Wow, what a week. I guess Kim Kardashian isn’t the only one that can blow up the Internet.

My blog post last week “Should Adverse Drug Event Reporting by Healthcare Providers be Mandatory?” was by far our most followed, favorited, commented, and shared blog post ever. It set off multiple strings of discussions in various LinkedIn groups (Pharmacovigilance & Drug Safety Network, ASHP) from all over the world and prompted the diversity of responses that only an online discussion can facilitate.

While some readers praised my “real guts and courage,” (and, let’s face it, what startup CEO doesn’t love that?), others called me a jerk (and much worse) for posing a question while offering no answers. Other thoughts varied. Some thought that if reporting was mandatory, there should be no penalties for non-reporting. Others believed that enforcement of mandatory reporting would be virtually impossible. Some noted that because medical education does not consider adverse event reporting a priority, doctors would be ill-prepared for such a requirement. One of the more impassioned commenters argued that requiring adverse event reporting by healthcare providers would break the whole system because it would be too much of a diversion and time sink for doctors.

But no matter the opinion, one prevailing message came through in almost all of the discussions – that healthcare providers need to know about, be able to analyze, and take action on adverse drug event information. As one commenter noted, “Unless you are alert to the consequences of your prescribed therapy and report suspected adverse effects you are not doing your duty as a health professional,” 

And yet the contradiction within the comments was striking. Everyone seems in favor of better access to information, better analytic tools, and using those to better treat patients. But almost everyone thought that requiring reporting, or doing much of anything that would disrupt the status quo, was doomed to failure.


Related Read: 3 Ways To Increase Adverse Event Reporting


I found that notion really disheartening. Is our healthcare system really that broken? Do we live in a society where it’s OK for our care-givers to want and need better information to help treat patients, but they don’t even bother asking for it because they know that any change in the system is going to face a wave of opposition and bureaucratic red tape?


Related Read: Pharma's Gonna Hate, and We Just Shake it Off


I simply can’t accept that. Maybe I’m too much of an optimist. Maybe I’m biased from having spent the last 15 years of my professional life disrupting the status quo. Maybe I just think that drug safety is too important of an issue to be hamstrung by the argument that “it’s too hard to change or fix the system”.

This is a straight forward issue for me. If the medicines we use to treat patients cause more harm than healing, then our healthcare system is a failure. And if that harm is largely preventable through better access to information, and we fail to prevent that harm, then our system is worse than a failure – it’s negligent. One of my favorite songs is Freewill by Rush. In it they sing, “If you choose not to decide, you still have made a choice”. Guess what? When we choose to not change the system because that change is too hard, we’re making a choice – and it’s a bad one.


Related Read: Quiz: What Type of Drug Safety Professional Are You?


We live and work in a country that is filled with ingenuity, technology, and information. If we can land a rocket on a comet, put a supercomputer in our pocket, and spend $2.4 billion to bring a new drug to market, then surely we can find a way to overcome the inertia of the status quo in the interest of public health, better outcomes, and cost savings.

Should adverse event reporting by healthcare providers be required? Heck, I don’t know. But I do know that “it’s too hard to do that” isn’t an acceptable answer. Not now, not ever. As one commenter pointedly noted, drug safety reporting is the “urgent requirement of this decade”.

I couldn’t agree more.


Freedom of Information Act Request - FAERS Report download

Brian Overstreet

Brian Overstreet


Brian Overstreet Linkedin Brian Overstreet Twitter

Topics: Drug Safety, FAERS

Brian Overstreet

Written by Brian Overstreet