TB Along the US/Mexico Border El Paso, Texas

August 22-23, 2007

International Standards for Tuberculosis Care

Barbara J. Seaworth, MD August 22, 2007

Barbara J Seaworth MD Medical Director Heartland National TB Center

El Paso, Texas August 22 – 23, 2007

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Organizations Responsible for ISTC

Why do we need a new document ? There are many guidelines, recommendations, and

manuals, but • few, if any, focus on TB care rather than control; • none are supported by a broad international

consensus; • most present the “how” of TB control rather than

the “why” (evidence base is lacking); • most are viewed as “government documents” and,

therefore not relevant to the private sector; • none can serve as the focus of a global campaign

to improve TB care and control globally through effective private sector involvement.

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ISTC; Focus of a Global Campaign • Intended to unite public and private sectors in

providing a uniformly accepted level of care forall patients with, or suspected of having, TB;

• Describes the essential elements of TB care that should be available everywhere;

• Provides a vehicle for mobilizing professionalsocieties globally in support of TB programs

• Serves as a powerful advocacy tool to ensurethat the essential elements are available;

• Serves as support for “The Patients’ Charter for Tuberculosis Care” that defines patients’ rights and responsibilities globally.

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The New Global Strategy to Stop TB

ISTC: Development Process • Funded (Oct 1, 2004) by USAID via TBCTA • Steering Committee: 28 members / 14 countries • Co chairs: Mario Raviglione (WHO) and Phil Hopewell

(ATS) • Process coordinated by ATS • Evidence-based with six systematic reviews. • Ten drafts prior to final • Final document December 2005 • Patients’ Charter for Tuberculosis Care developed in

tandem with ISTC • Launch on World TB Day (Mar 24) 2006

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J.W. Lee, Director General, World Health Organization: March 24, 2006

ISTC Steering Committee Selected to provide perspectives, not to

represent organizations Nursing Technical agencies Pediatrics MDR Tb Patients TB/HIV Private sector HIV care providers Medical students Laboratories NTPs Academic medicine NGOs WHO Professional societies Clinicians

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ISTC: Basic Philosophy

The ISTC focuses on the contribution that good clinical care of individual patients and public-private collaborations make to TB control. A balanced approach emphasizing both patient care and public health is essential to reduce the suffering and economic losses from TB.

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Introduction

Introduction: Key Points • Purpose: to describe a widely accepted level of

care that all practitioners should seek to achievein managing all patients

• Audience: all health care practitioners, publicand private

• Scope: diagnosis, treatment, and public health responsibilities; intended to complement local andnational guidelines

• Rationale: failure to reach goals in part relates tothe failure to effectively engage all providers inproviding high quality care and in collaboratingwith TB control programs

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Standards for Diagnosis

Diagnosis: Key Points

• Describes need for examination of patientswith cough for 2-3 weeks or more

• Emphasizes requirement for microbiologicalevaluation for suspected pulmonary andextra pulmonary sites; de-emphasizesradiography as a tool for diagnosis

• Describes a rigorous approach to diagnosisof smear negative tuberculosis (includingchildren)

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Standards for Diagnosis • Standard 1: All persons with otherwise

unexplained productive cough lasting> 2 – 3 weeks should be evaluated for TB

• Standard 2: All patients suspected ofhaving pulmonary TB should have at least 2, preferably 3 sputums for microscopic exam. If possible one early am sputum

• Standard 3: All patients suspected ofhaving extrapulmonary TB, appropriatespecimens from suspected sites should beobtained for microscopy and if possibleculture and pathology

Standards for Diagnosis

• Standard 4: All persons with CXR findings suggestive of TB should have sputumsubmitted for microbiological examination

• Standard 5: The diagnosis of sputumsmear negative pulmonary TB should bebased on: – At least 3 negative sputum smears (one early am) – CXR consistent with TB – Lack of response to trial of broad-spectrum antibiotics

(not Fluoroquinolones)

..if facilities for culture exist, should be done

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Standards for Diagnosis • Standard 6: Diagnosis of intrathoracic

(pulmonary, pleural, and mediastinal or hilarlymph node) TB in symptomatic childrenwith negative sputum smears should bebased: – on finding of CXR abnormalities consistent with TB – and either a history of exposure to an infectious case or

evidence of TB infection (+ TST or GIRA)

• …if facilities for culture exist, sputumspecimens should be obtained – expectoration, gastric washings or induced

Standards for Treatment

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Treatment: Key points • Emphasizes public health responsibility: prescribe

regimen, assess adherence, and address poor adherence

• Use of internationally accepted regimen(s)

• Focuses on a mutually acceptable patient-centered approach tailored to patient’s circumstances

• Describes need for recording and monitoring of treatment

• Presents indications for HIV testing of TB patients and for ARV treatment

• Presents situations in which DST is indicated and describes regimens

Standards for Treatment

• Standard 7: Any practitioner treating apatient for TB is assuming and important public health responsibility, therefore: – Prescribe appropriate regimen – Be capable of assessing the adherence of patient – Be capable of addressing poor adherence

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Standards for Treatment • Standard 8: All patients who have not

been treated previously should receive aninternationally accepted 1st line treatment regimen:

• using drugs of known bioavailability • Fixed dose combinations high recommended

– Initial phase: 2 months INH, rifampin, EMB, & PZA – Preferred continuation phase 4 months INH and rifampin – Alternative continuation phase is 6 months of INH and

ethambutol that can be used if adherence cannot be assessed • Associated with higher failure/relapse, especially in HIV+

Standards for Treatment

• Standard 9: To foster and assess adherence a patient-centered approach toadministration of treatment based on patient’s needs and mutual respectbetween patient and provider: – Supervision and support should be

• Gender specific • Age specific

– Measure to assess and promote adherence • DOT • Enhanced DOT

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Standards for Treatment

• Standard 10: All patients should bemonitored for response to therapy: – Sputum smears (2 specimens) at least at 2, 5 and

end of therapy at a minimum – Positive smears at 5th month are treatment failures – CXR is not required – Clinical assessment especially for extrapulmonary

• Patient monitoring is needed to: – Evaluate response, – Identify adverse drug reaction

Standards for Treatment

• Standard 11: A written record should be maintained for all patients of: – All medications given – Bacteriologic response – Adverse reactions

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Standards of Treatment

• Standard 12: In areas of high prevalenceof HIV in general population where TB and HIV are likely to co-exist, HIV counselingand testing is indicated for all TB patientsas part of routine management

• In areas with lower prevalence of HIV, HIVcounseling and testing is indicated for TBpatient with symptoms and/or signs of HIVrelated conditions or in TB patients with a history suggesting high risk of HIV exposure

Standards of Treatment

• Standard 13: All patient with TB and HIVshould be evaluated to determine need for anti-retroviral therapy during course of TB treatment: – Consultation with an expert in HIV TB is

recommended

– Patients with HIV TB should also receive cotrimoxazole as prophylaxis for other infections

• Initiation of treatment of TB should never be delayed!

WHO manual; TB/HIV: A Clinical Manual

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Standards for Treatment

• Standard 14: An assessment of likelihood of drug resistance should be obtained for allpatients: – History of prior treatment – Exposure to Possible drug resistance source case – Community prevalence of drug resistance

• Patients who fail therapy should always beassessed for drug resistance

• For patients with likely drug resistance,culture and drug susceptibility should beperformed promptly

Standards for Treatment

• Standard 15: Patients with drug resistant TB, especially MDR TB should be treatedwith specialized regimens containingsecond-line antituberculosis drugs: – At least 4 drugs to which the organisms are known

or presumed to be susceptible should be used – Treatment for at least 18 months – Consultation with a provider experienced in

treatment of patients with MDR TB

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Standards for Treatment

• Standard 15 (continued) • Specialized regimens

– Standardized treatment regimens • Based on representative drug resistance surveillance or

the history of drug use in the country

– Empiric treatment regimens • Used while DST results are pending • Recommended to avoid deterioration and transmission

– Individualized treatment regimens • Based on DST profiles and drug history of patient

Standards for Public Health

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Public Health Responsibilities: Key Points

• Describes need for investigation of high-riskcontacts (children <5 years and HIVinfected persons)

• Emphasizes need for reporting to publichealth authorities

Standard for Public Health

• Standard 16: All providers of care forpatient with TB should ensure that persons (especially children < 5 and HIV+) whohave close contact with infectious patientswith TB are evaluated and managed in linewith international recommendations: – Evaluate children <5 and HIV + persons for both TB

disease and latent infection – Union recommends that children <5 and high risk

HIV + persons living in same home as sputumsmear positive TB patient should be targeted for preventive therapy after excluding TB disease

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Standards for Public Health

• Standard 17: All providers must reportboth new and retreated TB cases and their outcomes to local public health authorities.

Research Needs

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Research Needs: Areas Included

• Diagnosis and case finding

• Treatment monitoring and support

• Public health and operational research

How ISTC will be used?

Providing a focus for a global campaignto improve TB Care and control

• As a tool to apply peer pressure viaprofessional societies

• As a core for medical and nursing schoolcurricula

• As a focus of continuing medical education programs

• As a guide for funders • As a focus for advocacy

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ISTC: Current Activities

• In-country consultations and “pilottesting”

• Developing information for an“Implementation Guide”

• Seeking endorsements • Translating the document • Exploring/exploiting all opportunities

ISTC: Test Sites

• Indonesia

• Kenya

• Tanzania

• Mexico

• India

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ISTC: Languages

• English • French • Spanish • Russian • Chinese • Indonesian • Vietnamese

Instructions for Global Fund Proposals

“Use interventions consistent with international best practices, as outlined in the Stop TB Strategy including the International Standards of Care and the Patients’ Charter.”

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