Patient Group Direction For the supply and administration of Adsorbed low dose DIPHTHERIA/TETANUS/acellular PERTUSSIS/ inactivated POLIO REPEVAX Vaccine (dtap/ipv) By Registered Nurse/Midwife/Health Visitor To Pregnant females from 28 weeks gestation and new mothers Valid from 1 st October 2012 Review Date End Sept 2014 Supersedes New PGD 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. Page 1 of 9
2. Clinical condition or situation Indication Vaccination of pregnant women and new mothers against pertussis to protect their infants Active immunisation against pertussis Criteria for inclusion *Varies from SPC covered within PGD by JCVI (DH) Criteria for exclusion Pregnant women from 28 weeks gestation* New mothers who have previously never been vaccinated against pertussis up to when their child receives their first vaccination (due at 8 weeks of age) A confirmed anaphylactic reaction to a previous dose of vaccine containing the same antigens A confirmed anaphylactic reaction to any component of the vaccine or to any substances carried over from manufacture (formaldehyde, glutaraldehyde, neomycin, streptomycin, polymyxin B or bovine serum albumin); (for previous severe hypersensitivity reactions see special precautions) An encephalopathy (brain disorder) of unknown origin within seven days of previous immunisation with pertussis-containing vaccine. No Valid Consent. * 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. Advise regarding risks of pertussis to the newborn Advise re risks of contracting Pertussis; diphtheria, tetanus; polio disease signs and symptoms Provide information about protective effects of vaccine Seek specialist advice if necessary Action if patient declines treatment Document refusal and action taken in patient s record. Advise potential risk to the newborn young infant contracting pertussis disease and signs and symptoms. Information about protective effects of vaccine. Page 2 of 9
2. Clinical condition or situation continued Special precautions/additional information Infanrix-IPV is NOT recommended for pregnant women or new mothers as it contains high dose diphtheria. Current acute febrile illness immunisation should be postponed until recovered Immunisation with a single dose of Repevax vaccine (dtap/ipv) should be offered to pregnant women, ideally at a routine antenatal visit, in the period weeks 28 to 38 (inclusive) of pregnancy; the optimal time is in the period weeks 28 to 32 (inclusive). Immunisation during weeks 28 to 38 of pregnancy is likely to maximise levels of anti-pertussis antibodies in the mother in time for optimal trans-placental transfer from the pregnant woman to foetus Pregnant women who are now beyond week 38 of pregnancy should be offered immunisation up to the onset of labour so that some direct protection may still be provided to the infant. In addition, vaccination of pregnant women, even after 38 weeks, will reduce the risk of the mother contracting pertussis in the postpartum period and therefore prevent her from infecting her infant. Women who become pregnant again while the programme is in place should be offered immunisation during each pregnancy to maximise trans-placental transfer of antibody Pregnant women who have received immunisation against pertussis, tetanus, diphtheria and/or polio relatively recently should also be offered immunisation, but with a gap of at least one month between immunisations. For new mothers effort should be made to clarify whether pertussis vaccination has ever been given (GP records/child health). If confirmed to be previously immunised further pertussis containing vaccination is not necessary. However if uncertain, individuals should be assumed unimmunised and a dose of Repevax given Although cumulative doses may increase the likelihood of injection site reactions or fever, this is outweighed by the expected benefit to the infant. A single 0.5ml dose of Repevax should be given irrespective of the number of foetuses in the pregnancy Page 3 of 9
2. Clinical condition or situation continued Special precautions/additional information There is no evidence of risk to pregnancy at any stage or to the infant with inactivated viral or bacterial vaccines or toxoids such as those against diphtheria, tetanus, polio and pertussis in Repevax. Use of Repevax in pregnancy is not contraindicated and breast-feeding should continue if that is the mother s wish. Repevax can be administered at the same time as influenza vaccine. Preferably using a different limb, or if the same limb - separate injection sites with a gap of 2.5 cm). NB Influenza vaccine should NOT be delayed until 28 weeks of pregnancy. Repevax can also be administered at the same time as anti D treatment, however a separate limb is advised due to the volume of the anti D. References to national/local policies or guidelines DH 27 th September 2012 Temporary Programme of Pertussis (whooping Cough) Vaccination of Pregnant Women Gateway reference: 18174 NMC (2010) Standards for Medicines Management NMC (2008) Code of Professional Conduct BNF63 March 2012 www.medicines.org.uksummary of Product Characteristics Repevax (Sanofi Pasteur MSD) 09/2012. http://www.dh.gov.uk/ - Immunisation Against Infectious Disease The Green Book relevant updated Chapters to September 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. Page 4 of 9
3. Description of treatment Name, strength & formulation of drug Adsorbed low dose Diphtheria, Tetanus, acellular Pertussis and inactivated Polio vaccine. Presented as a cloudy white suspension in a prefilled syringe Legal status Black Triangle Dose/Dose range Method/Route Frequency of administration Identification & Management of Adverse Reactions Additional Facilities Patient advice POM No 0.5ml 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. One dose Women who become pregnant again while the programme is in place should be offered immunisation during each pregnancy Fever, headache, nausea, diarrhoea and vomiting, Arthralgia, myalgia, fatigue, loss of appetite, 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 www.yellowcard.gov.uk Immediate access to Adrenaline 1 in 1000 injection Inform prior to the immunisation that the vaccine will also boost immunity to tetanus, diphtheria and polio Advise that if the woman has previously completed a full course of diphtheria and tetanus containing vaccines that there may be an increased likelihood of injection site reactions or fever but this risk is outweighed by the expected benefit to the infant Offer reassurances: There is no evidence of risk to pregnancy or the infant with inactivated viral or bacterial vaccines or toxoids such as those against diphtheria, tetanus, polio and pertussis in Repevax. Use of Repevax in pregnancy is not contraindicated and breast-feeding should continue if that is the mother s wish Inform of possible side effects and their management Page 5 of 9
3. Description of treatment continued Follow up Specific Product Information Records Re-arrange appointment if patient needs to postpone immunisation due to febrile illness or infection. Not applicable Record fully in Trust clinical record / GP records forward immunisation records to the Child Health Information System (CHIS) / Department as age appropriate. 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 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 Page 6 of 9
4. PGD Development Developed and Produced by Cheshire and Merseyside Childhood Immunisation PGD subgroup: PCT Represented Organisation Professional group Current group member Central & Eastern Cheshire PCT Halton & St Helens Knowsley Knowsley Liverpool Central & Eastern Cheshire PCT NHS Halton & St Helens 5 Boroughs Partnership 5 Boroughs Partnership Liverpool Community Health Primary Care Immunisation Facilitator Immunisation Co-ordinator Immunisation Co-ordinator Pharmacist V&I training Lead Sefton Sefton PCT Pharmaceutical Adviser in Public Health Cath Lilley Michelle Falconer Pauline Jones Carol Humphries Pauline Morris Helen Stubbs Warrington Warrington PCT Public Health Consultant Marioth Manche Warrington Western Cheshire Bridgewater Community Healthcare NHS Community Care Western Cheshire Immunisation Co-ordinator Lead Pharmacist Wirral NHS Wirral Immunisation Co-ordinator Wirral & Cheshire & Merseyside HPU Cheshire & Merseyside HPU Health Protection Agency Health Protection Agency CCDC & Unit Director Senior Health Protection Nurse Tracie Duffy John Hickey Claire Elliot Dr S Ghebrehewet Gill Marsh (chair) Page 7 of 9
5. PGD Authorisations PGD authorised for use across Cheshire & Merseyside on behalf of Cheshire and Merseyside Childhood Immunisation Strategic Advisory Group (CISAG) by: Lead Pharmacist: Name: Helen Stubbs Position: Pharmaceutical Adviser in Public Health Employer: Sefton PCT Signature: Date: Lead Medical Doctor: Name: Dr Sam Ghebrehewet Position: Unit Director Cheshire & Merseyside Health Protection Unit Employer: Health Protection Agency Signature: Date: 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 Name: Position: Signature: Date: Page 8 of 9
Individual Authorisation 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 Page 9 of 9