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FMD 2018-10-12T16:26:25+00:00

Falsified Medicines Directive (FMD)

An Integrated Solution for Analyst PMR

The integrated solution from PSL

Positive Solutions has worked in partnership with all regulatory bodies including the UK FMD Working Group for the development and implementation of its FMD-compliant dispensing solution for Pharmacy.

We will provide, for users of Analyst PMR and Analyst IPS, a fully integrated FMD solution phased into our systems software in three stages and supported by recommended system workflows.

Level 1 of our integrated solution will enable Analyst PMR users to achieve regulatory compliance by 9th February 2019, and will be available from January 2019.

FMD-aligned updated software will be automatically integrated by Positive Solutions into the existing Analyst PMR system at no additional cost. Pharmacies will simply need our FMD-ready 2D hand-held scanner for use with Analyst PMR terminals at accost of £159+VAT per scanner. (*see full details below)

Level 1 – minimum regulatory
Compliance by 9th February 2019
  • Full Pharmacy FMD Compliance with verification & decommission using aggregated codes

  • Basic date checking

  • Recalled Batch checking against the NMVS

  • Multiple workflow options

Analyst PMR users will need:

  • Our FMD-ready hand-held scanner (for use with Analyst PMR terminals)

  • Updated system software that will be automatically integrated by Positive Solutions into your existing Analyst PMR

*Please note

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.

Level 1

Min. Regulatory Requirement

Level 2

Additional Compliance

Level 3

Maximum Benefit

Levels 2 & 3 additional compliance and improved workflow opportunities

FMD provides Pharmacies with the opportunity to achieve greater pharmacy efficiency and therefore, increased financial benefit.

The fully integrated FMD solution from Positive Solutions will be a catalyst for additional PMR functionality. We see FMD as a toolkit capable of generating advanced levels of compliance and improved workflow opportunities for Pharmacy.

Through extensive IT research and development with pharmacy regulatory bodies, we have developed our integrated FMD solution to offer outstanding additional functionality and support pharmacies in achieving greater efficiency in their daily processes and procedures.

These enhanced benefits, will be phased into our FMD solution subsequent to the initial minimum regulatory compliance (Level 1). In addition, we will be providing recommended workflows solutions specifically created for the benefit of Analyst PMR users including:

Level 2 – Additional Compliance

  • Expiry Date Reports – What’s going out of date soon?

  • Dispensed Batch Reports – Have I dispensed a recalled item?

Level 3Improved Workflow Opportunities

  • Access to consumer data

  • Greater digital safety measures for patients when taking medication

  • Full stock control

  • Live inventory & accurate stock valuation

  • Supplier returns reports

FMD Registration (Responsibility of the Pharmacy)

*please note: Individual Pharmacy Contractors are responsible for the following actions:

1 Register with SecurMed (‘on-boarding’)

*Guidance on the registration and connection process is yet to be published by the regulatory body. Positive Solutions will endeavour to keep customers up to date with all the latest information in this regard at https://www.positive-solutions.co.uk/ 

2 Update internal SOPs to account for and ensure:
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To find out more about our products, services and FMD

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Automated Dispensing

The verification and decommissioning for minimum FMD compliance (PSL Level 1) with transfer of information from the FMD UIs will be done outside the automation process, when items are scanned into the unit prior to output. 

We recommend pharmacies check with their automation systems supplier with regard to any systems update requirements.

The use of FMD-aligned robots will, following further interface development (PSL Levels 2 & 3) allow the transfer of information from the robot to your Analyst PMR at the point of scanning items into the automated unit.

Changes to your workflow may be required in order to achieve the benefits of advanced integrated FMD compliance. This will be dependent on the automation system you have deployed.

The FMD Legislation for Community Pharmacy

From 9th February 2019, authorised suppliers of medication must add two safety features on all new packs of prescription medicines: 

  1. Unique identifier (UI) – a 2D barcode to be scanned at various points along the supply chain to determine authenticity
  2. Anti-tampering device (ATD) to ensure the product is intact before dispensing

The status of any medication pack needs to be changed from ‘active’ to ‘inactive—supplied’ in the UK National Medicines Verification System (NMVS). In order to achieve this, the 2D barcode on each pack must be scanned and the change automatically communicated to the NMVS.

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.

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Falsified Medicines Directive

Integrated Workflow Solutions for Analyst PMR
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