Is Australia's national medicines policy failing? The case of COX-2 inhibitors.
Australia has a National Medicines Policy with aims that include quality use of medicines, but policy stakeholders failed to protect Australia from the COX-2 (cyclo-oxygenase-2) inhibitor disaster. Drug regulators did not warn prescribers appropriately about potential cardiovascular risks. The Pharmaceutical Benefits Scheme did not limit unjustified drug expenditures on COX-2 inhibitors. Drug companies ran intense and misleading promotional campaigns on COX-2 inhibitors without adequate controls. Independent drug information was insufficient to counter the effects of the millions of dollars spent on advertising. Core elements of the National Medicines Policy--in particular the drug approval process, the post-marketing surveillance system, the control of drug promotion, and the quality of independent drug information--require major reappraisal if we want to avoid similar disasters in the future.
Vitry
Agnes
A
Sansom Institute, School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia. agnes.vitry@unisa.edu.au
Lexchin
Joel
J
Mansfield
Peter R
PR
D001315:Australia; D052246:Cyclooxygenase 2 Inhibitors / Q000009:adverse effects* / Q000191:economics; D016527:Drug Costs; D004335:Drug and Narcotic Control / Q000458:organization & administration; D064420:Drug-Related Side Effects and Adverse Reactions; D006291:Health Policy; D006801:Humans; D009313:National Health Programs / Q000191:economics / Q000458:organization & administration*; D004364:Pharmaceutical Preparations / Q000191:economics
D052246:Cyclooxygenase 2 Inhibitors; D004364:Pharmaceutical Preparations