/

Patient Group Direction (PGD) for the Supply of:

COMBINED ORAL CONTRACEPTIVE TABLETS (COC)

Prescription Only Medicine (POM)

To Females Aged 13 Years and Above YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT CLINICAL CONDITION OR SITUATION TO WHICH DIRECTION APPLIES Indication

Inclusion Criteria

Exclusion Criteria

Oral contraception in healthy women aged from 13 years to 50 years of age.

For the management of unscheduled bleeding in women using a progesterone-only injectable, implant or intra-uterine system (IUS).

Informed consent has been given in accordance with current Locala Community Partnerships guidelines for the supply of the medicine.

Female clients aged from 13 years of age and up to 39 years of age requesting contraception.

Female clients aged between 40 and 50 years of age with no additional risk factor.

Female clients, (aged from 13 years to 50 years), diagnosed with unscheduled bleeding secondary to progesterone-only injectable, implant or IUS, with no other risk factors (see exclusion criteria). A full clinical and sexual history should be taken from women using hormonal contraception with unscheduled bleeding to identify the possibility of an underlying cause. See ‘cautions/need for further advice’.

The full medical, obstetric, drug, family and social history has been taken and there is no reason for exclusion (see below).

Blood pressure below 140/90. See cautions/need for further advice for current users.

Breast feeding – between 6 weeks and 6 months post partum and partially breast feeding. E.g. less than half the feeds are breastfeeds.

Family history of breast cancer and no known gene mutation.

Treatment of clients aged 16 years or younger must meet Fraser guidelines.

Informed consent has NOT been given in accordance with current Locala Community Partnership (LCP) guidelines for the supply of the medicine.

Females under 13 years of age.

Female clients aged over 50 years of age.

Female clients aged between 40 and 50 with additional risk factor.

Pregnancy or suspected pregnancy.

Postpartum < 21 days.

Hypersensitivity/allergy to any constituent of combined oral contraceptives (COCs).

Obesity – defined as clients with a BMI of > 35kg/m2 History of severe depression induced by hormonal contraception.

Women undergoing sclerosing treatment for varicose veins Systemic lupus erythematosus Porphyria .History of haemolytic uraemic syndrome or history during pregnancy of pruritus, cholestatic jaundice, chorea, pemphigoid gestationis

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Exclusion Criteria continued

Undiagnosed vaginal bleeding.

Breast Feeding Breast feeding and less than 6 weeks post partum.

Breast feeding - between 6 weeks and 6 months postpartum and fully or almost fully breast feeding Venous Thromboembolism (VTE) Current VTE (on anticoagulants) Past history of VTE Known thrombogenic conditions e.g. Factor V Leiden; Prothrombin mutation; Protein S, Protein C, and Antithrombin deficiencies.

Secondary Raynauds with lupus anticoagulant (SLE) Family history of venous thromboembolism in first-degree relative < 45 years of age.

Immobility (unrelated to surgery) - e.g wheelchair use, debilitating illness Major surgery with prolonged immobilisation. (Major surgery includes operations > 30 minutes duration).

Smoking Smokers if aged 35 or over Ex smokers if aged 35 or over and have quit smoking less than 1 year ago.

Breast Disease Current or past breast cancer.

Carriers of known gene mutations associated with breast cancer.

Undiagnosed breast mass Diabetes Diabetes with nephropathy, retinopathy or neuropathy or other vascular disease Heart Disease/Stroke Current and history of ischaemic heart disease Stroke and transient ischaemic attacks.

Complicated congenital or valvular heart disease History of heart attack or stroke in first-degree relative aged < 45 years Cardiovascular disease - multiple risk factors for arterial cardiovascular disease e.g. older age,smoker, diabetes, hypertension, obesity, family history.

Known or family history of hyperlipidimia Hypertension A systolic of 140 or above and/or a diastolic of 90 or above. See cautions/need for further advice for current users.

History of COC induced hypertension.

Hypertension controlled by medication Vascular disease â&#x20AC;&#x201C; includes coronary heart disease presenting with angina; peripheral vascular disease presenting with intermittent claudication; hypertensive retinopathy; and transient ischaemic attacks.

Migraine Headaches Migraine headaches with aura at any age.

Past history of migraine headaches with aura at any age New diagnosis of migraine without aura in current user Liver or Gall Bladder Disease Current or medically treated gall bladder disease Liver disease including disorders of hepatic excretion e.g. DubinJohnson or Rotor syndromes History of COC related cholestasis

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Cautions/Need for Further Advice

Active hepatitis Severe Cirrhosis Liver tumour – benign and malignant Drug Interactions Clients taking liver enzyme-inducing drugs (e.g. rifamycin, rifabutin, St John’s Wort, rufinamide,barbiturates, griseofulvin, carbamazepine, oxcarbazepine, phenytoin, phenobarbital, primidone, topiramate, phenylbutazone, modafinil, aprepitant, bosentan, fosamprenavir, nelfinavir, nevirapine, amprenavir, atazanivir, lopinavir, saquinavir, ritonavir, efavirenz, nevirapine).

This list is not exhaustive – refer to appendix 1 of the current BNF. ALWAYS check concurrent medication for interactions before supply under this PGD. Smoker under 35 years with additional risk factors.

Migraine without aura under 35 years with additional risk factors Over 35 years with multiple risk factors.

Other risk factors include: Cardiovascular disease BMI > 30 kg/m2 Diabetes mellitus (type I or II with no vascular complications) Uncomplicated valvular and congenital heart disease Family history of VTE in a first degree relative aged > 45 Previous smoker History of high blood pressure during pregnancy Major surgery without prolonged immobilisation Raynaud’s disease (secondary without lupus anticoagulant) Inflammatory bowel disease – absorption of oral contraception may be reduced if severe malabsorption. Refer to a prescriber for advice or consider using the hormonal patch (Evra) HIV infected and using antiretroviral therapy – it is important to note that antiretroviral drugs (ARV) have the potential to either decrease or increase the bioavailability of steroid hormones in hormonal contraceptives. Thus, if a woman on ARV treatment decides to initiate or continue hormonal contraceptive use, the consistent use of condoms is recommended for preventing HIV transmission and may also compensate for any possible reduction in the effectiveness of the hormonal contraceptive.

Hormonal contraceptives may interfere with the metabolism of other drugs. Accordingly, plasma and tissue concentrations may either increase (e.g.cyclosporin), or decrease (e.g. lamotrigine).

The prescribing information of concomitant medications should always be checked for potential interactions before supply under this PGD. (Refer to appendix 1 of the current BNF).

The use of COCs are not generally recommended when blood pressure is consistently > 140mmHg systolic and/or > 90mmHg diastolic. However current users with BP >140/90, but <160/95, can be re-assessed on 2 subsequent visits at monthly intervals.

COC use poses an unacceptable risk if BP is > 160mmHg systolic and/or >95 mmHg diastolic and MUST NOT be given.

FSRH guidance on the management of unscheduled bleeding, (see references), states that a clinical history should be taken from women using hormonal contraception with unscheduled bleeding to identify the possibility of an underlying cause:

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Cautions/Need for Further Advice continued

Hormonal contraceptive users with unscheduled bleeding who are at risk of sexually transmitted infections should be tested for Chlamydia Trachomatis as a minimum.

Women using hormonal contraception with unscheduled bleeding who are not participating in a National Cervical Screening Programme should have a cervical screen.

A pregnancy test is indicated for women using hormonal contraception with unscheduled bleeding if the clinical history identifies the possibility of incorrect method use, drug interactions or illness. Refer to the full guidelines.

Some antibacterials may reduce the efficacy of combined oral contraceptives and contraceptive patches. Refer to chapter 7 of current BNF for further information.

If in any doubt always refer to an appropriate medical practitioner.

Action if Patient Declines or is Excluded

Clients who are excluded from treatment under the contraindications identified above should be referred to an appropriate medical practitioner/prescriber by one of 4 possible options: 1. See doctor if present at same session, OR 2. Phone doctor to discuss if at a different site, OR 3. Make appointment to attend next available session when doctor available, OR 4. Refer to GP Meanwhile offer alternative contraception Document fully in clientâ&#x20AC;&#x2122;s record any actions taken/advice given.

DESCRIPTION OF TREATMENT Name, Form & Strength of Medicine Route/Method Dosage and Frequency Starting Regimes

Combined hormonal contraceptive tablets (oestrogen and progestogen).

Authorised healthcare professionals may select from the list found at appendix A (last page of this document).

Oral ONE tablet ONCE a day for 21 days, then 7 day break before starting the next pack. If an every day preparation then tablets to be taken for 28 days Tablets should be taken at approximately the same time each day.

Up to and including day 5 of the menstrual cycle with no need for extra precautions (this is the preferred regime).

Women can start COC at other times in the menstrual cycle if it is reasonably certain that they are not pregnant but additional contraceptive protection is required for the first 7 days.

Refer to the current BNF for further information relating to starting regimes.

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Duration of Treatment

First Issue For Contraception Up to 3 cycles then review Subsequent Issues For Contraception In the absence of any problems, up to 12 cycles then review.

Always review medical and family history prior to re-supply.

Shorter supplies should be used in cases of young age, uncertainty, clinical concern, or if close monitoring is required.

Treatment can continue for as long as required for contraception, or until exclusion develops.

For Management of Unscheduled Bleeding Using a Progestogen-Only Injectable, Implant or IUS Up to 3 cycles only.

Clients should be encouraged to return at any time if problems arise.

Quantity to Supply

Licensing Information Side Effects & Risks

Initial supply 3 months – 3x21 tablet calendar packs Repeat supply up to 12 months ALWAYS review medical and family history prior to resupply of pills The products are licensed for the stated inclusions. Careful discussion and documentation is required regarding usage outside of product licence. See Special Considerations / Additional Information Gynaecological Disorders - breakthrough bleeding and spotting – particularly during the first 3 months of taking COCs. Conversely, reduced menstrual blood loss or absence of withdrawal bleeding may occur. Postmedication amenorrhoea.

General Disorders – headache or migraine, nausea, vomiting, abdominal cramps, breast tenderness, enlargement and secretion, depression, mood changes, changes in libido, changes in appetite, changes in weight, fluid retention, change in shape of the cornea (resulting in discomfort when wearing contact lenses), rise in blood pressure, vaginal thrush, skin reactions.

This list is not exhaustive. Refer to current BNF and individual product SPC for complete list.

Potential Side Effect Risks Small increase in the risk of heart attack and stroke.

Small increase in the risk of blood clots Possible small increased risk of breast cancer Small increase in the risk of cervical cancer with continual use of 5 years plus Potential Side Effect Benefits Reduction in menstrual pain and blood loss Improvement of acne Reduced risk of ovarian, endometrial and bowel cancer Please refer to current BNF and product SPC for full details. See References/Resources and comments Report all serious suspected adverse reactions in adults, and all serious and minor reactions in children (under 18 years), to the Medicines and Healthcare products Regulatory Agency (MHRA) using a yellow card (located at the back of the BNF) or on- line via www.yellowcard.gov.uk.

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Side Effects & Risks continued

Report serious suspected reactions even if they are listed above, in the BNF, or in the product SPC. Serious reactions are those that are fatal, life threatening, disabling, incapacitating or which result in or prolong hospitalisation and/or are medically significant.

Yellow cards may be completed by any healthcare professional or the patient.

Special Considerations / Additional Information

Advice to Patient

Follow Up

It is the responsibility of the healthcare professional identifying the suspected ADR to report it.

Following POEC clinicians can consider initiating a COC immediately if abstinence or careful condom use is unlikely. Careful discussion and documentation is required regarding usage outside of product licence.

Careful discussion should be done around the use of extra precaution especially following the use of ellaOne. Follow up 21 days after unprotected intercourse with a pregnancy test When used for unscheduled vaginal bleeding refer to primary hormonal method PGD. Verbal Information How to start the pill How to take the pill Mode of action Efficacy (more than 99%) Risks and benefits Potential side effects Information on symptoms which should prompt immediate medical consultation (refer to FPA leaflet) What to do about missed pills When to take extra precautions e.g. vomiting/diarrhoea; certain medicines â&#x20AC;&#x201C; refer to Chapter 7 Safe sex Travel â&#x20AC;&#x201C; for journeys > 5 hours the client should be advised to carry out appropriate exercises and may wish to consider wearing compression hosiery.

Written Information Patient information leaflet Manufacturers leaflet given with dispensed pills Clinic times and telephone numbers Women should be informed when contraceptives are used outside of the product licence and the discussion and reasons should be clearly documented in the clinical records.

3 months initially then up to 12 months if no problems

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REFERRAL ARRANGEMENTS AND AUDIT TRAIL Referral Arrangements Records/Audit Trail

See action if patient declines or is excluded In all cases manual records and computerised records including communication to the General Practitioner should include: Patient’s name, address, date of birth and consent given. If consent is either refused or withdrawn, this decision should also be documented.

Contact details of GP Dose administered and route.

Advice given to patient (including side effects, and risks) Date administered Signature and name of staff who administered or supplied the medication.

Details of any adverse drug reaction and actions taken including documentation in the patient’s medical record Also for clinic records BMI LMP Blood pressure Weight Height Bleeding pattern Any problems Information given (written/verbal) Past medical history Family history Drug treatment Amount dispensed Review period Follow up appointment Signature and date of clinician

STAFF CHARACTERISTICS Qualifications Specialist Training or Qualifications

Registered nurse with recognised post graduate qualification in contraception and Sexual Health currently working within Locala Community Partnerships Has undertaken appropriate training and is competent to undertake the clinical assessment of patients according to the indications listed in this PGD. Has undertaken appropriate training and is competent for working under PGDs for the supply and administration of medicines Has undertaken training appropriate to this PGD – e.g. updates in Contraception and Sexual health at recommended intervals Has undertaken training and is competent in the recognition and treatment of anaphylaxis.

Has undertaken training and is competent in resuscitation skills.

Accepts personal responsibility for working within the PGD, understands the legal implications of doing so and works within the scope of the PGD.

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Continuing Training & Education

The practitioner should be aware of any change to the recommendations for the medicine listed. It is the responsibility of the individual to keep upto-date with continued professional development and to work within the limitations of their scope of practice.

Attends updates in administration of medicines through the use of patient group directives at recommended intervals including updates on anaphylaxis and resuscitation.

Practitioner should have access to current BNF, Faculty of Contraception and Sexual Health Guidance (including current UK Medical Eligibility Criteria For Contraceptive Use), and updated DH advice where appropriate.

References/Resources and Comments

British National Formulary (BNF).62 September 2011 Faculty of Family Planning and Reproductive Healthcare Clinical Guidance, First Prescription of Combined Oral Contraception, July 2006 (updated January 2007). Accessed at: http://www.ffprhc.org.uk/admin/uploads/FirstPrescCombOralContJan06.p df Faculty of Family Planning & Reproductive Healthcare UK Medical Eligibility Criteria for Contraceptive (UKMEC 2009) Faculty of Family Planning and Reproductive Healthcare Clinical Guidance Combined Hormonal Contraception Clinical Effectiveness Unit October 2011.

SPC from Electronic Medicines Compendium http://www.medicines.org.uk/

This PGD is an amended version of PGD No 65, â&#x20AC;&#x2DC;Combined Hormonal Contraceptionâ&#x20AC;&#x2122;, which was produced in December 2009.

It was updated for use within Locala Community Partnerships by the authors as listed below Name

Position

Dawn Broadbent Shirley Tabner Lucianne Ricketts Linda Fox Dawn Toothill

CaSH Clinical Nurse Manager CaSH Clinical Lead Head of Medicines Management Community Services Manager Specialist Pharmacy Technician, Community Services

Date November 2011 November 2011 February 2012 February 2012 February 2012

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REVISION PROFORMA The following amendments have been made to PATIENT GROUP DIRECTION: No 65 v1 SECTION Exclusion criteria

CHANGES MADE Deleted – Gestational trophoblastic neoplasia when hCG is normal. This is now UKMEC 1 Deleted - Diabetes of > 20years duration. The FSRH no longer specifies a duration of diabetes in the patient

Cautions

Deleted – Migraine headaches without aura in women aged >35 years.

This is now UKMEC 2 Deleted – Diabetes of <20 years duration. The FSRH no longer specifies a duration of diabetes in the patient Deleted - Non-enzyme inducing antibiotics - some antibacterials may reduce the efficacy of combined oral contraceptives and contraceptive patches. The patient should be advised to use additional contraceptive precautions whilst taking a short course of an antibacterial drug that is not enzyme-inducing, and for a further 7 days after stopping. If concomitant administration runs beyond the 3 weeks of patch treatment, a new treatment cycle should be started immediately without a patch free break.

If the antibacterial course exceeds 3 weeks, additional precautions are unnecessary unless a new antibacterial is prescribed. Refer to chapter 7 of the current BNF for further information.

No longer necessary. BNF 62 September 2011

Advice to patient

Special Considerations

Inserted Some antibacterials may reduce the efficacy of combined oral contraceptives and contraceptive patches. Refer to chapter 7 of current BNF for further information.

Deleted – Antibiotics from occasions when extra precautions are needed and added ‘diarrhoea, and some medicines. Refer to BNF Chapter 7’ instead.

Deleted - Extra precautions for duration of treatment and for further 7 days required if patient takes non-liver enzyme inducing antibiotics. No longer necessary. BNF 62 September 2011 Deleted - If woman has been using non-liver enzyme inducing antibiotics for 3 weeks or more no additional protection is required unless the antibiotic is changed. No longer necessary. BNF 62 September 2011

List of COCs available to supply under this PGD

Additional brands available to use – Levest, Rigevidon (Levonorgestrel 150mcg / ethinyloestradiol 30mcg), Gedarel 30/150 (Desogestrel 150mcg / ethinyloestradiol 30mcg), Gedarel 20/150 (Desogestrel 150mcg / ethinyloestradiol 20mcg), Millinette 30/75 (Gestodene 75mcg / ethinyloestradiol 30mcg), Millinette 20/75 (Gestodene 75mcg / ethinyloestradiol 20mcg), TriRegol (Levonorgestrel 50mcg / ethinyloestradiol 30mcg (6 tabs), Levonorgestrel 75mcg / ethinyloestradiol 40mcg (5 tabs), Levonorgestrel 125mcg / ethinyloestradiol 30mcg (10 tabs)

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Individual Authorisation for the Supply of Combined Oral Contraceptives by appropriately qualified Nurses Working in Locala CaSH Services .

PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct I have read and understood the Patient Group Direction and agree to supply/administer this medicine ONLY in accordance with this PGD. In signing this declaration the registered healthcare professional is willing to be professionally accountable for this work as defined in their Code of Professional Conduct.

Name of Professional Signature Authorising Manager and Date signature

Staff who are no longer required to supply/administer under this PGD should be removed from it.

This can be done by crossing through the relevant name, adding date and initials.

Authorising Managers For Locala staff this will be the team leader, or relevant clinical manager.

Note to Authorising Managers: Authorised staff should be provided with an individual copy of the clinical content of the PGD and a photocopy of the document showing their authorisation

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Organisational Approval This patient group direction must be agreed to and signed by all health care professionals involved in its use. Locala Community Partnerships will hold the original signed copy. The PGD must be easily accessible in the clinical setting.

ORGANISATION Director of Clinical and Operational Services

Locala Community Partnership Name : Christina Quinn

Signature: Head of Medicines Management

Name: Lucianne Ricketts

Signature: Medical Lead

Date

Name: Eric Power

Signature: Medical Director

Date:

NHS Kirklees Name : Sheila Dilks

Signature: Senior Medicines Management Advisor

Date:

Name: Dr Stephen Warner

Signature:

PCT Authorisation ORGANISATION Director of Patient Care and professions

Date

Date:

Name: Jim Lee

Signature:

Date:

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Appendix A

List of COCs Available to Supply Under This PGD ALL are 21 tablet calendar packs

BRAND Microgynon 30 Levest Rigevidon Ovysmen Norimin Cilest Marvelon Gedarel 30/150 Mercilon Gedarel 20/150 Femodene Millinette 30/75 Femodette Millinette 20/75 Loestrin 30 Loestrin 20 Yasmin BiNovum

TriNovum

Logynon TriRegol

CONTAINS: Levonorgestrel 150mcg, ethinyloestradiol 30mcg Norethisterone 500mcg, ethinyloestradiol 35mcg Norethisterone 1mg, ethinyloestradiol 35mcg Norgestimate 250mcg, ethinyloestradiol 35mcg Desogestrel 150mcg, ethinyloestradiol 30mcg Desogestrel 150mcg, ethinyloestradiol 20mcg Gestodene 75mcg, ethinyloestradiol 30mcg Gestodene 75mcg, ethinyloestradiol 20mcg Norethisterone acetate 1.5mg, ethinyloestradiol 30mcg Norethisterone acetate 1mg, ethinyloestradiol 20mcg Drospirenone 3mg, ethinyloestradiol 30mcg Norethisterone 0.5mg, ethinyloestradiol 35mcg (7 tabs Norethisterone 1.0mg, ethinyloestradiol 35mcg (14 tabs) Norethisterone 0.5mg, ethinyloestradiol 35mcg (7 tabs) Norethisterone 0.75mg, ethinyloestradiol 35mcg (7 tabs) Norethisterone 1.0mg, ethinyloestradiol 35mcg (7 tabs) Levonorgestrel 50mcg, ethinyloestradiol 30mcg (6 tabs) Levonorgestrel 75mcg, ethinyloestradiol 40mcg (5 tabs) Levonorgestrel 125mcg, ethinyloestradiol 30mcg (10 tabs)

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