title: Economic and microbiologic evaluation of single-dose vial extension for hazardous drugs.
abstract: OBJECTIVE
  The update of US Pharmacopeia Chapter <797> in 2008 included guidelines stating that single-dose vials (SDVs) opened and maintained in an International Organization for Standardization Class 5 environment can be used for up to 6 hours after initial puncture. A study was conducted to evaluate the cost of discarding vials after 6 hours and to further test sterility of vials beyond this time point, subsequently defined as the beyond-use date (BUD).
  
  
  METHODS
  Financial determination of SDV waste included 2 months of retrospective review of all doses prescribed. Additionally, actual waste log data were collected. Active and control vials (prepared using sterilized trypticase soy broth) were recovered, instead of discarded, at the defined 6-hour BUD.
  
  
  RESULTS
  The institution-specific waste of 19 selected SDV medications discarded at 6 hours was calculated at $766,000 annually, and tracking waste logs for these same medications was recorded at $770,000 annually. Microbiologic testing of vial extension beyond 6 hours showed that 11 (1.86%) of 592 samples had one colony-forming unit on one of two plates. Positive plates were negative at subsequent time points, and all positives were single isolates most likely introduced during the plating process.
  
  
  CONCLUSIONS
  The cost of discarding vials at 6 hours was significant for hazardous medications in a large academic medical center. On the basis of microbiologic data, vial BUD extension demonstrated a contamination frequency of 1.86%, which likely represented exogenous contamination; vial BUD extension for the tested drugs showed no growth at subsequent time points and could provide an annual cost savings of more than $600,000.
authors.affiliation: University of North Carolina (UNC) Health Care, Chapel Hill, NC, USA. erowe@unch.unc.edu
authors.forename: Erinn C
authors.initials: EC
authors.lastname: Rowe
authors.forename: Scott W
authors.initials: SW
authors.lastname: Savage
authors.forename: William A
authors.initials: WA
authors.lastname: Rutala
authors.forename: David J
authors.initials: DJ
authors.lastname: Weber
authors.forename: Maria
authors.initials: M
authors.lastname: Gergen-Teague
authors.forename: Stephen F
authors.initials: SF
authors.lastname: Eckel
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D001419:Bacteria / Q000302:isolation & purification*; D017046:Cost Savings / Q000191:economics; D004340:Drug Contamination / Q000191:economics*; D004349:Drug Packaging / Q000191:economics; D004356:Drug Storage / Q000191:economics*; D015386:Hazardous Substances; D006801:Humans; D012189:Retrospective Studies; D013242:Sterilization / Q000191:economics
chemical_list: D000970:Antineoplastic Agents; D015386:Hazardous Substances