In REMS Revision, AMCP Sees Expanded Specialty Role

The Academy of Managed Care Pharmacy (AMCP) recommended an expanded role for managed care and specialty pharmacists as the FDA re-evaluates its mandated Risk Evaluation and Mitigation Strategies (REMS) program.

The organization’s suggestions came during a 2-day FDA meeting on REMS programs held July 25 and 26, 2013. The recent meetings follow a July 2010 meeting covering the development and implementation of REMS procedures, and a June 2012 public workshop assessing survey methodologies and instruments used to evaluate patient and provider knowledge of REMS drugs.

Each of the efforts aims to establish standard REMS and to reduce implementation burdens, as defined in the Prescription Drug User Fee Act, according to a May 22, 2013, announcement appearing in The Federal Register. As part of those ends, the FDA will issue a report of its findings that identifies projects in 4 areas: pharmacy systems, prescriber education, providing benefit/risk information to patients, and practice settings.

Portions of the statement that were particularly relevant to AMCP included sections covering REMS in drug-dispensing settings, standardization of REMS tools, and approaches to assessing the impact of REMS.

At present, certain REMS require distribution settings to obtain certification and training in order to dispense an associated therapy, The Federal Register states. Given that many drugs dispensed by specialty pharmacies have a REMS component, questions of certification, training, and implementation of REMS tools and projects come into question for the site and the dispensing pharmacist.

For AMCP, additional REMS requirements amount to a question of time and money.

“The addition of REMS to a medication often results in administrative activities above and beyond the normal dispensing process and patient care services provided by pharmacists,” AMCP’s release read. “Currently, these additional administrative responsibilities are not associated with additional dispensing fees, service fees, or other compensation to pharmacists or pharmacies.”

As a result of the increased workload associated with REMS, AMCP advocates a compensation mechanism for pharmacists and pharmacies administering REMS programs.

Standardizing REMS tools, including stakeholder enrollments, websites, and educational materials, is another focus for the FDA. Its concerns include the development and implementation of standardized REMS tools, integration of health information technologies, and the potential for developing a single web portal to store standardized REMS tools.

Although REMS procedures should have some standard elements, flexibility is paramount as well—particularly as more complex medications and biosimilar therapies enter the market, AMCP states.

“Information regarding these complex medications must be collected through an organized system that includes FDA, health care providers (including pharmacists and pharmacies), and others, as well as via health information technologies,” the AMCP release read. “As medicines become more clinically complex and this accountability system evolves, the current REMS approach may not be sufficient; therefore, FDA should provide flexibility in the approach to designing REMS, but support the adoption of a standard electronic solution.”

Assessment of REMS presents another query for the FDA, as it is considering options beyond its usual measures, The Federal Register states. Current tools for evaluating REMS include frequency of adverse outcomes, which are gathered through spontaneous adverse event reporting, stakeholder knowledge, and compliance with REMS safe-use conditions.

Managed care organizations have the potential to play a key role in this area, given the organizations’ access to patient information and REMS information needed for the FDA’s research. With the appropriate funding, it would also be possible for managed care organizations to conduct the REMS research, including in areas beyond REMS efficacy, AMCP’s release states.

“. . . The information generated by managed care organizations may also be used to determine whether and how REMS impact outcomes in the health care system,” the release states. “It could then be utilized in comparative effectiveness research and in other ways to provide better information about treatments, particularly complex specialty medications, which are more likely to be subject to REMS.”