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PGD for Fluenz

Reference Number: NHSE(LR)/PGD/Fluenz v1.1 of 10 Valid from: 1st April 2014 Review date: 1st January 2016 Expiry date: 31st March 2016

Patient Group Direction (PGD) for the Administration of Fluenz® Nasal Spray

Suspension (Influenza Vaccine, Live)

Note that Fluenz® is for nasal administration only

This PGD must be read in conjunction with the core PGD (Reference: NHSE(LR)/PGD/Core PGD for Immunisations), which details information that is

common to all of the immunisation PGDs.

This PGD must only be used by registered healthcare professionals, working within NHS England (London Region), who have been named and authorised to practice

under it.

Version number: 1.1

Expiry date: 31st March 2016 The master copy for this PGD is held N:\2.0 Medical\Clinical Adviser Medicines\Patient Group Directions\Final Signed PGDs\Immunisation PGDs 2014 Change history Version number

Change details Date

1.0 First version December 2013 1.1 Revision of content March 2014

PGD for Fluenz


PGD Development and Clinical Approval PGD Working Group This PGD was developed by a working group involving pharmacists from a number of Clinical Commissioning Groups across London, plus nurse representatives. Name and role Job title and organisation Jonathan Mason Pharmacist and Lead Author

Clinical Adviser (Medicines) NHS England (London Region)

Henrietta Hughes Doctor

Medical Director North Central and East London Area Team NHS England (London Region)

Eileen Bryant Nurse reviewer

Primary Care Nurse Adviser NHS England (London Region)

Nicola Pratelli Nurse Reviewer

Population Health Practitioner Manager Immunisation South NHS England (London Region)

Thara Raj Public Health Specialist

London Public Health Specialist (Immunisation) and Acting Public Health Consultant (Health in the Justice System) NHS England (London Region)

Nick Beavon Pharmacist Reviewer

Chief Pharmacist Wandsworth Clinical Commissioning Group

Raana Ali Pharmacist Reviewer

Senior Prescribing Adviser (Tower Hamlets) North and East London Commissioning Support Unit

Pauline Taylor Pharmacist Reviewer

Head of Medicines Management Haringey Clinical Commissioning Group

Helen Tsang Pharmacist Reviewer

Practice Link Pharmacist North West London Commissioning Support Unit

Dee Vadukul Pharmacist Reviewer

Senior Practice Pharmacist Richmond Clinical Commissioning Group

Seema Buckley Pharmacist Reviewer

Chief Pharmacist NHS Kingston Clinical Commissioning Group

References:

• SmPC Reference for Fluenz® (accessed March 2014): http://www.medicines.org.uk/emcmobile/medicine/25084/spc

• Green Book chapter on Influenza (accessed March 2014): https://www.gov.uk/government/publications/influenza-the-green-book-chapter-19

PGD for Fluenz


PGD for Fluenz


Patient Group Direction for the Administration of Fluenz® Nasal Spray Suspension (Influenza Vaccine, Live)

Clinical condition or situation to which this PGD applies

Active immunisation of infants, children and adolescents from 2 to 17 years of age, for the prevention of influenza infection, in line with national recommendations.

Inclusion criteria Patient over 2 years of age to 17 years of age (up to the day before their 18th birthday): • In a clinical at-risk group as specified by national

recommendations (refer to Appendix 1 for definitions and examples). Clinical at-risk groups include:

o Chronic respiratory disease (see Exclusion Criteria for severe asthma);

o Chronic heart disease; o Chronic liver disease; o Chronic kidney disease; o Chronic neurological disease; o Diabetes mellitus o Asplenia, or dysfunction of spleen;

• All patients (including those not in clinical at-rsk groups) within certain age groups as specified by national recommendations.

Exclusion criteria As per general exclusion criteria stated in the Core PGD, plus: • Children under 2 years of age (up to the day before their 2nd

birthday); • Patients over 18 years of age; • Patients with severe asthma (BTS/SIGN Guidelines step 4 or

above); • Patients with confirmed anaphylactic reactions to egg (see

general comment in Core PGD). Note: There are no data on the use of Fluenz® in children with egg allergy;

• Patients receiving salicylate therapy. This is because of the association of Reye’s syndrome with salicylates and wild-type influenza infection;

• Pregnancy - there is no need, however, to specifically test eligible girls for pregnancy, or to advise avoidance of pregnancy in those who have been recently vaccinated;

• Patients who are clinically severely immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; HIV infection not on highly active antiretroviral therapy (HAART); cellular immune deficiencies or high dose corticosteroids (at least 2mg/kg/day for a week or 1mg/kg/day for a month);

• There is a potential for influenza antiviral agents to lower the effectiveness of the live attenuated influenza vaccine. Therefore, influenza antiviral agents and Fluenz® should not be

PGD for Fluenz


administered concomitantly. Fluenz® should not be administered within 48 hours following the cessation of treatment with influenza antiviral agents. Administration of influenza antiviral agents within two weeks of administration of Fluenz® may adversely affect the effectiveness of the vaccine;

• *Administration should be postponed in patients suffering from heavy nasal congestion. This is because heavy congestion may impede delivery of the vaccine to the nasopharyngeal mucosa (see Green Book chapter on Influenza);

• *Administration should be postponed in patients with active wheezing at the time of vaccination.

Action if excluded/special considerations/ additional information

• *If excluded temporarily due to nasal congestion/wheeze, advise patient/parent/person with parental responsibility to return for vaccination once symptoms have resolved;

• Where age under 2 years is the exclusion criterion, advise parent/person with parental responsibility that the child can be vaccinated once they have reached 2 years of age;

• Fluenz® is not contraindicated for use in patients with stable HIV infection receiving antiretroviral therapy; or who are receiving topical/inhaled corticosteroids or low-dose systemic corticosteroids or those receiving corticosteroids as replacement therapy, e.g. for adrenal insufficiency, or low-dose immunosuppressive therapy.

• Pregnant patients should be offered inactivated influenza vaccine;

• Severely immunosuppressed patients should be offered inactivated influenza vaccine;

• Patients with confirmed anaphylaxis to egg can be immunised with an egg-free inactivated influenza vaccine if available. Patients with non-anaphylactic egg allergy can be given egg-free vaccine, or inactivated influenza vaccine with ovalbumin content less than 0.12µg/ml.

Details of the medicine

Name, form and strength of medicine

Fluenz® nasal spray suspension (0.2 ml) in pre-filled nasal applicator (Influenza vaccine, live). Fluenz® contains cold-adapted, temperature sensitive, attenuated virus strains.

Dose 0.2ml total dose (see method of administration). Fluenz® vaccine is supplied as a nasal spray suspension, colourless to pale yellow, clear to opalescent. Small white particles may be present. The suspension (0.2ml) is contained in a single-use nasal applicator with a plunger, plunger-stopper, dose-divider clip and protective tip cap.

Route/Method of Fluenz® vaccine is given intranasally (must NOT be

PGD for Fluenz


Administration injected): • Single application in each nostril of 0.1ml • Carefully remove rubber tip protector without removing the

dose-divider clip at the other end of the applicator; • With the patient in an upright position, place the tip just

inside the nostril and depress the plunger as rapidly as possible;

• Pinch and remove dose-divider clip from plunger and repeat administration of remaining vaccine into the other nostril immediately, or as soon as possible;

• The patient can breathe normally during administration, and there is no need to actively inhale or sniff;

• See below for step-by-step administration instructions.

Frequency Patients not in a clinical at-risk group, or patients in a clinical at-risk group who have previously received an influenza vaccination: • Single dose Patients over 2 and under 9 years of age in a clinical at-risk group who have never previously received an influenza vaccination: • Give the first dose, then give a second dose at least four

weeks later.

Quantity 1 x 0.2ml

Use outside the terms of the Summary of Product Characteristics (SmPC)

The SmPC states that Fluenz® should not be used in breastfeeding women. The Green Book states that breastfeeding is not a contra-indication to vaccination. This PGD authorises use of Fluenz® during breastfeeding.

Adverse effects Common: nasal congestion/rhinorrhoea, reduced appetite, weakness and headache Refer to SmPC for complete list.

PGD for Fluenz


Step-by-step administration instructions for Fluenz®

Check expiry date Product must be used before date on applicator label.

Prepare the applicator Remove rubber tip protector. Do not remove dose-divider clip at the other end of the applicator.

Position the applicator With the patient in an upright position, place the tip just inside the nostril to ensure FLUENZ is delivered into the nose.

Depress the plunger With a single motion, depress plunger as rapidly as possible until the dose-divider clip prevents you from going further.

Remove dose-divider clip For administration in the other nostril, pinch and remove the dose-divider clip from plunger.

Spray in other nostril Place the tip just inside the other nostril and with a single motion, depress plunger as rapidly as possible to deliver remaining vaccine.

PGD for Fluenz


Healthcare Professional’s Agreement to Practise and Practice/Pharmacy/Local Organisation Authorisation

PGDs 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 AND IN

ACCORDANCE WITH THEIR OWN CODE OF PROFESSIONAL CONDUCT. DECLARATION by healthcare professional: • I have read and understand this PGD; • I have been appropriately trained to understand the criteria listed, and the

techniques and record-keeping required to administer the vaccine in accordance with this PGD. Note: an online training programme is available to support healthcare professionals http://www.nasalspraylearning.co.uk/index.html;

• The training has included both the theoretical and practical aspects of the techniques required to administer this vaccine by the nasal route;

• I confirm that I have been assessed for my knowledge and clinical competency, and EITHER am experienced in administering vaccines in the past 12 months, OR I have been observed administering vaccines in practice;

• I confirm that I am competent to undertake administration of this vaccine; • I confirm that I will ensure that I remain up to date in all aspects of the

administration of this vaccine. Healthcare Professional’s Name:……………………………. Registration Number:………………………. Expiry Date: ………………………. Signature: …..………………….. Date: ………………………. Declaration by Authorising Manager*: Managers should only authorise staff who have received the required training and are competent to work to this PGD. Each authorised member of staff should be provided with an individual copy of the PGD, which they should also sign to declare themselves competent. A copy of the signed document should be kept by the individual staff member. The authorising manager should retain a copy of the signed individual authorisation page. I have read and understood the PGD and authorise the staff member named above to operate in accordance with this PGD. Authorising Manager’s Name:…………………………….. Signature: …..………………….. Date: ………………………

*The term manager refers to the person taking responsibility for authorising healthcare professionals to operate under the terms of this PGD, and includes lead GPs, nurse managers, pharmacy managers etc.

PGD for Fluenz


Appendix 1

Clinical At-Risk Groups for Vaccination With Fluenz® Nasal Spray Suspension (Influenza Vaccine, Live)

(Adapted from Table 19.5: Green Book, Chapter 19)

Clinical At-Risk Group

Examples

Chronic respiratory disease

• 1Asthma 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

• 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

• Chronic kidney disease at stages 3, 4 and 5 (see http://www.kidney.org/professionals/kdoqi/guidelines_ckd/p4_class_g1.htm for definitions);

• Chronic kidney failure; • Nephrotic syndrome; • Kidney transplantation.

Diabetes mellitus

• Type 1 diabetes; • Type 2 diabetes requiring insulin or oral hypoglycaemic

medicines; • Diet controlled diabetes.

Chronic liver disease Includes cirrhosis, biliary atresia, and chronic hepatitis.

Asplenia, or dysfunction of

spleen

Includes sickle cell disease, and coeliac syndrome that may lead to splenic dysfunction.

Chronic neurological disease

• Stroke, transient ischaemic attack (TIA); • Conditions in which respiratory function may be

compromised due to neurological disease (e.g. polio 1 Patients with severe asthma (BTS/SIGN Guidelines step 4 or above) are excluded from vaccination with Fluenz®

PGD for Fluenz


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.

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