Drug related problems and off-label drug treatment in children as seen at a drug information centre.
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.
Kimland
Elin
E
Karolinska Institutet, Division of Clinical Pharmacology, Department of Laboratory Medicine, Karolinska University Hospital, Huddinge, Stockholm, Sweden. elin.kimland@ki.se
Bergman
Ulf
U
Lindemalm
Synnöve
S
Böttiger
Ylva
Y
D000293:Adolescent; D002626:Chemistry, Pharmaceutical; D002648:Child; D002675:Child, Preschool; D004346:Drug Information Services / Q000706:statistics & numerical data*; D004347:Drug Interactions; D004348:Drug Labeling / Q000145:classification*; D064420:Drug-Related Side Effects and Adverse Reactions; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D010372:Pediatrics; D013548:Sweden