DM L7 Combined Manual v6 PDF

BOTULINUM TOXIN TYPE-A & DERMAL FILLERS PRE COURSE TRAINING MANUAL FOR DELEGATES LEVEL 7 / COMBINED COURSE 1 Welcome to Derma Medical’s Aesthetic Medicine Training Course! Shifting trends and advancements in the field of aesthetic medicine makes now the best possible time to start a career in this rapidly expanding field. Starting your medical cosmetics practice is both an exciting and stressful time. At Derma Medical we understand the difficulties that can be faced as well as the rewarding aspects of the job, and we are here to guide you through this journey. At Derma Medical we appreciate that the quality of your aesthetic treatments varies according to the quality of your training. We strongly believe in excellence and this is reflected in our high quality training. Our aim is to develop safe, competent and confident practitioners. Whatever route you decide to take in non-surgical cosmetics, we hope that you leave our training courses with confidence to develop new clinical and business skills. We hope you enjoy your botulinum toxin type-A and dermal filler training course and find this manual useful. Please use this course book as a reference for your practice. Dr Zack Ally Medical Director Derma Medical 2 CONTENTS Unit 1: Principles of History, Ethics and Law in Aesthetic Medicine 1.1 Historical background 1.2 Ethical principles 1.3 Professional bodies & guidance 1.4 Ethical considerations 1.5 Legal marketing of services 1.6 Legislation and liability Unit 2: Principles of Treatment in Aesthetic medicine 2.1 Aesthetic consultation 2.2 Informed consent, shared decision making & the ‘cooling off’ period 2.3 Consent, capacity, coercion & confidentiality 2.4 Managing expectations- client goals, conflict of interest, waivers and disclaimers 2.5 Combination treatments 2.6 Clinic requirements 2.7 Needle stick injuries & vasovagal responses- recognition and management Unit 3: Principles of Psychology in Aesthetic Medicine 3.1 Motivation behind cosmetic treatment 3.2 Impact of cosmetic treatments on psychological well-being 3.3 High risk groups & screening tools 3.4 NICE guidelines 3.5 Professional boundary setting 3.6 Support/referral pathways Unit 4: Principles of Dermatology in Aesthetic Medicine 4.1 Anatomy and function of skin 4.2 Facial aging- morphology, proportions, youth & attractiveness 4.3 Intrinsic vs extrinsic aging of skin 4.4 Dermatological conditions impacting appearance 4.5 Cosmetic treatments available for various dermatological presentations 4.6 Effects of skin care products 4.7 Skin health assessment tools 3 CONTENTS Unit 5: Principles of Botulinum Toxin in Aesthetic Medicine 5.1 Biochemistry & mechanism of action 5.2 Medical indications 5.3 Cautions & contraindications 5.4 Dilutions of various botulinum toxins 5.5 Equipment & patient positioning 5.6 Injection precautions & treatment areas 5.7 Foundation botulinum toxin procedures 5.8 Complications & management 5.9 Post treatment advice & reviews 5.10 Advanced botulinum toxin procedures Unit 6: Principles of Dermal Fillers in Aesthetic Medicine 6.1 Biochemistry & mechanism of action 6.2 Facial vasculature, nerves and fat pads 6.3 Product selection and variability 6.4 Cautions & contraindications 6.5 Injection techniques 6.6 Foundation dermal filler procedures 6.7 Complications & prevention/management 6.8 Post treatment advice 6.9 Hyaluronidase and how to use it 6.10 Advanced dermal filler procedures 4 Unit 1: Principles of history, Ethics and Law in Aesthetic Medicine 1.1 Historical Background The field of aesthetic medicine has significantly expanded in the last decade. More affordable treatments, minimally invasive approaches, reversible procedures and fewer complication rates have seen a large shift from surgical to non-surgical cosmetic treatments. Aesthetic/cosmetic medicine focuses on improving one’s cosmetic appearance. This can include both surgical and non-surgical procedures. Although aesthetic medicine procedures are typically elective, they can significantly improve quality of life, psychological well-being and social function. The general objectives of aesthetic medicine are: Prevention and treatment of all forms of aesthetic pathology Application of techniques to improve beauty and appearance Prevention of aging Promotion of health and psychological, physical and personal well-being Aesthetic medicine was in its infancy stages in the 1980s and 1990s The origin of the international organisation of aesthetic medicine began with the constitution of the French Society of Aesthetic Medicine. The founder and first president was Dr. Jean Jacques Legrand. Soon afterwards, the example was followed by a variety of other societies that were founded, including the Spanish Society of Aesthetic Medicine (SEME) in 1984. In the mid-2000 decade, aesthetic/ cosmetic medicine has exponentially taken off and is now a very well accepted field of medicine. The drive of this explosive growth has mainly been due to technological advances a growing demand. This relatively new field of aesthetic medicine basically involves three main categories. 1. Injectables - such as botulinum toxins and dermal fillers to help decrease the look of the natural aging process. 2. Lasers- this technology has rapidly surpassed some of the traditional medical training and can be used for a wide variety of applications such as hair removal, vein removal, collagen stimulation, non-traditional liposuction, hair stimulation, teeth whitening, and many more. 3. Minimally invasive cutting & suturing – These are minor procedures that do not require general anaesthesia such as hair transplants, thread lifts etc. 5 As described in The Review of the Regulation of Cosmetic Interventions (Keogh Review), cosmetic procedures represent a rapidly growing industry in the UK. Procedures can be surgical or non-surgical, with non-surgical procedures currently accounting for more than 75% of the market value. 1.2 Ethical Principles The aesthetic medicine industry has long been largely unregulated. Given the technical nature and large variety of treatments available, a clear need for regulation has been identified. As healthcare workers, ethical principles must always be maintained to ensure that patients/clients are never exploited. The aesthetic industry, by its very nature, has the potential to attract a vulnerable population. For this reason, regulation and professional bodies are required to ensure that interventions/treatments are always offered with ethical principles being upheld. Even now, many arguments against aesthetic medicine exist, questioning the ethics behind it as a medical practice. Such arguments revolve around it being; ‘unsafe practice/coercive/disrespectful of human dignity/creating inequalities/undermining the integrity of the medical profession.’ The four principles of health care ethics developed by Tom Beauchamp and James Childress provide medical practitioners with guidelines to make decisions when they inevitably face complicated situations involving patients. The four principles are: 1) Autonomy - the right of the patient to retain control over his or her body. A health care professional can suggest or advise, but any actions that attempt to persuade or coerce the patient into making a choice are violations of this principle. In the end, the patient must be allowed to make his or her own decisions – whether or not the medical provider believes these choices are in that patient’s best interests – independently and according to his or her personal values and beliefs. 2) Beneficence - This principle states that health care providers must do all they can to benefit the patient in each situation. All procedures and treatments recommended must be with the intention to do the good for the patient. To ensure beneficence, medical practitioners must develop and maintain a high level of skill and knowledge, make sure that they are trained in the most current and best medical practices, and must take their patients’ individual circumstances into account: what is good for one patient will not necessary benefit another. 6 1) Non-Maleficence - Non-maleficence is probably the best known of the four principles. In short, it means, “to do no harm.” This principle is intended to be the end goal for all of a practitioner’s decisions, and means that medical providers must consider whether other people or society could be harmed by a decision made, even if it is made for the benefit of an individual patient. 2) Justice - The principle of justice states that there should be an element of fairness in all medical decisions: fairness in decisions that burden and benefit, as well as equal distribution of scarce resources and new treatments, and for medical practitioners to uphold applicable laws and legislation when making choices. A successful training and education program should prepare practitioners not only to provide a high standard of safe and appropriate cosmetic intervention, but also to have an emphasis adhering to the principles of “do no harm” and promote public health at all times. 1.3 Professional Bodies & Guidance Health Education England (HEE) was commissioned by the Department of Health to develop standards of training to ensure the safe practice of aesthetic medicine. There are now defined qualification requirements for delivery of cosmetic procedures whereby experts from throughout the cosmetic sector contributed to the formulation of new guidelines. These guidelines ensure both improved training and patient safety. Clinical risk can be considerably reduced if practitioners have the appropriate skills and knowledge. HEE exists as a whole to improve the quality of care for patients by delivering a better health and healthcare workforce for England. This ensures a positive impact on the aesthetic industry through education, training and personal development of practitioners. This gives an overall emphasis on supporting and improving the quality and standards of patient and client care alongside safe delivery of cosmetic procedures. Derma Medical has been built around the new guidelines in an endeavour to support safer, regulated practice. The General Medical Council has also issued on the delivery of cosmetic injectable treatments. See unit 1.4 ‘Ethical Considerations’ below. 7 The GMC fitness-to-practice (FTP) panel, in response to any of the above, can de-register, suspend (for up to 12 months) or allow conditional registration for up to 3 years. Similarly, the General Medical Council (GMC) aims to protect patients and public interest by issuing doctors a license to practice and placing them on a register. Dental, Nursing, Midwifery and Pharmaceutical councils do the same with their respective professionals. Doctors are expected to revalidate every 5 years to retain this license. Complaints are taken seriously and the GMC will take action to investigate a doctor’s fitness to practice for the following reasons: 1) Deficient professional performance 2) A conviction for a criminal offence 3) Adverse physical or mental health The General Medical Council has also issued guidance on the delivery of cosmetic injectable treatments. See unit 1.4 ‘Ethical Considerations’ below. Derma Medical has been built around the new HEE and GMC guidelines in an endeavor to support safer, regulated practice. 8 1.4 Ethical Considerations On 1st June 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. Seven new standards were described, as follows: 1) Directly seeking patient consent: It is the responsibility of the treating practitioner to discuss cosmetic procedures with the patient, making sure they have the information they need to make an informed decision. This responsibility must not be delegated. 2) Give Patients Time for Reflection: Patients must be given time to consider the information about the risks and possible outcomes, so they can decide whether to go ahead with a procedure. 3) Consider Your Patients’ Psychological Needs: Patient’s vulnerabilities must be considered when discussing cosmetic interventions. The treating practitioner must make sure he/she is satisfied that their request for the procedure is voluntary. Patient/client well-being, psychological and emotional support are essential to enable prospective clients and patients seeking cosmetic procedures to make informed decisions and to recognise the importance of patients and practitioners working together to achieve realistic expectations. 4) Work Within Your Competence: Practitioners that feel they cannot safely meet a patient’s needs must ask for advice or refer a patient to a colleague. Practitioners must recognise and work within their own limits. 5) Make Sure Patients Have the Information They Want or Need: This includes written information to support continuity of care, which explains the medicines or implants used. 6) Take Particular Care if Considering Cosmetic Procedures for Children: Do not perform a cosmetic intervention on a child without directly judging it is wanted – even if the parent has given their consent. 7) Responsible Marketing: Promotional tactics to encourage patients to make ill considered decisions must be avoided and advertising must be clear and factual. Cosmetic procedures should not be offered as prizes. 9 1.5 Legal Marketing of Services Under the Medicines (Advertising) Regulations act 1994, and the Committee of Advertising Practice (CAP) code, botulinum toxin brands which are Prescription Only Medicines (POMs) should not be advertised or promoted to the public. Advertising for cosmetic clinics and services may promote the service provided, e.g. "treatment for lines and wrinkles" or "wrinkle relaxing/anti-ageing treatments", as this is non-specific and may include various procedures. However, advertising must not mention "Botox®", "Vistabel®" "Dysport®", "Azzalure®", "Xeomin®", "Bocouture®" and "Neurobloc®", or "botulinum toxin", "BTX-A" etc. as this is prohibited by the regulations. Equally, marketing content that does not belong to yourself can be subject to copyright amercements. It is the ethical and moral responsibility of the practitioner to advertise their own work, unless otherwise citing the original source after having had consent. Similarly, advertising treatments that over promise results, or treatments that you are not trained on breaches GMC guidance which can result in penalisation. For all photographic marketing or advertising of cosmetic work, patient consent must be obtained. In addition to marketing your services as per guidelines, it is equally important to advertise your title correctly. Fabricating your status or creating a ‘false impression’ of your qualification is against the law and could result in disciplinary action by the professional body (GMC/GDC/NMC/GPhc). Acceptable titles for the relevant groups are as follows: Aesthetic Doctor/Dentist/Nurse/Pharmacist Cosmetic Doctor/Dentist/Nurse/Pharmacist Cosmetic/Aesthetic Clinician/Physician (for doctors) Aesthetic Practitioner (all groups) The Advertising Standards Authority (ASA) is the UK’s independent advertising regulator. The ASA makes sure ads across UK media stick to the advertising rules (the Advertising Codes). The Committee of Advertising Practice (CAP) is the sister organisation of the ASA and is responsible for writing the Advertising Codes. The ASA and CAP are committed to regulating in a way that is transparent, proportionate, targeted, evidence-based, consistent and accountable. 10 1.6 Legislation and Liability Derma Medical has been built around the new Health Education England guidelines in an effort to support safer, regulated practice. The Key changes proposed are as follows: 1) The requirements apply to all practitioners, regardless of previous training and professional background (See fig 1). All groups will be required to: Undertake additional education and training to be able to deliver cosmetic intervention. Or Formally demonstrate that they already meet the qualification requirements if they are already practicing (Recognition of Prior Learning) 11 2) For practitioners who will be administering cosmetic injectables, the key points outlined from the report are as follows:- Dermal fillers are still classed as a medical device and don’t require a prescription. Trained practitioners can administer these upon completion of their training. Botulinum toxins are a Prescription-Only Medicine (POM). HEE agrees with GMC, GDC and NMC guidance on face-to-face consultations before prescribing. Remote prescribing is against the law. The following groups are able to prescribe botulinum toxins for cosmetic purposes: Doctors and dentists Pharmacist independent prescribers Nurse and midwife independent prescribers 3) Cosmetic insurance is an important consideration for aesthetic practitioners when practicing. Legislation and complaints can occur within the aesthetic industry so whilst carrying out the treatments safely and effectively is key, accurate documentation (see unit 2.3) and appropriate indemnity cover are equally pertinent. Cosmetic insurance can be attained in 2 ways: i) Defence unions: Medical/dental/nursing unions can cover trained practitioners by ‘topping-up’ existing indemnity to cover for cosmetic injectable treatments. (This is the more expensive option). ii) Cosmetic unions: Cosmetic indemnity providers such as Cosmetic Insure or Hamilton & Fraser provide direct indemnity cover for aesthetic treatments. They specialise in this service and offer cheaper quotations than defence unions. 12 Duty of care: In the public sector, a duty of care is imposed upon the practitioner once they assume responsibility of the patient under Common Law when assistance is requested or the practitioner is aware of the patient’s need for medical intervention. In the private sector, this practitioner-patient relationship is contractual. The duty of care here and terms will be expressed and negotiated precisely- typically when the patient/client pays for services. An individual doctor or clinic may choose to employ others to assist in the running of his/her practice/clinic and hence liability may be direct or vicarious. It is the duty of the responsible practitioner to provide a safe system of operations and not stretch or exhaust resources. It is important that all employed staff are adequately trained in the services they perform and have the necessary resources to perform their duties. Practitioners should work within their limits when extending their scope and not delegate unknowingly. Derma Medical endeavours to be at the forefront of the new change, and aid in producing the next generation of safe, competent and ethical aesthetic practitioners. 13 Unit 2: Principles of Treatment in Aesthetic Medicine 2.1 Aesthetic Consultation Following the new HEE changes, it is now the responsibility of the treating practitioner to discuss cosmetic procedures with the patient. The onus is on the practitioner to ensure customers have the information they need to make an informed decision. This responsibility must not be delegated. The aesthetic consultation can be divided into three steps. STEP 1 -Treating your client involves assessing their facial structures. It is important to take time to carefully observe their facial expressions and examine your patient whilst they are upright in good light to ascertain their facial anatomy. Appreciate how the face ages and apply this to your client. Remember everyone is anatomically different. It is important to take into consideration your client’s age and what intervention is realistic for them. With younger clients, the focus can be on prevention which can be straight forward, whereas other clients may be older and expect miracles. It is important to be honest and give your client enough time to ask questions. STEP 2 -We recommend dividing the face horizontally into thirds and tackling each part holistically. The face can further be divided vertically into two parts to assess symmetry. Here UPPER MID filler. STEP 3 -Once the initial assessment is complete, it is pertinent to mutually decide on a treatment plan with your client, ensuring they are aware of benefits, risks, costs and timeframes. It is important to give your client time to consider the LOW treatment, which may not necessarily occur at first you can appointment. Once decided, make sure adequate assess which informed consent is completed in writing and areas can be supplemented with adequate photography. addressed with botulinum toxin, and which areas may benefit with volume restoration in the form of 14 The Consultation and Assessment Process Within Aesthetic Medicine The pre-treatment consultation is the most important part of the process within aesthetic medicine and goes beyond the process of taking a medical history. Effective verbal and non-verbal communication should be maintained throughout the whole process as well listening to the client. Practitioners have a duty of care to ensure that a thorough consultation takes place. By doing this it ensures that patient safety is maintained, it minimises post treatment regret, improves compliance with aftercare and client satisfaction. A thorough pre-treatment consultation enhances the therapeutic relationship between the practitioner and patient thus encouraging a trusting relationship between patient and practitioner. Realistic expectations must be set by the practitioner and the investment required by the patient discussed. Not just financial investment but follow up appointments, aftercare, and in some instances a review of lifestyle such as the impact of sun bathing and smoking for example to enhance outcomes. The pre-treatment consultation should include assessing a patient's lifestyle and occupation as it can impact on treatment outcomes and compliance with aftercare intentionally or unintentionally. Lifestyle and occupation may impact on when patients book their treatment. For instance, a gym instructor should not book botulinum toxin treatment before work as they would not be able to adhere to the aftercare and will consequently have a detrimental effect on results. The potential impact of bruising and swelling should also be considered when booking treatments, for instance teachers may tend to book treatments in during the school holidays so they have time to recover. Advice regarding aftercare should be given such as the use of ice, arnica and antihistamines to minimise post procedure swelling and bruising. Therefore, plenty of time for recovery and follow up appointments need to be factored in when booking appointments. This should all be discussed and agreed during the pre treatment consultation. It is important to understand a patients motivation for treatment, is it that their friends are having treatments and they want something done? Do they need the treatment that they are asking for? How is the concern affecting them? Is there a special occasion coming up or is there an underlying mental health concern? Do they know or understand what it is that they want? Is the area of concern real or something that is perceived to be a concern? Ample time needs to be allowed for the pre-treatment consultation and should not be rushed, they may be anxious about going ahead with a treatment, this needs to be discussed and reassurance offered. This will make the client feel at ease to talk about concerns as it can be a very personal thing that has led to insecurities. By allowing ample time, the practitioner can listen to the concerns expressed by the patient. This also allows the practitioner time to complete a facial shape assessment. All treatment options should be discussed, and the risks and benefits of each treatment considered. 15 A treatment plan should be developed in conjunction with the patient and practitioner in order to maintain safe practise. Shared decision making and a patient centered treatment plan reduces the risk of post treatment regret and ensures compliance with regards to aftercare. In addition, it allows the patient to make a fully informed choice when deciding which treatment(s) to go ahead with. Offering written information and establishing the patients level of understanding is imperative as it informs the practitioner with regards to their capacity to undergo aesthetic treatment especially if there are mental health concerns. Pressure should not be given to a patient to go ahead with treatment and good practice stipulates that there should be a cooling off period so that patients can consider what has been discussed. Furthermore, incentives should not be offered as it has ethical implications associated with it. A detailed medical history including allergies, previous aesthetic treatments and surgery should be obtained and reviewed each time the patient is seen to ensure that there have been no changes to their health and medication. If any psychological assessment tools are used in clinic, the practitioner must have had the appropriate training to ensure that they are safe and competent to use them as this could be more damaging for the patient. Where appropriate onward referrals need to be made. 16 2.2 Informed Consent, Shared Decision Making & the 'Cooling off Period' Patients must be given time to consider the information about the risks and possible outcomes, so they can decide whether to go ahead with a procedure. Patients must not be rushed into making any decisions and should be given information required to aid them in selecting the best option for them. Any form of ‘hard-selling’ must not be performed. In June 2016, the General Medical Council (GMC) released the draft of its first set of guidelines for doctors offering surgical and non-surgical procedures in response to The Keogh Review in 2013. The guidance was officially released in April 2016 and came into effect in June 2016 and said that practitioners should give patients, ‘The time and information they need to reach a voluntary and informed decision about whether to go ahead with an intervention’. It added that the amount of time needed for reflection depends on ‘The invasiveness, complexity, permanence and risks of the intervention, how many intervention options the patient is considering and how much information they have already considered’ and that a practitioner must tell the patient they can change their mind at any point. More guidance aimed specifically at surgeons was also released in April 2016, and recommended that they should implement a two-week cooling-off period before any surgery is carried out. Cooling-off periods are important for a myriad of reasons; but ensuring that the patient has given due consideration to the treatment they wish to have, and that their expectations of the results are realistic, are of paramount importance. After an initial consultation, a tremendous amount of information has been imparted and it’s essential that the would-be patient has enough time to digest the facts. In terms of how long a cooling-off period should be, this remains at the subjective discretion of the practitioner. It’s often suggested to be anything from a couple of days to a week or more. It can depend less on the treatment and more on the individual – if there is a suspicion that a particular patient is acting on impulse, has widely unrealistic expectations or doesn’t have a proper understanding of any downtime post treatment, a longer time frame may be needed. Cooling-off periods can build stronger patient relationships. Not only do they increase patient practitioner trust, they also promote a certain sense of realism in the expected outcome. People who rush into treatment often expect dramatic results, which may lead to disappointment. 17 2.3 Consent, Capacity, Coercion & Confidentiality For legal and insurance purposes, consent must always be obtained in the following 3 ways prior to treating any patient: 1) Verbal Once the patient has been given all the relevant information and is fully informed, a verbal agreement is required between the patient and practitioner prior to any treatment. 2) Written The practitioner should document what has been agreed, along with any advice, realistic expectations and possible complications. 3) Photographic Photographic evidence should be taken in both a relaxed and contracted state prior to botulinum toxin treatment. Pre and post treatment photos are also encouraged with dermal fillers. Post treatment photographs should be taken at the 2-week review. Consent can be ‘basic’ or ‘full’. For basic consent to be legally valid, an individual must be capable and informed of the broad nature and purpose of the treatment and consent must be voluntarily given without duress or coercion. For full consent/disclosure, the patient/client must have been informed about all potential benefits, risks and alternative treatment options. The legal basis or need for consent is normally seen as a guarantee of patient autonomy. If basic consent is not obtained, an action will arise in Tort Law for ‘Trespass against the person’ (Civil Law not Criminal Law). In the event of coercion, this will fall into the category of Criminal Law. In the event of inadequate disclosure of benefits, risks, alternative (including no treatment), the action will lie in the category of negligence. In summary, in order for an individual to be able to give full consent to a medical intervention, he/she must not only give information about the nature/purpose of the intervention, but also adequate information about its benefits, risks, and the risks of not having the intervention and also alternative possible medical interventions. Consent can also be ‘implied’ or ‘expressed’. Implied consent can be assumed when a client/patient takes some physical action to cooperate with a suggested examination or investigation. Expressed consent is documented in writing as evidence of acknowledgement. 18 Voluntariness/Duress/Coercion: Within the context of a consultation, coercion refers to refers to persuasion, manipulation or exploitation. In the aesthetic consultation, this represents a ‘grey area’. Offering someone a large sum of money to practice procedures on may be seen as coercive, however if the offer is attractive it may also be arguably not. The same offer being made to someone in difficult financial circumstances may be seen as exploitative which may invalidate consent. While personality plays a big part, such offers may be exploitative as they may hinder a person’s freedom of choice and ultimately negatively impact on the outcome. GMC guidelines now state that any act of hard selling or offering medical treatments as prizes are not allowed to keep in line with good practice guidelines and patient safety. Capacity: Common law dictates that individuals possess autonomy and self-determination, which encompass the right to accept or refuse medical treatment. Management of medical treatment can be complicated in situations when the ability of the patient to make reasonable decisions is called into question. Our legal system endorses the principle that all persons are competent to make reasoned decisions unless demonstrated to be otherwise. Appreciation for the seriousness of the medical intervention and the ability to weigh risks and benefits are essential components to the capacity assessment, but are subjective and cannot easily be subjected to standardised instruments. Thus, the aesthetic practitioner is thrust into the conflict of rendering care for the patient while looking after the patient's interests and wishes. If the patient is deemed to lack capacity, the interests of the patient must be respected. We often use the terms "competence" and "capacity" interchangeably. However, they are not exactly the same. Competence is a legal term. Competence is presumed unless a court has determined that an individual is incompetent. A judicial declaration of incompetence may be global, or it may be limited (e.g., to financial matters, personal care, or medical decisions). Decision-making capacity, on the other hand, is a clinical term that is task-specific. A physician may determine that a patient does not have the capacity to make a decision. In order to make valid treatment decisions, a person must be able to (a) recognise there is a decision to be made, (b) understand the needed information, (c) understand the treatment options, (d) understand the likely consequences of each option (i.e. risks, burdens, and benefits), and (e) rationally manipulate the information to come up with a decision consistent with his or her values. The Mental Capacity Act 2005 and its ancillary code of practice restates the Common Law which applies to both the public and private sectors. Failure to follow the code can be used in evidence in Civil or Criminal Law proceedings. Hence, in the event of temporary lack of capacity, where treatment isn’t immediately necessary (such as a cosmetic treatment), the least restrictive treatment will be no treatment at all at that point in time. 19 Mature Minors: With social media trends and the notion of ‘prevention’, the aesthetic industry is seeing a large influx of younger groups. With mature minors up to 18 years old, capacity must be assessed. At 16 a young person can be presumed to have capacity. Good practice suggests deferring treatment up until the age of 18 and documenting psychosocial factors that justify treatment under the age of 18. For those younger than 18, parental consent should be sought if the minor is insistent. GMC and Medical Defence Union guidance can also be sought. Confidentiality: The right to privacy is enshrined within the Human Rights Act which has been deployed by the courts to develop the Common Law. Client/patient information must remain trusted and kept by the treating practitioner and disclosed only at the request of the client themselves. It’s important to distinguish the right to privacy from the right to confidentiality. Private information may or may not be confidential. The Law of Confidentiality is concerned with the trusting relationship between the practitioner, the patient/client, other professionals and individuals. For this reason, the law functions in the event of breach to compensate (for personal and economic injury) and to deter. The Law of Privacy serves to prevent misuse of private information- whether or not it is confidential. Both private and confidential information are protected by the Data Protection Act. Confidential information can be breached without consent in the following situations only, as per case law: 1/Preventing harm to other and 2/Preventing or detecting a crime. The Data Protection Act 1998 serves to protect individuals with regards to the processing and use of personal information. The act not only imposes on all businesses legal duties to protect the personal data of others but also gives individuals the right to access their personal information subject to certain exceptions. Individuals have a right to: 1) Know the content of information held within their file 2) To apply to the courts to order correction of inaccurate information 3) To request prevention of information processing that may cause unwarranted damage/distress 4) Prevent unsolicited marketing 5) Claim compensation through the courts 6) To complain to the ICO (Information Commissioner’s Office) The ICO can take enforcement against the organisation should there be incorrect breach of the above. Failure to comply with an enforcement notice is a criminal offence and can lead to a monetary fine which must be reported to the GMC. 20 2.4 Managing Expectations - Client Goals, Conflict of Interest, Waivers And Disclaimers It is important to take into consideration your client’s age and what intervention is realistic for them. With younger clients, the focus can be on prevention which can be straight forward, whereas other clients may be older and have unrealistic expectations. Expectations are managed during the consenting and consultation process. A correctly informed patient is less likely to be dissatisfied as they should have realistic expectations of how the intervention will impact them. It is now both an ethical and legal responsibility of the practitioner to ensure realistic expectations are conveyed to potential patients or customers. Patients should not be mis-sold a treatment outcome that cannot be achieved and equally a desired outcome that cannot be achieved should be discussed during the consent and disclosure stages with photographic evidence to support this and alternative procedures mentioned. Conflict of interest occurs when client and practitioner interests are more in favour of one party. This has potential to arise during the pre-treatment aesthetic consultation. Conflict of interest can be financial (a situation which can prove more lucrative to the treating practitioner when offering treatments), practical (a preferred treatment modality offered due to more experience/expertise in the area due to bias) or indirect (a patient requesting a cosmetic treatment that a practitioner can administer but in a different setting e.g. general practice medical encounter for something else). In such cases it would be necessary and ethical to disclose your interests to the client when recommending a particular aesthetic treatment over alternative appropriate options. 21 Waivers/Disclaimers are commonly used within aesthetic consultations as part of the pre treatment paperwork. A disclaimer is a formal statement saying that you are not legally responsible for something, such as the information given in a book/internet. Disclaimers are often used in situations that involve some level of uncertainty or risk. A disclaimer may specify mutually agreed and privately arranged terms and conditions as part of a contract; or may specify warnings or expectations to the general public (or some other class of persons) in order to fulfil a duty of care owed to prevent unreasonable risk of harm or injury. Some disclaimers are intended to limit exposure to damages after a harm or injury has already been suffered. The presence of a disclaimer in a legally binding agreement does not necessarily guarantee that the terms of the disclaimer will be recognised and enforced in a legal dispute. There may be other legal considerations that render a disclaimer void either in whole or part. A waiver is the voluntary relinquishment or surrender of some known right or privilege. While a waiver is often in writing, sometimes a person's words can also be used as a counteract to a waiver. An example of a written waiver is a disclaimer, which becomes a waiver when accept ed. When the right to hold a person liable through a lawsuit is waived, the waiver may be called an exculpatory clause, liability waiver, legal release, or hold harmless clause. At Derma Medical, we strive to ensure safe dosages and anatomical landmarks are used to produce desired results. Delegates are taught to encourage patients into making subtle changes if necessary with a gentle approach to cosmetic treatment. This allows patients to titrate up treatment and build on previous work, as opposed to being left dissatisfied and over-treated. 22 2.5 Combination Treatments Combination treatments are often utilised by large corporate brands, allowing clients/patients to save money by combining treatments. With the new HEE guidelines, there is a grey area between monetary incentive and over-treatment. This emphasises the need to ensure patients are fully informed and provided with all relevant information prior to agreeing on any intervention. Classically common combination treatments are taught at Derma Medical training courses. With experience within the industry, we hope for our delegates to transition from single intervention treatments to total facial sculpting based on a solid knowledge of complimentary treatments. The following are examples of treatments used in combination within the industry: Upper face botulinum toxins treatment with 3 or 4 areas treated at once Lower face botulinum toxins treatment to the depressor anguli oris and platysmal bands Full facial sculpting with cheek fillers and jawline botulinum toxins treatment Perioral sculpting with nasolabial & marionette line dermal fillers, lip and smoker’s line dermal fillers 23 2.6 Clinic Requirements Businesses offering cosmetic procedures are subject to a wide range of laws and duties. These primarily relate to public health, occupational health and safety, environmental protection, and in some parts of the UK to public control licensing. Most of this law is administered by local authorities, often through their environmental health departments. It was suggested in the Keogh review that restrictions should be applied to the types of premises used to deliver treatments where clinical oversight was requested, for example, clinics equipped to deal with medical emergencies. It has been left up to the individual providing clinical oversight to ensure the provision of an appropriate and safe environment. Hygiene measures, sharps disposal, in-date products and safety equipment are a must for all situations regardless of venue choice and will be taught during the practical training days. Save Face Ltd is an independent and impartial accreditation scheme for aesthetic medical professionals and clinics. They offer an optional registration service to regulated health professionals only and audit practitioners against seven core standards. Each practitioner must supply: 1) Evidence of registration and qualification with the relevant statutory board 2) Evidence of insurance and training for each procedure offered 3) Evidence of mandatory training 4) Evidence of registration with The Information Commissioners Office 5) Samples of patient information 6) Consent forms 7) Evidence of legitimate supply of medicines Each clinic premise is inspected by auditors who ensure standards are met with regards to infection control, consent and confidentiality, management and reporting of adverse events, appropriate sharps disposal, record keeping, managing complaints, and quality of equipment. A breach of standards can result in investigation, suspension or exclusion from the Save Face Ltd register. As this register gains momentum and reputation, clients/patients will increasingly look for such quality standard verification. 24 2.7 Needle Stick Injuries & Vasovagal Responses - Recognition and Management Needle Stick Injury As with other injectable procedures such as cannulation or venepuncture, there is a risk of needle stick injury with cosmetic injectable treatments. This can occur during reconstitution of botulinum toxins, needle change prior to injection, or needle fixation in the case of dermal fillers. The same protocols for prevention and management of such injuries applies as in an NHS setting, as demonstrated in fig.2 below: 25 The Vasovagal Response The vasovagal response is a malaise mediated by the vagus nerve. When it leads to fainting, it is also known as “syncope”. This commonly affects individuals of all ages, and is regularly triggered in response to pain or needles. Prior to losing consciousness, individuals display early signs or symptoms such as light headedness, nausea, sweating, tinnitus, weakness, visual disturbance or feelings of anxiety. These symptoms can last for seconds prior to loss of consciousness which typically happens in an upright patient. The body’s response to pass out and fall down aids in effectively supplying increased blood flow to the brain from a supine position. If dealt with appropriately, brief periods of dizziness/faintness or even loss of consciousness do no harm and are seldom symptoms of disease. The main risk lies in the act of falling, which can be prevented with early recognition of signs and symptoms. In most cases of vasovagal syncope, treatment is unnecessary. Early detection and safe positioning into a supine position with elevation of both legs will result in a full resolution. Prior to treatment of patients, it is good practice to ask about such incidents so that necessary precautions are taken. Those who faint frequently without an obvious stressor should be advised to visit their GP. 26 Unit 3: Principles of Psychology in Aesthetic Medicine 3.1 Motivation Behind Cosmetic Treatment The industry of non-surgical/minimally invasive cosmetic treatments has radically evolved over the last 15 years and normalised; what was once seen as something luxurious and “risky” is now mainstream. These procedures are now, not only an option for the rich, but accessible to all ends of the population. The number of clinics offering such treatments has dramatically increased with hundreds of cosmetic clinics, thousands of salons and 1 out of 4 dental practices now offering non-surgical cosmetic procedures in the UK. 27 The main reasons for this shift towards non-surgical cosmetic procedures in particular over the classic “plastic surgery” are as follows: 1. Price - far less expensive than the average surgical treatment 2. Safer - minimally invasive treatments 3. Quicker - Immediate results with little or no down-time 4. Non-permanent - and often reversible 5. Good first step – for those considering cosmetic surgery 6. Marketing / Social Media / Social Pressures - increased awareness and acceptability A recent American study found that one-third of patients suffered a major life event within the preceding one year of the treatment, 50% had experienced some form of mental health issues that required specialist intervention at some point and almost a quarter were on psychiatric medication at the time of the cosmetic treatment. Another study found that from the top 5 women’s magazines in Canada, 48% of articles discussed the positive effect that cosmetic surgery had to emotional well-being for women. Other studies have surmised that body image, body dysmorphic disorder, teasing/bullying at school for appearance, low self-esteem, knowing someone who has had cosmetic treatments or being recommended treatments are strong motivational factors for cosmetic procedures. A huge trend towards “prevention is better than cure” is driving the younger market to seek more non-surgical cosmetic treatments. In addition, the Kardashian family, especially Kylie Jenner, have sky rocketed the popularity of such treatments just in the last 5 years. Interesting ly also, the influence of celebrities and public figures has led to what is considered to be attractive in different parts of the world, e.g. in the west, V-shaped jawlines, high arched chiseled features and voluminous lips seems to be a popular choice, in contrast to parts of the middle east where large and round features are considered attractive. 3.2 Impact of Cosmetic Treatments on Psychological Well-Being Patients presenting for a cosmetic treatment are also presenting with a psychosocial concern a desire to feel better about their appearance. Alternatively, they may have psychosocial issues that may not be determined by their physical appearance. Furthermore, these presentations may be socially or culturally driven on a continuum of severity. Many patients may be led to believe that better self-esteem and psychological well-being can be achieved with a cosmetic treatment through modern-day social media advertising. 28 The psychology of appearance is a broad term but enables the classification of individuals into 4 main groups: 1) Those with a normal appearance- Normal psychosocial concerns 2) Those with a normal appearance- Abnormal psychosocial concerns 3) Those with an abnormal appearance- Normal psychosocial concerns 4) Those with an abnormal appearance- Abnormal psychosocial concerns Multiple studies have found that post-treatment, patients report greater well-being. For example, a recent prospective study found that non-surgical procedures resulted in improve ment of self-esteem and reported quality of life through questionnaires even after 6 months of having the treatment. Patients undergoing cosmetic treatments form a unique group, there fore it is important to recognise the psychological status of any patient before treatment and any suspicion of adversity should result in a referral for assessment to a specialist. Some research suggests that certain characteristics such as female gender, unstable relation ships and unrealistic expectations are all linked with a poor outcome of cosmetic treatments. Moreover, there does not seem to be any hard evidence to suggest that poor psychological status will result in poor perceived outcome. Thus, whilst a vast majority of patients with psychological issues seek cosmetic procedures, there is limited evidence to suggest that these patients would have a poor perceived outcome. To-date most data that examines the impact of cosmetic procedures on well-being remains subjective with a lack of objective data. 29 3.3 High Risk Groups & Screening Tools Currently, the only recommended screening tools for psychological disorders examine body dysmorphic disorder (BDD) in cosmetic patients (see unit 3.4). There is currently no evidence based, widely available screening tool to assess psychological well-being in cosmetic patients, therefore, it is of paramount importance that patients are separately assessed for mental health issues during the consultation process. There is one questionnaire, the FACE-Q that has gone through rigorous review and has been proven to be of evidence-based benefit with psychometric analysis. It focuses on specific treatments as well as the whole face in general with questions like, “How satisfied are you with how symmetrical your face looks?” Higher scores in the FACE-Q questionnaire have been shown to result in more satisfaction pre and post treatment. However, this is not widely accessible yet. As aesthetic practitioners, it is vital to recognise the following vulnerable patients; 1. Addicts - these patients will continually come back for more and more procedures that are not needed. Continuing to treat these patients too frequently can result in over treatment, toxin-resistance and potential dissatisfaction. It is the responsibility of the treating practitioner to set limitations here and make sure the patient abides by these. 2. High Risk Groups - patients with depression, BDD, OCD and adolescents. Recognising these groups and offering the right psychosocial support/referral is pertinent and should be addressed in the consultation process, explaining that cosmetic interventions may not necessarily be the solution. Cardinal features in these groups include: i) Body Dysmorphic Disorder (BDD): obsessive preoccupation that some aspect of one's own appearance is severely flawed and warrants exceptional measures to hide or fix. Common perceived bodily defect can be at virtually any area, yet is usually the face, nose, stomach, thighs, skin, or hair. ii) Obsessive Compulsive Disorder (OCD): Repetitive uncontrollable thoughts, acts or routines, which unless undertaken, result in severe anxiety. iii) Depressive Disorder: Low mood, self-esteem, anhedonia, sleep disturbances, poor focus, concentration and self-neglect. 30 Health Education England has advised that as practitioners of cosmetic procedures, you must offer the following psychosocial and emotional support to all of your patients, especially the high risk groups: 3.4 NICE Guidelines Currently, the only condition that must be assessed for under NICE guidelines when a patient is considering cosmetic treatment is BDD. It is good practice to also assess for other mental health problems such as Depression and OCD utilising knowledge of the cardinal features above. NICE recommend the following questions in the assessment of patients for BDD: 1. Do you frequently worry about the way you look and wish you could think about it less? 2. What specific concerns do you have about your appearance? 3. On a typical day, how many hours a day is your appearance on your mind (>1 hour a day is considered excessive) 4. What effect does your appearance have on your life? 5. Does it make it hard to do your work or be with friends? 31 A variety of other screening tools and assessments can be found on the BDD foundation website to help screen for ‘high-risk groups’ e.g. It’s important to remember that the questions derived from these screening tools and scales don’t offer a definitive diagnosis of the condition in question and should instead be used to support, not replace the clinician’s own judgement. While the use of these questions/tools can certainly be useful and provide a structured conversation to determine if the patient needs further counselling and support, it’s important to remember that they may have negative consequences too. For example, formal training may be needed, false positives/negatives may arise and of course consent to use them will be needed, which may appear offensive and unnecessary to some patient groups. Additionally, some clients/patients may have an unusual idea of what they consider attractive, which may differ to the norm. This doesn’t necessarily mean they have BDD but simply have a different opinion. If you suspect any of your patients to suffer from BDD, it is imperative that you refer them to be assessed by a mental health professional and refrain from administering cosmetic treatment. 32 3.5 Professional Boundary Setting HEE have advised that as aesthetic practitioners, a certain level of boundary setting is vital. As you have read, cosmetic patients are a vulnerable group of patients and tend to form attachments with their aesthetic practitioner. Therefore, it is important to have that level of empathy and care for the client; however, it is also good practice to follow these principles: 1. Never give your personal details such as mobile number or address 2. Do not follow or be friends with your clients on your personal social media pages (professional pages are acceptable) 3. During consultations, be friendly but always remain professional 4. Do not form personal relationships with your clients 3.6 Support/Referral Pathways As stated in previous sections, if you feel your clients suffer from any mental health condition, you must refer via their General Practitioner or directly to a mental health specialist. Agreeing to treat such patients where you feel it may not be suitable may result in difficult encounters that may not be in the patients’ best interests. You must always recognise the limits of your capacity and be ready to refer to other aesthetic practitioners, cosmetic surgeons or dermatologists when you encounter problems that you are not able to deal with. Unmet expectations or post-treatment regret may occur if the consultation didn’t thoroughly identify psychological aspects prior to treatment. Support pathways for treatment refusal, follow-up and onward referral should be put in place in advance including emergency contact details in the event of an adverse effect/reaction. The importance of client-centred continuity of care is pivotal in aesthetic medicine, both for the practitioner (to learn from previous work/develop treatment plans and mitigate risk) and also the patient (to develop rapport and build trust). This will not only impact upon treatment outcome but will also optimise the client experience. 33 The following questions could be used by the treating practitioner to consider during the consultation to help decide how to progress with the consultation moving forward: 1. Are the patient’s expectations realistic and even achievable? 2. Does the patient seem unusually preoccupied with their appearance? 3. Does the patient believe the procedure will improve their psychological well-being? 4. Will this patient benefit more from counselling? 5. Does this patient’s behaviour/request warrant a screening test or referral? 6. Will the patient be offended by the use of screening test? 34 Unit 4: Principles of Dermatology in Aesthetic Medicine 4.1 Anatomy and Function of Skin Skin is the largest organ of the body accounting for 15% of the total body weight. Its main functions are to act as a barrier, temperature regulation, sensory perception and excretion of waste products. When assessing the skin from a cosmetic perspective, it’s important to look at the following 5 parameters: 1/ Skin ranges: colour varies with race/geography/age/UV light exposure/cutaneous circulation. The colour (red,brown,pink,yellow,red,black) is affected by melanin concentration, cutaneous circulation & stratum corneum thickness 2/ S/C fat: dependent on anatomical site and BMI 3/ Skin thickness: depends on age/anatomical site/maturation/environment 4/ Wrinkles: wrinkles are caused by underlying muscle contraction- initially they are dynamic but eventually become static with time. 5/Striae: stretch marks caused by disruption of dermal collagen with excessive stretching. Haemorrhage within the dermis followed by poorly vascularised scar tissue leads to their colour 35 The skin has three main layers: 1) Epidermis 2) Dermis 3) Hypodermis/subcutaneous issue: Fig. 3: Structure and anatomy of the Skin The epidermis contains no blood vessels and is the main part acting as a barrier whilst the dermis contains nerve endings, apocrine/sweat glands, hair follicles, blood vessels and sebaceous glands. Knowledge of these layers is important with regards to delivering cosmetic injectable treatments. Botulinum toxin injections are delivered below the hypodermis into a muscle, while dermal filler injections are delivered into the dermis to add volume. Epidermal Layers & Barrier function: The epidermis is composed of 4 or 5 layers: Cornified layer (stratum corneum) Composed of 10 to 30 layers of polyhedral, anucleated corneocytes (final step of keratinocyte differentiation), with the palms and soles having the most layers. Corneocytes are surrounded by a protein envelope (cornified envelope proteins), f i l l e dwithwater-retainingkeratinproteins,attachedtogether through corneodesmosomes and surrounded in the extracellular space by stacked layers of lipids. Most of the barrier functions of the epidermis localise to this layer. Clear/translucent layer (stratum lucidum, only in palms and soles) The skin found in the palms and soles is known as "thick skin" because it has 5 epidermal layers instead of 4. 36 Granular layer (stratum granulosum) Keratinocytes lose their nuclei and their cytoplasm appears granular. Lipids, contained into those keratinocytes within lamellar bodies, are released into the extracellular space through exocytosis to form a lipid barrier. Spinous layer (stratum spinosum) Keratinocytes become connected through desmosomes and start produce lamellar bodies, from within the Golgi, enriched in polar lipids, glycosphingolipids, free sterols, phospholipids and catabolic enzymes. Langerhans cells, immunologically active cells, are located in the middle of this layer. Basal/germinal layer (stratum basale/germinativum). Composed mainly of proliferating and non-proliferating keratinocytes, attached to the basement membrane by hemidesmosomes. Melanocytes are present, connected to numerous keratinocytes in this and other strata through dendrites. Merkel cells are also found in the stratum basale with large numbers in touch-sensitive sites such as the fingertips and lips. They are closely associated with cutaneous nerves and seem to be involved in light touch sensation. The epidermis is made up of a self-containing stratified squamous epithelium consisting of keratinocytes and non-keratinocytes. Keratinocytes undergo continual renewal through mitosis. Non -keratinocytes include melanocytes derived from embryonic neural crest cells, Langerhans cells and lymphocytes. The epidermis serves as a barrier to protect the body against microbial pathogens, oxidant stress (UV light) and chemical compounds and provides mechanical resistance. Most of that function is played by the stratum corneum. 37 It also regulates the amount of water released from the body into the atmosphere through transepidermal water loss (TEWL). Characteristics of the barrier: Physical barrier through keratinocytes attached together via cell–cell junctions and associated to cytoskeletal proteins, which gives the epidermis its mechanical strength. Chemical barrier through the presence of highly organized lipids, acids, hydrolytic enzymes and antimicrobial peptides. Immunologically active barrier through humoral and cellular constituents of the immune system. Langerhans cells (frequently involved in skin immunity) are depleted by advancing age, UV radiation and topical/oral steroids. Water content of the stratum corneum drops towards the surface, creating hostile conditions for pathogenic microorganism growth. An acidic pH (around 5.0) and low amounts of water make it hostile to many microorganic pathogens. The presence of non-pathogenic microorganism on the epidermis surface help defend against pathogenic one by limiting food availability and through chemical secretions. Structure and function of hair: Hair is made of a tough protein called keratin. A hair follicle anchors each hair into the skin. The hair bulb forms the base of the hair follicle. In the hair bulb, living cells divide and grow to build the hair shaft. Blood vessels nourish the cells in the hair bulb, and deliver hormones that modify hair growth and structure at different times of life. 38 Hair growth occurs in cycles consisting of 3 phases: Anagen (growth phase): Most hair is growing at any given time. Each hair spends several years in this phase. Catagen (transitional phase): Over a few weeks, hair growth slows and the hair follicle shrinks. Telogen (resting phase): Over months, hair growth stops and the old hair detaches from the hair follicle. A new hair begins the growth phase, pushing the old hair out. Hair grows at different rates in different people; the average rate is around one-half inch per month. Hair colour is created by pigment cells producing melanin in the hair follicle. With aging, pigment cells die, and hair turns grey. The functions of hair include protection, regulation of body temperature, and facilitation of evaporation of perspiration; hairs also act as sense organs. The shaft of a hair consists of a cuticle and a cortex of hard-keratin surrounding, in many hairs, a soft-keratin medulla. Pigmented hairs contain melanin in the cortex and medulla, but pigment is absent from the surrounding sheaths. The root of a hair is situated in an epidermal tube known as the hair follicle, sunken into either the dermis or the subcutaneous tissue. The follicle is dilated at its base to form the bulb (matrix). In the obtuse angle between the root of a hair and the surface of the skin, a bundle of smooth muscle fibres, known as an arrector pili muscle, is usually found. It extends from the deep part of the hair follicle to the papillary layer of the dermis. On contraction it makes the hair erect. The arrectores pilorum are innervated by sympathetic fibres and contract in response to emotion or cold. This results in an unevenness of the surface called "goose pimples" or "goose skin." Hair acts as insulation for the body. When a person becomes cold, body hair stands up, creating added insulation and making body temperature rise. It also traps warm air next to the body, reducing a loss of heat. 39 The Skin Microbiome: The skin flora consists of many bacteria and fungi living on the skin’s surface that contribute to the skin’s physiology. They are usually non-pathogenic, and either commensal (are not harmful to their host) or mutualistic (offer a benefit). The benefits bacteria can offer include preventing transient pathogenic organisms from colonising the skin surface, either by competing for nutrients, secreting chemicals against them, or stimulating the skin's immune system. The skin flora varies between different individuals and different sites. Common skin bacterial flora include Staphylococcus species, Corynebacterium, Brevibacterium and Acinetobacter. Patho genic species include Staphylococcus Aureus (which can cause folliculitis and Impetigo) and Streptococcus Pyogenes (which can cause Erysipelas, cellulitis and Impetigo). When working with injectables, removing skin contaminants and reducing bacterial load is a key component of patient safety. Aseptic techniques are often applied in these situations and include the following key components: Hand washing Hand decontamination Barrier protection Use of sterile equipment A biofilm is any group of microorganisms in which cells stick to each other and often these cells adhere to a surface- often many species of bacteria. These adherent cells are frequently embedded within a self-produced matrix of extracellular polymeric substance (EPS). When using dermal fillers, a biofilm can implant into superficial tissues predisposing to abscess formation hence the need for aseptic techniques with invasive injectables. 40 4.2 Facial Aging- Morphology, Proportions, Youth & Attractiveness From around the age of 25 the first signs of aging start to become apparent on the surface of the skin. Fine lines appear first, and over time wrinkles , a loss of volume and a loss of density become noticeable. The aging pattern is described as a change in the balance of facial proportions. A youthful face represents the point in time when skeletal proportions are ideal for their soft tissues overlying. Bone resorption begins at the age of 20 at areas which are most frequently used such as the maxilla and bony orbitis. The combined result due length and density reduction is reduced mid facial surface area. Malar cheek pads and overlying skin displace inferiorly and the philtrum lengthens. Muscles of mastication erode bony mass over time at the mandibular insertion points. The ageing hallmarks are important when deciding on age-appropriate cosmetic intervention. The lower face diameter begins to widen as mid facial tissues inferiorly displace and with maxillary and mandibular bone resorption, changing the face from a youthful ‘V-shape’ into a squarer appearance. This shortening of the lower face creates a 1:1 ratio from upper lip-to nose and lower lip-to-chin, in contrast to a 1:2 ratio in a younger face. Similar descent occurs in the brow. With increasing age, loss of skin elasticity, subcutane ous tissue and progressive orbital bone resorption increases the brow-to-nasal angle. Palpebral ‘eye’ bags are formed when intra orbital fat herniates into a weakened orbital septum with excess sagging skin. This lower eyelid-to-cheek dimension widens and deep ens with increasing age, in contrast to the peri-orbital soft tissue in a youthful face which has a shallow and narrow orbit. Malar fat pad reduction and inferior displacement of cheek fat creates a nasolabial fold, leaving behind a cheek depression that can be accentuated by buccal fat attenuation, often known as a ‘mid-cheek groove’. Loss of orbicularis muscular tone creates an apparent inferior border which increases the lower eyelid-to-cheek margin length laterally, and medially creating a nasojugal fold. Oribital fat under a descended orbital septum creates an irregular contour and prominent orbital anatomy. This forms a double convex deformity of the lower eyelid and hence a deeper orbit. 41 Further anatomical changes affect the forehead whereby the middle portion flattens with age. Blunting of the nasofrontal angle gives the illusion of increased nasal length and progressive nasal tip ptosis weakens attachments between the upper and lower cartilages creating a lengthened and widened nose. Remodelling of the nasal spine at the alar base and maxillary resorption further accentuates nasal tip ptosis. The distance between the nasal base and chin prominence decreases due to mandibular resorption and inferior displacement of the chine ovale fat pads further emphasizing the illusion of increased nasal projection and length. Loss of definition of the chin and jaw line occurs with fat loss, bone resorption and downward pull of the platysmal bands. Platysmal band hypertrophy gives way to separation and loss of tone, creating anterior banding or the ‘turkey neck’ deformity. A large submental fat pad is situated deep to the platysmal muscle and a smaller fat pad more superficially. Age-related changes lead to herniation of this fat pad between the muscle, further contributing to anterior banding. The hyoid bone and larynx become more prominent due to descent, resulting in loss of the cervico-mental angle and recession of the mental prominence. 42 In different cultures, the perception of beauty has been historically shown to vary. In parts of Thailand, Women of the Kayan Tribe start wearing brass rings around their necks from the age of 5 to elongate their necks- perceived to be a sign of femininity and beauty. Mauritanian women and in parts of the middle east, women are lauded for gaining weight, as round, features are seen to symbolize beauty. In various parts of Asia, pale white skin and smaller feet are considered a sign of affluence and attractiveness. In Japan women avoid the sun at all costs and bleaching products are used to accentuate paleness. Foot binders were common in the 19th Century in parts of China to make feet smaller- seen as an attractive feature. In the West, contoured, chiseled features are considered more attractive with women often seeking high arched cheekbones, v-shaped faces, brow lifts and fuller lips. Facial proportions and the concept of symmetry = attractive follows on from people seeking the ‘perfect celebrity face.’ Golden/PHI ratios that determine attractiveness identify width as attractive in men (e.g. a chin being the width of the mouth), in contrast to women where a chin is attractive if more narrow (to the width of the nostrils). Equally, PHI ratios identify that an attractive lip should have a ratio of 1:1.6 (with a larger volume lower lip compared to the upper). 43 4.3 Intrinsic vs Extrinsic Aging of Skin Aging is a natural process. Skin changes are among the most visible signs of aging. Evidence of increasing age includes wrinkles and sagging skin. With aging, the outer epidermis thins, even though the number of cell layers remains unchanged. The number of pigment-containing cells (Melanocytes) decreases while the remaining melanocytes increase in size. Aging skin looks thinner, paler, and translucent. Large pigmented spots, including liver spots, or lentigo, may appear in sun-exposed areas. Changes in the connective tissue reduce the skin's strength and elasticity (elastosis) which is more noticeable in sun-exposed areas (solar elastosis). The blood vessels of the dermis become more fragile leading to bruising, bleeding under the skin (often called senile purpura) and cherry haemangiomas. Sebaceous glands produce less oil as you age. Men experience a minimal decrease, usually after the age of 80. Women gradually produce less oil beginning after menopause. This can make it harder to keep the skin moist, resulting in dryness and itchiness. The subcutaneous fat layer thins so it has less insulation and padding. This increases your risk of skin injury and reduces the ability to maintain body temperature Intrinsic aging and Extrinsic aging are terms used to describe cutaneous aging of the skin and other parts of the integumentary system, which while having epidermal concomitants, seems to primarily involve the dermis. Intrinsic aging is influenced by internal physiological factors alone, and extrinsic aging by many external factors. Intrinsic aging is also called chronological aging, and extrinsic aging is most often referred to as photoaging. INTRINSIC AGING The effects of intrinsic aging are caused primarily by internal factors alone. It is sometimes referred to as chronological aging and is an inherent degenerative process due to declining physiologic functions and capacities. Such an aging process may include qualitative and quanti tative changes and includes diminished or defective synthesis of collagen and elastin in the dermis. 44 Histologically, wrinkles can result from epidermal atrophy and thinning, in particular, reduced activity of the basal layer, flattening of the rete ridges and loss of glycosaminoglycans, elastin and collagen. Collagen loss is the result of reduced collagen synthesis and higher levels of matrix metalloproteinases (MMPs), Glycation of collagen creates less viscoelastic collagen which interacts with certain receptors enhancing oxidative stress and hence further break down. Proinflammatory cytokines increase with age which further accelerates loss of collagen and elastin. Vascular networks also diminish with age creating less nutrient support and increased pallor of the skin. EXTRINSIC AGING Extrinsic aging of skin is a distinctive declination process caused by external factors, which include ultra-violet radiation, cigarette smoking, air pollution, among others. Of all extrinsic causes, UV radiation from sunlight has the most widespread documentation of its negative effects on the skin (80%). Because of this, extrinsic aging is often referred to as photoaging. Photoaging may be defined as skin changes caused by chronic exposure to UV light. Photodamage, implies changes beyond those associated with aging alone, defined as cutaneous damage caused by chronic exposure to solar radiation and is associated with emer gence of neoplastic lesions. Photoaging is attributed to continuous, long-term exposure to ultraviolet (UVA- longwave and UVB-shortwave) radiation of approximately 300–400 nm, either natural or synthetic. Tretinoin is the best studied retinoid in the treatment of photoaging. UVB is responsible for sunburn and UVA for aging related to deeper penetration of the dermis, both of which are carcinogenic by directly or indirectly damaging DNA. UVC is filtered out by atmospheric ozone, UVB is filtered out by clothing/cloud but UVA can penetrate all the above. UVR damage contributes to the reduction of collagen and elastin. Photodamage leads to less structural association of hyaluronic acid with collagen and elastin, hence less water binding capacity. Histologically, photodamaged skin is characterised by fragmented collagen and elastin fibres, loss of collagen type 1 and loss of anchoring fibrils (collagen type IV). UVR has both local and systemic effects on cell-mediated immunity. Locally it turns-off immune responses to abnormal cells allowing the development of skin cancers. Fair skinned individuals produce less melanin than dark-skinned people and are less able to protect their skin from UVR damage, hence are intrinsically more susceptible to premature aging and skin cancers. Photodamaged skin often affects sun-exposed areas such as the face, and limbs, often present ing as wrinkles lentigines, hyperpigmented patches, guttate hypomelanosis and occasionally skin cancers. 45 Table 1 below that explains the intrinsic (natural) and extrinsic (environmental) causes of aging. Table 1: Intrinsic versus Extrinsic causes of aging 46 4.4 Dermatological Conditions Impacting Appearance There are several conditions to consider when administering cosmetic injectables that require some degree of knowledge prior to treatment due to the impact of the treatment itself. 1/ Diabetes Diabetic patients are prone to premature skin aging due to longstanding microvascular chang es altering blood flow to the tissues affecting the viscoelasticity and suppleness of the dermis. Diabetics are also more prone to bacterial or fungal skin infections and dry skin due to in creased urine output. Special care must be given to adopt a sterile approach to treatment and aftercare. In those with poorly controlled diabetes, its best advised not to administer injectable treatment. 2/ Immunocompromised patients These patients are at a higher risk of infection with skin puncture and biofilm formation with dermal fillers. Careful counselling is required prior to treatment and again a sterile approach must be adopted should they decide to go ahead. 3/ Autoimmune disease Various autoimmune diseases exist which may be dormant or active. It’s useful to ascertain a history of stability and potential triggers/flares before deciding to treat. If the condition is stable/in remission, then cosmetic intervention may be appropriate. If uncertain of disease state, it would be appropriate to contact the patient’s GP. Those on steroid medication may be at higher risk of infection and bruising which should to be explained during the consultation. 4/ Psoriasis/Dermatitis/Rosacea Facial psoriasis, Rosacea and Dermatitis often affects the nasolabial folds, chin, hairline and post-auricular area often presenting as a scaly/flaky erythematous rash with or without papules/pustules. Increased skin turnover/hyperkeratinisation may affect barrier function of the epidermis and lead to introduction of infection or a ‘koebner response’ at sites of injection when injected during active psoriasis. Treatment should not be administered during active flares. In cases of allergic contact dermatitis, patch testing may be necessary 47 5/ Melasma Dark, irregular well demarcated hyperpigmented macules to patches commonly found on the upper cheek, nose, lips, upper lip, and forehead which often develop gradually over time. Melasma does not cause any other symptoms beyond the cosmetic discoloration. Melasma is also common in pre-menopausal women. It is thought to be enhanced by surges in Oestrogen or stress hormones. Although it can affect anyone, melasma is particularly common in women, especially pregnant women and those who are taking oral or patch contraceptives or hormone replacement therapy (HRT) medications. The aim of treatment is to stop further melanocyte differentiation and destroy existing melanin. UVR avoidance and protection is key to inhibit differentiation of basal cells into melanocytes Existing melanin differentiation can be treated with bleaching agents (tyrosine inhibitors) such as 0.1% Tretinoin in combination with 4% Hydroxyquinone. Chemical peels, microdermabrasion and IPL laser treatments have been used to speed resolution. Accurate assessment of ethnicity is important to assess success of IPL treatments. 6/ Solar Lentigoes These are harmless patches of darkened skin often resulting from exposure to UVR which causes local proliferation of melanocytes and accumulation of melanin within the keratinocyte. Solar lentigos or lentigines are very common, especially in people over the age of 40 years on the face and extensor surfaces of limbs. Those invisible during consultation can be demonstrated under Wood’s light. Treatment options include retinoids, bleaching agents, sunscreens, anti-inflammatory agents and hydroxy acids. Dermabrasion, cryotherapy and light treatments may also be used but are more aggressive and can induce hypo or hyperpigmenta tion if too aggressive/used in the wrong candidate. 7/ Post-Inflammatory Pigment Alteration Post inflammatory pigmentation is temporary pigmentation that follows injury (e.g. thermal burn), insect bites, waxing, peels or inflammatory disorder of the skin (e.g. dermatitis, infection). It is mostly observed in darker skin types. Post inflammatory pig mentation is also called acquired melanosis. More severe injury results in post inflammatory hypopigmentation, which is usually permanent. Histologically melanophages are seen in the superficial dermis and lymphohistocytes may be seen around the dermal capillaries due to an inflammatory response. It’s often difficult to treat and only bleaching agents and retinoids may prove useful. UVR protection is also advised. 48 4.5 Cosmetic Treatments Available for Various Dermatological Presentations Many clients may request botulinum toxin or dermal fillers treatments for situations where they are not indicated. Other clients may not want to receive toxin or filler treatments, and would like to know what alternative treatment options exist for the same indication. It is therefore important to understand the variety of treatment options available to patients for various dermatological presentations and direct them accordingly. There are multiple cosmetic treatments on the market. Here are the top 6: 1. Laser Treatment: This is most commonly used for hair removal but now increas ingly used for fine lines and wrinkles, skin re-surfacing, rosacea, pigmentation and pore reduction. Laser treatments have their own associated risks and may not be suitable for all patients. 2. Microdermabrasion: This machine uses small microcrystals which encourage new collagen and epidermal skin layers to grow through mechanical skin exfolia tion without chemicals or laser. The treatment can be used on the face, chest, back or shoulders. It is used for fine lines and wrinkles, superficial blemishes and spots from sun damage and mild pigmentation. 49 3. Dermaroller: This treatment has been around for many years and has been found to be very effective for acne scarring, stretch marks, sun damaged skin, fine lines and wrinkles and also stimulates new collagen and epidermal skin growth through direct physical stimulation/trauma. 4. Chemical Skin Peels: There are multiple different skin peels, one of the most popular is the Obagi peel line. These are becoming more and more popular as they target pigmentation, solar damage, fine lines, and volume loss. 5. Sclerotherapy: This treatment targets thread veins, not large varicose veins. These thread veins generally appear on the trunk and legs most commonly, Thread veins on the face can be treated with laser therapy. A sclerosing agent is injected superficially into the thread veins which cause them to disappear completely over time. 50 6. Cosmeceuticals - cosmetic products consisting of biologically active ingredients that have or claim to have a medicinal property such as producing more even skin tone, in creasing skin radiance, improving texture and minimizing wrinkles. Cosmetics and cos meceuticals are not classified as drugs hence don’t need to meet rigorous testing therefore many claims are unsubstantiated. Active ingredients of cosmeceuticals may be active if they cross the epidermis/hypodermis in sufficient quantities. Cosmeceuti cals refer to products that are applied topically, such as creams, lotions and ointments. To be effective, a cosmeceutical must consist of an active ingredient that can cross the skin barrier and demonstrate a biochemical effect at a cellular level, visible on skin bi opsy and be supported by good clinical studies. There is good evidence that both Tretinoin and Vitamin C are effective. Little clinical evidence supports the benefits of antioxidants and peptides in human skin. The following ranges of cosmeceuticals are used in aesthetic practice: Antioxidants: inhibit the oxidation of other molecules. Oxidation is a chemical reaction that can produce free radicals, leading to chain reactions that may damage cells. The photochemical gener ation of reactive oxygen species (ROS) is the primary mechanism by which UVR damages skin cells. This results in the damage of nucleic acids, lipids and proteins including collagen, hence disrupting the integrity of skin leading to the formation of wrinkles. The skin itself protects itself with naturally occurring antioxidants such as vitamin A, C and E which become depleted with age and UVR. Vitamin C and alpha-hydroxyl acids have been demonstrated in research for their anti-aging properties. Antioxidant preparations must be able to penetrate the water and lipid phases of the epidermis. The following are able to cross this barrier: Vitamin C, E, B3 and B5, Ubiquinone, Selenium and Lipolic acid. Retinoic Acid: a metabolite of vitamin A (retinol) that mediates the functions of vitamin A required for growth and development. Vitamin A is a naturally occurring antioxidant in the skin. The biologically active form is tretinoin (Retin A) which aids in epidermal proliferation, keratinisation and peeling. It also contributes to fibroblast proliferation and collagen metabolism. Tretinoin was approved as the first topical POM in the treatment of photodamaged skin as it was found to improve the extracellular matrix of aging skin. Retinoids are contraindicated in pregnancy due to teratogenic effects and also increase photosensitivity Growth Factors: Are proteins that regulate cellular growth, proliferation and differentiation under controlled conditions. They play an important part in maintaining healthy skin structure and function. Growth factors are secreted by all cell types that make up the epidermis (outer layer of skin) and dermis (the layer of skin between the epidermis and subcutaneous tissue) of the skin including keratinocytes, fibroblasts and melanocytes. Topical skin creams containing endogenous (produced in the body) growth factors are used as cosmeceuticals. Skin creams containing a physiologically balanced mixture of growth factors and other proteins are available to reverse the signs of intrinsic and extrinsic skin aging. 51 4.6 Effects of skin care products 1/ Sun-Protective Factor (SPF)/Sunscreens: a topical product that absorbs or reflects some of the sun's ultraviolet (UV) radiation and thus helps protect against sunburn, especially for fair-skinned individuals. Diligent use of sunscreen can also slow or temporarily prevent the development of wrinkles and sagging skin. Depending on the mode of action, sunscreens can be classified into physical sunscreens (i.e., those that reflect the sunlight) or chemical sun screens (i.e., those that absorb the UV light). Sunscreen use can help prevent melanoma and squamous cell carcinoma but there is little evidence that it is effective in preventing basal cell carcinoma. Concerns have also been raised about potential vitamin D deficiency arising from prolonged use of sunscreen. Typical use of sunscreen does not usually result in vitamin D deficiency; however, extensive usage may. Sunscreen prevents ultraviolet light from reaching the skin, and even moderate protection can substantially reduce vitamin D synthesis. 2/ Ph Balancers: Skin has a thin, protective layer on its surface, referred to as the acid mantle. This acid mantle is made up of sebum excreted from the skin’s sebaceous glands, which mixes with lactic and amino acids from sweat to create the skin’s pH, which ideally should be slightly acidic – at about 5.5. Many factors can interfere with the delicate balance of the skin’s acid mantle, both externally and internally. With age, skin becomes more acidic in response to lifestyle and our environment. Everything that comes in contact with our skin (products, smoking, air, water, sun, pollution) can contribute to the breaking down of the acid mantle, disrupting the skin’s ability to protect itself. The acid mantle is an effective form of protection, but if your pH level is too alkaline or too acidic, the mantle is disturbed and skin conditions such as dermatitis, eczema, and rosacea may result. A skin care product may claim to be pH balanced, but you can verify the actual pH of a product by using an at-home pH testing kit. Choosing mild cleansers and toners that are slightly acidic (close to 5) may benefit all skin types in properly maintaining the acid mantle. 4.7 Skin health assessment tools When assessing skin during consultation, it’s important to identify features of youthful to provide a baseline of reference when assessing damaged skin. Youthful skin features include: Abundant collagen and elastin Smooth keratinisation Even pigmentation Adequate hydration Absence of facial dermatoses 52 The main indications for cosmetic medical skincare which help you construct your con 2) Oily/acne prone sultation include: 3) Flaky/scaly 1) Dryness/poor hydration 4) Pigmentation dermatological treatments) 5) Volume loss Patient concerns and expectations 6) Wrinkles Sun exposure Current skincare regime- types of product, frequency of use, compli ance and tolerance Skin assessment and grading using The Fitzpatrick Scale skin assessment tools A thorough skincare consultation should fo cus on identifying the following: Clinical photography Medical history (including previous A numerical classification schema for human skin colour. It was developed in 1975 by Thomas B. Fitzpatrick as a way to estimate the response of different types of skin to ultraviolet (UV) light. It was initially developed on the basis of skin and eye colour, but when this proved misleading, it was altered to be based on the patient's reports of how their skin responds to the sun; it was also extended to a wider range of skin types. The Fitzpatrick scale remains a recognised tool for dermatological research into human skin pigmentation.*pp. 53 The following list shows the six categories of the Fitzpatrick scale: Type I (scores 0–6) always burns, never tans (pale white; blond or red hair; blue eyes; freckles). Type II (scores 7–13) usually burns, tans minimally (white; fair; blond or red hair; blue, green, or hazel eyes). Type III (scores 14–20) sometimes mild burn, tans uniformly (cream white; fair with any hair or eye colour). Type IV (scores 21–27) burns minimally, always tans well (light brown). Type V (scores 28–34) very rarely burns, tans very easily (brown). Type VI (scores 35–36) never burns, always tans (deeply pigmented dark brown to darkest brown) The Glogau Scale The Glogau scale is a visual analogue scale classification system used to assess photoaging: 54 Unit 5: Principles of Botulinum Toxin in Aesthetic Medicine 5.1 Biochemistry & Mechanism of Action Botulinum toxin is a neurotoxin made by the bacteria clostridum botulinum, an anaerobic bacteria found in soil. Botulinum toxin is purified for clinical and cosmetic use. Botulinum toxins are divided into 7 serotypes by their differences in potency and duration of action. Botulinum toxin type A is the most potent of the serotypes and therefore is used for clinical and cosmetic purposes. Once injected into the muscle, the mechanism of action of botulinum toxin is to cause temporary muscle paralysis through inhibiting the release of the neurotransmitter acetylcholine from motor nerve terminals. This prevents muscular contraction and hence creates the desired cosmetic effects. With time, synaptic-sprouting and receptor formation leads to the reoccurrence of muscular contractions and hence the ‘wearing off effect’ of botulinum toxin. Fig. 1. Botox effect on muscle nerve terminals 55 5.2 Medical Indications 1) Cervical Dystonia Involuntary movements/contractions of muscles. BOTOX® is licensed in the UK for this use. 2) Cerebral Palsy and Limb Spasticity Cerebral Palsy affects balance, voluntary movement, and posture. BOTOX® is only licensed for the treatment of Spastic Cerebral Palsy and not the other forms of this disease 3) Blepharospasm Involuntary spasms of the eyelid muscles causing excessive blinking. BOTOX® is licensed in the UK for this use 4) Migraine BOTOX® is licensed specifically for the treatment of chronic migraine but has not been shown to be effective for any other headache type (e.g. episodic migraine, tension type headache, cluster headache) as yet. 5) Overactive Bladder BOTOX® is licensed to treat people with neurogenic detrusor over activity (or overactive bladder symptoms), commonly experienced in people with MS. 56 5.3 Cautions and Contraindications Contraindications for Treatment: 1. Those with a known hypers

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