April 28, 2023
  • Rushport Advisory

Major Changes to Pharmacy Regulations – Especially for 100 Hour Contractors

Today saw the announcement of the biggest change to the NHS Pharmacy Regulations since they were introduced in 2013 – so what do they mean for you?

Today’s changes to the “Pharmacy Regulations” are without doubt the most significant changes to be announced in 10 years. No contractor should underestimate what the changes mean for them and they will affect the value of pharmacies as well as their operations.

The changes below will come into effect from 25 May 2023.

The main changes can be summarised as follows;

1. 100 Hour Pharmacies

100 hour pharmacies can now reduce their operating hours to 72 per week without having to demonstrate any change in need. Effectively it is just a notification process, however some hours must be maintained and those are;
– Monday to Saturday between 5pm and 9pm (it is understood that no rest breaks are permitted during this time);
– Sunday between 11am and 4pm (a rest break is permitted during the time, subject to the requirements for rest breaks); and
– Sunday’s total opening hours (i.e. the existing, total core opening hours on Sundays must remain).

In other words the reduction of total core opening hours per week to not less than 72 is conditional on maintaining the above core opening hours. The terms “rest breaks” is new (from a regulatory perspective) and there are specific new Regulations to permit these.

HOWEVER – As I posted in a reply to a question on LinkedIn – However I think there are going to be some big problems. It is a “notification” so does not technically require permission. but unfortunately, about 4 in 5 of proposals I have received so far would be unlawful, ie reducing hours that can’t be reduced or some other error. Contractors who do this will likely implement their reduction after 5 weeks and then some time later (there are big delays in applications / considerations at present) they will receive an email from the NHS saying their notification was not valid. Then they probably have to revert back to 100 hours and submit a new notification – which may be very difficult to do if they have removed staffing. Then they may receive a breach notice for closing when they should have been open. In other words, you need to do this carefully and take advice if you are not 100% sure about what you are doing.

I have had a lot of queries from contractors asking if they can remove their Sunday core hours and redistribute them across other days first and then apply to reduce core hours down to 72 so that Sunday trading is removed. The NHS may permit you to amend Sunday core hours and redistribute them to other days (other than 11am to 4pm on a Sunday which must stay if you currently open during that time), but this will require a separate application that could take many months to be decided and may very well just result in a refusal. If you have relatively short core hours on a Sunday then it is unlikely to be worth going through this processs, however if you have very long Sunday opening hours then it may be worth a delay in the overall reduction to 72 whilst you try to amend the current Sunday hours. It is very important not to apply to reduce your core hours before trying to redistribute Sunday hours as this makes the likelihood of a successful redistribution of hours much lower, even though it may be tempting to try in order to benefit from a quicker reduction in overall operating hours.

2. Other Changes to Core Hours
The changes to core hours do not just affect 100 hour pharmacies. The process to amend 40 hour pharmacy core hours has historically been extremely difficult, but now the NHS (ie the ICB) can approve these changes;

– to maintain the existing level of NHS pharmacy provision; or
– to maintain a sustainable level of adequate NHS pharmacy provision where maintaining the existing level of provision is either unnecessary or not realistically achievable.

This may well mean approving changees to redistribute core hours to avoid a pharmacy being forced to close, hoever it will intersting to see how the NHS interprets these new Regulations and there may well be different interpretations in different areas of England.

3. Fitness to Practise
We have been campaigning behind the scenes for changes to this process for many years as it has been overly complex and burdensome for both new and existing contractors. The process is now significantly simplified and I can provide details on this to anyone who needs them, but still do not go far enough in my view.

4. Rest Breaks

There will be a new option to introduce a rest break of up to 1 hour for pharmacy staff during the normal core hours. However, this is likely to be of less value than it may initially seem as the rest break must start at least 3 hours after the pharmacy’s opening time and end at least 3 hours before the pharmacy’s closing time (except Sunday when it can be any time) and last for no longer than one hour AND the time taken dor this rest break must be added on to the same day’s opening hours elsewhere, ie an extra hour at the beginning or end of the day. There are some differences in how this applies to 40 versus 100 hour pharmacies that also need to be considered.

5. Other Changes
There are several other changes in these new Regulations that without the above headlines would merit their own post and they affect issues like a Notice of Commencement for new pharmacies and the requirement for a Business Continuity Plan to deal with unplanned closures. We can provide guidance on the other changes if required.