Seventy two hours after 2016 Q2 FDA Adverse Event Reporting System (FAERS) data were publicly released by FDA, our RxFilter® process had it standardized and loaded into the Evidex platform. Based on the volume of data in Q2, it looks like we’re well on the way to yet another record year of adverse events reported into FAERS.
Here is a chart of new case reports (including our estimate for full year 2016). Note that these numbers are based on a clean dataset; de-duplicated, primary suspect cases only).
With another year of drastic increases in reporting, we’ve been asked by our clients to identify what is behind the growth over the past few years. It’s not prescription growth. We know from Quintiles/IMS data that prescription rates are growing at about 1% per year, which is far lower than the 15-20% annualized growth that we have seen for FAERS. Moreover, t’s not that medications have suddenly become less safe and are now causing more adverse events.
We haven’t been able to identify a single explanation for the increased reporting, but rather a series of cumulative reasons – all of which are somewhat intermingled.
Regulatory / FDA:
Over the past few years, FDA has taken a harder stance on enforcement of adverse event reporting by manufacturers. Most reports still enter the system directly from the manufacturer. They have a legal obligation to report any adverse event they come across to FDA in a timely manner. Regulators have come down hard on some companies in the past few years for failing to file, leading to fines and other disciplinary action. At the same time, they’ve started to require all reports from manufacturers in electronic format, which has decreased paper filings and increased the timeliness of less serious AE reports.
FDA has also made direct reporting easier, via an online and mobile app. This is a huge step up from paper, pen, and facsimile. Rather than taking 20-30 minutes to report, it now takes about 10. I still think it needs to be faster, but there is no question that digital technology has made the process less painful than it has been in the past.
In addition to ease of reporting, FDA has made dissemination of FAERS data more prevalent via the OpenFDA effort. It’s far from perfect and there isn’t an easy-to-use search interface offered by FDA, but they do now make the data a bit easier to access. This level of access is important. One of the reasons we’ve cited in the past for lack of reporting is that it seems like the reports go into a black hole. If the reporter can see the data come back and make an impact in clinical decisions, they’re more inclined to continue to report.
Lastly, FDA has only in the past two years publicly acknowledged the importance of FAERS. When Advera Health first started to work with FAERS, FDA would either not comment on how they actually use the data or speak of it in general negative terms. In the past two years, Janet Woodcock and others have come forward to say publicly that FAERS is important and valuable, and specifically cite the database in almost all of their safety communications. Just recently, they used FAERS to issue a warning on the direct acting antivirals such as Sovaldi, Harvoni, and Viekira Pak. This is a major milestone and I strongly believe it has contributed to increased reporting.
FAERS data has long been the purview of data scientists and pharmacovigilance experts working at manufacturers and within FDA. It is a requirement to report data – it is an expense line item for pharma companies, and frankly from our experience a place where good data sat on a shelf without seeing the commercial light of day.
That is now changing. FAERS data are being used in many different areas of pharma – and even outside of pharma – as a predictive tool to better understand what’s happening with drug safety in the real world, outside the confines of a controlled, homogeneous clinical trial. The fact that these data are now considered useful outside of a traditional PV setting has raised the profile and importance of the PV department. They’re no longer people who just collect data, they’re people who actively manage signals. And GASP….work cooperatively with others throughout the organization to better steer R&D, market access, and competitive intelligence. The trend of the PV silo opening its hatch is something we expect to continue strongly in the next five years.
Maybe most importantly, FAERS data are now being used actively OUTSIDE of pharma - at health insurers, hospitals, and financial institutions to better understand risks and costs of prescribing one medication over another. The use of these data in those contexts feeds the importance of the data to pharma – who now have to contend with others having access to these once internal-only datasets.
The Advera Effect:
Perhaps I’m egotistical and self-serving… so be it. The fact is that Advera Health was the first to start working with FAERS data as a means of market insight five years ago. We raised the profile of FAERS by publishing scientific papers, journal and poster publications, and the occasional sensationalistic press story – all of which played a part in nudging/forcing FDA to take a number of the actions I detailed above. I firmly believe that if FDA didn’t start getting incessant calls from media asking for responses to the reports we were putting out, they would have been much slower in taking the steps that they’ve taken over the past few years.
The same very much goes for industry. We’re still the only ones who are taking FAERS data and making them actionable and insightful outside of a traditional PV setting (and more, and more, inside a PV setting too). We now have clients using these data throughout the healthcare ecosystem. Insurers are using FAERS data to support prior authorizations and formulary placement. Pharma is using FAERS data to better understand those same issues, and create new evidence to help support their market access strategies before market launch.
The bottom line is that while direct reporting by patients and healthcare providers is hugely important, pharma is still the primary driver of FAERS reporting volume. With the increased importance that pharma has placed on gathering these data, the more reports we’ve seen.
FDA can regulate until they’re blue in the face. It took pharma to realize that these data can contribute to (or take away from) their bottom lines before we began to see a greater interest in actively collecting and reporting quality data. Accordingly, we have no doubt that the sheer volume of FAERS reports is only going to continue to increase.
What do you think is behind this trend? Am I missing something? Let us know in the comments section.
Otherwise, to learn more about what we do with all these FAERS data to drive risk mitigation across multiple market segments, please click here.
Brian M. Overstreet, President, Advera Health Analytics, Inc.