Paediatric drug use with focus on off‐label prescriptions in Swedish outpatient care – a nationwide study

Abstract

AimTo determine drug prescription and proportion of off-label dispensing in the Swedish paediatric outpatient population.MethodsAll dispensed outpatient prescriptions to children aged 0 < 18 years as well as the proportion of off-label drug use during 2007 were analysed using data from the Swedish Prescribed Drug Register.ResultsIn total, 2.19 million drug prescriptions of 898 different drug substances were dispensed to paediatric patients, and of those substances, 64% had been dispensed off-label at least once. The overall off-label rate of all prescriptions was 13.5%, among which topical drugs as well as sex hormones were the most commonly prescribed off-label drugs. More than half of all children in Sweden had received at least one prescribed drug in 2007.ConclusionsThere is a high prescribing of medicines to children in outpatient care in Sweden with a considerable amount of off-label prescriptions. Topically administered drugs, sex hormones, antidepressants, hypnotics, cardiovascular drugs and nonsteroidal anti-inflammatory drugs were commonly prescribed off-label.

Off-Label Prescribing in Pediatric Outpatients

“…When we compare diagnosis profiles, respiratory symptoms are still the most common but with a lower prevalence (38.7% vs 56.5% in 2000). Symptoms (eg, fever) were more common in our study (16 [20][21][22] on prescription databases revealed high off-label rates, from 13.5% to 62%, except an Italian study 23 with a 3.3% rate. This heterogeneity in results could be explained by differences in off-label definitions.…”

“…Indeed, some studies found high rates of off-label prescribing of mental health or cancer medications. 22,26 The risk reported by Bellis et al becomes not statistically significant when oncology patients were excluded from the analysis. In our study, GPs were not treating children with severe mental health problems, cardiac diseases, or cancer.…”

“…The most common classes in the Italian study 23 were antibiotics and drugs for the alimentary tract, metabolism, and the respiratory tract. However, the age groups were not strictly similar; the Swedish study 22 exposed to tixocortol, exhibited a lower rate of unlabeled indications related to this drug.…”

“…In the Swedish study, 22 off-label prescribing involved mainly topically administered drugs, sex hormones, antidepressants, hypnotics, cardiovascular drugs, and nonsteroidal antiinflammatory drugs. The most common classes in the Italian study 23 were antibiotics and drugs for the alimentary tract, metabolism, and the respiratory tract.…”

A nationwide evaluation of off-label drug utilization in Turkey

“…OLDU is a common practice throughout the world with rates reported to be between 18% and 36% in adults (3)(4)(5)(6) and 3%-87% in pediatric patients (7)(8)(9)(10)(11)(12)(13)(14)(15). Moreover, the incidence of OLDU may vary depending on several factors such as the healthcare facility and the disease profile (11).…”