International Standards for Tuberculosis Care Barbara J. Seaworth, MD August 22, 2007

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1 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,

2 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. 2

ISTC; Focus of a Global Campaign Intended to unite public and private sectors in providing a uniformly accepted level of care for all patients with, or suspected of having, TB; Describes the

3 ISTC; Focus of a Global Campaign Intended to unite public and private sectors in providing a uniformly accepted level of care for all patients with, or suspected of having, TB; Describes the essential elements of TB care that should be available everywhere; Provides a vehicle for mobilizing professional societies globally in support of TB programs Serves as a powerful advocacy tool to ensure that the essential elements are available; Serves as support for The Patients Charter for Tuberculosis Care that defines patients rights and responsibilities globally. 3

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

4 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)

J.W. Lee, Director General, World Health Organization: March 24, 2006 ISTC Steering Committee Selected to provide perspectives, not to represent organizations Nursing

5 J.W. Lee, Director General, World Health Organization: March 24, 2006 ISTC Steering Committee Selected to provide perspectives, not to represent organizations Nursing Pediatrics Patients Private sector Medical students NTPs NGOs Professional societies Technical agencies MDR Tb TB/HIV HIV care providers Laboratories Academic medicine WHO Clinicians 5

6 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. 6

Introduction Introduction: Key Points Purpose: to describe a widely accepted level of care that all practitioners should seek to achieve in managing all patients Audience: all health care

7 Introduction Introduction: Key Points Purpose: to describe a widely accepted level of care that all practitioners should seek to achieve in managing all patients Audience: all health care practitioners, public and private Scope: diagnosis, treatment, and public health responsibilities; intended to complement local and national guidelines Rationale: failure to reach goals in part relates to the failure to effectively engage all providers in providing high quality care and in collaborating with TB control programs 7

Standards for Diagnosis Diagnosis: Key Points Describes need for examination of patients with cough for 2-3 weeks or more Emphasizes requirement for microbiological evaluation for

8 Standards for Diagnosis Diagnosis: Key Points Describes need for examination of patients with cough for 2-3 weeks or more Emphasizes requirement for microbiological evaluation for suspected pulmonary and extra pulmonary sites; de-emphasizes radiography as a tool for diagnosis Describes a rigorous approach to diagnosis of smear negative tuberculosis (including children) 8

9 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 of having pulmonary TB should have at least 2, preferably 3 sputums for microscopic exam. If possible one early am sputum Standard 3: All patients suspected of having extrapulmonary TB, appropriate specimens from suspected sites should be obtained for microscopy and if possible culture and pathology Standards for Diagnosis Standard 4: All persons with CXR findings suggestive of TB should have sputum submitted for microbiological examination Standard 5: The diagnosis of sputum smear negative pulmonary TB should be based 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 9

Standards for Diagnosis Standard 6: Diagnosis of intrathoracic (pulmonary, pleural, and mediastinal or hilar lymph node) TB in symptomatic children with negative sputum smears should be based: on

10 Standards for Diagnosis Standard 6: Diagnosis of intrathoracic (pulmonary, pleural, and mediastinal or hilar lymph node) TB in symptomatic children with negative sputum smears should be based: 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, sputum specimens should be obtained expectoration, gastric washings or induced Standards for Treatment 10

11 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 a patient 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 11

12 Standards for Treatment Standard 8: All patients who have not been treated previously should receive an internationally accepted 1 st 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 to administration of treatment based on patient s needs and mutual respect between patient and provider: Supervision and support should be Gender specific Age specific Measure to assess and promote adherence DOT Enhanced DOT 12

13 Standards for Treatment Standard 10: All patients should be monitored for response to therapy: Sputum smears (2 specimens) at least at 2, 5 and end of therapy at a minimum Positive smears at 5 th 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 13

14 Standards of Treatment Standard 12: In areas of high prevalence of HIV in general population where TB and HIV are likely to co-exist, HIV counseling and testing is indicated for all TB patients as part of routine management In areas with lower prevalence of HIV, HIV counseling and testing is indicated for TB patient with symptoms and/or signs of HIV related conditions or in TB patients with a history suggesting high risk of HIV exposure Standards of Treatment Standard 13: All patient with TB and HIV should 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 14

15 Standards for Treatment Standard 14: An assessment of likelihood of drug resistance should be obtained for all patients: History of prior treatment Exposure to Possible drug resistance source case Community prevalence of drug resistance Patients who fail therapy should always be assessed for drug resistance For patients with likely drug resistance, culture and drug susceptibility should be performed promptly Standards for Treatment Standard 15: Patients with drug resistant TB, especially MDR TB should be treated with specialized regimens containing second-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 15

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

16 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 16

17 Public Health Responsibilities: Key Points Describes need for investigation of high-risk contacts (children <5 years and HIV infected persons) Emphasizes need for reporting to public health authorities Standard for Public Health Standard 16: All providers of care for patient with TB should ensure that persons (especially children < 5 and HIV+) who have close contact with infectious patients with TB are evaluated and managed in line with 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 sputum smear positive TB patient should be targeted for preventive therapy after excluding TB disease 17

18 Standards for Public Health Standard 17: All providers must report both new and retreated TB cases and their outcomes to local public health authorities. Research Needs 18

19 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 campaign to improve TB Care and control As a tool to apply peer pressure via professional societies As a core for medical and nursing school curricula As a focus of continuing medical education programs As a guide for funders As a focus for advocacy 19

20 ISTC: Current Activities In-country consultations and pilot testing Developing information for an Implementation Guide Seeking endorsements Translating the document Exploring/exploiting all opportunities Indonesia Kenya Tanzania Mexico India ISTC: Test Sites 20

21 English French Spanish Russian Chinese Indonesian Vietnamese ISTC: Languages 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. 21

11/3/2009 SECOND EDITION Madhukar Pai McGill University. ISTC Training Modules Introduction

11/3/2009 SECOND EDITION Madhukar Pai McGill University. ISTC Training Modules Introduction SECOND EDITION 2009 Madhukar Pai McGill University Introduction 1 Purpose of ISTC ISTC Version 2: Key Points 21 Standards Differ from existing guidelines: standards present what should be done, whereas,