Medicines and Medical Devices Bill

Written evidence submitted by Pharmaceutical Services Negotiating Committee (PSNC) (MMDB17)

Summary of evidence

PSNC represents all NHS community pharmacies in England. Our interest in this bill concerns the changes set out within it which will enable hub and spoke dispensing of medicines.

While hub and spoke dispensing may help to free up capacity in the community pharmacy sector, the efficiencies that it may bring are as yet unproven, and there are several patient safety concerns which must be addressed before it can be widely implemented. We have outlined our key concerns and considered possible solutions for these below. We believe these caveats and the principles which we have identified must be given full consideration before hub and spoke dispensing is enabled, to assure ongoing fairness for pharmacies and safety for patients.

Introduction: Hub and spoke dispensing

For pharmacy, one of the most important aspects of the Bill is the change it will enable in access to hub and spoke dispensing models. These dispensing models involve the preparation of medicines in a ‘hub’ setting (the steps involved here include clinical safety checks and labelling) before the medicine is moved to a ‘spoke’ to be given to the patient, along with any relevant advice.

The NHS says that hub and spoke dispensing models could bring increased efficiencies in the dispensing of medicines, improve accuracy, and free up the time of pharmacists’ so they can deliver more clinical services. While evidence from multiple pharmacy businesses suggests that the model can be used to free up the time of pharmacists working in ‘spokes’ there is no clear evidence that the model improves the overall efficiency of dispensing as compared with the existing model (in which pharmacies perform both the hub and spoke functions on one site, and with one team).

Current legislation prevents a hub and spoke approach taking place between different business entities, which most notably prevents single independent pharmacies from making use of the model. The Bill will introduce regulatory changes allowing all pharmacies to take advantage of the hub and spoke dispensing models, if they wish to do so. For independent pharmacies, this is likely to involve them agreeing a contractual arrangement with a ‘hub’ and then the pharmacy acting as the ‘spoke’, alongside providing a range of different clinical services and healthcare advice.

As the representative body for community pharmacies in England, there are several concerns we have about the impending legislation, which are outlined below.

Concerns and principles

PSNC is concerned that enabling wider hub and spoke dispensing of medicines must be carried out in a way that assures fairness for pharmacies and safety for patients. Our key asks of the legislation can be divided into the following themes:

· Patient and public safety: this must be assured at all times

· Competition and fairness for the sector as a whole: the NHS community pharmacy network comprises a mixed economy of independent pharmacies and multiple businesses. Any changes to legislation must not disrupt competition in the market nor favour any one ownership model.

· Efficiency and capacity release: we do not yet know to what extent hub and spoke dispensing will improve efficiency and release capacity and we are seeking a commitment to ongoing joint and transparent assessment of that with the NHS.

· Safeguarding public expenditure and independent contractors: as above, the introduction of hub and spoke dispensing must not favour any one part of the community pharmacy sector over others, and it must provide value for money for taxpayers.

We have set out some further, more detailed considerations each of these areas below.

Patient and public safety

1. Hubs and spokes need to have recognised standards and validation/quality assurance of the shared dispensing processes to ensure patient safety. The General Pharmaceutical Council (GPhC) has responsibility for relevant professional standards. Only spoke pharmacies which are contracted NHS pharmacies should be able to supply dispensed medicines to patients, not hubs. The provision of medicines to patients is a highly regulated activity and many patients benefit from pharmaceutical advice as they receive their medicines. Agreeing this condition for dispensing would ensure that a loophole is not created allowing large numbers of patients to receive medicines without any relevant pharmaceutical care.

2. Only registered pharmacies should be hubs and spokes to ensure one continuous pharmacy process – this is to ensure that shared decision-making between pharmacists is regulated by one set of standards, with oversight from one professional regulator. This should help to assure the consistency and thus the safety of dispensing, regardless of where or how it is carried out.

3. NHS regulations underpin the provision of pharmaceutical services in England and we will discuss with the Department of Health and Social Care appropriate changes to the regulations may be needed for the safe introduction of hub and spoke dispensing between different business entities.

Competition and fairness for the sector as a whole

4. The legislation must create an environment that is fair for the sector as a whole – primarily for independent contractors, as they are at most risk of unfairness, as outlined above in point 4.

5. Hubs must have interoperability and be competitive, and all pharmacy spokes should have full access to funding. There needs to be competition on price, service levels and interoperability, to ensure that independent contractors have a choice of hubs. A particular concern for independent pharmacies is what will happen to their access to margin, which is part of community pharmacy funding, should they choose to use hubs.

6. All hubs should have equal access to dispensations around ‘Direct to Pharmacy’ arrangements and manufacturers’ quotas – this would ensure a level playing field for all hubs, particularly those set up by independent contractors. After the legislation is changed, any new hubs should also be able to benefit from existing arrangements currently enjoyed by existing hubs.

7. There should be no fee or other differential (direct or indirect) between ‘bricks and mortar’ pharmacies and distance-selling pharmacies. This ensures a level playing field for all providers of dispensing and pharmaceutical services.

Efficiency and capacity release

8. Pharmacies should be allowed to carry out Original Pack Dispensing, or be given flexibility to provide calendar packs. Currently, where doctors prescribe a specific quantity of a medicine, pharmacies have no flexibility to provide patients with complete packs of that medicine (original packs) and must instead take steps to supply the exact amount prescribed, even if that involved splitting packs of medicines. Allowing pharmacies some flexibility on this would help increase the efficiency of the dispensing process. This is currently being done in Scotland.

9. We would like recognition that there is no evidence of financial savings from hub and spoke dispensing, only evidence of potential capacity release. If hub and spoke dispensing works well then it may help to release capacity in pharmacies, but it is unclear whether this model will deliver any real cost savings. This is partly due to the high set-up and ongoing costs of hub and spoke dispensing in large, remote, automated facilities.

Safeguarding the public expenditure and independent contractors

10. The resilience and competitive purchasing of community pharmacy should be protected. Community pharmacies purchase medicines very efficiently, saving the NHS billions of pounds worth of potential spend on medicines in the process and ensuring that patients have access to the medicines they need. This ensures the continuity of supply of essential medicines with significant savings to the public purse, and these benefits should be preserved. In our response to the 2016 Government consultation on hub and spoke dispensing we indicated:

i) the alleged economic efficiency reasons for ‘hub and spoke’ dispensing are not evidenced and arguably such models will cost more overall: efficient pharmacy procurement, which has generated savings to the public purse of £10 billion pounds in the last ten years, may be lost.

11. Hub and spoke dispensing between different legal entities must remain voluntary – as the Impact Assessment for the Bill noted, the proposals are ‘entirely permissive’, and it is important this remains the case in practice. Small businesses need the freedom to choose whether to engage in a hub and spoke dispensing arrangement or not, depending on whether it generates benefits for them and their patients, and does not have a negative impact.

Background Information: About PSNC

The Pharmaceutical Services Negotiating Committee (PSNC) promotes and supports the interests of all NHS community pharmacies in England. We are recognised by the Secretary of State for Health as the body that represents NHS pharmacy contractors. We work closely with Local Pharmaceutical Committees (LPCs) to support their role as the local NHS representative organisations.

Our goal is to develop the NHS community pharmacy service, and to enable community pharmacies to offer an increased range of high quality and fully funded services; services that meet the needs of local communities, provide good value for the NHS and deliver excellent health outcomes for patients.

June 2020


Prepared 10th June 2020