NHS. NHS Grampian. Grampian. Dear Colleagues. The following PGD has not been reviewed within the set timescale.

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1 NHS Grampian Westholme Woodend Hospital Queens Road ABERDEEN AB15 6LS NHS Grampian Date 22 March 2018 Our Ref FA/PGD CHC /MGPG/Mar18 Enquiries to Frances Adamson Extension Direct Line tadamson(wnhs.net Dear Colleagues The following PGD has not been reviewed within the set timescale. Patient Group Direction For The Supply Of Combined Hormonal Contraceptive - Pill or Transdermal Patch By Nurses or Midwives Working Within NHS Grampian Although this PGD is still available for use, please be advised however, that the content of the PGD may no longer be valid, and its use should be risk assessed. This will remain the case until the lead author or those responsible for the guidance undertake its review. If you have any queries regarding this please do not hesitate to contact the Pharmacy and Medicines Directorate. Yours sincerely 4 Sandy Thomson Interim Chair of the Medicines Guidelines and Policies Group

2 Patient Group Direction For The Supply Of Combined Hormonal Contraceptive - Pill or Transdermal Patch By Nurses or Midwives Working Within NHS Grampian Co-ordinators: CHP Pharmacist, Aberdeen City CHP Consultation Group: See relevant page in the PGD Approver: Medicine Guidelines and Policies Group Signature: Signature: Identifier: NHSG/PGD/CHC/ MGPG462 Review Date: January 2015 Date Approved: January 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 Combined Hormonal Contraceptive - Pill or Transdermal Patch By Nurses or Midwives Working Within NHS Grampian NHSG/PGD/CHC/MGPG462 NHSG/PGD/CHC/MGPG315 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 Pharmacist, Aberdeen City CHP Patient Group Direction PGD, patient group direction, contraception, contraceptives, CHCs, combined hormonal contraception, COCs, oral contraceptives, the pill, family planning NHS Grampian This Patient Group Direction (PGD) authorises appropriately qualified and trained nurses and midwives to supply the combined contraceptive pill or transdermal patch 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: January 2015 Identifier: NHSG/PGD/CHC/MGPG462 - i -

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 Pharmacist, Aberdeen City CHP Pharmacy and Medicines Directorate Pharmacy and Medicines Directorate CHP Pharmacist, Aberdeen City CHP CHP Pharmacist, Aberdeen City CHP 0BRevision History: Date of Approval change date of PGD that is being Jan 2012 Jan 2012 Jan 2012 Jan 2012 Jan 2012 Jan 2013 superseded September 2009 September 2009 September 2009 September 2009 September 2009 March 2012 Summary of Changes The advice to use additional contraceptives whilst taking antibiotics that do not induce liver enzymes has been removed. No additional precautions are now required. Addition of lamotrigine to list of medicines not be administered concurrently with CHC under PGD as there is a risk to loss of seizure control. Removal of Femodene and Femodette from, addition of Rigevidon and Gedarel to this PGD. Use condoms or abstain if GI upset for more than 24 hours. Section heading 3.3 Concurrent medication 3.3 Concurrent Medication 3 Description of Treatment Appendix 3 Missed pill advice. Appendix 3 PGD reapproved by the Medicine Guidelines and Policies Group. New approval date is January UNCONTROLLED WHEN PRINTED Review Date: January 2015 Identifier: NHSG/PGD/CHC/MGPG462 - ii -

5 Patient Group Direction For The Supply Of Combined Hormonal Contraceptive - Pill or Transdermal Patch By Nurses or Midwives Working Within NHS Grampian Contents Part A Specific Drug Information 1 Introduction 2 2 Clinical Decision Making Patients who may be considered for the administration of combined 2 hormonal contraceptive 2.2 Patients who may receive the administration of combined hormonal 2 contraceptive 2.3 Contraindications Precautions Action to be taken when a patient is excluded from treatment under 4 this PGD 2.6 Action to be taken when a patient does not wish to receive treatment 4 under this PGD 3 Description Of Treatment Available Under This PGD Combined hormonal contraception 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 Administer Under This PGD 8 5 Documentation Authorisation to administration Record of administration Consent 9 6 Further Points 10 7 Facilities And Supplies To Be Available At Sites For The 10 Administration Of The 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 Administer 12 Medicines Under Patient Group Direction Appendix 2 - Certificate Of Competence To Administer Medicines 13 Under Patient Group Direction Appendix 3 - Checklist For Women Receiving A First Or Repeat Prescription Of Combined Hormonal Contraception (CHC) UNCONTROLLED WHEN PRINTED Review Date: January 2015 Identifier: NHSG/PGD/CHC/MGPG

6 Patient Group Direction For The Supply of Combined Hormonal Contraceptive Pill or Transdermal Patch By Nurses or Midwives Working Within NHS Grampian 1. Introduction Part A This patient group direction (PGD) will allow nurses or midwives to be authorised to supply combined hormonal contraceptives to women from 14 to 49 years. The combined contraceptive transdermal patch shares the beneficial and adverse effects of the combined oral pill. Use should be restricted to those individuals who have demonstrated poor compliance, or are likely to comply poorly with combined oral contraceptives. Alternative contraceptive methods should also be discussed, including the relatively lower failure rate of long-acting reversible contraceptive methods (LARC). This PGD relates only to the supply of combined hormonal contraceptives for contraception, not for other medical reasons. 2. Clinical Decision Making 2.1 Patients who may be considered for the administration of combined hormonal contraception Women aged from 14 to 49 years who choose combined hormonal contraception as their method of contraception after full discussion. In general terms combined oral or transdermal contraception can be supplied under PGD to women with conditions categorised as UK Medical Eligibility Criteria (UKMEC) 1 or 2, see Patients who may receive the administration of combined hormonal contraception 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/midwife. 2.3 Contraindications Women with conditions in UK Medical Eligibility Criteria (UKMEC) category 3 and 4 are not suitable for treatment under PGD ( UNCONTROLLED WHEN PRINTED Review Date: January 2015 Identifier: NHSG/PGD/CHC/MGPG

7 Additionally combined hormonal contraception should not be given under PGD to patients with the following conditions/characteristics: Interacting medicines as listed in the current BNF refer to a Doctor. See Section 3.3 Concurrent Medication. Known allergy to any excipients. Premenarche or age less than 14 years or age 50 years or over. Less than 21 days postpartum or less than 6 months postpartum and breastfeeding. Less than 6 weeks after third trimester delivery if pregnancy hypertension, BMI >30kg/m 2 or prolonged immobility after caesarean/instrumental delivery. Smoker aged 35 years and smoked at all in the last year. Obesity BMI >35kg/m 2. Migraine with or without aura at any age. Hypertension either controlled with treatment or untreated and consistently elevated BP>140mmHg systolic or >90mmHg diastolic. Personal history of venous or arterial thrombosis or a prothrombotic condition, e.g. Factor V Leiden, systemic lupus erythematosus. Family history of venous or arterial thrombosis in first degree relative under 45 years. Family history of prothrombotic condition. Acute Porphyria. Personal history of cardiovascular disease or cerebrovascular disease. Valvular and congenital heart disease. Diabetes with nephropathy/retinopathy/neuropathy. Peripheral vascular disease (not varicose veins or superficial thrombophlebitis). Immobility due to disability or illness, or surgery lasting longer than 30 minutes or any trauma, orthopaedic or neurosurgery procedures in previous 6 weeks or planned in next 6 weeks. Breast cancer - current or past personal history or family history of known BRCA1/2 mutation. (Family history of breast cancer alone without confirmed mutation is not a contraindication). Abnormal uninvestigated vaginal bleeding. Gestational trophoblastic neoplasia when hcg is abnormal. Symptomatic gallbladder disease -current or previously treated with medicines not surgery (previous cholecystectomy is not a contra-indication). History of cholestasis related to CHC use or to pregnancy. Liver Dysfunction: o Cirrhosis o Liver tumour past or present - benign or malignant o Viral Hepatitis acute infection or recurrent active disease Transdermal CHC only - skin lesions affecting large areas of the trunk or upper limbs. Transdermal CHC weight >90kg regardless of BMI. Personal or family history of conditions which are of unknown relevance to the nurse/midwife. Patient queries/anxieties that cannot be answered/addressed by the nurse or midwife. See UNCONTROLLED WHEN PRINTED Review Date: January 2015 Identifier: NHSG/PGD/CHC/MGPG

8 2.4 Precautions Combined hormonal oral or transdermal contraceptives are not suitable for all women and are associated with side effects including an increased risk of venous and arterial thromboembolic events. 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 to speak to a doctor. 3. Description Of Treatment Available Under This PGD 3.1 Combined hormonal contraception The dosage regimen supplied should be one that contains the least amount of oestrogen and progestogen that is compatible with a low failure rate, good cycle control and minimal side effects for the patient. History taking and examination should be completed as per Appendix 3 for first and repeat supply. For first prescription supply 3 months. Review at 3 months to assess any problems or uncertainty about pill taking procedure, check BP and BMI and provide further instruction. Give a 12 month supply if all well. For repeat supply - Update medical/drug/smoking history and check for contraindications. Specifically enquire about migraines and bleeding pattern. Refer to doctor if any concerns. Give sufficient supply to maintain contraceptive cover if there will be a delay before the patients can see the doctor. Record Blood Pressure and BMI after 3 months use and annually thereafter. Give 12 month supply if all well Combined hormonal contraception oral This PGD is for the initial supply of a CHC pill containing 30 micrograms ethinylestradiol and 150 micrograms levonorgestrel, i.e. Microgynon 30 or Ovranette or Rigevidon 30/150. Repeat supply may be of any of the pills listed below: Cilest - Janssen-Cilag (pack size 3 x 21) Norgestimate 250 micrograms, ethinylestradiol 35 micrograms Gedarel 20/150 Consilient (pack size 3 x 21) Ethinylestradiol 35 micrograms, norgestimate 250 micrograms UNCONTROLLED WHEN PRINTED Review Date: January 2015 Identifier: NHSG/PGD/CHC/MGPG

9 Loestrin 20 - Galen (pack size 3 x 21) Ethinylestradiol 20 micrograms, desogestrel 150 micrograms) Gedarel - 30/150 Consilient (pack size 3 x 21) Ethinylestradiol 30 micrograms, desogestrel 150 micrograms) Loestrin Galen (pack size 3 x 21) Ethinylestradiol 30 micrograms, desogestrel 150 micrograms). NB. Dianette is not licensed for contraception. It should only be used for hirsutism or acne when antibiotics have failed. Dianette has a four fold higher risk of VTE than other CHC. Phasic pills are excluded from this PGD whether initial or repeat supply Combined hormonal contraception - transdermal Evra patches Daily dose norelgestromin 150 micrograms, ethinylestradiol 20 micrograms. 3.2 Dose, route and frequency Oral tablet One oral tablet should be taken daily for twenty one days, starting on the first day of the menstrual cycle, followed by a seven-day pill-free interval. See also Appendix 3. Patch One patch should be applied on the first day of the menstrual cycle to clean dry skin on the upper arms, thigh or trunk but avoiding the breasts. The patch should be removed after 7 days and a new patch applied immediately to a different area of skin. A patch should be applied on three consecutive weeks, i.e. day 1,8,15. The third patch is removed on day 22 followed by a 7-day patch free interval. See also Appendix Concurrent medication Some prescribed and over the counter medicines accelerate the liver metabolism of combined hormonal contraceptives. When taken concurrently they increase the risk of contraceptive failure. Women on these medications are not suitable for supply under this PGD. These drugs include: St John s Wort, barbiturates, primidone, phenytoin, griseofulvin, rifampicin, rifabutin, carbamazepine, oxcarbazepine, topiramate, some protease inhibitors, e.g. ritonavir, nelfinavir and some non nucleoside reverse transcriptase inhibitors. CHC may affect the plasma levels of other drugs if taken at the same time and therefore are not suitable for supply under PGD. CHC can increase plasma levels of ciclosporin, theophylline and prednisolone. CHC may reduce levels of lamotrigine leading to loss of seizure control. UNCONTROLLED WHEN PRINTED Review Date: January 2015 Identifier: NHSG/PGD/CHC/MGPG

10 This is not exhaustive - refer to current British National Formulary or the Faculty of Sexual and reproductive health guidance. Patients taking interacting medicines are not suitable for treatment under the PGD and should be referred to a doctor. 3.4 Adverse effects Potential adverse effects will be discussed with the patient as per the checklist in Appendix 3. Minor side effects may include breakthrough bleeding, nausea, breast tenderness, headache and mood or weight change. Women may develop skin irritation at the site of transdermal patch application. In women where contraception is selected taking account of Sections 2.3 Contraindications and 2.4 Precautions, the incidence of serious adverse effects attributable to the combined oral /transdermal contraceptive is small. Severe adverse effects include cerebrovascular accident, venous thromboembolism and myocardial infarction. Epidemiological studies have demonstrated increased rates of breast and cervical cancer in current and past users of CHC. There is no evidence on risks related to the transdermal patch but rates are expected to be similar to those for oral preparations. Patients should be given verbal and written advice about which symptoms should lead them to seek urgent medical advice from clinic or the out-of-hours primary care service. Adverse events will be reported to the committee of safety of medicines via the yellow card scheme or on the website at and to the local risk management committee. Treatment of overdose For oral contraceptives: Overdosage may cause nausea, vomiting and withdrawal bleeding. There are no specific antidotes and treatment should be symptomatic. For transdermal patches: In cases of suspected overdose, all transdermal contraceptive systems should be removed and symptomatic treatment given. 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 patient information leaflet contained with the medicine(s) should be made accessible to the patient/parent/guardian. Where this is unavailable, or unsuitable, UNCONTROLLED WHEN PRINTED Review Date: January 2015 Identifier: NHSG/PGD/CHC/MGPG

11 sufficient information should be given to the patient/parent/guardian in a language that they can understand. 3.6 Follow up treatment Patients will be advised to make an appointment with the Sexual health and Reproductive Health (SFH) Clinic if they wish to discuss any aspect of their contraceptive use or alternatives to combined hormonal contraception. The health professional will ensure the patient has the contact number for the clinic. UNCONTROLLED WHEN PRINTED Review Date: January 2015 Identifier: NHSG/PGD/CHC/MGPG

12 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 Nurses 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 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) 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. (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. 5. Documentation 5.1 Authorisation to Supply Registered nurses and midwives can be authorised to supply the CHCs by their nurse manager. UNCONTROLLED WHEN PRINTED Review Date: January 2015 Identifier: NHSG/PGD/CHC/MGPG

13 Nurses and midwives are only authorised to supply CHC to patients aged 14 to 49 years. A certificate of competence (Appendix 2) signed by the authorising doctor/manager should be supplied. This should be held in the individual nurses 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) (ii) (iii) (iv) (v) (vi) (vii) (viii) (ix) (x) (xi) (xii) Name and address of patient, Unit No/CHI No Date of birth Consultant/General Practitioner details Risk group, if appropriate Physical examination required, if appropriate Exclusion criteria, record why drug not supplied Reason for giving Consent to the supply (if not obtained elsewhere) Drug manufacturer, batch number, expiry date Signature and name in capital letters of practitioner who supplied the drug Date drug given 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 10 years after conclusion of treatment. Or for 3 years after death, or in accordance with local policy, where this is greater than above. 5.3 Consent Prior to the supply 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. UNCONTROLLED WHEN PRINTED Review Date: January 2015 Identifier: NHSG/PGD/CHC/MGPG

14 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 The PGD The following should be available at sites where the drug is to be administered: (i) (ii) (iii) Safe storage areas for medicines and equipment. Equipment for disposal of used materials, i.e. waste-bins. Clean and tidy work areas. 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 LCHP/practice/service will be responsible for auditing completion of drug forms and collation of data. UNCONTROLLED WHEN PRINTED Review Date: January 2015 Identifier: NHSG/PGD/CHC/MGPG

15 9. Management And Monitoring Of Patient Group Direction Part C 9.1 Consultative group Susan Brechin Alison Davie Karen Hudson Linda Juroszek Susan Logan Sarah Wallage Consultant Sexual and Reproductive Health CHP Pharmacist Specialist Nurse in Sexual Health and Midwife CHP Pharmacist Consultant Sexual and Reproductive Health Consultant Sexual and Reproductive Health 9.2 Professional advisory group approving PGD Medicine Guidelines and Policies Group 9.3 Authorising managers Dr Roelf Dijkhuizen Medical Director, NHS Grampian Mr David Pfleger Director of Pharmacy and Medicines Management, NHS Grampian Ms Elinor Smith Nursing Director, NHS Grampian 10. References 1. Electronic Medicines Compendium Ovranette Date of Revision of Text 31/08/2011 Accessed 31/01/2012 Microgynon Date of Revision of Text 28/07/2011 Accessed 31/01/2012 Cilest Date of Revision of Text 08/12/2011 Accessed 31/01/2012 Loestrin 20 Date of Revision of Text 03/11/2011 Accessed 31/01/2012 Loestrin 30 Date of Revision of Text 03/11/2011 Accessed 31/01/2012 Evra Date of Revision of Text 21/01/2010 Accessed 31/01/ British National Formulary, 62 September 2011 The Pharmaceutical Press Faculty of Sexual and Reproductive Health Document: Drafted: November 2011 Completed: February 2012 Approved: January 2013 (published February 2013) Review date: Every 2 years or sooner if current treatment recommendations change. UNCONTROLLED WHEN PRINTED Review Date: January 2015 Identifier: NHSG/PGD/CHC/MGPG

16 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 Supply Of Combined Hormonal Contraceptive - Pill or Transdermal Patch By Nurses or 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: January 2015 Identifier: NHSG/PGD/CHC/MGPG

17 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 Supply Of Combined Hormonal Contraceptive - Pill or Transdermal Patch By Nurses or 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: January 2015 Identifier: NHSG/PGD/CHC/MGPG

18 Appendix 3 Checklist For Women Receiving A First Or Repeat Prescription Of Combined Hormonal Contraception (CHC) When counselling women receiving a first prescription of combined pills or patch all staff should follow this clinic guideline to ensure all women are given evidence-based information. Please record in the case notes: COUNSELLED AS PER CLINIC GUIDELINE and everyone seeing her subsequently will know what standard information has been given. If some information has been omitted state this in the case records. Confirmed Medical History In Case Notes Is Up To Date Confirm the patient has NO CONTRAINDICATIONS to use - see below and UKMEC for further details UKMEC 4 = unacceptable health risk UKMEC 3 risks of use outweigh benefits (but use may be considered with clinical judgement and/or referral to a specialist contraceptive provider) Women with conditions categorised as UKMEC 3 or 4 are excluded from treatment under this PGD Age premenarche or 50 years or more PGD 14 to 49 inclusive Interacting medicines as listed in the current BNF Known allergy to any excipients <21 days postpartum or <6 months postpartum and breast feeding ( UKMEC3) <6 weeks postpartum and breast feeding ( UKMEC4) Current smoker aged 35 years (UKMEC 3 or 4) and smoked at all in the last year Migraine with aura at any age (UKMEC 4) Migraine without aura when aged 35 years (UKMEC 3) or any age if migraine develops/worsens on CHC (UKMEC3) Women of any age with migraine with or without aura should not receive CHC under PGD BMI 35kg/m 2 (UKMEC 3) BP consistently > 140 mmhg systolic or > 90 mmhg diastolic (UKMEC 3 or 4) OR Controlled hypertension (UKMEC 3) Personal history of venous or arterial thrombosis FHx VTE in first degree relative < 45 years Known thrombotic condition e.g. Factor V Leiden or Serum lupus erythematosus Acute porphyria Immobility disability or illness or major surgery (>30 mins or orthopaedic/trauma/neurosurgery) in last or next 6 weeks Personal history of cardiovascular disease or cerebrovascular disease (UKMEC 4) Multiple cardiovascular risk factors eg BMI>30 + smoking + diabetes (UKMEC 3/4 ) Breast cancer in past 5 years (UKMEC 4) more than 5 years ago and no recurrence (UKMEC3) Known carrier of BRCA1/2 (UKMEC 3) Past or current benign or malignant liver tumour (UKMEC 4), cirrhosis ( UKMEC 3-4), current symptomatic or past non surgically treated gall bladder disease, CHC related cholestasis ( UKMEC 3) Diabetic with neuropathy/nephropathy/retinopathy (UKMEC 3) Active acute or recurrent viral hepatitis Abnormal uninvestigated vaginal bleeding Liver enzyme inducing drugs (UKMEC 3) - now or in last month - reduced efficacy advise IUD/IUS/Depo- Provera Gestational trophoblastic neoplasia when HCG is abnormal (UKMEC 4) Transdermal CHC only - skin lesions affecting large areas of the trunk or upper limbs Personal or family history of conditions which are of unknown relevance to the nurse/midwife. Patient queries/anxieties that cannot be answered/addressed by the nurse or midwife UNCONTROLLED WHEN PRINTED Review Date: January 2015 Identifier: NHSG/PGD/CHC/MGPG

19 Appendix 3 Checklist For Women Receiving A First Or Repeat Prescription Of Combined Hormonal Contraception (CHC) DISCUSS BENEFITS DISCUSS POTENTIAL HARMS 99% effective if used consistently and correctly But in typical use 4-8 pregnancies per 100 women in first year Risk of VTE, MI and ischaemic stroke increased but the absolute risk is small. Discuss symptoms which should be reported urgently Contraceptive protection remains during pill free interval if all pills before and after are taken correctly Any increased risk of breast cancer associated with CHC use is likely to be very small, no increased risk 10 years after stopping Menstrual pain and blood loss may be reduced Acne may improve Very small increase in the risk of cervical cancer with CHC use linked to duration of use. UK screening programme aims to detect changes at the pre-cancer stage. Fewer functional ovarian cysts and benign ovarian tumours DISCUSS PROBLEMATIC/MINOR SIDE EFFECTS No additional weight gain with CHC use 50% decrease in ovarian and endometrial cancer during use and for at least 15 years after stopping. First 3 months may notice irregular bleeding, mild headache, mood changes, breast tenderness. These symptoms usually resolve, persevere if possible and discuss at review appointment RECORD Blood pressure BMI LMP Additional notes Complete tick sheet for <16 s Record pill issued and amount When to start the method and whether needs condom too for first 2 days Give Family Planning Association leaflet Discuss safer sex and condom use UNCONTROLLED WHEN PRINTED Review Date: January 2015 Identifier: NHSG/PGD/CHC/MGPG

20 Appendix 3 Checklist For Women Receiving A First Or Repeat Prescription Of Combined Hormonal Contraception (CHC) Instructions for use of combined hormonal contraception (CHC) Start up to and including day 5 of the menstrual cycle or 5 days after ectopic, miscarriage or termination of pregnancy <24 weeks gestation or 21 days after a more advanced pregnancy with immediate contraceptive cover. Can start at other times if it is reasonably certain a woman is not pregnant in this case she needs to abstain/use condoms too for the first 7 days of CHC use. Serious symptoms which require immediate medical advice include chest pain, breathlessness, coughing up blood, painful leg swelling, weakness or numbness of an arm or leg, unusual headaches or migraines that are new or worse or more frequent than usual, sudden problems with speech or eye sight, jaundice, severe abdominal pains. Minor side effects (headaches, nausea, breast tenderness, mood changes or irregular bleeding) advise to persevere, these often resolve within a few months. Inform medical/dental staff that you are using CHC if starting new medication, planned/emergency admission to hospital for any reason including surgery, or if reduced leg mobility for any reason, e.g. fracture. Supply 3 months as first prescription. Review at 3 months to assess any problems or uncertainty about pill taking procedure, check BP and provide further instruction. Give a 12 month supply if all well. Repeat supply- update medical/drug/smoking history and check for contraindications. Specifically enquire about migraines and bleeding pattern. Refer to doctor if any concerns. Give sufficient supply to maintain contraceptive cover if there will be a delay before the patient can see the doctor. Record Blood Pressure and BMI after 3 months use and annually thereafter. Give 12 months supply if all well. UNCONTROLLED WHEN PRINTED Review Date: January 2015 Identifier: NHSG/PGD/CHC/MGPG

21 Appendix 3 Checklist For Women Receiving A First Or Repeat Prescription Of Combined Hormonal Contraception (CHC) Additional Instructions for use of the Combined Oral Contraceptive Pill One pill should be taken daily for 21 days followed by 7 pill free days. Can take three packets continuously followed by a 7 day pill free interval (unlicensed). Vomiting/diarrhoea - If vomits within 2 hours of taking pill, another pill should be taken as soon as possible. If persistent vomiting or severe diarrhoea for more than 24 hours continue to take pills but use condoms too/ abstain while ill and for 7 days after. Missed pills - One pill can be missed at any time in the packet without losing contraceptive cover. If miss 2-6 pills restart as soon as remember and use condoms too/abstain for the next 7 days. If these 7 days would run in to the pill free week omit the pill free interval and go straight on to the next pack. Emergency Contraception needed if miss x 2 pills (either 20micrograms or 30micrograms dose) in the first week of pack and had UPSI at any time since the start of the pill free interval. Patient should be advised to phone for advice if uncertain or refer to fpa leaflet. Additional Instructions for use of the Combined Contraceptive Patch Apply patch to dry skin (abdomen, thigh, buttock, upper arm) once a week on the same day for 3 consecutive weeks followed by a patch free week. Patches can be continued without patch free week to avoid a withdrawal bleed for up to 6 weeks (licensed). Late patch change There should not be more than a 7-day patch-free interval. If there is a 48 hour delay in changing a patch or starting a patch after patch free break the user should apply a new patch immediately and abstain/ use condoms too for the next 7 days. If these 7 days would run in to the patch free week omit the patch free week and go straight on to the next patch. Emergency contraception needed if 48 hour delay in applying 1 st patch after the patch free week and intercourse since start of patch free week. UNCONTROLLED WHEN PRINTED Review Date: January 2015 Identifier: NHSG/PGD/CHC/MGPG