WORK BASED COMPETENCY Botulinum Toxin Type A Background This is a prescription only medicine, which is being used outside its UK licence. It has been
used successfully for many years.
There are currently 3 licenced Botulinum Toxin type A for cosmetic purposes in the UK.
Allergan – Vistabel and Botox licensed for glabella and crows feet Hyperhidrosis
Merz - Bocouture licenced for glabella, crows feet and forehead
Galderma – Azzalure licensed for glabella and crows feet
All other indications are off license or off label.
Objective To ensure safe practice
To ensure all products used are stored safely, monitored and yellow carded if issues occur
That treatments are provided by practitioners competent in the practice and have
underpinning knowledge and understanding of the anatomy of the area to be treated
Botulinum Toxin Type A
The FDA (2001) description of Botulinum Toxin Type A is a protein produced by the
affected muscles the toxin blocks the release of the chemical Acetylcholine. This has the effect of stopping impulse information to the muscle inhibiting contraction by either conscious or subconscious behaviour.
It has been used for many years to treat Blepharospasm and Strabismus, two eye muscle
conditions. In recent years it has been licensed for the treatment of cervical dystonia and
hyperhidrosis. New trials into different medical conditions are continually broadening the uses of Botulinum Toxin A in managing disorders.
Anatomy The areas treated are those impacted by facial expression from muscle movement.
Facial Muscles The scalp and face are made up of 10 groups of muscles.
The muscles, which are especially important in this treatment, are:
Levator Anguli Oris
Though it is important to understand these in context of other surrounding connecting muscles.
Patient Selection Treatment: All patients must complete and sign a non‐surgical medical history
This is a clinically clean procedure using single‐use needles and syringes. It is
undertaken by nurses, doctors or dentists (with prescription) who have been trained and
deemed competent, not only in the procedure but their responsibilities as prescribers.
All clinical waste is disposed of:
‐ Sharps produced in yellow sharps bins
‐ Any gauze swabs or wipes in yellow bin bags
Unconstituted Botulinum Toxin A must be stored in a refrigerator (2° ‐ 8°). Bocouture is the only toxin that can be stored at room temperature in its unconstituted form.
Botox is reconstituted with bacteriostatic saline.
To dilute use an appropriately sized syringe and needle to draw up
Insert the needle at 45° angle and slowly inject into the Botulinum Toxin A vial.
Discardthe vial if a vacuum does not pull diluant into the vial. Report the incident to the local representative of the company and the supplier and return as instructed for investigation.
Gently rotate the vial and record the date and time of reconstitution on the space on
Reconstituted Botulinum Toxin A is clear, colourless and free of particulate matter.
Any reconstituted Botulinum Toxin A that does not meet these criteria must be
solution and disposed of in the sharps bin identified for this purpose by your local waste disposal company.
For treatment areas see fig 2.
All patients who wish to receive this treatment must be given a possible risks and
complications information sheet. They will also have a full consultation with the
practitioner who will undertake the treatment.
Signed consent for the treatment must be undertaken before any treatment is
commenced. Offer a hard copy of the signed consent form to the patient.
Botulinum Toxin A treatment is an important medical treatment with significant
consequences. The practitioner is duty bound to explain the treatment thoroughly
to the patient abiding by the Montgomery law pertaining to full informed consent.
The practitioner will take and retain before photographs which are taken to enable the evaluation of the treatment at a later date. Inform the patient these images form part of the medical records and will not be used outside of the treatment with express written consent.
The Medical History sheet will record the consultation and other issues discussed
Indications Temporary improvement in the appearance of moderate to severe glabellar lines associated
with corrugator and/or procerus muscle activity in adult patients < 65
Crows feet associated with Orbicularis Oculi muscle activity in adult patients < 65 years,
Forehead lines associated with the frontalis muscle that pulls the eyebrows up.
Lower face indications when practitioner is competent and advanced training in the procedures.
Contra‐indications The presence of infection at the proposed injection site(s) and in individuals with known
hypersensitivity to any ingredient in the formulation.
Patients who are pregnant or breast‐feeding should not be treated.
Precautions Epipen and resuscitation equipment must be readily available when treating patients with
Botulinum Toxin A.
All practitioners must undertake annual CPR and anaphylaxis training updates.
The safe effective use of Botulinum Toxin A is dependent on the proper storage of product,
patient selection, correct dose, and proper reconstitution and administration techniques.
Practitioners must understand the relevant neuromuscular and/or orbital anatomy of the
area treated. They must also be aware of the alteration to the anatomy following surgical
treatment to the area.
Treatment should be no more frequent than 3 months and should be performed using the