Improved REMS programs are focus of white paper

The article “APhA 2011 REMS White Paper: Summary of the REMS stakeholder meeting on improving program design and implementation” was published in the May/June issue of the Journal of the American Pharmacists Association.

The white paper focuses on improving risk evaluation and mitigation strategies (REMS) programs and designing a system that maximizes patient safety while minimizing burdens on the healthcare system. In addition, the white paper summarizes the outcomes of a REMS stakeholder meeting hosted by the American Pharmacists Association (APhA) and builds on themes from APhA’s 2009 REMS white paper.

The growing number of REMS programs and the rising need for implemented standards to establish these programs create an opportunity for pharmacists to continue collaborative work with FDA, manufacturers, and other stakeholders to improve the REMS development and implementation process. Recommendations in the white paper included:

• Standardizing REMS programs, components, and processes

• Using effective provider interventions such as personal consultations with patients

• Leveraging existing technology solutions in medical and pharmacy practice settings

• Establishing a central repository or clearinghouse for all REMS-related information

• Improving communication strategies and awareness of REMS programs and implementation requirements

• Establishing compensation models to ensure that providers have staff and resources to implement REMS programs

The REMS meeting took place last October and was attended by 34 stakeholders representing pharmacists and other healthcare providers, pharmacies, drug wholesalers, manufacturers, and patient advocacy, safety, and health information technology professionals. Staff from the FDA participated as observers.