Australia. Administrative Appeals Tribunal
A delegate of the Minister for Health and Ageing (respondent) decided that Di-Gesic and Doloxene should be removed from the Australian Register of Therapeutic Goods because recent and existing evidence regarding dextropropoxyphenel (DPP) indicated that their safety was unacceptable.
Aspen Phamacare Australia (applicant), who marketed Di-Gesic and Doloxene, sought review of the delegate's decision by the Administrative Appeals Tribunal.
The issue was whether the "quality, safety or efficacy" of each drug was "unacceptable" within the meaning of section 30(2)(a) of the Therapeutic Goods Act 1989 (Cth) (Act).
The Tribunal balanced efficacy against risks of hurt, injury or misuse.
On the issues of safety, the Tribunal found that:
- It is not appropriate to refuse registration approval simply because the drugs may be used for self-harm
- The risk of accidental overdose was real and could be mitigated but not entirely overcome
- Many medications have contra-indications for particular patient groups or conditions and DPP is no different.
The Tribunal considered whether there were other suitable and efficacious alternative pain relief medicines. It concluded that there was likely to be a group of patients for whom there was unlikely to be an adequate analgesic alternative to DPP for mild to moderate pain. Its position was that the needs of individuals should not be subjected to the larger community interest unless they are truly inconsistent.
Furthermore, additional conditions could be imposed under section 28 of the Act regarding sales and prescriptions. Therefore the matter was remitted back for reconsideration.
Toula Brakoulias (plaintiff) alleged that Dr Chitra Karunaharan (defendant) was negligent in prescribing her Reductil (weight loss drug) and that it caused her cardiac arrest and injuries.
The proper construction of section 59 of the Wrongs Act 1958 (Vic) was the issue. It stated that a professional was "not negligent" in providing a professional service if they acted in a manner that satisfied the standard of care described in the section.
The question was whether:
- S 59(1) superseded Rogers v Whitaker
- Rogers v Whitaker still applied unless the defendant adduced evidence of peer professional opinion and s 59 then became an evidentiary burden
- Rogers v Whitaker still applied and s 59 was a defence.
Amongst other reasons, the court noted the Act stated it did not intend to affect the common law. Therefore it held that s 59 should not supersede Rogers v Whitaker
The court stated that the common law creates the liability and the statute qualifies it. The words "a professional is not negligent if" appeared to make the section a defence. Two New South Wales decisions had concluded that for the NSW equivalent. The only person likely to rely on peer professional opinion under s 59 was the defendant professional. Therefore, s 59 enabled the professional to escape liability by bringing themselves within the section. This made s 59 a defence and was a legal burden, not an evidentiary burden.
New South Wales
Medical practitioners - disciplinary proceedings before Medical Tribunal - separate complaints based on fact of criminal convictions and that practitioner not of good character - reliance on conduct as basis for assessment as to character - whether abuse of Tribunal's process to lead evidence inconsistent with findings on which prior convictions based.
Residential Care Subsidy Amendment Principles 2012 (No. 1) - F2012L01279 " as made
Private Health Insurance (Complying Product) Amendment Rules 2012 (No. 6) - F2012L01276 " as made
Health Insurance (Allied Health Services) Amendment Determination 2012 (No. 2) - F2012L01267 " as made
Private Health Insurance (Benefit Requirements) Amendment Rules 2012 (No. 4) - F2012L01264 " as made
Health Insurance Act 1973 (Cth) - Declaration of Quality Assurance Activity under section 124X (QAA No. 2/2012) - F2012L01226 " QAA 2/2012 as made
Australian Capital Territory
Official Visitor Act 2012 No. 33 assented to on 15 June 2012
New South Wales
Health Services Amendment (National Health Reform Agreement) Act 2012 - Assent: 20 June 2012
Voluntary Euthanasia Bill 2012 - House of Assembly 14 June 2912 Motion for second reading lost (Bill rejected) (Private Member's Bill)
National Health Funding Pool Bill 2012 - Legislative Assembly second reading 20 June 2012
Mental Health Amendment Bill 2012 - Legislative Assembly on the 20 June 2012
Australia. Department of Health & Ageing
- 22 June 2012 - World Continence Week kicks off - In launching World Continence Week 2012 in Melbourne on 22 June, Minister for Ageing Mark Butler said an estimated four million Australians are affected to some degree by incontinence.
- 21 June 2012 - Patients to benefit from 30 additional MRI licences for regional Australia -Health Minister Tanya Plibersek has announced another 30 regional licences for Medicarerebated magnetic resonance imaging services.
- 21 June 2012 - You're not too old to donate life - Parliamentary Secretary for Health and Ageing Catherine King is appealing to older Australians to decide about and discuss their organ and tissue donation wishes with their loved ones.
- 20 June 2012 - $24 Million for drug and alcohol research - Minister for Mental Health Mark Butler has announced $24 million over three years to be invested into alcohol and drug research.
- 20 June 2012 - $8.7 million in grants for rural health practices - Rural patients will benefit from new infrastructure grants to 50 projects across Australia, Health Minister Tanya Plibersek announced on 20 June 2012.
- 19 June 2012 - Peter Shergold appointed Chair of Aged Care Reform Implementation Council - Minister for Ageing Mark Butler has appointed one of Australia's eminent public servants, Professor Peter Shergold AC to Chair of the Aged Care Reform Implementation Council.
- 18 June 2012 - $2.6 million for Drug Action Week - Drug Action Awareness activities will benefit from $2.6 million to support future events, Minister for Mental Health Mark Butler announced on 18 June. The announcement of this funding, which will also support the continuation of the National Drug and Alcohol Awards and other national drug-prevention activities, marks the start of Drug Action Week 2012.
- 18 June 2012 - Anne Gooley to lead development of Aged Care Workforce Compact -Minister for Mental Health and Ageing Mark Butler has announced the appointment of Commissioner Anne Gooley as the Chair of the Aged Care Strategic Workforce Advisory Group.
Private health insurance circulars
- PHI 44/12 Correction to PHI Circular No PHI 40/12 - Important dates for the August 2012 Prostheses List
- PHI 43/12 Release of Final Data Specifications for HCP and PHDB 2012-13 Data Collections
- PHI 42/12 Private Health Insurance (Data Provision) Rules 2012 and the Private Health Insurance (Health Insurance Business) Amendment Rules 2012
- PHI 41/12 Hospital Casemix Protocol (Hcp) Updates And Submissions
Australian National Audit Office
20 June 2012 - Administration of the Health and Hospitals Fund
Australian Competition & Consumer Commission (ACCC)
21 June 2012 - ACCC invites comment on proposal to conditionally authorise collective bargaining for small private hospitals - The ACCC is inviting submissions in response to its draft determination. Release # NR 121/12
Report to the Australian Senate on anti-competitive and other practices by health funds and providers in relation to private health insurance, 1 July 2010 to 30 June 2011 - This is the 13 th report prepared by the Australian Competition and Consumer Commission (ACCC) in compliance with an order agreed to by the Australian Senate on 25 March 1999.
Australian Institute of Health & Welfare
Australia. National Blood Authority (NBA)
The first two Patient Blood Management Guidelines have been released – Critical Bleeding/Massive Transfusion and Perioperative. Both available free of charge for download or hard copies on NBA website. Third Module (Medical) is currently with National Health and Medical Research Council for approval. Fourth Module (Critical Care) is currently in public consultation. Public consultation for Module 5 (Obstetrics) and Module 6 (Paediatrics/Neonates) is due to start later in 2012.
- Patient Blood Management Guidelines: Module 1 Critical Bleeding/Massive Transfusion
- Patient Blood Management Guidelines: Module 2 Perioperative
The National Blood Authority is undertaking a review of the authorisation process and clinical governance framework for immunoglobulin (IVIg). A Review Advisory Group chaired by Dr Stephen Christley is working with consultants Ernst & Young. The first stage of the review is now complete. Findings include: a lack of data on IVIg use and outcomes data; the reliance on paper-based systems; the passion and commitment of healthcare workers involved with IVIg; lack of consistent practice in review of patients when ongoing treatment is needed; and different jurisdictional policies related to access to normal immunoglobulin (NIg). View article
Australia. National E-Health Transition Authority
15 June 2012 - National Authentication Service for Health (NASH) delay will not impact consumer registration for Personally Controlled Electronic Health Record (PCEHR) - National E-Health Transition Authority CEO Peter Fleming said today the delayed delivery of the NASH programme from IBM will have no impact on the launch of the personally controlled eHealth records system in July, or the ability for consumers to register for an eHealth record. Read more: NASH delay will not impact consumer registration for PCEHR
7 June 2012 - National E-Health Transition Authority (NEHTA) signs up Aged Care Software Vendors for eHealth Panel - NEHTA CEO Mr Peter Fleming said today NEHTA has successfully completed the Expression of Interest EOI process for Aged Care Vendor Systems and had executed contracts with all shortlisted vendors. Read more: NEHTA signs up Aged Care Software Vendors for eHealth Panel
Australian Health Practitioner Regulation Agency & the Boards
21 June 2012 - The [Physiotherapy] Board has published a Fact Sheet on endorsement for acupuncture. | Read Article
21 June 2012 - The Podiatry Board of Australia releases a newsletter. | Read Article
20 June 2012 - Call for Nominations or Expressions of Interest for Board Members - Queensland. | Read Article
18 June 2012 - The Nursing and Midwifery Board and AHPRA have published further detail of the National Board's financial statements. | Read Article
18 June 2012 - The Board has published new limited registration standards for overseas trained physiotherapists. | Read Article
18 June 2012 - The National Board has released an Explanatory Note regarding the Australian College of Midwives original Position Statement on Homebirth. | Read Article
18 June 2012 - [Nursing & Midwifery Board] Seeking qualified and experienced parties to undertake PII research. | Read Article
18 June 2012 - The Chinese Medicine Board of Australia releases its latest Communiqué. | Read Article
18 June 2012 - The Aboriginal Torres Strait Islander Health Practice Board of Australia releases its latest Communiqué. | Read Article
24 May 2012 - 20 June 2012 - The Nursing and Midwifery Board of Australia releases its latest Communiqué. | Read Article
Australia. National Health & Medical Research Council
Research Tracker - 15 June edition
Australia. Therapeutic Goods Administration (TGA)
22 June 2012 - Medicinal gases: Guide to interpretation of the PIC/S Guide - Guide to interpretation of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products - 15 January 2009; applicable to the manufacture of medicinal gases.
21 June 2012 - Update on TGA decision to cancel prescription pain-killers - The TGA is updating the public and health care professionals about the regulatory status of dextropropoxyphene-containing pain-killers after a decision by the Administrative Appeals Tribunal that the TGA reconsider its decision to cancel Di-Gesic and Doloxene
20 June 2012 - Tuberculosis (BCG) vaccine - Sanofi-Aventis Australia Pty Ltd is recalling batches of tuberculosis (BCG) vaccine because the product's sterility cannot be assured.
18 June 2012 - Presentations about the regulation of biologicals - Presentations given by TGA staff about the regulation of biologicals.
Australian Capital Territory. Department of Health
- 21 June 2012 - $1m to support Canberra GPs - Katy Gallagher, MLA
- 21 June 2012 - ACT leads Australia in access to community mental health - Katy Gallagher, MLA
- 21 June 2012 - New GP workforce study announced - Katy Gallagher, MLA
- 18 June 2012 - Woden Rotary donates Cough Assist machine to Canberra Hospital - Katy Gallagher, MLA
- 17 June 2012 - Partnering with community to tackle chronic disease - Katy Gallagher, MLA
- 16 June 2012 - The Green Shed donates $10,000 to Ronald McDonald House - Katy Gallagher, MLA
New South Wales. Ministry of Health
- 20 June 2012 - NSW Government Commits to Medical Research
- 18 June 2012 - "Looking After Your Mind" in Drug Action Week
- 21 June 2012 - Payroll Codes for Paramedic Specialist - Extended Care Paramedic-IB2012_017
Northern Territory. Department of Health
Kon Vatskalis - Minister Welcomes Hospitals' Governing Councils - A new era in the governance of the Territory's public hospital system has begun, with the formation of the two new Governing Councils that will oversee the Top End and Central Australian Hospital Networks.
Kon Vatskalis - CLP's 'Vision' for Palmerston Hospital .... Is Barely Visible At All - The NT Government remains committed to delivering the Palmerston Hospital despite the CLP once again talking it down, Health Minister Kon Vatskalis said today.
Queensland. Department of Health
- 20 June 2012 - Correction: Hospital and Health Board Legislation
- 20 June 2012 - Hospital and Health Boards Pass State Parliament
Tasmania. Department of Health & Human Services
- 21 June 2012 - A New Mental Health Act for Tasmania
- 20 June 2012 - New Governing Council Members for Tasmanian Health Organisations
- 15 June 2012 - Federal Health Funding Injection Welcomed
Victoria. Department of Health
21 June 2012 - Mildura Base Hospital performing well - The Minister for Health David Davis has released the key findings of an independent review of Ramsay Health Care's delivery of health services in Mildura.
21 June 2012 - Modernising Victoria's health complaints arrangements - Submissions are being called for a review that aims to modernise the way health complaints are resolved by the Health Services Commissioner.
Evaluation of heatwave framework
Sustainability Update 6 May 2012
VICNISS eBulletin Jun 2012 (Edition52)
Western Australia. Department of Health
- 21 June 2012 - Public Accounts Committee report commends Serco contract
- 20 Jun 2012 - Waldron - Funds to drive regional epilepsy support
- 18 June 2012 - Minister for Mental Health: Busting the alcohol and pregnancy myth
Victoria. Office of the Health Services Commissioner
Review of the Health Services (Conciliation and Review) Act
Review of the Health Records Regulations 2002
Appointments to the Health Services Review Council
Health Records Act Online Training - Now Free
New Zealand. Ministry of Health
20 June 2012 - Annual Review of Drinking-Water Quality in New Zealand 2010-2011 - This report describes the microbiological and chemical quality of water in New Zealand drinking water supplies serving populations of more than 100 people, and progress towards meeting the requirements of the Health Act 1956, from July 2010 to June 2011. Read more
19 June 2012 - Refugee Health Care: A Handbook for Health Professionals - This handbook is designed to support health workers in primary, community and secondary health care settings in the delivery of safe, effective and culturally appropriate care for their refugee clients. Read more
New Zealand. Medsafe
Adrenaline Protocol Guideline for Schools - This has been updated
United Kingdom. Department of Health
Views sought on making Nursery Milk Scheme more cost effective - A consultation on how the Nursery Milk Scheme operates launches today. The current nursery milk scheme has been running since the 1940s. Read more ? Views sought on making Nursery Milk Scheme more cost effective
New working group to help families juggle work and caring responsibilities - Care Services Minister Paul Burstow has announced a new government and employers working group to help give carers the support they need to stay in work alongside their caring responsibilities. Read more ? New working group to help families juggle work and caring responsibilities - Published: 21 June 2012
The Year 2011/12 – National Health Service (NHS) Chief Executive's annual report published - The Year 2011/12 launched today at the annual NHS Confederation Conference and Exhibition. This is the annual report for 2011/12. Read more ? The Year 2011/12 – NHS Chief Executive's annual report published - Published: 21 June 2012
British Medical Association (BMA) industrial action on Thursday 21 June - Although members of BMA are taking industrial action this Thursday, all emergency and urgent care will be provided. All GP surgeries will be open as usual. Read more ? BMA industrial action on Thursday 21 June - Published: 19 June 2012
Personal health budget pilots: fifth interim evaluation report - The fifth interim independent evaluation report about the personal health budget pilot programme has been published by the personal health budgets evaluation team. Read more ? Personal health budget pilots: fifth interim evaluation report - Published: 19 June 2012
Alzheimer's Society training programme in care homes aims to reduce antipsychotic prescriptions - An Alzheimer's Society training programme, supported by funding from the Department of Health and the HC-One care home group, is being rolled out to 150 care homes across the UK. Read more ? Alzheimer's Society training programme in care homes aims to reduce antipsychotic prescriptions - Published: 18 June 2012
Final expert report on PiP breast implants published -The NHS Medical Director's expert group, which has been looking at PiP breast implants, has today published its final report. The group is led by Professor Sir Bruce Keogh. Read more ? Final expert report on PiP breast implants published Published: 18 June 2012
Canada. Health Canada
United States of America. Department of Health & Human Services (HHS)
New health IT effort aimed at reducing prescription drug abuse to be tested in Indiana and Ohio - Existing prescription drug use data will be made available to providers and pharmacists when treating patients in ambulatory and emergency departments through a new pilot program launched today by the HHS Office of the National Coordinator for Health Information Technology (ONC).
More than 100,000 health care providers paid for using electronic health records - More than 100,000 health care providers are using electronic health records that meet federal standards and have benefitted from the Medicare and Medicaid Electronic Health Record Incentive Programs, the Centres for Medicare and Medicaid Services and the ONC announced today.
Department of Health and Human Services releases annual Lesbian, Gay, Bisexual and Transgender (LGBT) report - HHS today released the 2012 report of the HHS LGBT Issues Coordinating Committee, which outlines many accomplishments from this past year and sets new goals for the coming year with respect to the health and wellbeing of the LGBT community.
HHS creates new centers to develop, manufacture medical countermeasures - The US Department of Health and Human Services today established three new centres to develop and manufacture medical countermeasures, such as vaccines and medicines used to protect health in emergencies, and can transition quickly and cost effectively between products. The centres will aid in bringing new medical countermeasures to the market faster and would help to train the biopharmaceutical workforce needed in the future.
British Medical Assocation
Australian Medical Association (AMA)
20 June 2012 - Submission: TGA consultation on evidence required to support indications for Listed Medicines - The AMA supports the improved evidence requirements contained in the Therapeutic Goods Administration's draft document Evidence Required to Support Indications for Listed Medicines. The AMA welcomes the strengthening of regulations to help protect the public. However, until the TGA has the resources to undertake more audits of sponsor information, the system for listing evidence will still be open to fraud.
20 June 2012 - Australian National Audit Office (ANAO) report shows that GP Infrastructure Grants deliver better primary care that GP Super Clinics - AMA President Dr Steve Hambleton said today that the latest report from ANAO on the Primary Care Infrastructure Grants Program shows clearly that the Program is a far better primary care investment for the Government than the troubled GP Super Clinics Program. Dr Hambleton said that investing in existing quality local general practices that have served their communities for years is much smarter than importing expensive poorly-planned "white elephants" that drain vital funds from the health system.
20 June 2012 - AMA launches medical training survey - The AMA has this week invited thousands of doctors in training nationwide to participate in a confidential online survey on the quality of the training, education and supervision they are receiving in hospitals across the country. The AMA Junior Doctor Training, Education and Supervision Survey is the second of its type, with a similar survey in 2009 attracting more than 900 responses.
20 June 2012 - Submission: Health Workforce Australia (HWA) Prescribing Pathways Project - Prescribing by non-medical health professionals should only occur within a consistent and sustainable medically delegated environment to ensure safe and high quality prescribing. This submission to HWA details the principles and requirements necessary for this to occur.
Canadian Medical Association
19 June 2012 - Wait times are getting worse: report card
18 June 2012 - New banking plan offers reduced costs for MDs
American Medical Association (AMA)
- 21 June 2012 - AMA Announces Board of Trustees for 2012-2013 - The AMA today introduced the 21 members of its Board of Trustees for the coming year following elections held during the Annual Meeting of the AMA House of Delegates in Chicago.
- 20 June 2012 - AMA Adopts Policy Addressing Obesity, Beverages with Added Sweeteners -The AMA voted today during its annual policy-making meeting to adopt policy addressing the obesity epidemic.
- 19 June 2012 - AMA Inaugurates Denver Psychiatrist Jeremy Lazarus as President - Jeremy A. Lazarus, MD, a Denver psychiatrist in private practice, was inaugurated today as the 167th president of the AMA.
- 19 June 2012 - AMA Adopts New Policies at Annual Meeting - The AMA voted today during its annual policy-making meeting to adopt the following new policies.
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