Topical anaesthetics are controlled by federal and state & territory government regulation and cosmetic tattooists need be very careful what they use, and how it is supplied, is legal. Health authorities are now conducting audits of premises to check what is being used.
Further information is available from Aesthetics Practitioners Advisory Network (APAN).
Topical anaesthetics are essential to keeping your clients as comfortable and pain-free as possible. This information is to help you understand what is currently safe and legal in Australia.
The main ingredients in topical anaesthetics can include one or more of the following: lidocaine (lignocaine), tetracaine, benzocaine, prilocaine and adrenaline (epinephrine). All these substances are regulated.
Topical anaesthetics with concentrations between 2 and 10% are classified under Schedule 2 of the Poisons Standard 2010 (and amendments). Topical anaesthetics containing epinephrine (adrenaline) in concentrations of 0.02 – 1% (used to stop bleeding and swelling) are classified under Schedule 3. Products with lower concentrations may also be regulated but are unlikely to have any significant anaesthetic effect during cosmetic tattooing procedures.
In addition to the Poisons Standard, topical anaesthetics are controlled under the Therapeutic Goods Act (1989). As topical anaesthetics are considered a ‘high risk’ product they are highly regulated and must be produced by a TGA-approved manufacturer. This can be identified by the ‘AUST R’ number. If your topical anaesthetic does not have an AUST R number or was not made by a compounding pharmacist it is illegal to use within Australia. This really limits your options, with a few weaker topical anaesthetics (less than 5%) being TGA-approved. EMLA is one of these.
What if I want to use a stronger topical anaesthetic?
Your client will need to obtain the anaesthetic from the pharmacist as it is specifically for their personal use. We (THink) have established an arrangement with a compounding chemist to be able to directly supply such anaesthetics to your client for use in your procedures.
Specific caution on EMLA:
A popular choice of over-the-counter topical anaesthetic is EMLA. This cream contains 2.5% lignocaine and 2.5% prilocaine. What you also need to be aware of is EMLA has a relatively high pH (approximately 9), which means it is more alkaline than other topical anaesthetics and may burn particularly sensitive body tissue.
Conducting eyeliner with EMLA is not recommended because of the risk of contact with the eye, which may result in injury resulting in the need for hospitalisation and extensive treatment (Alkaline chemical ocular injury from Emla cream, Brahma & Inkster, Eye (1995)).
Final Words of Caution:
- Check the anaesthetics you are using, including the ingredients and concentrations. Regulations change, and health authorities are now conducting inspections.
- Ensure the anaesthetics you use are obtained legally. There are on-line shops still selling topical anaesthetics that should not.
- All anaesthetics are not made equal, literally. Even with the same ingredients, performance varies according to the quality of the ingredients and skill of the compounding pharmacist.
- If you are unsure if you are using the correct anaesthetic consult with a suitably qualified medical practitioner or your qualified cosmetic tattoo trainer, who should be fully familiar with the current legal requirements, as well as developments in the available anaesthetics.
- Read and follow any instructions provided with the anaesthetic.
- Check with your client for any allergy or sensitivity (consent form).
- Observe carefully for any side effects or other contraindications after topical anaesthetic application and during procedures. Talk to your client and check all is well.
- Keep up to date with changes in regulations and industry information. What was acceptable when you were trained may be different now or change in the future.
Each state and territory also have their own acts which should also be considered.
Health (Drugs and Poisons) Regulation 1996
New South Wales
Poisons and Therapeutic Goods Regulation 2008
Drugs, Poisons and Controlled Substances Act 1981
Poisons Act 1971
Australian Capital Territory
Medicines, Poisons and Therapeutic Goods Act 2008
Controlled Substances (Poisons) Regulations 1996
Poisons Act 1964
Poisons & Dangerous Drugs Act