The Healthcare Distribution Association (HDA UK) has raised fundamental concerns about government proposals for widespread adoption of hub-and-spoke dispensing models.

In its response to the government’s Human Medicines Regulations 2012 consultation, HDA UK warned that hub-and-spoke technology was at a very early stage and the consequences of its introduction were not fully understood. It said that estimates of 45 per cent of medicines being dispensed through hub and spoke were "on the high side".

The HDA (formerly the British Association of Pharmaceutical Wholesalers) also warned the proposed legislative changes could open medicines distribution to new providers who might not be required to match the high quality and safety standards of the MHRA-endorsed HDA Gold Standard of Good Distribution Practice. Although these new providers would be subject to GPhC regulations, the distribution standards are not compatible with those currently in place for wholesale distribution.

The HDA argued that:

• The MHRA should be responsible for inspecting hubs and hub-to-spoke transportation to ensure they comply with wholesaling levels of European Union regulations for good distribution practice
• Pharmacy regulations for the appropriate storage and transportation of medicines should be reviewed to take into account the changes in pharmacy storage and transportation models prompted by hub and spoke.

It was also imperative that the distinction is made between hub and spoke and centralised dispensing, said the HDA. "The HDA feels it is crucial that the patient-pharmacist relationship is maintained and therefore does not support centralised dispensing, which sees prescriptions sent directly to patients," it said in its response. "It is a model that has been shown to be challenging and a substantial risk to patients receiving their medicines safely and in a timely manner. However, hub and spoke technology does have the potential of freeing-up the time of ‘spoke’ pharmacists to deliver further patient-centric services."

The HDA also asked the government to look into additional issues raised by the consultation, namely:

• The impact from hub and spoke on the implementation of the EU Falsified Medicines Directive (FMD)
• The need for contingency planning as a result of stock being centralised in large hubs
• The potential disruption to the certainty of supply of medicines, which could be caused through the challenging of any existing supply arrangements between pharmaceutical manufacturers and wholesalers.