Brand name and batch number traceability of biologics
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Brand name and batch number traceability of biologics According to study results reported in Drug Safety, the traceability of the brand names and batch numbers for recombinant biologics in the UK is low, and "shortcomings in the systematic recording of product details in UK clinical practice may contribute to the limited traceability". The study* included an online survey of 61 hospital pharmacists from 43 secondary care NHS hospitals in England. Most respondents indicated that prescribing by brand name occurred always (48%) or very often (31%), with many indicating that brand name prescribing was more likely where a biosimilar or a related product sharing the same INN** name was available. More than 79% of respondents indicated that brand names are routinely recorded for biologics during dispensing (40% vs 38% for inpatients vs outpatients) and administration (58% vs 57%, respectively). For biologic prescribing and administration, paper-based recording of product details was more frequent than electronic-based recording, while electronic-based recording was more frequent for dispensing. Bottlenecks identified included the lack of electronic recording systems for batch number information, indicating the need for appropriate barcodes and electronic systems to facilitate automatic scanning of batch numbers throughout the supply chain. Analysis of 6108 electronic adverse drug reaction (ADR) reports between 1 January 2009 and 30 September 2017 revealed 6219 reports at the level of the individual biologic. An identifiable brand name was present for 2358 reports (38%), and a specified batch number was present for 911 reports (15%). A biosimilar or related product was present for the suspect drug in 916 reports; the brand name was specified in 510 reports (56%), and the batch number was specified in 252 reports (28%). The frequency of batch number reporting decreased with increasing time from administration to reaction onset, with a similar but lesser effect for brand name identification. The authors note that "with an acute onset, the medicinal product packaging or container on which the batch number information is printed may still be present and therefor accessible". The brand name was most frequently specified in reports submitted by patients, and the batch number was most frequently specified in reports submitted by hospital nurses or patients. The authors note that "the availability of batch number identification at the point of administration allows for hospital nurses to have easier access to this information". For the twenty most commonly reported suspect biologics, 3165 reports involved ready-to-use formulations and 1339 reports involved biologics that required compounding, with identifiable batch numbers for 8% vs 26% of reports. * BIOlogical-TRAceability in Clinical practice (BIO-TRAC) ** International Non-Proprietary Name Klein K, et al. The UK BIO-TRAC Study: A Cross-Sectional Study of Product and Batch Traceability for Biologics in Clinical Practice and Electronic Adverse Drug Reaction 803444319 Reportin
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