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Dalvi Humzah

Regulation in the aesthetics industry

 

In this issue we have invited commentaries on regulation within aesthetics, in particular the voluntary register set up by the Joint Council for Cosmetic Practitioners (JCCP). Many medical practitioners are concerned regarding the number of regulatory bodies set up in order to bring a semblance of ‘control’ in aesthetics. Do we need these new registers to bring regulations into an unregulated sector? Following the Keogh Report, there has been very little regulation as envisioned and little change in the practice of aesthetics in the UK.

Scotland has started to regulate aesthetic practitioners – yet the question remains as to how regulations would be applied in the rest of the UK? There are many aspects to consider in a field that is currently unregulated and there are many views that are expressed by other practitioners. I have consolidated some views that have been discussed with my colleagues nationally and internationally.

One of the main questions is “who should be performing these procedures?” Unlike some other countries where the practice of aesthetic medicine is restricted to specific specialties we work in a multidisciplinary medical arena which is also open to non-medical practitioners. This makes regulation very difficult with the mix of professional regulations which may not relate to other professionals. With such diverse regulatory bodies it becomes imperative that we have a standard ‘professional behaviour’ that all practitioners adhere to. An example is the ‘cooling off period’ following a consultation for an aesthetic intervention (non-surgical), which the General Medical Council (GMC) has recommended as part of its good medical practice. However, this may not be adhered to by practitioners who are not regulated by the GMC or not regulated at all.

In the UK there is a 24-hour cooling off period before a tattoo is performed on the high street yet a patient could have a procedure that could result in serious adverse effects such as vascular compromise or blindness without being given an appropriate period to reflect on this. Should legislation be required to ensure that there is a standard of ‘Good Medical Aesthetic Practice’ that should be adhered to by all practitioners and ensure that all regulatory bodies explicitly recognise aesthetic practice that is performed by their members? If they are unable to then should the practitioner be under a different regulatory body or not be allowed to perform these procedures at all?

Another issue that plagues aesthetics is the definition of the scope of the procedure. In the UK, we face a dichotomy with botulinum toxins coming under the remit of a Prescription only Medicine (POM) i.e. a licensed medicine that is regulated by law to necessitate a medical prescription before it can be obtained; compared to dermal fillers that are classified as Medical Devices and as such do not have the strict criteria of a POM in terms of obtaining the product. However, once obtained and despite the requirement for a face-to-face consultation, the injection may legally be performed by virtually anyone as long as they do not make false assertions regarding their professional status.

This seems surprising as one of the main adverse events of dermal fillers is vascular compromise for which a POM (Hyalase) is the most immediate treatment option. It would be difficult for a non-prescribing practitioner to get access to this medicine to treat a patient with such an adverse event. Perhaps it is time for the Medicines and Healthcare products Regulatory Agency (MHRA) and other organisations to define these ‘non-interventional cosmetic procedures’ as medical treatments and to be regulated by the POM directive and to be administered by medically designated practitioners only? This is an area that should be discussed and debated without prejudice within aesthetics.

One of the possible outcomes of defining these cosmetic procedures as medical would result in regulatory bodies that are already established to ensure that standards of care are adhered to and are formally assessed. The Care Quality Commission (CQC) has recently re-defined the status of threads and as such these procedures now fall within the scope of registration of the CQC, requiring the provider to register with the CQC for the regulated activity of surgical procedures. The performance of a medical intervention would similarly require the premises to be regulated – this would address a major issue regarding the performance of these procedures in places with lack of aseptic clinical environments e.g. salons and other non-clinical premises.

In other countries such as China it is illegal to perform injectable cosmetic procedures outside of a hospital or registered cosmetic clinic; the result is that even at conferences and congresses the procedure has to be performed in a clinical environment and relayed into the main auditorium. This is something that also needs addressing by regulators and companies alike – we are aware that environmental conditions may have a bearing on later complications such as biofilm formation. As dermal fillers are, in reality, injectable implants perhaps we should all be more aware of the environment in which these products are injected.

A fundamental problem that regulators need to address is “what training is required to become an aesthetic practitioner?” If you visit your GP in the UK you can be fairly confident that he or she will have been trained sufficiently to work as an independent practitioner and should be able to diagnose and treat / refer a variety of conditions. Yet it is possible for a practitioner to have had very little training with no formal assessment to set up as an ‘aesthetic practitioner’ and start treating patients from day one – this is not in the best interests of patients.

We have several programmes in the UK offering different levels of certification, diplomas etc.; while applauding those who have worked hard in establishing these programmes, it is clear that each is different – some are theoretical with no practical component and assessments are different. All this only helps to confuse our patients who cannot differentiate from a certificate in aesthetics, diploma in aesthetics, etc. Recent moves in The Netherlands by the Dutch Cosmetic Medicine Association (NVCG) have led to a formal aesthetic training programme to be established with assessments that will lead to certification as an aesthetic specialist.

This has resulted in The College of Medical Specialisms (CGS) [Dutch equivalent of GMC] adopting the Cosmetic Medicine Decree on 10 April 2019. Following a request for recognition as a profile of the NVCG in 2016, the CGS recognised cosmetic medicine as a medical profile after a long period of preparation and coordination. Given the organisational structure of the study programme, the profile has been added to the medical specialties and profiles from cluster 1 (general practitioners, geriatric specialists, etc.). The decision does not have to be submitted to the minister for approval and is definitive from the moment of this announcement in Medical Contact (published 18 April 2019). The decision will then enter into force on 1 July 2019.

This is a unique moment where aesthetics is being recognised as a medical specialty. This is something that in the UK we need to look at seriously if we are to progress an unregulated ‘industry’ and make it into a ‘specialty’ – we need a formal curriculum and assessment to ensure practitioners are adequately trained and competent to provide care for aesthetic patients. This may prove to be unwanted as with any training programme and assessment there may be some who may not achieve the required standard to progress into the specialty. Unfortunately registers will not provide this structured training and if we want to develop aesthetics into a true medical specialty – such a training programme is required.

I hope these provocative views will stimulate further discussion on our website – we need to have more constructive discussions if we are to elevate aesthetics and above all maintain standards of safety for our patients.

 

 

 

Paul Charlson

What we need is light touch, high trust appropriate regulation

 

Regulation in aesthetic medicine is long overdue. The industry in England and Wales has virtually no controls placed upon it. In Scotland it is a different story. Regulation of clinics was introduced a year ago and further controls are planned.

The Department of Health asked the British College of Aesthetic Medicine (BCAM), the British Academy of Cosmetic Dentistry (BACD), the British Association of Dermatologists (BAD), the British Association of Aesthetic Plastic Surgeons (BAAPS) and the British Association of Plastic & Reconstructive Surgeons (BAPRAS) to create a framework for the aesthetics industry. Following this the JCCP and Cosmetic Practice Standards Authority (CPSA) were formed with the help of non-clinicians to create a body to set (CPSA) and police (JCCP) standards in aesthetics.

The CPSA created a framework of standards across the whole industry covering a range of procedures such as skin peels and micro-needling to laser and injectable procedures. There is a competence framework set at various levels of procedure. The JCCP has two registers one for non-professionals who cannot be registered to inject dermal fillers or botulinum toxin (called level 7) and another register for professionals. There is also a register of training providers who will be able to deliver training to various levels. This was launched in February 2018.

The standards provide an excellent framework for legislation across the whole industry. However the Government is reluctant to create legislation. Recently I met with Jackie Doyle-Price, the Parliamentary Under Secretary of State at the Department of Health, who clearly understands the issues within the industry. For the time being legislation is not likely. The Government wishes to rely on a campaign to increase public awareness about the risks of aesthetic procedures and to consult only those who can demonstrate competence.

The issue of demonstrating competence is a difficult one. JCCP registration is probably the most obvious route but is clearly not the only one. Arguments will continue but a single unified register would seem sensible.

There are countless healthcare professionals ‘doing a bit of botox’. Namely they attend a short course and treat a few patients as a side-show to their main job. Their professional training provides an understanding of infection control, ethics and consultation skills. A smaller number of these practitioners have the ability to deal with emergencies, complications or a basic understanding of dermatology. Some operate from inappropriate premises and lack experience which inevitably results in substandard aesthetic results and a greater likelihood of avoidable complications. With all the professional regulatory bodies having memorandums of understanding with the JCCP any professional facing a complaint referred to their regulatory body may have to justify why they are not registered with the JCCP or working to equivalent standard.

Personally I have some sympathy with my colleagues who say professionals are over-regulated. Experiences of applying senseless protocols and procedures and having to endlessly repeat sometimes irrelevant ‘mandatory’ training is draining and demoralising. Paradoxically it is this very issue that may have persuaded some to cease working in the NHS and move into the less regulated aesthetic industry. I would argue that until we accept we have to prove competence, it is more difficult to weed out those who are incompetent. What we need is light touch, high trust appropriate regulation which is actively policed to achieve this.

Non-professionals have it easier in that they do not have professional standards bodies and cannot be removed from any meaningful register. This effectively implies that they can virtually practice without any regulation.

Most people within the industry are sceptical that a public awareness campaign is going to be enough to stop poor practice especially from non-professionals.

The number of practitioners joining the JCCP register has at last begun to increase from a slow start. This is perhaps the beginning of change. Once a significant number of people are on the register the public may begin to look at it. The commercial advantage of registering then increases and may persuade more practitioners to join it. Perhaps a combination the Scottish experience plus increased JCCP registration, professional and media pressure may persuade the Government it is time to legislate.

As a minimum, practitioners should be adequately trained in assessment of patients and have the ability to apply the correct technique in a competent manner. They should practise in an appropriate environment and have the ability to deal with the complications. This is what the CPSA standards attempt to achieve and we can only keep applying these principles until this becomes industry standard and hopefully legislation will follow.

  www.bcam.ac.uk

 

 


Andrew Rankin

Why it’s time to pay more than lip service to regulating the non-surgical cosmetic industry

 

Scroll through any social media feed and alongside perfect profile pictures are offers of cut-price and incentivised cosmetic treatments, often carried out in non-clinical settings. Hardly surprising then, according to the market research company Mintel, 46% of Britons believe non-surgical procedures are increasingly becoming a part of everyday beauty routines [1].

Yet many of those tempted by cheaper alternatives are unware of the potential for risk, especially if carried out by untrained, unsupervised and unregulated hands. A worrying prospect, because when a cosmetic treatment goes wrong, the impact can be devastating.

In a recent judgment by the Advertising Standards Authority (ASA), concern was expressed about a treatment advertised – lip fillers in this case – as appearing “normal and safe”. They are neither of these things and I think we should welcome this ASA ruling [2].

There are now over 4000 aesthetic nurses in the UK [3] and I believe the time is right for us to unite, working cohesively with our medical colleagues and other stakeholders, to help shape the future of the industry.

Time to be transparent

Whilst treatments continue to be offered in salons, spas and high street shops, rather than in clinical settings, the potential for under-qualified practitioners to remain under the radar remains acute.

Given then the potential for harm, it’s important for the public to be able to differentiate between those qualified to practice and those lacking in suitable training and expertise.

In my view, aesthetic nurses, like myself, have the responsibility to take an active role in raising and maintaining high standards, helping to spearhead the movement for change in the sector.

We need to champion a move towards tighter regulation and a more transparent approach to evidencing good practice, or we could see the credibility of the sector damaged. We can do this by supporting mechanisms in place that will gather the evidence needed to bring about legislative change. One way that we can start to address this, is by providing prospective patients with access to a reliable source of information on suitably trained and qualified non-surgical cosmetic practitioners.

A step in the right direction

Educating the public that non-surgical does not mean non-medical, is an important driver in the debate to achieve regulatory change.

The good news is, we are moving in the right direction. A significant step towards increasing patient safety has been the creation of the JCCP, with practitioners signing up to the JCCP register. Patients can consult the register to see if their chosen practitioner is qualified in providing certain treatments and is working safely and ethically according to a strict code of practice. The significance of this principle has been enshrined within a recently signed Memorandum of Understanding between the Nursing and Midwifery Council (NMC) and the JCCP.

This approach gives patients the advantage of being able to identify and select someone with the proven experience, capability and knowledge needed for a specific procedure.

The benefit for practitioners of being part of this register is that they belong to an organisation in which members are constantly monitoring their own performance against a set of safety standards, and driving improvements across the industry. They can also be confident that their standard of practice is within what would be expected by their statutory regulator.

Evidencing good practice

But it’s not only the patients who should be evaluating the risk in cosmetic solutions. As medically trained professionals, we acknowledge how evidence has always played a fundamental role in both research and clinical practice and yet this is one sector yet to adopt a recognised system of data collection.

The more we collect information which can help in future decisions about treatments, the more we learn in the process. As we learn we become better placed, and more convincing, in informing regulatory change.

Clinical practitioners need to be at the forefront in changing the emphasis from marketing-led to evidence-driven and safeguarding patient safety. Data will help us make informed decisions around calculated risk and the procedures we administer.

Adopting an open and transparent approach to self-reporting will help build a knowledge database.

Alongside the JCCP, technology from Northgate Public Services collects data from practitioners surrounding treatments and adverse incidents, enabling practitioners to have access to reliable information to help them measure risk.

Reducing risk

Raising standards in the non-surgical cosmetic sector relies heavily on the goodwill of its own practitioners in sharing information. Reporting incidents in one place, will make evaluation easier to see which treatments are working well and which have a higher rate of poor outcomes, helping the sector to minimise risk and deliver better treatments.

Bringing about reform

A growing bank of data on cosmetic treatments, will make it easier to evidence good practice and help enhance the reputation of the industry. We, as practitioners, can make a significant contribution to raising standards and, by extension, the reputation of the sector, by supporting the JCCP and CPSA to bring about these much-needed reforms.

 

 

References

1. www.mintel.com/press-centre/
beauty-and-personal-care/nip-tuck-or-fill
-31-of-brits-are-interested-in-having
-cosmetic-surgery-in-the-future

2. www.asa.org.uk/rulings/royal-tunbridge
-wells-skin-clinic-ltd-a18-471927.html

3. www.bacn.org.uk

(All links accessed May 2019)

 

  www.jccp.org.uk
  www.northgateps.com

 

 

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CONTRIBUTOR
Dalvi Humzah

Consultant Plastic, Reconstructive and Aesthetic Surgeon, UK.

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CONTRIBUTOR
Paul Charlson

GPWSI in Dermatology; and President of BCAM.

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CONTRIBUTOR
Andrew Rankin

Former Vice Chair of the British Association of Cosmetic Nurses, JCCP trustee and co-chair of the JCCP Practitioner Register Committee.

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