Class 3 Medicines Recall: Besins Healthcare (UK) Ltd, Oestrogel Pump-Pack 750 micrograms/actuation Gel (estradiol), EL (24)A/09

[helvella]

In case any members are using this product:

Class 3 Medicines Recall: Besins Healthcare (UK) Ltd, Oestrogel Pump-Pack 750 micrograms/actuation Gel (estradiol), EL (24)A/09

Besins Healthcare (UK) Ltd has informed the MHRA that a defective pump system was detected in two batches of Oestrogel Pump-Pack 750 micrograms/actuation Gel.

gov.uk/drug-device-alerts/c...

Includes the following somewhat self-contradictory statement:

Advice for patients

Patients who experience issues with a pump from the batches specified in the table should return the defective pumps to their pharmacy. As this is a prescription only medicine, a new prescription will be required for the dispensing of a replacement product. Patients with a HRT pre-payment certificate will not incur any additional costs. Where patients pay for NHS prescriptions, a charge for the new prescription will apply; patients may contact the Defective Medicines Reporting Centre if further information is required.

No further action is required by patients as this is a Pharmacy and Wholesaler level recall. Where the pump is functioning correctly, patients should continue to take medicines from these batches as prescribed by your healthcare professional.

Strikes me that a true Pharmacy and Wholesaler level recall wouldn't have additional advice for patients. The simple fact this additional advice is present makes it a recall down to patient level in my view of the world! Even if the advice is that most patients can continue using it.

Obviously, all recalls have a tendency to affect availability of both the product itself and any possible alternatives.

[joydot]

why on earth would patients incur new cost?!

[helvella Administrator Thyroid UK in reply to joydot]

I agree!

[J972]

Thank you, I use that. I’m personally not overly worried about the fact that the issue relates to the pump. Obviously if it was a formulation problem, I’d be concerned.

It’s pretty shocking that patients will have to pay for a replacement! What’s that all about?!

[helvella Administrator Thyroid UK in reply to J972]

I think this needs to be raised as an issue.

After all, most products that you can buy will be replaced if defective. (Standard consumer law usually applies and say that, even if there are exceptions and limits.)

Whether consumer law applies to NHS charges (i.e. not payment for the product) is an interesting question - I'd guess probably not.

[RedApple Administrator in reply to J972]

No facility for pharmacies to dispense any medication (in England only) without taking the standard prescription charge I guess?

[Goldengirl01]

that’s where pre-payment prescriptions come in (pay yearly) then it shouldn’t be a problem but I do think it’s very unfair for people that pay as and when.