAIDS: Technical guide for countries to set targets for universal access to prevention, treatment and care for injecting drug users; 2009, World Health Organization http://www.who.int/hiv/pub/idu/targetsetting/en/index.html WHO, UNODC, UNAIDS: Policy guidelines for collaborative TB/HIV services for injecting and other drug users; 2008 http://whqlibdoc.who.int/publications/2008/9789241596930_eng.pdf Keshavjee S, Gelmanova IY, Pasechnikov AD, et al. Treating multidrug-resistant tuberculosis in Tomsk, Russia: developing programs that address the linkage between poverty and disease. Ann N Y Acad Sci 2008; 1136: 1-11. Keshavjee S, Farmer PE. Time to put boots on the ground: making universal access to MDR-TB treatment a reality. Int J Tuberc Lung Dis 2010; 14: 1222-1225. http://www.who.int/management/partnerships/en/ http://www.stoptb.org/assets/documents/countries/partnerships/power_of_partnerships.pdf http://www.stoptb.org/assets/documents/countries/partnerships/national_partnerships.pdf http://www.thepartneringinitiative.org/ World Health Organization. Policy Framework for Implementing New Tuberculosis Diagnostics, 2010. Available at: http://www.who.int/tb/dots/laboratory/policy/en/print.html). World Health Organization. Use of Liquid TB Culture and Drug Susceptibility Testing in Low- and Medium-income Settings, 2007. Available at: http://www.who.int/tb/dots/laboratory/policy/en/print.html). World Health Organization. Policy Guidance on Drug Susceptibility Testing (DST) of Second-line Antituberculosis Drugs. Geneva, WHO, 2008 (WHO/HTM/TB/2008.392. Available at: http://www.who.int/tb/dots/laboratory/policy/en/print.html) World Health Organization. Policy Framework for Implementing New Tuberculosis Diagnostics, 2010. Available at: http://www.who.int/tb/dots/laboratory/policy/en/print.html). World Health Organization. Use of Liquid TB Culture and Drug Susceptibility Testing in Low- and Medium-income Settings, 2007. Available at: http://www.who.int/tb/dots/laboratory/policy/en/print.html). World Health Organization. Policy Guidance on Drug Susceptibility Testing (DST) of Second-line Antituberculosis Drugs. Geneva, WHO, 2008 (WHO/HTM/TB/2008.392. Available at: http://www.who.int/tb/dots/laboratory/policy/en/print.html). Good Governance for Medicines. WHO Progress Report 2010 37 - - New Technologies for Tuberculosis Control: A Framework for their Adoption, Introduction and Implementation. “WHO/HTM/STB/2007.40”. Supporting Pharmacovigilance in Developing Countries: The Systems Perspective. Strengthening Pharmaceutical Systems (SPS). Submitted to the U.S. agency for international Development by the SPS Program. Arlington, VA: Management Sciences for Health. Global Fund Quality Assurance Policy for Pharmaceutical Products (as amended on 10 November 2009) Managing Pharmaceuticals and Commodities for Tuberculosis: A Guide for National Tuberculosis Programs. Rational Pharmaceutical Management Plus. 2008. Submitted to the U.S. Agency for International Development by the Rational Pharmaceutical Management Plus Program. Arlington, VA: Management Sciences for Health Acknowledgements The following individuals have contributed to development of the current document. Daniel Chemtob, Smiljka de Lussigny, Gunta Dravniece, Philipp Ducros, Dennis Falzon, Chris Gilpin, Peter Gondrie, Alejandra Gonzalez, Malgorzata Grzemska, Einar Heldal, Sven Hoffner, Barbara Huaer, Ineke Huitema, Sandra Irbe, Aziz Jafarov, Andrei Maryandyshev, Andrei Mosneaga, Olexandr Polishchuk, Paul Sommerfeld, Soren Thybo, Wim Vandevelde, Gulnoz Uzakova, Askar Yedilbayev and Andre Zagorsky. 38