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FMD FAQ’s 2019-07-31T11:41:05+00:00

FMD questions answered

What is the Falsified Medicines Directive (FMD)? 2018-10-05T16:17:43+00:00

Whilst the pharmaceutical industry is one of the most regulated industries in the world, an estimated 1% of the two billion items annually dispensed in the UK may be counterfeit. This creates the potential for 20 million packs of falsified medicines to circulate in the UK every year. 

The Falsified Medicines Directive is the EU’s response to this threat to the formal supply chain. FMD is designed to secure the UK supply chain by the checking of identity, history or source of the medications being dispensed. 

What is the UK Community Pharmacy FMD Working Group? 2018-10-05T16:18:29+00:00

Positive Solutions has and will continue to work with the UK Community Pharmacy FMD Working Group. The FMDWG brings together Community Pharmacy representative bodies and meets regularly to achieve practical solutions for the operation of FMD in the UK. The group, which includes representation from PSNC, NPA, AIMp, CCA, CPW, CPS and CPNI, has developed guidance and resources for pharmacy contractors. Further details are available from https://fmdsource.co.uk/

What is SecurMed? 2018-10-05T16:07:57+00:00

SecurMed UK is the not-for profit organization that will manage the UK Medicines Verification System under the supervision of the MHRA and Department of Health.

How much will FMD implementation cost? 2018-10-05T16:09:30+00:00

Updated system software that will be automatically integrated by Positive Solutions into your existing Analyst PMR at no additional cost. Our FMD-ready hand-held scanner for use with Analyst PMR terminals costs £159 + VAT per scanner.

All new Analyst terminals shipped since January 2018 have already been supplied with a Honeywell VMD-ready Xenon 2D scanner with intelligent area imager to scan the new 2D Data Matrix, also known as the unique identifier (UI) code.

Any 1D scanners currently being used by PSL Customers need to be upgrade to the Honeywell 2D indicated above.

Who will fund FMD? 2018-10-05T16:11:14+00:00

Under the Delegated Regulation, each sector -including Pharmacy- is responsible for its own costs for connecting to the NMVS. It is anticipated that FMD-related costs, including initial set-up, IT software and hardware and any ongoing operational costs, for Pharmacy contractors may be recognised in future NHS funding settlements.

The costs of establishing the NMVS will be borne by branded and generic medicines manufacturers and parallel distributors.

Will Brexit affect FMD? 2018-10-05T16:12:38+00:00

Whilst there’s a lot of clarification required between now and the introduction of the final legislation, the Medicines and Health Regulatory Association (MHRA) has been given ministerial guidance that the UK will apply all EU safety of medicine regulations prior to its planned departure from Europe. The UK FMD Working Group has also made it clear that there will be no cancellation of the regulation, no opt out by the UK and no delay in its enactment.

How will I deal with liquids? 2018-10-05T16:13:18+00:00

These will be decommissioned whenever the anti-tamper device has been broken i.e. when the bottle has been opened.

How will I deal with split packs? 2018-10-05T16:13:42+00:00

These will be decommissioned whenever the anti-tamper device has been broken. The pack can then be marked e.g. with a sticker to show it has been decommissioned.

How will decommissioning happen with split packs in MDS robots? 2018-10-05T16:14:16+00:00

These will be decommissioned whenever the anti-tamper device has been i.e. when the box is opened and the tablets put in the robot.

How will I deal with large bottles containing hundreds of tablets? 2018-10-05T16:14:43+00:00

These will be decommissioned whenever the anti-tamper device has been broken i.e. when the bottle has been opened.

How will dossette packs be handled? 2018-10-05T16:15:10+00:00

These will be decommissioned whenever the anti-tamper device has been i.e. when the box is opened and the tablets are put in the dossette.

What about instalment dispensing in Scotland? The script may be for a period time e.g. 8 times and could also involve split packs. When would decommissioning happen? 2018-10-05T16:15:30+00:00

You should decommission at each dispensing instance using the barcode on the bag label.

What level of functionality will be available from Feb 2019? 2018-10-05T16:15:53+00:00

Minimum regulatory requirement (PSL 1st Level) will be achieved. This will allow Analyst PMR users to commission using the barcode on the box and decommission using the barcode printed on the bag label, which will remain a standard barcode for the foreseeable future.

Will there be a warehouse/wholesaler solution? 2018-10-05T16:16:14+00:00

Yes, there will be a solution of this type in due course. Further details will be issued as soon as possible.

Will I need to replace the scanner I’m using now? 2018-10-05T16:16:35+00:00

Any 1D scanners currently being used by PSL Customers need to be upgrade to the Honeywell VMD-ready Xenon 2D scanner with intelligent area imager to scan the new 2D Data Matrix, also known as the unique identifier (UI) code.

All new Analyst terminals shipped since January 2018 have already been supplied with the Honeywell 2D scanner.

Can I still use my old 1D scanner when FMD comes into effect? 2019-01-23T17:15:13+00:00

No.  Positive Solutions will only support new FMD-aligned 2D technology.

Both scanners cannot be plugged into Analyst simultaneously and MediCyn FMD software can only be configured to use one scanner at a time.

How do I change my preferred FMD solution supplier after I’ve already registered with SecurMed? 2019-01-10T09:29:56+00:00

If a pharmacy/dispensing entity wants to change the system supplier they’ve already registered with SecurMed on boarding, the following process should be followed:

  • The end user registrant should Email registration@securmed.org.uk with all the details in the primary action.
  • Depending on whether the certificates and passwords have been allocated, SecurMed will advise accordingly.
  •  If the certificates and passwords have been supplied but not entered into any system, they are still relevant and usable with the new supplier.
  • If the certificates and passwords already supplied have already been entered, it is still possible to re-use the certificate and password – however technical support may be necessary.
  • If the business has moved location new certificates and passwords need to be registered and obtained via the SecurMed registration process.
What should I include in my SOPs for FMD? 2019-01-10T09:30:26+00:00

Community Pharmacy SOPs should account for the following processes in their revised SOPs

  • Checking of Anti-Tamper Devices.
  • Scanning of unique 2D codes.
  • Performing 2D barcode checks against the National Medicines Verification System.
  • Authentication and decommissioning of all relevant prescription medicines during the dispensing process, prior to hand-over to patients.
  • Unexpected results e.g. product recalls, identification of falsified medicines.

Revised SOPs must be in place by 9th February 2019.

What is likely to happen about FMD after Brexit? 2019-01-10T14:14:15+00:00

There are currently no official guidelines on this matter from the PSNC or other pharmacy representative bodies.

FMD comes into effect on 9th February 2019 prior to the UK’s departure from EU legislation. Full implementation of FMD going forward, is likely to depend on the UK’s relationship with the EU post-Brexit.

Access by pharmacies and other dispensing entities to the European FMD hub is likely to continue during the transition period. If the UK government realises its aim of a close alignment on medicines policy within the Brexit agreement, access to the European FMD hub is also likely to continue after 2020 for UK end users.

In the event of a breakdown in the UK’s relationship with Europe post-Brexit, access to the Europe medicines database may no longer be available. Instead, dispensing entities registered (on-boarded) with SecurMed may be required to register with a UK medicines database.

The following points should be considered regarding what is likely to happen post-Brexit:

  1. UK consultants and sector specialists have played a considerable part in leading the development and research to set up the EU FMD legislation, with investment of significant resources and funding. The UK Government is not likely to write-off this investment by withdrawing from any FMD implementation.
  2. There is heightened awareness of the increasing number of falsified medicines entering the UK supply chain. There is likely to be a greater need to establish measures to combat the spread of illegal and harmful products.
  3. In the event of a UK withdrawal from FMD, we will be the only country in Europe without control measures in place. The UK will therefore become an easy-target for flooding the market with falsified medicines.
How do I deal with India Pack Coding? 2019-01-31T10:04:47+00:00

India regulations to implement a Track and Trace system for export of pharmaceuticals and drug consignments were introduced as a phased programme to address counterfeit and ineffective product recall challenges under the control of the Directorate General of Foreign Trade, Department of Commerce, Ministry of Commerce and Industry from 2011.

Core features are:

  • Product Item serialisation and aggregate level to pallet
  • Track & Trace reporting to Government Database: DAVA (Drugs Authentication and Verification Application)
  • All exported drugs are in scope (Rx and OTC)
  • Specific requirements on use of the Pack Level indicator (1st character of the GTIN-14 that are narrower than the GS1 standard)

These requirements pose a challenge for EU-FMD requirements in relation to the treatment of GTINs and OTC products.

SecurMed has issued information on the identification of Indian Coding of packs with guidance on how to identify the packs in comparison with EU FMD compliant packs. The MHRA, is expected to  issue further information for the wholesale community.

India Pack Coding guidance from SecurMed

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My ‘FMD ready product’ is not scanning 2019-03-25T16:45:20+00:00
  • You should double check to ensure the product is in fact ‘FMD ready’. 99% of enquiries to the PSL Service Desk about this issue are incorrect.
  • Products may have a 2D barcode but the details of the product may not have yet been uploaded to the NMVS database by the supplier.
  • There is a huge backlog of products that are not FMD enabled. Suppliers are trying to get these into circulation before the FMD enabled products.
  • Only approx. 5% of products in circulation have FMD enabled barcodes. There is an estimated wait of 9 – 12 months until pharmacies see FMD enabled products on a regular basis.