Literature Surveillance for Pharmacovigilance in Kenya

Literature surveillance — the systematic screening of published medical literature for new safety information about your products — is one of the six required components of a PPB-compliant PV system, and one of the most resource-intensive to run manually.

What literature surveillance actually involves

• Searching relevant medical and scientific databases for new publications referencing your active ingredients or products
• Screening results for anything indicating a new adverse effect, changed risk profile, or emerging safety concern
• Documenting screened literature, even negative findings, as part of your PSMF and PSUR evidence base

Why this is harder than it sounds A single product might have dozens of relevant publications per quarter globally, most of them irrelevant to actual safety signals. Screening this manually is genuinely time-intensive, requires specific pharmacological literacy, and scales poorly across a large product portfolio — exactly the challenge that leads many PV teams to under-document this component even when other parts of their system are solid.

How this feeds into PSURs Literature surveillance isn't a standalone activity — findings need to flow directly into PSUR/PBRER documentation and, where relevant, trigger signal detection review.

How PvSentinel automates literature screening

FAQ

Do negative literature screening results need to be documented? Yes — demonstrating that screening happened, even with no new findings, is part of the audit trail PPB expects. How far back does literature monitoring need to go? Ongoing monitoring from the point of authorization is expected, not retrospective review unless specifically requested during an inspection.