Change history Version number Change details Date Updated for National ACWY programme to be implemented August June 2015.

Transcription

1 Patient Group Direction for Conjugate Meningococcal ACWY vaccine Version: MEN ACWY CONJUGATE Start 1 st August 2015 Expiry 31 st July 2018 THIS PATIENT GROUP DIRECTION HAS BEEN AGREED BY THE FOLLOWING ORGANISATIONS: BLACKPOOL TEACHING HOSPITALS NHS FOUNDATION TRUST CALDERSTONES PARTNERSHIP CUMBRIA PARTNERSHIP EAST LANCASHIRE HOSPITALS NHS TRUST LANCASHIRE CARE NORTH CUMBRIA UNIVERSITY HOSPITALS NHS TRUST UNIVERSITY HOSPITALS OF MORECAMBE BAY NHS FOUNDATION TRUST CLINICAL COMMISSIONING GROUPS: BLACKBURN WITH DARWEN BLACKPOOL CHORLEY AND SOUTH RIBBLE EAST LANCASHIRE FYLDE AND WYRE GREATER PRESTON LANCASHIRE NORTH WEST LANCASHIRE Change history Version number Change details Date Updated for National ACWY programme to be implemented August 2015 June 2015 [Type text]

2 CLINICAL CONTENT OF PATIENT GROUP DIRECTION FOR CONJUGATE MENINGOCOCCAL ACWY VACCINE Patient Group Direction Details VERSION: Men ACWY Conjugate (Page 1 of 4) Date comes into effect 1 st August 2015 Date of expiry + review 31 st July 2018 or sooner in the light of significant changes in best practice Staff characteristics Registered nurse or Pharmacist employed by the NHS organisations overleaf or independent contractors within them, who has completed immunisation and vaccination training (theoretical and practical) as per local policy, training in the recognition and treatment of anaphylaxis, including practical training in Basic Life Support (annual practice update session to be undertaken) and working under PGDs. Access to adrenaline and access to the complete updated relevant chapters in the current edition of the Green Book Immunisation against Infectious Disease. h-england/series/immunisationagainst-infectious-disease-the-green-book Clinical Details Indication >> YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION << >> OF THIS PGD BEFORE WORKING UNDER IT << This PGD is to be followed by all nurses and pharmacists who carry out immunisations in hospitals, clinics, schools, surgeries, patients homes or other locations. Facilities for treating anaphylaxis must be available. Immunisation against Meningococcal disease types A, C, W135 & Y NB: Quadrivalent Conjugate MenACWY vaccine should be used in preference to Polysaccharide ACWY vaccine (see most recent update to Green Book). Off label use NB: these recommendations are off-label, but are in line with recommendations of JCVI as contained in Immunisation against Infectious Disease (updated chapter) - Nimenrix for infants under 12 months. - Menveo for infants under 24 months. Inclusion criteria Cohorts identified in Annex A of this PGD Individuals identified as close contacts of patients with this disease, who have previously not received immunisation. Patients with splenectomy or dysfunctional spleen or complement deficiency. Patients who have previously received Meningococcal C conjugate vaccine may receive this vaccine to confer protection against disease caused by serogroups A, W135, Y. Exclusion criteria Confirmed anaphylactic reaction to any component or a preceding dose of the vaccine. Check the manufacturers information prior to administration of any vaccine/immunoglobulin re its latex content. If latex is a component of the vaccine/immunoglobulin or the administration system (e.g. vial or syringe etc.) then a latex-free alternative must be offered to patients with latex sensitivity. Precautions Management of excluded patients Action for patients not wishing/unable to receive care under this PGD Absence of valid consent Individuals who are travelling or going to reside in areas with increased risk for Meningococcal Meningitis Type A, C, W135 or Y -Vaccine must not be given under PGD for this purpose. An individual prescription or patient specific direction must be used. Absence of valid consent Immunisation must be postponed in patients with acute febrile illness/infection. Give information about when the vaccine may/may not be given or give a further appointment to attend for vaccination, or in the case of a previous severe allergic reaction be referred to the appropriate medical officer, e.g. CMO, GP Make patient aware of alternative, risks and potential consequences of not being vaccinated. Document refusal. Give advice about Meningococcal groups A,C,W &Y

3 CLINICAL CONTENT OF PATIENT GROUP DIRECTION FOR CONJUGATE MENINGOCOCCAL ACWY VACCINE Description of Treatment Name of medicine Formulation and route VERSION: Men ACWY Conjugate (Page 2 of 4) Quadrivalent (ACWY) conjugate vaccine. Menveo or Nimenrix By intra-muscular injection into the upper arm or anterolateral thigh. Vaccination by deep subcutaneous route must be reserved only for individuals with a bleeding disorder. Prepare as per manufacturers instructions. Strength Not applicable Dosage 0.5ml Repeated dose instructions National programme Single dose. Splenectomy or splenic dysfunction, complement deficiency refer to Annex B (Box 7.1 taken from chapter 7 of the Green book) 1_3.pdf Duration of treatment As above Quantity to supply See above Legal status Prescription only medicine (POM) Adverse effects Injection site reactions are very common, erythema, pruritis, induration and tenderness. Headache, drowsiness, nausea, loss of appetite, irritability, malaise and rash are also common. This list is not exhaustive. Refer to BNF and SPC for complete list. If serious reaction noted, complete & submit a Yellow Card via For drugs - Report all suspected adverse drug reactions For up to date SPCs and PILs Advice necessary Ensure that the patient information leaflet is available & offered to every patient/parent/guardian. Advice on the prevention and management of fever and local reactions and other adverse effects. Common post-vaccination adverse effects. Date of next vaccination as required. Records and Follow Up Referral arrangements Records to be kept Follow up Prior to vaccinating, any health professional administering a vaccination must be able to identify and contact an appropriate medical officer, e.g. CMO, consultant paediatrician, GP, as necessary, e.g. in the case of an immunocompromised child. As per local documentation requirements. Record the brand name of the vaccine given, date and time and route of administration, batch number, expiry date and immunisation site, supply/administration under PGD. Document any reaction in patient s medical notes. Subsequent vaccination as required as per UK schedule Patient Group Direction, organisation and individual authorisation signatures can be found on the managerial content sheet along with other non-clinical details relating to this patient group direction.

4 MANAGERIAL CONTENT OF PATIENT GROUP DIRECTION FOR CONJUGATE MENINGOCOCCAL ACWY VACCINE VERSION: Men ACWY Conjugate (Page 3 of 4) Patient Group Direction Owner Details of Patient Group Direction owner Patient Group Direction Details Name: Martin Samangaya Position: Screening and Immunisation Manager Contact Address: Public Health England, Lancashire Area Team Contact Telephone: Contact msamangaya@nhs.net Date comes into effect 1 st August 2015 Date of expiry + review 31 st July 2018 or sooner in the light of significant changes in best practice Staff characteristics Registered nurse or Pharmacist employed by the NHS organisations above or independent contractors within them, who has completed immunisation and vaccination training (theoretical and practical) as per local policy, training in the recognition and treatment of anaphylaxis, including practical training in Basic Life Support (annual practice update session to be undertaken) and working under PGDs. Access to adrenaline and access to the complete updated relevant chapters in the current edition of the Green Book Immunisation against Infectious Disease. >> YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION << >> OF THIS PGD BEFORE WORKING UNDER IT << Patient Group Direction Authorisation Lead Doctor Name: Dr John Astbury Position: Consultant in Health Protection, PHE NW Lead Pharmacist Lead Nurse Organisational Authorisation for Lancashire CCGs by Organisational Authorisation by Name: Julie Lonsdale Position: Head of Medicines Performance, Midlands and Lancashire CSU Name: Ms Kate Brierley Position: Acting Deputy Director - Health Protection, PHE NW Name: Dr Raj Patel Position: Medical Director, NHS England, North (Lancashire & Greater Manchester) Name: Karen O Brien Position: Controlled Drugs Accountable Officer, NHS England, North (Lancashire & Greater Manchester) Organisational Authorisation by Name: Position: Authorisation by Independent Contractor (for PGDs being used by the staff of Independent Contractors only) Name: Position: Patient Group Direction Peer Reviewed By Name Position Signature Date Cumbria and Lancashire Vaccine PGD Sub-Group (on behalf of group)

5 MANAGERIAL CONTENT OF PATIENT GROUP DIRECTION FOR CONJUGATE MENINGOCOCCAL ACWY VACCINE Individual Authorisation VERSION: Men ACWY Conjugate (Page 4 of 4) BY SIGNING THIS PATIENT GROUP DIRECTION YOU ARE INDICATING THAT YOU AGREE TO ITS CONTENTS AND THAT YOU WILL WORK WITHIN IT 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 IF THIS IS AN UPDATED OR REPLACEMENT PGD ENSURE THAT ALL OLDER VERSIONS ARE WITHDRAWN FROM USE WITH IMMEDIATE EFFECT IT IS YOUR REPONSIBILITY TO MAKE SURE YOU ARE USING THE CURRENT VERSION STAFF MUST ALSO HAVE READ AND BE FAMILIAR WITH ANY ORGANISATIONAL PROCEDURES IN RELATION TO PGDs NOTE TO AUTHORISING MANAGERS: AUTHORISED STAFF SHOULD BE PROVIDED WITH AN INDIVIDUAL COPY OF THE CLINICAL CONTENT OF THE PGD AND A PHOTOCOPY OF THE AUTHORISATION SHEET SHOWING THEIR AUTHORISATION Name of Professional Signature Authorising Manager Date References:

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8 Annex B (from Chapter 7, Green Book) Box 7.1 Practical schedule for immunising individuals with asplenia, splenic dys function or complement disorders (including those receiving complement inhibitor therapy*) depending on the age at which their at -risk condition is diagnosed. Individuals with asplenia or splenic dysfunction aged six months or older should also be offered influenza vaccine (see Chapter 19). First diagnosed under six months Give the MenB vaccine at 2, 3 and 4 months along with the routine infant immunisations (if the routine schedule has already been initiated, then give 3 doses of MenB with an interval at least one month apart) If MenC has not yet been given as part of routine schedule, give one dose of MenACWY conjugate vaccine followed by a second dose at least one month apart. If MenC has already been given as part of routine schedule, then give one additional dose of MenACWY at least one month later Give the routine 12-month boosters: Hib/MenC, PCV13 and MMR Give a MenB booster, an extra dose of PCV13 and one dose of MenACWY conjugate vaccine two months after the 12-month boosters After the second birthday, an additional dose of Hib/MenC should be given, along with the pneumococcal polysaccharide vaccine (PPV23). First diagnosed at 6-11 months Give 2 doses of MenB vaccine at least two months apart (the second dose may be given with the routine 12- month boosters) If MenC has not yet been given as part of routine schedule, give one dose of MenACWY conjugate vaccine followed by a second dose at least one month apart. If MenC has already been given as part of routine schedule, then give one additional dose of MenACWY at least one month after any MenC dose. Give the routine 12-month boosters: Hib/MenC, PCV13 and MMR Give a dose of MenACWY conjugate vaccine and an extra dose of PCV13 two months after the Hib/MenC booster After the second birthday, an additional dose of Hib/MenC and the MenB booster should be given, along with the pneumococcal polysaccharide vaccine (PPV23). First diagnosed at months If not yet administered, give the routine 12-month boosters: Hib/ MenC, PCV13 and MMR Give a dose of MenACWY conjugate vaccine and an extra dose of PCV13 two months after the Hib/MenC and PCV13 boosters Give 2 doses of MenB vaccine at least two months apart (either of these doses can be given at the same time as the other vaccine visits) After the second birthday, an additional dose of Hib/MenC should be given, along with the pneumococcal polysaccharide vaccine (PPV23) This age group should also receive an additional dose of MenB vaccine with an interval of 12 to 23 months after the primary course. First diagnosed from two years onwards Ensure that the child has been immunised according to national schedule, including the 12-month boosters Give an additional dose of Hib/MenC and the first dose of MenB vaccine, along with the pneumococcal polysaccharide vaccine (PPV23)** Give a dose of MenACWY conjugate vaccine and the second dose of MenB two months after the Hib/MenC booster***. * Soliris acts by down regulating the terminal complement components so those on Soliris therapy are not at increased risk of pneumococcal disease and do not require PPV23. ** Severely immunocompromised individuals (as described in Chapter 25) aged five years or over should receive one dose of PCV13 followed by PPV at least two months later, as well as annual influenza vaccinations (Chapter 19), but do not require meningococcal conjugate vaccination. *** In adolescents (from 11 years of age) and adults, this interval can be reduced to one month. f Check for recent amendments.

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