Work based competency



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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

Bacterium Clostridium Botulinum.
This protein is then produced in a sterile, purified form for injection. When injected into 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

 Corrugator

Frontalis

 Procerus

 Orbicularis Occuli

 Orbicularis 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

the saline.


 Insert the needle at 45° angle and slowly inject into the Botulinum Toxin A vial.
Discard the 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

the label.

 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

discarded immediately.
 When discarding any unused Botulinum Toxin A it must be mixed with Milton

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

with the patient. The following must be recorded:


Product dose

‐ Batch number and expiry date

‐ Injection site and dose

‐ Time of treatment

‐ Review date

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,

when smiling.


Forehead lines associated with the frontalis muscle that pulls the eyebrows up.
Hyperhidrosis
Lower face indications when practitioner is competent and advanced training in the procedures.
Contraindications
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

lowest effective dose.


TRAINING LOG



Date/Time

Patient Number

Area Treated

Mentor / Practitioner

Supervisor

Comments











































































Supervisor…………………………………..... Date …………………………………………...
Practitioner…………………………………… Date……………………………………………

To be deemed competent to carry out this treatment the practitioner must show

knowledge, understanding and competency in all the following areas.
Consultation:
 Discussing patient concerns, expectations and requirements

 Accessing the suitability of a patient for the treatment

 Alternative treatments that may be suitable for the patient.

 Discussing and explaining to patients the potential risks and complications.


Product:
 The anatomy and physiology of the area/s to be treated.

 The expected outcomes of treatment.

 The potential negative effects of the treatment.

 Risks and complications of treatment and how to manage them


Documentation:
 Knowledge of what photographs to take and when.

 How to take effective photographs.

 The importance of accurate and detailed documentation of patient care and

 Treatment.

 The safe confidential storage of documentation
This training is relevant at the date of completion; however practitioners must

continue to update knowledge and training.


If the practitioner ceases to undertake the treatment for a period of time a

refresher course will be necessary.



All practice must be in line with registering body's guidelines.

Date of Competency ……………………………………………………………


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