Patient Group Direction For the supply and administration of

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1 Patient Group Direction For the supply and administration of HAEMOPHILUS INFLUENZAE TYPE B AND MENINGOCOCCAL C CONJUGATE VACCINE (HIB-MenC) MENITORIX Vaccine By Registered Nurse/Midwife/Health Visitor To Adults and Children from 2 months of age Valid from 7 th August 2012 Review by Date End of July 2014 Supersedes Hib Men C template PGD V4 6.September 2010 Developed and Produced by Cheshire and Merseyside Childhood Immunisation PGD subgroup: PCT Professional group Current group member Central & Eastern Community Matron Cath Lilley Cheshire Knowsley Immunisation Co-ordinator Pauline Jones Knowsley Pharmacist Carol Humphries Liverpool V&I training Lead Pauline Morris Liverpool Pharmacist PGD Lead Sue Wright Sefton Pharmaceutical Adviser in Public Health Helen Stubbs Warrington Public Health Consultant Marioth Manche Warrington Immunisation Co-ordinator Tracie Duffy Western Cheshire Lead Pharmacist John Hickey (Provider Services) Wirral CCDC Dr S Ghebrehewet Cheshire & Merseyside HPU Senior Health Protection Nurse Gill Marsh Page 1 of 7

2 1. Characteristics of staff Qualifications required Additional requirements Continued training requirements Registered Nurse / Midwife/ Health Visitor having valid registration with the Nursing and Midwifery Council (NMC). 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. 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. 2. Clinical condition or situation Indication Criteria for inclusion Criteria for exclusion For active immunisation against invasive disease caused by haemophilus influenzae Type b (Hib) and neisseria meningitidis serotype C (MenC) Given as part of the routine childhood immunisation programme to children aged 12 months or over. As a primary immunisation to children age 12 months to 10 years who have not previously been vaccinated with MenC and/or Hib but have completed primary immunisation with diphtheria, pertussis tetanus and polio As a primary immunisation to infants from 2 months up to 12 months of age who have completed primary immunisation with diphtheria, pertussis tetanus and polio but not completed 3 doses of Hib A confirmed anaphylactic reaction to a previous dose of vaccine containing the same antigens A confirmed anaphylactic reaction to another component of the vaccine including tetanus toxoid. No Valid Consent. Refer clients with a previous severe hypersensitivity reactions (see special precautions) Review by: end July 2014 Page 2 of 7

3 Action if excluded Action if patient declines treatment Special precautions References to national/local policies or guidelines Medical Conditions o Individuals with asplenia and hyposplenia Individuals with complement deficiency (e.g. C1, 2, 3 or 4 deficiencies) (see updated Green Book chapters 16 & 22, seek specialist advice, seek appropriate vaccine PSD) *Exclusion under this PGD does not necessarily mean the vaccine is contraindicated Advise when patient may receive vaccine. Advise regarding risks of Hib and Meningococcal meningitis and disease transmission, signs and symptoms. Immunise as soon as valid consent is obtained. Seek specialist advice if necessary e.g. In the case of a previous severe reaction refer to the appropriate medical officer (Consultant or GP). If advised to proceed this will require a Patient Specific Direction from the medical officer. Document refusal and action taken in patient s record. Advise regarding risks of Hib and Meningococcal meningitis and disease transmission signs and symptoms. Information about protective effects of vaccine. Current acute febrile illness immunisation should be postponed until recovered Seek specialist advice if necessary e.g. In the case of a previous severe reaction refer to the appropriate medical officer (Consultant or GP). Patient 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 CONFIRMATION AND ADVICE FROM THE APPROPRIATE MEDICAL OFFICER NMC (2010) Standards for Medicines Management NMC (2008) The Code BNF 63 March Summary of Product Characteristics Menitorix (GlaxoSmithKline March 2011) - Immunisation Against Infectious Disease The Green Book updated Hib (March 2011) and Meningococcal (March 2012) Chapters 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 July 2014 Page 3 of 7

4 3. Description of treatment Name, strength & formulation of drug Legal status Dose/Dose range Method/Route Frequency of administration Haemophilus influenzae type b and Meningococcal C conjugate vaccine (Hib-MenC) POM 0.5ml Intramuscular injection. Shake well after reconstitution and immediately prior to vaccination. Individuals with a bleeding disorder should have vaccine by deep subcutaneous injection to reduce risk of bleeding. As part of the Routine Childhood Programme A single booster dose to be administered at 12 months of age or up to 10 years of age for children previously vaccinated with Hib and MenC. Vaccination of individuals with uncertain or incomplete immunisation status (per HPA Algorithm April 2010) Individuals under the age of 12 months who have an incomplete primary course of Hib require the appropriate number of doses to complete a 3 dose primary immunisation course Age 12 months-under 10 years of age where a course of both Hib and Men C or Hib only are required one dose should be given N.B. Previously unimmunised or incompletely immunised individuals from 12 months to under 10 years require consideration regarding the most appropriate vaccine -single Men C or combined Hib/Men C Identification & Management of Adverse Reactions Additional Facilities Patient advice Follow up Specific Product Information Fever, irritability, loss of appetite, drowsiness, local reactions such as pain, redness and swelling at the injection site, mostly within 48 hrs after vaccination. Any adverse events should be reported via yellow card system. Immediate access to Adrenaline 1 in 1000 injection. Inform of possible side effects and their management. Not applicable HIB/Men C can be given at the same time as other vaccines such as DTaP/IPV/Hib, MMR, Influenza and PCV. (Green Book Chapter 16 update) Review by: end July 2014 Page 4 of 7

5 3. Description of treatment (continued) Records 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 July 2014 Page 5 of 7

6 4. Authorisations Patient Group Direction Authorisation Lead Doctor Name: Dr Sam Ghebrehewet Position: Unit Director and Consultant in Communicable Disease Control, C&MHPU Lead Pharmacist Name: Helen Stubbs Position: Pharmaceutical Adviser in Public Health, Sefton PCT Lead Nurse Name: Gill Marsh Position: Senior Health Protection Nurse Practitioner, C&MHPU PGD Authorised on Behalf of NHS Wirral by: Governance Lead Name: Dr Phil Jennings Position: Wirral CCG Chair PGD Authorised for use in GP Practice by: Senior Partner (or delegate) for GP employed nurses only Name: Position: Review by: end July 2014 Page 6 of 7

7 5. Declaration Practitioner I have read the contents of this Patient Group Direction and will work within this remit. Name Signature Date Employer/ Line Manager I give authorisation for the named Health Care Professional who has signed this PGD to administer those vaccines as prescribed within this direction and in accordance with the current Department of Health guidelines (The Green Book - Immunisation against Infectious Disease, HMSO 2006 and most recent updates) Name Signature Date Review by: end July 2014 Page 7 of 7

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