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, 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 (ATD) and verifying the unique identifier (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 and decommissioning of the UI – The UI is scanned and the information is checked against data held on the UK hub. If the data matches, a confirmation message will be returned; this is known as verification. The pharmacy will then send another message to the UK hub to change the status of the UI to show that it has been dispensed; this is known as decommissioning the product. These two operations may take place simultaneously.
Verification can be undertaken on multiple occasions, for example, when a pharmacy receives an order from their wholesaler.
Community pharmacy contractors will have to ensure that all their pharmacies are connected to the UK hub to do this, as well as having appropriate software and hardware (scanners).
Standard operating procedures will need to be changed to ensure that all relevant prescription medicines are verified 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 selected, to when the patient (or their representative) receives the pack. The ATD check must take place during that period, as must the verification and decommissioning. It may be that during assembly, the UI 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 in the pharmacy 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.
The “10-day rule”
Once a product has been decommissioned, its status in the UK hub can be reversed to active where the product has not been supplied to a patient. However, this can only happen within 10 days of the product being decommissioned; this is known as the 10-day rule.
The process of reversing the status (recommissioning) 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.
Once a product has been decommissioned, if the patient does not collect the medicine, it cannot be supplied to another patient in due course. Consequently, if a pharmacy decommissions products at the point of dispensing, but the patient does not immediately collect the medicine, there is a risk that any subsequently uncollected medicine cannot be issued to another patient in due course, unless the product is recommissioned within the 10-day period.
This means that decommissioning products at the time of dispensing is not likely to be a workable option for most pharmacies. One way in which the authentication process can be handled is by using an FMD system which stores the UIs of multiple packs or items dispensed on a prescription and associates this data with a single code which would be printed on a label attached to the dispensing bag. Using this approach, products would be scanned and verified during assembly, then, at the final hand-over to the patient or representative, the single code on the dispensing bag would be scanned and this would trigger the decommissioning of the products on the UK hub.
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 should still be supplied to patients after this date. Manufacturers are changing production to incorporate the new 2D data matrix barcodes on their packs, but there will still be a considerable volume of older products in stock and in the supply chain in February 2019, so a long transition period is expected before the time when all products being supplied to patients include UIs.
Levels of FMD-compliant stock will increase over time and the amount of verification 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 to the UK hub, or where data uploads take place retrospectively. A presentation is available to help train pharmacy teams to recognise the types of packs that will need scanning for verification and decommissioning, and the features they need to look out for, as well as the types of pack that will not need authentication.
Special forms of dispensing, split packs and delivery of prescriptions
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 (MDS) and other compliance aids.
Where medicines need to be taken out of their original packs prior to being supplied to patients, 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 verified 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 antibiotic mixtures, 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 careful consideration will need to be given on where and when authentication checks take place. It may be that anti-tampering devices are examined during assembly and that UI data is stored by the IT system for the final verification and decommissioning when the prescription is handed to the patient or their representative at the spoke pharmacy.
Where prescriptions are to be delivered to the patient, it is suggested that the medicines are decommissioned at the point that they are handed to the delivery driver or courier.
Returning medicines to wholesalers
Pharmacies will still be able to return medicines to wholesalers in line with agreed timescales and commercial arrangements, but 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 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 UK hub.
The second set of data is the status of the UI that is held within the UK hub. 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 potential advantages, especially in facilitating patient-level recalls, adding to records in this way would require changes to PMR 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. What happens in between is not recorded.
The benefits of FMD
Beyond the benefit of identification of falsified medicines, FMD and its implementation has other potential benefits for pharmacy teams:
- Improved accuracy checking of items being dispensed. An integrated FMD system that allows prescribed items to be compared to the scanned items being dispensed could reduce the number of dispensing errors, particularly look alike, sound alike (LASA) errors;
- Date checking of all items being dispensed, which should prevent any out of date products being dispensed. FMD systems may also be able to be configured to alert pharmacy staff when products with short expiry dates are being dispensed;
- Easier management of stock recalls, potentially at patient level if the UI for the supplied product is stored in the individual PMR record for the patient;
- During implementation of FMD, an opportunity to review the dispensing process and any changes which could be made to optimise its efficiency; and
- Pharmacy stock management – if products are scanned into the pharmacy system when they are received from the wholesaler, FMD could support stock management and could also reduce or remove the need for manual date checking of dispensary stock.
Enforcement and sanctions for non-compliance
The Department of Health and Social Care (DHSC) has been clear that appropriate sanctions are required in order to make the FMD provisions enforceable in the
UK, and are important in acting as a deterrent to behaviour that would put public
health at risk.
In July 2018, DHSC and MHRA launched a consultation on some aspects of implementing FMD in the UK, which contained a section on sanctions for non-compliance. The consultation closed in September, and the MHRA published the following document which provides their official response to the more than 50 replies received from a wide range of stakeholders.
Overall, the responses broadly supported the Government’s proposed positions regarding the level of sanctions imposed, therefore, the Government intends to implement as per the positions proposed in their consultation document:
- the General Pharmaceutical Council/Pharmaceutical Society of Northern Ireland will use their existing inspection processes to assess whether pharmacies are meeting their standards;
- the MHRA is responsible for making decisions on and instigating any enforcement action in relation to the FMD legislation. It will work with the General Pharmaceutical Council/Pharmaceutical Society of Northern Ireland to help bring organisations into compliance. Where necessary, MHRA will use a phased approach with noncriminal enforcement measures, such as a formal written warning or suspension or revocation of a licence to practice, before any criminal proceedings are considered;
- The Government will introduce statutory ‘enforcement notices’ for breaches of the requirements around supplying medicines to the public. These must be issued before criminal proceedings can be considered against persons supplying medicines to the public. This provides reassurance that criminal prosecution would only be considered as a last resort.
The MHRA and General Pharmaceutical Council (GPhC) have published a joint statement on their respective roles in relation to the enforcement of the FMD legislation in England, Scotland and Wales.