Publication

Escher “Pharmacovigilance of Biologics” Project – Outcome

28 Aug 2017

The 2015 Escher project ‘Pharmacovigilance of Biologics’ investigated how adverse reactions to biologic medicines are recorded in different settings in the Netherlands, aiming to understand how traceable the products given to patients are in reality.

The original findings were discussed at a workshop organised by Escher in May 2015 – see here for the report.

The study resulted in several scientific publications:

  1. Klein, K., De Bruin, M.L., Broekmans, A.W. et al., Classification of Recombinant Biologics in the EU: Divergence Between National Pharmacovigilance Centers. BioDrugs (2015) 29: 373. doi: 10.1007/s40259-015-0149-y
  2. Klein K, Scholl JH, Vermeer NS, Broekmans AW, Van Puijenbroek EP, De Bruin ML, Stolk P., Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports. Drug Saf 2016; 39:185-92. doi: 10.1007/s40264-015-0383-8.
  3. Vermeer NS, Ebbers HC, Straus SM, Leufkens HG, Egberts TC, De Bruin ML., The effect of exposure misclassification in spontaneous ADR reports on the time to detection of product-specific risks for biologicals: a simulation study. Pharmacoepidemiol Drug Saf 2016 Mar;25:297-306. doi: 10.1002/pds.3929.

The output was further disseminated by the Generics and Biosimilars initiative (GaBi) on their online platform in February 2016. See GaBi online: http://gabionline.net/Biosimilars/Research/Pharmacovigilance-for-biologicals-in-The-Netherlands

The initial investigations highlighted the need to improve practices for tracing biological medicinal products in clinical practice in order to strengthen ADR reporting. Escher is currently following up on the findings through the UK BIO-TRAC study (see https://www.lygature.org/escher/uk-bio-trac-study). See also the Escher project website at https://www.lygature.org/escher/completed-projects/pharmacovigilance-biologics