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Patient Group Direction (PGD) for the Administration of:

PROGESTOGEN-ONLY INJECTABLE CONTRACEPTION – MEDROXYPROGESTERONE 150mg/ml (Depo-Provera)

Prescription Only Medicine (POM)

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 Long-acting reversible contraception for healthy women aged 13 years Indication Inclusion Criteria – INITIAL INJECTION

Inclusion Criteria – REPEAT INJECTION

Approval Date:

16.2.2012

and over wishing to prevent pregnancy, following full method teaching including mode of action, efficacy and side effects. Informed consent has been given in accordance with current Locala Community Partnership (LCP) guidelines for the supply of the medicine. Female clients aged 13 years to 45 years of age requesting longacting progestogen-only contraception. For young women aged between 13 years and 18 years of age an alternative method of contraception must be discussed, as Depo-Provera is not the first choice for this age group. See cautions need for further advice section. Female clients requiring short-term contraception in the following circumstances: (i) For partners of men undergoing vasectomy, for protection until the vasectomy becomes effective. (ii) In women awaiting sterilisation (iii) In women who are being immunised against rubella, to prevent pregnancy during the period of activity of the virus. Depo-Provera may be given if breastfeeding from day 21 after delivery Medical and family history has been taken and there is no reason for exclusion. 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. Patients requiring long-term contraception or awaiting sterilisation/vasectomy or rubella immunisation as described above. Women age 45 years to 50 years of age who wish to continue using Depo-Provera with no life style or medical risks factors for osteoporosis. No adverse reaction to the previous injection. Elapse time of between 10 and 14 weeks since the last injection** If more than 14 weeks since last injection but NO episodes of unprotected sexual intercourse since the injection ceased to provide contraceptive protection. (If the injection is administered advise woman to use additional contraception or avoid sex for the next 7 days). PGD No 66 v2 - Depo Provera Injection Review Date: 31.3.2014 Page 1


Inclusion Criteria – REPEAT INJECTION continued

Exclusion Criteria

Cautions/Need for Further Advice

Approval Date:

16.2.2012

Medical and family history has been taken and there is no reason for exclusion. Treatment of clients aged 16 years or younger must meet Fraser guidelines. **NOTE Repeat doses given after 89 days (12 weeks and 5 days) is outside the product license. Refer to additional information for further advice. Informed consent has NOT been given in accordance with current Locala Community Partnership (LCP) guidelines for the supply of the medicine Previous adverse reactions to Depo-Provera or a constituent or allergy to any progestogen Current or past history of breast cancer Known or suspected pregnancy Greater than 14 weeks since last injection and has had unprotected intercourse Age above 50 years or under 13 years. Fraser competence not confirmed. Unexplained vaginal bleeding (suspicious for serious underlying conditions) Diabetes with nephropathy, retinopathy or neuropathy Diabetes with other vascular disease Current or history of stroke Current and history of ischaemic heart disease Significant multiple risk factors for arterial cardiovascular disease e.g. older age, diabetes, smoking and hypertension Vascular disease (includes CHD presenting with angina; peripheral vascular disease presenting with intermittent claudication; hypertensive retinopathy and transient ischaemic attacks) Systemic lupus erythematosus (SLE) with positive (or unknown) antiphospholipid antibodies or with severe thrombocytopenia. Before menarche Active viral hepatitis History of liver tumour (benign or malignant) Severe cirrhosis Any medical condition of unknown significance or taking any medication that is of unknown significance to the nurse. Clients who have not be reviewed by a doctor or nurse prescriber within the last 2 years. The CSM has advised that in adolescents, Depo-Provera, should only be used when other methods of contraception are inappropriate. See ‘loss of bone mineral density’ in special considerations/additional information. Consistently elevated blood pressure readings – refer to GP. Established or significant risk of osteoporosis, if uncertain give and refer to doctor for next injection Serious weight gain, give life style advice and consider alternative method Patients with a history of endogenous depression should be carefully monitored. Some patients may complain of premenstrual-type depression while on Depo-Provera therapy.

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Action if Patient Declines or is Excluded

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). If in doubt always refer to an appropriate medical practitioner. For the management of unscheduled bleeding (> 3 months after starting method): (1) Full medical and sexual history including cytology (2) Obtain chlamydia screen (3) Discuss further management with doctor 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, AND/OR 3. Make appointment to attend next available session when doctor available, AND/OR 4. Refer to GP Meanwhile offer alternative contraception Document fully in client’s record any actions taken/advice given. If more than 14 weeks since last injection do a pregnancy test.

DESCRIPTION OF TREATMENT Depo-Provera 150mg/ml Injection Name, Form & Each ml of suspension contains 150mg medroxyprogesterone acetate Strength of Medicine Route/Method

By deep intramuscular injection Solution should be vigorously shaken and given by deep IM injection, preferably into the upper outer quadrant of the buttock.

Dosage & Frequency

150mg (1ml) Repeat injections should be given at 12 week intervals, but if necessary can be given up to 2 weeks early (i.e.10 weeks), or up to 2 weeks late (i.e. 14 weeks)** Patient to return sooner in the event of any adverse reaction eg persistent vaginal bleeding If unprotected intercourse after 14 weeks, repeat injection can NOT be given. Perform pregnancy test at initial presentation and at least 21 days later. Client must abstain from intercourse. **NOTE Repeat doses given after 89 days (12 weeks and 5 days) is outside the product license. Refer to additional information for further advice.

Starting Regime

Approval Date:

16.2.2012

Ideally, first injection should occur between days 1-5 (inclusive) of a normal menstrual cycle. May also be initiated at any other time in the menstrual cycle if woman reliably covered by other effective contraception e.g COC, PGD No 66 v2 - Depo Provera Injection Review Date: 31.3.2014 Page 3


Duration of Treatment

Quantity to Administer Licensing Information Managing and Reporting Adverse Events

and clinician is reasonably certain that the woman is not pregnant and that there is no risk of conception. (NB. Extra precautions to be used for the following 7 days) Or initial injection may be given if last sexual intercourse was 3 weeks ago or more and a pregnancy test is negative.(NB. Extra precautions to be used for the following 7 days) As long as client requests but: The re-evaluation of the risks and benefits of treatment should be carried out every 2 years in those who wish to continue use. If significant life style and/or medical risk factors for osteoporosis other methods should be considered. One single dose of Depo-Provera 150 mg injection The product is licensed for the stated indications. Repeat doses given after 89 days (12 weeks and 5 days) is outside the product license. Refer to additional information for further advice. Report any adverse drug reactions to the doctor. In addition use the Yellow Card Scheme to report serious adverse drug reactions directly to the CSM and complete a critical incident form. See below. It is the responsibility of the healthcare professional identifying the suspected ADR to report it. Yellow Card Scheme 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. 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. Common side effects include: Menstrual irregularities (bleeding and/or amenorrhoea), weight gain, headache, nervousness, abdominal pain or discomfort, dizziness, weakness and fatigue.

Side Effects

Less common (reported in 1% to 5% of subjects) include: Decreased libido or anorgasmia, backache, leg cramps, depression, nausea, insomnia, acne, leucorrhoea, vaginitis, pelvic pain, breast pain, no hair growth or alopecia, bloating, rash, oedema, hot flushes. This list is not exhaustive. Refer to current BNF and individual product SPC for complete list.

Additional Facilities

Approval Date:

16.2.2012

Anaphylaxis pack available Resuscitation equipment available Patient information leaflets available

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Special Considerations Loss of Bone Mineral Density Reduction in bone mineral density and, rarely, osteoporosis and / Additional osteoporotic fractures have been reported with Depo-Provera use. The information

reduction in bone mineral density occurs in the first 2-3 years of use and then stabilises. The CSM has advised that: In adolescents, Depo-Provera to be used ONLY when other methods of contraception are inappropriate. In all women, benefits of using Depo-Provera beyond 2 years should be evaluated against risks. In women with risk factors for osteoporosis a method of contraception, other than Depo-Provera should be considered. Off Label Use The SPC states that repeat doses should be given at 12 week intervals, but as long as the injection is given no later than 5 days after this time no additional contraceptive measures are required. This PGD is based on current expert family planning consensus opinion (FSRH Guidance, June 2009) that states that women attending up to 2 weeks late for repeat injection may be given the injection without the need for additional contraception. Medicines can be used outside their licensing indication and be given under a PGD if such use is exceptional, justified by best practice and the status of the product is clearly described. In addition, you should be satisfied that you have sufficient information to administer the drug safely and, wherever possible, that there is acceptable evidence for the use of that product for the intended indication. (NMC 2004). Where a medicine is supplied outside product license, the client should be informed and this must be documented in the patient’s record together with confirmation that the patient has consented to an unlicensed treatment being used.

Advice to Patient

Approval Date:

16.2.2012

At Initial Visit Full method teaching supplemented with patient information leaflet including mode of action and efficacy. Advice on potential harms e.g. delayed return to fertility, weight gain, irregular bleeding, amenorrhoea, possible reduction in bone mineral density. Breast cancer – it is important to inform clients that users of all hormonal contraceptives appear to have a small increase in the risk of being diagnosed with breast cancer, compared with non-users of hormonal contraceptives, but this has to be weighed against the known benefits. FPA patient information leaflet Manufacturers information leaflet Not to rub injection site List of clinic times and contact numbers if worried Life style changes if required- including safe sex Use of Depo-Provera outside product licence Follow up in 12 weeks Advise to return if they experience any signs or symptoms of infection at the site of injection. PGD No 66 v2 - Depo Provera Injection Review Date: 31.3.2014 Page 5


At Repeat Visit: Discussion of potential side effects and reminder of information on patient information leaflet Check if due 2 yearly review 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. Every 12 weeks (at time of next injection).

Follow up

Can be seen sooner at patient’s request if there are problems.

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. Site of injection. Batch details, expiry date and manufacturer, including brand name 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 Record for each patient:Date Weight height Blood pressure Date of last injection Elapse time LMP Bleeding pattern Any problems Injection site Expiry date Batch number Next appointment Signature of clinician

Approval Date:

16.2.2012

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STAFF CHARACTERISTICS Registered nurse with recognised post graduate qualification in Qualifications Specialist Training or Qualifications

Continuing Training & Education

References/Resources and Comments

Approval Date:

16.2.2012

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. The practitioner should be aware of any change to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-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. SPC from Electronic Medicines Compendium http://www.medicines.org.uk/ BNF No 62 – September 2011 http://www.bnf.org/bnf/ Faculty of Family Planning & Reproductive Healthcare UK Medical Eligibility Criteria for Contraceptive Use (UKMEC 2009) Faculty of Sexual & Reproductive Healthcare Clinical Guidance, Progestogen-only Injectable Contraception, November 2008 (updated June 2009) FFPRHC Clinical Guidance. The Use of Contraception Outside the Terms of Product Licence. July 2005

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This PGD is an amended version of PGD No 66, ‘Depo Provera Injection’ approved December 2009. It was updated for use within Locala Community Partnerships by the authors as listed below Name

Position

Date

Dawn Broadbent Kathryn Vasiljevs Shirley Tabner Lucianne Ricketts Linda Fox Dawn Toothill

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

February 2011 February 2011 February 2011 February 2011 February 2011

REVISION PROFORMA The following amendments have been made to PATIENT GROUP DIRECTION: No 66 v1 SECTION Exclusion critera

Approval Date:

CHANGES MADE The following exclusions have been deleted in line with latest UKMEC recommendations Acute Porphyria Diabetes of > 20 years duration Trophoblastic disease with abnormal Hcg Current venous thromboembolism (on current anticoagulants) A new development of Migraine with Aura in a current user

16.2.2012

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Individual Authorisation for the Administration of Depo-Provera Injection 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.

Approval Date:

16.2.2012

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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 Partnerships Name : Christina Quinn

Signature: Head of Medicines Management

Name: Lucianne Ricketts

Signature: Medical Lead

Date

Date:

Name: Dr Stephen Warner

Signature:

Date:

PCT Authorisation ORGANISATION Director of Patient Care & Professions

NHS Kirklees Name : Sheila Dilks

Signature: Senior Medicines Management Adviser

Name: Eric Power

Signature: Medical Director

16.2.2012

Date:

Name: Jim Lee

Signature:

Approval Date:

Date

Date:

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