Patient Group Direction

This Patient Group Direction (PGD) must only be used by registered nurses who have been named and authorised by their organisation to practice under it. The most recent and in date final signed version of the PGD should be used. Patient Group Direction for the supply of Progestogen only pills POP (Micronor and Cerelle) by registered nurses for oral contraception in Coalfields sexual health clinic Version number: 1.1 Change history Version number Change details Date V1.1 Initial approved version December 2015 Expiry date: December 2017 1

PGD development Name Job title and organisation Signature Date Medicines Optimisation Pharmacist Medicines Optimisation Pharmacist Practice Nurse Representative to the Executive Committee Medical Director Other members of the PGD working group PGD authorisation Hannah Willoughby (Interface Pharmacist) Paula Russell (Senior Pharmacist) Florence Gunn (Senior Nurse) Dr Claire Bradford (Senior Doctor) Not applicable Name Job title and organisation Signature Date Medicines Optimisation Pharmacist Practice Nurse Representative to the Executive Committee This PGD has been approved for use in by Medical Director, Person signing on behalf of authorising body Paula Russell (Senior Pharmacist) Florence Gunn (Senior Nurse) Dr Claire Bradford (Senior Doctor) Name Signatures to be determined locally, if relevant PGD adoption by the provider 1 Job title and organisation Signature Date Expiry date: December 2017 2

Training and competency of registered nurses Qualifications and professional registration Requirements of registered nurses working under the PGD Professionals using this PGD must be currently registered with their relevant professional body; For nurses: - Nursing & Midwifery Council (NMC) Initial training Have a current contract of employment with a GP practice within Competency assessment Ongoing training and competency Has had training in the use of PGDs Has had training which enables the healthcare professional to make a clinical assessment in order to establish the contraceptive need and supply the POP according to this PGD. Has undertaken the competency training appropriate to this PGD Has been assessed and achieved the required standard deemed necessary by the senior medical representative who deems the healthcare professional competent to practice under the PGD. Is competent in the assessment of the 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 Must have demonstrated an appropriate level of competence to their clinical manager in contraceptive services. The registered nurse should ensure she/he is aware of any changes to the recommendations for this medication. It is the responsibility of the healthcare professional to keep up-to-date with continuing professional development and take part in audit of clinical records on a regular basis. Continuous professional development completed as per governing body Reaccreditation of nursing qualification as dictated by governing body Expiry date: December 2017 3

Clinical condition Clinical condition or situation to which this PGD applies Inclusion criteria Contraception using progestogen only pills (POP). To supply combined oral contraception to female patients aged from menarche to 55 years of age. Only use those criteria that are specific to your authorised role & competence. Ensure appropriate consent has been obtained before proceeding. Any female (age menarche to 55 years of age) presenting for contraception Understands the risks, benefits and side effects Valid informed consent. Exclusion criteria Refer to current SPC for additional details Personal Characteristics & Reproductive History Known or suspected pregnancy Known hypersensitivity to any constituent of the POP Under 16 years of age and assessed as not competent using Fraser guidelines Any rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption Cardiovascular Disease Expiry date: December 2017 4 Active venous thromboembolic disorder. venous thromboembolism (VTE, deep venous thrombosis and pulmonary embolism) History of thrombo-embolic disorders Known thrombogenic mutations e.g. Factor V Leiden, prothrombin mutation, protein S. protein C, and antithrombin deficiencies Severe arterial disease Development of ischaemic heart disease, transient ischaemic attack or stroke History of cerebrovascular disease, including transient ischaemic attack occurring whilst taking POP Hyperlipidaemias Multiple risk factors for arterial cardiovascular disease (such as age, smoking, diabetes, hypertension and obesity) History of DVT or PE, current VTE on anticoagulants. Major surgery with prolonged immobilisation Chronic illness with prolonged immobilization Cancers Known or suspected sex-steroid sensitive

malignancies. Current or past history of breast cancer Benign liver tumour Malignant liver tumour (hepatocellular adenoma and malignant hepatoma) Progesterone dependent tumours Gastro-intestinal Conditions Severe decompensated cirrhosis Other conditions Interacting medicines see current British National Formulary (BNF) on interactions (This includes the use of potent enzyme inducers in the past 4 weeks) Liver enzyme inducing drugs including: Rifampicin, and rifabutin, anti-epileptics (carbamazepine, eslicarbazepine, barbiturates, oxcarbazepine, phenytoin, rufinamide primidone, topiramate), St John s Wort, griseofulvin. This list is not exhaustive. Refer to most recent edition of BNF Presence or history of severe hepatic disease as long as liver function values have not returned to normal. Ritonavir-boosted protease inhibitors Systemic Lupus Erythematosus (SLE) with positive or unknown anti-phospholipid antibodies Acute Porphyria Porphyria Individual wishes to see a doctor Undiagnosed abnormal vaginal bleeding Heavy, prolonged bleeding (includes regular and irregular) or irregular bleeding without heavy bleeding. Undiagnosed breast mass or carrier of known gene mutations associated with breast cancer eg.brca1 HIV infected and not using antiretroviral therapy AIDS Diabetes Past or current gallbladder disease History of cholestasis Choleostatic jaundice and/or pruritis Hepatic focal nodular hyperplasia Dubin-Johnson Syndrome and Rotor Syndrome Inflammatory bowel disease (includes Crohn s disease, ulcerative colitis) Raynauds disease with lupus anticoagulant. SLE without antiphospholipid antibodies Past ectopic pregnancy Non-nucleoside reverse transcriptase inhibitors Expiry date: December 2017 5

Cautions (including any relevant action to be taken) Arrangements for referral for medical advice Action to be taken if patient excluded Action to be taken if patient declines treatment If the patient is receiving any concomitant medication or treatment, it is the responsibility of the healthcare professional conducting the consultation and supply to ensure that treatment with the medicines detailed in this PGD is appropriate. In case of any doubt, further advice must be sought from an appropriate healthcare professional and this must be recorded as having been sought before the medicine is given.check drug history and refer to current BNF for more details and potential drug interactions and ask for advice on management if necessary. All patients taking a medication that interacts significantly (indicated with a black dot in the paper version, or shaded red in the online version) with the contraceptive being given, should be excluded. If under 13 years of age, follow local safeguarding policy Discuss with appropriate doctor/independent nonmedical prescriber any medical condition or medication of which the nurse is unsure/uncertain Doctor/specialist appointment as and when appropriate Refer to appropriate doctor/independent nonmedical prescriber Discuss /offer alternative contraceptive method Document all actions taken Record refusal in the clinical record Refer to appropriate doctor/independent nonmedical prescriber Discuss /offer alternative contraceptive method. For example condoms Document all actions taken Consider the supply of an alternative hormonal contraceptive under PGD or another method of contraception. Expiry date: December 2017 6

Details of the medicine Name, form and strength of medicine Include for black triangle medicines Brand Name Form Pack size Content Cerelle Tablet 84 Desogestrel 75micrograms Micronor Tablet 84 Norethisterone 350micrograms Description Progestogen only pill 28 day pack administration is continuous Progestogen only pill 28 day pack administration is continuous Legal category Indicate any off-label use (if relevant) Route/method of administration Expiry date: December 2017 7 Progestogen only oral contraceptives specified in this PGD will be available overlabelled. Stock which is not overlabelled must not be used In the event that no overlabelled stock is available, the patients current stock of medication should be ascertained. If the patient has no medication left, or is newly starting on this medication, the patient should be given an FP10 prescription for dispensing at a community chemist. The FP10 must be signed by a GP or other appropriate prescriber. The practice manager will be responsible for maintaining appropriate levels of stock. Prescription only medications Not applicable Tablets are for oral administration only Dose and frequency One tablet is taken daily at the same time without interruption for 28 days Once one pack has been completed, the next pack should be started immediately without a break. Tablets must be taken every day at about the same time so that the interval between two tablets always is 24 hours. The first tablet should be taken on the first day of menstrual bleeding. Cerelle can be started on days 2-5 of the menstrual cycle, but extra precautions should be taken for an additional 7 days Micronor 350mcg can be started on days 1-5 of menstrual cycle without need for additional precautions Micronor can be started at any other time, if pregnancy can reasonably be excluded. In this case, additional contraceptive precautions must be taken for the first 48 hours of tablet taking Thereafter, follow manufacturer s instructions for

Expiry date: December 2017 8 individual product use. If the patient is amenorrhoeic, pregnancy should be excluded prior to starting Micronor and there is no risk of conception. For guidance on changing from one contraceptive method to another, and when to start after an abortion and post partum, refer to Table 2 FSRH guidelines Progestogen-only Pills (March 2015)

Quantity to be administered and/or supplied Maximum or minimum treatment period Adverse effects Initial supply is three (3) months unless clinical reason for lesser supply. Maximum treatment period for repeat supplies is 6 months. Less of a supply may be made if there is concern for the individual. Duration of treatment is for as long as the individual requires the POP and for as long as the individual has no contraindications to use of the POP. As this PGD covers different oral contraceptives, please refer to the manufacturers guide (SPC or patient information leaflet) and the BNF for full information. The information listed below is a guide only. This list may not represent all reported side effects of this medicine Most POPs are well tolerated. Some of the common side effects are; Breast tenderness Headache Disturbance of bleeding patterns Changes in mood Weight change 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 nurse prescriber Complete incident procedure if adverse reaction is severe ( refer to local organisational policy) All serious adverse reactions should be reported using the Yellow Card system, which can be done online at http://yellowcard.mhra.gov.uk/ or obtained via Freephone 0808 100 3352. Records to be kept The registered nurse 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) Initial examination to include body mass index (BMI) Expiry date: December 2017 9

and blood pressure recording and thereafter according to local policy Inclusion or exclusion from PGD A statement that supply 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 supply outside the terms of the product 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 Record batch number and expiry date according to local policy or national guidelines Any referral arrangements Record follow up and/or signposting arrangements Any other relevant information that was provided to the individual Name and signature (which may be an electronic signature) of the nurse supplying the medicine Expiry date: December 2017 10

Patient information Written information to be given to patient or carer Follow-up advice to be given to patient or carer Provide manufacturer s Patient Information Leaflet (PIL) and discuss content including but not limited to missed pills advice and steps taken in the event of diarrhea or vomiting. Provide a copy of the FPA leaflet on the POP Explain mode of action, side effects, and benefits of the medicine Advise about the risks of the medication including failure rates and serious side effects and the actions to be taken Offer condoms and advice on safer sex practices and possible need for screening for sexually transmitted infections (STIs) Ensure the individual has contact details of the service /sexual health services. Reiterate to patient that oral contraceptives do not provide protection against STIs. Advise on what to do if vomits within two (2) hours of taking the pill or in cases of prolonged vomiting or severe diarrhoea. See FPA leaflet/fsrh guidance Advise on what to do if she forgets to take it (missed pills; three hours for all POPs except Cerazette and Cerelle which is 12 hours). See FPA leaflet/fsrh guidance Offer condoms and advise on safer sex practices Ensure individual knows what to do if her medical condition changes in the future Ensure individual has the contact details of the service. If the woman gets abdominal pain they should seek medical advice. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking Cerelle. Expiry date: December 2017 11

Appendices Appendix A Key references Please note; best practice advice given by Faculty of Sexual and Reproductive Healthcare (FSRH) is used for guidance in this PGD and may vary from the Summary of Product Characteristics (SPC). Faculty of Sexual and Reproductive Healthcare (FSRH) response to new data on quickstarting hormonal contraception after use of ulipristal acetate 30mg (ellaone ) for emergency contraception, September 2015. SPCs for Cerelle and Micronor via http://www.medicines.org.uk BNF online Patient Group Direction for the supply of progestogen only oral contraceptive (POP) pills by registered nurses in sexual and reproductive health services, London contraception and sexual health patient group direction, Version 1.1, Expiry 31.08.2016. Repeat issue of progestogen only oral contraceptives, NHS North Lancashire, NHS Cumbria and North Cumbria University Hospital Trust, Version: Repeat issue POP 2010.1, Expired 31 st October 2012. Patient Group Direction For The Initial And Repeat Supply Of The Contraceptive Progestogen-Only Pill By Nurses Within Sexual Health Services And Midwives Working Within NHS Grampian, NHS Grampian, Version 3, Expires October 2015. CEU Guidance - Quick Starting Contraception September 2010 (review: September 2015) Appendix B Registered nurses agreement to practise Insert statement to be signed by individual nurses agreeing to practice under the PGD. For example: I have read and understood the Patient Group Direction and agree to supply and/or administer this medicine only in accordance with this PGD. Name of nurse Signature Senior representative authorising nurse Date Other appendices may be added as agreed locally. Expiry date: December 2017 12