Regulation changes: Easements or appeasements?

Are the DHSC’s latest regulatory changes a lifeline for community pharmacy, or a missed opportunity to ease workload and funding pressures? By Saša Janković 

At the end of April, the Department of Health and Social Care (DHSC) announced a package of regulatory changes in response to the current pressures on community pharmacy and calls from Community Pharmacy England for measures to help contractors manage workforce and cost burdens.

The new statutory instrument – The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment) Regulations 2023 – was laid before Parliament on 27 April. It includes several easements for pharmacy contractors, including provisions for 100-hour pharmacies to apply to Integrated Care Boards to reduce their core opening hours to a minimum of 72 hours a week, as long as the pharmacy stays open between 5pm and 9pm Monday to Saturday, maintains all its pre-existing Sunday hours and stays open between 11am and 4pm on Sundays.

No similar flexibilities were announced for contractors operating fewer hours, which CPE says constitutes the majority (approximately 90 per cent) of the sector in England. However, a DHSC spokesperson told P3pharmacy: “We recognise the importance of maintaining good access to pharmaceutical services for all patients, which is why we have just announced an additional £645 million funding for services on top of the agreed £2.6 billion in the pharmacy framework.”

Other changes include:

• A notification procedure for introducing or changing rest breaks by changing core opening hours
• A requirement to have a business continuity plan dealing with temporary closures and to action it in the event of a temporary closure (suspension)
• Provision for local hours plans to be agreed by the local Integrated Care Board (ICB), with temporarily reduced opening hours for participating pharmacies within the area of the plan • Other regulatory amendments, including changes to fitness information and the procedures for applying to change core opening hours and notifying changes of supplementary opening hours.

Negotiator’s response 

CPE was quick to respond that it opposed the package, which “fell far short of the changes requested in March this year” and did “not adequately address the crippling pressures that contractors are facing”.

Calling the regulatory changes “divisive”, CPE said in a statement that they had been “imposed” on the sector and its “clear view remains that the sector’s finances and capacity are in a critical state, and that DHSC and NHS England have run out of money for new pharmacy services or activity”.

While admitting that the allowance to change core hours “may bring some small relief to contractors of 100-hour pharmacies”, the negotiator said it has been clear that any such change “needed to be matched with provisions for all other contractors who are facing the same pressures”.

“The overall package does not go far enough,” added CPE, “and does not show that DHSC and NHS England have recognised the severity of the situation for over-worked and under- funded community pharmacies.”

Grassroots effects 

So what could the changes actually mean for pharmacies on the ground?

Conor Daly – pharmacist, founder and partner at consulting firm Rushport Advisory LLP – says that, put simply, it means 100-hour pharmacies do not have to open for more than 72 hours a week “if they meet all the conditions required for removing hours”, but they cannot change their Sunday opening hours “in any meaningful way”. 

However, he believes that most 100-hour pharmacies were “not busy at all across their extended hours” and only offered them “because it was seen as the only option to be allowed to open a pharmacy”. 

“When you think about it,” he said, “100 hours just seems like an arbitrary, nice, round number that was used back in 2005 to allow more pharmacies to open with extended hours, but has never really made a lot of sense. The new rules are aimed to keep the extended hours to a great extent without requiring the arbitrary 100 hour provision.”

Kevin Murphy, superintendent pharmacist of Wellbeing Pharmacies Group and co-founder of MedPoint, says that while the almost 30 per cent reduction in overall opening hours of 100-hour pharmacies could save some from closing down permanently, it will be deemed by many as unfair – “especially if you own a 40-hour pharmacy that has been disadvantaged by the 100-hour exemption”. He also believes there is “very little in the changes that will benefit the 90 per cent of pharmacies operating on standard hours contracts”.

“Arguably, there may be an indirect effect on locum rates, which all pharmacies may benefit from,” says Murphy. “But I think this will be limited due to the fact that the hours that 100-hour pharmacies are allowed to cut are likely to be early morning and late night (pre-9am and post-9pm). So it remains to be seen if it will have any impact on locum demand and supply.”

Other easements

What about the announcements on rest breaks and local hours plans?

Michael Holden, associate director of Pharmacy Complete, says the regulatory changes that allow some flexibilities for contractors to close for rest breaks and also manage closures through ICB local hours plans is going to be “a clunky process and won’t allow contractors to flex in response to ‘in the moment’ resourcing challenges”.

Murphy says the rest breaks announcement will have “very little impact”, as the overall number of opening hours must remain the same. “If an hour’s lunch is taken, the pharmacy must open earlier or close later,” he explains. “I can’t see many pharmacies doing this. So, effectively, it is an almost pointless political gesture by DHSC.”

He believes it is “hard to predict” how local hours plans will help because it will ultimately be down to the local ICB to decide if the changes are needed. 

“I hope this will genuinely create greater flexibility on how core hours are delivered,” he says, “but it will take some test cases to help define what ‘sustainable’ and ‘realistically achievable’ actually mean. There is also bound to be variation between ICB areas.”

100-hour lifeline

Criticism of the perceived favouritism for 100-hour pharmacies aside, the changes could offer some of them a lifeline – especially when it comes to staffing costs.

Daly estimates the savings from these changes “could easily be £20,000 a year”, while Murphy suggests some businesses could recoup £70,000-£100,000 a year, depending on their staff levels and locum rates.

Nonetheless, Nathan Wiltshire, group chief executive of Cambrian Alliance, says that while some 100-hour pharmacies “will have small relief”, the changes don’t address the cause of the huge pressures contractors are under. “Pharmacies still have to work amidst a funding crisis, fight unpredictable remuneration and supply, whilst also being asked to undertake new services with no spare time,” he says. 

Indeed, Martin Bennett, managing director and superintendent pharmacist of Wicker Pharmacy in Sheffield, stresses that providing an extended hours, high quality service is “extremely expensive” and needs to be commissioned separately with additional funding. “Expecting 100-hour contractors to be able to fund this service from remuneration that is insufficient to fund a standard hours service continues to demonstrate the DHSC/NHSE total lack of understanding of the finance needed to run a pharmacy,” he says.

Of course, for those with long memories, this under-funding is a historic issue. Tony Schofield, superintendent pharmacist and owner of Flagg Court Pharmacy in South Shields, says: “One big point to consider is that when the Ridge reforms were introduced, many changes to regulations to ease the burden of delivering services were promised – particularly changes to the supervision regulations and the law on hub and spoke dispensing.

“While every negative development was unloaded onto the sector – funding cuts, new roles for pharmacists and technicians taking them out of the available employment market – absolutely nothing whatsoever was done to make good on those promises.”

And while the latest funding offer of £645m to go towards operating a Pharmacy First common ailments service has been broadly welcomed, Holden warns that it “will depend on how much is truly new money and what is expected for it”.

“It amounts to around £30,000 per contractor assuming [it is] fully realised at individual contractor level and they have the capacity and will to deliver,” he says. “This must deliver profitable revenue to the bottom line to offset some of the current underfunding and allow investment in workforce and technology. As ever, the devil will be in the negotiated detail and it is for the transformed CPE to deliver that for its contractors.”

Another point is that supply chain challenges and the price of medicines are exacerbating factors, with contractors too often dispensing at a loss. Holden says this is “potentially having an even bigger impact on workload and cash flow than the fee-based underfunding issues”. 

“If you speak to professional colleagues in dental and optometry, this is like groundhog day for them,” he says. “Those who have survived in those sectors have had to adapt their business operation and model to one less dependent on NHS funding.” 

With everyone in the sector working in difficult conditions, Wiltshire doesn’t see these changes as a magic bullet.

“Wherever you are a pharmacist, there are not enough hours in the day, thanks to the pressures,” he says, “and these regulations won’t change that ultimately.”