Drugs that are not specifically made for children (unlicensed) or prescribed outside the terms of the product licence (off label) are regularly being given to children in paediatric wards of British hospitals.
During 1996, researchers monitored 707 admissions in children’s wards for three months. In all, 2013 prescriptions were administered to 609 patients.
A total of 506 (25 per cent) of the drugs were either unlicensed (139) or off label (367), revealing also that drugs are more likely to be used for indications other than those they’ve been licensed for, rather than for the wrong population. Thirty six per cent of patients received more than one course of an unlicensed or off label treatment.
The drugs, which included morphine and salbutamol, were also given to children of inappropriate ages or in doses that were higher than recommended (BMJ, 1998; 316: 343-5).