Unit Operational Managers

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2 Title: Patient Group Direction for the administration of DTaP/IPV/Hib (Pediacel ) by nurses working within NHS Grampian Identifier: Replaces: Across NHS Boards NHSG/PGD/pediacel/MGPG536 NHSG/PGD/pediacel/MGPG370 Organisation Directorate Clinical Service Sub Wide Department Area Yes This controlled document shall not be copied in part or whole without the express permission of the author or the author s representative. Author: Subject Key word(s): Policy application: Purpose: PGD pharmacist, Pharmacy and Medicines Directorate Patient Group Direction PGD patient group direction diphtheria tetanus acellular pertussis inactivated poliomyelitis haemophilus influenzae type b vaccine childhood immunisation pediacel nurse NHS Grampian This Patient Group Direction (PGD) authorises appropriately qualified and trained nurses to administer DTaP/IPV/Hib vaccine to individuals without the requirement for a patient specific prescription written by a medical practitioner. Responsibilities for implementation: Organisational: Corporate: Departmental: Area: Hospital/Interface services: Operational Management Unit: Policy statement: Review: Chief Executive and Management Teams Senior Managers Heads of Service/Clinical Leads Line Managers Assistant General Managers and Group Clinical Directors Unit Operational Managers It is the responsibility of individual nurses and their line managers to ensure that they work within the terms laid down in this PGD and to ensure that staff are working to the most up to date PGD. By doing so, the quality of the services offered will be maintained, and the chances of staff making erroneous decisions which may affect patient, staff or visitor safety and comfort will be reduced. Supervisory staff at all levels must ensure that staff using this PGD act within their own level of competence. This policy will be reviewed at least every two years or sooner if current treatment recommendations change. UNCONTROLLED WHEN PRINTED Review Date: November 2014 Identifier: NHSG/PGD/pediacel/MGPG536 - i -

3 This document is also available in large print and other formats and languages, upon request. Please call NHS Grampian Corporate Communications on (01224) or (01224) Responsible for review of this document: Responsible for ensuring registration of this document on the NHS Grampian Information/Document Silo: Physical location of the original of this document: Job/group title of those who have control over this document: Responsible for disseminating document as per distribution list: PGD pharmacist, Pharmacy and Medicines Directorate Pharmacy and Medicines Directorate Pharmacy and Medicines Directorate Pharmacy and Medicines Directorate PGD pharmacist, Pharmacy and Medicines Directorate Revision History: Date of Approval change date of PGD being Summary of Changes Section heading superseded Sept 2012 Oct yearly update into new template Sept 2012 Oct 2010 Addition of weeks to define months Various Sept 2012 Oct 2010 Addition of licensed from 6 weeks 1 Sept 2012 Oct 2010 Removal of intradermal route as CI Addition of encephalopathy of unknown aetiology Sept 2012 Oct 2010 Updated in line with Green Book, Chapter 24, Pertussis. Added advice to closely monitor those with a family history of seizures. Sept 2012 Oct 2010 Updated in line with new product and SPC update. Addition of advice on disposal of vaccine. Sept 2012 Oct 2010 Addition of varicella 3.3 Sept 2012 Oct 2010 Vomiting and appetite loss moved from 3.4 common to very common Nov 2012 Oct 2010 Additional CI, progressive neurologic disorder 2.3 (iii) Nov 2012 October Simplification and addition of need to refer to Green Book Nov 2012 Oct 2010 Advice to use separate needles removed UNCONTROLLED WHEN PRINTED Review Date: November 2014 Identifier: NHSG/PGD/pediacel/MGPG536 - ii -

4 Patient Group Direction for the administration of DTaP/IPV/Hib (Pediacel ) by nurses working within NHS Grampian Contents Part A Specific Drug Information Page No 1 Introduction 2 2 Clinical Decision Making Patients who may be considered for the administration of DTaP/IPV/Hib Patients who may receive the administration of DTaP/IPV/Hib Contraindications Precautions Action to be taken when a patient is excluded from treatment under this 4 PGD 2.6 Action to be taken when a patient does not wish to receive treatment 4 under this PGD 3 Description Of Treatment Available Under This PGD DTaP/IPV/Hib Dose, route and frequency Concurrent medication Adverse effects Advice to patient Follow up treatment 5 Part B PGD General Information 4 Designated Staff Authorised To Administer Under This PGD 6 5 Documentation Authorisation of administration Record of administration Consent 7 6 Further Points 8 7 Facilities And Supplies To Be Available At Sites For The Administration 8 Of The Drug Specified In The PGD 8 Audit 8 Part C PGD Specific Information 9 Management And Monitoring Of Patient Group Direction Consultative group Professional advisory group approving PGD Authorising managers 9 10 References 9 Appendix 1 - Health Care Professional Agreement To Administer 10 Medicines Under Patient Group Direction Appendix 2 - Certificate Of Competence To Administer Medicines Under Patient Group Direction 11 UNCONTROLLED WHEN PRINTED Review Date: November 2014 Identifier: NHSG/PGD/pediacel/MGPG

5 Patient Group Direction For The Administration Of DTaP/IPV/Hib (Pediacel ) By Nurses Working Within NHS Grampian 1. Introduction Part A This patient group direction (PGD) will allow nurses to be authorised to administer DTaP/IPV/Hib vaccine to individuals for primary immunisation. Please note that the vaccine is licensed for use in children older than 6 weeks of age. This PGD should be used in conjunction with the recommendations in the current British National Formulary, The Green Book and individual Summary of Product Characteristics. 2. Clinical Decision Making 2.1. Patients who may be considered for the administration of DTaP/IPV/Hib Vaccination is recommended in children aged 2 months (8 weeks) to 4 months (16 weeks) as part of the primary immunisation schedule but can be given at any stage from two months (8 weeks) to ten years of age Patients who may receive the administration of DTaP/IPV/Hib All patients in 2.1 above, where their parent, guardian or person with parental responsibility does not want specifically to consult with a doctor and are happy for the administration to be given by the nurse Contraindications DTaP/IPV/Hib vaccine should never be administered intravascularly. Patients may be administered DTaP/IPV/Hib under this PGD unless: (i) They have had a confirmed anaphylactic reaction to a previous dose of DTaP/IPV/Hib - a doctor should be consulted. (ii) They have experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with Pediacel. Refer to a GP. (iii) They have a progressive neurologic disorder, including infantile spasms, uncontrolled epilepsy, progressive encephalopathy. Pertussis vaccine should not be administered to children with such conditions until a treatment regimen has been established and the condition has stabilised. UNCONTROLLED WHEN PRINTED Review Date: November 2014 Identifier: NHSG/PGD/pediacel/MGPG

6 (iv) They have known anaphylactic hypersensitivity to any of the excipients, neomycin, streptomycin, polymyxin B, glutaraldehyde, formaldehyde and bovine serum albumin. (v) They have a history of severe (i.e. anaphylactic) allergy to latex. Vaccination should be deferred until it can be ascertained that the vaccine to be used is latexfree. Check against SPC or with Pharmacy Medicines Information at ARI (tel: ). For latex allergies other than anaphylactic allergies (e.g. contact allergy to latex) vaccination may proceed as normal Precautions There will be very few occasions when deferral of immunisation is required. Deferral leaves the child unprotected; the period of deferral should be minimised so that immunisation can commence as soon as possible. If a specialist recommends deferral this should be clearly communicated to the General Practitioner who must be informed as soon as the child is fit for immunisation. (i) If the patient is suffering from any acute infectious illness the administration may need to be postponed. If the patient is unwell, pyrexial, off food, has diarrhoea or vomiting, or is lethargic, administration should be deferred until the patient has recovered. (ii) If the patient has had a significant local or general allergic reaction to a previous administration of DTaP/IPV/Hib - a doctor should be consulted. (iii) The presence of a neurological condition is not a contraindication to immunisation. Where there is evidence of a neurological condition in a child the advice given in the Green Book (Immunisation Against Infectious Disease DOH, SEHD ) should be followed. (iv) Individuals with immunosuppression or HIV infection (regardless of CD4 count) should be vaccinated in accordance with the routine Immunisation Schedule. These individuals may not have a full antibody response. Re-immunisation should be considered after treatment is finished and recovery has occurred. Specialist advice may be required. Refer to Immunisation Co-ordinator. (v) As with all vaccines, injections of adrenaline 1:1000 should be available as treatment for an anaphylactic reaction should this occur (refer to: NHS Grampian Patient Group Direction for the administration of adrenaline (epinephrine) in cases of suspected anaphylactic reactions by qualified health professionals). (vi) The vaccine should be administered with caution in patients with thrombocytopenia or a bleeding disorder since bleeding may occur following IM injection. DTaP/IPV/Hib vaccine can be administered by deep subcutaneous injection to reduce the risk of bleeding although there is an increased risk of local reactions (Green Book recommendation). (vii) Systemic and local reactions following a previous immunisation. UNCONTROLLED WHEN PRINTED Review Date: November 2014 Identifier: NHSG/PGD/pediacel/MGPG

7 The Green Book gives advice on the immunisation of children with a history of a mild or severe systemic or local reaction within 72 hours of a preceding vaccine. Children who have had a severe reaction to a previous immunisation should be discussed with a doctor where appropriate Action to be taken when a patient is excluded from treatment under this PGD If a patient is excluded from treatment under this PGD, medical advice should be sought refer to a doctor Action to be taken when a patient/parent/guardian/person with parental responsibility does not wish the treatment to be received under this PGD The patient/parent/guardian/person with parental responsibility should be advised of the risks of not receiving the administration. 3. Description Of Treatment Available Under This Direction 3.1. DTaP/IPV/Hib This is available as Pediacel. It is supplied as a 0.5mL single dose vial or a 0.5mL prefilled syringe. The vaccine is presented as a uniform cloudy, white to off-white suspension, no dilution or reconstitution is necessary. It does not contain thiomersal. The vial/syringe should be shaken well immediately before administering the vaccine. The vaccine should be inspected visually for extraneous particulate matter and/or discolouration prior to administration. In the event of either being observed, the vaccine must be discarded into a blue lidded bin labelled - medicinal waste products for yellow stream waste disposal. Vaccine should be stored between +2 C and +8 C, but not allowed to freeze. If frozen, the vaccine must be discarded into a blue lidded bin labelled - medicinal waste products for yellow stream waste disposal. Protect from light. DTaP/IPV/Hib vaccine is a Prescription-only Medicine (PoM) Dose, route and frequency Primary Immunisation of infants consists of three doses of 0.5mL given on three separate occasions with at least one month (4 weeks) between each dose, commencing from 2 months (8 weeks) of age. DTaP/IPV/Hib vaccine should be administered by intramuscular (IM) injection to the anterolateral aspect of the thigh in infants and the deltoid region in older children. Administration should be given with caution in patients with thrombocytopenia or a bleeding disorder since bleeding may follow IM injection. In these patients, vaccination may be by deep subcutaneous (SC) injection. Please note this is a Green Book recommendation and outwith the product license for Pediacel. UNCONTROLLED WHEN PRINTED Review Date: November 2014 Identifier: NHSG/PGD/pediacel/MGPG

8 3.3. Concurrent medication The vaccine should not be mixed with other vaccines or parenterally administered substances. DTaP/IPV/Hib vaccine may be administered at the same time as MenC, MMR, varicella and hepatitis B vaccines but preferably into a different limb. If given in the same limb, they should be given at least 2.5cm apart. The site of administration should be noted in the patient s records Adverse effects Pain, swelling or redness at the injection site are common and may occur more frequently following subsequent doses. A small painless nodule may form at the injection site; this usually disappears and is of no consequence. Very common adverse effects include appetite loss, vomiting, irritability, pain, erythema and oedema at the injection site, decreased activity and pyrexia (>38 C) and common adverse effects include diarrhoea and injection site bleeding, injection site bruising. Confirmed anaphylaxis occurs very rarely. Medical advice in cases of anaphylaxis Injections of IM adrenaline/epinephrine 1:1000 must be available to treat an anaphylactic reaction should this occur. Medical advice must be sought as soon as possible from a doctor if any patient develops any signs of hypersensitivity. If there is a delay in medical support arriving and the condition of the patient is deteriorating then an emergency ambulance must be called on 999 or direct via ambulance control or dial 2222 (hospital internal) according to local procedure, or seek urgent medical advice. (Refer to Patient Group Direction for the administration of adrenaline (epinephrine) in cases of suspected anaphylactic reactions by qualified health professionals). Treatment of overdose Overdosage is very unlikely to occur as vaccine is presented as a single dose Advice to patient (i) Advice should be given on what to expect and what to do for major and minor reactions. (ii) The patient information leaflet contained in the medicine(s) should be made accessible to the patient/parent/guardian/person with parental responsibility. Where this is unavailable, or unsuitable, sufficient information should be given to the patient/parent guardian/person with parental responsibility in a language that they can understand Follow up treatment It is not possible to specify an exact length of time, but patients should remain on the premises for at least minutes. Patients should not leave if they are feeling at all unwell without speaking to the nurse first. If necessary a doctor or the patient s GP should be contacted for advice. UNCONTROLLED WHEN PRINTED Review Date: November 2014 Identifier: NHSG/PGD/pediacel/MGPG

9 4. Designated Staff Authorised To Administer Under This PGD Part B The following staff are authorised to administer the drug specified in this PGD without an individual medical prescription providing the patient falls into one of the categories listed in 2.2 of this PGD. Staff must be employed either directly by NHS Grampian, or contracted to provide NHS services, or providing services in partnership with NHS Grampian under the direction of this authorised PGD. (i) Registered Nurse as recognised by the NMC. In addition the following requirements are necessary. Staff must: (i) agree to be professionally accountable for their work (Appendix 1). (ii) be competent to assess the patient s capacity to understand the nature and purpose of the administration in order for the patient to give or refuse consent. (iii) be aware of current treatment recommendations and be competent to discuss issues about the drug with the patient. (iv) have been trained and assessed as being competent in the administration of the drug. All staff will have access to the current PGD. (v) have undertaken an NHS e-anaphylaxis training session which includes basic life support (with annual updates) and covers all aspects of the identification and management of anaphylaxis. (vi) have immediate access to the appropriate equipment and drugs to treat anaphylaxis and have access to the current PGD for the management and treatment of anaphylaxis should this occur. (vii) maintain their skills, knowledge and their own professional level of competence in this area according to their individual Code of Professional Conduct. (viii) agree to work within the terms of the NHS Grampian PGD. Professional Managers/Nurse managers/lead nurses will be responsible for: (i) Ensuring that the current PGD is available to staff providing care under this direction. (ii) Ensuring that the staff have access to all relevant Scottish Government Health Directorate advice, including any relevant CMO letter(s). (iii) Ensuring that staff have received adequate training in all areas relevant to this PGD and meet the requirements above. (iv) Maintaining a current record of all staff authorised to administer the drug specified in this PGD. UNCONTROLLED WHEN PRINTED Review Date: November 2014 Identifier: NHSG/PGD/pediacel/MGPG

10 5. Documentation 5.1. Authorisation of administration Nurses working in GP surgeries can be authorised to administer DTaP/IPV/Hib by practice GPs. (NB. GP practices must have adopted NHS Grampian PGD for use in their practice). Nurses working within NHS Grampian can be authorised to administer DTaP/IPV/Hib by their nurse manager. A certificate of competence (Appendix 2) signed by the authorising doctor/manager should be supplied. This should be held in the individual staff records or as agreed locally Record of administration An electronic or paper record for recording the screening of patients and the subsequent administration of the drug specified in this PGD must be completed in order to allow audit of practice. This should include: (i) Name and address of patient/parent/guardian/person with parental responsibility, Unit No/CHI No (ii) Date of birth (iii) Consultant/General Practitioner details (iv) Risk group, if appropriate (v) Physical examination required, if appropriate (vi) Exclusion criteria, record why drug not administered (vii) Reason for giving (viii) Consent to the administration (if not obtained elsewhere) (ix) Drug manufacturer, batch number, expiry date (x) Site where drug administered, dose and route of administration (xi) Signature and name in capital letters of practitioner who administered the drug (xii) Date drug given (xiii) Record of adverse effects (advise patient s doctor). These records should be retained: For children and young people, retain until the patient's 25th birthday or for 3 years after death, or in accordance with local policy, where this is greater than above Consent Prior to the administration of the drug, consent must be obtained, preferably written, either from the patient, parent, guardian or person with parental responsibility and documented either in the patient s medical records/notes or on an administration form (see section 5.2). Consent must be in line with current NHSG Staff Policy for Obtaining Consent for Clinical Procedures and Healthcare Interventions. See link below. UNCONTROLLED WHEN PRINTED Review Date: November 2014 Identifier: NHSG/PGD/pediacel/MGPG

11 6. Further Points The manufacturers leaflet inside boxes of drug should be read and advice from them taken into consideration. 7. Facilities And Supplies To Be Available At Sites For The Administration Of The Drug Specified In The PGD The following should be available at sites where the drug is to be administered: (i) Pharmaceutical refrigerator (or validated cool box for storing vaccine if mobile unit). (ii) Resuscitation equipment. (iii) Access to medical support (this may be via telephone). (iv) Safe storage areas for medicines and equipment. (v) Approved equipment for the disposal of used materials. (vi) Clean and tidy work areas. (vii) Copies of the current PGD for the drug specified in the PGD (viii) PGD for the administration of adrenaline (epinephrine) in cases of suspected anaphylactic reactions by qualified health professionals. 8. Audit All records of administration of the drug specified in this PGD will be filed with the normal records of medicines administration in each practice/service. A designated person within each CHP/practice/service will be responsible for auditing completion of drug forms and collation of data. UNCONTROLLED WHEN PRINTED Review Date: November 2014 Identifier: NHSG/PGD/pediacel/MGPG

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13 Appendix 1 Health Care Professional Agreement To Administer Medicines Under Patient Group Direction I: (Insert name) Working within: e.g. CHP, Practice Agree to administer medicines under the direction contained within the following Patient Group Direction Patient Group Direction for the administration of DTaP/IPV/Hib (Pediacel ) by nurses working within NHS Grampian I have completed the appropriate training to my professional standards enabling me to administer medicines under the above Patient Group Direction. I agree not to act beyond my professional competence nor outwith the recommendations of the Patient Group Direction. Signed: Print Name: Date: NMC Registration No: UNCONTROLLED WHEN PRINTED Review Date: November 2014 Identifier: NHSG/PGD/pediacel/MGPG

14 Appendix 2 Certificate Of Competence To Administer Medicines Under Patient Group Direction This authorises: Working within: e.g. CHP, Practice To administer medicines under the following Patient Group Direction Patient Group Direction for the administration of DTaP/IPV/Hib (Pediacel ) by nurses working within NHS Grampian The above named person has satisfied the training requirements and is competent to administer medicines under the above Patient Group Direction. The above named person has agreed not to act beyond their professional competence nor outwith the recommendations of the Patient Group Direction Signed: Authorising Manager/Doctor Print Name: Date: UNCONTROLLED WHEN PRINTED Review Date: November 2014 Identifier: NHSG/PGD/pediacel/MGPG