Adverse Event Case Management
The PV Database
As referenced earlier in the chapter, a core component of the vigilance programme is the PV database – a live repository of adverse event data and associated case information. Beyond serving as a central repository for BAT, the database is an active platform, enabling systematic data management aligned with Good Vigilance Practices (GVP) and regulatory reporting standards.
Unlike traditional combustible tobacco products the emergence of a range of Smokeless Products introduce new dynamics. Consumers report a variety of adverse events, reflecting both the novel nature of these products and engagement with compliant reporting. This evolution demands enhanced surveillance and robust technologies to meet emerging product requirements and BAT’s expanding role in proactive post-market surveillance.
Leveraging a pharmaceutical sector-grade specialised vigilance database provides significant advantages, including: data management, data security, regulatory reporting, supporting PV operations and advancement in signal detection.
Features
- Seamless digital connection with local careline centre platforms
- Consistent end to end handling of individual case safety reports (ICSRs)
- Includes appropriate fields and functions for data
- Allows a bespoke, relevant, case processing workflow
- Compliant with general global vigilance standards
Adverse Event Case Processing Workflow
Cases from all data sources flow into the PV database, with the majority integrating automatically. For instance, when a consumer contacts the BAT Japan careline centre, the agent logs the case and full engagement details into their system. Upon saving, the record synchronises into the database within minutes, triggering the adverse event case processing workflow.
The workflow follows a structured five-phase process:
Case Intake
The process begins with case intake – an early quality control whereby reports that do not meet four basic criteria are filtered out:
Reporter | Consumer | Product | Adverse Event
This criteria is aligned with regulatory submission requirements. All non-valid cases are reviewed individually before archiving, with access available if required in future. Valid cases proceed onwards.
Assessment
Here, all required fields are quality checked for completeness, any translation and additional internal coding performed. Individual adverse events are coded using the MedDRA dictionary standard.
Medical Review
If a case hits pre-defined criteria or is coded with a specific MedDRA term, it will follow this step. The medical review evaluates the clinical relevance, expectedness, severity, seriousness and potential causality of the reported event. MedDRA coding is validated.
Supplemental Review
The supplemental review is conducted from a regulatory legal perspective, to identify any cases that may give rise to a regulatory reporting obligation or require escalation.
Final Review
The last phase of the workflow is the holistic final review, involving a cross-functional assessment to ensure each case is appropriately evaluated before closure. Subject matter experts (SMEs) provide their input, either providing information or triggering an investigation. For example:
- Quality assessors may request a due diligence manufacturing check for any associated product-related incident
- Toxicology may cross check product specifications and ingredients; providing insight into biological plausibility
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