Q&A: Everything you need to know about pharmacy supervision

Supervision is a minefield – and it has been a contentious topic within the pharmacy sector for years.

This week, the government revealed that it is “committed” to finally publishing its response to its pharmacy supervision consultation and reforming legislation “later this year”.

But what could it all mean in practice – and how did we get here?

C+D has created a round-up of everything you need to know about the issue...

What is supervision?

Supervision relates to the preparation, assembly, dispensing, sale and supply of pharmacy medicines (P-meds) and prescription-only medicines (POMs).

At the moment, this can only be carried out “by, or under, the supervision of a pharmacist”, according to the Department of Health and Social Care (DH).

Pharmacy technicians, however, are also “registered and regulated health professionals”, meaning they are “qualified to work without direct supervision”, it said.

Supervision is not currently defined in legislation – although there is “relevant case law” – and “it is recognised that there is some disagreement as to what the law currently requires in terms of supervision”, the DH added.

When was the supervision consultation launched?

The DH launched its 12-week consultation on December 7 2023 – coming up to a year and a half ago now.

It was announced to “more effectively [utilise] the skills of every member of the pharmacy team” while also creating “greater clarity” on how and when the legal requirements for supervision apply, the DH said at the time.

The consultation was published under the previous Conservative government, so it remains unclear what level of priority it holds with the new government.

However, then shadow health secretary Wes Streeting said in 2022 that “sensible improvements on things like medicine dispensing” could be made.

Streeting, who is now the health secretary, called rules requiring a pharmacist to be on site to supervise prescriptions getting handed to patients a “daft bureaucracy” at the time.

What did the consultation propose?

The consultation proposed that a pharmacist would be able to “authorise pharmacy technicians to run a dispensary with reference to a pharmacist only where necessary”.

It also proposed that:

Pharmacists would be able to authorise registered pharmacy technicians to perform tasks that would otherwise need to be performed by or under the supervision of pharmacists
Registered pharmacy technicians would be able to take primary responsibility for the preparation and assembly of medicinal products in highly specialised sterile manufacturing units in hospitals
Checked and bagged prescriptions could be handed out in a retail pharmacy in the absence of a pharmacist – where authorised by one - so patients could pick up their prescription when the pharmacist is at lunch or otherwise unavailable

Are the proposals safe?

The DH published an “impact assessment” alongside its consultation in which it admitted that the proposed changes pose a “potential risk to patient safety”.

It said that “the reduced pharmacist supervision could increase the number of errors made” and added that the changes “may” create “impacts on safety”, although it believes these risks are “extremely low”.

It stressed that it was proposing a “transition period before [the] legislation commences” to ensure “regulatory rules and standards and professional guidance” are in place.

What about remote supervision?

Remote supervision is the idea of removing pharmacists from the premises altogether and allowing them to supervise from afar, taking away the fallback of a pharmacist intervention, if needed.

But pharmacists have been strongly opposed to remote supervision for years.

Independent Pharmacies Association (IPA) – previously the Association of Independent Multiple Pharmacies (AIMp) - chief executive Dr Leyla Hannbeck stressed that “a pharmacy without the pharmacist is not a pharmacy” told C+D in 2021.

And chair of the Pharmacy Law & Ethics Association (PLEA) David Reissner said that one possible advantage of reworking the supervision legislation would be “the chance to put remote supervision out of reach”.

“The law could be changed to ensure that remote supervision is no longer possible,” he said at the time.

The 2023 consultation set out that its proposals are “not a move towards allowing pharmacists to remotely supervise a community pharmacy”.

And it stressed that the “physical presence of the responsible pharmacist in a retail pharmacy as the default is enshrined in primary legislation and that is not being changed as part of this reform”.

Any new legislation “will be underpinned by regulatory rules” and guidance to ensure it is implemented “safely”, it added.

When is the consultation response likely to be published?

According to Cabinet Office guidance, “government departments should aim to publish a response within 12 weeks of the end of the consultation period”.

However, the guidance also stresses that “what exactly happens at the end of a consultation period will vary depending on the public body that is carrying out the consultation and the issue that they are consulting on”.

This week – some 62 weeks after the consultation closed – pharmacy minister Stephen Kinnock revealed that the government is “committed to publishing the response…and to bringing forward the associated legislation later this year”.

He shared no further details on the timescales.

How did people react to the consultation?

Former pharmacy minister Andrea Leadsom said that the consultation would “give pharmacy technicians the chance to use their skills in a safe way and take on more responsibility for dispensing”.

She said this would allow pharmacists to have “more time to carry out the clinical assessments they are trained to do” and would “improve service delivery more generally”.

Community Pharmacy England (CPE), the National Pharmacy Association (NPA), the Company Chemists’ Association (CCA) and the Royal Pharmaceutical Society (RPS) all welcomed the consultation, with then NPA chair Nick Kaye saying that regulatory “modernisation” was “well overdue”.

But he stressed at the time that “any changes to legislation or regulations should maintain or improve, not diminish, the public’s access to a pharmacist”.

CCA chief executive Malcolm Harrison called the proposals “the basis for the greatest evolution in pharmacy practice for 70 years” and said that they would “free up” time for pharmacists to deliver NHS services.

But not all reactions were as positive, with some pharmacists raising concerns that the reforms would be “used by some to cut costs”.

Others said they doubted pharmacy technicians would “be paid much more” despite the additional burden of responsibility that they would be asked to bear under the proposals.

If passed, what would happen next?

Once the government’s response is finally published, there will have to be “additional public consultations for some of the changes proposed”, according to lawyer Susan Hunneyball.

And the Advisory Council on the Misuse of Drugs will have to be consulted “on the implications of the consequential changes to the Misuse of Drugs Regulations 2001”, she said.

However, the government proposed at the time that it would “bring in the provisions on handing out checked and bagged items in the absence of the pharmacist as soon as practically possible”, she added.

Meanwhile, the DH said that the consultation intends to “maximise the contribution pharmacists, pharmacy technicians and wider team members can make to address the challenges faced by the NHS”.

It could also “enable pharmacists to spend a greater proportion of their time delivering patient-facing clinical services” to “improve career progression and job satisfaction for the whole team”, it added.

How did we get here?

The consultation was part of the DH’s primary care recovery plan which, among other things, set out plans to “expand services offered by community pharmacy”.

It came after a cross-sector group was formed in 2021 to “refresh” discussions about changes to supervision in pharmacy – made up of the CCA, the NPA and the IPA (then AIMp).

Among other things, they called for “the pharmacist presence in the pharmacy to become more, not less, visible to patients”, inviting representatives at the time from the Pharmacists’ Defence Association (PDA) and the RPS to join their meetings.

“We intend to move forward on the basis of a broad consensus and look forward to finding a way forward together,” the bodies said at the time.

And in 2022, Welsh chief pharmaceutical officer (CPhO) Andrew Evans called for “legislative change around supervision”, saying the law should be “less inflexible”.

Pharmacists should “understand and work with pharmacy technicians, who would be very happy to carry on much of the business of the pharmacists without them being directly supervised”, he urged at the time.

It seems “completely wrong” that “autonomous” registered professionals such as pharmacy technicians need to be supervised by a pharmacist, he added.

What’s the history?

Discussions about remote supervision were around long before 2021 - the DH has been debating it for the best part of two decades.

The 2005 Health Bill proposed allowing registered and suitably trained staff working in the pharmacy to oversee medicines supply, which was “not what we asked for”, the PDA told C+D in 2021.

This created the idea of “not having a pharmacist in the pharmacy at all, that pharmacies could be supervised by a pharmacist that was not on the premises” – the equivalent of “send[ing] a bloke with a flamethrower” to tidy a house, it said.

Unsurprisingly, this part of the bill was not successful, and responsibility for supervision reform was then passed to the rebalancing medicines legislation and pharmacy regulation programme board in 2013.

Following this, conversations around pharmacy supervision effectively ended in 2017 after widespread controversy within the pharmacy community when C+D exclusively revealed plans to allow pharmacy technicians to oversee medicines supply.

Talks then resumed in early 2021 with the formation of the CCA, NPA, PDA and AIMp group, the Community Pharmacy Supervision Practice Group.

In August 2023, just months before the consultation was finally launched, a report by the cross-sector group recommended that supervision should not mean individual transactions are supervised.

The group agreed that while the “physical presence” of a pharmacist on the premises was the “defining element” of community pharmacy, directly supervising every transaction was “no longer suitable for modern practice”.

Four months later, the DH pharmacy supervision consultation was finally launched.