A Drug Safety Call To Arms

Earlier this week, the Institute for Safe Medical Practices (ISMP) published an alarming report exposing the dirty secret about drug safety in America.  Its report properly chronicled that pharmaceutical companies are largely responsible for collecting and reporting adverse drug events to the Food and Drug Administration (FDA), and most notably, that they’re doing a substandard job at it.  In addition, a day earlier, the Wall Street Journal published an exposé detailing how the vital task of drug safety monitoring and reporting is now being largely outsourced by pharmaceutical companies.

The FDA Adverse Events Reporting System (FAERS) is reliant on pharmaceutical companies to report adverse events.  Those pharmaceutical companies view this task as burdensome and expensive, and have outsourced it for the lowest possible cost or allocated the fewest resources to it internally.  The result is a drug safety monitoring system that, according to ISMP, “suffers from a flood of low quality reports from drug manufacturers.”

Does this concern anyone?

Let’s be very clear – FAERS is vitally important to the drug safety landscape.  As ISMP notes in its’ report:

“The FAERS system is of critical importance for two reasons. Studies by ISMP and the FDA have shown that a majority of new FDA safety warnings about approved drugs come from these adverse drug event reports. Despite its limitations, FAERS is the most reliable system for discovering new drug risks that had not been identified in pre-market drug testing. Also, despite additional perspectives on safety obtained from insurance claims and electronic health records, no other system has comparable international scope, sensitivity to detect rare but catastrophic side adverse events effects, and the capacity to pinpoint potential injuries that were unexpected.”

Even Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research wrote about it in a recent blog post:

“Over many years, FDA’s program that we now call FAERS has been our main tool for assessing the safety of medical products. This system relies on patients, medical professionals, and product manufacturers to report to us potential safety issues of the products FDA regulates. FAERS is an invaluable asset.”

What does all that mean? Simply, without FAERS there is no safety monitoring of prescription drugs in the public market.

Yet knowing that FAERS is the only public drug safety monitoring tool, the government and the healthcare industry continue to rely on a system of self-reporting by pharmaceutical companies whose primary goal is to deliver stellar financial results to their shareholders.

Foolhardy? Naïve? Perhaps. And it should concern everyone who cares about public health and safety. Because at the end of the day, it’s we, as patients and taxpayers, who ultimately pay the bill for the illness, hospitalizations and deaths caused by this broken system.

None of the revelations in the ISMP report came as a surprise to me.  At AdverseEvents we’ve had to build our tools and analytics specifically to correct for the flaws that exist within FAERS, and learn to draw valuable insight from those data in spite of the flaws. We have to correct for drug name misspellings, duplicate reports and improperly categorized data.  And we only use reports with the highest level of drug-adverse event causality and most serious adverse event types.

These flaws pose a serious risk to patients.  It’s time to fix this problem once and for all, either by mandating drug safety reporting by healthcare providers or simply by better enforcing the existing reporting rules on pharma – but with stricter consequences.  Just this week, The Japan Times reported that Japan ordered a 15-day business suspension for the local unit of Novartis for failing to report serious adverse events in a timely manner.  Clearly, it is time to take this issue seriously.

I hope the ISMP report and President Obama’s recent State of the Union speech, which highlighted the desire to utilize healthcare technologies, will spur FDA to take some of the actions proposed – including a modernization of the vital FAERS system since, according to ISMP, “modernizing the FDA’s manufacturer adverse event reporting requirements would offer a low-cost opportunity to improve safety surveillance.”

I hope this will raise some questions about whether it is in the public’s best interest that the responsibility for reporting adverse events of drugs falls to the same pharmaceutical companies that market them.

But most importantly, I hope this will open a dialogue between industry, public health officials and legislators about how vital it is to improve the system of gathering and reporting adverse events prescription drug data in order to ensure the public’s safety at large.



Brian Overstreet is co-founder and president of AdverseEvents, Inc., a healthcare informatics company that provides comprehensive analysis of post-marketing drug side effect data.

Morning Consult