The new hub and spoke dispensing regulations came into force on Tuesday (1), as do the Human Medicines Regulations 2012 (HMRs) hub and spoke changes announced in April this year.
They complement each other and apply to owners of NHS spoke pharmacies/pharmacy owners when the hub pharmacy is owned by a different legal entity.
Hub pharmacy owners must comply with the HMRs and may be impacted by contractors (spoke) complying with their Terms of Service.
Under the Terms of Service, contractors may not subcontract ‘core dispensing activities’ (broadly the assembly or part assembly of any prescription item, which includes labelling and bagging) unless certain conditions are met.
Before agreeing, the contractor must take steps to ensure that the owner of the hub pharmacy is a fit person to carry out the core dispensing functions on their behalf.
The hub owner must confirm that they have suitably qualified and trained staff, appropriate indemnity cover in place, and a business continuity plan.
The contractor should give notice to their integrated care boards (ICB) of the hub and spoke arrangements (using the NHS England-approved written notification form) not less than 28 days before the hub and spoke arrangements are intended to commence.
The contractor may commence the hub and spoke arrangements if there is no objection from the ICB within those 28 days.
The contractor should ensure the core dispensing functions are to be subcontracted under written hub and spoke arrangements with the hub pharmacy owner.
The written arrangement should provide a comprehensive statement of the responsibilities of the spoke and the hub for the core dispensing activities.
