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Pharmacists at risk of prosecution under DH’s shortages solution

The NPA said allowing pharmacies to substitute medicines was insufficient to deal with shortages
The NPA said allowing pharmacies to substitute medicines was insufficient to deal with shortages

Amending regulations to allow pharmacists to dispense an alternative in cases of medicines shortages could result in pharmacists breaking the law, sector bodies have said.

The proposed amendments to the Human Medicines Regulations 2012, which the Department of Health and Social Care (DH) said will go before parliament “towards the end of the month”, would allow pharmacists to dispense an alternative in accordance with a “serious shortage protocol”, rather than the prescription, without contacting the GP, in the event of a national medicines shortage.

The DH stressed last month (December 7) that the amendments “will come into force before March, regardless of the situation with Brexit”, but the proposals have been “prompted by the preparations for the UK’s exit from the EU”, it said in its consultation letter.

In their responses to the consultation, the Pharmacists’ Defence Association (PDA), the Pharmaceutical Services Negotiating Committee (PSNC) and the Association of Independent Multiple Pharmacies (AIMp) separately expressed concerns that the amendments do not protect pharmacists from breaching section 64 of the Medicines Act 1968, which prevents the sale of “any medicinal product which is not of the nature or quality demanded by the purchaser”.

Not covered by dispensing error defence

David Reissner, consultant at law firm Charles Russell Speechlys LLP and a director of AIMp, said the DH’s rush to implement the amendments ahead of Brexit means the proposed “new powers don’t address every potential pitfall for pharmacists, pharmacy staff and pharmacy owners”.

If a patient was harmed as a result of an alternative being supplied under the DH’s instructions, pharmacy staff would not be able to use the defence from criminal prosecution for an inadvertent dispensing error, which came into force last year, he explained.

“As a result, some pharmacists may be hesitant about providing an alternative, even though permitted to do so,” Mr Reissner told C+D.

“A pharmacy owner who provides an alternative medicine under a serious shortage protocol will also be in breach of the NHS terms of service in England,” he added. “So the DH will be reliant on NHS England taking a common-sense view about the breach.”

In its response to the government’s “informal consultation” on the proposed changes, AIMp highlighted the case of Martin White, a pharmacist in Northern Ireland who was prosecuted in 2016 under section 64 and given a suspended prison sentence for accidentally dispensing propranolol instead of prednisolone in the hours before a patient’s death in 2014.

AIMp stressed that the DH should ask the Crown Prosecution Service not to press charges in cases “where a pharmacist has genuinely purported to exercise his or her professional skill and judgement when seeking to act in accordance with [the DH's instructions]”.

In addition, the Company Chemists’ Association (CCA) – which represents the UK’s largest multiples – said in its response that pharmacists should not be sanctioned if acting in accordance with the DH’s shortages protocols breaches the National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013 – a point reiterated by AIMp.

Queries and clarifications

Pharmacy bodies also drew attention to other issues with the proposed legislative changes.

Gareth Jones, head of corporate affairs at the National Pharmacy Association, said allowing pharmacies to substitute medicines was “a good start”, but insufficient to deal with shortages.

“Pharmacies should be able to share medicines with each other if one or more pharmacies runs short of a particular line,” he said.

In addition, the PDA claimed that the changes could sanction the supply of medicines to patients in “non-pharmacy locations”, thus risking their safety.

PSNC, the CCA and the Royal Pharmaceutical Society argued that the legislation should be amended to allow pharmacists to dispense medicines of alternative strengths, not merely “a different quantity or dosage form”.

PSNC and the CCA also agreed that pharmacists should be given the power explicitly to substitute between branded medicines.

The DH responds

Responding to a question on the legislative amendments in parliament last week (January 11), pharmacy minister Steve Brine said the DH had received 47 written responses to its consultation, which were “broadly supportive” of the proposals.

The DH told C+D it was unable to comment on specific concerns, because the responses to its consultation are still being considered.

“These are sensible proposals that should reduce the time taken for alternatives to be provided to patients and make it easier for clinicians to deliver the appropriate treatment,” it said.

“We are currently reviewing the responses to the consultation and no decision has yet been made. Any protocol would be developed and signed off by highly specialised clinicians to ensure the system is robust and safe.”

Are you concerned about the DH's shortage proposals?

Jay Badenhorst, Superintendent Pharmacist

The community pharmacy sector should lead on this and not just merely 'referring back to the GP'. We always claim to be the experts on medicine. This is a great opportunity to influence change in our favour. We obviously need to demand the necessary protection with legislation and regulation but should not just pass this opportunity by.

M Yang, Community pharmacist

DH is obviously unaware that most pharmacists just ask the patient to go back to the prescriber for an alternative. Unless the law protects me, a piece of paper recommending that I should dispense something else because of a shortage isn't going to make me change my mind. Given how spineless and corrupt our regulator and policy makers can be, I'm not risking my career over this.

Leon The Apothecary, Student

Wholeheartingly agree here too, why take a risky option when a safer option exists? Give more incentives to surgeries to have prescription teams that have a full view of a patient record instead would be a more logical approach in my humble opinion.

Lucky Ex-Boots Slave, Primary care pharmacist

Well said. GPhC is so good at striking off individual pharmacists but not so good at failing inspections of the incompetent stores of some big chains. I have witnessed so many failed Bxxts stores passing their inspections despite being awful and a bomb is literally waiting to go off ! And don't forget NPA and CCA are working in the interests of the companies but not individual pharmaicsts, so despite having an insurance (e.g. Boots with NPA) both the company and insurance provider won't back you up in case of any serious errors and harm done! It's time to probably get your own indemnity from a company working in the interests of individual pharmacsts. PDA springs into mind in the first instance! 

Soon-To-Be Ex-Pharmacist, Superintendent Pharmacist

I'll just be referring patients back to the GP. I ain't taking no flak over this one.

Greg Lawton, Community pharmacist

Section 64 of the Medicines Act is here:

(1) "No person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser."

I can see two parts to assessing whether or not a supply against an SSP would be a breach of section 64.

1. When a medicine is supplied in accordance with an SSP, is it being sold? If so, who is the purchaser? Is it the DHSC? Could it really be said that the DHSC is demanding a medicinal product of a certain nature or quality? Or (again if it is being sold), is it to the patient - in which case section 64(1) would apply to the sale and would be breached. If it is not being "sold" when supplied in accordance SSP, then the considerations in part 2 below may still be relevant.

2. When a medicine is supplied in accordance with an SSP, is it being done in pursuance of a prescription? (See section 64(5)). My understanding is that the function of an SSP would be to allow a pharmacist to substitute a prescription medicine, where there was a shortage, without breaching the Human Medicines Regulations. The prescription would be the legal authority to supply anything at all, so it could be argued that the supply is being made in pursuance of a prescription (in which case section 64(1) would apply as a result of 64(5), and section 64(1) would be breached by a supply against an SSP).

Perhaps the DHSC's argument is that the supply is being made in pursuance of an SSP rather than a prescription and that the medicine is not being "sold", therefore section 64(1) does not apply. I'm not sure that's a valid argument. Could someone sucessfully argue that they're supplying a medicine only in accordance with a vehicle that is merely one of the requirements necessary to allow a supply of a medicine to take place without breaching section 214 of the Human Medicines Regulations? And that the prescription is not relevant?

The defences to section 64 would not apply.

I'm not a lawyer so... just a lay analysis. The fact that AIMp has raised this issue when David Reissner is a director says something.

I'm sure the DHSC has its own lawyers who can help explain the reasoning.

Mike Smith, Community pharmacist

Clarity is URGENTLY needed

Lucky Ex-Boots Slave, Primary care pharmacist

There won't be any clarification. Pharmacists will simply be the scapegoat of these medcine supply issues in this shambolic Brexit!

Leon O Hagan, Community pharmacist

But but but.....the decriminalisation that Ash et al promised!!

Lucky Ex-Boots Slave, Primary care pharmacist

Another flawed and messy system rushed by the government to deal with Brexit without thorough understanding and consultations. Community pharmacists will just end up being the scapegoat of this complete shambles. But you know what? Blame and sack the pharmacist as always no matter what's wrong! There are so many pharmacy schools churning out loads of new pharmacists anyway right so they are all dispensable. At least I can tell you some big chains management do see it that way! 

Kevin Western, Community pharmacist

 “So the DH will be reliant on NHS England taking a common-sense viewabout the breach.”

oh dear

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