Health Alert is a summary of the critical judgments, legislation, press releases and news items which have come to our attention each week. Many of the summaries will contain a hyperlink.
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Australia. Administrative Appeals Tribunal
Ego Pharmaceuticals Pty Ltd (Ego) applied for a review of a decision of the delegate of the Minister for Health and Aging to refuse applications made pursuant to the Therapeutic Goods Act 1989 (Cth) for the registration of Zatamil ointment, lotion and hydrogel.
Pharmaceutical products can only be marketed if they are registered in the Australian Register of Therapeutic Goods. Registration will be approved when quality, safety and efficacy have been satisfactorily established. In the case of pharmaceuticals containing the same active ingredient as products already registered, the requirements of the system may be less stringent than with new products. The new product is known as a ''generic''.
Ego sought approval to market such a generic, for use topically to treat dermatitis and other skin conditions. The generic is to be called Zatamil. The established product is called Elocon or Novascone. Although the active ingredient in products is identical, the bases of the ointment, lotion and hydrogel in which they are carried, are not. The question before the Tribunal was whether the testing undertaken by Ego sufficiently demonstrated equivalence between the two products to satisfactorily establish the quality, safety and efficacy of Zatamil for the purposes for which it is to be used.
The Tribunal was not satisfied that the evidence before it met the requisite equivalence. While the Tribunal declined to register Zatamil, it saw no reason why the product should not be registered if further tests were performed to achieve equivalence with the established product.
New South Wales. Medical Tribunal
15/10/2010: Martin, Jason
In 2003, the applicant, Jason Martin, became addicted to codeine. Following a hearing before the Impaired Registrants Panel, the applicant agreed to conditions being placed on his registration effective from 4 August 2004. The applicant breached some of these conditions. The Health Care Complaints Commission initiated proceedings before the New South Wales Medical Tribunal in March 2009.
The substance of the complaints was that the applicant had administered a narcotic derivative non-prescription compound analgesic and/or cold medication on 17 occasions between 20 December 2004 and 28 September 2007. The drugs detected were morphine and, on two occasions, pseudoephedrine. It was also alleged that the applicant, who was required to attend for urine testing three times per week, had provided dilute or very dilute samples on 72 occasions between December 2004 and September 2007 which registered the tests invalid.
Before the March 2009 Tribunal, the applicant admitted he had breached the conditions. He attributed his conduct to anxiety and depression. He also said he had a poor attitude caused by negative thought processes and he resented having to conform to the conditions of his registration.
The Tribunal reinstated the applicant's registration after he was de-registered in August 2009, subject to a number of conditions. The Tribunal noted that since the August 2009 hearing the applicant had entered into a regime of drug testing on a consistent basis and the tests had, without exception, been consistent with an absence of drug taking. The Tribunal concluded that these matters suggested a firm resolve on the applicant's part to discharge the proper ethical and professional standards expected of all medical practitioners.
15/10/2010: Woods, Ray
New South Wales
PHARMACIST – Deregistration – Continuing unfitness – Whether remorseful – Significance of finding of dishonesty – Requirements of procedural fairness – Whether breach of rule in Brown v Dunn - Error of law – Mistake of fact – Whether Supreme Court should hear and determine consequential orders when quashed – Remit to Tribunal for determination.
Federal Financial Relations Amendment (National Health and Hospitals Network) Bill 2010 [Bill Homepage] - Date: 27/10/2010 09:38:51 - Collection: Bills and Legislation - ID: legislation/billhome/r4485 - Source: House of Reps
Therapeutic Goods (Medical Devices) Amendment Regulations 2010 (No. 3) - F2010L02787 - Health - These Regulations amend the Therapeutic Goods (Medical Devices) Regulations 2002 to allow reduced assessment fees relating to IVDs where, under specified circumstances, an abridged assessment can be carried out.
Health Insurance (General Medical Services Table) Regulations 2010 - F2010L02791 - Health - These Regulations repeal the Health Insurance (General Medical Services Table) Regulations 2009 and prescribe a new Table for the 12 month period commencing 1 November 2010.
Health Insurance Amendment Regulations 2010 (No. 4) - F2010L02797 - Health - These Regulations amend the Health Insurance Regulations 1975 to implement a 2010-11 Budget measure to recognise Addiction Medicine, Sexual Health Medicine and Sport and Exercise Medicine as medical specialties.
Health Insurance (Diagnostic Imaging Services Table) Regulations 2010 - F2010L02765 - Health - These Regulations repeal the Health Insurance (Diagnostic Imaging Services Table) Regulations 2009 and prescribes a new table for the 12 month period commencing 1 November 2010.
Health Insurance (Pathology Services Table) Regulations 2010 - F2010L02766 - Health - These regulations repeal the Health Insurance (Pathology Services Table) Regulations 2009 and prescribes a new table for the 12 month period commencing 1 November 2010.
Health Insurance (Positron Emission Tomography) Facilities Determination 2010 (No. 2) - F2010L02816 - Health - This Determination revokes and replaces the Health Insurance (Positron Emission Tomography) Facilities Determination 2010 to allow for continued eligibility of Medicare benefits for positron emission tomography services.
Therapeutic Goods Amendment Regulations 2010 (No. 4) - F2010L02771 - Health - These Regulations amend the Therapeutic Goods Regulations 1990 to provide for the disposal of unused medical devices, allows for reduction of certain fees applying to in-vitro diagnostic medical devices and provides for other consequential changes.
Health Insurance Amendment Regulations 2010 (No. 2) - F2010L02796 - Health - These Regulations amend the Health Insurance Regulations 1975 to make consequential amendments due to changes to the General Medical Services Table.
Health Insurance Amendment Regulations 2010 (No. 3) - F2010L02770 - Health - These Regulations amend the Health Insurance Regulations 1975 to specify the pathology and diagnostic imaging services a participating midwife or participating nurse practitioner can request as Medicare eligible services; and a period of validity for referrals to specialists and consultant physicians made by a participating midwife or participating nurse practitioner.
Health Insurance (Home-Based Sleep Studies) Determination 2010 (No. 1) - F2010L02723 - Health - This Determination is to provide retrospective legal authority for annual indexation that was applied from 1 November 2009 to the Medicare Benefits Schedule fee for home-based sleep study which was indexed without a determination to reflect such an increase.
Health Insurance (Home-Based Sleep Studies) Determination 2010 (No. 2) - F2010L02724 - Health - This Determination permits ongoing payment of Medicare benefits for home-based studies ordered and analysed by practitioners qualified in the field of adult sleep medicine.
New South Wales
Health Services Amendment (Local Health Networks) Bill 2010 - Legislative Assembly and received its second reading speech on 21 October 2010.
Surrogacy Bill 2010 - private member's Bill, sponsored by John Hatzistergos, was introduced into the Legislative Council and received its second reading speech on 21 October 2010.
Australia. Department of Health & Ageing
28 October 2010 - E-Health Conference - Revolutionising Australia's Health Care - The nation's leading health experts, consumer groups and information technology specialists will come together to discuss the technological revolution in the delivery of health care at an e-health conference later this year.
28 October 2010 - National Epidermolysis Bullosa Scheme Helping Those In Need -This week, 26-31 October, is International Epidermolysis Bullosa Awareness Week and an important opportunity to highlight this rare and debilitating genetic disease.
28 October 2010 - Process Commences For The Next 28 GP Super Clinics - Minister for Health and Ageing, Nicola Roxon, announced the start of the process of delivering 28 new GP Super Clinics to local communities around Australia, an extra $233m investment in primary healthcare.
27 October 2010 - Consultation Open on Alcohol–Free Community Sponsorship Fund - As part of its National Binge Drinking Strategy, the Australian Government is seeking input from the community on how to remove links between alcohol and community sporting and cultural activities that young people are involved in.
25 October 2010 - New Eye Surgery 'Blitz' in Central Australia - A six-day intensive eye surgery 'blitz', funded by the Australian Government and coordinated by the Fred Hollows Foundation, has begun at Alice Springs Hospital.
22 October 2010 - $8 Million Boost For Remote And Regional Health Services -People living in rural and remote communities are already benefiting from an innovative program that is boosting health and medical services in communities across the nation.
Health Alert: Recall of food products containing an undeclared therapeutic substance - On 22 October 2010, Food Standards Australia New Zealand (FSANZ) advised that a recall was being conducted for Sumabe Acai Berry Coffee, Moti Angel Coffee and Leptin Weight Loss Chocolate due to the undeclared presence of the therapeutic substance, sibutramine.
Private Health Insurance Circulars
National Carer Strategy - The National Carer Strategy will formally acknowledge the vital role of carers. The strategy will provide a national framework for the development and implementation of policies, programs and services for carers as well as bring together the different reform agendas that impact on carers across governments - 18 October 2010
Australia. Therapeutic Goods Administration
Consultation: Improving advertising arrangements for therapeutic goods (added submissions)
TGA legal expenditure (updated)
Australian Public Assessment Report (AusPAR) for prescription medicines (added Agomelatine)
TGA business process reforms - transitional arrangements from 1 November 2010: Training sessions are being held on 26 October, 29 October & 3 November 2010 in Brisbane, Melbourne and Sydney. Register now at ARCS Australia http://www.arcs.com.au
Drugs designated as orphan drugs (added C1 esterase inhibitor (CINRYZE))
Budesonide/ eformoterol fumarate dihydrate
Dr Rohan Hammett - biographical details (updated)
TGA customer service charter (updated)
Fact sheet: Operation of the reciprocal arrangement between the Therapeutic Goods Administration (TGA) and Health Canada's Health Products and Food Branch (HPFB) on manufacturers of medical devices (new)
Australian Health Practitioner Regulation Authority
Australia. National Health & Medical Research Council
Cutting the Risk of Healthcare Infections - 28 October 2010 - The Australian Commission on Safety and Quality in Health Care delivered the Australian Guidelines for the Prevention And Control Of Infection In Healthcare to the Minister for Health and Ageing, the Hon Nicola Roxon MP on Tuesday. » View Media Release
Australian Institute of Health & Welfare
Annual report 2009-10 - The AIHW is a major driving force in Australia for national information and statistics on health, housing and community services. The AIHW's outcome, as stated in the 2009-10 Portfolio Budget. Published 27 October 2010.
AIHW Access no. 28: 2010 - Published 26 October 2010.
Australia. National e-Health Transition Authority
Standards Australia issues RFP for the development of technical specifications to underpin the electronic transfer of prescriptions in Australia - 22 October 2010. Standards Australia is seeking proposals from suitably qualified individuals and/or organisations (Respondents) to assist in the development of six draft Australian Technical Specifications (ATSs) to underpin the electronic transfer of prescription and dispensed medication information processes in Australia. - Read more
Australia. Private Health Insurance Ombudsman
28 Oct 2010 - 2009/10 Annual Report READ MORE
Australia. Professional Services Review
PSR Annual Report 2009 – 2010. Copy available Here
Australian Competition & Consumer Commission
ACCC calls for comment on proposed pharmaceutical acquisition - The ACCC today issued a Statement of Issues on the proposed acquisition of Sigma Pharmaceuticals. Issued: 27 October 2010 Release # NR 233/10
Australian Capital Territory. Department of Health
ACT Government focussed on keeping GPs in the Territory Katy Gallagher, MLA October 27 2010
Recall of weight loss products (23 October 2010) - Three brands of weight loss product have been recalled by the NSW Food Authority because they contain sibutramine.
New South Wales. Department of Health
Minister Praises Hospital Volunteers [28 October 2010]
Parents reminded to keep household poisons out of reach [26 October 2010]
Product recall due to presence of sibutramine [22 October 2010]
NSW Dementia Services Framework 2010-2015 22/09/2010
Northern Territory. Department of Health & Families
Queensland. Department of Health
25/10/2010 Abbott's chance to make amends to Queensland
South Australia. Department of Health
Private country hospital meeting at Parliament - Thursday, 28 October 2010 - Health Minister John Hill has thanked the representatives of the Keith, Moonta and Ardrossan Hospitals for a positive and cordial meeting at Parliament. Read more...
South Australia. Health & Community Services Complaints Commissioner
Ever felt like complaining? CLOSE THE GAP October 2010 - Health and Community Services Complaints Commissioner Aboriginal and Torres Strait Islander Outreach Project Update - HCSCC has produced a pamphlet and poster for Aboriginal and Torres Strait Islander communities. These resources can be ordered FREE (order form). This form can also be used to request an HCSCC speaker about the project. HCSCC provided a summary report about complaints and outreach activities since January 2010 to the Federal Minister for Indigenous Health, the Hon. Warren Snowdon, on 27 October 2010. (summary report – outreach activities). HCSCC will also be meeting with Minister Portolesi, Minister for Aboriginal Affairs and Reconciliation, South Australia, on 24 November 2010.
Tasmania. Department of Health & Human Services
Agenda for Children and Young People - 27 October 2010
Victoria. Department of Health
NSW recalls weight loss products containing sibutramine - 27 October 2010 - The Chief Health Officer has issued an alert following a product recall by Food Standards Australia and New Zealand.
Hepatitis C - 25 October 2010 - As an added precaution, the look back undertaken at Croydon Day Surgery to identify hepatitis C cases is being extended to three more facilities.
Victorian Aboriginal Suicide Prevention and Response Action Plan 2010-2015 - October 2010 - The Victorian Aboriginal Suicide Prevention and Response Action Plan 2010 - 2015 (the Action Plan) is the Victorian Government's strategy to prevent and reduce the incidence and impact of Aboriginal suicide and self harm. The Action Plan development was overseen by a working group comprising Victorian central agencies and Aboriginal community and health organisations.
VICNISS - eBulletin - Please click here for the most recent eBulletin distributed in October.
Western Australia. Department of Health
28 October 2010 - WA Health scoops the pool at Water Awards
24 October 2010 - WA Health reaches agreement with LHMU
22 October 2010 - WA Health response to LHMU statement
22 October 2010 - Product being recalled due to presence of sibutramine
28 Oct 2010 Hames New Hedland Health Campus completed on schedule
25 Oct 2010 Hames New $6million upgrade to WA's Telehealth system launched
New Zealand. Medical Council of New Zealand
An external audit of the Medical Council - In April this year, the United Kingdom based Council for Healthcare Regulatory Excellence (CHRE) undertook an audit of the Medical Council's policies and processes. The CHRE promotes the health and well-being of patients and the public in the regulation of health professionals. It also scrutinises and oversees the work of the nine UK regulatory bodies that set standards for training and conduct of health professionals. The audit has suggested that openness and transparency, together with public engagement are the two main areas for review by the Medical Council. CHRE final report pdf. - CHRE report - Philip Pigou - TNS Qualitative research with key audiences Doctors and Stakeholders
New Zealand. Medsafe
New Zealand. Health & Disability Commissioner
HRRT decision a strong message for rest home operators - 14 October 2010
United Kingdom. Department of Health
Canada. Health Canada
American Medical Association
AMA Teams With Press Ganey to Help Physicians Get Valid Patient Feedback - AMA Press Release, October 27, 2010 - New electronic tool measures patient satisfaction to enhance care and lower physician costs - Read the AMA Press Release
Canadian Medical Association
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