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Non-surgical cosmetic treatments and the use of botulinum toxin


26 April 2016

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Around the world, professional regulators (Dental Boards, Dental Councils) differ widely in the stance they take on particular issues. With over 68,000 members worldwide, DPL inevitably needs to take account of regulatory and legal variations between one country and another. DPL is not the arbiter of professional and clinical opinion although where appropriate it does lobby and has (where necessary and appropriate) taken legal action on behalf of its members.

The Medical Indemnity (Prudential Supervision and Product Standards) Act 2003 requires all professional indemnity in Australia to be provided by a regulated contract of insurance with an Australian insurer. To comply with this legislative requirement, DPL members in Australia are offered a claims made contract of indemnity insurance which is underwritten by MDA National Insurance Pty Ltd (MDANI). 

Background

DPL believes that dental healthcare professionals are better placed, in many respects, than many other potential providers to carry out non-surgical cosmetic treatments safely and successfully, not least because of their particular range of background knowledge and training, the standards of infection control and their ability to manage a medical emergency. The safety and welfare of patients should be the overriding consideration, and the patient's right to choose what treatment they wish to receive, when, and from whom, is fundamental to patient autonomy.

However, DPL also recognises that many of these procedures can present additional risks either because they are inherent in the procedures themselves, or because of a clinician's relative unfamiliarity with them when compared to ‘traditional‘ dental procedures, or sometimes because the patients who present themselves for such treatment are not typical of the population as a whole. In particular, they may well have different levels of expectation, or in terms of their willingness to accept a sub-optimal aesthetic outcome. Some of these patients may even present with a true body dysmorphic disorder (BDD) which the clinician may or may not recognise. 

A cosmetic procedure is one which is carried out, even in the absence of pathology, for the primary purpose of altering a patient's appearance. It might involve the teeth, the intra-oral tissues, the lips, the face and neck, and/or the bony structures of the head and neck.

Some of these procedures (for example, orthognathic surgery and orthodontics) are well recognised as forming a central part of the relevant specialties, but increasingly the distinctions are becoming blurred. 

An adjunctive procedure is a cosmetic procedure which is carried out as an adjunct to and/or alongside other dental procedures of a non-cosmetic nature. For example, a patient might receive treatment involving botulinum toxin or dermal fillers, alongside conventional complete dentures. The adjunctive use of botulinum toxin in paediatric and special needs dentistry to prevent muscle contraction and thereby facilitate the provision of dental care, is also well documented.

It is not always easy to separate cosmetic and adjunctive procedures from each other, nor from other dental procedures – especially when two of them (or all three) are being provided for the same patient at the same visit. In all ‘cosmetic‘ cases the consent process is crucially important, yet it is sometimes fraught with potential difficulties.

The regulatory position in Australia

The Regulatory Body for dentistry within Australia is the Dental Board of Australia which is one of the fourteen National Health Practitioner Boards underpinned by the Australian Health Professional Regulation Agency (AHPRA). As a registered practitioner, one is bound by a number of obligatory national standards, codes and policies, and guidelines published and updated from time to time by the Dental Board of Australia. These govern what is, and is not, acceptable contemporary practice in Australia, and whilst there is recognition and acceptance of qualifications, training and experience gained from outside Australia, Australian registrants are bound by the Australian regulations, laid down by the Dental Board and empowered by section 39 of the Health Practitioner National Law Act

The old position

In the three year period between September 2011 and 17 October 2014, the position of the Dental Board of Australia regarding the use of Botox had been in the form of an interim policy, Dental Interim Policy – Botulinum Toxin, while the Board was waiting to receive advice from an Expert Reference Group established to consider matters relating to the possession, administration, supply and prescription of restricted drugs, including botulinum toxin and dermal fillers. That interim policy permitted the use of botulinum toxin specifically for the treatment of certain tempero-mandibular joint disorders and had stated that:

The opinion of the Board is that injection of botulinum toxin outside of the use indicated in the Interim Policy does not form part of the practice of dentistry. Broader use by dentists whether trained or not is not appropriate. Dental practitioners should consult the Therapeutic Goods Administration (TGA) and manufacturers approved therapeutic use of such medications. Practitioners should also consult their professional advisers and indemnity cover for use in Australia.

DPL’s position throughout that period (and that of MDANI) reflected the above Dental Board of Australia.

The new position

On 17 October 2014 the Dental Board of Australia published a new statement which signals a departure from the September 2011 interim policy is some respects but – it is really important to note – not in all respects. In this statement there was no longer a definitive and deliberately restrictive statement as to what does and does not form part of the practice of dentistry, which encouraged some observers to conclude that that the Dental Board has issued an unequivocal ‘green light’ to facial aesthetics in all is forms, by all practitioners.

Consequently, on 11 December 2015 the Dental Board of Australia issued a new factsheet entitled The use of botulinium toxin and dermal fillers by dentists to explain what their expectations were of practitioners using botulinum toxin and dermal fillers in their practice. At this stage, the use of botulinum toxin and dermal fillers by dental practitioners is limited to use by dentists and dental specialists only as the fact sheet reiterates that any use of botulinum toxin or dermal fillers by dental prosthetists, dental hygienists, dental therapists or oral health therapists is stated to be outside their scope of practice, irrespective of any training they might have received in the use of these procedures and irrespective of any competence that they might consider themselves to have acquired in their provision. 

Practitioners prescribing and/or administering botulinum toxin or dermal fillers are just as accountable to AHPRA and the Dental Board as they would be when carrying out other dental procedures, and all of the National Registration Standards, Guidelines, Codes of Practice and Policies apply.

DPL would encourage any practitioners currently providing, or considering offering these services as part of their practice of dentistry to review the Factsheet, in conjunction with the Guidelines for scope of practice, the Code of conduct, and the Guidelines for advertising regulated health services. Most cosmetic procedures are provided electively. In this context the revised statement does not change in any respect the Board’s Guidelines for Advertising Regulated Health Services, which make it clear that the National Law restricts and in some cases prohibits the advertising or promotion of health services that encourage a patient to improve their physical appearance or to use health services regardless of clinical need or therapeutic benefit. Thus the promotion of facial aesthetic procedures may place a practitioner at risk even where the actual procedures and their provision do not. 

Additionally, it is imperative that practitioners adhere to the state and territory specific drugs and poisons legislations and regulations and understand and comply with the requirement of the Therapeutic Goods Administration.

Another key issue highlighted in the Factsheet relates to the requirement for the dentist to ‘perform only those dental procedures for which they have been educated and trained and are competent’.  It is important to remember that unlike some regulators elsewhere in the world, the Dental Board of Australia does not recognise, approve or accredit any specific courses providing training in the use of these procedures – and nor, it seems, does it intend to in the future. This has the effect of placing the burden of responsibility and accountability squarely on the shoulders of the practitioner who chooses to get involved in carrying out these procedures. 

The Dental Board have clarified that botulinum toxin and dermal fillers can be used for both approved and ‘off-label’ treatments in accordance with the principals of good practice.

Additionally, the Dental Board advises that;

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 dentists, but still within the definition of dentistry.
  • medical practitioner – when the proposed use of botulinum toxin or dermal fillers is outside the definition of dentistry.

It would be irresponsible of DPL to give members any advice or encouragement that had the potential to place them at greater risk of legal or regulatory challenge. However, to assist members, DPL has been in discussions with MDANI (the insurer), seeking appropriate advice and has prepared detailed frequently asked questions to inform and guide members and also to provide the associated risk management advice that DPL members have come to expect of us. 

Indemnity insurance implications

In the face of the latest statement issued by the Dental Board of Australia, the question arises of whether or not an insured practitioner could now expect to be covered for the use of Botulinum toxin or dermal fillers by any dental indemnity policy whose scope is limited to the practice of dentistry. 

In the case of the Dental Indemnity Policy provided for DPL members by MDA National Insurance Pty Ltd, the policy would respond to any claim which relates to the provision of dental treatment by an insured practitioner .. It would also be possible for the policy to respond in the event of any AHPRA investigation resulting from a practitioner’s involvement in these procedures. All this is available to members at standard subscription/premium rates, if their category is appropriate to the nature and extent of their involvement in dentistry.

DPL will continue to monitor this situation and make appropriate representations where necessary, and will update members and this webpage accordingly. If you would like to receive automatic notifications in the future of any significant change via email, please contact us.

Frequently asked questions

2 comments
  • By Alice on 14 June 2017 02:25 Thanks for your post, Jade. I've checked with a professional colleague and he advises that dermal fillers contain substances that are listed in Schedule 4 of the current Poisons Standard. Although there is slight variation in legislation between different states, the Standard allows for administration of S4 (restricted) substances ONLY by an endorsed person. Regardless of any level of training, a dental assistant is not listed as an endorsed person. Any registered practitioner (such as a dentist) who supplies S4 substances to a person who is not endorsed to administer it is also liable to sanctions. I hope this is helpful. With best wishes, The Web Team.
  • By Jade on 13 June 2017 07:15 Can dental assistants administer dermal fillers if they have been on appropriate training courses in the uk
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