First, a disclosure. I am Canadian. Well, I’m actually a dual U.S. – Canadian citizen. I was born in Toronto to a U.S. parent and lived there until my family moved to California when I was 15. Among other things, that means that I have two passports and that my kids are also dual citizens. And apparently I can still be President of the United States one day.
As a proud dually, I’ve long known that there are some things that Canadians just do better than Americans. Mass produced beer, hockey, extracting oil from sand, and curling all come immediately to mind (CNN has an expanded list).
But it’s become clear recently that another thing Canada does better than us here in the U.S. is drug safety.
We first noticed this when we began our work in 2011 to optimize the FDA’s Adverse Event Reporting System (FAERS). As we’ve documented numerous times, raw FAERS data is a real nightmare and nearly impossible for everyday citizens to use, search, and draw meaningful value from. About a year ago FDA launched OpenFDA to make these data a little more accessible, but there are still a number of issues.
By contrast, the Canadian health authorities maintain a simple, easy to use, searchable online database of drug adverse events reported in Canada. It’s nothing too fancy, just what you’d expect from a modern online search tool – with data properly mapped and optimized, very recently updated, and immediately accessible.
You know, all the things that FDA somehow isn’t able to do with FAERS.
Related Read: FAERS - Myths vs. Realities
With these data more readily accessible and available, the Canadian authorities are able to better monitor for drug safety issues. For example, an article in the Globe & Mail last week detailed Canada’s plan to add a suicide label warning on ADHD drugs.
In our analysis of data from FDA’s FAERS database, we see active safety signals on all of the main ADHD drugs for a number of suicide risks (meaning that the reported rate of these adverse events is a lot higher than we’d otherwise expect) and yet no such label changes have been warned or issued in the U.S.
Why? It’s not hard to assume that it has something to do with FDA’s inability to properly access their own FAERS data and identify these risks. We can see them, so why can’t they?
*RxSignal is the AdverseEvents proprietary safety signaling system which alerts clients to potential drug safety issues and predicts future drug label changes. An Active Signal means a higher likelihood of a safety problem and need for a labeling change.
In fact, on the back of their improved drug safety systems, Canada recently passed a new law that improves the requirements for adverse event reporting, ensures labeling guidelines and changes when safety issues impacting children are involved, and increases penalties for failure to comply (including jail time!) Now, we’re not advocating jail time for people failing to report adverse drug events, but it’s good to see someone putting some teeth behind these requirements.
As an American (and, yes, I consider myself as much of an American as you), I’m just as guilty as the rest of us of falling victim to the blind belief that we’re usually the best at everything. Unfortunately, when it comes to drug safety we’re very, very far from being the best.
Is that acceptable? We don’t think so. For the past few years we’ve used data, insight, and analytics to highlight the value of post marketed drug safety data and help our clients improve patient safety and lower healthcare costs.
But when we see stories like this one on Canada’s decisions on ADHD drugs (and more importantly, FDA’s failure to make a similar determination), it continues to reinforce our opinion that a systemic change needs to happen in the U.S. As the biggest market for prescription drugs in the world, it is simply unacceptable that we have a third world drug safety system.
Related Read: The State of Drug Safety
Our agencies and institutions charged with monitoring and safeguarding patient safety have an opportunity – no, an obligation – to change the paradigm and propel the U.S. back into the world leader it should be in this area.