Clinician's Library

Safety concerns over parallel imports of thickeners and thickened ONS

26 August 2021

We have been recently heard that there are concerns over the parallel imports of thickeners and thickened oral nutritional supplements and their labelling.

As it was something new to us, it might be new to you too and so thought we should share it with the aim of raising awareness and suggesting that the outer IDDSI labelled packaging matches the product packaging before use! Here is what has been reported…

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“As you know, background food and drink texture modification (including medications) are a widely accepted way to support the management of those with eating, drinking and swallowing difficulties (dysphagia).

However, parallel imported thickeners and ONS from countries that are not IDDSI-compliant are being reported and present significant risks.

The International Dysphagia Diet Standardisation Initiative (IDDSI)

In 2018, following an NHS improvement Patient Safety Alert NHS/PSA/RE/2018/004, the Department of Health issued HSC (SQSD) 16 /18 Resources to Support Safer Modification of Food and Drink, which mandated the global International Dysphagia Diet Standardisation Initiative (IDDSI) terminology and provided implementation guidance across Health and Social Care settings.

This meant a change in the way dysphagia diets were classified from the old “National Descriptors” to the new IDDSI levels. As a result, UK manufacturers of thickeners and thickened oral nutritional supplements changed their labelling and instructions accordingly.

Speech and Language Therapists (SLTs) could now assess patients who need texture modified food and/or thickened drinks and make recommendations on their required IDDSI level. While there was a transition period in 2018, there is now a full implementation across all four nations.

Risk of serious harm or death from choking on food or drink with incorrect IDDSI levels

People with dysphagia must receive their recommended fluid and food consistency to reduce the risk of complications, such as choking and aspiration. However, different Scoop Size Parallel import thickening products from countries that are not IDDSI compliant have different mixing instructions on the labels, and different scoop sizes to UK products.

Incorrect mixing instructions and incorrect scoop size can lead to patients receiving the incorrect thickness of food/drink. This poses a significant risk to patients who need texture modified food and/or thickened drinks. For example: a parallel import of thickener had a 1.5g scoop size, but the original scoop size was: 4.5g.

In this case, the parallel import was over-labelled to reflect the IDDSI levels framework, but the scoop supplied was the old 4.5g size. Therefore, a patient assessed as requiring a Level 1 could potentially receive parallel imported nutritional product and risk to patient safety.

While IDDSI is the recognised international descriptor, not every country has adopted this framework.

Parallel imported products could cause confusion and increase risk

SLTs and dietitians have reported that patients have received parallel imported products dispensed from community pharmacies that could cause confusion and increase patient risk.

These include thickening products that are not IDDSI compliant and thickened oral nutritional supplements in packs using older “Stage” terminology rather than the new “level” description.

Other reported issues that pose significant risk include Non-IDDSI descriptors clearly visible on the top of packaging, but the sides of the pack and individual bottles were not.

Parallel imported products are similar in appearance to the UK product, but include the pre-IDDSI “Stage” descriptor, causing confusion and increasing the risk of an incorrect IDDSI level product being used, e.g., “Stage 2” is not equivalent to IDDSI “Level 2”.

To ensure patient safety and reduce the risks associated with imports of thickeners and thickened ONS, it is vital products are IDDSI compliant.”

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We are confident that suppliers of these products will have worked hard to resolve the issue.

It is good practice to always double check the IDDSI flow rate. Check the outer packaging and product packaging have an IDDSI Level printed on them, they match and it doesn’t just claim “Suitable for Dysphagia”.

For more information about IDDSI labelling visit www.IDDSI.org or look through our site www.slodrinks.com

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