Patient Group Direction for IBUPROFEN (Version 03) Valid From 1 November 2020 - 31 October 2022
Version Control This PGD has been FCMS agreed by the following PDS Medical organisations Doncaster CCG Lancashire CCGs including East Lancashire, Fylde and Wyre and North Lancashire CCGs Change history 31/07/17 V02 Review. Quantity to supply – ADD 8 days – patient advised to seek further medical advice if required over 7 days. Minor editing changes. 28/08/17 V02 Review. Updated doses as per BNFC. Minor editing changes. 28/09/20 V03 Review. Updated.
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Patient Group Direction for IBUPROFEN (Version 03) Valid From 1 November 2020 - 31 October 2022
CLINICAL CONTENT OF PATIENT GROUP DIRECTION
Staff Characteristics Qualifications Registered nurse, Paramedic practitioner, ECP (Paramedic) or Nurse practitioner Specialist competencies Received training to undertake administration and supply of medicines or qualifications under PGD. Has undertaken appropriate training to carry out clinical assessment of patient, leading to diagnosis. Also that such diagnosis requires treatment according to the indications listed in this PGD. Continuing training and The practitioner should be aware of any change to the recommendations for education 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 individual scope or practice.
Clinical Details Indication For the treatment of mild to moderate pain (including musculoskeletal, dental, period pain, neuralgia and migraine). For the relief of pyrexia. Inclusion criteria Patients with the above indications. Exclusion criteria Hypersensitivity to ibuprofen, aspirin, other NSAIDs or any component of the product. Pregnancy or breast feeding. Children under 6 months of age or under 5kg body weight. Patients with asthma in whom exposure has led to symptoms such as bronchospasm. Patients with coagulation defects, severe cardiac disease (including all patients with heart failure), cardiovascular event or procedure in the last month, oedema or uncontrolled hypertension. Current or previous peptic ulceration (gastric or duodenal), GI bleeding or perforation. Active bleeding problems (apart from small wounds that are to be managed). Patients with severe renal impairment (known chronic kidney disease stages 4 or 5, or creatinine clearance / eGFR < 30ml/minute). Severe hepatic impairment. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Patients with inflammatory bowel disease: NSAIDs may exacerbate symptoms. Patients with systemic lupus erythematosus or connective tissue disorders (increased risk of aseptic meningitis). Patients already taking an NSAID including coxibs (except low-dose 28/08/2017 Page 2 of 7
Patient Group Direction for IBUPROFEN (Version 03) Valid From 1 November 2020 - 31 October 2022
aspirin for cardiovascular prophylaxis) or more than one antiplatelet medication (e.g. aspirin and clopidogrel). Patients taking anticoagulants (e.g. warfarin, heparins, Direct Oral Anticoagulants such as apixaban, dabigatran, edoxaban or rivaroxaban), baclofen, caplacizumab, ciclosporin, colismethate, deferasirox, erlotinib, fluconazole, ketorolac, lithium, methotrexate, mifamurtide, nicorandil, nicotinic acid, omega-3-acid ethyl esters, penicillamine, permetrexed, quinolone antibiotics, ritonavir, tacrolimus volanesoren, voriconazole, zidovudine. Patients with more than one caution (see below) affecting the same system (eg bleeding risk, renal risk), or patients with multiple cautions where risk of treatment outweighs benefit. Current varicella (chickenpox or shingles) infection.
PGDs should be used only where appropriate, suitable and legal. PGDs should not be routinely used when an independent prescriber is available. Precautions Patients with asthma who have never previously been exposed to NSAIDs: monitor for any change in symptoms. Children with allergic disorders. Elderly patients: higher risk or adverse effects. Patients with moderate renal impairment (known chronic kidney disease stage 3b or creatinine clearance / eGFR < 45ml/minute): increased risk of renal adverse effects. Patients taking single antiplatelet medications, e.g. low-dose aspirin, clopidogrel: higher risk of bleeding. Patients taking ACE inhibitors or angiotensin 2 receptor antagonists (increased risk of renal adverse effects), antihypertensive agents (increased BP), diuretics (increased risk of renal impairment), iloprost (increased risk of bleeding), oral corticosteroids (increased risk of bleeding), pentoxifylline (increased risk of bleeding), SSRIs e.g. fluoxetine, or venlafaxine (increased risk of bleeding), sulfonylureas (potential increased hypoglycaemic effect). Management of Discuss with GP or Clinical Lead or refer. excluded patients Action for patients not Make patient aware of risks and potential consequences of not taking wishing / unable to medicine. receive care under this Discuss any alternatives if available. PGD Discuss alternative options with GP or Clinical Lead. Document discussion with patient.
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Patient Group Direction for IBUPROFEN (Version 03) Valid From 1 November 2020 - 31 October 2022
Description of Treatment Name of medicine Ibuprofen Formulation and route Oral tablets or oral solution Strength 400mg tablets (adults and children 12 years and over only) 100mg/5ml sugar-free oral solution Dosage Use the minimum effective dose for the shortest time necessary.
Adults and children 12 years and over: 400mg up to three times daily with or after food
Children under 12 years: For all ages a maximum total daily dose of 30mg/kg bodyweight 6-11 months: 50mg (2.5ml) three to four times daily 1-3 years 100mg (5ml) three times daily 4-6 years 150mg (7.5ml) three times daily 7-9 years 200mg (10ml) three times daily 10-11 years 300mg (15ml) three times daily Repeated dose See above instructions Duration of treatment Maximum 7 days in adults and children 12 years and over. For younger patients give clear instructions on appropriate shorter periods of use without further review, e.g. 24-48 hours for fever in young children. Quantity to supply Tablets – pack of 24 Oral solution – 100ml of 100mg/5ml Legal status P/GSL Special precautions Explain indications, contraindications and cautions (refer to BNF) Adverse effects Dyspepsia, nausea, vomiting, diarrhoea, abdominal pain, gastric irritation causing bleeding or ulceration, hypersensitivity reactions (rash, angioedema, bronchospasm), headache, dizziness, vertigo. Increased blood pressure and oedema. Renal impairment and failure. Hepatic dysfunction, rashes and serious skin reactions. Bleeding and bruising.
This is not a complete list. Refer to BNF or SPC (summary of product characteristics) for full information. Advice necessary Provide the patient with the manufacturer’s Patient Information Leaflet. Advise on dose and administration with reference to the cautionary label information and give any further instructions to aid compliance. Advise on storage or expiry details and to dispose of any unused medicines appropriately. Give advice on practical self-care if appropriate, including management of likely symptoms (including fever management where appropriate). Make patient aware of potential adverse effects and the action to take if they occur. 28/08/2017 Page 4 of 7
Patient Group Direction for IBUPROFEN (Version 03) Valid From 1 November 2020 - 31 October 2022
Provide appropriate worsening advice describing the range of signs and symptoms to monitor for and the action to take if they occur. Consider whether the provision of health promotion material is appropriate e.g. on smoking or lifestyle factors. Provide any advice relevant to the patient from the Precautions section above. Prescribing guidance Doncaster, East Lancashire, Fylde and Wyre and North Lancashire CCG local guidelines. Relevant NICE guidelines and advice from Clinical Knowledge Summaries.
Records and Follow Up Referral arrangements Inform GP as soon as possible. Advise if worsening or no improvement to seek further medical advice. Records to be kept Patient’s name, address, date of birth and consent given. Contact details of GP (if registered). Diagnosis. Dose and form administered. Batch and expiry details. Advice given to patient (including side effects). Signature / name of staff who administered or supplied the medication. If relevant, signature / name of staff who removed / discontinued the treatment. Details of any adverse drug reaction and actions taken, including documentation in the patient’s medical record. Referral arrangements (including self-care). Any serious side effects attributable to drug should be recorded and medicine management advised via yellow card system found in BNF. Follow up Advise follow up with GP/ Practice nurse.
Patient Group Direction, organisation and individual authorisation signatures can be found on the managerial content sheet along with other non-clinical details relating to this patient group direction.
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Patient Group Direction for IBUPROFEN (Version 03) Valid From 1 November 2020 - 31 October 2022
MANAGERIAL CONTENT OF PATIENT GROUP DIRECTION
Patient Group Direction Owner Details of PGD owner FCMS (NW) Ltd Newfield House Vicarage Lane Blackpool FY4 4EW
Patient Group Direction Authorisation Lead Doctor
Dr Zakyeya Atcha Lead Pharmacist
Magnus Hird Lead Nurse
Amanda Fewtrell Lead Paramedic
Andrew Shakesby Organisational Authorisation for FCMS Alison Unsworth Organisational Authorisation for Doncaster CCG
Patient Group Direction Peer Review Reviewed by FCMS/PDS PGD Review Group
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Patient Group Direction for IBUPROFEN (Version 03) Valid From 1 November 2020 - 31 October 2022
Individual Authorisation BY SIGNING THIS PATIENT GROUP DIRECTION YOU ARE INDICATING THAT YOU AGREE TO ITS CONTENTS AND THAT YOU WILL WORK WITHIN IT. PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. IF THIS IS AN UPDATED OR REPLACEMENT PGD ENSURE THAT ALL OLDER VERSIONS ARE WITHDRAWN FROM USE WITH IMMEDIATE EFFECT. IT IS YOUR RESPONSIBILITY TO MAKE SURE YOU ARE USING THE CURRENT VERSION. NOTE TO AUTORISING MANAGERS: AUTHORISED STAFF SHOULD BE PROVIDED WITH AN INDIVIDUAL COPY OF THE CLINICAL CONTENT OF THIS PGD AND A PHOTOCOPY OF THE AUTHORISATION SHEET SHOWING THEIR AUTHORISATION. Name of Professional Signature Authorising Manager Date
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