Researchers unable to identify batches of biologic drugs from 85% of Yellow Card reports

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Only 15% of biologic drug batches can be identified from Yellow Card adverse drug reaction (ADR) reports, a study published in Drug Safety
(23 December 2019) has found.

Researchers analysed 6,108 electronic ADR reports for recombinant biologics submitted to the Medicines and Healthcare products Regulatory Agency’s Yellow Card reporting scheme between 1 January 2009 and 30 September 2017.

They found found that only 15% of these had identifiable batch numbers, and just 38% of reports had an identifiable name. 

As part of the study, UK Drug Safety Research Unit (DSRU) researchers also asked hospital pharmacists how they recorded product details of biologics during prescribing, dispensing and administration in routine practice.

Of the 61 responses received, they found that pharmacists recorded batch numbers during drug administration 58% and 57% of the time in the inpatient and outpatient settings, respectively. Batch numbers were recorded during dispensing 40% and 38% of the time in the respective settings.

The researchers said that batch numbers were most likely to be recorded when the drug is administered owing to the use of peel-off stickers that contain the batch number. Electronic recording was used more often when dispensing drugs, but EU barcode standards do not require batch numbers to be included.

Saad Shakir, director of the DSRU, said batch traceability “means regulatory bodies and pharmaceutical companies can see whether any reported adverse side effects are about a specific batch, or are more widespread,” allowing action to be “taken promptly”.

He added that while wider use of electronic prescribing should improve batch number recording, “it’s vital we educate and inform health professionals so they understand why this seemingly small task is so important”.


Last updated
The Pharmaceutical Journal, Researchers unable to identify batches of biologic drugs from 85% of Yellow Card reports;Online:DOI:10.1211/PJ.2020.20207522

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