The Dental Board of Australia (the Board) has published this fact sheet to explain what we expect of dentists when using botulinum toxin1 and dermal fillers in their practice.
The Therapeutic Goods Administration approves and specifies the clinical uses of scheduled medicines, including botulinum toxin or dermal fillers. The supply, storage, use and administration requirements for scheduled medicines are set out in state and territory specific drugs and poisons legislation and regulations. Dentists2 who use botulinum toxin or dermal fillers in their practice must comply with all relevant laws.
When using botulinum toxin and/or dermal fillers the Board expects dentists to:
The Board removed its interim policy on the use of botulinum toxin and the associated fact sheet in October 2014 following discussion with the TGA.
We consider that a specific policy is not required because the existing regulatory framework, which includes the Board’s standards, codes and guidelines, applies to all dental practitioners regardless of the care being delivered or the setting.
When the Board receives a notification (complaint) about the use of botulinum toxin or dermal fillers by a dental practitioner, it considers whether the facts and circumstances of that use are consistent with good practice and accord with all applicable legislation. In managing and assessing a notification, the Board may draw on advice from a range of experts, including health practitioners other than dental practitioners.
Nothing has changed.
The interim policy set out the Board’s position regarding a specific clinical use of botulinum toxin at the time of transition to the National Registration and Accreditation Scheme in July 2010.
The intent of the interim policy was never to limit the use of botulinum toxin and/or dermal fillers by dentists to this specific clinical use. Dentists were always able to use these medicines in their practice if they adhered to the Board’s and other regulators’ requirements.
The Scope of practice registration standard and guidelines are part of the Board's broad regulatory framework.
These documents do not refer to specific clinical areas of practise as they need to apply to all dental practitioners across a range of clinical settings to meet the needs of patients.
The Board expects dentists to practice within this regulatory framework at all times including when using botulinum toxin and/or dermal fillers. The Scope of practice registration standard, approved by health ministers in 2014, describes the Board’s requirements of all dental practitioners to practice within the scope of their education, training and competence.
The associated Guidelines for scope of practice include a broad definition of dentistry.
Dentists need to practise within this definition when using botulinum toxin and/or dermal fillers.
The Code of conduct describes our expectations of what constitutes good practice. Dental practitioners have a duty to make the care of patients their first concern and to practise safely and effectively at all times.
Botulinum toxin and dermal fillers should only be used if the treatment can be justified. Informed consent, including financial consent, must be obtained and the risks associated with the treatment, explained to the patient, and documented.
Dentists need to be particularly aware of the patient’s expectations regarding the use of botulinum toxin and dermal fillers. Dentists must communicate effectively with the patient to ensure that they are understood and that the patient’s expectations are reasonable.
TGA-approved indications for scheduled medicines are published in the Australian Register of Therapeutic Goods.
The use of a medicine outside the approved indication/s for supply is often referred to as 'off label' use. The TGA does not assess 'off-label' uses and they are therefore regarded as experimental.
Dentists using botulinum toxin and dermal fillers in their practice should be familiar with the approved indications of this scheduled medicine. For example, the use of botulinum toxin for the treatment of temporomandibular joint (TMJ) disorder/dysfunction is considered to be ‘off-label’.
If a dentist decides to use a scheduled medicine ‘off-label’ then this is a clinical judgement that should be made in consultation with their patient. The patient must be made aware that the proposed use is experimental only and all risks must be explained. Informed consent from the patient must be obtained in writing. Dentists must ensure that any ‘off-label’ use of scheduled medicine accords with principles of good practice.
The Board expects dentists to refer a patient to a suitably trained and qualified:
Dentists administer a range of scheduled medicines in their practice. The authority to obtain these restricted substances for the purpose of administration is drawn from the applicable state and territory drugs and poisons legislation and authority.
These authorities may vary across jurisdiction but will generally allow dentists to obtain these restricted substances from wholesalers.
Generally, dentists are prohibited from on-supplying restricted medicines for therapeutic use to others including dental hygienists, dental therapists, oral health therapists, registered nurses and other unauthorised persons, in circumstances where these people are not under the direct supervision of the dentist.
The dentist must take responsibility for the receipt, security and administration of scheduled medicines. Dentists must adequately consult and review patients and ensure that only people with the requisite authority administer restricted medicines under adequate supervision.
The Board expects all dental practitioners to be aware of their legal obligations under the drugs and poisons legislation in their jurisdiction(s), and to practise in accordance with professional practice standards.
Any person, including businesses, advertising the use of botulinum toxin and/or dermal fillers must comply with the:
The Board’s Guidelines for advertising of regulated health services also apply.
This fact sheet will be reviewed from time to time as required. This will generally be every three years.
1We refer to botulinum toxin. This information would also apply to other neurotoxins.
2The term ‘dentists’ includes dental specialists. Dentists are the only dental practitioners with the authority under drugs and poisons legislation to use these scheduled medicines.
3As described in the Board’s Scope of practice registration standard and associated guidelines.