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How national regulation will improve patient outcomes

02 December 2022
Volume 11 · Issue 10

Abstract

Anna Lee discusses UK law and ethics within the realm of aesthetic medicine and the upcoming licensing scheme

Not enough enphasis is placed the importance of defined training and practice standards to protect patient welfare

Non-surgical aesthetic treatments are a rapidly growing healthcare domain in the UK, significantly outnumbering surgical procedures. Analysis of The British Association of Aesthetics Plastic Surgeons’ (BAAPS) audit (2020-2021) reports a 27% decline in surgical treatments from 2020 to 2021 in the UK, while non-surgical treatments, such as dermal fillers and botulinum toxin injections, have increased (BAAPS, 2022). The global nonsurgical aesthetic treatment market was valued at USD $53.8 billion in 2021 and is projected to grow to USD $190 billion in 2030 (Grand View Research, 2020). The 2020 International Society of Aesthetic Plastic Surgeons (ISAPS) global audit also demonstrated the rising trend of non-surgical procedures;however, the UK data was not included due to poor survey uptake (ISAPS, 2020). Despite this growing global demand for non-surgical aesthetic treatments, the UK sector remains unregulated and without any statutory licensing. Following the 2021 Joint Council of Cosmetic Practitioners (JCCP) 10-point plan (Figure 1) (JCCP, 2021), this article looks at how national regulation in the non-surgical aesthetics sector will maximise patient outcomes.

The Wild West

The UK aesthetics sector is widely recognised to need statutory regulation and greater patient safety. Often referred to as the ‘Wild West’, the UK currently allows non-medical professionals to legally obtain and administer dermal filler injections from unregulated pharmacies and distributors following an unregulated 1-day training course (Latham et al, 2020). Therefore, this leaves the potential for profit to be placed above patient safety and care (BAAPS, 2019). The All-Party Parliamentary Group on Beauty, Aesthetics and Wellbeing conducted a year-long investigation into the sector. It concluded that the regulation of cosmetic treatments was fragmented, obscure and outdated, meaning anyone can carry out any treatment, anywhere, with no restrictions on what qualifications they musthaveto do so (All-Party Parliamentary Group on Beauty, Aesthetics and Wellbeing, 2020). Furthermore, Withey (2018) also highlighted the gap in training standards and not enough emphasis is placed on the importance of defined training and practice standards to protect patient welfare.


Table 1. Joint Council for Cosmetic Practitioners’ 10-point plan (2020)
1. Statutory regulation Seek and advise on statutory regulation for the non-surgical aesthetics and hair restoration surgical sector
2. Mandatory education and training standards Government and education/training regulators in the UK to mandate specific qualifications, education and training requirements for specific modalities
3. Clear, transparent information Aesthetic service providers display simple, informative guides on all services provided, including risks, benefits, costs, qualifications and insurance to members of the public
4. Definition of medical and cosmetic treatments Work with Government agencies to clearly define in law what constitutes a ‘medical’, or ‘medically related’ treatment and what is ‘cosmetic’ only
5. Safe and ethical prescribing Implement robust standards and regulations for safe, ethical and professional prescribing within non-surgical aesthetics
6. More regulated advertising and social media Tighter controls and penalties on exaggerated, inaccurate and misleading advertising and social media posts in relation to aesthetic treatments, hair restoration and training
7. National complications reporting Introduce enhanced and coordinated processes for the reporting and analysis of adverse incidents at a national level
8. Adequate insurance cover Legislate all cosmetic non-surgical aesthetics and hair restoration surgical practitioners to hold robust and adequate indemnity insurance covering each service provided
9. Licensing of premises, treatments and practitioners Set nationally agreed standards for licensing and regulating premises, treatment procedures and individuals
10. Raising consumer awareness Raise public awareness of the risks and benefits associated with non-surgical treatments and hair restoration surgery

There have been attempts to regulate the sector following the Poly Implant Prothèse (PIP) breast implant scandal (Martindale and Menache, 2013). The then secretary of state for the DOH, Andrew Lansley, commissioned NHS England's medical director, Sir Bruce Keogh, to review the regulation of cosmetic practice (Department of Health and Social Care [DHSC], 2013). The review stated that a person having non-surgical procedures, such as dermal fillers, has ‘no more protection and redress than someone buying a ballpoint pen or a toothbrush’ and was ‘a crisis waiting to happen’. Unfortunately, this is a reflection of what is happening in current practice. According to Save Face, an accredited voluntary register for medical practitioners, patient complaints increased from 378 in 2017 to 2083 in 2020 (Hill, 2022). They also say that patients are suffering at the hands of unscrupulous practitioners and, in some cases, have suffered serious and permanent harm. Ashton Collins, the director of Save Face, highlights thread lifts as an example of treatments that are particularly high-risk, with some patients suffering from ‘horrendous complications’ and infections caused by threads inserted into women's faces incorrectly, resulting in surgical intervention to be safely removed (Wace, 2022). Since the publication of Keogh's review, some moves toward regulation have been made. Perhaps most significantly, a Health and Care Act recently approved by Parliament announced the introduction of a new licencing programme for professionals to safeguard patients (DHSC, 2022). The JCCP works very closely with the UK Government to help achieve this. The JCCP holds an accredited voluntary register of practitioners and a register of education and training providers. In March 2021, they published a 10-point plan outlining their goals and campaigns (Sines, 2021). This recent change in the law, combined with the industry support for the JCCP's work, is the most significant step yet in regulation. However, the details regarding who will be able to administer such procedures are still under public consultation. Therefore, with no set timeframe, this still leaves the patient seeking cosmetic treatments at risk.

Since the publication of the 10-point plan, over 500 stakeholder members from the aesthetics industry have responded in favour of national licensing and regulation (Sines, 2021). Sines also reports that opinions were particularly strong in the call for non-health professionals to perform less invasive treatments, while 85% of respondents emphasised the importance of ensuring practitioners apply robust, evidence-based physical and psychological assessments and face-to-face consultations with their patients to ensure their suitability for treatment. To highlight the additional risk to patients in an unlicensed industry, reports commissioned by the Chartered Institute of Environmental Health and Institute of Licensing state that a lack of current regulation on aesthetic treatments can cause serious harm to patients if they are not carried out correctly in a safe environment, including numerous examples of severe infections, burns, allergic reactions and injuries resulting from a procedure (Matthewman, 2020). However, local authorities do not have the power or authority to regulate these treatments and, therefore, cannot impose minimum standards on the training and competence of practitioners.

» By acknowledging the importance of ethics in practice, practitioners can avoid engaging in activities that are not in line with the guidance from statutory bodies and build the sector's reputation, setting a clear example to new and existing aesthetic practitioners «

Code of conduct

The Nursing and Midwifery Council's (NMC) code sets standards of performance and ethics for nurses and midwives to uphold. They are expected to be professional, accountable, able to justify their decisions and work within their level of competence at all times (NMC, 2018). Harrison (2020) also highlights the importance of basing decisions on high-quality evidence, and not doing so may harm patients. Aesthetic nursing is still a relatively new career for registered nurses and lacks defined standards of knowledge or education (Holmberg et al, 2019). According to Greveson (2013), it is an area of nursing similar to an advanced nurse practitioner's (ANP) role, where nurses work autonomously and make clinical decisions regarding treatment options based on comprehensive consultation and physical assessment. ANPs are also educated to master's level (Level 7) and are independent prescribers (HEE, 2020). Collier (2018) goes further by saying that nurses should not enter the aesthetics sector without the right level of training and with at least 5 years of post-graduate experience. She also says that 1–2-day training courses are inadequate and do not offer acceptable levels of training. When carrying out a Google search, the author found an abundance of training courses targeting non-medical and medical professionals, which allow the individual to administer botulinum toxin injections after a 1-day course. Collier (2018) feels that responsibility should lie with training academies that ‘churn out in mass a new generation of practitioners who are ill-prepared for a very challenging branch of medicine which is detrimental to patient safety and the professional integrity of those specialising in the field’. The JCCP have a list of approved education providers that follow strict criteria and meet the highest standards of education in the aesthetics industry (JCCP, 2022). This stands at four providers, all awarded accreditation for delivering the Level 7 Diploma in injectables for clinical aesthetics. Although the JCCP does not promote the Level 7 qualification as mandatory, it could be argued that accrediting such a qualification would suggest this is the current benchmark level of aesthetic education in the UK. Therefore, without professional regulation and formal educational standards, aesthetic nurses must remain legally accountable and answerable for their decisions and the consequences of those decisions, in line with their code of professional conduct (NMC, 2018).

Independent prescribers

In addition to adhering to the NMC's code of professional conduct (2018), aesthetic nurses who independently prescribe are also guided by the Royal Pharmaceutical Society's (RPS) competency framework (2021). The framework highlights skills and behaviours required for safe prescribing that upholds ethical, legal and professional standards. Despite this, one area that has come under intense scrutiny by professional statutory regulators is the use of prescription-only medicines (POMs) in the aesthetic sector, following the discovery of a range of unacceptable prescribing practices that have compromised public protection and patient safety (Sines, 2020). POMs are increasingly widespread across the sector, not just for non-surgical treatments but also for the emergency reversal of dermal filler injections, sometimes in emergency situations (Bennett, 2021). With increasing demands in non-surgical treatments requiring POMs, access to these POMs (many of whom are beauty therapists or non-medical prescribers) requires legitimate and ‘regulated’ prescribers to assume longer-term responsibility (Sines, 2020). Professor Sines also expands on this by stating that in the interest of patient safety, prescribers should supervise the patient for whom they have prescribed the prescription and ensure they are happy that all potential risks have been minimised (Sines, 2020). Furthermore, Bennett (2021) believes that the prescriber should be familiar with the patient through an initial face-to-face consultation and diagnostic assessment of the patient's suitability for treatment and be available to deal with complications or adverse events following the procedure, should they arise. When Health Education England (HEE) (2014) looked at the health and education of practitioners, they concluded that those without a licence to prescribe should only practise under the supervision of a prescriber. Davies (2022) agrees with this recommendation and emphasises the nurse's ability to independently prescribe by using the example of delaying the management and treatment of a complication. As registered healthcare professionals, aesthetic nurses are fully accountable for their professional, medical and ethical standards (Holmberg et al, 2019) and, according to Davies (2022), if all nurses took their professional standards seriously, nurses would not be practising without a prescriber in place to work with. Therefore, it should be the responsibility of the registered nurse to uphold safe practice and set a clear example to the profession.

It should be the responsibility of the registered nurse to uphold safe practice and set a clear example to the profession

Ethical practice

Aesthetic medicine has a reputation for being an unregulated and financially rewarding field of practice that occasionally draws practitioners with questionable morals and ethics, which can have significant consequences for patient safety (Collier, 2019). According to the NMC (2018), ethics are the benchmark or gold standard that guides the behaviours and actions of nurses and midwives working with the public. The NMC seeks to uphold moral standards in all aspects of nursing practice. The four pillars of medical ethics are autonomy, beneficence, non-maleficence and justice. These principles serve as the foundation for clinical judgement and decision-making when faced with moral dilemmas in medicine (Beauchamps and Childress, 2019). In terms of the scope of aesthetic practice, that can be related in the following ways:

  • Autonomy is a fundamental principle of medicine and describes the patient's ability and capacity to make an informed decision. Patients must undertake a thorough medical assessment and be made fully aware of the proposed treatment plan, risks, benefits and expectations (Haswell, 2019).
  • Beneficence is doing what is best for the patient. This is particularly relevant when dealing with a patient with body dysmorphic disorder (BDD). Some 75% of patients with BDD will seek aesthetic treatment, and it is the practitioner's duty not to treat them and refer them to specialist care (Harris and Johnson, 2017).
  • Non-maleficence is the principle of doing no harm, whether this is intentional or unintentional. The practitioner should always advocate for the patient and ensure treatments are appropriately assessed regarding risk versus benefit (Haswell, 2019).
  • Justice is described by Fred (2008) as a complex ethical principle that covers a range of issues. These include treating patients fairly, distribution of resources, respect for people's rights and morally acceptable laws. According to Wondergem (2017), the consent process is an example of this; practitioners can ensure the patient's autonomy is protected by ensuring the treatment plan is fair and in the interests of the patient.

It is essential for the aesthetic nurse to always question whether they are practising ethically (Haswell, 2019). However, in the absence of regulation, Rankin (2014) recognises that it is not always possible. Aesthetic medicine is a complex area, as it combines treatments promoting confidence, health and wellbeing but with a commercial gain. By acknowledging the importance of ethics in practice, practitioners can avoid engaging in activities that are not in line with the guidance from statutory bodies and build the sector's reputation, setting a clear example to new and existing aesthetic practitioners.

Conclusion

This article critically evaluates the absence of regulation in the aesthetics sector. It convincingly establishes the need for statutory licencing by the UK Government to maximise patient outcomes and raise industry-wide standards. With an increasing trend in non-surgical aesthetic treatments in a fragmented and unregulated industry, it is of little surprise that there is an increase in patient complaints and complications. With no minimum standard of education within the sector, it is clear that higher educational standards are vital. The introduction of a Level 7 qualification as a requirement would go some way to achieving this. There is also a clear need to safeguard the registered nurse and the general public against unethical behaviour. However, in the absence of regulation, nurses need to follow the RPS competency framework and the NMC code and ensure all prescribing practices are always in the patient's best interests. Nurses are in an excellent position to promote best practice and set clear examples for the profession as a whole.