Regulator cautions against one business model being considered by cosmetic injectable nurses
The cosmetics injectables industry is facing a seismic shift, with businesses facing a shake-up. The Australian put some of the industry’s most pressing questions to the regulator.
Cosmetic injectables are big business in Australia with patients willing to hand over large sums of money, out of pocket, to achieve their desired looks.
However, the medications used to achieve a fuller or less wrinkled appearance are restricted prescription drugs known as schedule 4, or S4, medications. In Queensland, the regulator has spent the past several months explaining the rules governing all S4 medications, especially as they apply to the cosmetics industry.
However, its explanations have spawned confusion and panic because what it has described as being law for several years now is not how actually how the industry has ever operated, meaning hundreds of nurses are now operating outside Queensland’s interpretation of the legislation.
Most clinics offering cosmetic injectables are owned or operated by registered nurses who do not have the qualifications needed to prescribe. Instead, they use telehealth companies that often both prescribe a patient the drugs and supply the clinic with S4 medications.
For convenience, the clinics hold the drugs on consignment under the name of a doctor so a patient can simply walk in, have a quick telehealth consultation, and be assigned one of the medications already on site and then injected, all in one appointment.
However, Queensland Health says the only clinics where that can legally happen in that state are those where there is a doctor or nurse practitioner on site.
All other clinics need to work with a nearby pharmacist so the medication can be dispensed only after a patient has been prescribed the medication. Depending on how a clinic operates, and how far away the pharmacy is, it means there could be a gap between when a patient is prescribed and injected.
Since updating an information sheet in April, thousands of nurses have been wading through information to understand if they are compliant. Information sessions have also been held by some of the major players in the industry that have a lot of money tied to what happens next. One of the main questions being pondered is around what constitutes a doctor being “on site”.
It’s a question being considered by operators in other states too, with attention turning to whether other regulators will agree with Queensland’s interpretation. Schedule 4 medications are legislated under national law, which is interpreted and enforced by each state and territory.
Given the amount of money at stake, The Australian has put to Queensland Health a series of common questions being asked by nurses and business owners.
The updated advice, published in April, states registered nurses are not authorised to buy S4 cosmetic injectable medicines. It is common for nurses to purchase S4s using the name of their prescribing doctor or telehealth clinic doctor. the nurse then pays for the medications. Is this legal?
Under Queensland’s medicines and poisons laws, registered nurses cannot buy medicines, including S4 cosmetic injectables.
The process described is not considered lawful under Queensland laws as this would amount to the RN buying the medicines.
As stated in the revised fact sheet, with respect to a doctor’s or nurse practitioner’s access to a supplier’s electronic ordering system, no other person can use the doctor’s or NP’s unique username or account number to buy medicines on the secure ordering system.
This includes, for example, an RN who is not authorised under Queensland laws to buy S4 cosmetic injectable medicines, and also cannot do so on behalf of a doctor or NP.
If that is not legal, are clinics currently being audited and, if so, how many breaches are you aware of?
Queensland Health undertakes both proactive and reactive monitoring and regulation of persons and places using medicines, including inspections and audits. Queensland Health is not able to provide breach numbers specifically for cosmetic clinics.
The document states that only a medical practitioner or nurse practitioner can buy S4 cosmetic injectable medicines to hold as stock for use at a clinic where they will exercise exclusive custody and control over the stock of S4 medicines (or joint custody and control only with another doctor or NP). Is there a minimum number of days or times a doctor or NP must physically practise from a clinic under this rule?
In Queensland, stock of S4 cosmetic injectable medicines cannot be purchased and held at clinics where the doctor or NP does not have exclusive custody and a significant level of control of the medicines.
The number of days or times a doctor or NP spends attending a clinic is not determinative. RNs cannot have custody and control of S4 medicines unless it is for a purpose set out in the legislation. Importantly, RNs cannot hold stock of S4 cosmetic injectable medicines.
If an S4 cosmetic injectable medicine has not been sold or dispensed to a particular person, a doctor or NP must have exclusive custody and control over the S4 medicines stored at a clinic. It is not sufficient for a doctor or NP to have some custody and control over S4 medicines if RNs also have custody and control of the S4 medicines.
My understanding is some telehealth companies are considering a model where they recruit doctors or NPs who will work across several clinics and drop in from time to time. Would that be legal?
Queensland’s medicines and poisons laws do not prohibit doctors and NPs providing telehealth services such as prescribing across multiple clinics.
However, in Queensland, stock of medicines cannot be purchased and held at clinics where the doctor or NP does not have exclusive control of the medicines (other than co-jointly with another doctor or NP).
If it is proposed that the doctor or NP will only visit the clinic sporadically, this is unlikely to satisfy the Queensland laws as they will not be exercising exclusive possession of the medicines.
The document states doctors and NPs are not approved persons to supply a stock of cosmetic injectables for use at cosmetic injectables clinics where they will not have exclusive custody and control over the stock, including where cosmetic injectables are supplied “on consignment”. Can you please explain if that means the person prescribing the medication must be the one to take its custody?
This means that doctors and NPs cannot purchase stock of S4 cosmetic injectables for another person or clinic – and where they also do not have exclusive custody and control of the medicines.
However, this does not mean that the prescriber (doctor or NP) must be the one to take custody of the stock of medicines, as multiple prescribers (doctors and NPs) may practice together and have joint custody and control of the stock.
RNs are only permitted to possess S4 cosmetic injectable medicines for a purpose mentioned in the table in Schedule 7 (Part 3, s11) of the MPMR, including administering a medicine on a prescription, or in accordance with its approved label. Does this mean non-prescribers can only hold stock once it has been prescribed to a patient?
This may be dependent on what is meant by “non-prescribers” – for example, this could refer to persons who are authorised to prescribe but did not prescribe the particular medicines in question.
It is important to note that as per Schedule 1 of the Medicines and Poisons Act 2019 (Qld) (MPA), “stock” has a specific meaning, namely:
•a regulated substance that is intended for supplying a place or a person who is authorised to carry out a regulated activity with the substance, or;
•a regulated substance that is not sold or dispensed to a particular person.
This means that a reference to “stock” of medicine does not include a medicine that has been dispensed for an individual person.
RNs are not approved persons authorised to be in possession of a stock of S4 cosmetic injectables and are only permitted to possess S4 cosmetic injectable medicines for administering a medicine on a prescription, or in accordance with its approved label.
When will authorities begin audits to ensure compliance, and what can individuals and businesses in breach of these conditions expect?
As these are existing requirements, industry participants must take immediate steps to ensure any noncompliances with relevant Queensland laws are addressed.
Queensland Health is working with the industry to ensure compliance with Queensland laws; however, any entities that pursue unlawful activities under the MPA may be prosecuted and are liable to the penalties stated in the Act. Unlawful buying, possession, prescribing or administration of S4 medicines currently carries a maximum penalty of $32,260. Unlawful supply currently carries a maximum penalty of $80,650.
Any regulatory action that may be taken by Queensland Health will be commensurate with the nature and type of any identified unlawful activities.
This information is significantly different to the way nurse-led clinics currently operate in several states. Do you think other states will follow Queensland’s reading of the legislation?
Each state and territory has its own laws that govern how medicines must be handled in that state or territory.
Queensland’s MPA and MPMR detail the authorities and limitations relevant to regulated substances placed on different health professionals in Queensland.
Queensland Health is unable to comment on actions that may be taken by other jurisdictions.
The Australian has been informed that several nurses have been advised by some telehealth companies they should diversify into GLP1 medications, hair loss, lash serum, and “women’s health” as a result of the updated Queensland advice. Do you have any regulatory advice for anyone considering such a move?
Any activities or dealings with medicines that fall within the scope of Queensland’s medicines and poisons laws must be undertaken in compliance with the authorities allowed under these laws.
These laws in Queensland are not limited to S4 cosmetic injectables medicines, and also apply to, for example, other S4 medicines such as GLP1 medications.
Is there anything you would like to add?
There have been no changes to the legislation as it applies to the industry, or its interpretation, since September 2021 when the MPA and MPMR both commenced.
Queensland Health’s focus on minimising risk of harm to the public is reflective of the purposes stated in the MPA. It is the responsibility of all practitioners to ensure their business models comply with relevant laws.
Following an initial fact sheet published in December 2024, Queensland Health published a revised fact sheet and frequently asked questions document that outlines requirements relevant to cosmetic injectables, and examples of business models that are compliant with obligations under the MPA and MPMR.
While some businesses are already compliant, any business models that do not reflect these requirements may need to be reconsidered to ensure they comply with these Queensland laws.
Know more about this story or have a tip off? Contact the reporter: pennytimms@protonmail.com
To join the conversation, please log in. Don't have an account? Register
Join the conversation, you are commenting as Logout