How REMS Affect Pharmaceutical Distribution Processes and Partners
First-ever study of the impact of REMS on supply chains finds that collaboration is a critical requirement
Working with the Campbell Alliance Group, Inc., the Center’s newly published report, Assessing the Impact of Risk Evaluation and Mitigation Strategies (REMS) Requirements on the Pharmaceutical Supply Chain, documents the impact of the REMS mandate on manufacturers (brand, generic, biologic and small-molecule drugs); distributors (traditional wholesale, specialty and self-distributing specialty pharmacy); and providers (physicians, nurses, patient advocates and retail and specialty pharmacists). Using interviews and secondary data, this timely research presents opportunities, challenges and recommendations for process improvement and, for the first time, offers insights into the economic impact of REMS.
These strategies reflect FDA-approved manufacturer mitigation objectives and can be described as simple or complex programs that are broken down into four components. “Simple” REMS employ one or more of the first two components: medication guides for patients and communications plans to educate healthcare professionals. “Complex” REMS add elements to assure safe use (ETASU)—such as training, certification and registries documenting compliance; and systems to implement the ETASU. All strategies require assessment tactics and timetables to measure the strategies’ mitigation effectiveness (Fig. 1). More than 175 drugs currently have REMS; the most recent requirement being a class-wide mandate for long-acting and extended-release opioid products.
The study offers lessons learned noting that distributors, dispensers and providers all wish to be involved in the design and implementation of REMS programs. This appeal underscores their desire to provide input into the program, obtain sufficient time to develop internal training to ensure smooth program execution and time to test each system prior to product launch. Interviews with manufacturers revealed a growing willingness to work with downstream partners while advancing with the design of new REMS programs.
The study’s economic analysis indicates REMS requirements are costly to the supply chain and underscore the need for additional research into REMS program costs, including those that are hidden, unforeseen and not reimbursable through current business practices and government benefit programs. Assessing the Impact includes separate sections reviewing tasks and associated of REMS for manufacturers, distributors and healthcare providers. These data were based on interviews and documentation from:
For manufacturers, costs are divided between setup and monthly maintenance. Each line item ranges from a low of $5K-250K, to a high of $100K-500K. Development times range from 20 to 120 days, depending on the task. For distributors, line items range from “minimal” to $5K-$1M (indicative of the wide range of data reporting that can be required). Healthcare provider economics are evaluated on the basis of time estimates to complete various tasks; for example, physicians’ patient counseling is 10-15 minutes (per patient), while physician certification can require an hour. Fuller details are available in the report.
Finally, the research provides recommendations on future enhancements for REMS, as well as other insights that are helpful to anyone seeking to understand the potential impact of REMS on the pharmaceutical supply chain. Key findings highlight the need for supply chain collaboration, the need to build on the experiences past REMS and the need for uniformity in programs, operating procedures, data management and communications. PC
The Center for Healthcare Supply Chain Research is a 501(c)(3) non-profit charitable organization that serves as the knowledge partner of the Healthcare Distribution Management Association (HDMA). The Center’s mission is twofold: to conduct research and disseminate information that will enhance the knowledge base, efficiency and effectiveness of the total healthcare supply chain; and to provide thought leadership to further enhance the safety and security of the healthcare supply chain through future-focused study and programming.