目的:分析达比加群的严重用药错误(MEs),及其相关因素,以避免或减少不良事件的发生。
方法:使用国际监管活动医学词典(MedDRA)的“用药错误和其他产品使用错误和问题”高级组术语(HLGT),从WHO全球报告的药品潜在副作用数据库(VigiBase)中提取与达比加群相关的严重MES。记录良好的报告,VigiGrade完整性评分≥0.80,或有信息叙述的分析重点是病例的临床特征.在我们的病例分析中,使用PCNE药物相关问题分类(DRP)对用药错误进行分类。
结果:直到2020年1月26日,VigiBase共有453例与达比加群有关的严重MEs,113个有很好的记录。其中,69名患者(61%)住院或住院时间延长,16人(14%)有危及生命的事件,12人(11%)死亡。ME发生在处方阶段的77例,在35年的给药中,在一种情况下在分配阶段。处方中的ME与44例患者的药物选择错误有关(24例涉及禁忌症和20种药物相互作用),与33例患者的剂量错误有关(17例剂量过大;8例频率不足;4例时间不正确;在3例中,剂量太低;在一个,太频繁了)。管理中的MES是5例与医务人员相关的错误(3例管理途径错误,一个行政遗漏,和一次用药过量),28例患者相关错误(14例剂量不足或没有给药,七药品储存不当,四个错误的管理方法,和三个超过处方剂量),和其他两个错误(没有功效监测)。在药房中发生了错误的药物强度的分配错误。113例患者的主要不良事件为出血57例(50%)和缺血29例(26%)。
结论:根据对VigiBase报告的分析,与达比加群相关的严重MEs主要发生在处方和给药期间。尽管无法确定使用达比加群时具有临床后果的MEs的发生率,应注意在处方中为正确的患者选择合适的剂量,以及患者在药物管理中的依从性和储存。患者的伤害主要表现为出血或缺血,包括罕见患者的致命结局。
OBJECTIVE: To analyze the
serious medication errors (MEs) on dabigatran, and their related factors, in order to avoid or reduce the occurrence of adverse events.
METHODS: Serious MEs related to dabigatran were extracted from the WHO global database of reported potential side effects of medicinal products (VigiBase) by using \"Medication errors and other product use errors and issues\" High Level Group Term (HLGT) of the international Medical Dictionary for Regulatory Activities (MedDRA). Well-documented reports, vigiGrade completeness score ≥ 0.80, or with an informative narrative were analyzed with a focus on the clinical features of the cases. The PCNE Classification for drug-related problems (DRP) was used to classify medication errors in our analysis of cases.
RESULTS: Until January 26, 2020, there were 453 cases with
serious MEs related to dabigatran in VigiBase, and 113 were well-documented. Among these, 69 patients (61%) were hospitalized or had prolonged hospitalization, 16 (14%) had life-threatening events, and 12 (11%) died. The MEs occurred in the prescription phase in 77 cases, in administration in 35, and at the dispensing stage in one case. The MEs in prescription were related to a drug selection error in 44 cases (24 concerning contraindications and 20 drug interactions) and to dose error in 33 cases (17 with excessive dose; eight with insufficient frequency; four had an incorrect time; in three, the dose was too low; and in one, too frequent). The MEs in administration were medical-staff-related errors in five cases (three with wrong administration route, one administration omission, and one overdose), patient-related errors in 28 (14 insufficient dose or no administration, seven improper drug storage, four wrong administration method, and three over prescribed dose), and other errors in two (without efficacy monitoring). The dispensing error of a wrong drug strength occurred in a pharmacy. The main adverse events in the 113 patients were haemorrhage in 57 cases (50%) and ischemia in 29 cases (26%).
CONCLUSIONS: Based on the analysis of reports in VigiBase,
serious MEs related to dabigatran mainly occurred during prescription and administration. Although the incidence of MEs with clinical consequences in the use of dabigatran cannot be determined, attention should be paid to selection of the appropriate dose to a right patient in the prescription, and to patient compliance and storage in drug administration. The patient harm mainly manifested itself as bleeding or ischemia including fatal outcome in rare patients.