[Is pediatrics excluded from pharmaceutical innovation?]
G Hébert1, S Prot-Labarthe2, M-E Tremblay3
1Service de pharmacie, hôpital Robert-Debré, AP-HP, 48, boulevard Sérurier, 75019 Paris, France; Pharmacie - unité de recherche en pratique pharmaceutique, CHU Sainte-Justine, 3185, chemin de la Côte-Sainte-Catherine, Montréal, Québec H3T 1C5, Canada.
Insights
Access to new pediatric drugs is limited in France and Canada, leading to widespread off-label prescribing. This highlights a critical need for more drugs with specific pediatric indications and adapted formulations.
Area of Science:
- Pediatric pharmacology
- Drug accessibility and regulation
Background:
- Therapeutic strategies for children require drugs with approved pediatric indications.
- Availability of new drugs, especially for pediatric use, varies significantly between countries.
- This study focuses on the disparity in pediatric drug access between France and Canada.
Purpose of the Study:
- To compare the market launch and pediatric indications of new drugs in France and Canada during 2009.
- To identify differences in the availability of new therapeutic drugs for children in these two countries.
Main Methods:
- A retrospective analysis of newly marketed drugs in France and Canada in 2009.
- Data collected from official health agencies in France (HAS, Thériaque, ANSM) and Canada (CEPMB, BDPP).
Main Results:
- France (37) and Canada (30) introduced different numbers of new drugs in 2009.
- Only 38% of new drugs in France and 27% in Canada had pediatric indications.
- Most drugs lacked planned pediatric studies, and some with indications lacked age-appropriate formulations.
Conclusions:
- A significant deficit in new pediatric drugs contributes to extensive off-label prescribing for children.
- Children often receive medications without approved dosages or suitable pharmaceutical forms.
- Improvements in pediatric drug development and market authorization are crucial.
Objective:
The development of therapeutic strategies for children depends unequivocally on the commercial launching of drugs with pediatric indications. New therapeutic drugs differ from one country to another, particularly considering children. The objective of this study was to compare access to new drugs by children in France (FR) and Canada (CA).
Material And Methods:
Retrospective study comparing newly marketed drugs in FR and CA from 1 January to 31 December 2009. Data were collected through independent sources: (HAS, Thériaque, ANSM for FR and CEPMB, BDPP for CA).
Results:
Respectively, 37 and 30 new drugs were put on the market in 2009 in FR and CA. Among them, 38% (n=14) and 27% (n=8) had a pediatric indication. For 91% (FR) and 95% (CA) of the drugs not indicated for children, no clinical study has been planned to define pediatric indications. All the drugs (100%) with pediatric indications presented dosages based on age or weight, but it should be noted that two drugs had no form adapted to children. Fifty-seven percent of these drugs were first available on the French market and later on the Canadian market, with a median delay of 8.5months.
Conclusion:
This study highlights the obvious lack of pediatric drugs contributing to large prescriptions of off-label drugs for children, with no dosage or adapted pharmaceutical form for this population.
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