Author: Supriya Desai, Sciformix Corporation
In recent times, pharmacovigilance regulations have focused increasingly more on medical literature monitoring (MLM), a complex process whose scope continues to expand and deepen. Existing regulations provide detailed guidance on literature searches and review to enable reporting of those individual case safety reports (ICSRs) not already directly reported to the sponsor (clinical, spontaneous and solicited data) and also help in signal detection and BRE of products1–3.
Per the European Medicines Agency (EMA), MAHs are required to monitor local scientific and medical publications in countries where they have a marketing authorisation, irrespective of commercial status of products. The US Food and Drug Administration (FDA) requires submission of reports of serious,unexpected adverse drug reactions (ADRs) described in the scientific literature for products with the same active moiety as products marketed in the US, even though excipient, dosage forms, strengths, routes of administration and indications may vary4.
The “literature” section of the periodic benefit–risk evaluation report (PBRER) requires a summary of new and significant safety findings for approved products, obtained from published peer reviewed scientific literature or unpublished manuscripts during the reporting interval. Literature searches for PBRERs should be wider than those for individual ADRs and include studies reporting safety outcomes in groups of subjects2. EMA guidelines also require inclusion of relevant applicable safety information for other active substances of the same class as the marketed drug. Consequently, any potentially relevant event identified in the literature may be considered an emerging safety issue requiring prompt immediate analysis and, if needed, corrective and preventive
Furthermore, special types of safety information that require inclusion are all pregnancy outcomes (including termination), use in paediatric populations, compassionate supply and named patient use, lack of efficacy, asymptomatic overdose, abuse or misuse, medication error where no adverse events occurred and important non-clinical safety results5.