(FMD) Falsified Medicines Directive

Falsified Medicines Directive: Guidance for Pharmacies

Please read the following guidance for pharmacies on the impending Falsified Medicines Directive coming on 9th February 2019:

New FMD guidance for community pharmacy contractors 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 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 after 2019, what IT systems will need to deliver and implications for patient safety.

FMD system suppliers list

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.PSNC recommend that pharmacy contractors that have not yet started to prepare for the introduction of FMD on 9th February 2019, should:

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.

Click here to visit PSNCs FMD Page

FMD Source – is a new website developed for the UK FMD Working Group for Community Pharmacy

This website provides UK community pharmacies with authoritative and reliable information on how to implement the Falsified Medicines Directive (FMD).

Community pharmacies must comply with the requirements of FMD from 9th February 2019 onwards.

Visit FMD Source at https://fmdsource.co.uk/

PSNC Webinar

Community pharmacy contractors can now access an online recording of PSNC’s recent webinar about the Falsified Medicines Directive (FMD).

Click here to view an on-demand version of the webinar.*

You can also click here to view the slide pack used in the webinar.

*Please note, to watch the recording, you will need to register (or input the email address you registered with previously).

Falsified Medicines Directive toolkits 

NHS Digital have produced guidance toolkits to support the NHS in implementing the Falsified Medicines Directive (FMD).

Toolkits for community pharmacies and secondary care providers are now available on the NHS Health Developer Network.

If you have an NHS email address, you can also join the FMD Google+ community. Please email FMD@nhs.net to request an invite.

If you work in secondary care or community pharmacy and are interested in working with us as an early adopter, please register your interest by email: FMD@nhs.net 

Falsified Medicines Directive (FMD) – registering as an end user

All community pharmacy are classed as end users and must register with SecurMed to enable them to scan and decommission POM from 9th February 2019.

As the 9th February 2019 is fast approaching SecurMed are receiving a large number of registration requests.

The Registration process to create an account requires the following steps:-

Select a software provider and ensure readiness to connect to UK MVS The system uses locations not people to define access. UK post codes are used to define locations as registered on appropriate registration databases e.g. GPhC, CQC, EudraGDMP
Decide whether you are registering one or many locations The system uses locations not people to define access. UK post codes are used to define locations as registered on appropriate registration databases e.g. GPhC, CQC, EudraGDMP
Follow the End User Registration Process through this website Either the company or its representative (e.g. software supplier). Follow the instructions on the portal, selecting either single or bulk registration. You will need to agree to accept the EULA T&Cs to complete registration
Access credentials will be sent to you by two separate communications Once the request is verified, access credentials will be sent back via email and via postal mail in 10 to 15 days. The content of both will need to be used in conjunction to validate connection.

https://www.securmed.org.uk/register/end-user-registration/

SecurMed web information
https://www.securmed.org.uk/

Royal Pharmaceutical Society –  Guidance
https://www.rpharms.com/resources/ultimate-guides-and-hubs/fmd

GPhC – will be the regulator
As the regulator for registered pharmacies in Great Britain, the GPhC will use its existing inspection processes to assess whether pharmacies are meeting its standards. For those registered pharmacies that are found not to have met the standards for registered pharmacies, and where a contributing factor relates to breaches of the new safety feature provisions, the GPhC will use its regulatory powers, including improvement action plans, to make sure that pharmacies take action to meet the standards and requirements under legislation.
https://www.rpharms.com/resources/ultimate-guides-and-hubs/fmd