REMS Patient Packs
Celgene manufactures several products that fall within the FDA REMS Program. In order for Celgene to sell these products, strict FDA guidelines must be followed by prescribers and pharmacists in order to ensure that patients who are prescribed these products are well informed about the risks and safe-use conditions associated with them, as well as about their responsibilities when starting, renewing, and discontinuing their use.
In addition, Celgene’s REMS Advisor Department felt that mailing a New Patient Packet to every new patient that is prescribed any of these products would ensure that they receive the critical information they need.
Having also determined through Patient Focus Groups that patients thought the materials that were currently in the New Patient Packet were not written in an easy to understand or friendly manner, the REMS Advisor Department wanted to improve upon materials in the Packet by applying Health Literacy principles so that they are presented using simple, straight-forward language, look like (and are) easy to read, and don’t communicate “gloom and doom.”
In response to this need, Celgene partnered with i3 to redesign the layout and rewrite the Welcome Packet and REMS Guide. One of i3’s experts, with extensive specialized experience writing educational materials and communications for the medical and pharmaceutical industry, adeptly created the new materials applying health literacy principles.
The new materials, with discrete versions produced for female and male patients, informed them about the REMS program, how it works, how to lower potential risks, how to take regular surveys, what they must know and understand about their prescription, and where to go with questions and for additional information.
The new materials were designed to be reusable in both print and online formats.
Patient Focus Groups conducted to introduce and get feedback on the new design and language were a big success:
” Terrific news…. we have now conducted both Patient Focus Groups, and the response to the new Patient Packs was overwhelmingly positive. All felt it’s wonderful to have the packs when they start treatment and said they wouldn’t change a thing! They liked everything about them! One patient even called them a “treasure!”