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Xrayser: Pharmacists are ethically bound to replace faulty devices

"Up to a third of adult patients with monitored dosage inhalers have incorrect technique"

After a manufacturer refused to accept responsibility for a broken inhaler, Xrayser explains why he was ethically bound to replace it himself

Dear David,

Your letter to me explaining why pharmacists don't legally have to replace faulty devices, published on C+D on March 2, is very interesting. Thinking about it, I can understand that there’s no contract, in the sense of consumer rights, between pharmacist and patient.

However, there falls upon us pharmacists an ethical obligation to provide appropriate clinical care for the patient, as you acknowledge, and this was why I felt it appropriate to immediately replace an inhaler that had stopped working when confronted with such a situation – as otherwise the patient would have gone without treatment.

I’d always understood that the Medicines Act 1968 requires us to supply drugs of a satisfactory nature. I’m old enough to recall pharmacy inspectors taking samples of dispensed medicines, although that harks back to a time when we compounded medicines in the dispensary. I believe that a dispensing error can, in some cases, be a criminal offence because it contravenes sections of the Medicines Act, but presumably that doesn’t apply to delivery devices that don’t deliver.

As to the question of being “faulty”, it’s difficult with dry powder inhalers to check the operation without administering a dose of drug. And, even if I were prepared to do so, the issue of hygiene – particularly pertinent in these days of the novel coronavirus – further complicates the activation of a device returned by a patient’s representative.

So, we come to the aspect of design, and whether that constitutes a fault is perhaps a moot point. It’s generally held that up to a third of adult patients with a traditional monitored dosage inhaler are unable to practice the correct technique and therefore do not receive the correct dose, if any. So does that mean all such inhalers are faulty?

No, if I’m honest this whole business makes me think about the new fan I recently purchased.

I’ve just paid hundred of pounds for a bladeless fan that heats, cools, and purifies the air in my room. It's designed with a large loop on top that makes a perfect handle, and for me is the only easy and comfortable way to pick up and move this large item.

However, the instructions are adamant that under no circumstances should it by carried this way. Instead, I must crouch down to the floor and use two hands to grip the heavy base. This technologically advanced device is a wonder of design, except that it has not been designed for how the average person will naturally behave.

Equally, the long list of potential patient errors supplied to me by the manufacturer of the dry powder inhaler returned by my patient suggested to me that this device has been made so the patient must fit the design rather than the design fitting the patient.

That might be a difficult argument to make to the Medicines and Healthcare products Regulatory Authority, but it’s one that I will make to our local respiratory prescribers, and that may be of similar concern to the company’s shareholders.

Yours sincerely,

Xrayser

A long-running C+D contributor, the identity of Xrayser remains a mystery, but his irreverent views are known by all. Tweet him @Xrayser

2 Comments

Alexander The Great, Community pharmacist

The cost should never fall on us.... too much already does. Return it to wholesaler and they can sort it out with manufacturer, and report to MHRA as faulty medical device. Last resort, ask dr to issue another script.

Adam Hall, Community pharmacist

I disagree that we are ethically obliged. We supplied the original in good faith. The manufacturer refuses to replace so either they are in breach of their obligation or it is not truly faulty - either way, the responsibility (and cost) does not lie with us.

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