Explanation comment on the new laws covering the administration, storage and record keeping of cosmetic medicines that came into effect in NSW from September 1.
NSW Health has 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 amendments to the Poisons and Therapeutic Goods Regulation 2008 came into effect from September 1 and are intended “to improve the safety of the use of cosmetic medicines in NSW”.
The category “cosmetic medicines” is listed to include: botulinum toxins; calcium hydroxylapatite; collagen; deoxycholic acid; hyaluronic acid and its polymers; polyacrylamide; polycaprolactone; and polylactic acid. The new regulation:
- prohibits 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);
- requires a medical practitioner or nurse practitioner to personally interview (including via audio-visual link) before authorising administration of the cosmetic medicines;
- if the cosmetic medicine is administered by a nurse, requires 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, requires records of the administration to be made and kept by the nurse administering on the direction of a medical practitioner or nurse practitioner;
- sets storage requirements on the occupier of the premises where cosmetic medicines are stored;
- requires 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;
- requires 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;
- requires business that provide services using cosmetic medicines to ensure that the regulations are complied with.
A breach of the regulation will attract:
- a maximum penalty between $5,500-$22,000 and/or imprisonment for 6 months for an individual; and
- a maximum penalty between $27,500-$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”.
The changes follow NSW Minister for Health Brad Hazzard requesting NSW Health “undertake a review to determine whether the regulation of cosmetic procedures was appropriate to ensure the safety of consumers”, and its subsequent delivery of the Report on the Review of the Regulation of Cosmetic Procedures.
As a result, in July this year NSW enacted the Poisons and Therapeutic Goods Amendment (Cosmetic Use) Regulation 2021 – under the Poisons and Therapeutic Goods Act 1966
– to commence operation from 1 September 2021.
Dr Gabrielle Caswell
President of the Australasian College of Aesthetic Medicine
ACAM welcomes the changes in NSW prescribing rules as they are ‘patient centric’, attempting to ensure that patients are acquainted with their treating doctor in the situation whereby their treatments are performed by a supervised delegated injector.
Like all professions, cosmetic medicine is becoming more professionalised – and with that movement there will be revisions of ‘how’ and ‘where’ services are provided; hence, like all medical centres, the basics, such as correct monitoring and storage of medications, the implementation of drug records and the proper keeping of medical records, should be adhered to.
The need for resuscitation training and equipment ensures that, though rare, if complications occur or the situation arises that a patient gets into difficul , the training and equipment is ‘on hand’ – hopefully providing the best possible outcome in those circumstances.
ACAM recognises that delegated injectors are part of our delivery of cosmetic medicines; however for the ‘best care’ outcomes, patients should be regularly reviewed by their treating doctor.
And it is paramount that all medications which are injected are properly stored and recorded, in the event those records are required at some future point in time.
ACAM per se does not feel that ‘telemedicine’ is suitable for cosmetic medicine; however the Medical Board of Australia guidelines do not specifically exclude cosmetic medicine.
Dr John Flynn
Past President of the Australasian College of Cosmetic Surgery
I always welcome sensible regulation to protect patient safety and to raise standards. This new amendment draws a tighter nexus between the prescribing practitioner and the person delivering the treatment.
It imposes a requirement that any injection location is to be properly equipped and staffed – as you would expect for a medical procedure, even though that procedure might be cosmetic in nature. This is only what medical professionals and the public should expect.
We always expect that things will work out well – and that optimism is understandable and, indeed, justifiable since the vast majority of cosmetic injections are safe.
But it is essential that we are prepared for the unusual, however uncommon that may be. Patients do get allergic reactions, they do have anxiety, panic attacks, anaphylaxis. This may translate into cardiac events.
I know it sounds dramatic to talk about these things in the context of cosmetic injections. But guess what? They can and do happen.
If and when it does, patients deserve to be confident that it can be managed.
Dr Lisa Friederich
Sydney Plastic and Cosmetic Surgeon
As a plastic surgeon and cosmetic injector, I welcome the tightening of regulations within the industry. Significant complications can occur with the use of these medicines and this is sometimes not fully appreciated by injectors.
Complications do occur – and the person it impacts most is our patient. Education and safety must be foremost in our use of these products, and they should override the commercial interests that dominate the industry.
Let us hope these amendments encourage all clinics and practitioners to optimise their standard of care.
Dr Michael Molton
President of the Cosmetic Physicians College of Australasia
The CPCA applauds NSW Health for strengthening its regulations to improve safety in the use of cosmetic medicines in the state.
The College is particularly pleased to see the amendments now define who is an ‘authorised practitioner’ concerning these prescription-only medications when used for cosmetic health purposes.
The legislative changes in NSW now define an ‘authorised practitioner’ as one who is permitted to procure, transport, store and administer prescription-only medications for the purpose of cosmetic procedures.
The importance of this definition essentially protects those members of the Australian public who seek cosmetic health services; furthermore, this legislation has effectively stemmed the eventuality of the same circumstances that continue to be allowed to occur without regulatory control in the UK happening here in Australia – rightly placing emphasis on increased patient safety for patients in NSW today and in the future.
NSW Health Minister Brad Hazzard is recorded in Hansard as acknowledging the importance of consultation with medical practitioners on the proposed amendments. As the leading stakeholder in cosmetic medical procedures in Australia, the CPCA fully supported the amendments through correspondence and face- to-face meetings with NSW Health following the NSW HCCC Joint Ministerial Inquiry into Cosmetic Procedures in August 2018.
The amendments not only protect against the misuse of prescription-only medications administered in cosmetic health services but also provide protection in the use of these same medications in therapeutic applications such as cerebral palsy and spasticity.
Dr Naveen Somia
Past President of the Australasian Society of Aesthetic Plastic Surgeons
ASAPS thanks the NSW Health Minister and the NSW Department of Health for this initiative and supports the legislative changes introduced to strengthen the use of prescription-only medications for cosmetic procedures in NSW.
These changes will protect patients by explicitly defining who is an ‘authorised practitioner’, along with legislation that governs supply, storage and standard of the premises for injecting that include infection control standards.
In addition, these new changes legislate the need for premises and practitioners to have expertise to manage complications and emergencies should they arise. All authorised practitioners should be aware of this – and remain committed to ongoing learning in complication management, so they can deliver a very high standard of care. AMP
