Improvements needed in recording brand and batch numbers for biological medicines to ensure patient safety

3 January 2020

Health professionals need to improve how they record brand and batch numbers for biologic medicines to ensure patients stay safe, according to a new study published this week.

The research, carried out by the UK’s Drug Safety Research Unit (DSRU) and Dutch not-for-profit organisation, Lygature, and published in the journal Drug Safety, shows hospital pharmacists, doctors and nurses only recorded batch numbers for biologic medicines between 38 per cent and 58 per cent of the time during routine hospital practice. The analysis of UK data showed brand names were recorded more frequently – between 79 per cent and 91 per cent of the time.

Analysis of spontaneous adverse drug reaction (ADR) reports showed brand names were only included 38 per cent of the time, while batch number traceability was only 15 per cent.

While generic small molecule drugs are considered chemically identical to an original branded drug, the fact biological medicines are large complex molecules produced by living cells means biosimilars – the biologic equivalent of generics – cannot also be considered identical to an original drug. Increasing numbers of biologic medicines, including biosimilars are being used by patients.

European pharmacovigilance legislation from 2012 states health professionals should record the exact name and batch number to aid traceability.

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.”

Improved traceability of biologic medicines would help reduce medication errors, improve batch-recalls and also improve inventory management.

In July the DSRU and Lygature presented findings from their research at a meeting with the NHS, Medicines and Health Regulatory Authority, Association of the British Pharmaceutical Industry, International Society of Pharmacovigilance, British Biosimilars Association, academics and Medicines for Europe, which represents pharmaceutical companies manufacturing generics and biosimilars.

The full study is now available online in Drug Safety (https://doi.org/10.1007/s40264-019-00891-6)