In order to comply with the requirements of the FMD directive pharmacy contractors will need to ensure their premises connect electronically with the National Medicines Verification System (NMVS).

Once the NMVS is finally ready the Blueprint Service provider Arvato and the UK National Medicines Verification Organisation (NMVO) SecurMed UK will be responsible for ensuring all pharmacy contractors, and other persons permitted to supply medicines to the public, can connect to the system to enable scanning and decommissioning to occur. This process is termed “on-boarding” or registration.

In order to connect to the NMVS the NMVO will need to identify legitimate pharmacies and establish an account for them.  

It is important that on-boarding is completed well in advance of the February 2019 "go live" date to ensure contractors are ready and able to comply with the legislation. The UK FMD working Group for Community Pharmacy has urged SecurMed UK and Arvato to issue guidance on the registration process as soon as possible. The working group is trying to ensure that pharmacy contractors have full connectivity before the 31st October 2018, so that pharmacy contractors can avoid changing their IT systems during the busy Christmas period.

Potential IT Solutions for FMD

Contractors will have the option of two distinct IT solutions to provide the interface between their pharmacy and the NMVS. These options are:

  • FMD capable PMR system
  • Stand-alone FMD (only) system

It is likely that because of the complexity of adding FMD capability to existing PMR systems that the stand-alone option will be available earlier. 

Each contractor will be able to choose the system that best meets the requirements of their individual pharmacy. Contractors are strongly advised to consider the full range of options before investing in an IT system as switching to a different IT solution at a later date will incur additional cost and disruption.

The FMD capable PMR option will expand the functionality of the contractors existing PMR system to allow scanning, verification and decommissioning of prescription medicines to take place.

The UK FMD working Group for Community Pharmacy has identified the following as key advantages and disadvantages of this type of system:

Advantages:

  • Ability to generate aggregated codes
  • Maintain relationship with existing PMR provider
  • Potential for on-going developments such as accuracy checking (as discussed later in this article)

Disadvantages:

  • Increased initial cost
  • Pharmacy layout may need to be adapted to incorporate additional PMR terminals*
  • Changes to dispensary assembly workflow process is highly likely

*An additional PMR terminal may be necessary where the dispensing process would be significantly disrupted by the decommissioning of medicines at the point of supply to the patient. The pharmacy layout may require modification where the available terminals for decommissioning are not located close to the reception area.

A stand-alone FMD (only) option will be a system distinct from the pharmacies existing IT systems. This option will have the single function of scanning the UI on FMD compatible products to facilitate verifying and decommissioning of the medicine prior to supply to the patient. In the short term this may be the cheaper and easier to source option although it is unlikely to offer the potential for additional functionality at a later date.

A stand-alone system has the following advantages and disadvantages:

Advantages:

  • May be cheaper to obtain and install
  • Scanning at the dispensary reception will have less of an impact on the assembly of prescriptions

Disadvantages:

  • Additional power and network connection will be needed
  • Scanning at the counter takes time, increases queues and could negatively impact patient confidentiality
  • On-going development to include additional functionality such as accuracy checking less likely than with an integrated system
  • May not be available from the pharmacies existing  IT system supplier
  • May require additional space within the dispensary dependent on the system configuration
  • Pharmacy could incur additional costs if the PMR capable option is adopted at a later date

Both the FMD capable PMR and stand-alone systems will need to satisfy pre-determined standard requirements along with selected optional requirements as specified by the UK FMD working Group for Community Pharmacy.

Examples of the standard system requirements include:

  • Scanners must be able to scan prescription or token barcodes, UI 2D data matrix codes, or aggregated codes (where used)
  • System must be capable of verification scans, decommissioning and re-commissioning
  • Provision of feedback to the user on pack status, successful decommissioning, decommissioning errors or failures, successful re-commissioning
  • Must be able to support an offline function
  • Functionality to support manual entry of the UI
  • Facility to print multiple aggregated bag labels and link the bags together e.g. for prescriptions including controlled drugs or fridge lines

The full system specification is available on the UK FMD Working Group for Community Pharmacy website (http://www.fmdsource.co.uk/) and can be accessed here.

EMIS have provided information for pharmacy contractors regarding the FMD compatibility for the ProScript system. Access via EMIS.

See details of FMD compatible options available from other PMR system suppliers (FMD source)

Future developments

Before committing to an FMD IT system contractors are advised to consider the possible future developments and additional functions that could be incorporated into their chosen system. The information included in the 2D data matrix (UI) may enable these systems to support additional functions including:

  • identify specific products supplied to individual patients supporting patient level recalls
  • date checking and electronic checks of expiry dates
  • enhanced stock control options
  • accuracy checking functionality to reduce the incidence of dispensing errors resulting from product mis-selection

Funding

At present the key restrictor in developing the IT interfaces to support FMD compliance is funding. The development of these systems will require considerable financial input the source of which has yet to be confirmed.

The EU directive specifies that the cost of establishing the NMVS will be met by the manufacturers, i.e. companies that hold the marketing authorisations for branded, generic and parallel imported medicines. In addition the delegated regulation specifies that each sector, including pharmacy, will be expected to bear the individual cost of the IT system option they choose including the initial set up costs for both the software and hardware and any additional on-going operational costs.

At present there has been no confirmation of this financial burden being underwritten by the government, although the trade and negotiating bodies representing pharmacy contractors in the discussions with DHSC and MHRA over the implementation of FMD are pressing the government to guarantee the underlying funding. This will ensure that the costs incurred by contractors in meeting the requirements of FMD are recognised in future funding settlements.