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

Abstract

ObjectivesThis study aims to establish expert opinion and potential improvements for the Falsified Medicines Directive mandated medicines authentication technology.Design and interventionA two-round Delphi method study using an online questionnaire.SettingLarge National Health Service (NHS) foundation trust teaching hospital.ParticipantsSecondary care pharmacists and accredited checking technicians.Primary outcome measuresSeven-point rating scale answers which reached a consensus of 70–80% with a standard deviation (SD) of <1.0. Likert scale questions which reached a consensus of 70–80%, a SD of <1.0 and classified as important according to study criteria.ResultsConsensus expert opinion has described database cross-checking technology as quick and user friendly and suggested the inclusion of an audio signal to further support the detection of counterfeit medicines in secondary care (70% consensus, 0.9 SD); other important consensus with a SD of <1.0 included reviewing the colour and information in warning pop up screens to ensure they were not mistaken for the ‘already dispensed here’ pop up, encouraging the dispenser/checker to act on the warnings and making it mandatory to complete an ‘action taken’ documentation process to improve the quarantine of potentially counterfeit, expired or recalled medicines.ConclusionsThis paper informs key opinion leaders and decision makers as to the positives and negatives of medicines authentication technology from an operator's perspective and suggests the adjustments which may be required to improve operator compliance and the detection of counterfeit medicines in the secondary care sector.

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

“…Here, we would like to stress the fact that GAP can be helpful in the successful implementation of a new framework for hospital pharmacies [ 17 , 25 ]. In line with GAP, our study suggested that the most desirable authentication should be provided by hospital pharmacists or technicians, at the final step of dispensing medications.…”

Medicine authentication technology: a quantitative study of incorrect quarantine, average response times and offline issues in a hospital setting

“…The Naughton et al 201613 study methodology was then repeated under near-identical conditions with one alteration to the MA technology. This change involved the inclusion of an audio alert which was suggested by study participants as part of a Delphi-method study 14. This audio alert sounded upon the authentication of a falsified medicine (authenticated elsewhere) or a substandard medicine (expired or recalled).…”

Falsified drugs as a challenge to public health - an attempt to define the concept and scale of the phenomenon in the world as well as legal and sociological approach

“…Badanie metodą Delphi przeprowadzone przez Naughtona i wsp. wykazało, że eksperci oczekują jasnej informacji przekazywanej podczas dyspensowania -połączenia alertu dźwiękowego i graficznego, przejrzystej szaty graficznej minimalizującej ryzyko pomyłki i przeoczenia komunikatu [13]. Badania testowe wykazały, że nawet przy w pełni spełnionych wymaganiach technicznych opisanych przez ustawodawcę, co do dokładności, precyzji i szybkości serializacji oraz przy poprawnym wyświetlaniu komunikatów i niezawodności oprogramowania i urządzeń do serializacji, rzeczywista detekcja leków sfałszowanych, wycofanych i przeterminowanych nie przekroczyła 90% [14,15].…”