Healthy Skepticism Library item: 11560

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Kimland E, Bergman U, Lindemalm S, Bottiger Y.
Drug related problems and off-label drug treatment in children as seen at a drug information centre.
Eur J Pediatr 2007 Jun; 166:(6):527-32
http://www.springerlink.com/content/b44266l0382632j3/

Abstract:

The aim of this work was to analyse the characteristics of Questions and Answers (Q&As) at a drug information centre (DIC) regarding drug related problems and off-label drug treatment in children. All questions concerning children 15 years or younger at a DIC in Stockholm, Sweden during the years 1995-2004 were analysed with respect to the main drug related problem, drug/s and drug group/s, whether the drugs were licensed or not, pediatric labelling of the drug/s and age and sex of the patient. Q&As were classified as whether or not they included evaluated literature information, adding to the labelling of the drugs. We identified 249 Q&As concerning pediatric drug treatment. Each question addressed an average of 1.5 drugs. More than two-thirds of the Q&As concerned adverse drug reactions and pediatric drug choice or dosing. Every second question was classified as off-label, psychotropic drugs being the most common. In half of all off-label Q&As, pediatric documentation on drug efficacy and safety outside the Swedish catalogue of medical products was found. Most Q&As concerned newborns and infants. However, the off-label proportion among questions was highest in adolescence as well as the evaluated literature information, adding to the labelling of the drugs. It was thus found that off-label drug treatment is common among pediatric questions at a DIC. This service can provide additional literature based information contributing to a safer use of drugs in children. There is still, however, a substantial need for clinical documentation of drug use in children.

Keywords:
Drug labelling - Child - Drug therapy - Drug information services - Adverse drug reactions MeSH Terms: Adolescent Chemistry, Pharmaceutical Child Child, Preschool Drug Information Services/statistics & numerical data* Drug Interactions* Drug Labeling/classification* Drug Therapy/adverse effects* Humans Infant Infant, Newborn Pediatrics Sweden