We have received several phone calls from disturbed members who have heard of major changes to the use of topical anaesthetics regulations.  Several Councils in different States have also conducted inspections to determine practices when topical anaesthetics are used.

In terms of regulatory changes, we submitted a comprehensive CASE FOR CHANGE when the Drugs and Poisons Bill was up for review, however, this matter is still in the process of being reviewed.  However, regardless of the State here are the guidelines you should be following when it comes to compounded anaesthetic formulas:

Compounding pharmacies are allowed to prepare topical anaesthetics under very strict guidelines regulated by theTherapeutic Goods Administration (TGA) as well as each states health authority.

These conditions specify compounding only when commercially available topical anaesthetics are unsuitable and is:

  • For a particular person in response to a request

An order for each client needs to be received prior to commencing the compounding process. The ordered product can only be used for the intended patient, NOT for another person, or for multiple patients. This is where some are getting into trouble.

The product needs to be labelled by the compounding pharmacy for the patient in accordance with each states poisons standard or regulations. Essentially this means clearly displaying the patients’ name, product name, ingredients, directions for use and the compounding pharmacies contact details.

  • For therapeutic application to that person

This implies therapeutic suitability in terms of volume, potency, dose, frequency, and patient safety. Supply of 100gram for 1 or 2 procedures requiring 10gram each would be regarded as excessive. As would a high potency formulation used for a minor or low pain procedure. Regular use of a formulation by a particular patient, considered too frequent or too soon in terms of the professional standards for a procedure, could also be questioned in terms of appropriate therapeutic application. Supply for staff not intending to undergo a procedure is also inappropriate.

Australian compounders are able to develop formulations that can meet the individual needs of patients and cosmetic procedures.

Many medicines are unavailable in suitable forms for particular patients.  In fact, the small size of the Australian market precludes registration of products required for small, but significant, patient populations.  In addition, many products are unavailable or discontinued for economic rather than safety reasons.

As a result of the limited range and unsuitability of the Australian commercially available topical anaesthetics for a number of cosmetic and tattoo procedures,  patients have been seeking overseas formulations. A number of topical anaesthetic brands manufactured overseas for the tattoo industry have been obtained by some local distributors and on-sold to clinics unaware that these products are unlicensed by the TGA and hence illegal for sale in Australia. In the case of an adverse reaction, the use of an unlicensed product may have implications for your professional and other insurances.

Not on a wholesale basis. Pharmacies are not permitted to sell topical anaesthetics to clinics or surgeries for resale to patients. Selling for resale is defined as wholesaling.

Not on a manufacturing basis There is no exemption for the making of batches or bulk supply in advance for surgery and clinic use, or in anticipation of future sales. Supply to another party for re-labelling, or on a wholesale basis for resale, is also considered manufacturing and is not exempt from the TGA licencing regulations.

The common ingredients found in topical anaesthetic include Lidocaine (Lignocaine), Tetracaine (Amethocaine), Prilocaine, Benzocaine and the vasoconstrictor Epinephrine (Adrenaline). These topical anaesthetics on their own, or in combination in concentrations of 2-10%, are classified as a Schedule 2 (S2) medicine. Formulations containing Epinephrine in concentrations of 0.02-1%  are classified as Schedule 3 (S3). Combinations of topical anaesthetics or topical anaesthetics on their own in concentrations greater than 10% are clarified as Schedule 4 (S4).

Schedule 2: 

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. i.e. only available from a pharmacy, or for remote locations from a suitable person who has been granted a special license by the appropriate state regulator.

Topical anaesthetics in this schedule require contact with a pharmacist prior to supply. A pharmacist is required to verify therapeutic need as well as provide advice on dose, toxicity, adverse effects, contradictions, and precautions.

Schedule 3:

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.i.e. only available from a pharmacist, but without the need for a doctors prescription.

Products in strengths above these concentrations are classified as a Schedule 4 (S4).

Schedule 4:

Prescription Only Medicine- 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.

i.e. only available with a doctors prescription and dispensed by a pharmacist.

Patient Evaluation Form

The ‘Patient Evaluation Form’ was designed to broadly cover circumstances relevant to the safe use of the topical anaesthetic for a patient as well as some factors that could impact upon the clinical procedure. It can be edited or incorporated into your own consent documentation information or substituted (if suitable). The form was not intended to inconvenience your business and we are happy to discuss how we can assist with information collection to best suit your practice.

If you require a copy please email us info@apanetwork.com.  However, we highly recommend that you also complete the online course on the Safe Use Of Topical AnaestheticsThis will allow you to gain a wealth of knowledge and work safer and more efficiently with the use of numbing creams.

IN SUMMARY

  1. You are not permitted to purchase a compounded anaesthetic formulation and on-sell it to your client or patient.  You are also not permitted to put a markup on anything that is a scheduled compounded medication this includes topical anaesthetics. Therefore, either your client needs to purchase the anaesthetic directly from the compounding pharmacy, or you can order it for them (with their consent) and the pharmacy should contact them directly for payment and medical evaluation.
  2. A compounded anaesthetic formula must have the client’s or patient’s name on the container and must not be used for any other purpose other than for that individual’s treatment. The client is required to apply the anaesthetic with your instructions and you may assist them upon the client’s request and consent in writing.
  3. The client is required to apply the anaesthetic with your instructions and you may assist them upon the client’s request and consent in writing.