Title Document Details Patient Group Direction (PGD) Ibuprofen 200mg tablets and Ibuprofen oral liquid 100mg in 5ml Trust Ref No 1445-36348 Local Ref (optional) Main points the document The treatment of mild to moderate pain and inflammation covers especially in musculoskeletal trauma/disorders and burns Who is the document Clinical staff treating mild to moderate pain and inflammation aimed at? Author Rita O Brien Approval process Approved by Quality and Safety Delivery Group (Committee/Director) Approval Date 10 th May 2017 Initial Equality Impact yes Screening Full Equality Impact no Assessment Lead Director Director of Nursing and Operations Category Policy Sub Category Patient Group Direction Review date 30 th May 2019 Distribution Who the policy (PGD) will be distributed to Clinical areas providing treatment for mild to moderate pain and inflammation Method Email notification of entry onto webpage Document Links Required by CQC Regulation 12 Required by NHLSA yes Other Amendments History No Date Amendment 1 September 2014 Scheduled review no changes 2 October 2016 Scheduled review addition of paramedics to list of authorised practitioners 3 March 2017 Addition of exclusion for patients displaying signs of chickenpox Page 1 of 8
PATIENT GROUP DIRECTION Ibuprofen 200mg tablets and Ibuprofen oral liquid 100mg in 5ml Lead clinicians consulted in the development of this PGD Andrew Thomas Head of Nursing and Quality Rachel Mole Clinical Services Manager Carolyn Michie ENP MIU Doctor If any signatures are missing below, then the PGD is not valid APPROVED FOR USE BY: Medicines Management Group Dr Emily Peer Associate Medical Director 6/4/2017 Pharmacist Rita O Brien Chief Pharmacist 5/4/2017 RATIFIED BY: Quality & Safety Delivery Group Page 2 of 8
Governance Lead Steve Gregory Director of Nursing and Operations 10/5/2017 Page 3 of 8
STAFF CHARACTERISTICS Employed by Shropshire Community Health NHS Trust Eligible nurse or paramedic with current registration Specialist competencies or qualifications: The clinical manager has evidence that the health care professional has undertaken training to carry out clinical assessment of patient leading to diagnosis that requires treatment according to the indications listed in the PGD. Provide evidence of training, annual updates and Continuing Professional Development undertaken. The clinical manager has proof of training by the health care professional on the legal aspects of supply or administration of medicines under a Patient Group Direction The clinical manager has assessed the competency (against the national framework) of the healthcare professional to work to a Patient Group Direction at least every 2 years. Has undertaken training and annual updates in the recognition and treatment of anaphylaxis, including practical in Basic Life Support and has immediate access to an in-date supply of adrenaline 1mg in 1ml (1:1000) at the time of the consultation. Must have access to all relevant sources of information e.g. information issued by the Department of Health (DH), British National Formulary (BNF), Summary of Product Characteristics (SPC), and the clinical guideline concerning medicine(s) within this Patient Group Direction (PGD). The practitioner needs to reinforce and update their knowledge and skills in this area of practice with particular reference to changes and national directives The registered health care practitioner is professionally accountable for supply or administration under the PGD as defined in their own profession s Code of Professional Conduct and Ethics. YOU MUST BE AUTHORISED BY NAME BY YOUR MANAGER UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT Page 4 of 8
CLINICAL CONDITION Clinical need addressed The treatment of mild to moderate pain and inflammation especially in musculoskeletal trauma/disorders and burns Inclusion criteria Adults and children minimum of 3 months (over 5kg in body weight) Patient presenting with pyrexia (that is either not relieved by paracetamol, or, where paracetamol is contraindicated). Exclusion criteria (for full details of interacting medicines refer to current Summary of Product Characteristics (SPC) & BNF Exclusion under this Patient Group Direction does not necessarily mean contraindicated Caution / need for further advice Previous sensitivity to NSAIDS e.g. aspirin, ibuprofen Any ingredient contained in the product. Active or previous gastro-intestinal ulceration or bleeding. Asthmatics that have had severe asthma or had worsening of asthma symptoms after previous use. Known heart failure, renal or hepatic impairment. Currently taking ciclosporin, clopidogrel, corticosteroids, lithium preparations, methotrexate, other NSAIDS, tacrolimus, warfarin. Patients with coagulation defects. Pregnancy and breastfeeding. No consent Patients displaying signs of chickenpox Asthmatics that have never used NSAIDs. May worsen control of asthma and hypertension. Increased risks of side effects in the elderly Management of excluded patients Action for patients not wishing to receive care under this PGD Referral to doctor, independent prescriber or other appropriate service if necessary Document action and advice given Refer to doctor or independent prescriber Page 5 of 8
Drug details Name form and strength of medicine Ibuprofen 200mg tablets or capsules and Ibuprofen oral suspension 100mg in 5ml Legal classification Route / method Dose / Frequency Pharmacy Only Medicine Oral Child 3 6 months 50 mg 3 times daily; max. 30 mg/kg daily in 3 4 divided doses Child 6 months 1 year 50 mg 3 4 times daily; max. 30 mg/kg daily in 3 4 divided doses Child 1 4 years 100 mg 3 times daily; max. 30 mg/kg daily in 3 4 divided doses Child 4 7 years 150 mg 3 times daily; max. 30 mg/kg daily in 3 4 divided doses Child 7 10 years 200 mg 3 times daily; max. 30 mg/kg (max. 2.4 g) daily in 3 4 divided doses Child 10 12 years 300 mg 3 times daily; max. 30 mg/kg (max. 2.4 g) daily in 3 4 divided doses Child 12 18 years and adults initially 300 400 mg 3 4 times daily; increased if necessary to max. 600 mg 4 times daily; maintenance dose of 200 400 mg 3 times daily may be adequate Number of times treatment may be administered Quantity to be supplied or administered Side effects Full details of side effects are available in the SPC. Suspected adverse reactions to drugs including vaccines should be reported on the yellow card available at the back of the BNF. Also at www.yellowcard.gov.uk Advice to patient / carer Single age appropriate dose with food may be administered in the minor Injuries Unit and/or one labelled patient pack to take home 100ml suspension with oral syringe or 24 tablet patient pack GI discomfort, nausea, diarrhoea occasionally GI bleeding & ulceration Hypersensitivity reactions rashes & bronchospasm. Oedema has been reported in association with ibuprofen treatment. These effects may be minimised by taking these drugs with food & milk. Seek medical advice if any of these side effects are experienced Page 6 of 8
Follow up Error reporting RECORD KEEPING Documentation needed / treatment records to be kept for audit purposes A computer or manual record of all individuals receiving treatment under this Patient Group Direction should also be kept for audit purposes. Advise patient not to take other NSAID containing products at the same time e.g. over-the-counter medicines containing aspirin Seek medical advice if there is no improvement in condition in 48 hours Referral to doctor or independent prescriber if necessary Any incidents or near miss issues must be reported via the organisation s internal reporting system (Datix). Patient s name, address, date of birth and GP Manufacturer / brand of product, batch number, expiry date Dose Date of administration, route Advice given to patient / carer Details of staff who administered (sign and print name) Details of any adverse drug reactions, and action taken including informing GP Reconciliation stock balances should be reconcilable with receipts, administration, records and disposal on a patient by patient basis. REFERENCES British National Formulary 70 Last accessed 5/10/2016 Summary of Product Characteristics www.medicines.org.uk Last accessed 5/10/2016 British National Formulary for Children Online Last accessed 5/10/2016 UKMi https://www.sps.nhs.uk/articles/do-nsaids-increase-the-risk-of-severe-skin-reactions-in-children-withchickenpox/ Page 7 of 8
Register of practitioners qualified to administer and / or supply Ibuprofen 200mg tablets and Ibuprofen oral suspension 100mg in 5ml under this Patient Group Direction Name of clinical team manager Signature of clinical team manager Date: All PGD documentation must be kept for 8 years and for children until the child is 25 years old A copy of this page should be retained by the authorising manager for audit purposes. Please state clinical area where this PGD is in use Healthcare professional individual declaration: I have read and understood the Patient Group Direction and agree to supply this medicine only in accordance with this PGD PGDs DO NOT REMOVE INHERANT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. It is the responsibility of each professional to practice only within the bounds of their own competence. All practitioners operating in accordance with this PGD should have a current, signed copy of it readily available for reference. If a practitioner is asked to supply, or administer a medicine not covered by this or any other PGD then a patient specific direction is required from a doctor, dentist or independent prescriber. Name of professional (please print) Signature Authorising Manager (Must sign against each entry) Date of authorisation Page 8 of 8