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Advancing healthcare policy

Drug packaging and patient safety

Prescrire's Packaging Working Group

A drug's packaging refers to all of the items that either protect it until its administration or provide information useful for patient care: the drug's name (INN), information on dosing, drug interactions, adverse effects, preparation and administration, storage (1). It must help to prevent medication errors and accidental ingestion by children. Packaging is therefore an important component of a drug's harm-benefit balance.

Over 5000 analyses in 30 years
Prescrire analyses the packaging of the new drugs evaluated in the "New Products" section of its French edition, la revue Prescrire.

It also re-examines the packaging of existing products when changes are introduced: name change, different dosing device, usage broadened to include vulnerable patients (children, pregnant women, patients with renal impairment), major new data on adverse effects, etc. Prescrire's Packaging Working Group then checks whether any item of the packaging is more dangerous as a result of these changes: is the INN harder to read, the closure too weak or the dosing device dangerous or unsuitable? And is the information about pregnancy ambiguous or has information about adverse effects been omitted?

Prescrire analyses the packaging of about 150 drugs every year, and has examined over 5000 products in the past 30 years.

Systematic analysis
Every item of the packaging is examined in detail using a standardised form. When the drug is part of an umbrella range, we compare its appearance with the other products in the range. We check the labelling for the legibility and position of key information (INN, dose strength, storage, etc.). We test the quality of blister pack films and bottle caps, especially for dangerous drugs.

We test whether tablets are easily divisible. We prepare formulations that require reconstitution. We try out dosing devices, referring to the patient leaflet. We check whether oral delivery syringes could be attached to an injection needle. We taste and smell the drug. We analyse the usability and safety of the information provided, especially in the patient leaflet, including symbols, pictograms and dosing schedules.

©Prescrire May 2013

1- Prescrire Editorial Staff "Drug packaging. A key factor to be taken into account when choosing a treatment" Prescrire Int 2011; 20 (120): 247-249.