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Unlicensed omeprazole liquid

Tags: Safety

What is this measure?

The proportion of all omeprazole liquid issued as unlicensed products.

How is it calculated?

We divide the number of Defined Daily Doses (DDDs) of unlicensed liquid omeprazole products by the total number of DDDs of all liquid omeprazole products and then multiply by 100 to obtain a percentage each month.

Why does it matter?

An unlicensed medicine (sometimes called a special or special-order medicine) is a medicine that does not hold a UK marketing authorisation (product licence) from the Medicines and Healthcare products Regulatory Agency (MHRA).

That means it has not gone through the usual MHRA approval process for safety, quality, and efficacy for its intended use.

The MHRA states that prescribers should be satisfied that an alternative, licensed medicine would not meet the patient’s needs before prescribing an unlicensed medicine see, MHRA Off-label or unlicensed use of medicines: prescribers’ responsibilities.

Licensed formulations of omeprazole liquid began to become available in 2020, and prescribers should consider using these in preference to unlicensed products.

Which NHS Trusts are included?

Trusts are only included in this measure if they have issued any products included in the denominator for this measure.

For this measure, 186/227 Trusts are included. A full list of Trusts included is available on the Submission History page.