Are you ready for the Falsified Medicine Directive?

FMD

Falsified medicines are “fake” medicines that pass themselves off as real, authorised medicine

The final phase of FMD is due to be rolled out from 9th February 2019

In order to comply with the requirements of the Falsified Medicines Directive (FMD), pharmacy contractors will be required as part of the dispensing process to:

  • check the anti-tampering device (ATD) to ensure it is intact prior to dispensing; and
  • change the status of the pack in the UK’s National Medicines Verification System from “active” to “inactive—supplied”. This involves scanning the 2D barcode on each pack and communicating with the National Medicine Verification System (NMVS).

The UK’s National Medicines Verification Organisation (NMVO) is SecurMed UK, which comprises bodies representing manufacturers, importers, wholesalers and pharmacies.

What are Falsified Medicines?

Falsified medicines are “fake” medicines that pass themselves off as real, authorised medicines. Falsified medicines might contain ingredients, including active ingredients, which are of poor quality or of the wrong strength. This could be detrimental to patients’ health, as they have not been properly evaluated to check their quality, safety and efficacy.

Market authorisation holders are required to place two safety features on all new packs of prescription medicines placed on the market in Europe:

  • unique identifier (UI) in the form of a 2D data matrix (barcode) which can be scanned at various points along the supply chain to determine its authenticity; and
  • an anti-tamper device (ATD).

Medicine can be scanned at various points along the supply chain to determine its authenticity

What will I need to do?

A requirement for new pharmacy software is likely. Either as an update to your existing Pharmacy module within Compucare or as a new standalone system. Current Compucare users can find further information on how to setup FMD via our knowledge base.

Standard operating procedures (SOPs) will also have to be updated. Incorporating the authentication scan into the current dispensing process, and of course, staff training will have to take place.

To discuss further how Streets Heaver and Compucare can meet your pharmacy FMD requirements, call us on 01522 872000 or use our contact page.