ArticleBMJ open2019
Medicine authentication technology: a quantitative study of incorrect quarantine, average response times and offline issues in a hospital setting.
Article in BMJ open, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 2 of them syntheses that pooled it.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- The impact of global falsified medicines regulation on healthcare stakeholders in the legitimate pharmaceutical supply chain: a systematic review.Frontiers in medicine · 2024Pooled it
- A systematic review of substandard, falsified, unlicensed and unregistered medicine sampling studies: a focus on context, prevalence, and quality.BMJ global health · 2020Pooled it
- Workarounds in Electronic Health Record Systems and the Revised Sociotechnical Electronic Health Record Workaround Analysis Framework: Scoping Review.Journal of medical Internet research · 2022Article
- Pharmacists' views on the impact of the Falsified Medicines Directive on community pharmacies: A cross-sectional survey.Exploratory research in clinical and social pharmacy · 2022Article
- Article
- Medicine quality in high-income countries: The obstacles to comparative prevalence studies.Medicine access @ point of careArticle
Corrections and comments
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Authors and funding
1 author.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesTo introduce serialised medicines into an operational hospital dispensary and assess the technical effectiveness of digital medicine authentication (MA) technology under European Union Falsified Medicines Directive (EU FMD) conditions.
designThirty medicine lines were serialised using 2D data matrix labels and introduced into an operational UK National Health Service (NHS) hospital dispensary. Staff were asked to check medicines for two-dimensional (2D) data matrices and scan those products, in addition to their usual medicine preparation and checking processes. Four per cent of the study medicines were labelled with a 2D barcode which generated a pop-up, identifying the medicine as either authenticated elsewhere (falsified), authenticated here, expired or recalled.
settingAn NHS teaching hospital based in the UK, the same site as the Naughton
participantsGeneral Pharmaceutical Council registered, accredited accuracy checking technicians and pharmacists. PRIMARY OUTCOME MEASURES: Average response times, offline issues, instances of incorrect quarantine and workarounds. The EU FMD maximum response time is 300 milliseconds (ms).
resultsDuring the checking stage of medicine preparation, the average response time for MA in this study was 131 ms. However, 4.67% of attempted authentications experienced offline issues, an increase of 4.23% from the previous study. An increase in offline instances existed alongside an increase in incorrect quarantine.
conclusionsDigital drug screening has the capability of operating with average response times which are below the maximum EU FMD limit of 300 ms. However, there was an increased incidence of offline errors and cases of incorrect quarantine. The practical and legal implications of supplying a substandard or falsified medicine during offline periods without prior authentication or withholding supply until online status resumes are not yet fully understood.
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