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Pandemic Preparedness EURIPA Conference Marseille Sept 2016
Jo Buchanan EURACT Introduce selves – why have come to this workshop EU FP7-HEALTH-2013-INNOVATION-1
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Conflict of Interest None Regular Family Doctor GP Educator
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Introductions
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Aim of workshop Background to pandemics Role of antivirals
Identifying issues for GPs/FDs during a pandemic Understanding the PREPARE project and WONCA’s role Identifying any ongoing learning needs I would like to thank EURIPA for inviting me to give this workshop. I am here as I represent WONCA Europe in the PREPARE project, I am not an expert on pandemics, but I am a practising GP and this project is particularly interesting and challenging as it is asking us as non experts to identify our learning needs in this area and how to fill them. However I have been working on the project for about 9 months so I am developing some understanding of the issues for health communities as we consider how to respond to a pandemic.
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Platform foR European Preparedness Against Re-emerging Epidemics
EU funded network to develop large scale clinical research studies on infectious diseases Aims to provide real time evidence for clinical management of infectious diseases Research studies already ongoing So let us start by understanding something about PREPARE and its activities
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Pandemic Influenza – history
Year Deaths 1918 Spanish flu 20-40 million 1957 Asian flu 1-4 million 1968 Hong Kong Flu 1 million 2009 200,00
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2009 – Pandemic declared How was it managed in your country?
How did it affect your practice? What did you learn from it?
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Pandemic Influenza New influenza virus circulates, population little or no immunity Once arrives in a country likely to spread to all major centres of population within 2 weeks Peaks – possibly as early as 50 days
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Pandemic Influenza contd
Clinical attack rate % Normal seasonal flu rate 5- 15% 50% those infected no symptoms 4% with clinical influenza may need hospital admission One third of patients likely to need a primary care clinician assessment Practice of 6000 patients 3-4 GPs additional 180 consultations in the peak week
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National responses Vary country to country Intensely political
Impact of social media
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Antivirals Mainly concerned with neuraminidase inhibitors
Ostelamivir [Tamiflu] Zanamivir [Relenza] Data from seasonal flu No randomised controlled trials in pandemics
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Jefferson et al Cochrane review 2014
Meta-analysis industry sponsored trials using primary data sources. Healthy participants Ostelamivir vs placebo approx pts Reduction of symptoms adults 16.8 hours, children 29 hours No effect on hospitalisations Reduction of self reported pneumonia – NNT 100 Increased nausea and vomiting As prophylaxis reduces the risk of developing influenza Cochrane Database Syst Rev Apr 10;(4):CD doi: / CD pub4. Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children. Jefferson et al
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Dobson et al 2015 Independent re-analysis – 9 trials
Symptom relief 25.2 hours Fewer lower respiratory tract infections needing antibiotics – NNT 26 Fewer hospitalisations – NNT 90 Increased nausea and vomiting Oseltamivir treatment for influenza in adults: a meta-analysis of randomised controlled trials Joanna Dobson Lancet Volume 385, No. 9979, p1729–1737, 2 May 2015
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Observational studies during pandemic – Muthurie meta-analysis
78 centres patients – confirmed H1N1 Primary outcome influenza related mortality Significant reduction if treated within 48hours Most benefit adults, pregnant women, critcally ill adults No benefit identified in children Impact of Neuraminidase Inhibitor Treatment on Outcomes of Public Health Importance During the 2009–2010 Influenza A(H1N1) Pandemic: A Systematic Review and Meta-Analysis in Hospitalized Patients Stella G. MuthuriJ Infect Dis Feb 15; 207(4): 553–563.
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Antiviral use by country in 2009 Pandemic
Country level data on use of antivirals Each 10% increase in Kgs ostelamivir per 100,000 population associated with a 1.6% reduction in mortality Supply of Neuraminidase Inhibitors Related to Reduced Influenza A (H1N1) Mortality during the 2009–2010 H1N1 Pandemic: An Ecological Study Paula E. Miller
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Figure 2. Fitted univariate poisson regression line and observed values for total influenza A (H1N1) mortality, per 100,000 people, by total oseltamivir supply, per 100,000, from April 2009 to August 2010, with corresponding 95% confidence intervals. Miller PE, Rambachan A, Hubbard RJ, Li J, Meyer AE, et al. (2012) Supply of Neuraminidase Inhibitors Related to Reduced Influenza A (H1N1) Mortality during the 2009–2010 H1N1 Pandemic: An Ecological Study. PLoS ONE 7(9): e doi: /journal.pone
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Use of Facemasks Limited evidence of effectiveness
May be effective as a bundle of personal protective measures such as hand hygiene Effectiveness likely to be related to consistent, correct usage and compliance – difficult to ensure Dept of health UK, 2014 A review of the scientific evidence for the use of Facemasks and respirators during an influenza pandemic
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Role of Vaccination Limited in the classical influenza pandemic
6 months from appearance of virus to first vaccine production When poor match for seasonal influenza vaccine – increase in cases and fatalities
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Scenario The health ministry has declared the outbreak of a pandemic virus with very little or no herd immunity. Public Health messages about staying at home whilst suffering from flu-like symptoms. Over the subsequent weeks it becomes clear that this strain of influenza has a particularly high fatality rate in people aged 40 to 60, and that a higher than usual proportion suffer from a more severe illness requiring assessment and possible antibiotic or respiratory support. This requires assessment of many potentially seriously ill adults in their homes. What are your first thoughts about this? Issues? Fears? How to manage?
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Platform foR European Preparedness Against Re-emerging Epidemics
EU funded network to develop large scale clinical research studies on infectious diseases Aims to provide real time evidence for clinical management of infectious diseases Research studies already ongoing So let us start by understanding something about PREPARE and its activities
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Why? Lessons learnt from previous epidemics:
Research difficult to coordinate quickly Ensuring findings are implemented is difficult e.g. H1N1 it took 9 months to learn and disseminate that 40% of deaths in children were from secondary staph infection with MRSA Ebola – IV fluids crucial to survival Zika – clinical course not well understood. Why would the EU seek to devote a significant amount of money to this project? Does not the European Centre for Communicable Disease control deal with this area. Well it has been developed because of some very real problems in the management of pandemics and emerging infections.
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Five pillars The project has five themes looking at the causes, clinical management, diagnostics and how to share research findings. Then underpinning all this is the CREATE Virtual Learning Platform. I will explain some of the activities of the work packages that are relevant to us in FM.
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WP 1 & 2 WP 1 EARL – Identify the barriers to rapid set up of clinical trials Regulatory frameworks Funding Intellectual property Goal is to develop a fast track system WP 2 PRIME – Clinical counterpart to EARL – identify the clinical bottlenecks Harmonising case definition Developing pre-approved protocols for large multi-site clinical studies
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WP 3 PRACTICE Large scale prospective observational study of infections with epidemic potential will Focus on: Acute respiratory infections Central Nervous system infections Severe acute diarrhoea Severe undifferentiated fever syndrome
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WP 4 PRACTICE Largest-ever pragmatic, publically funded randomised trial of antivirals for influenza like illness in primary care. Cost effectiveness Which groups most helped 20 primary care research networks across Europe Open adaptive trial methodology
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Influenza like Illness
Influenza like Illness? A rCt of Clinical and Cost effectiveness in primary CarE (ALIC4E) Chris Butler, Theo Verheij, Alike van der Velden, Johanna Cook Venice 2015. Funded by the European Union
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ALIC4E: aim and design Aim:
To assess cost effectiveness of oseltamivir in children, adults and elderly with influenza-like illness in primary care To assess the diagnostic value of a new rapid influenza test Design: Adaptive open clinical trial in 20 EU countries among around 4800 study subjects Data collection October April 2018
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WP 5, 6 & 7 WP 5 PRACTICE C – Interventions in Intensive Care for pts with community acquired pneumonia, aiming for sites. WP 6 PATHOS – Looking at pathophysiology of severe acute respiratory infections to identify gaps in knowledge. Also looking at host gene expression profiles WP 7 PREDICT Protocols for standardised collection of samples and detection of pathogens.
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WP 8, 10 & 11 WP 8 CRISP – Data management for all data collected within PREPARE WP 10 – DEAN – Communication - Promote PREPARE results WP 11 Coordination – Management framework for PREPARE
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WP 9 CREATE -Clinical Research and Education and Training in Europe
WP9 or CREATE - to develop a virtual learning centre as a resource for hospital and primary care specialists, aimed at ensuring the incorporation of existing evidence based practice and new findings from research in the response to severe infectious disease outbreaks. Led by Professor Anita Simmonds Respiratory Physician, London. WONCA Europe is a partner in CREATE – our role is to develop materials for the Virtual Learning Centre
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Educational needs for Primary Care already identified
Research methodology Encouraging recruitment to trials Good Clinical Practice Clinical updates on diagnosis and management of influenza Management of epidemics in daily primary care Use of diagnostics Infection control principles
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