From Burden to Breakthrough: Leveraging Technology to Reduce Pharmacy REMS Stakeholder Burden
Discover why utilizing new REMS technology can help to reduce treatment delays, improve patient safety and drive innovation in an ever-evolving industry landscape.
In the high-stakes world of biopharma, where innovation has the power to save lives, minimizing Risk Evaluation and Mitigation Strategy (REMS) burden is a focus area for sponsors. Manual workflows, patient access delays and mounting compliance risks not only hinder progress but also stifle opportunities for groundbreaking therapies to reach those who need them most.
Explore how Syneos Health technology innovation can transform your REMS programs with our Global Risk Management and REMS solution.
For pharma development teams, these challenges highlight an urgent need for transformation.
A recent webinar hosted by Syneos Health in collaboration with the National Council for Prescription Drug Programs (NCPDP) Foundation, CVS Pharmacy and InfoWerks underscores the need for innovation to address these challenges. Webinar participants discussed how the NCPDP Foundation, FDA, pharmaceutical companies, specialty pharmacies and REMS industry partners are working together to promote REMS pharmacy technology integration by creating a robust network exchange that facilitates seamless data exchange between pharmacies and REMS administrators.
The Current State of REMS: A Bottleneck for Progress
Manual tasks that are out of the healthcare professional's normal workflow are at the heart of current inefficiencies, placing a large load on pharmacies, healthcare providers and REMS administrators as well as patients. Pharmacies and healthcare providers face hurdles in identifying REMS drugs and the need to access the proper REMS portals with unique logins for each. This results in extra time spent on REMS drugs as well as increasing the risk of becoming noncompliant.
Further, the inefficiencies of traditional REMS processes not only delay access to critical therapies but also introduce risks of human error that can compromise patient safety. By integrating automation and real-time data exchange, REMS technology innovation can ensure that high-risk medications are dispensed accurately and efficiently, reducing administrative burdens while safeguarding patient well-being.
"The pharmacy had this huge burden of not only needing to recognize that the drug they were trying to dispense was a REMS drug, but then figuring out who the REMS administrator was, finding their portal, figuring out how to log in… sitting in the swivel chair, moving from computer to computer to try and get a dispense done."
-- Jeff Deitch, CEO, InfoWerks, January 23, 2025 webinar
"We're always thinking of the ultimate safety of the patient. And I don't want that part to get lost here… One error with a REMS product could lead to a patient safety issue. If we prevent one dispense from going out the door incorrectly, that’s going to be worth it."
-- Matt Wright, Director of Specialty Pharmacovigilance, CVS Specialty, January 23, 2025, webinar
Leveraging Automation and Standardization
"One of our main goals as part of this effort is to get rid of the data feeds, get rid of the portals, get rid of this burden and make this a natural process that is in pharmacy workflow."
-- Justin Wilson, Executive Director, Global Risk Management & REMS Technology Lead, Syneos Health, January 23, 2025 webinar
Leveraging automation, standardization and real-time integration into the REMS process can be transformative for biopharma companies, especially through the adoption of NCPDP SCRIPT standards. These standards can help with real-time adjudication, which ensures faster therapy initiation and significantly reduces patient delays—a critical factor in improving outcomes. Additionally, seamless data exchange between pharmacies and REMS administrators reduces administrative burden, allowing pharmacists to stay in their natural workflows to focus more on patient care rather than, for example, having to remember unique passwords to the multitude of unique REMS portals for each therapy.
Automation also introduces compliance checks, with hard stops that are built into pharmacy management systems, helping to mitigate regulatory risks and ensure adherence to REMS requirements. The result is not only improved operational efficiency but also lower costs across the entire value chain, positioning companies for both short-term success and long-term sustainability in an increasingly competitive market.
Financial and Strategic Benefits: From Cost Savings to Market Leadership
Automating and integrating REMS processes into pharmacies’ natural workflows offers a powerful pathway to reducing operational costs by eliminating manual interventions, thus driving efficiency across the entire value chain. Faster patient access to life-saving therapies improves adherence, resulting in better overall patient outcomes. Streamlined workflows further accelerate time-to-market for high-risk medications, ensuring that critical treatments reach patients when they need them most.
By proactively adopting automation, biopharma companies position themselves as leaders in the industry, earning the trust of patients, healthcare professionals and regulators alike. This forward-thinking approach fosters long-term success and innovation, setting the stage for continued leadership in an increasingly competitive healthcare environment.
"By building this into their workflow, it'll become just a standard part of filling the script, the same as checking a claim. The biggest thing is it will cut down a huge amount on the call center burden… ensuring scripts get filled faster, easier and still with the extra patient safety that this whole program is about.”
-- Jeff Deitch, CEO of InfoWerks, January 23, 2025 webinar
Explore how Syneos Health technology innovation can transform your REMS programs with our Global Risk Management and REMS solutions.
Contributors
Paul Sheehan | Vice President, Global Risk Management & REMS Business Development
Justin Wilson | Executive Director, Global Risk Management & REMS Technology Lead
Related Content
Looking for exclusive insight?
