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Tuberculosis is completely curable through short-course chemotherapy. Treating TB cases who are sputum-smear
positive (and who can therefore spread the disease to others) at the source, it is the most effective means of
eliminating TB from a population.
DOTS or Directly Observed Treatment Short course is the internationally recommended strategy for TB control that
has been recognized as a highly efficient and cost-effective strategy. DOTS comprises five components:
The new global Stop TB Strategy builds on the DOTS strategy, which remains the fundamental basis for TB control.
The six additional essential elements in the new strategy are:
1. Sustaining, improving and accelerating quality DOTS expansion
2. Addressing TB-HIV, MDR-TB and other special challenges
TB/HIV collaborative interventions
DOTS-Plus for MDR-TB
LHIL/JP Zellweger
DOTS remains at the heart of the Stop TB Strategy. To enable known constraints to be addressed and new
challenges met, further strengthening of the basic five components of the DOTS approach is required.
2
Guidelines
for the programmatic management of drug-resistant tuberculosis
Various languages
Treatment services
The mainstay of TB control is organizing and administering standardized treatment across the country for all adult
and paediatric TB cases – sputum smear-positive, smear-negative, and extrapulmonary. In all cases, WHO
guidelines on patient categorization and management should be followed.1 These guidelines emphasize use of the
most effective standardized, short-course regimens, and of fixed-dose drug combinations (FDCs) to facilitate
adherence to treatment and to reduce the risk of the development of drug resistance. Separate WHO guidelines are
also available for management of patients with drug-resistant TB.2
Supervision and patient support
Services for TB care should identify and address factors that may make patients interrupt or stop treatment.
Supervised treatment, which may have to include direct observation of therapy (DOT), helps patients to take their
drugs regularly and complete treatment, thus achieving cure and preventing the development of drug resistance.
Supervision must be carried out in a context-specific and patient-sensitive manner, and is meant to ensure adherence
on the part both of providers (in giving proper care and support) and of patients (in taking regular treatment).
Depending on the local conditions, supervision may be undertaken at a health facility, in the workplace, in the
community or at home. It should be provided by a treatment partner or treatment supporter who is acceptable to the
patient and is trained and supervised by health services. Patient and peer support groups can help to promote
adherence to treatment. Selected patient groups, for example prisoners, drug users, and some people with mental
health disorders, may need intensive support including DOT.
Improving access to treatment
Locally appropriate measures should be undertaken to identify and address physical, financial, social and cultural
barriers – as well as health system – barriers to accessing TB treatment services. Particular attention should be given
to the poorest and most vulnerable population groups. Examples of actions that may be appropriate include
expanding treatment outlets in the poorest rural and urban settings, involving providers who practise close to where
patients live, ensuring that services are free or heavily subsidized, offering psychological and legal support,
addressing gender issues, improving staff attitudes, and undertaking advocacy and communication activities.
Pursue high-quality DOTS expansion and enhancement
Element 4: An effective drug supply and management system
RELATED DOCUMENTS
1
4 million treatments in
4 years. Achievement report [pdf 416kb]
What is DOTS?
Global Drug Facility (GDF)
Green Light Committee (GLC) Initiative
An uninterrupted and sustained supply of quality-assured anti-TB drugs is fundamental to TB control. For this
purpose, an effective drug supply and management system is essential. A reliable system of procurement and
distribution of all essential anti-TB drugs to all relevant health facilities should be in place. The TB recording and
reporting system is designed to provide the information needed to plan, procure, distribute and maintain adequate
stocks of drugs.
Anti-TB drugs should be available free of charge to all TB patients, both because many patients are poor and may
find them difficult to afford, and because treatment has benefits that extend to society as a whole (cure prevents
transmission to others). Legislation related to drug regulation should be in place, and use of anti-TB drugs by all
providers should be strictly monitored. The use of FDCs of proven bioavailability and of innovative packaging such
as patient kits can help to improve drug supply logistics as well as drug administration, promote adherence to
treatment and prevent development of drug resistance.
The Stop TB Partnership's Global Drug Facility and the Green Light Committeeoffer countries with limited capacity
the benefit of access to quality-assured TB drugs at reduced prices and also facilitate access to training on drug
management.1
Pursue high-quality DOTS expansion and enhancement
Element 5: Monitoring and evaluation system, and impact measurement
Recording and reporting system
Establishing a reliable monitoring and evaluation system with regular communication between the central and
peripheral levels of the health system is vital. This requires standardized recording of individual patient data,
including information on treatment outcomes, which are then used to compile quarterly treatment outcomes in
cohorts of patients.
These data, when compiled and analysed, can be used at the facility level to monitor treatment outcomes, at the
district level to identify local problems as they arise, at provincial or national level to ensure consistently high-
quality TB control across geographical areas, and nationally and internationally to evaluate the performance of each
country. Regular programme supervision should be carried out to verify the quality of information and to address
performance problems.
Enhanced recording and reporting
Both developed and developing countries now have additional diagnostic information at their disposal, including
sputum culture, DST and HIV test results, all of which can be used to guide patient management. TB programme
managers also need to monitor records and reports from public and private care providers not directly linked to the
national TB programme (NTP). Special attention must be paid to ensuring the confidentiality of patient information.
Use of electronic recording systems will be considered where appropriate.
Making the best use of data at all levels will mean many countries having to train staff in the analysis and
interpretation of data, as well as in the use of the computer software that can greatly facilitate this work. As
electronic recording systems become more widely available, consideration should be given to storing individual
patient data, which will make more detailed analyses of aggregated data possible.
WHO's report on Global TB Control compiles data from 200 countries each year, monitoring the scale and direction
of TB epidemics, implementation and impact of the Stop TB Strategy, and progress towards the Millennium
Development Goals.
TB impact measurement
TB impact measurement has two major components. The first is measuring the epidemiological burden of TB, and
trends in this burden, in terms of three so-called "impact indicators": incidence (the number of newly-arising cases
of TB each year), prevalence (the number of cases of TB in the population at a given point in time) and mortality
(the number of deaths from TB in a given year). These are the major indicators being used to measure progress in
TB control at global level, for example in the context of targets set within the Millennium Development Goals
(MDGs) and by WHO and the Stop TB Partnership. The second major component of TB impact measurement is
evaluation of the extent to which interventions to control TB are responsible for changes in incidence, prevalence
and mortality (so-called "impact evaluation").
WHO has established the Global Task Force on TB Impact Measurement.
Ethical issues in tuberculosis care and control
Background
Tuberculosis (TB) prevention, care and control raise important ethical and policy issues that need to be adequately
addressed. These concerns have been accentuated by the problem of multidrug-resistant TB (MDR-TB) and, most
recently, by the emergence and spread of “extensively” drug-resistant TB (XDR-TB) which is especially difficult to
detect and treat.
Following the recommendation of the WHO Task Force on XDR-TB at their 2nd meeting (April 2008), the Ethics
and Health Team of the Department of Ethics, Equity, Trade and Human Rights and the Stop TB Department jointly
established aWHO Task Force on Addressing Ethical Issues in TB Care and Control Programmes in August
2008.
Goal
The aim was to undertake a comprehensive analysis of ethical issues in TB and to lay the groundwork for the
formulation of WHO guidance in order to help governments and other stakeholders to implement TB care and
control programmes in an ethical manner.
Composition of the Task Force
Twenty-two members from a variety of fields, including national TB programmes, civil society, ethics, human
rights, and health law.
Major issues
Discussion papers on the following topics were commissioned:
1. Access to diagnosis and treatment;
2. Obligations and rights of health care workers and patients;
3. Public health measures; and
4. Research.
Development of WHO guidance
The Task Force held its first meeting 8-10 December 2008 at the Joint Center for Bioethics at the University of
Toronto, a WHO Collaborating Center for Bioethics. During the meeting, members discussed the background papers
prepared for the meeting and the main points to be included in the global guidance document.
A second meeting of the Task Force was held 26-28 August 2009 at WHO in Geneva. The goal was to draft an
outline for the WHO guidance document.
On 15 October 2009, a consultation with additional representatives of civil society and national TB programmes
took place in Geneva. The goal was to discuss the outline of the guidance document and to ensure further input and
participation of civil society, national TB programme managers, policy-makers, and field workers.
Currently, the draft WHO document, entitled "Ethical guidance for TB Care and Control Programmes" is being
finalized by the Secretariat and Task Force.
The draft document was presented at the STB department's Strategic and Technical Advisory Group for
Tuberculosis (STAG-TB) in November 2009 and at the 40th Union World Conference on Lung Health in December
2010 in order to receive final input.
In addition, the draft document will be shared with other key stakeholders for comment in order to engage a full
range of end users to ensure the practical interpretation, adaptability and use of the guidance document.
The final guidance document was published in December 2010.
Planned activities for 2011
The development of case studies is planned in order to give concrete examples of ethical dilemmas that decision-
makers face in TB policies and programmes, and to illustrate some of the challenges and solutions proposed in the
guidance document.
Training materials for ethics and TB will be developed and used in workshops for programme managers and other
stakeholders in order to build capacity at the local level.