NHS FIFE COMMUNITY HEALTH PARTNERSHIPS Patient Group Direction for Named Nurses to Supply / Administer

Haemophilus influenzae type B and Meningococcal C Conjugate vaccine (Hib/MenC) –(Menitorix ®▼) during the Hib Catch-up Programme to children aged from 3 years 4 months old to under 6 years of age, who have already had their pre-school booster but require a booster dose of Hib. Number

140

Issued

November 2007

Issue Number

1

Date of review

March 2009

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It is the responsibility of the person using this PGD to ensure that they are using the most recent issue Signed on their behalf by Joan Butchart Pharmacist NHS Fife Community Health Partnerships

Reviewed by Dr Charles Saunders

Designation Consultant in Public Health Medicine (Communicable Disease & Environmental Health) Fife NHS Board

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Developed by Joan Butchart & Margaret Vass

THIS PATIENT GROUP DIRECTION HAS BEEN APPROVED BY:

NHS Fife Community Health Partnerships Clinical Policies & PGD Authorisation Group Name

Designation

Mr James Slaven

Head of Nursing NHS Fife Community Health Partnerships

Dr Stella Clark

Medical Director NHS Fife Primary Care

Mrs Evelyn McPhail

Chief Pharmacist NHS Fife Community Health Partnerships

Patient Group Direction No 140 Hib/MenC vaccine for Catch-up

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1.

Clinical situation/condition to which the protocol applies •

During the Catch-up Programme for Hib vaccine which will run from 5th November 2007 until 3rd March 2009, children aged from 3 years 4 months old to under 6 years of age who require a booster dose of Hib (to be given as Hib/Men C (Menitorix▼)) and who have already had their pre-school booster with a vaccine that did not have a Hib component (i.e. It was either dTaP/IPV (Repevax▼) or DTaP/IPV (Infanrix IPV▼) • Children in the eligible group for the Hib Catch Up Programme are those born between 4th April 2003 and 3rd September 2005 Signed medical consent for immunisation is required in all cases. For children: Parent/legal guardian must be present OR have given written permission for immunisation.

Objectives of care

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For active immunisation against invasive diseases caused by Haemophilus influenzae type B (Hib) and Neisseria meningitidis serotype C (MenC)

Criteria for inclusion

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During the Hib Catch Up Programme older children aged from 3 years 4 months old to under 6 years of age who require a booster dose of Hib and who have already had their pre-school booster with a vaccine that did not have a Hib component (i.e. either dTaP/IPV (Repevax▼) or DTaP/IPV (Infanrix IPV▼) There has been a gap of at least one month since any previous dose of Hib or Men C vaccine Agreed consent obtained

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Criteria for exclusion

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Child that is not part of the Hib Catch Up Programme Child who has already had a fourth booster dose of a Hib containing vaccine Child who has not yet had their pre-school booster. (Go to PGD 139-Infanrix-IPV+Hib▼) There has been a gap of less than one month since any previous dose of Hib or Men C vaccine Acute febrile illness Child who has had a confirmed anaphylactic reaction to a previous dose of either Hib or MenC conjugate vaccine Known hypersensitivity to the active substances, including tetanus toxoid, or to any of the excipients. See SPC or manufacturer’s package insert. Consent refused

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Cautions/Additional Information

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No data is available on the use of Menitorix ®▼ in individuals with chronic immunodeficiency (such as those with HIV or on long-term immunosuppressive therapy). A protective immune response to Hib and Men C conjugate vaccines may not be obtained in these individuals. Specialist advice may be required.

Action if excluded

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Febrile illness – make another appointment All others -seek advice from a Registered Medical Practitioner (General Practitioner, Paediatrician or Consultant in Public Health Medicine as appropriate).

Action if patient declines treatment

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Ensure patient/parent/guardian is aware of risk of disease Record in medical records If further advice is required, discuss with a Registered Medical Practitioner (General Practitioner, Paediatrician or Consultant in Public Health Medicine as appropriate).

Patient Group Direction No 140 Hib/MenC vaccine for Catch-up

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Reference to national/local guidelines

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Immunisation against Infectious Disease “The Green Book” See the latest Chapters (Currently December 2006) available at www.dh.gov.uk CMO letter SEHD/CMO (2007)(7) haemophylus Influenzae Type B (HIB) vaccine for young children catch-up programme. British National Formulary (BNF) Current Edition (54th) Guidelines for the Administration for Medicines 2004 NMC Refer to the Clinical Policies and Procedures file for Resuscitation Guidance NHS Fife Community Health Partnerships Immunisation Policy NHS Fife Community Health Partnerships Medicines Fridge Policy & Procedure NHS Fife Community Health Partnerships Vaccine Handling Policy & Procedure NHS Fife Community Health Partnerships Operational Procedure for the Management of Anaphylaxis Summary of Product Characteristics Menitorix▼ (GlaxoSmithKline UK) December 2005

Characteristics of staff •

Registered Nurse with current NMC registration

Additional experience/training required

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Training and competence in all aspects of immunisation including contraindications and the recognition and management of anaphylaxis Must be conversant with key issues in vaccine management (e.g. safe transport, maintaining cold chain etc) in accordance with local NHS Fife CHP Policy

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Updating of anaphylaxis management according to NHS Fife CHP Policy number R2-5

Description of treatment

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Continued training requirements

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Qualifications required

Name, strength & formulation of drug

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Menitorix▼– Powder and solvent for solution for injection Haemophilus type b and Neisseria meningitidis group C conjugate vaccines The product consists of a vial and a pre-filled syringe, one containing a white powder and the other a clear colourless solvent.

Legal class – POM/P/GSL

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POM

Storage

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Between 2-8oC Do not freeze. Vaccine that has been frozen should not be used Protect from light Ensure within expiry date After reconstitution, the vaccine should be administered promptly. Any vaccine that has been reconstituted but not used should be discarded.

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Patient Group Direction No 140 Hib/MenC vaccine for Catch-up

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In cool-boxes that have been tested and validated for use by Pharmacy Services, NHS Fife Community Health Partnerships

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Dose/Dose range

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0.5ml

Method/Route

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Follow the instructions for reconstitution of the vaccine as given in the Manufacturer’s package leaflet. The vaccine must be reconstituted by adding the entire contents of the pre-filled syringe of solvent to the vial containing the powder. After the addition of the solvent, the mixture should be well shaken until the powder is completely dissolved in the solvent. The reconstituted vaccine should be inspected visually for any foreign particulate matter and/or variation of physical aspect prior to administration. In the event of either being observed, discard the vaccine. Hib/Men C vaccine is routinely administered by intramuscular injection preferably in the deltoid region for children in this age group Vaccination by a deep subcutaneous route should be reserved only for individuals with a bleeding disorder.

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Hib/Men C conjugate can be given at the same time as other vaccines including MMR vaccine, (however, at present the advice is that it should not be given with pneumococcal conjugate vaccine (PCV)). Reference The Green Book” Chapter 16 (Currently December 2006) Page 131 If other immunisations are given at the same time the vaccines should be given at a separate site, preferably a separate limb. If given in the same limb, they should be given at least 2.5 cm apart. The exact site at which each vaccine was given should be noted in the child’s record. Hib/Men C vaccine (Menitorix▼) must not be mixed with any other vaccine in the same syringe. Hib/Men C conjugate vaccine should be administered via the intramuscular route, except where there is a bleeding disorder when the deep subcutaneous route should be used.

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Frequency of administration

As a booster dose of Hib as part of the Hib Catch-up Programme, one single dose to children from 3 years 4 months old to under 6 years of age

Maximum dose and number of treatments

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Once-only as a booster dose

Follow up treatment

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None

Patient advice (verbal and written)

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Temperature control Management of local reactions Issue manufacturer’s patient information leaflet if available

Identification and management of adverse reactions

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Patient Group Direction No 140 Hib/MenC vaccine for Catch-up

Fever, irritability, drowsiness, loss of appetite, local reactions (pain, erythema, induration and oedema) mostly within 48 hours following vaccination Observe for signs of anaphylaxis and treat as per current guidelines Parent/guardian asked to seek medical advice for significant side effects or if concerned

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Reporting procedure of adverse reactions

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Parent/guardian to inform GP/Nurse of any significant adverse reactions or if concerned This is a black triangle medicine▼. All suspected reactions should be reported directly to CSM Scotland (0131 2422919) through the yellow card scheme and recorded in the patient’s medical records. Yellow cards are available at the back of the BNF.

Arrangements for referral to medical advice

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GP appointment/duty GP depending on urgency

Additional facilities/supplies required

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Ensure immediate access to anaphylaxis medication as appropriate to current NHS Fife Community Health Partnerships Operational Procedure for the Management of Anaphylaxis Immediate telephone access Access to a BNF Adhere to Hand Decontamination Policy

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Sharps, vials and other vaccine equipment and any reconstituted vaccine that has not been used should be disposed of following NHS Fife Community Health Partnerships policies for disposal of sharps and other harmful substances.

Records

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Enter in medical record - date - dose/volume - title of vaccine - batch number and manufacturer - expiry date - injection site and route - name of clinician providing treatment - signature of clinician providing treatment Record on computer Record in patient-held record card

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Disposal

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Patient Group Direction No 140 Hib/MenC vaccine for Catch-up

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4.

Management and monitoring of Patient Group Direction

This patient group direction is to be read, agreed to, and signed by all nurses it applies to. One signed copy is to be given to each nurse with the original being kept on file by the line manager. One signed copy should be forwarded to the appropriate lead nurse Name of nurse-------------------------------------------------------------------Is authorised to give------------------------------------------------------------under this patient group direction Signature of nurse---------------------------------------------------------------Date--------------------------------------------------------------------------------

Authorised by: Name of authorising clinician/manager-----------------------------------------------

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Patient Group Direction No 140 Hib/MenC vaccine for Catch-up

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