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GPhC may issue further regulatory guidance if hub-and-spoke law changes

The General Pharmaceutical Council (GPhC) will consider whether “additional guidance is required” should the law change so that the hub-and-spoke model can be rolled out across all pharmacies, the regulator's CEO Duncan Rudkin has said.

Mr Rudkin spoke at a Sigma webinar on the hub-and-spoke model last week (November 16), alongside representatives from the Department of Health and Social Care (DH) and the National Pharmacy Association (NPA).

Following the passing of the Medicines and Medical Devices Bill in February, the DH now has the power to change legislation so that all community pharmacies can operate a hub-and-spoke dispensing model, regardless of whether they are part of a chain or an independent.

Responding to a question from C+D on how the regulator is preparing for this potential change in the law, Mr Rudkin told delegates that the GPhC might issue additional guidance, as it has done in the past with other “particular topics”.

The additional guidance, Mr Rudkin continued, would set out the regulator’s expectations for pharmacies and pharmacists in more detail.

 

Broaden inspectors’ skills

 

The GPhC will also expand “the range of skills available” to inspection teams either “directly or through on-call support”, Mr Rudkin told delegates.

This will ensure inspectors know “the right technical questions to ask when they're seeking assurance around how people are applying the standards” in the context of hub and spoke.

The regulator will expect businesses implementing hub-and-spoke dispensing “to be ready to explain” how they intend to “use system changes to actively promote professionalism” and “uphold the ability of pharmacy technicians to live up to their professional obligations”, Mr Rudkin said. 

The GPhC is also in “detailed discussions” with the Medicines and Healthcare products Regulatory Agency (MHRA), he added, regarding “the interface” between the regulator’s and the MHRA’s requirements.

 

Follow the GPhC's standards

 

Those unsure of the GPhC's requirements for pharmacies interested in hub-and-spoke dispensing should consult the regulator’s standards for pharmacy professionals and the standards for registered pharmacies, Mr Rudkin advised.

These will provide “an essential framework for you to think through the issues in designing your models if you go down this road”, he noted.

Mr Rudkin highlighted that “making and using appropriate records” and “communicating effectively with others involved in the person's care” – as advised by the standards for pharmacy professionals – would be important in the hub and spoke context.

The standards for registered pharmacies – which the GPhC uses to inspect pharmacies – “can be used as a framework for risk assessment and risk management”, Mr Rudkin said, as was done in the development of vaccination sites.

He highlighted principles four and five, which call for storing medicines and medical devices securely until they are supplied to the patient and ensuring that business systems are “safe and fit to use”.

Principle one will be “very relevant to the hub and the spoke and the relationship between them”, Mr Rudkin continued, as the guidance advises pharmacies to have “clear definitions of the roles and accountabilities of the people involved in providing and managing pharmacy services”.

Mr Rudkin emphasised that patients should always be able to get help in the event of something going wrong. “The arrangements between the pharmacy parties” should never leave a patient “stranded” while “the hub and spoke [point] their finger at each other”, he said.

The GPhC “is very committed to using its regulatory levers and influence to really be proactive in enabling and supporting responsible innovation”, Mr Rudkin noted.

However, “there will be limitations to the kind of topics that we would get involved in”, he added. “We certainly wouldn't regard it as part of our role to arbitrate between businesses in commercial issues between them.”

 

No date confirmed for hub-and-spoke consultation

 

On November 11, the DH published the results of an eight-week consultation it ran in 2016, which included questions on the hub-and-spoke model.

Claymore Richardson, senior policy manager at the DH, emphasised during the webinar that the publication of the DH’s response to the 2016 consultation does not mean it is starting from scratch on the upcoming consultation.

The DH reviewed its 2016 consultation to identify the “main areas for further discussion” for hub-and-spoke dispensing, Mr Richardson told delegates, and subsequently progressed to “pre-consultation engagement” by holding several workshops.

These outlined the main themes to be addressed in the DH’s next consultation on hub and spoke, including concerns over accountability and transparency.

The finalised DH proposals will be published and tested in “a full public consultation”, Mr Richardson said.

“We do not have a date for consultation yet confirmed”, he stressed, though the DH is “moving in that direction”.

 

“No assumption that hub and spoke will reduce costs”

 

Gareth Jones, head of corporate affairs at the NPA, told delegates that it was up to individual businesses to implement hub and spoke in the future and assess whether the model would benefit them.

In response to Mr Jones’s comments, DH principal pharmacist Susan Grieve stressed that the DH is not “forcing anybody to do this”.

She added that the DH would be publishing an impact assessment alongside the consultation, which would outline its “view” on different businesses' feasibility in implementing the system.

However, Mr Jones argued that there is not “a huge business incentive for independent pharmacies” to introduce the model.

“I don’t see [hub and spoke] revolutionising pharmacy practice within multiples either”, Mr Jones continued, as pharmacies within the same legal entity using hub-and-spoke services have reported that long, complicated prescriptions “often can’t be handled at the hub in an automated way”.

He added that he was not seeing lots of investment into the hub-and-spoke model from the multiples, “which would be a sign that they thought it was working really well for them”.

C+D revealed last year that Lloydspharmacy had reviewed the number of branches suitable for its hub-and-spoke model after finding that it only works for “some” pharmacies.

Meanwhile, speaking at the Pharmacy Show in October, Numark managing director Jeremy Meader said that while the model has “proved very successful” for Rowlands, independents or small pharmacy chains may find an alternative solution “easier”.

In April, C+D's Big Debate asked whether independent pharmacies can ever truly benefit from a hub-and-spoke dispensing model. Head to the Big Debate room to read what people had to say and join the discussion.

 

What are your thoughts on implementing hub-and-spoke?

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