Antibiotic Oral (tablet/capsule/suspension) PATIENT GROUP DIRECTION (PGD) FOR YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT Caution: This drug is also available in a different presentation or dose. Please ensure this is the correct PGD prior to administration Clinical Information: This PGD is indicated for use as a combination therapy with Clarithromycin Clinical Condition Indication Treatment and prophylaxis of animal and human bites Inclusion criteria Adults & Children over 12 Exclusion criteria Very superficial bites involving epidermis only Human bites over 72 hours old with NO evidence of infection Animal bites over 48 hours old with NO evidence of infection Bites in which there is clinical suspicion of underlying fracture or tendon injury (except where specific advice has been given from a Dr) Hypersensitivity to metronidazole Severe renal, hepatic or biliary disease Alcohol abuse Patients on warfarin (or other anticoagulants), phenytoin disulfiram and busulfan. Blood dyscrasias Cautions Generic Cautions with Antibiotic Use. Patients on Warfarin (advise to see GP at end of course for INR/dose review) Patients with renal impairment Patients whom are pregnant Patients who are breastfeeding Patients who are immunocompromised Efficacy of oral contraceptives Specific Advise for Metronidazole Bites to the face. NB The majority of bites to the face will require referral to A&E; some very superficial, low risk bites may be treated using this PGD but ALL cases must be discussed prior to treatment Bites to the face NB The majority of bites to the face will require referral to the emergency department. Consider plastic surgery referral. Clinical suspicion of underlying tendon injury or fracture (exclusion for bites) Patients on interacting medication such as primidone, phenobarbitone, lithium, cimetidine and fluorouracil. See BNF Ref : MTZ_tab_PO_v1.0 Page 1 of 9
Action if patient declines or is excluded Refer to supervising doctor/receiving facility. Document findings and action taken in patient s record Ref : MTZ_tab_PO_v1.0 Page 2 of 9
Drug Details Name, form & strength of medicine Route/Method Dosage Frequency Duration of treatment Maximum or minimum treatment period Metronidazole 400mg tablets Oral Adults and Children 12 and over: 1 x 400mg tablet Three times a day (TDS) 5 days 5 days Quantity to 15 tablets supply/administer Side effects` Nausea, vomiting, unpleasant taste, furred tongue and gastrointestinal disturbances Rashes, pruiritis, urticaria, angiodema and anaphylaxis Rarely drowsiness, headache, dizziness, ataxia, darkening of urine, erythema multiforme Abnormal liver function tests, hepatitis, jaundice and blood disorders Disulfiram-like reaction with alcohol Advice to patient/carer Avoid alcoholic drinks during and for 48 hours after stopping metronidazole Tablets: doses should be taken with plenty of water at mealtimes, swallowed whole and not chewed Take at regular intervals It is important to finish the course even if the symptoms have resolved Advise that any suspension or tablets remaining after proper completion of the course should be safely discarded If any side effects occur such as nausea and vomiting, or severe diarrhoea advise patient to see GP for further advice If rash develops discontinue treatment and see GP Broad-spectrum antibiotics may reduce the efficacy of combined oral contraceptives. The FPA advise additional contraceptive precautions whilst taking antibiotics and for 7 days after stopping. If these 7 days run beyond the end of a packet the next packet should be started immediately without a break. (In the case of ED tablets the inactive ones should be omitted) Product information leaflet should be given to the patient Follow up Advise patient to return or see GP if they become more unwell, feverish or symptoms do not resolve Ref : MTZ_tab_PO_v1.0 Page 3 of 9
Review wounds in 48hours If established wound infection, then take a swab and ask patient to contact GP in 5 days for result. For human bites consider hepatitis/hiv risk- seek further medical advice from GP or Emergency Department if concerned Check tetanus status Consider safeguarding issues (vulnerable adult or child protection) with human bites particularly where patterns of injury are present. Ref : MTZ_tab_PO_v1.0 Page 4 of 9
Staff Characteristics Professional qualifications Ambulance Paramedic with Paramedic Practitioner Qualification (must have passed minor injury, minor illness and applied pharmacology module or equivalent qualification). Registered Nurse with current Nursing and Midwifery Council (NMC) registration and on SECAmb paramedic practitioner pathway (must have passed minor injury, minor illness and applied pharmacology module). Specialist competencies or qualifications Continuing education & training Has undertaken appropriate training and successfully completed the competencies to undertake the clinical assessment of patient leading to diagnosis that requires treatment according to the indications listed in this PGD. Has undertaken appropriate training for working under PGDs for the supply and administration of medicines. Demonstrates ongoing competency for treating condition indicated for use of each PGD. 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 of practice. Consider discussing with your PP CEM or GP mentor if you have concerns over your ongoing competency. Ref : MTZ_tab_PO_v1.0 Page 5 of 9
Referral Arrangements and Audit Trail Referral arrangements Instruct patient and/or carer to seek advice in the event of condition worsening. Records/audit trail Patient s name, address, date of birth and consent given Contact details of GP (if registered) Diagnosis or working diagnosis Dose and form supplied Batch and expiry details Duration of antibiotic treatment given Advice given to patient (including side effects) Signature/name of staff who administered or supplied the medication Details of any adverse drug reaction and actions taken including documentation in the patient s medical record Referral arrangements (including self-care) Document that patient has received the patient advice leaflet with the medication (where applicable) References/Resources and comments British National Formulary 57 Clinical Knowledge Summaries http://www.cks.nhs.uk/bites_human_and_animal National Electronic Library for Medicines http://www.nelm.nhs.uk/en/originalsearch/?parent=11968&query=metronidazole Ref : MTZ_tab_PO_v1.0 Page 6 of 9
This patient group direction must be agreed to and signed by all health care professionals involved in its use. The NHS Trust should hold the original signed copy. The PGD must be easily accessible in the clinical setting Organisation South East Coast Ambulance Service NHS Trust Ambulance Headquarters The Horseshoe Banstead, Surrey, SM7 2AS Authorisation Organisational authorisation by Name: Position: Paul Sutton Chief Executive Signature: Lead Doctor Name: Dr Jane Pateman Position: Medical Director Date: Lead Allied Health Professional Signature: Date: 25/3/2010 Name: Andy Newton Position: Clinical Director & Consultant Paramedic Signature: Date: 29/3/2010 Lead Pharmacist Name: Ian Bourns Position: Pharmacy Advisor Clinical Governance Lead Signature: Date: 29/3/2010 Name: Nicola Brooks Position: Assistant Clinical Director (Governance) Signature: Date: 25/3/2010 PGD Authored by Name: Andy Collen Position: Head of Programmes & Planning Signature: Date: 25/3/2010 Ref : MTZ_tab_PO_v1.0 Page 7 of 9
Patient Group Direction Peer Reviewed by Name Position Date Andy Collen Head of Programmes and Planning August 2009 Andy Newton Clinical Director August 2009 Jane Pateman Medical Director August 2009 Nicola Brookes Assistant Clinical Director August 2009 Kalvinder Gahir Trust Pharmacist August 2009 Robert Jennings Paramedic Practitioner September 2009 Sally Hills PP CEM September 2009 Stuart Rutland PP CEM September 2009 Nick Best PP CEM September 2009 Andy Parker PP Coordinator September 2009 Ref : MTZ_tab_PO_v1.0 Page 8 of 9
Individual Authorisation 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 scope of practice and in accordance with their own Code of Professional Standards and Conduct. Note to Authorising Managers: authorised staff should be provided with an individual copy of the clinical content of the PGD and a photocopy of the document showing their authorisation. I have read and understood the Patient Group Direction and agree to supply/administer this medicine only in accordance with this PGD. Name of Professional Signature Authorising Manager Date Ref : MTZ_tab_PO_v1.0 Page 9 of 9