This month, members of UBC’s Safety & Risk Management team attended Fierce Pharma’s Drug Safety Summit (previously known as the REMS Summit). Although this event was held virtually, it was still a great opportunity to gather with industry innovators in Risk Evaluation and Mitigation Strategy (REMS) and pharmacovigilance.
Throughout this event, there was a clear point that was consistently highlighted in discussions about REMS: collaboration. As we all strive to improve our safety and risk management activities, open and successful work with others is a key to developing effective programs and to gaining new efficiencies.
REMS requirements are put in place to ensure products with tighter risk-benefit considerations are appropriately controlled, involving many stakeholders in their design, implementation, and day-to-day use. This starts with internal stakeholders. REMS programs involve IT, data management, quality control, project management, regulatory, and pharmacovigilance team members. These varied points of connection must work in harmony to assure a smooth start-up. It is also critical to know the capabilities of internal team members. It is a time-consuming process to create an RFP, evaluate proposals from vendors, and then contract with your selected partner. The sooner you evaluate your team’s expertise and identify gaps where external support is needed, the faster you can begin planning in concert with product approval.
Dialogue with the Food and Drug Administration (FDA) as early as possible is critical to ensuring success for your mandated REMS. Although the FDA reviewers may not be ready to comment on the need for a REMS at the pre-NDA/BLA meeting or at the time of submission, not yet having a full safety profile of the product, it is important to present your rationale for whatever risk minimization actions you propose, whether they are within a REMS or outside of a REMS. Likewise, if you are proposing a REMS modification, a rationale, accompanied by data analyses (qualitative and/or quantitative) to support the proposed changes is required. Sponsors were advised that they should not be afraid to negotiate with the FDA.
Vendors for various services involved with REMS would naturally be considered as collaboration points, but their explicit callouts throughout the Summit showed that many in industry want to continue improving these relationships. You should contract with an organization and become hands-off, even if they are running the entire program. The internal resources above will still need to be intimately involved in decision-making and document review, and, of course, regulatory interactions. Ultimately, the most successful programs will have manufacturers and vendors working as partners, with open and frequent communication.
Patients are key stakeholders in REMS programs, and this was emphasized by many presenters. It is important that a REMS is designed in such a way as to minimize patient burden, reduce barriers to access, and provide a good patient experience. It is important to get patient input on the REMS materials during the design phase, not only to be sure they are acceptable from a health literacy and readability perspective, but also from a logistics perspective. It can also be useful to have the REMS materials evaluated by patient advocacy groups and other similar constituents. As with clinical research, it is imperative to understand the patient population being served before beginning to design your REMS.
Healthcare Professional Collaboration
The other stakeholder group frequently mentioned was healthcare professionals (HCP) who must navigate the REMS system, both in order to prescribe and to dispense therapies. There are many ways that administrative burdens can be reduced on HCPs, allowing patients to start therapy more quickly. This includes streamlining contact with prescribers through a single point of contact and setting up e-prescriptions. In addition, seeking HCP feedback during REMS development will better enable them to interact with a product that has a REMS. For example, it can be very insightful to invite pharmacists who will use an online portal to engage in user-testing before deployment to ensure it is straightforward and causes minimal disruption to their workflow.
UBC is a leading provider of risk management and REMS services. Our consultation, design, and implementation aim to reduce stakeholder burden, minimize barriers to access, and ensure products’ safety and value. You can learn more about our services here or contact us here to discuss your safety and risk management needs with one of our experts.
About the Author
Erika Kirsch is the Research Services Librarian at UBC. She provides reference services and supports UBC researchers by designing both targeted and comprehensive search strategies and executing searches in all types of health science and drug information databases, particularly medical literature indexes such as Embase and PubMed/MEDLINE. She has co-authored abstracts accepted to major health science conferences regarding health resource utilization and drug safety. Erika provides her research services to the Risk Management Team at UBC by supporting RMP development outside the US and by evaluating risk management precedents in North America. She holds a Master of Library and Information Science (MLIS) degree from McGill University (Montreal, Quebec, Canada), and is a member of the Medical Library Association.