Patient Group Direction for Rotavirus vaccine Version: ROTAVIRUS (Rotarix ) Start Date: 1 st July 2013 Expiry Date:30 th June 2015

Transcription

1 Patient Group Direction for Rotavirus vaccine Version: ROTAVIRUS (Rotarix ) Start 1 st July 2013 Expiry 30 th June 2015 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 CLINICAL COMMISSIONING GROUPS: BLACKBURN WITH DARWEN BLACKPOOL CHORLEY AND SOUTH RIBBLE CUMBRIA EAST LANCASHIRE FYLDE AND WYRE GREATER PRESTON LANCASHIRE NORTH WEST LANCSHIRE.

2 CLINICAL CONTENT OF PATIENT GROUP DIRECTION FOR Patient Group Direction Details VERSION: ROTAVIRUS (Rotarix ) (Page 1 of 4) Date comes into effect 1 st July 2013 Date of expiry + review 30 th June 2015 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 Inclusion criteria Exclusion criteria Precautions Management of excluded patients Action for patients not wishing to receive care under this PGD >> 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 rotavirus Infants aged 8 weeks to 23 weeks and 6 days. Confirmed anaphylactic reaction to any component or a preceding dose of rotavirus vaccine. History of intussusception. Infants with uncorrected congenital malformations of the gastrointestinal tract that could predispose for intussusception. Infants with severe combined immunodeficiency (SCID) disorder. Infants with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase insufficiency. Infants over 24 weeks of age. 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. Absence of valid consent Immunisation should be postponed in patients with acute febrile illness/infection. Immunisation should be postponed in patients suffering from diarrhoea or vomiting. 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 good hygiene which apart from vaccination is the most important way of preventing the spread of rotavirus.

3 CLINICAL CONTENT OF PATIENT GROUP DIRECTION FOR Description of Treatment Name of medicine Formulation and route Strength Dosage Repeated dose instructions Duration of treatment Quantity to supply Legal status Special Precautions Adverse effects Advice necessary Records and Follow Up Referral arrangements Records to be kept Follow up VERSION: ROTAVIRUS (Rotarix ) (Page 2 of 4) Rotarix Rotarix live attenuated vaccine is supplied as an oral suspension of clear colourless liquid in an oral applicator containing the suspension solution (1.5 ml) with a plunger, stopper and a protective tip cap. For oral use only. Rotarix should under no circumstances be injected. See Appendix 1. Not applicable First dose of 1.5 ml of Rotarix vaccine at two months (approximately eight weeks) of age.(please see special precautions) Second dose of 1.5 ml at least four weeks after the first dose. (please see special precautions). Second dose should be given no later than 23 weeks and 6 days of age. As above See above Prescription only medicine (POM) Rotarix should not be given to infants under 6 weeks of age. Vaccination with Rotarix should not be started for infants aged 15 weeks and 0 days or older. Infants who have received their first dose of vaccine under 15 weeks and 0 days of age should receive their second dose of Rotarix after a minimum interval of 4 weeks and by 23 weeks and 6 days of age. Rotarix vaccine should not be given to an infant who is 24 weeks and 0 days of age or older. Explain indications, contraindications and cautions (refer to Green Book) Common- diarrhoea and irritability Uncommon-abdominal pain, flatulence and dermatitis This list is not exhaustive. Refer to BNF and SPC for complete list. If noted, complete & submit a Yellow Card via For drugs - Report all suspected adverse drug reactions For up to date SPCs and PILs 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. 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, 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 Patient Group Direction Owner Details of Patient Group Direction owner Patient Group Direction Details VERSION: ROTAVIRUS (Rotarix ) (Page 3 of 4) 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 July 2013 Date of expiry + review 30 th June 2015 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. >> 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 Steven Gee Position: Consultant in Health Protection, C&LPHEC Lead Pharmacist Lead Nurse Organisational Name: Melanie Preston Position: Assistant Director - Medicines Optimisation, Blackpool CCG Name: Ms Kate Brierley Position: Consultant Nurse Health Protection, C&LPHEC Name: Dr J Gardner Position: Medical Director, Lancashire Area Team, NHS England Organisational Organisational Name: Position: Name: Position: Independant Contractor (for PGDs being used by the staff of Independant 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 Individual Authorisation VERSION: ROTAVIRUS (Rotarix ) (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 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

6 Appendix 1 Administration Rotarix vaccine is given orally. Rotavirus vaccines must not be injected. To administer the vaccine, carefully remove the protective tip-cap from the oral applicator. Seat the child in a reclining position and administer the entire content of the oral applicator orally (i.e. into the child s mouth, towards the inner cheek). Instructions for administration of the vaccine: 1. Remove the protective tip cap from the oral applicator. 2. This vaccine is for oral administration only. The child should be seated in a reclining position. Administer orally (i.e. into the child s mouth, towards the inner cheek) the entire content of the oral applicator. 3. Do not inject.