EK012



Written by:Laraine ClarkSigned by:Senior Clinician:Senior Clinician NamePharmacist:Pharmacist NameNHS Authorising Body:see page 10 Date of Issue:28/11/2018Review Date:28/11/2021DOCUMENT HISTORYVersionAuthorDateMain Changes/CommentsNext Action Required1.0Laraine Clark18/05/2017Based on June 2014 version 1.5 (LC)Review group teleconference 1.11.171.1Laraine Clark 01/11/2017Clarified options for treatment in patients excluded due to penicillin allergy External reviewer1.2Laraine Clark 09/11/2017Added ‘assess for risk’ ( of blood borne infection) to special considerations human bites External reviewer1.3Laraine Clark 16/11/2017Slight change to wording ‘assess risk of tetanus, rabies, HIV, hepatitis B/C’1.4Laraine Clark15/01/2018Changed inclusion for 6months old for bites1.5Laraine Clark 17/10/2018Removal of exclusion for patients taking MethotrexateINSTRUCTIONSStepDetails1Replace all the green text in this document with organisation specific data & dates as shown.2Read all of the draft content for the specified medication details. These have been provided based on previous PGD documentation (version shown above where available) and are there to assist the provider organisation. They should be confirmed and amended as required.3NHS Authorising Body. Check page and amend above as required.YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO ITClinical ConditionIndicationFor the treatment and prophylactic treatment of animal + human bites Inclusion CriteriaHuman bites – prophylactic treatment is advised. Infected animal biteAnimal bite that requires prophylactic treatment due to HIGH RISK of infection and where the patient presents within 24 hours of the bite. High risk wounds includeA deep puncture-type bite that cannot be easily cleaned e.g. cat biteBites of the hand, foot, joint, tendon, ligament or faceA wound in an immunocompromised patient including patients with asplenia, diabetes, mastectomy, liver disease or prescribed systemic corticosteroid therapyA wound in an elderly patientA wound in a patient with a prosthetic heart valveTopical cleansing, irrigation and debridement should be completed as necessaryExclusion CriteriaA patient presenting with a suspected deep wound (e.g. deep structures such as tendon or joint capsule visible) or moderate to severe wound (especially if crush injuries or oedema are present) must be referred immediately to A+E for consideration of surgical exploration and irrigation.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 A+E.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 Children <6 months oldPatient not suitable for Co-amoxiclav treatment due to - Penicillin hypersensitivityHistory of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam).A previous history of co-amoxiclav/penicillin-associated jaundice / hepatic dysfunctionHepatic impairmentRenal impairmentGlandular feverCytomegalovirus infectionAcute or chronic lymphocytic leukaemiaCautions / Need for Further AdvicePatients on combined oral contraceptives –see section on advice for patient/carerPatient taking Mycophenolate to prevent transplant rejection – plasma concentration possibly reduced by co-amoxiclav Patients taking Methotrexate should be advised to withhold their next dose (or doses, and folic acid if prescribed) until this course of antibiotic is finished, and they are infection free. They can then restart Methotrexate treatment on their usual day of the weekCheck with patient if taking any current medicines which could give rise to a drug-drug interaction Consult the current BNF and/or SPC for full detailsAction if Patient is Excluded Document advice given and decision reached.Refer to A+E if appropriatePenicillin (or other beta lactam) allergic individuals may be offered the following treatment under the relevant PGDs:Adults: Metronidazole PLUS Clarithromycin (human bites) Metronidazole PLUS Doxycycline (cat,dog bites) Children under 12 years :Metronidazole PLUS Clarithromycin (human, and cat, dog bites) AND must be reviewed again after 24h and 48h, as not all pathogens are covered. Action if Patient Declines TreatmentSeek medical advice.Advise patient of possible consequences of refusing treatment and of alternative sources of treatmentDocument refusal and advice given in patient’s recordDrug DetailsName, form and strength of DrugCo-amoxiclav 625mg tablets (contains 500mg amoxicillin and 125mg clavulanic acid) Co-Amoxiclav 125 / 31 oral suspension Co-Amoxiclav 250 / 62 oral suspension Legal StatusPOMIs product a black triangle drug NoIs product being used outside terms of license NoRoute / Method ORALDosagePlease note-although a range of doses are provided here, practitioners should ONLY supply for children within the age range specified for their contracted service AND within the bounds of their professional competenciesFrom BNF :Adults and children over 12 years: One 625mg tablet Children aged from 1-11months : 0.25ml/ kg (doubled in severe infection)Children aged from 1y to 6 years: One 5ml spoonful of 125/31 suspension Children aged from 6y to12 years: One 5 ml spoonful of 250/62 suspensionNo dose adjustment needed in elderly.No dose adjustment needed where Creatinine clearance is greater than 30ml/minFrequencyEvery 8 hours Duration of Treatment7 DAYS, or until the bottle of suspension is finished Maximum or Minimum Treatment Period7 DAYSQuantity to Supply / AdministerAdults and children over 12 years: 21 tabletsChildren aged from 1y to 6 years: 100mls of 125 / 31 suspension Children aged from 6y to 12 years: 100mls 250 / 62 suspension Side EffectsDiarrhoea, indigestion, nausea and vomiting are common side effects. To reduce GI side effects advise the patient to take at the start of a mealMucocutaneous candidiasis has been reported.Antibiotic-associated colitis (including pseudomembranous colitis and haemorrhagic colitis) has been reported rarely. As with other antibiotics the incidence of gastrointestinal side effects may be raised in children under two years. In clinical trials, however, only 4% of children under two years were withdrawn from treatment. Superficial tooth discolouration has been reported rarely, mostly with the suspension. It can usually be removed by brushing.This list may not represent all reported side effects of this medicine. Refer to the most current BNF and/or SPC for more information. Special Considerations and Additional InformationHuman bites – possibility of blood borne infection so assess risk of tetanus, rabies, HIV, hepatitis B/C + need for post-exposure prophylaxis – if needed must be referred to A+EAnimal bites – assess for risk of tetanus and rabies + need for post-exposure prophylaxis – if needed must be referred to A+EWarfarin, acenocoumarol (nicoumalone) and phenindione anticoagulants; the INR may be altered by co-amoxiclav. Practitioners must check that the patient’s latest INR is up to date and within the target therapeutic range as stated in the patient’s yellow anticoagulant record bookIf the latest INR is up to date and within the therapeutic range then patient may be supplied with co-amoxiclav but must be advised to contact their usual anticoagulant clinic to inform their clinic that they have been prescribed co-amoxiclav. The patient will usually be asked to attend for an INR testIf the latest INR is out of date, out of therapeutic range or unknown then the patient is excluded from supply under this PGD and must be referred to their GP or A+E as appropriate.This PGD is only for use when providing NHS treatment to patients in primary care settings by Organisation Name staffUnder a PGD medication can only be supplied when :the Healthcare Professional (HCP) has had a face to face consultation with the patient the HCP administers or supplies directly to the patient . Supply via a third party is not permitted.Reporting procedure of Adverse ReactionsAll adverse reactions (actual and suspected) will be reported to the Patients own GP Where appropriate, a Yellow Card Report will be sent to the Commission on Human Medicines.? A supply of these forms can be found at the rear of the BNF. Alternatively, a report can be submitted electronically via using the yellow card system always remains the responsibility of the healthcare professional who supplies and/or administers a medication.Additional Facilities and SuppliesLockable storage cupboard Product information leafletCurrent BNF or access to Access to working telephoneSuitable waste disposal facilitiesPatient education leafletsAnaphylaxis kitSuitable refrigeration facilities where items require storage between +2° - +8° Celsius.Public Health England Infection guidance see Faculty of Sexual and Reproductive Healthcare (January 2017) to Patient The patient/carer should be given the following information verbally and in writing if appropriate and available.Please read the Patient Information Leaflet provided with the product The patient should be advised to complete the courseFor children under 12 years of age the parent/guardian must be advised to store the reconstituted suspension in the fridge and to discard the remaining suspension when the course is completePregnancy and breastfeeding – not known to be harmful Women taking Oral Contraceptives: .Latest recommendations are that no additional contraceptive precautions are required when combined oral contraceptives are used with antibacterials that do not induce liver enzymes, unless diarrhoea or vomiting occur. These recommendations should be discussed with the woman, who should also be advised that guidance in patient information leaflets may differ. Co-amoxiclav is not a liver enzyme inducerHypersensitivity reactions: The patient should be warned to discontinue treatment and seek medical advice if hypersensitivity reactions occurBreast feeding: BNF states appropriate to use . Advise patient to seek immediate medical advice however, if the infant shows any symptoms of a hypersensitivity reaction Follow UpThe patient should be advised to contact their GP if there is no improvement or if the presenting complaint worsens after two or three days of antibiotic treatmentError ReportingAs per the Organisation Name incident reporting policy.In addition incidents, near misses or errors should also be reported via the NPSA system at which is applicable to a GP practice or Out of Hours setting.Staff CharacteristicsQualificationsIs a:Registered Nurse (Nursing and Midwifery Council: NMC)Pharmacist (General Pharmaceutical Council).Paramedic (UK Health & Care Professions Council: HCPC) with a current professional registration.Other (to be agreed).Specialist Competencies or QualificationsThe registered HCP must complete the declaration on the PGD section for each commissioned service in which they are delivering services under this PGDThe registered HCP must hold a full Nurse Practitioner degree,ORhave passed the following modules from the nurse practitioner degree: Minor Illness management, Consultation and Clinical Examination.ORhave passed the following paramedic practitioner modules: Clinical Reasoning in Physical Assessment (CRIPA), Management of Minor Health Problems and Drugs and Therapeutics.ORhave relevant and documented clinical experience in an appropriate healthcare role and qualifications equivalent to those already cited.The HCP must fulfil the competency framework as reviewed annually.The registered HCP must have completed their annual Resuscitation training (Basic Life Support) within the last 18 months. The registered HCP is willing to be professionally accountable for this work as defined in their Code of Professional Conduct and Ethics.Continuing Training & EducationThe registered HCP 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 (CPD) in line with post registration and practice (PREP/CPD) and to work within the limitations of individual scope of practice.The registered healthcare professional should be aware of local benchmarking policies regarding the stewardship of the medication that is the subject of this PGD.Referral Arrangements and Audit TrailReferral ArrangementsAs per local arrangementsRecords / Audit TrailIn all cases records must be made in electronic/paper clinical record and should include:Patient’s name and date of birth That the medication has been given by the healthcare professional under PGDBrand, batch number and expiry date of medication Date and time givenSignature and printed name of staff who administered or supplied the medicationThe diagnosis as per inclusion criteriaDetails of any adverse drug reaction and actions taken including documentation in the patient’s clinical record Advice given to patient (including side effects)Referral arrangements (including self-care)Each pack of medication to be labelled with patient’s name and date of supply (only where supply permitted under PGD)Guidance/References/ Resources and CommentsBNF/cBNF onlineSummary Product Characteristics (SPC): Generic or brand nameAccessed on:Date of last text revision of SPCAugmentin 625mg tablets20.07.1726.08.15Augmentin 125/31 and 250/62 SF suspension20.07.1724.05.17NMC (2007) Standards for Medicines ManagementNMC (2015) The CodeStandards of Proficiency-Paramedics Health Professions Council Sept 2014Standards of Conduct, Performance and Ethics Health and Care Professions Council January 2016PHE Summary tables 2017 MPG 02 Patient Group Directions August 2013.This PGD must be agreed to and signed by all registered healthcare professionals involved in its use. Organisation Name (Main office) will hold the original signed copy. The PGD must be easily accessible in the clinical anisationOrganisation NameAuthorisationNHS Authorising Body Signature Name:Sarah VauxPosition:Chief Nurse for East Kent CCGsSignature:Date: Name:Position:Signature:In the event that the above is not available then deputy to sign:Dr. Simon Lundy Clinical Lead Deputising for Clinical Chair Canterbury and Coastal CCG Date: Organisation NameSignatoriesSignature:SENIOR CLINICIANName:Click here to enter text.Position:Signature:Date: PHARMACISTName:Click here to enter text.Position: Signature:Date: Patient Group Direction Reviewed byNamePositionOrganisationDr.Richard Brice GP Prescribing Lead Whitstable Minor Injuries ServiceDr Daniel MooreGP Prescribing LeadFaversham Medical PracticeDr Jeremy CarterGP Prescribing LeadPark Medical Practice (Herne Bay ICCU)Kathy EllisLead Nurse/Advanced Nurse PractitionerWhitstable Medical PracticeHeidi EdmundsLead Emergency Nurse PractitionerWhitstable Medical PracticeSheila Brown Head of Medicines ManagementCanterbury & Coastal CCGLaraine Clark Pharmacist Reviewed at PGD Virtual Review Meeting on: 16/08/2018Responsibilities of the Contracted Service Provider (e.g. General Practice, Community Pharmacy), Their Lead Or Their Nominated Deputy The contracted service provider, their lead or their nominated deputy will be responsible for ensuring that:PGDs are implemented within a robust clinical governance structure The most recent, in date version of all PGDs are implemented and in use in all relevant areasAny expired or abandoned PGDs are removed from practice and the date of change recorded in case of any litigation following an incidentThe CCG is informed of any changes to services that may affect how the PGD is used in practice e.g. increased cohort of non-medical prescribers/change in demographics.There is a process in place to train registered healthcare professionals who will work under the PGDs, relating to both the clinical management and legal aspects of the PGD and the service.There is a process in place whereby registered healthcare professionals are deemed competent and given individual authorisation to practice under the PGDs. The record of authorisation (see overleaf) has been signed by both the registered Healthcare Professional and the Contracted Service Provider or their nominated deputy.The original signed copy of the record of authorisation is retained by the Contracted Service Provider.The registered Healthcare Professional is provided with a copy of the signed record of authorisation as their record to supply medication under this PGD for this provider. All authorised registered Healthcare Professionals are supplied with an up to date hard copy of this PGD if requested.There is a mechanism in place to authorise, record and maintain a list of those registered healthcare professionals approved under the PGD and this record is available to the CCG on request. Any incidents, near misses, or errors are reported via the NPSA system at which is applicable to a GP practice or Out of Hours setting.PGDs are audited annually and the results of audits are available to the CCG.PGDs for antimicrobials are audited annually in line with the CCG’s recommendations to practices and the results of audits are submitted to the Antibiotic Stewardship Group.Multiple practitioner authorisation sheetPGD: EK012Co-Amoxiclav v.5Expiry: November 2021PGDs 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.Practitioner’ declarationI confirm that I have read and understood the content of this PGD and that I am willing and competent to work under it within my professional code of conduct.I confirm that I will only supply for children within the age range specified for the contracted service AND within the bounds of my professional anisation Name is contracted to provide a service for children aged xx months and over.By signing this patient group direction you are indication that you agree to its contents and that you will work within it. I confirm that I have read and understood the content of this Patient Group Direction and that I am willing and competent to work to it within my professional code of conduct.NameDesignationSignatureDateAuthorising ManagerI confirm I have read and understood the responsibilities of Organisation Name . I confirm that the practitioners named above have declared themselves suitably trained and competent to work under this PGD. I give authorisation on behalf of Organisation Name for the above named health care professionals who have signed the PGD to work under it.NameDesignationSignatureDateNote to Authorising ManagerScore through unused rows in the list of practitioners to prevent additions post managerial authorisation and use a further sheet for any additional staff. This authorisation sheet should be retained to serve as a record of the practitioners authorised to work under this PGD. ................
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