MedicalResearch.com Interview with:
Dr Barbara Mintzes PhD
The University of Sydney Charles Perkins Centre and School of Pharmacy
Faculty of Medicine and Health
The University of Sydney
MedicalResearch.com: What is the background for this study?
Response: When medicines are approved for marketing, the information available on rare serious harmful effects, longer-term effects, and outcomes in vulnerable populations is often limited. New serious safety concerns often arise when a medicine is already on the market. In many cases these can be managed for example through dose reductions or avoiding prescribing to at-risk patients. Drug regulatory agencies such as the US FDA often issue safety warnings to let health professionals and the public know about new evidence of potential harm and often to provide advice on how to avoid this.
We were interested to know how consistent these warnings are between different countries. This is a research project funded by Australia’s National Health and Medical Research Council and the Canadian Institutes of Health Research. We examined warnings for medicines in Australia, Canada the US and the UK over a 10-year period, from 2007 to 2016 inclusive. We were looking at how often regulators issue the same warning if the drug is approved for marketing at the time.
MedicalResearch.com: What are the main findings?
Response: There were 1441 safety advisories in this 10 year period, covering 680 drug safety concerns. We found a very low level of consistency between regulators in the decision to issue warnings: less than 10% of the time, all of the regulators with the drug on the market issued a warning about a specific drug safety concern. Australia was the least likely to issue warnings of the four regulators; the UK the most likely.
MedicalResearch.com: What should readers take away from your report?
Response: There has been very little research into regulatory safety warnings on medicines although this is an important tool used by national governments to protect public health. We are currently carrying out additional research comparing prescribing rates in countries with and without these warnings in order to better understand the impacts of these warnings, and are also carrying out an interview study with doctors, a regulatory policy analysis, media coverage analysis and a systematic review on the outcomes of other studies of regulatory warnings.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: More research is needed to find out what the most effective approach is to safety warnings on medicines in order to best protect public health. There is also a need for better transparency about the decision-making process, so that the public and health professionals can understand why one regulator might decide to warn about a specific issue and another might not.
MedicalResearch.com: Is there anything else you would like to add?
Response: Disclosure: I do not have any pharmaceutical industry funding. I have acted as an expert witness in a Canadian application for a class action suit on cardiovascular risks of a testosterone treatment.
Perry LT, Bhasale A, Fabbri A, et al. Comparative Analysis of Medicines Safety Advisories Released by Australia, Canada, the United States, and the United Kingdom. JAMA Intern Med. Published online April 29, 2019. doi:10.1001/jamainternmed.2019.0294
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