Third: Engage users and stakeholders
Horner: Evaluate user understanding.
To address the regulatory requirement of assessing the effectiveness of REMS for marketed products, you must evaluate user understanding of the risks involved in using the medicine. The regulations stipulate that this evaluation must occur at 1.5, 3, and 7 years after a REMS program is implemented.
Traditionally, medicine labeling and package inserts have contained safety information for users. These traditional REMS tools are increasingly being proven ineffective, and they must often be supplemented with more effective communication methods.
Fetterman: Engage stakeholders in the design of the REMS elements to help ensure the program will be pragmatic, feasible, and acceptable.
Gallo: Line up the appropriate resources and experience.
Research best practices and the changing REMS landscape, and consider the types of tools that may be part of the REMS program to determine the expertise you'll need. Most companies don't have all of that expertise available internally. Secure the resources on the front end of the process.