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Evolution of paediatric off-label use after new significant medicines become available for adults: a study on
Johanna Lindkvist1, Marja Airaksinen, Ann Marie Kaukonen
1Division of Social Pharmacy, Faculty of Pharmacy, University of Helsinki, Helsinki, Finland. lindkvistjohanna@gmail.com
Insights
Off-label prescribing in children begins with adolescents and extends to younger ages over time. Even after a new medicine is approved for a specific pediatric group, off-label use continues to dominate.
Area of Science:
- Pediatric pharmacology
- Drug utilization research
- Clinical therapeutics
Background:
- Off-label medication use in children is common due to a lack of pediatric marketing authorization for new, beneficial drugs.
- Limited data exists on the temporal evolution of off-label drug use in children following adult approval and subsequent pediatric labeling.
Purpose of the Study:
- To examine the changes in pediatric off-label drug use after a new class of medications for a common condition was approved for adults but later, with a delay, for children.
Main Methods:
- Triptans, used for migraines common in children, served as a model medication.
- Prescription data from the Finnish Prescription Register (1994-2007) were analyzed for pediatric triptan use trends.
Main Results:
- Pediatric triptan prescriptions surged from 204 in 1994 to 2618 in 2007, with sumatriptan being the most prescribed.
- Following sumatriptan's 2003 labeling for children aged 12+, off-label use in younger children (6-11) doubled.
- By 2007, 72% of all pediatric triptan use remained off-label, despite increased on-label prescriptions for adolescents.
Conclusions:
- Off-label pediatric drug use initiates in adolescents and gradually extends to younger children, with market size minimally affected by delayed pediatric labeling.
- Off-label prescribing continues to be the primary mode of pediatric treatment, even when age-appropriate formulations are eventually approved.
What Is Already Known About This Subject:
• Off-label use in children is widespread. New medicines lack marketing authorization for paediatric use, even when they represent significant therapeutic advantages and are intended for treatment of conditions common in children. • Until now no information exists on how off-label use in children develops over time after a significant new medicine is approved for adults and what happens when it is later labelled for one paediatric age group.
What This Study Adds:
• Off-label use of a new significant medicine begins in adolescents and extends to younger children with delay. First marketing authorization to adolescents, providing a more child-friendly formulation, results in increase of off-label use in younger children, and has limited effect on total off-label use.
Aim:
To investigate the evolution of paediatric off-label use after a therapeutically new group of medicines for a common condition becomes available for adults but is labelled for children with a delay of several years.
Methods:
Triptans were used as a model, because migraine is common in children, and is the only indication for triptans. Data on all triptan prescriptions 1994-2007 were extracted from the nationwide Finnish Prescription Register. Prescriptions for children were compared over time.
Results:
Paediatric patients with triptan prescriptions increased from 204 in 1994 to 2618 in 2007. Sumatriptan accounted for 64% of all paediatric triptan prescriptions. When sumatriptan in a nasal formulation was labelled for children ≥ 12 years in 2003, off-label prescribing to younger children (6-11 years) doubled in 2003-2004. Sumatriptan on-label prescriptions increased to 728 adolescents (45% of sumatriptan in the age group) in 2007, but its off-label use continued also to increase to 1119 (61% of paediatric sumatriptan prescriptions) in 2007. In that year 72% of paediatric triptan use was off-label, 28% on-label.
Conclusions:
When a new significant medicine becomes available in adults, off-label use in children starts slowly but continues to extend to younger children reaching a market size which is little influenced by late appearance of a labelled product. Paediatric treatment remains dominated by off-label use despite labelling of a product in an age appropriate formulation to the most relevant age group.
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