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Recent experience with Vioxx and some other prescription medicines, which were withdrawn on safety grounds after marketing, has shown that reliance on pre-marketing trials and voluntary adverse reaction reports from health professionals does not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“The current system for evaluating drug safety is outdated,” Assoc Prof Kelman said.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:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association (PHA) ... will receive two significant new grants to support its work to advance research ... anniversary by recognizing patients, medical professionals and scientists for their work in fighting ...
(Date:6/24/2016)... (PRWEB) , ... June 24, 2016 , ... ... now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive experience with ... Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation is a ...
(Date:6/24/2016)... NY (PRWEB) , ... June 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin ... companies that call for a minimum wage raise to $12 an hour by 2020 and ... This will restore the lost value of the minimum wage, assure the wage floor does ...
(Date:6/24/2016)... ... June 24, 2016 , ... EB Medicine presented its ... Emergency Medicine conference in Ponte Vedra Beach, FL. The awards honor the outstanding ... Medicine Practice and Pediatric Emergency Medicine Practice. , “With this award, we ...
(Date:6/24/2016)... ... June 24, 2016 , ... Puradigm® & Innovative Solutions today ... cultivation and processing operations at its production facility, and opened its first two ... the manufacturer of a complete system of proactive air and surface purification solutions ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... June 24, 2016 Research ... "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural Health ... Structural electronics involves electronic and/or electrical ... structures, replacing dumb structures such as vehicle bodies ...
(Date:6/24/2016)... Mass. and SAN CLEMENTE, Calif. , ... California -based mobile pulmonary function testing company, is now able ... PFT devices developed by ndd Medical Technologies , Inc. ... testing done in hospital-based labs.  Thanks to ndd,s EasyOne PRO ® ... , can get any needed testing done in the comfort ...
(Date:6/24/2016)...   Pulmatrix, Inc ., (NASDAQ: PULM ... announced today that it was added to the Russell ... comprehensive set of U.S. and global equity indexes on ... milestone for Pulmatrix," said Chief Executive Officer Robert ... progress in developing drugs for crucial unmet medical needs, ...
Breaking Medicine Technology: