EK038



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 July 2014 version 1.5 (LC)1.1Laraine Clark10/01/2018Minor wording change to clarify frequency + max. doseDateDateDateDateINSTRUCTIONSStepDetails1Replace 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 ConditionIndication and Inclusion CriteriaFacilitating examination of a painful eye, and/or removal of foreign body, providing temporary pain relief during the investigative stage and in preparation for investigationsExclusion Criteriaany patient with a known history of allergy to Oxybuprocaineanyone presenting with suspected corneal perforation pre-term neonates (BNF: Local anaesthetic eye drops should be avoided in preterm neonates because of the immaturity of the metabolising enzyme system.) Cautions / Need for Further AdviceThe anaesthetised eye should be protected from dust and bacterial contamination. This product should not be used in pregnancy or lactation, unless considered essential by the healthcare professionalConsult the current BNF and/or SPC for full detailsAction if Patient is ExcludedDocument advice given and decision reached.Refer to A+E or Eye clinic as appropriateAction if Patient Declines TreatmentDocument advice given and decision reached.Refer to A+E or Eye clinic as appropriateDrug DetailsName, form and strength of DrugOxybuprocaine hydrochloride eye drops 0.4%w/v ,single dose units Legal StatusPOMIs product a black triangle drug NoIs product being used outside terms of license NoRoute / MethodInstilled topically into the eye. Systemic absorption may be reduced by compressing the lacrimal sac at the medial canthus for a minute during and following the instillation of the drops. (This blocks the passage of the drops via the naso-lacrimal duct to the wide absorptive area of the nasal and pharyngeal mucosa. It is especially advisable in children).DosageFrom SPC: Adults (including the Elderly) and Children: Three drops at 90 second intervals provides sufficient anaesthesia for a foreign body to be removed from the corneal epithelium. Corneal sensitivity is normal again after about one hour. Instil dropwise into the eye according to the recommended dosage.Each single dose unit should be discarded after use.FrequencySee dosage aboveDuration of TreatmentOne course of 3 drops as noted in dosage sectionMaximum or Minimum Treatment PeriodOne course of 3 drops as noted in dosage sectionQuantity to Supply / AdministerA single dose unit which must be discarded after use.Side EffectsTransient stinging and blurring of vision may occur on instillation 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 permittedReporting 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.Advice to Patient The patient/carer should be given the following information verbally and in writing if appropriate and available.Please read the patient information sheet supplied with the medication. Cover eye with an eye pad for 1h after instillation.The anaesthetised eye should be protected from dust and bacterial contamination.Give practical advice on how to avoid further injury and sources of irritation for the duration of the numbing anaesthetic effect on the eye. Patients should be advised not to drive or operate hazardous machinery until normal vision is restored. Follow UpAdvise patient to seek further medical advice if symptoms fail to improve or worsen.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 SPCMinims Oxybuprocaine Hydrochloride 0.4% w/v/20.8.171.8.06NMC (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 2016NICE 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 PractitionerHerne 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: EK038Oxybuprocaine eye dropsExpiry: 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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