The UK BIO-TRAC Study: A Cross-Sectional Study of Product and Batch Traceability for Biologics in Clinical Practice and Electronic Adverse Drug Reaction Reporting in the UK

Abstract

Introduction Due to the complexity of biologics and the inherent challenges for manufacturing, it is important to know the specific brand name and batch number of suspected biologics in adverse drug reaction (ADR) reports. Objective The aim of this study was to assess the extent to which biologics are traceable by brand name and batch number in UK hospital practice and in ADRs reported by patients and healthcare professionals. Methods We performed an online hospital pharmacist survey to capture information on how specific product details are recorded during the processes of prescribing, dispensing and administration of biologics in routine UK hospital practice. We also assessed the proportion of ADR reports specifying brand name and batch number from electronic ADR reports submitted to the UK national spontaneous reporting database, the Yellow Card Scheme, between 1 January 2009 and 30 September 2017. Results Brand name recording in routine hospital processes ranged from 79 to 91%, whereas batch numbers were less routinely recorded, ranging from 38 to 58%. Paper-based recording of product details was more commonly used for recording information. A total of 6108 electronic ADR reports were submitted to the Yellow Card Scheme for recombinant biologics, of which 38% and 15%, respectively, had an identifiable brand name and batch numbers. Whereas batch number traceability in electronic ADR reports improved slightly after the implementation of the European Union pharmacovigilance legislation in 2012, no improvement of brand name traceability was observed. Conclusion Brand name and batch number traceability for biologics in UK ADR reports are generally low. Shortcomings in the systematic recording of product details in UK clinical practice may contribute to the limited traceability.

Familiarity, Knowledge and Practices of Healthcare Professionals Regarding the Pharmacovigilance of Biological Medicines in Lusaka, Zambia: A Multi-Facility Cross-Sectional Study

“…Studies conducted in Latin America [15], Europe [22], and Australia [23], which aimed to determine the lack of inclusion of batch numbers in ADR reports, found that many prescribers did not have the information available at the time of reporting. A solution to this problem would be the education of HCPs on the importance of batch number inclusion in ADR reports and PMRs [17].…”

“…This may mean that the lack of use of batch numbers when dispensing or administering BMs may also indicate additional barriers to recording them in clinical practice. HCPs in other countries have expressed difficulty in recording batch numbers, some stating that electronic patient records do not have fields to include batch numbers [24], while others have stated that it is impractical to manually record batch numbers when dispensing and administering medicines [17]. This may also be the case at the selected hospitals where the study was conducted.…”

“…Healthcare professionals extract information to include in an ADR report from patient medical records (PMRs) [17]. For biological medicines, this means that brand names (or another identifier) and batch numbers must be used during the prescribing, dispensing, and administration, to be included in the ADR report for their PV to be effective.…”

Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions

“…This supports the need for traceability (e.g., the ability to trace which batch the patient has received despite the observation that, so far, differences in certain quality attributes between batches had limited impact on efficacy and safety). Previous studies have shown that the availability of the specific batch number in spontaneously recorded ADRs is generally low with percentages ranging between 0 and 20% 20,25 . Therefore, traceability needs improvement and several proposals have already been made 15,26 .…”

“…Previous studies have shown that the availability of the specific batch number in spontaneously recorded ADRs is generally low with percentages ranging between 0 and 20%. 20 , 25 Therefore, traceability needs improvement and several proposals have already been made. 15 , 26 Questions have, however, been raised about the cost‐effectiveness of improvement of traceability as tools for improvement place more pressure on the healthcare budget.…”