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FMD Dispensing Doctors Toolkit

Purpose

The purpose of this toolkit is to prepare and inform dispensing doctors and any associated staff on the implementation of the Falsified Medicines Directive (FMD).

This toolkit can be used to help identify the most suitable place(s) to verify/decommission based on user needs and the EU Delegated Regulation. This toolkit can also be used to inform users of what is needed to successfully implement FMD ensuring compliance, in addition to signposting sources of relevant FMD information.

Audience

The majority of healthcare settings receive and supply meds and therefore need to implement FMD for verification and decommission purposes (this includes secondary care, community pharmacies and dispensing Doctors).

How to use this toolkit

The FMD toolkit will identify and outline all the possible points within a doctors dispensary that verification and decommissioning could happen. Due the varied landscape within dispensing doctors, each individual setting will need to the apply the information to their own unique supply chain/business needs.

UPDATE: For more information in the event of a ‘No Deal’ Brexit, click here

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.

Dispensing Doctors Guidance

The UK has classed General Practitioners (GPs) as health centres and therefore healthcare institutions – that includes both dispensing and non-dispensing GPs.  We have recently reviewed this alongside the consultation and can confirm this position stands, GPs are not exempt under Article 23 and must decommission medicines.  In fulfilling their obligations on decommissioning, because of the nature of their activity Dispensing Doctors should seek to remain equitable to what pharmacies do where appropriate.  This needs to fit with the nature of the business, for example out of hours care decommissioning could happen when medicines are prepared and sealed in drugs bags, effectively as close to the point of supply as is reasonably possible.

Verification and Decommission

When to Decommission

Dispensing Doctors and/or dispensary staff will be required to authenticate products, which means visually checking the anti-tamper device and performing a verification and decommissioning scan, “at the time of supplying it to the public”. Although the term “time of supply” is ambiguous, what is clear is that the FMD process must have been completed at the point the medicine is released to the patient or their representative. One way of doing this efficiently, where more than one product is involved, is to used and aggregated barcode on the bag label.

Aggregated Barcodes

Aggregated barcodes are not required under the Delegated Regulation but may be generated by pharmacy IT systems to link several pack identifiers together, if this functionality has been provided by the IT supplier. They are not mandatory, but may be used to facilitate decommissioning. Aggregated codes may be printed directly onto dispensing bags, or on a separate adhesive label to be applied to dispensing bags, and then scanned at the time of supply. Aggregated barcodes could either contain all of the data of the pack identifiers or simply provide a link to the data stored on the pharmacy IT system.

Whats In and Out of Scope?

Almost all prescription medicines with a Marketing Authorisation are in scope of FMD with only a few specialist products, radionuclide kits and medicinal gases being out-of-scope. All non-prescription medicines are out-of-scope, with the exception of two omeprazole products (which were subject to falsification in the past).

Unlicensed products, including specials and clinical trial supplies, are out-of-scope, but any licensed products being incorporated into them (such as ingredients for specials) would have to be authenticated and decommissioned before they could be used.

Medical devices are out-of-scope, but separate changes are being made to regulation of medical devices.

 

Verification and Decommission Options

 

Potential FMD Scanning 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

Verification and Decommission 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 – 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 Feb-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

Next Steps

Useful Links

For help in understanding how to map your processes please click here

Medicines and Healthcare products Regulatory Agency (MHRA) Implementation Guidance

The way forward for FMD in Community Pharmacy

SecurMed Registration

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

Pharmacy System Supplier List

AAH Pharmaceuticals Ltd (EMIS Partner) http://www.carewaylink.co.uk PharmData Ltd http://www.pharmdata.co.uk
Advansys Technologies Limited http://www.atlsystems.co.uk Positive Solutions http://www.positive-solutions.co.uk
Aln Technology Limited http://www.alntechnology.com Quick Pharm Solutions Limited https://www.quickpharmsolutions.com
CegedimRx http://www.cegedimrx.co.uk Rfxcel Corporation http://www.rfxcel.com
Codesplice Ltd http://fmverify.com/ Robosol Software UK Limited http://www.robosol.com
Deans Computer Services plc https://www.deansplc.co.uk RxWeb (Clanwilliam Health) https://www.rxweb.co.uk
DXC.technology https://www.dxc.technology Serialogical http://www.serialogical.com/
EMIS Health http://www.emishealth.com Socius24 Limited http://www.socius24.com
Falsified Medicines App Ltd http://www.falsifiedmedicinesapp.co.uk TCK GmbH https://nmvs-connect.com
FMD IT http://www.fmd-it.co.uk Tracelink UK Limited http://www.tracelink.com
Invatech Health https://invatechhealth.com/ Vcare Systems http://www.vcaresystems.co.uk
McLernon Computers Ltd http://www.mclernons.com/ Vivitech Ltd http://www.vivitech.co.uk/
MedAspis B. V. https://medaspis.com Voyager Medical Limited http://www.voyagermedical.com
Melior Solutions Ltd http://promo.meliorsolutions.com Wise Software (UK) Limited https://www.orderwise.co.uk
Optel Group http://www.optelgroup.com Zetes Limited http://www.zetes.com

Jump back to the Falsified Medicines Directive (FMD) Implementation Toolkits.