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Falsified Medicines Directive Secondary Care Toolkit

Summary

The purpose of this toolkit is to inform and prepare staff throughout secondary care for the implementation of the Falsified Medicines Directive (FMD).

This toolkit can be used to assist each individual healthcare setting to identify the most suitable place to verify/decommission medicines based on their needs. In addition it can be used to inform staff of what they need to do to successfully and implement FMD and be compliant. Furthermore the toolkit can also provide useful links to other sources of relevant FMD information.

Who this is for

Nearly all settings within secondary care receive and supply medicines and therefore need to implement FMD for verification and decommission purposes. This includes secondary care settings that hold a Wholesale Dealers Licence (WDL) or Wholesale Distribution Authorisation (WDA). The majority of care settings that receive and supply medicines will need to implement FMD for verification and decommission purposes.

How to use this toolkit

The FMD toolkit aims to highlight various supply chain scenarios common across secondary care and identify all possible points at which verification and decommissioning could take place. Due to the complexity and varied landscape within secondary care, each individual setting will need to the apply the scenario to their own unique supply chain/business needs.

Overview

The Directive on the Falsified Medicines was legislation passed by the European Union Parliament, which aimed to increase the security of the manufacturing and delivery of medicines in Europe and provide protection to patients from falsified medicines in the legal supply chain of pharmaceuticals.

What’s in scope?

A list of prescription medicines which are not in scope to bear safety features is contained within an annex to the delegated regulation. This list is shown below and includes references to the ATC codes to help with identification of the specific products where the annex only makes reference to classes of product which are exempt.

Name of active substance of product category Pharmaceutical form Strength
Homeopathic medicinal products Any Any
Radionuclide Generators Any Any
Kits Any Any
Radionuclide precursors Any Any
Advanced therapy medicinal products which contain or consist of tissues or cells Any Any
Medicinal gases Medicinal Gas Any
Solutions for parenteral nutrition having an anatomical therapeutical chemical (‘ATC’) code beginning with B05BA Solution for Infusion Any
Solutions affecting the electrolyte balance having an ATC code beginning with B05BB Solution for Infusion Any
Solutions producing osmotic diuresis having an ATC code beginning with B05BC Solution for Infusion Any
Intravenous solution additives having an ATC code beginning with B05X Any Any
Solvents and diluting agents, including irrigating solutions, having an ATC code beginning with V07AB Any Any
Contrast media having an ATC code beginning with V08 Any Any
Tests for allergic diseases having an ATC code beginning with V04CL Any Any
Allergen extracts having an ATC code beginning with V01AA Any Any

The UK National Competent Authority have published a newsletter containing a complete list of medicines within the ATC code ranges listed above which. This list is available to download here ATC codes list 0518 and these medicines will not be expected to be subject to the safety features.

Verification and decommissioning options

Possible scanning system error messages

The error messages below are the output of a working group combining a number of key pharmacy organisations and is likely to be favoured by the majority of system suppliers. However, as exact error messages are not mandated, these may vary slightly from supplier to supplier.

There will need to be some further work by system suppliers to match this to the error messages returned from the SecurMed system, but the image below is a good guide to start planning SOPs.

FMD error and alert messages

FMD solution options

Stand alone system - best suited for small volume decommission

These systems work independently from other software solutions and support communication with the National Medicines Verification Service (NMVS) on barcode scanning facilitated by a member of staff.

Selection of any system should include a check that the system can deal appropriately with the volume of items to be scanned and the ‘cost’ of the system should include the staff time taken in scanning items for verification and decommission.

Delegated staff member scans medicines using a 2D compliant scanning device. Staff then have to manually enter relevant data into any existing system to record dispensing activity and deduct from stock.

  • Total Manual Process
  • Increased labour time
  • Lowest Cost Option

Integrated system - best suited for medium to large volume decommission

These systems are integrated into an existing system (such as the stock control system). Such solutions would normally incorporate the scan into the normal business process workflow and minimise the ‘additional operator’ demand or provide a business benefit that allows the increased staff time for scanning to be off-set by other benefits. System suppliers may be taking an incremental approach to offering such ‘business benefits’ but should be looking to deliver these within a reasonable timescale post February 2019.

Delegated staff member scans medicines using a 2D compliant scanning device. Existing systems used to record dispensing activity and/or stock control are automatically updated with pack information, reducing the manual data entry need.

  • Reduction in manual data entry

Automated - best suited for small volume decommission

These are solutions such as robotic systems where the barcode scan is a normal part of the ‘loading’ of the machine and where the output from the machine can be attributed to an individual, identifiable pack. These systems have developed the links to the NMVS to support verification messages on ‘receipt’ or loading and decommission messages on supply. There would need to be a facility to support scanning of ‘non-robot’ items. Such systems minimise the staff implications of FD scans but may require further integration with stock control systems to leverage full ‘user-benefits’ from the use of FMD barcodes.

Stock or order fulfilment machines, such as robotic dispensing machines, performs the FMD scanning as the pack flows through the machine. May or may not be integrated with other pharmacy systems.

  • Not all medicine can go through robot, additional scanning solution necessary

Contractual agreements/service level agreements (SLA)

Guidance regarding contractual agreements/SLAs within secondary care will be added.

Next steps

Today

Understand your own process

Understand and map your own business process in order to consider where verification and decommissioning fits best and has the least impact on your own business processes.

Speak to system suppliers

It is important to speak with your current software solutions supplier to evaluate their readiness for FMD. It is your responsibility to be compliant and if your system supplier will not have a solution in place before February, we recommend looking at alternative solutions.

Register with SecurMed

SecurMed UK registration is now open. SecurMed will manage the process via a web-facing registration page accomodating registration for single locations and a bulk registration process for organisations registering multiple locations.

9 February 2019

Verify and decommission

Begin to scan FMD compliant medicine. In the unusual event you encounter issues with scanning, there is a manual process to verify and decommission.

Help in understanding how to map your processes from NHS Improvement

Medicines and Healthcare products Regulatory Agency (MHRA) Implementation Guidance 

SecureMed

FAQs (January 2019)

There is a Google+ FMD Community available to anyone with an NHS email, if you are interested in joining please email FMD@nhs.net.

Last edited: 19 March 2019 5:24 pm