Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study
Objectives To identify the authentication and detection rate of serialised medicines using medicines authentication technology.Design and intervention 4192 serialised medicines were entered into a hospital dispensary over two separate 8-week stages in 2015. Medicines were authenticated using secure...
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BMJ Publishing Group
2016-12-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/6/12/e013837.full |
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| author | David Brindley Stephen Chapman Lindsey Roberts Bernard Naughton Sue Dopson |
| author_facet | David Brindley Stephen Chapman Lindsey Roberts Bernard Naughton Sue Dopson |
| author_sort | David Brindley |
| collection | DOAJ |
| description | Objectives To identify the authentication and detection rate of serialised medicines using medicines authentication technology.Design and intervention 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.Setting A site within a large UK National Health Service teaching hospital trust.Participants Accredited checking staff, pharmacists and dispensers in a pharmacy department.Primary outcome measures Authentication and detection rate of counterfeit expired and recalled medicines.Results 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.Conclusions 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. |
| format | Article |
| id | doaj-art-4a217a7db999419b9210f5cec7ab45f7 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2016-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-4a217a7db999419b9210f5cec7ab45f72025-08-20T02:13:44ZengBMJ Publishing GroupBMJ Open2044-60552016-12-0161210.1136/bmjopen-2016-013837Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care studyDavid Brindley0Stephen Chapman1Lindsey Roberts2Bernard Naughton3Sue Dopson41 Department of Paediatrics, University of Oxford, Oxford, UK5Department of Paediatrics, University of Oxford, Oxford, UK4Medicines Optimisation Clinical Network, Oxford Academic Health Science Network (AHSN), Oxford, UK1Institute of Science and Technology in Medicine, Keele University, Stoke-on-Trent, UK2Said Business School, University of Oxford, Oxford, UKObjectives To identify the authentication and detection rate of serialised medicines using medicines authentication technology.Design and intervention 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.Setting A site within a large UK National Health Service teaching hospital trust.Participants Accredited checking staff, pharmacists and dispensers in a pharmacy department.Primary outcome measures Authentication and detection rate of counterfeit expired and recalled medicines.Results 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.Conclusions 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.https://bmjopen.bmj.com/content/6/12/e013837.full |
| spellingShingle | David Brindley Stephen Chapman Lindsey Roberts Bernard Naughton Sue Dopson Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study BMJ Open |
| title | Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study |
| title_full | Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study |
| title_fullStr | Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study |
| title_full_unstemmed | Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study |
| title_short | Effectiveness of medicines authentication technology to detect counterfeit, recalled and expired medicines: a two-stage quantitative secondary care study |
| title_sort | effectiveness of medicines authentication technology to detect counterfeit recalled and expired medicines a two stage quantitative secondary care study |
| url | https://bmjopen.bmj.com/content/6/12/e013837.full |
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