Drug wholesalers vent concerns about government’s hub and spoke plans

Medicines and Healthcare Products Regulatory Agency

A trade body representing drug wholesalers who distribute more than 92% of NHS medicines has warned that the full implications of hub and spoke technology have yet to be determined and its widescale implementation risks reducing the quality and safety of dispensing.

Responding to the UK government’s Human Medicines Regulations 2012 consultation, the Healthcare Distribution Association (HDA UK) – the former British Association of Pharmaceutical Wholesalers, which was rebranded in February 2016 – has agreed that independent pharmacies should be allowed the same access to hub and spoke technology as vertically integrated pharmacy chains.

Currently, section 10 of the Medicines Act 1968 only allows hub and spoke dispensing if the ‘hub’ and the ‘spoke’ pharmacy are both part of the same retail pharmacy business.

However, HDA UK warns that removing this legislative impediment could open drug distribution to new providers which may not be required to match the same standards mandated by the UK regulator, the Medicines and healthcare Regulatory Agency (MHRA).

It urges that the MHRA should be made responsible for inspecting hubs and ‘hub to spoke’ transportation to ensure they comply with European Union regulations for good distribution practice and that pharmacy regulations should be reviewed to take into account new requirements for storage and transportation prompted by hub and spoke systems.

HDA UK emphasises the need to discern between hub and spoke and centralised dispensing. It is crucial to maintain the patient-pharmacist relationship, it says, adding it does not support centralised dispensing, which sees prescriptions sent directly to patients. “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.”

It admits that hub and spoke technology has the potential to free up spoke pharmacists’ time to deliver further patient-centric services, but says estimates that 45% of medicines will be dispensed through hub and spoke were on the “high side”.

HDA UK has also asked the UK government to look into additional issues raised by hub and spoke, including the impact on the implementation of the EU Falsified Medicines Directive, the need for contingency planning as a result of stock being centralised in large hubs, and any potential issues arising from any existing supply arrangements between drug manufacturers and wholesalers.

Last updated
Citation
The Pharmaceutical Journal, May 2016;Online:DOI:10.1211/PJ.2016.20201188