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LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION by registered nurses in Sexual and Reproductive Health services Version Number 1.2 Change History Version and Date Change details 1.2 New template. Updated SPC/BNF/NICE and other references Amendments in line with FSRH guidelines (2015) Each organisation using this PGD must ensure that it is formally authorised by a pharmacist, a medical lead and a governance lead on behalf of the authorising organisation to ensure that this document meets legal requirements for a PGD. This Patient Group Direction (PGD) must only be used by registered nurses who have been named and authorised by their organisation to practise under it. The most recent and in date final signed version of the PGD must be used. Version No: 1.2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date: 18.5.2018 Reference Number : Page 1 of 14 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION 150mg/mL TABLE OF CONTENTS CONTENTS PAGE NUMBER PGD for the supply and administration of intramuscular Medroxyprogesterone Acetate (DMPA) injection 150mg/mL Pages Staff Characteristics Page Authorisation and Signatures 12 To be added by approving organisation Individual authorisation to supply and administer Medroxyprogesterone Acetate (DMPA) injection 150mg/mL using this PGD Version No: 1.2 Approving Organisation Name: Approval Committee Name: Date of authorisation: 1-14 To be added by approving organisation Expiry date:18.5.2018 Reference Number : Page 2 of 14 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION 150mg/mL DRUG NAME /STRENGTH/FORM: Medroxyprogesterone acetate (DMPA) injection 150mg/mL CLINICAL CONDITION TO WHICH THIS DIRECTION APPLIES INCLUSION CRITERIA Contraception Any individual (menarche to 50 years of age) presenting for contraception and who has no contraindications EXCLUSION CRITERIA Personal Characteristics & Reproductive History Known or suspected pregnancy Known hypersensitivity to any constituent of the injection Individuals under 16 years of age and assessed as not competent using Fraser guidelines Individuals 16 years of age and over and assessed as not competent to consent using local safeguarding guidelines Cardiovascular Disease Multiple risk factors for cardiovascular disease e.g. older age group, smoking, diabetes, hypertension and obesity Hypertension with vascular disease Current and history of ischaemic heart disease Current and history of stroke/transient ischaemic attack Diabetes with end organ disease Cancers Current or past history of breast cancer Benign liver tumour Malignant liver tumour (hepatoma) Gastro-intestinal conditions Severe decompensated cirrhosis See next page Version No: 1.2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date:18.5.2018 Reference Number : Page 3 of 14 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION 150mg/mL EXCLUSION CRITERIA Continued from previous page Other conditions Systemic Lupus Erythematosus (SLE) with positive or unknown anti-phospholipid antibodies CAUTIONS (INCLUDING ANY ACTION TO BE TAKEN) Systemic Lupus Erythematosus (SLE) with severe thrombocytopenia if starting DMPA Undiagnosed abnormal vaginal bleeding Individual wishes to see a doctor If individual is under 13 years of age, follow local safeguarding policy Interacting medicines – see current BNF on interactions Ensure emergency drugs and equipment, including adrenaline are available for the treatment of anaphylaxis and emergencies according to local policy Caution in adolescence; guidance from the Medicines Health Regulatory Authority (MHRA) states that individuals under 18 years of age should only be offered this method of contraception if other methods are unsuitable, due to the potential effect on bone mineral density Discuss with appropriate doctor/independent nurse prescriber any medical condition or medication of which the nurse is unsure ACTION IF EXCLUDED Refer to appropriate doctor/independent nurse prescriber Discuss /offer alternative contraceptive method Document all actions taken ACTION IF PATIENT DECLINES TREATMENT Record the refusal in the clinical record and document all other actions Refer to appropriate doctor/independent nurse prescriber where required Discuss/offer alternative contraceptive method Version No: 1.2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date:18.5.2018 Reference Number : Page 4 of 14 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION 150mg/mL DRUG DETAILS NAME, FORM & STRENGTH OF MEDICINE ROUTE/METHOD Medroxyprogesterone Acetate (Depo Provera®) 150 mg in 1 mL Injection (vial/pre-filled syringe) Intramuscular Shake the syringe/vial vigorously before administration (SPC) Deep intramuscular injection into the gluteal (preferred) or deltoid muscle Do not massage the site after the administration of the injection LEGAL CATEGORY Prescription Only Medicine USE OUTSIDE THE TERMS OF THE MARKETING AUTHORISATION Best practice advice given by the Faculty of Sexual and Reproductive Healthcare (FSRH) is used for guidance in this PGD and may vary from the Summary of Product Characteristics (SPC ) This PGD includes unlicensed use by extending the window for administration as follows: Supply and administration at 10 weeks Supply and administration to 14 weeks FSRH (2010) guidance on Contraceptive choices for young people and FSRH guidance on Progestogen-only injectable contraception (2015)- see reference section QUANTITY Version No: 1.2 Approving Organisation Name: Approval Committee Name: Date of authorisation: 1 mL injection Expiry date:18.5.2018 Reference Number : Page 5 of 14 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION 150mg/mL DOSAGE/FREQUENCY 150mg in 1mL injection (vial/pre-filled syringe) Start on day 1-5 of the menstrual cycle with no need for additional protection DMPA can be started at any time as quick start after day 5 if it is reasonably certain that the individual is not pregnant. Additional contraception is then required for 7 days after starting Starting the DMPA as quick start after levonorgestrel emergency contraception, additional contraception is required for 7 days. If started after ulipristal acetate emergency contraception, 14 days of additional precautions are required. A pregnancy test is advised 21 days after UPSI in either circumstance DMPA should be repeated 13 weeks after the last injection. A repeat injection can be given up to 14 weeks after the previous dose with no additional contraceptive precautions If required it may be repeated as early as 10 weeks after the last injection If it is more than 14 weeks since the last DMPA and UPSI has occurred, refer/discuss with appropriate doctor /independent nurse prescriber For guidance on changing from one contraceptive method to another, and when to start after an abortion/miscarriage or post partum, refer to the appropriate doctor/independent nurse prescriber/FSRH guidelines on switching methods. DURATION OF TREATMENT Contraceptive cover is maintained for 14 weeks after injection and repeat doses may be given after an interval of 10-14 weeks under this PGD, as long as no contraindication to use of DMPA MAXIMUM OR MINIMUM TREATMENT PERIOD Minimum ten weeks Maximum fourteen weeks Version No: 1.2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date:18.5.2018 Reference Number : Page 6 of 14 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION 150mg/mL SIDE EFFECTS Any drug may produce unwanted or unexpected adverse reactions. Detection and recording of these is of vital importance. Patients should be actively encouraged to report any suspected adverse reaction, particularly to black triangle medicines. This list may not represent all reported side effects of this medicine. DMPA is well tolerated. Common side effects Headache Disturbance of bleeding patterns Changes in mood Weight change Loss of libido Delay in return to fertility after stopping the medication Association with a small loss of bone mineral density which is recovered after discontinuation of the injection Possible weak association current use of DMPA and breast cancer Weak association between cervical cancer and use of DMPA Refer to current Summary of Product Characteristics (SPC) of relevant product and current British National Formulary (BNF) for full list and further information. 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) Use yellow card system to report serious adverse drug reactions directly to the Medicines and Healthcare products Regulatory Agency (MHRA). Yellow cards are available in the back of the BNF or obtained via Freephone 0808 100 3352 or online at www.yellowcard.mhra.gov.uk. The public can report adverse effects directly to the MHRA via the yellow card scheme and should be encouraged to do so. Version No: 1.2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date:18.5.2018 Reference Number : Page 7 of 14 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION 150mg/mL ADVICE TO INDIVIDUAL FOLLOW UP Version No: 1.2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Provide Manufacturer’s Patient Information Leaflet (PIL) Explain mode of action, side effects, and benefits of the medicine Advise individual about need to return for repeat injection Remind individual about need for Human Papilloma Virus (HPV) vaccination and regular cervical smears, where appropriate Individual to return to clinic if she has any concerns Review in thirteen weeks Review and evaluate use of the method after two years of use Expiry date:18.5.2018 Reference Number : Page 8 of 14 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION 150mg/mL RECORDS Version No: 1.2 Approving Organisation Name: Approval Committee Name: Date of authorisation: The authorised 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) Inclusion or exclusion from PGD A statement that supply or administration 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 referral arrangements Any administration outside the terms of the product licence The consent of the individual If individual is under 13 years of age record action taken. If individual is under16 years of age document competency using Fraser guidelines If individual is 16 years of age and over not competent, record action taken Record the name/brand, dose of the medication, quantity supplied and site of injection Record batch number and expiry date according to local policy or national guidelines 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 or administering the medicine Expiry date:18.5.2018 Reference Number : Page 9 of 14 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION 150mg/mL REFERENCES Manufacturer’s Summary of Product Characteristics Depo-Provera 150 mg/ml Pfizer Ltd https://www.medicines.org.uk/emc/medicine/11121 23.03.2015 Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press <http://www.medicinescomplete.com National Institute for Health and Care Excellence (2013). Patient Group Directions. Medicines Practice Guidelines 2 http://www.nice.org.uk/guidance/MPG2 Faculty of Sexual and Reproductive Healthcare (2015) Progestogen - only Injectable Contraception http://www.fsrh.org/pdfs/CEUGuidanceProgestogenOnlyInjectabl es.pdf Faculty of Sexual and Reproductive Healthcare (2010.) UK Medical Eligibility Criteria for Contraceptive Use http://www.fsrh.org/pages/Clinical_Guidance_1.asp Faculty of Sexual and Reproductive Healthcare (2011) Drug interactions with hormonal contraception https://www.fsrh.org/pdfs/CEUGuidanceDrugInteractionsHormon al.pdf Faculty of Sexual and Reproductive Healthcare (2010) Antiepileptic drugs and contraception: CEU statement January 2010 http://www.fsrh.org/pdfs/CEUStatementADC0110.pdf Faculty of Sexual and Reproductive Healthcare (2013) Update on newer antiepileptic and antiretroviral drugs and interactions with hormonal contraceptives (CEU statement http://www.fsrh.org/pdfs/CEUstatementUpdateNewerAntiepilepti cAntiretroviralDrugs.pdf Faculty of Sexual and Reproductive Healthcare (2004) Statement on MHRA Guidance on Depo-Provera http://www.fsrh.org/pdfs/archive/CEUstatementDepoProveraYou ngPeople.pdf See next page Version No: 1.2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date:18.5.2018 Reference Number : Page 10 of 14 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION 150mg/mL Continued from previous page Version No: 1.2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Faculty of Sexual and Reproductive Healthcare (2009) Management of unscheduled bleeding in women using hormonal contraception http://www.fsrh.org/pdfs/UnscheduledBleedingMay09.pdf Faculty of Sexual and Reproductive Healthcare (2010) Service Standard for Resuscitation in Sexual Health Services http://www.fsrh.org/pdfs/ServiceStandardsResuscitation.pdf Faculty of Sexual and Reproductive Healthcare (2010) CEU: Quick starting contraception http://www.fsrh.org/pdfs/CEUGuidanceQuickStartingContracepti on.pdf Faculty of Sexual and Reproductive Healthcare (2010) Contraceptive choices for Young people. http://www.fsrh.org/pdfs/ceuGuidanceYoungPeople2010.pdf Expiry date:18.5.2018 Reference Number : Page 11 of 14 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION 150mg/mL STAFF CHARACTERISTICS The named nurse authorised to supply and/or administer medications under the PGD must meet the following criteria: THE NURSE MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORKING ACCORDING TO IT Registration Nurses must be registered with the Nursing and Midwifery Council (NMC) Education/training, qualifications and competencies Nurses must satisfy the following criteria: Qualification in contraception/sexual health (university modules/FSRH). Note- an introduction to contraception is not sufficient Has had training in the use of PGDs Has had training which enables the nurse to make a clinical assessment in order to establish the contraceptive need and supply the medication according to this PGD. Has undertaken the competency training appropriate to this PGD. Is competent in the assessment of 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 Maintenance of competencies The nurse should ensure she/he is aware of any changes to the recommendations for the medication. It is the responsibility of the nurse to keep up-to-date with continuing professional development and take part in audit of clinical records on a regular basis The nurse should be familiar with current FSRH guidelines on Progestogen-only injectable contraception An up to date list and signatures of registered practitioners who are authorised to practise under this PGD is kept in by Practitioners not listed are not authorised to practise under this PGD. Version No: 1.2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date:18.5.2018 Reference Number : Page 12 of 14 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION 150mg/mL PGD DEVELOPMENT GROUP Date PGD template comes into effect: Review date Expiry date: 18/05/2015 30/11/2017 or earlier in the light of significant changes in best practice 18/05/2018 This template was peer reviewed and ratified by London Contraception and Sexual Health PGD Working Group: NAME/ROLE POSITION DATE Independent Nurse Advisor SRHC, Project Lead 18/05/2015 Principal Pharmacist Medicines Information Projects. Guy’s and St Thomas’ NHS Foundation Trust. 18/05/2015 Lead Medical Doctor Dr Sarah Pillai Lead Associate Specialist, Contraception and Sexual Health Service, Central London Community Healthcare NHS Trust 18/05/2015 Lead Pharmacist Sandra Wolper Associate Director for Specialist Pharmacy Service Hounslow and Richmond NHS Trust 18/05/2015 Lead Contraception & Sexual Health Nurse Lead Nurse Integrated Sexual Health Barts Health NHS Trust 18/05/2015 Kathy French Chair - Working Group Angela Bussey Advisor - Working Group Sandra Bennett The PGD template is not legally valid until it has had the relevant organisational approval. See next page Version No: 1.2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date:18.5.2018 Reference Number : Page 13 of 14 LONDON CONTRACEPTION AND SEXUAL HEALTH PATIENT GROUP DIRECTION (PGD) TEMPLATE (add organisational logo) PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF INTRAMUSCULAR MEDROXYPROGESTERONE ACETATE (Depo Provera®)(DMPA) INJECTION 150mg/mL ORGANISATIONAL AUTHORISATIONS AND OTHER LEGAL REQUIREMENTS The PGD is not legally valid until it has had the relevant organisational authorisations. To ensure compliance with the law, organisations must add local authorisation details i.e. clinical authorisations and the authorising organisation. Complete details below or use format agreed according to local policy. Name Job title and organisation Signature Date Senior doctor Senior pharmacist Senior representative of professional group using the PGD e.g. Lead Contraception /Sexual Health Nurse Person signing on behalf of authorising body e.g. Director of Public Health on behalf of a local authority or a clinical governance lead on behalf of an NHS Trust. It is the responsibility of the authorising organisation to ensure that all legal and governance requirements are met. To meet legal requirements, organisations must add an Individual Practitioner Authorisation sheet or List of Authorised Practitioners. This varies according to local policy and how the service is managed but this should be a signature list or an individual agreement. 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. Individual practitioners must declare that they have read and understood the Patient Group Direction and agree to supply/administer medicines listed only in accordance with the PGD. ORGANISATIONS MAY ALSO ADD: Local training and competency assessment documentation. Other supporting local guidance or information. Links to local PGD Policy and other supporting guidance. Version No: 1.2 Approving Organisation Name: Approval Committee Name: Date of authorisation: Expiry date:18.5.2018 Reference Number : Page 14 of 14