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Illustrated examples of dangerous drug packaging, from Prescrire's annual packaging review

A drug’s packaging (box, bottle, leaflet, etc.) is crucial in preventing administration errors. Three examples from Prescrire's annual drug packaging review illustrate the types of packaging flaws we identified as dangerous in 2019, flaws which have long been known to health authorities.

Illustrated examples of dangerous drug packaging, from Prescrire's annual packaging review
• 20-ml oral syringe: delivers 10 times the paediatric dose
Oral syringe
Drugs are often first authorised for use in adults. When their marketing authorisation is later extended to include paediatric use, their packaging is not always adapted accordingly, or is insufficiently adapted. This is a failing of marketing authorisation extension procedures, including European centralised procedures, under the responsibility of the EMA. For example: the capacity of the oral syringe for Inovelon° (rufinamide) was left unchanged, yet it is far too high for infants.
 
• Deroxat° (paroxetine): an inaccurate dosing device (measuring cup) + 2 scales (in mg and ml)
Deroxat dosing device
Another type of flaw is choosing a graduated measuring cup as a dosing device. Several products examined in 2019 were marketed with a measuring cup, including the antidepressant Deroxat° (paroxetine). The measuring cup for paroxetine had two graduated scales, one in milligrams of the drug and the other in millilitres, a known source of confusion resulting in double or half doses because the drug is a 2 mg/ml suspension.
 
• Blister packs without, and with, unit-dose labelling
Blister packs
In France, the ANSM has recommended perforated unit‑dose blister packs as the quality standard for the labelling and safety of all tablets and capsules, whatever drug they contain. But they remained rare among the packaging examined by Prescrire in 2019: for example Baclocur° (baclofen).

©Prescrire 1 July 2020

Source: "2019 drug packaging review: slow progress and dangers" Prescrire International 2020; 29 (217): 191-195. Free.

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For more information:

"Prescrire's annual drug
packaging review: slow
progress and dangers "
(July 2020)
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See also:

Drug packaging and
patient safety
Advancing healthcare policy
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"The Prescrire Drug
Packaging Awards for 2019"
(February 2020)
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