The French drug regulatory agency (Afssaps) began harmonising the labelling of ampoules of certain injectable drugs in 2005. Initially, 5 drugs were included: adrenaline, atropine, ephedrine, potassium chloride and morphine (1). In 2009, Afssaps added some other electrolytes, anaesthetics, dopamine, drugs used in dental practice, etc. (2).

INN and dose strength
In 2009, Afssaps published photographs of the ampoules before and after modification on its website (www.afssaps.fr) (2). Standardisation of information and its layout has made the labelling clearer. The main advances are that the international nonproprietary name (INN) is given greater prominence and the total quantity of drug present in the total volume of solution is displayed. Positioning the label along the length of the ampoule rather than perpendicular to this axis increases surface area for label information, making it more visible.

Reservations. Some information is still etched on the glass. It becomes difficult to read when layers of information are superimposed due to the transparency of the glass. Manufacturers need to explain why they cannot make more legible labels in their marketing application (1). But what could possibly justify the absence of a label on ampoules of Dopamine Aguettant°, Xylocaine° 50 mg/ 5 ml (lidocaine) and Naloxone Mylan° (2)? 

More widespread application. These recommendations should be applied more extensively, beyond their official scope. For example, Mundipharma has applied them to the labelling of injectable oxycodone (Oxynorm°) 20 mg (Rev Prescrire 313). In 2009, the box showed the total quantity of oxycodone close to the total volume (20 mg - 2 ml) instead of just displaying the concentration "10 mg/ml" near the total volume, which is a potential source of errors. 
This type of improvement should be more widely applied. 

©Prescrire April 2010

"Drug packaging in 2009: a few advances" Prescrire Int 2010; 19 (107): 135-137

References:
1- Prescrire Rédaction "Étiquetage des médicaments injectables: des progrès, à poursuivre" Rev Prescrire 2007; 27 (290): 903.
2- Afssaps "Référentiel comportant les photographies de l’ensemble des spécialités concernées par la 2e vague du plan d’harmonisation, avec un comparatif avant et après mise en œuvre des recommandations, classé par substance active et par laboratoire" October 2009: 92 pages.
3- Afssaps "Affiche générale" + "Affiche spécifique aux spécialités à usage dentaire" 10 décembre 2008: 4 pages.