title: Obtaining i.v. fosfomycin through an expanded-access protocol.
abstract: OBJECTIVE
  One hospital's experience with procuring i.v. fosfomycin via an expanded-access protocol to treat a panresistant infection is described.
  
  
  CONCLUSIONS
  In mid-2014, a patient at a tertiary care institution had an infection caused by a gram-negative pathogen expressing notable drug resistance. Once it was determined by the infectious diseases (ID) attending physician that i.v. fosfomycin was a possible treatment for this patient, the ID pharmacist began the process of drug procurement. The research and ID pharmacists completed an investigational new drug (IND) application, which required patient-specific details and contributions from the ID physician. After obtaining approval of the IND, an Internet search identified a product vendor in the United Kingdom, who was then contacted to begin the drug purchasing and acquisition processes. Authorization of the transaction required signatures from key senior hospital administrators, including the chief financial officer and the chief operating officer. Approximately 6 days after beginning the acquisition process, the research pharmacist arranged for the wholesaler to expedite product delivery. The ID pharmacist contacted the wholesaler's shipping company at the U.S. Customs Office, providing relevant contact information to ensure that any unexpected circumstances could be quickly addressed. The product arrived at the U.S. Customs Office 8 days after beginning the acquisition process and was held in the U.S. Customs Office for 2 days. The patient received the first dose of i.v. fosfomycin 13 days after starting the expanded-access protocol process.
  
  
  CONCLUSIONS
  I.V. fosfomycin was successfully procured through an FDA expanded-access protocol by coordinating efforts among ID physicians, pharmacists, and hospital executives.
authors.affiliation: Department of Pharmacy, Memorial Regional Hospital, Hollywood, FL. corey.frederick26@gmail.com.
authors.forename: Corey M
authors.initials: CM
authors.lastname: Frederick
authors.affiliation: Department of Pharmacy, Jackson Memorial Hospital, Miami, FL.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Burnette
authors.affiliation: Department of Pharmacy, Jackson Memorial Hospital, Miami, FL.
authors.forename: Laura
authors.initials: L
authors.lastname: Aragon
authors.affiliation: Department of Pharmacy, Miami Veterans Affairs Healthcare System, Miami, FL.
authors.forename: Timothy P
authors.initials: TP
authors.lastname: Gauthier
mesh_terms: D061605:Administration, Intravenous; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D057176:Compassionate Use Trials / Q000331:legislation & jurisprudence / Q000379:methods*; D024881:Drug Resistance, Bacterial / Q000187:drug effects*; D015507:Drugs, Investigational / Q000008:administration & dosage*; D005578:Fosfomycin / Q000008:administration & dosage*; D016905:Gram-Negative Bacterial Infections / Q000175:diagnosis / Q000188:drug therapy*; D006801:Humans; D017387:Investigational New Drug Application / Q000331:legislation & jurisprudence / Q000379:methods; D010595:Pharmacists / Q000331:legislation & jurisprudence; D010607:Pharmacy Service, Hospital / Q000331:legislation & jurisprudence / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence
chemical_list: D000900:Anti-Bacterial Agents; D015507:Drugs, Investigational; D005578:Fosfomycin