Meyers Rachel S, Thackray Jennifer, Matson Kelly L, McPherson Christopher, Lubsch Lisa, Hellinga Robert C, Hoff David S
J Pediatr Pharmacol Ther. 2020;25(3):175-191. doi: 10.5863/1551-6776-25.3.175.
The safe use of medications in pediatric patients requires practitioners to consider the unique pharmacokinetics and pharmacodynamics of drugs prescribed in this age group. In an effort to create a standard of care for the safe use of medications in this population, a list of drugs that are potentially inappropriate for use in pediatric patients has been developed and titled the "KIDs List."
A panel of 7 pediatric pharmacists from the Pediatric Pharmacy Association were recruited to evaluate primary, secondary, and tertiary literature; FDA Pediatric Safety Communications; the Lexicomp electronic database; and product information for drugs that should be considered potentially inappropriate for use in pediatric patients. Information was rated using predefined criteria. A PubMed search was conducted using the following terms: adverse drug events OR adverse drug reactions. The search was limited to humans; age <18 years; case reports, observational studies, or clinical trials; and English language. No date range was used. Results were used to create an evidence-based list of candidate drugs that was then peer-reviewed and subjected to a 30-day public comment period prior to being finalized.
A PubMed search yielded 4049 unique titles, of which 210 were deemed relevant for full review. Practitioner recommendations highlighted an additional 77 drugs. FDA Pediatric Safety Communications and the Lexicomp database yielded 22 and 619 drugs, respectively. After critical analysis, peer review, and public review the final KIDs List contains 67 drugs and/or drug classes and 10 excipients.
This extensive effort led to compilation of the first list of drugs that are potentially inappropriate for prescribing in all or in a select subgroup of pediatric patients. If avoidance is not clinically possible, the drug should be used with caution and accompanied by appropriate monitoring.
儿科患者安全用药要求从业者考虑该年龄组所开药物独特的药代动力学和药效学特性。为制定该人群安全用药的护理标准,已制定了一份可能不适用于儿科患者的药物清单,名为“儿童清单”。
招募了来自儿科药学协会的7名儿科药剂师组成小组,以评估一级、二级和三级文献、FDA儿科安全通讯、Lexicomp电子数据库以及应被视为可能不适用于儿科患者的药物的产品信息。信息根据预定义标准进行评级。使用以下术语在PubMed上进行搜索:药物不良事件或药物不良反应。搜索仅限于人类;年龄<18岁;病例报告、观察性研究或临床试验;以及英语。未使用日期范围。结果用于创建一份基于证据的候选药物清单,该清单随后经过同行评审,并在最终确定前有30天的公众评论期。
PubMed搜索产生了4049个独特标题,其中210个被认为与全面审查相关。从业者的建议又突出了77种药物。FDA儿科安全通讯和Lexicomp数据库分别产生了22种和619种药物。经过批判性分析、同行评审和公众评审后,最终的“儿童清单”包含67种药物和/或药物类别以及10种辅料。
这项广泛的工作促成了第一份可能不适用于所有或特定亚组儿科患者处方的药物清单的编制。如果临床上无法避免使用该药物,则应谨慎使用并进行适当监测。