The latest updates and different viewpoints, on the current hot topics in the industry, including informed consent, cooling-off periods and the use of skype consultations in prescribing Schedule 4 injectables.

A recent Public Consultation Paper by the Medical Board of Australia (MBA) provides recommendations and seeks feedback on a number of issues relating to medical practitioners who provide cosmetic medical and surgical procedures in Australia.

It discusses issues such as informed consent, cooling-off periods and remote consultations – with particular reference to doctors prescribing schedule 4 (S4) injectables via Skype, email or phone consultations, to nurses’ patients.

The paper was released in response to a specific problem – consumers making rushed decisions to have cosmetic medical and surgical procedures without adequate information. The paper states:
“As cosmetic medical and surgical procedures become more accepted and the scope of cosmetic practice increases with new technology and new procedures, the numbers of consumers having cosmetic procedures provided by medical practitioners, and therefore at risk
of making decisions without adequate information, is likely to increase.”

Informed Consent

A New South Wales report released by the Health Care Complaints Commission noted that the absence of general practitioner referral in the cosmetic industry exacerbates the information asymmetry between medical practitioners and patients. The consultation paper cited this, alongside a lack of reliable data in the cosmetic medical market, as reasons for consumer uncertainty surrounding the quality of service in the cosmetic arena – and therefore a grey area involving informed consent.

The paper found informed consent processes for consumers undergoing cosmetic medical procedures ‘vary’.
In particular, the elective nature of cosmetic surgery means the risks and the benefits of undergoing a procedure are assessed differently by patients, compared with other medical situations.

A cooling-off period after the initial consultation with the medical practitioner, as part of a two-stage consent process, was considered a key element in securing informed consent. The paper suggests a “period of reflection during which the patient has the opportunity to consider the full implications of the proposed procedure.”

The prescription of S4 injectables

Drafted guidelines regarding the prescription of S4 injectables were included in the consultation paper. The guidelines of Option Three (that suggest a strengthening of current guidelines for medical practitioners providing cosmetic procedures) suggest a face-to-face consultation should be necessary in prescribing and administering S4 injectables.

The guidelines state: “Medical practitioners must not prescribe S4 (prescription-only) cosmetic injectables unless they have had a face-to-face consultation with the patient. A face-to-face consultation is required for each course of injections. Remote prescribing (for example,
by phone email or video conferencing) of cosmetic injectables is not appropriate.”

A recent review in the United Kingdom was also referenced, where the UK Department of Health found that there was inadequate protection for consumers against many of the potential risks from cosmetic procedures. Among other regulations, the UK review made face-to-face consultations mandatory in prescribing cosmetic injectables.

On the following pages we outline the various positions and perspectives of key professional societies in the industry on several topics discussed in the paper. Contributors include Vice-President of the Australasian Society of Aesthetic Plastic Surgery Dr Mark Magnusson; President of the Australasian College of Cosmetic Surgery, Dr Soo-Keat Lim; and President of the Cosmetic Physicians Society of Australasia, Dr Gabrielle Caswell.

Dr Mark Magnusson
Vice-President of the Australasian Society of Aesthetic Plastic Surgeons

The consultation process is about patient safety and we applaud the Board for its goals. The focus should always be firmly on patient safety.

The number of cosmetic procedures is likely to increase over time and is being driven by a number of factors. On the demand side, we are seeing the ‘normalisation’ of cosmetic procedures, determined predominantly by cultural and societal factors, many of which are socioeconomic. On the supply side, we are seeing an increasing number of practitioners offering an increasing number of services.

ASAPS is concerned that the number of new entrants into the aesthetic space may result in many commonly performed treatments becoming commoditised. Should this be the case, many patients will choose their provider on price alone. Whilst keeping costs as low and as competitive as possible is good for patients, ASAPS believes this should not be pursued at the expense of poorer outcomes in efficacy and safety.

In ASAPS’ view, the public interest is best served by patients engaging reputable practitioners who have the requisite training and who make the necessary commitments to maintain their skills through ongoing education, audit and peer review. It is incumbent upon these practitioners to practice according to the highest ethical standards.

The codes and guidelines articulated by bodies such as the Medical Board and Royal Australasian College of Surgeons provide for adequate guidance to medical practitioners providing cosmetic medical and surgical procedures. However, in ASAPS’ view, problems arise from poor compliance with these guidelines.

The use of doctor consultations performed via video calls, for the purpose of prescribing toxins Electronic consultation is an important component of good medical practice, particularly for patients who live in remote areas and is actively encouraged in some jurisdictions to reduce time away from work, travel distances and cost to the community.

ASAPS believes that aesthetic medicine should not be treated as a category separate to mainstream medicine.

ASAPS is also mindful of the fact that some treatments are performed by non-medical practitioners in facilities that are not hospitals or doctors’ rooms (eg, beauty salons). Under these circumstances, a doctor may be available through electronic consultation with the sole purpose of formalising prescription of injectables. ASAPS is not in support of this process.

ASAPS believes that all medical treatments should be carried out in medical facilities/practices with appropriately trained personnel
to provide treatments as well as manage all complications. These personnel need to be subject to consistent rigorous processes to maintain professional standards such as CPD, audit and membership of a professional society with a suitable code of conduct. The patient remains the direct responsibility of the medical director of the practice.

A compulsory face-to- face consultation before prescribing S4 injectables There needs to be a thorough medical examination prior to prescribing any S4 medication for the first time or after a change to an existing prescription, a deviation from the expected outcome/ complication or for a prolongation of the prescription after 12 months. As an example, a plan to repeat the same dose of neurotoxin previously administered with a good effect could be repeated during this 12-month period without further review unless there is a plan to change dose, add another treatment area/medication or a problem arises.

A patient has the right to a medical review at other times if requested or to be treated by the supervising medical practitioner.

The suggested cooling-off period between consultation and treatment ASAPS does not believe that a mandated cooling-off period will lead to better outcomes compared with a comprehensive consultation with the doctor combined with relevant printed information.

The process of obtaining informed consent requires the practitioner to ensure that patients have had adequate opportunity to digest information and ask questions, often requiring more than a single consult to allow adult consumers to make a well-informed decision.

Best practice in the informed consent process will provide a better outcome for the consumer and medical practitioner, and will not be improved by the implementation of a mandatory timeframe as a standalone measure. A fixed duration will not protect patients from unscrupulous operators.

It is ASAPS’ view that providers of these services need to be adequately trained and have the requisite knowledge to ensure that patients are well educated and informed, that their expectations are comprehensively managed and
that they have had the opportunity to make considered decisions.

ASAPS does not make the claim that these attributes are limited to its members alone. However, it does consider that the attainment of standards comparable to those of which ASAPS expects its members to adhere to and uphold are essential for the safe and effective provision of aesthetic medical and surgical services.

Dr Gabrielle Caswell
President of the Cosmetic Physicians Society of Australasia

The CPSA’s protocol for delegated cosmetic S4 injections state that a doctor must consult face-to-face with a patient and formulate a written treatment plan prior to delegating the administration of S4 medicines for cosmetic purposes to a registered nurse.
The CPSA is of the view that the national protocol that allows medical practitioners to consult and assess patients by using a video conference or a similar device is appropriate only in the event of emergency situations where a medical practitioner is not physically available, for example in remote and regional areas.
The CPSA believes that telemedicine does not apply to cosmetic medicine but only in the case of emergency medicine as described in the guidelines.

Dr Jass Narulla, President of ACAM &
Dr Sharron Phillipson, Immediate Past President
Australasian College of Aesthetic Medicine (ACAM) – except from submission

There are occasions when telemedicine is both necessary and desirable for the best medical management of a patient, particularly for urgent care of patients in remote areas. However, aesthetic medicine is elective and non-urgent, and require careful assessment of the suitability of the patient for the proposed treatment.

Documentation and responsibility are also important issues, as is the medico legal position and whether a doctor’s medical defence organisation would provide cover for this sort of activity.

ACAM does not endorse telemedicine for aesthetic medicine consultation purposes and is concerned that this practice, in many cases, is just legitimising the prescription for a fee. ACAM believes that doctors should be required to have face-to-face consultations with the patient before prescribing any cosmetic injectable treatments. Doctors must not prescribe cosmetic injectables remotely, including by phone, email, video-link or fax.

Dr Soo-Keat Lim
President of the Australasian College of Cosmetic Surgery (ACCS) – excerpt from submission

The College is concerned that the Board has not attempted to establish a case, as required under COAG guidelines, for the proscription on
the use of telemedicine in cosmetic medical practice. Although the College does have strong concerns about the abuse of remote prescribing, the College believes that further consultation and investigation on the use of telemedicine issue is required before regulation, beyond the existing telemedicine guidelines that apply to all health care practitioners, is considered.

The draft guidelines (“Option 3”) pertain to practitioner medical judgment. Medical judgment is informed by a matrix of legislation, regulation, guidelines, ethics, practice codes, education, training, competency and experience, which all play a vital role. A heavy reliance on prescriptive practice regulation, particularly at the procedural level, cannot alone improve professional standards. In that sense, the College believes that the consultation paper is, in part, misguided.

There are at least three ways that relevant national standards of education, training and accreditation for Cosmetic Medical Practice can be developed in Australia.

  1. Recognition of cosmetic medicine and surgery as a medical specialty, which would establish national standards against which any university or medical college training program could apply to have its standards accredited.
  2. Approval for cosmetic medicine and surgery as an area of endorsement for medical practitioners.
  3. Establishment of a national “Cosmetic Surgery Credentialing Council” of key stakeholders to develop and promulgate national standards of education, training and accreditation.

Remote prescribing and nurse injectors

Remote or technology-based diagnoses and treatment using telemedicine technology has been employed in Australia for several years. Specialist dermatologists use telemedicine to consult and diagnose skin cancer, for example. Specialist psychiatrists use telemedicine to diagnose and treat patients. Other areas of medicine also make increasing use of telemedicine in a variety of clinic contexts.

Remote treatment, usually involving assessment for botulinum toxin injection, in the Australian cosmetic context should be done in a team health care arrangement with a trained cosmetic physician and cosmetic nurse. The College provides training to doctors and nurses and has in place a cosmetic nurse diploma training program, and, recently, released a draft cosmetic nursing standard – the first of its kind in Australia. The College has considered developing a telemedicine module.

Currently, the College’s cosmetic injectable prescribing protocol, developed in consultation with the NSW Health Care Complaints Commission and the Pharmaceutical Services Branch, states that nurses may give S4 substances such as botulinum toxin to a patient if a doctor is not present so long as the patient has been properly assessed and reviewed by a doctor who has provided a written prescription or written orders for that patient and is under the supervision of a doctor.

Of more immediate concern to the College are instances where doctors are not seeing patients whatsoever, whether in the next room or further away; nurses who may be administering without proper supervision; or S4 drugs which are not being properly obtained, controlled or supplied.

These and other concerns were raised by the College and other stakeholders at the February 2014 College-hosted Injectable Safety Roundtable attended by the Medical Board, state departments of health, the NSW HCCC, the Pharmaceutical Services Branch, the TGA, manufacturers, insurers, and other medical colleges and organisations.

The Medical Board’s consultation paper notes that the UK GMC has stated that doctors must undertake a physical examination of patients before prescribing non-surgical cosmetic injectables such as botulinum toxin, and may not use telemedicine for patient consultations, and has included this ban in its Draft Guidelines (Option 3).

The College is also aware that, as in the UK, increasingly nurses in Australia are gaining increased prescribing rights. In Victoria, for example, nurse practitioners autonomously prescribe and may now prescribe botulinum toxin to patients.

The College believes that medical practitioners should remain responsible for the care of cosmetic medical patients in a patient-focused, team approach. Telemedicine run under strict protocols would appear to offer a way to achieve this and, in the College’s view, would be preferable to an alternative arrangement in which medical practitioners have no involvement. AMP

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