REMS update

May 15, 2011

FDA recently called for the addition of new Risk Evaluation and Mitigation Strategy requirements for medications. This article examines some resulting challenges and potential solutions.

Key Points

The safe use of medications is a significant consideration for both healthcare providers and FDA. Evidence of a recent increase in the emphasis on drug safety includes the addition of new Risk Evaluation and Mitigation Strategy (REMS) requirements for medications.

REMS: Purpose and components

OBRA '90 rules versus REMS

The Omnibus Budget Reconciliation Act of 1990 (OBRA '90) included mandates for the states to improve the understanding of medications on the part of Medicaid beneficiaries, according to Fink. However, most states extended the initiative to all patients.

"OBRA '90 included specific components that clearly affected the practice of pharmacy, such as prospective drug utilization review, patient counseling, and record maintenance," said Vivian.

REMS, however, "are part of the labeling of a drug product, and its goal is a 'balancing act' between risks and benefits. REMS mandates have an impact not only on pharmacists, but other healthcare practitioners as well," Fink stated.

Challenges and potential solutions

In July 2010, FDA held a public meeting to gather comments on concerns associated with REMS implementation.

Criticisms included disruption of workflow by a multiplicity of unique REMS programs, primarily paper-based initiatives that have not evolved as has e-prescribing; lack of compensation for complying with REMS requirements; and negative impact on patient access (e.g., delay in treatment, or the choice of prescribers/pharmacies not to participate because of the burden imposed).

Participants recommended standardization of programs, integration of REMS into existing healthcare systems, and use of developed informatics systems (e.g., e-prescribing, e-health records) to execute REMS more efficiently.

Officials at the American Pharmacists Association (APhA) also recognize the challenges that pharmacists face. At the APhA annual meeting in March in Seattle, Wash., Marcie Bough, PharmD, APhA's senior director of Government Affairs, assured attendees that "APhA has led pharmacy in REMS discussions, focusing on the need to use a standardized, system-based approach to improve REMS, decrease the burden on the healthcare system, and ensure patient access to needed medications."