Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study

Abstract

ObjectivesTo identify the authentication and detection rate of serialised medicines using medicines authentication technology.Design and intervention4192 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.SettingA site within a large UK National Health Service teaching hospital trust.ParticipantsAccredited checking staff, pharmacists and dispensers in a pharmacy department.Primary outcome measuresAuthentication and detection rate of counterfeit expired and recalled medicines.ResultsThe 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.ConclusionsTDRs 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.

Awareness of the implementation of the Falsified Medicines Directive among pharmaceutical companies’ professionals in the European Economic Area

“… 25 Moreover, as suggested by Naughton et al , current technology needs further improvement before there can be harmonization with the current workflow in community and hospital pharmacies. 26 …”

Medicine authentication technology as a counterfeit medicine-detection tool: a Delphi method study to establish expert opinion on manual medicine authentication technology in secondary care

“…Although the technical detection rate of the technology was 100% and the response rate of the technology was <300 ms (as mandated by the FMD), 13 14 not all medicines requiring authentication were authenticated and of those authenticated not all of those that generated a warning pop up were quarantined. 17 Following the service evaluations study, this Delphi method study was conducted to identify the reasons for poor authentication and detection rates and identify improvements.…”

Hospital Audit as a Useful Tool in the Process of Introducing Falsified Medicines Directive (FMD) into Hospital Pharmacy Settings—A Pilot Study

“…Standard procedures should be introduced and harmonized with European laws, and further adjusted to the national practice [ 23 ]. Additionally, there is a strong need to adapt the protocols to the workflow available in a particular community or hospital pharmacy [ 24 ].…”