Evidence points towards an association between the absence of brand names and/or batch numbers in adverse drug reaction (ADR) reports for biologics and shortcomings in the routine recording of this information in clinical practice.

The routine recording of dynamic product information such as batch numbers and expiry dates by means of electronic barcode scanning is not supported by the current barcoding standards for pharmaceuticals in the EU.

Efforts to achieve a full track-and-trace system with new barcoding standards and requirements to improve the traceability of medicinal products should be aligned with other drug safety topics, such as the Falsified Medicines Directive and initiatives to reduce medication errors.