Post-market Safety Communication for New Drugs Approved in Australia 2010-2016

Background: Regulators communicate important information about emerging post-market safety concerns by issuing ‘safety advisories'. We aimed to compare the use of advisories by the Australian national regulatory authority with other regulators, for a cohort of new drugs approved in Australia.

Objectives: We aimed to compare the issuing of advisories for post-market safety concerns in Australia with that of regulators in Canada, the United Kingdom and the United States. We examined safety advisories for new drugs approved in Australia from 2010 to 2016 for frequency and timing of post-market safety advisories; characteristics of the safety concerns; nature of advice provided; and actions taken by regulators

Methods: We examined the timing, use and content of advisories issued by regulators in Australia, Canada, the United Kingdom and the United States, for new chemical and biological entities approved in Australia from 2010-2016. Advisories were coded for characteristics of the safety concerns, regulatory actions, and advice to consumers and clinicians. We carried out a content analysis examining the nature of the safety concern, the way harm was described, the evidence cited to support the concern, advice to prescribers and consumers, and regulatory actions including whether the advisory described product information changes. Severity or seriousness were assessed according to whether outcomes met the standard regulatory definition of serious adverse reactions and whether product information was changed to include a new contraindication, boxed or other warning, and/or loss of indication.

Results: Of 173 new drugs approved in Australia, advisories were issued for 30% (51), with 73 different safety concerns communicated by any regulator from 2010-2016. Australian advisories were issued for less than a quarter of the safety concerns communicated by other regulators (20.5% - 15/73); UK advisories were issued for 63% (46/73). Most (67/73 - 91.8%) safety concerns were serious, 39/73 (53.4%) mentioned death, and 32/73 (45.2%) led to a significant product information change such as a new contraindication or warning. Australia issued advisories for 7 of the 39 (17.9%) safety concerns for which death or fatal outcomes was mentioned by any regulator (39/73; 53.4%), and 7/33 (21.1%) of significant product information changes described by any regulator.

Conclusions: Around a third of new drugs approved in Australia within a 10-year period were associated with post-market safety concerns. Australia's Therapeutic Goods Administration communicated fewer of these concerns in safety advisories than the US, the UK or Canada. The reasons appear unrelated to prioritisation of more severe harm.