In 2013, more than 800,000 serious adverse events from on-the-market prescription drugs were reported to FDA. Those reports included over 148,000 hospital admissions, over 65,000 deaths, and over 14,000 disabilities. That’s 800,000 patient lives put at risk, many times unnecessarily, and approximately $25 billion in potentially avoidable treatment costs that were added to the U.S. healthcare burden. And we expect those numbers to keep rising, likely doubling by the end of 2016.

For the last four years, I’ve been part of a small dedicated team that has worked tirelessly to raise awareness about the safety and economic risks presented by adverse drug events. And more than just issue an alarm, we’ve taken a series of actions to help mitigate those risks at many levels within the healthcare system. From our deep-dive analysis and our peer-reviewed and published research to our specially designed data and analytic tools we have done everything in our power to get the message out that these risks exist and that they can be mitigated or avoided entirely.

During that time, we’ve seen a lot of success. A diverse group of forward-thinking healthcare decision makers within insurance companies, hospital systems, and even pharmaceutical companies have come to recognize the importance of these data and how they should be incorporated into all phases of the drug lifecycle – from drug design, FDA approval, market access, pricing, and formulary decision making, to patient treatment and prescription dispensing. The FDA has even completely reversed course and come out in public support for these data including making access to the data easier. Some of our partners have become so passionate about this issue that they’ve written about it too.

But the healthcare system is slow to adopt new technologies and for all the talk about “Big Data” in healthcare, the industry has been even slower to adopt new data and analytics into its workflow. So while nearly a million patient lives are put at risk and billions of dollars spent every year, there is no mandate for including this data in decision making. Many leaders have expressed their desire to incorporate these analytics and tools at their organizations, however until this becomes a priority established by elected officials and government agencies, the status quo will remain. After a lot of thought and deliberation, we’re announcing today our effort to make the analysis and use of adverse events data a requirement for payers that participate in government sponsored healthcare in this country.

Late last month, the Centers for Medicare and Medicaid Services (CMS) released its long awaited new proposed rule aimed at improving quality and performance of managed care plans that serve the Medicaid program. The new rule seeks to align Medicaid Managed Care regulations with existing commercial, marketplace, and Medicare Advantage regulations and to increase accountability for managed care program rates and promote quality of care, particularly by requiring states to establish quality ratings for Medicaid plans.

Today we submitted our comments to CMS on that rule and recommended changes to strengthen the Medicaid drug benefit within managed care programs. Specifically, we encourage CMS to use existing, federal data on post-approval adverse drug events, available through the FDA Adverse Event Reporting System (FAERS), to evaluate the real world safety and cost of FDA-approved drugs.

We strongly believe that the active use of these data on post-approval adverse drug events will help Medicaid managed care programs:

  • Improve outcomes for Medicaid patients by helping ensure beneficiaries receive the safest medication therapy and empowering prescribers and dispensers with the latest information
  • Reduce beneficiary death and disability by identifying Medicaid-covered, low-risk medications that can be substituted for high-risk drugs
  • Reduce federal and state costs by preventing hospital admissions, readmissions, and emergency department visits
  • Increase transparency by using all available information including real world data on safety and the medical costs of post-approval adverse events, rather than merely emphasizing net unit costs

Accordingly, our comment to CMS include recommendations to incorporate reduction of preventable events affecting outcomes and costs, including adverse drug events, as part of CMS’ overall quality strategy, to incorporate reduction of post-approval adverse drug events as a performance measure, and to require consideration of post-approval adverse drug event data in drug coverage decisions. You can view our entire comment letter here.

Despite the availability and accessibility of the needed data, few health plans and no state Medicaid agencies currently use post-marketed adverse events intelligence when creating preferred drug lists, writing prior authorization criteria, negotiating supplemental rebates, educating prescribers and dispensers, or performing prospective, concurrent, or retrospective drug utilization reviews.

Without the use of these data, states and health plans spend more money on poorer outcomes. More importantly, they place patients at unnecessary risk and waste billions of taxpayer money for suboptimal and costly care.

We have the data and tools needed to change this paradigm. The question is – do government leaders have the will to prioritize the use of data to improve outcomes and protect patient safety?

To learn more about our policy initiatives and to help with our drug safety efforts click here


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Brian Overstreet

Brian Overstreet


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Brian Overstreet

Written by Brian Overstreet