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transcript
THEORY OF
VACCINATIONS –
DELEGATE
HANDOUT
ABSTRACT The course covers the background of
vaccines; current issues and
controversies; legal aspects of
vaccines; communication with patients
and parents; the correct handling and
storage of vaccines
© ECG
ECG © Clients/Vaccine/2019/Delegate Handout May 2019
Contents Objectives ............................................................................................................................................... 2
Principle aim of immunisations............................................................................................................... 2
History of Immunisation ......................................................................................................................... 2
Aims of immunisation programmes ....................................................................................................... 4
Immunisation programmes are designed to protect individuals .................................................... 4
Implementing UK vaccine policy ............................................................................................................. 5
Vaccine Trials .......................................................................................................................................... 6
Introduction to the immune system ....................................................................................................... 6
Immune response ................................................................................................................................... 8
Herd immunity ........................................................................................................................................ 9
Uncertain or incomplete vaccination status ........................................................................................... 9
Different types of vaccine ....................................................................................................................... 9
Response to vaccines ............................................................................................................................ 10
Combination vaccines ........................................................................................................................... 11
Immunoglobulin and the timing of doses ............................................................................................. 11
Efficacy .................................................................................................................................................. 11
Current Issues and Controversies ......................................................................................................... 12
Dealing with issues and controversies .................................................................................................. 12
Some of the myths about vaccination .................................................................................................. 13
Communicating with patients and parents .......................................................................................... 14
Factors affecting immunisation rates ................................................................................................... 16
Strategies for improving immunisation rates ....................................................................................... 16
Consent ................................................................................................................................................. 16
Capacity to consent ............................................................................................................................... 17
Who can consent .................................................................................................................................. 17
Consent on behalf of another ............................................................................................................... 18
Consent for young children ................................................................................................................... 18
Other Legal Points ................................................................................................................................. 18
Storage of vaccines ............................................................................................................................... 19
Managing the cold chain ....................................................................................................................... 20
Ordering and disposal of vaccines ........................................................................................................ 21
Reconstitution of vaccines .................................................................................................................... 22
Safe use of sharps ................................................................................................................................. 24
Handling of spillages ............................................................................................................................. 24
ECG © Clients/Vaccine/2019/Delegate Handout May 2019
Objectives
By the end of reading this course booklet, you will be able to:
• Know the aims of immunisation
• Know the immune system and how vaccines work
• Know the different types of vaccines used and their composition
• Know the vaccine preventable diseases - influenza
• Know the current issues and controversies regarding immunisation
• Communicate with patients and parents/guardians
• Understand the legal aspects of vaccines
• Know the storage and handling of vaccines
• Know the correct administration of vaccines
• Know the adverse events including faint, anaphylaxis and panic attacks
The practical elements of the vaccination course will be completed within face to face training. Please
also ensure that you speak with your employer after completing this training course so that you are
aware of any local policies or procedures that you may need to follow to ensure compliance.
Principle aim of immunisations
Immunisation prevents illness, disability and death from vaccine preventable diseases.
The principal aims of immunisation are to:
• Protect the individual who receives the vaccine
• Prevent outbreaks of disease
• Eradicate infectious diseases world-wide
The two public health interventions with the greatest impact are clean water and vaccination
History of Immunisation
FACT: Over the last 50 years, immunisation has saved more lives worldwide than any other medical
product or procedure, and it's estimated that immunisation currently averts 2 to 3 million deaths every
year.
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1796: Edward Jenner discovers vaccination
Dr Edward Jenner, British physician, discovered vaccination
and proved to the scientific community that it worked.
1803: Royal Jennerian Institute founded
Jenner was awarded government funding, and the Royal Jennerian Institute was founded. Support for
vaccination grew with it becoming popular throughout Europe and the US.
1870s: Opposition to vaccination
Despite vaccination being taken up enthusiastically by many, there was also violent opposition as it
became widespread. People found it difficult to believe that it really worked, and felt it took away
people's civil liberties when it was made compulsory.
1880s: Rabies vaccine
Louis Pasteur improved vaccination even more and developed a vaccine for rabies. The science of
immunology developed and more vaccines were created as scientists began to understand more about
how diseases worked.
1890: Diphtheria and tetanus vaccines developed
Scientists discovered the antitoxins of diphtheria and tetanus and demonstrated that animals injected
with small amounts of the tetanus toxin became immune to the disease.
1920s: Vaccines become widely available
By the end of the 1920s, diphtheria, tetanus, whooping cough and tuberculosis (TB) vaccines were all
available. Vaccination spread across the world and although crude, these early vaccines worked. The
first programmes dramatically reduced the number of deaths from disease.
1955: Polio vaccination begins
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Polio vaccination was introduced in the UK, dramatically reducing the incidence of the disease. Polio is
now extremely rare and is close to being completely eliminated world-wide.
1956-1980: WHO fights to eradicate smallpox
In 1956 the World Health Organization (WHO) decided to try to eradicate smallpox across the world by
using the smallpox vaccine on a global scale. By 1980 it was declared as being eradicated.
2008: Cervical cancer scientist awarded Nobel Prize
It was discovered that cervical cancer was caused by a virus, Human Papillomavirus (HPV) making it
possible to develop a vaccine for the disease. The NHS cervical cancer vaccination programme began,
in which all girls aged 12 to 13 are offered HPV vaccination. HPV vaccination is the first routine universal
vaccine that has been given to prevent a type of cancer.
2013: NHS vaccinates against shingles, rotavirus and children's flu
The NHS vaccination programme introduced the rotavirus vaccination for babies and a shingles vaccine
for over-70s. The intranasal flu vaccine for children was also launched.
2015: NHS vaccinates babies against meningitis B
The NHS vaccination programme saw the introduction of Men B vaccination for babies - the first
national, routine, universal and publicly funded Meningitis B vaccination programme in the world.
Aims of immunisation programmes
Immunisation programmes are designed to protect individuals Immunisation programmes are designed to protect individuals at highest risk or to control or eliminate
disease:
Selective immunisation strategy:
Implemented to protect those at highest risk of a particular disease, for example, clinical, travel or
occupational risk
Universal immunisation:
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Implemented to control, eliminate and eradicate disease (e.g. all routine immunisations offered in
childhood)
Designing and monitoring immunisation programmes
The role of surveillance in designing and monitoring immunisation programmes:
Surveillance refers to monitoring the occurrence and spread of a disease, along with the efficacy and
safety of vaccines
It is an ongoing process that is undertaken before and after a vaccine programme is introduced
Before a vaccine programme is designed the burden of the disease is surveyed, which informs the
vaccination strategy
Epidemiological data and surveillance
Using epidemiological data and surveillance the following questions are answered:
• Is there a need for the vaccination programme?
• Is there a safe and effective vaccine available?
• What other issues need to be considered? For example cost, cultural attitudes
Monitoring following implementation of a
vaccine programme
Once a vaccine programme is implemented the
following are monitored:
• Incidence of the disease
• Vaccine coverage
• Adverse Events Following Immunisation
(AEFIs)
• Adverse Drug Reactions (ADRs)
• Vaccine safety
Implementing UK vaccine policy The following bodies are responsible for implementing UK vaccine policy:
• Joint Committee on Vaccination and Immunisation (JCVI) - Reviews evidence and
advises the Department of Health
• Department of Health (DH) - Sets national policy and leads the national programmes
• Regular guidance is issued through the Green Book, CMO and other guidance letters
• Medicines and Healthcare products Regulatory Agency (MHRA) Responsible for the
licensing of vaccines and the Yellow Card reporting system
• National Institute for Biological Standards and Control (NIBSC) Responsible for the
quality and safety of vaccines
• The Green Book Guidance from The Green Book plus manufacturer's instructions should be
used to define local policies and PGDs.
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Vaccine Trials
In the UK, vaccines are tested for safety, efficacy, quality, and immunogenicity before they are licensed
for use. Click on the circles to the right to find out more about each phase.
Ongoing monitoring
Once marketed, the Medicines and Healthcare Regulatory Agency (MHRA) is responsible for monitoring
all medicines and medical devices including adverse reactions.
Yellow Card scheme
Any suspected adverse drug reactions (ADR) following the use of a medicine, vaccine or medical device
should be reported to the MHRA using the Yellow Card scheme.
Once reported the data is entered onto a database and reviewed regularly. Appropriate investigation
and action is initiated if a possible problem is identified.
Phase 1
The safety and tolerability of the vaccine is tested on
a small number of healthy adult volunteers.
Phase 2
Involves proving that the vaccine is safe and effective
at preventing the disease.
The dose, age ranges and schedules for the vaccine
are also devised.
Phase 3
The vaccine is trialled on the population it is designed
to protect.
Introduction to the immune system
Innate, passive and active immunity
Immunity is the ability of the human body to protect itself from infectious diseases. The complex
mechanism of defending the body can be either innate or acquired.
Innate immunity
Innate immunity refers to immunity present from birth, which includes:
• physical barriers (such as the skin and mucous membranes) and
• chemical barriers (such as digestive enzymes)
Acquired immunity
There are two mechanisms for acquiring immunity, passive and active
• Passive immunity - This is protection provided from the transfer of antibodies from immune
people:
o Commonly across the placenta
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o The protection from transfer of antibodies across the placenta differs in effectiveness
depending on the infection and is temporary - often for a few weeks or months
o Immunity can also occur from the transfusion of blood or blood products such as
immunoglobulin
• Active immunity - Immunisation is the induction of artificial immunity through the
administration of a vaccine or immunoglobulin. Vaccines tend to provide immunity
comparable to the natural disease without the risk from the disease or it's complications.
Active immunity can be either cell mediated, or antibody mediated. This type of protection is
produced by an individual's own immune system:
o It is normally long lasting
o It can be acquired by vaccination or natural disease
o This type of immunity can be either
- antibody-mediated or
- cell-mediate
An antigen - any substance capable of eliciting an immune response. Antibodies -
proteins that are produced by the immune system in response to infection or
vaccination.
Active immunity
Lymphocytes
The cells responsible for immune specificity are lymphocytes, which are found in large numbers in the
blood, lymph and lymphoid organs. There are two major classes of lymphocytes - T cells and B cells:
• T cells are responsible for cell mediated immunity
• B cells produce antibodies and act as memory cells
Antibody Mediated Immunity
Antibody mediated responses are produced by B cells:
• When a B cell encounters an antigen, the B cell is stimulated to proliferate and produce large
numbers of antibody to the antigen
• These antibodies circulate in the bloodstream, where they bind specifically to the antigen that
induced them
• This binding inactivates viruses and bacterial toxins by blocking their ability to bind to receptors
on target cells
• Antibody binding also labels invading microorganisms, making it easier for phagocytic cells to
ingest them, or activates complement mediated killing
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Cell Mediated Immunity
Cell mediated immunity relies on a system of antigen recognition and cytokine production rather than
antibody production and is controlled by T cells:
• The T cells recognise antigens present on the surface of cells which generates their effect
• Once activated T cells produce cytotoxic cells
• These destroy infected cells, and stimulate the release of cytokines which prevent
microorganisms from replicating within cells
Types of T cells
There are several types of T cells:
• T helper cells stimulate the immune response of other cells, including the release of cytokines
• T suppressor cells play an inhibitory role and control the level and quality of the immune
response
• Cytotoxic T cells recognise and destroy infected cells and activate phagocytes to destroy
pathogens
Immune response The immune response to a vaccine
• A vaccine is a biological preparation that improves immunity to a certain disease
• A vaccine typically contains an agent that resembles a disease-causing microorganism • It is often made from weakened or killed forms of the microbe, its toxins or one of its surface proteins
How it works The agent stimulates the body's immune system in order to:
This means that the immune system can more easily recognise and destroy any of these microorganisms
that it later encounters.
Vaccines produce their protective effect by inducing active immunity and immunological memory
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This memory means that the immune system is able to recognise and respond quickly to an exposure to
natural infection, and prevent or modify the disease.
Conditions that might affect the immune response to vaccines:
• Immunosuppression by disease or treatment
• Impaired immunological mechanism
• Malnutrition and chronic disease
• Sickle cell disease and other causes of hyposplenism
• Simultaneous administration of immunoglobulin
Herd immunity The primary aim of vaccination is to protect the person who receives the vaccine. Those vaccinated are
also less likely to be a source of infection to others, thus reducing the risk of an un-vaccinated
individual's exposure to infection. This means that those unable to be vaccinated, or for whom
vaccination has failed, will also benefit from the vaccine programme - This is known as herd immunity.
When high levels of population immunity exist, infection may be eliminated.
High vaccine coverage is required to be maintained to prevent the disease from returning.
Uncertain or incomplete vaccination status If children or adults present with unknown vaccination history, every effort needs to be made to
ascertain which vaccines they may have had. If this is not possible, the assumption that they are
unimmunised should be made and a full course of the immunisation given. If any course of
immunisation is interrupted, The Green Book guidance advises to resume and complete it as soon as
possible.
NOTE: There would be no need to re-commence the whole course again, as the immunological
memory from the previous doses is likely to be maintained
Different types of vaccine There are two types of vaccine, inactivated and attenuated.
Inactivated Vaccines
• Inactivated bacteria or viruses - e.g. pertussis
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• Inactivated toxins (toxoids), only the antigens that are needed for protection - e.g. tetanus and
diphtheria
• A surface protein (hemagglutinin) - e.g. influenza
• A polysaccharide from the bacteria capsule - e.g. pneumococcal
Conjugate Vaccines
Polysaccharide vaccines do not stimulate the immune system as broadly as protein antigens. Therefore
the protection from these vaccines is short lived, and the response is poor in infants and young
children. Some polysaccharide vaccines have been enhanced whereby the polysaccharide antigen is
attached to a protein carrier. This enables the immune system to respond more effectively to the
antigen and provide an immunological memory (e.g. Hib and Men C vaccines).
This is known as a conjugate vaccine.
Adjuvants
Some inactivated vaccines contain adjuvants such as aluminium phosphate or aluminium hydroxide,
in order to enhance the antibody response to the antigen.
Response to vaccines The body’s response to inactivated vaccines
The first injection results in a primary
antibody response - Where an inactivated
vaccine or toxoid is given to someone without
previous exposure to the antigen.
Further injections may be needed to elicit
such a response in young infants - This is
known as the primary course.
Further injections will lead to an accelerated
response dominated by IgG - Depending on
the potency of the product and the time
interval. This is known as the secondary
response.
Following a primary course of vaccination, antibodies may persist for months or years - Even if the
level of detectable antibody subsequently falls, the immune system has been primed. Therefore an
individual may be protected.
Further reinforcing doses of vaccine are used to boost immunity and to provide longer-term
protection Inactivated vaccines cannot cause the disease that they are designed to prevent.
The body’s response to live attenuated vaccines
• Live attenuated virus vaccines, such as MMR, usually promote a full, long-lasting antibody
response after one or two doses
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• To produce an immune response, the live organism must replicate (grow) in the vaccinated
individual over a period of time (days or weeks)
• The immune system responds in the same way as it does to natural infection
• It usually does this without causing the disease itself (because the vaccine virus is weakened or
'attenuated'), but for some vaccines, a mild form of the disease may rarely occur (e.g. a rash
following measles-containing vaccines)
Combination vaccines Vaccines are either monovalent or combination:
• Monovalent vaccines immunise against a single antigen or microorganism
• Combination vaccines immunise against two or more strains of the same microorganism or two
or more microorganisms
Before combination vaccines are licensed, studies are carried out to ensure that:
• The immune response to any of the combined antigens is just as good as the response to the
individual vaccines
• The rates of adverse reactions are the same as they would be if the vaccines were administered
separately
Immunoglobulin and the timing of doses Immunoglobulin
Injecting human immunoglobulin can provide passive immunity:
• It contains the antibodies to target the infection thus temporarily increasing the antibody levels
to the specific infection
• It may be recommended when protection is required quicker than it takes for the vaccine to
provide protective antibody response, (e.g. after exposure to the disease)
Advice on the use of immunoglobulins is given in The Green Book
Timing of doses
Intervals are necessary between vaccine doses to enable the vaccine response to develop properly:
• After a primary response to a vaccine, subsequent doses may be needed to ensure a longer
lasting response (secondary response)
• The interval between doses will depend on the vaccine given
Live vaccines should be deferred until 3 months after receiving any blood products. This is because the
human normal immunoglobulin found in blood products could prevent vaccine virus replication.
Efficacy Vaccines do not offer 100% protection from the disease, with a small percentage of individuals getting
infected in spite of vaccination.
Vaccines can fail in two ways:
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• Primary Failure - When someone fails to make an immunological response to the vaccine.
• Secondary Failure - When an individual initially responds but protection wanes over time.
Those who acquire infection despite vaccination may have a milder form of the disease. They
are also less likely to suffer severe complications than if not previously vaccinated.
Current Issues and Controversies Healthcare professionals are the primary point of contact for the general public regarding
immunisation.
By accessing up-to-date information about vaccines and vaccine programmes, practitioners can deliver
programmes effectively and actively address concerns that patients and parents may have. Being well
informed and communicating effectively can have a significant impact on vaccine uptake rates.
Dealing with issues and controversies All healthcare professionals involved in immunisations should have access to The Green Book and be
able to access relevant immunisation guidance e.g.
• Department of Health (DH)
• World Health Organisation (WHO)
• Public Health England (PHE)
Those performing vaccinations can subscribe to regular email vaccine updates which describe the latest
developments in vaccines, policies and procedures.
Points to consider when critically evaluating vaccine research
• The background and expertise of the author
• Where it was published
• Any author bias - i.e. do they have a vested interest in presenting a particular viewpoint
• The intended audience
• Is the source peer-reviewed - i.e. is it agreed upon by multiple credentialed members of the
same field?
• Make sure the study quoted followed all research protocols and resulted in statistically
significant findings that are conclusive - These findings should also be peer-reviewed
• Is the connection noted "causal" or "correlated"?
• Was the sample large enough to be statistically sound?
• Correlated findings are only suggestive, and further research is necessary to determine if the
two factors under investigation are truly related
• Causal findings suggest the factors under study are actually related
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It is important to use information that is reliable and
valid
Misconceptions and beliefs can have an effect on
vaccine update rates
Some of the myths about vaccination Read each fact below and decide if it is true or false and then click on the button to find out more.
• Better hygiene and sanitation means vaccines are not necessary
o FALSE. If vaccination programmes are stopped, the diseases that are vaccinated
against will return. Whilst improved hygiene, hand washing and clean water help
protect people from infectious diseases, many infections can spread regardless of
cleanliness. If people are not vaccinated, diseases that have become less common,
such as polio and measles, will quickly reappear.
• Vaccines have damaging and long-term side-effects that are not known
o FALSE. Vaccines are very safe. Most vaccine reactions are minor and temporary, such
as an achy arm or mild fever. Serious health events are extremely rare and are carefully
monitored and investigated. The combined vaccine can cause sudden infant death
syndrome.
• The combined vaccine against diphtheria, tetanus and pertussis (whooping cough) and the
vaccine against poliomyelitis cause sudden infant death syndrome.
o FALSE. There is no causal link between vaccines and sudden infant death. However,
these vaccines are administered at a time when babies can suffer sudden infant death
syndrome (SIDS). In other words, the SIDS deaths are co-incidental and would have
occurred without vaccinations being given. It is important to remember that these
four diseases are life-threatening and babies who are not vaccinated against them
are at serious risk of death or serious disability.
• Vaccine-preventable diseases are almost eradicated, so vaccination is unnecessary
o FALSE. Although vaccine preventable diseases have become uncommon in many
countries, the infectious agents that cause them continue to circulate in some parts of
the world. In our highly inter-connected world, these agents can travel across
geographical borders and infect anyone who is not protected. Successful vaccination
programmes depend on the cooperation of every individual.
• Giving somebody more than one vaccine at a time can increase the risk of side-effects
o FALSE. Evidence shows that giving several vaccines at the same time has no adverse
effect on someone's immune system. People are exposed to several hundred foreign
substances every day that trigger an immune response. The simple act of eating food
introduces new antigens into the body, and numerous bacteria live in the mouth and
nose. An individual is exposed to far more antigens from a common cold or sore
throat than they are from vaccines.
• Influenza isn’t serious, and the vaccine isn’t very effective
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o FALSE - Influenza is a serious disease that kills 300,000 - 500,000 people worldwide
every year. Pregnant women,
small children, elderly people and
anyone with a chronic condition,
such as asthma or heart disease,
are at higher risk for severe
infection and death. Most of the
influenza vaccines offer immunity
to the three most prevalent
strains circulating in any given
season. It's the best way to reduce
the chance of severe flu and of
spreading it to others.
• It is better to be immunised through disease than through vaccines
o FALSE - Vaccines stimulate the immune system to produce an immune response similar
to that produced by the natural infection - However they do not cause the disease or
put the immunised person at risk of its potential complications. In contrast, the risk
from getting immunity through natural infection can be high and can result in, e.g.
o Mental retardation from Haemophilus influenzae type b (Hib)
o Birth defects from rubella
o Liver cancer from hepatitis B virus
o Death from measles
• Vaccines contain mercury, which is dangerous
o FALSE - Thiomersal (an organic compound that contains mercury) is added to some
vaccines as a preservative. It is the most widely-used preservative for vaccines that are
provided in multi-dose vials. There is no evidence to suggest that the amount of
thiomersal used in vaccines poses a risk to health.
Communicating with patients and parents Decision Making
Factors affecting people's decision-making around vaccines can include:
o Religious beliefs
o Medical reasons - sometimes people believe a vaccine is contraindicated or have been mal-
advised by a healthcare professional
o That healthy living conditions make immunisation unnecessary
o That the risks of the vaccine are greater than the risk of the disease
o That herd immunity will protect them, so vaccination is unnecessary
o That their/their child's immune system will be overloaded
o Belief that as they have already had the disease, there is no need to have the vaccine
o Concerns about vaccine production/material
o That the vaccine will not protect them
o That the vaccine isn't safe
o Emotional distress at prospect of pain from the injection
Questions and Misconceptions
Addressing questions and correcting misconceptions about vaccines:
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Those giving vaccines need to be well informed with the facts about individual vaccines, particularly
when the media have raised fears about the safety of vaccination:
o Reassure patients (or parents) that vaccine safety is taken extremely seriously, that vaccines go
through rigorous trials and are strictly regulated and monitored
o Be aware of any current controversies and misconceptions surrounding immunisations, using
reliable and official sources to keep up to date (e.g. Public Health England) so you can discuss
them with patients
o Provide patients with up to date immunisation information leaflets (in the patient's language)
o Be aware of advertisement campaigns and documentaries and be able to discuss them
Risks
To effectively communicate about risks associated with vaccination:
o Communicate openly
o Be open and honest about known adverse effects of vaccines
o Keep vaccine related risks in context - i.e. the minimal risk of vaccination reactions compared
with the potential of the disease and its complications
o Emphasize the benefits of vaccines
o Ensure you can take time to answer any questions
o Be confident and empathic
o Acknowledge factors affecting an individual's decision‐making
o Explore any specific concerns
o Take into account the individual's level of knowledge
o Give written information and signpost to reliable sources of information
Anxious Patients
People of all ages can become anxious about having injections. Consider the following when dealing
with anxious patients:
o Adopt a calm approach
o Use distraction techniques, for example, engage them in conversation unrelated to the
vaccination
o Explain the procedure to ensure that the patient knows what to expect
o Reassure that it is a quick and simple process
o Prepare the vaccine and administer out of sight of the patient where possible
Other Factors
Other factors affecting immunisation rates are:
o Socioeconomic - such as living in deprived areas, living in lone parent families or being part of
a travelling community
o Attitudes - including personal beliefs and experiences, media portrayal, family and friends'
beliefs
o Health service issues - misconceptions regarding contraindications, lack of knowledge on
current policies, inadequate immunisation services
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Factors affecting immunisation rates Flu vaccine uptake data is collected via the web-based ImmForm system where it is managed and
published by Public Health England. Over 90% of GP practices are able to make automated data returns
where the number of their patients vaccinated is directly extracted from their IT system and put into
ImmForm. For data to be accurate and complete, it is critical that vaccines given outside the surgery
e.g. in pharmacies are reported to the patient's GP. Data is collected and published monthly on all the
groups for whom flu vaccine is indicated at national level and local NHS England team level, to enable
performance to be reviewed and time to take action if needed.
Public Health England set annual targets for uptake of the vaccine and these are as follows:
o Actively offering flu vaccination to 100% of all those in eligible groups
o Vaccinating at least 75% of those aged 65 years and over
o Vaccinating at least 75% of healthcare workers with direct patient contact
o Improving uptake for those in clinical risk groups, particularly for those who are at the highest
risk of mortality from flu but have the lowest rates of vaccine uptake e.g. those with long-term
liver and neurological disease, including people with learning disabilities
o For children, a minimum uptake of 40% has been shown to be achievable in pilots conducted
to date
As a minimum we would expect uptake levels between 40% and 60% to be attained.
Strategies for improving immunisation rates All healthcare professionals who immunise need to be knowledgeable and confident about the subject:
Providing a flexible and accessible service
o Are your clinics held at convenient times for patients?
o Do you hold evening or weekend immunisation clinics?
o Are you flexible in when you offer immunisations? Not just at 'baby' or 'child health' clinics?
o Are clinics adequately staffed with sufficient administrative support?
o Are clinic appointments long enough to allow discussion with parents / patients?
If you can't currently say yes to all the above, consider what more you could do to maximise uptake.
Consent It is a general legal and ethical principle that valid consent must be obtained before starting any
treatment, investigation, or providing personal care for a person. This includes administering a vaccine.
The principle reflects the right of patients and is a fundamental part of good practice. To gain informed
consent, health professionals should ensure that the individual (or those giving consent on their behalf)
fully understands the consent process. The consent process should include discussion on:
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o What immunisation(s) are to be given
o Which disease(s) will be prevented
o Benefits and risks of immunisation versus risks of
disease(s)
o Possible side effects and how these should be dealt
with
o With any follow-up/action required
o Information flows necessary for the appropriate
recording in the patient's GP practice record
o In the case of vaccinations administered under the
NHS, it also covers the sharing of information with NHS
England and the NHS Business Service Authority for the purpose of administration and
evaluation of the care provided
The individual must be informed about the process and be able to communicate their decision.
Further points on consent
o Consent must be given voluntarily and freely
o Information given should be relevant to the individual patient, explained properly and
questions answered fully
o The Community Pharmacy Seasonal Influenza Vaccination Advanced Service Specification
requires each patient to complete a consent form before the vaccine is administered
Any healthcare professional who does not respect this principle may be liable to legal action by the
patient and to action by their professional body.
Capacity to consent For consent to be valid it must be given by an appropriately informed person who has the capacity to
consent. The Mental Capacity Act defines someone who lacks capacity as "someone who is unable to
make a decision for themselves due to impairment or disturbance in the functioning in their mind or
brain."
Capacity
A person's mental capacity may be impaired either temporarily or permanently:
o Temporary impairment may be due to sedative medications or acute confusion.
o Longer term impairment may be as a result of dementia, brain injury or a learning disability.
To be deemed to have capacity an individual must be able to make a decision and therefore, be able
to do the following:
o Understand the information relevant to that decision, including understanding the likely
consequences of making, or not making the decision
o Retain that information
o Use or weigh that information as part of the decision-making process
o Communicate their decision
Who can consent o An adult is considered as a person over the age of 18
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o People of 16-17 years of age are presumed to give consent for their own medical treatment.
o Children under 16 years who have sufficient understanding and intelligence to enable them to
understand fully what is involved in a proposed intervention will also have the capacity to
consent to that intervention. This is described as being Gillick Competent
o If a person aged 16 or 17 or a person that is Gillick Competent consents to treatment, a parent
is unable to override that decision
o Where a young person of 16 or 17 or a child under 16 but Gillick Competent refuses treatment,
it is possible that this refusal could be over-ruled, if in all probability it could lead to the death
of the child or severe permanent injury.
Consent on behalf of another Individuals who are able to give consent on behalf of another individual are:
Those with parental responsibility (for a patient under the age of 18)
o Someone authorised under a Lasting Power of Attorney
o Someone who has the authority to make decisions about their treatment as a court appointed
deputy
Consent for young children For young children, not competent to give or withhold consent, such consent can be given by a person
with parental responsibility, provided that person is capable of consenting to the immunisation in
question and is able to communicate their decision."
See Chapter 2 of The Green Book for further details on "Who has parental responsibility?"
The child should be given an explanation (age appropriate) of the vaccination process. Evidence shows
that children appear to be less traumatised when parents value vaccinations and the child has been
prepared for what is going to happen.
For more information see Department of Health Reference Guide to consent for examination and
treatment
Other Legal Points
Data Protection
From the 25th May 2018 GDPR set standards which must be satisfied when obtaining, holding, using
or disposing of personal data. In adherence with current data protection legislation, individuals should
be informed about:
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o How data about immunisations will
be stored
o Who can access that information
o How the data may be used,
emphasising that it would be used to
monitor the safety and efficacy of
vaccination programmes
Patient Group Directions (PGDs)
PGDs are written instructions for the supply or administration of medicines to patients who may not
be individually identified before the presentation for treatment. They provide a legal framework for
supplying and administrating medications by a range of qualified healthcare professionals.
Organisations must ensure that individual users of PGDs are fully competent and trained in their use.
PGDs should be reserved for situations where they provide an advantage for patient care whilst not
compromising patient safety.
o Healthcare professionals using the PGD must
o Be individually named
o Have signed the PGD
o Act within their code of professional conduct
Documentation
Accurate, accessible records of vaccinations given are important for keeping individual clinical records,
monitoring immunisation uptake and potentially facilitating the recall of recipients of vaccines or
reporting Adverse Drug Reactions (ADRs).
The following information should be accurately recorded:
o Vaccine name, product name, batch number and expiry date
o Dose administered
o Site(s) used - including clear description of which injection was administered in each site,
especially where two injections were administered in the same limb
o Date given
o Name and signature of vaccinator
Professional Accountability
Healthcare professionals involved in the administration of immunisations are not normally negligent
if they are acting within their own competencies and within practice that conforms to that of a
responsible body of medical opinion held by practitioners skilled in the particular field.
Storage of vaccines There are a number of best practice principles governing the storage and handling of vaccines:
Store on delivery
• Store immediately
• Use a locked designated vaccine fridge
• Maximum/minimum thermometer
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• Allow room for air to circulate - This enables temperature to remain constant
Storing vaccines
• Specialised pharmaceutical fridges must be used for vaccines
and diluents
• The fridge must be lockable or in a locked room
• The temperature of the fridge must be monitored with a
maximum-minimum thermometer and recorded at least once
a day on a chart specifically designed for recording
temperatures.
• Sufficient space around the vaccine packages must be left
allowing air to circulate
• Vaccines should be store away from the side and back of the
fridge to prevent them from freezing
• To maintain a constant temperature of the fridge, keep the
opening of the fridge door to a minimum
• Ensure electricity to the fridge is safeguarded against inadvertent breaks by the use of a
switchless electric socket or a plug clearly marked "pharmacy fridge - do not switch off"
Daily monitoring
• Monitor and record maximum/minimum and current temperature
• Reset max and min thermometer readings daily
• Record at least daily in log books
• If any variations, take action accordingly
Ensure good practice
Reset fridge temp after clinics, re-stocking etc.
• Rotate stock
• Records to be kept for a minimum of 5 years
• Regular audit of current practice
• Training around the cold chain
• Local multidisciplinary support
Defined local policies should be in place. Written in accordance with PGDs, SPCs, The Green Book.
Managing the cold chain The cold chain refers to the cold conditions that certain products require to be kept at during storage and distribution. Vaccines should be stored according to the manufacturers Summary of Product Characteristics (SPC), usually between +2 and +8 degrees centigrade, in their original packaging. They must also be protected from light. Efficacy, quality and safety of vaccines may be affected if they are not stored at the temperatures stipulated in the SPC. Storage outside of the recommended temperature range speeds up irreversible loss of potency which may result in the vaccine being less effective at creating the desired immune response and subsequently reducing protection. Heat speeds up the decline in potency of most vaccines, therefore reducing their shelf life.
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Storage
IMPORTANT: Vaccines must never be frozen This causes deterioration of vaccines and may give rise to a loss of potency and an increase in reactogenicity by:
• Irreversibly denaturing the proteins in the vaccine • Causing the emulsions in the vaccines to become unstable • Producing hairline cracks in the ampoule/vial/pre-filled syringe, potentially contaminating the contents • The glass spicules (small sharp pointed fragments) produced may also cause serious local adverse
reactions Persons involved in the handling of vaccines should follow appropriate policies to ensure the cold chain is maintained until the point of administration.
Breaks in the cold chain
Management of breaks in the cold chain Any vaccine that has not been stored or transported according to the requirements, stated in the SPC, should not be used without a risk assessment of the likely impact of the temperature variation on the vaccine. Guidance on how to manage breaks in the cold chain can be found in the Health Protection Agency (HPA) document "Vaccine Incidence guidance". NOTE: Ensure you are familiar with your local policy in the event of a failure in the cold chain, and who to contact, if necessary.
Cool boxes
Setting up and using cool boxes
• Validated cool boxes and cool packs should be used (from a recognised medical supply company) • As well as a maximum minimum thermometer • The temperature should be recorded at the beginning and end of each session • Using a validated cool box ensures that the cold chain will be maintained for several hours
NOTE: Vaccines must be kept in their original packaging, wrapped in bubble wrap (or similar insulation material) to protect them from any contact with the cool packs and placed in the cold box as per manufacturer's instructions.
Ordering and disposal of vaccines Ordering stock
Stocks of vaccines should be monitored regularly by nominated staff members to avoid over-ordering or shortages. Vaccination providers should have no more than two to four weeks' supply of vaccines at any one time. Best practice is to order small quantities on a regular, scheduled basis.
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Disposal of vaccines
• Vaccines must never be used if they have passed their expiry date • Any out of date stock should be labelled, immediately removed from the fridge and disposed of as per
local policy • There should be locally written policy and procedures for the disposal of vaccines by incineration, these
must be followed • Equipment including any vials, ampoules, needles and syringes should be disposed of by placing into a
suitable sharps box (they come in varying sizes) • Sharps boxes should be sealed and replaced once they are two-thirds full or at the level indicated on
the box
Reconstitution of vaccines Some vaccines are supplied in a pre-filled syringe, others need to be reconstituted before use. Vaccines should be reconstituted when required, not in advance of an immunisation session, to avoid errors and maintain vaccine efficacy and stability. To reconstitute:
• Only use the diluent supplied and note the time scale in which it must be used after dilution (often 1-4 hours).
• Ensure correct diluent is used • Carry out away from direct sunlight to protect the vaccine • A green needle (21G x 38mm (11/2 inch)) should be used to draw up the diluent and to inject it slowly
into the ampoule containing the vaccine. • Injecting diluent rapidly into the vaccine may cause frothing, which can affect the dilution and
consequent potency of the vaccine; shaking the ampoule may have a similar effect. • If the freeze-dried powder does not instantly dissolve in the diluent, gently rotate the ampoule until it
dissolves. • Draw up the appropriate dose. • Unless the vaccine is supplied in a pre-filled syringe with an attached needle, a new needle should be
used to inject the vaccine. • The needle should be selected according to the patient's size
When removing liquid from a vacuum-sealed ampoule, in order to break the vacuum first inject the equivalent measure of air to the volume of liquid to be removed. When drawing up from a glass ampoule, use a needle gauge no larger than 21G to eliminate the possibility of drawing up glass fragments
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Vaccines are usually supplied as a vial of powder and a solvent in a prefilled syringe.
Add the entire contents of the prefilled syringe into the vial.
If the powder does not dissolve immediately, gently rotate the ampoule
until it dissolves.
After reconstitution, the mixture should be drawn up in full and used in accordance
to the manufacturers recommendation
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Safe use of sharps There are some key points to remember when handling sharps in order to reduce the risk of injury.
• Consider the use of needle-less and safer needle systems whenever available and appropriate • Sharps should not be passed directly from hand to hand, and handling should be kept to a minimum • Used standard needles:
- Must not be bent or broken before disposal - Must not be recapped
• Remove the sheath just before you intend to administer the vaccine
• Used sharps must be discarded immediately by the person generating the sharps waste into a sharps container conforming to current standards Always dispose of the sharp prior to placing cotton wool on the patient's arm
• Some vaccine sheaths are tight to get off, so point the needle and syringe down and away from you and gently twist to remove sheath
Sharps containers:
• Must be located in a safe position that avoids spillage, are at a height that allows the safe disposal of sharps within an arm's distance from the site of injection, are away from public access areas and are out of the reach of children
• Must not be used for any other purpose than the disposal of sharps • Must not be filled above the fill line and must be disposed of when the fill line is reached • Should be temporarily closed when not in use • Should be disposed of every 3 months even if not full, by the licensed route in accordance with local
policy
Handling of spillages
• There should be locally written procedures on how to clean the area, this may include the use of a spill kit
• You should also refer to the manufacturers' Control of Substances Hazardous to Health (COSHH) safety data sheets
• Spillages should be cleared up quickly and gloves worn • Care should be taken to avoid skin puncture from glass or needles • If a vaccine is splashed in the eyes, they should be washed with sterile 0.9% sodium chloride
solution and medical advice sought
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References British National Formulary British National Formulary (BNF) November 2016
Department of Health, 2006
Department of Health, 2006. A review of services to allergy: The epidemiology, demand for and the provision of treatment and effectiveness of clinical interventions.
EMC www.medicines.org.uk
Immform https://portal.immform.dh.gov.uk/Logon.aspx?returnurl=%2f
JCVI https://www.gov.uk/government/groups/joint-committee-on-vaccination-and-immunisation
MHRA https://www.gov.uk/government/organisations/medicines-and-healthcare-products-regulatory-agency
NHS Patient Group Direction for Adrenaline
NHS Patient Group Direction for Adrenaline 1 in 1000 Nov 2014 March Review 2016
NIBSC http://www.nibsc.org/
Resuscitation Council Guidelines
Resuscitation Council Guidelines 2015
The Green Book https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
Update of the Evidence Base: World Allergy Organization Anaphylaxis Guidelines
Simons F, Ebisawa M, Sanchez-Borges M et al. (2015) 2015 Update of the Evidence Base: World Allergy Organization Anaphylaxis Guidelines. World Allergy Organization Journal. 8:32
WHO http://www.who.int/en/