english.prescrire.org > Spotlight > Archives : 2016 > 2015 drug packaging review: drug companies and insufficient regulation are putting patients at risk

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2015 drug packaging review: drug companies and insufficient regulation are putting patients at risk

Pharmaceutical companies are fully aware of the solutions for ensuring the quality and safety of drug packaging. But too much drug packaging remains unsafe and too many package leaflets are inadequate.

Ease of use is an important factor in a drug’s harm-benefit balance. Packaging design (i.e. the secondary packaging, package leaflet, bottle or blister pack, dosing device, etc.) can either contribute to patient safety or be a source of harm. Ease of use can even be a key factor when choosing a treatment. Over the years, Prescrire’s packaging analyses have highlighted progress but also identified numerous cases of packaging that represents a risk.

Prescrire’s examination of the packaging of 240 drugs in 2015  revealed no new advances, while some of the packaging exposes patients to an array of risks.

Some positive recent developments, such as more legible INNs (international non-proprietary names) and clearer, more informative package leaflets, are not applied sufficiently to older drugs.

Overall, a large number of drugs are hard to identify, their preparation ranges from not very safe to highly unsafe – dangerous even – and the package leaflet is not sufficiently informative. Furthermore, procedures for making packaging child-proof to avoid the risk of child poisoning need to be completely overhauled.

A wake-up call to the authorities is needed, because solutions do exist for improving drug packaging, especially when it comes to bottles, unit packs, dosage devices, and ‘umbrella’ ranges likely to cause confusion.

In practice, healthcare professionals and patients need to remain vigilant and report problem packaging. There is a growing need for a large-scale European drug packaging initiative.

©Prescrire 1 June 2016

"Drug packaging in 2015: risky industry choices and lax regulation" Prescrire Int 2016; 25 (172): 159-163. (Pdf, free).

Download the full review.
Pdf, free

See also:

Drug packaging
and patient safety
(Advancing healthcare