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Drug Resistance as a Global Health Policy Priority Susan Foster, Martha Gyansa-Lutterodt & Rachel Nugent Drug Resistance Working Group Global Ministerial.

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Presentation on theme: "Drug Resistance as a Global Health Policy Priority Susan Foster, Martha Gyansa-Lutterodt & Rachel Nugent Drug Resistance Working Group Global Ministerial."— Presentation transcript:

1 Drug Resistance as a Global Health Policy Priority Susan Foster, Martha Gyansa-Lutterodt & Rachel Nugent Drug Resistance Working Group Global Ministerial Forum on Research for Health November 18, 2008 Bamako, Mali

2 2 Session Objectives To communicate the evidence that drug resistance is an important global (also African) policy priority; To articulate a common solution framework based on the risk factors for resistance across treatments for HIV/AIDS, malaria, TB and other key microbial infections; To share the CGD Drug Resistance Working Groups preliminary recommendations for the set of incentives, governance capabilities and actions, and financing mechanisms that could reduce drug resistance globally.

3 3 Session Overview I. Introduction to the CGD DRWG, our presenters today and brief summary of what the DRWG aims to achieve II. Is drug resistance currently an important global policy priority? An overview of the reasons why it should be III. The drug resistance problem from a West African perspective (malaria, tuberculosis, other neglected diseases) IV. Working towards a common solution framework to address drug resistance across diseases V. Preliminary recommendations and conclusion VI. Q&A

4 4 Introduction to the Center for Global Development, the CGDs Drug Resistance Working Group and our presenters today

5 5 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 Climate Change

6 6 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

7 7 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 Background paper Final report launch Working Group Timeline Stakeholder Consultations Outreach & Dissemination Staff draft distributed for feedback from broad set of stakeholders Considered by WG & reflected in revised product Policy Impact Consultation draft Materials developed for specific audiences Briefs, journal articles, etc. Large & small events

8 8 DRWG 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

9 9 Drug Resistance as an important global public health policy priority

10 10 Impacts of drug resistance Resistance limits the effective useful lifespan of drugs Makes industry less interested in research and development Older antibiotics to treat common infectious diseases are often more toxic e.g. chloramphenicol and gentamicin, or more expensive e.g. amoxiclav, or both Treatment options become more limited Higher 2 nd and 3 rd line treatment costs Some conditions become untreatable – XDR-TB, MRSA, will cholera and shigella be next?

11 11 Why is drug resistance a global public health policy priority? Resistance causes avoidable mortality and morbidity, undermining renewed global health efforts Resistance occurs across major infectious diseases Drug use for one condition affects resistance for other conditions, e.g. cotrimoxazole for HIV affects use for ARI Resistance means spending more on drugs to get the same effect, in an era of extreme competition for health budgets Resistance knows no barriers and requires international coordination to control

12 12 Incentives to slow resistance are lacking Divergence between private and social interests and incentives As a parent, I want to treat my child with antibiotics - I am not concerned about the common good! Drug efficacy is a diminishing resource – a public good, shared by all Yet there is no mechanism for control or rationing of this resource (no OPEC of antibiotics!) Most incentives are for more, not less, use A transnational issue – crosses borders and regions, but no control body (or even tracking body) Resistance which develops in one area soon spreads Tension between preventive and therapeutic AB use Pharmaceutical industry incentives are mixed

13 13 The supply of new antibiotics is drying up Zero? Total number of new antibacterial agents introduced

14 14 Newer antibiotics are more expensive Amoxicillin and clavulanic acid is 20 times more expensive than ampicillin The change in standard therapy for malaria from chloroquine (CQ) and sulfadoxine/pyrimethamine (SP) to artemisinin containing therapy (ACT) has increased the cost of treating a case of malaria by a factor of 10 or more It costs up to 500 times as much to treat drug- resistant TB compared to standard TB

15 15 Drug prices compared DrugPrice/ unit Units/ dosePrice/dose Amoxicillin 250 mg tab/cap$0.0228$0.43 Amoxicillin/clavulanic acid$0.3028$8.40 Ampicillin 250 mg tab/cap$0.0128$0.41 Azithromycin 250 mg tab/cap$0.226$1.31 Chloramphenicol 250 mg tab/cap$0.0128$0.39 Ciprofloxacin 250 mg tab/cap$0.0256$1.09 Cotrimoxazole (b) mg tab/cap $0.0228$0.47 Doxycycline 100 mg tab/cap$0.0111$0.11 Erythromycin 250 mg tab/cap$0.0340$1.05 Penicillin V 250 mg tab/cap$0.0156$0.71 Tetracycline 250 mg tab/cap$0.0136$0.27

16 16 The cost of poor diagnosis Much of the expenditure on drugs is wasted because they are not appropriate or indicated for the patients condition Antibiotics may be given for acute respiratory infections which are viral in origin, or antimalarials given for pneumonia: young, febrile children are often treated empirically for malaria, when in fact they have pneumonia (Kallander, Nsungwa-Sabiiti et al. 2004) Antibiotics continue to be used where resistance is already very high

17 17 Friend or foe? Resistance increases as drug access improves and urbanization increases (more informal sector options?) Source: MMV Over 20 informal sector drug outlets along a 2 km stretch of road in a new urban settlement in East Africa

18 18 Drug Resistance: a global snapshot

19 19 Ciprofloxacin resistance increasing Consistent increase in the median MIC* of V. cholerae O1 strains isolated at the Dhaka Hospital: μ g/mL in μ g/mL in to 0.5 μ g/mL in 2005 Source: A.S.G. Faruque, J HEALTH POPUL NUTR 2007 Jun;25(2): MIC, minimum inhibitory concentration, is the minimum concentration of antibiotic which will inhibit the growth of the isolated microorganism

20 20 Multidrug resistance in S. pneumoniae In Asia a very high % of S. pneumoniae isolates collected during were multi-drug resistant (to penicillin, erythromycin and ciprofloxacin) (Song et al, 2004) % resistant

21 21 Multidrug resistant cholera in Bangladesh is rapidly rising – over 7 months! Strains resistant to furazolidone, trimethoprim/sulphamethoxazole, tetracycline, and erythromycin Source: A.S.G. Faruque, J HEALTH POPUL NUTR 2007 Jun;25(2):

22 22 The current situation HIV/AIDS – lots of activity: lifelong therapy, industrialized market Main issue is price Malaria – after artemisinin, le déluge? Tuberculosis – much too little attention given the size of the problem! Industry not very interested, relying on PPPs Bacterial infections – many pathogens, short duration of therapy (7-10 d), complex Companies just not interested in this field! Need to use what we have as well as possible

23 23 A strategy for antibiotics – to use the little we have Much (perhaps most?) outpatient antibiotic use is for children, maternal, and adults with HIV Specifically for a few conditions: Pneumonia and ARI Diarrheal disease (often inappropriate) Infections Earache, throat Wounds and skin infections Tuberculosis (both children and adults, esp. w/ HIV) Maternal infections and sepsis If we get these right, major progress could be made

24 24 Drug Resistance: a West African snapshot

25 25 Political map of West Africa

26 Drug resistance challenges: selected findings on malaria 26 Chloroquine and sulphadoxine/pyrimethamine resistance has been reported throughout West Africa (Spencer et al 1986, Amukoye et al 1997, and in Ghana (Neequaye 1986, Koram et al, 2005) Led to change in treatment policy of ACTs across the sub region IMPACT o Huge resource allocation o Monotherapies still available o Substandard /counterfeit ACTs still circulating in the regional markets (Minzi et al,2003, Amin et al, 2005, Bates et al, 2008 )

27 27 Resistance of P. falciparum around the world: when to switch to ACT?

28 Drug resistance challenges: selected findings on TB and neglected diseases 28 Mycobacterium tuberculosis drug resistant to at least streptomycin, isoniazid and rifampin has been reported (van der Werf TS et al 1989, Lawn et al 2001, and Owusu- Dabo et al, 2006 ) o New medicines for TB slow to emerge o Situation exacerbated by HIV/AIDs co-infection Onchocerciasis worms non-responsive to ivermectin have been reported with an increase in the rate of re- population by adult worms (Osei-Antweneboana et al, 2007) Data on other neglected diseases is limited For example, concern has been raised about schistosomiasis and resistance to praziquantel…

29 In short: 29 Drug resistance is not limited to the developed world; indeed it is present in Sub-Saharan Africa with grave consequences The drivers of resistance are well known and very challenging for West Africa, stemming primarily from Weak health systems Behavioral issues – including, but also going beyond, those behaviors resulting from low literacy and high poverty levels Drug and diagnostics technologies – limited research in Africa It is clear that a global framework for action is required

30 30 Towards a common solution framework and a snapshot of potential recommendations

31 Common solution framework to address resistance across diseases 31 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

32 32 Common health system factors that drive resistance across diseases Key health system drivers include: Paucity or poor quality of resistance surveillance efforts Lack of connection between resistance situation and drug selection/procurement Lack of high-quality rapid diagnostic and monitoring tests and algorithms Lack of or poor quality services Lack of education and training among dispensers accompanied by poor monitoring and enforcement Lack of or weak implementation of infection control policies Direct/indirect costs of accessing services: one possible cause of poor adherence Lack of/poor implementation of regulations governing prescribing and dispensing Under and over-prescription of (usually broad-spectrum) antibiotics, when not clear pathogen is viral or bacterial = inappropriate drug use

33 33 Common behavioral factors that drive resistance across diseases Factors motivating or demotivating patients: Poor quality/lack of services Health worker attitudes Drug and supply availability and access Direct and indirect costs Community and/or family-level disease associated stigma Cultural preferences/beliefs Gender-related issues

34 34 Common behavioral factors that drive resistance across diseases (2) Factors motivating or demotivating providers: Who gains where financially along the patient- prescriber-dispenser (possible drug) transaction Poor quality/lack of diagnostic tests can lead to over- prescription Evidence that providers may not trust negative diagnostic result Cultural preferences/beliefs and gender-related issues Pharmaceutical industry efforts to influence prescribing behavior And there are also factors that motivate or demotivate behaviors during the patient-provider interaction

35 35 Common drug and drug technology factors that drive resistance Key drug and drug technology drivers include: Drug half-life Monotherapy favors acquired resistance; combination therapies are challenging to formulate What possibility is there that the pathogen will become re-sensitive to a given drug? Cross-resistance across and within drug classes Length and complexity of treatment: impact on adherence and resistance selection pressure Absolute levels of drug use, fitness and virulence What alternatives might there be to using drugs?

36 IssuesBacterial InfectionsTBMalariaHIV Inappropriate Use Contributes to Drug Resistance Yes Need for New Drug Development Yes Detection of Pathogen Reasonably Easy and Feasible 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 slowSomeNo Yes, but expensive and with limited availability Observed TreatmentNoYes DOTSNo Antimicrobial Treatment Single Agent, Short Duration Multiple Agents, Long Duration 1 Agent, Short DurationMultiple Agents, Lifelong HIV Interaction Some: Especially Nosocomial Risk Massive: Personal & Nosocomial Risk PossiblyN/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 Comparison of Disease-Related Resistance Issues (adapted from the 2001 WHO Global Strategy for Containment of Antimicrobial Resistance)

37 Snapshot of potential DRWG recommendations Health Systems: Establish cross-disease laboratory systems based on molecular technologies Build on WHONET to insert resistance into public health surveillance systems Add resistance to HealthMap and other informal surveillance systems Scale up ADDO/similar approaches to franchise or certify dispensers Proliferation of GMP Industry self-regulation for QA (e.g. ISO) Continuing professional education; the role of professional assns. and drug reps Behavioral: Cross-country drug regulatory networks (ex. WADRAN) Drug dispenser checklist (potential to work with FIP) Options to improve consumer education Technology: Public, web-based compound library showcase to accelerate early-stage product development Other: Health and Development Conference on Resistance 37

38 Conclusion Next steps Last working group meeting in early December to solidify recommendations Continue consultation sessions through to end January 2009 Launch WG report in April/May Outreach and dissemination IMPACT We need your thoughts: how to have input Please attend our open session on 20 November here in Bamako (Hotel Laico el Farouk 9:30-11:30, Room Kafo) to give input on our preliminary recommendations Sign up for Monthly CGD Drug Resistance e-newsletter 38

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