And so the battle lines are drawn in the fight over who should be administering dermal fillers to the public.
Side 1 - The Medical Professionals, Suppliers and Regulators
Doctors, Nurses (including Independent Nurse Prescribers) and Dentists, alongside the dermal filler product manufacturers (Allergan, Merz Aesthetics etc.) and the self-regulatory Treatments You Can Trust (TYCT) register who all argue that only those with a medical qualification should be administering these cosmetic medical products. There are frequent dermal filler training courses on offer for members of the medical profession.
Side 2 – The Non-Medics
Primarily Beauty Therapists dominate the group, but there are many other non-medically qualified individuals who are currently facilitated through short training courses and insurance products to administer dermal fillers, including, but not exclusively, Paramedics, Dental Hygienists and Therapists, Podiatrists, Operating Department Practitioners (ODPs), Pharmacists and Phlebotomists. Beauty Therapists argue, mostly via organisations such as BABTAC, HABIA and CTIA that this is a cosmetic beauty treatment so they are well placed to offer it.
The Referee - Keogh
The recently published Keogh report into the Review of Cosmetic Interventions in England was the first to scrutinise the industry again since the Expert Group and Healthcare Commission reports in 2005 which recommended at the time that ‘temporary aesthetic fillers are only injected by a doctor or nurse, and that permanent and semi-permanent fillers are only injected by a doctor’.
With regulation still just as poor eight years later, Keogh has sought to address the safety of the filler products themselves, through medical device legislation, as well as to ensure that those who offer them have ‘appropriate skills’ to do so. By making fillers prescription only devices it hopes to achieve both these aims. Yet it also recommends that ‘non-healthcare practitioners who have achieved the required accredited qualification may perform these procedures under the supervision of an appropriate qualified clinical professional’. Keogh argues for the development of an ‘accredited qualification’ for ALL levels of professional groups involved in delivering non-surgical cosmetic interventions (medics and non-medics); the ‘meat’ of which is conveniently left out of the recommendation! This is a far cry from the 2005 report’s recommendation and is tantamount to laying out the red carpet to non-medics who wish to offer this service, despite talk of prescriptions being required.
Why Non- Medics Should Not Be Injecting Dermal Fillers
- They have inadequate training and study time devoted to facial anatomy.
- They are unable to take and understand a detailed patient medical history to determine contra-indicating factors to treatment.
- They have limited knowledge of sterile techniques, clinical waste, infection or cross contamination risks.
- Over filling, asymmetric correction or minor reactions to hyaluronic acid products can be treated with hyaluronidase (Hyalase®).This is a prescription only medicine so is not readily available to non-medics.
- Rarely, hypersensitivity to hyaluronic acid can occur causing an anaphylactic reaction. Treatment required includes respiratory assistance (provision of oxygen) and the administration of adrenaline (epinephrine), these are not readily available to non-medics.
- The use of permanent and semi-permanent fillers pose more problems than temporary (hyaluronic acid based) products. Non-medics using these readily available products will not be aware of the risks or specific injection protocols required for these more complex products and could do permanent harm.
- They are not able to recognise or adequately treat other known complications which can occur from filler treatments, e.g., infections, migration, granulomas, necrosis etc.
- There are several documented cases of blindness and other complications of the eye and ocular region as a direct result of dermal filler injection by medics, this makes the risk of non-medics causing injury much higher.
- Non-medics may have difficulty obtaining fillers through many of the traditional supply routes open to medics (e.g., direct from manufacturers/distributors, or through wholesale pharmacies) so may be tempted to source products online, cheaply, which poses risks that counterfeit or copy-cat products whose provenance is unknown may be used on the UK public.
- In the case of an adverse incident they would be not be aware of the need, nor would they want to draw attention to their activities by reporting it to the MHRA.
Although much maligned by the Keogh report who branded it a failure with limited industry support and public awareness, the TYCT self-regulatory scheme, whatever your opinion is of it, good or bad, it is the only practical regulatory system that is currently available to attempt to safeguard patients who receive fillers and offer best practice parameters for clinicians to aspire to achieve in order to be registered. Better the devil you know perhaps.
The concept of an ‘accredited qualification’ for both medics and non-medics is a little utopian and ill thought through in order to accommodate the many and varying levels of knowledge and understanding of the non-medics wishing to offer this service, with an aim of achieving a standard level of accreditation in non-surgical treatments.
TYCT can’t stop non-medics from practicing filler services but neither will making dermal fillers prescription only medical devices in our opinion. Has it worked with botulinum toxin brands being prescription only medicines? No. Is the door firmly shut on non-medics getting hold of toxins to inject the public? Of course not, so we would all be a little naive to think that simply reclassifying dermal fillers as products which require a prescriber to see a patient and sign a piece of paper will in any way stop the current supply to non-medics – ‘accredited’ ones or otherwise.
It seems that Keogh has bowed down to lobbying and pressure from non-medics. Simply saying that something has been going on for a while now (non-medics offering fillers), doesn’t make it right, or make it something that should be ‘fitted’ into the best practice through a vague nod to an overarching qualification and some level of ‘supervision’.
We believe this lies with the insurers, from the brokers all the way up to the underwriters who work on the financials of risk of non-medics practicing in this arena and give no thought to patient safety or ethics. For every insurance company or brokerage who has been pointed towards doing the right thing over the years, there are seemingly many more who are happy to take the premiums and support the risk of non-medics operating in this marketplace.
If they can get hold of the most potent toxin (botulinum toxin) in the world and inject it, is this not the ‘thin end of the wedge’; what’s to stop them treating headache or migraine with Botox®, (it’s a licensed indication), or getting hold of other prescription medicines (maybe a topical antibiotic to treat acne)? Exactly where is the division between the non-medic and the medic from an insurance perspective in the administration of medicines?
It is our opinion that they should be made to stop this practice and should only insure medical professionals for the provision of dermal fillers and other injectables, perhaps the Prudential Regulation Authority (PRA) formerly part of the FSA (Financial Services Authority) needs to be brought into the debate.
With Keogh now giving the nod to non-medics, the report is simply opening the door yet further for insurers to offer indemnity for any Tom, Dick or Harriet who wants to perform these treatments no matter what their background. It is our belief that much like most people would not drive a car without car insurance, if you take away the ability for non-medics to get indemnity insurance to perform these treatments, no matter what ‘accredited qualification’ they are able to wave in the insurers’ face you will rid the market of many operators and increase patient safety.
For additional opinion on the Keogh report and non-healthcare professionals injecting the public, please see this interview with Advanced Nurse Prescriber and Consulting Room Advisor Marea Brennan Thorns.
Watch video here.