Improvements needed in biologics traceability to ensure patient safety

Improvements in recording brand and batch numbers for biologic medicines are needed if patient safety is to be ensured, a new study suggests.

Research carried out by the UK’s Drug and Safety Research Unit (DSRU) and Dutch not-for-profit organisation, Lygature, shows batch numbers for biologic medicines are only recorded between 38-58% of the time during routine hospital practice.

The UK data showed that brand names were recorded more frequently, between 79-91% of the time.

More so, when looking at adverse drug reactions (ADRs), reports show brand names were included 38% of the time by health professionals, whereas batch number traceability was only 15%.

With increasing numbers of biologic medicines being used by healthcare professionals, there is a need to improve the way they are recorded if medication errors are to be reduced, the study states.

Professor Saad Shakir, director of the DSRU, said: “Being able to trace the exact brand and batch of a biological medicines means regulatory bodies and pharmaceutical companies can see whether any reported adverse side effects are about a specific batch, or are more widespread. Actions can then be taken promptly to deal with any issues and prevent more patients experiencing side effects.

“Our study findings suggest we have some way to go to encourage health professionals to record this information. As we move towards more electronic prescribing, this should help reduce the problem because brand and batch numbers can be more readily available. But in the meantime, it’s vital we educate and inform health professionals so they understand why this seemingly small task is so important.”

Kevin Klein, programme Manager at Lygature, said: “With more and more UK healthcare institutions moving from paper-based recording to electronic-based recording, this could provide an opportunity to facilitate routine brand name and batch number recording without excessively increasing the burdens for healthcare professionals. However, current limitations of barcodes, which are often not printed on the single unit dose and lack encoded batch number information, need to be addressed first to create cost-effective solutions to improve the traceability in the hospital setting.”