[Is pediatrics excluded from pharmaceutical innovation?].
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).


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.


CONCLUSIONS
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.
Service 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.
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G
Hébert
Service de pharmacie, hôpital Robert-Debré, AP-HP, 48, boulevard Sérurier, 75019 Paris, France; Pharmacie clinique, faculté de pharmacie, PRES Sorbonne Paris Cité, université Paris Descartes, 75006 Paris, France.
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S
Prot-Labarthe
Pharmacie - unité de recherche en pratique pharmaceutique, CHU Sainte-Justine, 3185, chemin de la Côte-Sainte-Catherine, Montréal, Québec H3T 1C5, Canada.
M-E
ME
Tremblay
Pharmacie - unité de recherche en pratique pharmaceutique, CHU Sainte-Justine, 3185, chemin de la Côte-Sainte-Catherine, Montréal, Québec H3T 1C5, Canada.
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JF
Bussières
Service de pharmacie, hôpital Robert-Debré, AP-HP, 48, boulevard Sérurier, 75019 Paris, France; Pharmacie clinique, faculté de pharmacie, PRES Sorbonne Paris Cité, université Paris Descartes, 75006 Paris, France; Laboratoire de pédagogie de la santé EA 3412, université Paris 13-Bobigny, Sorbonne Paris Cité, 93000 Bobigny, France. Electronic address: olivier.bourdon@rdb.aphp.fr.
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Bourdon
D002170:Canada; D002648:Child; D004345:Drug Industry; D005602:France; D006801:Humans; D010372:Pediatrics; D012189:Retrospective Studies; D035703:Therapies, Investigational