Cosmetic Medical Versus Cosmetic Beauty. Why Non-Medics Should Not be Offering Fillers

Posted on the 23 May 2013 at 11:43

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 BABTACHABIA 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.

The Problem
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’.

The Solution?
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.

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Blog Comment(s) [7]

Good well written article. The problem as I see it, without Government regulation, companies with shareholders baying in a recession will just follow market forces. The dermal filler companies will continue sell to non-medics as it increases their sales, the insurance companies will continue to cover them if their claims do not outstrip their premiums ( and obviously they don't), the non-medics continue in the marketplace as they sell product at a lower price than medics ( who will always require some reward for countless years of training!). This just leaves us back to proper regulation.
There are over 5,000 cosmetic type practices in the UK daily offering dermal fillers. If Keogh et al. prove incapable of regulating this market properly then medics should take it to European Standards (i.e. European CEN Standard for Aesthetic Surgery and Aesthetic Non-surgical Medical Services) who I know would readily welcome putting proper practice in place in the UK by making dermal fillers a prescribable item.

Dr Patrick J. Treacy |

Sadly I don't think making fillers a POM would stop non medics obtaining and injecting them Botox is a POM and non medics are able to obtain and inject that, albeit with a medical professional prescribing for them, there seems to be plenty of people willing to prescribe in this way.
I don't think much is going to change now, there was an excellent bill going through the houses of commons suggesting a statutory regulator "offcos" with the powers to regulate, inspect and penalties including fines and prison for those that didn't comply. However it didn't make it past the third reading.

Diane Jeffery

It so so sad that the article have no clue between non medics and medically trained professions. Podiatrists provide medical and surgical treatment of foot and lower limbs to put them on beauty therapists side is totally unethical. To Lorna please go back and get educated before you write a such rubbish Podiatrists are Surgeon, Doctor etc.

Who are non medical

Your blog regarding Dental Hygienist’s & Dental Therapist’s in March 2013 has several inaccuracies. This latest blog has further inaccuracies. I will address two.

Lorna’s blog - a Dental Therapist is not adequately qualified and able to deal with any medical emergencies or possible adverse reactions such as anaphylactic reaction which could occur. Of course a Dental Therapist is qualified. They routinely administer local anaesthetic and inhalation sedation and are fully trained in medical emergencies such as anaphylactic reaction with annual checks. There is a serious lack of knowledge among the medical profession and suppliers such as consulting rooms about the level of training and procedures carried out by these Dental Practitioners -extractions, fillings crowns etc Non surgical procedures such as Botox and Dermal Fillers are simple procedures compared to their other tasks.
Sally Taber director of the TYCT was initially contacted in 2007 to allow Dental Hygienist’s & Therapist’s to register. Over a six year period she has denied them access to the register which was funded by the government . The TYCT register backs mobile nurses working in non registered premises with out resuscitation equipment yet blocked access to Dental Hygienist’s & Dental Therapist’s who work in registered CQC premises with resuscitation equipment. The TYCT group consists partly of leading market suppliers to the industry such as Allergan. Pressure from this group was put on the insurance company Hamilton Fraser in 2012 to with draw insurance cover from Dental Hygienist’s & Dental Therapist’s. Hamilton Fraser had insured them for six years with no claims! The TYCT & Hamilton Fraser are also responsible for blocking access to some training courses for these professionals.
CODE Lobbies IHAS to Include Dental Hygienists in Register of Injectable Cosmetic Providers

Posted on 14/06/2010 at 14:22:06 | by Lorna Jackson

He asks; is the IHAS shooting itself in the foot with this approach?

In line with the obvious thumbs up from the insurers, Paul Mendlesohn argues that; “hygienists have excellent clinical and cross-infection skills, training in medical emergencies and can administer dental anaesthetic injections. In addition, there are established team working skills; hygienists work closely with the dentist which gives an ideal scenario for skin treatment; and this frees up the dentist for more advanced treatments.”
The consulting rooms is responsible for many inaccuracies being posted over the internet effecting the credibility of Dental Hygienist’s & Dental Therapist’s. I refer to a statement that Ron Myers made in the medical aesthetic magazine in 2008 - if a Dental Therapist can carry out non surgical treatments than you might as well let the receptionist!
Heather Tooley

Heather Tooley

Whilst I`m glad to see that my blog as garnered some healthy debate. I feel that some of the comments posted are a little hostile so perhaps addressing some of these points in more detail may go towards explaining the position held by The Consulting Room over this subject.

Firstly the distinction between medics and non-medics is based on the requirement to undertake a medical or nursing qualification to practice as a Doctor or Nurse, versus the various qualifications and degree courses required to practice as, for example a podiatrist, paramedic or operating department practitioner, and be registered with the Health & Care Professions Council. The latter do not cover a detailed education and development of medical knowledge but specialise exclusively in one area of healthcare, such as the feet, to become the best in that professional arena; which is not being dismissed in any way. We appreciate that such allied healthcare professionals have more medical knowledge than beauty therapists, but nonetheless they have not undertaken a broad medical qualification like a doctor or nurse.

For the purposes of medical aesthetics it is felt by The Consulting Room, the manufacturers of the dermal fillers and botulinum toxin products, as well as the limited regulation bodies currently in place (e.g., TYCT) that neither beauty therapists nor other health and care professionals including, but not limited exclusively to those mentioned who are known to be operating in aesthetics, have adequate general medical training to be able to safely manage the provision of aesthetic treatments in terms of anatomy, physiology and pharmacology knowledge or to deal with any complications which may arise, following such short training courses that are widely available. In some cases complications require perscribeable solutions (e.g. hyaluronidase) which are not available to non-medics or easily sourced if they are not working with a prescribing medic. This is of particular relevance to those who do the training course, get the insurance and then practice on their own, without the support of a medical professional. We have seen cases of dental therapists working with a dentist as prescriber and supervisor within a dental clinic which offers aesthetic treatments to clients, which is preferable; but many have also chosen to set up aesthetic clinics on their own and operate as sole traders outside of their primary dental day job. This is of concern to medical professionals, manufacturers and regulators who fear for patient safety. As I said, we are not singling out one specific profession, but refer to those we know are operating in aesthetics who are considered to be non-medics.

In a previous blog, we highlighted how many of the product manufacturers within the industry including Allergan (Botox(R) and Juvederm(R)) and Q-Med/Galderma (Restylane(R) and Azzalure(R)) do not support the use of their products by anyone other than Doctors, Nurses or Dentists. Since that blog was published, Merz Aesthetics (Belotero(R), Bocoutour(R) and Radiesse(R)) have also voiced that opinion. This is a stance which we at The Consulting Room wholeheartedly support and agree with.

For this reason any other non-medic (beauty therapist, dental therapist or other allied healthcare professional) would find themselves out in the cold if they approached these companies for help, support, training, mentoring etc. in relation to the use of their filler and toxin products. Operating without this support structure (particularly as a sole trader and not under the supervision of another medical practitioner who can count on the support of the companies - Doctor, Nurse, Dentist) would surely make anyone uneasy and reconsider whether they were in fact working outside of their scope of practice and skill?

Current regulation of medical aesthetics, particularly cosmetic injectables is poor and was high on the list of recommendations from the Keogh Report. Whilst we wait to see what action the Department of Health intends to take following those recommendations, I do feel it important to raise the additional point against non-medics offering treatment which is covered by the CEN Standard for Aesthetic Surgery and Aesthetic Non-Surgical Medical Services, as mentioned by Dr. Patrick Treacy. This standard, currently completing its second public consultation and due for implementation in 2014, advocates that only doctors, nurses and dentists should carry out treatments. The addition of nurses and dentists to that list was included by a special deviation to the standard for the UK, as most other European Union countries only recognise administration of treatment by doctors.

We feel that insurers (most, but not all) are very much to blame, because as well as providing the indemnity cover, (all based on number crunching some figures on risk rather than consideration of ethics or patient safety), they also lull the non-medics into a false sense of security that if they can get cover then it must be okay to do the one day course and set about treating the public. We have yet to see a true test case where a non-medical practitioner has fallen back on the insurance cover following a patient complaint only for the insurer to wash their hands of them and leave them with a financial burden after consultation with the product supplier who says `no we don`t support them to administer our product into a patient`. We all know how some insurance companies will find any way they can to invalidate a claim and this could well be used one day.

The Consulting Room thus believe, that as well as better regulation, there needs to be a concerted effort by the insurance underwriters to not just take the mathematical risk factors into the decision whether to insure or not.

So the position is that the product suppliers, the regulators (TYCT, CEN) and the general industry sentiment does not advocate the use of cosmetic injectables on the public by anyone other than a doctor, dentist or nurse. We at The Consulting Room agree with this stance.

Finally, I pride myself on researching fully any of the blogs and articles that I write on The Consulting Room and make every effort to show all sides and opinions on a story. In the case of the blog on dental hygienists I sought opinion from trade organisations who represent the profession, as well as those practicing in aesthetics. Responses are not always forthcoming, something out of my control, but unbiased reporting of facts is paramount with an avoidance of inaccuracies at all times. The Consulting Room reflect general aesthetic industry sentiment and opinion and try to remain independent of emotional judgements or scaremongering by presenting factual information.

Lorna Jackson |

Another threat to the lucrative “doctor/nurse only” pie and surprise, surprise another “un-bias” inaccurate Consulting room article pops up by our uneducated friends!

I completely agree with Heather and Who are non medics yet also believe regulation of this ludicrous industry is the answer.

When will some one just be honest here and admit this is about market monopolization? The industry “old boys” (and we all know who they are, usually the first to comment on blogs like this when they see comments that are too honest), they don’t want the “new generation” of practitioners taking a slice of what they see to be their pie and are making out that this is a “profession only” skill set backed up by over publicized media. What a load of rubbish!!

The chosen “victim” of another inaccurate blog, about a dental therapist, you ask who will deal with a medical emergency? She works alongside the registered dentist in CQC registered premises, unlike a mobile mental health nurse doing this on the side with no clinical support!

So, should the “old boys” be worried after they congratulate themselves after their birdie on the 7th? …………ABSOLUTELY. They have tried to bully the insurers, this only created new insurance companies, they have tried to influence government, but this has only brought about new non profession specific regulation, they have hassled professional bodies, who have demonstrated they have better things to worry about.

The new generation of practitioners is ready for all of this victimization, they welcome regulation, it does not faze them, they know their professional boundaries and are keen to expand skill sets. It was due to the “old boys” cutting corners with the PIP crisis that lead to the introduction of new regulation in the first place. There are many doctors (granted not all) in this cowboy industry that have not seen a university or done any CPD since qualifying from med school, some have GMC cautions on their records, and most never even completed F1 or F2 status, so please lets not start to preach that Doctors are the most skilled here, many nurse and other prescribing registered health care professional have these skills and can deal with the adverse reactions these drugs bring about. Many of these health care professionals you class as non medics have been doing the roles of junior doctors as Advanced Practitioners in hospitals for years prior to entering the aesthetics industry, credit them with a little intelligence please!

Lets take profession out of this argument. If a person can evidence the right skills, training and is registered with the new government body (OffCos) then they will be able to practice. Profession should have nothing to do with it, change the record and at least admit this is about money and some of the of boys not wanting to play nicely, nothing else!

A newly qualified mental Health nurse does not have the training of an advanced practitioner, who’s background could be a paramedic or podiatrist who are also prescribes, yet TYCT back these novices??

This argument is sad, old and soon to be defeated as the government (Health Education England) will be approving training providers to provide specific education programs accessible for everyone dependent on past qualifications the door is already wide open to regulation.

And for your knowledge Launa, if you do look closer you will find for most AHP’s undergraduate training does include full body anatomy and physiology, dissection of cadavers and prescribing, the feet are attached to the rest of the body and if a podiatrist prescribes an oral antibiotic, believe me they need to know how it can affect the whole body.

The bias bill has been kicked out of government and was described as “a witch hunt” the new regulation will provide a pathway for entry for every one, wake up and smell the coffee. Chanel your energies to supporting the market not monopolizing it for the wrong reasons!!

Sally Thompson

There are a few inaccuracies - the "PIP crisis" was due to the illegal activities of the owner of the company using inappropriate material and then hiding that activities from the regulatory bodies that failed to pick up that activity. Not at all due to "old boys" cutting corners. Before the crisis the PIP manufacturers were the 3rd largest provider of prosthesis - pure greed on the commercial level led to their actions in using a not-for human substance.

A first step in patient safety should be transparency in the professional declaring themselves to the patient - all too often the injector is described as a "Practitioner ", perhaps the patient should be openly informed in all the literature and web that the practitioner is a "Dr", "Nurse", "Dentist" "Surgeon" "Podiatrist" "Dental Hygienist" and if they are on the Specialist register. The patient then has more information as to who they are trusting their treatments to.

I am also not sure as to the Professional regulation of the podiatrist / dental hygienists the GMC/GDC & NMC have a central role in professional regulations and a mechanism for protecting the public - as stated earlier they can caution and also "strike off " professionals - does that hold true to the others and do their professional regulatory body have a view on their profession providing "Cosmetic Services"? It would be good to have a representation from those bodies on this issue.

I am surprised to hear that there are Drs practising ".. that have not seen a university or done any CPD since qualifying from med school, ..., and most never even completed F1 or F2 status" as stated by a respondent, the GMC would be interested to know who these individuals are; if a Dr has not completed F1 a or F2 status they would not be able to be fully registered by the GMC and the current framework of yearly appraisal and revalidation would make it difficult if they were not completing their CPD requirements - the RCN is also setting up such a process for its profesional members. It would beg the question once again if the other "practitioners" are also undergoing a whole practice appraisal.

An issue is that anyone can be trained to inject - what is required is getting the correct patient , with the correct product, treated by the correct person in the correct place.. get that right and all aspects of patient care, outcome and safety is addressed. We already have regulatory bodies GMC/ GDC/ NMC that have processes that identify those who have obtained the appropriate qualifications to treat patients - we should support and strengthen those bodies views on cosmetic practice.

Dalvi Humzah