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Related Experiment Videos

Obtaining i.v. fosfomycin through an expanded-access protocol.

Corey M Frederick1, Jennifer Burnette2, Laura Aragon2

  • 1Department of Pharmacy, Memorial Regional Hospital, Hollywood, FL. corey.frederick26@gmail.com.

American Journal of Health-System Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists
|June 30, 2016
PubMed
Summary
This summary is machine-generated.

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Procuring intravenous fosfomycin for a drug-resistant infection involved a hospital team coordinating an FDA expanded-access protocol. This process successfully obtained the necessary medication for patient treatment.

Area of Science:

  • Infectious Diseases
  • Pharmacology
  • Hospital Administration

Background:

  • A patient presented with a severe infection caused by a multidrug-resistant gram-negative pathogen.
  • Limited treatment options necessitated exploring alternative therapeutic strategies.

Purpose of the Study:

  • To describe a hospital's experience in procuring intravenous (IV) fosfomycin.
  • To detail the process of using an FDA expanded-access protocol for a panresistant infection.

Main Methods:

  • An investigational new drug (IND) application was completed by infectious diseases (ID) physicians and pharmacists.
  • Procurement involved identifying an overseas vendor and navigating hospital administrative approvals.
  • Logistics included expediting shipping and coordinating with U.S. Customs.

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Main Results:

  • The procurement process took 13 days from initiation to the first patient dose.
  • Successful acquisition of IV fosfomycin was achieved through interdisciplinary collaboration.
  • The expanded-access protocol facilitated the treatment of a previously untreatable infection.

Conclusions:

  • Effective coordination among ID physicians, pharmacists, and hospital executives enabled the successful procurement of IV fosfomycin.
  • Expanded-access protocols are a viable pathway for obtaining essential medications for critical patient needs.