In this edition: Informed consent guidance for GP's, Medical Board of Australia updates, Services Australia Family and Domestic Violence Strategy 2020-2023, Dental practitioner prosecuted, Unique Device Identification system for medical devices proposed.
The latest insights from our Health Law team:
Obtaining valid informed consent – new guidance for GPs
Medical Board of Australia updates
Services Australia launches its Family and Domestic Violence Strategy 2020-2023
Dental practitioner prosecuted for a failure to properly prescribe medicines
Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia
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Obtaining valid informed consent – new guidance for GPs
The Australian Commission on Safety and Quality in Health Care (ACSQHC) has released a new fact sheet for GPs and healthcare providers.
Obtaining informed consent prior to treatment is a legal, professional and ethical requirement which applies to all health professionals. It forms part of many professional Codes of Conduct, the National Safety and Quality Health Standards and is an important aspect of the right to information which is set out in the Australian Charter of Healthcare Rights, which is available here.
The fact sheet, available here, sets out:
- key principles for informed consent, which include the capacity to consent, circumstances in which consent is not required (e.g. in emergency situations or certain mental health interventions), the right to refuse treatment, documenting discussions surrounding consent and the duty to warn about material risks of treatment;
- requirements for valid informed consent, including that the person consenting must;
- have capacity to consent;
- give consent voluntarily;
- give consent to the specific treatment, procedure or intervention being discussed; and
- have enough information about their condition, treatment options, the benefits and risks relevant to them and alternatives options, such that that person can make an informed decision to consent.
- details surrounding how to obtain valid informed consent;
- principles for assessing legal capacity, including a person’s ability to understand facts, treatment choices, consequences of treatment, ability to retain and recall information, assess consequences of options available and communicate decisions and understanding of implications; and
- information surrounding state and territory based legal obligations about informed consent.
The Royal Australian College of General Practitioners’ (RACGP) publication regarding the new fact sheet is available here. Further information regarding informed patient consent, published by RACGP, is available here.
Medical Board of Australia updates
The Medical Board of Australia (MBA) has published updates to the Good medical practice: a code of conduct for doctors in Australia and Standards for the assessment of specialist international medical graduates.
The code of conduct for Good medical practice took effect on 1 October 2020, and describes the MBA’s expectations for all doctors who practise medicine in Australia, setting out the principles of good medical practice, and ethical and professional conduct. The changes to the 2020 code are intended to make these expectations clearer and easier to understand, and include strengthened guidance about discrimination, bullying and sexual harassment.
You can access Good medical practice here.
The Standards for the assessment of specialist international medical graduates will come into effect for international medical graduates and medical colleges on 1 January 2021. The purpose of the revised Standards is to improve transparency and procedural fairness, rather than to change the approach to assessment.
You can access the Standards for the assessment of specialist international medical graduates here.
Services Australia launches its Family and Domestic Violence Strategy 2020-2023
Services Australia’s mission to support its customers with simple, helpful, respectful and transparent services has been furthered by the launch of its Family and Domestic Violence Strategy 2020-2023 (Strategy).
The Strategy sets out a number of initiatives, including, but not limited to:
- creating an environment where customers and staff feel comfortable reaching out for support;
- training staff to recognise when customers might be affected by family and domestic violence;
- helping customers experiencing family and domestic violence to get the support they need without having to tell their story multiple times; and
- working with community and government to better support customers.
The Strategy can be accessed from the Services Australia website or by clicking here.
Dental practitioner prosecuted for a inappropriate prescription of opioids
The NSW Civil and Administrative Tribunal (Tribunal) recently handed down its decision against dental practitioner, Dr Peter Joseph Brian Buys.
In an earlier decision this year, Dr Buys was prosecuted by the Health Complaints Commissioner (HCCC) for prescribing 10 patients with excessive quantities of Schedule 4 and 4D drugs over an “excessive period”, outside of the acceptable standards. He was found guilty of professional misconduct.
It was established that Dr Buys failed to engage in appropriate monitoring, review and management of prescriptions. He also failed to maintain adequate clinical records for these patients, in particular the dates on which prescribed the medication Oxycodone, and the reasons of his decision.
In light of this decision, the issue before the Tribunal was what protective orders would be appropriate in light of Mr Buys’ professional misconduct under section 149C of the National Law. The Tribunal cancelled Dr Buys’ registration and restricted his ability to apply for a review of this Order to after 12 months.
In reaching its decision, the Tribunal took into consideration the importance of
- protecting the public;
- maintaining public confidence in the integrity of the dental profession; and
- the deterrent effect both on Dr Buys and on other members of the dental profession.
Dr Buys produced character references, expressed remorse over his decision making processes and attended a course on safe prescription and drug use in dental practice. However, this was overcome by the Tribunal’s regard of the severity, nature and extent of the worker’s misconduct.
Read the Tribunal’s full decision here.
Proposal to introduce a Unique Device Identification (UDI) system for medical devices in Australia
As part of its reform of the regulation of therapeutic goods in Australia, the Department of Health has released a second consultation paper relating to the proposal to implement a UDI system for medical devices (the Proposal). The Government is inviting responses to this second consultation paper through an online survey (both of which are accessible here).
The first consultation paper, published in January 2019, sets out the rationale for the Proposal, including the benefits to patient safety. There was a strong consensus across various stakeholders on the need for a UDI system in Australia.
The second consultation paper seeks the views of stakeholders on areas including:
- the benefits of an Australian UDI system across the broader health system;
- whether the first phase of implementation should be limited to a small number of high-risk devices;
- what mechanisms should be considered for submitting the UDI data to the Therapeutic Goods Administration; and
- what the impact will be of fully aligning implementation with the guidance of the International Medical Device Regulators Forum.
This consultation closes on 18 November 2020.
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