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Why the government's hub-and-spoke plans are legally flawed

"Changing hub-and-spoke law seemed easy, but the situation isn't straightforward"

Issues with liability, data protection and EU law have still not been addressed, says Noel Wardle

The Department of Health (DH) has recently announced that it intends to postpone changing the law to allow greater use of hub-and-spoke dispensing, so that it can explore “issues” that have been raised by stakeholders about the proposals.

Hub-and-spoke dispensing is not lawful in the UK, save where a single company owns both the hub and the spoke. Changing the law to allow hub-and-spoke dispensing between companies probably seemed easy. However, as the DH has now realised, the situation is nowhere near that straightforward.

Liability

In terms of liability for a dispensing error, pharmacists owe a duty of care to their patients. That includes taking reasonable care to ensure that the medicine supplied is suitable for the patient, as well as being what the doctor prescribed.

That duty of care must extend to the hub, where part of the dispensing process takes place. If the hub makes a mistake and a patient suffers harm as a result, who would be responsible for compensating the patient: the hub, the spoke, or both?

The law imposes criminal liability for a dispensing error and pharmacists and others working in the pharmacy are occasionally prosecuted. The government has proposed a statutory defence to some of these offences. However, the defence is complicated – with numerous conditions that must be satisfied – and would probably not extend to dispensing errors that arise out of hub-and-spoke.

Particular consideration would need to be given to whether professional responsibility rests at the hub or spoke. For example, will a pharmacist at the spoke have responsibility to check medicines dispensed at the hub? If the spoke pharmacist must make a further check of medicines dispensed at the hub, would there be significant time savings in the hub-and-spoke model?

Data protection problems

The hub may require access to a patient’s PMR and summary care record, if a professional assessment is to be undertaken at the hub. But passing information to the hub in this way may breach the Data Protection Act – unless the patient has given explicit consent – and could be a criminal offence.

EU law

Meanwhile, the Falsified Medicines Directive [due to come into force in 2019] will require medicinal products within the EU to include tamper-proof packaging and contain a unique identifier code. These requirements are probably incompatible with widespread hub-and-spoke dispensing across companies.

Given the list of issues that the DH faces, it is unsurprising that it is going to postpone the changes. The question is, have the changes really just been postponed, or will they now gather dust, never to be seen again?

In the absence of a significant appetite for change, either within the DH or within community pharmacy, the likelihood is that these proposals have been kicked into the long grass.

Noel Wardle is a partner at law firm Charles Russell Speechlys

5 Comments

Dodo pharmacist, Community pharmacist

Keith Ridge does not have a clue about community pharmacy. He is from a hospital background and has an interest in pharmacy automation. He has no clue of all the legal counter arguments and vast array of reasons why hub and spoke could never work for independents. His position has become untenable and he should be forced to resign.

Paul Dishman, Pharmaceutical Adviser

I completely agree, Ridge has been a disaster from day 1 when he wrote to every pharmacy telling us what sort of delivery van to buy. No idea about community pharmacy, giving out disasterous and poor quality advice, he should resign or be fired.

b t, Manager

So, were the DoH lawyers unaware of these issues prior to making the announcements about the hub and spoke models proposed ?

Paul Dishman, Pharmaceutical Adviser

They probably consulted Keith Ridge first

b t, Manager

Do you think the lawyers made a mistake if they did indeed ask  the Chief Pharmacist with ZERO practical experience (or understanding) of community pharmacy ?

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