english.prescrire.org > Spotlight > Archives : 2013 > Prescrire looks back at drugs packaging in 2012: too many dangerous flaws

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Prescrire looks back at drugs packaging in 2012: too many dangerous flaws

The analyses carried out over the past year by Prescrire's editors reveal that in too many cases, drug packaging is dangerous for children. Too many patient leaflets contain incomplete information on adverse effects, resulting in the most vulnerable patients being the least protected.

In the course of reviewing new drugs, or in reporting on changes in existing drugs, Prescrire methodically examines drug packaging, carrying out around 150 such analyses every year. That allows Prescrire's editors to single out quality packaging, and also to detect packaging that can give rise to confusion or even danger, in order to keep healthcare professionals informed. All aspects of the packaging are examined: the labelling of the boxes, blister packs, bottles, syringes, etc; any devices supplied in the box for the preparation or administration of the drugs; safety features such as caps; as well as the informational value of the leaflets as regards directions for use, adverse effects, etc.

Prescrire's annual Packaging Awards underscore in a most dramatic way the generally poor quality of the packaging of new drugs, to such an extent that not one Packaging Award was given out for 2012.

However 4 "Yellow Cards" and 10 "Red Cards" were handed out: missing information due to the absence of the drug's real name, the International Nonproprietary Name (INN) on the blister pack; danger to the unborn child due to unclear warnings in case of pregnancy; dangers to young children caused by drugs which may be more or less toxic but are insufficiently secured, etc.
Pharmaceutical companies and drugs regulatory agencies must undertake a major overhaul of packaging safety, with children and other vulnerable patients firmly in mind: ban bulk bottles without a safety cap; test safety caps to ensure that they are child-proof; require the use of secure blister packs for the most dangerous drugs; strengthen warnings about overdose in the leaflet and encourage poison control centres to carry out studies of accidental poisonings.  

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©Prescrire 1 May 2013

"2012 drug packaging review: many dangerous, reportable flaws" Prescrire Int 2013; 22 (138): 134-137. (Pdf, free)

Download the full review.
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See also:

The Prescrire
Packaging Awards
for 2012