- Prescribers. The greatest burden of a REMS program is typically borne by prescribers, who often find that participation can take already-scarce time away from patient care. A prescriber may need to become certified to participate and then may be responsible for enrolling their patients appropriately, making sure the results of any mandatory testing requirements are entered into the REMS system, and facilitating any staff training needed. These logistical burdens multiply in larger group practice and health system settings, and the time all this takes is largely uncompensated.
For REMS to be carried out effectively, information must be regularly exchanged between prescribers and REMS administrators. Tools such as Web portals and integration with electronic health records are needed to seamlessly and efficiently manage REMS requirements within existing patient care workflows and healthcare systems, and to simplify prescribers’ interactions with REMS programs. Technologies are available—and becoming more accessible— to support multichannel, targeted and clinically relevant messaging to prescribers and integrate REMS requirements into clinical workflows and electronic medical record/electronic health record systems. These should be further evaluated and utilized in real-world REMS programs and key learnings more widely shared.
- Patients. REMS programs attempt to place the least amount of burden possible on the patient. Beyond simple enrollment requirements, however, patients often must undergo additional testing before a drug is prescribed as well as during treatment. In some cases, the drug may need to be administered in an out-patient or hospital setting. Greater use of automated scheduling and reminders—for example, through mobile apps that can integrate information into patients’ daily lives—might not entirely eliminate these burdens but could make it easier for patients to navigate and adhere to program requirements.
In addition, patient education needs to be comprehensive, streamlined and coordinated, and ideally allow for customization based on the patient’s stage of therapy. Patients often have concerns about what a REMS means. There is an opportunity to improve patient adherence by producing patient-focused material that more effectively helps patients understand the benefits of the proposed medication as well as the associated risks, and the steps being taken to mitigate those risks. Making relevant information easy to understand and even easier to access via different channels, including Web-based formats (e.g., patient portals), may help improve the patient experience, treatment adherence and their overall success in the program.
- Pharmacists. The third stakeholder that bears much of the burden in a REMS program is the pharmacist. Pharmacists have historically been relied upon to determine prescription qualifications although they may have limited access to helpful technology to aid in determining patient eligibility. To facilitate this, electronic telecommunication systems used for pharmacy claim adjudication (i.e., switch technology) has been utilized per the approval of the FDA for the last several years. The benefits of using such an established system are predominantly due to its integration with the standard pharmacy work flow and ability to leverage standardized technology and data standards already in place. One of the primary disadvantages of using such a system is that it was not designed with specific REMS program requirements in mind.
Another concern is that pharmacists often find themselves the primary healthcare professional answering questions about the drug, the REMS program, and what impact it may have. Patients should be able to supplement their interactions with pharmacists and prescribers with access to clear, actionable information to enhance their understanding of complex benefit/risk issues.
- Manufacturers. Another area in need of modernization is the REMS assessment process, which is critical to ensuring that a program is working as intended to mitigate risk without limiting patient access or increasing burden on the healthcare system. As part of this process, manufacturers typically use surveys to evaluate patient and healthcare provider understanding of the serious risks associated with, and safe use of, the drug in question—a central objective of any REMS program. Acknowledging challenges in the survey process (e.g., survey recruitment, attaining sufficient sample sizes, survey fatigue, lack of standardized metrics) and the burden these place on stakeholders, the FDA has released various guidances over the last several years, most recently in April 2019 concerning REMS assessment and survey methodologies.2,3 More progress from a technological standpoint is needed to enable expanded, efficient access to and communication with providers, patients and prescribers as part of the REMS assessment process.
In addition, to reduce the considerable time and cost associated with making modifications to a program once it is fully operational, manufacturers are looking for ways to engage key stakeholders in REMS program design much earlier but without introducing significant delays in the REMS approval process. One option might be to consider the benefit from a program being piloted first, providing opportunity for adjustments based on stakeholder feedback and behaviors. This approach might take more time up front in the process and require even closer coordination with the FDA, but could be well worth the resources saved over time.
