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The following articles have the tag adverse events
ADVERSE events resulting from the use of a sports supplement continued to occur after the stimulant was banned by the TGA last year, according to a letter published in the Medical Journal of Australia.
AN EARLY warning system for safety concerns about medicines and medical devices based on the US Food and Drug Administration (FDA) model is being planned for Australia and New Zealand.
DOCTORS are calling for action on look-alike and sound-alike medicines and for the names of active ingredients to be displayed more prominently than brand names, amid concerns about patient safety.
THE TGA has issued a safety alert to health professionals after receiving adverse event reports of medical devices being incorrectly implanted into patients.
PUBLIC health experts are ramping up calls for a no-fault compensation scheme to assist Australian families affected by “very rare” adverse reactions to childhood immunisations.
MARKETING dabigatran to general practitioners could lead to the drug being prescribed for patients in whom it has not been proven to be safe or effective, according to an editorial in the Internal Medicine Journal.
THE TGA has issued a medicines safety update for PPIs, warning of the risk to patients of hypomagnesaemia and other life-threatening events, pointing to an advisory released by the US Food and Drug Administration in March. “A recent international safety advisory has warned of a potential association between prolonged use of PPIs and serious hypomagnesaemia-related adverse events such as tetany, seizures, delirium and cardiac arrhythmias,” the TGA said. “While this occurs rarely, prescribers should be vigilant to PPI-associated hypomagnesaemia [and] patients presenting with hypomagnesaemia may require PPI discontinuation.” Two Australian cases of low magnesium levels linked ...
STAKEHOLDERS agree on the need for an overhaul of vaccine safety monitoring in Australia in line with the Horvath report recommendations, but views are mixed on the best way forward. Former Commonwealth Chief Medical Officer Professor John Horvath investigated the public health response to the spike in adverse reactions in young children receiving Fluvax vaccine (CSL) last year and suggested various models for reform. The Public Health Association of Australia (PHAA) has told MO it supported the option at "the extreme end of what [Professor Horvath] is suggesting... which is to establish a centre for ...
THE TGA has blamed this year’s paediatric influenza vaccination debacle on the overzealous approach of West Australian health authorities. In an apparent bid to deflect criticism from the Commonwealth’s handling of the high rate of febrile convulsions linked to Fluvax, a TGA report has criticised WA for setting up a program “outside national immunisation guidelines”. In its first official response to the August WA ministerial review authored by Professor Bryant Stokes, the TGA takes repeated swipes at the WA program, calling it a “trial” that had been set up without appropriate safety considerations. “There is a ...
THE pressure is on for a new, robust, national vaccine adverse events reporting system following a scathing review of the official response to this year’s influenza vaccine crisis. GPs are saddled with a confusing, cumbersome system which varies between states and impairs timely response to issues such as the high rate of febrile convulsions in children seen in April, a report to the WA Government said. The reviewer, former WA chief medical officer Professor Bryant Stokes, also called for a formal review of allegations that adverse events surveillance in Australia was fraught by conflicts of interest with ...
PHARMACISTS could soon be reporting adverse medication events for the first time, with the planned rollout of a new software system. Called PROMISe, the software will allow pharmacists to log all adverse reactions that patients report to them, and this data will then be collated at a central repository where it can be analysed to identify problematic scenarios. Pharmacists would also be prompted to refer patients with certain symptoms back to their GPs.The data will be used to educate pharmacists, GPs and consumers about high-risk adverse events. PROMISe chief developer Professor Gregory Peterson said along with ...
ADVICE against seasonal flu vaccination of children younger than five years of age will remain, with an extensive inquiry failing to identify a cause of this year’s spate of febrile seizures. The TGA said there were 100 confirmed cases of post-vaccination febrile convulsions in young children, including 58 from Western Australia. “CSL’s Fluvax or Fluvax Junior was used in all 66 cases where the brand of the seasonal influenza vaccine was reported,” the authority said. The Commonwealth Chief Medical Officer suspended use of trivalent seasonal vaccine in children younger than five years in late April and ...
No-one seems to know whether Australia’s health system is any safer today than it was more than a decade ago. Rosemarie Milsom examines why. WHILE collecting data for the landmark Quality in Australian Healthcare Study back in 1992, researchers reviewing the medical records of more than 14,000 admissions to 28 hospitals thought they had made a mistake. The data, which was being collected on a scale never before seen in Australia, was shocking: 16.6% of admissions were associated with an adverse event, and 3% of people admitted to hospital died or had permanent disability. Half ...
Everyone makes mistakes – but how should GPs handle them? Dr Kathy Kramer asks the experts. “IT’S a heartsink feeling when you realise that you’ve made an error,” Brisbane GP Dr Genevieve Hopkins admits. Dr Hopkins is a member of the RACGP National Standing Committee on GP Advocacy and Support. “Patient safety and support for GPs following an adverse event is a priority for the RACGP,” she says. “When the error is major, such as a significant delay in diagnosis that will lead to patient harm, the impact can be devastating for both the patient and the ...