Falsified Medicines Directive

mixture-of-tablets-resize1417x710

Introduction

The EU Falsified Medicines Directive (FMD) legislation aims to create a system that ensures medicines supplied in the UK are safe. It ensures the trade in medicines is controlled to reduce the risk of fake medicines entering the medicines supply chain and reaching patients.

Delegated Regulation to the FMD will come into force from 9 February 2019. This will include new security features on individual packs and a new electronic scanning authentication process to be undertaken at the point of dispensing.

Security features required on medicinal pack

Scanning authentication process

The FMD system requires UI data from packs to be uploaded by manufacturers onto a central European hub. The data can then be accessed by a national system (National Medicines Verification System (NMVS)to enable the process of verification and authentication of packs by pharmacy teams. Further information and a visual representation of the system including data upload, verification and decommissioning requirements in the supply chain can be found on the FMD Source website.

What does FMD apply to?

 FMD does apply to:

 FMD doesn't apply to:

  • Prescription Only Medicines (POMs) for human use (except those listed in  Annex 1 of the Delegated Regulation)
  • NHS and Private supplies
  • Over the counter medicines (except those listed in Annex 2 of the Delegated Regulation)
  • Medical devices
  • Specials
  • Veterinary medicines 

 

  Member only content

Only Royal Pharmaceutical Society members can view this content.

Join today Login

Professional decision-making guidance for FMD alerts and dispensing

If there is an issue with a pack during the verification step, the NMVS will flag this up and provide a message with a reason why. The guidance below provides possible error messages you may get and what you should do about them. 

Remember, the wording may vary from system to system, so you'll need to contact your IT system supplier and consult the IT systems manual for your systems responses.

Click on the guide below (from the drop-down menu) to find out more.

Professional decision-making guidance for FMD alerts and dispensing Professional decision-making guidance for FMD alerts and dispensing

Green Green

Alert

Action

Positive scan

It is assumed that virtually all stock being verified and/or decommissioned will produce a positive response from the NMVS. It is also assumed that virtually all products will pass a visual inspection of their anti-tampering devices. Such products can be dispensed and supplied as normal.

 

Amber Amber

Alert

Action

Fails to scan due to damage

A small number of packs may fail to scan because of damage to the 2D data matrix containing the unique identifier. These packs can still be dispensed if:

The human-readable elements of the unique identifier are still present, can be read and, following input via the manual data entry process for the NMVS, give a positive response

The end user is satisfied that any damage to the 2D data matrix has not been caused by tampering (normally because the cause of the damage is obvious or known to them)

Damaged packs should only be returned to wholesalers or suppliers for credit where this has been agreed within normal terms of business.

Scan returns “unknown pack” message

Many existing packs would fail to scan (or produce an “unknown pack” response) because they are either out-of-scope for FMD (non-prescription products, medical devices, specials, non-medicines) or are pre-existing stock without compliant safety features. These products do not require verification and can be dispensed and supplied as normal as long as they are still within their expiry date. Such products should NOT be returned to wholesalers or suppliers as to do so risks clogging up the pathway for medicines that need to be returned for legitimate reasons. Staff should receive suitable training so that they know how to identify and handle such packs. They should not simply just quarantine them as this could delay handing products over to patients who need them.

Red Red

Pack produces a warning generated by local system

These warnings can be generated in response to data held within a unique identifier 2D data matrix (e.g., expiry data) or in response to end user operator actions (e.g., double scans of same pack). They do not require a live connection to the NMVS at the time of scanning to generate a warning, however the NMVS will also generate an alert message, when or if connected, if the relevant conditions are met.

Alert

Action

Out of date

Packs that have passed their expiry date should not normally be dispensed or used, unless there are exceptional circumstances covered by a local or national policy agreed by relevant clinical professionals and management. This is not a new scenario and existing procedures should be followed.

Double scan

A double scan occurs when the same pack is scanned more than once at the same location, often in quick succession. Operators should acknowledge any warnings generated by their local systems. These packs can still be dispensed and supplied in the normal way. Repeated generation of double scan warnings is an indication of poor operational design and/or implementation and should prompt a review of processes and operator training or guidance. Local operational solutions can be put in place to minimise quick-succession double scans.

In order to minimise double scan warnings, processes should be put in place to ensure that packs which are split or opened during dispensing or assembly are not accidentally rescanned. This could include obscuring the 2D data matrix with a suitable sticker or heavy marker pen. Where packs are to be split or opened, they should be verified, and the anti-tampering device inspected before opening as opened packs cannot be recommissioned or returned.

Visual training guides that distinguish between “right” and “wrong” products in order to minimise scanning errors are available on FMD Source (www.fmdsource.co.uk) and may also be provided by other bodies, including end user organisations, systems suppliers, NMVOs and trade associations.

It is suggested that there should be a clear separation between packs that are expected to be active (i.e., saleable or dispensing stock on shelves), those packs which are inactive because they have been decommissioned (i.e., dispensed items awaiting collection, split packs, packs awaiting recommissioning) and packs with an uncertain status (i.e., “sin bin” or returns awaiting verification).

Alerts generated by NMVS

These alerts are generated when UI data from packs is compared with the data and status information held on NMVS. They require a live connection to the NMVS.

Alert

Action

Recalled or withdrawn

Packs that have been recalled (normally at a batch level) or withdrawn (permanent removal of all packs from the market) should not be supplied or dispensed, unless otherwise indicated in relevant recall guidance or notice. These alerts indicate a serious level of concern for patient safety around these packs or products initiated by the manufacturer and/or regulatory authorities. You should obtain and follow any specific guidance notes. Normal procedures for return or disposal of packs should be followed, as indicated in any recall advice issued by regulators. Specialist guidance issued by appropriate expert groups should be consulted before considering dispensing such packs in exceptional circumstances and advice sought from relevant clinical colleagues. You are advised to document any decisions made.

Status errors

Packs marked as “stolen”, “sample (not for commercial sale)”, “free sample”, “exported from EU”, “for destruction” or “checked-out” (part of the parallel import process) should not be in circulation in the supply chain. These packs should not be supplied or dispensed. Overriding status error messages of this kind would not normally be considered reasonable professional behaviour unless there were extreme extenuating circumstances clearly covered by an agreed internal policy document.

Other than “stolen”, packs being marked in this way through the NMVS should be physically isolated and used only for the indicated purpose. Any packs marked by manufacturers or wholesalers as “stolen” that reach end users should be quarantined and reported to the NCA (see “FMD error and alert messages guidance notes”).

Data errors

Scanning of 2D data matrix codes may return “unknown pack” or “no matching data” errors if the pack in question is out-of-scope for FMD (non-prescription products, medical devices, specials, non-medicines) or because they are pre-existing stock for which no relevant UI data was uploaded to the NMVS. These packs can still be supplied or dispensed as normal, as long as they meet all other relevant requirements (e.g., not yet expired). They should NOT be returned to wholesalers or suppliers unless this is specifically requested.

“Unknown packs” are likely to be very common during the initial phase of FMD authentication as only low levels of fully-compliant products will be present in the supply chain to start with. Levels of compliant stock will increase as new packs are released to the market.

Manufacturers are required to ensure that the data for all unique identifier fields (product information, serialisation, batch, expiry) is encoded in to the 2D data matrix barcodes that are printed on to packaging. The same information should be present in human-readable form (space permitting). Barcodes should be read back and confirmed during manufacturing and packing. Packs that fail at this stage should not be released to the market.

As such, packs that return alert messages because they have data gaps or missing information fields should not be supplied or dispensed as these are not compliant with FMD. Improper coding, including the use of non-permitted characters, may indicate falsification. Any such packs should be quarantined and reported to the NCA (see “FMD error and alert messages guidance notes”).

Already used

The entire FMD system is set up on the presumption that, in time, all relevant packs across the European market will carry individual and unique identifiers. The system is designed to identify any duplication of identifiers and to treat this as evidence that the packs in question may be falsified ones. As such, for packs that return an “already used” alert (whether referring to use at another location in the same EU/EEA market or a different one) the presumption is that they should not be supplied or dispensed. Any such packs should be quarantined and reported to the NCA (see “FMD error and alert messages guidance notes”).

In particular, it would be unreasonable to use a pack producing an alert message if other packs that pass verification are available to hand.

However, there may be extenuating circumstances, particularly in specialist treatment areas, where no other stock is easily available or no alternative treatment could easily be arranged. Pharmacy professionals would need to weigh up the risks to patients of being unable to supply or administer a product promptly. The design of the FMD system means that it is possible that the pack they hold is genuine and it was the other pack (or packs) that may be falsified.

Other circumstances, including the security of the supply chain (e.g., whether the product was purchased directly from a manufacturer or their agent) and a lack of any other indication that the product might have been tampered with would need to be considered. As well as local policies, specialist guidance issued by appropriate expert groups should be consulted before considering dispensing such packs in exceptional circumstances and advice sought from relevant clinical colleagues.

Any decision to supply or administer a product that has failed an FMD verification check should be carefully documented at the time, including the reasoning that led to the decision, and notified to relevant senior managers within the organisation.

Pack locked

Packs can have their status set to “locked” on a temporary basis. Only manufacturers and wholesalers can do (and undo) this. Processes should be put in place to ensure these packs do not reach dispensing points. Such packs should not be supplied or dispensed and, if found, should be returned to the relevant wholesaler or supplier.

Other IT system & connection issues Other IT system & connection issues

There may be occasions when end user connections to the NMVS are temporarily lost. This may result from local IT or infrastructure failures (power cuts) or problems with national or organisation infrastructure. In the first instance, end users should contact the support teams for their own organisation and/or their IT suppliers. End users should not normally have to contact the NMVO (SecurMed UK) directly.

End user organisations should adapt their existing business continuity plans to take account of the requirements of FMD, including the caching of information pending reconnection. This should include guidance on decisions as to whether it is appropriate to continue making supplies of products during a period when NMVS connection has been lost and, if so, what processes are in place to deal retrospectively with any packs that might fail a verification check once connection is restored. Pharmacy professionals have a duty of care to their patients and would have to make reasonable efforts to contact patients or retrieve packs, if deemed necessary and a supply has already been made, depending on the nature of the alert raised.

Any decision to continue supplying or dispensing FMD-compliant packs during a prolonged loss of NMVS connection should be carefully documented at the time, including the reasoning that led to the decision and any subsequent actions, and notified to relevant senior managers within the organisation.

Acknowledgement Acknowledgement

We would like to thank Jonathan Buisson MFRPSII MRPharmS for his contribution to the Professional decision-making guidance for FMD alerts and dispensing.

Learn more about FMD

Gino Martini, RPS' Chief Scientist, will discuss FMD further at our Science and Research Summit on 8 February.

Get your tickets for the Science & Research Summit

Acknowledgements

We would like to thank the MHRA FMD Implementation Group, RPS Standards Team and the RPS Professional Support Team for their contribution towards this pharmacy guide.

Whatever matters most to you in 2019, we’re here to help.