Health Equity: 09/09/10

Thursday, September 9, 2010

[EQ] Antibiotic Resistance: Implications for Global Health and Novel Intervention Strategies

Antibiotic Resistance: Implications for Global Health and Novel Intervention Strategies:
Workshop Summary

Eileen R. Choffnes, David A. Relman, and Alison Mack, Rapporteurs
Forum on Microbial Threats; Institute of Medicine IOM - ISBN: 0-309-15612-2 - (2010)

US Board on Global Health

Available online at: http://bit.ly/8ZDOPK

“……Infectious diseases remain among the leading causes of morbidity and mortality on our planet. The development of resistance in microbes—bacterial, viral, or parasites—to therapeutics is neither surprising nor new. However, the scope and scale of this phenomenon is an ever increasing multinational public health crisis as drug resistance accumulates and accelerates over space and time.

Today some strains of bacteria and viruses are resistant to all but a single drug, and some may soon have no effective treatments left in the “medicine chest.” The disease burden from multidrug-resistant strains of organisms causing AIDS, tuberculosis, gonorrhea, malaria, influenza, pneumonia, and diarrhea is being felt in both the developed and the developing worlds alike.

The accelerating growth and global expansion of antimicrobial1 resistance (hereinafter referred to as AMR) is a demonstration of evolution in “real time” in response to the chemical warfare waged against microbes through the therapeutic and non-therapeutic uses of antimicrobial agents. After several decades in which it appeared that human ingenuity had outwitted the pathogens, multidrug-resistant “superbugs” have become a global challenge, aided and abetted by the use, misuse, and overuse of once highly effective anti-infective drugs. …”

“…..Pathogens resistant to multiple antibacterial agents, while initially associated with the clinical treatment of infectious diseases in humans and animals, are increasingly found outside the healthcare setting. Therapeutic options for these so-called community-acquired pathogens, such as methicillin-resistant Staphylococcus aureus (MRSA) are extremely limited, as are prospects for the development of the next generation of antimicrobial drugs.

On April 6 and 7, 2010, the Institute of Medicine’s (IOM’s) Forum on Microbial Threats convened a public workshop in Washington, DC, to consider the nature and sources of AMR, it implications for global health, and strategies to mitigate the current and future impacts of AMR.

Through invited presentations and discussions, participants explored the evolutionary, genetic, and ecological origins of AMR and its effects on human and animal health worldwide.

Participants also discussed host and environmental factors associated with the expansion of AMR; strategies for extending the useful life of antimicrobials; alternative approaches for treating infections; incentives and disincentives for prudent antimicrobial use; and prospects for the discovery and development of ”next generation” antimicrobial therapeutics. While it was the “intent” of the workshop planners and organizers to cover the phenomenon of AMR broadly, workshop presentations and discussions focused almost exclusively on bacterial resistance to antibacterial drugs……”

Contents

Workshop Overview References

Contributed Manuscripts:

- The Case for Pathogen-Specific Therapy

- Waves of Resistance: Staphylococcus aureus in the Antibiotic Era

- Sublethal Antibiotic Treatment Leads to Multidrug Resistance via Radical-Induced Mutagenesis

- Antibiotic-Induced Resistance Flow

- Actinobacteria: The Good, The Bad, and The Ugly

- Antibiotics for Emerging Pathogens

- Averting a Potential Post-Antibiotic Era

- Antibiotic Effectiveness: New Challenges in Natural Resource Management

- The Role of Health Care Facilities

- Challenges and Opportunities in Antibiotic Discovery

- Responding to the Global Antibiotic Resistance Crisis: The APUA Chapter Network

- Population Mobility, Globalization, and Antimicrobial Resistance

- Population Mobility, Globalization, and Antimicrobial Drug Resistance

- The Bacterial Challenge: A Time to React, Executive Summary
- The Effects of Antibiotic and Pesticide Resistance on Public Health

- Clinical Issues and Outcomes Associated with Rising Antimicrobial Resistance

- WHO Activities for Control of Antimicrobial Resistance Due to Use of Antimicrobials in Animals Intended for Food

- The Antibacterial Pipeline: Why Is It Drying Up, and What Must Be Done About It?

- Challenges in Antimicrobial Susceptibility Testing of Clinical and Environmental Isolates

- Measuring the Cost of Antimicrobial-Resistant Infections: The Feasibility and Accuracy of Economic Analysis Using Electronic Medical Record Databases

- The Antibiotic Resistome

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[EQ] Policies and incentives for promoting innovation in antibiotic research

Policies and incentives for promoting innovation in antibiotic research

Elias Mossialos, Chantal M Morel, Suzanne Edwards, Julia Berenson, Marin Gemmill-Toyama, David Brogan

This study was commissioned and financed by theSwedish Government

World Health Organization 2010, on behalf of the European Observatory on Health Systems and Policies

Available online PDF [224p.] at: http://bit.ly/aEepeE

“……Bacterial resistance to currently available antibiotics is becoming increasingly frequent in both hospital and community settings. We are even starting to see resistance to entire antibiotic classes such as beta-lactams, quinolones, tetracyclines, glycopeptides and macrolides.

Resistance to antibiotics presents a major challenge in health care as resistant bacteria dramatically decrease the chances of treating infections effectively and increase the risk of complications and death (ReAct – Action on Antibiotic Resistance 2007). Within the European Union (EU) alone it is estimated that 2 million patients acquire nosocomial infections each year (European Academies Science Advisory Council 2007), over half of which are drug resistant (Vicente et al. 2006). Coupled with the lack of investment to discover new antibiotics, we are facing a potential health crisis. In response to this growing threat, in December 2009 the Council of the European Union called upon the European Commission (EC) 6 to:

within 24 months, develop a comprehensive action-plan, with concrete proposals concerning incentives to develop new effective antibiotics, including

ways to secure their rational use; and ensure that these proposals take account of the economic impact on the financial sustainability of healthcare systems.

Around the same time the United States joined forces with the EU to help tackle the issue through the formation of a transatlantic taskforce on antimicrobial

resistance.7 This book is intended to help shed light on some of the key policies and incentives proposed to tackle this problem…..”

Content:

Introduction

Chapter 1 Background on antibiotics

1.1 What are antibiotics?

1.2 Why antibiotics are important

1.3 Externalities of antibiotics and AR

Chapter 2 Background on AR

2.1 What is AR?

2.2 Severity of AR

2.2.1 AR trends in developed countries

2.2.2 AR trends in developing countries

2.3 Clinical and economic impact of AR

2.3.1 Clinical outcomes

2.3.2 Costs of resistance

Chapter 3 Causes of AR

3.1 Misuse of antibiotics

3.1.1 Physicians and health-care providers

3.1.2 Livestock and agriculture

3.2 Role of diagnostics in AR

3.3 Role of vaccines in AR

3.3.1 Examples from Europe

3.3.2 Examples from the United States

3.4 Lack of new antibiotics

3.4.1 The antibiotic market

3.4.2 Areas of unmet need

Chapter 4 Reasons for limited innovation

4.1 Antibiotic restrictions deter pharmaceutical investment in R&D 49

4.2 Challenges in the antibiotics market – NPV

4.3 Regulatory environment

4.4 Estimated cost of drug development

4.5 Scientific challenges

Chapter 5 Health system responses to AR

5.1 Examples from Europe

5.2 Examples from the United States

Chapter 6 Analysis of opportunities and incentives to stimulate R&D for antibiotics

6.1 Push incentives

6.1.1 Increasing access to research

6.1.2 Scientific personnel

6.1.3 Direct funding of research

6.1.4 Translational research

6.1.5 Tax incentives

6.1.6 PDPs

6.2 Pull incentives

6.2.1 Monetary prizes

6.2.2 Advance market commitments

6.2.3 Patent buyout

6.3 Lego-regulatory mechanisms

6.3.1 Clinical trials

6.3.2 Intellectual property mechanisms

6.3.3 Expedited regulatory review

6.3.4 Pricing and reimbursement

6.3.5 Liability protection

6.3.6 Antitrust laws

6.3.7 Sui generis rights

6.4 Combined push-pull incentive models

6.4.1 Orphan drug designation

6.4.2 Call options for antibiotics model

Chapter 7 Conclusions

7.1 Rationale for intervention in the antibiotics market

7.2 Preserving the effective life of existing and new antibiotics

7.3 Key concepts in incentive design

7.4 Conclusions on individual incentives

7.4.1 Direct public subsidy for basic research

Appendix A. EU Council conclusions on innovative incentives

Appendix B. US-EU joint declaration on creation of transatlantic taskforce on antimicrobial resistance

Appendix C. Global vaccine research

Appendix D. Possible funding mechanisms for a COA scheme

References

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[EQ] Key factors influencing adoption of an innovation in primary health care

Key factors influencing adoption of an innovation in primary health care:
a qualitative study based on implementation theory

Siw Carlfjord 1 , Malou Lindberg 2 , Preben Bendtsen 1 , Per Nilsen 1 and Agneta Andersson 2

1 Department of Medical and Health Sciences, Linköping University, Linköping, Sweden

2 R&D Department of Local Health Care, County Council of Östergötland, Linköping University, Linköping, Sweden
BMC Family Practice 2010, 11:60doi:10.1186/1471-2296-11-60 - Published: 23 August 2010

Available online at: http://bit.ly/d1dqIo

Background: Bridging the knowledge-to-practice gap in health care is an important issue that has gained interest in recent years. Implementing new methods, guidelines or tools into routine care, however, is a slow and unpredictable process, and the factors that play a role in the change process are not yet fully understood. There is a number of theories concerned with factors predicting successful implementation in various settings, however, this issue is insufficiently studied in primary health care (PHC). The objective of this article was to apply implementation theory to identify key factors influencing the adoption of an innovation being introduced in PHC in Sweden.

Methods: A qualitative study was carried out with staff at six PHC units in Sweden where a computer-based test for lifestyle intervention had been implemented. Two different implementation strategies, implicit or explicit, were used. Sixteen focus group interviews and two individual interviews were performed. In the analysis a theoretical framework based on studies of implementation in health service organizations, was applied to identify key factors influencing adoption.

Results: The theoretical framework proved to be relevant for studies in PHC. Adoption was positively influenced by positive expectations at the unit, perceptions of the innovation being compatible with existing routines and perceived advantages. An explicit implementation strategy and positive opinions on change and innovation were also associated with adoption. Organizational changes and staff shortages coinciding with implementation seemed to be obstacles for the adoption process.

Conclusion: When implementation theory obtained from studies in other areas was applied in PHC it proved to be relevant for this particular setting. Based on our results, factors to be taken into account in the planning of the implementation of a new tool in PHC should include assessment of staff expectations, assessment of the perceived need for the innovation to be implemented, and of its potential compatibility with existing routines. Regarding context, we suggest that implementation concurrent with other major organizational changes should be avoided. The choice of implementation strategy should be given thorough consideration…..”

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[EQ] Medical devices: managing the mismatch: an outcome of the priority medical devices project - Global Forum

Medical devices: managing the mismatch:
an outcome of the priority medical devices project

ISBN 978 92 4 156404 5 (NLM classification: WX 147) -
World Health Organization 2010

Available online PDF [36p.] at: http://bit.ly/brPeBd

“….Medical devices are important to provide health care and to improve the health of individuals and populations. The World Health Organization (WHO) recognizes this. One of WHO’s strategic objectives is to ensure improved access, quality and use of medical devices. Without medical devices, routine medical procedures—from bandaging a sprained ankle, to diagnosing HIV/AIDS or implanting an artificial hip—would be impossible. Concurrently, modern technology is producing an overwhelming abundance of medical devices at a rate that soon makes the latest device obsolete.

Key issues affecting progress include the extreme diversity of the medical device arena—diverse in terms of types of devices, degrees of complexity, applications, usage, users and categories and issues like the context dependency of medical devices and research in medical devices often not based on public health needs.

However, as a crucial component of health care, medical devices will be most effective when considered in the wider context of the complete health-care package necessary to address public health needs: prevention, clinical care (investigation, diagnosis, treatment and management, follow up, and rehabilitation) and access to appropriate health care. Therefore, rather than just focusing on the technological issues involved in medical devices, it is necessary to frame medical devices in another way—as an agenda to improve global access to appropriate medical devices.

This agenda is composed of the crucial “4 As”—Availability, Accessibility, Appropriateness, and Affordability.

These four components help to widen the scope of the medical device agenda so that it does not just focus on “upstream” innovation efforts but also on choosing which medical devices to procure in a rational way, responding to the needs, and in ensuring that they are used as effectively as possible to best improve health….”

The First Global Forum on Medical Devices
The World Health Organization is pleased to announce the First Global Forum on Medical Devices to be held 9-11 September, 2010 in Bangkok, Thailand. A webcast is available to view the sessions. Overview

Watch the webcast live

Baseline country survey: http://www.who.int/medical_devices

Medical devices: managing the mismatch – Contents

Overview

1. Introduction 1

1.1 Prioritizing medical devices: setting the scene

1.2 The Priority Medical Devices project

1.3 The mismatch

1.4 This report

2. Medical devices

2.1 Medical devices: what’s in a name?

2.2 Past, present, and future

2.2.1 Recent key trends

2.2.2 Future trends

2.3 Assistive products

2.4 Pharmaceuticals and medical devices: similarities and differences

2.4.1 Access to essential medicines

2.4.2 Access to appropriate medical devices

2.5 The medical device market

2.6 Medical device regulation

2.7 An introduction to medical device innovation

2.7.1 Applying non-medical innovation to health care

3. Public health needs

3.1 A health-based approach to choosing medical devices

3.2 Identifying current and future public health needs

3.2.1 Disability

3.2.2 Global trends

3.3 Public health: the missing research target

3.3.1 Drivers of research

3.4 The gap

4. Priority Medical Devices project: methods used

4.1 Methodology

4.1.1 Identifying key medical devices in high-burden diseases

4.1.2 Identifying the medical device gap

4.2 Results

4.2.1 Identifying key medical devices in high-burden diseases

4.2.2 Identifying the medical device gaps

4.3 Identifying key assistive products for high-burden diseases

5. Medical devices: problems and possible solutions

5.1 Choosing medical devices

5.1.1 Barriers to choosing medical devices

5.1.2 Possible solutions to overcoming these barriers

5.2 Using medical devices

5.2.1 Barriers to using medical devices

5.2.2 Overcoming barriers to using medical devices

5.3 Medical device innovation

5.3.1 Barriers to innovation

5.3.2 Barriers to appropriate innovation uptake

5.3.3 Overcoming the barriers to medical innovation

5.4 Assistive devices

5.5 Emerging themes

5.5.1 Applying the 4 As to medical devices and medical interventions

6. Towards appropriate medical devices: options for future research

6.1 Methodology

6.2 Results

6.2.1 Scoping exercise

6.3 Future research areas in cross-cutting areas

6.3.1 Study design and clinical outcome

6.3.2 Laboratory diagnostic tools

6.3.3 Telemedicine and labour-saving technologies

6.3.4 Safe injections

6.4 Future research areas in global high-burden diseases

6.4.1 Perinatal conditions

6.4.2 Lower respiratory tract infections

6.4.3 Unipolar depressive disorders

6.4.4 Ischaemic heart disease

6.4.5 Cerebrovascular disease (stroke)

6.4.6 HIV/AIDS

6.4.7 Road traffic accidents

6.4.8 Tuberculosis

6.4.9 Malaria

6.4.10 Chronic obstructive pulmonary disease

6.4.11 Cataract

6.4.12 Hearing loss

6.4.13 Alcohol use disorders

6.4.14 Diabetes mellitus

6.5 Future trends in high-burden diseases

6.5.1 Alzheimer disease and other dementias

6.5.2 Cancer (malignant neoplasms)

6.5.3 Osteoarthritis

6.6 A possible way forward

References

Glossary

Annex 1 List of background papers and methods used in preparing the report

1. A stepwise approach to identifying gaps in medical devices (Availability Matrix and survey methodology)

2. Building bridges between diseases, disabilities and assistive devices: linking the GBD, ICF and ISO 9999

3. Clinical evidence for medical devices: regulatory processes focusing on Europe and the United States of America

4. Increasing complexity of medical devices and consequences for training and outcome of care

5. Context dependency of medical devices

6. Barriers to innovation in the field of medical devices

7. Trends in medical technology and expected impact on public health

8. Future public health needs: commonalities and differences between high- and low-resource settings

Annex 2 Conflict of interest statement

Annex 3 Steering bodies of the Priority Medical Devices project

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