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

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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 carried out by Kevin Klein and Pieter Stolk from Lygature, and Lorna Hazell and Saad Shakir from UK’s Drug Safety Research Unit (DSRU).

The research, 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 importance of being able to trace the exact brand and batch of a biological medicines stems from the fact that unlike generic medicine, biosimilars – the biologic equivalent of generics – cannot be considered identical to an original drug, and in the case of any reported adverse side effects regulatory bodies and pharmaceutical companies can see if those relate to a specific batch or if they are more widespread. Improved traceability of biologic medicines would also help reduce medication errors, improve batch-recalls and improve inventory management.

In an earlier study of Escher, conducted in the Netherlands in collaboration with Utrecht University, the Royal Dutch Pharmacists Association, the Dutch Association of Hospital Pharmacists and the Netherlands Pharmacovigilance Centre Lareb, it was shown that that brand names were not routinely recorded (60-79%) in Dutch clinical practice and batch numbers were not routinely recorded at all (0%). This study suggested that the shortcomings in the recording and tracing of product information in clinical practice contribute to the limited traceability of brand names and batch numbers in ADR reports for biologics.

Throughout the last four years, the Lygature team has gained ample experience on this topic and tries to contribute to improving the traceability of biologics in clinical practice and ADR reporting by engaging with relevant stakeholders in the field.

You can read the whole press release here.

The research was funded by the Association of the British Pharmaceutical Industry.

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