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Should Adverse Drug Event Reporting by Healthcare Providers be Mandatory?

November 14, 2014

A recent article by Pharmacy Times titled, “Pharmacists Underreport Adverse Drug Reactions Due to Inadequate Training” made me really angry.

I’m angry at the pharmacists, I’m angry at FDA, I’m angry at the academic institutions, I’m angry at the whole damn system.

Why? – go read the article. Here’s the link again.

Indifference, insecurity, ignorance, guilt, fear, complacency, and lack of training. Those were the main factors the authors of the underlying study cited for why pharmacists fail to report adverse drug events. It’s like the 10 plagues on Passover, except worse.

And the pharmacists aren’t alone in their under-reporting. Doctors and nurses are just as guilty.

And who can blame them?

FDA makes reporting an adverse event a huge pain, the data goes into a black box with no visibility on what anyone at the agency is doing with the information, and then FDA regularly tells people not to rely on those data. I’ve been thinking of an analogy for this insane scenario and can’t come up with one – it’s just that stupid. Here’s the best I can do - I have three school-aged kids. If their homework wasn’t required, wasn’t checked, didn’t count toward their grade, and made absolutely no impact on their current or future learning, why should they waste their time on it? And yet that’s essentially what the FDA says about adverse event reporting. It’s not required, incentivized, or reimbursed, may not be checked by anyone, and may or may not ultimately contribute to overall patient safety. So, yeah, why the heck should healthcare professionals bother to file adverse event reports?

Starting back in 2012, FDA made a modest investment in upgrading its FAERS and MedWatch capabilities. As far as we can tell, most of that money went to do some rather basic database updates and provide FDA with some improved internal front-end monitoring tools. Around the same time, FDA made the online reporting tool a bit easier to use and helped launch a mobile reporting app. Earlier this year, they also launched the OpenFDA effort. So, they’re not totally standing still on the issue of adverse event data.

 

Related Read: OpenFDA - The Good, The Bad, And The Ugly

 

But, at the same time, FDA recently committed another $150M toward the Sentinel program. Sentinel is intended to find adverse event information from patient medical records and is built on the $120M Mini-Sentinel pilot project. This despite the fact that after 8+ years of development, the program has yielded questionable results and, as the NY Times has reported here and here, EHR systems are in no way the information panacea everyone believes them to be.

In the face of all of that, you’d think it perfectly rationale for healthcare providers to not waste their time submitting adverse event reports.

 

Related Read: 3 Ways to Increase Adverse Event Reporting

 

But, here’s the kicker. They do – and they’re doing so at a record rate.

We just processed the most recent FAERS data release for Q1 2014 (and don’t even get me started on why we’re just now getting vital drug safety data from 7 months ago…..). The most recent quarter contained the largest number of overall reports (261,884) and the largest number of healthcare provider reports (114,447) since we started tracking the data back in 1997. You can see the growth curve of both in the chart below.

 

Click here to enlarge

chart

 

 

How can that be? How can it be that FDA puts up so many roadblocks to reporting and yet the overall reporting into FAERS and the reporting by healthcare providers continues to grow and grow? And how can it be that the FDA is seeing this trend and not reversing course on some of its ridiculous policy stances and not encouraging even more reporting? When we’re on course to receive more than a million voluntary reports a year of adverse drug events into a system that has been totally underutilized by the agency that maintains it, doesn’t that say something about people’s demand and desire to participate and benefit from this system?

I titled this post ‘Should Adverse Drug Event Reporting by Healthcare Providers be Mandatory?’ for a reason. I was running through some of these issues with a policy guy in DC this week and he flat out asked me whether I thought adverse event reporting by healthcare providers should be mandatory. My knee-jerk reaction was a solid “no”. I’m not a fan of more regulation and instituting more hoops that our over-worked front-line healthcare workers need to jump through. But I’ve spent a lot more time thinking about this issue over the past couple of days and I’ve come to a more nuanced reaction to his question.

When we look through FAERS data, we value reports from healthcare providers over other reports. Some people disagree with this approach, but for us it helps to combat the issue of causality. Specifically, when we see a report with only a single drug listed as a suspect cause and that the report was submitted voluntarily by a healthcare provider, we tag that report with the highest of priority. If a trained medical professional believes so strongly that a single drug caused a specific serious side effect that she was willing to spend the 20+ minutes it takes to file the report, then we need to hold that information in very high regard.

So, what would happen if healthcare providers were required to file adverse event reports? Certainly the volume of data would increase exponentially. But, more importantly, so would the overall quality and reliability. While the FDA is trying to swim around in the medical records and extract adverse event signals from what they think healthcare providers have entered into those records, why not just ask them?

 

Related Read: Drug Safety Advocate Call to Action

                       

Well, there’s a couple of big problems. Most notably is how hard it is to report. Healthcare providers don’t have any more time in their day to file these reports. And if people are going to have to report, I think they deserve to see what comes from that information. So any attempt to force this issue would have to include a mandate for the FDA to improve the reporting system, to speed release of the overall data, and to provide more and better actionable intelligence from their signaling and surveillance.

Can this be done? Should this be done? I have mixed feelings. Unlike my friends in Silicon Valley, I’m not a full-on libertarian. While I’d prefer to see the government stay out of most things, I also recognize that there are times and places where it makes the most sense for a central authority to play a leadership role. And certainly public health is one of those areas.

Hundreds of thousands of lives and billions of dollars are risked every year by an outdated and largely overlooked system for reporting and acting on adverse drug event data.

Maybe it’s time to make fixing this system a requirement.

 

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