Inappropriate drug labelling.

Abstract

We wish to draw your attention to another case of inappropriate drug labelling on the ampoules of 0.5% heavy Marcain used for spinal anaesthesia. The ampoule is labelled as: ‘For spinal anaesthesia by parenteral injection’(Fig. 7), as is the packaging box. There have been previous reports of inappropriate drug labelling [1, 2]. Strictly speaking the word ‘parenteral’ is defined: ‘by some other means than through the gastrointestinal tract’[3]. However, as Bromhead and Walker have rightly pointed out, the common understanding among anaesthetists is that, ‘parenteral’ refers to the intravenous route. This labelling could therefore lead to a disaster if the drug were to be injected in the wrong place. S. Gupta M. Khan Epsom General Hospital, Epsom KT18 7EG, UK Thank you for giving us the opportunity to respond to the comments raised by Drs Gupta and Khan. The current labelling for Marcain Heavy is in compliance with its Summary of Product Characteristics and the current labelling regulations and as such has been approved by the Medicines Control Agency. As Drs Gupta and Khan note in their letter, the use of the term, ‘parenteral injection’ on the label and packaging is not incorrect. We are currently investigating the implications of amending the wording on the Marcain Heavy label.