Unlicensed and off label prescribing of drugs in general practice
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General practitioners are prescribing significant numbers of drugs to children that are outside the terms of the product license - "off label" - finds research in the Archives of Disease in Childhood.
Recent research suggests that this type of prescribing to children in hospitals is very common in the UK and in certain parts of Europe. And there is some evidence to suggest that adverse drug reactions among children in hospital are higher for off label and unlicensed drugs.
The research team examined the prescribing records for 1997 for one suburban general practice in the Midlands. Children up to the age of 12 represented a fifth of this practice's list. Around two thirds of them were given at least one prescription during the year.
The practice records showed that there were almost 3,500 prescriptions for almost 1200 children involving 160 different drugs. Eighty four per cent of the drugs had been prescribed for licensed medicines within the terms of the product licence. Less than half a per cent were for unlicensed medicines, but one in 10 were for off label licensed medicines. Almost all of these had involved dosage.
By far the most frequently prescribed off label drugs were systemic antibiotics, making up just under a third of the category, followed by anti-asthmatic medications, creams, and antihistamines. GPs are not at fault, say the authors; rather, they are victims of inadequate product licence information which recommends, for example, that the same dose of a commonly prescribed antibiotic should be given to a newborn and a 10 year old.
Licensing, say the authors, is unable to keep abreast of current practice and there is no system to monitor and coordinate the information. Furthermore, there is little incentive for the pharmaceutical industry to carry out research on drugs that are already licensed, and funding for research into the way medicines are used in children is not considered a high priority. But they say, "it is essential that the regulatory framework ensures medicines in children are safe, effective, and of high quality."
Contact:
Dr John McIntyre, Academic Division of Child Health, University of Nottingham
Email: John.Mcintyre@nottingham.ac.uk
Journal
Archives of Disease in Childhood