Mitigations and proposed legislative amendments will 'ensure patient safety, transparency and accountability’ in hub and spoke changes, the government has said in its consultation response.

The planned changes will allow hubs to assemble medicines and then send them to back to the spoke for supply to the patient, or directly to the patient.

This second direct-to-patient model was opposed by the community pharmacy negotiator in its 2022 response to the consultation, citing patient safety concerns.

'Model 2 in the consultation, a hub direct to patient supply of dispensed medicines, raises patient safety issues and we cannot support this model,' Community Pharmacy England (CPE) said in 2022.

But in its consultation outcome this week, the government said that it believed it had ‘taken appropriate action' to address concerns and had provided mitigations and proposed legislative amendments ‘to ensure patient safety, transparency and accountability’.

Gordon Hockey, CPE director of legal, told The Pharmacist this week that hub and spoke reform was 'long overdue' and the negotiator was 'pleased to finally get an indication of the government’s plans for this'.

'However, much still needs to be done to develop a model that works for community pharmacy, and we are already working with DHSC to consider the implications of these changes for NHS dispensing in England,' he said.

'Written arrangements' must be in place

In 2022, CPE suggested that 'Local non-automated hub and spoke arrangements that are informal and unwritten could result in misunderstandings or responsibilities between hubs and spokes'.

And in the government's final proposals published this week, the Department of Health and Social Care (DHSC) said that the hub and the spoke must have 'written arrangements' in place that set out the responsibilities of each.

‘We think this is one of the key pillars to ensure that there is accountability so the supply of medicines through hub and spoke arrangements is safe and effective,’ the government said.

Hubs will be regulated by the GPhC or appropriate regulator

Both the hub and the spoke must be registered as retail pharmacies and therefore will be subject to regulation by the General Pharmaceutical Council (GPhC) in Great Britain or the Pharmaceutical Society of Northern Ireland (PSNI), as hub and spokes operating within the same legal entity already are, the government said.

Roz Gittins, chief pharmacy officer and deputy registrar at the GPhC, said that the regulator would be reviewing its inspection methodology to ensure it reflects any changes to legislation as a result of the government response to the hub and spoke consultation.

Patients must be clear who to talk to

In its 2022 response, CPE suggested that 'patients may receive medicines from a number of hubs' which could be difficult to manage in the case of any issues, while patients receiving medications directly from a hub might not have a relationship with the person dispensing their medication or know who to turn to with problems.

It added that 'the ability of the spoke to intervene for patient safety reasons' could be 'reduced or lost' in a hub-to-patient model.

And it warned: 'supply from a hub reduces the opportunity to drive value through spokes in the provision of clinical services – every contact should count'.

In this week's consultation outcome, the government proposed that either the hub or the spoke may be named on the dispensing label – but not both, to ensure that the patient is clear about who to talk to about their medication.

‘The government recognises that the implementation of hub and spoke introduces new risks, just as any change or new process carries risk,’ it added.

But the Royal Pharmaceutical Society (RPS) has suggested that the proposed labelling requirements ‘may confuse the public’.

RPS president professor Claire Anderson told The Pharmacist: ‘Patients and the public have the transparency and knowledge of where their medications and personal data are being sent and supplied from.’

Automation and increased capacity could improve patient safety

While recognising the caveats raised by some respondents to the consultation, the government said that ‘a proportion of both individuals and organisations felt that patient safety would be at least as good or would be improved by hub and spoke dispensing, as long as appropriate arrangements and processes were in place’.

For instance, it said there was evidence that ‘while error rates in community pharmacy are already very low, the error rates using automation can be even lower, with the right arrangements in place’.

‘In addition, we received evidence from respondents to suggest that there can be calmer, more focused, working environments in both the hub and spoke - for example, staff working in the hub are likely to face fewer disruptions to the dispensing processes that they are responsible for and so are less likely to make errors. At the spokes, staff have more time to deal with complex issues and patient-facing work, so are less likely to make errors,’ the government added.

‘Further, having more time to explain medications to patients could increase compliance.’

Acute prescriptions may not be suitable for hub and spoke

‘Some prescriptions, such as acute ones for pain management, antibiotics or where a patient has run out of their repeat medication, may not be suitable for the hub and spoke models,’ the government acknowledged in response to concerns that the hub and spoke process could cause access to medicine to be delayed.

And it said that it saw hub and spoke models ‘being of use in the main for patients who are stabilised on repeat prescriptions and so normally do not need their repeat medicines immediately’.

‘This issue of timing will be for each hub and spoke to address when they establish their operational processes - we have received anecdotal evidence that some of the existing hub and spoke models work to next day timescales,’ the government added.

Hub and spoke ‘not compulsory’

The government also stressed that it was ‘not compulsory for pharmacists to use either or both hub and spoke models if they do not wish to’.

‘Model 2 [hub to patient] was included so as to not stifle innovation and could also be useful where the spoke pharmacies or dispensing doctors are already offering a delivery service to patients - in these cases, it would be quicker for the patient to receive their medication directly from the hub rather than for the hub to send it back to the spoke and then for the spoke to deliver it to the patient,’ the government said in its consultation response.