Quadrivalent influenza vaccine (Split virion, inactivated) - ECG ...
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Patient Group Direction
Quadrivalent influenza vaccine (Split
virion, inactivated)
Version 3
Effective from: 1st September 2020
Review date: 31st March 2021
Registered Company Address and Head Office: Sapphire Court, Walsgrave Triangle,
Coventry, CV2 2TX
Registered in England and Wales No. 1830630Patient Group Direction – Influenza – Quadrivalent Influenza vaccine (Split
virion, inactivated)
This patient group direction has been drawn up, approved and authorised for use by the following:
Name Position Date Signature
Senior MASTA Doctor September
David A Ross
2020
Pharmacist September
Naomi Harradence
2020
Superintendent September
Faisal Tuddy
Pharmacist 2020
Head of Clinical September
Michelle Rhodes
Standards 2020
Influenza – Quadrivalent Inactivated vaccine (Split virion, inactivated)
(v3) 2Delegation of Authority Following guidance issued by Public Health England in April 2020, pharmacists who have previously undertaken vaccination training and are due to repeat face-to-face training for both injection technique and basic life support (including administration of adrenaline) in 2020 do not need to complete this until 2021. There is still the requirement for all pharmacists to complete online annual refresher training. Any Pharmacists who has not previously trained to undertake vaccinations or have not delivered a minimum of 20 vaccinations in 2019/20 MUST undertake full training before commencing flu vaccination service. All pharmacists must confirm by signature that they have read the PGD, agree to work within the PGD framework, have adequate knowledge and that they will work to the General Pharmaceutical Council Standards for pharmacy professionals (May 17) before they can supply these vaccines. Subject to the above I give authorisation for the ASDA pharmacists to administer and supply these medications in accordance with this PGD and current Public Health England guidelines. Delegating Doctor Name: Dr David A Ross Date: Signature: Influenza – Quadrivalent Inactivated vaccine (Split virion, inactivated) (v3) 3
Delegation of Authority
Practitioner authorisation
By signing this PGD you are indicating that you agree to its contents and that you will work within it. It
is the responsibility of each professional to practise only within the bounds of their own competence
and professional code of conduct.
I confirm that I have read and understood the content of this PGD and that I am willing and
competent to work to it within my professional code of conduct.
Name Designation Signature Date
A copy of this PGD with completed practitioner authorisation sheet should be retained and available
at the pharmacy premises as a record of those pharmacists authorised to work under this PGD.
Influenza – Quadrivalent Inactivated vaccine (Split virion, inactivated)
(v3) 4Influenza – Quadrivalent Influenza vaccine (Split virion, inactivated)
Review Date: 31st March 2021
Name of vaccines Quadrivalent Influenza vaccine (Split virion, inactivated) – Sanofi Pasteur ▼
Legal status Prescription-only medicine (POM)
Quadrivalent Influenza vaccine (Split virion, inactivated) is subject to additional
monitoring as black triangle products. Healthcare professionals are asked to
report any suspected adverse reactions:
Dose Individuals aged 12-64 years (clients due to become 65 years old by 31st March
2021 must be given Fluad under the NHS service):
One single 0.5ml dose for one year’s cover
Quantity/ Course Quadrivalent Influenza vaccine (split virion, inactivated) contains the
following strains:
• A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09 - like strain
(A/Guangdong-Maonan/SWL1536/2019, CNIC-1909)
• A/Hong Kong/2671/2019 (H3N2) - like strain (A/Hong Kong/2671/2019, IVR-
208)
• B/Washington/02/2019 - like strain (B/Washington/02/2019, wild type)
• B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, wild type)
This vaccine complies with the WHO recommendations (Northern Hemisphere)
and EU recommendation for the 2020/21 season.
Frequency of Annual vaccination if requested
administration
Pharmaceutical Quadrivalent Influenza vaccine (Split virion, inactivated) is presented as
form and strength suspension for injection in pre-filled syringe.
After shaking gently, the vaccine is a colourless opalescent liquid.
The vaccine should be allowed to reach room temperature before use.
The vaccine should be visually inspected before administration. The vaccine
should not be used if there are visible particles or variation in its physical
appearance away from that described in the SPC.
Storage Store at 2°C – 8°C (in a refrigerator fit for purpose).
Do not freeze.
Keep the syringe in the outer carton in order to protect from light.
Route Intramuscular injection - into the deltoid muscle is recommended.
N.B. Care is needed when injecting into the deltoid. Injecting too high into the
shoulder can result in pain and ongoing disability around the joint.
Deep subcutaneous injection - Individuals with a bleeding disorder may be
given Quadrivalent Influenza vaccine (Split virion, inactivated) by deep
Influenza – Quadrivalent Inactivated vaccine (Split virion, inactivated)
(v3) 5subcutaneous injection to reduce the risk of bleeding – see Green Book,
Chapter 19.
These vaccines should NEVER be given into a vein or artery.
Clinical situations Prevention of seasonal influenza
for which the
medicine is to be
used
Inclusion criteria • Provision of informed consent to vaccination
• Individuals who have no contraindications to receiving the vaccination and
are not excluded below
• Children and adults aged 12 years to under 64 years of age
• Breastfeeding mothers and pregnant women
Exclusion criteria/ • Absence of valid consent.
contraindications • Individuals under the age of 12 and over 64 years (clients becoming 65 years
of age by 31st March 2021: these clients must be given Fluad under the NHS
service)
• Any individual who has already received an influenza vaccination against
seasonal flu since September 2020
• Acute febrile infection with a temperature above 37.5C However, the
presence of a minor infection, such as a cold, should not result in the deferral
of vaccination.
• Anaphylactic reaction to a previous vaccine or any components of the
vaccine, latex or any unidentified allergen
• Severe reaction or hypersensitivity to the active substances or any of the
excipients of the vaccine such as such as eggs (ovalbumin, chicken proteins),
neomycin, formaldehyde and octoxinol-9.
Note: Individuals in a particular risk groups due to age, pregnancy or pre-
existing medical condition may be entitled to free vaccination at their GP
surgery.
Action if excluded • Temporary exclusion - Rearrange a date for administration of the vaccine
• Permanent exclusion - Ensure appropriate signposting advice is provided –
for example, the patient’s GP
Pregnancy / Pregnancy:
lactation A seasonal influenza vaccine is recommended at any stage of pregnancy. There
is no evidence that inactivated vaccines will cause any harm to an unborn baby.
These individuals may be vaccinated with Quadrivalent Influenza vaccine (Split
virion, inactivated) and may be entitled to free vaccination at their GP surgery.
Breastfeeding:
Quadrivalent Influenza vaccine (Split virion, inactivated) may be used during
breastfeeding.
Influenza – Quadrivalent Inactivated vaccine (Split virion, inactivated)
(v3) 6Warnings / • As with all injectable vaccines, appropriate medical treatment and
precautions supervision should always be readily available in case of an anaphylactic
event following the administration of the vaccine.
• Syncope (fainting) can occur following, or even before, any vaccination as a
psychogenic response to the needle injection. Procedures should be in
place to prevent injury from fainting and manage syncopal reactions.
• This vaccine should not be administered intravascularly.
• The immunological response may be reduced if the patient is undergoing
immunosuppressant treatment.
• Following influenza vaccination, false positive results in serology tests using
the ELISA method to detect antibodies against HIV1, Hepatitis C and
especially HTLV1 have been observed.
• As with any vaccine, vaccination with an inactivated influenza vaccine may
not protect 100% of susceptible individuals.
• Regarding passive protection, not all infants less than 6 months of age born
to women vaccinated during pregnancy will be protected.
Potential adverse The safety profile of this vaccine is available to see on the Summary of Product
reactions Characteristics.
Refer to the following document in SOP F9 - Vaccination Services for clear
guidance on the recognitions and management of adverse reactions:
• Management of Adverse Events Algorithm
In the case of anaphylaxis, adrenaline must be used as detailed in SOP F9 -
Vaccination Services
• Mild/common adverse events should be treated as appropriate and the
client advised to seek a medical opinion if the symptoms persist or their
condition deteriorates.
Commonly reported symptoms following intramuscular vaccination are:
• Pain
• swelling or redness at the injection site
• low-grade fever
• malaise
• shivering
• fatigue
• headache
• myalgia and arthralgia
• A small painless nodule (induration) may also form at the injection site.
• Immediate reactions such as urticaria, angio-oedema, bronchospasm and
anaphylaxis can also occur
Most symptoms normally occur within 3 days following vaccination and are
mild. They usually resolve spontaneously within 1 to 3 days after onset.
Influenza – Quadrivalent Inactivated vaccine (Split virion, inactivated)
(v3) 7Mild/common adverse events should be treated as appropriate and patient
advised to seek medical opinion if symptoms persist or condition deteriorates.
This is a black triangle product; ALL reactions should be reported to the MHRA
via the yellow card reporting scheme.
Interactions No interaction studies have been performed with this vaccine.
Quadrivalent Influenza vaccine (split virion, inactivated) can be given at the
same time as other vaccines, based on experience with Inactivated Influenza
Vaccine (Split Virion) BP.
The ‘Green Book’ (Public Health England) CH19 states that the vaccines should
be given at separate sites, preferably in a different limb. If given in the same
limb, they should be given at least 2.5cm apart.
The immunological response may be reduced if the patient is undergoing
immunosuppressant treatment.
Further information • Quadrivalent Influenza Vaccine (Split virion, inactivated) has no or negligible
influence on the ability to drive and use machines.
• Sero-protection is generally obtained within 2 to 3 weeks.
Antibodies against one influenza virus type or subtype confers limited or no
protection against another.
Vaccinees should be warned that many other organisms cause respiratory
infections similar to influenza during the influenza season, which influenza
vaccine will not prevent. They may otherwise become disillusioned with the
vaccine, especially in a non-epidemic year.
Information • Vaccine name,
recorded • Date of administration,
• Batch number,
• Expiry date,
• Site,
• Name of administrator.
Contact MASTA if Pharmacy medical support team telephone number:
you have any 0330 100 4188
concerns
Influenza – Quadrivalent Inactivated vaccine (Split virion, inactivated)
(v3) 8Supporting Documents • Summary of Product Characteristics (SPC), QUADRIVALENT INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED): (accessed 08/2020) • Public Health England National flu immunisation programme 2019/20: (accessed 08/2020) • Public Health England Immunisation against Infectious Disease – “The Green Book”. Chapter 19 - Influenza https://www.gov.uk/government/publications/influenza-the-green-book-chapter-19 (accessed 08/2020) Influenza – Quadrivalent Inactivated vaccine (Split virion, inactivated) (v3) 9
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