a pharmacist dispensary shelves imageFebruary 2 2018

Details of what some of the practical implications of the Falsified Medicines Directive (FMD) will mean for community pharmacy have been published.


The UK FMD Working Group for Community Pharmacy has said that from February 9 2019 pharmacy contractors will need to carry out checks on medicines as part of the dispensing process. This will include:

  • a simple visual inspection to check the anti-tampering device (ATD) to ensure it is intact prior to dispensing;
  • scanning the 2D-barcode on each pack of dispensed medicine so that the supply can be recorded in the UK’s National Medicines Verification System as having been supplied. This will mean that the product status will be changed on the central record from “active” to “inactive—supplied”.

The FMD is a European Union Directive intended to make the medicines supply chain is secure. It will mean medicines are tracked throughout the supply process from manufacture, through wholesaler distribution channels to the point of supply to the patient in the pharmacy. In preparing to implement the FMD, “there is much work still to do to ensure community pharmacy is ready,” said the UK FMD Working Group.

Among the aspects that will need to be in place are:

  • updating IT systems and associated hardware;
  • connecting community pharmacies to the verification system (‘registration/on-boarding’);
  • revising workflows and standard operating procedures;
  • training staff;
  • providing patient information.

UK FMD’s guidance, ‘The way forward for FMD in community pharmacy’, says that further information will be published once known, but at the moment there are still a number of assumptions being made about the implementation of the Directive.

It notes: “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.”

The October 2017 issue of Today’s Pharmacist magazine carried an article on the background to the FMD and what it is expected to entail.

Links:
UK FMD announcement            
UK FMD ‘The way forward for FMD in community pharmacy’ January 2018         
Today's Pharmacist 'The state of play with FMD'. Published October 2017.