Embed Size (px)
Citation preview
Fluenz PGD v02.00 Valid from: 01/09/2015 Expiry: 31/08/2016 Page 1 of 16
PHE publications gateway number: 2015271
For the supply and administration, or supply only, of Fluenz Tetra®▼ nasal spray suspension (influenza vaccine, live attenuated) by currently registered nurses, pharmacists or paramedics to children and adolescents aged 2–17 years in accordance with the national flu immunisation programme for active immunisation against influenza.
Reference no: Fluenz PGD
Version no: v02.00
Valid from: 1 September 2015
Review date: 31 March 2016
Expiry date: 31 August 2016
Public Health England has developed this PGD for local authorisation by NHS England to facilitate delivery of the national immunisation programme. Those using this PGD must ensure that it is formally authorised and signed by a clinical governance or patient safety lead, who has designated responsibility for signing PGDs on behalf of the commissioning NHS England sub-region, so that this document meets legal requirements for a PGD. THE PGD IS NOT LEGAL OR VALID WITHOUT THIS LOCAL, FORMAL AUTHORISATION. Authorising organisations must not alter or amend the body of this document; such action will invalidate the clinical sign-off with which it is provided. Operation of this PGD is the responsibility of commissioners and service providers. THE PRACTITIONER MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORKING ACCORDING TO IT. Practitioners and organisations must check that they are using the current version of the PGD. Amendments may become necessary prior to the published expiry date. Current versions of PHE PGD templates for local authorisation can be found from: https://www.gov.uk/government/collections/immunisation Any concerns regarding the content of this PGD should be addressed to: [email protected]
PATIENT GROUP DIRECTION (PGD)
Supply and administration of Fluenz Tetra®▼ nasal spray suspension (influenza vaccine, live attenuated) OR supply only in well-defined local circumstances.
Children and adolescents aged 2–17 years in accordance with the national flu immunisation programme
Fluenz PGD v02.00 Valid from: 01/09/2015 Expiry: 31/08/2016 Page 2 of 16
Change History
Version number Change details Date
Final version New PHE Fluenz PGD 1 September 2013
Final version – revised 9 September 2013
Dose Section: Second dose amended from 0.1ml to 0.2ml 9 September 2013
Version 02.00 PHE Fluenz PGD transferred to new PHE PGD template
Updated for 2015/16 flu programme cohorts
Included supply only, for subsequent administration outside the PGD
Included concomitant administration with other live vaccines following updated JCVI advice
Egg allergic children exclusion amended following updated JCVI advice
Individuals with asthma requiring systemic or high dose inhaled corticosteroids excluded following updated JCVI advice
Included registered nurse, pharmacist and paramedic professionals
11 August 2015
Fluenz PGD v02.00 Valid from: 01/09/2015 Expiry: 31/08/2016 Page 3 of 16
1. PGD Template Development
This PGD template has been developed by the following on behalf of Public Health England:
Developed by: Name Signature Date
Pharmacist (Lead Author)
Elizabeth Graham Lead Pharmacist Immunisation Services, PHE
19/08/2015
Doctor
Mary Ramsay Consultant Epidemiologist and Head Immunisation, Hepatitis & Blood Safety Department, PHE
19/08/2015
Registered Nurse
David Green Nurse Consultant – Immunisations, PHE
19/08/2015
This PGD template has been peer reviewed by the PHE Immunisations PGD Expert Panel in accordance with PHE Policy for PGD Templates. It has been ratified by PHE Medicines Management Group and PHE Clinical Governance Group.
Acknowledgements
Name Designation
Dr Richard Pebody Consultant Medical Epidemiologist, Head of Influenza Surveillance and Acting Head of Respiratory Diseases, Centre for Infectious Disease Surveillance and Control
Dr Max Kammerling Screening and Immunisations Lead (SIL) – Surrey and Sussex
Jacqueline Lamberty Medicines Management Adviser – Public Health England
Gill Marsh Senior Health Protection Nurse Practitioner, Cheshire &
Merseyside Health Protection Team, Public Health England
Lesley McFarlane Screening and Immunisation Co-ordinator (SIC) NHS England
Leicestershire and Lincolnshire
Sue Mulvenna Pharmacist Lead - NHS England South West
Graham Munslow Clinical Screening and Immunisation Manager, NHS England
Lancashire & Greater Manchester / Public Health England.
Fluenz PGD v02.00 Valid from: 01/09/2015 Expiry: 31/08/2016 Page 4 of 16
2. Organisational Authorisations The PGD is not legally valid until it has had the relevant organisational authorisation. It is the responsibility of the organisation that has legal authority to authorise the PGD, to ensure that all legal and governance requirements are met. The authorising body accepts governance responsibility for the appropriate use of the PGD. NHS England South (South Central) authorise this PGD for use by the services or providers listed below:
Authorised for use by the following organisations and/or services
All NHS England South (South Central) directly commissioned immunisation services In addition, PGD adoption by provider organisations (e.g. Sirona) providing this vaccination should have this PGD signed by their governance lead prior to use. Provider organisation staff will be expected to follow local policies and procedures.
Limitations to authorisation
None stated
Organisational approval (legal requirement)
Role Name Sign Date Medical Director Dr Geoffrey Payne
26/08/2015
Additional signatories according to locally agreed policy
Role Name Sign Date
Local enquiries regarding the use of this PGD may be directed to [email protected]
Organisations must add an individual practitioner authorisation sheet or list of authorised practitioners. This varies according to local policy but this should be a signature list or an individual agreement as included at the end of this PGD.
Fluenz PGD v02.00 Valid from: 01/09/2015 Expiry: 31/08/2016 Page 5 of 16
3. Characteristics of Staff
Qualifications and professional registration required
Registered professional with one of the following bodies:
Nurses currently registered with the Nursing and Midwifery Council (NMC).
Pharmacists currently registered with the General Pharmaceutical Council (GPhC).
Paramedics currently registered with the Health and Care Professions Council (HCPC).
Additional requirements Must be authorised by name as an approved practitioner under the current terms of this Patient Group Direction before working to it.
Must have undertaken appropriate training for working under PGDs for supply/administration of medicines.
Must be competent in the use of PGDs (see NICE Competency framework for health professionals using patient group directions).
Must be familiar with the vaccine product and alert to changes in Summary Product Characteristics, Immunisation Against Infectious Disease (“The Green Book”), and national and local immunisation programmes.
Must have undertaken training appropriate to this PGD as required by local policy and in line with the National Minimum Standards for Immunisation Training (2005).
Must be competent to undertake immunisation and to discuss issues related to immunisation.
Must be competent in the handling and storage of vaccines, and management of the “cold chain”.
Must be competent in the recognition and management of anaphylaxis.
Have access to the Patient Group Direction and associated online resources.
Should fulfil any additional requirements defined by local policy.
THE PRACTITIONER MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORKING ACCORDING TO IT.
Continued training requirements
Practitioners must ensure they are up to date with relevant issues and clinical skills relating to immunisation and management of anaphylaxis, with evidence of appropriate Continued Professional Development (CPD).
Practitioners should be constantly alert to any subsequent recommendations from Public Health England and/or NHS England and other sources of medicines information. Note: The most current national recommendations should be followed but a Patient Specific Direction (PSD) may be required to administer the vaccine in line with updated recommendations that are outside the criteria specified in this PGD.
Fluenz PGD v02.00 Valid from: 01/09/2015 Expiry: 31/08/2016 Page 6 of 16
4. Clinical condition or situation to which this PGD applies.
Clinical condition or situation to which this PGD applies
Fluenz Tetra®▼is indicated for the active immunisation of children and adolescents aged 2 to 17 years (inclusive) for the prevention of influenza infection, in line with the recommendations given in Chapter 19 of Immunisation Against Infectious Disease: The Green Book, the Flu Plan and the annual flu letter.
Criteria for inclusion This PGD includes vaccination of children and adolescents for whom Fluenz Tetra®▼ is indicated across the 2015/16 national influenza immunisation programme. Users of this PGD should note that where they are commissioned to immunise certain groups this PGD does not constitute permission to offer Fluenz Tetra®▼ beyond the groups they are commissioned to immunise.
1. Children and Adolescents in Clinical Risk Groups
Children and adolescents aged 2 to 17 years (up to their 18th birthday) who are in a clinical risk group category listed in Chapter 19 of “The Green Book” - Fluenz Tetra®▼ is the influenza vaccine of choice, unless it is clinically contraindicated, because Fluenz Tetra®▼ provides greater protection for children than inactivated influenza vaccine.
2. Children eligible for vaccination with Fluenz Tetra®▼ in accordance with national recommendations for 2015/16:
Children aged two, three, and four years on 31 August 2015 (i.e. date of birth on or after 1 September 2010 and on or before 31 August 2013)
Children of school years 1 and 2 age (i.e. five to seven year olds with a date of birth between 1 September 2008 and on or before 31 August 2010) o Some children in years 1 and 2 might be outside of these
date ranges (eg if a child has been accelerated or held back a year). It is acceptable to offer and deliver immunisations to these children with their class peers under this PGD
Primary school-aged children in areas that participated in primary school pilots in 2014/15
Children and adolescents aged 2 to 17 years (up to their 18th birthday) who are 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. (See exclusion for contacts of severely immunocompromised individuals).
Fluenz PGD v02.00 Valid from: 01/09/2015 Expiry: 31/08/2016 Page 7 of 16
Criteria for exclusion1
Criteria for exclusion (continued over page)
Children and infants under 2 years of age
Adults aged 18 years and over
Patients for whom no valid consent has been received
In addition Fluenz Tetra®▼should NOT be given to:
Individuals with a confirmed anaphylactic reaction to a previous dose of influenza vaccine.
Individuals with a confirmed anaphylactic reaction to any component of the Fluenz Tetra®▼ vaccine, except egg proteins.
Individuals with severe anaphylaxis to egg which has previously required intensive care.
Individuals with severe asthma, for example children who have taken oral steroids in the past 14 days or are currently taking a high dose of an inhaled steroid – budesonide >800 micrograms/day or equivalent (eg fluticasone >500 micrograms/day) – such children should only be given Fluenz Tetra®▼ on the advice of their specialist. As these children are a defined risk group for influenza, those who cannot receive Fluenz Tetra®▼ should receive an inactivated influenza vaccine.
Individuals receiving salicylate therapy (other than topical treatment of localised conditions). This is because of the association of Reye’s syndrome with salicylates and wild-type influenza infection.
Individuals with unrepaired craniofacial malformations.
Pregnant teenagers. See Actions if excluded below. Note: There is no need to specifically test eligible girls for pregnancy or to advise avoidance of pregnancy in those who have been recently vaccinated.
Individuals who are clinically severely immunodeficient due to conditions or immunosuppressive therapy such as: o acute and chronic leukaemias o lymphoma o HIV infection not on highly active antiretroviral therapy
(HAART) o cellular immune deficiencies o high dose corticosteroids (prednisolone at least 2mg/kg/day for
a week or 1mg/kg/day for a month or equivalent)
Individuals for whom close contact with very severely immunocompromised patients (eg bone marrow transplant patients requiring isolation) is likely or unavoidable (for example, household members). However, appropriate alternative inactivated influenza vaccines should be considered.
Fluenz Tetra®▼is not contraindicated for use in children or adolescents with stable HIV infection receiving antiretroviral therapy; or who are receiving topical corticosteroids, standard dose inhaled corticosteroids, low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, eg for adrenal insufficiency or low-dose immunosuppressive therapy. This PGD may be used for these individuals.
In other cases of immunosuppression, the vaccine may be considered – but this is not within the remit of this PGD. In such cases, the individual’s General Practitioner (GP) should issue a Patient Specific Direction (PSD) or administer the vaccine themselves. As with all
1 Exclusion under this Patient Group Direction does not necessarily mean the medication is contraindicated, but
it would be outside its remit and another form of authorisation will be required
Fluenz PGD v02.00 Valid from: 01/09/2015 Expiry: 31/08/2016 Page 8 of 16
Criteria for exclusion (continued)
complex cases, it is good practice to involve the individual’s specialist clinician in the decision whether to vaccinate. See Chapter 6 of “The Green Book” for further guidance.
Temporary Exclusion
Acute febrile illness – postpone administration until completely recovered
Heavy nasal congestion may impede delivery of the vaccine to the nasopharyngeal mucosa – postpone administration
Wheezing in the past 72 hours or those who have increased their use of bronchodilators in the previous 72 hours – postpone administration and if their condition has not improved after a further 72 hours then, to avoid delaying protection in this high risk group, these children should be offered an inactivated influenza vaccine.
Treatment with influenza antiviral agents in the last 48 hours – postpone administration until 48 hours following the cessation of treatment with influenza antiviral agents.
Cautions including any relevant action to be taken
Individuals who have immunosuppression and HIV infection may not make a full antibody response. Consideration should be given to the influenza vaccination of household contacts of immunocompromised individuals.
There is a potential for transmission of live attenuated influenza virus in Fluenz Tetra®▼ to immunocompromised contacts for one to two weeks following vaccination. Where close contact with severely immunocompromised patients is likely or unavoidable, appropriate alternative inactivated influenza vaccines should be considered.
Action to be taken if the patient or carer declines treatment
Informed consent, from the patient or a person legally able to act on the patient’s behalf, must be obtained for each administration.
Advise parent/carer about the protective effects of the vaccine, the risks of infection and potential complications.
Document advice given and decision reached.
In a GP practice setting, inform or refer to the GP or prescriber as appropriate.
Action to be taken if the patient is excluded
(continued over page)
Where individuals are excluded and are in a routine cohort with no clinical risk factors, no further action will be required.
Patients temporarily excluded may be offered Fluenz Tetra®▼ at a later date. In case of postponement arrange a future date for vaccination.
Patients with clinical risk factors should be considered for inactivated influenza vaccine.
All pregnant teenagers should be offered inactivated influenza vaccine.
Vaccination with inactivated influenza vaccine should be considered in most patients with immunosuppression.
Children and adolescents with a history of severe anaphylaxis to egg which has required intensive care, and who require protection against flu because they are in a clinical risk group, should be referred to specialists for immunisation in hospital.
Fluenz PGD v02.00 Valid from: 01/09/2015 Expiry: 31/08/2016 Page 9 of 16
Action to be taken if the patient is excluded
(continued )
Seek appropriate advice from the local Screening and Immunisation Team, a Consultant in Health Protection or individual’s clinician, as a PSD may be indicated.
The risk to the individual of not being immunised must be taken into account.
Document reason for exclusion and any action taken in the individual’s clinical records.
In a GP practice setting, inform or refer to the GP or a prescriber as appropriate.
Arrangements for referral for medical advice
As per local policy
Fluenz PGD v02.00 Valid from: 01/09/2015 Expiry: 31/08/2016 Page 10 of 16
5. Description of Treatment
Name, strength & formulation of drug
Fluenz Tetra®▼ nasal spray suspension (0.2 ml) in pre-filled nasal applicator (Influenza vaccine, live attenuated).
Legal category Prescription Only Medicine (POM).
Black triangle Yes.
Off-label use Fluenz Tetra®▼ Summary of Product Characteristics includes a contraindication for patients with a hypersensitivity to egg or egg proteins. However, JCVI has advised that, except for those with severe anaphylaxis to egg which has previously required intensive care, children with an egg allergy can be safely vaccinated with Fluenz Tetra®▼ in any setting.
Fluenz Tetra®▼ Summary of Product Characteristics states “For children who have not previously been vaccinated against seasonal influenza, a second dose should be given after an interval of at least 4 weeks.” However, JCVI has advised that children aged two years to under nine years of age who are not in a clinical risk group, only require a single dose of live attenuated influenza vaccine irrespective of whether they have received influenza vaccine previously.
Route / method of administration
Administration under this PGD must be directly by the registered health professional named in section 7.
If the PGD is used for “supply only”, subsequent self-administration or administration by another healthcare worker is outside the remit of this PGD and should be in well-defined local circumstances covered by protocols and training.
Fluenz Tetra®▼ vaccine is given intranasally.
Fluenz Tetra®▼ vaccine must NOT be injected.
Instructions for administration of the vaccine by the registered practitioner:
Single application in each nostril of 0.1ml
The patient can breathe normally during vaccine administration and there is no need to actively inhale or sniff.
Fluenz Tetra®▼ vaccine is for intranasal application only.
Remove protective tip cap. Do not remove the dose-divider
With the patient upright, position the applicator and depress as rapidly as possible
Pinch and remove the dose-divider clip from the plunger
Administer the remaining vaccine into the other nostril
The Summary of Product Characteristics for Fluenz Tetra®▼ provides further guidance on administration. http://www.medicines.org.uk/emc/medicine/25084
Fluenz PGD v02.00 Valid from: 01/09/2015 Expiry: 31/08/2016 Page 11 of 16
Dose and frequency of administration
Single dose of 0.2ml of Fluenz Tetra®▼ intranasal vaccine administered as 0.1ml in each nostril.
Children in Clinical Risk Groups
Children aged 2 to less than 9 years who are in a clinical risk group category listed in Chapter 19 of the “The Green Book” and who have not received influenza vaccine before, should receive a second dose of Fluenz Tetra®▼ at least 4 weeks after the first dose.
Second dose of 0.2ml of Fluenz Tetra®▼ intranasal vaccine administered as 0.1ml in each nostril.
Duration of treatment See section on Dose.
Quantity to be supplied / administered
0.2ml dose to be administered.
OR
0.2ml Fluenz Tetra®▼ intranasal vaccine supplied for immediate self-administration or administration by an appropriately trained healthcare support worker (HCSW) within the clinic setting. Note: The act of administration by anyone other than the registered professional named in Section 7 is outside the remit of this PGD and should be in well-defined local circumstances covered by protocols and training.
Children aged 2 years to less than 9 years old and in a clinical risk category
This dose (0.2ml) should be repeated after a 4 week interval.
Supplies Live attenuated influenza vaccine (Fluenz Tetra®▼) has been purchased centrally for children aged 2 years to less than 17 years in the annual routine cohorts and for children aged 2 years to less than 18 years in clinical risk groups. These vaccines should be ordered as per the usual mechanisms for the routine childhood immunisation programme.
Storage Store in a refrigerator at +2°C to +8°C. Store in original packaging in order to protect from light. Do not freeze.
Before use, the vaccine may be taken out of the refrigerator, without being replaced, for a maximum period of 12 hours at a temperature not above 25°C. If the vaccine has not been used after this 12-hour period, it should be disposed of.
Disposal Equipment used for immunisation, including used vials, ampoules, or partially discharged vaccines in an applicator, should be disposed of at the end of a session by sealing in a proper, puncture-resistant ‘sharps’ box, according to local authority regulations and guidance in the technical memorandum 07-01 (Department of Health, 2013).
Fluenz PGD v02.00 Valid from: 01/09/2015 Expiry: 31/08/2016 Page 12 of 16
Drug interactions2
There is a potential for influenza antiviral agents to lower the effectiveness of the live attenuated influenza vaccine (Fluenz Tetra®▼). Therefore, influenza antiviral agents and Fluenz Tetra®▼should not be administered concomitantly.
Fluenz Tetra®▼should be delayed until 48 hours following the cessation of treatment with influenza antiviral agents.
Administration of influenza antiviral agents within the two weeks following administration of Fluenz Tetra®▼may adversely affect the effectiveness of the vaccine.
Children and adolescents younger than 18 years of age: Do not administer Fluenz Tetra®▼ if receiving salicylate therapy and do not use salicylates for 4 weeks after vaccination.
The live attenuated vaccine can be given at the same time as other live or inactivated vaccines. Although it was previously recommended that, where vaccines cannot be administered simultaneously, a four-week interval should be observed between live viral vaccines, JCVI have advised that no specific intervals need to be observed between the live attenuated intranasal influenza vaccine and other live vaccines (see Chapter 6 of “The Green Book”).
Identification and management of adverse reactions2
The most common adverse reactions observed after administration of Fluenz Tetra®▼ are decreased appetite, headache, nasal congestion, rhinorrhoea, malaise. Less common reactions include myalgia and pyrexia and uncommon reactions include hypersensitivity reactions, epistaxis and rash.
A detailed list of adverse reactions associated with Fluenz Tetra®▼ is available in the Summary of Product Characteristics for this vaccine, which is available from the electronic Medicines Compendium website: www.medicines.org.uk
Reporting procedure of adverse reactions
As Fluenz Tetra®▼is black triangle, any suspected adverse reactions should be reported via the National Reporting System to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card reporting scheme on: http://yellowcard.mhra.gov.uk
Any adverse reaction to the vaccine should be documented in the indvidual’s record and the individual’s GP should be informed.
Written information to be given to patient or carer
Supply marketing authorisation holder's patient information leaflet (PIL) provided with the vaccine.
Patient advice / follow up treatment
(continued over page)
Inform patient/carer of possible side effects and their management.
The parent/carer should be advised to seek medical advice in the event of a severe adverse reaction.
When applicable, advise parent/carer when the subsequent dose is due.
Vaccine recipients should be informed that Fluenz Tetra®▼ is an attenuated live virus vaccine and has the potential for transmission to immunocompromised contacts. Vaccine recipients should attempt to avoid, whenever possible, close association with severely
2 Refer to British National Formulary (BNF) and Summary of Product Characteristics (SPC) for complete list
Fluenz PGD v02.00 Valid from: 01/09/2015 Expiry: 31/08/2016 Page 13 of 16
Patient advice / follow up treatment
(continued)
immunocompromised individuals (eg bone marrow transplant recipients requiring isolation) for 1-2 weeks following vaccination.
If the PGD is used for supply only, advise the patient/carer the process they need to follow for subsequent administration eg. refer immediately to appropriately trained HCSW within the clinic setting.
When administration is postponed advise the patient when to return for vaccination.
Special considerations / additional information
As with most vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic event following the administration of Fluenz Tetra®▼.
Immediate access to adrenaline (epinephrine) 1 in 1000 injection and access to a telephone.
Minor illnesses without fever or systemic upset are NOT valid reasons to postpone immunisation. 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 signs or symptoms to adverse effects of the vaccine.
JCVI has advised that, except for those with severe anaphylaxis to egg which has previously required intensive care, children with an egg allergy can be safely vaccinated with Fluenz Tetra®▼ in any setting (including primary care and schools).
Individuals on high dose inhaled corticosteroids are excluded from this PGD, due to the severity of their respiratory disease, and Fluenz Tetra®▼ should only be given on the advice of their specialist. Individuals on high dose inhaled corticosteroids are not excluded for reasons of immunosuppression.
Exposure of healthcare professionals
Very severely immunosuppressed individuals should not administer live attenuated influenza vaccine. Other healthcare workers who have less severe immunosuppression or are pregnant, should follow normal clinical practice to avoid inhaling the vaccine and ensure that they themselves are appropriately vaccinated.
If the PGD is used for supply only for subsequent administration by an appropriately trained HCSW, the registered practitioner named in Section 7 of this PGD must supply the vaccine to the patient/carer. The HCSW cannot supply the medicine.
Records
(continued over page)
Record:
That valid informed consent was given
Name of patient, address, date of birth and GP with whom the individual is registered
Name of immuniser
Name and brand of vaccine
Date of administration or supply
Dose, form and route of administration of vaccine
Quantity administered or supplied
Batch number and expiry date
Advice given; including advice given if excluded or declines immunisation
Details of any adverse drug reactions and actions taken
Record whether supplied only or supplied and administered via Patient Group Direction (PGD).
Fluenz PGD v02.00 Valid from: 01/09/2015 Expiry: 31/08/2016 Page 14 of 16
Records (continued)
Records should be signed and dated (or password controlled immunisers record on e-records).
All records should be clear, legible and contemporaneous.
It is important that vaccinations given either at a general practice or elsewhere (for example, at schools or community pharmacies) are recorded on appropriate health records for the individual (using the appropriate clinical code). If given elsewhere, a record of vaccination should be returned to the patient’s general practice to allow clinical follow up and to avoid duplicate vaccination.
The local Child Health Information Systems team (Child Health Records Department) must be notified using the appropriate documentation/pathway.
A record of all individuals receiving treatment under this Patient Group Direction should also be kept for audit purposes in accordance with local policy.
Fluenz PGD v02.00 Valid from: 01/09/2015 Expiry: 31/08/2016 Page 15 of 16
6. Key References
Key references Chapter 19 of 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
Collection: Annual Flu Programme. https://www.gov.uk/government/collections/annual-flu-programme
Flu Plan: Winter 2015 to 2016. Published 27 March 2015 https://www.gov.uk/government/publications/flu-plan-2015-to-2016
The national flu immunisation programme 2015 to 2016: supporting letter. Published 27 March 2015 https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/418428/Annual_flu_letter_24_03_15__FINALv3_para9.pdf
Fluenz Tetra®▼ Summary of Product Characteristics. 19 February 2015 http://www.medicines.org.uk/emc/medicine/29112
Revised recommendations for administering more than 1 live vaccine. 24 April 2015. https://www.gov.uk/government/publications/revised-recommendations-for-administering-more-than-1-live-vaccine
General
PHE Immunisation Collection. Updated 22 June 2015 https://www.gov.uk/government/collections/immunisation
British National Formulary (BNF) and British National Formulary for Children (BNF-C) www.BNF.org https://www.evidence.nhs.uk/formulary/bnf/current/14-immunological-products-and-vaccines/144-vaccines-and-antisera/influenza-vaccines/influenza-vaccines/tetravalent-seasonal-influenza-vaccine-for-intranasal-use/fluenz-tetra
National Minimum Standards for Immunisation Training (2005) https://www.gov.uk/government/publications/immunisation-training-national-minimum-standards
NICE Medicines Practice Guideline 2 (MPG2): Patient Group Directions https://www.nice.org.uk/guidance/mpg2
NICE MPG2 Patient group directions: competency framework for health professionals using patient group directions https://www.nice.org.uk/guidance/mpg2/resources/competency-framework-for-health-professionals-using-patient-group-directions-60468733
Competency Framework – assessment tool (Appendix). Supporting the delivery of immunisation education. Royal College of Nursing (RCN) 2013. http://www.rcn.org.uk/__data/assets/pdf_file/0005/553748/004479.pdf
Health Technical Memorandum 07-01: Safe Management of Healthcare Waste. Department of Health 20 March 2013 https://www.gov.uk/government/publications/guidance-on-the-safe-management-of-healthcare-waste
Fluenz PGD v02.00 Valid from: 01/09/2015 Expiry: 31/08/2016 Page 16 of 16
7. Individual Practitioner Authorisation Sheet BY SIGNING THIS PATIENT GROUP DIRECTION YOU ARE INDICATING THAT YOU AGREE TO ITS CONTENTS AND THAT YOU WILL WORK WITHIN IT PATIENT GROUP DIRECTIONS DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY IT IS THE RESPONSIBILITY OF EACH PROFESSIONAL TO PRACTISE ONLY WITHIN THE BOUNDS OF THEIR OWN COMPETENCE Practitioner I confirm that I have read and understood the content of this Patient Group Direction and that I am willing and competent to work to it within my professional code of conduct Signed……………………………….………………………….…..Date……….….………….... Name (Print)…………….…………..………….………………………………………….…….............
Designation……………………………………………………………….…..………………...... Authorising Manager Manager to give authorisation on behalf of for the named Health Care Professional who has signed the PGD
Signed…………………………………….………………………. Date………………………..........
Name (Print)………………………..…………………………………….……………..………..........
Designation………………………………………………………………..…………….…….............
Note to Authorising Manager
By signing above you are confirming that you have assessed the staff member as competent to work under this PGD and that they have the organisational approval to do so
You must give this signed PGD to each Authorised Practitioner as it shows their authorisation to use the PGD
