Navigation Links
Time to Overhaul Australia's Medicines Safety Surveillance System

New medicines should be granted a provisional safety rating until their safety and effectiveness have been proven amongst the wider //population, experts have said in the latest Medical Journal of Australia.

Recent experience with Vioxx and some other prescription medicines, which were withdrawn on safety grounds after marketing, has shown that reliance on pre-marketing trials and voluntary adverse reaction reports from health professionals does not provide adequate protection, said population health expert Associate Professor Chris Kelman, of the National Centre for Epidemiology and Population Health in Canberra, and colleagues.

Trials usually last no more than 12 months, so do not evaluate the increasingly common longterm use of medicines by patients with chronic disorders, Assoc Prof Kelman said. Voluntary adverse reaction reports depend on a health professional making a link between the drug and an adverse event. This system fails when the adverse outcome is common and has other causes, as with heart attacks and Vioxx.

“The current system for evaluating drug safety is outdated,” Assoc Prof Kelman said.

“We propose an expanded and integrated system of medicines regulation for Australia, based on a surveillance system that improves safety monitoring by complementing existing systems, making best use of routinely collected health and pharmaceutical data, and leveraging the power of information technology to link and analyse these data.

“Other countries have established such systems successfully, and Australia has fallen behind the rest of the world, despite the availability of excellent data.”

Under the proposed system, new drugs would be given provisional approval with a ‘Caution – New Medicine’ rating, and be required to undergo strict periodic review using linked population health data-sets.

“Periodic review would be based on accumulated adverse drug reaction reports, recent dru g studies, and commissioned Australian controlled analytical studies using the linked databases,” Assoc Prof Kelman said.

“Provisional approval could be upgraded once significant market experience is gained; for example, a medicine could be given a ‘gold’ safety rating after achieving an agreed benchmark.”

Prominent child health advocate Professor Fiona Stanley, of the Telethon Institute for Child Health Research in Western Australia, agreed that as medical care becomes more complex, it is paramount that Australia modernises its ‘archaic’ system of postmarketing surveillance for new drugs.

“The system proposed by Prof Kelman and colleagues has several advantages,” Prof Stanley said in an editorial written with Dr Eric Meslin, of Indiana University, USA, in the same issue of the MJA.

“However, there are also potential disadvantages associated with such a data linkage system.

“We must be able to demonstrate to the community that linking data for the sake of the public good does not invade their privacy.”

The National Health and Medical Research Council and the Australian Law Reform Commission are both reviewing alternative systems. Prof Stanley said she hopes these reviews will clarify and support the impetus to change.

“We strongly believe that Australia has an opportunity to establish a cutting-edge capacity to monitor its health care system, to avoid a repeat of the type of situation we saw with Vioxx,” she said.

“If society has the capability to better monitor the safety of new drugs, it may be unethical not to do so.

“We think the time has come to expect more … to actively seek to maximise the wellbeing of all citizens. Improved pharmacovigilance is one important step towards this goal.”

Source-AMA
SRM
'"/>




Related medicine news :

1. Health Insurance Needs Overhauling: Experts
2. U.S. Child Health System Needs Total Overhaul
3. U.S. Child Health System Needs Total Overhaul
4. Australias Mentally ill, ill at ease with Quality of Care
5. Training in Australias Medical Schools Inadequate
6. Australias Baby Bonus Plan has Increased the Birth Rate
7. Keep Australias GP Workforce Numbers Healthy, AMA Urges
8. Medicines on the move
9. Advent of New, More Effective and Personalized Medicines
10. Be Wary Of Heavy Metal Poisoning From Ayurvedic Medicines
11. Metal In Medicines Can Fight Diseases Effectively
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:8/17/2017)... ... August 17, 2017 , ... CareAcademy, ... that it has raised $1.675 M in seed funding to further expand its ... and Techstars Venture Capital Fund are the company’s primary investors. , ...
(Date:8/17/2017)... ... , ... Centrifugation is more than just spinning. Like a car in our ... do without. And just like a car, there are a few points to consider ... will learn about the most important safety aspects while using a centrifuge, as well ...
(Date:8/16/2017)... ... , ... The next Patient Care Academy at Kalamazoo Valley Community College begins ... the seven-week long Patient Care Academy are eligible to take the State of Michigan ... CNA in Kalamazoo is $24,428.* , As a CNA, one is equipped for employment ...
(Date:8/16/2017)... ... August 16, 2017 , ... The Data Council, the leading ... was acquired by Advantage Solutions. The Data Council’s IX-ONE platform is the ... industry’s leading suppliers, brokers, distributors and retailers. The Data Council will become a ...
(Date:8/16/2017)... ... August 16, 2017 , ... QualDerm Partners , ... development, today announced Cumberland Skin Surgery and Dermatology has joined the ... offices in both Hermitage and Lebanon, Tennessee, provides comprehensive general dermatology and skin ...
Breaking Medicine News(10 mins):
(Date:8/7/2017)... GAITHERSBURG, Md. , Aug. 7, 2017 /PRNewswire/ ... for healthcare member acquisition, retention, and engagement, announced ... Director of Strategy and Product Development, effective as ... strategic consulting and technology implementation strategy for our ... years of experience in consulting and business analytics ...
(Date:8/7/2017)... 7, 2017  Endo International plc (NASDAQ: ... resolve virtually all known U.S. mesh product liability claims ... the known remaining U.S. claims at reasonable values. Under ... the fourth quarter of 2017 and continuing through the ... quarter 2017 results, the Company intends to increase its ...
(Date:8/2/2017)... , Aug. 2, 2017 Fenita ... Who as a Pinnacle Lifetime Professional in the ... Account Manager at Turing Pharmaceuticals, AG. Her skills ... and relationship building.                ... than 25 years of experience as a highly ...
Breaking Medicine Technology: