IBUPROFEN PATIENT GROUP DIRECTION CHILD HEALTH 1. Aim/Purpose of this Guideline 1.1. This Patient Group Direction (PGD) applies to all nursing and clinical staff in the Child Health Department and its aim is to ensure appropriate supply of Ibuprofen. 2. The Guidance 2.1 Clinical condition Indication of situation/condition Relevant National Guidance Children and babies from 3 months of age or weigh over 5kgs presenting with: Mild to moderate pain Pyrexia with associated distress, and only after initial treatment with Paracetamol. BNF for children 2015-2016 NICE: Feverish illness in children 2013 for inclusion Mild to moderate pain, assessed using relevant pain tool. Pyrexia with associated distress, and only after initial treatment with Paracetamol. for patient exclusion Children and babies will not be treated under this direction if: Allergic to Ibuprofen or non-steroidal antiinflammatory drugs (NSAID). They have previously had any Ibuprofen or NSAID s containing products within the last 6 hours. Under 3 months of age or weigh less than 5kgs. Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal anti-inflammatory drugs Have a history of recurrent indigestion or peptic ulceration. Varicella infection (NICE CKS June 2015). Cautions/ Need for further Renal impairment. advice Liver impairment. Cardiac impairment. Are taking oral anticoagulants. Have a blood clotting disorder e.g. thrombocytopenia. Action if patient excluded Document in patient medical records. Consider other forms of analgesia/antipyretic. Refer to medical staff for prompt assessment. Page 1 of 11
Action if patient declines Additional Action to be taken Document in patient medical notes. Discuss with medical staff the need for treatment. ne 2.2 Characteristics of Health Care Professionals Class of Healthcare professional for whom PGD is applicable and qualifications Specialist competencies or qualifications considered relevant to the medicines used in the direction. Competencies required: Registered nurses (RN (Child) or RSCN) with 12 months post registration experience. Agency or Bank nurses are not eligible to administer drugs under Patient Group Directions. Comply with NMC s of Medicine Management. PGD workbook and Child Health Drug Workbook must be completed. Practical assessment must be completed (see competency framework). Continuing training and education The responsibility for continuing education lies with the individual practitioner. Yearly updates will be provided through the Paediatric Pain Study morning. 2.3 Description of treatment Name and Form of Medicine E.g. tablets Legal status Prescription Only Medicine (POM) / General Sales List (GSL), Pharmacy Only (PO) Licensed / Unlicensed / Off-licensed Dose/s (where range is applicable include criteria for deciding on a dose) Route/Method of Administration Frequency of Administration Total dose/number of times treatment can be administered over what time Ibuprofen Syrup 100mg/5mls Tablets 200mg and 400mg General Sales List Licensed 10mg/kg Maximum dose- 400mg Oral Once only Once only Page 2 of 11
Side Effects of drugs (to include potential adverse reactions) and any monitoring required Procedure for reporting Adverse Drug Reactions (ADR) Special consideration for patients receiving concurrent medication Information on follow-up treatment if needed Written / verbal advice for patient / carer before / after treatment. Product information leaflet should be given to the patient / carer Method of recording supply / administration, names of HCP, patient identifiers, sufficient to enable audit trail. Gastro-intestinal discomfort Nausea Diarrhoea Rashes Bronchospasm Trust Procedure: The event is recorded on DATIX Yellow card completed before sending to pharmacy. Establish if the patient is taking any other products that may contain Ibuprofen or NSAID s. Dependant on clinical condition. Avoid other products containing Ibuprofen or NSAID s. Your child has had a febrile convulsion leaflet, RCHT048. Paediatric pain management RCHT756. The PGD should be recorded on EPMA. If not an inpatient then it should be recorded in the patient s notes. 3. Monitoring compliance and effectiveness Element to be monitored Lead Tool Frequency Reporting arrangements Acting on recommendations and Lead(s) Compliance of following the PGD process will be yearly Monitoring of drug doses will be monitored monthly. Sarah Fox and Kim Philp Retrospective audit of patient notes for auditing the PGD process (see appendix 3) EPMA report will be used to monitor doses. A full audit using the attached tool will be completed yearly and a report will be written. EPMA are produced monthly The report will be shared at the Paediatric audit and guidelines meeting and the PGD working Group. Monthly monitoring of doses using the EPMA report will be shared with the Matron for Child Health. Paediatric audit and Guidelines PGD working group Required actions will be identified and completed in a specified timeframe Change in Required changes to practice will be identified and actioned within 3-6 practice and months. A lead member of the team will be identified to take each Page 3 of 11
lessons to be shared change forward where appropriate. Lessons will be shared with all the relevant stakeholders 4. Equality and Diversity 4.1. This document complies with the Royal Cornwall Hospitals NHS Trust service Equality and Diversity statement which can be found in the 'Equality, Diversity & Human Rights Policy' or the Equality and Diversity website. 4.2. Equality Impact Assessment The Initial Equality Impact Assessment Screening Form is at Appendix 2. Page 4 of 11
Appendix 1. Governance Information Document Title Date Issued/Approved: 1 Jan 16 Ibuprofen Patient Group Direction Child Health Date Valid From: 1 Jan 16 Date Valid To: 1 Jan 19 Directorate / Department responsible (author/owner): Sarah Fox, Acute Paediatric Pain Service Contact details: 01872 252800 Brief summary of contents Describes the process for supplying Ibuprofen in the Child Health Department using a PGD Suggested Keywords: Target Audience Executive Director responsible for Policy: PGD, Ibuprofen, Paediatric, Children RCHT PCH CFT KCCG Medical Director Date revised: 1 Jan 16 This document replaces (exact title of previous version): Approval route (names of committees)/consultation: Ibuprofen Patient Group Direction Child Health Medicines Practice Committee PGD working group (child health) Divisional Manager confirming approval processes Name and Post Title of additional signatories Name and Signature of Divisional/Directorate Governance Lead confirming approval by specialty and divisional management meetings Dr Julian Berry Dr Julian Berry, Paediatric Consultant Anaesthetist Mary Baulch/Mel Gilbert, Matron for Child Health Phil Dale, Paediatric Pharmacist {Original Copy Signed} Name: Helen Ross-McGill Signature of Executive Director giving {Original Copy Signed} approval Publication Location (refer to Policy Internet & Intranet Intranet Only on Policies Approvals and Page 5 of 11
Ratification): Document Library Folder/Sub Folder Links to key external standards Related Documents: Training Need Identified? Clinical/Paediatrics NICE(2013) Good practice guidelines- Patient Group Directions NICE(2013): Feverish illness in children As above Comply with NMC s of Medicine Management. PGD workbook and Child Health Drug Workbook must be completed. (See competency framework- Procedural Guidelines for Developing, Implementing and Reviewing the Supply or Administration of Medicines under a Patient Group Direction (PGD)). Version Control Table Date Version 10 Jan 12 V1.0 Initial Issue 1 Jan 14 V2.0 Full review, reformat. Summary of Changes 1 Jan 16 V3.0 PGD reapproved by MPC Changes Made by (Name and Job Title) Sarah Fox Acute Paediatric Pain Service Sarah Fox Acute Paediatric Pain Service Sarah Fox Acute Paediatric Pain Service All or part of this document can be released under the Freedom of Information Act 2000 This document is to be retained for 10 years from the date of expiry. This document is only valid on the day of printing Controlled Document This document has been created following the Royal Cornwall Hospitals NHS Trust Policy on Document Production. It should not be altered in any way without the express permission of the author or their Line Manager. Page 6 of 11
Appendix 2. Initial Equality Impact Assessment Form Name of Name of the strategy / policy /proposal / service function to be assessed (hereafter referred to as policy) (Provide brief description): ): Ibuprofen Patient Group Direction Child Health Directorate and service area: Is this a new or existing Policy? Clinical/Paediatric Existing Name of individual completing Telephone: 01872 252800 assessment: Sarah Fox, Paediatric Pain Specialist Nurse 1. Policy Aim* As per paragraph 1 of this document. Who is the strategy / policy / proposal / service function aimed at? 2. Policy Objectives* As per paragraph 1 of this document. 3. Policy intended Outcomes* 4. *How will you measure the outcome? 5. Who is intended to benefit from the policy? 6a) Is consultation required with the workforce, equality groups, local interest groups etc. around this policy? b) If yes, have these *groups been consulted? C). Please list any groups who have been consulted about this procedure. 7. The Impact Please complete the following table. Are there concerns that the policy could have differential impact on: Equality Strands: Rationale for Assessment / Existing Evidence Age Sex (male, female, transgender / gender reassignment) As per paragraph 1 of this document. As per paragraph 3 of this document All paediatric patients Page 7 of 11
Race / Ethnic communities /groups Disability - Learning disability, physical disability, sensory impairment and mental health problems Religion / other beliefs Marriage and civil partnership Pregnancy and maternity Sexual Orientation, Bisexual, Gay, heterosexual, Lesbian You will need to continue to a full Equality Impact Assessment if the following have been highlighted: You have ticked in any column above and consultation or evidence of there being consultation- this excludes any policies which have been identified as not requiring consultation. or Major service redesign or development 8. Please indicate if a full equality analysis is recommended. 9. If you are not recommending a Full Impact assessment please explain why. Signature of policy developer / lead manager / director Date of completion and submission Names and signatures of members carrying out the Screening Assessment 1. Sarah Fox 2. Keep one copy and send a copy to the Human Rights, Equality and Inclusion Lead, c/o Royal Cornwall Hospitals NHS Trust, Human Resources Department, Knowledge Spa, Truro, Cornwall, TR1 3HD A summary of the results will be published on the Trust s web site. Signed _Sarah Fox Date 5/1/16 Page 8 of 11
Appendix 3 Audit tool PATIENT GROUP DIRECTIONS (PGD) AUDIT- 411 AREA OF AUDIT... NAME OF AUDITOR... DATE OF AUDIT.. 1. : The PGD documentation is accessible and up to date Practitioners surveyed confirmed that the PGD is accessible for reference at consultations (min number surveyed 10% of signatories) 100% 10 staff Copies of the PGD are located in the areas stated within the PGD 100% 1 area 2. : Local practice meets the standards detailed within the PGD Patients treated under the PGD for stated clinical indication only. (Min number of patient records surveyed should be at least 20 records or 50% (whichever is smaller)). Patients included for treatment under the PGD fit the inclusion criteria. The practitioners operating under the PGD are confirmed as competent to use PGDs (surveyed 10% of signatories) Page 9 of 11
3. : The following information is recorded in the patient record by the practitioners using the PGD (min number of patient records surveyed should be at least 20 records or 50% (whichever is smaller)). The name of the medicine The dose of the medicine The practitioners name The date when the patient received treatment under the PGD The practitioners signature Page 10 of 11
: The minimum records kept for audit purposes: (Gwithian and PAC only) The date of supply (record sheets) 100% 5 The patients name (record sheets) 100% 5 A unique identifier for the patient (NHS no) (record sheets) The practitioners name (record sheets) 100% 5 100% 5 4. : The reporting of adverse of clinical incidents (min number of patient records surveyed at least 20 records, or 50% (whichever is smaller)) Any adverse clinical incidents involving the medicine have been recorded via the local clinical incident reporting policy 0% N/A of incidents identified 5. : Education and training for using a PGD There is an individual identified who is responsible for ensuring the practitioners are trained and competent. (NB: training records should be available) Individual training records indicate that practitioners are ensuring they are updated. (min sample 10% of signatories) PGD update is included within paediatric pain study morning. 100% 100% N/A Page 11 of 11