What

Support AE investigations with interoperable Label

As a first step toward streamlining the ability to support rapid investigation of new or increased adverse events related to medical products, structured drug labeling information  is a critical advancement. With structured labels that include sections such as structured adverse reaction section and ingredients adverse events related to medical products can more easily be updated and discovered.

Why

Transform fragmented sources of AE investigations into a harmonized interoperable ecosystem

Ability to identify source of adverse events (e.g., specific ingredient, manufacturer or drug-drug interaction) is limited because:

• No interoperable standards exist to support a harmonized data ecosystem for AE investigations

• Medical product information (labeling data) is siloed, if structured, or unstructured

• AE identification and reporting is a highly manual process

• Pharmacy information are typically siloed

Benefits

Reduce unnecessary health issues and save more lives

Enhance speed, accuracy, and comprehensiveness of:

• Detection of new and/or increased medical products-related adverse events
• Investigation of the source of medical product adverse events

Integration of healthcare, pharmacy and public health information systems.  

Promotes rapid public health actions to reduce and prevent adverse events, improving health outcomes.