Patient Group Direction For the supply and administration of

Transcription

1 Patient Group Direction For the supply and administration of Adsorbed low dose DIPHTHERIA/TETANUS/acellular PERTUSSIS/ inactivated POLIO REPEVAX Vaccine (dtap/ipv) Or Adsorbed DIPHTHERIA/TETANUS/acellular PERTUSSIS/ inactivated POLIO INFANRIX-IPV Vaccine(DTaP/IPV) By Registered Nurse/Midwife/Health Visitor To Children aged 3 years 4 months to under 10 years. Valid from 5 th July 2012 Review Date June 2014 Supersedes Infanrix IPV and Repevax IPV template PGD V4September 2010 Developed and Produced by Cheshire and Merseyside Childhood Immunisation PGD subgroup: PCT Professional group Current group member Central & Eastern Cheshire Community Matron Cath Lilley Knowsley Immunisation Co-ordinator Pauline Jones 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 (Provider Services) Lead Pharmacist John Hickey 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 / 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. 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 Booster vaccination given as part of the routine childhood immunisation programme for active immunisation against diphtheria, tetanus, pertussis and poliomyelitis. Criteria for inclusion All children from 3 years 4 months of age to under 10 years of age. Criteria for exclusion Children under the age of 3yrs and 4months or over 10 years of age A confirmed anaphylactic reaction to a 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. Unstable neurological condition Exclusion under this PGD does not necessarily mean contraindicated Action if excluded Document reason for exclusion Advise when patient may receive vaccine. Immunise as soon as valid consent is obtained. Unstable neurological condition defer immunisation and consider referral to paediatrician or paediatric neurologist Advise regarding risks of diphtheria, tetanus, pertussis, polio disease signs and symptoms Provide information about protective effects of vaccine Seek specialist advice if necessary Review by end June 2014 Page 2 of 7

3 2. Clinical condition or situation (continued) Action if patient Document refusal and action taken in patient s record. declines treatment Advise regarding risks of contracting diphtheria, tetanus, pertussis or polio and disease transmission, signs and symptoms. Information about protective effects of vaccine. Special precautions Current acute febrile illness immunisation should be postponed until recovered Either Repevax or Infanrix-IPV can be used for boosting diphtheria, tetanus pertussis and polio in children age 3 years 4 months to under 10 years. Repevax is not recommended for primary immunisation in children under 10 years of age because it contains lowdose diphtheria. Infanrix-IPV is not recommended for primary immunisation in children under 10 years of age because it contains 3-component acellular pertussis vaccine and not the required 5-component. 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 Patients who are immunosuppressed may not be adequately protected against tetanus, despite having been fully immunised. They should be managed as if they were incompletely immunised. References to national/local policies or guidelines NMC (2010) Standards for Medicines Management NMC (2008) Code of Professional Conduct BNF63 March of Product Characteristics Infanrix-IPV (GlaxoSmithKlineUK) 01/2012; Repevax (Sanofi Pasteur MSD) 02/ Immunisation Against Infectious Disease The Green Book relevant updated Chapters to June 2012 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 June 2014 Page 3 of 7

4 3. Description of treatment Name, strength & Infanrix-IPV is adsorbed Diphtheria, Tetanus, acellular formulation of drug Pertussis and inactivated Polio vaccine. Repevax is adsorbed low dose Diphtheria, Tetanus, acellular Pertussis and inactivated Polio vaccine. Both Repevax and Infanrix-IPV are presented as a cloudy white suspension in a prefilled syringe Legal status POM Black Triangle No Dose/Dose range 0.5ml Method/Route The vaccine is a suspension. Shake well before use Intramuscular injection, usually into the deltoid muscle but anterolateral thigh muscle may be used. Individuals with a bleeding disorder may have vaccine by deep subcutaneous injection to reduce risk of bleeding. Frequency of administration Identification & Management of Adverse Reactions Additional Facilities Patient advice Follow up Specific Product Information One dose. Ideally, the dose is given 3 years after completion of the primary course, at age 3 years 4months (or as soon as possible after this age). If the primary course was delayed, and the child is over 3 years 4 months, give the booster dose as soon as 1 year has elapsed from completion of the primary course. Fever, restlessness, irritability, abnormal crying, loss of appetite, drowsiness, local reaction (pain, erythema, induration and oedema) within 4 hrs after vaccination and persisting for 1-2 days. Any adverse events that may be attributable to the vaccine should be documented and reported via yellow card system Immediate access to Adrenaline 1 in 1000 injection Inform of possible side effects and their management. Re-arrange appointment if patient needs to postpone immunisation due to febrile illness or infection. Not applicable Review by end June 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 June 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 June 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 updated chapters). Name Signature Date Review by end June 2014 Page 7 of 7