Archive for April, 2019

For those concerned by proposed changes to Oz guidelines for Doctors re complementary medicine: what the proposed changes are

April 8, 2019

Actual proposed  Oz guidelines for doctors re complementary and unconventional medicine, from https://www.medicalboard.gov.au/News/Current-Consultations.aspx are copied in below.  Much of the concern seems to be from those who have not read them.  Read before worrying, then you will sound more sensible if you comment in the way described on the medicalboard.gov.au site.

The consultation is called

Public consultation on clearer regulation of medical practitioners who provide complementary and unconventional medicine and emerging treatments

Guidance for all registered medical practitioners

This section of the guidelines includes guidance for all registered medical practitioners including those doctors whose patients use complementary and unconventional medicine and emerging treatments, but who don’t themselves provide these treatments.

  1. Discussion with patients

The use of complementary and unconventional medicine and emerging treatments is increasing. It is therefore important that all medical practitioners are aware of these areas of practice and how they may affect their patients and impact other treatments, regardless of whether they themselves provide or recommend these treatments. There are resources available for medical practitioners when discussing complementary and unconventional medicine and emerging treatments with their patients.[1]

Good medical practice for all medical practitioners involves:

  • Asking your patients about their use of complementary and unconventional medicine and emerging treatments regardless of whether you provide or recommend these treatments.
  • Taking into consideration your patient’s use of complementary and unconventional medicine and emerging treatments when determining appropriate management for your patient.
  • Respecting your patient’s right to make informed decisions about their health and their right to choose complementary and unconventional medicine and emerging treatments.

 

 

Guidance for registered medical practitioners who provide complementary and unconventional medicine and emerging treatments

This section of the guidelines includes guidance for registered medical practitioners who provide complementary and unconventional medicine and emerging treatments.

  1. Knowledge and skills

Safe patient care relies on the medical practitioner having the knowledge and skills in the area of medicine in which they practise. This is both for the treatments being provided and the conditions for which patients seek treatment. This is particularly important where treatments may not be part of standard medical training, for alternative uses of conventional treatments and for new and emerging treatments that are continuously evolving.

Good medical practice for medical practitioners providing complementary and unconventional medicine and emerging treatments involves:

  • Ensuring you have current knowledge and skills for your scope of practice to ensure safe patient care.
  • Only offering treatments if you have the appropriate training, expertise and experience in both the treatment and the condition being treated.
  • Arranging appropriate and timely specialist referral, when indicated.
  • Undertaking necessary training if you intend to change your scope of practice to include complementary and unconventional medicine and emerging treatments.
  1. Conflicts of interest

Conflicts of interest can arise when providing complementary and unconventional medicine and emerging treatments. This is the case when there are high costs involved as well as because of the experimental and commercial aspects of some treatments.

Good medical practice for medical practitioners providing complementary and unconventional medicine and emerging treatments involves:

  • Always acting honestly and only in your patient’s best interests when providing complementary and unconventional medicine and emerging treatments.
  • Ensuring that you do not have a financial or commercial conflict of interest that may influence the advice and/or treatment that you give your patients.
  1. Informed consent

Patients have a right to know if the treatment they are being offered is not considered to be ‘conventional medicine’. They have the right to know the evidence for its efficacy and safe use.

Medical practitioners proposing complementary and unconventional medicine and emerging treatments must obtain informed consent from their patient. Good medical practice involves:

  • Providing your patient with enough information, preferably in written form, for them to make informed decisions about proposed assessments, investigations and treatments.
  • Providing your patient with clear information about:
    • the extent to which the assessment, investigation and treatment is consistent with conventional medicine and accepted by the medical profession or if it is considered alternative and/or experimental
    • the degree to which, and how, diagnostic investigations and tests have been formally evaluated and what is known about their reliability, safety and risks
    • the degree to which, and how, the proposed treatments have been formally evaluated or proven and what is known about their safety, side effects, risks, likely effectiveness and a realistic likelihood of benefit for the proposed use.
    • the range of possible outcomes, taking into consideration the patient’s expectations
    • the likely number of investigations and treatments required and the costs involved
    • other treatment options (including conventional treatments), their risks, likely benefits and efficacy based on the best current available information.
  • Ensuring that patients who may be vulnerable because of the serious and/or chronic nature of their condition and/or because conventional medicine has not been effective, are not exploited or unduly influenced.
  • Ensuring that information provided about complementary and unconventional medicine and emerging treatments does not create unrealistic patient expectations.
  • Informing your patient of their right to seek a second opinion regarding their treatment and options from another independent medical practitioner when proposing treatments that are complementary, unconventional or emerging.
  1. Assessment and diagnosis

Some medical practitioners providing complementary and unconventional medicine and emerging treatments use diagnostic methods and tests that are not considered to be part of conventional medicine.

Good medical practice in the assessment and diagnosis of patients involves:

  • Ensuring the assessment and examination of your patient is comprehensive and considers all relevant information.
  • Ensuring that any recommendation for investigations or tests is based on the best current available information.
  • Performing and/or ordering any generally recognised diagnostic investigations and tests that would be reasonably expected for appropriate patient care.
  • Ensuring you consider appropriate differential diagnoses for each individual patient.
  • Ensuring that your diagnosis is supported by sound clinical judgement and informed by the best current available information.
  1. Treatment

Providing a treatment in the absence of an identified therapeutic need can unnecessarily expose a patient to risk of harm. Patient harm can also result if the provision of complementary and unconventional medicine and emerging treatments results in delays in accessing more appropriate treatments for the patient.

Good medical practice when providing complementary and unconventional medicine and emerging medicine involves:

  • Ensuring that you do not discourage the use of conventional treatment options when this is clinically appropriate.
  • Only recommending treatments where there is an identified therapeutic need, quality and safety can be reasonably assured and that have a reasonable expectation of clinical efficacy and benefit.
  • Ensuring that the provision of any complementary and unconventional medicine and emerging treatments comply with any relevant Therapeutic Goods Administration requirements.[2]
  1. Patient management

Good patient care is supported when there is good communication with, and coordination of care between, all treating practitioners. When the provider of complementary and unconventional medicine or emerging treatments does not have a role in the patient’s regular medical care it is important to ensure that there are measures in place for the coordination of care. Follow-up of patients is particularly important where treatment is provided that is experimental and/or part of a formal research clinical trial – both for the patient’s wellbeing and for the contribution to medical knowledge.

Good medical practice for the care of your patients to whom you are providing complementary and unconventional medicine and emerging treatments involves:

  • Documenting information including the diagnosis, treatment, efficacy, side-effects and known risks of interactions in the patient’s medical record.
  • Ensuring that you take responsibility for appropriate monitoring and follow-up of patients to whom you are providing complementary and unconventional and emerging treatments. This is even more important when you are providing experimental treatments.
  • Encouraging your patients to tell their other health practitioners about their use of complementary and unconventional medicine and emerging treatments.
  • With permission from your patient, communicating with their other treating doctors (if applicable). You should inform other treating medical practitioners of the investigations, the diagnoses, treatments, known risks of interactions and patient progress.
  • Reporting adverse events to the relevant authority to assist safety monitoring.
  1. Advertising

Some patients who seek complementary and unconventional medicine or emerging treatments may be vulnerable to advertising that may lead to unreasonable expectations. The advertising provisions in Section 133 of the National Law include that a regulated health service must not be advertised in a way that is false, misleading or deceptive or creates an unreasonable expectation of beneficial treatment.

Good medical practice when advertising complementary and unconventional medicine and emerging treatments involves:

  • Ensuring that all advertising material, including practice and practitioner websites, complies with the Board’s Guidelines for advertising of regulated health services, including the advertising requirements of section 133 of the National Law, of the Therapeutic Goods Administration and the Therapeutic Goods Advertising Code and of the Australian Competition and Consumer Commission.
  • Ensuring that you do not create the impression that you are a specialist in an area of practice that is not a recognised specialty.
  • Ensuring advertising material does not create unreasonable patient expectations of the benefits of the complementary and unconventional medicine and emerging treatments.
  1. Research and advancing knowledge

Innovation and research in new treatments is necessary to improve health outcomes. However, there must be protections in place for patients. Efforts to make advancements in treatments should not jeopardise patient safety.

Good medical practice in the research and advancement of complementary and unconventional medicine and emerging treatments involves:

  • Ensuring that research involving complementary and unconventional medicine and emerging treatments complies with the National Health and Medical Research Council’s (NHMRC) current ‘Australian Code for the Responsible Conduct of Research’ and ‘National Statement on Ethical Conduct in Human Research’.
  • Where tests and treatments are experimental, being prepared to contribute to and share new knowledge with the profession.

Acknowledgements

The Board acknowledges the following organisations’ codes and guidelines, which helped inform the development of the Board’s draft guidelines:

  • Medical Council of New South Wales (2015) Complementary health care policy
  • Medical Council of New Zealand (2011) Statement on complementary and alternative medicine

Implementation date and review

These guidelines will take effect on <date>.

The Board will review these guidelines at least every five years.

[1] For example, National Health and Medical Research Council (NHMRC), Talking with your patients about Complementary Medicine – a Resource for Clinicians, 2014 and NHMRC, Stem Cell Treatments – A Quick Guide for Medical Practitioners, 2013

[2] For example, Therapeutic Goods Administration (TGA), Australian regulatory guidelines for complementary medicines, 2018 and TGA, Australian regulatory guidelines for biologicals, 2017.

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