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'Dear Xrayser, pharmacists don't have to replace faulty devices'

"You could consider taking up your concerns about a design fault with the MHRA"

Pharmacists are not obligated to provide new devices to patients who have returned faulty ones, lawyer David Reissner says in response to one of Xrayser's blogs

Dear Xrayser,

I read with interest your C+D blog published on February 11 titled “Let’s make auto-injectors more patient friendly.”

You wrote that when a patient brought her housebound husband’s dry powder inhaler back to your pharmacy, saying “it’s faulty – he needs a new one”, she assured you that it wouldn’t activate. As this patient had been using the inhaler for over 18 months without a problem you presumed it was indeed faulty due to a design flaw that meant the device was prone to clogging up. You supplied a replacement. You contacted the manufacturer, who did not accept any responsibility for the issue.

When you supply something to a patient on an NHS prescription, there is no contract between you and the patient. This means the patient has no rights under the Consumer Rights Act 2015 to say that the inhaler must be of satisfactory quality. I quite understand that, being in a caring profession, you chose to try to provide a new inhaler – but you were not under an obligation to do so. You could have told the patient to get a new prescription.

However, there is a contract between you and your wholesaler containing an ‘implied term’ [a term that wasn’t in the contract, but that a court would assume was intended to be included] saying that the inhaler was of satisfactory quality. In deciding whether you have a claim against the wholesaler, the inhaler’s durability is a factor to be taken into account. You would have to suggest a reason why the problem was not caused by patient misuse. Can you provide evidence that the same inhalers have been returned to you or other pharmacies because they wouldn’t activate?

There is no contract between you and the manufacturer, so you have no rights there. If a design fault means the product was defective and caused the patient injury, the patient could sue the manufacturer under the Consumer Protection Act 1987. For example, a number of patients have filed lawsuits against GlaxoSmithKline over problems they allege arose from taking Seroxat. However, in your case there appears to have been no injury to the patient.

You could consider taking up your concerns about a design fault with the Medicines and Healthcare products Regulatory Agency (MHRA) because regulations say devices must achieve the performance intended by the manufacturer. Alternatively, if you can get hold of someone sufficiently senior at the manufacturer, mentioning the possibility of complaining to the MHRA might change their attitude because large corporations do not like having to report regulatory complaints to their shareholders.

I hope this advice is helpful.

Best wishes,

David Reissner

Chair of the Pharmacy Law & Ethics Association

Look out for Xrayser's upcoming response to the letter on C+D.

13 Comments

Adam Hall, Community pharmacist

If it has been used successfully for a while, I would question if it is actually 'faulty' or has the patient (or a relative) damaged it in some way. Ventolin inhalers clog up - it doesn't make them faulty - a quick rinse under the hot tap and it's as good as new.

Chemical Mistry, Information Technology

knowing my luck i would refuse and the patient would have a asthma attack and drop dead and be sued by the family and struck off by the gphc for not putting the patient first but maybe this where numsas or cpcs service comes into play to replace the inhaler patient willing.

Dave Downham, Manager

...so what is your advice when an angry Mrs Jones is thumping the counter demanding a replacement in front of a full shop? Pragmatism trumping legality here?

Benie I, Locum pharmacist

You can capitulate. And pray Mrs Jones and nobody observing will see it as weakness and an opportunity to walk all over you again  in the near future.

Tarvinder Juss, Locum pharmacist

If you are a single pharmacy owner, the cost of a single powder inhaler may be quite significant. I congratulate Mr. Reissner and express my gratitude, for a very relevant and informative article. I wasn't aware of the information he provides.

Ka Yiu Leung, Student

Understand the cost aspect esp if you are from an independent Pharm. However couldn't you exchange the item then claim for refund from your supplier for sending a faulty product? - providing they obtain the item from your pharmacy.

Thus we can still put patient interest first and get money back

Adam Hall, Community pharmacist

You mean - defraud your supplier?

Ka Yiu Leung, Student

Not necessary defraud. If the product is faulty in the first place, they should refund u the cost... Manufacturing faults happen all the time, why cant it happen with medical devices?

Obviously I am putting patient safety first. Will it make him / her condition worst without the medication for a prolong period of time whilst waiting for replacement or even a reply from manufacturer?

Leon The Apothecary, Student

For many of the larger chains, even if they are not responsible, for the sake of goodwill, they'll do it. For the sake of avoiding a complaint, they'll do it.

Is this the right attitude we should take?

ABC DEF, Primary care pharmacist

Who cares about the money of a large chain? Is the company in my name if I hit the targets or make them money? It isn't and not a single bit of appreciation even if I did so why should I care about their pockets? Just give another one out to stop the earache! (and for patient care, obviously).

''Boots (or insert any other large chain here) can always suck it up'' - the best motto in my life.

Adam Hall, Community pharmacist

Actually, they are not prepared to 'suck it up' any more - hence store closures and redundancies

Benie I, Locum pharmacist

The very attitude that has landed comminity pharmacy in the mess it faces today. 

Bob Dunkley, Locum pharmacist

Hmmm a very thoughtful piece David, but I suspect that in the rough and tumble of community pharmacy, you would swap the thing. However it remains to be seen, which maxim prevails: " The patient's wellbeing comes first" or " We are not responsible for faulty devices as the patient has no contract with us and we are not obligated in law to replace faulty devices."  Interesting...

 

 

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