The FDA is becoming more proactive in monitoring the safety of drugs. Rather than being caught off guard by safety discoveries the FDA might make, pharma companies have an opportunity to demonstrate results to the FDA that are timely, clear and credible. What steps should your organization be making now to get ahead of the growing data-gathering capabilities through its Sentinel Initiative?
Fueled by Technology and Emerging Collaboration
As you may recall, Sentinel is the FDA’s national electronic system, which was launched in 2008 as a follow up to the FDA Amendments Act (FDAAA) of 2007. It’s a system that, using a distributed data approach, allows the FDA to take a more proactive approach to monitoring the safety of regulated medical products, including drugs, vaccines, biologics and medical devices.
The Sentinel Initiative is made possible not only because of technology, but also because of the emerging collaborations and coordination taking place among multiple players in the healthcare arena, from Pharma, to providers, to insurers, to the government. All of these players have access to data that can be collected, aggregated and analyzed to identify safety issues, risks and adverse events that might otherwise have gone unnoticed or under-reported. This is a complement or a companion to the FDA’s Adverse Event Reporting System (FAERS), where adverse events are self-reported. Data is populated by clinicians, pharmacists, hospitals, lawyers, manufacturers (e.g., pharmaceutical companies) and even consumers.
Big Data Drives Change
In the past, the FDA had taken a more passive approach to the identification of potential issues, calling upon patient self-reporting to alert the organization when an adverse event had occurred. But big data can now bring these issues to light.
The healthcare industry is a potential beneficiary of big data, but there are challenges in accessing data in a timely manner in order to evaluate and assess risks. Electronic health records (EHRs) and various registries capture a wide range of data on patients and their care. That data can be used to improve care; it can also be used to identify adverse events or safety issues that drug companies, payers and the FDA all want to be aware of.
Transparency Provides Crucial Information
All drugs carry risks. While many risks are discovered during the clinical development process through clinical trials, it’s not uncommon for risks to emerge after approval. While clinical trials are well controlled and conducted in a defined population, real world data in larger and often broader populations provide valuable insights for risk assessment. Manufacturers are required to report an adverse event within 15 days “if it is serious and unexpected” to health agencies.
Meanwhile, under a system where reporting by physicians and patients to the FDA is voluntary, drug safety experts estimate that only about 10 percent of adverse drug events are reported through FAERS, according to a Health Affairs Health Policy Brief.
By monitoring relevant information, impacts can be explained in context. For example, a patient who has a negative reaction may be taking more than one prescribed medication, in addition to over-the-counter remedies and other treatments. Patients may also suffer from co-morbidities, leading to further complexity. These impacts must be monitored closely to identify root causes by minimizing the noise and, then, bringing the information forward.
As the healthcare industry has discovered over the past several years as it has worked to minimize medication errors, encouraging openness and transparency ultimately serves to identify safety risks that can be addressed through process improvement and the sharing of best practices.
Opportunities for Pharma
Initial Sentinel pilot programs began in 2008 and have had setbacks along the way.
Despite the promise of applying large amounts of data to identify potential safety risks, the reality is that the Sentinel database is still a distributed database, relying on inputs from independent participants that are not currently merged to allow for deeper analysis and comparison. Some critics have also noted that most of this data still relies upon claims that don’t offer insights into treatment outcomes.
These programs, however, are maturing and the FDA now has almost 10 years of experience and insights to draw upon as it ramps up efforts to realize the promise of the Sentinel initiative.
But data without context are just numbers. Data with context are information.
Pharma can provide this context by monitoring and sharing information on post-approval data of real-world studies and usage to get ahead of potential medical product safety questions. By being transparent and proactively presenting clear and credible data about drug efficacy, risks and successes, Pharma has an opportunity to help put the best science forward, starting internally. Employees can be strong brand ambassadors and can help patient outcomes when armed with the right information.