Center for Healthcare Supply Chain Research Publishes First Comprehensive Impact Study of Risk Evaluation and Mitigation Strategies (REMS)
The Center for Healthcare Supply Chain Research, the research foundation of the Healthcare Distribution Management Association (HDMA), today released Assessing the Impact of Risk Evaluation and Mitigation Strategies (REMS) Requirements on the Pharmaceutical Supply Chain, the first comprehensive research study analyzing the impact of REMS programs across the healthcare supply chain.
Produced in collaboration with Campbell Alliance Group, Inc., the study outlines the current REMS landscape, evaluates the impact of these requirements on key supply chain stakeholders and challenges the industry faces, examines economic considerations, assesses two program case studies and highlights opportunities for future program enhancements. Research was based on primary and secondary sources, including interviews with 45 industry stakeholders from across the supply chain — manufacturers, distributors and providers.
The U.S. Food and Drug Administration (FDA) is authorized through the 2007 Food and Drug Administration Amendments Actto require a REMS program to mitigate risks associated with certain medications, ensuring patients receive the optimal benefits of the drug. These programs outline the steps a drug manufacturer must take to enhance a medication’s safe use, and may require up to four distinct components, ranging from a medication guide; a communication plan to educate healthcare professionals; elements to assure safe use (ETASU), such as training, certification or patient registry programs; and systems to implement the ETASU. All REMS require a timetable for submission of assessments to the FDA. One other element that all REMS programs have in common is that they affect all stakeholders across the supply chain.
In its analysis, the Center and Campbell Alliance found that cross-industry collaboration, communication and uniformity are essential to successfully implement the still-evolving REMS initiative. Specifically, it notes that the industry can benefit by acknowledging their trading partners’ capabilities and limitations as well as the challenges they may face.
“As today’s healthcare system faces the dual challenge to improve efficiency and patient care, our research defines the critical issues we all face in meeting the REMS requirements for specific medicines on the frontier of development,” said Karen J. Ribler, Executive Vice President and COO of the Center for Healthcare Supply Chain Research. “It draws from experience and rigorous analysis showing how industry-wide strategies can enable and speed the use of specialized medicines to treat serious diseases.”
Assessing the Impact of Risk Evaluation and Mitigation Strategies (REMS) Requirements on the Pharmaceutical Supply Chainis now available for purchase through the HDMA Marketplace, http://www.ShopHDMA.org.
Source: Press Release