Drug related problems and off-label drug treatment in children as seen at a drug information centre

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 offlabel, 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.

Evacuation of Children: Movement on Stairs and on Horizontal Plane

“…However, information on this vulnerable part of the population is frequently neglected when it comes to collecting data and developing models for society. This is not only a problem when it comes to fire safety [2], but also in other areas such as medical studies [3][4][5], where it has consequences for estimating dosage and type of medication for children. When designing new buildings and applying performance-based codes it is important to have an understanding of human evacuation dynamics as well as having access to performance models which are valid for a broad population in order to reduce the risk of exposing occupants to critical conditions in case of fire.…”

Off-label use of contrast agents

“…Off-label use is daily routine in hospitals with up to 23% of the prescriptions identified as off-label in a French study [11]. Numerous reports from different specialities identify off-label applications [2,7,10,[13][14][15][16][17][18][19][20][21][22][23][24][25][26][27]. Off-label use may thus represent standard practice in a paediatric population.…”

“…In some areas like oncology, use of medicinal products in paediatric patients or infectious diseases, the medical practice relies substantially on the prescription of offlabel or unlicensed medicines [5][6][7][8][9]. The situation in paediatric patients is well documented and acknowledged, since there are difficulties in developing formulations appropriate for children.…”

Klinische Prüfung an Kindern im Spannungsfeld zwischen wissenschaftlichen Anforderungen, der Sicherstellung der korrekten Behandlung und ethischen Aspekten

“…In der KVO ist festgelegt, dass im Zulassungsantrag für das Inverkehrbringen eines neuen Arzneimittels vom Antragsteller auch ein Nachweis über einen genehmigten pädiatrischen Prüfplan vorlegt werden muss, der die Arzneimittelentwicklung für Kinder beschreibt (siehe oben) [14]. In diesem Zusammenhang hat die KVO ausdrück-lich auf die Überprüfung der Sicherheit der Arzneimittel für Kinder hingewiesen, was sicher nicht nur auf die Pharmakovigilanz nach der Zulassung gerichtet sein wird.…”