APhA to FDA: Standardize, integrate REMS programs into regular pharmacy operations

Comments focus on REMS standardization, patient education, tools in dispensing settings, and assessment

In September 13 comments to FDA, APhA continued to advocate for a standardized, systems-based approach that uses existing technologies and infrastructures to implement and evaluate Risk Evaluation and Mitigation Strategies (REMS) programs.

“It is apparent that the FDA’s investment in stakeholder discussions is leading to progress in standardizing and streamlining REMS programs,” the Association wrote. “If appropriate time and resources are invested, pharmacists can further improve public health and education regarding REMS medications.”

APhA’s comments answered questions in FDA’s May 22 Federal Register notice on standardizing and evaluating REMS. The notice announced a July 25–26 public meeting at which APhA Senior Vice President of Government Affairs Stacie Maass, BSPharm, JD, spoke on a panel for REMS tools in dispensing settings.

The comments were organized around standardization of REMS programs, educational tools and patient outreach, REMS tools in dispensing settings, and assessing the impact of REMS.

On REMS standardization, APhA recommended that REMS processes be integrated into regular operations by leveraging existing information technology systems, that front-line providers such as prescribers and pharmacists be involved early in the development of new REMS program protocols, that manufacturers begin the REMS education process with an information packet that includes clear identification of which provider is responsible for which requirement, that FDA consider centralizing all REMS information through the FDA website, and that FDA organize REMS programs based on risk-based levels similar to the schedules for controlled substances or to TIRF (Transmucosal Immediate Release Fentanyl) drugs.

On educational tools and patient outreach, APhA advocated that FDA simplify patient educational materials to a single information sheet, that FDA and stakeholders consider face-to-face and telehealth consultations as key elements of REMS programs with appropriate compensation, that FDA and REMS sponsors fold REMS patient education into medication therapy management (MTM) programs both to benefit patients and to present a way to collect data on REMS and medication use issues, and that FDA become familiar with the work of the Pharmacy e-Health Information Technology Collaborative’s work to create SNOMED codes to allow pharmacists to document their services in electronic health records (EHRs).

On REMS tools in dispensing settings, APhA suggested that REMS training be incorporated into required provider education related to licensure; that REMS requirements be accommodated by electronic prescribing platforms, EHRs, and prescription claims adjudication processing already in place; that every pharmacist be certified for REMS programs as is required for prescribers participating in REMS programs; and that National Provider Identifiers be used by pharmacists to access the centralized REMS clearinghouse and to track practitioner-specific REMS requirements.

On REMS assessment, APhA urged that FDA require assessment tools that generate usable data and build on information from previous assessments; that FDA streamline the process for making changes to REMS tools when such changes are prompted by assessment data; and that each REMS program assessment process involve input and guidance from prescribers, pharmacists, and patients.