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1.
J Antimicrob Chemother ; 79(7): 1564-1568, 2024 Jul 01.
Article in English | MEDLINE | ID: mdl-38717472

ABSTRACT

OBJECTIVES: To evaluate carbapenem prescribing rates for initial definitive treatment of urinary tract infections and clinical outcomes before and after removing ESBL status labels on antibiotic susceptibility reports. METHODS: This was a retrospective cohort study of adult patients treated for at least 48 h for an ESBL-producing/ceftriaxone-resistant Enterobacterales urinary tract infection. ESBL status reporting ceased in September 2022 for a network of seven community hospitals within the USA. The primary endpoint was the rate of carbapenem prescribing for initial definitive treatment of urinary tract infections. Secondary endpoints included total days of therapy for initial definitive treatment with carbapenems, clinical cure rates, time to transition to oral antibiotic therapy for initial definitive treatment, rate of guideline-compliant therapy, rate of relapsed infection within 30 days, 30 day readmission rate, and 30 day all-cause in-hospital mortality. RESULTS: Of 3055 patients screened, 199 were included in the pre group and 153 were included in the post group. The rate of carbapenem prescribing for initial definitive treatment was 156 patients (78%) in the pre group, compared with 93 patients (61%) in the post group (P = <0.01). Days of therapy for initial definitive therapy with carbapenem was 620 in the pre group compared with 372 in the post group (P < 0.01). There was no difference between other secondary outcomes. CONCLUSIONS: Removing ESBL status labels from laboratory reports reduced carbapenem use for initial definitive treatment of urinary tract infections from 78% to 61% (P < 0.01) without impacting clinical outcomes.


Subject(s)
Anti-Bacterial Agents , Carbapenems , Enterobacteriaceae Infections , Urinary Tract Infections , beta-Lactamases , Humans , Carbapenems/therapeutic use , Urinary Tract Infections/drug therapy , Urinary Tract Infections/microbiology , Retrospective Studies , Female , Male , Middle Aged , Anti-Bacterial Agents/therapeutic use , Aged , Enterobacteriaceae Infections/drug therapy , Enterobacteriaceae Infections/microbiology , Microbial Sensitivity Tests , Enterobacteriaceae/drug effects , Enterobacteriaceae/enzymology , Enterobacteriaceae/isolation & purification , Adult , Aged, 80 and over , Antimicrobial Stewardship
2.
Am J Health Syst Pharm ; 73(16): 1250-3, 2016 Aug 15.
Article in English | MEDLINE | ID: mdl-27354037

ABSTRACT

PURPOSE: One hospital's experience with procuring i.v. fosfomycin via an expanded-access protocol to treat a panresistant infection is described. SUMMARY: 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. CONCLUSION: I.V. fosfomycin was successfully procured through an FDA expanded-access protocol by coordinating efforts among ID physicians, pharmacists, and hospital executives.


Subject(s)
Anti-Bacterial Agents/administration & dosage , Compassionate Use Trials/methods , Drug Resistance, Bacterial/drug effects , Drugs, Investigational/administration & dosage , Fosfomycin/administration & dosage , Gram-Negative Bacterial Infections/drug therapy , Administration, Intravenous , Compassionate Use Trials/legislation & jurisprudence , Gram-Negative Bacterial Infections/diagnosis , Humans , Investigational New Drug Application/legislation & jurisprudence , Investigational New Drug Application/methods , Pharmacists/legislation & jurisprudence , Pharmacy Service, Hospital/legislation & jurisprudence , Pharmacy Service, Hospital/methods , United States , United States Food and Drug Administration/legislation & jurisprudence
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