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Prescrire's packaging review for 2018: ways to reduce dangers

A drug's packaging (box, bottle, delivery device, leaflet, etc.) is especially important in preventing patient errors in taking the drug. Hence the usefulness of Prescrire's methodical analysis.

In 2018, Prescrire examined the packaging of 220 pharmaceutical products. Since 1981, we have analysed some 7 000 packaging items, and the results are incontrovertible: most do not guarantee the administration of the right drug at the right dosage in the foreseeable contexts of use. The main reasons for this are:

  • the lack of clear labelling as to the international nonproprietary name (INN) – the drug's real name – and the dosage;
  • the rarity of unit-dose packaging; 
  • the inadequacy of precautionary information in the leaflets with regard to many risky situations.

The tightening up of labelling standards in France in 2018 by the French Health Products Agency (ANSM) and its recommendations to manufacturers to eliminate umbrella ranges and to package drugs in unit-dose blisters, demonstrate at last that packaging dangers are being taken seriously.

Practices that are on the rise include advance preparation of doses to be administered, oral chemotherapy at home and measures aiming to prevent medication errors. They all reveal the dangers associated with some packaging.

For example, it is common for drugs to be marketed for use by children without sufficient adaptation of the packaging of the drug already available for adults. One illustration is sevelamer, taken as a drinkable suspension. For children over the age of six, doses of 0.8 g or 1.6 g are required, adjustable in increments of 0.4 g or 0.8 g respectively. But in early 2019, in France, no dosing device was provided with the 2.4 g sachet, while 0.8 g and 1.6 g dosages are not available and no 0.4 g dosage has been authorised.

©Prescrire 1 July 2019

"2018 drug packaging review: proposals to reduce the dangers of poor-quality packaging" Prescrire Int 2019; 28 (206): 190-194. (Pdf, free).

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Download the full review.
Pdf, free

See also:

2018 Prescrire
Packaging Awards
(February 2019)

Drug packaging
and patient safety
(Advancing healthcare