Embed Size (px)
Citation preview
• 2005 sir Harry Cayton (regulation of cosmetic surgery) ○ Increasing specialist training and accountability
• Provision of cosmetic surgery in England ( healthcare commission 2007)
• Good Surgical Practice 2008• Good Medical Practice in Cosmetic procedures
Independent Healthcare Advisory Service 2010.• NCEPOD (National Confident Enquiry into patient
Outcome and Death 2010 ○ Lack of appropriate facilities ○ Surgeons competence ○ Lack of information for patients to understand risks of procedures.
• RCS published this year Professional Standards for Cosmetic Procedure
• 2005 sir Harry Cayton (regulation of cosmetic surgery) ○ Increasing specialist training and accountability
• Provision of cosmetic surgery in England ( healthcare commission 2007)
• Good Surgical Practice 2008• Good Medical Practice in Cosmetic procedures
Independent Healthcare Advisory Service 2010.• NCEPOD (National Confident Enquiry into patient
Outcome and Death 2010 ○ Lack of appropriate facilities ○ Surgeons competence ○ Lack of information for patients to understand risks of procedures.
• RCS published this year Professional Standards for Cosmetic Procedure
AuStralian Government in 2010• New training Standards•Advertising restrictions
• Hong Kong : where to draw line between medical treatment and the beauty one
• Denmark has introduced new regulation ( who can perform the procedures)
• Sweden is following Denmark • France set new Standards and
regulation in details
1. France has passed the regulation in cosmetic procedures in 2009.
2. Main point of concern is cosmetic surgery. 3. Safety of patients is paramount. i. There is a 15 days cooling period. a. This is including information about surgical fees
and services 4. Patient information is consent is a must. 5. Regulation of surgical facilities 6. There are restrictions on advertising and
publicities.they all are forbidden! 7. NSFA needs training and under supervision of a
plastic surgeon.
Non- health care professional can perform dermal filler ,weaker chemical peel and IPL but no botulinum toxin injection,microdermabrasion or sclerotherapy
1) They should hold recognized beauty therapy qualification
2) To demonstrate their competent 3) Qualification should be recognized by
Denish Health Board 4) The doctor employed them should deem
their competent too.
a-Practitioners should be register with Denish Health board and pay1850 pounds per year:
b. Non-surgical cosmetic procedures like botulinum toxin injection,dermal fillers injections , lasers or IPL,chemical peel should be performed by:
i. Consultant dermatologist ii. Plastic surgeons iii. Ophthalmologist and neurologist for
Botox iv. Nurses and junior doctors can
performs all of them but undersupervision and the consultant remains responsible for the procedure or any complication.
1. OTC in EU is classified as cosmetic in USA 2. New development of cosmetic regulation in EU.(pharmaceutical affair law):
• a. Drugs,quasi‐drugs or cosmetic. 3. No license needed in EU or USA for
manufacturing ,distribution and importation.• a. These are license in Japan
4. Homogenization of EU and USA' cosmetic regulation is possible:• a. Japan needs more serious commitment to
achieve this harmonization .
Safety and quality • To act in case of concern on patient safety • To protect patients and public 1. To improve and promote patient safety via quality
assurance 2. Regular clinical audits including feedback from patients 3. To report adverse incidents either via using a device or
products as well as suspected events. 4. To contribute to to confidential enquiries. 5. To co- operate with other organization dealing with public
health. 6. To seek advice from colleagues or defence body if any concern
regarding performance of colleague (not fit for practice and put patients at risk)
7. To consult a colleague if Any concern regarding health and performance of ours
8. To be immunized against common serious contagious disease. 9.To be registered with a GP .
Knowledge ,skill and performanceLicense to practice • Must have a license to practice • Should be registered with GMC AND
other regulating body • Must demonstrate the confidence
and knowledge through appraisal and revealideation process.
Professional performances 1. Competent in all aspect of work a. Management b. Research c. Teaching
Knowledge ,skill and performance To keep professional performance up
to date a. Participate in activities to maintain
and develop it b. Mentoring c. Up dated with guidelines and
knowledge d. To monitor and improve the
quality of care
Applying knowledge and experience to the NSFA a. Practice in the limit of competence b. To provide a high quality of care c. To provide advice, treatment and investigation
if necessary d. To prescribe the medication when needed with
taking patient needs into consideration e. To provide the best suitable treatment based on
available evidence. f. To consult colleagues as needed g. To get the consent before implementation or
involving in patients in a research project.
Safety and quality, Knowledge ,skill and performance,
4. Record keeping a. Clear,accurate and legible records b. Confidentiality and data protection c. clinical records should include: i. Clinical finding with the case ii. The decision for treatment iii. Provided information to the patient iv. Medication or other investigation
Communication ,partnership and teamwork 1. To listen to the patients 2. To respond honestly to their question and concerns 3. Provide enough clear information about the
procedure,complication and out come 4. With keeping confidentiality in mind providing
information to those close to the patient. 5. Been access able and available on duty and other
time if any concern or emergency arises 6. To treat colleagues family and respectfully. 7. To contribute toward teaching of staff and other
colleague. 8. To supervise other colleague if needed. To explain and justify If refuses to provide a treatment
.
To treat patients as individual and respect their dignity
• To be polite in the treatment procedure
• To keep patients' confidentiality • To provide enough information in
order to help patient for an informed decision
• To share treatment plan with patients
• To correlate with colleague in order to maximize patients' care and therapeutic plan
1. Not to use professional position in pursuing a sexual relationship with a patient or close relative
2. To be honest with patients if things go wronga. To put matter rightb. To offer an apology
c. To explain fully what happened and what to expect as long and short term effect.
d. Not to discriminate against patients or colleagues. e. To response promptly,fully and honestly to complaints f. To apologies when needed and appropriate. g. To end a professional relationship with a patient just when the trust is broken. h. To have adequate insurance and indemnity cover.
i. To be honest about qualification and experience as well as current role
j. To be honest while designing ,organizing research k. To be honest on providing information as well as communicating with colleagues and patients
l. Marketing and advertising should be factual and does not exploit patients' vulnerability(this emphasis in Keogh report too) m. To be honest and trust worthy in writing reports and signing forms.In area of conflict of interest ,to act in the best interest of patient and community .General
1.The report and review was initiated by PIP implant scandal. 2. Non surgical procedures accounts for 9/10 of all procedures
. 3. NSA accounts for 75% of market value. 4. It emphasis the consumer of this market does not have any
protection and so much vulnerable . 5. It emphasis dermal fillers are particularly the cause of
concern 6. There is no control on fillers in comparison to purchase a
bottle of toilet cleaner. 7. The commercial income is stalling. 8. Dermal fillers are a sitting duck. 9. Previous attempts failed. 10. The report provide a framework for surgical and non‐
surgical fields. 11. Practitioners will need to have appropriate skills as well as
safe products. 12. The report has emphasis on individual safety and health. 13. There is no balance between the rapidly growth of
cosmetic procedures and existing regulatory framework .
High quality care plus safe products(effectiveness,safety)
i. Fillers as prescription only medical device ii. EU medical device to expand to cover all
cosmetic implants including fillers iii. UK legislation to facilitate this expansion 1) To set standard 2) Formal certification of all practitioners 3) Training and experiences iv. RCS(Royal College of Surgeons) to established
an inter speciality committee on cosmetic surgery v. Performers of cosmetic procedures to get
registered. vi. Record keeping for patients and their GPs vii. Skilled practitioners in line with responsible
providers
People to get accurate advice ii. Vulnerable are protected iii. Accessible redress and resolutions in
case of complications iv. Multi-stage consent process for
operation in order to share understanding of desired out come between patients and practitioners (RCS to do this)
v. Patient information leaflet by RCS vi. Record of consent for non surgical
procedures Advertisement and marketing should be up
dated in a way not to avoid inappropriate influence on pubic.
Accessible resolution and redress•Continuity of care should be provided in the event of complication.
• Insurance schemes to provide support and reassurance
• Patients' access to guidance and help in case of dispute resolution.
Current situation• No restriction on a person performing• No qualification• Training course by anyone to offer a qualification• A number of self accredited training organization
have sprung up.• Non-medical,non-dental and non- nursing
practitioners were greatly valued by consumers No specific accredited training on
• i. physiology• ii. Anatomy• iii. Infection control• iv. Treatment of anaphylaxis• v. Understanding of co morbidity or per-existing
health problem
1. RCS to stablished Cosmetic Surgery inter speciality committee:• a. To set standards for training and practice
of cosmetic surgery• b. Issuing formal certification of surgeons• c. To work with PHSO(Parliamentary Health
Service Ombudsman) regarding dispute resolution
• d. Regular meeting with GMC, CQC and MHRA(Medicine and Healthcare products Regulatory Agency)
• e. To develop A specific code of ethic for cosmetic surgery (advertising, insurance and psychological Assesment of patients
i. Training necessary to able practitioners to identify complications and treat them
ii. Regular trading for practitioners to deliver latest treatments
iii. The curriculum and training Requirement should be reviewed regularly.
iv. Accountability to a professional regulator in case of prescribing filler or performing other potentially harmful non surgical cosmetic procedures.
2. Performing non surgical aesthetic procedures must be under responsibility of an accredited and qualified clinical professional.
3. Non- health practitioners with required accredited qualification may perform the procedures but under supervision of qualified clinical professional.
4. HEE(Health Education England ) mandate should include the development of appropriate accredited qualification for non
surgical procedures and its various professional groups.5. All practitioners must register with annul fee to fund the
registration body. a. Accredited qualification b. Premises meeting certain requirements c. Code of practice to cover handling complain and redress , responsible advertising and consent practice. d. Annual appraisal6. Criteria to enter to the Registery should be:
• a. Accredited qualification• b. Premises meeting certain requirements• c. Code of practice to cover handling complain and redress , responsible advertising and consent practice
7. Non- surgical premises subject to inspection by local authorities.• a. Awareness of requirement to operate from a safe
premises and responsibility involved.• b. Training curriculum should include infection
control, treatment room safety and adverse incident report.
• c. Code of conduct: minimum standards for premises.
8. UK legislation to make fillers as prescription only medical device. (EU Medical Device Directive to cover dermal fillers and all cosmetic implants.)
9. For any non surgical intervention a record of consent is necessary (must)
10. Advertisement should be conducted in a socially responsible manner.
11. The following advertisements should be prohibited
a. Time- limited deals b. Financial inducements c. Refer a friend, reduced price for
two people, buy one get one free d. Competition prize as cosmetic
intervention
12. Continuity of care and follow up should be offered
13. Medical director on board for all organization offering cosmetic procedures
14. Complains investigated by the Ombusdman should be publicly available.
15. Adequate professional indemnity cover is a must. The insurance status should be displayed on the practitioner register.
16. Creation of insurance risk pool
1. It is strange attempts to justifying certain surgical or aesthetic procedures when it comes to particular cultures or religious tradition.
2. Most religions like Christianity, Islam and Judaism affect human behaviors in avarious way.
3. This is including affecting profoundly and dictating some rigid positions regarding
critical health issues. 4. This issues become more dominant in
countries where the religious leaders are decision makers like Iran.
This can be compromise sometimes in western societies as patients invariably present with diverse ethical decision‐ making models or religious/ spiritual preferences and may not hold western, bioethical views.
8. Muslims today facing a crisis of knowledge or a crisis in connecting knowledge and faith as well as other religious.
9. A good medical practice is meant to take this diversity into consideration.
10. There is a challenge do up dating surgeons or NSFA practitioners to achieve these skill.(advanced cross‐cultural communication and consultation in the clinical encounter).
11. If there is going to be regulation , these issues of religious believe and regulation needs to be taken into consideration in introducing new law and regulation.
12. There is no such consideration in sir Keogh report . The following recommendation need to be implemented:• a. Receiving culturally/religiously acceptable care and treatment.• b. Highly organized religions or beliefs with a centralized governing
body to express their stance on any arising issue.• Considering religions and specially Islam and their influence on
decision making and inform consent as a part of report recommendations:
• d.Islam shares the same code of morality as Judaism and Christianity. a.It is just different in some a. doctrinal area.
b. However,there are simple prohibited or allowed (hallal and haram) declaration for given products or technologies.
c.Physicians need to master these spirituals issues as there might be some discrepancy in the consultation or clinical encounter.
d. This raised the concern that how religion should be integrated with health care and in this case cosmetic surgery and beautification.
Awareness of requirement to operate from a safe premises and responsibility involved.
Holding accredited qualification from a well known training body(university)
Registered with a regulatory body as well as GMC or DMC.
holding an Adequate professional indemnity cover for the procedures performing
To be honest on providing information as well as communicating with colleagues and patients
To be honest and trust worthy in writing reports and signing forms.
In area of conflict of interest ,to act in the best interest of patients
Regular clinical audits including feedback from patients.
specific accredited training on:• physiology• Anatomy• Infection control• Treatment of anaphylaxis• Understanding of co- morbidity or per‐ existing health
problem • Updated with Regular training for practitioners to
deliver latest treatments.• Up dated with Training necessary to able practitioners
to identify complications and treat them. Awareness of advanced cross‐cultural communication and
consultation in the clinical encounter
Keogh-Cosmetic-Interventions-Final-Report 2013 General medical council ,2013. Good Medical Practice. Royal College of Surgeons, 2008. Good surgical Practice, Royal College Of surgeons,2013. Professional Standards for Cosmetic Procedure. ATIYEH, B., KADRY, M., HAYEK, S. and MUSHARAFIEH, R., 2008. Aesthetic Surgery and Religion:
Islamic Law Perspective. Aesthetic Plastic Surgery, 32(1), pp. 1-10. DE ROUBAIX, J.A.M., 2011. Beneficence, non-maleficence, distributive justice and respect for
patient autonomy – reconcilable ends in aesthetic surgery? Journal of Plastic, Reconstructive & Aesthetic Surgery (JPRAS), 64(1), pp. 11-16.
FOGLI, A., 2009. France sets standards for practice of aesthetic surgery. Clinical Risk, 15(6), pp. 224-226.
GOGOS, A.J., CLARK, R.B., BISMARK, M.M., GRUEN, R.L. and STUDDERT, D.M., 2011. When informed consent goes poorly: a descriptive study of medical negligence claims and patient complaints. The Medical journal of Australia, 195(6), pp. 340-344.
JANDHYALA, R., 2013. Improving consent procedures and evaluation of treatment success in cosmetic use of incobotulinumtoxinA: an assessment of the treat-to-goal approach. Journal Of Drugs In Dermatology: JDD, 12(1), pp. 72-78.
JANSEN, C., 2006. [Aesthetic medicine and aspects related to liability, medical professional and social law]. Zeitschrift Für Ärztliche Fortbildung Und Qualitätssicherung, 100(9-10), pp. 655.
KISLALIOGLU, M.S., 1996. Cosmetic Regulations of the United States, European Union, and Japan. Clinical Research and Regulatory Affairs, 13(3-4), pp. 211-229.
LATHAM, M., 2010. A poor prognosis for autonomy: self-regulated cosmetic surgery in the United Kingdom. Reproductive health matters, 18(35), pp. 47-55.
MAKDESSIAN, A.S., ELLIS, D.A.F. and IRISH, J.C., 2004. Informed Consent in Facial Plastic Surgery: Effectiveness of a Simple Educational Intervention. Archives of Facial Plastic Surgery, 6(1), pp. 26-30.
MCHALE, J.V., 2012. Regulating cosmetic surgery: a scalpel where it is needed. British Journal of Nursing, 21(3), pp. 190-191.
PEATE, I., 2011. Ethics and law: principles of patient consent. Dental Nursing, 7(12), pp. 712-714.
