HOW TO ENSURE POLITICAL COMMITMENT FOR MDR TB MANAGEMENT

César Bonilla MD. REGION OF THE AMERICAS , YEAR 2004

Canada 9% USA Haiti Dom. Rep. Mexico 6.8% Honduras 75% Ecuador Total: 247,387 Peru Bolivia Brazil Peru 50% Nicaragua Brazil

Source: WHO Report 2006. Global Tuberculosis Control. Surveillance, Planning, Financing BASIC PRINCPLES IN MDR-TB MANAGEMENT

1. To establish a National TB Program that is efficient, effective and integrated into general health care services 2. To assure free access to quality medication (through application to the Green Light Committee). 3. To coordinate with the community and local governments to establish strategies that help ensure treatment adherence of the TB patient. 4. To provide free access to drug sensitivity tests. 5. To design an appropriate TB treatment regimen for the patient.

POSITIONING THE NATIONAL TB CONTROL PROGRAM AS A FUNDAMENTAL ELEMENT IN ENSURING POLITCAL COMMITMENT TECHNICAL EFFICIENCY IN MDR-TB MANAGEMENT

1. Clear objectives for the 6. Coordination and strategic short, medium, and long partnerships that facilitate term. a leadership role of MDR-TB 2. Clear components that management in the health improve processes care reform process, especially in regards to 3. Consistency in application Cross-sectional decentralization. of the DOTS strategy Approach: 4. Transparency in decision- 7. Organizational aspects: POLITCAL making and in the use of ƒ Laboratory conditions COMMITTMENT resources ƒ Treatment strategy 5. Work in a multidisciplinary ƒ Information system and team at different levels of data management health care. ƒ Supervision and monitoring of patient care PRODUCTS OF THE APPROPRIATE APPLICATION OF THE BASIC PRINCIPLES IN MDR-TB MANAGEMENT

1. Reliable distribution of medication. 2. Professional commitment, commitment at health care establishments, and experience in MDR-TB patient care that Cross-sectional helps ensure treatment adherence. Approach: 3. Implementation of reliable sensitivity tests POLITCAL for first- and second-line drugs. COMMITTMENT 4. Availability of human and physical resources. STEP-BY-STEP BUILDING OF POLITICAL COMMITMENT IN MDR-TB MANAGEMENT 1. Explanation of the causes of MDR-TB. 2. TB Control: • Towards our intended direction. • DOTS strategy, the right way. 3. Magnitude of the MDR-TB problem. 4. Intervention strategies. • Positioning. • Marketing and Merchandizing. • Strategic partnerships with the civil society and TB patient organizations. • Advocacy, social mobilization, and strategic communication. • Technical efficiency in resource utilization. • Investigation: operational, epidemiological, and clinical. 5. Consolidating political commitment. 1.EXPLAINING THE CAUSES OF MDR-TB MAGNITUDE OF THE MDR-TB PROBLEM IN PERU

CHILDREN < 18 YEARS OLD WITH MDR-TB THAT HAVE ACCESS TO STANDARD AND INDIV. RETREATMENT, The presence of MDR-TB is the THREE-YEAR TREND LINE result of numerous failures by PERU 1996-2004 the health care system over 300 time: 1. Use of ineffective treatment regimes for MDR-TB during the 250 80’s and 90’s amplified y = 26,8x - 53,778 resistance. R2 = 0,9352 2. Persistent MDR-TB cases in the 213 community without timely 200 access to adequate treatments MDR-TB increased sources of 173 with MDR bacilli among the population. 150 3. Poorly defined therapeutic 124 policies in regards to new MDR-

of children with 100 TB cases among contacts of 92 documented MDR-TB cases. Nº < 18 years Trend line (< 18 y) 4. Underestimation of the 56 magnitude of MDR-TB resulted 50

in inadequate diagnosis and 32 treatment interventions. 26

5 0 1 96 97 98 99 00 01 02 03 04 2. TB CONTROL IN PERU: • TOWARDS OUR INTENDED DIRECTION • DOTS STRATEGY THE RIGHT WAY TB MORBIDITY AND INCIDENCE RATES IN PERU, 1990-2005

EpidemiPicoolog ical IniciStarto of de Ref Reformaorm GestManaiógementn y 300 PeakEpidemiológico DOTS ExpansiDOTS Expansión y Sostenibon and ilidadSustainab DOTSility anyd Perdida Loss of de Recuperaciand Recoveryón LeaderLidershipazgo ofde Leadeliderazgorship

250

200

150

100 EpidemioloPico gical EpidemiolPeakógico 50

0 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005

MORBILIDADMORBIDITY 198,6 202,3 256,1 248,6 227,9 208,7 198,1 193,1 186,4 165,4 155,6 146,7 140,3 123,8 124,4 129,0 INTBCID. INCID. TBC 183,3 192 243,2 233,5 215,7 196,7 161,5 158,2 156,6 141,4 133,6 126,8 121,2 107,7 107,7 109,7 INBKCID.+ IN CID.BK+ 116,1 109,2 148,7 161,1 150,5 139,3 111,9 112,8 111,7 97,1 87,9 83,1 77,4 68,8 66,4 67,1

Source: National Health Strategy for TB Prevention and Control-DGSP/MINSA WHAT ARE WE LOOKING FOR IN MODERN PUBLIC HEALTH?

Equity Efficiency Quality

What is the target Human population? Guarantee good Resources use of the HR

Clergy Collective To whom are we obligated? Health Management of Individual Services PLANNING EXECUTION Health What are the priorities when Avoid overlapping Sustainability considering the situation at each management level? of duties

Social Participation PUBLIC HEALTH AND TB CONTROL PROGRAMS

State Policies

HOW TO CONFRONT THE CURRENT SCENARIO

HUMAN RESOURCES EQUIPMENT INFRASTUCTURE

GLOBAL CONTEXT

• Aging of the population • Increase in public expectations • Globalization • Advances in science and knowledge • Epidemiological change • New demands in regards to learning POLICY GUIDELINES FOR THE HEALTH CARE SECTOR AND THE NATIONAL HEALTH STRATEGY FOR TB PREVENTION AND CONTROL Continuous QualityImprovement

DOTS Supply and Rational Use of Drugs DOTS PLUS

Technical Ef Sector Management Health HR Prevention Funding Technologic. Comprehensive MINSA and Developm. Care Promotion Democratization Decentralization ficiency Modernization Institutional Comprehensive Local Culture HIV/TB Insurance Governments Strategic Accreditation PAL Partnerships HRTAs PPM Service Others

HRTA: High Risk AMSC Training Advocacy, of Transmission Evaluation Areas Social Research Supervision Mobilization Biosafety Monitoring

Multidisciplinary, Multifunctional, Intersectorial and Interinstitutional Team Public Health Technical Strategic and Specialization Management Epidemiology Criteria

STOP TB Committee Peru

National Multisectorial • Coordination, Administration, National Health Strategy for Communication, Cooperation. Health TB Prevention and Control Coordinator • Shared management, leadership and accountability. TB/HIV Co- Infection Committee

Group of Experts Scientific Associations

Civil Society ComitéTECHNICALTécnic o ADVISORY NGOs PermanenteSTANDING COMMITTEE COMMITTEE Universities

MINSA EsSALUD Representatives & Departments Dep. of Health

Technical Strategies and Criteria, Strategies, Plans and Criteria Programs Commitments Public Stakeholders (Citizens)

Citizen Watch

National Health Strategy for Institutional and MINSA TB Prevention Intersectorial and Articulation Control

Comprehensive Institutional Stakeholders Care AND Intersectorial Stakeholders TB CONTROL ATTITUDES AND COMMITMENTS

1. Promotion of a health culture in the context of TB control, considering the impact of TB on the person and the society.

2. Personal dignity & bioethical behavior.

3. Promotion & social participation as an expression of active citizenship.

4. Evidence-based information to guide social, technical & political interventions. NEW PARADIGMS

1. Promoting TB and MDR-TB control while preserving human dignity, bioethics, and human rights within a healthy citizen context.

2. Comprehensive and integrated health care to enhance TB and MDR- TB control actions.

3. Promoting advocacy and guiding public policy through intersectoriality, interinstitutionality and development of strategic partnerships for TB and MDR-TB control.

4. Organizing and providing care to people with TB and MDR-TB through multidisciplinary teams comprised of a healthcare team, civil society representatives, and associations of people living with TB.

5. Strategic communication. 4. MAGNITUDE OF THE MDR-TB PROBLEM INITIAL RESISTENCE OF MDR-TB (Americas, 1994-2002)

CAN 1.2%

USA 1.2%

MEX DOM REP 6.6% CUBA 0.3% 3 estadostates s2.4% 2.4% PR 2.5% GUA 3.7% HON 1.8% ELS 0.3% VE 0.3% >= 4 HOT SPOTS NIC 1.2% CO 1.47% WITH MDR ECU 5.0% 0.9% PER 3.0% Bo 1.2%

Ch 0.6% (MDR-TB >= 3%) Ar Ur 0.01% (MDR-TB < 3%) 1.8%

(MDR-TB =< 1%) No data Sources: PAHO DRUG-RESISTANT TB IN DRUG-RESISTANT TB IN NEW PREVIOUSLY TREATED PATIENTS, PATIENTS, WHO/UICTER 1999 WHO/UICTER 1999

25 23.3 23.5 %20 17.8 WORLD 20 WORLD PERU 15 PERU 15 % 10.7 % 12.3 10 9.3 10

5 3 5 1 0 0 DR TB MDR TB DR TB MDR TB

Fuente: WHO/IUATLD. Anti-tuberculosis drug-resistance in the world. Report Nº2. Prevalence and trends. DRUG-RESISTANT TB IN PREVIOUSLY TREATED PATIENTS, WHO/UICTER 1999

25 23.3 23.5 % WORLD 20 PERU

15 12.3 9.3 10

5

0 DR TB MDR TB

Fuente: WHO/IUATLD. Anti-tuberculosis drug-resistance in the world. Report Nº2. Prevalence and trends. CHILDREN WITH MDR-TB <18 YEARS THAT CONSENTED TO STANDARD AND INDIVUDUALIZED RETREATMENT, TREND LINE AT THREE YEARS. PERU 1996-2004

300

250 y = 26,8x - 53,778 R 2 = 0,9352

213 200 MDR-TB th 173 wi 150 dren l 124 chi

of 100 92 Nº < 18 years Trend line (< 18 años) 56 50

32 26

5 0 1 1996 1997 1998 1999 2000 2001 2002 2003 2004 5. MDR-TB INTERVENTION STRATEGIES METHODOLOGICAL FOUNDATIONS AND IMPACT OF MDR-TB CONTROL

Bacteriological “Fitness” of the etiological agent Microorganism Phenomenon of genetic mutation of M-TB

Identification of probable cases and Clinical clinical presentation. Individual Diagnostic and therapeutic methods.

Epidemiology of MDR-TB Epidemiological Community Identification of high risk areas

Operational Intervention strategies Control Control principles POINT OF EQUILIBRIUM OR RUPTURE OF BALANCE

Control Strategies

M.TB Resistant M. TB Sensitive

DOTS PLUS Treatment DOTS Prevention

MULTI-DRUG RESISTANT TUBERCULOSIS ORIGIN OF MDR-TB

DOTS Human error Bad treatments

Responsibility of the health care system & the Medical responsibility ESNC-TB

Administration of inadequate Logistics of inadequate Inadequate treatment treatment chemotherapy Uninformed patient Unsupervised treatment

DOTS PLUS ACQUIRED RESISTANCE PRIMARY RESISTANCE

AmericanThoracic Society/CDC. Treatment of tuberculosis infection in adults and children. Am Resp Crit Care Med 1994;149:1359-1374 FOCUS ON MDR-TB CONTROL WITHIN THE CONTROL PROGRAM PLANS

9 Adequate therapeutic arsenal. 9 Rapid diagnostic tests that are accessible at low cost. 9 Organizational support : • Case identification and rapid initiation of treatment. • DOTS strategy that prevents irregularity and defaults. • Monitoring and consistent clinical follow-up. • Management of RAFA. • Complementary interventions. FOCUS ON MDR-TB CONTROL WITHIN THE CONTROL PROGRAM PLANS

9 Efficient application of the DOTS strategy. 9 A TB control strategy integrated into the health care system. 9 Population with access to health care services. 9 Strategic partnerships. 9 Community participation. FACTORS THAT HAVE FACILITATED THE STRENGHTENING OF MDR-TB MANAGEMENT

1. To implant the DOTS strategy, tuberculosis control must fulfill the standards established by the WHO. Thus, it is safe to give credence to the treatment results obtained by the Peruvian program. These results reflect the general effectiveness of treatment strategies that employ first- and second-line drugs. 2. The situation in Peru is unique, as it is a country where these strategies of standardized and individualized treatment have been employed side by side. 3. In Peru, the use of treatment with second-line drugs has evolved over time. TECHNICAL HEALTH STANDARDS (TS) AND PUBLICATIONS

TS – TUBERCULOSIS TS MDR-TB

Biosafety Training Tuberculosis Evaluation Report Module Training Module Building Strategic ESN-PCT 2004 Partnerships 6 IMPORTANT REASONS WHY IT IS NECESSARY TO BE CONCERNED ABOUT MDR-TB

1. PUBLIC HEALTH MDR-TB exerts pressure on the epidemiological nature of the disease. Patients that are not treated represent sources of future infection and a public health risk in the community. 2. ECONOMICAL When cases of MDR-TB are not given appropriate treatment regimens, a curable illness that can be treated at low cost becomes an unmanageable health problem. 3. SOCIO-MEDICAL ANTHROPOLOGICAL MDR-TB patients face disability and/or death. 6 IMPORTANT REASONS WHY IT IS NECESSARY TO BE CONCERNED ABOUT MDR-TB

4. POLITICAL To be concerned with MDR-TB is to be concerned with those who are the most poor and marginalized. To confront MDR-TB can signify the eradication of one of the most severe kinds of poverty and discrimination. 5. BIOETHICAL In its human dimension, access to treatment is considered a human right. 6. INSTITUTIONAL IMAGE An MDR-TB problem can lower public opinion of the and the National TB Program. HOW MUCH IS INVESTED IN PULMONARY HEALTH ?

$ 507 600 Exacerbation COPD $ 7,100 500 x 14 days

Severe Pneumonia $ 3,500 x T 400 $ 250

S 14 days O 300 MDR-TB $ 4,000 x 24 months C

Y

L 200 $ 10

I

A 100

D 0 COPD PNEUMONIA MDR-TB SEVERE

Khaled A, et al. Bull of The WHO 2001 In a study conducted in 2001 by the World Health Organization (WHO) and the National TB Control Program of Peru (PNCT), the cost-effectiveness of providing second-line drugs to chronic TB patients (in comparison to the baseline situation in which these dugs were not available and the use of health services for chronic patients was considered null) was evaluated from the perspective of the public health system and found a cost benefit of $150 to $200 per DALY (Disability-Adjusted Life Years).

Suarez P, Floyd K, Portocarrero J, Alarcon E, Rapiti E, Ramos G, Bonilla C, Sabogal I, Aranda I, Dye C, Raviglione M , Espinal M. Feasibility and cost effectivieness of standardised second-line drug treatment for chronic tuberculosis patients : a national cohort study in Peru. Lancet 2002 Nov 2:360 (9343):1340 AVERTED MORBIDITY-MORTALITY

Averted Morbidity-Mortality 2002 2003 2004 2005 2006 Total

A) Total cases in retreatment 1,423 1,679 1,919 2,365 526 7,912

B) Infected cases prevented per year (Nºx10x5 years) 71,150 83,950 95,950 118,250 26,300 395,600

C) Disease cases prevented 7,115 8,395 9,595 11,825 2,630 39,560

D) Deaths prevented (A+C) 8,538 10,074 11,514 14,190 3,156 47,472 Disease prevented: USA $ 118,680,000 Deaths prevented: USA $ 142,416,000 TOTAL PREVENTED: USA $ 261,096,000 WORLD TUBERCULOSIS DAY MARCH 24, 2005 WORLD TUBERCULOSIS DAY MARCH 24, 2006 7. TECHNICAL EFFICIENCY IN RESOURCE UTILIZATION CASES ENROLLED IN MDR-TB TREATMENT AND % OF DEATHS, PERU 1997 – 2005

14.7 % 3000 16 2,641 14

2500 % MDR-TBDeaths t 12

2000 10

1500 8 rolled in Retreatmen 6 1000

4 500 68 3 % 2 of MDR-TB cases en 0 0 Nº 1997 1998 1999 2000 2001 2002 2003 2004 2005

Source: National Health Strategy for TB Prevention and Control-DGSP/MINSA FATALITY RATE DURING STANDARDIZED VS INDIVIDUALIZED RETREATMENT 1997-2005

16.0 14.7 14.1 14.0 13.1 12.8 12.0 13.1 12.1

11.5 10.5 10.0 Standard 8.7

% 8.0 8.3 8.1 Individual 6.8 6.5 6.0

4.0 4.1 4.3

2.0 2.2

0.0 0.0 0.0 1997 1998 1999 2000 2001 2002 2003 2004 2005

Source: Technical Unit-National Health Strategy for TB Prevention and Control-DGSP/MINSA DEFAULTS FROM MDR-TB RETREATMENT BY YEAR, Peru 1997-2005

25

20

15

defaults 10 % of 5

0 1997 1998 1999 2000 2001 2002 2003 2004 2005

Source: Technical Unit-National Health Strategy for TB Prevention and Control-DGSP/MINSA BACTERIOLOGICAL CONVERSION THROUGH SIX MONTHS OF MDR-TB RETREATMENT, PERU 1997 – 2006

100 90 ases

C 80 Implementation of MDR-TB Technical Standard, New Standardized Regime and Strengthening of MDRTB-Technical Unit ent

m 70 Changes in Inclusion Criteria for Former 60 Standardized Regime (Recommended for failures to primary and secondary regime) 50 40 30 Culture in MDR-TB Retreat Implementation of Former Standardized Regime (To access e 20 this treatment, patients had to go through various first-line

gativ drug treatments) 10 % Ne 0 0123456

2005-2006 0 73.3 86.3 90.6 93.9 92.5 93.9 2002-2004 0 32.3 42.3 47.2 43.8 42.6 42.8 1997-2001 0 15.4 32.5 36.9 41.7 40.7 40.1 Months of Re-Treatment

Source: National Health Strategy for TB Prevention and Control-DGSP/MINSA 8. CONSOLIDATING POLITICAL COMMITMENT PERU STOP TB PARTNERSHIP

CEREMONY FOR INSTALLATION OF THE COMMITTEE BUDGET OF THE NATIONAL HEALTH STRATEGY FOR TB PREVENTION AND CONTROL, PERU 1991-2006

Millions $ USD

12

9 780,000 $ USD

10 DOTS STRATEGY: 8 POLITICAL Average Annual Budget COMMITMENT 6 1991- 2005: $ 3 000,000 USD

4

2

0 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006

Source: National Health Strategy for TB Prevention and Control-DGSP/MINSA STEP-BY-STEP BUILDING OF POLITICAL COMMITMENT IN MDR-TB MANAGEMENT 1. Explanation of the causes of MDR-TB. 2. TB Control: • Towards our intended direction. • DOTS strategy, the right way. 3. Magnitude of the MDR-TB problem. 4. Intervention strategies. • Positioning. • Marketing and Merchandizing. • Strategic partnerships with the civil society and TB patient organizations. • Advocacy, social mobilization, and strategic communication. • Technical efficiency in resource utilization. • Investigation: operational, epidemiological, and clinical. 5. Consolidating political commitment. Where do we come from? Who are we? Where are we going? Paul Gauguin