Patient Group Direction

Transcription

1 Patient Group Direction For the supply and administration of PNEUMOCOCCAL POLYSACCHARIDE VACCINE (23 VALENT) PNEUMOVAX II Vaccine By Registered Nurse/Midwife/Health Visitor To Adults and children over 2 years of age Valid from September 2012 Review Date August 2014 Supersedes Pneumovax II template PGD V4 September 2010 Developed and Produced by Cheshire and Merseyside Childhood Immunisation PGD subgroup: PCT Represented Organisation Professional group Current group member Central & Eastern Central & Eastern Immunisation Facilitator Cath Lilley Cheshire Cheshire PCT Halton & St NHS Halton & St Immunisation Coordinator Michelle Falconer Helens Helens Knowsley 5 Boroughs Immunisation Coordinator Pauline Jones Partnership Knowsley 5 Boroughs Pharmacist Carol Humphries Partnership Liverpool Liverpool V&I training Lead Pauline Morris Community Health Sefton Sefton PCT Pharmaceutical Adviser Helen Stubbs in Public Health Warrington Warrington PCT Public Health Consultant Marioth Manche Warrington Western Cheshire Bridgewater Community Healthcare NHS Trust Community Care Western Cheshire Immunisation Coordinator Lead Pharmacist Wirral NHS Wirral Immunisation Coordinator Wirral & Cheshire Health Protection CCDC & Unit Director & Merseyside Agency HPU Cheshire & Merseyside HPU Health Protection Agency Senior Health Protection Nurse Tracie Duffy John Hickey Claire Elliot Dr S Ghebrehewet Gill Marsh 1. Characteristics of staff Review by end August 2014 Page 1 of 8

2 Qualifications required Registered Nurse / Midwife/ Health Visitor having valid registration with the Nursing and Midwifery Council (NMC). Additional requirements Received training to undertake supply and administration of medicines under Patient Group Directions. Received appropriate training and updates on the administration of immunisations, in accordance with local policy and national HPA guidance, and can demonstrate competence in these areas. Received appropriate training and updates on resuscitation and management of anaphylaxis and demonstrates competence in this area. Practitioners should be constantly alert to any subsequent recommendations from the Department of Health and Joint Committee on Vaccination and Immunisation, including Clinical Medical Officer letters, additional immunisation advice / campaigns, product updates and updates to the Department of Health Green Book. Information in such documents supersedes information within the PGD and should be followed. However if this advice affects the inclusion /exclusion criteria, then the practitioner MUST seek a PSD until the PGD has been revised. Continued training requirements Annual attendance at update on resuscitation skills and the management of anaphylaxis in the community. Able to provide evidence of continued professional development i.e. meeting Post-Registration Education & Practice (PREP) requirements. Review by end August 2014 Page 2 of 8

3 2. Clinical condition or situation Indication Active immunisation against Pneumococcal disease Criteria for inclusion Criteria for exclusion All adults aged 65 years and over. Adults and children over the age of 2 years who are in an at risk group (see Table A). Occupational health indication: Welders: there is a strong association between welding and Pneumococcal disease; therefore welders who have NOT received PPV previously should be offered a single dose. A confirmed anaphylactic reaction to previous dose of vaccine containing the same antigens. A confirmed anaphylactic reaction to another component contained in the relevant vaccine. (for previous severe hypersensitivity reactions see special precautions) No Valid Consent. Current acute febrile illness - immunisation should be postponed until recovered * Exclusion under this PGD does not necessarily mean contraindicated Action if excluded Advise when patient may receive vaccine. Advise regarding risks of Pneumococcal disease and disease transmission, signs and symptoms. Immunise as soon as valid consent is obtained. Seek specialist advice if necessary. Action if patient declines treatment Special precautions Document refusal and action taken in patient s record. Advise regarding risks of Pneumococcal disease and disease transmission signs and symptoms. Information about protective effects of vaccine. Inform or refer to General Practitioner as appropriate Seek specialist advice if necessary e.g. In the case of a previous severe reaction refer to the appropriate medical officer (Consultant or GP). May be given to pregnant and breast feeding women SEEK ADVICE. PNEUMOVAX II and ZOSTAVAX should not be given at the same time because simultaneous use in a clinical trial resulted in reduced immunogenicity of ZOSTAVAX Patients who are immunosuppressed due to disease, e.g. HIV, Hodgkins, or treatment e.g. corticosteroids therapy may not achieve an adequate immune response and may require additional doses. SEEK ADVICE FROM THE APPROPRIATE MEDICAL OFFICER. Children and adults requiring splenectomy or commencing immunosuppressive treatment, SEEK SPECIALIST ADVICE as to the timing of vaccination in reference to Green Book Review by end August 2014 Page 3 of 8

4 2. Clinical condition or situation continued References to national/local policies or guidelines NMC (2010) Standards for Medicines Management. NMC (2008) Professional Code. BNF 63 March Summary of Product Characteristics Pneumococcal Vaccine, Pneumovax II (Sanofi Pasteur MSD 22 June 2011 downloaded 1 st August Immunisation Against Infectious Disease The Green Book updated Chapter th October 2011 downloaded 1 st August Health care professionals are reminded that in some circumstances the recommendations regarding vaccines given in the Green Book chapters may differ from those in the Summary of Product Characteristics (SPC) for a particular vaccine. When this occurs, the recommendations in the Green Book are based on current expert advice received from the JCVI and should be followed. Review by end August 2014 Page 4 of 8

5 3. Description of treatment Name, strength & Pneumococcal Polysaccharide Vaccine (PPV). formulation of drug Legal status Black Triangle Dose/Dose range Method/Route Frequency of administration Total Dose Number Identification & Management of Adverse Reactions Additional Facilities Patient advice POM No 0.5ml Intramuscular injection. Single dose. NB: Re-immunisation with a single dose of PPV is recommended every five years for individuals with no spleen, splenic dysfunction or chronic renal disease (including nephrotic syndrome, chronic kidney failure, kidney transplantation and coeliac disease). One dose. Soreness and redness at the injection site. Low grade fever Any serious adverse reaction to the vaccine in adults and any reaction in children to be documented and should be reported via yellow card system. Immediate access to Adrenaline 1 in 1000 injection. Inform of possible side effects and their management. Follow up Re-arrange appointment if immunisation is postponed due to acute febrile illness. Children in at risk groups - A single dose of the 23-valent pneumococcal polysaccharide vaccine (PPV) should be given after their second birthday and at least two months after the final dose of the conjugate vaccine (see Table B). Specific product info. Records Ensure the product is clear and colourless Record fully in Trust clinical record / GP records and as required in parent held records and forward immunisation records to the Child Health Information System (CHIS) / Department. Patient name and date of birth Dose, site and route of injection Antigen(s) given, brand, batch and expiry date of vaccine Date and time given and by whom Consent obtained Stage of immunisation (if appropriate) and if/when next dose is due. State if immunisation was given as scheduled or unscheduled. An indication that the vaccine has been administered under a PGD Advice given Immuniser s signature on appropriate record/ password controlled immunisers record on patient e-records. An electronic or manual record of all individuals receiving immunisation under this PGD should be kept for audit purposes. Review by end August 2014 Page 5 of 8

6 4. Authorisations PGD Authorised on Behalf of NHS Wirral by: Governance Lead Name: Dr Phil Jennings Position: Wirral CCG Chair Signature: Date: PGD Authorised for use in GP Practice by: Senior Partner (or delegate) for GP employed nurses only Individual Authorisation Name: Position: Signature: Date: 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 and in accordance with their own Code of Conduct Note to Authorising Managers: authorised staff should be provided with an individual copy of the clinical content of the PGD and a copy of the document showing their authorization. In the case of the Practice Nurses the Authorising Manager is one of the GPs. Nurses named below based at Clinic or GP Practice I have read and understood the Patient Group Direction and agree to supply / administer this medicine only in accordance with this PGD: - Name of Professional Signature Authorising GP Date Review by end August 2014 Page 6 of 8

7 Table A: Clinical Risk Groups Who Should Receive the Pneumococcal Immunisation (Green Book October 2011) Clinical risk group Asplenia or dysfunction of the spleen Chronic respiratory disease Examples (decision based on clinical judgement) This also includes conditions such as homozygous sickle cell disease and coeliac syndrome that may lead to splenic dysfunction This includes chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema; and such conditions as bronchiectasis, cystic fibrosis, interstitial lung fibrosis, pneumoconiosis and bronchopulmonary dysplasia (BPD). Children with respiratory conditions caused by aspiration, or a neuromuscular disease (e.g. cerebral palsy) with a risk of aspiration. Chronic heart disease Chronic kidney disease Chronic liver disease Diabetes (requiring insulin or oral hypoglycaemic drugs) Immunosuppression Asthma is not an indication, unless so severe as to require continuous or frequently repeated use of systemic steroids (as defined in immunosuppression below). This includes those requiring regular medication and/or follow up for ischaemic heart disease, congenital heart disease, hypertension with cardiac complications, and chronic heart failure. This includes nephrotic syndrome, chronic kidney failure, and kidney transplantation. This includes cirrhosis, biliary atresia, and chronic hepatitis. Diabetes mellitus requiring insulin or oral hypoglycaemic drugs. This does not include diabetes that is diet controlled. Due to disease or treatment, including asplenia or splenic dysfunction and HIV infection at all stages. Patients undergoing chemotherapy leading to immunosuppression. Individuals on or likely to be on systemic steroids for more than one month at a dose equivalent to Prednisolone at 20mg or more per day (any age), or for children under 20kg, a dose of 1mg or more per kg per day. Individuals with cochlear implants Individuals with cerebrospinal fluid leaks However, some immunocompromised patients may have a sub optimal immunological response to the vaccine. It is important that immunisation does not delay the cochlear implantation. This includes leakage of cerebrospinal fluid such as following trauma or major skull surgery. Review by end August 2014 Page 7 of 8

8 Table B: Vaccination Schedule for Those in a Clinical Risk Group (Green Book October 2011) PATIENT AGE AT PRESENTATION VACCINE GIVEN AND WHEN TO IMMUNISE 13-valent pneumococcal conjugate vaccine 23-valent pneumococcal polysaccharide vaccine* At-risk children two months to under 12 months of age At-risk children two months to under 12 months of age who have asplenia or splenic dysfunction or who are immunosuppressed At-risk children 12 months to under five years of age At-risk children 12 months to under five years of age who have asplenia or splenic dysfunction or who are immunosuppressed Vaccination according to the routine immunisation schedule at two, four and between 12 and 13 months of age (i.e. within one month of the first birthday) Vaccination according to the routine immunisation schedule at two, four and between 12 and 13 months of age (i.e. within one month of the first birthday) One dose Two doses, with an interval of two months between doses One dose after the second birthday One dose after the second birthday One dose after the second birthday, and at least two months after the final dose of PCV. One dose after the second birthday, and at least two months after the final dose of PCV. At-risk children aged over five years and at-risk adults PCV is not recommended One dose Review by end August 2014 Page 8 of 8