Litalien Catherine, Autmizguine Julie, Carli Antoine, Giroux Denis, Lebel Denis, Leclerc Jean-Marie, Théorêt Yves, Gilpin Andrea, Bérubé Sophie
, MD, FRCPC, is with the Rosalind & Morris Goodman Family Pediatric Formulations Centre, the Department of Medical Biology, and the Research Centre of the CHU Sainte-Justine, Montréal, Quebec. She is also with the Department of Pediatrics and the Department of Pharmacology and Physiology, Université de Montréal, Montréal, Quebec.
, MD, FRCPC, MSc, is with the Rosalind & Morris Goodman Family Pediatric Formulations Centre, the Department of Medical Biology, and the Research Centre of the CHU Sainte-Justine, Montréal, Quebec. She is also with the Department of Pediatrics and the Department of Pharmacology and Physiology, Université de Montréal, Montréal, Quebec.
Can J Hosp Pharm. 2020 Fall;73(4):247-256. Epub 2020 Oct 1.
Many medications given to children have no commercially available, age-appropriate formulations. This leads to manipulation of dosage forms designed for adults (compounding), which can result in an increased risk of dosing errors and adverse events, lack of medication adherence because of taste issues, and suboptimal dosing with therapeutic failure.
To determine which drugs required compounding for oral administration to children in a Canadian hospital and, for each compounded drug, to determine whether it was available as licensed oral pediatric formulations in the United States or the European Union.
Drugs requiring compounded liquid formulations for oral administration, dispensed from January 1 to December 31, 2015, at a Canadian university-affiliated tertiary pediatric hospital, and prepared in a quantity exceeding 0.5 L per year, were retrospectively identified. The online drug databases of Health Canada, the US Food and Drug Administration, the European Medicines Agency (EMA), and the UK Medicines and Healthcare Products Regulatory Agency were searched to determine the availability of child-friendly oral formulations for these drugs. The regulatory status in each jurisdiction was also compared. For licensed formulations with potential concerns about excipient safety, EMA guidelines for sorbitol, propylene glycol, ethanol, and sodium benzoate were used to determine pediatric suitability.
Of the 56 compounded drugs investigated, 27 (48%) had a suitable commercialized child-friendly formulation available outside Canada. Overall, these drugs had been on the Canadian market for a median of 35 years, and almost half (27 [48%]) had a pediatric indication in Canada.
Canada is lagging behind the United States and the European Union in ensuring availability of and access to suitable pediatric formulations. Potential explanations for this gap include small market size, regulatory uncertainties, and reimbursement shortcomings. Steps must be taken to implement pediatric-sensitive regulations and incentives, as well as reimbursement policies, to address these unmet needs.
许多给儿童使用的药物没有适合其年龄的市售剂型。这导致了对成人剂型进行调配（配制），这可能会增加用药错误和不良事件的风险，因口味问题导致用药依从性差，以及剂量不足导致治疗失败。
确定加拿大一家医院中哪些药物需要为儿童口服进行调配，并且对于每种调配药物，确定其在美国或欧盟是否有经许可的口服儿科剂型。
回顾性确定2015年1月1日至12月31日在加拿大一所大学附属三级儿科医院调配分发的、用于口服的需要配制液体制剂且每年配制量超过0.5升的药物。检索加拿大卫生部、美国食品药品监督管理局、欧洲药品管理局（EMA）和英国药品与保健品监管局的在线药物数据库，以确定这些药物是否有适合儿童的口服剂型。还比较了每个司法管辖区的监管状况。对于对辅料安全性有潜在担忧的许可剂型，使用EMA关于山梨醇、丙二醇、乙醇和苯甲酸钠的指南来确定儿科适用性。
在调查的56种调配药物中，27种（48%）在加拿大境外有合适的商业化儿童友好剂型。总体而言，这些药物在加拿大市场上的中位时间为35年，近一半（27种[48%]）在加拿大有儿科适应症。
加拿大在确保合适的儿科剂型的可及性方面落后于美国和欧盟。造成这一差距的潜在原因包括市场规模小、监管不确定性和报销缺陷。必须采取措施实施对儿科敏感的法规和激励措施以及报销政策，以满足这些未满足的需求。
