Community Pharmacy England (CPE) has today (April 30) announced that the government has laid new amendments to the Human Medicines Regulations 2012 (HMR) allowing pharmacies not owned by the same legal entity to start hub-and-spoke dispensing by the end of October.
It said that the legislative changes have “permitted” model one of hub-and-spoke – in which a patient brings a prescription to the spoke pharmacy and the pharmacy sends it to the hub, which prepares and assembles the medicines before sending them back to the spoke.
Read: Government to introduce hub-and-spoke regs in ‘the coming weeks’
And it added that the HMR amendments have set rules around how the model must work in practice, including that:
- The spoke pharmacy “must have entered into written arrangements” with the hub pharmacy that “must include a comprehensive agreement of the responsibilities each has” in the dispensing process
- “The spoke must sell, supply or dispense the medicine to the patient, the hub having assembled or part assembled it”
- The dispensed medicine “must be labelled with the spoke’s name and address and the date on which the hub assembled or part assembled the medicine” as well as the usual information required
- Both pharmacies can share patient data with each other – without their “explicit consent” – through an “information gateway” that requires the spoke to “display an appropriate notice to patients” and staff at both to maintain the confidentiality of the patient data
“Notify their ICB”
CPE revealed that it is now discussing “associated amendments” to NHS regulations with the Department of Health and Social Care (DH).
It added that “these amendments are likely to include a requirement that NHS spoke pharmacies must notify their integrated care board (ICB) 28 days in advance of commencing hub-and-spoke dispensing for NHS prescriptions”.
Read more: Government set to ‘introduce’ hub-and-spoke legislation in 2025
CPE said that October 1 – the date that the HMR amendments come into force – is set to be “the earliest that an NHS spoke pharmacy will be able to notify their ICB”.
Therefore “the use of hub-and-spoke dispensing would only be able to start at the earliest on October 29” this year, it added.
Currently, hub-and-spoke dispensing is only permitted between pharmacies within the same legal entity – meaning smaller independent pharmacies have been excluded from it.
How did we get here?
Last month, the government announced that it was “going with” hub-and-spoke model one, instead of model two, in which the hub sends the medicines directly to the patient’s home rather than to the retail pharmacy.
In December, pharmacist MP Sadik Al-Hassan said that hub-and-spoke legislation is the “only” way to expand pharmacy capacity in Parliament.
Read more: Promised hub-and-spoke legislation delayed indefinitely
He stressed that ministers should focus on “finally implementing the hub-and-spoke legislation, which was inexplicably shelved in September without warning or explanation”.
In the autumn, the government indefinitely delayed changes to the legal status of hub-and-spoke arrangements that were set to come into force in January.
At the time, it said that it was “not in a position to implement these proposals” by the beginning of 2025.
Read more: We just bought 45 pharmacies - now we have an urgent need for Hub and Spoke
The previous government dithered on publishing its hub-and-spoke response for more than two years after launching a consultation in March 2022, after a previous consultation on the model in 2016.
At the time, feedback was mixed – with CPE claiming that the proposals were “more likely to add cost to the community pharmacy sector”.
