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Pharmacy owners may be surprised by some factors included in the long-awaited consultation on hub-and-spoke dispensing, but the government has not provided details on some key areas, says Noel Wardle
After many years of discussion, and a previous aborted attempt, the Department of Health and Social Care (DH) has finally started a consultation on proposed changes to UK legislation that would enable wider use of hub-and-spoke dispensing (that is, the supply of medicines would involve part of the dispensing process taking place at premises – the hub – other than the supplying pharmacy – the spoke).
Read more: Hub and spoke: NPA says DH’s £4k set-up cost per pharmacy is ‘very low estimate’
By way of a reminder, the law as it currently stands allows for hub-and-spoke dispensing, but has two main restrictions: the hub and the spoke pharmacies must be owned by the same legal entity and the medicines that have been prepared by the hub must be supplied to the patient via the spoke pharmacy in order for the spoke pharmacy to claim for payment. The consultation proposes to remove those two restrictions and make some other legislative changes.
The consultation document is lengthy, but the main headlines of the proposals are:
Making it clear that the proposed legislation changes are enabling, not mandatory. Pharmacy businesses can choose whether or not to participate in a hub-and-spoke dispensing scheme.
Removing the part of the Medicines Act 1968 that currently only allows a hub to assemble medicines on behalf of a spoke that is part of the same retail pharmacy business.
Enabling the hub pharmacy to supply medicines either back to the spoke pharmacy or directly to the patient.
Defining any supply by the hub as a retail supply, even if the medicine is being sent back to the spoke, thereby removing a concern that the supply by the hub to the spoke would be a wholesale supply (and would require the hub to hold a wholesale dealer’s licence). However, this only applies if there are “arrangements” in place between the hub and spoke.
Requiring any spoke pharmacy that is participating in a hub and spoke arrangement to display a notice in the spoke pharmacy that provides details of the hub pharmacy or pharmacies being used. The DH does not think patients should have to be told explicitly about the use of a hub pharmacy or to have to “opt-in”, but leaves open the possibility that patients could choose to “opt-out”.
Clarifying that the dispensing label can include details of either the hub or the spoke pharmacy. This is, again, an example of the DH wanting maximum flexibility in the system.
I anticipate that the proposal that hubs can supply directly to patients (without the medicine having to go back to the spoke pharmacy) will come as a surprise to many pharmacy owners. However, there are some other areas where the consultation is either silent, or the DH is leaving the issues to others to resolve.
Read more: 'Pharmacy's hub-and-spoke model: we must consider the profound business impact’
In relation to the question of professional accountability, the consultation document provides that there should be “arrangements” in place between the hub and the spoke. There isn’t any detail on what these “arrangements” may look like – the DH has opted for maximum flexibility by not defining which activities should take place at each site as a minimum and who would be responsible for those activities. For example, the consultation is silent on the issue of professional accountability for the various parts of the dispensing process that are taking place at the hubs and spokes.
The DH notes that both the hub and spoke would have to be registered pharmacies (or the spoke can be a dispensing doctor), in which case they would both be regulated by the General Pharmaceutical Council (GPhC). The consultation document notes that “it is for [the GPhC] to consider how they will regulate hub-and-spoke dispensing”.
I would imagine that many pharmacy owners would prefer to have an idea how the GPhC “will regulate hub-and-spoke dispensing” at this stage, as this may be an important part of the wider debate that would feed into the current consultation.
Another area where the consultation is leaving the detail to others is around the impact of the proposals on the NHS market entry regime. As stated above, the consultation proposes that the hub may supply either back to the spoke for onward supply to the patient, or may supply directly to the patient.
Since the hubs will not be NHS pharmacies – they will not be included in a pharmaceutical list – this raises the prospect of supplies being made directly to patients from unlisted pharmacies. This creates a risk of undermining NHS market entry rules because there may be nothing to stop notional “hubs” opening up around the country and supplying directly to patients. The DH is alive to these risks, but states that “these need to be addressed through amendments to the [NHS pharmaceutical services regulations] in discussion with the Pharmaceutical Services Negotiating Committee (PSNC)”.
Again, community pharmacists may have preferred to have some reassurance about these risks as part of the current consultation rather than waiting until after the law has been changed.
On the subject of NHS regulation, the consultation is also silent on the issue of remuneration. It will be for the hub-and-spoke pharmacies to decide how the hub will be remunerated for the dispensing and supply service (both in terms of the dispensing cost and reimbursement for medicines).
But there is nothing in the consultation on the practicalities of how spoke pharmacies would claim for payment for orders that have been sent to the hub for dispensing and onward supply. For example, can the spoke pharmacies claim for payment when the order is transferred to the hub, or do they have to wait for the hub to confirm supply has been made and, if so, how will that be confirmed? Also, how will spoke pharmacies know what to endorse on the prescription, and who will be responsible if the endorsement does not reflect what the hub has supplied?
The consultation is also silent on the pharmacy’s patient medication record (PMR) system. The current regulations state that the pharmacy which is supplying medicines to the patient must hold the PMR details. Where the supply may be made by the hub or the spoke, does the obligation to hold the PMR details rest with the hub, the spoke or both?
While the DH consultation does provide quite some detail about how proposed changes to the law on hub-and-spoke dispensing will work, there are still some areas to be resolved, and it seems unlikely that these will all be dealt with as part of the consultation and any subsequent law change.
If the law is changed as proposed in the consultation, some of the detail will be down to the GPhC and negotiations between PSNC and the DH. This uncertainty may make some contractors nervous, even though the goal of “maximum flexibility” may be laudable.
There is no timeline for the proposed regulatory change, but the consultation closes on June 8, 2022. Even if the law is changed, it is clear that there will have to be further work before the changes can be fully implemented.
Noel Wardle is a solicitor and Partner at Temple Bright LLP, specialising in pharmacy law.
Last year, C+D's Big Debate asked whether independent pharmacies can ever truly benefit from a hub-and-spoke dispensing model. Head to the Big Debate room to read what people had to say and join the discussion.
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Subject: ‘The DH’s hub-and-spoke dispensing consultation remains silent on key areas’
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