Working within the FMD
The EU FMD project is designed to ensure that only genuine prescription drugs can be dispensed. The authorised manufacturer seals the packet and affixes a unique code. At the point of dispense that code is checked and if valid and not already decommissioned the drug can be dispensed. The process is not designed for track and trace so how and why are the middle traders such as wholesalers involved in the process?
Each product will have a unique id and that will be linked to information on the FMD verification system. This will include medical information about the product but also specify its approved supply chain. There will be details of wholesalers and other distributors that are strongly linked with the original manufacturer. Article 33 section 2(h) of the FMD legislation clarifies that the product identifier is linked to; ‘a list of wholesalers who are designated by the marketing authorisation holder, by means of a written contract, to store and distribute the products covered by his marketing authorisation on his behalf’. These organisations are trusted by the manufacturer and would not be expected to verify every prescription drug that passes through their systems.
Other suppliers are required to verify products as they are received. An example business model might buy surplus heavily discounted product from a pharmacy chain or ‘approved’ wholesaler and later sell the product on to other wholesalers or dispensers at a price that is still below the market value. This business will probably already sort the stock by product and batch (or lot) as it is booked in. Wholesaler access to the NMVO allows a combined file of codes with the same product, expiry date and batch to be uploaded as a single operation. This could be more convenient than scanning and checking the packs one at a time as it does not rely on a live connection to the NMVO. The subsequent file upload operation does incur a time lag before the results are returned. If products are to be scanned to a local system before verifying with the NMVO procedures need to be in place to find any specific pack within the batch after the NMVO reply comes back. Although it would be expected that the overwhelming majority of packs will pass verification and the few failures would be for a whole batch there is the possibility of a small part of a batch failing. Those specific packs will need to be tracked down and removed from the immediate supply chain.
Verification by wholesalers outside the ‘official’ supply chain is a legal requirement but it also makes commercial sense. If packs were to arrive at a dispenser and were to fail verification they might be returned without payment and the customer might look to other suppliers in future.
A wholesaler is able to conduct other operations beside verification. The full list is verification or decommission and label as ‘dispense’, ‘destroy’, ‘export’, ‘sample’, ‘free sample’, ‘lock’ or ‘stolen’. These can all be achieved on a pack by pack basis or as a bulk operation of packs with the same product code, expiry date and batch number. The ‘destroy’ and ‘stolen’ states are irreversible. The other states can be undone but only by the same NMVO account holder that made the original decommission. The ‘export’ state would probably apply to exporting outside the area covered by the FMD. Within the FMD countries a pack might have a code that is valid for more than one market or a specialised parallel distributor will be able to change the pack code from that valid for one country to that used by another.
A decommissioned pack cannot be subsequently dispensed so is of limited monetary value to the wholesaler. The ‘sample’ and ‘export’ states assume that some payment has previously taken place. There are cases where the wholesaler may legitimately dispense packs and still sell them on. This is where the body supplied needs to provide drugs to patients but does not deal directly with a pharmacist. This is covered by ‘Article 23’of the FMD legislation. It relates to persons authorised to supply medicines to the public who do not operate within a healthcare institution or a pharmacy. Examples would include prisons, care homes, dentists and veterinary surgeons. The wholesaler is supplying already decommissioned drugs to bodies who are allowed to issue them but not able to connect to the NMVO itself. Each body involved with the FMD process needs specific log on credentials to send and receive data. The number of pharmacies alone is significant and it is not surprising that some cap has been put on who needs access to the FMD system. Some of these ‘Article 23’ entities will deal with relatively small quantities of prescription drugs and the trade-off of volume of traffic to number of end points will be worthwhile.
It has been stated that the FMD system is not track and trace but each transaction with the NMVO is recorded and linked to a time and the initiator of that event. This information is currently used to warn a user when a product is dispensed twice by the same user. It also allows a body to undo actions such as ‘dispense’ that it made itself. A different user cannot undo an action made by the first. Finally the transaction ids of data scanned to file then uploaded to the NMVO are used to find the results of that upload transaction. The file is first uploaded; an acknowledgement sent then the reference of that acknowledgement is used to report on the verification status details of that file. Although not designed to track, this information might be used to discover who read or changed details of any specific pack and when. There are data privacy issues here with who should be allowed access to this information but it might prove useful where criminal activity is suspect.
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