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UNIT 1: Principles of History, Ethics and Law in Aesthetic Medicine. UNIT OVERVIEW. 1.1 Historical Background 1.2 Ethical Principles 1.3 Ethical Considerations 1.4 Professional Bodies & Guidance 1.5 Legal Marketing of Services 1.6 Legislation and Liability. UNIT OVERVIEW.
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UNIT 1:Principles of History, Ethics and Law in Aesthetic Medicine
UNIT OVERVIEW 1.1 Historical Background 1.2 Ethical Principles 1.3 Ethical Considerations 1.4 Professional Bodies & Guidance 1.5 Legal Marketing of Services 1.6 Legislation and Liability
UNIT OVERVIEW 1.1 Historical Background of Aesthetic Medicine 1.2 Ethical Principles 1.3 Ethical Considerations 1.4 Professional Bodies & Guidance 1.5 Legal Marketing of Services 1.6 Legislation and Liability
Historical Background • The concept of aesthetic medicine focuses on improving one’s appearance • This can include both surgical and non-surgical treatment modalities • Aesthetic procedures have been shown to significantly improve clients’ quality of life, psychological wellbeing and social function
Historical Background The general objectives of aesthetic treatments are: • Prevention and treatment of all forms of aesthetic pathology • Application of techniques to improve beauty and appearance • Prevention of ageing • Promotion of health, psychological, physical and personal well- being
Historical Background of Aesthetic Medicine It is essential to consider the following points when considering the history of aesthetic medicine and how it has evolved. Please undertake ‘directed study time’ to research these points further now. Hint: this research may be very useful for your course work! • The influence of the Nazi regime regarding beauty and social hygiene policy • The influence of technology • The influence of social media and concepts of beauty • The influence of World Wars on surgical techniques (see next slide) • Ethnic variation and modification
Influence of World Wars on Surgical Techniques • Plastic surgery (and thus aesthetic surgery by proxy as a specialty and some revolutionary surgical techniques were born out of WWI and WWII • Mass casualties requiring timely attention were seen with injuries to the face and limbs. • Whereas limbs were commonly amputated, facial injuries required immediate, but most importantly, delayed attention for a number of functional, social and even aesthetic reasons. • It was from this delayed work that the field of plastic surgery gained recognition and growth.
Influence of World Wars on Surgical Techniques • Some of the first successful skin grafts were performed on soldiers whose faces had been badly disfigured by bullets and flying shrapnel on the Western Front • Harold Gillies, a New Zealand-born surgeon, pioneered the treatment in England. • His actions were fueled by the thousands of casualties returning from the Battle of the Somme in 1916 and are credited with paving the way for modern-day plastic surgery. • From plastic surgery to aesthetic surgery….
Historical Background: General • Ancient Egyptians used animal oils, salt, alabaster and sour milk to aesthetically improve skin quality • First chemical peel described in 1871 by Tilbury Fox - 20% phenol to lighten skin • First injections for tissue augmentation in 1893 by Franz Neuber using autologous fat as filler material • Later in 1899 liquid paraffin commonly used as filler • Serious complications were often incurred through the historical practice of aesthetic medicine such as granuloma formation Krueger N et al. The History of Aesthetic Medicine and Surgery. J Drugs Dermatol 2013;12(7):737-742. http://granuloma.homestead.com/infections-non-mycobacterial.html
Botulinum Toxin Botulinum toxin, one of the most poisonous biological substances known, is a neurotoxin produced by the bacterium Clostridium botulinum. C. botulinum elaborates eight antigenically distinguishable exotoxins (A, B, C1, C2, D, E, F and G). All serotypes interfere with neural transmission by blocking the release of acetylcholine, the principal neurotransmitter at the neuromuscular junction, causing muscle paralysis.
Historical Background: Botulinum toxin • 1992 Canadian ophthalmologist and dermatologist Alastair Caruthers published treatment of glabellar frown lines with with bacterial Clostridium botulinumtype A. • “Botox” coined by Allergan, rose to fame in 2002 after its approval for cosmetic use. Krueger N et al. The History of Aesthetic Medicine and Surgery. J Drugs Dermatol 2013;12(7):737-742. http://ballsbridgeclinic.ie/wp-content/uploads/2015/03/botox-allergan.jpg
Historical Background: General Botulinum toxin, also called “miracle poison,” is one of the most poisonous biological substances known. It is a neurotoxin produced by the bacterium Clostridium botulinum, an anaerobic, gram-positive, spore-forming rod Scott first demonstrated the effectiveness of Botulinum toxin type A in strabismus in humans Scott AB. Botulinum toxin injection of eye muscles to correct strabismus. Trans Trans Am Ophthalmol Soc. 1981;79:734–70
Historical Background: Dermal fillers • In 1981, bovine collagen became the first FDA approved facial filler • 1998: first clinical study in Sweden using hyaluronic acid in skin augmentation • Hyaluronic acid quickly replaced collagen as number one filler substance • US FDA approved it in 2003, many years after market release in Europe Krueger N et al. The History of Aesthetic Medicine and Surgery. J Drugs Dermatol 2013;12(7):737-742. http://i0.wp.com/chollywood.info/wp-content/uploads/2016/09/Hyaluronic -Acid-Based-Dermal-Fillers-Market.jpg?fit=600%2C250&resize=350%2C200
Historical Background: Modern day • American Society for Aesthetic Plastic Surgery (ASAPS) reports that cosmetic procedures have increased by 197% from 1997-2011 • In the United States in 2011 almost 9.2 million cosmetic surgical & non-surgical procedures were performed • Aesthetic procedures are evidently on the rise! Krueger N et al. The History of Aesthetic Medicine and Surgery. J Drugs Dermatol 2013;12(7):737-742. www.rubytechco.com/wp-content/uploads/2016/11/Botox.jpg
Financial background and current projections The global aesthetics market has been and is projected to continue to experience rapid growth and shows no current signs of slowing. From $2.5 billion in 2013 to $5.4 billion in 2020 at a Compound Annual Growth Rate of 11% according to GBI Research Revenue ($bn) Year
Financial background and current projections Value of the UK Cosmetic surgery market (£m) Year
UNIT OVERVIEW 1.1 Historical Background 1.2 Ethical Principles 1.3 Ethical Considerations 1.4 Professional Bodies & Guidance 1.5 Legal Marketing of Services 1.6 Legislation and Liability
Ethical Principles • Ethics is the philosophical inquiry into nature and ground of morality • Beauchamp and Childress described four principles of modern medical ethics: Gupta S. Ethical and legal issues in aesthetic surgery. Indian Journal of Plastic Surgery 2012;45(3):547-549. https://prsay.prsa.org/wp-content/uploads/2016/05/006fb46.jpg
1. Beneficence Beneficence – moral obligation to act in a patient’s best interests • Medical practitioners should act in patients’ best interests • Undertaking treatments to improve patients’ self-image and esteem is deemed acceptable • Be aware of Body Dysmorphic Disorder – psychiatric syndrome characterised by pre-occupation with non-existent cosmetic defect and persistent attempts to have perceived defect surgically corrected Mousavi SR. The Ethics of Aesthetic Surgery. J Cutan Aesthetic Surg.2010;3(1):38-40.
1. Beneficence Beneficence – moral obligation to act in a patient’s best interests • The potential benefit for the client should always be identified and even analysed • This should be done from a physical, psychological and emotional point of view.
2. Non- maleficence Non maleficence – a moral obligation to protect patients from harm and negligence • Never act against the patient’s best interests or in a way that may harm patients • Decline to undertake a procedure if it is not in the patient’s best interest • Do not treat if there are unrealistic expectations or if excessive risks of treatment outweigh benefits - Never proceed purely for personal pecuniary gain Mousavi SR. The Ethics of Aesthetic Surgery. J Cutan Aesthetic Surg.2010;3(1):38-40.
2. Non- maleficence Non maleficence – a moral obligation to protect patients from harm and negligence • Treatment risk should always be minimsed • Non medically suitable clients should be identified and treatment should be avoided.
3. Autonomy Autonomy – recognition that all persons have an unconditional right to determine their own path • It is the patient’s right to decide on whether to undergo treatment • Patient’s have a right to make an informed decision and this must be respected • Informed consent implies: • Sufficient and correct information is provided to the patient • Risks and benefits of procedures and alternative treatments are discussed and explored • That the patient has capacity and is competent to consent Mousavi SR. The Ethics of Aesthetic Surgery. J Cutan Aesthetic Surg.2010;3(1):38-40.
3. Autonomy Autonomy – recognition that all persons have an unconditional right to determine their own path • Clients’ decisions should be respected and they have the right to refuse treatment at any point • Permission should always be obtained to physically touch the client – consider the Human Rights Act • The practitioner must accept that clients have varying opinions and preferences regarding aesthetic preferences • Treatments must be designed and carried out to protect a client’s ability to function- emotionally, physically, socially and economically.
4. Justice Justice – the recognition that goods and services should be fairly distributed among all citizens • Practitioners should ensure that medical care is available to all • Equitable access to healthcare is regarded as a basic human right • Private sector- those who can afford - pay required fee Mousavi SR. The Ethics of Aesthetic Surgery. J Cutan Aesthetic Surg.2010;3(1):38-40. https://img.clipartfest.com/ff54f6280f01def80be4a351f7dc9f1c-criminal-justice-clipart-clip-art-criminal-justice_2800-2800.jpeg
4. Justice Justice – the recognition that goods and services should be fairly distributed among all citizens • It is essential that all clients are treated equally irrespective of their resources • Clients should not be treated with any favouritsm or discrimination
UNIT OVERVIEW 1.1 Historical Background 1.2 Ethical Principles 1.3 Ethical Considerations 1.4 Professional Bodies & Guidance 1.5 Legal Marketing of Services 1.6 Legislation and Liability
Ethical Considerations • Right for autonomy may, in certain situations, contradict non- maleficence i.e. body dysmorphic disorder • Open and aggressive advertising of the aesthetic practitioner may negatively influence public perception of body image • Adolescent and young adult clients may lack capacity to make informed decisions regarding aesthetic procedures Mousavi SR. The Ethics of Aesthetic Surgery. J Cutan Aesthetic Surg.2010;3(1):38-40. Gupta S. Ethical and legal issues in aesthetic surgery. Indian Journal of Plastic Surgery 2012;45(3):547-549.
UNIT OVERVIEW 1.1 Historical Background 1.2 Ethical Principles 1.3 Ethical Considerations 1.4 Professional Bodies & Guidance 1.5 Legal Marketing of Services 1.6 Legislation and Liability
Professional Bodies and Guidance • Health Education England was commissioned by the Department of Health to develop standards of training in 2014 • This guidance was developed to ensure the safe practice of aesthetic medicine and was in response to the Keogh Review, 2013.
Professional Bodies and Guidance • On June 1st 2016, the General Medical Council (GMC) issued new guidance to aesthetic practitioners • The standards are outlined in Guidance for doctors who offer cosmetic interventions and relate to patient consultations, giving patients time to reflect and advertising responsibly http://www.gmc-uk.org/Guidance_for_doctors_who_offer_cosmetic_interventions_210316.pdf_65254111.pdf
Professional Bodies and Guidance Seven new standards are summarised and described by the GMC. They are as follows: 1) Directly seek patient consent: it is the responsibility of the treating practitioner to obtain consent and to make sure that the patient is given enough information to make and informed decision. The responsibility must not be delegated.
Professional Bodies and Guidance 2) Give patients time for reflection: patients should be given enough time to consider information about the risks and possible outcomes of a procedure. 3) Consider your patients psychological needs: appreciate your patient’s vulnerabilities and discuss these openly when considering cosmetic interventions. Use screening tools to assess for your patient’s psychological status.
Professional Bodies and Guidance 4) Work within your competencies 5) Ensure patients have the information that they want or need: this includes written information to support continuity of care, which explains the medicines and/ or implants used
Professional Bodies and Guidance 6) Responsible marketing: Promotional tactics to encourage patients to make ill- considered decisions must be avoided. Advertising must be clear and factual. Cosmetic procedures should not be offered as prizes.
Professional Bodies & Guidance • General Medical Council Guidance for practitioners offering cosmetic procedures- some more detail… • The GMC states: • Recognise and work within the limits of your competence • Before carrying out procedures make sure you can do so safely e.g. by undergoing training www.gmc-uk.org/guidance/ethical_guidance?29004.asp https://www.skinvivatraining.com/uploads/gmc.-guidance-doctors-cosmetic-treatments.jpg
Professional Bodies & Guidance • Take part in activities to maintain and develop your competence e.g. attending conferences • Keep up to date with the law, clinical and ethical guidelines • Seek out and act on feedback from clients on their satisfaction with procedures performed and results achieved https://www.gmc-uk.org/guidance/ethical_guidance/28688.asp www.healthwatchwarrington.co.uk/wp-content/iploads/2016/02/gmc-300x214.jpg
Professional Bodies & Guidance • Keep clients safe by monitoring outcomes and report product safety concerns to relevant regulator • Tell clients how to report complications and adverse reactions www.gmc-uk.org/guidance/ethical_guidance?29004.asp www.renewskinandhealthclinic.co.uk/media/articles/278/dermal-fillers-treatments-lip-augmentation_big.jpg
Professional Bodies & Guidance • Carry out physical examination of client before prescribing injectable fillers – i.e. not telephonically • Communicate clearly and respectfully with clients – listen closely to questions and concerns www.gmc-uk.org/guidanceethical_guidance?29004.asp https://dermabare.com/wp-content/uploads/2012/07/Untitles-11.jpg
Professional Bodies & Guidance • Give the client the time and information required to reach a voluntary and informed decision regarding the procedure • Remind the client that they can change their mind at any point www.gmc-uk.org/guidance/ethical_guidance?29004.asp www.renewskinandhealthclinic.co.uk/media/articles/327/medical-beauty-consultation-treatments_big.jpg
Summary of GMC role • Authority over GMC registered practitioners • Enforcement of best practice • Enforcement of professional codes of practice • Publication of guidance and legislation relating to surgical and non- surgical procedures • Collaboration with Health Education England to set standards
Limitations of the GMC • Lack of authority over non- GMC registered practitioners • Treatment delivery in non- hospital settings presenting a problem with regards to treatment traceability and audit • Issues concerning the control of remote- prescription • A decreased efficiency within the aesthetic arena compare to general healthcare (e.g. difficulty revoking GMC registration; requires more serious or persistent failure to follow guidance and this being reported effectively)
Professional Bodies & Guidance Other sources of guidance • NHS Health Education England • British Association of Aesthetic Plastic Surgeons • Royal College of Surgeons • Committee of Advertising Practice www.hilltopcentre.org.uk/wp-content/uploads/2015/10/nhs-england-1000x288.jpg https://oup.silverchair-cdn.com/ImageLibrary/ASJ/baaps.jpg https://www.rcseng.ac.uk/-/media/images/rcs/system/rcs-logo.png?h=186&w=438&la=en&hash=B40A2FB4B388A93A3B48DE332BC3
UNIT OVERVIEW 1.1 Historical Background 1.2 Ethical Principles 1.3 Ethical Considerations 1.4 Professional Bodies & Guidance 1.5 Legal Marketing of Services 1.6 Legislation and Liability
Legal Marketing of Services • Committee of Advertising Practice (CAP) creates the advertising code of practice enforced and regulated by Advertising Standards Authority (ASA) • According to ASA >3000 adverts relating to cosmetic and aesthetic interventions received complaints in the last 5 years – and over 400 were banned • Advertising and marketing that influences the public to be dissatisfied with their appearance has been deemed aggressive and unethical • Please review the ASA and CAP websites and your additional learning material for more information regarding advertising of cosmetic interventions and procedures. www.aestheticsjournal.com/feature/advertising-in-aesthetics
Legal Marketing of Services • The ASA role is growing due to: • Increasing sector regulation (consider the Cosmetic Practice Standards Authority (CPSA) and Joint Council of Cosmetic Practitioners (JCCP)) • Increasing industry requiring the regulation • Increased availability of aesthetic treatments and increased popularity
Legal Marketing of Services • The ASA role involves • Enforcement of advertising standards and best practice • Enforcement of codes of practice • Addressing complaints or particularly unethical forms/ styles of aesthetic advertising • The ASA enforcement strategy is currently more reactive than practice
Legal Marketing of Services • The ASA focusses on • Promoting client informed decision making (e.g. expected treatment results, potential treatment complications, treatment safety, treatment costs and short and long term treatment requirements including aftercare • Minimising treatment coercion (e.g. special offers that may wrongly encourage an ill- informed treatment decision or wrongly entice clients)
Legal Marketing of Services • Issues included trivialising risks of procedures and misleading individuals to having unrealistic expectations • Advertising should promote the consultation and not only the product • Information advertised needs to be factual and balanced www.aestheticsjournal.com/feature/advertising-in-aesthetics
Legal Marketing of Services • Visual aids such as before and after pictures should be accurate and truthful – no retouching of images should occur • The GMC explicitly advised that marketing should in no way directly target young people www.aestheticsjournal.com/feature/advertising-in-aesthetics www.theyouthdoctor.co.uk/wp-content/uploads/Facelift-Before-After-1-UK.png