The Chain Reaction Pandemic Flu and the Medicines Supply Chain Michael Young MPI Department of Health PDIG Summer Symposium Thursday 5 th June 2008 (with thanks to Health Protection Agency and MICE Associates)‏

The Brief from PDIG 1. Flu Pandemic Myth or Reality? 2. How will the Supply Chain cope? 3. Key Strategic measures which will affect the whole Supply Chain?

Section 1 - Myth or reality? Seasonal, avian and pandemic influenza: Based on presentation given by Dr Nick Phin Pandemic Flu Office Health Protection Agency, Centre for Infections 23 rd January 2008 – Exercise Chain Reaction Briefing

The Influenza Paradigm There are known knowns - there are things we know we know. We also know there are known unknowns, that is to say, there are some things we do not know. But there are also unknown unknowns – the ones we don’t know we don’t know. Donald Rumsfeld

Overall clinical attack rate in previous pandemics

Pre-requisites for pandemic influenza ‘PAN’ (all) ‘DEMOS’ (people) = an epidemic that affects all people New influenza A sub-type: Haemagglutinin (H)‏ unrelated to immediate (pre-pandemic)‏ predecessor. Little or no pre-existing population immunity Causes significant clinical illness Efficient person-to-person spread

Public Health Measures (hygiene; masks; distancing; infection control, etc.)‏ Antibiotics Antivirals Pre-pandemic vaccine? Pandemic Specific Vaccine Defence in layers

Personal Hygiene Respiratory hygiene (“sneeze in your sleeve” – USA CDC; “coughs and sneezes spread diseases” UK DH)‏ Virus survival on ‘soft furnishings’ (such as sleeves) is relatively short Hand washing – evidence in school settings Adherence As yet, no embedded UK culture outside ‘health’

Pandemic Vaccine It may take 4-6 months or longer to produce a vaccine Unlikely to be available during early stages of a pandemic Not enough for everybody – production capacity Benefits of pre-pandemic vaccine?

Likely shape of the first Wave

Lessons learned from the past and the current situation in South East Asia maximum recorded interval between pandemics is 39 years – it could be soon (but it remains unpredictable)‏ the likely origin will be SE Asia – but we can’t say for sure global spread will be rapid – we either prepare now, or risk being caught by surprise may be several epidemic waves; first may be ‘milder’ than subsequent ones – sustainability and resilience will be key issues excess mortality and morbidity difficult to predict but may be high (but it doesn’t follow that the next pandemic will be like 1918)‏ overall population clinical attack rate is likely to be 25-33% there may be a shift towards younger age groups in terms of severity and mortality – with implications for business workforce

Section 2 – How will the UK medicines supply chain cope? Context In normal times we can experience shortages Pandemic Flu may be global sustained threat Most production is overseas

DH - mitigating actions so far National Pandemic Planning including –Antivirals – Stockpiles currently being increased to cover 50% of population –Antibiotics – Stockpile being created of 14.8 million courses –Possible Amendments to Medicines Legislation Consultation – response just published and next step agreed Exercise Chain Reaction (ECR) commissioned and held (facilitated by HPA and MICE Associates)

ECR Background Exercise Chain Reaction (ECR) – held 30 th January 2008 Looked at effect of pandemic influenza on community pharmacy supply chain Wide and high level representation from manufacturers, distributors, community pharmacy and dispensing doctors, associated pharmacy services and Government departments. Sessions on prescription sizes, panic buying, fuel supply difficulties, staff shortages Report on ECR from Health Protection Agency

1 st HPA inject re panic buying Play HPA DVD Bulletin 2 – re panic buying

ECR players concluded Immediate shortage likely and concern relating to impact on price Different mitigating options need to be considered Increase stocks – either nationally or encourage individuals to create their own buffers at home?

2 nd HPA inject re staff absence Play HPA DVD – Bulletin 4 – re staff absences

ECR players concluded Need for Business Continuity Planning Identify key staff Need for training and multiskilling Identify key tasks Need for remote working IT infrastructure

Issues raised by ECR players (1)‏ Need to maintain normality: - manufacture, distribution, supply and prescribing Likely to be increase in demand for some medicines which could lead to shortages Some current production on two year cycles Request for central co-ordination to support planning for priority products What if country with manufacturing HQ promotes restrictive practice?

Issues raised by ECR players (2)‏ Distribution – Fuel and security issues + possible need for joint distribution arrangements to ensure all pharmacies covered? Would DH request comprehensive review of legal and regulatory frameworks and establish emergency triggers to allow flexibility? Need to understand impact of trigger points in other countries

Issues raised by ECR players (3)‏ Supply and prescribing – need to keep to normal patterns (one month preferable) to support stable supply chain Need for guidance for professionals and public on what to expect and how to act to mitigate possibility of shortages.

Summary - Section 3 The key strategic measures that will affect the whole supply chain ? ECR Report being reviewed by DH DH legislative amendments – Summary of responses to initial consultation published and next steps technical consultation to take place over the summer, led by MHRA DH Pandemic Influenza National Framework and supporting guidance Business Continuity Plans – Are public organisations DH/SHAs/PCTs and private companies sharing their plans and co-ordinating action and resilience?