The EU Falsified Medicines Directive will introduce major changes for community pharmacists across the UK when its requirements for medicines verification are introduced from 9th February 2019. This page explains what community pharmacists and their teams will have to do.
Under FMD, all new packs of prescription medicines placed on the market in Europe from 9th February 2019 onwards will have to bear two safety features: a unique identifier (UI) in the form of a 2D data matrix (barcode) and an anti-tampering device (ATD). In order to reduce the risk of falsified medicines reaching patients, community pharmacies (and others “authorised to supply medicines to the public”) will have to authenticate each pack as part of the dispensing process before the medicine is supplied.
Authentication has two parts – checking the anti-tampering device and verifying the UI:
- Checking the ATD A visual check is made of the ATD at the start of the dispensing process. There are many different forms of ATD (such as labels, glues or shrink-wraps) to take account of. The ATD can be broken, if necessary, when the medicine is assembled or if the pack is to be split, as long as it was intact when originally checked.
- Verification of UI The UI is scanned and the information is checked against data held on a National Medicines Verification System. If the data matches, a confirmation message will be returned. The dispenser will then send another message to the NMVS to change the status of the UI to show that it has been dispensed. These two operations may take place simultaneously.
Community pharmacy contractors will have to ensure that all their pharmacies are connected to the UK Medicines Verification System to do this, as well as have having updated software and hardware (scanners) as needed.
Standard operating procedures will need to be changed to ensure that all relevant prescription medicines are authenticated and decommissioned during the dispensing process, prior to hand-over to patients. Processes will be needed to deal with any unexpected results (such as product recalls), where necessary.
Pharmacies will be required to authenticate products “at the time of supplying it to the public”. At the time of supply is not an instant but a period of time, from when a pack is picked, to when the patient (or their representative) has the pack. The ATD check must take place during that period, as must the decommissioning. It may be that during assembly, the barcodes are scanned and linked to an aggregated barcode placed on the dispensing bag. Decommissioning can then be accomplished by scanning the aggregated barcode before hand-over to the patient (or their representative).
The precise process will depend on each contractor’s SOPs and may vary depending on whether the patient (or their representative) is present or not. It is important to note that the check of the ATD and the decommissioning scan may occur at different points in that process. Decommissioning should happen as close to the time of supply to the patient as possible, but there are other important considerations, for example disruption to the dispensing workflow could jeopardise patient safety and emptying out bags to scan packs in front of the patient could compromise patient privacy and poses problems if any pack fails to authenticate for any reason.
“Aggregated codes” and the “10-day rule”
One way in which the authentication process could be handled is by using “aggregated codes”. This would involve associating the UIs of multiple packs or items with a single code which would be printed on a label attached to the dispensing bag, perhaps as part of the address labels commonly used today. Products would be scanned and verified during assembly, then, at the final hand-over to the patient or representative, the aggregated code would be scanned and this would trigger a message to change the status of all the products to show that they had been “decommissioned” or dispensed.
Once a product has been decommissioned, there is only a fairly short period – 10 days – in which this can be reversed. The process of reversing the status has to take place in the same location, i.e. within the same pharmacy, as the initial decommissioning and the product must not have been supplied to a patient, expired or been recalled during that time. Using aggregated codes would be one way of avoiding having to reverse too many decommissioned products, or having stock that cannot be reused.
The transition of product compliance with FMD
The EU Delegated Regulation only applies to new stocks of products released to the market on or after 9th February 2019. Older packs do not have to be withdrawn and can still be supplied to patients after this date. Manufacturers are beginning to change production to incorporate the new 2D data matrix barcodes on their packs but it is expected that there will still be a considerable volume of older products in stock and in the supply chain and a long transition period is expected.
Levels of FMD-compliant stock will increase over time and the amount of verification, authentication and decommissioning to be carried out in pharmacies will increase in proportion until all stock is fully compliant.
At the time FMD comes into force, there may be existing products in the system that bear 2D data matrix barcodes but which have not had their unique identifier data uploaded in to the verification system, or where data uploads take place retrospectively. Pharmacy teams will need to take care in dispensing these products.
Special forms of dispensing
Community pharmacies supply medicines to patients in many forms. All of these will have to be adapted to cope with the requirements of FMD. This includes preparing Monitored Dosage Systems and other compliance aids.
Where medicines need to be taken out of their original packs prior to being supplied to patients, then authentication will need to take place at the start of the process. So, for example, when MDS trays are being prepared, each pack will need to be authenticated and decommissioned at that point. There will not be a further requirement to authenticate the finished tray.
If a pack needs to be opened during assembly, such as when reconstituting, then it will be necessary to examine the ATD before this happens. Pharmacy staff may need to explain to the patient why the seal is not intact. Medicines regulators discourage the use of phrases such as “Do not use if seal is broken” on medicines packaging, recognising that pharmacists may have to open packs for different reasons.
FMD does, at the UK Government’s request, contain provisions for splitting packs. Here again the authentication must take place when the pack is first used. There is no requirement to re-authenticate the remainder of a pack when it is subsequently used.
Specials and other one-off products are outside the scope of FMD as they are not part of the marketing authorisation (licensing) system. However, any licensed products that are used in their production will need to be authenticated before they are first used.
Centralised or “hub-and-spoke” operations for assembling prescriptions are not specifically excluded by FMD, but clarity will be needed on where and when authentication checks take place. It may be that anti-tampering devices are examined during assembly and that “aggregated codes”, as mentioned above, will be used for the final verification and decommissioning.
Returning medicines to wholesalers
Pharmacies will still be able to return medicines to wholesalers in line with agreed timescales and commercial arrangements, but it should be noted that, under FMD, wholesalers have an obligation to verify all relevant medicines returned to them. They will need to check that these products still have an “active” status before accepting them back in to their own stock.
In light of the requirement that packs must have their ATDs checked before they are supplied to patients, it is unlikely that wholesalers will accept returns where the ATD is damaged, unless the product is subject to a specific recall.
Making use of FMD data
There are two forms of FMD data that pharmacy owners will be able to make use of. The first is the “hard data” which will be printed on each pack, and encoded in the machine-readable 2D data matrix. This includes information on the product (name, strength, form, etc.) and the batch/expiry data. These should prove useful for stock control, re-ordering, accuracy checking and expiry date checking, for example, and this data can be read and used at any time without a live link to the national verification system.
The second part is the status of the UI that is held within the verification system. This lies at the heart of the authentication system and requires a live link. This data can be used any time that a product is scanned and will give updates on whether products are subject to a withdrawal or recall, for example.
There is flexibility within FMD for national governments to use this data for reimbursement purposes, as well as for pharmacovigilance (drug safety) and pharmacoepidemiology (drug use in populations), however the UK Government has indicated that it does not see any current need to use the data for reimbursement purposes.
There is also no requirement that pharmacists have to add details of each UI into individual patient records. Although there are some perceived advantages, especially in facilitating patient-level recalls, adding to records in this way would require major changes to pharmacy software.
Both the Directive and the governing principles of the European Medicines Verification Organisation, which runs the European hub and oversees FMD, state very clearly that data security and data privacy have the highest priority.
Data is owned by the party that generates it, and it cannot be used or shared with other parties without explicit consent (other than for investigating suspected incidents of falsification).
It is not possible for manufacturers to see where or when a pack is verified or dispensed. FMD has not been designed as a “track-and-trace” system and it does not maintain any central log of where each and every pack of medicine is at any given time. It is based on a “book-end” model, with UI data being uploaded at the start by manufacturers and these being decommissioned or checked out one at a time during dispensing, predominantly by community pharmacies. What happens in between is not recorded.