Standard operating procedure

Botulinum Toxin Prescribing & Administration Procedure

Step-by-step chairside workflow for confirming the prescriber assessment and prescription, screening contraindications, checking and reconstituting the product, marking, injecting, documenting and reviewing botulinum toxin type A treatment.

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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. Equipment and materials
  • 6. Procedure
  • 7. Aftercare and documentation
  • 8. Records
  • 9. Related documents
  • 10. Review and version control
  • 11. Disclaimer

Legislation & standards it maps to

  • Human Medicines Regulations 2012, Regulation 214 (prescription-only medicines - sale or supply on prescription)
  • The Summary of Product Characteristics (SmPC) for the specific botulinum toxin product used
  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12 (Safe care and treatment)
  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 11 (Need for consent)
  • Botulinum Toxin and Cosmetic Fillers (Children) Act 2021
  • Medicines and Healthcare products Regulatory Agency (MHRA) Yellow Card scheme for reporting suspected adverse drug reactions

Who it applies to

All prescribers and registered practitioners at [Organisation Name] who assess for, prescribe, prepare or administer botulinum toxin type A, together with the clinical support staff who assist them and manage stock.

Glossary

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

0.9% sodium chloride for injection
A sterile salt-water solution used as the diluent to dissolve the freeze-dried toxin before injection.
Acetylcholine
A natural chemical messenger that nerves release to make a muscle contract; botulinum toxin works by blocking its release.
Adverse drug reaction
An unwanted or harmful response to a medicine given at a normal dose.
Anaphylaxis
A severe, life-threatening allergic reaction needing immediate emergency treatment.
Aseptic non-touch technique (ANTT)
A careful method of preparing and giving an injection that keeps the key parts and the injection site free from contamination.
Batch (lot) number
A code identifying the specific production run of a product, used to trace it if a problem arises.
Botulinum toxin type A
A prescription-only medicine that temporarily relaxes muscles and is used in aesthetics to soften facial lines.
Botulinum Toxin and Cosmetic Fillers (Children) Act 2021
The law making it a criminal offence to give botulinum toxin or cosmetic fillers to under-18s for cosmetic purposes in England.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Chairside workflow
The set of steps a clinician follows at the patient's side during a treatment.
Cold chain
Keeping vaccines and certain medicines within a safe temperature range from delivery to use.
Contraindication
A reason why a treatment should not be given to a particular person because it could cause harm.
Diluent
The sterile liquid mixed with a freeze-dried medicine to turn it into a solution that can be injected.
Excipient
An inactive ingredient in a medicine, such as a stabiliser, that someone could still be allergic to.
Haemostasis
Stopping or controlling bleeding, for example by pressing gauze on the injection site.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting the fundamental standards of safety and quality that registered care providers must meet, enforced by the Care Quality Commission.
Human Medicines Regulations 2012
The main law in the United Kingdom controlling how medicines are made, supplied, prescribed and administered.
Indication
The medical or treatment reason for which a medicine is given.
Infection prevention and control (IPC)
The measures used to stop infection spreading between patients, staff and visitors.
Informed consent
Agreement to treatment given freely after the risks, benefits and alternatives have been clearly explained.
Lyophilised (freeze-dried)
Dried into a stable powder by freezing and removing water, which must be reconstituted with liquid before use.
Medicines and Healthcare products Regulatory Agency (MHRA)
The United Kingdom body that regulates medicines and medical devices and runs the Yellow Card reporting scheme.
Neuromuscular blocking agent
A medicine that reduces or blocks signals between nerves and muscles and can strengthen the effect of botulinum toxin.
Neuromuscular disorder
A condition affecting the nerves that control muscles (for example myasthenia gravis), which can make botulinum toxin unsafe.
Neuromuscular junction
The point where a nerve meets a muscle and passes on the signal to contract.
Patient Group Direction (PGD)
A written instruction letting named staff supply or give a medicine to a group of patients without an individual prescription; it cannot be used for botulinum toxin in aesthetics.
Patient-specific prescription
A prescription written by a prescriber for one named patient who has been individually assessed.
Personal protective equipment (PPE)
Items such as gloves, aprons and masks worn to protect against harm or infection.
Potentiate
To make the effect of a medicine stronger, for example when another drug increases the action of the toxin.
Prescriber (independent or supplementary)
A qualified professional legally allowed to prescribe medicines; a supplementary prescriber works to an agreed plan set with a doctor.
Prescription-only medicine (POM)
A medicine that may lawfully be supplied or given only on the instruction of an appropriate prescriber.
Ptosis
Drooping of an eyelid or brow, which can occur temporarily as a side effect of treatment.
Reconstitution
Mixing a freeze-dried medicine with a sterile liquid to make a solution of a known strength 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.
Sharps
Needles, blades and other items that can cut or puncture the skin.
Standard Operating Procedure (SOP)
A document setting out the agreed step-by-step way a particular task must be carried out.
Summary of Product Characteristics (SmPC)
The manufacturer's licensed document setting out a product's dose, mixing, storage and safety information.
Yellow Card scheme
The Medicines and Healthcare products Regulatory Agency system for reporting suspected side effects of medicines and faults with products.

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