K Klein 1, 2, 3, L Hazell 4, P Stolk 1, 2, 3, S Shakir 4
Affiliations: 1Lygature, Utrecht, The Netherlands. 2Utrecht University, Utrecht, The Netherlands. 3Exon Consultancy, Amsterdam, The Netherlands, 4Drug Safety Research Unit (DSRU), Southampton, United Kingdom
Biological medical products (‘biologics’) are derived from living cells or organisms. Due to their complex molecular structures and sensitivity to changes in the manufacturing process, variations may exist between biologics with the same active substance from different manufactures (e.g. ‘biosimilars’) or between different batches of the same product.
It is of vital importance that biologics are traceable by brand name and batch number when reporting an adverse drug reaction (ADR) but such product details are not always provided . In a recent study in the Netherlands, the brand name was identifiable in 76% of ADR reports submitted for biologics, whereas only 5% contained a batch number . Shortcomings in the recording and tracing of product and batch information in clinical practice are believed to be associated with the limited traceability of biologics found in ADR reports in the Netherlands.
The UK BIO-TRAC study was initiated to assess the current status of traceability of brand names and batch numbers for (recombinant) biologics in UK clinical practice within the hospital setting and in the UK ADR reporting database (Yellow Card Scheme).
An on-line survey has been set up for hospital pharmacists in England to capture information on recording practices that contribute to the traceability of brand names and batch numbers for biologics in UK clinical practice and to gather the views and experiences of hospital pharmacists on current bottlenecks and how to improve the current systems. In addition, a comprehensive analysis of 9036 ADR reports for biologics submitted to the UK Yellow Card Scheme between January 2009 and September 2017 will assess the extent to which brand name or batch number details are included in these reports. This includes a stratified analysis by reporter type, therapeutic product classes, calendar year and other variables.
The results of the UK BIO-TRAC study will be presented in the context of both objectives, the assessment of the recording practices for product specific details in routine clinical practice and the ADR data analysis of the MHRA Yellow Card database.
- Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010, amending as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Available from: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf
- Klein K, Scholl JHG, Vermeer NS, Broekmans AW, Van Puijenbroek EP, De Bruin ML, et al. Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports. Drug Saf. 2016 Feb;39(2):185–92.
The study is conducted by DSRU Education and Research Ltd in collaboration with Lygature and is funded by a grant from ABPI.
This study is based in part on data obtained under licence from the UK Medicines and Healthcare Products Regulatory Agency. However, the interpretation and conclusions contained in this study are those of the author/s alone.