RESUMO
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.
Assuntos
Antimetabólitos Antineoplásicos/uso terapêutico , Citarabina/administração & dosagem , Citarabina/provisão & distribuição , Quimioterapia de Indução/métodos , Leucemia Mieloide Aguda/tratamento farmacológico , Idoso , Feminino , Humanos , Revisão da Utilização de Seguros , Masculino , Medicare/economia , Estudos Retrospectivos , Programa de SEER , Estados UnidosRESUMO
No disponible
Assuntos
Humanos , Feminino , Citarabina/administração & dosagem , Citarabina , Leucemia Linfoide/complicações , Leucemia Linfoide/diagnóstico , Linfoma/complicações , Linfoma/enzimologia , Hipersensibilidade/patologia , Protocolos Clínicos/classificação , Citarabina/síntese química , Citarabina/provisão & distribuição , Leucemia Linfoide/metabolismo , Leucemia Linfoide/patologia , Linfoma/diagnóstico , Linfoma/tratamento farmacológico , Hipersensibilidade/metabolismo , Protocolos Clínicos/normasRESUMO
PURPOSE: The importation of cytarabine into the United States during a critical national drug shortage is described. SUMMARY: In March 2011, the hospital pharmacy team at an acute care hospital was struggling to supply cytarabine for four specific patients, all of whom needed critical maintenance therapy after induction. Cytarabine was not available from any source in the United States, and the team had no realistic projected release dates for back orders. Idis UK, a pharmaceutical distributor, was asked to identify available drug and eventually found an unrestricted source of cytarabine in Switzerland. Once available drug was identified, a price quote for the supply amount was written for our consideration. This was inspected carefully to ensure that the drug, strength, dosage form, and any other ingredients listed were indeed what were expected. The pharmacy department worked with the hospital's department of finance and accounting to submit the necessary financial paperwork. Payment was electronically sent to the distributor before the drug was shipped. Before the order for cytarabine was placed, the associated risks and benefits were assessed. The patients provided consent to treatment with the unapproved product. Acceptance of the price quote and instructions to order the drug were e-mailed to the distributor. The necessary documentation was completed and included with the shipment. The importation process, from initial inquiries to delivery, took 21 days. CONCLUSION: The importation of cytarabine amid a drug shortage required a complex process that involved the efforts of an overseas distributor, the cooperation of multiple health professionals, and meticulous attention to detail.
