Hedlund Nancy G, Isgor Zeynep, Zwanziger Jack, Rondelli Damiano, Crawford Stephanie Y, Hynes Denise M, Powell Lisa M
School of Public Health, University of Illinois at Chicago, Chicago, IL.
Department of Medicine, University of Illinois at Chicago -UI Health, UIC Center for Global Health, COM, Chicago, IL.
Health Serv Res. 2018 Dec;53(6):5078-5105. doi: 10.1111/1475-6773.13028. Epub 2018 Sep 10.
Examine the impact of the 2011 shortage of the drug cytarabine on patient receipt and timeliness of induction treatment for Acute Myeloid Leukemia (AML).
A retrospective cohort was utilized to examine odds of receipt of inpatient induction chemotherapy and time to first dose across major (N = 105) and moderate (N = 316) shortage time periods as compared to a nonshortage baseline (N = 1,147).
DATA COLLECTION/EXTRACTION METHODS: De-identified patient data from 2008 to 2011 Surveillance, Epidemiology, and End Results (SEER) were linked to 2007-2013 Medicare claims and 2007-2013 Hospital Characteristics.
Compared to prior nonshortage time period, patients diagnosed during a major drug shortage were 47 percent less likely (p < .05) to receive inpatient chemotherapy within 14 days of diagnosis. Patients who were younger, had a lower Charlson Comorbidity score, and for whom AML was a first primary cancer were prioritized across all periods.
Period of major shortage of a generic oncolytic, without an equivalent therapeutic substitute, reduced timely receipt of induction chemotherapy treatment. More favorable economic and regulatory policies for generic drug suppliers might result in greater availability of essential, older generic drug products that face prolonged or chronic shortage.
研究2011年阿糖胞苷短缺对急性髓系白血病（AML）患者接受诱导治疗的情况及及时性的影响。
采用回顾性队列研究，比较在主要短缺时期（N = 105）和中度短缺时期（N = 316）与非短缺基线时期（N = 1147）相比，患者接受住院诱导化疗的几率以及首次给药时间。
数据收集/提取方法：将2008年至2011年监测、流行病学和最终结果（SEER）中去识别化的患者数据与2007 - 2013年医疗保险理赔数据以及2007 - 2013年医院特征数据相链接。
与之前的非短缺时期相比，在主要药物短缺期间被诊断出的患者在诊断后14天内接受住院化疗的可能性降低了47%（p <.05）。在所有时期，年龄较小、Charlson合并症评分较低且AML为首次原发性癌症的患者都被优先考虑。
在没有等效治疗替代药物的情况下，一种通用溶瘤药物的主要短缺时期会降低诱导化疗治疗的及时接受率。对仿制药供应商更有利的经济和监管政策可能会使面临长期或慢性短缺的基本老仿制药产品有更大的可及性。
