Dear PharmaPlus Member,

Over the last few months FMD has been a hot topic of conversation on our WhatsApp group and via email. Discussions have been surrounding the process, costs and how best to implement this in your pharmacies.

We understand that members are frustrated and angry with FMD but Pharma Plus would like to reiterate that members need to be FMD ready by 9^th February 2019 regardless of Brexit and/or any other uncertainty surrounding Pharmacy. It’s your regulatory responsibility to comply with this directive and therefore recommend that members choose either of the two FMD solutions negotiated by Pharma Plus.

Below we have summarised our current view, Pharma Plus FMD deals and details of some of the common concerns/ topics:

1.   Pharma Plus FMD deals – PMR integrated and Standalone

2.   Operational considerations in your pharmacy (Layout & Dispensing Process)

3.   Funding the extra costs of FMD

4.   Enforcement and sanctions for non-compliance to FMD standards

We hope this message helps clarify certain aspects of FMD and please contact the Pharma Plus office on 0208 863 3335 for further information on getting ready for FMD by 9^th February 2019.

1. Pharma Plus FMD deals – PMR integrated and Standalone

PMR integrated:

Emis Health - ProScript Connect Integrated FMD Solution – Click here for full details  

Standalone FMD

FMD IT – FMD Pharmacy Connect Standalone Solution – Click here for full details

To help with funding, Pharma Plus have subsidised both our deals with ProScript and a standalone solution by FMD IT. We realise the pressure on members regarding funding & hope that the steps taken by Pharma Plus will help reduce that pressure somewhat.

2. Operational considerations in your pharmacy (Layout & Dispensing Process)

When choosing the FMD solution you will need to consider many aspects. These include pros and cons of integration to the PMR, the cost, training, extra future functions such as error checking. You may need extra power points, network points and in some cases extra PMR terminals too. Your EPOS system may also connect to FMD.

The pharmacy layout and dispensing process you use are important to consider.

The 3 main new tasks that need to be undertaken are:

A)     Check the pack, Anti-Tampering device and verify the pack is still “Active” to supply

B)      Aggregate the packs (at normal checking & bagging)

C)      Hand out / deliver and Decommission the pack (or bag)

A typical pharmacy has two PMR terminals in the dispensary, a checking area and a pharmacy counter with EPOS tills. As you can see from the above you will need to consider where you will place FMD scanners (and maybe new equipment / extra PMRs). Which terminal will be used for the FMD process parts? Otherwise you risk constant interruptions to the dispensing process when any of the above need to be performed as they all need a scanner and screen.

3. Funding the extra costs of FMD

PSNC are have issued the following statement regarding funding (please see below). 

Funding for FMD

"The costs of establishing the UK’s National Medicines Verification System are to be borne by manufacturers of branded and generic medicines and parallel distributors. Under the Delegated Regulation, each sector, including pharmacy, is responsible for its own costs for connecting to the NMVS. The PSNC, is working to ensure that contractors’ FMD-related costs are recognised in future NHS funding settlements. Some of the costs involved include initial set-up, IT, both software and hardware, plus ongoing operational costs.”

4. Enforcement and sanctions for non-compliance to FMD standards

The Department of Health and Social Care (DHSC) and MHRA are currently consulting on enforcement and sanctions. An outcome we be published in due course.

If the Government decide to adopt the approach to enforcement and sanctions which they proposed in their consultation, it is likely:

• that the General Pharmaceutical Council will enforce the requirements in community pharmacies; It expected this will be incorporated into normal GPhC inspection process. This indicates a failed inspection could occur and usual process for that may be used.
• Furthermore, the GPHC may refer serious cases to other authorities and a mixture of both criminal and civil sanctions could be used to tackle non-compliance, but criminal sanctions would only be used for the most serious (intentionally fraudulent) breaches.

We hope this message helps clarify certain aspects of FMD and please contact the Pharma Plus office on 0208 863 3335 for further information on getting ready for FMD by 9^th February 2019.