P20: Designing and Implementing a Product Labeling Utility to Support Medical Assessment of Adverse Events
Director, Case Management Operations
Bristol Myers Squibb United States
The objective was to implement a tool within the safety database that automatically provides a hyperlink to the version of the investigator brochure (IB) in effect when an adverse event (AE) occurred to enable pharmacovigilance (PV) experts to assess expectedness of the event.
The experiment involved: 1) Extracting the labeling document reference links; 2) Generating the labeling reference document with the correct IB; 3) Attaching the IB as an artifact within the case source documents; and 4) Synchronization between the safety database and the labeling portal.
In this study we demonstrate the feasibility of building and implementing a tool, the Product Labeling Utility (PLU), into our existing safety database to effectively surface the appropriate IB document version to support our users in assessing the expectedness for individual case safety reports (ICSRs) per regulatory requirements. The PLU bridges regulatory requirements and ensures proper documentation exists in safety cases for consistency and inspection readiness. To date, the correct IB version has been assessed for 81,573 ICSRs. In addition, the correct version of the Summary of Product Characteristics [SmPC] labelling document has been identified for 6,038 ICSRs.
In PV, expectedness of an AE is assessed by determining if it is listed (expected) or not listed (unexpected) in the product’s labeling documentation (i.e., the IB, SmPC, Package Insert, or Company Core Data Sheet). Because these documents change over time, care must be taken to assess expectedness based on the version of the reference document in effect at the time of the AE. Expectedness of a serious AE is an important factor in determining the reporting timeline to regulatory authorities. The PLU was able to meet regulatory requirements by automating the generation of labeling references and eliminating manual work and errors. This proprietary, innovative solution was well received by regulators, permitting us to expand its use to address updates within the SmPC labeling documents as well as comparator labeling documents.