Track & Trace: Still ongoing issues

Recommendation

5/6 June 2024

GMP for Cannabis – what you need to know - Live Online Conference
All relevant GMP/GDP/GACP aspects for Medical Cannabis

For roughly half a year now, manufacturers have only been allowed to enter medical products (which are subject to verification) into the market if they bear the new safety features; this includes the 2D code. So far, however, this has hardly worked out anywhere: many issues arose, the project has not been properly adapted EU-wide and discontentment is spreading amongst pharmacists.

Ongoing issues

• In Germany, where everything had been tested extensively beforehand, there are issues concerning the accessibility of the database. There are frequent error messages, and as of right now, the original purpose of protecting the supply chain from falsifications cannot be fulfilled (see also: "Safety Features - how is it progressing?"). In case of a temporary failure in the system at the time of administration, pharmacists are instructed to dispense a medical product and perform the verification and decommissioning manually as soon as the error has been eliminated (to that end, the serial number and product code must be noted down, or the 2D code must be photographed). This, however, proved to be anything but practical.
• In France, pharmacies have only just been connected to the system.
• It may occur that a scanner cannot read a 2D code even though it works smoothly when scanning other medicinal products. Despite apparently correctly printed, the 2D code is not or not fully legible.
• There were cases where the information from the conventional bar code and the 2D code did not match (e.g. regarding the package content). This may lead to recalls on wholesale level.
• The system appears to be overstrained with large data sets when uploading large data volumes into the database (e.g. when uploading large batch-sizes of a serialised drug).

Conclusion: right now, these issues and deviations are "accepted", i.a. because there is a need of these medicinal products. However, the pharmacist's daily routine is made considerably more difficult since error messages necessitate time-consuming communication (i.a. with SecurPharm and the drug manufacturers) and documentation, amongst other things.