DoH Proposes Changes to the Pharmacy Regulations

Will 100 hour pharmacies be allowed to reduce their operating hours and will distance selling pharmacies be forced to have fully functioning websites as a result of the latest DoH review of the pharmacy Regulations?

Last week the Department of Health published its review of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 (“the 2013 Regulations / Regulations”).

This is effectively a review of how the 2013 Regulations have performed and it considered whether the Regulations should be kept as they are, abolished, or changed a bit.

The overall recommendation is to keep the Regulations, but there are interesting changes proposed that will have an impact on every single pharmacy contractor and some proposals that will raise a few eyebrows. Unfortunately, there are other changes that really should have been considered which are not even mentioned.

There is a lot of detail in the review and I have just chosen some highlights to write about below, so please feel free to contact me at if you would like to discuss anything in more detail.

The parts that will interest existing and potential contractors the most are;

1.      The Possibility of 100 hour pharmacies being allowed to reduce their hours

Whilst this is not yet a “done deal”, the DoH has listened to contractors who complained that when a 100 hour pharmacy was losing money due to low usage outside normal working hours, their only option was to close it down. Many in the business will say that this is exactly what should happen as these contractors signed up to offer 100 hours of service and had a significant impact on the business of other pharmacies in the area. However, it now looks like the DoH has forgotten that they previously stated that 100 hour pharmacies would not be permitted to reduce their hours and they are now saying

This review therefore recommends that Government conduct a review of 100 hours per week pharmacies that analyses who uses these services and considers if any amendments to the terms of service for 100 hour per week pharmacies should be made.”

Could this be the way out that 100 hour pharmacies have been desperately hoping for?

2.      Tightening up of the rules on distance selling pharmacies

It should be no surprise that there have been a significant number of complaints about distance selling pharmacies focussing on providing a service at a local level rather than a national level.

The DoH reviews states;

“During the consultation period two concerns about the functioning of DSPs were raised; the first in relation to subversion of the 2013 Regulations for the purpose of local supply and the second regarding direction of prescriptions to DSPs.

Several stakeholders outlined instances where DSPs were operating on a predominantly local level, instead of delivering a national service as stipulated. Examples of DSPs discouraging

‘non local’ use and or lacking the infrastructure to deliver national services were supplied to the Department as part of the consultation process.

Stakeholders also raised concerns about vested interests resulting in the direction of prescriptions to a particular DSP for personal commercial gain. Evidence and examples were supplied to the Department as part of the consultation process. This demonstrated sudden drops in the dispensing volume at bricks and mortar pharmacies following the opening of a DSP located nearby, with a corresponding spike in prescriptions at the new DSP, the vast majority coming from a single general practice.”

Analysis of prescription records shows that between May 2016 and August 2017, an average of 6.7% of DSPs only dispensed prescriptions to locations within a distance of 10km from the patient. Specifically in the month of August 2017, this represented 16 out of the 248 actively dispensing DSPs that month. Slightly under half of the remaining DSPs supplied to patients located between 10km and 100km from the DSP, with just over half supplying to distances over 100km.

Findings and recommendations

This analysis supports stakeholder concerns that a small proportion of the DSPs may be misusing the DSP exemption for the purpose of local supply. This review also finds strong evidence of prescription direction to some DSPs with a small number of DSPs dispensing more than 1,000 items a month receiving more than 90% of their prescriptions from a single prescriber.

This review recommends that the Department consults on changes to the 2013 Regulations to:

• require DSPs to declare any vested or significant interests – including if any of the business owners or partners, are themselves, or have family members who are prescribers of NHS prescriptions dispensed by the DSP; and

• require DSP contractors to maintain functional websites which detail how their services can be accessed nationally and their arrangements for the disposal of patient returned waste medicines.

 This review also recommends that:

• NHS England develop a complaints process to allow suspected breeches to be reported investigated; and

• DHSC consider how the development and roll out of the electronic prescription service and patient nomination processes could help mitigate prescription direction.

Declaring a financial interest isn’t a new idea and we have been recommending this to our clients for years, but if the Regulations are changed to require fully functioning websites then this will mean a lot more work being required during the application process for new entrants as currently there is no requirement for a website at all.

3.       Minor Relocations

The DoH has accepted that the process for relocating a pharmacy when the relocation is over a very small distance is too cumbersome and lengthy. In fact, we are currently dealing with one NHS Area Team that has insisted that one of our clients applies for a relocation of their premises just because our client wants to make their premises smaller!

The review now says that the DoH should consult on amendments to the 2013 Regulations to allow for a more streamlined application process in the event of very minor or temporary relocation; and NHS England should review and develop guidance to facilitate and administer accelerated application routes for very minor and temporary relocations.

This sounds suspiciously like a return to the “relocations under 500 metres” rules that were done away with under the new Regulations. We hope that the DoH will remember the reasons why the old rules did not work last time round and come up with a more elegant solution this time round.

There are a few other good proposals such as;

  • Changing the “5 year rule” as it applies to pharmacy applications in rural areas where a previous application was refused due to an administrative error. As some contractors will be aware, these “errors” were often not errors at all, but a deliberate strategy employed by some dispensing doctors to prevent pharmacies from opening.
  • Oral Hearings – changing the rules so that interested parties do not have to state at an early stage in an application process that they would wish to attend an oral hearing if one was held. The review describes the current rule as an “unintended consequence”. This shows how short memories can be as it was not an unintended consequence at all and was quite purposefully brought in to the 2013 Regulations to try to limit the number of parties that could attend hearings. It might be better for the DoH to say that it was always a terrible idea rather than describing it as an unintended consequence.

What is missing?

It is a shame that some of the more obvious errors in the Regulations have not been mentioned at all and that the DoH is missing an opportunity to help reduce pharmacy numbers in a way that contractors might actually support. We would like to have seen some comment on;

  • Allowing pharmacies that use the new consolidation Regulations to choose which pharmacy’s core hours they keep. This would have allowed a reduction in the number of 100 hour pharmacies, but would have given NHS England the power to refuse a consolidation of this type if it would adversely affect patients.
  • Allowing consolidations over long distances as long as no gap is created. This would allow poorly performing pharmacies to be sold rather than closed down and the new owner could reduce operating hours elsewhere.
  • Removing the unintended consequence of Regulation 31, which is currently being interpreted by NHS Resolution as meaning that a 40 hour pharmacy cannot relocate to the same site as a 100 hour pharmacy in order to allow the 100 hour pharmacy to close.
  • Changing the rules on Notices of Commencement to allow them to be submitted more than 14 days before a contractor wishes to open. Some Area teams allow this even though the shouldn’t and it often means that pharmacies are forced to open without it being possible to have the codes required from the NHS to set up their PMR system correctly.
  • Being clear that the NHS should be permitted to remove commercially sensitive information from its published appeal decisions and to agree what constitutes commercially sensitive material.

We have already raised most of these points with the NHS and hopefully they will find their way into the next set of changes being made to the Regulations.

In summary, it looks like the Regulations are here to stay, but there might be some interesting changes being made, especially to 100 hour pharmacies and distance selling pharmacy regulations.

This is only a summary of what was a long document, so if you would like any more information, please feel free to contact me.

Conor Daly

Partner | Rushport Advisory LLP