Appendix 3 Cardiac Catheter Lab at Musgrove Park Hospital PATIENT GROUP DIRECTION (PGD)

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Appendix 3 Cardiac Catheter Lab at Musgrove Park Hospital PATIENT GROUP DIRECTION (PGD) PGD for the supply/administration of: Lidocaine 1% and Adrenaline 1:200,000 Master document reference number: This PGD is valid for two years from: 2011 Validity expires on: 2012 * (*after this date, the version of the PGD is not valid and cannot be used) Name & contact number of Lead Author: Simon Adams 342067 YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT Indication Legal Classification Inclusion criteria Exclusion criteria Cautions/Seek further Advice For use as a local anaesthetic to subcutaneous skin implantation of Implantable Cardiac Monitors POM Male and female patients who have been assessed by a Cardiologist and deemed suitable for implantation of an Implantable Cardiac Monitor by the Cardiac Nurse Specialist or Cardiac Physiology Specialist. Known hypersensitivity to Lidocaine or Adrenaline or other exipients Injection into appendages Hypersensitivity to parabens Patients with complete heart block IV administration Inflamed or infected tissue Patients with significant renal or hepatic impairment Patients in whom the diagnosis is uncertain Patients who decline to be treated using a PGD Patients who meet any of the above exclusion criteria Patients whose current medication may produce a clinically significant interaction with Lidocaine and adrenaline Patients with epilepsy Patients with respiratory impairment

Action if patient declines or is excluded Patients with impaired cardiac conduction Patients with bradycardia Elderly and or debilitated patients Pregnancy and breast feeding Patients with shock Patients with hypertention Cardiac disease Cerebral insufficiency Hyperthyroidism Advanced diabetes Patients with myasthesia gravis Patients with porphyia Refer to an appropriate medical practitioner as appropriate Document refusal or exclusion in patient s records

:PGD Guide Cardiac Cath Lab Lidocaine 1% and Adrenaline 1:200,000 injection DRUG DETAILS Name, form & strength of medicine Route/Method Lidocaine hydrochloride 1% and Adrenaline 1:200,000 for injection Subcutaneous infiltration Dosage Up to 15ml Frequency As appropriate for skin incision and implantation of device Duration of treatment Maximum or minimum treatment period Quantity to supply / administer Single episode Single episode Up to 15ml SIDE EFFECTS: Side Effects & interactions CNS effects include a feeling on inebriation, lightheadedness, sedation, tingling lips, twitching, confusion and convulsions Respiratory depression Nausea and vomiting. Rarely respiratory derpression Neuropathy Hypotension, bradycardia, cardiovascular collapse (if inadvertently administered IV) Hypersensitivity reactions including urticarial & maculopapular rashes, angioedema & anaphylaxis may occur Use the Yellow Card System to report adverse drug reactions directly to the CSM Please refer to SPC or current BNF for full details Ensure resuscitative equipment is readily avaliable CLINICALLY SIGNIFICANT INTERACTIONS: Anti-arrhythmics Quinupristin and dalfopristin (anti-bacterials) Amprenavir, atazanivir and lopinavir (anti-viral) Propranolol (beta-blocker) Acetazolamide, loop diuretics and thiazides and related diuretics (if hypokalaemic) Cimetidine Cautions with: Tricyclic antidepressants + MAOI may cause prolonged hypertention Please refer to Appendix 1 of the BNF for full details

DRUG DETAILS Advice to patient / carer Provide patient with the relevant patient information leaflet Explain what the treatment is for Explain potential side-effects & interactions as appropriate (see section above). Discontinue treatment if necessary If symptoms persist, condition worsens or adverse event occurs seek further medical advice Follow up If symptoms persist, condition worsens or adverse event occurs seek further medical advice

:PGD Guide Cardiac Cath Lab Lidocaine 1% and Adrenaline 1:200,000 injection STAFF CHARACTERISTICS Professional qualifications Specialist competencies or qualifications Continuing education & training Registered Nurse with a current registration with The Nursing & Midwifery Council (NMC) Registered Cardiac Physiologist with a current registration with Registration council for Cardiac Physiologists (RCCP) Working as a Cardiac Nurse in the Cardiac Cath Lab Working as a Cardiac Physiologist in the Cardiac Cath Lab Has been assessed as being competent to administer Lidocaine 1% and Adrenaline 1:200,000 to patients needing implantation of an implantable Cardiac Monitor. Has undertaken appropriate training to carry out clinical assessment of patients leading to diagnosis that requires treatment according to indications listed in this PGD Has undertaken appropriate training for working under PGDs for the supply and administration of medicines Has undertaken training appropriate to this PGD Has been assessed as competent to use this PGD using agreed competency criteria The practitioner 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 Annual updates as specified above REFERRAL ARRANGEMENTS AND AUDIT TRAIL Referral arrangements Records/audit trail NB. All records should be clear, legible and contemporaneous References / resources & comments An appropriate medical practitioner in Cardiology must be available at all times whilst undertaking the PGD in case of emergency or if further advice is required 1. Complete Personal Record of Drugs Given Under PGD form (Refer to File). Details must include: Patient s name and Unit Number Date of administration Particulars of the medicine supplied i.e. Name, Form, Strength and Dose administered Signatures/names of staff who administered / supplied and checked the medication Any other details specified in the PGD itself 2. Undertake each of the following: Informed verbal consent obtained Advice given to patient (including side effects) Expiry date checked Details of any adverse drug reaction and actions taken including documentation in the patient s medical record (if appropriate) Specific reference/s for condition (eg: Prodigy website) SPC Summary of Product Characteristics for Lidocaine and Adrenaline (Xylocaine) (Link via intranet Medicines Management site) BNF British National Formulary BNF 51 (Link via intranet Medicines Management site)

:PGD Guide Cardiac Cath Lab Lidocaine 1% and Adrenaline 1:200,000 injection 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, Musgrove Park Hospital, Taunton, Somerset, TA1 5DA Aurthorisation Lead Doctor Name: Mark Dayer Position: Cardiology Consultant Lead Nurse Name: Simon Adams Position: Staff Nurse Lead Pharmacist Name: Mark Ashley Position: Senior Clinical Pharmacist Clinical Governance Lead Name: Dr. Cecil Blungart Position: Lead for Clinical Governance, Representative from partnership organisation (if applicable) Microbiology Lead (only needed for PGDs involving anti-microbials) Name: Position: Name: Date Date Patient Group Direction Peer Reviewed by Name Position Date