News

HDA UK MEDIA AND POLITICAL BULLETIN – 21 August 2017

MEDIA SUMMARY 

DDA adds voice to FMD concerns
Dispensing Doctors, Ailsa Colquhoun, 21 August 2017

The DDA has joined forces with pharmacists to fight for more support to implement the Falsified Medicines Directive (FMD). The FMD is due to be introduced in 18 months time. DDA Chairman, Dr Richard West, said: “Dispensing doctor practices have seen no evidence of any preparedness by the GP IT system suppliers, NHS Digital, or NHS England for the implementation of the FMD…Given the current financial constraints in general practice, there is no way that dispensing practices can afford the costs associated…”. The DDA has already identified the FMD as a current challenge for dispensing practice, and has publicly expressed worries that the FMD imposes additional costs on the NHS just as it shifts resources to negotiate and implement a Brexit agreement. The DDA’s views on implementation of the FMD were also endorsed by Numark, an independent pharmacy membership organisation.

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DDA adds voice to FMD concerns
Dispensing Doctors, Ailsa Colquhoun, 21 August 2017

The DDA has joined pharmacists in the fight to see more support for dispensers faced with managing the practical implications of the Falsified Medicines Directive (FMD). This is due for implementation in the UK in around 18 months’ time.

DDA chairman, Dr Richard West, said: “Dispensing doctor practices have seen no evidence of any preparedness by the GP IT system suppliers, NHS Digital, or NHS England for the implementation of the FMD.  There is no question that implementation will be workload intensive and require significant changes in working practices within dispensaries.  Given the current financial constraints in general practice, there is no way that dispensing practices can afford the costs associated with either the workload, or the acquisition of compliant IT systems, for the FMD.”

In information for pharmacies that also applies to dispensing practices, the UK FMD working group, FMDSource, gives general pointers to the additional processes to be implemented in dispensaries by the February 2019 FMD deadline. These include the following potential changes to SOPs:

  • Extra assembly processes to include FMD authentication and decommissioning (dispensing)
  • Processes to deal with any unexpected results (such as product recalls)
  • Processes to manage (create and decommission) “aggregated codes”. An aggregated code associates multiple products’ unique identifiers/barcodes with a single code; when created, this will manage all individual products’ barcodes in one action
  • Processes to reverse products that are decommissioned but not collected
  • Processes to manage special forms of dispensing, eg monitored dosage systems and other compliance aids, split packs and reconstitution.
    – MDS: It is expected that authentication and decommissioning will need to take place at the start of assembly, with no further FMD processes required
    – Split packs: FMD authentication must take place when the pack is first used – no further re-authentication is required for the remainder of a pack
    – Reconstitution: Dispensing staff may need to explain to the patient why the anti-tamper device (seal) is not intact.
  • Processes to manage returned medicines:  Under FMD, wholesalers have an obligation to verify all relevant medicines returned to them. Wholesalers will need to check that returned products still have an “active” status before accepting them back into stock.

The DDA has already identified the FMD as a current challenge for dispensing practice, and will ensure that members are fully supported when further details of the implementation processes are available. Dr West said: “Given that Brexit is supposed to mean Brexit, I am deeply concerned that the NHS is to be loaded with additional costs and workload associated with EU legislation, at the very time that the UK is negotiating to leave the institution.”

The DDA’s views on implementation of the FMD are endorsed by Numark, an independent pharmacy membership organisation. The DDA has joined Numark in calling for urgent action to resolve dispensers’ concerns.  Numark director of marketing Mandeep Mudhar told the DDA that what dispensers need most is “a regular flow of information and a countdown to it going live”.

He said imperatives include a clear rationale for the initiative, training, SOPs and troubleshooting support for dispensers. “There are still so many gaps – who is paying for it, who will supply scanners, what happens if we leave EU.  But where are all the parties in this? Do the PMR providers have the clarity they need?  Are the representative bodies embracing and ready – or are we all playing the ‘it will never happen’ card?

He added: “Our next step is to start asking for more clarity and for our representative bodies to … start going more public and vocal on this topic.  PMR providers are critical too, as they will have to support the scanner.”

HDA UK MEDIA AND POLITICAL BULLETIN – 21 August 2017

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