BACN submission to the APPG Beauty Aesthetics and Wellbeing

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Response to APPR Request for Evidence – June 2020

The British Association of Cosmetic Nurses (BACN)was formed in 2013 and is now the largest professional association for medically trained aesthetic professionals in the UK. It has approaching 1000 nursing members many of whom are regarded as the leading practitioners in the field.

The British Association of Cosmetic Nurses (BACN) has always maintained that the regulation of all non-surgical cosmetic procedures (including injection of Botulinum Toxins, Hyaluronic Acid & other dermal fillers, insertion of absorbable & non absorbable threads & sutures, injection lipolysis, and all aspects of laser & IPL treatments resulting in the destruction or alteration of skin lesions), should be strictly regulated and be only practiced by  appropriately qualified and trained medical, dental or nursing professionals.

The Regulatory Bodies (GMC, NMC, GDC) have all recognized the importance of registrants working within a specific Code of Practice that reflects patient safety linked to long established and strict ‘Fitness to Practice’ procedures . There cannot be a reckless standard of care for patients who seek medical aesthetics services. The reasonable standard of patient care that is clinically necessitated, requires that medical aesthetics practitioners are a Nurse, Doctor or Dentist and regulated by a statutory body. There is a raft of statutory provision in this respect, which underpins the facts, and which encompasses education, training and the practices of Doctors, Nurses and Dentists.

The BACN welcomes the establishment of the APPR at a time when many of the issues associated with the aesthetics sector have been further highlighted by the COVID 19 crisis. The BACN will separately offer a view in relation to the key subject areas outlined in the programme of sessions of the APPR. Confusion over the definition of a ‘medical service’ or a ‘medical treatment’ has led to all kinds of interpretation of government guidelines and whether they apply to the sector. The BACN has always maintained that the higher ‘risk’ treatments in aesthetics are ’medical’ treatments’ and a such should not be considered as part of treatments carried out by non-medical practitioners in hairdressing or beauty salons. The guidelines recently issued by the BACN for when its members commence practice are clearly medical and relate to working in a medical environment or an environment that has been designed for medical practice.

In 2013 a Government review was carried out by Keough and recommendations were made.

  https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/192028/Review_of the_Regulation_of_Cosmetic_Interventions.pdf

Recommendations 4 • All non-surgical procedures must be performed under the responsibility of a clinical professional who has gained the accredited qualification to prescribe, administer and supervise aesthetic procedures.

Recommendation 5 • Non-healthcare practitioners who have achieved the required accredited qualification may perform these procedures under the supervision of an appropriate qualified clinical professional.

The BACN has reviewed the questions issued by the APPR on non-surgical aesthetic treatments and has set out below some key areas of concern which it feels the APPR should consider:

Regulatory and Legal Issues

Definition of a ‘Medical Service’

The most fundamental issue at stake here is the definition in law of a ‘medical’ service. As the aesthetics sector has grown so has the range of treatments and the BACN maintain that the legal framework for practice and definition of a ‘medical’ treatment has not caught up. This is fundamental to any kind of regulatory, licensing and inspection systems operating. Whilst aesthetic treatments are not treated as ‘medical’ then there is no requirement for CQC oversight or specification.  The CQC position on defining ‘medical treatments’ is confusing as they deem some procedures in the world of aesthetics as medical e.g thread lifts and then ignore other complex procedures.

Both NMC and GMC are looking at the sub-specialty of aesthetic medicine and nursing and accept it falls under the remit of their registrants. The British Standards Institute have published standards EN 16372 which clearly defines who may or may not practice and outlines the levels of risk for specific procedures based on evidence and consensus. At no point does it allow for non-healthcare personnel to carry out procedures. The standards can be cited in law.

The BACN accepts that many ‘cosmetic’ treatments are not medically based and not in the ‘at risk’ category and there is no problem with these being administered by non-medically trained practitioners however it is our contention that the administering of injectable treatments such as botulinum toxins and dermal implants (injectable fillers) must be deemed to be ‘medical’.

Complications arising from Non-Surgical Cosmetic Procedures

The BACN echo the views of all of the professional medical associations and a number of key bodies who are collecting data on complications (such as ACE, CPSA, Save Face and the JCCP etc) in relation to the evidence around complications, most of these cases relate to filler treatments carried out by non-medically trained practitioners.

The Aesthetics Complications Expert Group (ACE) is a ‘not for profit organization with over  4500 members whose purpose is to ‘improve patient safety by producing evidence on the wide variety of complications that can be caused by non-surgical cosmetic procedures.

www.acegroup.online

A recent survey of members of the ACE Group found the following:

  • 98.4% of members have dealt with or managed a complication caused by a treatment carried out by a person who is not a registered health care professional.
  • Of the procedures that were treated, advised or corrected 66% related to dermal fillers and 20% to Botulinum Toxin injections.
  • Nearly 69% of the respondents had treated between 1 – 10 complications arising from treatments carried out by non-healthcare professionals, 21% had dealt with between 10 – 30 cases and 5% between 30 – 50 and 5% more than 50.

The complications only present to a medically qualified practitioner (Doctor, Nurse or dentist) when complications arise and attempts to contact the injecting practitioner have failed or where completely inappropriate advice has been given. The result is often significant tissue damage, disfigurement, mental health anguish and substantial cost to the patient.  

There are often costs to the NHS when the patient is unable to fund further corrective or restorative treatment and these are not separately recorded so cost data is not available. Current NHS coding is not currently set up to highlight and record specific cosmetic medical complications but is absorbed in a wider reporting code.

The BACN recommends that as part of the triage process in A & E departments this data is collected. Current NHS coding is not set up to highlight cosmetic medical complications but is absorbed in a wider reporting code.

The reality is that non-medical practitioners can easily walk away from any responsibility for complications and often do. Many BACN nurses are approached by patients who have been abandoned by non-medically trained practitioners as soon as a complication arises. Only a registered healthcare professional can consult, assess, manage, and treat patients as appropriate to their needs in the field of medical practice. Only medical and nursing practitioners can manage significant/major complications at the time they occur.

Age and Non-Surgical Procedures

The BACN is fully aware of the issues surrounding underage patients (under 18) and under its Code of Conduct will only treat these if there is an ‘acute’ medical justification and with insurers approval. In these circumstances it is appropriate that the patient is referred to their GP and if necessary secondary care.  The BACN would support legislation to outlaw under 18’s having access to injectables and filler treatments unless medically justified as set out above.

Remote Prescribing and Supervision

Prescribing is a key factor in all injectable cosmetic treatments if patient safety is to be maintained, within a framework of practice that meets legal and regulatory parameters. It is commonly understood through explicit statutory regulator statements and implicit regulator guidelines that remote prescribing is in no circumstances acceptable for cosmetic medical treatments. Therefore, appropriate access to medicines which supports both safe and legal practice is necessarily limited, but imperative.

The prescribing practitioner may delegate treatments they prescribe, but they are required to maintain overarching responsibility for the welfare of the patient and, to an important extent, for the actions of the person to whom they have delegated. When delegating within a supervisory role – that is, within the same premises – safe and legal practice can be maintained. However, current prescribing arrangements within the non-healthcare sector are not typically organised in this way. Lone prescribing practitioners who work over large geographical areas and larger ‘networks’ of prescribing ‘supervisor’ practitioners are currently an answer to a problem born of commercial, rather than client, need. It is the BACN’s experience that these systems lead to shortcuts through:

  • Being commercially driven
  • Providing prescription treatments outside prescribed parameters
  • Absence of suitable assessment of practitioner policies leading to unqualified practitioners who lack competence providing treatment or competence to understand and implement medicines legislation.
  • Absence of client follow-up policies
  • Inability to attend emergency or urgent scenarios which require immediate intervention.

The above factors compromise either safety, legality or both. They are driven by the beauty industry but remain the responsibility of the prescribing professionals who are accountable but who are, through the nature of the opaque systems in place, able to practice without scrutiny.

Standards, Education and Qualifications

The lack of an agreed set of standards for aesthetic treatments has bedevilled the sector for many years but this has been changing recently. The framework of standards published by the JCCP/CPSA and its competency framework linked to the previous work undertaken by the HEE is welcomed by the BACN whilst recognising that there will always be debates about individual levels and descriptions. It should also be noted that there are other frameworks and standards in place. The BACN Chair was also involved in the development of European wide standards for non-surgical treatments but with Brexit and other issues these have not been implemented in the UK.

The BACN believes that the APPR should be looking to gain agreement from the sector on standards and that these should then be embodied as mandatory and that all education, training, CPD and qualifications should reflect these standards. The BACN cannot support the recent  attempt by the beauty sector to use National Occupational Standards to produce a framework of progression for non-medically trained practitioners to carry out the most ‘high risk’ and as we determine ‘medical’ procedures. The BACN also notes that within this framework there is no reference to medical training and that the treatments at the highest risk levels have been downgraded from the HEE recommendation of being at L7 to L6.

The lack of agreement over standards, entry requirements, competences and qualifications has enabled some training companies to exploit these loopholes and make numerous unsubstantiated claims about ‘accreditation’ and ‘recognized’ qualifications. The BACN supports the campaign being led by the JCCP/ASA in this area.

The BACN would also like to inform the APPR about its actions in developing a new ‘Career Framework for Aesthetic Nurses’. The development of this framework is based around the acceptance that aesthetics is seen as a ‘medical specialism’. The BACN is supported in this approach by the Doctors who are also looking at mapping competences in this area into its specialist registers and the GMC looking at ‘credentialing’. The BACN many years ago developed the first ‘Competency Framework for Aesthetics’ and it is now in the process of updating this in line with the different standards frameworks for aesthetics and also the career frameworks that have been developed by the NMC and the RCN.

Who regulates the Sector?

The BACN would not in any way support a parallel system of regulation for non-medical practitioners for the ‘high risk’ treatments. Non-medics do not undertake clinical training to a level required to demonstrate professional fitness and standards of competent medical and nursing practitioners as set out within the legal purpose tests. To deliver a 360 full clinical understanding of the requirements and ability to carry this out can only be achieved through a nursing or medical training programme.  The law ensures that registered nursing and medical practitioners can fulfil this role and can demonstrate accountability. A non- medic cannot. Both doctors and nurses are subject to a mandatory Revalidation process to maintain their registration by their regulator.

If the APPG decides to support further regulation of non-medical practitioners, then it must deal with the issue of who regulates these groups and the consequences of the complications for the public. Doctors, Nurses and Dentists are all regulated by statutorily established regulators nothing exists in this area for beauty therapists. Industry associations do exist for these groups, but they have no real power to call members to account or to address any kind of ‘Fitness to practice’ concerns.

A non-medic cannot detect disease or care for patients undertaking medical treatments and to do so would be to breach public health and safety standards and endanger lives. The medical aesthetic patient pathway requires by definition a ‘reasonable’ standard of care that reflects the complex medical needs of patients and risk factors involved. Only a registered healthcare professional can complete all of the stages in this process - consultation, assessment, management and treatment of patients as appropriate to their needs in this field of medical practice and then if required manage complications.

Non regulated individuals are currently free to practice increasingly complex and ‘high risk’ procedures without regulation orredress– indeed there is no requirement for insurance, adequate premises, sterile procedures, safe disposal of sharps or contaminated (essentially clinical) waste nor for the testing andvaccination of non-medical “practitioners” for Hepatitis B.

The BACN would also like to draw the attention of the APPR to the lack of consistency across the UK re the licensing and inspection of premises. In Scotland HIS has introduced mandatory licensing and inspection of aesthetic clinics this is NOT the case in England. In England the CQC inspects premises where surgical procedures are carried out and GP practices but not aesthetic clinics.

The role of the MHRA is critical when it comes to product certification but the BACN draws attention of the APPR to a huge issue around the importing of non-MHRA or EU certified products. The BACN expects the pharmaceutical companies with whom it has excellent relationships in the UK to highlight this issue.

Who speaks for the sector?

One of the key problems of dealing with a new and rapidly expanding sector such as aesthetics is its lack of history in relation to the development of a coherent vehicle to represent its interests to Government. The infrastructure to support practitioners is mixed, conflicted and divergent yet there are so many stakeholders:

Professional Associations – representing both medical (BACN, BCAM, BAD, BAAPS, BAPRAS etc) and non-medical practitioners.

Regulators – GMC, GDC, NMC – these are all medical bodies embodied in statute, there is nothing like this for the beauty sector.

Voluntary Registers – JCCP and Save Face

CQC

MHRA

Pharma Companies

Clinic Chains

Qualification Regulators – Ofqual, SQC, UKAS.

Complications Bodies – ACE, IAPCAM

 

The divergence is even more exacerbated, by the rift between the bodies representing medical practitioners and non-medical practitioners.

 

Patient Safety and Awareness

The issue of patient awareness of the risks associated with non-surgical treatments is huge and cannot be addressed by a single approach. It needs a multi stakeholder strategy and plan linked to actions in the following areas:

  • Raising consumer awareness of the risks associated with the more complex medical procedures.
  • Practitioners providing detailed information to all patients prior to treatment and the implementation of detailed consent procedures.

There have been previous unsuccessful Government Campaigns in this area and the BACN would recommend that these are reviewed and lessons learnt. Full engagement of the stakeholders in a new national strategy to raise patient/consumer awareness is recommended.

Recently there has been a very strong focus on the ‘mental health and wellbeing’ of patients seeking treatment. The BACN recognizes that the diagnosis of such conditions as body dysmorphia (BDD) is complex but would support the mandatory training of practitioners in processes to highlight this condition and then to refer to appropriately qualified professionals. The BACN believes this is an area of activity that needs serious attention and would be willing to participate in a Working Group to research this further and to recommend action if suggested by the APPR in its findings.    

Research and Data

The aesthetics sector is bereft of any kind of systematically collected data on its size, range of activities, complications etc. Many of the key stakeholders collect data but none of this has been brought together. This has often led to the debate being led by anecdotal evidence or research based on very limited sample size and not collected in a structured way. There is more evidence and data available in relation to medical practitioners, this is not the case with the beauty sector. The BACN would encourage the APPR to look at how this lack of data can be addressed by key stakeholders and government. The process put in place to collect data and to trace products and practitioners emanating out of the breast implant crisis is an excellent model to follow.

Conclusions

The BACN would ask that the APPG pays particular attention to the following when considering its recommendations:

  • The danger to patients caused by non-medically trained practitioners offering non-surgical treatments, such as botulinum toxin and dermal fillers as the current regulatory framework allows them to practice in these areas.
  • The need for practitioners to be able to carry out and complete processes for ensuring ’informed consent’ by patients being made fully aware of all the risks involved.
  • The use of prescription only medicines and the inability of non-medical practitioners to resolve problems using prescription only medicines as a solution.
  • Clear definitions of what are considered non-surgical ‘high risk’ treatments and holding all practitioners to account when new procedures emerge – looking at evidence-based research to determine risk.
  • The requirement to report adverse events in a timely manner, including information on the treatment and the product.
  • That the Keough review recommendations be considered and adopted ensuring the public are under the safety net of regulated healthcare professionals.
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Key Contacts

Sharon Bennet – Chair – BACN

chair@bacn.org.uk

Paul Burgess MBE – CEO – BACN

pburgess@bacn.org.uk

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