inactivated influenza vaccine - nhs england · inactivated influenza vaccine can be safely and...

________________________________________________________________________________________________________ Drug name: Influenza Vaccine Start date: September 2014 Expiry date: September 2015 of 18

Document Title: Patient Group Direction for administration of Inactivated Influenza Vaccine

during flu immunisation programme 2014/15

PCT Doc Ref.:

Version No.: 8/2014

Local Doc Ref.: PGD

Author/Owner: Jacqui Seaton, Head of Medicines Management

Owner: Rebecca Woods, Head of Public Health Commissioning

File Reference: I:\AngleseyHouse\Commissioning Directorate\Primary Care & Specialised Commissioning\Public Health\Immunisation\2014-15\PGDs\Approved

Document Overseeing Group:

PGD Working Group

Placement in Framework:

Approval Level:

Date of Approval: October 2014

Review Date: October 2015

Amendment Dates: Page(s) Brief Description

August 2014 October 2014 October 2014

8 7 17

Update to the information regarding the administration of flu vaccine to those with egg allergy. Re-worded information under ‘Selecting the appropriate vaccine for children’ for clarification. Re-worded information beneath flowchart on appendix 2 for added clarification.


Approved By

NHS England

and Staffordshire Area Team Name Signature

Medical Director Dr Ken Deacon

LPN Pharmacy Chair Dr Manir Hussain

Head of Public Health Commissioning

Rebecca Woods

Date of patient group direction approved

October 2014

Date this patient group direction becomes due for review

October2015 or in response to new local/national guidelines.

Patient Group Direction for administration of Inactivated Influenza Vaccine during flu

immunisation programme 2014/15


STAFF CHARACTERISTICS

Provider of NHS services within NHS England (Shropshire & Staffordshire Area Team)

Registered nurse with current NMC registration Specialist competencies or qualifications:

The health care professional should undertake the Public Health England training for healthcare practitioners on the national flu immunisation programme 2014/15 which can be accessed via (https://www.gov.uk/government/publications/national-flu-programme-training-slide-set-for-healthcare-professionals)i.

The health care professional must have a good understanding of the NICE Good Practice Guidance on Patient Group Directionsii.

The NICE competency framework: For health professionals using Patient Group Directionsiii should be used by health care professionals planning to work under this PGD to identify any gaps in their knowledge. The gaps should be addressed before the healthcare professional is authorised to work under this PGD.

The clinical manager/ lead GP/commissioner must have evidence that the health care professional has undertaken training to carry out clinical assessment of patient leading to confirmation that the patient requires treatment according to the indications listed in the PGD.

The healthcare professional must provide evidence of training, appropriate annual updates and continued professional development undertaken to support their competence for administration of this treatment.

The clinical manager/ lead GP/commissioner must have assessed the competency of the healthcare professional to work to this Patient Group Direction. The NICE competency framework: For health professionals using Patient Group Directionsiii should be used to support this assessment.

The health care professional must have undertaken training and annual updates in the recognition and treatment of anaphylaxis, including practical in Basic Life Support and has immediate access to an in-date supply of adrenaline 1mg in 1ml (1:1000) at the time of the consultation. (The practitioner must be deemed competent in basic life support and in emergency administration of adrenaline)

The health care professional must have access to all relevant sources of information e.g. information issued by the Department of Health (Green Book), British National Formulary (BNF), Summary of Product Characteristics (SPC), and the clinical guideline concerning medicine(s) within this Patient Group Direction (PGD).

The practitioner must be competent and knowledgeable in vaccine cold chain standards.

The registered health care practitioner is professionally accountable for supply or administration under the PGD as defined in their own profession’s Code of Professional Conduct and Ethics.

YOU MUST BE AUTHORISED BY NAME BY YOUR CLINICAL LEAD UNDER THE CURRENT VERSION OF THIS PGD

BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT

PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY

https://www.gov.uk/government/publications/national-flu-programme-training-slide-set-for-healthcare-professionals


https://www.nice.org.uk/guidance/mpg2/resources/mpg2-patient-group-directions7




CLINICAL CONDITION

Clinical need addressed In accordance with the flu immunisation programme 2014/15, inactivated Influenza vaccination is indicated for active immunisation of individuals considered at risk as defined by NHS England Immunisation update Gateway

Reference Number 01287: The national flu immunisation programme 2014/15) for the prevention of influenza infection and reduction in transmission of influenzaiv

Inclusion criteria Eligible Groupi,iv,v Further Details

All patients aged 65 years and over

"Sixty-five and over" is defined as those aged 65 years and over on 31 March 2015 (i.e. born on or before 31 March 1950).

Chronic respiratory disease aged six months or older∞

Asthma that requires continuous or repeated use of inhaled or systemic steroids or with previous exacerbations requiring hospital admission. Chronic obstructive pulmonary disease (COPD) including chronic bronchitis and emphysema; bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and bronchopulmonary dysplasia (BPD).

Children who have previously been admitted to hospital for lower respiratory tract disease.

Chronic heart disease aged six months or older∞

Congenital heart disease, hypertension with cardiac complications, chronic heart failure, individuals requiring regular medication and/or follow-up for ischaemic heart disease.

Chronic kidney disease aged six months or older∞

Chronic kidney disease at stage 3, 4 or 5, chronic kidney failure, nephrotic syndrome, kidney transplantation.

Chronic liver disease aged six months or older∞

Cirrhosis, biliary atresia, chronic hepatitis

Chronic neurological disease aged six months or older∞

Stroke, transient ischaemic attack (TIA). Conditions in which respiratory function may be compromised due to neurological disease (e.g. polio syndrome sufferers).

Clinicians should consider on an individual basis the clinical needs of patients including individuals with cerebral palsy, multiple sclerosis and related or similar conditions; or hereditary and degenerative disease of the nervous system or muscles; or severe neurological or severe learning disability.

Diabetes aged six months or older∞

Type 1 diabetes, type 2 diabetes requiring insulin or oral hypoglycaemic medicines, diet controlled diabetes.

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/316007/FluImmunisationLetter2014_accessible.pdf

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/316007/FluImmunisationLetter2014_accessible.pdf


Immunosuppression aged six months or older∞

Immunosuppression due to disease or treatment, including patients undergoing chemotherapy leading to immunosuppression, bone marrow transplant, HIV infection at all stages, multiple myeloma or genetic disorders affecting the immune system (e.g. IRAK-4, NEMO, compliment deficiency). Individuals treated with or likely to be treated with systemic steroids for more than a month at a dose equivalent to prednisolone at 20mg or more per day (any age), or for children under 20kg, a dose of 1mg or more per kg per day. It is difficult to define at what level of immunosuppression a patient could be considered to be at a greater risk of the serious consequences of influenza and should be offered influenza vaccination. This decision is best made on an individual basis and left to the patient’s clinician.

Some immunocompromised patients may have a suboptimal immunological response to the vaccine.

Asplenia or dysfunction of the spleen

This also includes conditions such as homozygous sickle cell disease and coeliac syndrome that may lead to splenic dysfunction.

Pregnant women

Pregnant women at any stage of pregnancy (first, second or third trimesters).

Inactivated influenza vaccine can be safely and effectively administered during any trimester of pregnancy. There is no evidence to date to demonstrate an increased risk of either maternal complications or adverse fetal outcomes associated with inactivated influenza vaccinei,v

∞ See page 7 ‘selecting the appropriate flu vaccination for children’ In addition to the groups above, immunisation should be provided to reduce the transmission of influenza within health and social care premises, to contribute to the protection of individuals who may have a suboptimal response to their own immunisations or to avoid disruption to services that provide their carei,iv.


People living in long-stay residential care homes or other long-stay care facilities

Vaccination is recommended for people living in long-stay residential care homes or other long-stay care facilities where rapid spread is likely to follow introduction of infection and cause high morbidity and mortality. This does not include, for instance, prisons, young offender institutions, or university halls of residence.

Carers

Those who are in receipt of a carer’s allowance, or those who are the main carer, or the carer of an elderly or disabled person whose welfare may be at risk if the carer falls ill. Vaccination should be given on an individual basis at the discretion of the practitioner. (Please note – this category refers to individual carers entitled to a free flu vaccine on the NHS, not professional health and social care workers who should be vaccinated by their employer, as part of an occupational health programme).

The groups listed in the table above are considered priority however the list is not exhaustive, the healthcare practitioner should apply clinical judgement to take into account the risk of flu exacerbating any underlying disease that a patient may have, as well as the risk of serious illness from flu itself. Flu vaccine should be offered in such cases even if the individual is not in the clinical risk groups specified above.i,iv Consideration should also be given to the vaccination of household contacts of immunocompromised individuals, i.e. individuals who expect to share living accommodation on most days over the winter and therefore for whom continuing close contact is unavoidable.v

Health and Social Care staff - involved directly in delivering health and social care such that they and vulnerable patients/clients are at increased risk of exposure to influenza

Vaccination is recommended, however professional health and social care workers should be vaccinated by their employer as part of an occupational health programme they are not covered by this PGD.

The vaccine will be administered in line with recommendations given in Chapter 19 of the Immunisation against infectious Disease: The Green Book.

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/147958/Green-Book-Chapter-19-v4_71.pdf

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/147958/Green-Book-Chapter-19-v4_71.pdf


Selecting the appropriate vaccine for children

Eligible cohort Vaccine to be offered

Six months to less than 2 years old in clinical risk groupiv

Offer suitable inactivated flu vaccine using this PGD (see appendix 1)

Two years old to less than 17 years old in roll-out cohort and pilotsiv

Offer live attenuated influenza vaccine (Fluenz Tetra®) – Refer to Fluenz Tetra® PGD. If Fluenz Tetra is contraindicated or not recommended, offer a suitable inactivated flu vaccine using this PGD*.

Two years old to less than 18 years old in clinical risk groups (not in roll-out cohort and pilots)iv

Offer live attenuated influenza vaccine (Fluenz Tetra®) – Refer to Fluenz Tetra® PGD. If Fluenz Tetra is contraindicated or not recommended, offer a suitable inactivated flu vaccine using this PGD*

Child contacts of very severely immunocompromised individualsi

Offer suitable inactivated flu vaccine using this PGD

*The quadrivalent inactivated influenza vaccine (Fluarix® Tetra▼) is authorised for children aged three years and older and is preferred because of the additional protection offered. Otherwise, in children aged two years, a suitable inactivated trivalent vaccine should be given. (See appendix 1) BEWARE OF PRODUCT CONFUSION! Care must be taken not to confuse the two ‘Tetra’ brands. One way of remembering which vaccine is which is:-

Fluenz is the nasal flu vaccine

Fluarix is the arm injected vaccine

Exclusion criteria (for full details of interacting medicines refer to current Summary of Product Characteristics (SPC) www.medicines.org.uk & BNF)

Patients who do not fall in the categories listed within the inclusion criteria.

Children in whom live attenuated influenza vaccine (Fluenz Tetra®) is appropriate under the national flu immunisation programme 2014/15 (refer to Fluenz Tetra® PGD).

In the interests of maintaining the highest level of safety, and in order to set a clear and manageable limit, healthy children that turn two years of age after the 1 September 2014 should not be offered influenza vaccine i,iv

Patients who have had a confirmed anaphylactic reaction to a previous dose of the vaccine.

Patients who have a confirmed anaphylactic reaction to any component of the vaccine (see cautions for guidance on egg allergy)i,v .

Hypersensitivity to the active substances, to any of the excipients or to any component of the vaccine (see individual product SPC for specific components and excipients of each vaccine).

Consent not received - Individuals, or those giving consent on their behalf, must be given enough information to enable them to make an informed decision before they can give consent. This should include information about the vaccine, the vaccination process, benefits and risks of the immunisation(s)

Temporary Exclusion

If an individual is acutely unwell, immunisation may be postponed until they have fully recovered. This is to avoid confusing the differential diagnosis of any acute illness by wrongly attributing any signs or symptoms to the adverse

http://www.medicines.org.uk/


effects of the vaccine. v

Otherwise, minor illnesses without fever or systemic upset are NOT valid reasons to postpone immunisationv.

Caution/need for further advice /Interactions

Influenza vaccine enhances the effect of phenytoin, possibly increases plasma concentration of theophylline and may enhance the anticoagulant effect of warfarin.vi

Influenza vaccine can be given at the same time as other vaccines. The vaccines should be given at separate sites preferably in a different limb. If given in the same limb they should be at least 2.5cm apart. v

Should be given with caution to individuals with thrombocytopenia or any coagulation disorder as bleeding may occur following an intramuscular administration with these individuals

Individuals who have immunosuppression and HIV infection (regardless of CD4 count) should be given influenza vaccine in accordance with the recommendations and contraindications above. These individuals may not make a full antibody response v

Egg Allergy

Most children (under the age of 18 years) with egg allergy should be immunised in primary care using an inactivated influenza vaccine with an ovalbumin content less than 0.12 μg/ml (equivalent to 0.06 μg for 0.5 ml dose)v.

Children with either confirmed anaphylaxis to egg or with egg allergy and severe uncontrolled asthma should be referred to specialists for immunisation in hospitalv.

The ovalbumin-free influenza vaccine Optaflu®, if available, can be used in primary care patients from the age of 18 years regardless of the severity of the allergy. If there is no egg-free vaccine available, adult patients with either confirmed anaphylaxis to egg or with egg allergy and severe uncontrolled asthma should be referred to specialists for immunisation in hospital. Other adult patients can be immunised in primary care using an inactivated influenza vaccine with an ovalbumin content less than 0.12 μg/ml (equivalent to 0.06 μg for 0.5 ml dose)v.

Vaccines with ovalbumin content more than 0.12 μg/ml (equivalent to 0.06 μg for 0.5 ml dose) or where content is not stated should not be used in egg-allergic individualsv.

In all settings providing vaccination, facilities should be available and staff trained to recognise and treat anaphylaxisv.

See appendix 1 for ovalbumin content of influenza vaccines.

Management of excluded patients

Document in the individual’s notes, advise and counsel accordingly.

Refer to medical practitioner or seek appropriate advice from a Consultant in Health Protection if necessary

For individuals temporarily excluded due to acute or febrile illness advise when the vaccine may be given and arrange another appointment.

Action for patients not wishing to receive care under this PGD

Advise the individual about the protective effects of the vaccine, the risks of infection, including potential complications.

Document action and advice given (record declined vaccine in the individuals clinical record).

Refer to doctor or independent prescriber.

Advise with regard to flu symptom management.


Treatment and Drug details

Name form and strength of medicine

Licensed preparations for: Inactivated Influenza Vaccine (trivalent influenza vaccine) approved for use under this PGD iv,v:

None of the influenza vaccines for the 2014/15 season contain thiomersal as an added preservative iv,v. BEWARE OF PRODUCT CONFUSION! Care must be taken not to confuse the two ‘Tetra’ brands. One way of remembering which vaccine is which is:-

Fluenz is the nasal flu vaccine

Fluarix is the arm injected vaccine See appendix 1 for specific age related indications and ovalbumin content for the individual vaccines.

CSL inactivated influenza vaccine/Enzira® - has been associated with a high rate of febrile convulsions in children under five years of age in other countries. The SPC for Enzira® also indicates that a high rate of fever was reported in the age group aged five to under nine years. Due to the risk of febrile convulsions, the indication for Enzira is restricted to use in adults and children aged five years and older. This vaccine will not be part of the central supply for use in children in the 2014/15 season, but may be available for purchase by the practice. If no suitable alternative vaccines are available, clinicians should ensure parents are aware of the risk and give advice on the management of vaccine-induced fever v

Manufacturer Preparation Vaccine Type

Abbott Healthcare

Influvac® Surface antigen, inactivated

Imuvac®

Surface antigen, inactivated

GlaxoSmithKline Fluarix Tetra ® ▼ Split virion Inactivated Virus

MASTA Imuvac® Surface antigen, inactivated

Inactivated Influenza Vaccine (Split Virion) BP

Split virion Inactivated Virus

Enzira®

Split virion inactivated virus

Novartis Vaccines Agrippal® Surface antigen, inactivated

Optaflu® ▼

Surface antigen, inactivated, prepared in

cell cultures

Pfizer Vaccines CSL Inactivated Influenza Vaccine Split virion inactivated virus

Enzira®


Sanofi Pasteur MSD



Legal classification POM – Prescription only medicine.


Black triangle warning Suspected adverse reactions. Should be reported using the Yellow Card reporting scheme (www.yellowcard.gov.uk).

Optaflu® ▼

Fluarix Tetra ® ▼

All other inactivated influenza preparations no black triangle warning

Method of obtaining supply Influenza vaccine for eligible patients age 18 years and older:-

Directly from manufacturers

Community pharmacy GP practices are responsible for ordering sufficient flu vaccine for eligible patients (see notes below for eligible children). It is recommended that practices order from more than one supplier in case of disruption in the supply of vaccine from one manufacturer. GP practices should also order appropriate vaccines for those with egg allergy. Influenza vaccine for all children aged from six months to less than 18 years

Order through the ImmForm website (www.immform.dh.gov.uk) Public Health England (PHE) has centrally procured flu vaccine for all children aged from six months to less than 18 years old. This is for both those children who are part of the extension of the programme, and those children in clinical risk groups who are not part of the extension (ie both live attenuated influenza vaccine (Fluenz Tetra®) and inactivated trivalent vaccine (Sanofi Pasteur MSD inactivated influenza (split virion) or Fluarix® Tetra) for those children for whom Fluenz Tetra® is contraindicated or not suitable).i,iv Some flu vaccines are restricted for use in particular age groups (see Appendix 1 for further information). The Summary of Product Characteristics for individual products should always be referred to when ordering vaccines for particular patients.

Site for treatment GP surgeries

Community Pharmacies

Patients home

Route/method Intramuscular injection, preferred site is the deltoid area of the upper arm or anterolateral thigh in infants i,v

For individuals who have a bleeding disorder, vaccines should be given by deep subcutaneous injection to reduce the risk of bleeding (‘off license’ use) i,v

Influenza vaccine should be allowed to reach room temperature before use.

Shake well before administration.

Dose Children aged 6 months and older and adults should receive a single intramuscular injection of 0.5ml.

Children aged 6 months to less than 9 years who have not received influenza vaccine before should receive a second dose of vaccine at least 4 weeks later. (Inactivated influenza vaccines are interchangeable)

NB. Some flu vaccines are restricted for use in particular age groups. The Summary of Product Characteristics for individual products / Appendix 1 should always be consulted.

Some influenza vaccine summaries of product characteristics (SPCs) of intramuscular inactivated influenza vaccines indicate that young children can be given either a 0.25ml or a 0.5ml dose. The Joint Committee on Vaccination and

http://www.immform.dh.gov.uk/


Immunisation has advised that where these alternative doses are indicated in the SPC, the 0.5ml dose of intramuscular inactivated influenza vaccine should be given to infants aged six months or older and young children because there is evidence that this dose is effective in young children.i,v

See Appendix 2 for flow chart summarising the advice on flu vaccination for 2014/15

Number of times treatment may be administered

Single dose unless child aged 6 months to less than 9 years and has never received influenza vaccine before, in which case a repeat dose should be given 4 weeks after receiving inactivated influenza vaccine for the first timei,v. When to stop offering the vaccine to pregnant women The ideal time for flu vaccination is between September and early November before flu starts circulating. However flu can circulate considerably later than this and it may therefore be necessary to continue offering the vaccine to groups such as newly pregnant women. Clinicians should apply clinical judgement to assess the needs of an individual patient, taking into account the level of flu-like illness in their community and the fact that the immune response following flu vaccination takes about two weeks to develop fully i,v. See Appendix 2 for flow chart summarising the advice on flu vaccination for 2014/15

Quantity to be supplied or administered

Single dose to be administered (0.5ml)

Side effects Full details of side effects are available in the SPC. www.medicines.org.uk Suspected adverse reactions to drugs including vaccines should be reported on the yellow card available at the back of the BNF. Also at www.yellowcard.gov.uk

Common side effects i,v

These symptoms usually disappear within one to two days without treatment

Pain, swelling or redness at the injection site

low grade fever

malaise

shivering

fatigue

headache

myalgia

arthralgia

A small painless nodule (induration) may form at the injection site

Rare side effects:

Please refer to individual summary of product characteristics.

Additional Information (including storage and disposal)

Store in a refrigerator (20C – 80C) i

Do not freeze i

Store in original packagingi

Protect from light i

Equipment used for vaccination should be disposed of by placing in a proper, puncture-resistant ‘sharps’ box according to local authority regulations and guidance in Health Technical Memorandum 07-01: Safe management of healthcare waste (Department of Health, 2013)v.

http://www.medicines.org.uk/


Advice to patient/carer Before Treatment:

Advise patient/parent or guardian of possible common side effects and their management.

Supply marketing authorisation holder's patient information leaflet (PIL) provided with the vaccine.

The patient/parent or guardian should be advised to seek medical advice in the event of a severe adverse reaction. After Treatment:

Any serious adverse reaction to the vaccine should be documented in the individual’s medical records.

Home visit patients should be advised that a responsible adult should be present with them when receiving vaccination.

Patients receiving vaccination should be observed for immediate adverse reactions. There is no requirement to keep patients under longer observation but immunisers should assess the potential risk of anaphylaxis, (onset of anaphylaxis is rapid, typically within minutes) especially for those receiving influenza vaccination for the first time.

Immune response following flu vaccination takes about two weeks to develop fullyi,v.

Advise patients who are immunocompromised that response to the vaccine may be sub-optimal and therefore these patients should take precautions to prevent influenza.iv

Patients should be advised that many other organisms cause respiratory infections similar to influenza during the influenza season, e.g. the common cold and respiratory syncytial virus (RSV). Influenza vaccine will not protect against these diseases.

Protection afforded by the vaccine is thought to last at least one influenza season, however as antibody levels are likely to reduce with time and the circulating strains of flu may change from one season to the next, annual revaccination is importanti.

Follow up When applicable, advise parent/carer when the subsequent dose is due, otherwise no routine follow up required

Suspected adverse reactions Patient presenting with suspected adverse drug reaction should be referred to a doctor for further investigations.

All serious suspected reactions following influenza vaccines should be documented in the patient’s medical record and reported to the Medicines and Healthcare products Regulatory Agency using the Yellow Card scheme at http://yellowcard.mhra.gov.uk/ i

Error reporting Any incidents or near-miss issues must be reported via the organisation’s internal reporting system

RECORD KEEPING

Documentation needed/treatment records to be kept for audit purposes A computer or manual record

Patient’s name, address, date of birth and registered GP

Record of informed consent

Manufacturer, vaccine name, product name, batch number, expiry date

Dose administered

Date of administration

Anatomical site of vaccination

http://yellowcard.mhra.gov.uk/


of all individuals receiving treatment under this Patient Group Direction should also be kept for audit purposes.

Route of administration

Advice given to patient (including advice given if vaccination is declined)

Details of staff who administered (sign and print name)

Details of any adverse drug reactions, and action taken including informing GP

Record as supplied via Patient Group Direction (PGD) in patient’s clinical record

All records should be clear, legible and contemporaneous. This information should be recorded as appropriate in the patient’s General Practitioner record or other patient record, depending on location AND the personal Child Health record (PCHR) – the Red Book. A computerised or manual record of all individuals receiving treatment under this Patient Group Direction should also be kept for audit purposes. If vaccination has been completed by a provider other than the GP practice, timely communication to the GP practice to enable the patients record to be updated must be completed. Any noted adverse effects following vaccination must also reported to the GP practice. Clinical records must be kept for at least 8 years following completion of treatment. In patients who are aged under 17 years, clinical records must be kept until the patient’s 25th birthday, or for 8 years following a child’s death. Data must be stored in accordance with Caldicott guidance and the Data Protection Act.

Reconciliation – stock balances should be reconcilable with receipts, administration records and disposal.


Register of practitioners qualified to administer and/or supply

Inactivated Influenza Vaccine under this Patient Group Direction

Name of clinical manager/GP Lead/Commissioner

Signature of clinical manager/GP Lead / commissioner

Date:

A copy of this page should be retained by the authorising manager for 2 years for audit purposes

Please state clinical area where this PGD is in use

Healthcare professional individual declaration

I have read and understood the Patient Group Direction and agree to supply this medicine only in accordance with this PGD

PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. It is the responsibility of each professional to practice only within the bounds of their own competence.

All practitioners operating in accordance with this PGD should have a current, signed copy of it readily

available for reference.

If a practitioner is asked to supply, or administer a medicine not covered by this or any other PGD then a patient specific direction is required from a doctor, dentist or independent prescriber.

Name of professional (please print)

Signature Authorising Manager (Must sign against each

entry)

Date of authorisation

The clinical lead should review competency of authorised practitioners annually. Authorisation to use this PGD does not remove inherent professional responsibility and accountability


Appendix 1 Vaccines available for the flu immunisation programme 2014/15

Supplier iv,v Name of Productiv,v Vaccine Typeiv,v

Age Indications iv,v Ovalbumin content μg/ml (μg/dose)iv,v

Contact detailsiv,v

Abbott Healthcare Influvac Desu® Trivalent. Surface antigen, inactivated

From 6 months 0.2

(0.1/0.5ml dose)

0800 358 7468

Imuvac® Trivalent. Surface antigen, inactivated

From 6 months 0.2

(0.1/0.5ml dose)

GlaxoSmithKline

Fluarix Tetra ®▼ Quadrivalent


From 3 years 0.1

(≤0.05/0.5ml dose)

0800 221 441 *

MASTA Imuvac® Trivalent.


From 6 months 0.2

(0.1/0.5ml dose)

0113 238 7552


Trivalent.

Inactivated Split virion inactivated virus

From 6 months ≤0.1

(≤0.05/0.5ml dose)

Enzira® Trivalent.


From 5 years (but see treatment section on use in children aged 5 to < 9 years)

≤2

(≤1/0.5ml dose)


Supplier Name of Product Vaccine Type

Age Indications Ovalbumin content μg/ml (μg/dose)

Contact details

Novartis Vaccines Agrippal® Trivalent.



(≤0.2/0.5mL dose)

08457 451 500

Optaflu® ▼ Trivalent. Surface antigen,

inactivated, prepared in cell cultures

From 18 years No ovalbumin

Pfizer Vaccines

CSL Inactivated Influenza Vaccine® Trivalent. Split virion inactivated virus

From 5 years (but see treatment section on use in children aged 5 to < 9 years)

≤2

(≤1/0.5ml dose)

0800 089 4033

Enzira® Split virion inactivated virus From 5 years (but see treatment section on use in children aged 5 to < 9 years)

≤2

(≤1/0.5ml dose)

Sanofi Pasteur MSD Inactivated Influenza Vaccine (Split Virion) BP®

Trivalent.



(≤0.05/0.5ml dose)

0800 085 5511*

None of the influenza vaccines for the 2014/15 season contain thiomersal as an added preservative. * Fluarix Tetra and Sanofi Pasteur MSD inactivated influenza vaccine (split virion) BP should be ordered for children under 18 years of age via the ImmForm website (https://www.immform.dh.gov.uk/) and are distributed by Movianto UK (Tel: 01234 248631) as part of the national immunisation programme. Some flu vaccines are restricted for use in particular age groups. The Summary of Product Characteristics (SPC) for individual products should always be referred to when ordering vaccines for particular patients.


Appendix 2

Chart summarising the advice on influenza vaccination for the 2014/15 influenza vaccination programme.v

1 All those aged 65 years or older including all those aged 65 years on or before 1 March 2015.

2 All children aged two, three or four years (but not five years or older) on or before 1 Sept 2014.

3 If quadrivalent inactivated vaccine is available, consider for children age three years and older only. If quadrivalent is unavailable, offer suitable trivalent inactivated influenza vaccine. Refer to table on page 7 and appendix 1 for vaccine options. NB. Some are not suitable for young children.

4 Cannot receive if: under age of two years; 18 years and older; have egg allergy; a history of active wheezing at the time of vaccination (until at least 7 days after wheezing has stopped); on oral steroids or high dose inhaled steroids for asthma; certain immunodeficiencies; or pregnant.

Influenza vaccination for Winter 2014/15

Children & adults in clinical risk groups:

Chronic respiratory disease

Chronic heart disease

Chronic liver disease

Chronic kidney disease

Chronic neurological disease

Diabetes

Immunosuppression

All pregnant women (at any stage of pregnancy)

See pages 4&5 for additional guidance

Other

Health & Social Care

workers

People in long-stay

residential homes or

other long-stay facilities

Carers

Household contacts of immunocompromised patients

See page 6

All people aged 65yrs and over

1

Children aged two, three or four years who are not in a clinical risk group

2

Children aged two years to less than 18 years One dose of inactivated

influenza vaccine

Can they receive Fluenz Tetra®?4 First dose of inactivated

influenza vaccine3

Can they receive Fluenz Tetra®?

4

First dose of Fluenz Tetra® influenza vaccine

If never received influenza vaccine before and 2 years to less than 9 years of age, give second

dose of Fluenz Tetra® at least four weeks later

If never received influenza vaccine before and aged 6

months to less than 9 years of age, give second dose at least

4 weeks later

One dose of Fluenz Tetra® influenza vaccine

No No

No

No

Yes

Yes

Yes


References

i Public Health England. Training for healthcare practitioners. The National Flu Immunisation Programme 2014/15. Accessed via: https://www.gov.uk/government/publications/national-flu-programme-training-slide-set-for-healthcare-professionals ii National Institute for Health and Care Excellence. Good Practice Guidance: Patient Group Directions. August 2013

iii National Institute for Health and Care Excellence. Competency framework: For health professionals using Patient Group

Directions. Jan 2014 iv NHS England. The flu immunisation programme 2014/15. Gateway Reference Number: 01287. 28 April 2014

v The Green Book – Immunisation Against Infectious Disease: Influenza Chapter 19

vi BNF 66 September 2013

Acknowledgement: Medicines Management Team, Telford & Wrekin CCG for developing the PGD.


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