Version Control This PGD has been agreed by the following organisations FCMS PDS Medical Doncaster CCG Lancashire CCGs including East Lancashire, Fylde and Wyre and North Lancashire CCGs Change history 10/07/17 V02 Review. No changes needed. 28/08/17 V02 Review. Minor editing changes. 28/08/2017 Page 1 of 7
CLINICAL CONTENT OF PATIENT GROUP DIRECTION Staff Characteristics Qualifications Specialist competencies or qualifications Continuing training and education Registered nurse, Paramedic practitioner, ECP (Paramedic) or Nurse practitioner Received training to undertake administration and supply of medicines under PGD. Has undertaken appropriate training to carry out clinical assessment of patient, leading to diagnosis. Also that such diagnosis requires treatment according to the indications listed in this PGD. 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 and to work within the limitations of individual scope or practice. Clinical Details Indication Local anaesthetic for wound cleaning, wound closure, removal of foreign body(ies), examination and ring block. Inclusion criteria Patients who requires the infiltration of a local anaesthetic to facilitate exploration, inspection, cleaning or closure where there is no known underlying nerve or tendon damage. Exclusion criteria Hypersensitivity to lidocaine, amide anaesthetics or any other constituent of the product. Pregnancy or breast feeding. Aged under 2 years. Wounds beyond the competence of the clinician to appropriately care for / close or procedures beyond their competence. Dental or ocular use. Maximum 1% solution to be used in children under 18 years. Porphyria. Complete heart block. Hypovolaemia. Severe renal impairment (known chronic kidney disease stages 4 or 5, or egfr <30ml/min). Severe hepatic impairment. Patients taking 5HT3 antagonists, anti-arrhythmics, antipsychotics, cimetidine, fluvoxamine, nadolol, propranolol, quinopristin/dalfopristin, saquinavir, timolol, verapamil. Inflamed or infected tissue involved or there is underlying damage to nerve/tendons. 28/08/2017 Page 2 of 7 PGDs should be used only where appropriate, suitable and legal. PGDs should not be routinely used when an independent prescriber is available.
Precautions Use with caution in patients with epilepsy (potential for reduced seizure threshold), respiratory impairment, marked hypoxia, impaired cardiac conduction, bradycardia, severe shock, myaesthenia gravis. The elderly/debilitated patients: use lower doses and titrate more slowly. Hepatic impairment: use lower doses and titrate more slowly. Patients with cardiac failure or following cardiac surgery: use lower doses and titrate more slowly. Patients taking atazanavir, beta-blockers, darunavir, fosamprenavir, lopinavir, oestrogens, phenytoin: use lower doses and titrate more slowly. DO NOT administer intravenously or intra-articularly: take special care when administering to extremities. Facilities for resuscitation MUST be available. The anaesthetic effect may be reduced when infiltrated into an inflamed or infected area. Management of Discuss with GP or Clinical Lead or refer. excluded patients Action for patients not wishing / unable to Make patient aware of risks and potential consequences of not taking medicine. receive care under this Discuss any alternatives if available. PGD Discuss alternative options with GP or Clinical Lead. Document discussion with patient. Description of Treatment Name of medicine Formulation and route Strength Dosage Lidocaine (Lignocaine) Injection 1% injection [10 mg/ml], in 2-mL, 5-mL, 10-mL and 20-mL ampoules 2% injection [20 mg/ml], in 2-mL and 5-mL ampoules Depends on size/number of wound sites. Infiltrate a sufficient dose to ensure wound care can proceed without discomfort to the patient: the lowest possible dose needed to provide anaesthesia should be administered. 1 20 ml of 1% solution (20 ml = 200 mg) or 1 10 ml of 2% solution (10 ml = 200 mg) Repeated dose instructions Duration of treatment 28/08/2017 Page 3 of 7 Maximum dose: Adults: 200 mg. Smaller amounts are often sufficient. Children: 3 mg/kg body weight (must not be greater than 200 mg). Not applicable Once only monitor for 15 minutes post injection for adverse effects
28/08/2017 Page 4 of 7 Patient Group Direction for LIDOCAINE INJECTION (Version 02) Quantity to supply Administration only Legal status POM Special precautions Explain indications, contraindications and cautions (refer to BNF) Adverse effects Adverse reactions rare and usually due to raised plasma concentrations if accidently injected intravascularly, excess dosage or rapid absorption from highly vascular areas. Light-headedness, drowsiness, dizziness, fear, confusion, tremor, tinnitus, blurred or double vision, nystagmus, vomiting, and feeling hot or cold or numb. Twitching. Tremors and paraesthesia. Convulsions, unconsciousness, respiratory depression, hypotension, bradycardia, cardiac arrest and anaphylaxis have been associated with lidocaine. This is not a complete list. Refer to BNF or SPC (summary of product characteristics) for full information. Advice necessary Provide the patient with the manufacturer s Patient Information Leaflet. Advise with reference to the cautionary label. Give advice on practical self-care if appropriate, including management of likely symptoms (including fever management where appropriate). Make patient aware of potential adverse effects and the action to take if they occur. Explain injection may be uncomfortable. Provide appropriate worsening advice describing the range of signs and symptoms to monitor for and the action to take if they occur. Consider whether the provision of health promotion material is appropriate e.g. on smoking or lifestyle factors. Provide any advice relevant to the patient from the Precautions section above. Appropriate follow up wound care advice. Prescribing guidance Doncaster, East Lancashire, Fylde and Wyre and North Lancashire CCG local guidelines. Relevant NICE guidelines and advice from Clinical Knowledge Summaries. Records and Follow Up Referral arrangements Inform GP as soon as possible. Advise if worsening or no improvement to seek further medical advice. Records to be kept Patient s name, address, date of birth and consent given. Contact details of GP (if registered). Diagnosis. Dose and form administered. Batch and expiry details. Advice given to patient (including side effects).
Signature / name of staff who administered or supplied the medication. If relevant, signature / name of staff who removed / discontinued the treatment. Details of any adverse drug reaction and actions taken, including documentation in the patient s medical record. Referral arrangements (including self-care). Any serious side effects attributable to drug should be recorded and medicine management advised via yellow card system found in BNF. Follow up Advise follow up with GP/ Practice nurse. Patient Group Direction, organisation and individual authorisation signatures can be found on the managerial content sheet along with other non-clinical details relating to this patient group direction. 28/08/2017 Page 5 of 7
Patient Group Direction Owner Details of PGD owner FCMS (NW) Ltd Newfield House Vicarage Lane Blackpool FY4 4EW Patient Group Direction Authorisation Lead Doctor MANAGERIAL CONTENT OF PATIENT GROUP DIRECTION Lead Pharmacist Lead Nurse Dr Jonathan Bundy Magnus Hird Alison O Connor Lead Paramedic Organisational Authorisation for FCMS Organisational Authorisation for East Lancashire CCG Gillian Gregory Patient Group Direction Peer Review Reviewed by Wendy Lambert, Nurse Practitioner 28/08/2017 Page 6 of 7
Individual Authorisation BY SIGNING THIS PATIENT GROUP DIRECTION YOU ARE INDICATING THAT YOU AGREE TO ITS CONTENTS AND THAT YOU WILL WORK WITHIN IT. PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. IF THIS IS AN UPDATED OR REPLACEMENT PGD ENSURE THAT ALL OLDER VERSIONS ARE WITHDRAWN FROM USE WITH IMMEDIATE EFFECT. IT IS YOUR RESPONSIBILITY TO MAKE SURE YOU ARE USING THE CURRENT VERSION. NOTE TO AUTORISING MANAGERS: AUTHORISED STAFF SHOULD BE PROVIDED WITH AN INDIVIDUAL COPY OF THE CLINICAL CONTENT OF THIS PGD AND A PHOTOCOPY OF THE AUTHORISATION SHEET SHOWING THEIR AUTHORISATION. Name of Professional Signature Authorising Manager Date 28/08/2017 Page 7 of 7