HMR 2012 Regulation 225 on a Saturday morning | PharmacistDaz

This is not a post about a poor pharmacist. It is not a post about a poor pharmacy either. It is about what happens when a decision is made from habit rather than from the text in front of us, and what we can do about it.

What happened

My father was prescribed analgesia for a fractured pelvis, with an initial acute supply of seven days. As it ran down, he contacted his surgery for a continuation. The practice pharmacist said they would try to send the prescription ready to collect on Saturday, but the surgery is closed on a Saturday. The medication was a Schedule 5 controlled drug.

On Saturday I went to the pharmacy and the prescription had not arrived. That was not unexpected. Rather than leave him waiting, I used the NHS 111 emergency prescription route to ask the pharmacist to contact him. NHS 111 online and 111 by phone can help with emergency supplies, including for non-repeat medicines, as the NHS website guidance on emergency prescriptions explains.

I half expected a refusal to supply once the referral landed, because I have seen the same misunderstandings of Regulation 225 of the Human Medicines Regulations 2012 many times. Sure enough, when the pharmacy contacted us, the first reason I heard was that it was not a repeat medicine and so a supply could not be made.

I was annoyed. Properly annoyed, as any person would be, with a relative in pain. Luckily for me I know the law around this, and have practised long enough to know the error in that statement. I politely pointed to the regulation and to the Royal College of Pharmacy in the Medicines, Ethics and Practice (MEP) guidance, and left them to have a discussion, and time to consider my challenge.

They checked the National Care Records Service (NCRS) and could see that a prescription was in the process of being issued, it just hadn’t reached the Electronic Prescription Service (EPS) yet - probably due to it waiting to be signed by a clinician.

Shortly after that, they contacted my father to say that a supply would be made, enough to reach Monday, when the EPS prescription should arrive. My father was covered.

What has stayed with me is the other possible version of that morning. A patient without a pharmacist in the family, in pain from a fractured pelvis, is told no, accepts it, and goes without the care they need, or an unnecessary call to an out of hours service, to try and persuade another prescriber to pick up the issue.

I also need to be honest. None of us are immune to this. On a bad day, with a queue, a ringing phone and an unfamiliar system, “no” can feel like the safest answer. But doing nothing can have as many consequences as taking action.

We are only as good as our worst day.

What Regulation 225 actually asks

This is my summary of the regulations, but please do your own research into the regulations.

The patient-request route has five conditions.

Condition A: the pharmacist has interviewed the person requesting the medicine and is satisfied that there is an immediate need, that it is impracticable to obtain a prescription without undue delay, that the medicine has previously been prescribed by a relevant prescriber for that person, and as to the appropriate dose.
Condition B: the quantity is within the limit. For a Schedule 4 or 5 controlled drug that is five days’ treatment. For most other prescription only medicines it is 30 days.
Condition C: the medicine is not a Schedule 18 substance and is not subject to special medical prescription. In practice that rules out Schedule 1, 2 and 3 controlled drugs, with the exception of phenobarbital for epilepsy.
Condition D: the supply is recorded as required, including the nature of the emergency.
Condition E: the label shows the date, the name, quantity and strength, the name of the person requesting it, the pharmacy name and address, and the words “Emergency Supply”.

Now look at what is not there.

There is no requirement that the medicine is a repeat. The test is that it has been prescribed “on a previous occasion”. A seven day acute course from a prescriber meets that.
There is no requirement that the surgery is closed. An open surgery is relevant to whether getting a prescription is impracticable without undue delay. It is part of the judgement, not a bar. Published pharmacy guidance says the same: you can make an emergency supply when the GP practice is open.

An NHS 111 referral sits in the same place. It is a request to contact and assess the patient. It does not oblige a supply, and it does not oblige a refusal. The conditions still do the work.

The same is true of an NHS 111 referral or a Pharmacy First urgent medicines supply. The NHS funds the service, but the legal basis for the supply is still Regulation 225, so every condition above still has to be met.

Autonomy still matters

I respect the autonomy of every registrant. The provision gives us a discretion, not a duty. There are many sound reasons to decline:

The medicine is a Schedule 3 controlled drug. Tramadol, gabapentin, pregabalin and temazepam are all Schedule 3 and cannot be supplied this way.
There is no reliable evidence it has been prescribed before.
We cannot be satisfied about the dose.
The need is not immediate.
There are genuine concerns about misuse or a pattern of repeated requests.

What matters is that the reason can be traced to the law, the patient’s interests and the information available.

“It is not a repeat” fails the first test because it is not in the regulation.

“The surgery is open” is a factor, not a rule.

If we cannot explain a refusal against the conditions, we have not yet made a decision. We have followed a habit.

A checklist you can use on your worst day

Interview the patient. Condition A starts here.
Immediate need: what happens if they go without until the prescription arrives? Consider the condition, the risk and the timescale.
Impracticable without undue delay: what has already been tried, who has been contacted, what has been promised and when, and can the prescriber realistically help now? Note that an electronic prescription promised for later is not the same as one in hand.
Check the EPS Prescription Tracker and shared records (such as the NCRS) for pending or recent prescriptions. In this case, that check changed the conversation.
Previously prescribed: what evidence do I have (packaging, patient record, shared record, discharge information)? It does not need to be a repeat.
Dose: am I satisfied what the patient takes, and from what source?
Legal exclusions: check the schedule of the drug rather than trusting memory. Schedule 3 is out. Schedule 4 and 5 are in, for five days at most.
Quantity: supply what bridges the gap safely. That is often less than the maximum.
Clinical safety: other medicines, interactions, the history of requests, misuse risk.
Record and label: complete the record with the nature of the emergency, and label with the words “Emergency Supply”.
If I refuse: say why in plain terms, record the reason, and signpost to a route that exists today, such as urgent care or an out of hours service. Do not leave the patient with only a “no”.
Afterwards: let the prescriber know where that is appropriate, so the record and the next prescription line up.

Reflect on your process

None of this is difficult.

All of it is hard at 11am on a Saturday with one pharmacist and a full waiting area. That is exactly why the process has to carry us when we cannot carry it ourselves.

So I would ask you to look at your own pharmacy.

Does your SOP say “repeat medicines only”? Does it say “refuse if the surgery is open”? Where did those lines come from?
Does everyone who might make this decision, including locums, know where to find the conditions?
Would your refusal stand up if you had to explain it to the patient, to an inspector, and to your own family?

Autonomy is not the absence of justification. It is the freedom to exercise judgement we can explain.

A good pharmacist can say no.

A good process makes sure that when we say no, it is for the right reason.

Review your own practice

Three ways to investigate:

Read your emergency supply SOP alongside Regulation 225. Mark any rule that does not appear in the regulation.
Look back at your last few declined requests. Is the reason recorded, and can it be traced to a specific condition?
Check that every pharmacist and locum knows how to open the EPS Prescription Tracker and the NCRS in your pharmacy.