Risk assessment

Botulinum Toxin (Botox) Risk Assessment

Safe administration of botulinum toxin type A injectable treatments in an aesthetic clinic setting

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  • Editable Microsoft Word (.docx)
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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 - Regulations 9, 10, 11, 12, 17, 18, 19 and 20
  • Care Quality Commission (Registration) Regulations 2009
  • Human Medicines Regulations 2012 (as amended) - prescription-only medicine supply and prescribing
  • Health and Safety at Work etc. Act 1974 and the Management of Health and Safety at Work Regulations 1999
  • Control of Substances Hazardous to Health Regulations 2002
  • Health and Safety (Sharps Instruments in Healthcare) Regulations 2013
  • Health and Social Care Act 2008 (Regulated Activities) (Amendment) Regulations 2022 and the Botulinum Toxin and Cosmetic Fillers (Children) Act 2021
  • UK General Data Protection Regulation and the Data Protection Act 2018

Who it applies to

All prescribers, practitioners, registered managers, clinical and administrative staff involved in the consultation, prescribing, preparation, administration and aftercare of botulinum toxin injectable treatments at [Organisation Name].

Glossary

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

Adrenaline 1:1000
The strength of injectable adrenaline kept ready to treat a severe allergic reaction (anaphylaxis).
Aftercare
The advice and follow-up support given to a client after a treatment to aid recovery and spot any problems.
Anaphylaxis
A severe, life-threatening allergic reaction needing immediate emergency treatment.
Aseptic non-touch technique
A careful method of carrying out a procedure so that the parts that must stay sterile are never touched, reducing the risk of infection.
Aspiration
Drawing back on the syringe before injecting to check the needle is not in a blood vessel.
Basic life support (BLS)
Emergency first aid, including chest compressions and rescue breaths, used to keep someone alive until further help arrives.
Blood-borne virus (BBV)
An infection such as hepatitis B, hepatitis C or HIV that can be passed on through blood.
Body dysmorphic disorder (BDD)
A mental health condition in which a person worries excessively about perceived flaws in their appearance.
Botulinum toxin
A prescription-only medicine, sold under brand names such as Botox, that relaxes muscles and is injected for cosmetic or medical reasons.
Botulinum Toxin and Cosmetic Fillers (Children) Act 2021
The law making it a criminal offence to give botulinum toxin or fillers for cosmetic reasons to anyone under 18 in England.
Bruxism
Involuntary grinding or clenching of the teeth, which can be treated with botulinum toxin.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Cellulitis
A bacterial infection of the skin and the tissue beneath it, causing redness, swelling and pain.
Chlorhexidine
An antiseptic used to clean the skin before an injection to reduce the risk of infection.
Cold chain
Keeping vaccines and certain medicines within a safe temperature range from delivery to use.
Control of Substances Hazardous to Health Regulations 2002 (COSHH)
The law for safely managing chemicals and other hazardous substances at work.
Cooling-off period
A set period of time between consultation and treatment that lets a client reflect before deciding to go ahead.
Cosmetic Practice Standards Authority (CPSA)
A body that sets recognised clinical standards for non-surgical cosmetic procedures.
Diplopia
Double vision, which can occur if botulinum toxin spreads to the muscles that move the eye.
Dose map
A record showing exactly where on the face and at what dose each injection of botulinum toxin was given.
Duty of candour
The legal duty to be open and honest with a person and their family when something goes wrong with their care.
Dysphagia
Difficulty swallowing, which can occur if botulinum toxin spreads beyond the intended muscles.
Excipient
An inactive ingredient, such as human albumin, included alongside the active medicine in a product.
Fundamental standards
The minimum standards of safety and quality below which care must never fall.
General Dental Council (GDC)
The body that registers and regulates dentists and dental professionals in the UK.
General Medical Council (GMC)
The body that registers and regulates doctors in the UK.
General Pharmaceutical Council (GPhC)
The body that registers and regulates pharmacists and pharmacy professionals in Great Britain.
General practitioner (GP)
A doctor who provides general medical care in the community and is usually a patient's first point of contact.
Glabellar lines
The vertical frown lines between the eyebrows, a common area treated with botulinum toxin.
Grey market
The buying or selling of genuine products through channels that are not officially authorised, which can risk supplying unsafe or unverified stock.
Health and Care Act 2022
A law reforming the health and care system in England, including powers to set up a licensing scheme for cosmetic procedures.
Health and Safety (Sharps Instruments in Healthcare) Regulations 2013
The law requiring healthcare employers to prevent and manage injuries from needles and other sharp instruments.
Health and Safety at Work etc. Act 1974
The main law setting out employers' duties to protect the health and safety of staff and others affected by their work.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting out the fundamental standards that providers of regulated care must meet.
Hepatitis B
A blood-borne virus that infects the liver and which clinical staff are usually immunised against.
Human albumin
A protein from human blood used as a stabilising ingredient in some botulinum toxin products.
Human Medicines Regulations 2012
The main law governing how medicines are licensed, supplied, prescribed and sold in the UK.
Hyperhidrosis
Excessive sweating, a medical condition that can be treated with botulinum toxin.
Indemnity (professional indemnity)
Insurance cover that protects a practitioner and compensates clients if something goes wrong with treatment.
Independent prescriber
A qualified health professional legally allowed to assess patients and prescribe medicines on their own responsibility.
Infection prevention and control (IPC)
The measures used to stop infection spreading between patients, staff and visitors.
Inoculation injury
An injury, such as a needlestick, that could expose a person to infected blood or bodily fluids.
Joint Council for Cosmetic Practitioners (JCCP)
A voluntary register of practitioners who meet recognised standards for non-surgical cosmetic treatments.
Mental capacity
Whether a person can understand and make a particular decision for themselves at the time it needs to be made.
Near miss
An event that could have caused harm but did not, by chance or because it was caught in time.
Nominated Individual
The senior person responsible to the regulator for supervising how a service is provided.
Nursing and Midwifery Council (NMC)
The body that registers and regulates nurses and midwives in the UK.
Off-label use
Using a licensed medicine for a purpose, dose or group of people not covered by its official licence.
Personal protective equipment (PPE)
Items such as gloves, aprons and masks worn to protect against harm or infection.
Prescription-only medicine (POM)
A medicine that may lawfully be supplied only on the instruction of an appropriate prescriber.
Ptosis
Drooping of the upper eyelid, which can occur if botulinum toxin spreads to nearby muscles.
Reconstitution
Mixing a powdered medicine with a liquid to make it ready for injection.
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.
Residual risk
The level of risk that remains once existing control measures are taken into account.
Risk assessment
A structured check identifying what could cause harm and what is being done to prevent it.
Risk matrix
A grid that scores how likely a harm is against how serious it would be, to rank risks for action.
Risk register
A record listing identified risks, their ratings and the actions being taken to manage them.
Safeguarding
Protecting people's health, wellbeing and rights and keeping them safe from abuse, harm or neglect.
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).
Standard operating procedure
A written, step-by-step instruction for carrying out a routine task consistently and safely.
Statement of Purpose
A required document describing who a service is, what it does and where, shared with the regulator.
UK General Data Protection Regulation (UK GDPR)
The UK's main data-protection law governing how personal information is collected and used.
Vascular occlusion
Blockage of a blood vessel, a serious complication that can cut off blood supply to tissue.

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