CGD/Rachel Nugent Bamako Presentation Consultation Session

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  • 1. Preventing Global Drug Resistance Rachel Nugent, Ph.D. Global Ministerial Forum on Research for Health November 20, 2008 Bamako, Mali Drug Resistance Working Group Consultation Session
  • 2. About the Center for Global Development
    • Independent, non-partisan think tank
    • Focus on the effects of rich-country policies on poor countries
    • Promote policy alternatives
    • Research Areas :
      • Development Aid Effectiveness
      • Global Health & Education
      • Debt
      • Migration
      • Trade
  • 3. Features of CGD Working Groups
    • Leading experts in public health, economics and other social science and technical fields
    • Original, focused research on high-priority global health policy / finance issues
    • Improve the outcomes of donor decision-making in global health with:
      • Expanded evidence-base
      • New people and perspectives
      • Innovative solutions/ approaches
      • Active communication and outreach
      • Supported with a grant from the Bill & Melinda Gates Foundation
  • 4. Working Group Experiences
    • What Works? Working Group: Identified, analyzed and documented large implementation successes in global health
      • Millions Saved: Proven Successes in Global Health, used in global health organizations and classrooms
    • Advance Market Commitment Working Group: Examined how donors could accelerate the development of vaccines for diseases concentrated in developing countries by guaranteeing to pay for such vaccines if and when they are created and introduced
      • Making Markets for Vaccines: Ideas to Action
      • GAVI & World Bank launched a pilot AMC for pneumococcal vaccines in 2007
    • Evaluation Gap Working Group: Proposed a major international initiative to increase the number and quality of impact evaluation in the social sectors
      • When Will We Ever Learn: ? Improving Lives through Impact Evaluation
      • Creation & funding of the International Initiative for Impact Evaluation
    • Global Health Forecasting Working Group: Issued recommendations that would improve access to information and better align forecasting incentives, ensuring that increasing donor funds for health are used effectively
      • A Risky Business: Saving Money and Improving Global Health through Better Demand Forecasts
    • Working Group on IMF & Health: Investigated how macroeconomic policies under IMF programs in low-income countries interacted with the management of health spending in a context of scaled-up aid.
      • Does the IMF Constrain Health Spending in Poor Countries? Evidence and an Agenda for Action
  • 5. Working Group Timeline
    • Problem definition
      • Conceptual framework/summary of empirical research
      • Identification/invitation of working group members
      • Development of timeline
      • Outline of outreach strategy and goals for policy impact
    Initial Conceptualization Working Group Meetings
    • In-depth topic exploration
    • Targeted analyses
    • Analysis of potential solutions
    • Proposed policy recommendations
    Final report launch Stakeholder Consultations Outreach & Dissemination
    • Staff draft distributed for feedback from broad set of stakeholders
    • Considered by WG & reflected in revised product
    Policy Impact
    • Materials developed for specific audiences
      • Briefs, journal articles, etc.
    • Large & small events
    Background paper Consultation draft
  • 6. Statement of Purpose
    • The Drug Resistance Working Group will generate critical thinking about:
      • Magnitude and nature of emergence and spread of drug resistance
        • Differences across diseases and regions
      • Implications of drug resistance for multiple stakeholders
      • Specific actions and investments by international actors to create a systematic response to resistance
    • Resulting in analytically-based policy recommendations for:
      • Multi- and bilateral funders
      • Technical agencies
      • Policymakers in developing countries
  • 7. Drug Resistance Working Group
    • THE PROBLEM:
    • Resistance to drugs limits their effective lifespan
      • Resistance is occurring across major diseases
      • Resistance rises as drug access increases
    • Treatment options are more limited
      • Higher cost of treatment
      • Unavailable or unaffordable 2 nd and 3 rd line drugs
      • Some conditions untreatable
    • Incentives to prevent drug resistance are misaligned and inadequate
      • Divergence between private and social costs -- externality
      • Drug efficacy as a diminishing resource – public good
      • High discount rate
      • Principal-agent problem
      • Transnational issue
      • Informational asymmetries
  • 8. Our questions
    • What are the causal risk factors, and how do they vary by region and disease?
    • What information is available and how is it shared?
    • What are the true economic costs of resistance?
    • What linkages contribute to cross-country transmission?
    • Can collective action slow resistance?
    • What should private and public sector actors do now for long-term containment of resistance?
  • 9. Tripartite Framework Resistance Drug Technology Factors long drug half-life, cross-resistance, treatment length and complexity, monotherapy Behavioral Factors (Patient): poor adherence, self-medication, cultural preferences/beliefs (Provider):unclear diagnosis, financial incentives, industry promotion Health Systems Factors Poor quality, unregulated prescribing/dispensing, weak infection control, lack of rapid diagnostic tools, poor surveillance
  • 10. Comparison of Disease-Related Resistance Issues (from the 2001 WHO Global Strategy for Containment of Antimicrobial Resistance) Issues Bacterial Infections TB Malaria HIV Inappropriate Use Contributes to ↑ Drug Resistance Yes Yes Yes Yes Need for New Drug Development Yes Yes Yes Yes Detection of Pathogen Reasonably Easy and Feasible Easy Easy Easy Detection of in vitro resistance Reasonably Easy and Feasible Feasible but Expensive Difficult, Expensive, Rarely Feasible Difficult, Expensive, Limited Availability Diagnostics Able to Detect Resistance Yes, but slow Some No Yes, but expensive and with limited availability Observed Treatment No Yes  DOTS No No Antimicrobial Treatment Single Agent, Short Duration Multiple Agents, Long Duration ≥ 1 Agent, Short Duration Multiple Agents, Lifelong HIV Interaction Some: Especially Nosocomial Risk Massive: Personal & Nosocomial Risk Possibly N/A Potential Impact of One Program on Another Yes; Some Antibiotics Could Affect Malaria Resistance Little; Except for Rifampicin Use on Staph . Spp. Some; e.g. doxycyline, sulphadoxine-pyrimethamine Yes; e.g. cotrimoxazole + isoniazid prophylaxis
  • 11. Snapshot of potential DRWG recommendations
      • Build on WHONET to insert resistance into public health surveillance systems; add resistance to HealthMap and other informal surveillance systems
      • Establish cross-disease laboratory systems based on molecular technologies
      • Encouraging drug development via access to compound libraries and creating a web-based drug resistance technology marketplace
      • Improved prescribing and use of drugs and technologies, via:
        • Drug dispenser checklist (potential to work with FIP)
        • Options to improve consumer education
        • Continuing professional education; the role of professional assns. and drug reps
        • Scale up approaches to franchise or certify dispensers
      • Proliferation of GMP  Industry self-regulation for QA (e.g. ISO)
      • Cross-country drug regulatory networks (ex. WADRAN)
      • Health and Development Conference on Resistance
    37
  • 12. Possible Recommendations
    • Increasing Surveillance (1)
    • Recommendation:
    • To provide more resources for WHONET and other formal national public health surveillance systems ; to strengthen both local and global surveillance systems
    • To add resistance to informal surveillance systems like ProMed and HealthMap
    Issues Bacterial Infections TB Malaria HIV Treatment Indication Generally Pathogen-Based (+/- resistance) Pathogen-Based Frequently Syndromatic Pathogen-Based Antimicrobial Treatment Single Agent, Short Duration Multiple Agents, Long Duration ≥ 1 Agent, Short Duration Multiple Agents, Lifelong Potential Impact of One Program on Another Yes; Some Antibiotics Could Affect Malaria Resistance Little; Except for Rifampicin Use on Staph . Spp. Some; e.g. doxycyline, sulphadoxine-pyrimethamine Yes; e.g. cotrimoxazole + isoniazid prophylaxis
  • 13. Possible Recommendations
    • Increasing Surveillance (II)
    • Issues and questions to consider:
    • Who is already doing this? What platforms currently exist? Good models?
    • What are the appropriate biomarkers and/or survey standards for this informal surveillance?
  • 14. Possible Recommendations
    • Laboratory Systems (1)
    • Recommendation:
    • To establish – as part of the public health system – cross-disease lab systems based on molecular technologies for diagnosis and surveillance of drug resistance
    Issues Bacterial Infections TB Malaria HIV Detection of Pathogen Reasonably Easy and Feasible Easy Easy Easy Detection of in vitro resistance Reasonably Easy and Feasible Feasible but Expensive Difficult, Expensive, Rarely Feasible Difficult, Expensive, Limited Availability Potential Impact of One Program on Another Yes; Some Antibiotics Could Affect Malaria Resistance Little; Except for Rifampicin Use on Staph . Spp. Some; e.g. doxycyline, sulphadoxine-pyrimethamine Yes; e.g. cotrimoxazole + isoniazid prophylaxis
  • 15. Possible Recommendations
    • Laboratory Systems (II)
    • Issues and questions to consider:
    • Is this scientifically feasible? (How similar are molecular techniques by disease?)
    • Is this economically feasible? (Does this compete with other initiatives to scale-up/increase laboratory capacity?)
    • What incentives for whom might help make this cross-disease recommendation a reality?
  • 16. Possible Recommendations
    • Encouraging drug development(I)
    • Recommendation:
    • Public, web-based compound library showcase to accelerate early-stage product development
    • Share original nascent technology ideas in a web “marketplace”
    Issues Bacterial Infections TB Malaria HIV Need for New Drug Development Yes Yes Yes Yes Potential Impact of One Program on Another Yes; Some Antibiotics Could Affect Malaria Resistance Little; Except for Rifampicin Use on Staph . Spp. Some; e.g. doxycyline, sulphadoxine-pyrimethamine Yes; e.g. cotrimoxazole + isoniazid prophylaxis
  • 17. Possible Recommendations
    • Encouraging drug development(II)
    • Issues and questions to consider:
    • How can we bring resistance targets into the current efforts? Or does it require a stand alone effort?
    • What would be the licensing/IP arrangements necessary to make this work?
    • Should this be completely open access or should access be somewhat limited? If the latter, what should restrictions be?
  • 18. Possible Recommendations
    • Improved prescribing and use of drugs and technologies (I)
    • Recommendation:
      • Looking at it from a provider/dispenser/consumer education angle and realigning incentives
      • Encourage use of new technologies?
      • Consider development of checklists?
    Issues Bacterial Infections TB Malaria HIV Inappropriate Use Contributes to ↑ Drug Resistance Yes Yes Yes Yes Observed Treatment No Yes  DOTS No No Antimicrobial Treatment Single Agent, Short Duration Multiple Agents, Long Duration ≥ 1 Agent, Short Duration Multiple Agents, Lifelong
  • 19. Possible Recommendations
    • Improved prescribing of drugs and use of technologies (II)
    • Issues and questions to consider:
    • How to discourage over- and under-use?
    • How to achieve better access and use of diagnostics?
  • 20. Possible Recommendations
    • Franchising/Certification of Dispensers (I)
    • Recommendation:
    • To scale up dispenser certification or similar approaches to guarantee high standards of drug distribution (e.g. Accredited Drug Dispensing Outlets (ADDO).
    Issues Bacterial Infections TB Malaria HIV Inappropriate Use Contributes to ↑ Drug Resistance Yes Yes Yes Yes Treatment Indication Generally Pathogen-Based (+/- resistance) Pathogen-Based Frequently Syndromatic Pathogen-Based Potential Impact of One Program on Another Yes; Some Antibiotics Could Affect Malaria Resistance Little; Except for Rifampicin Use on Staph . Spp. Some; e.g. doxycyline, sulphadoxine-pyrimethamine Yes; e.g. cotrimoxazole + isoniazid prophylaxis
  • 21. Possible Recommendations
    • Franchising/Certification of Dispensers (II)
    • Issues and questions to consider:
    • How can this best be done in the informal private sector?
    • How effectively can quality be differentiated?
    • Will consumers come?
  • 22. Possible Recommendations
    • Industry Self-Regulation (I)
    • Recommendation:
    • Introducing industry self-regulation to instill good manufacturing practices for quality assurance (e.g. ISO)
    Issues Bacterial Infections TB Malaria HIV Need for New Drug Development Yes Yes Yes Yes Potential Impact of One Program on Another Yes; Some Antibiotics Could Affect Malaria Resistance Little; Except for Rifampicin Use on Staph . Spp. Some; e.g. doxycyline, sulphadoxine-pyrimethamine Yes; e.g. cotrimoxazole + isoiazid prophylaxis
  • 23. Possible Recommendations
    • Industry Self-Regulation (II)
    • Issues and questions to consider:
    • Is this something that quality manufacturers would back?
    • How to share the costs of achieving quality standards?
    • How do you monitor ALL manufacturers?
  • 24. Possible Recommendations
    • Cross-Country Regional Regulatory Networks (I)
    • Recommendation:
    • To expand innovative cross-border collaborations like the West African Drugs Regulatory Authorities Network (WADRAN), which provide collective behavioral incentives at the country level to increase regulatory capacity and fight products of substandard quality.
    Issues Bacterial Infections TB Malaria HIV Inappropriate Use Contributes to ↑ Drug Resistance Yes Yes Yes Yes Need for New Drug Development Yes Yes Yes Yes HIV Interaction Some: Especially Nosocomial Risk Massive: Personal & Nosocomial Risk Possibly N/A Potential Impact of One Program on Another Yes; Some Antibiotics Could Affect Malaria Resistance Little; Except for Rifampicin Use on Staph . Spp. Some; e.g. doxycyline, sulphadoxine-pyrimethamine Yes; e.g. cotrimoxazole + isoniazid prophylaxis
  • 25. Possible Recommendations
    • Cross-country Regional Regulatory Networks (II)
    • Issues and questions to consider:
    • What lessons can be learned from the WADRAN experience in the first few years since its creation?
    • Are there other good examples of successful regulatory networks?
    • How do you create the political will and buy-in from all parties to make regulatory harmonization successful?
  • 26. Conclusion
    • Next steps
      • Last working group meeting in early December to solidify recommendations
      • Continue consultation sessions through to end January 2009
      • Launch of WG report in April/May 2009
      • Outreach and dissemination  IMPACT
    • How to have input
      • Comment on our draft report. Please send comments to [email_address]
    • Sign up for Drug Resistance e-newsletter
      • http://www.cgdev.org /Drug_Resistance