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               (EXTENSIVE VERSION)
                              DRAFT V.5 MARCH 2011

                                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 2011-
2015 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.

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.37
   Annex II: References ............................................................................................................. 37

Acronyms and abbreviations
ACSM          Advocacy, Communication and Social Mobilization
AIDS          Acquired Immuno-deficiency Syndrome
BCG           Bacille Calmette Guérin (Tuberculosis vaccine)
CSO           Civil Society Organization
DOT           Directly Observed Treatment
DOTS          The WHO-recommended essential strategy for TB control
EEA           European Economic Area
EU            European Union
EQA           External Quality Assurance
GLC           Green Light Committee
GFATM         GFATM, Global Fund for AIDS, Tuberculosis and Malaria
GDF           Global Drug Facility (for Tuberculosis Programmes)
HIV           Human Immunodeficiency Virus
HPC           High (TB) Priority Countries
HRD           Human Resources Development
HRH           Human Resources for Health
IUATLD        International Union Against TB and Lung Diseases
MDR-TB        Multi Drug Resistant Tuberculosis (resistance to at least isoniazid and
              Rifampicin, the two most effective drugs available)
MDR HBC       MDR high burden country, incidence > 4000 cases or >10% of the new
              TB cases with MDR.
MOH           Ministry of Health
MOJ           Ministry of Justice
NGO           Non-Governmental Organization
NTP           National Tuberculosis Programme
PHC           Primary health care
PMDT          Programmatic Management of Drug-resistant Tuberculosis
PSM           Procurement and supply management
SLD           Second line anti-TB drugs
SNRL          Supra-national Tuberculosis Reference Laboratory
WHO           World Health Organization
XDR-TB        MDR-TB resistant also to a fluoroquinolone and a second line injectable

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.

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 2011-
2015 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/XDR-
TB 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)

        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 (XDR-
TB). 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 non-
EU/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.

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

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             Estimated MDR-TB             Reported MDR-TB
                              annual incidence          among new TB cases (%)              in 2009

Armenia                          480 (380-580)                 9.4 (7.3-12.1)                   156
Azerbaijan                    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
Republic of Moldova           2,100 (1,700-2,400)            19.4 (16.8-22.2)                  1069
Russian Federation          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

   Estimated annual incidence over 4000 MDR-TB cases and/or at least 10% newly registered cases with MDR-
    TB. 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
     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.

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 MDR-
             TB 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
 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.

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

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 MDR-
           TB 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
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

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

Regional SWOT analysis in relation to M/XDR-TB

  -   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/XDR-
  -   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
  -   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

  -   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
  -   External quality assurance of culture and DST has not yet covered all patients
-   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
-   Poor coordination among TB and other programmes for collaborative activities (HIV,
    alcohol, drug users and tobacco and other communicable and non communicable
-   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
-   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 (socio-
    economic 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-the-
    counter 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

  -   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

  -   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
  -   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

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
     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
      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.

   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
     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.


     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 and at .

      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
      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
       Best practices
       one paragraph with reference from published source preferably

   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
      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
    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.

   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
     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

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,

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
       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.

   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 TB-
IC 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
one paragraph with reference from published source preferably

     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, hand-
held 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.

  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.
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.

   6. Expand country capacity to scale up the management of drug-
      resistant TB including advocacy, partnership and policy
      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.
     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
          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
          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
         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

     HIPP website
       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

   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

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.

     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.

     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.

   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:
    Engaging in planning, decision-making, implementation and monitoring and evaluation
    Working on the social determinants that increase vulnerability to TB such as poor
     quality housing, inadequate nutrition, drug and substance misuse, discrimination and
    Increasing community awareness and mobilization of TB in general and MDR-TB in
    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

Best practices
A good current example is the Find and Treat programme in London, United Kingdom Find
and Treat, London, United Kingdom

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
These groups are at high risk of infectious drug resistant forms of TB, delayed presentation,
onward transmission and death [2].

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

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:
 (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

     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 patient-
cantered care and human rights in TB and HIV

       Best practices
       one paragraph with reference from published source preferably

   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

   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

   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

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
  -   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
  -   Report from the meeting: “Accelerating the implementation of collaborative TB/HIV activities in the
      WHO European Region”, July 2010, Vienna
  -   Report of the 16th TB/HIV Core Group meeting, May 2010, Almaty, Kazakhstan
  -   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
  -   WHO, UNODC, UNAIDS: Policy guidelines for collaborative TB/HIV services for injecting and other drug
      users; 2008
  -   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.
  -   World Health Organization. Policy Framework for Implementing New Tuberculosis Diagnostics, 2010.
      Available at:
  -   World Health Organization. Use of Liquid TB Culture and Drug Susceptibility Testing in Low- and
      Medium-income                     Settings,              2007.              Available              at:
  -   World Health Organization. Policy Guidance on Drug Susceptibility Testing (DST) of Second-line Anti-
      tuberculosis     Drugs.      Geneva,     WHO,     2008      (WHO/HTM/TB/2008.392.      Available   at:
  -   World Health Organization. Policy Framework for Implementing New Tuberculosis Diagnostics, 2010.
  -   Available at:
  -   World Health Organization. Use of Liquid TB Culture and Drug Susceptibility Testing in Low- and
      Medium-income                     Settings,              2007.              Available              at:
  -   World Health Organization. Policy Guidance on Drug Susceptibility Testing (DST) of Second-line Anti-
      tuberculosis     Drugs.      Geneva,     WHO,     2008     (WHO/HTM/TB/2008.392.       Available   at:
  -   Good Governance for Medicines. WHO Progress Report 2010

   -   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


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.


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