The announcement of the contract also contained several hints at regulatory reform which could have far-reaching implications for English pharmacies. Photo: iStock

By Noel Wardle

The headlines for the new deal for community pharmacy in England are likely to focus on the funding freeze and changes to essential and advanced services that will be phased in over time. However, the announcement of the contract also contained several hints at regulatory reform which could have far-reaching implications for English pharmacies.

Hub and spoke

Having taken a break for a few years, the Department of Health and Social Care (DHSC) has pledged to tackle the thorny issue of hub and spoke dispensing. For those who aren’t familiar with the concept, this is where part of the dispensing process is undertaken at a central hub facility, which does not hold an NHS contract, on behalf of the spoke, which supplies the pre dispensed medicine to the patient and does have an NHS contract.

The problem that the DHSC needs to grapple with is that current legislation, which is over 50 years old, does not allow hub and spoke dispensing between different legal entities – the hub and the spoke have to be owned by the same person or company. This means that larger multiples can implement hub and spoke, but smaller independents cannot.

On the face of it, it should be quite easy to change the legislation to remove this restriction, but all sorts of other legal (and political) obstacles got in the way last time the DHSC tried back in 2016. Let’s see if it has more luck in 2020.

Noel Wardle

Better use of skills

The Rebalancing Medicines Legislation and Pharmacy Regulation Programme Board – the Board that brought us the “decriminalisation” of dispensing errors – has also been looking at other changes to medicines legislation. One of those changes is what “supervision” means in the context of medicine supplies.

Medicines legislation in the UK requires that POM and P medicines must be supplied “by, or under the supervision of” a pharmacist. “Supervision” is not defined in medicines legislation, however, which has left the courts to interpret its meaning. The courts have concluded that “supervision” essentially means being present on the premises and in a position to intervene.

It is over 60 years since the court looked at the meaning of “supervision”, however, and times have changed. We now have pharmacy technicians, technology that means a pharmacist may be in a position to intervene even if they are not physically present on the premises, and a new pharmacy contract that will have less and less emphasis on dispensing and more and more emphasis on clinical services.

If the pharmacy contract takes pharmacists out of the dispensary and into the consultation room, what does that mean for supervision?

Over to the Board to look at this. Expect a review of who in the pharmacy team can supervise and does supervision look different for different medicines. For example, is supervision the same for acute supplies of controlled drugs as it is for repeat, low-risk, medicines?

Merger regulations

When the pharmacy funding cuts were announced almost four years ago, the DHSC appeared to accept that pharmacy closures were inevitable. Indeed, it looked like part of the rationale for the cuts was to “reduce clustering”.

To enable pharmacies that were close to each other to merge, the DHSC made changes to the market entry rules at the end of 2016. Those changes allowed a pharmacy contractor to apply to NHS England to consolidate two contracts into one, and to obtain protection from another operator trying to open a new pharmacy by arguing that the closure had left a gap in service provision.

There have been quite a few consolidation applications made over the last two and a half years, but a lot of contractors have been put off by restrictions in the merger rules.

The first issue is that the protection from a competing new pharmacy contract application being made only lasts until the next Pharmaceutical Needs Assessment (PNA) is published. PNAs have to be published at least every three years, so the maximum protection would be three years, but in practice could be much less, including only a matter of months. Expect the DHSC to set a specific time period for protection in forthcoming regulatory change.

The second issue is that the consolidation rules require the contractor to keep the opening hours of the pharmacy which will remain open following the consolidation. That means if a contractor merges a 40-hour pharmacy with a 100- hour pharmacy, but wants to stay open at the 100-hour site, the contractor will have to keep the 100 hours going. This seems arbitrary and has been a significant barrier to consolidation applications taking place.

Again, expect the DHSC to look at this, and, perhaps to provide NHS England with flexibility to agree the opening hours at the remaining site by reference to patient needs.

The above is a general overview and we recommend that independent legal advice is sought for your specific concerns. If you require further information in relation to the points raised in this article you should contact Noel Wardle who is a Partner and Head of Healthcare Regulation at Charles Russell Speechlys LLP. Noel can be contacted on [email protected]

This article also appears in the September issue of Pharmacy Business.