Duplicate Literature Records in PV: The Compliance Risk No One Talks About, Until Inspection

 Most pharmacovigilance (PV) teams treat duplicate literature records as an operational nuisance. A few cases get merged, a few line listings get cleaned up, and the case backlog moves forward. The problem is that this view holds only until an inspector starts asking why the same patient case appears as three separate ICSRs in your safety database, or why your signal counts for a specific product look inflated against EudraVigilance reference data.



At that point, duplicate literature records stop being a housekeeping issue and become a data integrity finding.

The European Medicines Agency itself acknowledges the scale of the problem. Its Medical Literature Monitoring (MLM) service was created specifically to “avoid duplication of effort by marketing authorisation holders” and to “prevent the same reports being entered into databases by multiple marketing authorisation holders” for substances with many authorisations across the EEA. When a regulator builds an entire centralised service to suppress duplicate literature ICSRs, that is a signal worth taking seriously.

This article looks at why duplicate literature records carry real compliance weight, where manual deduplication breaks down, and what defensible literature automation in pharmacovigilance actually looks like under inspection

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