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Package leaflets for medicines could be clearer – despite EC tests

[30 Sept 2015] If you’re prescribed the iron supplement Ferrograd C, you’ll get the bonus of a diverting package leaflet published by makers Teofarma SRL. First it warns of a terrible disease that could afflict your furniture: ‘Your stools may turn black whilst taking Ferrograd C.’ Then it says, ‘Ferrograd is not recommended for children under 12 years old. Acute iron poisoning is a serious risk in the paediatric population.’

When ‘paediatric population’ is used as supposedly elegant variation for ‘children under 12’, you wonder how the leaflet passed the mandatory European Commission clarity test that pharmaceutical firms have to use – we trust no VW-style defeat device was applied.

The leaflet says Ferrograd C may not work properly if the user is also taking ‘zinc - containing preparations’, which presumably means ‘zinc-containing preparations’. Odd that the clarity tests didn’t pick this up.

Official guidance on the clarity tests says: ‘A satisfactory test outcome […] is when the information requested[…] can be found by 90% of test participants, of whom 90% can show they understand it. That means to have 16 out of 20 participants able to find the information and answer each question correctly and act appropriately’. It goes on: ‘In approving package leaflets the competent authorities will look for evidence that people who are likely to rely on the package leaflet can understand it and act appropriately.’

The EC’s guideline on the readability of the labelling and package leaflet of medicinal products for human use, also known as ‘ENTR/F/2/SF/jr(2009)D/869 (Brussels; 2009 Jan 12)’ is available from: [cont]

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