CATEGORY 58 AUSTRALASIAN DENTIST Off-label botulinum toxin prescribing: what dentists should revisit after Ahpra’s new guidance CLINICAL Dr Giulia D’Anna By Dr Giulia D'Anna BDSc, MRACDS, FIADFE A dentist can be confident in facial anatomy and injection technique yet still need to answer a separate question before treating: is this use approved for the particular botulinum toxin product I have chosen? In September 2026, Ahpra published guidance on prescribing off-label, unapproved or compounded medicines. The guidance is a timely reminder of existing professional responsibilities. Off-label prescribing is not automatically prohibited, but it calls for careful patient assessment, a sound clinical reason, consideration of the evidence and alternatives, informed consent, and documentation of the decision. For dentists, the practical message is straightforward: a familiar procedure is not necessarily an on-label procedure. Neither patient demand nor the fact that a treatment is routinely offered elsewhere establishes that it is appropriate for the person in your chair. What does off-label mean? An off-label use involves a medicine included on the Australian Register of Therapeutic Goods (ARTG) being prescribed or administered differently from its TGA-approved Product Information. That difference may involve the indication, dose, route of administration or patient population. Off-label use should be distinguished from use of an unapproved medicine, which is not included on the ARTG, and from a compounded medicine, which has been prepared for an individual patient. These categories have different considerations. Off-label use also should not automatically be described to patients as “experimental.” Explain precisely what has and has not been approved, and discuss the strength and limitations of the evidence supporting the proposed use. Gummy-smile treatment: a useful test case Consider an adult who asks for botulinum toxin because they are concerned about how much gingiva shows when they smile. Treatment of a gummy smile is not listed among the approved Australian indications for Botox, Dysport, Xeomin or Nuceiva or the other botulinum toxin formulations available in Australia. Using one of these products for that purpose is therefore an offlabel decision. Approval to treat glabellar lines or another facial concern does not transfer to excessive gingival display. Product What the dentist should check Botox Its current Australian Product Information, including approved indications, preparation and precautions. Gummy-smile treatment is not among its listed indications. Dysport Its own indications and reconstitution instructions. Dysport units are specific to Dysport and are not interchangeable with another brand’s units. Xeomin Its approved indications and product-specific preparation instructions. Experience preparing or using another toxin product does not replace this check. Nuceiva Its approved indication – temporary improvement of moderate to severe glabellar lines in adults – and its current directions. A proposed gummy-smile use requires separate justification. This table does not imply that all four products are equally suitable for gummy-smile treatment, or that an offlabel indication establishes a dentist’s authority to provide it. Check the current Product Information for the exact product and presentation, relevant medicines legislation, and your individual scope and competence before making that decision. The Dental Board expects practitioners to perform only dental treatment for which they have been educated, trained and are competent. Your training needs to be up-to date and robust with scientific principles. Establish what is causing the gingival display “Gummy smile” describes an appearance, not a diagnosis. Increased gingival display may relate to upper-lip movement or length, altered passive eruption, gingival enlargement, tooth position or vertical maxillary excess. Several factors may contribute at once. Reducing lip elevation will not correct every cause. That distinction matters when discussing alternatives. If altered passive eruption is the principal finding, periodontal assessment may be relevant. Tooth-position concerns may warrant orthodontic assessment; skeletal factors may warrant specialist referral. The patient can also choose no treatment. Although published studies suggest botulinum toxin can temporarily reduce excessive gingival display, results vary and the evidence does not establish one approach for every patient or cause. The following table shows the questions a consultation and clinical record should answer. Its examples are prompts for individual reasoning, not text to paste unchanged into every patient’s notes. What to discuss and document What concerns this patient?: Record the patient’s own description and desired change. Examine and document the relevant smile, dental, gingival and lip findings rather than relying on the label “gummy smile.” What is the likely cause? Record the working assessment and any uncertainty. If more than one factor contributes, explain which factor the proposed treatment could address. Why consider botulinum toxin? Explain why a temporary reduction in lip movement might benefit this patient, what evidence supports that possibility, and why the anticipated benefit may justify the risks. What alternatives were considered? Discuss options appropriate to the findings, which may include no treatment, dental or periodontal care, orthodontic assessment or specialist referral. Record why an alternative was accepted or declined. What must the patient understand? Explain that the proposed indication is offlabel; the effect is temporary and variable; and the treatment may alter smile shape or symmetry and affect upper-lip function. Discuss relevant risks, costs, follow-up and the possibility of further treatment. What must the treatment record show? Identify the chosen product, the preparation and treatment details, the individual rationale, the informed-consent discussion, the patient’s decision and the review plan. Document each decision, not just the first one The importance of documentation does not end after an initial consultation. Each treatment visit needs a current clinical
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