EU FMD: FACILITATING FMD IN THE WORK PLACE
From 9th February 2019 all dispensers of prescription medicines have been required to validate the unique identification codes on each packet before issuing them. This code is present as a 2D barcode and in clear text. The packing will also involve a tamper-proof seal. If this seal has been interfered with the contents cannot be trusted and must not be dispensed.
The codes are used to decommission each individual packet preventing the same packet (or an illegal clone of it) being dispensed twice.
Approved bodies will be able to scan in pack codes and use software such as Serialogical’s approved solutions to send that data for verification or dispensing. Serialogical offer advice and proven solutions to minimise the volume of scans required to comply with FMD.
We maintain a support forum for our software. Access to the latest version of our software is available to registered users. It will run on a Windows (8 or 10) computer with an attached (USB or wireless) scanner. Connection to the verification database is secure, data transfers are encrypted and identities checked ensuring that communications are protected and recipients can be trusted.
We provide a user-friendly interface that will scan in the pack data (also including the batch number and expiry date), transmit the information to the verifying authority and report on the status of the packet. We can customise the interface colours and logo to match the user’s corporate ‘look and feel’.
In the event of a connection to the verifying authority not being available data can be scanned and stored locally for subsequent processing. The wholesaler can upload an entire batch of a single product as a single action for verification or decommissioning.
If goods are received direct from the manufacturer or from their approved supplier the wholesaler is not required to verify those goods. In all other cases the wholesaler is expected to verify their stock. They will also need to decommission some stock for example as export or to destroy packs that are no longer fit for market. Serialogical software supports uploading a CSV file of codes from the same product, batch and expiry but varying serial numbers. This file format compatible with software such as NotePad, Excel and many stock and accounting solutions. Our software also allows exporting packs as they are scanned to a CSV file. This can accompany orders leaving the wholesaler and offering a market advantage over companies whose deliveries need to be verified through scanning every single pack. Serialogical are working with wholesalers to agree on a de facto standard for bulk files. We encourage suppliers to provide access to FMD codes as computer files or summary barcode sheets with physical shipments. Until an industry wide standard is adopted we can provide solutions to convert file formats to optimise their use in FMD and minimise individual pack scans.
A pharmacist is required to verify and decommission prescription drugs at the point of dispense. The decommission process includes verification but if the goods fail verification at the point of dispense they cannot be dispensed. The implications to the pharmacist and patient are obvious. A preferred solution is to verify the goods before they are dispensed then decommission at the time of dispensing. There is a 10 day window during which a body may undispense goods but only the same body that dispensed the goods may undispense them. Some other decommission activitives are reversible but setting to destroy or stolen cannot be undone. The pharmacist can avoid the double scanning (verify, store, dispense) by scanning codes into a ‘virtual presecription bag’. Packs are verified as they are put into a physical bag. The Serialogical PR software will only allow packs that register as active to be placed in the linked ‘virtual bag’. When the goods are dispensed the dispenser calls up the ‘virtual bag’ reference on our software and the ‘virtual bag’ contents are dispensed as a set, the individual packs do not need scanning again. The dispenser still needs to check the results of dispensing as it is possible that a pack may be recalled or otherwise become inactive between bagging and dispensing.
The software and connection issues of FMD have been solved but the best way to implement FMD in the workplace is still a work in progress. Different bodies will require different solutions. With our experience in developing FMD solutions Serialogical can offer trusted advice on FMD implementation. We know how FMD works under the hood and hence what can or cannot be done within the system.
Local data from scans are stored as plain CSV files or in a database structure. Import and export options enable our verification solution to be configured and extended to integrate with stock control systems and maintain an up-to-the-minute accurate record of verified, commissioned, decommissioned status of product packs.
Serialogical was one of the first companies in the UK to begin FMD development. We have worked through 3 changes in the NMVS portal before FMD went live in February 2019.
Initially the FMD code consisted of 4 elements. A 5th element (the NHRN) is now being implemented in Germany, France, Spain and Portugal. The code is not yet required in the UK. At present it is not possible to upload the NHRN data from UK packs but Serialogical software is able to read and display the NHRN data (if present) in UK packs.
We envisage further changes as the NMVS bring on new features. Serialogical are committed to keeping their software in line with NMVS developments.