title: Bringing greater transparency to "black box" warnings.
abstract: The number of drugs with boxed warnings and the detail in the box are much greater in the USA than Australia. US warnings are up to ten times longer and often include a great deal of detail and qualified advice. Australian warnings are usually just a few sentences long and the expected response unequivocal. Other details are relegated to the relevant section within the product information. The restriction of warnings such that they are succinct and used sparingly are explicitly highlighted in the guidelines for boxed warnings in Australia. In addition, the range of other risk management strategies used may be broader. Widespread prescription drug subsidies and mechanisms set up to implement the "Quality Use of Medicines" policy provide a complementary range of options. Withdrawal of registration, removal of subsidies for all or selected indications, changed product information and labels, consumer-targeted information, prescriber mail outs, education programmes, restriction to authorised prescribers, and changed pack size and packaging have all been applied at some time in response to safety concerns. The diversity of approaches around the world provides an opportunity for a systematic approach to look at the effects of boxed warnings on prescribing practices so that we might discover what works best. While there are many studies on the effect of warnings from the USA, there are few comparable studies done where different approaches are used. Further, it is not possible to easily examine the total number and purpose of boxed warnings via any government websites. If there were always explicit and potentially verifiable changes in practice as the stated goal for each boxed warning in each jurisdiction and a requirement that the effectiveness of the intervention was measured against these goals, then we might have the evidence base for better policy around boxed warnings.
authors.affiliation: Professorial Medicines Unit, University of NSW, Sydney, Australia. n.buckley@unsw.edu.au
authors.forename: Nick A
authors.initials: NA
authors.lastname: Buckley
authors.forename: Simone
authors.initials: S
authors.lastname: Rossi
mesh_terms: D001315:Australia; D004348:Drug Labeling / Q000592:standards*; D064420:Drug-Related Side Effects and Adverse Reactions; D017408:Guidelines as Topic; D006801:Humans; D007880:Legislation, Drug; D010353:Patient Education as Topic; D012308:Risk Management; D014481:United States; D014486:United States Food and Drug Administration