Document Details Title Co-amoxiclav 250/125 tablets, co-amoxiclav 500/125 tablets, co-amoxiclav 125/31.25 oral suspension and co-amoxiclav 250/62 oral suspension Patient Group Direction (PGD) Trust Ref No 1615-50625 Local Ref (optional) Main points the Broad Spectrum Antibiotic for the treatment of animal document covers and human bites Who is the document Appropriately trained healthcare professionals within aimed at? Minor Injury units (MIU), prison service and DAART Owner Susan Watkins Approval process Approved by Quality and Safety Delivery group (Committee/Director) Approval Date 16 th January 2019 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 31 st December 2020 Distribution Who the policy (PGD) MIU, prison service, DAART will be distributed to Method Required by CQC Required by NHLSA Other Email notification of entry onto webpage Document Links Amendments History No Date Amendment 1 September 2014 Scheduled review. Minor changes to referral pathway 2 December 2015 Addition of higher strength. Approved by Dr Damoa- Saikwan, SaTH Microbiologist 3 December 2017 Schedule review. Dose update and extra cautions added. 4 November 2018 Addition of prison service, Standardised wording in record keeping section. Page 1 of 8
PATIENT GROUP DIRECTION co-amoxiclav 250/125 and 500/125 tablets and co-amoxiclav 125/31 and 250/62 Oral Suspension Original PGD prepared by: (author / owner) Updated Updated Gilly Scott Clinical lead for MIU/DAART Diane Kitching Community Health Services Pharmacist governance Diane Kitching Lead Pharmacist for Children s and governance 11/9/2012 08/11/2017 14/11/2018 If any Peer review by Dr signatures S Damoa-Saikwan are missing below, then the PGD is not valid Consultant APPROVED microbiologist, FOR USE Shrewsbury BY: Medicines and Telford Management Hospitals Group Doctor Dr Emily Peer Associate Medical Director 14/11/2018 Pharmacist Susan Watkins Chief Pharmacist 29/11/2018 RATIFIED BY: Quality & Safety Delivery Group Governance Lead Alison Trumper Associate Director for Quality 16/01/2019 Page 2 of 8
STAFF CHARACTERISTICS Employed by or contracted to Shropshire Community Health NHS Trust Registered healthcare professional 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 patient group direction (PGD). The healthcare professional provide evidence of training, annual updates and continuing professional development to support their competency. The clinical manager has proof of training by the health care professional on the legal aspects of supply or administration of medicines under a PGD The clinical manager has assessed the competency (against the NPC framework) of the healthcare professional to work to a PGD at least every 2 years. The registered healthcare professional has undertaken training and annual updates in the recognition and treatment of anaphylaxis, including practical in basic life support (BLS) and has immediate access to an in-date supply of adrenaline 1mg in 1ml (1:1000) at the time of the consultation. The registered healthcare professional 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 registered healthcare professional needs to re - enforce and update their knowledge and skills in this area of practice with particular reference to changes and national directives, along with a clear understanding of the drug to be supplied including side effects and contraindications. The registered health care professional 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 8
CLINICAL CONDITION Clinical need addressed Inclusion criteria Treatment of infected animal and human bites. Prophylaxis of animal and human bites <48-72 hours old when infection risk is high. Adults and children over one year with a human or animal bite Bites with associated redness, swelling, serosanguinous or purulent discharge, pain, localised cellulitis, lymphadenopathy or fever Animal or human bite that requires prophylactic treatment due to the high risk of infection. High risk wounds include: All cat bites under 48 hours old All human bites under 72 hours old Any bite causing a deep puncture Wounds that require closure due to excessive bleeding Bites to the hand, foot or face Wounds that involve joints, tendons, ligaments Wounds in people with prosthetic joints or valves Patients who are diabetic, asplenic, cirrhotic or immunosuppressed, who have had a mastectomy, or who have lymphoedema after radiotherapy 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 but it would be outside its remit and another form of authorisation will be required Orbital cellulitis immediate referral to Ophthalmologist needed Facial cellulitis refer to an appropriate prescriber or to Accident and Emergency Department as appropriate A patient presenting with a suspected deep wound (e.g. deep structures such a tendon or joint capsule visible) or moderate to severe wound (especially if crush injuries or oedema are present) must be referred immediately to an Accident and Emergency Department (AED) for consideration of surgical exploration and irrigation Extensive or multiple bites refer to maxillofacial where appropriate or otherwise to Accident & Emergency Department Immunocompromised patients who have active infection present (refer urgently to GP or AED if active infection present) Patient not suitable for Co-amoxiclav treatment (see alternative PGD for penicillin allergic patients) due to - hypersensitivity to penicillins or cephalosporins or other beta lactam agent ie carbapenem or monobactam hypersensitivity to co-amoxiclav or product excipients A previous history of co-amoxiclav/penicillin-associated jaundice / hepatic dysfunction Hepatic impairment Renal impairment with egfr<30 Glandular fever avoid use of co-amoxiclav if infectious mononucleosis is suspected since the occurrence of a morbilliform rash has been associated with this condition following the use of amoxicillin Cytomegalovirus infection Acute or chronic lymphocytic leukaemia A patient presenting with any other category of moderate to severe wound (e.g. adjacent to a prosthetic joint or in the genital area) or in any case where the practitioner feels the wound is outside their field of clinical competence must be referred immediately to AED Page 4 of 8
Children less than 12 months old A patient presenting later than 48 hours for animal bite, or 72 hours for human bite, that does not show signs of infection and is not considered to be high risk.( Antibiotics are not generally needed if the wound is more than 2 days old and there is no sign of local or systemic infection) Superficial bites involving the epidermis only Patients taking warfarin, acenocoumarol (nicoumalone) or phenindione whose latest INR is out of therapeutic range, out of date or unknown (refer to GP) Patients taking allopurinol, probenecid, mycophenolate, sulfinpyrazone or methotrexate Pregnancy and breast feeding, refer to an appropriate prescriber as coamoxiclav should only be used if the potential benefits outweigh the potential risks of treatment. Caution / need for further advice Management of excluded patients Action for patients not wishing to receive care under this PGD Patients on coumarin anticoagulants like warfarin will need INR check, usually within 5-7 days. Patients are encouraged to maintain adequate fluid intake, particularly if catheterised. Refer to child protection protocols if child presents with adult bites or signs of neglect Referral to doctor,independent prescriber or other appropriate service if necessary Document action and advice given Refer to doctor, independent prescriber, or other service as necessary Page 5 of 8
Drug details Name form and strength of medicine Legal classification Black triangle warning? Use within licence? Yes Route / method Orally Dose / Frequency/ total maximum dose ADULT: Co-amoxiclav 250/125 tablets Co-amoxiclav 500/125 tablets Co-amoxiclav 125/31 oral suspension Co-amoxiclav 250/62 oral suspension POM No Over 40kg - one 500/125mg tablet every 8 hours Under 40kg - one 250/125mg tablet every 8 hours Quantity to be supplied or administered CHILD : 1 5 years - 5 ml of 125/31 suspension three times a day (every 8 hours) 6 12 years - 5 ml of 250/62 suspension three times a day (every 8 hours) 12-17 years - one 250/125 strength tablet three times a day (every 8 hours), increasing to 500/125mg tablet for severe infections. Seven days Side effects Refer to the full list of side effects that can be found within the summary of product characteristics (SPC) Suspected adverse reactions to Common - diarrhoea, indigestion, nausea vomiting and mucocutaneous drugs including vaccines should be reported on the yellow card candidiasis available at the back of the BNF. Also reports of. hepatitis, cholestatic jaundice; Stevens-Johnson Also at www.yellowcard.gov.uk syndrome, toxic epidermal necrolysis, exfoliative dermatitis, vasculitis reported; rarely prolongation of bleeding time, dizziness, headache, convulsions (particularly with high doses or in renal impairment); superficial staining of teeth with suspension. Advice to patient / carer Co-amoxiclav suspensions may contain aspartame, a source of phenylalanine. This medicine should be used with caution in patients with Phenylketonuria. Discuss the patient s dietary regime to assess if suitable for them to take this preparation Space the doses evenly throughout the day. Keep taking this medicine until the medicine is finished, unless you are told to stop. Administer at the start of a meal to minimise potential gastrointestinal intolerance and optimise absorption of amoxicillin/clavulanic acid. Superficial tooth discolouration has been reported rarely, mostly with the suspension. It can usually be removed by brushing Contraceptives: Additional contraceptive precautions are not required during or after courses of antibiotics that do not induce liver enzymes updated advice http://www.fsrh.org/pdfs/ceuguidancedruginteractionshormonal.pdf ] Contact usual anticoagulant clinic for INR test within 5-7 days of starting antibiotic. Explain to clinic that antibiotics have been commenced If not responding to treatment, advise patient to consult GP 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. Referral to doctor, independent prescriber, or other service 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, GP and allergies Reason for inclusion / exclusion and consent obtained Manufacturer / brand of product, strength, batch number, expiry date Dose Date of administration, and 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 74 ( Last accessed 21.11.17) Summary of Product Characteristics available at< www.medicines.org.uk>. Last accessed 14.11.17 CKS. Animal and Human bites. Available at < https://cks.nice.org.uk/bites-human-and-animal>. Last accessed 21.11.17. Community Antibiotic Policy v5.1 May 2015 SaTH microbiology accessed 14.11.18 via Telford and Wrekin CCG microapp Page 7 of 8
Register of healthcare professionals qualified to administer and / or supply co-amoxiclav 250/125, 500/125 tablets co-amoxiclav 125/31 and 250/62 Oral Suspension 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 8 of 8