FMD in a nutshell

Introduction to the Falsified Medicines Directive

The introduction of the Falsified Medicines Directive (FMD) is intended to increase security in the pharmaceutical supply chain. The Directive requires pharmaceutical manufacturers to label pharmaceutical packages in order to make counterfeiting more difficult. For this purpose, each individual package is marked and given an individual number. With this individual number, the package can be identified throughout its entire lifetime. The number is printed on the package and can be read automatically.

Here is a fictitious example for demonstration purposes:    

The combination of the product code (PC) – also known as the  GTIN number – 0107777777818369 and the serial number (SN) 74EGDMMF8NWC is unique worldwide and identifies this specific individual pack of medicine. The batch number (BN) – also known as the Lot – 12 and the expiry date (Exp) 20.12.31 are also included. All these data are stored in the 2D matrix code; when this code is scanned, the four data elements are captured by the scanner and sent to the national database, known as the National Medicine Verification System (NMVS), for checking.

It is mandatory for participants in the pharmaceutical supply chain to scan the 2D matrix codes on the medicine packs and to check them via the NMVS.

Community pharmacies, hospital pharmacies and wholesalers have specific FMD tasks to perform, the most common being verification and decommissioning:

  • In a community pharmacy setting, all medicines must be decommissioned (or deregistered) before they are supplied to the patient and as close as possible to the handover of the pack to the patient.
  • In the hospital pharmacy setting, this decommissioning process can take place at any time whilst within the hospital’s ownership ie between goods-received and dispensing/handing/supply to the patient.
  • In a wholesale setting, verification of medicinal products which do not originate directly from the manufacturer or from a wholesale setting intended for placing on the market is mandatory. All returns must also be verified. Medicines that are not delivered to a pharmacy must be decommissioned by the wholesaler prior to delivery (for example, direct deliveries to dentists, veterinarians, nursing homes, police and the military).

The medAspis system can perform all these verification and decommissioning tasks in the community and hospital pharmacy and wholesale setting, with each having bespoke functionality as required by European and National law.

These respective FMD functions are pre-set in the application that has been downloaded on to your medAspis handheld PDA, each having a different range of functions:

 

Pharmacy:

Dispense
Verify
Mark as Sample
Mark as Destroyed

Wholesale

Dispense
Verify
Mark as Sample
Mark as Destroyed
Mark as Exported
Mark as Stolen
Mark as Free Sample
Mark as Locked

These functions are described in more detail below:

Verify (verification) – This function checks the status of medicine pack and displays the result on the handset. This function is used in the wholesale setting to check medicines that are procured from other wholesalers or are returned from previous deliveries. Pharmacies can also check their inventory at any time using this function. There is no limit to the number of times a pack can be verified.

Dispense (decommission) – This function logs out/checks out the scanned packs from the central database. This function is mostly used in the pharmacy, and – to a lesser extent – in the wholesale setting (e.g. with direct delivery to dentists or veterinarians). These packages are checked out of the pharmaceutical supply chain after this step and can no longer be traded or sold after the current transaction, except if reinstating the pack under certain conditions.

Special forms of decommission/deregistration are used for specific situations. All apply to the wholesale setting, with only those marked * applying to the pharmacy setting:

Mark as Sample*: For medicines designated for testing by regulatory authorities

Mark as Destroyed*: For medicines that need to be destroyed

Mark as Exported: For medicines to be exported outside of the EU

Mark as Stolen: For medicines declared as stolen

Mark as Free Sample: For medicines declared as medical samples

Mark as Locked: For medicines marked as blocked

 

All functions can be executed even if the 2D matrix code cannot be scanned for technical reasons. In this case, all these data (product number, serial number, batch number and expiry date) can be entered manually. In the medAspis system, this is done via a keyboard on the handheld PDA.

According to the FMD, the dispensed/decommissioned action can be revoked/reversed within 10 days of the initial dispense/decommission scan; however, this revocation/reversal must be performed in the same location. The medAspis service contains this functionality.

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