Uppal Navjeet K, Dupuis Lee L, Parshuram Christopher S
Department of Critical Care Medicine, Hospital for Sick Children, Toronto, Ontario, Canada.
Paediatr Drugs. 2008;10(3):193-7. doi: 10.2165/00148581-200810030-00007.
To describe the provision of pediatric drug safety information in a national formulary of manufacturers' drug product monographs.
We performed a cross-sectional evaluation of comprehensive product monographs contained in the 2005 Canadian Compendium of Pharmaceuticals and Specialities (CPS). We abstracted data describing indications for prescription, statements about pediatric safety, available preparations, and provision of dosing guidelines. For each monograph we classified pediatric safety data as either present, present but limited or absent. We then described the pediatric safety data in CPS monographs for drugs listed in the published formulary of the Hospital for Sick Children, Toronto, Ontario, Canada.
A total of 2232 product monographs were screened; 684 were excluded and 1548 (66%) were further analyzed. 1462 (94%) had indications that did not exclude children. Pediatric safety information was present in 592 (38%), present but limited in 148 (10%), and absent in 808 (52%) drug monographs. Safety statements were absent in 224 (14%) drug monographs that provided both dosing guidelines and formulations suitable for administration to children, and in 214 (52%) of 411 drugs in the pediatric hospital formulary.
We evaluated a widely available national source of pediatric prescribing information. Safety data for children was not mentioned in more than half of the product monographs. Moreover, the provision of safety data was discordant with indications for prescription, the availability of pediatric formulations, and dosing guidelines within the monographs, and with inclusion in a pediatric hospital formulary. Our study suggests that the presentation of pediatric safety data in drug product monographs can be improved to better inform prescribing and to optimize pharmacotherapy in children.
描述在一份制造商药品说明书的国家处方集里儿科药物安全信息的提供情况。
我们对2005年《加拿大药品及特殊制品汇编》（CPS）中的综合产品说明书进行了横断面评估。我们提取了描述处方适应症、儿科安全性声明、可用制剂以及给药指南提供情况的数据。对于每份说明书，我们将儿科安全数据分类为存在、存在但有限或不存在。然后我们描述了加拿大安大略省多伦多市病童医院已发布处方集中列出的药物在CPS说明书中的儿科安全数据。
共筛选了2232份产品说明书；排除684份，对1548份（66%）进行了进一步分析。1462份（94%）有不排除儿童的适应症。592份（38%）药物说明书中有儿科安全信息，148份（10%）存在但有限，808份（52%）不存在。在提供了适合儿童给药的给药指南和制剂的224份（14%）药物说明书中，以及在儿科医院处方集的411种药物中的214份（52%）中，没有安全声明。
我们评估了一个广泛可用的国家儿科处方信息来源。超过一半的产品说明书未提及儿童安全数据。此外，安全数据的提供与处方适应症、儿科制剂的可用性、说明书中的给药指南以及是否被纳入儿科医院处方集不一致。我们的研究表明，药品说明书中儿科安全数据的呈现方式可以改进，以便更好地为处方提供信息并优化儿童药物治疗。
