When pholcodine is mentioned, I immediately think of a fitness-to-practise (FtP) case I dealt with decades ago when I was a young solicitor. A lady bought a bottle over the counter (OTC) in a pharmacy. The pharmacist owner who made the sale was unaware that the bottle did not contain pholcodine linctus but instead contained urine.

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We never discovered how or why. It was an era when pregnancy testing was done with urine specimens, but there was far more liquid in the pholcodine bottle than would have been needed for a pregnancy test. The lady went home, took a spoonful and spat it out, telling her husband it tasted disgusting.

He replied that it was meant to taste disgusting and persuaded her to take another spoonful. The customer’s daughter who was a nurse recognised the ammoniac smell coming from the bottle and stopped her mother taking any more.

That case went through my head when I read about the recent Medicines and Healthcare products Regulatory Agency (MHRA) recall of pholcodine following a review where it found an “increased risk of the very rare event of anaphylaxis to neuromuscular blocking agents (NMBAs) used in general anaesthesia”.

I heard a doctor say on breakfast television that patients could continue to use pholcodine they had previously purchased from a pharmacy because the likelihood of an adverse reaction was very small.

The TV doctor’s advice would not be inconsistent with the MHRA’s advice for patients which does not suggest patients should return pholcodine to the pharmacies they bought from and ask for a refund.

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I’m not a doctor or a pharmacist, but I don’t agree with the TV doctor.

If a patient asks a pharmacist whether they can still use pholcodine previously purchased – perhaps from a different pharmacy – I consider that a pharmacist's duty of care would require them to say no.

The likelihood of an adverse reaction may be very small, but if an adverse reaction does occur, for example during a subsequent surgical procedure, the level of harm is likely to be serious.

I do not see how a patient could reasonably be advised to take medication that is the subject of a recall, especially when there are alternative medicines that could be taken.

In my view, if pharmacists are asked about taking pholcodine that has previously been purchased, they should reassure patients that there is very little risk of harm but that – to be on the safe side – they should bring the bottle in for disposal.

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If a patient did ask for a refund at the pharmacy from which pholcodine had been bought, I believe they would be entitled to their money back.

Under the Consumer Rights Act 2015, goods must be fit for purpose and I doubt whether a product that could not now be sold because of a recall could be said to have been fit for purpose when it was sold.

At the time of writing, the General Pharmaceutical Council (GPhC) has not specifically commented on the pholcodine recall. GPhC standards and guidance do not expressly mention recalls.

However, its standards do require pharmacy owners to deliver services and manage medicines in a way that safeguards the health, safety and wellbeing of patients and the public.

A failure to remove pholcodine from pharmacy shelves could well be regarded as a breach of the GPhC’s standards and result in FtP proceedings.

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When there is a product recall, manufacturers and marketing authorisation holders have legal duties. I was curious about whether pharmacy owners and pharmacists also have any legal obligations to remove products that are the subject of a recall. I expected to find something in the NHS terms of service, for example in the section on clinical governance.

The nearest I could find was a duty to deal appropriately and “timeously” with any communications concerning patient safety from the secretary of state and NHS England (NHSE). A breach of this requirement could expose the pharmacy owner to sanctions such as the withholding of remuneration.

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The only other legal obligation that could apply to pharmacies is in the obscure General Product Safety Regulations 2005, which impose a duty on professionals in the supply chain to act with due care in order to help ensure compliance with applicable safety requirements.

In particular, a professional must not “expose or possess for supply or offer or agree to supply, a product…which he knows or should have presumed…as a professional, is a dangerous product”.

This is an offence that can be committed by professionals – pharmacists or pharmacy technicians – not by pharmacy owners. It is the job of local authorities to enforce these regulations and any breach is a criminal offence with a possible sentence of up to 12 months in jail or a fine of up to £20,000 or both.

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Product recalls are not a recent thing, so I expected to find something spelled out clearly both in the GPhC’s publications and in laws relevant to pharmacy. After all, pharmacy practice is subject to many legal restrictions and there are numerous criminal offences that pharmacy owners, pharmacy professionals and employees can commit.

However, it is preferable if failures in pharmacy practice are treated as professional conduct matters for the regulator rather than treating pharmacy owners, pharmacy professionals and other staff as criminals.

 

David Reissner is a solicitor and chair of the Pharmacy Law & Ethics Association