title: Drug shortage-associated increase in catheter-related blood stream infection in children.
abstract: BACKGROUND
  Ethanol lock therapy (ELT) has been shown to reduce the incidence of catheter-related blood stream infections (CRBSI) in intestinal failure (IF) patients. Dosing and frequency remains undefined. Scrutiny of pharmaceutical facilities by the Food and Drug Administration led to the voluntary shutdown of the sole supplier of ethanol, resulting in a nationwide shortage. To conserve supply, we reduced ELT frequency from a daily regimen. We examined the impact that reduction in ELT frequency had on CRBSI in pediatric IF patients.
  
  
  METHODS
  We retrospectively reviewed our parenteral nutrition-dependent IF children. Primary outcome measure was CRBSI per 1000 catheter days after ELT frequency reduction. Data were compared (paired t test) to the same group over 1 year before ethanol shortage and to historical controls.
  
  
  RESULTS
  During the shortage 13 outpatients received ELT. Eight met study criteria. Mean ± SD age was 9.1 ± 7.8 years. Mean CRBSI rate per 1000 catheter days was 0.7 ± 1.3 before ELT shortage. This increased to 6.2 ± 2.5 after frequency reduction (P < .001). This CRBSI rate was similar to historical IF children not on ELT (8.0 ± 5.4). Seven children developed CRBSI after frequency reduction, 6 requiring hospitalization, 2 to the ICU. Mean length of stay (15.5 days) averaged $104,783(± 111,034) in hospital charges. Organisms included Gram-negatives (6), methicillin-resistant Staphylococcus aureus (1), and Candida spp (1).
  
  
  CONCLUSIONS
  ELT frequency reduction resulted in complete failure in CRBSI prophylaxis. The nationwide shortage of this drug has been costly both financially and in patient morbidity.
authors.affiliation: Section of Pediatric Surgery, Department of Surgery, The University of Michigan Medical School and the CS Mott Children's Hospital, Ann Arbor, Michigan, USA.
authors.forename: Matthew W
authors.initials: MW
authors.lastname: Ralls
authors.forename: R Alexander
authors.initials: RA
authors.lastname: Blackwood
authors.forename: Meghan A
authors.initials: MA
authors.lastname: Arnold
authors.forename: M Luisa
authors.initials: ML
authors.lastname: Partipilo
authors.forename: James
authors.initials: J
authors.lastname: Dimond
authors.forename: Daniel H
authors.initials: DH
authors.lastname: Teitelbaum
mesh_terms: D016470:Bacteremia / Q000453:epidemiology* / Q000209:etiology*; D058387:Candidemia / Q000453:epidemiology* / Q000209:etiology*; D055499:Catheter-Related Infections / Q000453:epidemiology* / Q000209:etiology*; D002648:Child; D000431:Ethanol / Q000600:supply & distribution*; D006801:Humans; D010288:Parenteral Nutrition / Q000009:adverse effects*; D012189:Retrospective Studies
chemical_list: D000431:Ethanol