NHSG/PGD/lido_eton/MGPG412 Organisation Wide

Title: Patient Group Direction For The Administration Of Lidocaine 2% Injection For The Insertion/Removal Of The 68mg Etonogestrel Contraceptive Implant By Nurses And Midwives Working Within NHS Grampian Identifier: NHSG/PGD/lido_eton/MGPG562 Replaces: Across NHS Boards NHSG/PGD/lido_eton/MGPG412 Organisation Wide Directorate Clinical Service Sub Department Area Yes This controlled document shall not be copied in part or whole without the express permission of the author or the author s representative. Author: Subject Key word(s): Policy application: Purpose: CHP Lead Pharmacist Patient Group Direction PGD patient group direction nurse midwife lidocaine injection etonogestrel contraception NHS Grampian This Patient Group Direction (PGD) authorises appropriately qualified and trained nurses and midwives to administer lidocaine injection 2% for the insertion/removal of the 68mg etonogestrel contraceptive implant to individuals without the requirement for a patient specific prescription written by a medical practitioner. Responsibilities for implementation: Organisational: Corporate: Departmental: Area: Hospital/Interface services: Operational Management Unit: Policy statement: Review: Chief Executive and Management Teams Senior Managers Heads of Service/Clinical Leads Line Managers Assistant General Managers and Group Clinical Directors Unit Operational Managers It is the responsibility of individual nurses and midwives and their line managers to ensure that they work within the terms laid down in this PGD and to ensure that staff are working to the most up to date PGD. By doing so, the quality of the services offered will be maintained, and the chances of staff making erroneous decisions which may affect patient, staff or visitor safety and comfort will be reduced. Supervisory staff at all levels must ensure that staff using this PGD act within their own level of competence. This policy will be reviewed at least every two years or sooner if current treatment recommendations change. UNCONTROLLED WHEN PRINTED Review Date: March 2015 Identifier: NHSG/PGD/lido_eton/MGPG562 - i -

This document is also available in large print and other formats and languages, upon request. Please call NHS Grampian Corporate Communications on (01224) 551116 or (01224) 552245. Responsible for review of this document: Responsible for ensuring registration of this document on the NHS Grampian Information/ Document Silo: Physical location of the original of this document: Job/group title of those who have control over this document: Responsible for disseminating document as per distribution list: CHP Lead Pharmacist Medicines Management Pharmacist Pharmacy and Medicines Directorate CHP Lead Pharmacist CHP Lead Pharmacist Revision History: Date of Approval change date of PGD that is being Summary of Changes Section heading superseded Jan 2013 Jan 2011 2 yearly update into new template Mar 2013 Jan 2011 Addition of injection to title Throughout Mar 2013 Jan 2011 Use only for implant insertion/removal added Purpose UNCONTROLLED WHEN PRINTED Review Date: March 2015 Identifier: NHSG/PGD/lido_eton/MGPG562 - ii -

Patient Group Direction For The Administration Of Lidocaine 2% Injection For The Insertion/Removal Of The 68mg Etonogestrel Contraceptive Implant By Nurses And Midwives Working Within NHS Grampian Contents Part A Specific Drug Information Page No 1 Introduction 2 2 Clinical Decision Making 2 2.1 Patients who may be considered for the administration of lidocaine 2 2% injection 2.2 Patients who may receive the administration of lidocaine 2% injection 2 2.3 Contraindications 2 2.4 Precautions 3 2.5 Action to be taken when a patient is excluded from treatment under 3 this PGD 2.6 Action to be taken when a patient does not wish to receive treatment 3 under this PGD 3 Description Of Treatment Available Under This PGD 3 3.1 Lidocaine 2% Injection 3 3.2 Dose, route and frequency 3 3.3 Concurrent medication 4 3.4 Adverse effects 4 3.5 Advice to patient 5 3.6 Follow up treatment 5 Part B PGD General Information 4 Designated Staff Authorised To Administer Under This PGD 6 5 Documentation 7 5.1 Authorisation of administration 7 5.2 Record of administration 7 5.3 Consent 8 6 Further Points 8 7 Facilities And Supplies To Be Available At Sites For The 8 Administration Of The Drug Specified In The PGD 8 Audit 8 Part C PGD Specific Information 9 Management And Monitoring Of Patient Group Direction 9 9.1 Consultative group 9 9.2 Professional advisory group approving PGD 9 9.3 Authorising managers 9 10 References 9 Appendix 1 - Health Care Professional Agreement To Administer 10 Medicines Under Patient Group Direction Appendix 2 - Certificate Of Competence To Administer Medicines Under Patient Group Direction 11 UNCONTROLLED WHEN PRINTED Review Date: March 2015 Identifier: NHSG/PGD/lido_eton/MGPG562-1 -

Patient Group Direction For The Administration Of Lidocaine 2% Injection For The Insertion/Removal Of The 68mg Etonogestrel Contraceptive Implant By Nurses And Midwives Working Within NHS Grampian 1. Introduction Part A This patient group direction (PGD) will allow nurses and midwives to be authorised to subcutaneously administer lidocaine 2% injection to individuals prior to the removal or insertion of the 68mg etonogestrel contraceptive implant. This PGD should be used in conjunction with the PGD for the insertion of the 68mg etonogestrel contraceptive implant which is available under PGD for women aged from 14 years up to and including 49 years. This PGD should be used in conjunction with the recommendations in the current British National Formulary and individual Summary of Product Characteristics. 2. Clinical Decision Making 2.1. Patients who may be considered for the administration of lidocaine 2% injection Women who require the insertion or removal of the 68mg etonogestrel contraceptive implant. 2.2. Patients who may receive the administration of lidocaine 2% injection All patients in 2.1 above, who do not want specifically to consult with a doctor and are willing to have treatment from the nurse or midwife 2.3. Contraindications Patients may be administered lidocaine 2% injection under this PGD unless they have known anaphylactic hypersensitivity to lidocaine or any of the excipients. Also, under this PGD, subcutaneous lidocaine 2% injection for 68mg etonogestrel contraceptive implant insertion/removal should not be administered to patients with the following personal or medication history: (i) Age less than 14 years. (ii) Current venous thrombosis/thromboembolism. (iii) Porphyria. UNCONTROLLED WHEN PRINTED Review Date: March 2015 Identifier: NHSG/PGD/lido_eton/MGPG562-2 -

(iv) Previous adverse reaction to local anaesthesia. A careful history of reason for the previous local anaesthesia and exact adverse reaction must be taken. (v) Medication as detailed in Section 3.3. 2.4. Precautions Lidocaine should be used with caution in patients with: epilepsy, impaired cardiac conduction, congestive cardiac failure, bradycardia or impaired respiratory function and impaired hepatic function. 2.5. Action to be taken when a patient is excluded from treatment under this PGD If a patient is excluded from treatment under this PGD, medical advice should be sought refer to a doctor. 2.6. Action to be taken when a patient does not wish to receive treatment under this PGD The patient should be advised of the risks of not receiving the administration of lidocaine 2%. The 68mg etonogestrel contraceptive implant insertion or removal should not proceed under PGD. 3. Description Of Treatment Available Under This Direction 3.1. Lidocaine 2% Injection Lidocaine 2% is a Prescription-only Medicine (PoM). Lidocaine 2% is an amide local anaesthetic. It is supplied as a clear solution in sterile ampoules. Lidocaine 2% injection without adrenaline should be used under this PGD. 3.2. Dose, route and frequency The lidocaine 2% solution should be drawn up from the ampoule into a sterile syringe using an 18G (green) needle and aseptic technique. The skin at the injection site should be cleaned with an antiseptic solution/gel/alcohol swab and it must be allowed to evaporate (dry) before injection. Do not physically dry the site or remove the agent by the use of cotton wool. N. B. The maximum safe dose of 2% lidocaine is 10mL. When used for simultaneous removal and insertion of the 68mg etonogestrel contraceptive implant the volumes used for insertion (5mL) and removal (2mL) are lower than this threshold. For implant insertion: Lidocaine 2% is injected subcutaneously along the planned line of implant insertion on the medial aspect of the upper arm. The needle should be inserted subcutaneously and 0.5mL injected directly below the insertion point. UNCONTROLLED WHEN PRINTED Review Date: March 2015 Identifier: NHSG/PGD/lido_eton/MGPG562-3 -

The needle should then be inserted subcutaneously in the line of implant insertion to its full length (3.5cm) and the syringe drawn back to confirm the tip is not within a blood vessel. Approximately 2.5mL of lidocaine 2% should be injected evenly along the subcutaneous needle track as the needle is withdrawn. Maximum dose for insertion under this PGD is 5mL. A sterile swab should be placed over the injection site in case of bleeding. For implant removal: Between 0.5-2mL lidocaine 2% is injected subcutaneously directly beneath the distal tip of the implant to be removed. Maximum dose for removal under this PGD is 2mL. The position for injection is identified by first pushing the proximal end of the implant distally and towards the skin surface. The lidocaine 2% should be injected beneath the position of the distal tip when this pressure is exerted. After 3 minutes the anaesthetic effect should be tested by light pressure on the overlying skin with the needle tip. The patient may be aware of pressure but should not feel any sharp sensation. If the area is numb, proceed with implant removal. If after a maximum of 2mL has been injected and a painful sharp sensation is still felt with needle pressure, refer to doctor. An increased local anaesthetic dose may be needed. 3.3. Concurrent medication Women on a therapeutic dose of anticoagulant drugs such as heparin or warfarin have a higher risk of bleeding/haematoma with subcutaneous injection and are not suitable for treatment under this PGD. The cardiac depressant effects of lidocaine are additive to those of other antiarrhythmic agents. Patients on these medicines must be referred to a doctor. 3.4. Adverse effects Subcutaneous injection of lidocaine 2% is associated with initial stinging followed by loss of sensation to pain in the injected area. The anaesthetic effect may last for 30-60 minutes. There may be a continued awareness of touch/pressure in an effectively anaesthetised area. There may be transient local swelling and erythema at the injection site. Subcutaneous injection as described in 3.2 should not be associated with systemic side effects. Inadvertent intravascular injection may cause dizziness or paraesthesia. If this occurs, stop injecting, calmly call for assistance. Lidocaine 2% is rapidly metabolised and any symptoms should resolve in 15-20 minutes. Allergy to lidocaine 2% is very rare. Symptoms include excessive pain, itching or swelling at injection site. Breathlessness and collapse with tachycardia and hypotension suggest anaphylaxis. Facilities and support should be available to manage collapse from toxicity or anaphylaxis. UNCONTROLLED WHEN PRINTED Review Date: March 2015 Identifier: NHSG/PGD/lido_eton/MGPG562-4 -

The woman may need reassurance throughout the procedure. Hyperventilation or tachycardia due to anxiety may cause symptoms which may be wrongly attributed to the local anaesthetic. Adverse events will be reported to the Committee on Safety of Medicines via the yellow card scheme or on the website at www.yellowcard.gov.uk and to the local risk management committee. Medical advice in cases of anaphylaxis Injections of IM adrenaline/epinephrine 1:1000 must be available to treat an anaphylactic reaction should this occur. Medical advice must be sought as soon as possible from a doctor if any patient develops any signs of hypersensitivity. If there is a delay in medical support arriving and the condition of the patient is deteriorating then an emergency ambulance must be called on 999 or direct via ambulance control or dial 2222 (hospital internal) according to local procedure, or seek urgent medical advice. (Refer to Patient Group Direction for the administration of adrenaline (epinephrine) in cases of suspected anaphylactic reactions by qualified health professionals). Treatment of overdose See Section 3.4 above, paragraph 3. Effects on ability to drive or operate machinery No effects on driving or operating machinery due to the lidocaine 2% injection itself. However, women may need to avoid activity which exerts pressure on the arm after implant insertion or removal. 3.5. Advice to patient (i) Advice should be given on what to expect and what to do for major and minor reactions. (ii) The adverse effects of lidocaine administration must be clearly explained to the patient before administration. (iii) The patient information leaflet contained in the medicine(s) should be made accessible to the patient/parent/guardian. Where this is unavailable, or unsuitable, sufficient information should be given to the patient/parent/guardian in a language that they can understand. 3.6. Follow up treatment Patients should not leave if they are feeling at all unwell without speaking to the nurse or midwife first. If necessary a doctor or the patient s GP should be contacted for advice. UNCONTROLLED WHEN PRINTED Review Date: March 2015 Identifier: NHSG/PGD/lido_eton/MGPG562-5 -

4. Designated Staff Authorised To Administer Under This PGD Part B The following staff are authorised to administer the drug specified in this PGD without an individual medical prescription providing the patient falls into one of the categories listed in 2.2 of this PGD. Staff must be employed either directly by NHS Grampian, or contracted to provide NHS services, or providing services in partnership with NHS Grampian under the direction of this authorised PGD. (i) Registered nurse or midwife as recognised by the NMC. In addition the following requirements are necessary. Staff must: (i) agree to be professionally accountable for their work (Appendix 1). (ii) be competent to assess the patient s capacity to understand the nature and purpose of the administration in order for the patient to give or refuse consent. (iii) be aware of current treatment recommendations and be competent to discuss issues about the drug with the patient. (iv) have been trained and assessed as being competent in the administration of the drug. All staff will have access to the current PGD. (v) have undertaken an NHS e-anaphylaxis training session which includes basic life support (with annual updates) and covers all aspects of the identification and management of anaphylaxis. (vi) have immediate access to the appropriate equipment and drugs to treat anaphylaxis and have access to the current PGD for the management and treatment of anaphylaxis should this occur. (vii) maintain their skills, knowledge and their own professional level of competence in this area according to their individual Code of Professional Conduct. (viii) agree to work within the terms of the NHS Grampian PGD. Professional Managers/Nurse managers/lead nurses will be responsible for: (i) Ensuring that the current PGD is available to staff providing care under this direction. (ii) Ensuring that the staff have access to all relevant Scottish Government Health Directorate advice, including any relevant CMO letter(s). (iii) Ensuring that staff have received adequate training in all areas relevant to this PGD and meet the requirements above. (iv) Maintaining a current record of all staff authorised to administer the drug specified in this PGD. UNCONTROLLED WHEN PRINTED Review Date: March 2015 Identifier: NHSG/PGD/lido_eton/MGPG562-6 -

5. Documentation 5.1. Authorisation of administration Nurses and midwives working in GP surgeries can be authorised to administer the drug specified in this PGD by practice GPs. (NB. GP Practices must have adopted NHS Grampian PGD for use in their practice). Nurses and midwives working within NHS Grampian can be authorised to administer the drug specified in this PGD by their nurse manager. Nurses and Midwives working within sexual health clinics can be authorised to administer the drug specified in this PGD by the Consultant in Sexual Health Services, NHS Grampian. A certificate of competence (Appendix 2) signed by the authorising doctor/manager should be supplied. This should be held in the individual nurse and midwives records or as agreed locally. 5.2. Record of administration An electronic or paper record for recording the screening of patients and the subsequent administration of the drug specified in this PGD must be completed in order to allow audit of practice. This should include: (i) Name and address of patient/parent/guardian/person with parental responsibility, Unit No/CHI No (ii) Date of birth (iii) Consultant/General Practitioner details (iv) Risk group, if appropriate (v) Physical examination required, if appropriate (vi) Exclusion criteria, record why drug not administered (vii) Reason for giving (viii) Consent to the administration (if not obtained elsewhere) (ix) Drug manufacturer, batch number, expiry date (x) Site where drug administered, dose and route of administration (xi) Signature and name in capital letters of practitioner who administered the drug (xii) Date drug given (xiii) Record of adverse effects (advise patient s doctor). These records should be retained: For children and young people, retain until the patient's 25th birthday or 26th if the young person was 17 at the conclusion of treatment. For 17 years and over retain for 6 years after last date of entry. Or for 3 years after death, or in accordance with local policy, where this is greater than above. UNCONTROLLED WHEN PRINTED Review Date: March 2015 Identifier: NHSG/PGD/lido_eton/MGPG562-7 -

5.3. Consent Prior to the administration of the drug, consent must be obtained, preferably written, either from the patient, parent, guardian or person with parental responsibility and documented either in the patient s medical records/notes or on an administration form (see section 5.2). Consent must be in line with current NHSG Staff Policy for Obtaining Consent for Clinical Procedures and Healthcare Interventions. See link below. http://intranet.grampian.scot.nhs.uk/ccc_nhsg/15692.html?pmenuid=460& 6. Further Points The manufacturers leaflet inside boxes of drug should be read and advice from them taken into consideration. 7. Facilities And Supplies To Be Available At Sites For The Administration Of The Drug Specified In This PGD The following should be available at sites where the drug is to be administered: (i) Resuscitation equipment. (ii) Access to medical support (this may be via telephone). (iii) Safe storage areas for medicines and equipment. (iv) Approved equipment for the disposal of used materials. (v) Clean and tidy work areas. (vi) Copies of the current PGD for the drug specified in the PGD (vii) PGD for the administration of adrenaline (epinephrine) in cases of suspected anaphylactic reactions by qualified health professionals. 8. Audit All records of administration of the drug specified in this PGD will be filed with the normal records of medicines administration in each practice/service. A designated person within each CHP/practice/service will be responsible for auditing completion of drug forms and collation of data. UNCONTROLLED WHEN PRINTED Review Date: March 2015 Identifier: NHSG/PGD/lido_eton/MGPG562-8 -

Appendix 1 Health Care Professional Agreement To Administer Medicines Under Patient Group Direction I: (Insert name) Working within: e.g. CHP, Practice Agree to administer medicines under the direction contained within the following Patient Group Direction Patient Group Direction For The Administration Of Lidocaine 2% Injection For The Insertion/Removal Of The 68mg Etonogestrel Contraceptive Implant By Nurses And Midwives Working Within NHS Grampian I have completed the appropriate training to my professional standards enabling me to administer medicines under the above Patient Group Direction. I agree not to act beyond my professional competence nor outwith the recommendations of the Patient Group Direction. Signed: Print Name: Date: HPC Registration No: UNCONTROLLED WHEN PRINTED Review Date: March 2015 Identifier: NHSG/PGD/lido_eton/MGPG562-10 -

Appendix 2 Certificate Of Competence To Administer Medicines Under Patient Group Direction This authorises: Working within: e.g. CHP, Practice To administer medicines under the following Patient Group Direction Patient Group Direction For The Administration Of Lidocaine 2% Injection For The Insertion/Removal Of The 68mg Etonogestrel Contraceptive Implant By Nurses And Midwives Working Within NHS Grampian The above named person has satisfied the training requirements and is competent to administer medicines under the above Patient Group Direction. The above named person has agreed not to act beyond their professional competence nor outwith the recommendations of the Patient Group Direction Signed: Authorising Manager/Doctor Print Name: Date: UNCONTROLLED WHEN PRINTED Review Date: March 2015 Identifier: NHSG/PGD/lido_eton/MGPG562-11 -