Patient Group Direction for the Supply or Administration of combined Diphtheria, Tetanus, acellular Pertussis, inactivated Polio vaccine and Haemophilus type b conjugate Vaccine (Infanrix-IPV-HIB) to children aged 3 years 4 months and above as part of their primary vaccination schedule until 3 rd March 2009 attending vaccination clinics in NHS Borders. This document authorises the administration of combined Diphtheria, Tetanus, acellular Pertussis, inactivated Polio vaccine and Haemophilus Type b Conjugate Vaccine (Infanrix-IPV-HIB) by registered nurses to children aged 3 years 4 months and above as part of their primary vaccination schedule until 3 rd March 2009 who meet the criteria for inclusion under the terms of the document. The registered nurse seeking to supply administer combined Diphtheria, Tetanus, acellular Pertussis, inactivated Polio vaccine and Haemophilus type b conjugate vaccine (Infanrix-IPV-HIB) must ensure that all clients have been screened and meet the criteria before supply takes place. The purpose of this Patient Group Direction is to improve access to combined Diphtheria, Tetanus, acellular Pertussis, and inactivated Polio vaccine to ensure adequate population coverage for the vaccine. PGD reviewed by: Dr Tim Patterson, Chris Faldon, John Maloney, Adrian Mackenzie This direction was authorised on 1/11/2007 The direction will be reviewed by 1/11/2009 Clinician Responsible for Training and Review: Dr Tim Patterson
Patient Group Direction for Administration of combined Diphtheria, Tetanus, acellular Pertussis, inactivated Polio vaccine and Haemophilus type b conjugate vaccine (Infanrix-IPV-HIB) without a Prescription for a Named Individual by registered nurses employed by NHS Borders 1.This Patient Group Direction relates to the following specific Vaccine preparation: Name of Vaccine Legal status Storage Dose Route/method Frequency Total dose number Relevant Warnings Combined Diphtheria. Tetanus, acellular Pertussis, inactivated Polio vaccine and Haemophilus type b conjugate vaccine (Infanrix-IPV-HIB). POM (Prescription only Medicine.) The lyophilised powder and the suspension for injection have to be stored at +2 C to +8 C. The suspension should not be frozen. Discard if it has been frozen. Consult pharmacy if above 8 C 0.5ml Intramuscular injection. Combined DTaP/IPV/Hib vaccine can be given at the same time as other vaccines but at a different injection site, preferably different limbs. If given in the same limb, they should be administered at least 2.5cm apart. Vaccination by deep subcutaneous route should be reserved only for individuals with a bleeding disorder where intramuscular route is contraindicated. For the purpose of this PGD one vaccination only. One It is recommended that the pre-school booster is given three years after completion of primary immunisation, that is at three years and four months of age, or soon after. However, when primary immunisation has been delayed, the pre-school booster may be given at the scheduled preschool immunisation visit, as long as this is at least one year since completion of primary immunisation. Reference: CMO letter SEHD/CMO(2007)(7) Page 5
If a child has previously had a severe allergic reaction (which is not anaphylaxis) following immunisation they may be immunised as normal, however, advice should be sought from a GP/Paediatrician as appropriate. If the child has an evolving neurological condition including poorly controlled epilepsy, advice from a Paediatrician should be sought. Infanrix-IPV+Hib immunisation should be delayed until the condition has become stable. Where there is a personal or family history of febrile seizures, there maybe an increased risk of a child experiencing a seizure following immunisation that leads to a fever. In these circumstances advice on the prevention and management of fever should be given before immunisation. There will be very few occasions when deferral is required. The period of deferral should be minimised as it leaves the child unprotected. The circumstances in which deferral may be necessary are detailed below. If a child experienced encephalopathy or encephalitis within 7 days of a previous immunisation, it is unlikely to have been caused by the vaccine, but should still have been investigated. Immunisation should be deferred if no underlying cause was found and the child did not recover completely within 7 days, otherwise immunisation should proceed as recommended. Young children with thrombocytopenia or other bleeding disorder can be given this vaccine, but care should be taken when it is given because of the risk of bleeding. It should be given by deep subcutaneous injection to reduce the risk of bleeding if that is considered appropriate. It is recommended that children with chronic immunodeficiency (such as those with HIV or on longterm immunosuppressive therapy) should be immunised even though they may not mount a full immune response and will only have limited protection. Re-immunisation should be considered when the individual has recovered from the condition or has completed and recovered from the treatment.
Side Effects Local reactions (pain, erythema, induration and oedema) within 48 hours after vaccination and persisting for 1-2 days. Fever Anaphylactic reactions are rare but can be fatal Guillain-Barré Syndrome has been reported as a very rare, late reaction after vaccination with tetanus toxoid containing vaccine. Advice to Parents Follow up Arrangements For full details of side effects, the product literature should always be consulted. Temperature control. Management of local reactions Issue manufacturer s patient information leaflet if available. Observe for signs of anaphylaxis and treat as per current guidelines. Parent/guardian asked to seek medical advice for significant side effects or if concerned. Parent/guardian to inform GP/Nurse of any adverse reactions or if concerned. This is a black triangle medicine. All suspected reactions should be reported directly to CSM Scotland (0131 2422919) through the yellow card scheme and recorded in the patient s medical records. Yellow cards are available at the back of the BNF. GP appointment/duty GP depending on urgency. 2. Clinical condition Clinical Condition to be treated A pre-school booster vaccination, to be used during the Hib Catch-up Programme, against Diphtheria, tetanus, Pertussis, Poliomyelitis and Hib in children aged from 3 years 4 months old to under 6 years of age*. Children in the eligible group for the Hib Catch Up
Programme are those born between 4 th April 2003 and 3 rd September 2005. Note* This recommendation to use Infanrix-IPV+Hib in children over 36 months of age is off-licence, but is in line with the recommendation of JCVI as contained in the CMO letter. Signed consent for immunisation is required in all cases. Criteria for inclusion Children in the eligible group aged from 3 years 4 months old to under 6 years of age where: Parent/guardian consent has been given to receive the vaccine. A booster of Diphtheria, tetanus, Pertussis, poliomyelitis and Hib is indicated. A primary course of three doses of diphtheria, Tetanus, Pertussis, Poliomyelitis and Hib has been given. The primary course should ideally have been completed at least 3 years previously (but see first bullet point in Cautions/further information). Criteria for exclusion Any individual who has had a true anaphylactic reaction to a previous dose of Diphtheria, Tetanus, Pertussis, live/inactivated Poliomyelitis or Hib. A true anaphylactic reaction to, neomycin, polymyxin or polysorbate 80 (which may be present in trace amounts) or to any excipient (additive) of the vaccine. (Consult SPC or manufacturer s package leaflet.). No valid consent. Where there is less than 1 year since the completion of primary immunisation. Child in the eligible group, who has already received a pre-school booster with a vaccine that did not have a Hib component. (i.e. It was either dtap/ipv (Repevax) or DTaP/IPV (Infanrix IPV). Go to PGD for Hib/Men C (Menitorix). If a child is ill with a fever immunisation should be postponed until the child has recovered. Action if excluded Febrile or current viral infection - make another appointment.
A child in the eligible group, who has already received a pre-school booster with a vaccine that did not have a Hib component, should be offered a further vaccination with Hib/Men C. Where there is a personal or family history of febrile seizures there maybe an increased risk of a child experiencing a seizure following immunisation, which leads to a fever. In these circumstances advice should be given by the nurse on the prevention and management of fever before immunisation. Action if declines Interactions with other medicaments and other forms of interaction All others -seek advice from a Registered Medical Practitioner (General Practitioner, Paediatrician or Consultant in Public Health Medicine as appropriate). The risk to the individual of not being immunised must be taken into account. Ensure patient/parent/guardian is aware of risk of disease. Record in medical records. If further advice is required, discuss with a Registered Medical Practitioner (General Practitioner, Paediatrician or Consultant in Public Health Medicine as appropriate). INFANRIX -IPV+Hib should not be mixed with other vaccines or medicinal products in the same syringe. 3. Records- GPASS or GP Patient Record 1. The following records should be kept (either paper or computer based) The GP practice, clinic, hospital, and ward or department.
The patient name and CHI number. The medicine name, dose, route, time of dose(s), and where appropriate, start date, number of doses and or period of time, for which the medicine is to be supplied or administered. Drug batch number and expiry. The signature and printed name of the approved healthcare professional who supplied or administered the medicine. The patient group direction title and/or number. Whether patient met the inclusion criteria and whether the exclusion criteria were assessed. Quantity supplied / received and current stock balance (Appendix 4). 2. Preparation, audit trail, data collection and reconciliation- Stock balances should be reconcilable with Receipts, Administration, Records and Disposals on a patient by patient basis. 3. Storage- The lyophilised powder and the suspension for injection have to be stored at +2 C to +8 C. The suspension should not be frozen. Discard if it has been frozen. 4. Anaphylaxis Emergency Treatment (if appropriate for individual vaccination PGDs) When giving any vaccination the following should be available: Access to the patients notes. Epinephrine (Adrenaline) 1 in 1000 for i.m. use in emergency (NB: check expiry dates regularly). Syringes and needles of suitable size and capacity for dose. Epinephrine (Adrenaline) 1 in1000 For intramuscular injection (1mg/ml) Age Volume of epinephrine (adrenaline) 1 in 1000 (1mg/ml) Under 6 months 0.05ml 6months to 6 years 0.12ml 6 12 years 0.25ml Adults and adolescents 0.5ml These doses may be repeated if necessary at 5 minute intervals according to blood pressure, pulse and respiratory function. Special cautions: see BNF 3.4.3 Epinephrine/ Adrenaline BNF (54 th edition) section 3.4.3 page 168 and 169
5. Professional Responsibility All Health Professionals will ensure he/she has the relevant training and is competent in all aspects of medication, including contraindications and the recognition and treatment of adverse effects. He/she will attend training updates as appropriate. For those involved in immunisation, regular anaphylaxis updates are mandatory. Nurses will have due regard for the NMC code of Professional Conduct: standards for conduct, performance and ethics (0704) and NMC Guidelines for administration of medicines (0104) Sources of Evidence used for the PGD. Immunisation against Infectious Disease The Green Book See the latest Chapters (Currently December 2006) available at www.dh.gov.uk. CMO letter SEHD/CMO(2007)(7) Haemophilus Influenzae Type B (HIB) vaccine for young children catch-up programme. Draft Example PGD for Infanrix-IPV+Hib from the NHS Immunisation website available at www.immunisation.nhs.uk. British National Formulary (BNF) current edition (54 th ).