During the 12th REMS Summit in Virginia, UBC’s Natalie O’Donnell, Corporate Vice President, Safety, REMS, and Strategic Engagement and Justin Wilson, Director, Software Development and Technology, presented a session on the impact technology has had on REMS and the potential effect it can have in the future. They discussed how technology has become transformative, reducing patient and health care professional burden and improving compliance with REMS requirements.
The presentation included an overview of key drivers in REMS technology:
- Cloud Computing – Offers incredible computing power and scalability, on-demand support, and ability to handle intensive workloads without any upfront investments
- Data Network Effect – Utilizes real world data (RWD) that already exist – critical to program efficiency (cost/time)
- Artificial Intelligence (AI) and Automation – Offers ongoing interpretations of data for developing insights and evidence generation
- Intelligent Interfaces (IoT) – Provides ongoing patient communication with new ways of engagement such as virtual assistants, creating new data sets for better analysis of the engagements
With the emphasis on reducing stakeholder burden and minimizing barriers to access, innovations in REMS technology are ever more important. Three examples of technologic innovation that impact REMS are automated AE reporting, the use of RWD and RWE, and virtual assistants.
Automated AE Reporting
According to the FDA Adverse Event Reporting System (FAERS), there were more than 2.1 million unique patient reports submitted to FAERS in 2018. Of those, 9.1% or 196,807 resulted in patient deaths, while 60% of the events were categorized as “serious”.1 Numbers of adverse event reports submitted to the FDA continue to rise; when comparing the last four reported years (2015 – 2018) in FAERS to the previous four years (2014-2011), there has been an 85% increase in numbers of AE reports. Therefore, it is imperative that accurate/efficient reporting systems are in place for any REMS to ensure patient safety. Current challenges, however, exist related to current AE reporting tools, including:
- Fractured data entry environment
- Double data entry with multiple systems
- Inefficient use of fax and e-mail to submit reports
- Unique reporting requirements for each REMS Sponsor
One solution is implementing an automated adverse event reporting platform, like UBC’s eREF (electronic reportable event form) platform. This allows sponsors and vendors to collect more detailed information on a greater number of cases and transmit data in a more consistent and reliable manner.
Real World Data (RWD) and Real World Evidence (RWE) and Their Applications in REMS
A massive ecosystem of diverse data has been accumulating from sources like electronic medical records (EMRs), claims databases, health surveys, patient registries, and mobile devices that form RWD. These data sources can now be brought together to provide valuable insights that previously could not be observed. Up until now, linking these data has been a very laborious and ineffective task. UBC is using a unique HIPAA/GDPR/CCPA – compliant next-gen technology to link these data sets using a tokenization engine to link patient data throughout the healthcare landscape. Enriching the REMS data with the RWD has allowed UBC to provide actionable insights that allow UBC and the manufacturer to make proactive decisions to help reduce REMS participant burden.
Traditionally, REMS stakeholders are engaged by communications from a call center, email, website, app, and written documents. However, patients and providers are becoming less likely to respond to calls and emails due to increases in spamming and apps losing their appeal, so these communication strategies are falling short. Fortunately, virtual assistants offer a solution. Stakeholders are able to converse with a virtual assistant through text and/or voice as if they are speaking with a real person. Virtual assistants are growing in popularity.
- Talking to patients when and where they prefer
- Allowing common workflows and conversations to be automated and standardized
- Augmenting call center teams to enable them to focus on high priority, key interactions
- Adding a high scale engagement layer to existing IT systems
- Gleaning deeper behavior and performance analytics
- Improving operational effectiveness
As part of the UBC Pathways® suite of technology solutions, we offer a virtual assistant, Linda, which will forever change your REMS. Linda works in conjunction with UBC REMS experts to keep your patients and providers informed and engaged throughout the therapeutic journey. Linda can welcome stakeholders into the REMS, educate prescribers, and provide status updates and reminders, all through a streamlined, comprehensive, secure, and auditable path.
As advancements in technology evolve at a dizzying pace, we will continue to explore solutions that enhance our offerings to better serve our clients with patient safety as our top priority.