In the complex world of Risk Evaluation and Mitigation Strategies (REMS), pharmacies are a pivotal stakeholder. They are critical, and often the final checkpoint before a REMS product can reach the patient.
Prior to product shipment, the pharmacy has a litany of steps to complete, including the added REMS verification and authorization to dispense. The current platforms and systems in place in the market require additional manual effort to perform REMS-required activities adding burden to the healthcare system.
What if that didn’t have to be the case?
As a leader in REMS Consulting, Strategy, Operations and Compliance Reporting – UBC is introducing a transformative solution that reimagines how pharmacies verify and adhere to REMS requirements, easing the burden, decreasing the number of manual processes and increases the efficiency of meeting the REMS requirements: RAPID – REMS API Data exchange.
This National Council for Prescription Drug Programs (NCPDP) standards-based, secure, application programming interface (API)-enabled service connects the Pharmacy Management System (PMS) directly to the REMS database to streamline pharmacy workflows, minimize operational burden, and elevate compliance, to help ensure patient safety.
The Current Problem: Fragmented Workflows, Manual Burden, and Compliance Risk
Today, pharmacies dispensing REMS products experience a disjointed and manual process to verify REMS requirements and report REMS-product dispenses. Pharmacy staff must exit their existing workflow to log into external REMS portals, remember multiple passwords, and manually verify stakeholder enrollment or generate REMS Dispense Authorizations (RDAs). Then, the REMS required dispense reporting often involves additional separate steps to exchange the REMS required data. These fragmented workflows introduce multiple points of failure to adhere to REMS requirements including:
- Transcription errors from manual data entry
- Missed verification steps due to human oversight
- Delays in RDA generation that slow down prescription fulfillment
- Increased non-compliance, such as invalid RDAs or unreported dispenses which can impact patient safety
This not only burdens pharmacy staff with additional time to process a REMS product but also increases the cost and risk for manufacturers and patients alike.
UBC Solution: Seamless, Standards-Based Integration. Built for Scale
Built on the NCPDP SCRIPT industry standard and adhering to HIPAA and 21 CFR requirements, RAPID ensures a secure, direct interoperability across pharmacy systems and REMS programs. It’s designed to be scalable, secure, and adaptable – capable of supporting both specialty and retail distribution models. The API operates behind the scenes, automating REMS tasks and eliminating the need for manual intervention.
This pharmacy integration allows for real-time data sharing that allows pharmacy staff to complete the following REMS activities from within their existing PMS workflow, without toggling between systems:
- Verify ETASU, such as stakeholder enrollment and certification
- Generate RDAs
- Report dispenses
Shifting from Manual to Automated
UBC’s solution is not just a technical upgrade – it’s a strategic shift in how REMS can be operationalized at the pharmacy level.
Figure 1, Illustrates differences between the current state versus the UBC-enhanced process emphasizes the importance and benefits of integration and automation:
| Traditional REMS Workflow | UBC RAPID |
| Manual portal access | Automated PMS integration |
| Multiple logins and systems | Single sign-on and workflow within PMS |
| Transcription errors | Real-time, accurate data exchange |
| Delayed RDA generation | Instant RDA response |
| Potential Non-compliance and patient risk | Built-in ETASU verification and REMS compliance |
| Additional time to process a REMS product | Reduced time to process a REMS product |
Figure 1: Current Workflow (Left), and the Revised RAPID driven Streamlined workflow (Right)
Pharmacy staff no longer need to leave their PMS or rely on memory to complete REMS tasks. Instead, verification, authorization, and reporting happen automatically, reducing errors and accelerating prescription processing.
Efficiency, Compliance, and Minimized Stakeholder Burden
UBC’s RAPID delivers measurable benefits to manufacturers:
Enhanced REMS Compliance
Invalid RDAs are a leading cause of REMS non-compliance. UBC’s integration automatically verifies the elements to assure safe use (ETASU) during the pharmacy’s regular process, reducing the risk of non-compliant dispensing and enhancing patient safety.
Industry Alignment
FDA is actively encouraging the adoption of technological innovations that integrate REMS into pharmacy workflows. UBC’s solution is built on NCPDP SCRIPT standards – ensuring compliance with FDA initiatives and positioning manufacturers as forward-thinking leaders in REMS technology.
Burden and Error Reduction
By keeping pharmacy staff within their PMS, UBC eliminates the need for external portals, reducing training requirements, time spent processing REMS products, and minimizing transcription errors. This leads to higher data quality and fewer compliance issues.
A Better Experience for Pharmacies, Manufacturers, and Patients
This isn’t just an API – it’s our strategic investment in the future of REMS and driving a better experience for those participating stakeholders.
By reducing pharmacy burden and time, improving compliance, and aligning with FDA standards, UBC’s RAPID strengthens the entire REMS ecosystem:
- Patients benefit from safer, quicker access to medications
- Pharmacies gain efficiency and clarity
- Manufacturers reduce non-compliance and risk
- FDA receives higher-quality data
UBC’s solution is already generating interest across the pharmacy network and is poised to become the new standard for REMS integration.
Let’s explore how this integration can elevate your REMS program and deliver measurable impact.
About UBC
United BioSource LLC (UBC) is the leading provider of evidence development solutions with expertise in uniting evidence and access. UBC helps biopharma mitigate risk, address product hurdles, and demonstrate safety, efficacy, and value under real-world conditions. UBC leads the market in providing integrated, comprehensive clinical, safety, and commercialization services and is uniquely positioned to seamlessly integrate best-in-class services throughout the lifecycle of a product.
About the Authors
Tracy Gentile serves as a REMS Operations Project Director at UBC. With a focus on patient safety and reducing stakeholder burden, Ms. Gentile and her team support the REMS lifecycle blending regulatory compliance, strategic planning, stakeholder engagement, and technological advancements to ensure REMS programs are compliant and successful. With almost two decades of industry experience, Ms. Gentile has worked across various therapeutic areas, indications, and risks. She has worked at UBC for the past 7 years.
Haresh Patel serves as Director of Software Engineering at UBC, where he leads the development of technology solutions that power REMS programs. He brings more than 20 years of experience in the technology industry, including over a decade dedicated to REMS.
As a solutions architect and strategic technology leader, Mr. Patel has been instrumental in shaping the technology behind the majority of UBC’s REMS programs. He partners closely with pharmaceutical manufacturers, healthcare providers, and pharmacies to deliver systems that simplify compliance, enhance patient safety, and reduce burden for all stakeholders.
