Drug Shortage Impacts Patient Receipt of Induction Treatment

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 basehne (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.Key Words. Cytarabine, drug shortage, receipt of treatment, timeliness of treatment, prioritization, acute myeloid leukemia
The Food and Drug Administration (FDA) considers a drug entity to be in a state of shortage when the total supply of all interchangeable versions of a drug across manufacturers [...]