Standard operating procedure

Adverse-Effects Management Procedure

How [Organisation Name] advises patients about, recognises, manages and reports the adverse effects of glucagon-like peptide-1 (GLP-1) receptor agonists and related weight-loss medicines, including the red flags that require the medicine to be stopped and urgent assessment or emergency care.

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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. Supportive self-care advice for patients (summary)
  • 7. Red flags and escalation
  • 8. Records
  • 9. Related documents
  • 10. Review and version control
  • 11. Disclaimer

Legislation & standards it maps to

  • The Summary of Product Characteristics (SmPC) and Patient Information Leaflet for the specific weight-loss medicine prescribed, as published by the manufacturer and approved by the Medicines and Healthcare products Regulatory Agency (MHRA)
  • Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card scheme for reporting suspected adverse drug reactions, and current MHRA Drug Safety Updates and safety communications
  • National Institute for Health and Care Excellence (NICE) guidance on obesity and on the relevant weight-management medicines, including NICE guideline NG246 (Overweight and obesity management, 2025)
  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 - Regulation 12 (Safe care and treatment)
  • General Medical Council, Good practice in prescribing and managing medicines and devices (2021)
  • Human Medicines Regulations 2012 (SI 2012/1916, as amended)

Who it applies to

All prescribers (doctors, non-medical prescribers and pharmacist prescribers), pharmacists, nurses, healthcare assistants and administrative or reception staff at [Organisation Name] who counsel, assess, monitor, triage or take calls from patients prescribed weight-loss medicines, together with any locum, bank or agency staff working in these roles.

Glossary

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

Acute kidney injury (AKI)
A sudden drop in how well the kidneys work, which dehydration from vomiting or diarrhoea can cause or make worse.
Acute pancreatitis
Sudden inflammation of the pancreas, a gland in the upper abdomen, which can be serious and causes severe pain that often spreads to the back.
Adverse drug reaction (ADR)
An unwanted or harmful effect that is suspected to be caused by a medicine.
Adverse effect
An unwanted or harmful effect experienced after taking a medicine.
Anaphylaxis
A severe, life-threatening allergic reaction needing immediate emergency treatment.
Black triangle symbol
An inverted black triangle marked on a medicine to show it is under extra safety monitoring, so all suspected reactions to it should be reported.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Cautions
Situations where a medicine can be used but with extra care, monitoring or advice because of a possible increased risk.
Contraindication
A specific situation or condition in which a medicine should not be used because the risk of harm is too high.
Drug Safety Update
A regular bulletin from the medicines regulator giving prescribers important new safety information about medicines.
Duty of candour
The legal duty to be open and honest with a person and their family when something goes wrong with their care.
Fast-acting carbohydrate
A sugary food or drink, such as glucose tablets or fruit juice, taken quickly to raise low blood glucose.
Gallbladder disease
Problems affecting the gallbladder, such as gallstones or inflammation, which can cause pain in the upper right abdomen.
Gallstones
Hard lumps that form in the gallbladder and can cause pain, especially after fatty meals.
Gastric emptying
The rate at which food leaves the stomach and passes into the gut; some weight-loss medicines deliberately slow this down.
Gastrointestinal
Relating to the stomach and gut, for example nausea, vomiting, diarrhoea or constipation.
General Medical Council (GMC)
The body that registers and sets standards for doctors in the United Kingdom.
General practitioner (GP)
A family doctor who provides general medical care in the community.
GLP-1 receptor agonist
A class of injectable medicine for weight management and type 2 diabetes (for example semaglutide or liraglutide) that slows stomach emptying and reduces appetite.
Glucose-dependent insulinotropic polypeptide (GIP)
A natural gut hormone; some newer weight-loss medicines act on its receptor as well as the GLP-1 receptor.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting out the fundamental standards that providers of regulated care must meet, including Regulation 12 on safe care and treatment.
Human Medicines Regulations 2012
The main set of rules governing how medicines for human use are licensed, supplied and monitored in the United Kingdom.
Hypoglycaemia
Abnormally low blood glucose (blood sugar), which can cause sweating, shaking, confusion and, if severe, collapse.
Inverted black triangle symbol
A mark on a medicine showing it is under additional safety monitoring, so all suspected reactions should be reported.
Jaundice
Yellowing of the skin or the whites of the eyes, which can be a sign of liver or gallbladder problems.
Liraglutide
A GLP-1 receptor agonist medicine used for weight management and type 2 diabetes.
Locum, bank or agency staff
Temporary or stand-in staff who cover shifts but are still expected to follow the service's procedures.
Medicines and Healthcare products Regulatory Agency (MHRA)
The United Kingdom body that regulates medicines and medical devices and monitors their safety.
National Institute for Health and Care Excellence (NICE)
The body that produces evidence-based guidance on treatments and care for use across health and care services.
Non-medical prescriber
A trained healthcare professional who is not a doctor, such as a nurse or pharmacist, who is qualified to prescribe medicines.
Palpitations
An awareness of the heart beating fast, hard or irregularly.
Patient Information Leaflet
The leaflet supplied with a medicine explaining in plain language how to take it and its possible side effects.
Pharmacist prescriber
A pharmacist who has completed additional training that allows them to prescribe medicines.
Red flag
A symptom or sign that may point to a serious problem and means the medicine should be stopped and the patient assessed urgently or sent for emergency care.
Registered Manager
The person registered with the regulator as responsible for the day-to-day running of a service.
Regulated activity
A type of care or treatment the law requires a provider to register with the regulator to deliver.
Regulation 12 (Safe care and treatment)
The legal requirement that care and treatment must be provided in a safe way, including by managing risks to people's health and safety.
Semaglutide
A GLP-1 receptor agonist medicine used for weight management and type 2 diabetes.
Standard Operating Procedure (SOP)
A written, step-by-step instruction setting out how a particular task or process should be carried out consistently.
Sulfonylurea
A type of tablet for type 2 diabetes (for example gliclazide) that can cause low blood glucose, especially when combined with a GLP-1 receptor agonist.
Summary of Product Characteristics (SmPC)
The manufacturer's official, regulator-approved document describing how a medicine should be used, including its cautions, contraindications and side effects.
Tirzepatide
A medicine that acts on both the GLP-1 and GIP receptors, used for weight management and type 2 diabetes.
Titration
Increasing a medicine's dose in planned steps over time so the body can adjust and side effects are reduced.
Triage
Quickly sorting patients or symptoms by how urgent they are so the most serious are dealt with first.
Type 2 diabetes
A long-term condition where the body cannot properly control blood glucose levels.
Yellow Card scheme
The United Kingdom system for reporting suspected side effects of medicines to the medicines regulator, used by both staff and patients.

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