The NSW Health Minister Brad Hazzard has issued an update to the Poisons and Therapeutic Goods Amendment (Cosmetic User) Regulation 2021 which has been published and commences 1st September 2021.
The new laws apply to administering cosmetic medicines. Amendments to the Poisons and Therapeutic Goods Regulation 2008 will come into effect from 1 September 2021 to improve the safety of the use of cosmetic medicine in NSW. The regulation will set additional requirements relating to the administration, storage, and record-keeping of medicines commonly used for cosmetic purposes, such as anti-wrinkle injections and dermal fillers. The new regulations will require that not just the nurse but also the business retain comprehensive records of the patient. If you are operating a salon or clinic that does not include a doctor to supervise these procedures it is important that you adhere to regulatory requirements for which you will also be liable under vicarious liability for referring clients/patients to the nurse or doctor. If you are not aware of your obligations
APAN can help. We have developed a fantastic Standards and Regulations Kit for business owners you can find out more information here: www.apanetwork.com/resources/resource-documents
New Requirements Under The new regulation will:
Prohibit a person other than an authorised practitioner, or a nurse acting under the direction of a medical practitioner or nurse practitioner, from administering cosmetic medicines (An authorised practitioner includes a medical practitioner, nurse practitioner, or dentist)
· Require a medical practitioner or nurse practitioner to personally review the patient (including via audio-visual link) before issuing a direction to administer cosmetic medicines
· A written direction has effect for the period specified in the direction, not exceeding 6 months from the date the medical practitioner or nurse practitioner personally reviewed the patient
· If the cosmetic medicine is administered by a nurse, require records of the direction to be made and kept by the medical practitioner or other authorised practitioner
· If the cosmetic medicine is administered by a nurse, require records of the administration to be made and kept by the nurse administering on the direction of a medical practitioner or nurse practitioner · Set storage requirements on the occupier of the premises where cosmetic medicines are stored
· Require businesses that provide services using cosmetic medicines to keep records made by the medical practitioner or other authorised practitioner, and by the nurse administering on the direction of a medical practitioner or nurse practitioner
· Require businesses that provide services using cosmetic medicines to have appropriate risk management policies and procedures in place to protect the health and safety of patients; appropriate equipment for use in a patient medical emergency; and to ensure that nurses are adequately trained for patient medical emergencies
· Require businesses that provide services using cosmetic medicines to ensure that the regulations are complied with.
Penalities for breaching the regulation:
A breach of the regulation is an offense with a maximum penalty of between $5,500 to $22,000 and/or imprisonment for 6 months for an individual, and between $27,500 and $110,000 for a body corporate. These restrictions do not apply where the administration is undertaken by an authorised practitioner themselves or by an employee in a hospital acting on an authorised practitioner’s direction.
What is classified as Cosmetic Medicine?
· botulinum toxins
· calcium hydroxylapatite
· deoxycholic acid
· hyaluronic acid and its polymers
· polylactic acid.
What will these changes involve?
Currently, cosmetic nurses are concerned that some of these restrictions may be excessive. One such concern is that the amendment will reclassify the currently S4 drugs used in cosmetic medicine, including hyaluronic acid and botulin toxin, to become S4(b). This will potentially restrict the ability of nurses to inject without a doctor on site. Remote or Skype consultations will no longer be allowed under the proposed changes. As a result, there is a Change.org petition circulating that aims to oppose the amendment, supporting that Cosmetic Nurses that operate safely, diligently and within regulatory practices should not be restricted. We understand that the petition has been supported with over 7,000 signatures in just one week since it was launched.
While APAN supports regulations, we also recognise that over-regulating can be detrimental to a business. Many nurses operate within non-medical clinics and salons that do not have a resident doctor. We believe with the appropriate protocols medical supervision can be achieved without a doctor having to be physically present.
Sign the petition here
If you’re a nurse, we recommend that you consider signing this petition. APAN will also appeal to the NSW Government regarding this proposed amendment, and we will keep you posted on developments.