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LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% w/v BY NURSES/MIDWIVES IN SEXUAL & REPRODUCTIVE HEALTH SERVICES TO FACILITATE SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL Version Number 1.3 Version/Date Version 1.1 Aug 2013 Change details Version 1.1 Aug 2013 Updated SPC/BNF/NICE references Minor changes to text highlighted in blue Cautions – added – emergency drugs and equipment, including adrenaline. NMC Standards for medicines management (2008) added Maximum dose not to exceed 2mL for insertion and/or removal Page 10 – Organisational approval statement amended to reflect new PGD legislation e.g. local authorities. Version 1.2 Nov 2015 New template Black triangle deleted from Nexplanon® Version 1.3 February 2017 Amendments to text highlighted in blue Updated Summary of Product Characteristics (SPC) references To include registered midwives and altered nurse prescribers to independent non-medical prescribers Minor editorial changes Each organisation using this PGD must ensure that it is formally authorised by a pharmacist, a medical lead and a governance lead on behalf of the authorising organisation to ensure that this document meets legal requirements for a PGD. This Patient Group Direction (PGD) must only be used by registered nurses/midwives who have been named and authorised by their organisation to practise under it. The most recent and in date final signed version of the PGD must be used. Version No: 1.3 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 03/02/2020 Reference Number : Page 1 of 10 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL. TABLE OF CONTENTS CONTENTS PAGE NUMBER PGD for the supply and administration of subcutaneous Lidocaine Hydrochloride injection BP 1% w/v 1-10 Staff Characteristics 8 Authorisation and Signatures To be added by approving organisation Individual Authorisation to supply and administer subcutaneous Lidocaine Hydrochloride injection BP 1% w/v to facilitate subdermal implant insertion/removal Version No: 1.3 Approving Organisation Name: Approval Committee Name: Date of authorisation: To be added by approving organisation Expiry date: 03/02/2020 Reference Number : Page 2 of 10 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL. DRUG NAME /STRENGTH/FORM : Lidocaine Hydrochloride BP 1% w/v subcutaneous injection CLINICAL CONDITION TO WHICH THIS DIRECTION APPLIES INCLUSION CRITERIA EXCLUSION CRITERIA Local anaesthetic for insertion and/or removal of subdermal contraceptive implant (See PGD template for the supply and insertion of Etonogestrel (Nexplanon®) subdermal implant by nurses/midwives in Sexual & Reproductive Health Services) Any individual requiring the insertion and/or removal of subdermal contraceptive implant Individual requiring insertion and /or removal of subdermal contraceptive implant should also meet the inclusion criteria of the subdermal contraceptive implant PGD Personal Characteristics & Reproductive History Known hypersensitivity to Lidocaine Hydrochloride or anaesthetics of the amide type Individual who had received a previous maximum infiltration of local anaesthetic within 4 hours Individuals under 16 years of age and assessed as not competent using Fraser guidelines Individuals 16 years and over and not competent to consent Existing implant cannot be palpated (for removals only) Cardiovascular Disease Complete heart block Hypovolaemia CAUTIONS (INCLUDING ANY ACTION TO BE TAKEN) ACTION IF EXCLUDED ACTION IF PATIENT DECLINES TREATMENT Other conditions Porphyria Inflammation or infection in the tissues to be injected Individual wishes to see a doctor If under 13 years of age follow local safeguarding policy Interacting medicines–see current BNF Discuss with appropriate doctor/independent non-medical prescriber any medical condition or medication of which the nurse/midwife is unsure/uncertain Ensure emergency drugs and equipment, including adrenaline are available for the treatment of anaphylaxis and emergencies according to local policy Refer to appropriate doctor / independent non-medical prescriber Document all actions taken Record the refusal in the clinical record Refer to appropriate doctor/independent non-medical prescriber where required. Version No: 1.3 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 03/02/2020 Reference Number : Page 3 of 10 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL. DRUG DETAILS NAME, FORM & STRENGTH OF MEDICINE Lidocaine (Lignocaine) 1% w/v (10 mg in 1 mL) in 2mL, 5 mL or 10 mL ampoules Subcutaneous ROUTE/METHOD Prescription Only Medicine LEGAL CATEGORY N/A USE OUTSIDE THE TERMS OF THE MARKETING AUTHORISATION Maximum dose not to exceed 2mL for insertion and/or removal QUANTITY Single episode of treatment DOSAGE/FREQUENCY Single episode of treatment DURATION OF TREATMENT Single episode of treatment MAXIMUM OR MINIMUM TREATMENT PERIOD SIDE EFFECTS Any drug may produce unwanted or unexpected adverse reactions. Detection and recording of these is of vital importance. Patients should be actively encouraged to report any suspected adverse reaction, particularly to black triangle medicines. Version No: 1.3 Approving Organisation Name: Approval Committee Name: Date of authorisation: Refer to current Summary of Product Characteristics (SPC) of relevant product and current British National Formulary (BNF) for full list and further information. This list may not represent all reported side effects of this medicine. Serious symptoms When used for surface anaesthesia rapid and extensive absorption may result in systemic side effects. CNS effects include: Confusion Respiratory depression Convulsions Hypotension Bradycardia Hypersensitivity Expiry date: 03/02/2020 Reference Number : Page 4 of 10 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL. See next page SIDE EFFECTS Any drug may produce unwanted or unexpected adverse reactions. Detection and recording of these is of vital importance. Patients should be actively encouraged to report any suspected adverse reaction, particularly to black triangle medicines. Continued from previous page In the event of untoward or unexpected adverse reactions: If necessary seek appropriate emergency advice and assistance Document in the individual’s clinical record and inform appropriate doctor/independent non-medical prescriber Complete incident procedure if adverse reaction is severe (refer to local organisational policy) Use yellow card system to report serious adverse drug reactions directly to the Medicines and Healthcare products Regulatory Agency (MHRA). Yellow cards are available in the back of the BNF or obtained via Freephone 0808 100 3352 or online at www.yellowcard.mhra.gov.uk. The public can report adverse effects directly to the MHRA via the yellow card scheme and should be encouraged to do so. ADVICE TO INDIVIDUAL FOLLOW UP Version No: 1.3 Approving Organisation Name: Approval Committee Name: Date of authorisation: Provide Manufacturer’s Patient Information Leaflet (PIL) and discuss Explain mode of action, side effects, and benefits of the medicine Ensure individual has the contact details of the service Individual to return to clinic if she has any concerns Expiry date: 03/02/2020 Reference Number : Page 5 of 10 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL. RECORDS Version No: 1.3 Approving Organisation Name: Approval Committee Name: Date of authorisation: The authorised registered nurse/midwife must ensure the following is documented in the clinical record: Individual’s name, address and date of birth GP contact details where appropriate Attendance date Reason for attendance Relevant past and present medical and family history, including drug history Any known allergy Relevant examination findings (where appropriate) Inclusion or exclusion from PGD A statement that supply and administration is by using a PGD Advice given about the medication including side effects, benefits, and when and what to do if any concerns Details of any adverse drug reactions and what action taken Any referral arrangements Any administration outside the terms of the marketing authorisation The consent of the individual If individual is under 13 years of age, record action taken If individual is under 16 years of age document competency using Fraser guidelines If individual is 16 years of age and over and not competent, record action taken Record the name/brand, dose of the medication and quantity supplied and administered Record batch number and expiry date according to local policy or national guidelines Record follow up and/or signposting arrangements Any other relevant information provided to the individual Name and signature (which may be an electronic signature) of the nurse/midwife supplying and administering the medicine Expiry date: 03/02/2020 Reference Number : Page 6 of 10 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL. REFERENCES All references and links correct at time of publication. (February 2017) Manufacturer’s Summary of Product Characteristics Lidocaine hydrochloride injection BP 1% Hemeln Pharmaceuticals. Date of revision of the text20/05/2015 accessed 11/01/2017 https://www.medicines.org.uk/emc/medicine/20887 Concordia International (formerly AMCo) Date of revision of the text 06.12.2013 Date accessed 18/01/2017 https://www.medicines.org.uk/emc/medicine/25036 Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press http://www.medicinescomplete.com [Accessed on 11/01/2017] National Institute for Health and Care Excellence (2013) Patient Group Directions. Medicines Practice Guidelines 2 http://www.nice.org.uk/guidance/MPG2 Faculty for Sexual and Reproductive Healthcare (2016) Standards for Resuscitation in Sexual Health Services https://www.fsrh.org/documents/service-standards-forresuscitation-in-sexual-and-reproductive/ Faculty for Sexual and Reproductive Healthcare (2014) Progestogen only Implants CEU .http://www.fsrh.org/pdfs/CEUGuidanceProgestogenOnlyImplants .pdf Version No: 1.3 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 03/02/2020 Reference Number : Page 7 of 10 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL. STAFF CHARACTERISTICS The named nurse/midwife authorised to supply and/or administer medications under the PGD must meet the following criteria: THE NURSE/MIDWIFE MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORKING ACCORDING TO IT Qualifications The nurse/midwife must be registered with the Nursing and Midwifery Council (NMC) Education/training, qualifications and competencies The nurse/midwife must satisfy the following criteria: Qualification in contraception/sexual health (university modules/FSRH): Note: an introduction to contraception/ sexual health is not sufficient. Has had training in the use of PGDs Has had training which enables the nurse/midwife to make a clinical assessment in order to supply and administer the medication according to this PGD Has undertaken the competency training appropriate to this PGD Is competent in the assessment of individuals using Fraser guidelines Has undergone regular training and updating in safeguarding children and vulnerable adults Has undergone regular updating in basic life support and anaphylaxis Maintenance of competencies The nurse/midwife must ensure she/he is aware of any changes to the recommendations for these medicines It is the responsibility of the nurse/midwife to keep up to date with continuing professional development and take part in audit of clinical records on a regular basis An up to date list and signatures of registered practitioners who are authorised to practise under this PGD is kept in by Practitioners not listed are not authorised to practise under this PGD. Version No: 1.3 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 03/02/2020 Reference Number : Page 8 of 10 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL. PGD DEVELOPMENT GROUP Date PGD template comes into effect: Review date Expiry date: 03/02/2017 03/08/2019 or earlier in the light of significant changes in best practice 03/02/2020 This template was peer reviewed and ratified by London Contraception and Sexual Health PGD Working Group: NAME/ROLE POSITION DATE Independent Nurse Advisor SRHC Project Lead 03/02/2017 Principal Pharmacist Medicines Information Projects. Guy’s and St Thomas’ NHS Foundation Trust. 03/02/2017 Lead Doctor Sarah Pillai Lead Associate Specialist, Contraception and Sexual Health Service, Central London Community Healthcare NHS Trust 03/02/2017 Lead Pharmacist Sandra Wolper Associate Director for Specialist Pharmacy Service Hounslow and Richmond NHS Trust 03/02/2017 Lead Nurse Lead Nurse Integrated Sexual Health Barts Health NHS Trust 03/02/2017 Kathy French Chair - Working Group Angela Bussey Advisor - Working Group Sandra Bennett The PGD template is not legally valid until it has had the relevant organisational approval. See next page Version No: 1.3 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 03/02/2020 Reference Number : Page 9 of 10 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF SUBCUTANEOUS LIDOCAINE HYDROCHLORIDE INJECTION BP 1% W/V BY REGISTERED NURSES/MIDWIVES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES TO FACILITATE SUBDERMAL IMPLANT INSERTION AND/OR REMOVAL. ORGANISATIONAL AUTHORISATIONS AND OTHER LEGAL REQUIREMENTS This page may be deleted if replaced with a format agreed according to local PGD policy with relevant approvals and authorisation. The PGD is not legally valid until it has had the relevant organisational authorisations. To ensure compliance with the law, organisations must add local authorisation details i.e. clinical authorisations and the person signing on behalf of the authorising organisation. You may either complete details below or delete and use a format agreed according to local PGD policy which complies with PGD legislation and NICE MPG2 PGD 2013. Name Job title and organisation Signature Date Senior doctor Senior pharmacist Senior representative of professional group using the PGD e.g. Lead Contraception /Sexual Health Nurse Person signing on behalf of authorising body e.g. Director of Public Health on behalf of a local authority or a clinical governance lead on behalf of an NHS Trust. It is the responsibility of the authorising organisation to ensure that all legal and governance requirements for authorising the PGD are met. It is the responsibility of the provider organisation to ensure that all legal and governance requirements for using the PGD are met. To meet legal requirements, organisations must add an Individual Practitioner Authorisation sheet or List of Authorised Practitioners. This varies according to local policy and how the service is managed but this should be a signature list or an individual agreement. PGDs 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. Individual practitioners must declare that they have read and understood the Patient Group Direction and agree to supply/administer medicines listed only in accordance with the PGD. ORGANISATIONS MAY ALSO ADD: Local training and competency assessment documentation. Other supporting local guidance or information. Links to local PGD Policy and other supporting guidance. Version No: 1.3 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 03/02/2020 Reference Number : Page 10 of 10