Off-Label Prescribing to Children in the United States Outpatient Setting

Bazzano, Alicia; Mangione-Smith, Rita; Schonlau, Matthias; Suttorp, Marika J; Brook, Robert H.

doi:10.1016/j.acap.2008.11.010

Cited by 127 publications

(104 citation statements)

References 34 publications

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“…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.…”

Section: Studies Of Off-label Prescribing In Outpatient Settingsmentioning

confidence: 92%

Off-Label Prescribing in Pediatric Outpatients

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Bissuel²,

Renaud

et al. 2015

Pediatrics

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To study the characteristics of off-label prescribing and adverse drug reaction (ADR) occurrence in a sample of pediatric outpatients treated by general practitioners.METHODS: A survey on pediatric drug prescribing was implemented in 46 general practices in southwestern France. All consecutive patients aged 0 to 16 years were included. Patient characteristics, reasons for consultation, and drug prescribed (including indications) were collected. ADRs occurring #10 days after the date of consultation were recorded by the general practitioners (spontaneous notification). Off-label prescription was defined as prescribing outside the specifications of the Summary of Product Characteristics.RESULTS: Among the 2313 children seen between March 8, 2011 and July 31, 2011, 1960 were exposed to $1 prescribed drug. Mean age was 5.6 years, with a gender ratio of 1.1. Among children with prescriptions, 37.6% (n = 736) were exposed to $1 off-label prescription and 6.7% (n = 132) to $1 unlicensed drug. Off-label prescribing involved an unapproved indication in 56.4% of cases (n = 416), a lower dosage (26.5%, n = 195) or higher dosage (19.5%, n = 144) than specified, age not labeled (7.2%, n = 53), incorrect route of administration (3.5%, n = 26), and contraindication (0.3%, n = 2). A total of 23 ADRs were reported (1.5% of patients with off-label prescriptions). ADR occurrence was not significantly related to off-label drug prescribing.CONCLUSIONS: Despite the numerous initiatives implemented for promoting rational medicine use in children, the prevalence of off-label prescription in outpatient pediatric practice remains high.

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Section: Studies Of Off-label Prescribing In Outpatient Settingsmentioning

confidence: 92%

Off-Label Prescribing in Pediatric Outpatients

Palmaro

Bissuel²,

Renaud

et al. 2015

Pediatrics

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“…The International Conference of Harmonisation divides childhood into 5 age groups related to the developmental stages, derived from the physiologic and pharmacokinetic differences mentioned earlier. 28 These groups (with age ranges) are: preterm newborn infants; term newborn infants (0-27 days); infants and toddlers (1-23 months); children (2-11 years); and adolescents (12)(13)(14)(15)(16) years in the United States or 12-18 years in the European Union). 5,36 The European Committee for Medicinal Products for Human Use further subdivides the age group "children" (2-11 years) into "preschool children" (2-5 years), and "school children" (6-11 years) to more precisely reflect the children' s ability to accept and use different dosage forms.…”

Section: Diversity In Childrenmentioning

confidence: 99%

“…[6][7][8][9][10][11][12] As a result, many adult medicines are used off-label in children, a practice that carries additional health and environmental risks. [13][14][15] To strengthen the development of pediatric drug formulations, new legislation was introduced in the United States and Europe, and efforts for global collaboration were made by the World Health Organization (WHO). [16][17][18][19][20] A number of innovative pediatric formulations have followed, but their actual effect on pediatric drug approvals remains to be seen, as clinical trials and marketing authorization take a substantial amount of time.…”

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confidence: 99%

Pediatric Drug Formulations: A Review of Challenges and Progress

et al. 2014

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Children differ from adults in many aspects of pharmacotherapy, including capabilities for drug administration, medicine-related toxicity, and taste preferences. It is essential that pediatric medicines are formulated to best suit a child' s age, size, physiologic condition, and treatment requirements. To ensure adequate treatment of all children, different routes of administration, dosage forms, and strengths may be required. Many existing formulations are not suitable for children, which often leads to off-label and unlicensed use of adult medicines. New regulations, additional funding opportunities, and innovative collaborative research initiatives have resulted in some recent progress in the development of pediatric formulations. These advances include a paradigm shift toward oral solid formulations and a focus on novel preparations, including flexible, dispersible, and multiparticulate oral solid dosage forms. Such developments have enabled greater dose flexibility, easier administration, and better acceptance of drug formulations in children. However, new pediatric formulations address only a small part of all therapeutic needs in children; moreover, they are not always available. Five key issues need to be addressed to stimulate the further development of better medicines for children: (1) the continued prioritization of unmet formulation needs, particularly drug delivery in neonates and treatment gaps in pediatric cancers and childhood diseases in developing countries; (2) a better use of existing data to facilitate pediatric formulation development; (3) innovative technologies in adults that can be used to develop new pediatric formulations; (4) clinical feedback and practice-based evidence on the impact of novel formulations; and (5) improved access to new pediatric formulations. Pediatrics

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“…Offlabel prescription to children is unfortunately very common in the United States and Europe, with a rate of over 60% [30,31] . A large proportion of children are medicated without precaution, and this may be an increased risk factor for other types of disorders such as loss of appetite, insomnia and increased heart rate that may endanger the child's life.…”

Section: Discussionmentioning

confidence: 99%