Scottish Cosmetic Interventions Expert Group Report July 2015

1. Executive Summary

This report summaries the work of a range of stakeholders with expertise in: different areas of health care (including dentistry, general practice, medicine, surgery, nursing, pharmacy), regulation of health care professionals, cosmetic industry provision and regulation, public engagement, data analysis, public health, higher education, and social marketing.

The deliberations of the SCIEG and its subgroups were aimed at improving the safety of the public who choose to have services in the independent cosmetic health care sector. The work revolved around four themes: improved and proportionate regulation; enhanced communication and care between patient and provider; increased knowledge and awareness of the risks and benefits among potential customers; and finally and crucially, the need for a monitoring framework to find out the impact of this work.

There is considerable diversity in the cosmetic interventions sector. People with a broad range of backgrounds provide rapidly changing interventions which are becoming increasingly popular. To better understand the most appropriate approach to improving quality in the cosmetic interventions sector, a range of evidence was considered. These included a literature review, Omnibus survey of the general population, survey of consumers, survey of providers and a series of focus groups with the public. To clarify current regulation of providers, the term 'regulated professional' means a health care professional who is required to register with a statutory regulatory body in order to practice in the UK, such as a dentist with the General Dental Council, or a nurse with the Nursing and Midwifery Council, a medical doctor with the General Medical Council.

The recommendations that the Group puts forward to the Scottish Government are:

1. REGULATION

The SCIEG recommends a three phase approach to introducing regulation of cosmetic procedures. The rationale for this approach is outlined in chapter 6. Regulation should operate on a cost-recovery basis, based on fairness. The three phase approach combines proportionality and timeliness:

a. Phase 1: Regulation of independent clinics (on the basis of services being provided by a doctor, dentist, dental care professional, nurse or midwife) with Healthcare Improvement Scotland. Statutory arrangements for independent clinics and the capacity for Healthcare Improvement Scotland to receive complaints from the public will foster improvement in the delivery of high quality care.

b. Phase 2: Extending regulation through the use of one or more of the following options:

i) Certain high-risk procedures (and especially dermal fillers) should only be provided by, or on behalf of, regulated health care professionals who have an appropriate level of expertise. If at all possible, this should be introduced in a coordinated manner across the UK, to reduce the chance of 'cross-border tourism'. When provided on behalf of a regulated health care professional, that professional should ensure that all reasonable steps have been taken to assure the training of those delivering the procedure and should have overall responsibility for the quality of care delivered.

ii) In addition, compulsory licensing by local authorities should be required for all cosmetic practitioners delivering specific cosmetic procedures (a broader range of procedures than covered by i).

c. Phase 3: A few individuals with health care professional training who are outwith the groups noted in phase one may provide specific cosmetic procedures now and in the future to consumers. The numbers are expected to be very small compared to the professional groups involved who would have acquired the necessary additional skills and expertise. This may include for example, any clinical scientists who are supervising and performing aesthetic laser procedures, whose services can be regulated as independent clinics in their own right if necessary. Progress on the regulation of independent clinics will be monitored and consideration given to a new accreditation scheme, voluntary or legislative, for specified health care professional groups who wish to join the regulatory process.

2. GOOD PRACTICE

According to the data gathered, consent for surgical and non-surgical interventions is mainly taken in writing. Implied consent is used by a minority for non-surgical procedures. The main reason for health care professionals and cosmetic practitioners refusing treatment is that it will not meet the expectations of the clients. Ensuring the client / patient is fully informed about a procedure so that they are able to give genuinely informed consent is known to be difficult. Clients / patients are often unable to recollect information they have been given or misinterpret what they have been told, despite the best efforts of providers.

The new ruling from the recent Supreme Court (Montgomery vs Lanarkshire HB) dictates an explicit need to detail and record discussion around risk. Risk is 'material' if it is seen as of significance to a reasonable person in the patient's position.

A new concept developed from the plastic surgery speciality is a 'request for treatment' agreement between the provider and client. This allows the client to state what they are expecting to occur as a result of the treatment and an explicit discussion to be had on the likely outcomes. The first recommendation for good practice is:

a. 'Request for treatment'^[1] should be used as the standard agreement between a provider and a consumer of cosmetic interventions to obtain informed consent.

Advertisements were seen as presenting an unrealistic image of cosmetic interventions by the participants in the focus groups. There are standards on what can and cannot be advertised, including restrictions on advertising prescription-only medicines and the need to present a fair portrayal of what outcomes are likely from treatments. Sales promotions should be guided by UK advisory bodies and must not pressurise consumers with time-limited offers. The SCIEG observed many instances in which existing guidance on the marketing of cosmetic procedures is ignored. In order to reduce problematic marketing, poor practice needs to be notified to the Advertising Standards Authority (ASA). The second recommendation is:

b. It should be the duty of regulated care professionals and cosmetic practitioners providing cosmetic interventions to report breaches of advertising guidelines to the Advertising Standards Authority

The training of all health care professionals and practitioners of cosmetic interventions must be kept up to date and linked to national standards (such as the Royal College of Nursing accredited competencies used by the British Association of Cosmetic Nurses). The developing certification for surgeons from the Royal College of Surgeons and the Health Education England (HEE) framework for qualifications accrediting individuals to carry out non-surgical procedures are helpful additions. Both reports are likely to be published by the middle of 2015. The third recommendation is:

c. Health care professionals and cosmetic practitioners undertaking cosmetic interventions must be aware of training standards in their sphere of practice and keep up to date. The HEE training framework for nonsurgical cosmetic interventions will need to be assessed for relevance to Scotland.

New procedures, medical devices and devices sold for cosmetic interventions without a medical purpose, can be introduced into independent health and beauty care without strict monitoring processes. The literature review carried out for SCIEG found major limitations in the evidence base for many procedures and this makes it difficult for health care professionals and cosmetic practitioners to accurately inform potential consumers about the risks and benefits of many cosmetic procedures. Regulated health care professionals are required to demonstrate through revalidation how they are examining and reflecting on their practice. It is vital that all adverse events are reported promptly and feedback given on the outcome of reports. The fourth recommendation is:

d. Providers are expected to have clear governance processes (similar to those in the NHS) and pursue evidence-based practice by collecting, analysing and making available comparable data.

Focus group participants suggested that psychological assessment or group work would be beneficial to some people before having a cosmetic intervention. Patient/ client group work has been used with success in certain other areas of surgery (e.g. bariatric surgery) where individuals provide support for each other. Therefore the fifth recommendation for good practice is:

e. Providers of cosmetic services should always consider, and record the outcome of their assessment of the current and on-going psychological and emotional support requirements of their clients.

3. INFORMED AND EMPOWERED PUBLIC

Evidence from the focus groups and questionnaires found understanding of the potential risks of cosmetic intervention treatments varied widely. The gap in knowledge tends to be partly filled after a poor experience of a family member or friend. The consequences of some procedures are also masked when offered in situations where clients are under time pressure (e.g. offer ends today) or when alcohol is available. The likelihood of a procedure having long-term adverse effects may not be clearly stated. The IEP subgroup identified a need to improve the public's knowledge so that the right questions can be asked by potential clients from their providers; they know what to reasonably expect from a provider; and know who to report any problems to if things go wrong. The first recommendation for informing and empowering the public is:

a. Conduct a social marketing campaign, targeted at groups with specific need such as young people, to inform and empower the public so that they have a realistic understanding of the potential risks and benefits of treatments.

Cosmetic procedures are requested to change or improve an aspect of an individual's appearance. The change is usually enjoyed and the market for new and improved procedures expanding. There is concern among some providers and sections of the public that a false image of what is normal, age appropriate or can be realistically achieved may also be growing. Opportunities to teach and explore body image within personal development classes, young people's groups, older people's forums and elsewhere, could contribute to enhanced self-esteem and foster mental wellbeing. The second recommendation is:

b. Consider ways of supporting positive views of body image through education, mental health and broader wellbeing initiatives amongst different population groups

4. ACCESSIBLE REDRESS AND RESOLUTION

The consumer questionnaires and the focus groups found that sometimes clients are not aware of who is providing their cosmetic procedure, or of their relevant qualifications. This is unprofessional and risks compromising follow-up with the provider should difficulties arise. The recommendation is:

a. The client / patient must be given information on the name and the relevant qualification(s) of the person providing the procedure

The PiP silicone breast implant failure was followed by some independent providers indicating they had insufficient resources to respond to all those in need of care. This situation was unusual but the need for adequate indemnity is now a requirement for all health care professionals and must be a feature of the training and business management information for all those providing cosmetic interventions. The second recommendation is:

b. All providers undertaking any cosmetic intervention must have sufficient indemnity for their services

While Healthcare Improvement Scotland receives complaints about those services which it inspects, it is where to complain when issues arise in different settings or after a course of treatment has finished may be unclear to clients and the general public. The Independent Sector Complaints Adjudication Service (ISCAS) requires all independent hospitals to have transparent complaints systems.

Follow-up needs to be clearly described for both clients and the general public for care in the independent health care sector. Local authorities may receive complaints either directly or through the Citizen Advice Bureau. However, there appears to be reluctance for members of the public to complain if they have experienced poor care or an adverse event. Clinicians have found people are often not willing to complain about poor care but will seek out another practitioner. Being aware of how to complain and providing support to complain, in a manner that is sensitive to different ethnic groups, is a key component of accessible redress and resolution. The third recommendation is:

c. Transparent complaints systems must be visible for all services, enforced by Healthcare Improvement Scotland for the services they regulate, the Independent Sector Complaints Adjudication Service for independent hospitals and the Local Authorities for the services they monitor.

Revalidation is the process by which licensed doctors are required to demonstrate on a regular basis that they are up to date and fit to practice. The process is also being introduced for dentists, nurses and midwives. The formal system is supported by annual appraisal meetings at which the outcomes of their NHS work and any other work should be discussed and examined. Appraisals can be informed by reviewing compliments, complaints and any significant adverse events. The fourth recommendation is:

d. Appraisal of health care professionals should include discussion about the entirety of their practice, including cosmetic procedures.

The PiP silicone breast implants and metal on metal hips device failures highlighted the need for people to know what implant they have in place and for their medical records to be easily examined to find out if they are potentially at risk of an adverse outcome. The Private Healthcare Information Network (PHIN) is mandated by the Competition and Market Authority to collect data from all organisations undertaking cosmetic surgery. Currently all implants must be recorded in operation notes and kept for life. Some patients receive an implant card with all details listed. However patients' paper records may become detached from the operation notes and searching through all records to find those that might be affected by a device failure is time-consuming and may be impractical. Therefore there is a concurrent project examining whether a unique device identifier (barcode) can be entered into the electronic patient record so in case of device issues, patient requests, needs for certain medical scans and death certification, the information can be easily retrieved. This project is exploring the feasibility of such an approach and the first report is likely to be at the end of 2015. To support this work the fifth recommendation is:

e. Data including the UDI on all devices and implants must be included and easily extracted from electronic records of patients and clients and comply with any future / evolving UDI requirements.

5. MONITORING AND EVALUATION

It is important to monitor and evaluate the impact of any actions taken forward by Scottish Government and other stakeholders as a result of the recommendations of SCIEG. Questions on cosmetic procedures have been added to the Scottish Health Survey and will provide a baseline picture, prior to the implementation of these recommendations. A draft logic model has been developed and will be revised once the policy response to this report is available. A basket of process and outcomes indicators will be selected to keep track of progress and evaluate the outcomes of policies. The recommendation is:

a. A framework for monitoring and evaluation is expected to be developed by the Scottish Government to ensure monitoring of the implementation of the recommendations and evaluation of their impact.