Patient Group Direction (PGD) for the Supply of:
Prescription Only IBUPROFEN 400mg TABLETS Medicine (POM) 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 DIRECTION APPLIES For the control of mild to moderate pain and inflammation following Indication foot/ankle surgery.
Inclusion Criteria
Informed consent has been given in accordance with current Locala Community Partnership (LCP) guidelines for the supply of the medicine. The medical and drug history has been taken and there is no reason for exclusion. Anticipated or actual post operative pain following foot surgery, as identified by the Podiatric Surgeon Treatment of patients aged over 16 years.
Exclusion Criteria
Informed consent has NOT been given in accordance with current Locala Community partnership (LCP) guidelines for the supply of the medicine. Pregnancy and breastfeeding Known hypersensitivity to aspirin, ibuprofen or any other NSAID Known hypersensitivity to the active substance or to any of the excipients of the tablets. Patients with a history of gastrointestinal bleeding or perforation related to previous NSAID therapy. Current or history of dyspepsia, peptic ulcer or gastrointestinal bleeding. Patients with severe heart failure, liver failure or kidney failure. Patients with renal, cardiac or hepatic impairment. Patients with uncontrolled hypertension, congested heart failure, established ischaemic heart disease, peripheral arterial disease, or cereborvascular disease. Patients with coagulation disorders Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Patients taking aspirin or other NSAIDs Patients taking concomitant medicines which could increase the risk of ulceration or bleeding; such as oral corticosteroids, anticoagulants such as warfarin, SSRIs or anti-platelet agents such as clopidogrel. Asthmatics who have severe asthma or experienced worsening of asthma symptoms after taking a NSAID. Patients who have taken mifepristone within the last 12 days. Patients taking Lithium, Methotrexate, Tacrolimus, Ciclosporin
PGD No 85v2 - Ibuprofen 400mg Tablets Approval Date:
24.4.12
Review Date: 31.5.14 Page 1
Exclusion Criteria cont.
Patients taking any other interacting drug as listed in appendix 1 of the current BNF. Concurrent medication MUST always be checked for interactions before supply under the PGD. Please also see Cautions/Need for further advice section
Cautions/Need for further advice
The elderly are at increased risk of serious consequences of adverse reactions, especially GI bleeding and perforation. If Ibuprofen is considered to be necessary, the lowest effective dose should be used and for the shortest possible duration. NSAIDs should be given with care to patients with a history of ulcerative colitis or Crohn’s disease as these conditions may be exacerbated. Asthmatics that have never used NSAIDs Caution is required for patients suffering from, or with a previous history of asthma since NSAIDs are reported to precipitate bronchospasm in such patients. In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders there may be an increased risk of aseptic meningitis. Caution should be used when initiating treatment with ibuprofen in patients with considerable dehydration. Use with caution in patients with risk factors for heart disease e.g. diabetes, high cholesterol.
Action if Patient Declines or is Excluded
Patients who are excluded from treatment under the contraindications identified above should be referred to an appropriate medical practitioner/prescriber. This should be documented clearly in the patient’s record. Where patients do not wish to receive treatment under this PGD, refusal and action taken should be documented in the patient’s record. Give information about risks of infection and benefits of treatment (where appropriate). Give information about how to recognise signs and symptoms of infection (where appropriate). Give information about when the medicine may be given.
DESCRIPTION OF TREATMENT Name, Form & Strength of Medicine
Ibuprofen Tablets 400mg
Route/Method
Oral
Dosage & Frequency
400mg (ONE tablet) every SIX to EIGHT hours.
Duration of Treatment Maximum or Minimum Treatment Period
Up to 7 days 7 days
PGD No 85v2 - Ibuprofen 400mg Tablets Approval Date:
24.4.12
Review Date: 31.5.14 Page 2
Quantity to Supply
24 x 400mg Tablets
Licensing Information
This product is licensed for the listed indication
Side Effects
The most commonly observed adverse effects are gastrointestinal and include: peptic ulcers, perforation or GI bleeding, nausea, vomiting, diarrhoea, flatulance, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis. Other side effects include hypersensitivity reactions (particularly rashes, angioedema, and bronchospasm), headache, dizziness, nervousness, depression, drowsiness, insomnia, vertigo, hearing disturbances such as tinnitus, photosensitivity, and haematuria. Blood disorders have also occurred. Fluid retention may occur; blood pressure may be raised. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring within the first month of treatment in the majority of cases. Ibuprofen should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. This list is not exhaustive. Please refer to current BNF and product SPC for full details. 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 health professional or the patient.
Special Considerations /Additional Information
It is the responsibility of the health professional identifying the ADR to report it. The use of ibuprofen may impair female fertility. This effect is reversed once the medicine is stopped. NSAIDs may be associated with a small increased risk of thrombotic events particularly when used at high doses and for long term therapy. Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
PGD No 85v2 - Ibuprofen 400mg Tablets Approval Date:
24.4.12
Review Date: 31.5.14 Page 3
Advice to Patient/Carer/ Parent/Guardian
Explain treatment, course of action and provide relevant patient information leaflets if available. Give the manufacturer’s patient information leaflet. Take medicine with or after food or take with milk, and do not exceed the stated dose. Discuss potential side effects. Patients who experience visual disturbances, dizziness, drowsiness, fatigue or other central nervous system disturbances while taking NSAIDs should refrain from driving or operating machinery. Ibuprofen may be taken with paracetamol if necessary Advise the patient not to take other NSAID containing products at the same time e.g. over-the-counter medicines containing aspirin Discontinue if indigestion or other gastro-intestinal symptoms develop e.g. haematemesis Discontinue immediately and seek medical help if signs of hypersensitivity occur. Patients who experience visual disturbances, dizziness, drowsiness, fatigue or other central nervous system disturbances while taking NSAIDs should refrain from driving or operating machinery. If condition worsens or symptoms persist seek further medical advice. Advise patient to seek further medical advice if:
Follow Up
The condition worsens or does not improve. They experience any hypersensitivity reaction Patient to be telephoned on the day following surgery. To be reviewed in clinic within 8 days.
PGD No 85v2 - Ibuprofen 400mg Tablets Approval Date:
24.4.12
Review Date: 31.5.14 Page 4
REFERRAL ARRANGEMENTS AND AUDIT TRAIL Referral Arrangements
Referral arrangements (including self-care) to be documented in patients notes. If patient is excluded from this PGD refer to an appropriate medical practitioner/prescriber.
Records/Audit Trail
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 supplied and route Batch number, expiry date, manufacturer and supplier. Advice given to patient (including side effects) Date supplied Name of staff who supplied the medicine Where applicable, details of any subsequent adverse drug reaction and actions taken including referral arrangements. This MUST be documented in the patient’s medical record. Current medication Known allergies Diagnosis STAFF CHARACTERISTICS Registered professional who is either a State Registered Podiatrist undergoing a surgical fellowship training programme approved by the College of Podiatrists or a Fellow of The College of Podiatrists (Faculty of Surgery) or a Registered general nurse with current registration working within Locala Podiatric Surgery Unit
Qualifications
Specialist Training or Qualifications
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 in working under PGDs for the supply and administration of medicines Has undertaken training and is competent in the recognition and treatment of anaphylaxis. Has undertaken training and is competent in resuscitation skills. Accepts personal responsibility for working within the PGD, understands the legal implications of doing so and works within the scope of the PGD. Keep updated via departmental meetings and updates Has undertaken training appropriate to this PGD
PGD No 85v2 - Ibuprofen 400mg Tablets Approval Date:
24.4.12
Review Date: 31.5.14 Page 5
Continuing Training & Education
References & Resources
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. Practitioner should have access to current BNF and updated DH advice where appropriate. Attends updates in administration of medicines through the use of Patient Group Directives at recommended intervals including mandatory annual updates on Anaphylaxis and Resuscitation. Keeps undated via departmental updates and meetings 1. Current edition of the British National Formulary (BNF) Number 62 September 2011 2. Summary of Product Characteristics (SPC) available at: www.medicines.org.uk 3. Patient Information Leaflet (PIL) available at: www.medicines.org.uk
PGD No 85v2 - Ibuprofen 400mg Tablets Approval Date:
24.4.12
Review Date: 31.5.14 Page 6
This PGD is an updated version of: PGD 85 Ibuprofen 400mg tablets, February 2010 It was updated for use within Locala Community Partnerships by the authors as listed below. Name
Position
Date
Lucianne Ricketts
Head of Medicines Management
March 2012
Linda Fox
Community Services Pharmacy Manager
March 2012
Dawn Toothill
Specialist Pharmacy Technician
Andy Naismith
Consultant Podiatric Surgeon
February 2012
March 2012
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 (if this is applicable) This will result in an unlicensed use of a licensed product following current DH guidance.
Approval Date: 24.4.12
PGD No 85v2 - Ibuprofen 400mg Tablets Review Date: 31.5.14 Page 7
Individual authorisation for the supply of Ibuprofen 400mg tablets by appropriately qualified Locala Staff at Holme Valley Podiatric Surgery Unit 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. 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 Locala staff this will be the team leader, or relevant clinical manager. 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 supply/administer medicines away from the base should have an individual copy of the relevant signed PGD with them when supplying/administering the medicine.
PGD No 85v2 - Ibuprofen 400mg Tablets Approval Date: 24.4.12
Review Date: 31.5.14 Page 8
Organisational Approval This patient group direction must be agreed to and signed by all health care professionals involved in its use. Locala Community Partnerships will hold the original signed copy. The PGD must be easily accessible in the clinical setting.
ORGANISATION Director of Clinical and Operational Services
Locala Community Partnership Name: Christina Quinn
Signature: Head of Medicines Management
Name: Lucianne Ricketts
Signature: Medical Lead
Date
Date:
Name: Dr Stephen Warner
Signature:
Date:
PGD No 85v2 - Ibuprofen 400mg tablets Approval Date: 24.4.12
Review Date: 31.5.14
PCT Authorisation ORGANISATION Governance lead
NHS Kirklees Name: Sue Cannon
Signature: Senior Medicines Management Advisor
Name: Eric Power
Signature: Medical Director
Date
Date:
Name: Dr Matt Walsh
Signature:
Date:
PGD No 85v2 - Ibuprofen 400mg tablets Approval Date: 24.4.12
Review Date: 31.5.14