Categorisation of Off-Label Medical Information Enquiries: Definition, Challenges and Impact

Introduction & Definition

Medical Information (MI) responds to unsolicited requests from Healthcare Professionals (HCPs) and patients; however, patients can only be provided with information that is on-label, whereas off-label information can only be provided in response to a specific HCP request.

The importance of this categorisation impacts what, where and how the information can be disseminated across communication channels and defines the intended target audience.

The definition of off-label requests needs to clarify whether it pertains to the actual use of a product or simply a request for information. Company procedures can establish that when MI is aware that a product has already been used in an off-label manner, then pharmacovigilance (PV) will need to be notified. If the request is about prospective use, or if actual use cannot be confirmed, then MI will consider this to be a request for information only, and some companies may decide that PV will not be informed. However, there may be value in sharing off-label requests with PV even when the request may not have been reportable. Requests for off-label information can be of value to the HCP for an informed decision, gaining valuable safety information for specific patients or clinical conditions. Companies are actively looking into safety and efficacy in non-approved indications, and this information frequently comes from off-label use of certain medicines based on established clinical practices defined by HCP communities.