European Union Standards for Tuberculosis Care

Joint meeting of Wolfheze Workshops, ERLN-TB, ECDC/WHO European Tuberculosis Surveillance Network

Dr. Andreas Sandgren, Expert in Tuberculosis European Centre for Disease Prevention and Control

The Hague, The Netherlands, 29 May 2013

Progressing towards TB elimination

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Fin

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EU/EEA 2011

14.2/100,000

Tuberculosis Coalition for Technical Assistance. International Standards for Tuberculosis Care (ISTC). The Hague: Tuberculosis Coalition for Technical Assistance, 2006

Tuberculosis Coalition for Technical Assistance. International Standards for Tuberculosis Care (ISTC), 2nd ed. The Hague: Tuberculosis Coalition for Technical Assistance, 2009

Existing International Standards

The International Standards focus on high-burden low-income settings.

In the EU:

Burden is low/intermediate but heterogeneous

Long tradition of TB prevention and control

Resources are available

Need to assure optimal use of these resources

TB services integrated within the health system

Every patient’s right to have access to best possible care.

Why EU-adapted standards?

Higher standards needed to progress towards elimination in the EU-setting

ECDC/TBNET survey on case management

• Using a standardised and comprehensive survey tool developed to evaluate TB case management in the EU

• Management activities according to guidelines

- Part 1: features of the site (62 items)

- Part 2: individual patient record (141 items)

- Part 3: individual vs. standard (25 scored questions)

• Review of 40 patient records per site (30 MDR)

• Performed in 5 EU countries

Inadequate TB regimen choice (4 active drugs

ensured), no. (%) 20/200 (10)

Inadequate dosage, no. (%) 13/200 (6.5)

Inadequate duration, no. (%) 34/200 (17)

Ineffective management adverse events TB

treatment, no. (%) 1/200 (0.5)

ECDC/TBNET survey: Deviations identified

Component 3: Treatment

• Evidence for the need and added-value of developing EU-adapted standards.

• Gaps in TB case management are evident even in high resource settings and in MDR-TB reference centres.

• Progress towards further TB control and ultimately elimination in low/intermediate incidence settings requires adherence to the highest standards.

Conclusions of ECDC/TBNET survey

Rationale for ESTC

Panel of 30 experts including:

• ERS experts

• ECDC experts

• Country representatives (EU and non-EU)

• International societies

• Civil society representatives

• International organisations

Involved in the process

• ISTC document

• ECDC survey on TB/MDR-TB case management in the EU/EEA

• ERS TB management guidelines

• Full series of Wolfheze policy documents

• Non-systematic review of the evidence (original articles and systematic reviews included in the ISTC document and those published after the ISTC 2nd Edition)

Documents used as framework for ESTC

Responsibilities

• ERS has taken the lead to develop the clinically related standards.

• ECDC has responsibility for the public health standards.

Process for developing ESTC

Opinions

• Delphi process

• Literature synopsis scoring

Concept

• Standards conceptualized into four sections

• Complete draft by ESTC core group

Draft & Finalize

• Draft circulated for two rounds of review by international group of experts

• Supporting enablers added to complement the standards

Launch

• Endorsement: ERS scientific committee and ECDC Advisory Forum

• Publication in ERJ 1 April 2012

The ESTC is a “living document”

A total of 21 EU Standards for TB Care

Standards for TB diagnosis

Standards for TB treatment

Standards for addressing HIV infection and comorbid conditions

Standards for public health and TB prevention

• ISTC is valid

• ISTC is valid with EU-adapted supplement

• ESTC replaces ISTC

ESTC 2 (replaces ISTC 2) All patients (adults, adolescents, and children who are capable of producing sputum) suspected of having pulmonary TB should have at least two sputum specimens submitted for microscopic examination, culture and DST in a quality-assured laboratory. When possible, at least one early morning specimen should be obtained. In countries, settings or populations in which MDR TB is suspected in a patient, rapid testing for the identification of RIF and INH resistance should be performed, using validated tools in a quality-assured laboratory.

Standards for TB diagnosis

ESTC 8 (with EU-adapted supplement)

Standards for TB treatment

All patients who have not been previously treated and without any risk factors for drug resistance should receive an internationally accepted first-line treatment regimen using drugs of known bioavailability. […] (2HRZE/4HR).

EU-adapted supplement

The selection of standardised regimens should be performed according to international recommendations in centres having the necessary expertise, as defined by at the national level.

Based on confirmed DST results, treatment must be adapted according to the DST pattern.

Ideally, MDR TB should be excluded in all TB cases. Retreatment cases should be managed according to the individual risk of MDR TB until it has been excluded.

ESTC 16 (with EU-adapted supplement)

Standards for addressing HIV infection and comorbid conditions

Persons with HIV infection who, after careful evaluation, have a positive test for presumed latent infection with M. tuberculosis (TST and/or IGRA), but do not have active TB, should be treated with INH for 6-9 months or any new regimen for which evidence becomes available.

EU-adapted supplement

HIV-seropositve persons who have been in contact with a case with MDR-TB should undergo strict regular clinical follow-up. The standard should also be applicable for persons with comorbidities or on treatments that increase the risk for TB reactivation (TNF-antagonists, cancer chemotherapy, diabetes, high dose corticosteroids).

ESTC 20 (with EU-adapted supplement) Each healthcare facility caring for patients who have, or are suspected of having infectious TB, should develop and implement an appropriate TB infection control plan.

EU-adapted supplement

Smear-positive TB patients should ideally be isolated in appropriate rooms until they achieve bacteriological conversion. Patients suspected of having TB (if feasible) and MDR TB (strongly recommended) should be isolated in negative-pressure ventilation rooms.

With regard to the need of isolating infectious TB patients, it is important to consider several options for isolation, and not only that of hospitalisation.

Standards for public health and TB prevention

Acknowledgement ERS (chair of the ERS Scientific Committee, Head of the Respiratory Infections Assembly, Chair of 10.2 (TB), ERS Vice-President, ERS Guidelines Coordinator and ERJ Editor)

ECDC Advisory Forum

Country representatives: Belgium, Denmark, Estonia, Germany, Italy, Latvia, the Netherlands, Portugal, Romania, Spain, Switzerland, the United Kingdom and USA

American Thoracic Society

WHO HQ & EURO

IUATLD Europe Region

KNCV