title: Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study.
abstract: To identify the authentication and detection rate of serialised medicines using medicines authentication technology.
  
  
  
  4192 serialised medicines were entered into a hospital dispensary over two separate 8-week stages in 2015. Medicines were authenticated using secure external database cross-checking, triggered by the scanning of a two-dimensional data matrix with a unit specific 12-digit serial code. 4% of medicines included were preprogrammed with a message to identify the product as either expired, pack recalled, product recalled or counterfeit.
  
  
  
  A site within a large UK National Health Service teaching hospital trust.
  
  
  
  Accredited checking staff, pharmacists and dispensers in a pharmacy department.
  
  
  
  Authentication and detection rate of counterfeit expired and recalled medicines.
  
  
  
  The operational detection rate of counterfeit, recalled and expired medicines scanned as a combined group was 81.4% (stage 1 (S1)) and 87% (stage 2 (S2)). The technology's technical detection rate (TDR) was 100%; however, not all medicines were scanned and of those that were scanned not all that generated a warning message were quarantined. Owing to an operational authentication rate (OAR) of 66.3% (over both stages), only 31.8% of counterfeit medicines, 58% of recalled drugs and 64% of expired medicines were detected as a proportion of those entered into the study. Response times (RTs) of 152 ms (S1) and 165 ms (S2) were recorded, meeting the falsified medicines directive-mandated 300 ms limit.
  
  
  
  TDRs and RTs were not a limiting factor in this study. The suboptimal OAR poses significant quality and safety issues with this detection approach. Authentication at the checking stage, however, demonstrated higher OARs. There is a need for further qualitative research to establish the reasons for less than absolute authentication and detection rates in the hospital environment to improve this technology in preparation for the incumbent European Union regulative deadline.
authors.affiliation: Institute of Science and Technology in Medicine, Keele University, Stoke-on-Trent, UK.|Said Business School, University of Oxford, Oxford, UK.|Pharmacy Department, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
authors.forename: Bernard
authors.initials: B
authors.lastname: Naughton
authors.affiliation: Medicines Optimisation Clinical Network, Oxford Academic Health Science Network (AHSN), Oxford, UK.
authors.forename: Lindsey
authors.initials: L
authors.lastname: Roberts
authors.affiliation: Said Business School, University of Oxford, Oxford, UK.
authors.forename: Sue
authors.initials: S
authors.lastname: Dopson
authors.affiliation: Institute of Science and Technology in Medicine, Keele University, Stoke-on-Trent, UK.|Department of Paediatrics, University of Oxford, Oxford, UK.
authors.forename: Stephen
authors.initials: S
authors.lastname: Chapman
authors.affiliation: Said Business School, University of Oxford, Oxford, UK.|Department of Paediatrics, University of Oxford, Oxford, UK.|The Oxford-UCL Centre for the Advancement of Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, UK.|Centre for Behavioural Medicine, UCL School of Pharmacy, University College London, London, UK.|Harvard Stem Cell Institute, Cambridge, Massachusetts, USA.|USCF-Stanford Centre of Excellence in Regulatory Science and Innovation (CERSI), USA.
authors.forename: David
authors.initials: D
authors.lastname: Brindley
mesh_terms: D058110:Counterfeit Drugs; D056736:Drug Recalls; D006801:Humans; D008508:Medication Errors / Q000517:prevention & control*; D004364:Pharmaceutical Preparations / Q000592:standards*; D036301:Qualitative Research; D063127:Secondary Health Care / Q000379:methods; D013678:Technology, Pharmaceutical / Q000379:methods*
chemical_list: D058110:Counterfeit Drugs; D004364:Pharmaceutical Preparations
keywords: COUNTERFEIT DRUGS; MEDICAL INFORMATICS; PUBLIC HEALTH