Introduction. For children, many drugs are used without marketing authorization (“unlicensed”, e.g. imported drugs, drugs prepared by a pharmacy) or outside the terms of marketing authorization (“off-label”). In Switzerland, around half of all prescriptions for paediatric inpatients were either off-label or unlicensed .
Purpose To determine the proportion of unlicensed and off-label prescriptions at discharge, which has not been investigated previously, and the proportion of parents informed about such a prescription.
Materials and Methods Prospective study including all discharge prescriptions of inpatients over a two-month period at the Children’s Hospital of Aarau. Exclusion criteria: hospitalisation for chemotherapy only, age over 18, re-entry during study period, no informed consent of parents. At discharge parents were asked to fill in a questionnaire about the information they got on discharge medicines as well as about their satisfaction with this information. This questionnaire was available in German, French, Croatian, Turkish, Albanian, Spanish and English.
Results During the study period 503 children were discharged, 231 children could be included. Discharge prescriptions were written for 140 children (61%). A total of 227 drugs were prescribed, especially anti-inflammatory/analgesic, anti-asthmatic and anti-infective drugs. 38.5% of all prescriptions were off-label, regarding dosage in 51%, age in 40% and indication in 9% of all cases. Only 0.5% of drugs were unlicensed. Discharge questionnaires were returned by 103 of 140 children. Most parents (>80%) were informed about purpose, dosage and use of the drugs for their child, and satisfied with obtained information, but only 9% of parents getting an off-label/unlicensed prescription for their child were informed about the off-label/unlicensed use.
Conclusions There is a high percentage of drugs prescribed off-label at hospital discharge. Most drugs are well known substances and regularly prescribed for children. This emphasises the need to update marketing information for older substances, or the need for a national database for drug use and dosage in children.
Paolo, E et al, 2006. Swiss. Med. WKLY. 136, 218–222.
No conflict of interest.
Statistics from Altmetric.com
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.