American researchers have recently evaluated the extent of agreement of medicines safety recommendations between drug regulatory authorities in Australia, Canada, the United Kingdom and the United States, examining this issue over a period of 10 years. For 680 separate safety issues communicated, the frequency at which each regulatory authority issued safety advice for drugs in their individual jurisdictions varied significantly, from 29.6% in Australia to 52.4% in the United Kingdom. When assessing instances where only one of the four regulatory authorities issued safety advice for an individual matter, the frequency also varied from 11.1% in Australia to 20.7% in the United Kingdom. These results suggest that the usefulness of communications from these global authorities requires further examination. The full details of this study can be viewed here. The authors conclude that discordance occur for many reasons,”but are most likely to occur either when there are differing conclusions about whether a risk exists or when there is agreement on the risk assessment but a difference in the benefit-risk analysis or risk management options. With the increasing global reach of communications, such discordance can create confusion if the basis for the differing conclusions is not made clear.”
Contributed by Australian Medication Safety Services Associate – Isabella Singh