Pharmacies can now register with SecurMed UK

SecurMed UK opened its registration system for community pharmacies on 31st October 2018.

Each community pharmacy in the UK will need to connect to the SecurMed UK system so that they can comply with the Falsified Medicines Directive. The process of identifying legitimate pharmacies and granting them an account to connect is known as registration or “on-boarding”. This can’t be done until pharmacy contractors have decided which FMD IT system they will be using.

Once pharmacy contractors are ready to register with SecurMed UK they should visit https://www.securmed.org.uk/register/end-user-registration/ to register.

Update to FMD error messages and alerts

The UK Community Pharmacy FMD Working Group has published an updated version of its FMD – error and alert messages (for pharmacy and wholesale) flowchart.

The chart looks specifically at handling of alert messages and is intended to inform wider discussions on implementing FMD, including amending Standard Operating Procedures. It will link with other industry guidance on the assessment of suspect packs once an alert has been raised and professional guidance on ethical decision making related to FMD.

Amendments have been made this month so that the chart represents current thinking at this point and the documentation has been added to a new section of the FMD Source website.

The updated chart and accompanying guidance notes are based on a workshop held at Walgreens Boots Alliance, Weybridge, on 5th September and subsequent discussions with relevant experts.

However, the chart is a working document and will be updated in light of feedback and experience. Comments and feedback are therefore encouraged and can be sent to jonathan.buisson@wba.com

UK FMD Working Group for Community Pharmacy responds to MHRA consultation on FMD

The UK FMD Working Group for Community Pharmacy has responded to the Medicines and Healthcare products Regulatory Agency (MHRA) consultation on implementing safety features under FMD.

The response is available from the National Pharmacy Association press office and will be posted on the working group’s website.

Speaking after a meeting of the working group, where the response was finalised, working group chair Raj Patel, said:

“The working group’s position has not changed and we urge people to engage with FMD. The community pharmacy sector needs to move quickly.

“Irrespective of any Brexit confusion and whatever our post-Brexit position might be, we need to have a viable solution by the February 9 deadline.

“FMD aims to make medicine falsification detectable and uneconomic. We recognise contractors will need to make substantial time and investment, but it is important that community pharmacy meets its obligations.

“I urge all community pharmacies to start planning for FMD now.”

Read the consultation response in full

FMD update for contractors

Following its latest  meeting, the UK Community Pharmacy Falsified Medicines Directive (FMD) Working Group is advising that uncertainties related to Brexit mean that all pharmacies need to carefully consider which systems they choose to verify the authenticity of the medicines they supply. Authentication of medicines under FMD will start from 9th February 2019.

Arvato, part of the Bertelsmann group, has recently signed a contract with SecurMed UK to provide the UK FMD system. Community pharmacies should be able to start getting connected to the system from September this year. The UK system will connect to the central EU FMD hub.

Commenting after the meeting, Chairman of the working group and NPA Board member Raj Patel, said:

“Given continued Brexit uncertainties, we recommend that whatever system pharmacies choose, they ensure that termination of the contract without penalties is possible, in the remote possibility there is no workable UK FMD repository.”

Continued access to the EU FMD hub will depend on the future relationship between the UK and the EU. Access is likely to continue during the transition period, and if the UK government realises its aim of a close alignment on medicines policy within the Brexit agreement, it will continue after 2020 too.

Meanwhile, the Department of Health and Social Care and MHRA have launched a consultation on some aspects of implementing FMD in the UK, which contains a section on sanctions for non-compliance.

Mr Patel continued: “With a lack of certainty as to just how long the FMD system will be needed for, combined with the financial squeeze on community pharmacy, and the lack of any announcement on government funding for this regulation, it is hard to justify the investment. However, we are mandated to comply so we must proceed, albeit with caution.”

One of the key requirements of FMD is the ‘decommissioning’ of a medicinal product before a supply is made to a patient. IT solutions will be available which will include standalone FMD systems or FMD capability integrated into patient medication record (PMR) systems. The working group has published a list of FMD IT system suppliers for any contractors who have not yet started to prepare for FMD, to help them consider their options.

List of FMD system suppliers published

The UK Community Pharmacy FMD Working Group has published a list of Falsified Medicines Directive (FMD) IT system suppliers who will be offering an FMD IT solution. The list will be updated as additional suppliers are identified.

We recommend that pharmacy contractors use the list to start considering the offerings from their PMR supplier and other FMD IT suppliers.

A range of options are expected to be available for use in pharmacies, including FMD solutions integrated within the PMR system and standalone systems. Contractors will need to consider the usability of the different options for each pharmacy, dependent on when and where the FMD scan will be undertaken in the dispensing process, and the impact on the workflow of their pharmacy team members.

New guidance sets out the way forward for FMD

New guidance for community pharmacy owners has been issued by the UK FMD Working Group for Community Pharmacy. The detailed guidance is intended to build understanding of the options open to pharmacy contractors as the 12-month milestone for implementation approaches.

The Way Forward for FMD in community pharmacy covers key assumptions about FMD, high level processes for incorporating authentication in to existing dispensing workflows, handling stock transition, what IT systems will need to deliver and implications for patient safety.

European conference highlights varying progress with FMD

Varying progress with implementing the EU Falsified Medicines Directive (FMD) across different Member States and different sectors of the medicines supply chain has been highlighted at a conference in Estonia.

The meeting, hosted by the Estonian Presidency of the Council of Europe, brought together representatives from National Medicines Verification Organisations (NMVOs), the European Medicines Verification Organisation (EMVO), Member States and trade bodies. Raj Patel, Chair of the UK FMD Working Group for Community Pharmacy and President of the Pharmaceutical Group of the European Union (which represents community pharmacy organisations), was among the UK’s representatives.

With exactly 15 months to go before the deadline imposed by EU Delegated Regulation 2016/161, the conference heard that while most Member States now have a functioning NMVO, a few have still to appoint their IT Blueprint Service Provider. Progress with connecting manufacturers to the central “hub” (the EMVS) through which they upload the unique identifiers used to determine the authenticity of medicines, is also behind schedule with fewer than 300 of the expected 2,500 connected so far, well behind the planned target of 1,900 by the end of 2017.

Some countries, including Ireland, Germany and Sweden, are making good progress. They have set up their NMVSs and are planning to start pilot testing with selected pharmacies, wholesalers and hospitals in early 2018.

The spectre of Brexit still hangs over the UK’s progress with implementing FMD. Although the UK Government maintains that it is committed to implementing FMD by February 2019, before the UK leaves the European Union at the end of March 2019, uncertainty over what will happen afterwards has delayed progress and the UK has fallen back compared with other countries.

Arvato holds FMD workshop for pharmacy IT suppliers

Arvato Systems, which will be implementing the UK’s National Medicines Verification System (NMVS) on behalf of SecurMed UK, has held a workshop session for the main suppliers of IT systems for community pharmacies.

The workshop was held at the National Pharmacy Association in St Albans and hosted by the UK FMD Working Group for Community Pharmacy. During the event, Arvato and SecurMed UK outlined their plans for developing the NMVS and invited the IT suppliers to register for the software development kit and access to Arvato’s test-bed systems.

Connecting IT suppliers to the early-stage NMVS is the first step in a process which should lead to all pharmacies, wholesalers and others handling medicines being connected. This will enable them to undertake the authentication of medicines required under the Falsified Medicines Directive.

Arvato is also holding workshops for IT suppliers to wholesalers, hospitals and dispensing doctors.

SecurMed UK appoints Arvato to develop verification system

SecurMed UK has signed a letter of intent with Arvato Systems GmbH as the Blueprint Service Provider (BSP) for the UK. The two organisations have started work to plan the implementation of the UK’s Medicines Verification System.

Arvato’s role will be to develop, implement and maintain the National Medicines Verification System (NMVS) that is required as part of the EU Falsified Medicines Directive. Pharmacies, wholesalers and others handling medicines will connect to the NMVS in order to authenticate medicines. This will be done by comparing the unique identifiers on packs of prescription medicines with data uploaded by manufacturers through the central “hub”, the European Medicines Verification System (EMVS).

One of Arvato’s first tasks will be to engage with the IT providers who supply the patient medication record systems used by community pharmacies. FMD authentication could be handled by add-ons to existing PMR systems or by developing stand-alone systems to go alongside PMRs. It is likely to be up to pharmacy owners to decide which type of system they will install.