A178A: Tracking the impact of drug regulatory actions: Consumer health outcomes, risk-benefit issues and policy framework

Tracking the impact of drug regulatory actions: Consumer health outcomes, risk-benefit issues and policy framework

Approved: 2008

Collaborators:

Prof Lynne Parkinson
A/Prof Anne Young
Mr Richard Gibson
Prof David Henry
Dr Xenia Dolja-Gore
Mr Ian Robinson
Dr Evan Doran
Dr Jane Robertson
Dr Andrew Searles
Dr Melissa Harris
Dr Paul Kowal
Prof Glenn Salkeld
Dr Jennifer Stewart Williams
Ms Lisa Notley
Dr Alison Gibberd

Synopsis

In 2004, a prescribed medicine for the relief of arthritis pain and inflammation (Vioxx) was taken off the market due to safety concerns. Caution in the use of other related medicines was also advised. When a medicine such as Vioxx is withdrawn (or a whole class of medicines discredited), follow-up of impacts at consumer level can be difficult and costly. The Australian Longitudinal Study on Women’s Health provided an opportunity to examine medicine use by individuals following a major discrediting event (withdrawal of Vioxx and discrediting of Cox-2s); using a novel mixed methods approach which included exploration of secondary data analyses of longitudinal medicines use from Pharmaceutical Benefits Scheme records linked to health surveys, qualitative in-depth interviews of women and prescribers, and a qualitative analysis of the regulatory context. When first marketed, Vioxx was expected to reduce the health problems related to arthritis medicine use; however, it was later found that this medicine could actually increase the risk of heart and kidney problems for some people. This study found that women who had frequently used Vioxx often switched to medicines related to Vioxx for their arthritis pain, once Vioxx was no longer available. This conflicted with public health advice at the time. Whether this choice was mostly made by women or by their prescribers depended upon their age group. Overall, we found little evidence that discrediting Vioxx resulted in harm for this group of Australian women, in terms of health outcomes and quality of life, and effect on perceptions of safety of medicines overall. These findings contribute to our understanding of how public safety concerns with medicines should be managed and communicated in future events, and provides important information for improvements in regulatory and provider responses when other medicines are discredited in the future.