Progestogen Only Pills POP (Micronor and Cerelle)

Patient Group Direction

forthe supply of

Progestogen only pills ‘POP’ (Micronor and Cerelle)

by registered nurses for

oral contraception

inCoalfields sexual health clinic

Version number: 1.1

Change history

PGD development

PGD authorisation

PGD adoption by the provider[1]

Training and competency of registered nurses

• For nurses: - Nursing & Midwifery Council (NMC)

• Have a current contract of employment with a GP practice within Sunderland CCG
• 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

Clinical condition

• Any female (age menarche to 55 years of age) presenting for contraception
• Understands the risks, benefits and side effects
• Valid informed consent.

• 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 glucose-galactose malabsorption

• 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

• 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

• Severe decompensated cirrhosis

• 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

• If under 13 years of age, follow local safeguarding policy
• Discuss with appropriate doctor/independent non-medical prescriber any medical condition or medication of which the nurse is unsure/uncertain

• Refer to appropriate doctor/independent non-medical prescriber
• Discuss /offer alternative contraceptive method
• Document all actions taken

• Record refusal in the clinical record
• Refer to appropriate doctor/independent non-medical prescriber
• Discuss /offer alternative contraceptive method. For example condoms
• Document all actions taken

Details of the medicine

• 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.

• 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 individual product use.If the patient is amenorrhoeic, pregnancy should be excluded prior to starting Micronor and there is no risk of conception.

• 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.

• Breast tenderness
• Headache
• Disturbance of bleeding patterns
• Changes in mood
• Weight change

• 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)

• 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) 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

Patient information

• 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.

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 Micronorvia
• 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 31st 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.

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.

Other appendices may be added as agreed locally.

Valid from: December 2015

Review date: September 2017

Expiry date: December 20171