Document Details Title Patient Group Direction (PGD) Flucloxacillin 250mg or 500mg capsules Flucloxacillin 125mg/5millilitres or 250mg / 5ml oral solution Trust Ref No 1614-33450 Local Ref (optional) Main points the document covers The management of wound and skin infections in line with the Community Antibiotic Policy Who is the document aimed at? Nursing staff working within the minor injuries units in Shropshire community health NHS Trust Owner Rita O Brien Approval process Approved by Quality and Safety Delivery Group (Committee/Director) Approval Date 9/11/2016 Initial Equality Impact yes Screening Full Equality Impact no Assessment Lead Director Director of Nursing & Operations Category Policy Sub Category Patient Group Direction Review date 30/11/2018 Distribution Who the policy (PGD) Minor Injury Units will be distributed to Method Email notification of entry onto webpage Document Links Required by CQC Regulation 12 Required by NHLSA Other Amendments History No Date Amendment 1 5/7/2013 Inclusion of option of 500mg capsules and 250mg / ml oral solution in line with Community Antibiotic Policy 2 24/9/2014 Scheduled review removal of adult dose option of 250mg as per guideline 3 October 2016 Scheduled review addition of paramedics to list of authorised practitioners Page 1 of 7
PATIENT GROUP DIRECTION Flucloxacillin 250mg or 500mg capsules / Flucloxacillin 125mg/5ml or 250mg / 5ml oral solution Peer review by Lead clinicians consulted in the development of this PGD Dr S Damoa-Saikwan Consultant microbiologist, Shrewsbury & Telford Hospitals Rachel Mole Clinical Services Manager Andrew Thomas Head of Nursing and Quality 24/10/2016 If any signatures are missing below, then the PGD is not valid APPROVED FOR USE BY: Medicines Management Group Doctor Dr Emily Peer Associate Medical Director 24/10/2016 Pharmacist Rita O Brien Chief Pharmacist 9/11/2016 RATIFIED BY: Quality & Safety Delivery Group Governance Lead Steve Gregory Director of Nursing and Operations 9/11/2016 Page 2 of 7
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 3 of 7
CLINICAL CONDITION Clinical need The management of wound and skin infections e.g. cellulitis addressed Inclusion criteria Adults and children over one year 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 Patients with a known history of hepatic disorder or jaundice Patients with a known history of renal disorder, Patients with a known history of porphyria, Patients known to be immunosuppressed, Patients known to be taking methotrexate, Patients known to be taking phenindione or warfarin, Patients known to be taking probenecid, Pregnancy or breast feeding Patients known to be allergic to penicillin antibiotics or to any ingredient of the preparation Caution / need for further advice Management of excluded patients Action for patients not wishing to receive care under this PGD Cholestatic jaundice may occur up to several weeks after treatment with flucloxacillin has been stopped Referral to doctor, independent prescriber or other appropriate service if necessary Document action and advice given Refer to doctor or independent prescriber Page 4 of 7
Drug details Name form and strength of medicine Flucloxacillin 250mg or 500mg capsules Flucloxacillin 125mg/5ml or 250mg in 5ml oral solution Legal classification POM Black triangle warning? No Use within licence? Yes Route / method By Mouth Dose / Frequency Adults: 500 mg every 6 hours. If patient weighs over 70kg, dose is 1g four times a day Children: 1 to 2 years: 62.5mg to125mg every 6 hours, 2 to10 years: 125mg to 250mg every 6 hours, 10 to 18 years: 250mg to 500mg every 6 hours 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 Additional Information One course of 7 days 28 or 56 x 500mg capsules (dependant on dose needed) or 100ml bottle oral solution of appropriate strength (when reconstituted) hypersensitivity reactions including urticaria, fever, joint pains, rashes, angioedema, anaphylaxis, serum sickness-like reaction; rarely CNS toxicity including convulsions (especially with high doses or in severe renal impairment), interstitial nephritis, haemolytic anaemia, leucopenia, thrombocytopenia, and coagulation disorders; also reported diarrhoea (including antibiotic-associated colitis) Store in a locked cupboard Advice to patient / carer Space the doses evenly throughout the day. Keep taking the medicines until the course is finished, unless you are told to stop. Take this medicine when your stomach is empty. This means an hour before food or 2 hours after food Patients should be advised that the capsules should be swallowed whole and not chewed Advise the patient that flucloxacillin is an antibiotic used to treat the infected wound and should be taken for 7 days and that the course should be completed Flucloxacillin suspension should be stored in a refrigerator, any preparation remaining after completion of the course should be discarded Discuss administration and side effects with the patient and provide a manufacturers patient information leaflet Patients who experience severe side effects or who develop hypersensitivity reactions should discontinue the medication and seek medical advice Follow up Error reporting 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). Page 5 of 7
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. 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 Community Antibiotic Policy British National Formulary 70 Summary of Product Characteristics www.medicines.org.uk British National Formulary for Children Online Page 6 of 7
Register of practitioners qualified to administer and / or supply Flucloxacillin 250mg or 500mg capsules Flucloxacillin 125mg/5ml or 250mg /5ml oral solution 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 Minor Injuries Units In Shropshire Community NHS Trust 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 7 of 7