News

23 May 2016, The Pharmaceutical Journal

The Pharmaceutical Journal reports on the HDA’s response to the UK Government’s Human Medicines Regulations 2012 consultation. It details the Association’s concerns that drug distribution could be opened to new providers not required to match the standards mandated by the MHRA. The HDA also calls for the UK Government to further investigate issues raised by hub and spoke including the impact of the implementation of the EU Falsified Medicines Directive.

PSNC responds to ‘Hub and Spoke’ consultation

23 May 2016, PSNC

Yesterday, the pharmacy body published its response to the UK Government’s Human Medicines Regulations 2012 consultation, otherwise known as the ‘Hub and Spoke’ consultation. Amongst the issues raised in response to the consultation, PSNC argues that ‘hub and spoke’ dispensing may not be able to comply with the Falsified Medicines Directive.

The full response is available here.

GIVE US EVIDENCE TO BACK UP HUB AND SPOKE, GOVERNMENT TOLD

23 May 2016, Pharmacy Biz, Neil Trainis

PSNC has called for the UK Government to make publically available evidence backing up the claims that a hub and spoke dispensing model would generate significant efficiencies.  Rob Darracott, chief executive of Pharmacy Voice, stated:  “Pharmacy Voice believes it is a flawed assumption that hub and spoke dispensing must be more efficient, cost-saving or safer and we do not recognise the validity of the assumptions which are proposed to form the basis of the impact assessment.”

The campaign against the community pharmacy funding cuts announced by the UK Government was further covered by The Pharmacist, Pharmacy Biz and the NPA.

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Full Coverage

23 May 2016, The Pharmaceutical Journal

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.

PSNC responds to ‘Hub and Spoke’ consultation

23 May 2016, PSNC

PSNC has today published its response to the consultation on ‘hub and spoke’ dispensing.

This follows discussion between PSNC and the Department of Health to clarify various concerns that PSNC had with the draft regulations.

The Department of Health has confirmed that the draft regulations, if implemented, would permit hub and spoke dispensing between “relevant clinical entities” which it is proposed would include hospitals and surgeries (premises at or from which primary medical services are provided as part of the health service), potentially bypassing registered pharmacy premises. There would still be pharmacist supervision of dispensing, but it is not clear if there would be pharmacist supervision of assembly or supply of the dispensed medicine at non-pharmacy relevant clinical settings.

While changes to the Medicines Act 1968 or Human Medicines Regulations 2012 do not change NHS provisions (and doctors have always been able to supply medicines to their patients), these changes, if implemented, would provide an entirely new legislative framework for the retail supply of medicines on which there has been no consultation.

Other issues PSNC raised in response to the consultation include:

• the impossibility of creating a level playing field when independents must use and share patient lists with third party hubs;
• the proposed unrestricted wholesale dealing between relevant clinical settings is arguably contrary to European legislation;
• professional and legal issues and a change in legislative emphasis from pharmacies to pharmacists have not been considered and could lead to patient safety issues;
• redesign of section 10 of the Medicines Act is unnecessary as a result of the Abcur judgment;
• ‘hub and spoke’ dispensing may not be able to comply with the Falsified Medicines Directive;
• that the alleged safety arguments are not evidenced and sharing the dispensing process between two legal entities could lead to quite the opposite effect; and
• that the alleged economic efficacy arguments are not evidenced and arguably ‘hub and spoke’ dispensing could cost more overall.

GIVE US EVIDENCE TO BACK UP HUB AND SPOKE, GOVERNMENT TOLD

23 May 2016, Pharmacy Biz, Neil Trainis

Pharmacy Voice has urged the government to make public any evidence it has backing up its claims that a hub and spoke dispensing model in community pharmacy will generate significant efficiencies.

An extended consultation on ministers’ pharmacy efficiency plans concludes tomorrow but has done very little to placate the pharmacy profession which continues to battle huge funding cuts and other contentious measures including a hub and spoke dispensing model.

That model has been pushed forward enthusiastically by senior figures, notably the chief pharmaceutical officer Dr Keith Ridge, much to pharmacy’s chagrin since serious doubts persist over the benefits such a system would actually bring to patient care.

The pharmacy profession is infuriated by what it regards as a poorly conducted consultation on measures it regards as hugely counter-productive to the pharmacy profession and patient care.

There has been particular concern that the government has failed to reinforce its support for hub and spoke with concrete evidence.

“The proposed changes to enable hub and spoke dispensing were first announced against a backdrop of uncompromising and arbitrary funding cuts being imposed on the community pharmacy sector,” said Rob Darracott, chief executive of Pharmacy Voice.

“This subsequent consultation does not shed any further light on what basis the Department of Health believes the proposed changes to the (Human Medicines Regulations) HMR 2012 will make the dispensing process more efficient or how it will lower operating costs.

“Importantly, there is still no consistency in the terminology being used to describe what the government is trying to achieve, and there is no indication of how the consequent complex legal and professional issues will be resolved.

“The opportunity for constructive, informed policy engagement has been constrained by the rushed and poorly timed consultation.”

Darracott added: “Pharmacy Voice believes it is a flawed assumption that hub and spoke dispensing must be more efficient, cost-saving or safer and we do not recognise the validity of the assumptions which are proposed to form the basis of the impact assessment.

“Currently there are no ‘hub and spoke’ dispensing models operating across different legal entities and therefore no data that could be used to extrapolate from. If the Department (of Health) has such data or hypotheses we call on them to publish it without delay.”