CLINICAL CONTENT OF PATIENT GROUP DIRECTION FOR PNEUMOCOCCAL CONJUGATE VACCINE (Prevenar 13 )

Transcription

1 Patient Group Direction for Pneumococcal Conjugate Vaccine (Prevenar 13 ) Version: PNEUMOCOCCAL CONJUGATE Start 1 st February 2014 Expiry 31 st January 2017 THIS PATIENT GROUP DIRECTION HAS BEEN AGREED BY THE FOLLOWING ORGANISATIONS: BLACKPOOL TEACHING HOSPITALS NHS FOUNDATION TRUST CUMBRIA PARTNERSHIP NHS FOUNDATION TRUST EAST LANCASHIRE HOSPITALS NHS TRUST LANCASHIRE CARE NHS FOUNDATION TRUST NORTH CUMBRIA UNIVERSITY HOSPITALS NHS TRUST UNIVERSITY HOSPITALS OF MORECAMBE BAY NHS FOUNDATION TRUST NHS ENGLAND LANCASHIRE AREA TEAM CLINICAL COMMISSIONING GROUPS: BLACKBURN WITH DARWEN BLACKPOOL CHORLEY AND SOUTH RIBBLE EAST LANCASHIRE FYLDE AND WYRE GREATER PRESTON LANCASHIRE NORTH WEST LANCASHIRE

2 CLINICAL CONTENT OF PATIENT GROUP DIRECTION FOR PNEUMOCOCCAL CONJUGATE VACCINE (Prevenar 13 ) VERSION: PNEUMOCOCCAL CONJUGATE (Page 1 of 5) Patient Group Direction Details Date comes into effect 1 st February 2014 Date of expiry + review 31 st January 2017 or 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. 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 registered health care professionals, authorised to work under PGD, who carry out immunisations in hospitals, clinics, schools, surgeries, patients homes or other locations. Facilities for treating anaphylaxis must be available. Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from two months to five years of age. Inclusion criteria Prevenar 13 ( ) is recommended for all infants from two months of age as part of the routine childhood immunisation programme and children under five years of age in a clinical risk group. Refer to Green Book Pneumococcal chapter 25. Exclusion criteria A confirmed anaphylactic reaction to a previous dose of the Prevenar 13 ( ) or Prevenar 7 vaccine. A confirmed anaphylactic reaction to any component of the vaccine. Absence of valid consent Precautions Management of excluded patients Action for patients not wishing to receive care under this PGD Immunisation should be postponed in patients with acute febrile illness/infection. Prevenar 13 ( ) can be given at the same time as other vaccines such as DTaP/IPV/Hib, MMR, MenC, Hib/MenC and influenza. The vaccines should be given at separate sites, preferably in different limbs. Prevenar 13 ( ) the current presentation does not contain any latex or thiomersal. A history of severe (i.e. anaphylactic) allergy to latex - Check with the manufacturer 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. Children who have an impaired immune response may have reduced antibody response to active immunisation (see Green Book). Very premature infants (born 28 weeks of gestation) who are in hospital should have respiratory monitoring for hrs. when given their first immunisation, particularly those with a previous history of respiratory immaturity. If the child has apnoea, bradycardia or desaturations after the first immunisation, the second immunisation should also be given in hospital, with respiratory monitoring for hrs. As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed. Give information about when the vaccine may 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 pneumococcal infection.

3 CLINICAL CONTENT OF PATIENT GROUP DIRECTION FOR PNEUMOCOCCAL CONJUGATE VACCINE (Prevenar 13 ) Description of Treatment Name of medicine Formulation and route Strength Dosage Repeated dose instructions VERSION: PNEUMOCOCCAL CONJUGATE (Page 2 of 5) Pneumococcal Conjugate Vaccine (13 valent, absorbed) PCV Trade Names: Prevenar 13 ( ) Intramuscular injection, preferably into the lateral aspect of the mid-thigh in infants under the age of 1, and into the deltoid muscle in children over 1 year. Vaccination by deep subcutaneous route should be reserved only for individuals with a bleeding disorder. Prepare as per manufacturers instructions. Not applicable Prevenar 13 ( ) 0.5 ml. 1. Routine childhood immunisation schedule: Primary course 2 doses, each of 0.5ml, usually given at 2 months of age and 4 months of age (with an interval of 2 months) Booster dose 1 dose of 0.5ml, usually given at 13 months of age. 2. Children from one year to under two years of age: Primary course- 1 dose of 0.5 ml at least 1 month after any preceding dose. If the primary course in children under one year was not completed, then a single booster dose of PCV should be given at least one month after the last dose to complete the course. 3. Infants and children with unknown/incomplete vaccination status : Infants under one year of age 2 doses, each of 0.5ml, given at least two months apart, with a further booster dose of 0.5ml to be given in the second year of life (with an interval of at least one month after the second dose). Children aged one to under two years of age a single dose of 0.5ml. 4. Risk Groups: Children presenting late for vaccination Infants under one year of age - should be offered 2 doses of 0.5ml given before the age of 12 months, with a further booster dose of 0.5ml to be given in the second year of life. Children aged one to under two years of age - a single dose of 0.5ml. Children aged two to five years of age at risk children under five years of age who have either not been vaccinated with PCV or not completed a primary course should have a single dose of PCV. NB children aged 1-5 who have asplenia or splenic dysfunction or who are immunocompromised and may have a sub-optimal immunological response to the first dose of vaccine, a second dose should be given two months after the first dose. Please refer Green Book Chapter for advice for cases of invasive pneumococcal disease. All at risk children should be offered a single dose of PPV when they are two years and over. As above See above Prescription only medicine (POM) Duration of treatment Quantity to supply Legal status Special Precautions Explain indications, contraindications and cautions (refer to Green Book) Adverse effects Prevenar 13 ( ) vaccine common and very common adverse effects may include decreased appetite, pyrexia; irritability; any injection-site erythema: induration/swelling or pain/tenderness; somnolence; poor quality sleep. This list is not exhaustive. Refer to BNF and SPC for complete list. Prevenar 13 ( ) is a black triangle medicine. Side effects following vaccination are to be reported to the MHRA using the Yellow Card system found at: 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 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 Records to be kept Follow up the case of an immunocompromised child. As per local documentation requirements. Record the brand name of the vaccine given, 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

4 CLINICAL CONTENT OF PATIENT GROUP DIRECTION FOR PNEUMOCOCCAL CONJUGATE VACCINE (Prevenar 13 ) VERSION: PNEUMOCOCCAL CONJUGATE (Page 3 of 5) Table 1 Vaccination schedule for those in a clinical risk group Patient age at presentation Vaccine given and when to immunise 13 valent PCV (PCV13) 23-valentPPV At-risk children 2 months to under 12 months of age (including infants who have asplenia or splenic dysfunction or who are immunosuppressed) At-risk children 12 months to under 5 years of age who have asplenia or splenic dysfunction or who are immunosuppressed All other at-risk children 12 months to under 5 years of age Vaccination according to the routine immunisation schedule at 2, 4 and 12 months Two doses, with an interval of 2 months between doses One dose One dose after the second birthday. One dose after the second birthday and at least 2 months after the final dose of PCV13 One dose after the second birthday and at least 2 months after the final dose of PCV13 At-risk children aged 5 years and at-risk adults PCV is not recommended unless severely immunocompromised (see Green Book for advice for severely immunocompromised) One dose (see Green Book for advice for severely immunocompromised) Reference: Green Book Chapter 25 v5_0 December 2013 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.

5 MANAGERIAL CONTENT OF PATIENT GROUP DIRECTION FOR PNEUMOCOCCAL CONJUGATE VACCINE (Prevenar 13 ) Patient Group Direction Owner Details of Patient Group Direction owner Patient Group Direction Details VERSION: PNEUMOCOCCAL CONJUGATE (Page 4 of 5) Name: Martin Samangaya Position: Screening and Immunisation Manager Contact Address: NHS England, Lancashire Area Team Contact Telephone: Contact msamangaya@nhs.net Date comes into effect 1 st February 2014 Date of expiry + review 31 st January 2017 or 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. Patient Group Direction Authorisation Lead Doctor >> YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION << >> OF THIS PGD BEFORE WORKING UNDER IT << Name: Dr Steven Gee Position: Consultant in Health Protection, C&LPHEC Lead Pharmacist Lead Nurse Organisational Authorisation for Lancashire CCGs by Organisational Authorisation by Name: Ms Julie Lonsdale Position: Head of Medicines Performance, Lancashire CSU Name: Ms Kate Brierley Position: Consultant Nurse Health Protection, C&LPHEC Name: Dr J Gardner Position: Medical Director, Lancashire Area Team, NHS England 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) Andrea Stewardson Health Protection Practitioner

6 MANAGERIAL CONTENT OF PATIENT GROUP DIRECTION FOR PNEUMOCOCCAL CONJUGATE VACCINE (Prevenar 13 ) Individual Authorisation VERSION: PNEUMOCOCCAL CONJUGATE (Page 5 of 5) 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 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