HC 499 - Scientific advice and evidence in emergencies

Memorandum submitted by the British Medical Association
(SAGE 32)

Executive Summary

· The UK had been preparing for pandemic flu for several years prior to the H1N1 pandemic in 2009. Although the UK is one of the best prepared countries for a pandemic, the H1N1 flu pandemic highlighted a number of challenges such as ensuring consistent service-wide demand management; the maintenance of adequate staffing levels; and effective engagement of all areas of the National Health Service (NHS). The UK’s preparations were beneficial in the event of the H1N1 pandemic, but it must be emphasised that the H1N1 virus was a ‘mild’ flu virus, and planning for future pandemic scenarios should be based on the worst case possibilities.

· During the containment phase of the H1N1 pandemic, a shortage of staffing capacity amongst public health doctors, general practice and in laboratories providing analysis of swabs taken from suspected H1N1 carriers meant that the pandemic surveillance efforts stretched these bodies to the limit, hampering their ordinary work and slowing down analysis of the pandemic spread. Demands for epidemiological information should be streamlined and coordinated in the event of a future pandemic.

· The provision of certain scientific information and evidence to the frontline medical staff dealing with the pandemic response was subject to delay, causing confusion amongst doctors. Doctors felt overwhelmed by the sheer volume of scientific (and operational) information with which they were presented, and a clearer, more coordinated system of cascading information to ordinary doctors should be developed.

· The Government’s use of scientific information in devising the pandemic flu response plan was beneficial but the provision of more information on the scientific evidence underpinning the decision to widely distribute antiviral medication would have been appreciated by doctors. Publication of scientific evidence regarding the safety of the H1N1 vaccine with regards to pregnant women and their unborn babies should have been distributed to midwives at an earlier stage. Clear information on the side effects of antivirals would have calmed the anxiety of patients suffering from their side effects.

· Organisational cooperation on local, national and international levels helped to assess the capacity of organisations to deal with the H1N1 flu pandemic. It facilitated both the relay of information for the monitoring of the pandemic and the dissemination of scientific information amongst relevant bodies. The 2009 pandemic helped to develop links between organisations in practice, and enabled identification of the most relevant body to provide information on different matters.

About the BMA

1. The British Medical Association (BMA) is an independent trade union and voluntary professional association which represents doctors and medical students from all branches of medicine all over the UK. With a membership of over 143,000 worldwide, the BMA promotes the medical and allied sciences, seek to maintain the honour and interests of the medical profession and promote the achievement of high quality healthcare.

Introduction

2. The UK has been preparing for a pandemic flu outbreak for a number of years and a very wide range of guidance has been developed through joint working between the Department of Health (DH) and the devolved administrations, the Health Protection Agency (HPA), the BMA, the Royal College of GPs (RCGP) the College of Emergency Medicine and the Royal College of Nursing, amongst others.

3. Although the UK is one of the best prepared countries for a pandemic, the H1N1 flu pandemic highlighted a number of challenges such as ensuring consistent service-wide demand management; the maintenance of adequate staffing levels; and effective engagement of all areas of the National Health Service (NHS).

With regards to scientific advice and evidence, what are the potential hazards and risks and how were they identified?

Morbidity and mortality directly related to infection with H1N1 flu

4. Early indications from experience of H1N1 flu infections in Mexico suggested a very high mortality rate (above that modelled pre-pandemic), but this was not borne out by UK and global experience.

Hine, D (2010) The 2009 Influenza Pandemic An independent review of the UK response to the 2009 influenza pandemic . London : Cabinet Office

www.cabinetoffice.gov.uk/media/416533/the2009influenzapandemic-review.pdf

Insufficient health service resources

5. The first ten weeks of the pandemic – the containment phase - were used to allow the NHS time to set up its pandemic response. This phase was characterised by evolving epidemiology, and attempts to contain all cases of H1N1 infection. This period was particularly difficult for HPA doctors and GPs, in terms of the complexity of management, lack of (human) resources, and the requirements for the collection of information to inform rapidly changing health policy.

6. It has been estimated that undertaking containment delayed the pandemic in the UK by several weeks compared to countries that did not do this, and this was valuable in giving the NHS time to prepare for the treatment phase.

British Medical Journal (15 July 2009) How well are we managing the influenza A/H1N1 pandemic in the UK? (BMJ 2009; 339 :b2897 )

www.bmj.com/content/339/bmj.b2897.full?sid=4af8291e-afea-4e68-a473-f259f305d8b6

7. Public health doctors in the HPA and in PCOs were heavily involved in planning for pandemic flu and the response to it. Public health doctors and frontline medical staff worked extremely long hours in difficult circumstances for protracted periods, often with insufficient rest time.

8. Setting up for the treatment phase was extremely labour intensive. On a local basis, preparation for the treatment phase relied heavily on individual public health doctors working in PCOs, who had to also simultaneously ensure that the rest of their remit was delivered as normal.

9. Modelling of the effects of pandemic flu relied on accurate estimates of the available healthcare workforce. Double counting occurred with regards to some GPs who worked during the day and undertook Out of Hours (OOH) work in a different role. The volume of calls to GP surgeries and OOH services, as well as NHS Direct, meant that there was a high risk that patients suffering from serious-non flu illnesses would experience a delay in diagnosis, which could severely affect their prognosis.

Information demands

10. In response to demands for information from the Cabinet Office and Chief Medical Officer (CMO), the HPA requested a range of information from public health doctors, and PCOs requested information from GPs. The number and nature of organisational and governmental information demands led to a huge workload and this diverted healthcare staff away from the frontline planning and delivery of services.

11. Public health doctors were required to submit information on the number of local H1N1 cases, the number of contacts per case, the clinical outcome per case and the duration of symptoms, which was essential to monitor the spread and severity of the disease spread. Information which was far less pertinent to the clinical monitoring of the pandemic was also requested from doctors, such as on the number of hours spent on H1N1 work by grade of employment and the names of family contacts of clinical staff.

12. Some PCOs requested that GPs complete detailed pandemic influenza investigation forms for every suspected case of H1N1 infection that they encountered. Such requests were uncoordinated and disruptive to doctors’ work during a period of high demand for their services. Due to the demands placed on public health doctors, GPs had to carry out most of the swabbing of patients with suspected H1N1 infection, using up further staff time during the busy period of pandemic flu response.

13. In the containment phase, healthcare workers were required to swab patients and patients’ contacts suspected to have contracted the H1N1 virus. Contact tracing of symptomatic patients was also required, in order to provide information on the spread of the disease to the HPA. These activities took up a further proportion of health professionals’ time in a period of high demand for their services.

14. As a consequence of the difficulties encountered in terms of information demands, the BMA recommends for the future that organisational and governmental information demands on public health and frontline healthcare staff are streamlined in future contingency situations.

Maintaining normal service for other services

15. Maintaining the response to swine flu took up so much public health, GP, OOH GP services and intensive care resources that it was not possible or very difficult to properly maintain other services. The impact of this has not been quantified.

16. During the first three months of the pandemic, public health doctors were unable to carry out their normal business continuity work, as there was insufficient staffing to also carry out the more urgent pandemic related tasks – provision of advice on how to respond to the flu at a public level, contact tracing and reporting activities. Public health staff were also requested to travel, with very little notice, to pandemic ‘hotspots’ in London and Birmingham in order to contribute to the flu response efforts in these cities.

17. During the containment phase of the pandemic, GPs had to swab all patients with suspected H1N1 infection, carry out home visits to patients with suspected flu, submit detailed information on H1N1 cases and provide much advice and reassurance to patients anxious about the pandemic. In ‘hotspot’ areas of H1N1 infection, GP practices had to suspend non-urgent activities such as medicines use reviews and elements of work connected with the Quality and Outcomes Framework (following negotiation between the NHS Employers and the BMA’s General Practitioners Committee to ensure that this did not impact adversely upon practice incomes).

18. The analysis of the swabs of suspected H1N1 patients was slow, due to the intense demands on public health laboratories. In some cases, swab samples were sent by couriers to distant laboratories, further slowing down the communication of the results of the analysis, heightening patient anxiety.

19. OOH GP services were severely stretched by responding to the pandemic flu. In many areas, OOH doctors carried out home visits to swab suspected H1N1 victims. The volume of calls to OOH services in the flu ‘hotspots’ of London, Birmingham and Glasgow was extremely high at the peak of the pandemic, resulting in delays of several hours in responding to less urgent cases.

20. In intensive care units (ICUs), patients suffering from complications related to contraction of the H1N1 virus took up beds, eliminating extra capacity for further patients. There were only a very low number of specialist paediatric ICU places available, and measures had to be taken to adapt adult ICU facilities for children. Extracorporeal membrane oxygenation (ECMO) facilities were also taken up by patients suffering from H1N1-related complications, and the number of available facilities had to be increased during the pandemic.

Issues with the provision of scientific advice to frontline healthcare staff

21. Pandemic flu guidance for use in periods of an extreme surge in demand for medical services - Pandemic flu Managing Demand and Capacity in Health Care Organisations. (Surge ) - was published in April 2009.

Department of Health (2009) Pandemic flu: Managing Demand and Capacity in Health Care Organisations. (Surge) . London : Department of Health www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/documents/digitalasset/dh_098750.pdf

22. During the initial stages of the pandemic, GPs required information on how to minimise transmission of the H1N1 virus. The BMA’s General Practitioners Committee received many queries from GPs on the use of face marks, overalls, goggle, gloves and respirators (personal protective equipment - PPE), and the type of equipment to use. Doctors were unsure when to use PPE (for example, when visiting people suspected to have contracted the H1N1 virus, or when carrying out certain medical procedures on any patients), and which items to use. Definitive information on the use of PPE from the HPA was not provided for several weeks.

23. GPs were given confused messages about the prescription of antiviral medication in a prophylactic capacity. For example, in cases where people contracted H1N1 and had close contacts who were at risk from developing serious complications if they contracted the virus, it was advised by the CMO that prophylactic antivirals be administered to the vulnerable contacts, whereas local specialists (such as microbiologists) advised that antivirals were not to be used in a prophylactic capacity. Such contradictory messages were reinforced by the antiviral voucher system. Antiviral vouchers enabled symptomatic patients to obtain antivirals for treatment purposes only, with no provision for prophylactic purposes possible. Doctors were unable to prescribe antivirals (for prophylactic or treatment purposes) due to the regulations surrounding the system of antiviral voucher provision.

24. There were delays in the provision of information on the administration and storage of the H1N1 vaccines, which was required by GPs in order to effectively plan for vaccination clinics. The development of an H1N1 vaccine by the major pharmaceutical companies (the Baxter Celvapan and Glaxosmithkline’s Pandemrix) took time, and it was therefore not possible for full information on the vaccine storage tolerances and detailed logistics to be disseminated prior to its final development. Final vaccine distribution and storage logistical information could not be issued until the conclusion of Government negotiations regarding the supply contract of H1N1 vaccines. It is unlikely that fuller information on the vaccines could have been supplied to doctors at an earlier stage of the planning process.

25. Doctors felt overwhelmed by the volume of information about the H1N1 pandemic issued by various bodies, such as the HPA, RCGP, BMA, DH, PCOs and Local Medical Committees (LMCs). Key advice was lost within the large quantity of emails received, which often duplicated information already disseminated by other organisations. The specific highlighting of any changes to advice and evidence, and provision of information at the top of the email body, would have aided doctors in assimilating changes to information.

26. The BMA believes that in future, essential scientific information should be clearly marked and consistent. Organisations disseminating such information should coordinate their releases to minimise repetition.

27. Sessional GPs were heavily involved in responding to the H1N1 pandemic.

Sessional GPs are fully qualified GPs who are either have a contract to provide for contractor or a PCO, providing GP cover for a specified period or working on a freelance basis; or are employed by a practice, PCO or alternative provider of medical services.

28. The scientific evidence upon which the English policy of distributing antiviral medication was devised should have been made readily available to clinicians. In the professional clinical opinion of many doctors, there was no reason for healthy adults with no underlying health problems to take antivirals, and the H1N1 virus was a mild strain of flu. The policy of wide scale distribution of antivirals to all symptomatic patients undermined the clinical judgement of such doctors. Doctors do not tend to prescribe antivirals to symptomatic but otherwise healthy patients for seasonal flu. It is also notable that antiviral medication was not distributed to all symptomatic patients in Northern Ireland, Scotland and Wales on the same scale as it was in England during the H1N1 pandemic, and that this did not lead to higher morbidity and mortality rates from H1N1 in these countries. Doctors feared that the policy of distributing large quantities of antiviral medication was based on economic, rather than scientific reasoning.

29. GPs reported cases in which midwives advised pregnant women against receiving H1N1 vaccination, claiming that it had not been fully tested and could harm their baby. Pregnant women were at risk of developing complications in the case of contracting H1N1. Immunisation would reduce such a risk. Clear and direct communications to midwives of scientific evidence regarding the safety of the H1N1 vaccination could have helped to overcome this issue. Additionally, it was not beneficial for pregnant women to receive messages from their doctors (urging H1N1 vaccination) and midwives (advising against vaccination).

Identification of risks and hazards associated with a flu pandemic

30. Since 2008, the BMA’s General Practitioners Committee has been involved in working with representatives of the DH and the RCGP in order to develop guidance for use by GPs in the case of a flu pandemic. This guidance, Pandemic influenza Guidance for GP practices, was first published in January 2009.

British Medical Association and Royal College of General Practitioners (2009) Pandemic influenza - Guidance for GP practices: Swine flu H1N1 preparedness London: British Medical Association

www.bma.org.uk/images/panfluguide_tcm41-192666.pdf

31. In 2006, the BMA provided evidence to the House of Lords Science and Technology Committee regarding the response to a flu pandemic, helping to highlight the potential problems which had to be considered in devising the healthcare response to a flu pandemic.

House of Lords Science and Technology Committee (2005) Science and Technology Committee 4th Report of Session 2005-06 – Pandemic Influenza: Report with Evidence London: The Authority of the House of Lords

How prepared is/was the Government for the emergency?

32. The UK was well prepared for the H1N1 pandemic flu emergency, especially in comparison with the response readiness of other developed countries.

Hine, D (2010) The 2009 Influenza Pandemic An independent review of the UK response to the 2009 influenza pandemic . London : Cabinet Office

www.cabinetoffice.gov.uk/media/416533/the2009influenzapandemic-review.pdf

33. The BMA maintains that the experience of the healthcare response to the H1N1 pandemic must not lead to complacency or undermine plans to deal with future pandemics. The BMA also believes that pandemic planning must continue along a "plan for the worst case and hope for the best case" basis.

34. Following the H1N1 pandemic in 2009, the links between the organisations – DH, HPA, PCTs, SHAs, LMCs, Royal Colleges of Medicine, BMA and public health dealing with and providing information on pandemic flu have been strengthened, improving the preparedness of the UK to deal with future pandemics.

How does/did the Government use scientific advice and evidence to identify, prepare for and react to an emergency?

35. The Government utilised information derived from the previous pandemics of 1918-19, 1957-58 and 1968-69 to plan well for future ones

Department of Health (2002) Explaining pandemic flu: A guide from the Chief Medical Officer London: Department of Health

www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4121749.pdf

36. The UK’s involvement in the World Health Organisation Global Influenza Surveillance Network, providing international disease tracking and epidemiology, helped to identify the emergent threat from the H1N1 virus in good time.

37. The epidemiology undertaken during the containment phase was properly used to develop and refine clinical algorithms as the pandemic progressed. The number and frequency of these refinements meant it was difficult to ensure all clinical staff that needed to know were always up to date with the most recent advice.

38. In the response to the H1N1 pandemic, the clinical algorithms used by non-clinically trained call handlers at the Flu Line were effective for the provision of advice to callers with mild symptoms of the H1N1 virus, but did not result in the correct advice being provided to callers who had more complex or severe symptoms, or who were at greater risk from complications from the flu virus. The National Patient Safety Agency was notified of many incidents relating to delayed or missed diagnosis of "other" conditions mistakenly labelled initially as "flu" by call handlers.

39. The CMO’s monitoring and weekly announcement of key indicators was found to be useful by healthcare staff and helped to fine tune the healthcare response to the pandemic. The weekly information from the CMO allowed the public to understand at least part of how the pandemic was progressing. However, the public information/advice on what to do and what not to do was overly simplistic and the message was not amended as the pandemic progressed. This should have been addressed at the time.

40. Widespread information on the potential side effects of Tamiflu, disseminated to the public and provided at an earlier stage of the pandemic response would have ensured that people were fully informed and less likely to contact health services after suffering side effects from the drug.

What are the obstacles to obtaining reliable, timely scientific advice and evidence to inform policy decisions in emergencies? Has the Government sufficient powers and resources to overcome the obstacles? Was there sufficient and timely scientific evidence to inform policy decisions?

Information gathering

41. Gathering epidemiological data on an emerging pandemic is labour intensive. The HPA did not have sufficient resources to undertake all of the information gathering that could have been carried out.

42. A lack of pre-prepared systems for information gathering resulted in frequent demands for different types of information related to the effects of the pandemic and the healthcare response. Frontline healthcare staff were thus overburdened and the BMA believes that this resulted in a reduction in the efficiency of the containment policy.

43. In many instances during the containment phase of the pandemic response, GP practices ran out of HPA-approved swabbing equipment, hampering the provision to the HPA of information on the progress of the spread of the virus.

The use of information to decide policy and clinical algorithms

44. Policy and clinical algorithms were decided using available information streams on the H1N1 pandemic. Had additional resources been available to the bodies gathering information, it would have been reasonable for additional information to have been collected by those deciding policy and developing clinical algorithms. Such extra information could have led to the avoidance of other difficulties.

Dissemination of information to those that need to implement pandemic response policy

45. The advice provided to central Government for the purposes of informing policy was timely and useful. It was difficult to disseminate advice to clinicians in the field – particularly GPs – in a timely fashion. Advice was also subject to overtly frequent change, with often daily minor incremental change to the advice.

46. There were problems in providing clinical backup advice to GPs facing complex problems as a result of the H1N1 pandemic. Routine and basic advice and assistance was provided by administrative staff working from clinical algorithms, but it remained difficult to provide expert back up advice from clinical public health staff due to mismatch of the volume of demand and the small numbers of consultant staff. Consultants in communicable disease control, who were the group best qualified to give this advice, were mostly engaged in containment or epidemiological work and could not be spared to give clinical backup to GPs until late in the containment phase. The BMA would be happy to offer frequent updates to all doctors through its, and the BMJ’s, websites to contribute to ensuring rapidly updated, single and consistent messaging during any future epidemic/pandemic.

47. The BMA recommends that the Government must ensure that relevant organisations liaise with each other, and that the appropriate personnel are in contact with each other, so that in the event of an emergency, communications can be made quickly and effectively. In order to make certain that staffing levels are optimal to provide a response to a pandemic, the Government should agree the arrangements for resourcing the public health departments and frontline healthcare providers in emergency situations. In the 2009 H1N1 pandemic, many GPs were concerned by the lack of an emergency Statement of Financial Entitlements, arrangements for death in service benefits for locum GPs and payment arrangements for providing H1N1 vaccination.

48. The BMA also believes that contingency plans should be developed in order to cope with excessive demand on services providing scientific advice and monitoring to overcome problems associated with high demand. Measures should also be taken to ensure that the scientific advice given to health professionals and the public is consistent in an emergency scenario.

How effective is the strategic coordination between Government departments, public bodies, private bodies, sources of scientific advice and the research base in preparing for and reacting to emergencies?

49. Engagement between key public stakeholders – including in regional and local pandemic resilience fora was key to mounting an effective, joined up response to the H1N1 pandemic.

Pandemic resilience fora consisted of police leads, category 1 responders (‘blue light’ services, the NHS, local authorities, HPA, Health and Safety Executive, etc.) plus more lower key category 2 responders (representatives from other public organisations, etc).

British Medical Association

14 September 2010

50. Pandemic resilience fora failed to engage private bodies in the pandemic preparation phase and during the emergency itself, despite efforts to do so. Private sector representatives could not recognise direct benefit to their organisations in participating in the fora.

51. Frontline clinician representatives were not always included in PCO H1N1 response meetings. The involvement of clinicians was essential in order to ensure that the H1N1 response plans were achievable and realistic, and that any potential problems identified by clinicians could be highlighted.

52. Many PCOs had not prioritised the development of technological solutions to enable GPs to gain secure, remote access to GP clinical systems, hampering the flexibility of GPs to work at different sites when the demand for their services was very high. GPs with remote access reported that they were able to complete work away from their surgeries, which aided their response to the demands of the pandemic.

53. The BMA suggests that PCOs should ensure that technology is enabled to allow secure remote access to GP clinical systems in times of emergency.

How important is international coordination and how could it be strengthened?

54. Coordination at any level of organisation (local, national or international) helps to improve the overall response to emergency situations. A united, UK-wide response to the flu pandemic, backed up by evidence and the same scientific strategy across all four UK administrations would have aided the emergency response to the pandemic.

55. The UK’s pandemic response planning was greatly aided by its involvement in international disease tracking and epidemiology, via the World Health Organisation Global Influenza Surveillance Network.

References