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Sexual health intramuscular medroxyprogesterone (DMPA) acetate injection

This Patient Group Direction (PGD) must only be used by registered healthcare professionals who have been named and authorised by their organisation to practice under it. The most recent and in date final signed version of the PGD should be used.

To access the equality impact assessment for this policy, please see the overarching equality impact assessment.

Authorisations

This PGD template has been peer reviewed by the Reproductive Health PGDs Short Life Working Group (SLWG) in accordance with their Terms of Reference. It has been approved by the Faculty for Sexual and Reproductive Health (FSRH) in January 2023.

  • Dr Cindy Farmer Vice President Professional Learning and Development FSRH.
  • Michelle Jenkins Advanced Nurse Practitioner, Clinical Standards Committee FSRH.
  • Elaine Scott Senior Quality Matron British Pregnancy Advisory Service (BPAS).
  • Kalpesh Thakrar Lead Pharmacist British Pregnancy Advisory Service (BPAS).
  • Sim Sesane CASH Nurse Consultant MSI Reproductive Choices.
  • Tanya Lane FSRH Faculty Registered Trainer, Registered Nurse MSI Reproductive Choices.
  • Kate Devonport National Unplanned Pregnancy Association (NUPAS).
  • Chetna Parmar Pharmacist adviser Umbrella.
  • Heather Randle Royal College of Nursing (RCN).
  • Carmel Lloyd Royal College of Midwives (RCM).
  • Clare Livingstone Royal College of Midwives (RCM).
  • Portia Jackson Lead Pharmacist iCaSH, Cambridgeshire Community Services.
  • Kirsty Armstrong National Pharmacy Integration Lead, NHS England.
  • Dipti Patel Local authority pharmacist.
  • Emma Anderson Centre for Postgraduate Pharmacy Education (CPPE).
  • Alison Crompton Community pharmacist.
  • Lisa Knight Community Health Services pharmacist.
  • Bola Sotubo NHS North East London ICB pharmacist.
  • Tracy Rogers Director, Medicines Use and Safety, Specialist Pharmacy Service.
  • Sandra Wolper Associate Director Specialist Pharmacy Service.
  • Jo Jenkins Lead Pharmacist PGDs and Medicine Mechanisms Specialist Pharmacy Service.
  • Rosie Furner (Working Group Co-ordinator), Specialist Pharmacist, Medicines Governance, Medicines Use and Safety, Specialist Pharmacy Service.

Organisational authorisation

  • Medical Director (RDaSH).
  • Stephen Davies, Chief Pharmacist (RDaSH).
  • Steve Forsyth, Chief Nurse (RDaSH).
  • Tina Proctor, Nurse Consultant, Senior Representative of professional group using the PGD.

Contents

  1. Characteristics of staff
  2. Clinical condition or situation to which this patient group direction applies
  3. Description of treatment
  4. Key references
  5. Appendices

1 Characteristics of staff

1.1 Qualifications and professional registration

Current contract of employment within a local authority or NHS commissioned service or an NHS trust or organisation.

Registered healthcare professional listed in the legislation as able to practice under patient group directions.

1.2 Initial training

The registered healthcare professional authorised to operate under this patient group directions (PGD) must have undertaken appropriate education and training and successfully completed the competencies to undertake clinical assessment of patients ensuring safe provision of the medicines listed in accordance with local policy.

Recommended requirement for training would be successful completion of a relevant contraception module or course accredited or endorsed by the Faculty of Sexual and Reproductive Healthcare (FSRH), Centre for Pharmacy Postgraduate Education (CPPE) or a university or as advised in the Royal College of Nursing (RCN) training directory.

Individual has undertaken appropriate training for working under PGDs for the supply and administration of medicines. Recommended training eLfH PGD elearning programme (opens in new window).

The healthcare professional has completed locally required training (including updates) in safeguarding children and vulnerable adults or level 2 safeguarding or the equivalent

1.3 Competency assessment

1.4 Ongoing training and competency

  • Individuals operating under this PGD are personally responsible for ensuring they remain up to date with the use of all medicines and guidance included in the PGD, if any training needs are identified these should be addressed and further training provided as required.
  • Organisational PGD and, or medication training as required by employing trust or organisation.

The decision to administer any medication rests with the individual registered health professional who must abide by the PGD and any associated organisational policies.

2 Clinical condition or situation to which this patient group direction applies (contraception)

2.1 Criteria for inclusion

  • Individual (age from menarche to 50 years) presenting for contraception.
  • Informed consent given.

2.2 Criteria for exclusion

  • Informed consent not given.
  • Individuals under 16 years of age and assessed as not competent using Fraser guidelines.
  • Individuals 16 years of age and over and assessed as lacking capacity to consent.
  • Established pregnancy. Note, risk of pregnancy with a negative pregnancy test is not an absolute exclusion.
  • Known hypersensitivity to the active ingredient or to any constituent of the product, see summary of product characteristics (opens in new window).
  • Unexplained vaginal bleeding suspicious of a serious medical condition.
  • Acute porphyria.

2.2.1 Cardiovascular disease

  • Current or past history of ischaemic heart disease, vascular disease, stroke or transient ischaemic attack.
  • Individuals with multiple risk factors for cardio-vascular disease (such as smoking, diabetes, hypertension, obesity and dyslipidaemia).
  • Hypertension with vascular disease.

2.2.2 Cancers

  • Current or past history of breast cancer.
  • Malignant liver tumour (hepatocellular carcinoma).
  • History or diagnosis of meningioma.

2.2.3 Gastro-intestinal conditions

  • Severe decompensated cirrhosis.
  • Benign liver tumour (hepatocellular adenoma).

2.3 Cautions including any relevant action to be taken

  • If the individual is less than 16 years of age an assessment based on Fraser guidelines must be made and documented.
  • If the individual is less than 13 years of age the healthcare professional should speak to local safeguarding lead and follow the local safeguarding policy.
  • Discuss with appropriate medical or independent non-medical prescriber any medical condition or medication of which the healthcare professional is unsure or uncertain.
  • Individuals aged under 18 years, should not use intramuscular medroxyprogesterone acetate (IM DMPA) first line for contraception because of its effect on bone mineral density. IM DMPA may be considered if all alternative contraceptive options are unsuitable or unacceptable.
  • Individuals of any age with significant lifestyle and, or medical risk factors for osteoporosis, other methods of contraception should be considered prior to use of IM DPMA, IM DMPA may be considered if all alternative contraceptive options are unsuitable or unacceptable. Significant risk factors for osteoporosis include:
    • alcohol abuse and, or tobacco use
    • chronic use of drugs that can reduce bone mass, for example, anticonvulsants or corticosteroids
    • low body mass index or eating disorder, for example, anorexia nervosa or bulimia
    • previous low trauma fracture
    • family history of osteoporosis
  • Offer long acting reversible contraception (LARC) to all individuals in particular those with medical conditions for whom pregnancy presents an unacceptable risk and those on a pregnancy prevention plan.
  • If an individual is known to be taking a medication which is known to be harmful to pregnancy a highly effective form of contraception is recommended. Highly effective methods include the LARC methods intrauterine device (IUD), intrauterine system (IUS) and implant. If a LARC method is unacceptable or unsuitable and an IM-DPMA is chosen then an additional barrier method of contraception is advised. See Faculty of Sexual and Reproductive Healthcare advice (opens in new window).

2.4 Action to be taken if the individual is excluded or declines treatment

  • Explain the reasons for exclusion to the individual and document in the consultation record.
  • Record reason for decline in the consultation record.
  • Where required refer the individual to a suitable health service provider if appropriate and, or provide them with information about further options.

3 Description of treatment

3.1 Name, strength and formulation of drug

Medroxyprogesterone Acetate 150mg in 1ml Injection (vial or pre-filled syringe),

3.2 Legal category

Prescription only medicine (POM).

3.3 Route of administration

Intramuscular injection (IM).

Advice for administration:

  • follow manufacturers’ guidance for administration
  • shake the syringe or vial vigorously before administration
  • deep intramuscular injection into the gluteal (preferred) or deltoid muscle
  • ensure that the full contents of the syringe or vial is administered
  • do not massage the site after the administration of the injection.

3.4 Off label use

Best practice advice is given by the Faculty of Sexual and Reproductive Healthcare (FSRH) and is used for guidance in this patient group direction (PGD) and may vary from the summary of product characteristics (SPC).

This PGD specifically includes inclusion criteria and dosage regimens which are outside the market authorisation for the available products but which are included within FSRH guidance:

  • can be administered after day 5 of a cycle
  • can be administered between 10 and 14 weeks, refer to FSRH guidance for administration after 14 weeks
  • administration after five days postpartum if not breastfeeding or before six weeks postpartum if breastfeeding. FSRH guidance supports the use of intramuscular medroxyprogesterone acetate (IM DMPA) any time after childbirth for both breastfeeding and non-breastfeeding individuals

Medicines should be stored according to the conditions detailed in the Storage section below. However, in the event of an inadvertent or unavoidable deviation of these conditions the local pharmacy or Medicines Management team must be consulted. Where medicines have been assessed by pharmacy or medicines management in accordance with national or specific product recommendations as appropriate for continued use this would constitute off-label administration under this PGD. The responsibility for the decision to release the affected medicines for use lies with pharmacy or medicines management.

Where a medicine is recommended off-label consider, as part of the consent process, informing the individual, parent, or carer that the medicine is being offered in accordance with national guidance but that this is outside the product licence.

3.5 Dose and frequency of administration

  • Single IM injection (150mg/1ml) on day 1 to 5 of the menstrual cycle with no need for additional protection.
  • IM DMPA can be started at any time after day 5 if it is reasonably certain that the individual is not pregnant. Additional precautions are then required for 7 days after starting and advise having follow-up pregnancy test at 21 days after last unprotected sexual intercourse (UPSI).
  • When starting or restarting IM DMPA as quick start after levonorgestrel emergency contraception, additional contraception is required for 7 days and follow-up pregnancy test at 21 days after last UPSI is required.
  • In line with FSRH guidance, individuals should delay starting or restarting hormonal contraception for 5 days following use of ulipristal acetate for emergency contraception. Avoidance of pregnancy risk (for example, use of condoms or abstain from intercourse) should be advised for a further 7 days and follow-up pregnancy test at 21 days after last UPSI is required.
  • IM DMPA dose should be repeated 13 weeks after the last injection.
  • If required a repeat injection can be given up to 14 weeks after the previous dose with no additional contraceptive precautions.
  • If required on an occasional basis, IM DMPA injection may be repeated as early as 10 weeks after the last injection.
  • If the interval from the preceding injection is greater than 14 weeks the injection may be administered or supplied, the professional administering the injection should refer to FSRH current guidelines for advice on the need for additional contraception and pregnancy testing.
  • For guidance on changing from one contraceptive method to another, and when to start after an abortion and postpartum, refer to the Faculty of Sexual and Reproductive Healthcare (FSRH) guidelines.

3.6 Duration of treatment

For as long as individual requires IM DMPA and has no contraindications to its use.

Note, in individuals of all ages, careful re-evaluation of the risks and benefits of treatment should be carried out in those who wish to continue use every 2 years. In particular, in individuals with significant lifestyle and, or medical risk factors for osteoporosis, other methods of contraception should be considered prior to use of IM DPMA, IM DMPA may be considered if all alternative contraceptive options are unsuitable or unacceptable. Significant risk factors for osteoporosis include:

  • alcohol abuse and, or tobacco use
  • chronic use of drugs that can reduce bone mass, for example, anticonvulsants or corticosteroids
  • low body mass index or eating disorder, for example, anorexia nervosa or bulimia
  • previous low trauma fracture
  • family history of osteoporosis

If no risks are identified then it is safe to continue IM DMPA for longer than 2 years until the age of 50.

3.7 Quantity to be supplied

Single dose is to be administered per episode of care.

3.8 Storage

Medicines must be stored securely according to national guidelines.

3.9 Drug interactions

The efficacy of IM DMPA is not reduced with concurrent use of enzyme-inducing drugs.

All concomitant medications should be checked for interactions.

A detailed list of drug interactions is available in the individual product SPC, which is available from the electronic Medicines Compendium (opens in new window), the BNF (opens in new window) and FSRH CEU Guidance: Drug Interactions with hormonal contraception (opens in new window).

Refer to a prescriber if any concern of a clinically significant drug interaction.

3.10 Identification and management of adverse reactions

A detailed list of adverse reactions is available in the summary of product characteristics (SPC), which is available from the electronic Medicines Compendium (opens in new window) and BNF (opens in new window).

The following possible adverse effects are commonly reported with IM DMPA (but may not reflect all reported adverse effects):

  • headache, dizziness
  • disturbance of bleeding patterns
  • changes in mood
  • weight change
  • breast tenderness
  • loss of libido
  • abdominal discomfort or distension, nausea
  • alopecia, acne, rash
  • genitourinary tract infection
  • association with a small loss of bone mineral density which is recovered after discontinuation of the injection
  • the available evidence suggests a possible association between current or recent use of hormonal contraception (including progestogen-only injectables) and a small increase in risk of breast cancer; absolute risk remains very small
  • there is a weak association between cervical cancer and use of DMPA for 5 years or longer. Any increased risk appears to reduce with time after stopping and could be due to confounding factors
  • individuals should be advised that evidence suggests a link between the prolonged use of medroxyprogesterone acetate and a small increased risk of intracranial meningioma requiring surgery

4.11 Additional facilities and supplies

  • Access to working telephone.
  • Suitable waste disposal facilities.
  • Immediate access to in-date anaphylaxis kit (IM adrenaline 1:1000).

4.12 Management of and reporting procedure for adverse reactions

  • Healthcare professionals and patients or carers are encouraged to report suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card reporting scheme (opens in new window).
  • Record all adverse drug reactions (ADRs) in the patient’s medical record.
  • Report via organisation incident policy.

4.13 Written information and further advice to be given to individual

  • Provide patient information leaflet (PIL) provided with the original pack.
  • Explain mode of action, side effects, risks and benefits of the medicine.
  • 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 local service or sexual health services.

4.14 Advice or follow-up treatment

  • The individual should be advised to seek medical advice in the event of an adverse reaction.
  • Individual to seek further advice if they have any concerns.

4.15 Records

Record:

  • the consent of the individual and:
    • If individual is under 13 years of age record action taken
    • If individual is under 16 years of age document capacity using Fraser guidelines, if not competent record action taken
    • if individual over 16 years of age and not competent, record action taken
  • the consent of the individual and if individual not competent to consent record action taken
  • name of individual, address, date of birth
  • GP contact details where appropriate
  • relevant past and present medical history, including medication and family history
  • any known allergies
  • name of registered health professional
  • name of medication supplied or administered
  • date of administration
  • dose administered and site of administration
  • batch number and expiry date of administered product in line with local procedures
  • advice given, including if excluded or declines treatment
  • individual has been advised on the date(s) for next appointment as required
  • details of any adverse drug reactions and actions taken
  • advice given about the medication including side effects, benefits, and when and what to do if any concerns
  • any referral arrangements made
  • any administration outside the terms of the product marketing authorisation
  • recorded that administration is via patient group direction (PGD)

Records should be signed and dated (or a password controlled e-records) and securely kept for a defined period in line with local policy.

All records should be clear, legible and contemporaneous.
A record of all individuals receiving treatment under this PGD should also be kept for audit purposes in accordance with local policy.

4 Key references

4.1 Key references (accessed January 2023, July 2023, April 2024, and June 2024)

5 Appendices

5.1 Appendix A Example registered health professional authorisation sheet patient group direction administration of intramuscular (IM) Medroxyprogesterone Acetate (DMPA) injection

Document control

PGD development group

  • Date PGD template comes into effect: August 2023.
  • Review date: February 2026.
  • Expiry date: July 2026.

Change history

  • Version 1.0 August 2020: New template
  • Version 1.1 November 2020: Minor rewording and highlighting of contents cautions section relating to individuals for whom pregnancy presents an unacceptable risk and those on a pregnancy prevention plan. Acute porphyria and hypertension with vascular disease added as exclusion criteria.
  • Version 2.0 April 2023: Updated template (no clinical changes to expired V1.1)
  • Version 2.1 September 2023: Reworded section on cervical and breast cancer risk, in line with updated FSRH guidance. Updated references.
  • Version 2.2 July 2024: Statement added regarding a suggested link between the prolonged use of medroxyprogesterone acetate and a small increased risk of intracranial meningioma in line with FSRH statement. Added exclusion of meningioma as per SPC. Updated references. Updated SLWG.

Page last reviewed: December 05, 2024
Next review due: December 05, 2025

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