Standard operating procedure

Pregnancy & Contraception Check Procedure

How [Organisation Name] establishes pregnancy status and intentions before initiating a weight-management medicine, advises on effective contraception, and acts promptly where a patient becomes or plans to become pregnant, for medicines that are contraindicated in pregnancy, including glucagon-like peptide-1 (GLP-1) receptor agonists.

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What's inside

This standard operating procedure is fully drafted and structured, ready to brand and complete for your service. It covers:

  • 1. Purpose
  • 2. Scope
  • 3. Definitions and abbreviations
  • 4. Responsibilities
  • 5. Procedure
  • 6. Action if a patient becomes pregnant or plans to during treatment
  • 7. Records
  • 8. Related documents
  • 9. Review and version control
  • 10. Disclaimer

Legislation & standards it maps to

  • The Summary of Product Characteristics (SmPC) for each weight-management medicine prescribed, which sets out the pregnancy, contraception and breastfeeding advice for that specific product
  • Medicines and Healthcare products Regulatory Agency (MHRA) guidance, including drug safety advice, together with the Medicines and Healthcare products Regulatory Agency and Commission on Human Medicines Yellow Card scheme for reporting suspected adverse drug reactions and exposures in pregnancy
  • Faculty of Sexual and Reproductive Healthcare (FSRH) contraception guidance
  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, in particular Regulation 12 (Safe care and treatment)
  • General Medical Council, Good practice in prescribing and managing medicines and devices (2021)
  • Data Protection Act 2018 and the UK General Data Protection Regulation (UK GDPR)

Who it applies to

All prescribing clinicians (doctors, and where appropriate nurse and pharmacist independent prescribers), registered pharmacists, clinical and triage staff at [Organisation Name], and the registered manager or [Insert Job Title], involved in assessing, initiating, reviewing or supplying weight-management medicines for any patient who is, or could become, pregnant.

Glossary

Plain-English explanations of the technical terms and legislation used in this document.

Adverse drug reaction
An unwanted or harmful effect experienced after taking a medicine.
Antenatal care
The health care and check-ups a woman receives during pregnancy, before the baby is born.
Barrier method
A type of contraception, such as a condom, that physically blocks sperm from reaching an egg.
Breastfeeding
Feeding a baby with milk from the mother's breast.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Childbearing potential
A way of describing anyone who could become pregnant.
Commission on Human Medicines
An expert advisory body that advises UK ministers on the safety and effectiveness of medicines.
Contemporaneous record
A note written at the time of, or immediately after, the event it describes, so it is accurate and reliable.
Contraindicated
Describes a situation in which a medicine or treatment should not be used because it could be harmful.
Data Protection Act 2018
The UK law that sets the rules for how personal information must be handled and protected.
Effective contraception
A reliable method of preventing pregnancy, used correctly and consistently.
Emergency contraception
Contraception used after unprotected sex, or a contraception failure, to help prevent pregnancy.
Faculty of Sexual and Reproductive Healthcare (FSRH)
The professional body that sets standards and guidance for contraception and sexual health care in the UK.
General Medical Council (GMC)
The body that registers doctors in the UK and sets the standards they must follow.
General practitioner (GP)
A family doctor who provides general medical care in the community.
GLP-1 receptor agonist
A type of medicine that mimics a natural gut hormone (glucagon-like peptide-1) to reduce appetite, used for weight management and not safe in pregnancy.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations that set out the fundamental standards of safety and quality that care providers must meet.
Independent prescriber
A trained nurse, pharmacist or other professional allowed to prescribe medicines in their own right, without a doctor's sign-off.
Last menstrual period (LMP)
The first day of a person's most recent period, used to help work out whether they could be pregnant.
Maternity care
The care provided to a woman during pregnancy, birth and the period shortly after.
Medicines and Healthcare products Regulatory Agency (MHRA)
The UK body that regulates medicines and medical devices and monitors their safety.
Near miss
An event that could have caused harm but did not, by chance or because it was caught in time.
Pre-conception care
Advice and health checks given to someone before they try to become pregnant, to support a healthy pregnancy.
Pregnancy exposure
When a pregnant person has taken, or been given, a medicine that may affect the pregnancy or baby.
Prescriber
A clinician, such as a doctor or qualified nurse or pharmacist, who is authorised to decide and order a patient's medicines.
Registered manager
The person registered with the regulator as responsible for the day-to-day running of a service.
Registered pharmacist
A pharmacist registered with the regulator who is qualified to supply and advise on medicines.
Regulated activity
A type of care or treatment the law requires a provider to register with the regulator to deliver.
Signpost
To direct a patient to another service or professional who can provide the help they need.
Single assessment framework
The structure the regulator uses to judge a service, built around quality statements and five key questions (safe, effective, caring, responsive, well-led).
Standard Operating Procedure (SOP)
A written, step-by-step instruction setting out how a particular task must be carried out consistently and safely.
Summary of Product Characteristics (SmPC)
The official document for a medicine that describes how it should be used, including its risks and any situations in which it must not be used.
Triage
Sorting patients by how urgent their needs are, so the right level of care is given in the right order.
UK General Data Protection Regulation (UK GDPR)
The UK's main data-protection law governing how personal information is collected and used.
Washout period
The time a medicine must be stopped before a planned pregnancy so it can fully clear from the body.
Yellow Card scheme
The UK system for reporting suspected side effects of medicines and safety problems, run by the Medicines and Healthcare products Regulatory Agency.

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