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Inadequate ampoule labelling
Article first published online: 6 JUL 2006
Volume 61, Issue 8, page 819, August 2006
How to Cite
Adekanye, O. and Vasoya, R. (2006), Inadequate ampoule labelling. Anaesthesia, 61: 819. doi: 10.1111/j.1365-2044.2006.04737_1.x
- Issue published online: 6 JUL 2006
- Article first published online: 6 JUL 2006
We would like to draw attention to the fact that norepinephrine as provided by Abbott Laboratories (Queenborough, UK) appears to have insufficient information on the ampoule. Each 4-ml ampoule contains 4 mg of norepinephrine tartrate. On the packaging, the description includes number of ampoules in a pack, the concentration (1 : 1000), and the amount of norepinephrine base and norepinephrine tartrate in mg per ml. On the ampoule, however, the description includes the amount of content in millilitres and concentration as 1 : 1000, but it does not state the amount of norepinephrine in mg per ml or units per ml. More often than not the information on the ampoule is what is available to anaesthetists during emergency situations. The ampoule is labelled as containing 1 : 1000 units, suggesting that the whole ampoule is 1 : 1000 units (1 mg). Although more detailed information is written on the pack, and the information leaflet within it, insufficient information on the ampoule may predispose a patient to the danger of overdose.
Although there is no international standard for labelling of drugs, the World Health Organization states that the packaging should state the name, strength, quantity and physical description or identification of the medicinal product, that the labels should permit the identification of each active ingredient, and give the dosage form [1, 2]. The labelling of these norepinephrine ampoules does not meet the NHS specification devised in 1991 by the National Pharmaceutical Supply Group which states that units should be SI and the amount/concentration should be expressed as the amount of ‘x’ in ‘y’ ml, where ‘y’ is the total volume of the ampoule [1, 3]. Furthermore, EU directive 92/27EEC states that an ampoule label should include a statement of the active ingredients expressed qualitatively and quantitatively, the pharmaceutical form and the contents by weight, by volume or by number of doses . The labelling displayed on this ampoule does not satisfy this directive either.
Critical incidents in the peri-operative period as a result of faulty drug labelling practice are well recognised . As a result of the awareness of the dangers of improper labelling of drugs in the clinical setting, we have moved on from the days when syringes were unlabelled and the drug contained in each syringe was determined by the volume of each syringe. Although the norepinephrine ampoule labelling may satisfy the minimum British legal requirement and the WHO document, and the NHS specification and the EU directive are not legal requirements in the same way that the Medicine Act 1968 is, the norepinephrine ampoule labelling still falls short of what could be regarded as best labelling practice. We believe that the description given on the norepinephrine ampoules should include the concentration of the drug per ml, as well as the dose of the drug in mg per ml.
- 2WHO. Expert Committee on specification for pharmaceutical preparations, 36th Report. WHO technical report Series 902, 2002. http://www.Who.International/Entity/Medicines/Publications/Pharmprep/En/[accessed 22 February 2006].
- 3National Pharmaceutical Supply Group. Ampoule Labels: NHS Specification. London: HMSO, 1994.
- 4EEC. EEC directive 92/27 on labelling of medicinal products for human use and on package leaflets, 31.03, 1992. http://www.Ikev.org/docs/eu/392L0027.pdf[accessed 22 February 2006].