02 February 2025
Botox and dermal fillers: Where do dentists stand?
Drugs, Poisons and Controlled Substances: our obligations
The Drugs, Poisons and Controlled Substances Act 1981 and the Drugs, Poisons and Controlled Substances Regulations 2017 regulate medicines and poisons in Victoria. All medicines supplied in Australia must be included in the Australian Register of Therapeutic Goods (ARTG) and will be either registered or listed.
Many cosmetic injectables are available both in Australia and overseas. A parallel import occurs when a legitimate version of an overseas product is imported with the intention of it being sold in Australia. They have not been assessed by the ARTG and met their standards. For example, one of the known issues with parallel imports is that they may not be delivered using appropriate cold chain storage protocols. The consequences of importing unapproved cosmetic injectables are loss of product, fines or court action, referral to AHPRA and the Dental Board.
Scheduling is a national classification system which controls how medicines and poisons are made available to patients. Almost all drugs, poisons and controlled substances used by dentists fall under Schedule 4 or 8. Botox is a Schedule 4 Poison which in Victoria should not be prescribed or supplied by a Dentist unless it is for the dental treatment of a patient under their care, and they have taken all reasonable steps to ensure that a therapeutic need exists for that person.
Records of transactions involving Schedule 4 & 8 poisons. Registered dental practitioners must make true and accurate records of all drugs administered or supplied, retain them and produce them, on demand, to an authorised officer. Schedule 4 poisons (including professional samples) must be stored in a lockable storage facility (e.g. cupboard, drawer, fridge, filing cabinet).
The TGA and “off-label” use of a medicine
The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and is responsible for regulating therapeutic goods including prescription medicines. TGA-approved indications for scheduled medicines are published in ARTG.
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. Dentists must ensure that any ‘off-label’ use of scheduled medicine accords with principles of good practice. 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.
DBA Policy
The DBA produced an Interim Policy which set out the Board’s position regarding a specific clinical use of Botox at the time of transition to AHPRA in July 2010. This Interim Policy was subsequently removed as it was considered that a specific policy is not required because the existing regulatory framework, which includes the DBA’s standards, codes and guidelines, applies to all dental practitioners regardless of the care being delivered or the setting.
The DBA has a Fact Sheet, extracts from which lie below:
Dentists who use Botox 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:
- practice in accordance with the Board’s regulatory standards, codes and guidelines by:
- performing only those dental procedures for which they have been educated and trained and are competent
- practising within the definition of dentistry contained in the Board’s Guidelines for scope of practice
- ensuring they have appropriate professional indemnity insurance arrangements in place for all aspects of their practice
- meeting the Board’s recency of practice requirements
- acting in accordance with the standards set out in the Code of conduct including expectations about informed and financial consent, and
- completing ongoing continuing professional development that contributes to the development, maintenance and enhancement of knowledge, skills and performance. This means having documented evidence of training, including formal qualifications, courses, CPD and supervised or self-directed training and evidence of logged experience in the advanced or new area of practice.
- adhere to the relevant state and territory drugs and poisons legislation and regulations by using scheduled medicines only for the purpose that the authority is granted. This is usually described in terms such as ‘for dental therapeutic use’, and
- understand and comply with the requirements of the TGA in relation to:
- the advertising of therapeutic goods
- approved uses of botulinum toxin and dermal fillers for use in Australia, and
- ‘Off-label’ use of botulinum toxin and dermal fillers.
Botulinum toxin and dermal fillers should only be used if the treatment can be justified. 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. Informed consent, including financial consent, must be obtained and the risks associated with the treatment, explained to the patient, and documented.
The Board expects dentists to refer a patient to a suitably trained and qualified:
- dental practitioner - when the treatment required by the patient is outside the personal scope of practice of the individual dentist, but still within the definition of dentistry, or
- medical practitioner - when the proposed use of botulinum toxin or dermal fillers is outside the definition of dentistry.
Applications of botox and dermal fillers NOT allowed to be performed by dentists in Victoria:
- Cosmetic applications: treatment of any facial wrinkles regardless of location is prohibited.
- Dentists are prohibited from using Botox to treat functional disorders (eg. cervical dystonia, cervicogenic headaches, migraine, etc) involving the head and neck region.
- Dentists are prohibited from using dermal fillers outside the oral cavity or jaws.
- Dentists are prohibited to use so-called permanent fillers in the lips, cheeks and perioral region such as acrylic-containing materials, silicones and hydroxyapatite. These materials have been associated with the development of giant-cell foreign body reactions.
Can Allied Health Professionals use Botox?
There is no approved training for dental prosthetists, dental hygienists, dental therapists or oral health therapists in the use of botulinum toxin or dermal fillers. Any use of Botox or dermal fillers by these practitioners would be considered as practising outside of the practitioner’s scope of practice.
Item codes
The Australian Schedule of Dental Services and Glossary – Thirteenth Edition – includes the following relevant item codes:
929 – Provision of neuromodulator therapy #
Injection of neuromodulators for the treatment of oral and maxillofacial diseases and disorders.
987 – Recontour tissue – per appointment #
Recontour of oral and associated tissue not elsewhere in the Thirteenth Edition of the Australian Schedule of Dental Services and Glossary, such as the injection of dermal fillers.
Private Health Funds
Patients should be encouraged to contact their health fund to ascertain whether their fund will pay a benefit as the funds have different rules and different policies.
Professional Indemnity (PI) and AHPRA considerations
- If injectable Botox or dermal fillers are prescribed other than for dental therapeutic use, dentists may find they are not covered by their PI insurance for any claims arising out of their practice in this area. The ADAVB suggests that if a dentist wishes to embark on these treatments, it would be advisable to obtain confirmation from his/her PI insurer that their policy covers these treatments.
- If injectable Botox or dermal fillers have been prescribed other than for dental therapeutic use, this will constitute a breach of the drugs and poisons legislation in Victoria but may also lead to adverse disciplinary action by the DBA if a complaint is made to AHPRA.
Dr Anna Talacko
Dental Consultant
Sources:
1. dentalboard.gov.au/Codes-Guidelines/FAQ/botulinum-toxin-and-dermal-fillers.aspx
2. htga.gov.au
3. health.vic.gov.au/public-health/drugs-and-poisons/pharmacotherapy
