2SPD-021 Noncompliance of datamatrix codes, an obstacle to implementation of the falsified medicines directive
2019
Background To reduce counterfeit drugs, the serialisation will become mandatory on 9 February 2019. A DataMatrix code will be used to encode each secondary packaging. This 2D barcode makes it possible to indicate an important number of traceability data in a small area. The technical characteristics of DataMatrix codes were defined in standard ISO/CEI 16022:2006. Our university hospital is equipped with an automated storage and dispensing system of drugs. Unfortunately, this automat is not able to read the totality of Datamatrix codes. This obliges us to store manually in the automat the products concerned, which increases the duration of reception and the labour cost. Purpose The purpose of this work is to identify the medicines for which the datamatrix code cannot be read by the automaton and the causes of this problem. Material and methods In our hospital, a total of 2107 references need to be serialised, including 1252 references stored in our automat. From June 2018 to September 2018, the products concerned by the impossibility of reading the codes, the laboratories involved and the causes of illegibility were compiled. Results During the period of collection, 107 products from 23 providers have presented a problem of legibility. This represented 8.5% of products stored in the automat. The problem has always been the black colour of the background. Conclusion Only one cause of noncompliance was identified, but we should note that our enquiry is not a comprehensive collection of data because we did not receive all the medicines referenced during the mentioned period. We imagine that other problems could be encountered such as too small Datamatrix codes or shiny backgrounds. A solution could be the change of reader heads of our automat but this represents an important investment. The second part of this work will consist in collaboration between pharmacist buyers, pharmaceutical laboratories and equipment manufacturers to encourage the standardisation of the datamatrix codes in order to facilitate compliance with the Falsified Medicines Directive. References and/or acknowledgements Thank you to storekeepers. No conflict of interest.
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