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Patient Group Direction (PGD) for the Administration of:

DIPHTHERIA, TETANUS, PERTUSSIS (ACELLULAR) AND INACTIVATED POLIO VACCINE DTaP/IPV (INFANRIX - IPV)

POM Prescription Only Medicine

This vaccine contains 3 component Acellular Pertussis Vaccine YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT CLINICAL CONDITION OR SITUATION TO WHICH THE DIRECTION APPLIES: As part of the national immunisation schedule for active immunisation Indication against Diphtheria, Tetanus, Pertussis and Poliomyelitis in children from the age of 3 years 4 months to 10th birthday, as a booster dose following primary immunisation. Infanrix-IPV is NOT intended for primary immunisation.

Inclusion Criteria

Exclusion Criteria

For advice regarding children who have not received 3 doses of a Pertussis containing vaccine with their primary immunisations see special consideration section. Informed consent has been given, in accordance with current PCT guidelines, for the administration of the vaccine Children from 3 years 4 months to 10th birthday, who have completed their primary course of 3 doses of diphtheria, tetanus, pertussis and polio vaccines at least 1 year earlier. For advice regarding children who have not received 3 doses of a Pertussis containing vaccine with their primary immunisations see special consideration section. Informed consent has NOT been given for the administration of the vaccine Aged under 3 years 4 months or 10 years or older Current acute febrile illness The patient completed their primary course of immunisations to the vaccine components less than 12 months ago. Any individual who has had a confirmed anaphylactic reaction to: (i) A previous dose of a vaccine containing diphtheria, tetanus, pertussis or inactivated polio. (ii) Any constituent of the vaccine (refer to product leaflet). (iii) Neomycin, Polymyxin B, or Streptomycin (which may be present in trace amounts) DTaP/IPV– Infanrix IPV is not provided for the purpose of primary immunisation. The 3 component acellular pertussis does not provide the same level of protection against whooping cough in primary immunisation as a 5 component preparation. See special considerations section. Neurological Conditions Detailed guidance on the use of pertussis containing vaccines in

PGD No 3 v5 Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis (inactivated) Vaccine DTaP/IPV Approval Date:31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 1


patients with neurological conditions, discussed as a precaution rather than a contraindication, is given on pages 286 to 289 of ‘Immunisation against Infectious Disease’ (the Green Book). Pre-Existing Neurological Conditions o Where there is an unstable, evolving or deteriorating neurological abnormality, including poorly controlled epilepsy, immunisation should be deferred and patient should be referred to a paediatrician. See Green Book chapter 24 for details. o

Neurological Abnormalities Following Immunisation If a child experienced encephalopathy or encephalitis within 7 days of immunisation, OR a seizure associated with a fever within 72 hours of immunisation, further immunization should be deferred and the child referred to a paediatrician.* *NB – For children with a history of seizure associated with fever within 72 hours of immunization, if a cause is identified, or the child recovers within 24 hours, immunization should continue as recommended.

Please also see Cautions/Need for further advice section

Cautions/Need for Further Advice

Hypersensitivity to: (i) A previous dose of a vaccine containing diphtheria, tetanus, pertussis, or inactivated polio, (ii) Any constituent of the vaccine (refer to product leaflet). (iii) Neomycin, Polymyxin B, Streptomycin, (which may be present in trace amounts). Refer to a prescriber for further advice. Pre-existing neurological conditions. For stable pre-existing neurological abnormalities, such as spina bifada, congenital abnormality of the brain or perinatal hypoxic ischaemic encephalopathy, the Green Book (chapter 24) advises that immunisation can continue. Where there is personal or family history of febrile seizures, there is an increased risk of these occurring after any fever, including that caused by immunisation. These children should be referred to a prescriber. Refer to Green Book chapter 24. Previous severe reaction to vaccination. The Green Book (chapter 24) states that immunisation with pertussis-containing vaccine should continue following a history of: o Fever, irrespective of its severity; o Hypotonic-hyporesponsive episodes (HHE); o Persistent crying or screaming for more than three hours; o Severe local reaction, irrespective of extent.

PGD No 3 v5 Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis (inactivated) Vaccine DTaP/IPV Approval Date:31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 2


within 72 hours of a preceding vaccine. Whilst these are not contraindications, individuals working under this PGD must seek further clinical advice from an appropriate prescriber before the vaccine is administered if there is a history of a previous severe reaction. Thrombocytopenia, Haemophilia or any other problem that may stop blood from clotting properly, or patient taking anti coagulants The immunogenicity of the vaccine could be reduced in immunosuppressed patients. Consult with the individual’s clinician to find out whether vaccination should be postponed until immune function has recovered. For individuals with chronic immunodeficiency, such as HIV, vaccination is recommended even if the antibody response might be limited. Some ointments and creams which are prescribed to treat eczema can affect the immune response. DTaP/IPV vaccine should not be given during treatment with, and for 14 days after stopping treatment with, either Tacrolimus (Protopic) ointment, or Pimecrolimus (Elidel) cream, or similar preparations which may affect the immune response. Allergy to latex – Vial stoppers and syringe plunger stoppers are often made of this type of rubber and there is a risk of an allergic reaction to the vaccine because of this. However, for latex allergies other than anaphylactic allergies (e.g. a history of contact allergy to latex gloves), vaccines supplied in vials or syringes that contain latex can be administered. Refer to Green Book chapter 6. If an individual has a history of severe (i.e. anaphylactic) allergy to latex, vaccines supplied in vials or syringes that contain latex should not be administered. For these individuals contact the manufacturer to confirm whether the vaccine to be administered contains latex.

Action if Patient Declines or is Excluded

Refer to supervising doctor if appropriate. Document findings and action taken in patient’s record. Give information about risks of disease Give information about how to recognise signs and symptoms. of the diseases. Give information about when the vaccine may be given.

PGD No 3 v5 Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis (inactivated) Vaccine DTaP/IPV Approval Date:31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 3


DESCRIPTION OF TREATMENT: Name, Form & Strength of Medicine

Infanrix IPV Diphtheria, Tetanus, acellular Pertussis and Poliomyelitis (inactivated) vaccine – DTaP/IPV. Injection, presented in a pre-filled syringe. This vaccine contains 3 component Acellular Pertussis Infanrix IPV is thiomersal free.

Route/Method

VACCINES MUST NOT BE GIVEN INTRAVENOUSLY

To be given by intramuscular injection into the deltoid muscle. For individuals with a bleeding disorder, however, vaccines should be given by deep subcutaneous injection to reduce the risk of bleeding. Upon storage, a white deposit may be present. Shake the pre-filled syringe well to re-suspend the deposit. This should give a homogeneous cloudy white suspension. If any particulate matter is present the syringe and contents should be discarded. DTaP/IPV (Infanrix –IPV) vaccine may be given at the same time as other vaccines including MMR, Men-C and Hep B. Vaccines should be given at a separate site, preferably a separate limb. If given in the same limb, they should be given at least 2.5 cm apart. The site at which each vaccine was given should be noted in the individual’s record.

Dosage Frequency

Duration of Treatment Maximum or Minimum Treatment Period Quantity to Supply/Administer Side Effects

0.5 ml Single dose as a booster – usually given between the ages of 3 years 4 months and 3 years 6 months. Ideally should be at least 3 years after completion of primary course, but may be given a minimum of one year after completion of primary immunisations if these have been delayed. Refer to special considerations section for advice regarding children who have not received 3 doses of a Pertussis containing vaccine as primary immunisations. See Frequency See Frequency See Frequency and dosage Reactions are usually mild and confined to first few days after immunisation. Common side effects include: Local reactions (pain, redness and swelling at the injection site), fever,

PGD No 3 v5 Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis (inactivated) Vaccine DTaP/IPV Approval Date:31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 4


malaise, headache, somnolence, irritability, loss of appetite, restlessness, unusual crying, nausea, vomiting, diarrhoea, asthenia. This list is not exhaustive. Please refer to current BNF and product SPC/leaflet for complete list. The pre school booster dose of DTaP vaccine may be more reactogenic in children who have been previously primed with acellular pertussis-containing vaccines. Extensive swelling of the limb where the injection has been given has been reported. In general, these reactions began within 48 hours of vaccination and spontaneously resolved over an average of 4 days without sequelae Guillain-BarrĂŠ-Syndrome has been reported after vaccination with tetanus-toxoid containing vaccines. Anaphylactic reactions to vaccines are extremely rare but have the potential to be fatal. Onset is rapid, usually within minutes but can occur within hours of vaccine administration. It is not possible to define a particular time period in which an individual should be observed following immunisation. See Green Book Chapter 8 (latest edition). Report all serious suspected adverse reactions (ADRs) in adults and all serious and minor reactions in children (under 18 years), to the Medicines and Healthcare products Regulatory Agency (MHRA) using a yellow card (located at the back of the BNF) or on- line via www.yellowcard.gov.uk. Report serious suspected reactions even if they are listed above, in the BNF, or in the product SPC. Serious reactions are those that are fatal, life threatening, disabling, incapacitating or which result in or prolong hospitalisation and/or are medically significant. Yellow cards may be completed by a nurse, pharmacist, the patient or a doctor, but it is the responsibility of the health professional identifying the ADR to report it. Yellow cards and guidance on their use are also available at the back of the BNF.

PGD No 3 v5 Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis (inactivated) Vaccine DTaP/IPV Approval Date:31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 5


Additional Facilities

Special Considerations / Additional information

Immediate access to Adrenaline/Epinephrine for treatment of Anaphylaxis Access to a telephone. Vaccines must be stored and transported according to manufacturers’ guidelines and PCT Cold Chain policy Vaccine and solvent should be stored in the original packaging at a temperature of 2 to 8º C. If the vaccine has been frozen, it should be discarded. DTaP/IPV is compatible with previously administered DTwP and oral polio vaccines. Healthcare professionals are reminded that in some circumstances the recommendations regarding vaccines given in the Green Book chapters may differ from those in the Summary 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. Green Book recommendations are reflected in this PGD which in some instances could result in an unlicensed use of a licensed product. Children who have not received 3 doses of a Pertussis containing vaccine with their primary immunisation:If the child has completed a primary course (as 3 doses of diphtheria, tetanus and polio vaccines) but has not received 3 doses of a pertussis containing vaccine, they should be offered either a dose of Infanrix IPV or Pediacel vaccine to provide some priming against pertussis. They should then receive the first reinforcing dose as scheduled, also as Infanrix IPV or Pediacel, preferably leaving an interval of one year. Refer to chapter 24 of the green book, (updated 25th October 10),for further information.

Advice to Patient/Carer/ Parent/Guardian

Follow Up

Explain procedure and further action if required Give a copy of the manufacturer’s patient information leaflet and discuss as required Advice on the management of fever and other common/uncommon post-vaccination adverse effects. Management of local/general reactions. Anaphylaxis is rare but a delayed reaction can occur. Advise to seek urgent medical attention if the patient develops breathlessness, swelling or rash Advise that a further booster of Diphtheria Tetanus and Polio vaccine will be needed approximately 10 years later (school leaver booster).

PGD No 3 v5 Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis (inactivated) Vaccine DTaP/IPV Approval Date:31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 6


REFERRAL ARRANGEMENTS AND AUDIT TRAIL Referral Arrangements

If patient is excluded from this PGD refer to GP or other appropriate clinician. Any health professional administering a vaccination must be able to identify and contact an appropriate clinician, e.g. GP, or the NHS Kirklees Immunisation Coordinator, as necessary, e.g. in the case of a child with an allergy to components of the vaccine.

Records/Audit Trail

Self referral to GP practice or A&E department if appropriate (post immunisation The following information must be documented in records which should be stored appropriately and can be easily retrieved where necessary Patient’s name, address, date of birth and consent given. If consent is either refused or withdrawn, this decision should also be documented. Contact details of GP if applicable Dose administered and route. Site of injection. Batch details, expiry date, manufacturer, supplier and brand name Advice given to patient (including side effects) Date administered Signature and name of staff who administered the vaccine. For paperless practices the electronic record should identify the name of the nurse administering the vaccine and should ideally have an electronic signature. Scanned paper records are acceptable Details of any subsequent adverse drug reaction and actions taken including referral arrangements. (This MUST be documented in the patient’s medical record) For all vaccines administered to children or young people up to age 16 or still in full time education. The following records must also be completed. Computerised records and data collection held by Child Health Information Services (CHIS) The Personal Health Child Record (PHCR –red book) (manual records) should be completed if available, failure to present this is not a reason to refuse to administer vaccination. If the red book is not available vaccination may proceed as long as there is clear information in respect of which vaccinations the child is due to receive. Every effort should be made to complete the red book at the earliest opportunity and the importance of providing it at subsequent vaccination appointments should be communicated to the parent/guardian. If applicable to the vaccine given Travel destination Liaison with HPA

PGD No 3 v5 Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis (inactivated) Vaccine DTaP/IPV Approval Date:31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 7


STAFF CHARACTERISTICS Qualifications Specialist Training or Qualifications

Continuing Training & Education

Registered nurse with current registration working in Kirklees PCT Has undertaken appropriate training and is competent to undertake the clinical assessment of patients according to the indications listed in this PGD. Has undertaken appropriate training and is competent for working under PGDs for the supply and administration of medicines Has undertaken training appropriate to this PGD – e.g. annual updates in Immunisation and Vaccination. Has undertaken training and is competent in all aspects of immunisation including contraindications and the recognition and treatment of anaphylaxis Has undertaken training and is competent in resuscitation skills. The practitioner should be aware of any change to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-date with continued professional development and to work within the limitations of their scope of practice. Attends compulsory annual updates in Immunisation and Vaccination Undertakes mandatory annual updates on Anaphylaxis and Resuscitation. Practitioner should have access to product leaflet, current BNF and green book chapters, and to updated DH advice where appropriate.

References/Resources SPC from Electronic Medicines Compendium http://www.medicines.org.uk/ and Comments BNF chapter 14 http://www.bnf.org/bnf/ DH Immunisation Against Infectious Disease (The Green Book) chapters 15,24,26,30. These can be accessed at: http://www.dh.gov.uk/PolicyAndGuidance/HealthAndSocialCareTopics/Gree nBook/fs/en (Chapter 24 updated 25th October 2010, chapters 15 & 26 updated November 2009 and chapter 30 updated August 2009)

Advice contained in the individual Summary of Product Characteristics (SPC) may have been overridden in accordance with guidance issued by the relevant Dept of Health Green Book Chapter. This will result in an unlicensed use of a licensed product following current DH guidance.

PGD No 3 v5 Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis (inactivated) Vaccine DTaP/IPV Approval Date:31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 8


This PGD is an amended version of the Kirklees PCT PGD No 3 v4, ‘Diphtheria, Tetanus, Pertussis (acellular) and Inactivated Polio Vaccine’. It was updated for use in Kirklees Primary Care Trust by the individuals listed below: Name Dr Ebere Okereke Julie Bulmer Jane O’Donnell Lucianne Ricketts Deborah Mitchell Karen Gillings Sally Wright Lisa Meeks

Position

Date

Consultant in Communicable Disease Control (West Yorkshire Health Protection Agency) School Nurse Team Leader

9th November 2010

Deputy Director Infection Control

9th November 2010

Senior Medicines Management Adviser - Strategy and Operational Development. GP Practice Nurse

9th November 2010

GP Practice Nurse

9th November 2010

Immunisation Nurse Team Leader

9th November 2010

Specialist Technician – Community and Support Services

9th November 2010

9th November 2010

9th November 2010

Refer to Revision Proforma (over-leaf) for list of amendments made to original document. Reason(s) for amendment Date of amendment List of persons/groups involved in amending PGD

Operational issues highlighted with regards to pre-existing stable neurological conditions. Risk assessed and wording reviewed. April 2011 Lisa Meeks – Specialist Technician, Community & Support Services

(including job title) List of persons involved in

PGD Review Group members

consultation process (including job title)

PGD No 3 v5 Diphtheria, Tetanus, acellular Pertussis and Poliomyelitis (inactivated) Vaccine DTaP/IPV Approval Date:31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 9


REVISION PROFORMA The following amendments have been made to PATIENT GROUP DIRECTION: No 3 version 4 SECTION Exclusion Criteria

CHANGES MADE Following bullet removed: o

Cautions/Need for Further Advice

For stable pre-existing neurological abnormalities, such as spina bifada, congenital abnormality of the brain or perinatal hypoxic ischaemic encephalopathy, the Green Book (chapter 24) advises that immunisation can continue. However these patients are not covered under this PGD – refer to a prescriber.

Following bullet added: Pre-existing neurological conditions. For stable pre-existing neurological abnormalities, such as spina bifada, congenital abnormality of the brain or perinatal hypoxic ischaemic encephalopathy, the Green Book (chapter 24) advises that immunisation can continue.

PGD No 3 v5 Diphtheria, Tetanus, acellular Pertussis and Poliomyelitis (inactivated) Vaccine DTaP/IPV Approval Date:31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 10


Individual Authorisation for the Administration of Diphtheria, Tetanus, Acellular Pertussis and Poliomyelitis (inactivated) Vaccine (DTaP/IPV – Infanrix-IPV) by Nurses Employed either by the PCT/KCHS or GP Practices within Kirklees PCT. THE PCT DOES NOT ACCEPT LIABILITY IN RESPECT OF GP EMPLOYED STAFF. 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 Professional Conduct. I have read and understood the Patient Group Direction and agree to administer this medicine only in accordance with this PGD. In signing this declaration the nurse is willing to be professionally accountable for this work as defined in the NMC Code of Professional Conduct 2008. Name of Professional Signature Authorising Manager and Date signature

Staff who are no longer required to administer under this PGD should be removed from it. This can be done by crossing through the relevant name, adding date and initials. Authorising Managers For Practice Staff this will be the GP. For PCT staff this will be the team leader, or relevant clinical manager (see PGD policy) Note to Authorising Managers: Authorised staff working at a fixed base should have access to the signed PGD held at the base. Authorised staff who may give vaccinations away from the base should have an individual copy of the relevant signed PGD with them when administering the vaccine. PGD No 3 v5 Diphtheria, Tetanus, acellular Pertussis and Poliomyelitis (inactivated) Vaccine DTaP/IPV Approval Date:31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 11


AUTHORISATION This patient group direction must be agreed to and signed by all health care professionals involved in its use. The NHS Trust should hold the original signed copy. The PGD must be easily accessible in the clinical setting

Kirklees Primary Care Trust ORGANISATION: Director of Patient Care Name : Sheila Dilks & Professions

Signature:

Date:

Assistant Director of Name: Neill McDonald Medicines Management and Prescribing

Signature:

Medical Director

Name: Dr Judith Hooper

Signature:

CEC Chair

Date:

Date:

Name: Dr David Anderson

Signature:

Date:

PGD No 3 v5 Diphtheria, Tetanus, acellular Pertussis and Poliomyelitis (inactivated) Vaccine DTaP/IPV Approval Date:31/5/11 Review By: 31/12/13 (or earlier in the light of new evidence) Page 12


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