We have had numerous requests from shop customers for the purchase of topical anaesthetics and to assist our customers we shall clarify some of the issues pertaining to supply;

Some of the common ingredients that may be found in topical anaesthetics include Lignocaine (Lidocaine), Amethocaine (Tetracaine), Benzocaine, Prilocaine and the vasoconstrictor Adrenaline (Epinephrine). The supply of those substances are regulated under the Therapeutic Goods Act 1989 and section 52D(2)(b) of the act refers to the Poisons Standard, at the time of writing the current standard is the Poisons Standard 2010

The common ingredients within topical anaesthetics, as listed above, that have concentrations of 2 - 10% are classified under Schedule 2 of the Poisons Standard 2010, and under Schedule 3 in mixtures containing epinephrine with concentrations of 0.02 - 1%. Products that have less than these concentrations are unlikely to have any significant benefit during cosmetic tattooing procedures and above those concentrations they would be classified under Schedule 4.

What do the schedules mean?

Schedule 2 (S2). Pharmacy Medicine – Substances, the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person.

In most situations Schedule 2 means only available from a pharmacy except for in remote locations where there is no pharmacy a suitable person might be granted a special license for the supply of some S2 products where there is a legitimate need.

Schedule 3 (S3). Pharmacist Only Medicine – Substances, the safe use of which requires professional advice but which should be available to the public from a pharmacist without a prescription.

In most situations Schedule 3 means only available from a pharmacist (but without the need for a doctors prescription).

Schedule 4 (S4). Prescription Only Medicine, or Prescription Animal Remedy – Substances, the use or supply of which should be by or on the order of persons permitted by State or Territory legislation to prescribe and should be available from a pharmacist on prescription.

In most situations Schedule 4 means only available via a doctors prescription and dispensed by a pharmacist, or other persons authorised by the relevant State or Territory laws.

Quite simply this means that products that are likely to have any beneficial use in cosmetic tattooing are at least going to be classified under Schedule 2 or 3 of the Poisons Standard and therefore need to be supplied by a pharmacy/pharmacist.

Is Emla a suitable topical anaesthetic to use prior to cosmetic tattooing?

Emla is not a suitable topical anaesthetic to use prior to Cosmetic Tattooing because its PH is quite alkaline and particularly using it near the eye could cause permanent damage to the sight of the client. It is best practice to always ensure that topical anaesthetics are PH safe. It is also conceivable that pigment colour changes could occur due to chemical interaction with an alkaline cream.

What about products that contain the ingredients Prilocaine and Benzocaine?

A review published by the International Anesthesia Research Society in 2009 found that of 242 reported cases of anaesthetic related Methemoglobinemia found within the medical literature since the year 2000, 105 were related to Benzocaine used alone, 44 were related to Prilocaine used alone and only 10 were related to Lidocaine used alone, just 1 was related to Tetracaine. The conclusion of the review was that Benzocaine should no longer be used.

It is reasonable to conclude from the review that there is significantly less risk of a client/patient developing Methemoglobinemia with preparations containing Lidocaine and or Tetracaine than with preparations containing Prilocaine and or Benzocaine.

What about the using occlusive wraps, external heating, and ultrasonic stimulators to increase absorption?

These methods should not be used as they can increase the amount of anaesthetic entering the blood stream and could lead to heart block, seizures or even cardiac arrest, as has been the case with a number of recorded cases within the medical literature. The Food and Drug Administration of the United States Department of Health And Human Services had such concern over the improper use of topical anaesthetics, such as the use of occlusive wraps and external heating, that in 2009 they issued an open letter to health professionals urging caution.

General Precautions When Using Topical Anaesthetics

We suggest that all Cosmetic Tattooists read the exceptional publication "Topical Anaesthetics & Cosmetic Procedures" available on CosmeticTattoo.org it is the most comprehensive industry publication in relation to the use of anaesthetics that we encountered and is recommended reading.

Products within Australia

We have been in close consultation with a PhD pharmacist who has developed a range of products that are (S2 / S3), and suitably qualified Australian Cosmetic Tattooists who are active CT-Shop customers can ask us for the pharmacists contact details to obtain further information and advice.

If you are already an approved 'Active CT-Shop Customer' Click Here for the contact details of the pharmacist.

In general terms when using topical anaesthetics during a Cosmetic Tattooing procedure it is important to ensure that;

• You obtain the products from a legal source.
• The products are clearly labelled with the active ingredients and concentrations.
• You use a suitable anaesthetic for the specific procedure.
• The products are PH safe, especially if used anywhere near the eye!
• You are following the manufacturers/suppliers instructions.
• The client does not have any medical condition that may preclude the use.
• You check that the client does not have any allergy or sensitivity to any ingredients.
• You are aware of any possible side effects.
• You are complying with your local laws & regulations.
• You are using the products safely.

Each state and territory also have their own acts which should also be considered.

Queensland
Health (Drugs and Poisons) Regulation 1996

New South Wales
Poisons and Therapeutic Goods Regulation 2008

Victoria
Drugs, Poisons and Controlled Substances Act 1981

Tasmania
Poisons Act 1971

Australian Capital Territory
Medicines, Poisons and Therapeutic Goods Act 2008

South Australia
Controlled Substances (Poisons) Regulations 1996

Western Australia
Poisons Act 1964

Northern Territory
Poisons & Dangerous Drugs Act

References
1. Eaglstein, NF. Chemical injury to the eye from EMLA cream during erbium laser resurfacing. Dermatol Surg. 1999 Jul;25(7):590-1.
2. Guay, Joanne. Methemoglobinemia related to local anesthetics a summary of 242 episodes. Anesthesia and analgesia 838 Vol. 108, No. 3, March 2009: 1526-7598.
3. Ohzeki K, Kitahara M, Suzuki N, Taguchi K, Yamazaki Y, Akiyama S, Takahashi K, Kanzaki Y. Local anesthetic cream prepared from lidocaine-tetracaine eutectic mixture. Yakugaku Zasshi. 2008 Apr;128(4):611-6.
4. Carruthers, J. Alastair; Carruthers, Jean D.A.; Poirier, Judith; Oliff, Heather S.; Mordaunt, Julie; Schreiber, William E. Safety of Lidocaine 15 % and Prilocaine 5 % Topical Ointment Used as Local Anaesthesia for Intense Pulsed Light Treatment. Dermatologic Surgery 36 (7): 1130-1137, 2010.
5. Lambertz CK, Johnson CJ, Montgomery PG, Maxwell JR. Premedication to reduce discomfort during screening mammography. Radiology. 2008 Sep;248(3):765-72. Epub 2008 Jul 22.
6. Toigo, Theresa. USA Food and Drug Administration Topical Anaesthetics Stakeholder Letter January 16, 2009.
7. Australian Therapeutic Goods Act 1989 & Poisons Standard 2010

NB: This is not an advertisement for any product nor any form of therapeutic treatment it is merely a discussion of some of the issues that prevent us from supplying topical anaesthetics.
Last Updated: 18/03/2011