EK033



Written by:Laraine ClarkSigned by:Senior Clinician:Senior Clinician NamePharmacist:Pharmacist NameNHS Authorising Body:see page 10 Date of Issue:01/12/2017Review Date:31/12/2020DOCUMENT HISTORYVersionAuthorDateMain Changes/CommentsNext Action Required1.0Laraine Clark18/05/2017Based on Dec 2014 version 1.6 (LC)1.1Laraine Clark 25/10/2017Additional monitoring when used for bites(under dosage section)Review group teleconference 1.11.171.2Laraine Clark 01/11/2017Further clarity on use with Doxycycline + Clarithromycin External reviewer1.3Laraine Clark17/11/2017Moved from exclusions to cautions warning on alcohol + hepatic encephalopathy + impairment 1.4Laraine Clark15/01/2018Minor change to wording on sidebar to dose sectionDateINSTRUCTIONSStepDetails1Replace 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 ConditionIndicationAdults and children who have sustained a human/ animal bite wound Inclusion CriteriaManagement of patients with animal or human bite wounds (also those with infected bites) who are known to be allergic to penicillin or cephalosporins.Adults and children over 12 years :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.see relevant PGDs.Exclusion CriteriaKnown hypersensitivity to Metronidazole, or any of the excipients. Active disease of the CNS, Pregnancy or breast feeding, Immunocompromised or known to have a blood disorder (abnormalities of Full Blood Count) Porphyria Patients known to be taking tacrolimus, warfarin, acenocumarol, ciclosporin,phenytoin, barbiturates, lithium or cimetidineCautions / Need for Further AdvicePatients taking Busulfan – risk of toxicity Anyone who will not comply with avoidance of alcohol whilst taking and for 48 hours after completing course of metronidazole (risk of disulfiram-like reaction )Hepatic encephalopathy and hepatic impairmentCheck with patient if taking any current medicines which could give rise to a drug-drug interaction Consult the current BNF and SPC for full details Action if Patient is ExcludedDocument advice given and decision reached.Refer to A+E or GP as appropriateAction if Patient Declines TreatmentSeek medical advice.Document advice given and decision reached.Drug DetailsName, form and strength of DrugMetronidazole tablets 200 mg, Metronidazole suspension 200 mg /5 mlLegal 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 competenciesThe following doses are all licensed doses and appear in SPC :For the indication of Anaerobic infectionAdults and children over 12 years - 400 mg orally three times daily.From BNF for Children:Child 1-2 months 7.5 mg/kg every 12 hoursChild 2 months-12 years 7.5 mg/kg (max. 400 mg) every 8 hoursIn accordance with Public Health England Infection guidance: Treatment must be combined with either Clarithromycin or Doxycycline – see relevant PGDs Patients should be monitored at 24 and 48h, as not all pathogens are covered by these combinations.FrequencyThree times daily – except for younger children + infants when once daily dose can be given – see dosageDuration of Treatment7 daysMaximum or Minimum Treatment PeriodAs aboveQuantity to Supply / AdministerAdults & children over 12 years: Supply one pack of Metronidazole 200 mg x 42 tablets Children under 12 years: Supply one (or two if required) packs of Metronidazole 200 mg/5 mlx 100 mlSide EffectsMost common: are nausea, vomiting, unpleasant taste and gastro-intestinal disturbances. Rashes Rarely: drowsiness, headache, dizziness, ataxia, darkening of urine, erythema multiforme, pruritis, urticaria, angioedema and anaphylaxis 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 InformationThis 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 permittedHuman bites – possibility of blood borne infection + 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+EReporting 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 Advise patient not to drink alcohol whist taking metronidazole and for 48 hours after finishing your course of metronidazole Metronidazole may darken urine. Patients should be warned about the potential for drowsiness, dizziness, confusion, hallucinations, convulsions or transient visual disorders, and advised not to drive or operate machinery if these symptoms occur.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. Metronidazole is not a liver enzyme inducer.Follow UpAdvise patient to seek further medical advice if symptoms worsen or fail to improve after 3 days.With GP if necessary.Error 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 settingStaff 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 SPCFlagyl 200mg tablets1.11.176.02.17Metronidazole suspension 200mg/5ml. (Rosemont Pharmaceuticals) 1.11.1719.06.17NMC (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:Bethan HaskinsChief of Nursing Quality and SafetyAlison Brett (Interim Chief)Position:Chief Nurse for NHS Ashford CCG and NHS Canterbury and Coastal CCGSignature: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 PracticeNick BestLead Clinical Practitioner Herne Bay Integrated Care CentreSheila Brown Head of Medicines ManagementCanterbury & Coastal CCGLaraine Clark Pharmacist Reviewed at PGD Review Meeting on: 28/09/2017Responsibilities 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: EK033MetronidazoleExpiry: December 2020PGDs 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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