Drug Shortage Impacts Patient Receipt of Induction Treatment

• Published in: Health services research Vol. 53; no. 6; pp. 5078 - 5105
• Main Authors: Hedlund, Nancy G., Isgor, Zeynep, Zwanziger, Jack, Rondelli, Damiano, Crawford, Stephanie Y., Hynes, Denise M., Powell, Lisa M.
• Format: Journal Article
• Language: English
• Published: United States Health Research and Educational Trust 01.12.2018; Blackwell Publishing Ltd; John Wiley and Sons Inc
• Subjects: Acute myelocytic leukemia; Acute myeloid leukemia; Aged; Analysis; Antimetabolites, Antineoplastic - therapeutic use; Cancer; Cancer Care and Cost; Care and treatment; Chemotherapy; Comorbidity; Cytarabine; Cytarabine - administration & dosage; Cytarabine - supply & distribution; Data collection; drug shortage; Drugs; Epidemiology; Extraction; Female; Generic drugs; Generic prescribing; Government programs; Health care; Hospitalization; Humans; Identification methods; Induction; Induction Chemotherapy - methods; Insurance Claim Review; Leukemia; Leukemia, Myeloid, Acute - drug therapy; Male; Medical diagnosis; Medicare; Medicare - economics; Myeloid leukemia; Oncolysis; Patients; prioritization; receipt of treatment; Retrospective Studies; SEER Program; Supply and demand; Surveillance; timeliness of treatment; United States; United States; timeliness of treatment; Cytarabine; drug shortage; acute myeloid leukemia; receipt of treatment; prioritization
• ISSN: 0017-9124; 1475-6773
• DOI: 10.1111/1475-6773.13028

Objective Examine the impact of the 2011 shortage of the drug cytarabine on patient receipt and timeliness of induction treatment for Acute Myeloid Leukemia (AML). Study Design 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. Principal Findings 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. Conclusions 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.