Memorandum by the Department of Health
INTRODUCTION
1. The Government welcomes this opportunity
to set out its position on allergy and allergic conditions.
2. This memorandum is structured in accordance
with the particular questions asked in the Committee's Call for
Evidence. Although this inquiry will not focus primarily on allergy
service provision, many of its questions were addressed in the
recently completed review of services for allergy ("the DH
review") that was undertaken by the Department of Health
(DH) following an inquiry (Report, November 2004) by the House
of Commons Health Committee.
3. This memorandum therefore refers to—but
does not repeat at length—the evidence presented in the
report of the DH review, A review of services for allergy—the
epidemiology, demand for and provision of treatment and effectiveness
of clinical interventions, published in July 2006. Members
of the Committee have had printed copies of this report. It is
available on the DH website, along with supporting information
on the epidemiology and on clinical interventions, at:
http://www.dh.gov.uk/PublicationsAndStatistics/Publications/PublicationsPolicyAndGuidance/PublicationsPolicyAndGuidanceArticle/fs/en?CONTENT_ID=4137365&chk=/Z3Wtj.
4. The memorandum includes contributions
from:
— the Health and Safety Executive (HSE)
and the Department for Work and Pensions (DWP), covering work-related
allergy and Industrial Injuries Disablement Benefit, attached
as Annex A;
— the Department for Education and
Skills (DfES) on allergic diseases and schools—including
a summary of medicines guidance to schools, attached as Annex
B; and
— the Department for Communities and
Local Government (DCLG) on housing policy and regulations, attached
as Annex C.
5. The key points made in Annex A are that:
— work-related allergies have declined
over the last 10 years;
— HSE is working in partnership with
key stakeholders to ensure this downward trend continues; and
— there is a robust regulatory framework
in place to tackle work-related allergies.
22 NOVEMBER 2006
DEFINING THE
PROBLEM
What is allergy?
6. Allergy can be defined as a hypersensitivity,
a heightened or exaggerated immune response to some external stimulus
or stimuli. Allergic processes contribute to a range of conditions—including
asthma, rhinitis and eczema—many of which also occur in
the absence of a specific allergy. Various allergic conditions
often co-exist in the same individual. Also, some individual allergic
disorders may cause symptoms in several organ systems simultaneously.
7. Allergy is very common. Around a third
of the population have some form of allergy at some point in their
lives. In England, about three million people each year are seen
in primary care with conditions that may be allergic in origin.
What is the difference between allergy and intolerance?
8. Unlike allergy, intolerance (for example,
food intolerance) does not involve the immune system. It is generally
not life threatening. Around 20 per cent of adults have perceived
food intolerance. The correct diagnosis of food intolerance generates
a substantial workload for services.
What is and what is not known about the origins
and progression of allergic disease?
9. Whilst a good deal is known about the
mechanisms of allergic processes, the underlying causes of allergic
conditions in individuals and populations are more difficult to
understand. A variety of factors have been identified as possible
causes or modifiers of allergic illness. These include genetic
factors, early allergen exposure, maternal and infant feeding
practices, viral infections, environmental tobacco smoke and other
pollutants, pet contact, family size and rural living.
10. Allergies, once established, tend to
be lifelong despite treatment, although some forms—such
as egg and milk allergy in infants—do frequently resolve.
Why is the incidence of allergy and allergic diseases
rising? Why does the UK in particular have such a high prevalence
of allergy?
11. The DH review found good evidence that
allergy has increased in the population in the last 30 years.
However, for the last 10 years the picture is less clear—some
studies suggest that it has not increased, and may even have fallen
(for example, the latest ISAAC study data from the UK), whilst
others show a continued rise in allergy symptoms.
12. The apparent changes in the prevalence
of allergy over the last three decades cannot be reliably explained,
and nor can the particularly high prevalence of allergic conditions
in the UK and certain other developed countries. A number of theories
have been considered, to do with changes in our environment as
a consequence of increasing affluence and modern lifestyles. Possible
influences include increased exposure to allergens or pollutants,
dietary changes and a change in infectious triggers.
13. In 1995, DH's Committee on the Medical
Effects of Air Pollutants (COMEAP) published a major report on
Asthma and Outdoor Air Pollution. It concluded that, with
regard to the initiation of asthma (ie causing the disease in
the first place), most of the available evidence did not support
a causative role for outdoor air pollution. While it was accepted
that exposure to air pollutants could produce a worsening of symptoms
in those suffering from asthma, factors other than air pollution
(diet and the role of infections, for instance) were more likely
to have had more of an impact on the number of people suffering
from asthma.
14. COMEAP is working on a new report, Does
Air Pollution Cause Asthma?, to be published in 2008.
What gaps exist in establishing the overall disease
burden for all types of allergy and what are the barriers to filling
these gaps?
15. From secondary analyses of national
databases, the direct cost to the NHS of managing allergic diseases
has recently been estimated at over £1 billion per annum
in the UK. Primary care prescribing costs are around £0.9
billion per annum, or 11 per cent of the total drugs budget.
16. There is a considerable body of data
on the occurrence of allergic conditions in the population, although
the distribution of research studies is heavily weighted towards
asthma. There is much less information about the extent to which
these conditions are caused by untreated allergy in the community,
or about the distribution of severity and unmet need for specific
services.
17. Furthermore, as the DH review concluded,
the absence of baseline data on the profile of services and the
cost makes it difficult to develop a strategic national view of
how and where services could be developed. DH will consider what
actions may need to be taken to support the NHS and others in
developing baseline data on NHS services, capacity and costs,
and workforce—including cost modelling, using evidence from
a range of services in different settings.
In addition to the impact on the health service,
what is the overall socio-economic impact of allergic diseases
(for example, absence from work and schools)?
18. The DH review highlighted that the indirect
and intangible costs of allergic diseases, such as school or workdays
lost, lower productivity or diminished quality of life, are potentially
huge. A survey in the late 1990s found that 38 per cent of children
and 16 per cent of adults in the UK had lost school/work days
due to their asthma in the past year. In 1994-95, it was estimated
that 17 million work days were lost due to asthma, costing an
estimated £1.1 billion. Studies have also reported the economic
burden due to reduced productivity at work caused by allergic
rhinitis to be greater than that resulting from the treatment
of the condition and its symptoms.
19. Evidence on the socio-economic impact
of work-related illness is given in the corresponding section
of Annex A.
20. In general, it is not possible to say
how many pupils do not attend school or miss exams because they
are affected by allergies, because data on pupil absence is not
routinely collected in this level of detail. From September 2006,
schools will be asked to inform the Department for Education and
Skills (DfES) of the reasons for pupil absence from school. Illness
will be one category—but it would overburden schools to
have to record for each absent pupil their individual type of
illness.
21. Pupils who suffer from allergies may
need to have medication whilst at school: a summary of the current
guidance is at Annex B.
TREATMENT AND
MANAGEMENT
What is the effect of current treatments on the
natural history of allergic disease?
22. The DH review report sets out what is
known about the nature and the effectiveness of clinical interventions
for allergy, drawing on professional input, including clinical
guidelines which have been informed by research.
23. Making an allergy diagnosis is a key
step in allergy management. An accurate diagnosis targets the
appropriate clinical intervention and allows avoidance of the
allergic trigger and amelioration or resolution of symptoms.
24. Allergy treatments in widespread use
can be classified in four broad categories—symptom control,
allergen avoidance, rescue medication and immunotherapy. Examples
are given in the DH review report. New therapies are also in development.
What is the evidence-base for pharmacological
and non-pharmacological management strategies?
25. A number of Royal Colleges and professional
bodies have drawn up good practice guidelines for specific allergic
conditions. However, there are no nationally agreed, evidence
based clinical guidelines which address allergic conditions as
a whole—nor nationally agreed clinical guidelines or protocols
addressing how patients with less serious allergies can be treated
in primary care.
26. As early steps to follow its review,
DH will consider the options for commissioning the development
by the National Institute for Health and Clinical Excellence (NICE)
of guidelines for the diagnosis and management of allergic conditions,
and work with the Royal Colleges and others on guidance for referral
and care pathways.
27. To inform its review, DH commissioned
an overview of systematic reviews of the research evidence on
clinical interventions for allergy, focusing particularly on service
delivery and organisation. This "review of reviews"
also identified significant gaps in research knowledge. The full
report was published on the DH website with the DH review report
itself.
Is the level of UK research into allergy and allergic
disease adequate?
28. There is no absolute way of determining
whether a level of research spend is adequate. Ultimately, it
is a value judgement by a range of research funders with differing
remits. Such judgements will include consideration of disease
burden, likely success of scientific endeavour, likely impact
on health of affected population, capacity to address issues relevant
to the UK and assessment against other competing priorities.
29. In May 2006, the UK Clinical Research
Collaboration (UKCRC) published the first ever national analysis
of spending on health research in the UK (UK Health Research Analysis).
This analysis included most government and charity funding on
all types of health research across all areas of health and disease
during the year 2004-05.
30. Analysis was done by "high level"
categories such as respiratory disease and cardiovascular disease.
The UKCRC analysis shows that there appears to be an imbalance
in research funding for respiratory disease against burden of
disease. The majority of research on allergies has focused on
asthma, and therefore probably falls within the respiratory disease
category. However, it is not clear that the imbalance in spend
against disease burden reflects the position for allergy-related
respiratory disease (since much of respiratory disease burden
is not allergic in origin); and it obviously provides no indicators
about non-respiratory allergic research.
31. The main agency through which the government
supports medical and clinical research is the Medical Research
Council (MRC). Other research councils—the Biotechnology
and Biological Sciences Research Council and the Economic and
Social Research Council, for example—also support research
of relevance to health and healthcare. The Councils' umbrella
body, Research Councils UK, is submitting a separate memorandum
of evidence to the Committee.
32. DH funds research to support policy
and the delivery of effective practice in the NHS through a number
of national programmes. It also meets the service costs to the
NHS of research funded by the research councils and charities
and undertaken in research-active NHS organisations.
33. The new health research strategy, Best
Research for Best Health, was launched in January 2006. It set
out the Government's goals for research and development in the
NHS and demonstrated DH's commitment to creating a vibrant research
environment that will contribute to the health and wealth of our
nation.
34. The key planks of the strategy are to:
— establish the NHS as an internationally
recognised centre of research excellence;
— attract, develop and retain the best
research professionals to conduct people-based research;
— commission research focused on improving
health and care;
— strengthen and streamline systems
for research management and governance; and
— act as sound custodians of public
money for public good.
35. Best Research for Best Health has
a range of related objectives that require different approaches.
We have developed implementation plans for sixteen of the major
components for the new National Institute of Health Research (NIHR),
through which we shall deliver many of the components of the strategy.
Further details are available on the NIHR website (www.nihr.ac.uk),
together with details of calls for proposals.
36. Some of the programmes of research being
carried out by NHS organisations and that have allergy and allergic
disease as a major component are shown in the following table.
| NHS organisation
| Programme | NHS R&D allocation 2005-06 (£m)
| External funding 2005-06 (£m) |
| Guy's and St Thomas' NHS Foundation Trust |
Allergy and obstructive lung disease | 0.6
| 2.6 |
| King's Consortium | Allergy and obstructive lung disease
| 0.5 | 0.7 |
| Royal Brompton and Harefield Hospitals NHS Trust
| Management of severe respiratory disease: atopy, allergy and asthma
| 3.5 | 3.0 |
| Southampton University Hospitals NHS Trust |
Allergy and inflammation | 1.2 |
1.8 |
| South Manchester University Hospitals NHS Trust
| Obstructive and parenchymal lung disease |
0.6 | 1.2 |
37. The DH Policy Research Programme funds a programme
of research at the Social Medicine and Health Services Research
Unit, now based at Imperial College. Part of this programme focuses
on the role of allergy in asthma. In addition, it has funded a
£1 million initiative on the impact of air pollution on health,
which is now drawing to a close.
38. Other national programmes (principally the Health
Technology Assessment programme) have, over the last five years,
allocated some £2.2 million to primary research and systematic
reviews concerned with allergy.
39. The Food Standards Agency supports a programme of
research on food allergy and intolerance. It is submitting a separate
memorandum to the Committee.
40. Research on allergy is also supported through EC
Research Framework Programmes. Proposals for the 7th Framework
Programme (2007-13) make provision for research relating to allergy
and allergic diseases in several areas of the Programme—including
under "chronic diseases" within the Health theme, "food,
health and wellbeing" within the Food, Agriculture and Biotechnology
theme, and "environment and health" within the Environment
theme.
41. Funding for research in allergy and allergic disease
under the 6th Framework Programme (2002-06) includes 14.4 million
euros (£9.7 million) for a Global Allergy and Asthma European
Network and 14.1 million euros (£9.5 million) for a UK-led
integrated project on the prevalence, cost and basis of food allergy
across Europe.
42. The review of systematic reviews commissioned by
DH for its review of services for allergy found that much current
research deals with specific interventions, but fails to address
questions around models and methods of service delivery. It suggested
that more work might be required to investigate the role of specialists,
and the linkage between specialist and generalist services. Such
studies would need to collect basic demographic information. The
review also highlighted the need for consistency in the standardisation
of key measures in trials.
43. In all, the DH review highlighted a range of gaps
in the research evidence—relating to epidemiology, diagnostics
and interventions, service models and also basic science. The
Department proposes to invite key research funders to note these
gaps.
What are the most promising areas of research into preventing
or treating allergy?
44. The Government is aware that new therapies are being
developed that are aimed at modifying the underlying immunological
processes that either cause or mediate clinical allergy. Examples
include:
— anti-IgE therapy, which is presently licensed
in the UK only for severe asthma, but could potentially be used
in the management of other severe IgE (immunoglobulin E) mediated
allergic problems;
— new types of immunotherapy, for example with recombinant
allergens or peptides, are in development and clinical trials:
for example, peptides have been used in a randomised controlled
trial in cat allergy and recombinant allergens are being developed
for use in peanut allergy;
— sublingual immunotherapy (SLIT) is a safe treatment
significantly reducing symptoms and medication requirements in
allergic rhinitis; further research is required concentrating
on optimising allergen dosage and patient selection;
— vaccines are in development for a number of different
allergic conditions; and
— other research on prevention is in progress, although
this approach is not yet clinically validated or adopted in current
allergy practice.
45. Extensive research on the mechanisms of allergy and
therapeutics to combat allergic disease will provide an opportunity
to find new strategies for establishing effective treatments.
Continued research on the molecular mechanisms of allergic disease
can be expected to generate new forms of therapy.
GOVERNMENT POLICIES
How effective have existing Government policy and advice been
in addressing the rise in allergies?
46. The DH review identified good practice in the NHS,
across the wide range of services available for people with allergies,
and the spectrum of skills and competences of clinicians involved
in their care. However, it has also revealed some gaps in the
knowledge and skills of clinical staff dealing with allergy (especially
in diagnosis), in systematic planning and commissioning of services
for allergy, in baseline data on NHS services for allergy, relevant
service capacity and costs, and workforce, and in research.
47. The DH review report acknowledges that, although
incomplete, the evidence is sufficient for recommendations to
be made for action over the next few years in order to improve
services for allergy. It identifies three areas in which initial
action will be of key importance:
— local commissioners to establish levels of need
for services for allergy in their health community;
— SHA workforce planners to work with Deans and
providers to explore the scope for creating additional training
places for allergists; and
— DH to consider the options for commissioning the
development of NICE guidelines for allergy, and work with the
Royal Colleges on guidance for referral and care pathways.
48. The key levers for change for NHS services for allergy
in the future will, essentially, continue to be for local rather
than national level action. In the light of local priorities,
local health commissioners will need to consider—for allergy
as for other services—how to include patient choice, high
quality information for the public, increased investment in the
Expert Patient Programme, practice based commissioning for services,
joint commissioning between Primary Care Trusts and local authorities,
introducing a wider range of providers, workforce modernisation,
better clinical and management information and a focus on self
care, in line with the White Paper Our health, our care, our
say: a new direction for community services (January 2006).
49. Nevertheless, at national level, the DH review has
been a catalyst in energising and bringing together a wide range
of national and local interests in constructive debate on the
future of services for allergy. The Government is committed to
sustaining and building on that momentum.
50. The DH review report stresses that, in the context
of current constraints in the NHS and the Department, any initiatives
to support the NHS and others to generate and lever change in
services for allergy will need to be incremental, phased in steps
over a number of years. It will be essential for stakeholders—including
patients, the NHS, Royal Colleges, the independent sector and
voluntary organisations—to work together if this is to be
achieved.
How is current knowledge about the causes and management of
allergic disease shared within Government?
For example:
— Do housing policy and regulations governing the
indoor environment pay enough attention to allergy?
51. A contribution from the Department for Communities
and Local Government (DCLG) addressing this question is attached
at Annex C.
— How effectively are food policy and food labelling
regulations responding to the rise in food allergies?
52. The separate memorandum to the Committee from the
Food Standards Agency will cover food policy and labelling.
53. The Committee may also wish to know that the Government
has an air pollution information service, the "Air Quality
Bulletin", which provides free up-to-date information and
forecasts on air quality in areas throughout the UK. It informs
the public when pollution levels are high and advises accordingly.
54. The Department for Environment, Food and Rural Affairs
(Defra) has published a leaflet, in partnership with DH, the Scottish
Executive and the Department of Environment in Northern Ireland,
entitled Air Pollution: what it means for your health; the
public information service. It explains where to get up-to-date
information on current levels of air pollution, what air pollution
can mean for your health, and what you can do about it.
PATIENT AND
CONSUMER ISSUES
What impact do allergies have on the quality of life of those
experiencing allergic disease and their families?
55. The DH review was informed by people with—and
parents of children with—allergic conditions, both through
individuals as members of the National Allergy Advisory Group
or attending the stakeholder workshops, and through evidence submitted
by patient representative organisations.
56. As the Parliamentary Under Secretary of State acknowledges
in his foreword to the DH review report, "those living with
severe allergy can face a huge battle every day, and their quality
of life and that of their extended family may be greatly affected.
In surveys, many people express feelings of constant stress and
anxiety. Everyday areas of life may be affected, such as eating
out as a family, school trips, schools meals and packed lunches,
children's parties and other social situations."
57. The evidence is that people with allergies often
feel let down by a poor and frequently unobtainable service. For
those living with allergy severe enough to require specialist
care, the lack of allergy services is a problem which can greatly
affect their quality of life.
What can be done to better educate the public and to improve
the quality of information that is available to patients and undiagnosed
sufferers?
58. With high quality information and guidance, those
affected by allergy can be empowered to manage the condition and
protect themselves from harm, generally by learning to self-administer
appropriate medication or to avoid those allergens which cause
an allergic reaction. The DH review recognises the help that not-for-profit
organisations give, through helplines and other information services,
to fulfil an important need that is yet to be addressed by the
NHS. DH has helped support these efforts through grants made under
Section 64 of the Health and Public Services Act 1968.
59. The DH review highlighted the importance of general
practitioners and others in primary care having sufficient clinical
knowledge and support systems in order to spot allergy in the
early stages, so that an effective management plan can be offered
from the start, and patients are not referred unnecessarily to
specialists for care of less severe allergic disease.
Are current regulatory arrangements, for example, those governing
private clinics offering diagnostic and therapeutic services and
the sale of over the counter allergy tests, satisfactory?
60. Private and voluntary healthcare providers are subject
to regulation by the Healthcare Commission if they provide services
set out in current legislation. Those services do not include
over the counter allergy tests. However, providers registered
with the Commission might offer allergy tests as part of a wider
range of services.
61. DH will be consulting later in the year on the range
of services, including diagnostic techniques, to be subject to
regulation by the Healthcare Commission. There are no plans to
extend the scope of regulation specifically to include over the
counter allergy tests.
62. Allergy test kits can be regulated as either medicines
or medical devices, depending on how they work. Those that place
something on or under the skin to provoke a reaction act immunologically,
and are regulated as medicinal products. There are currently no
such test kits available over the counter in the UK. There are,
however, products available on prescription and these tests are
usually carried out in specialist clinics.
63. The safety, quality and performance of those tests
which detect antibodies from blood or other human fluid samples
in vitro are regulated under the Medical Devices Regulations
2002. Those in vitro diagnostic devices (IVD) intended
to be supplied direct to the public have the self test element
assessed by a third party certification organisation, known as
a notified body, which has been designated by an EC member state
on the basis of strict expertise criteria. Moreover, the instructions
for use that the manufacturer is required to supply would be expected
to warn of possible false results, and provide guidance on interpretation
and that, if symptoms persist, the user should seek medical advice.
64. UK manufacturers of IVDs have to register with the
Medicines and Healthcare products Regulatory Agency (MHRA). The
Agency believes the current regulatory regime is appropriate to
control those over the counter allergy test kits that are devices.
65. Other over the counter allergy tests, employing such
techniques as hair analysis and electromagnetic field detection,
which are not for a medical diagnostic purpose do not come within
the scope of the Medical Devices Regulations. They would, however,
be regulated as consumer products under the General Product Safety
Regulations, which are enforced by local authority Trading Standards
Departments.
Annex A
Work-related aspects—contribution from the Health
and Safety Executive and the Department for Work and Pensions
INTRODUCTION
1. The tripartite Health and Safety Commission (HSC)
has overall responsibility for policy on health and safety, and
advises Ministers on relevant standards and regulations. The Chair
and members of the Commission are appointed by the Secretary of
State for Work and Pensions following consultation, advertisement
and open competition. The Health and Safety Executive (HSE) advises
and assists HSC and has a statutory responsibility to make adequate
arrangements for the enforcement of the Health and Safety at Work
Etc Act 1974 and other relevant statutory provisions in Great
Britain.
DEFINING THE
PROBLEM
What is allergy? What is the difference between allergy and
intolerance?
2. Chemicals and biological agents used in or arising
from work activities can cause the same allergic diseases, and
by the same mechanisms, as those in the more general environment.
The most commonly reported work-related allergic respiratory disease
is occupational asthma, though rhinitis and extrinsic allergic
alveolitis (EAA) are also important. By far the most common type
of work-related skin allergy is allergic contact dermatitis. Anaphylaxis
is a rare consequence of some workplace exposures.
3. High levels of substances irritant to the lung can
cause persisting asthma and exposures to low levels of irritants
at work can exacerbate pre-existing asthma, but these are not
allergic reactions. Exposure to beryllium arising from work activities
may cause a rare, specific and atypical allergic disease of the
lungs called berylliosis.
What is and what is not known about the origins and progression
of allergic disease?
4. Occupational asthma, rhinitis, EAA and occupational
skin allergy arise because of abnormal sensitivity of the human
immune system to specific substances. High molecular weight substances,
such as laboratory animal proteins, enzymes in detergents or mouldy
hay, may provoke the response directly. Low molecular weight substances,
such as isocyanates probably combine with proteins in the body,
and provoke the allergic reaction by altering human protein structure.
Little is known about the relative contributions of different
routes of exposure (ingestion, inhalation and/or penetration through
the skin) to the development of allergy.
5. The main causes of occupational asthma are reviewed
in HSE's publication Asthmagens? Critical Assessments of the
evidence for agents implicated in occupational asthma
(http://www.hse.gov.uk/asthma/asthmagen.pdf). Lists
of substances that commonly cause occupational asthma and rhinitis
are included in the Regulations of the Industrial Injuries Scheme
(http://www.iiac.org.uk/prescribed_diseases/index.asp).
6. Within groups of people exposed to respiratory allergens:
— some will show no evidence of an allergic reaction;
— some will show evidence in immunological tests
of some immune reaction—they will be "sensitised"—but
not have any symptoms;
— some will be sensitised and have symptoms; and
— some may have symptoms without objective evidence
of sensitisation in immunological tests.
7. It is easier to demonstrate sensitisation to high
molecular weight substances by laboratory tests than to those
of low molecular weight.
8. Three general determinants have been identified for
an increased risk of occupational asthma, and are likely to be
relevant to rhinitis too. They are: atopy (in the case of high
molecular weight allergens); smoking (low molecular weight allergens);
and a particular genotype. There is good evidence that the risk
of developing occupational asthma is directly related to the levels
of exposure in the workplace, although there is insufficient data
to define a level at which there is no risk. It is generally thought
that clinical allergic reactions can be induced in sensitised
individuals by much lower exposures than are required to initiate
disease.
9. EAA is most often due to a work exposure. It is not
associated with atopy, and less readily associated with specific
genotypes. Smoking appears to reduce the risk.
10. Little is known about individual susceptibility to
the development of skin allergy, except that allergic skin conditions
(along with other allergic conditions such as asthma and hay fever)
may run in families. A family history of asthma, hay fever or
eczema (skin allergy) may predispose to childhood eczema—this
is known as atopic dermatitis. An individual with atopic dermatitis
may be more prone to skin allergy and skin irritation in later
life.
11. Specific respiratory allergies persist once they
have become established. There is evidence that longer exposure
to occupational respiratory allergens, and the presence of more
severe disease, before diagnosis is associated with a poorer prognosis
(eg persisting symptoms after cessation of further exposure to
the allergen in the case of asthma, development of irreversible
fibrosis—scarring—of the lung in the case of EAA).
Complete prevention of exposure to the causative agent does not
necessarily lead to complete remission of symptoms, but improvement
can continue over years afterwards. Where affected individuals
reduce, but do not eliminate, further exposure they are more likely
to have persisting symptoms, and worsening asthma over the longer
term.
12. There is very little published information on clinical
outcome in cases of workers who develop skin allergy related to
exposures at work. HSE is jointly funding, with the British Occupational
Health Research Foundation (BOHRF), a research project to identify
prognostic factors for people diagnosed with work-related contact
dermatitis. However, in general, once work-related skin allergy
has developed, avoidance of exposure is necessary to control progression
of the disease and prevent the reoccurrence of symptoms.
13. HSE's approach, through the appropriate regulatory
framework, is to prevent individuals from developing occupational
allergic diseases by ensuring that employers use, where possible,
a safer alternative or, if this is not possible, that workplace
exposures are adequately controlled. Health surveillance in the
workplace is also important so that early signs of allergic diseases
can be identified and exposures controlled.
Why is the incidence of allergy and allergic diseases rising?
Why does the UK in particular have such high prevalence of allergy?
14. Although the overall burden of occupational asthma
and work-related allergic contact dermatitis in the UK is not
known, a number of sources provide information on the possible
scale and probable trends in the diseases.
15. The latest Survey of Self-reported Work-related Illness
estimated that:
— 137,000 people who had ever worked in 2004-05
had "breathing or lung problems" caused or made worse
by work; and
— 29,000 people who had ever worked in 2004-05 had
"skin problems" caused or made worse by work.
16. Although these figures give an indication of the
number of people currently suffering from occupational lung and
skin problems (the disease prevalence), it is difficult to estimate
what proportion are suffering from asthma or allergic contact
dermatitis. Estimates of the proportion of asthma cases that are
work-related from other studies (the challenge is to identify
cases that are primarily due to work activities in any common
disease having both work and non-work-related causes) vary between
2 per cent and 15 per cent.
17. An indication of the number of new cases of occupational
asthma and contact dermatitis (including allergic contact dermatitis)
occurring each year (the disease incidence) can be obtained from
the reports of cases from physicians who participate in the respective
voluntary surveillance schemes forming part of The Health and
Occupation Reporting network (THOR). According to these figures,
over the last three years (2003-05):
— there were around 570 new cases of occupational
asthma per year, compared with about 1,000 new cases per year
during the mid 1990s; and
— there were around 2,400 new cases of work-related
contact dermatitis per year, compared with 3,000-4,000 new cases
per year during the late 1990s.
18. These figures tend to underestimate the true incidence,
since many cases will not be referred to a consultant physician,
and not all workers have access to occupational physicians. Whilst
trends can also be misleading, because of year-by-year variability
caused by changes in the numbers of participating doctors and
alterations in their caseloads, more detailed analyses suggest
that there is likely to have been a real reduction in the incidence
of both diseases. Further statistical information is available
at:
http://www.hse.gov.uk/statistics/.
19. Prevalence and incidence statistics are available
from other countries but the comparison of national rates is problematic,
because of differences in the data collection procedures and systems
of notification. No firm conclusions can, therefore, be drawn
from international comparisons about whether or not the prevalence
of work-related allergy in the UK is higher than that in other
countries.
What gaps exist in establishing the overall disease burden
for all types of allergy and what are the barriers to filling
these gaps?
20. There is currently no simple test for objectively
confirming cases of work-related allergic respiratory disease.
Diagnosis depends on expert clinical judgement in the great majority
of cases. Standardised criteria for diagnosis and for accepting
an occupational origin would significantly assist with measuring
the trends in the incidence of these diseases.
21. An HSE funded investigation of patient referrals
from primary to secondary care found that there were some significant
delays before patients were being referred to secondary care and
subsequently diagnosed. A baseline audit of hospital medical care
provision for diagnosis of occupational lung disease, undertaken
for HSE and the British Thoracic Society, illustrated a wide variation
in the facilities available in respiratory departments and clinical
approaches employed by general respiratory consultants for treatment
of occupational asthma. It found that it was usual for patients
to be diagnosed in-house, as opposed to being referred to a specialist
occupational respiratory centre, but that respiratory departments
often lacked the necessary resources to arrive at a definitive
diagnosis.
22. A Group of Occupational Respiratory Disease Specialists
(GORDS), convened regularly by HSE, aims to develop a standard
of care document for the diagnosis of occupational asthma, that
will be ratified by the relevant medical bodies. This will reiterate
key messages from other work, highlighting diagnosis and management
issues and will be promulgated throughout the medical community,
including general respiratory consultants, general practitioners,
occupational health consultants and other occupational health
professionals.
23. The wide variation in disease severity is likely
to be a key issue -particularly for skin disease—since many
less serious cases may not be recognised by individuals or by
physicians. Thus, the THOR schemes are subject to under-reporting
since specialist physicians only tend to see the more serious
cases, and those with more minor symptoms may not seek medical
attention anyway. In addition, many workers do not have access
to occupational physicians. The Self Reported Work Related Illness
Surveys rely on individuals" own perceptions of the problem
and there may be a tendency for people to misinterpret the relevance
of their work exposures to their symptoms.
24. Difficulties in attribution of cases to workplace
causes are likely to affect both these sources. Comprehensive
epidemiological assessment of work-related allergic disease is
impractical because of, for example, the wide range of occupational
allergens and the circumstances in which they are used.
In addition to the impact on the health service, what is the
overall socio-economic impact of allergic diseases (for example,
absence from work and schools)?
25. In the 2004-05 Survey of Self-reported Work-related
Illness (SWI), an estimated 791,000 full time equivalent working
days were lost due to breathing or lung problems in 2004-05 (95
per cent CI: 387,000-1,194,000), a substantial proportion of which
may be due to occupational asthma, with an average of 18.6 days
lost per case (95 per cent CI: 9.9-27.3). This compares with 28.4
million days lost due to all self-reported work-related illness
in the same year, with an average of 23.1 days lost per case.
26. In the 2001-02 SWI (the most recent year in which
there were sufficient sample cases to produce a reliable estimate
of the number of working days lost due to skin problems), it was
estimated that 230,000 (95 per cent CI: 96,000-370,000) working
days were lost due to skin problems, with an average of 8.2 days
lost per case (95 per cent CI: 3.9-12.5). The total number of
days lost due to all self-reported work-related disease in 2001-02
was about 32 million days with an average of 23 days lost per
case.
27. Research recently published by HSE on The True
Costs of Occupational Asthma in Great Britain (http://www.hse.gov.uk/research/rrhtm/rr474.htm
found that the cost burden of new cases falls most heavily on
the individual worker and society (taxpayers or Government). The
report estimates total lifetime costs to society of new cases
diagnosed in 2003 ranging from £71.7 to £100.1 million.
If comparable numbers of new cases were diagnosed in future years,
this would give rise to additional streams of lifetime costs of
similar magnitude.
TREATMENT AND
MANAGEMENT
What is the effect of current treatments on the natural history
of allergic disease?
28. Treatments for occupational allergic disease are
identical to those for non-occupational allergic disease. HSE
is not involved in the treatment of individual sufferers. Our
focus is on preventing ill health by ensuring that the legislative
framework means that employers prevent or, if this is not possible,
adequately control exposures to substances known to cause work-related
allergic disease, and that health surveillance is in place to
identify signs of disease as soon as possible.
What is the evidence-base for pharmacological and non-pharmacological
management strategies?
29. Within the occupational setting, the most effective
strategy is removal of the allergic individual from exposure to
the substance causing the allergy.
Is the level of UK research into allergy and allergic disease
adequate, and what are the most promising areas of research into
preventing or treating allergy?
30. Much valuable research has already been conducted
by HSE on substances causing asthma in the workplace. There are
areas that could be explored in further detail (primary causes,
individual susceptibility, prognosis and mechanisms). HSE is now
aware of the main causes of allergic disease and how exposures
can be controlled. Therefore, our emphasis is now on achieving
the behaviour change in the workplace so that employers and employees
understand the need for, and use, suitable control measures.
GOVERNMENT POLICIES
How effective have existing Government policy and advice been
in addressing the rise in allergies?
31. Evidence suggests that there is a downward trend
in the incidence of work-related allergies. We do not have information
at this stage on how HSE policy and advice has contributed to
this trend, although a planned programme of evaluation will address
this over the next two years.
32. Nevertheless, occupational asthma and allergic contact
dermititis continue to be priorities for HSE within its Disease
Reduction Programme; the aim is a 10 per cent reduction in the
incidence of these diseases by 2008 from a 2004 baseline. HSE
also has a target to reduce the incidence of occupational asthma
by 30 per cent by 2010 compared with the 2000 baseline.
How is current knowledge about the causes and management of
allergic disease shared within Government?
33. In 2001, the Health and Safety Commission agreed
a package of measures aimed at achieving the 2010 target. An Asthma
Project Board was set up, because partnerships with stakeholders
are vital if this target is to be reached. Its members include
representatives from unions, industry, an asthma charity and health
professionals. The board provides mechanisms to ensure that information
is shared with organisations who have an interest in occupational
asthma.
34. As a result of partnership working, Asthma UK has
developed a Workplace Charter that sets out 10 steps to reduce
the impact of asthma in the workplace
(http://www.asthma.org.uk/all_about_asthma/asthma_at_work/workplace.html),
and the British Occupational Health Research Foundation has published
an evidence based review and guidelines on the identification,
management and prevention of occupational asthma. These are aimed
at doctors and nurses in general practice, occupational health
and respiratory medicine and at employers, safety representatives
and workers who might be exposed to occupational asthmagens
(http://www.bohrf.org.uk/downloads/asthevre.pdf).
35. GORDS allows for a dialogue between clinicians who
see cases of respiratory allergy and HSE. It provides an opportunity
for the early identification of any new workplace allergens.
36. The THOR scheme for reporting work-related respiratory
and skin disease also presents a mechanism for the identification
of new allergens, and provides a useful recurring reminder to
NHS physicians of the need to consider the possible work-relatedness
of allergic respiratory and skin disease.
37. Clinicians and others can also seek advice about
specific incidents of allergic disease from HSE's experts, including
doctors, inspectors and hygienists. HSE works in partnership with
the Local Authorities and is making scientific resource available
to tackle occupational asthma and dermatitis in premises for which
they are responsible (eg bakeries and hairdressers).
38. The HSC's Advisory Committee on Toxic Substances
and various Industry Advisory Committees also provide a route
for working with key stakeholders in specific areas. Coordination
and information sharing across administrations, departments and
agencies dealing with risks from chemicals is well developed,
and HSE plays a full part in this. The Government carries out
a significant amount of monitoring for chemicals in the environment,
in food and in biota. Much of the monitoring currently carried
out is in response to legislative requirements, which increasingly
is driven by Europe.
39. In its February 1999 report, an interdepartmental
working group, chaired by HSE and constituted to review the arrangements
in place across Government for monitoring the ill-health effects
of pesticide exposure, noted the well-recognised difficulty in
determining a causal link between chronic ill-health symptoms
and exposure to hazardous substances such as pesticides. There
is little evidence to suggest that pesticides are a significant
contributory factor in incidences of allergy, other than a small
number of cases of alleged multiple chemical sensitivity following
exposure to, for example, pesticide spray drift. In the light
of the known difficulty set out above, the working group recommended
the continued use of studies to investigate alleged links between
chronic ill health and pesticide exposure. The Government's response
to the Royal Commission on Environmental Pollution report Crop
Spraying and the Health of Residents and Bystanders is at
www.defra.gov.uk/environment/rcep/pdf/rcepcropspray-response.pdf.
PATIENT AND
CONSUMER ISSUES
What impact do allergies have on the quality of life of those
experiencing allergic disease and their families?
40. Both occupational asthma and dermatitis can interfere
with normal life and cause significant disability. It is generally
accepted that a diagnosis of work-related allergic disease is
often associated with economic disadvantage for the affected person,
either because of the impact of the illness itself on sickness
absence, ability to maintain employment or the need for job change
to avoid further exposure. Individuals diagnosed with occupational
asthma or severe dermititis can suffer financial and employment
consequences as a consequence of having to move to a lower paid
job, or leave the labour force, in order to avoid exposure. The
diseases may significantly affect all aspects of life, particularly
if the work-related allergen is a substance that is ubiquitous
in the domestic situation—eg allergy to a fragrance present
in cosmetic products, cleaning products, food protein.
41. For those with chronic symptoms and a minimum degree
of disability, no-fault compensation is available in the form
of state-funded Industrial Injuries Disablement Benefit (IIDB).
IIDB provides compensation for disablement due to an industrial
accident or prescribed disease. It is paid according to the degree
of disablement and takes no account of factors other than the
physical or mental condition of the injured person. It can be
paid whether or not the person is working and is not taxable.
42. A number of prescribed diseases are allergic responses
to substances encountered at work. They are:
— extrinsic allergic alveolitis (EAA), including
farmer's lung;
— non-infective dermatitis: and
43. The Secretary of State for the Department for Work
and Pensions (DWP) is advised which diseases should be prescribed
by the Industrial Injuries Advisory Council (IIAC). It is a statutory
function of IIAC to review all aspects of the current IIDB scheme.
The Secretary of State will normally implement IIAC recommendations.
For example, following an incident of occupational asthma at a
major car manufacturer in the UK, IIAC have recently published
a report recommending that the current legislative description
of EAA be broadened to include exposure to the mists of metal
working fluids. The Secretary of State has accepted the report
and is considering its recommendations.
What can be done to better educate the public and to improve
the quality of information that is available to patients and undiagnosed
sufferers?
44. HSE is involved in a wide range of interventions
in specific industries, to raise awareness of health risks amongst
employers and employees and to provide information about how to
control exposures in the workplace. We consider during the planning
process the most effective way of communicating with individual
groups, whether through a leaflet, detailed guidance, a website,
interactive seminars or an inspector visit.
45. The Chemicals (Hazard Information and Packaging for
Supply) Regulations 2002 require the supplier of a dangerous chemical
to identify the hazards of the chemical, give information about
the hazards to their customers and package the chemical safely.
In some cases, from HSE's perspective, the information provided
could be improved and we are working with suppliers to achieve
this.
46. More emphasis could be placed within occupational
training provision on causes of allergy and its prevention. This
would be particularly relevant for those occupations where the
risk of allergy is highest. Improvements could also be achieved
through better training for primary care physicians on early recognition
and diagnosis of work-related allergy. HSE is currently funding
research to develop training for practice nurses on the symptoms
and causes of occupational asthma, to empower them to give advice
and guidance to patients as well as to reduce the time it takes
to diagnose cases of occupational asthma.
Are current regulatory arrangements, for example, those governing
private clinics offering diagnostic and therapeutic services and
the sale of over the counter allergy tests, satisfactory?
47. The health and safety legislative framework is robust
and comprehensive. Under the Control of Substances Hazardous to
Health 2002 (as amended) Regulations (COSHH)—and an accompanying
Approved Code of Practice for the control of substances that cause
occupational asthma—employers are required to ensure that
exposure to substances which may cause asthma or dermatitis is
prevented or adequately controlled. COSHH also requires that all
employees exposed, or liable to be exposed, to a substance that
may cause occupational asthma or severe dermatitis should be under
suitable health surveillance.
48. Some specific legislation has been introduced to
address particularly significant workplace skin allergens—for
example, marketing and use restrictions on the presence of chromium
(VI) in cement were introduced in 2005. Experience from other
countries demonstrates that this restriction will have a very
significant impact on the incidence of chromium-related skin allergy
in workers exposed to cement.
49. A key difference between work-related allergic diseases
and the generality of these conditions is that it should be easier
to control exposure, and monitor the effectiveness of preventive
measures, within the context of specific health and safety legislation.
50. Changes to the COSHH regulations in April 2005 placed
an explicit emphasis on the need to follow good practice to control
exposure. HSE is currently making considerable efforts to enhance
the effectiveness of these regulations by raising awareness, and
providing free industry and task-specific COSHH guidance sheets
tailored to a wide range of businesses and employees.
Annex B
Summary of Department for Education and Skills/Department
of Health medicines guidance to schools
1. In March 2005, DfES and DH issued joint guidance,
Managing medicines in schools and early years settings.
This document updates, and extends to early years settings, 1996
DfEE/DH guidance on supporting pupils with medical needs in school.
2. The DfES/DH joint guidance sets out a clear framework
within which local authorities, local health trusts, schools and
early years settings can work together to develop policies to
ensure that children requiring medicines receive appropriate support.
It explains the roles and responsibilities of employers, parents
and carers, governing bodies and management groups, head teachers
and heads of settings, teachers and other staff, and of local
health services. It considers staffing issues including employment
of staff, insurance and training.
3. Other issues covered in the document include drawing
up a health care plan for a pupil, confidentiality, record keeping,
the storage, access and disposal of medicines, home to school
transport, and on-site and off-site activities. It also contains
a set of forms which can be photocopied by users.
4. The guidance takes account of the recommendations
from the National Service Framework for Children (2004) to ensure
safe practice in the management of medicines for children, the
new duties on local education authorities, schools and early years
settings under the Disability Discrimination Act, and latest medical
advice.
5. Chapter 5 of the guidance provides brief information
and guidance on anaphylaxis, including food triggers. A child's
health care plan should include information on:
— anaphylaxis—what should trigger it;
— what to do in an emergency;
— precautionary measures.
Annex C
Housing policy and regulations—contribution from
the Department for Communities and Local Government
Do housing policy and regulations governing the indoor environment
pay enough attention to allergy?
INTRODUCTION
1. The Department for Communities and Local Government
(DCLG) is responsible for two housing policy areas that have a
bearing on the prevention of allergies: Building Regulations and
the Housing Health and Safety Rating System, which relate to new
and existing buildings respectively.
BUILDING REGULATIONS
2. The Building Regulations are intended mainly for the
following purposes:
— to protect the health and safety of people in
and about buildings;
— to provide access to buildings for people with
disabilities; and
— to conserve energy and water.
3. Apart from a few exceptions, the Building Regulations
are applied uniformly and do not have different provisions for
the needs of different building occupants. Building owners are
free to add their own special requirements.
Part F—Ventilation
4. The part of the Building Regulations most relevant
to allergies is Part F—Ventilation. The legal requirement
of Part F is set out in Schedule 1 of the Building Regulations
(2000), and is: There shall be adequate means of ventilation
provided for people in the building. We interpret the requirement
to mean that the ventilation system should be able to provide
sufficient fresh air to maintain reasonable indoor air quality.
This assumes the outdoor air is of reasonable quality.
2006 Revision of Approved Document F
5. Ventilation has a significant energy cost, so there
is pressure to reduce ventilation rates to the minimum without
jeopardising health. Technical guidance on ventilation to support
the legal requirement of Part F is given in Approved Document
F. This has just been revised to complement guidance on energy
saving in the Approved Documents that support Part L—Conservation
of fuel and power.
6. For dwellings, Approved Document F recommends the
ventilation rate to be between about 0.5 and one air changes per
hour. This is considered to be sufficient to control typical levels
of the following: moisture (to prevent mould growth), nitrogen
dioxide, carbon monoxide, total volatile organic compounds and
bio-effluents. As there are probably hundreds (or thousands) of
chemical compounds in indoor air, it is not easy to identify the
main ones that adversely effect health.
7. The Approved Document F provisions are intended to
limit relative humidity in dwellings to below 70 per cent, as
current opinion is that this is sufficient to prevent mould growth
and associated allergens. If the relative humidity is low enough
(eg below 50 per cent), it could slow the development of dust
mites (dust mite faeces are associated with triggering asthma
attacks).
8. In order to inform the revision of Approved Document
F, we have recently sponsored research at University College London
(UCL) on the effect of ventilation rate on dust mite and mould
growth. This was mainly a desk exercise but included some computer
modelling. An extract from the executive summary of the final
report is below:
(d) Of particular interest to this project, it appears
that most existing data are inadequate for conclusions to be drawn
regarding the direct association between ventilation rates and
respiratory problems. It is noted that there are many real difficulties
in attempting to establish such a relationship.
9. We have also contributed to research by Gaia Architects
to develop guidance on Affordable Low Allergy Housing.
The current research programme includes:
— work at UCL to refine understanding of the hygrothermal
conditions (ie pertaining to heat and humidity) in real homes
needed to prevent mould growth—which will consider transient
as well as steady state moisture levels; and
— a feasibility study of introducing a scheme for
labelling construction products according to Volatile Organic
Compounds (VOC) emissions. There is already a voluntary scheme
for paint.
10. The Building Regulations apply to England and Wales.
Scotland and Northern Ireland have their own systems, which have
broadly similar technical requirements.
HOUSING HEALTH
AND SAFETY
RATING SYSTEM
(HHSRS)
11. As stated above, Building Regulations apply mainly
to new buildings. Existing housing is covered by the Housing Health
and Safety Rating System, which has replaced the housing fitness
standard. HHSRS was introduced in England in April and in Wales
in June 2006. It brings a prescribed list of 29 health and safety
hazards into consideration for compliance with the Decent Home
standard and also as a basis for statutory enforcement in the
private sector.
12. One of the hazards covered by the system is "damp
and mould growth", and the statutory guidance to local authorities
notes that mould spores can trigger allergic reactions, especially
asthma. Another is "volatile organic compounds", some
of which are noted in the guidance as potentially causing allergic
reactions, especially in people with asthma.
13. The HHSRS is based upon data from the Home Accident
Surveillance System, the Home Accident Death Database and the
English House Condition Survey. Some hazards (including excess
cold, exposure to radiation and falling on stairs) are flagged
as particularly relevant to older people, while others (including
damp and mould growth, lead ingestion and electrical hazards)
particularly the young.
14. The HHSRS regulations and supporting statutory guidance
do not dictate the action that local authorities should take in
response to particular situations. They provide support for local
authority officers' professional judgement. The guidance would
assist a local authority in considering how to deal, for instance,
with damp in a dwelling occupied by an asthmatic person. In such
a case, the authority might require a landlord to take more comprehensive
or urgent action than it would require in a case involving an
able-bodied and less susceptible occupier.
CONCLUSION
15. Through the Building Regulations and the HHSRS, current
housing legislation brings into the mainstream a number of health
and safety issues, including cold, exposure to radiation and features
in a dwelling giving rise to fall hazards, that were neglected
by the old fitness provisions. As it covers existing homes, Government
regards the HHSRS in particular as a significant step forward,
moving the emphasis from the condition of the fabric of a dwelling
to the impact of any defects on health and safety.
16. Whilst the new system does not address allergies
specifically, it does provide local authorities with more of the
kind of guidance they need in order to make informed decisions
for the benefit of people's health. Statutory guidance recognises
that people with certain pre-existing conditions, such as asthma,
may be more susceptible to certain hazards than the population
at large.
17. Extending control provisions beyond those in Building
Regulations or HHSRS guidance would be likely to have significant
cost implications for local authorities and the house building
industry. Subject to the Committee's recommendations, this would
need more detailed consideration.
18. There is a need for more research on the connection
between health and indoor air quality, and we have made a start
on this as stated above (paragraphs 8 and 9). In this context,
we are committed to keeping the evidence base and guidance under
review, and also to an evaluation of the impact of the new system—but
it will take time for local authorities and landlords to come
to terms with it and for its health and safety impacts to be quantified.
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