Paediatric Department/Service. KINGSTON HOSPITAL NHS FOUNDATION TRUST Galsworthy Road, Kingston upon Thames KT2 7QB PATIENT GROUP DIRECTION

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1 Paediatric Department/Service KINGSTON HOSPITAL NHS FOUNDATION TRUST Galsworthy Road, Kingston upon Thames KT2 7QB PATIENT GROUP DIRECTION For Nurse Administration of a Single Dose of Chlorphenamine as Injection, Suspension or Tablet Indication: Signs of Anaphylaxis or Allergic Reaction following Immunisation, Food challenge or Drug Reaction Legal status of Medicine: GSL / P / POM Black Triangle: No Product Licensed: Suspension- not licensed under one year Tablets not licensed under 6 years Injection not licensed for neonates Indication Licensed: Yes Commencement Date: 01/11/2015 Review Date: 01/11/2017 This document will be reviewed every two years or sooner if: There is a change in the status or name of an organisation There is a change in the licensed indications of the product or a change in evidence base Further guidance is issued by the DoH There is a change in legislation Patient Group Direction Developed by (As members of Paediatric wards, Kingston Hospital NHS Trust) Carol Richards-Scully Paediatric Nurse Practitioner Tamsin Turley Principal Pharmacist Haroon Hafeez Senior Pharmacist Paediatrics Dr.Johnathan Filkin Paediatric Consultant Sarah Shade Matron Authorised by Trust Patient Group Direction Group on: (date) Duncan Burton Miss Jane Wilson Derek Cock Director of Nursing Medical Director Chief Pharmacist Review:- November 2016 Page 1 of 6

2 Named Nurses To Supply/ Administer Chlorphenamine Under the Direction Date Added Date Removed Name Job Title Signature Review:- November 2016 Page 2 of 6

3 Clinical Considerations Clinical condition or situation the Direction is intended to address Relevant National Guidance and References Emergency treatment or prevention of anaphylactic reaction following vaccination, drug reaction or food challenge NMC code of Professional Conduct NMC Standards for medicines management (2008) HSC 2000/026 Patient Group Directions (England only) Kingston Hospital NHS Foundation Trust Patient Group Directions Policy and Procedure Summary of Product Characteristics for Chlorphenamine, Available from British National Formulary July 2014 to July 2015 Criteria for inclusion Signs of anaphylaxis or allergic reaction following immunisation, food challenge or drug reaction Criteria for exclusion* Known allergy to Chlorphenamine Maleate Intravenous cannula in-situ Infants under one month Action to be taken for excluded patients Action for patients who do not wish to receive treatment under the Direction Circumstances where further advice should Immediate referral to Paediatrician Document action taken Respect their views Advise and counsel accordingly Complete the decline section of the consent form and file in medical notes Patient who do not fit the inclusion criteria Patients who fit the exclusion criteria Clinical deterioration despite administration of anaphylaxis treatment be sought from doctor Consent Informed consent should be obtained and the signed consent form should be filed in medical notes. * Details of contraindications, cautions, drug interactions, adverse effects and other product details are provided under the Description of Treatment Section. This section should be referred to before administering the medicine; as should general advice on immunisation from the green book (if the product is a vaccine or immunisation) Review:- November 2016 Page 3 of 6

4 Administrative Considerations Documentation needed/ treatment records to be kept for audit purposes Arrangements for auditing the quality of care specified Copies of PGD to be available in Appropriate records should be kept that comply with NMC Guidelines Record kept of medication administration to include: (delete as appropriate see below) Patient s name, DOB, hospital number Name of member of staff administering the medication Date and time of administration Dose administered, site and route Dose and form of medication administered Details of any problems encountered and action taken. All records must be sufficient to enable an audit trail Consent form to be signed and added to medical notes In accordance with KHFT PGD Audit policy Pharmacy (Master copy) Relevant Department Qualifications & Training Qualifications NMC registered Children s nurse on the register maintained by NMC Other professional qualification/grade: Senior Band 5 and above Training required & The nurse must receive training and complete the Kingston Hospital NHS frequency of PGD Competency Assessment Tool and Kingston Intravenous Medicines update Test for the supply and administration of Chlorphenamine The nurse must receive training and be competent in all aspects of basic life support and anaphylaxis treatment The nurse must be willing to be professionally accountable for this work as defined the NMC guidance on the Scope of Professional Practice guidelines and NMC guidelines for Administration of Drugs Review:- November 2016 Page 4 of 6

5 Description of Treatment Name, strength and pharmaceutical form of medication INTRAMUSCULAR Dose (including maximum dose) Chlorphenamine Tablets: 4mg Oral Suspension: 2mg/5mL Injection: 10mg/1mL Child under 6 months : 250micrograms/kg (Maximum 2.5mg) Child 6 months to 6 years: 2.5mg Child 6-12 years: 5mg Intramuscular Child years: 10mg Intramuscular ORAL Dose (Including Maximum dose) MAX ONE DOSE ON PGD Child 1 month- 2 years: 1mg Maximum of twice a day Child 2-6 years: 1mg every 4-6 hours Maximum 6mg per day Child 6-12 years: 2mg every 4-6 hours Maximum 12mg per day Child years: 4mg every 4-6 hours Maximum 24mg per day Route & site/method of Administration MAX ONE DOSE ON PGD Orally or Intramuscular injection Frequency of administration (including maximum frequency) Review:- November 2016 Page 5 of 6 Maximum of one dose to be administered under PGD for each admission- After which if medication needs to be continued a formal prescription must be obtained. Frequency as above Period of administration Inpatient- Sunshine, Dolphin and PAU Contraindications Pregnancy or breastfeeding Severe liver disease Common side effects sedation, somnolence, disturbance in attention, abnormal coordination, dizziness, headache, blurred vision, nausea, dry mouth, fatigue Cautions/special precautions Use with caution in children with epilepsy, urinary retention, glaucoma or pyloroduodenal obstruction Drug interactions Opioid analgesia and other sedating drugs: increased sedating effect

6 Identifying & managing potential adverse outcomes Advice to patient/carer before and/or after treatment Patients with persistent side effects OR unusual side effects should be reviewed by their Consultant Suspected adverse reactions should be reported to the CSM via the yellow card system in line with CSM All cases of anaphylaxis should be reported via the yellow card system Verbal and written information (in the form of an information leaflet) should be provided Instructions for use/handling Follow dosage and administration instructions See manufacturer s package insert for further information Storage Chlorphenamine 2mg/5ml Elixir Store below 25 C. Protected from light in a locked cupboard Chlorphenamine injection Do not store above 25 C. Keep the container in the outer carton in order to protect from light in a locked cupboard Review:- November 2016 Page 6 of 6