Hébert G, Prot-Labarthe S, Tremblay M-E, Bussières J-F, Bourdon O
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.
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.
Arch Pediatr. 2014 Mar;21(3):245-50. doi: 10.1016/j.arcped.2013.12.016. Epub 2014 Jan 23.
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).
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).
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.
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.
儿童治疗策略的发展无疑依赖于具有儿科适应症的药物的商业上市。新型治疗药物在不同国家存在差异，尤其是在儿童用药方面。本研究的目的是比较法国（FR）和加拿大（CA）儿童获取新药的情况。
回顾性研究，比较2009年1月1日至12月31日在法国和加拿大新上市的药物。数据通过独立来源收集（法国的卫生高级管理局、Theriaque、法国国家药品安全局，以及加拿大的药品和卫生产品管理局、加拿大药品价格数据库）。
2009年在法国和加拿大分别有37种和30种新药上市。其中，38%（n = 14）和27%（n = 8）有儿科适应症。对于91%（法国）和95%（加拿大）未标明儿科适应症的药物，尚未计划进行临床研究来确定儿科适应症。所有有儿科适应症的药物（100%）都有基于年龄或体重的剂量，但应注意有两种药物没有适合儿童的剂型。这些药物中有57%首先在法国市场上市，随后在加拿大市场上市，中位延迟时间为8.5个月。
本研究突出表明明显缺乏儿科药物，这导致大量为儿童开具无该人群剂量或合适剂型药物的非适应症用药处方。
