Scottish Cosmetic Interventions Expert Group Report July 2015

7. Recommendations

1. REGULATION

After extensive deliberation, 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 health care professionals through a requirement to register 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

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: progress on regulation will be monitored and consideration given to a new accreditation scheme, voluntary or legislative, for specified health care professional groups.

2. GOOD PRACTICE

According to the providers questionnaire, consent is taken mainly in writing for both procedures and the taking of photographs. 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 professionals.

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'^[19] agreement between the health care professional and client. This allows the client to state what is expected and an explicit discussion to be had on the likely outcomes. The first recommendation for good practice is:

a. 'Request for treatment' should be used as the standard agreement between a health care professional and a consumer of cosmetic interventions to document 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 appears to be ignored. In order to reduce problematic marketing, poor practice needs to be notified. The second recommendation is:

b. It should be the duty of regulated health 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. The newly developed certification for surgeons from the Royal College of Surgeons is helpful as is the Health Education England framework for qualifications for non-surgical procedures. 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 and medical devices and devices sold for cosmetic interventions without a medical purpose, can be introduced into independent health and beauty care with strict monitoring processes or without. For devices with a medical purpose, the Medical Device Regulations require the manufacturer to carry out post market surveillance on their CE marked devices. There needs to be additional evidence gathered robustly on effectiveness that is shared with consumers. The limitations in the evidence base for many procedures as shown by the literature review makes it difficult for health care professionals and cosmetic practitioners to 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. A representative of a patient group wrote to the secretariat highlighting the longer term need for specific, trained psychological support for people who want to change their appearance. 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 beneficial 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. As creating a social environment can be done in many ways, the first recommendation for informing and empowering the public is:

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

Cosmetic procedures are requested to change or improve an aspect of an individual's appearance, entirely within their control. 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 altered permanently may also be growing. Opportunities within personal development classes, young people's groups, older people's forums and elsewhere, to teach and explore body image 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 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 developments for all those providing cosmetic interventions. The second recommendation is:

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

Healthcare Improvement Scotland receives complaints about those services which it inspects but it not clear that clients and the general public know where to complain when issues arise in different settings or after a course of treatment has finished. 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 Local Authorities for their services and by the Independent Sector Complaints Adjudication Service

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 compliments and complaints and any significant adverse events reviewed. The fourth recommendation is:

d. Appraisal of health practitioners should include discussion about all 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 the 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, death certification, the information can be easily retrieved. This project has a number of additional requirements 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. The Scottish Health survey questions on cosmetic procedures will provide a baseline picture, prior to the implementation of these actions. 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