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FMD is not near, it’s here!

30.01.2019 Company

As featured in the Pharmacy Show magazine issue 1/2019.

For most, the new year means big transformations, which is indeed the case for the world of pharmacy. After what seems like a life time of preparation, development and testing we are finally just a few weeks away from the FMD (Falsified Medicine Directive) deadline. On 9 February 2019 the cogs of this EU legislation will begin to turn, consequently affecting healthcare establishments in all regions. The major solution providers are all prepared. Are you?

What is the Falsified Medicine Directive (FMD)?

The goal of the FMD regulations is to track and verify the authenticity of pharmaceuticals that are being distributed into and throughout the European Union. Most importantly, it is aimed to improve the safety of patients by decreasing the risk of receiving counterfeit or tampered with medication.

So, how will the process look? It starts with the manufacturers who apply, to each package, a 2D barcode. Once a medication is scanned it is uploaded to the National Medicines Verification System (NMVS). Each pharmacy (Community, Hospital or a dispensing General practice) will be required to scan the barcode and verify it against the NMVS. The medicine is then officially decommissioned once it is supplied to the customer.

For the patient, the new law will go virtually unnoticed and nothing will change when picking up their prescription. However, operationally, everyone along the supply chain will be making changes in order to comply.

One of the most substantial changes that will be implemented is the addition of the previously mentioned 2D barcode, more specifically, the GS1 Data Matrix. The GS1 Data Matrix is a 2D barcode that can contain a lot of data condensed into a small printed code, making it the ideal solution to fit on medicines of all shapes and sizes. For many, this change will mean new hardware that will be able to read 2D barcodes.


Hardware: Success stories with Newland EMEA

Both private and public sector entities that are responsible for providing an FMD solution have faced a common dilemma. Their customer base was being forced by legislation to procure new systems and hardware. They all needed a solution that would do the job well but at a price point sympathetic to a long list of customers being compelled, in most cases, to drop their perfectly good 1D scanners for new 2D ones.

Every major and some not so major barcode scanner manufacturers can deliver a solution. Therefore, it is important to take a look at performance, knowledge, support and, of course, price point. Newland is one of the manufacturers that is taking the lead in that today. It is undeniable that Newland’s price, quality and ability to deliver large quantities with a short lead-time sets them apart from their rivals. Accomplishing these key objectives have allowed them to build a strong network of partners throughout the UK. With pre- and postsale support readily available, including installation of scanners, in both small and large batches, it is easy to see why Newland has gained success.

Newland rapidly gained traction in the pharmaceutical market as soon as the FMD law started to take shape. Currently, they are working with some of the major players in the industry. This includes: Cegedim Rx, EMIS Health, FMD IT and the NHS.

EMIS Health’s journey with Newland scanners

EMIS Health were one of the first software companies interested in Newland’s 2D scanning technology, identifying their customer’s need for a 2D scanner that could scan the new Data Matrix code became a necessity.

EMIS chose to test Newland’s hand scanners, first inhouse and then in a selected few live environments, for a period of 3 months. The barcodes used on prescriptions vary throughout the home nations and Ireland. It was important, therefore, that the hardware worked on the large 2D codes seen in Wales, the 1D codes still used in England and the new FMD codes. To further test the resolve of each scanner, the codes are being printed using a plethora of different printers with varying degrees of print quality. Newland’s sensibly priced HR22 Dorada stood up to the test and was approved as the recommended scanner for the EMIS solution.

“The HR22 Dorada scanned all the codes needed for the pharmacy scripts and FMD codes, enabling the business to offer a competitive solution to its clients.” — Carl Marchant, Regional Manager — Pharmacy, EMIS

In support of EMIS

EMIS Health is a leader in healthcare software and services. Their ProScript Connect software, which offers a fully integrated FMD module, runs on a Windows OS and requires their scanners to work via USB virtual com ports. During testing, Newland worked with EMIS to adjust the drivers to auto-configure the comports in order to help the end users have a “plug and play” installation experience. Newland helped EMIS create a configuration sheet, created custom settings for the scanners and have ensured all scanners arrive preconfigured.

Cegedim Rx supports FMD compliance with Newland scanning technology

Cegedim Rx provides innovative technology and services for healthcare professionals. As the FMD deadline approached, they were looking for a 2D scanning solution for their estate. Newland UK reseller partners took the lead role of guiding Cegedim Rx throughout the scanner selection process. Having built up a reputation in the market already, the HR22 Dorada was a clear, and obvious, staring point but other units in the range were also evaluated.

Cegedim Rx were keen to be able to offer a choice of cabled and wireless solutions to their members as an FMD solution. As a corded option, the HR22 Dorada was selected due to scanning effectiveness on their specific codes and could be provided at a better price than alternative options. As a wireless option, Cegedim Rx selected the HR3290 CS Marlin due to scanning performance and identical drivers to the already chosen HR22 Dorada. This choice eases the burden of supporting different middle-ware profiles.

Custom settings

For Cegedim Rx it was necessary to have six different configurations for their scanning hardware. Across both software platforms (Pharmacy Manager and Nexphase), Cegedim Rx require a mixture of scanner set ups. So, Newland created quick reference documents for the six different configurations. Newland UK’s distribution channel adds further value by setting up each scanner for Cegedim Rx when requested. This means Cegedim Rx can have one stock of the same default scanner but react ad-hoc to customer preferences.

“We require many different configurations of scanners across the software estate, so Newland supporting us with creating simple batch solutions for each configuration was a big reason we selected them as a hardware partner.” — Lee Nicholson. Hardware Support Manager, Cegedim Rx

FMD IT creates a cost-effective solution to FMD legislation

If their name doesn’t give it away, FMD I.T. Ltd is a company dedicated to providing UK Pharmacy an effective solution to ensure FMD compliance is met by its customers. When looking to competitors in the market, FMD I.T. Ltd identified early on that the integration of an FMD solution within the existing Pharmacy management providers could be a long and tricky process.

The potential bottle neck of pharmacies needing a solution, but no time to supply, motivated FMD I.T. Ltd to create a standalone software solution aptly named FMD Connect.

Since their FMD ready software solution is not integrated into already existing software, they have been able to offer an instant solution that can sit along-side their current pharmacy software. They were looking to give their customers an alternative way to establish FMD compliance without having to purchase upgrades from their incumbent suppliers or the need to change the user interface and SOPs that staff have been use too.

Workflow optimization was always the number one goal, closely followed by cost effectiveness and robust support by way of hardware and tech support. This has been achieved by a close working relationship with Newland and the development of their UK based support centre in the Midlands.

Industry standards

FMD I.T. Ltd has been developed by a management team who have over 30 years combined experience working within the pharmacy sector. Naturally by selecting the same scanner the industry was already getting used to, it negated the need for a conversation with the end users about scanning hardware. The more established companies had already started to let the market know they were using the Newland HR22 Dorada, so by also selecting the HR22, FMD I.T. Ltd.’s focus could be purely on the merits of their software.

“Our team at FMD I.T. Ltd understands the challenges this sector faces and the pressure on various legislative changes and funding restrictions. Given our supportive focus on the ‘commercials’ for our customers and importantly the quality of the Newland HR22 we agreed on a partnership very early on and have deployed Newland HR22 scanners to ALL our users. As we rapidly approach our 3000th unit we have been delighted with the support and technical guidance Newland have offered” — Gareth Dunsmore, Managing Director, FMD IT

Simplicity in common

Newland’s HR22 Dorada, with few custom settings, are essentially “plug and play” into the FMD Connect Software solution which mirrors the FMD I.T. Ltd software rhetoric when compared to their competitors.

“It’s literally ‘FMD Compliance in a box’ which is what you would expect from a company dedicated to workflow optimisation!” — Gareth Dunsmore, Managing Director, FMD IT

NHS “Out with old, in with the new”

The public sector didn’t get a free pass on FMD compliance and, like the private sector, the NHS dispensing Pharmacies were mostly using scanners capable of only reading 1D barcodes. When details of the FMD legislation were released, it became equally necessary to replace the old scanners with the new 2D scanners.

Trusts have autonomy on solutions for their pharmacies. Therefore, there is a mixture of those that already subscribe to Cegedim or EMIS solutions and those that have requested information on Newland scanners from resellers. However, in some cases, NHS trusts have approached partners for guidance on developing their own solutions with Newland scanners.

Because there is a wider spread of smaller solutions in the NHS, Newland have had to respond to many different configuration requests. Newland takes great pride in treating the large, medium and small requirements with equal effort and consideration.


FMD continues

The FMD scanning requirements are evolving. There has been a shift from low cost and capable to more aggressive and versatile, even if it comes with a higher price tag. Renewed attention from other major players in the scanning industry has created an appetite for faster scanning on a wider variety of barcodes. As pharmacy software suppliers look towards adding EPOS (Electronic Point of Sale) modules to their software, scanners must also be able to read a great range of retail product codes.

The next phases of FMD will not just affect dispensing pharmacies but will involve general practices, emergency care, care homes, hospitals, hospices and other medical centers. The need is also arising for markets outside the EU, regarding FMD, for import and export.

Looking Forward

For the world of scanning, the FMD legislation has provided motivation to expand and make technological advances. Not only for medication but other healthcare applications as well. In the Netherlands, one hospital is already using scanners as a source of patient check in. This allows patients to check in via a barcode scan, without entering information manually, and gives healthcare professionals a more efficient and safe way to look up patient information.

One thing is for sure, scanning capabilities within healthcare will become more necessary than ever in order to keep up with legislation and the competition. Newland expects to see wireless scanners, tablets and mobile computers as added solutions and has come prepared.

FMD is here! Are you ready?

Good luck to everyone involved in FMD compliance solutions. For the ones using Newland scanners, thank you and please don’t hesitate to lean on us or our partners for support. To those that have yet to commit to a scanning solution or are looking for alternatives leave your information below for FMD advice.


We'll help you get FMD ready!

The FMD deadline is on Feb 9. Get in touch for help on getting compliant.

Design & development: BuroBureaux