Risk assessment

GLP-1 Safety Risk Assessment

Safe prescribing, supply and monitoring of GLP-1 receptor agonists for weight management

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  • Editable Microsoft Word (.docx)
  • Mapped to the CQC standards
  • Optional 3-monthly updates

What's inside

This risk assessment is fully drafted and structured, ready to brand and complete for your service. It covers:

  • 1. Scope and purpose
  • 2. Legal and regulatory framework
  • 3. Risk assessment methodology
  • 4. Hazards, controls and risk rating
  • 5. Action plan
  • 6. Monitoring and review
  • 7. Disclaimer

Legislation & standards it maps to

  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (in particular Regulation 9 (Person-centred care), Regulation 12 (Safe care and treatment), Regulation 17 (Good governance) and Regulation 19 (Fit and proper persons employed))
  • Care Quality Commission (Registration) Regulations 2009
  • Human Medicines Regulations 2012 (as amended)
  • Medicines and Medical Devices Act 2021
  • General Pharmaceutical Council Standards for Registered Pharmacies and guidance on online prescribing (updated 2024)
  • Management of Health and Safety at Work Regulations 1999
  • Control of Substances Hazardous to Health Regulations 2002 (COSHH)
  • Health and Safety (Sharps Instruments in Healthcare) Regulations 2013
  • Data Protection Act 2018 and the UK General Data Protection Regulation (UK GDPR)
  • Medicines and Healthcare products Regulatory Agency (MHRA) National Patient Safety Alerts and Drug Safety Updates on GLP-1 receptor agonists (2024 - 2025)

Who it applies to

All prescribers, pharmacists, registered managers, clinical and administrative staff involved in the assessment, prescribing, supply, administration, counselling and follow-up of GLP-1 receptor agonist medicines (including semaglutide, liraglutide and tirzepatide) at [Organisation Name]

Glossary

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

Accident and emergency (A&E)
The hospital department that treats people with serious or life-threatening injuries and illnesses needing urgent care.
Acute kidney injury (AKI)
A sudden drop in how well the kidneys work, often caused by dehydration or illness, which can be serious if not treated.
Acute pancreatitis
Sudden, painful inflammation of the pancreas that can become a medical emergency.
Adverse drug reaction
An unwanted or harmful effect experienced after taking a medicine.
Adverse event
Any unexpected or unwanted occurrence linked to a treatment that harms, or could harm, a patient.
Body mass index (BMI)
A measure of body weight in relation to height, used to estimate whether a person is underweight, a healthy weight or overweight.
Caldicott Guardian
The senior person responsible for protecting the confidentiality of people's health and care information.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Chaperone
A trained person present during an intimate examination to support and protect the patient and the clinician.
Clinical governance
The system through which a service monitors and improves the quality and safety of the care it provides.
Cold chain
Keeping vaccines and certain medicines within a safe temperature range from delivery to use.
Comorbidity
An additional long-term health condition a person has alongside the main condition being treated.
Contraindication
A specific situation or condition in which a medicine or treatment should not be used because it could cause harm.
Control of Substances Hazardous to Health Regulations 2002 (COSHH)
The law for safely managing chemicals and other hazardous substances at work.
Data Protection Act 2018
The UK law that sits alongside the UK General Data Protection Regulation and governs how personal information must be handled.
Data Protection Impact Assessment (DPIA)
A check done before a new activity to identify and reduce risks to people's personal data.
Data Protection Officer (DPO)
The person responsible for overseeing how an organisation protects and uses personal data and for advising on data-protection law.
Diversion
The redirecting of a medicine away from its intended patient, for example for resale or misuse.
Drug Safety Update
A regular safety bulletin from the Medicines and Healthcare products Regulatory Agency giving prescribers important advice 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.
Excursion (temperature)
An occasion when a medicine is stored outside its required safe temperature range.
Falsified medicine
A fake medicine with a false identity, history or source, which may be unsafe or ineffective.
Fundamental standards
The minimum standards of safety and quality below which care must never fall.
Gallbladder disease
Problems affecting the gallbladder, such as gallstones, which can cause pain and may need treatment.
General Pharmaceutical Council (GPhC)
The body that regulates pharmacists, pharmacy technicians and registered pharmacies in Great Britain.
General practitioner (GP)
A doctor based in the community who provides general medical care and coordinates a patient's wider treatment.
GLP-1 receptor agonist
A type of injectable or oral medicine that mimics a natural gut hormone to lower appetite and help manage weight or blood sugar.
Glucose-dependent insulinotropic polypeptide (GIP)
A natural gut hormone involved in blood sugar control; some weight-management medicines act on both this and the GLP-1 hormone.
Good Distribution Practice (GDP)
The quality standards a medicines wholesaler must follow so that products are stored and transported safely and remain genuine.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting out the fundamental standards that providers of regulated care must meet.
Information Commissioner's Office (ICO)
The UK regulator that upholds information rights and enforces data-protection law.
Information governance
The framework for handling people's personal and health information legally, securely and appropriately.
Informed consent
Agreement to treatment given freely after the risks, benefits and alternatives have been clearly explained.
Liraglutide
A GLP-1 receptor agonist medicine (brand name Saxenda) given by injection to help manage weight.
Medicines and Healthcare products Regulatory Agency (MHRA)
The UK body that regulates medicines and medical devices and monitors their safety.
National Early Warning Score
A scoring system used to spot and respond to patients whose condition is deteriorating.
National Institute for Health and Care Excellence (NICE)
The body that produces evidence-based guidance on treatments and care for use across health and social care.
National Patient Safety Alert
An official warning telling health services to take specific action to prevent harm to patients.
Near miss
An event that could have caused harm but did not, by chance or because it was caught in time.
Needlestick injury
An accidental skin puncture from a needle or sharp instrument, which carries a risk of infection.
Nominated Individual
The senior person responsible to the regulator for supervising how a service is provided.
Off-licence (off-label) use
Using a medicine in a way not covered by its official licence, for example for a different condition or group of people.
Pharmacovigilance
The monitoring of medicines once in use to detect and reduce side effects and other safety problems.
Prescription-only medicine (POM)
A medicine that may lawfully be supplied only on the instruction of an appropriate prescriber.
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.
Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013 (RIDDOR)
The law requiring certain workplace injuries, diseases and dangerous events to be reported to the Health and Safety Executive.
Residual risk
The level of risk that remains after existing control measures have been put in place.
Responsible Pharmacist
The pharmacist legally accountable for the safe and effective running of a pharmacy at a given time.
Risk assessment
A structured check identifying what could cause harm and what is being done to prevent it.
Risk matrix
A grid that combines how likely harm is with how serious it would be to give each risk a rating.
Safeguarding
Protecting people's health, wellbeing and rights and keeping them safe from abuse, harm or neglect.
Safety-netting
Giving a patient clear advice on what warning signs to watch for and what to do if their condition worsens.
SCOFF questionnaire
A short set of screening questions used to help identify a possible eating disorder.
Semaglutide
A GLP-1 receptor agonist medicine (brand name Wegovy for weight management) given by injection.
Sharps
Needles, blades and other items that can cut or puncture the skin.
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).
Special-category data
Sensitive personal information, such as health details, that the law gives extra protection.
Standard operating procedure (SOP)
A written, step-by-step instruction for carrying out a routine task safely and consistently.
Statement of Purpose
A required document describing who a service is, what it does and where, shared with the regulator.
Summary of Product Characteristics (SmPC)
The official document for a medicine setting out how it should be prescribed, used and monitored.
Superintendent Pharmacist
The senior pharmacist with overall professional responsibility for the running of a pharmacy business.
Tirzepatide
A medicine (brand name Mounjaro) that acts on both the GIP and GLP-1 gut hormones to help manage weight or blood sugar.
Titration
Gradually adjusting a medicine dose, usually increasing it in steps, to reach the right level while limiting side effects.
UK General Data Protection Regulation (UK GDPR)
The UK's main data-protection law governing how personal information is collected and used.
Unlicensed medicine
A medicine that does not have a UK licence for the way it is being supplied or used.
Wholesaler
A licensed company that buys medicines in bulk and supplies them to pharmacies and clinics.
Yellow Card Scheme
The Medicines and Healthcare products Regulatory Agency system for reporting suspected side effects and faulty medicines or devices.

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  3. Complete the placeholders for your service, then have it approved before use.
  4. Add the optional updates subscription and we keep it current as guidance changes.

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