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Working Within Your Scope of Practice – the Controversy Around the Hyaluron Pen

September 19, 2019

We recently had a phone call from the NSW Health Department notifying us of their concern with several non-medical practitioners who are undertaking treatments with a new device call Hyaluron Pen.  While hyaluronic acid is a common ingredient used in skincare when used with the Hyaluron Pen in its injectable form it is classified as an S4 drug and therefore can only be used by a medical practitioner or a registered nurse who is working under the direction of a doctor.

If you are tempted to introduce this device in your business and you are a non-medical practitioner please be advised that it is illegal for you to deliver this treatment.  If you would like further information please feel free to contact APAN on 07 55930 360.  Below we have included some information from the WA Department of Health.  These restrictions apply to ALL STATES in
Australia.

A “Hyaluron Pen” is a device which is used to administer hyaluronic acid (HA) into the skin using pressure rather than a needle. The devices have become very popular in the United Kingdom, with one to two-day training courses on their use offered from £580 to £1,600 (AUD $1,035 to $2,860). The Environmental Health Directorate is aware that interest in this product is beginning to increase in Australia.

What is hyaluronic acid and why is it used in beauty therapies?

Hyaluronic acid is a natural substance found in the skin that retains water and helps keep it hydrated and plump. Injectable HA is a type of dermal filler, used to add volume to the dermal layer of the skin to minimise the appearance of fine lines and wrinkles. However, even when injected the effect is temporary and usually only lasts for up to six weeks.

Use of HA in Hyaluronic Pens

Hyaluronic acid is found in many topical serums and moisturisers, however, when it is prepared for injection it becomes a Schedule 4 (prescription only) product, therefore the use of a Hyaluron Pen must be prescribed by a medical practitioner and administered by a medical practitioner or registered nurse.

The Hyaluron Pen itself is considered a therapeutic device and would, therefore, require registration with the Therapeutic Goods Administration (external site). Similar pens are available to diabetics for insulin injection however they are also only available on prescription.

Given the medical restrictions on both injectable hyaluronic acid and the needleless injecting device, these procedures may only be offered by registered medical professionals.  

Health Departments across Australia are requesting that if one becomes aware of a non-medical practitioner offering this service to please contact their local Department of Health immediately.

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