GPs prescribe significant numbers of "off label" drugs to children

November 19, 2000

Unlicensed and off label prescribing of drugs in general practice

PLEASE NOTE: Unfortunately we are unable to post the PDF link to this paper. If you require the full research paper, we can fax it to you. Please telephone or e-mail Emma Wilkinson on +44-20-7383-6529, or Email: ewilkinson@bmj.com

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."
-end-
Contact:

Dr John McIntyre, Academic Division of Child Health, University of Nottingham
Email: John.Mcintyre@nottingham.ac.uk

BMJ Specialty Journals

Related Children Articles from Brightsurf:

Black and Hispanic children in the US have more severe eczema than white children
A presentation at this year's virtual American College of Allergy, Asthma and Immunology (ACAAI) Annual Scientific Meeting reveals the disparities that exist for Black and Hispanic children when it comes to Atopic Dermatitis (AD), commonly known as eczema.

Black children with cancer three times less likely to receive proton radiotherapy than White children
A retrospective analysis led by investigators from Brigham and Women's Hospital has found racial disparities in the use of the therapy for patients enrolled in trials.

The Lancet Child & Adolescent Health: First Europe-wide study of children confirms COVID-19 predominately causes mild disease in children and fatalities are very rare
Children with COVID-19 generally experience a mild disease and fatalities are very rare, according to a study of 582 patients from across Europe published today in The Lancet Child & Adolescent Health journal.

Children not immune to coronavirus; new study from pandemic epicenter describes severe COVID-19 response in children
- While most children infected with the novel coronavirus have mild symptoms, a subset requires hospitalization and a small number require intensive care.

How many children is enough?
Most Russians would like to have two children: a boy and a girl.

Preterm children have similar temperament to children who were institutionally deprived
A child's temperament is affected by the early stages of their life.

Only-children more likely to be obese than children with siblings
Families with multiple children tend to make more healthy eating decisions than families with a single child.

Children living in countryside outperform children living in metropolitan area in motor skills
Residential density is related to children's motor skills, engagement in outdoor play and organised sports. that Finnish children living in the countryside spent more time outdoors and had better motor skills than their age peers in the metropolitan area.

Hispanic and black children more likely to miss school due to eczema than white children
In a study that highlights racial disparities in the everyday impact of eczema, new research shows Hispanic and black children are more likely than white children to miss school due to the chronic skin disease.

Children, their parents, and health professionals often underestimate children's higher weight status
More than half of parents underestimated their children's classification as overweight or obese -- children themselves and health professionals also share this misperception, according to new research being presented at this year's European Congress on Obesity (ECO) in Glasgow, UK (April 28-May 1).

Read More: Children News and Children Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.