272 - We are developing a patient-directed instructional guide on how to use an injectable medication. The format is a flip chart, with visual instructions on one side (for the patient), and more detailed instructions on the reverse side (for the nurse's eyes only). Given the new PAAB code, and the fact that this is a HCP-delivered patient APS based on Section III of the product monograph, would the lowest level of fair balance suffice?
-
In this case, probably no. The HCP portion of the flip chart would be reviewed as an HCP piece, and therefore it would be required to meet the guidelines and restrictions for HCP material. The level of fair balance would be based on the content that is presented within the HCP portion of the piece. The PAAB guidance document "Guidance on base fair balance level selection and placement" provides a list of considerations when determining the appropriate level of fair balance. This document outlines the types of messages that are associated with each of the levels of fair balance. The HCP presentation (and weblink) should not be visible to the patient.
