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 31/07/17 V02 Review. Exclusion criteria Add If unprotected sex was more than 72 hours ago then consider EllaOne or Intra- Uterine Contraceptive Device (up to 120 hours). Minor editing changes. 28/08/17 V02 Review. Adjusted dose advice to reflect FSRH advice on 3mg dosing. Adjusted exclusions to allow treatment of patients on enzyme-inducing drugs. Strengthened advice regarding IUCD use and ongoing contraceptive care. 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 Emergency hormonal contraception (EHC). Inclusion criteria Any woman requesting EHC following an episode of unprotected sexual intercourse (i.e. no or failed contraception) in this menstrual cycle. Exclusion criteria Hypersensitivity to levonorgestrel or any of the constituents of the product. Known to be pregnant. Breast feeding. First episode of unprotected sexual intercourse in this cycle was more than 72 hours ago. If unprotected sex was more than 72 hours then consider EllaOne (ulipristal) or Intra-Uterine Contraceptive Device (up to 120 hours). A copper IUCD is a more effective form of emergency contraception and this point must be conveyed to the patient. Patient under the age of 16 and not deemed to be Fraser competent. Patients with a history of salpingitis or ectopic pregnancy. Patients with severe hepatic impairment. Patients with severe malabsorption syndomes, e.g. Crohn s disease. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Third-party requests, i.e. not being made by the woman concerned. PGDs should be used only where appropriate, suitable and legal. PGDs should not be routinely used when an independent prescriber is available. Precautions Consider whether any safeguarding concerns exist. Patient has accessed EHC regularly: do not necessarily withhold supply but consider wider contraception and sexual health issues. Where menstrual bleeding is overdue perform a pregnancy test before proceeding. 28/08/2017 Page 2 of 7
Management of excluded patients Action for patients not wishing / unable to receive care under this PGD Data are uncertain regarding effectiveness in relationship to bodyweight but Levonelle potentially becomes less effective as weight/bmi rises. A copper IUCD or ulipristal are preferable forms of emergency contraception but if these are not available then a higher dose is advocated for some patients based on weight/bmi see below. This use is off label and the patient must be appropriately advised. Patients taking (or who have taken in the last 4 weeks) enzyme-inducing drugs, i.e. aprepitant, bosentan, carbamazepine, ciclosporin, crizotinib, dabrafenib, efavirenz, eslicarbazepine, fosaprepitant, fosphenytoin, griseofulvin, lumacaftor with ivacaftor, nevirapine, olaparib, oxcarbazepine, perampanel, phenobarbital, phenytoin, primidone, rifabutin, rifampicin, ritonavir, rufinamide, selegiline, St John s wort, topiramate, ulipristal, vermurafenib. These drugs may impair the effectiveness of Levonelle. A copper IUCD or ulipristal are preferable forms of emergency contraception but if these are not available then a higher dose is advocated for patients using these drugs see below. This use is off label and the patient must be appropriately advised. Warfarin/coumarins EHC may alter the anticoagulant effect. Women should be advised to have INR checked in 2-3 days so that Warfarin dosage can be adjusted if necessary. Discuss with GP or Clinical Lead. Discuss IUCD or ulipristal as alternative and refer immediately as per local protocol. Make patient aware of risks and potential consequences of not taking medicine. Discuss any alternatives if available. Discuss alternative options with GP or Clinical Lead. Document discussion with patient. Description of Treatment Name of medicine Levonelle 1500 Formulation and route Tablet, oral Strength 1.5mg Dosage Standard dose: One 1.5mg tablet immediately If the woman vomits within 3 hours of taking the tablet then a replacement dose should be issued so long as the woman remains within the 72 hour time frame 28/08/2017 Page 3 of 7 Women with body weight >70kg or BMI > 26kg/m 2 or taking enzymeinducing drugs: See advice above a copper IUCD or ulipristal are preferable forms of emergency contraception. If however these are not suitable/available
or declined then levonorgestrel may be used at a higher dose. Two 1.5mg tablets (i.e. 3mg dose) taken immediately If the woman vomits within 3 hours of taking the tablet then a replacement dose should be issued so long as the woman remains within the 72 hour time frame This dose is outside the product license and represents off label use. However it is consistent with advice in the BNF and from the Faculty of Sexual and Reproductive Health. Repeated dose Not applicable instructions Duration of treatment Single dose Quantity to supply One tablet Legal status POM Special precautions Explain indications, contraindications and cautions (refer to BNF) Adverse effects Nausea (23%), Vomiting (6%) breast tenderness, dizziness & fatigue. The woman should be told that EHC could make the next period earlier or later and lighter or heavier than usual. If they have not had their next period within 5 days of expected start date they should return for a pregnancy test. The CSM has advised that in patients that become pregnant, the possibility of an ectopic pregnancy should be considered, especially if they have a history of a previous ectopic pregnancy, fallopian tube surgery or pelvic inflammatory disease. 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 on dose and administration with reference to the cautionary label information and give any further instructions to aid compliance. 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. 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. Explain options including use of IUCD a copper IUCD is a more effective method of post-coital contraception. Explain possible bleeding pattern following use and risk of ectopic pregnancy. 28/08/2017 Page 4 of 7
Discuss efficacy rates and in particular that Levonelle is not 100% effective taken within 24 hours 95%, 24-48 hours 85%, 48-72 hours 58%. Discuss STI and condom use. Discuss need for reversible contraception for remainder of cycle for maximum effect, including continuation of regular hormonal contraception where appropriate. Signpost to appropriate provider of ongoing contraception and encourage early attendance to access up to date advice and contraceptive care. 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