This letter authorises the extended use of the following PGD until 1st January 2017:

Transcription

1 NHS Grampian Westholme Woodend Hospital Queens Road ABERDEEN AB15 6LS Date 18 th December 2015 Our Ref SHCon_MGPG/Dec15 Enquiries to Caroline Hind Extension Direct Line Dear Colleague This letter authorises the extended use of the following PGD until 1st January 2017: Patient Group Direction For The Supply Of Ulipristal 30mg (ellaone ) By Nurses Working Within Sexual Health Services Or Midwives Working In NHS Grampian The review of this PGD will commence in August 2016 following the publication of updated UK Medical Eligibility Criteria for Contraceptive use guidance. This letter provides permission to continue using the PGD to a new expiry date of 01 January 2017 and should be kept with the PGD records in the Sexual Health Clinics and brought to the attention of the individual Nurses and other healthcare professionals who operate under the PGD currently. If you have any queries regarding this please do not hesitate to contact the Pharmacy and Medicines Directorate. Yours sincerely Caroline Hind Deputy Director of Pharmacy and Medicines Directorate Chair Medicines Guidelines and Policies Group

2 Patient Group Direction For The Supply Of Ulipristal 30mg (ellaone ) By Nurses Working Within Sexual Health Services Or Midwives Working In NHS Grampian Co-ordinators: CHP Lead Pharmacist Consultation Group: See relevant page in the PGD Approver: Medicine Guidelines and Policies Group Signature: Signature: Identifier: NHSG/PGD/ellaOne/ MGPG604 Review Date: August 2015 Date Approved: August 2013 A Patient Group Direction is a specific written instruction for the supply or administration of named medicines in an identified clinical situation. It is drawn up locally by Doctors, Pharmacists and other appropriate professionals, approved by the Employer and advised by the relevant professional advisory committees. In most cases, appropriate clinical care is provided on an individual basis by a specific prescriber to a specific individual patient. Patient Group Directions should only be considered where they offer a benefit to patient care without compromising patient safety in any way. Uncontrolled when printed Version 2

3 Title: Identifier: Replaces: Patient Group Direction For The Supply Of Ulipristal 30mg (ellaone ) By Nurses Working Within Sexual Health Services Or Midwives Working In NHS Grampian NHSG/PGD/ellaOne/MGPG604 NHSG/PGD/ellaOne/MGPG387 Across NHS Boards 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 nurses midwives emergency contraception after 72 hours ulipristal ellaone NHS Grampian This Patient Group Direction (PGD) authorises appropriately qualified and trained nurses and midwives to supply ulipristal acetate 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: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG604 - i - PGD for the supply of ulipristal by SHS nurses or midwives Version 2

4 This document is also available in large print and other formats and languages, upon request. Please call NHS Grampian Corporate Communications on (01224) or (01224) 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 Pharmacist, Pharmacy and Medicines Directorate Pharmacy and Medicines Directorate Pharmacy and Medicines Directorate CHP Lead Pharmacist Revision History: Date of Approval change date of PGD that is being superseded August 2013 August 2013 August 2013 August 2013 Summary of changes Following treatment Breast milk must now be discarded for 7 days after taking Ulipristal, previously this was 36 hours Age reduced to 13 years to be in line with Levonelle PGD Removal of Black Triangle symbol, which was to highlight intensive monitoring by MHRA. Section heading Precautions 2.4 Throughout document Throughout document UNCONTROLLED WHEN PRINTED Review Date: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG604 - ii - PGD for the supply of ulipristal by SHS nurses or midwives Version 2

5 Patient Group Direction For The Supply Of Ulipristal 30mg (ellaone ) By Nurses Working Within Sexual Health Services Or Midwives Working In NHS Grampian Contents Part A Specific Drug Information 1 Introduction 2 2 Clinical Decision Making Patients who may be considered for the supply of ulipristal Patients who may receive a supply of ulipristal Contraindications Precautions Action to be taken when a patient is excluded from treatment under this PGD Action to be taken when a patient does not wish to receive treatment under 5 this PGD 3 Description Of Treatment Available Under This PGD Ulipristal 30mg tablet (ellaone ) Dose, route and frequency Concurrent medication Adverse effects Advice to patient Follow up treatment 7 Part B PGD General Information 4 Designated Staff Authorised To Supply Under This PGD 8 5 Documentation Authorisation to supply Record of supply Consent 9 6 Further Points 9 7 Facilities And Supplies To Be Available At Sites For The Supply Of The 10 Drug Specified In The PGD 8 Audit 10 Part C PGD Specific Information 9 Management And Monitoring Of Patient Group Direction Consultative group Professional advisory group approving PGD Authorising managers References 11 Appendix 1 - Health Care Professional Agreement To Supply Medicines 12 Under Patient Group Direction Appendix 2 - Certificate Of Competence To Supply Medicines Under 13 Patient Group Direction Appendix 3 Emergency Hormonal Contraception Example Proforma Appendix 4 - Emergency Contraception - After 72 HOURS - Patient Information Appendix 5 - Post Coital Contraception Flowchart 18 Appendix 6 - Emergency Contraception After 72 hours 19 UNCONTROLLED WHEN PRINTED Review Date: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG

6 Patient Group Direction For The Supply Of Ulipristal 30mg (ellaone ) By Nurses Working Within Sexual Health Services Or Midwives Working In NHS Grampian Part A 1. Introduction Ulipristal (ellaone ) is an emergency hormonal contraceptive. It is a progesterone receptor modulator and is licensed for use as an emergency contraceptive for up to 120 hours (5 days) after unprotected sexual intercourse (UPSI) or contraceptive failure. NHS Grampian approved ulipristal (ellaone ) for inclusion in the Grampian Joint Formulary for emergency contraception within 72 hours to 120 hours (3-5 days) of UPSI or contraceptive failure. Up to 72 hours after unprotected sexual intercourse levonorgestrel (Levonelle 1500) is the preparation of choice for the majority of women as it has similar efficacy and a much lower financial cost. This patient group direction (PGD) will allow nurses working within Sexual Health Services and midwives to supply ulipristal (ellaone ) in order to prevent an unplanned pregnancy for woman 13 years and over who present between 72 hours and 120 hours after unprotected sexual intercourse. Explanation to allow informed choice and correct use of the method is essential. Women must be informed that the copper IUD is a more effective alternative postcoital contraceptive. Off licence levonorgestrel (Levonelle 1500) may also be offered between 72 hours and 120 hours if ulipristal (ellaone ) is unsuitable although this may have little effect between 96 hours and 120 hours. 2. Clinical Decision Making 2.1 Patients who may be considered for the supply of ulipristal (ellaone ) Follow the contraceptive proforma and Post Coital Contraception Flowchart (see Appendices 3 and 5). (i) Women from age 13 to menopause. (ii) Women who are not excluded by criteria in sections 2.3, 2.4. (iii) Women with existing pregnancy excluded by history and if necessary a urine pregnancy test. UNCONTROLLED WHEN PRINTED Review Date: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG

7 (iv) Women presenting between 72 hours and 120 hours of UPSI. UPSI includes sex without contraception or condom/diaphragm failure/inadequate use. This includes women who were advised to use condoms as additional contraception when quick starting hormonal contraception out with day 1-5 of their cycle. (v) Women using other contraceptive methods under the following circumstances: Combined oral contraceptive pills (21 active tablets) If two or more ethinylestradiol pills of any dose have been missed in the first week of pill taking (i.e. days 1 7) and UPSI occurred in Week 1 or the pill-free week. Progestogen-only pills If one or more progestogen-only pills (POPs) have been missed or taken >3 hours late (>12 hours late for Cerelle or Cerazette ) and UPSI has occurred before a further two pills have been taken appropriately. Intrauterine contraception If complete or partial expulsion is identified or mid-cycle removal of an IUD/IUS is deemed necessary and UPSI has occurred in the last 7 days. Progestogen-only injectables If the contraceptive injection is late (>14 weeks from the previous injection for medroxyprogesterone acetate or >10 weeks for norethisterone enantate) and UPSI has occurred within the last 120 hours. Transdermal contraception - Evra Patch More than 2 days late starting first patch of new pack and has UPSI in week one or the prior patch free week. 7 days late starting third patch of pack, no EHC needed but omit patch free week. If more than 9 days late starting second/third patch, count as UPSI. Up to 7 days late starting second patch, no EHC needed. Vaginal contraceptive ring NuvaRing Ring removed for more than 3 hours in any 24 hour period and UPSI in last 7 days. Delay inserting new ring by more than 3 hours and UPSI in last 7 days. Delay changing ring left in place more than 28 days and UPSI last 7 days. (vi) Women must have had a full medical and clinical assessment, and full method specific contraceptive counselling as outlined in the FSRH Document Service Standards for Record Keeping (May 2005/2007) and CASH Method Checklist UNCONTROLLED WHEN PRINTED Review Date: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG

8 ellaone Emergency Contraception. Verbal information provided about the method must be backed up by the relevant FPA information leaflet. 2.2 Patients who may receive a supply of ulipristal (ellaone ) 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 Supply can only be made to those aged 13 years and over. Patients may not be supplied ulipristal (ellaone ) under PGD if there is: (i) Current persistent vomiting. (ii) Actual or possible pregnancy (if the last menstrual period was abnormal in time and character or if pregnancy is suspected, then this should be excluded by a pregnancy test). (iii) Previous unprotected intercourse in current cycle more than 120 hours ago. (iv) Previous ulipristal (ellaone ) use in the current cycle. (v) Previous levonorgestrel (Levonelle 1500) use in the current cycle. (vi) Porphyria. (vii) Severe asthma currently insufficiently controlled by oral glucocorticoids. (viii) Severe hepatic impairment. (ix) Anaphylactic hypersensitivity to ulipristal, or any of the excipients. (x) Severe malabsorption syndromes, e.g. severe diarrhoea or Crohn s disease. (xi) Concomitant use (or use within the last 3 weeks) of enzyme inducing drugs such as barbiturates, primidone, phenytoin, carbamazepine, rifampicin, ritonavir, rifabutin, griseofulvin and St John's Wort may reduce blood levels of ulipristal (ellaone ). No evidence of efficacy of a double dose so ulipristal (ellaone ) is not suitable. (xii) Concomitant administration of medicinal products that increase gastric ph (e.g. proton pump inhibitors, antacids and H 2 -receptor antagonists) may reduce plasma concentrations of ulipristal (ellaone ) and may decrease efficacy. Ulipristal (ellaone ) should not be given if there has been proton pump inhibitor use in last 7 days or H 2 antagonist use in the last 24 hours. UNCONTROLLED WHEN PRINTED Review Date: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG

9 2.4 Precautions (i) Concomitant use of ketoconazole, itraconazole, telithromycin or clarithromycin may increase the blood levels of ulipristal (ellaone ) however no harmful effects are known and so ulipristal (ellaone ) may be given. (ii) Due to lack of data, it is at present unknown whether ulipristal (ellaon e ) is excreted in breast milk. A risk to the breast-fed child cannot be excluded so after intake of ulipristal (ellaone ), breast milk should be discarded for 7 days. (iii) Lactose content: ulipristal (ellaone ) contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take ulipristal (ellaone ). 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 supply of ulipristal (ellaone ). 3. Description of Treatment Available Under This Direction 3.1 Ulipristal 30mg tablet (ellaone ) Ulipristal 30mg tablet (ellaone ) is a Prescription-only Medicine (PoM). 3.2 Dose, route and frequency One tablet as a single dose to be taken orally as soon as possible between 72 hours (3 days) and no later than 120 hours (5 days) after UPSI or contraceptive failure. If vomiting occurs within 3 hours of taking the tablet, a further dose should be taken as soon as possible. The patient should be told where she can access a further supply, i.e. the next appropriate clinic or GP. 3.3 Concurrent medication See 2.3 and 2.4. UNCONTROLLED WHEN PRINTED Review Date: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG

10 3.4 Adverse effects Nurse/patient to report unusual or severe reactions to Clinic Doctor. All suspected reactions should be reported directly to the Commission on Human Medicines through the yellow card scheme, (Yellow Card Centre Scotland ) and recorded in the patient s medical records. Yellow cards are available at the back of the BNF. Reports may also be made online at Abdominal pain is a common side effect and patients may also experience nausea, vomiting, dyspepsia and diarrhoea. Other minor side effects include headache, dizziness, fatigue, back pain, muscle spasms and dysmenorrhoea. The patient may notice light vaginal bleeding within a few days of EHC. This should not be assumed to be her menstrual period. The next menstrual period begins within a week of its expected date for most women but may be early or late. Follow up and pregnancy testing is essential if a normal period is delayed by more than 5 to 7 days or is lighter than normal. Follow up is essential as not all pregnancies will be prevented by use of EHC. 3.5 Advice to patient (i) Advice should be given on what to expect and what to do for major and minor reactions. Ulipristal (ellaone ) may have minor or moderate influence on the ability to drive or use machines as mild to moderate dizziness is a common adverse effect. (ii) 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. (iii) Discuss mode of action, failure rate and possible side effects. Also discuss that there is insufficient knowledge of the effect on the foetus in case of method failure, although no teratogenic effect has been observed so far. (iv) Breastfeeding is not recommended in the 7 days following ulipristal (ellaone ) intake. Refer to advice in the manufacturer s Patient Information Leaflet. (v) Advise that a barrier form of contraception should be used until the next period, and give a supply of condoms. (vi) If client is taking hormonal contraceptive pills (COC or POP) or using the Evra transdermal patch, NuvaRing vaginal ring, Depo-provera or Nexplanon she should be advised to continue the method and also abstain or use condoms for 2 weeks, following advice by the FSRH Clinical Effectiveness Unit (CEU). Concomitant condom use is important because of the anti-progestogen effect of ulipristal (ellaone ) which may interfere with the action of progestogen containing medicinal products. UNCONTROLLED WHEN PRINTED Review Date: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG

11 (vii) Ongoing contraception must be discussed and provided using the relevant Patient Group Direction. (viii) Currently the FSRH CEU would advise that women wait until their next menstrual period (or until pregnancy has been excluded by pregnancy testing in 3 weeks) before starting a new hormonal contraceptive method (POP, CHC, Nexplanon, Depo- Provera IUS). Barrier contraception should be used until then. However immediate start of any of these methods (except IUS and cyprindiol containing CHC pills) is acceptable if she is at continued high risk of pregnancy and it is her preference. (ix) Vomiting within 3 hours will reduce the efficacy of EHC. The woman should be advised where to obtain more supplies plus antiemetic if this occurs. If the woman is nauseous when she presents or has vomited previously with EHC an antiemetic should be given, domperidone 10mg orally (see PGD - Administration of domperidone to prevent vomiting following emergency hormonal contraception by nurses and midwives working within NHS Grampian). (x) Patients should be advised to do a pregnancy test if next period is overdue by one week, or if the period is exceptionally light or after 3 weeks for reassurance that they have not become pregnant from this episode of UPSI. Women should also be advised to seek medical advice if they have signs and symptoms suggestive of an ectopic pregnancy. See 3.6 for information on a pregnancy registry. (xi) The Emergency Contraception - After 72 hours - Patient Information (Appendix 4) should be discuss and given to the patient. 3.6 Follow up treatment Patients should not leave if they are feeling at all unwell without speaking to the nurse/midwife first. If necessary a doctor or the patient s GP should be contacted for advice. Patients will be advised to make an appointment for STI testing if appropriate. It may take 14 days for a chlamydia test to show positive after infection and 3 months for an HIV, hepatitis B, C, or syphilis test to show positive. Testing may be deferred for this time if asymptomatic. Women with symptoms of infection should seek medical advice. The patient may wish to make an appointment to discuss any aspect of their EHC use. The supplier will ensure the client has the contact number for appropriate follow up services. As ulipristal (ellaone ) may fail to prevent pregnancy, the European Health Authorities have requested that a pregnancy registry is set up. HRA Pharma therefore aims to collect all data available on pregnancies exposed to ulipristal (ellaone ), either in the case of undetected pregnancy before ulipristal (ellaone ) intake or in the case of treatment failure. The pregnancy registry website is available at UNCONTROLLED WHEN PRINTED Review Date: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG

12 4. Designated Staff Authorised To Supply Under This PGD Part B The following staff are authorised to supply 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) Nurses working within Sexual Health Services and Midwives 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 supply 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 supply of the drug. All staff will have access to the current PGD. (v) maintain their skills, knowledge and their own professional level of competence in this area according to their individual Code of Professional Conduct. (vi) 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 supply the drug specified in this PGD. 5. Documentation 5.1 Authorisation to Supply Nurses working in NHS Grampian can be authorised to supply the drug specified in this PGD by their nurse manager. UNCONTROLLED WHEN PRINTED Review Date: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG

13 Midwives working within NHS Grampian can be authorised to supply the drug specified in this PGD by their nurse manager. A certificate of competence (Appendix 2) signed by the authorising doctor/manager should be supplied. This should be held in the individual nurse or midwife records or as agreed locally. 5.2 Record of supply An electronic or paper record for recording the screening of patients and the subsequent supply 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, 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 supplied (vii) Reason for giving (viii) Consent to the supply (if not obtained elsewhere) (ix) Drug manufacturer, batch number, expiry date (x) Signature and name in capital letters of practitioner who supplied the drug (xi) Date drug given (xii) 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. 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 Further Points The manufacturers leaflet inside boxes of drug should be read and advice from them taken into consideration. UNCONTROLLED WHEN PRINTED Review Date: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG

14 7. Facilities And Supplies To Be Available At Sites For The Supply Of The Drug Specified In The PGD The following should be available at sites where the drug is to be administered: (i) Access to medical support (this may be via telephone). (ii) Safe storage areas for medicines and equipment. (iii) Clean and tidy work areas. (iv) Copies of the current PGD for the drug specified in the PGD. 8. Audit All records of the supply of the drug specified in this PGD will be filed with the normal records of medicines supply 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: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG

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16 Appendix 1 Health Care Professional Agreement To Supply Medicines Under Patient Group Direction I: (Insert name) Working within e.g. CHP, Practice Agree to supply medicines under the direction contained within the following Patient Group Direction Patient Group Direction For The Supply Of Ulipristal 30mg (ellaone ) By Nurses Working Within Sexual Health Services Or Midwives Working In NHS Grampian I have completed the appropriate training to my professional standards enabling me to supply 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: NMC Registration No: UNCONTROLLED WHEN PRINTED Review Date: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG

17 Appendix 2 Certificate Of Competence To Supply Medicines Under Patient Group Direction This authorises: Working within: e.g. CHP, Practice To supply medicines under the following Patient Group Direction Patient Group Direction For The Supply Of Ulipristal 30mg (ellaone ) By Nurses Working Within Sexual Health Services Or Midwives Working In NHS Grampian The above named person has satisfied the training requirements and is competent to supply 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: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG

18 Emergency Hormonal Contraception - Example Proforma Appendix 3 DATE: NAME: DOB: AGE: LMP: NORMAL? YES CYCLE REGULAR? YES NO NO PREGNANCY TEST: NOT DONE NEGATIVE POSITIVE Do test if period late or LMP unsure or LMP unusual. Refer to Doctor if positive CIRCUMSTANCES: UPSI CONDOM FAILURE OTHER (SPECIFY): When was the first UPSI? Since the start of her last period or since method failure? DATE: TIME: DAY OF CYCLE: HOURS SINCE: If more than 72 hours refer to Doctor for IUD or consider ellaone Any EHC already this cycle Sex Consensual Previous vomiting with EHC YES NO If already used EHC this cycle refer to Doctor If assault refer to guidelines If yes, give domperidone 10mg orally 20 minutes before EHC MEDICAL HISTORY: YES NO Allergy levonorgestrel Severe liver disease Severe absorption problems Porphyria Antacid drugs, e.g. omeprazole/ranitidine If yes Refer to Doctor If yes Refer to Doctor If yes Refer to Doctor If yes Refer to Doctor No effect IUD or levonorgestrel (Levonelle 1500) May affect ulipristal (ellaone ) if taken last 7 days- refer to Doctor Breastfeeding No effect IUD or levonorgestrel (Levonelle 1500) Discard milk 7 days after ulipristal (ellaone ) Enzyme inducing medication Double dose levonorgestrel (Levonelle 1500 )or IUD Not suitable ulipristal (ellaone ) e.g. carbamazepine, phenytoin, primidone, topiramate, phenobarbital, rifampicin, rifabutin, oral griseofulvin, some anti HIV drugs, St John's Wort. See BNF If 13, 14, 15 YEARS OLD Explain confidentiality Is anyone with her? If so who? Who knows she is here? How old is partner? Attends school? Lives with: family/friends/in care/homeless Concerns re assault/abuse? Concerns drugs/alcohol? ASSESSED FRASER COMPETENT Yes Not competent/12 years old/ child protection issues Follow Child protection Guidance UNCONTROLLED WHEN PRINTED Review Date: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG

19 EMERGENCY CONTRACEPTION METHODS DISCUSSED ORAL IUD Days % risk of pregnancy with UPSI Days 1-7 and >17 2-3% Levonorgestrel (Levonelle 1500) within 96 hours Levonorgestrel (Levonelle 1500) hours (off licence but can give under PGD) Ulipristal (ellaone ) 72 hours 120 hours Copper IUD up to 120 hours after UPSI / or ovulation EHC ISSUED levonorgestrel (Levonelle 1500) (one tablet as single dose) levonorgestrel (Levonelle 1500) (3 mg single dose) off licence but can give under PGD If on enzyme inducers Ulipristal 30mg (ellaone ) Separate PGD Batch No Expiry date Batch No Expiry date Batch No Expiry date 2-3 in 100 women will become pregnant97% Efficacy unknown 1-2 in 100 women will become pregnant98% < 1 in 100 women will become pregnant>99% No EHC needed Too late for EHC IUD this visit Refer for IUD Domperidone 10mg PGD Batch No Expiry Date e ADVICE CHECKLIST Action if vomits within 3 hours May be light bleeding next fewdays- don t count this as period Next period may be early or Return if further UPSI Failure rate Pregnancy test in 3 weeks unless normal period If levonorgestrel fails not harmful to pregnancy Unknown effects on pregnancy if ulipristal (ellaone ) fails FPA EHC leaflet offered INTENDED CONTRACEPTION DECLINED UNDECIDED POP PATCH COC DEPO PROVERA IMPLANT CONDOMS ONLY RING IUD/IUS Condoms /abstain for 2 weeks after ulipristal (ellaone ) FPA method leaflet Continue pills / patch + condoms/abstain 7 days FP Clinic details Start pills / patch/ ring first day of next period Contact GP/FP CLINIC/SMS to arrange dose/fitting with next period SEXUALLY TRANSMITTED INFECTION STI risk discussed day window period for Chlamydia, GC 3 month window period for syphilis, Hep B, C, HIV How/where to access STI tests or treatment if appropriate SIGNATURE AND PRINTED NAME OF ISSUER: UNCONTROLLED WHEN PRINTED Review Date: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG

20 Appendix 4 Emergency Contraception - After 72 HOURS - Patient Information You have had unprotected sex and are now too late for the licensed use of the emergency contraceptive pill levonorgestrel (Levonelle 1500). This tablet is usually taken within 72 hours of the first episode of unprotected sex. There are three types of emergency contraception which you can use after 72 hours. Not all methods are suitable for all women - the doctor or nurse will advise which options you have. Please take your time to decide what is best for you and ask the doctor or nurse if you have any questions. The most effective emergency contraceptive after 72 hours is a copper IUD coil. Less than 1 in 100 women who have an IUD fitted as emergency contraception will become pregnant. The IUD is fitted inside the uterus (womb) by the clinic doctor or nurse; we will discuss this in more detail before going ahead. You can either keep the IUD as your ongoing method of contraception or it can be removed after your period comes. Although the chance of a pregnancy after the IUDis fitted for emergency contraception is very low if you do become pregnant there is an increased risk of miscarriage. The IUD is the most effective method of contraception after unprotected sex but isn t suitable for all women and some women just do not like the idea of it. There are two other tablet options. A tablet called ellaone (ulipristal) is another method of emergency contraception. We offer this between 72 hours and 120 hours after the first episode of unprotected sex. If 100 women take ellaone (ulipristal) as emergency contraception 1-2 will become pregnant. ellaone emergency contraception may make your period late. It is important that you do a pregnancy test 3 to 4 weeks later, unless you have had a normal period to make sure that you are not pregnant. The doctor or nurse will discuss your ongoing contraceptive needs. It is important to use condoms or avoid sex completely for 2 weeks after taking ellaone as it can make hormonal methods less effective until then. UNCONTROLLED WHEN PRINTED Review Date: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG

21 ellaone will only work for the unprotected sex that you have already had. If you have more unprotected sex you would need more emergency contraception. If the ellaone does not work and you become pregnant we do not know whether it has any effect on that pregnancy. The emergency contraceptive pill called levonorgestrel (Levonelle 1500) can be given between 72 hours and 120 hours after unprotected sex. It may not be as effective as it would have been if it had been taken within 72 hours of unprotected sex. We do not know if it has any effect between 96 and 120 hours. The use of levonorgestrel (Levonelle 1500) after 72 hours is not licensed by the manufacturer. Many medicines are used in unlicensed ways if there is evidence to support this. The use of levonorgestrel (Levonelle 1500) may make your period late. It is important that you do a pregnancy test 3 to 4 weeks later unless you have a normal period to make sure that you are not pregnant. Levonorgestrel (Levonelle 1500) does not increase the risk of abnormality in the baby if someone becomes pregnant after taking it. The levonorgestrel (Levonelle 1500) will only work for the unprotected sex that you have already had. The doctor or nurse will discuss your ongoing contraceptive needs. If you have more unprotected sex you would need more emergency contraception. Approximate Pregnancy Risk If 100 women have unprotected sex once No EHC used at all Copper IUD Levonorgestrel (Levonelle 1500) before 96 hours Ulipristal (ellaone ) before 120 hours 3-25 pregnancies Less than 1 pregnancy 2-3 pregnancies 1-2 pregnancies UNCONTROLLED WHEN PRINTED Review Date: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG

22 Postcoital Contraception Flowchart Appendix 5 Complete Grampian EHC proforma Less than 72 hours after first unprotected sex since first day of last period? YES 1) 2) 3) IUD: <1 pregnancy per 100. Levonorgestrel (Levonelle 1500): See PGD including double dose for women taking enzyme inducers. Do not use if previous ulipristal (ellaone ) use in the current cycle. Ulipristal 30mg (ellaone ) licensed but not for use in Grampian. <72 hours for financial reasons - See >72 hour advice. NO hours after first UPSI since first day of last period? YES NO > 120hours 1) IUD:<1 pregnancy per 100 women. 2) Ulipristal 30mg ( ellaone ): Do not use if previous levonorgestrel (Levonelle 1500) use in the current cycle. DO NOT use if severe asthma poorly controlled by steroids, i.e. current inpatient. Discard milk for 7 days if breastfeeding. Do not give at all if on enzyme inducers - no evidence double dose works. Do not give at all if on proton pump inhibitors last 7 days /ranitidine last 24 hours - reduced acidity may reduce absorption and effects. Don t know effect on pregnancy if EHC fails. Do need condoms/abstain for 2 weeks after taking as may reduce progestogen effect in other contraceptives. 3) Levonorgestrel (Levonelle 1500) off licence: uncertain effect after 96 hours. 2-3 pregnancies per 100 women hours uncertain effect efficacy unknown. Double dose if enzyme inducers off licence Only use if patient declines IUD and declines/is unsuitable for ellaone May still be suitable for IUD if pre implantation, i.e. D19 of 28 day cycle UNCONTROLLED WHEN PRINTED Review Date: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG

23 Emergency Contraception After 72 hours Appendix 6 How to arrange supply Give the patient the Information leaflet to read through to see which option she prefers. Levonorgestrel (Levonelle 1500) hours - supply off licence by any nurse signed up to PGD. Ulipristal (ellaone ) hours - licensed for use under PGD. Ulipristal (ellaone ) PGD is only for specialist nurses who have signed up to the PGD in agreement with their line manager. Copper IUD Moray The referring nurse/pharmacist/a&e Doctor should page the on call gynaecology F2/GPST through ARI switchboard - give patient details in particular the deadline for IUD insertion. The Gynae F2/GPST will liaise with the on call gynaecology consultant about time/place of fitting. This will usually be at the gynaecology clinic. The Sexual Health doctor clinic only runs 2 Thursdays/month- probably won t suit deadline. However check the FP electronic diary option 1 The Gynae F2/GPST will call the referrer back with arrangement details. Aberdeen City/Aberdeenshire The referring nurse/pharmacist can phone or ask the female to phone the Sexual Health Services based in the Aberdeen Community Health Village, telephone number The address is Aberdeen Community Health Village, 50 Frederick Street, Aberdeen AB25 5HY. Emergency IUDs are fitted by appointment Monday - Friday. The female needs to know the deadline for IUD insertion. Some GP practices will be able to fit a postcoital IUD but the tight timescale may not fit in with room/iud trained Doctor availability. Please photocopy the completed Grampian EHC proforma and send with patient. Consider giving levonorgestrel (Levonelle 1500) anyway as PGD now includes use between 72 hours and 120 hours just in case she does not actually make it to hospital for the IUD. UNCONTROLLED WHEN PRINTED Review Date: August 2015 Identifier: NHSG/PGD/ellaOne/MGPG