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Making sense of the Falsified Medicines Directive In preparation for the European Falsified Medicines Directive, new resources are now available for those working in community pharmacy in the UK. A new resource hub FMD Source (www.fmdsource.co.uk) has been launched to provide UK community pharmacists and their teams with detailed information to help them prepare for the start of the EU Falsified Medicines Directive (FMD). FMD Source has been developed by the UK FMD Working Group for Community Pharmacy which brings together all the main bodies representing community pharmacy to influence and inform the implementation of FMD in the UK. It is designed to help UK pharmacies prepare for whatever new authentication systems are developed and introduced. Under the EU Directive, all new packs of prescription medicines placed on the market in Europe from February 2019 onwards will have to bear two safety features: a unique identifier (UI) in the form of a 2D data matrix (barcode) and an anti-tamper device (ATD). The UK’s database will be developed by a new organisation, SecurMed UK, which comprises of all the main supply chain
to the database, as well as for software upgrades. The pharmacy negotiating bodies are represented on the UK FMD Working Group and are working hard to ensure there is a pragmatic solution that recognises the additional costs and impacts that FMD could have on community pharmacies and their suppliers.
bodies representing manufacturers, wholesalers and pharmacies. Pharmacy is represented jointly by the NPA and CCA and Raj Patel of the NPA is currently the “dispensing entities” Director of SecurMed UK. Who will be paying for FMD? The costs of establishing each database is to be borne by manufacturers of branded and generic medicines and parallel distributors though additional licensing fees. Pharmacies and wholesalers will be responsible for making their connections
Updated NHS Identity Guidelines: NHS logo use by pharmacies NHS England has updated its guidelines on the use of the NHS Identity, including revised guidance for all primary care contractors who are commissioned under a primary care contract such as community pharmacy contractors. The updated guidelines include information on the use of the NHS logo, which is a registered trademark protected by copyright. Contractors who choose to use the NHS Identity must ensure that the revised guidance is adhered to and the new guidance includes a range of best practice examples demonstrating the correct use of the NHS Identity on various materials and in digital applications. NHS England has advised that implementation of the updated NHS Identity guidelines should be gradual; existing offline materials should continue to be used until they need to be replenished or replaced. Contractors are, however, advised that they should aim to update existing digital channels, such as websites and social media accounts by January 2018. A PSNC Briefing has been published summarising the main changes to the NHS Identity guidelines; read and download it from: ow.ly/hQIg308Xl6Y
What about Brexit? Although the result of the referendum in 2016 has started the UK on a path towards leaving the European Union, it is unlikely that this will have taken place before FMD scanning and authentication comes in to effect from 9th February 2019. Other EEA countries and Switzerland are also participating in FMD. The full implementation of FMD may depend on the UK’s future relationship with the EU. Pack serialisation is now a global approach to tackling falsification and similar systems are being developed in many markets, including India and China. As a result, serialised packs are already appearing in UK pharmacies.
Annual NHS complaints report now due Community pharmacy contractors are reminded of the need to prepare their annual NHS complaints report for 2016/17. The annual complaints report covers a number of aspects and must be available to any person on request. Information and guidance on how to compile the report can be found on the NHS Complaints Procedure part of the PSNC website: psnc.org.uk/NHScomplaints A copy of the completed report should be sent to the pharmacy’s local NHS England team as soon as practicable after 31st March 2017. Even if a pharmacy has not received any complaints, the contractor must prepare a complaints report confirming that they have received no complaints as part of their terms of service.
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