Unlicensed and off label drug use in neonates

Editor—Most papers in this journal have a commendable clear “take home” message, but this was not really true of the recent paper by Conroy et al. 1 They described a 13 week, one unit study in Derby as finding that two thirds of all neonatal prescriptions (294 out of 455) involved the use of a drug in a way that the manufacturers had no license to recommend. The authors do not say what should be done about it.2

They note that 84 prescriptions for vitamins and 77 for penicillin or an aminoglycoside used a dose other than the one mentioned in the drug data sheet. But they must be aware, surely, that data sheet information is advisory in nature. Secondly, an immense amount of information has been published on these issues since the data sheets were first prepared. Thirdly, many UK college and American academy guidelines recommend doses that differ from those in the data sheets. The authors note that 36 prescriptions for caffeine, morphine, or parenteral nutrition had to be made up in the local pharmacy aseptic service unit, and the products were therefore classes as unlicensed. They do not suggest, however, how they would prefer to see the prescribing and dispensing of these drugs handled.

What was the intended message when arrangements were made for the news media to latch on to this report before most clinicians had had their chance to read the paper for themselves? Were headlines such as “Doctors raise alarm over drugs given to babies,” and “Babies used as drug guinea pigs” really what you hoped to generate? Coming only a week after an article in the New Scientist,3 inspired by a steer from the Derby clinicians, the journal article led the …