Q&A - Informed consent – A legal and regulatory requirement

As prescribing of pharmaceuticals is a medical treatment, the usual principles and requirement for informing  patients of the benefit, side effects and risks apply. This is required from the patient or advance care directive or a medical treatment decision maker.

If you are seeking the consent from a medical treatment decision maker to administer medication, the medical treatment decision maker must be provided with the information needed to make an informed decision about the treatment, including benefits, side effects and material risks.

Your prescribing and warnings of side effects should be based on consideration of your patient’s presentation and medical history. Always note the consent discussion in your records.

A pharmacist may also provide information on the side effects but the responsibility for the prescribing and an informing of the benefits, risks and side effects lies with the prescribing practitioner.

Consent for vaccination is similar for any consent. Discuss common side effects, serious side effects and then discuss material risks for that patient. Verbal consent is appropriate.  Often practice nurses or others also outline, so the patient often hears twice. As always document in the patient notes all consent discussion.

The Commonwealth Department of Health provides the Australian Immunisation Handbook which provides clinical guidelines for healthcare professionals and others about using vaccines safely and effectively.

In general, separated parents have the same rights as non-separated parents (only one parent consent needed) unless you are aware or should reasonably be aware that the other parent objects or is likely to object, or if there is a specific court order in place requiring consent of both parents.

Members should do what is in the best interest of the child and seek further advice and assistance particularly if the primary caregiver is not easily discernible.

Telehealth services can be provided in situations when it is both safe and clinically appropriate to do so and patients’ consent is obtained and documented.

You should adhere to all relevant practice guidelines from AHPRA, Colleges and MBS on technology-based patient consultations.

AHPRA expects that you:

• act in accordance with the standards set out in your professions’ Code of conduct or equivalent including expectations about confidentiality and privacy, informed consent, good care, communication, health records and culturally safe practice.
  • ensure you have appropriate professional indemnity insurance (PII) arrangements in place for all aspects of your practice, including telehealth consultations.
• are aware of and comply with:
  • state and territory legislative requirements including (but not limited to) authorities that regulate heath records
  • privacy legislation and/or any other relevant privacy requirements
  • when appropriate, the use of government health and prescription monitoring services such as Prescription Shopping Programme, SafeScript, My Health Record, Healthenet, and
  • any other relevant legislation and/or regulatory requirements.

The Medical Board of Australia has developed Guidelines for technology-based patient consultations.

Commonwealth Department of Health has developed DHS Covid 19 Telehealth-items-guide

The adequacy or other wise of your consent process is ultimately determined by a court of law or assessed by your regulator. There is no formula or template, but the following legal and regulatory factors are to be noted.

General

• Document all informed consent discussions in the patient’s medical record accurately
• Patients must have the legal capacity to provide both clinical and financial consent
• Communicate information about clinical procedures using plain, non-technical language and ensure your message is tailored to the patient’s circumstances, values and culture
• You must inform the patient of any material risks.

A risk is material if, in the circumstances of the particular case, a reasonable person in the patient's position, if warned of the risk, would be likely to attach significance to it

Or

If the medical practitioner is or should reasonably be aware that the particular patient, if warned of the risk, would be likely to attach significance to it

In Australia, a health professional has a duty to exercise reasonable care and skill in the provision of professional advice and treatment. The standard of reasonable care and skill required is that of the ordinary skilled person exercising and professing to have that special skill. A court of law decides  whether a health professional  met a reasonable standard of care when obtaining consent in respect of  clinical treatment. The High Court has ruled that a health professional has a duty to inform patients of material risksof any proposed treatment. 

Medical/Dental Board Code of Conduct

3.5 Informed consent

• Provide information to patients in a way that they can understand before asking for their consent.
• Obtain informed consent or other valid authority before you undertake any examination as you would in any consultation
• Inform patients about any costs, fees and charges before proceeding

Gillick Competence

Based on a landmark case in UK, House of Lords in Gillick v West Norfolk and Wisbech AHA [1986].  A mother of girl under 16 objected to Department of Health advice that allowed doctors to give contraceptive advice and treatment to children without parental consent. The court held that a child under 16 had the legal competence to consent to medical examination and treatment if they had sufficient maturity and intelligence to understand the nature and implications of that treatment.

So children and adolescents who fully understand a proposed treatment can give consent to that treatment. There is no age limit defined, merely the understanding of the treatment.

Be mindful that informed financial consent( and approval to proceed) needs to come from parents or legal guardian if they are the ones paying the bill

AMA Guide to Social media Feb 2020

Medical Board Social Media Guide 

MIPS article