title: New thoughts on the "forgotten" aspect of antimicrobial stewardship: adverse event reporting.
abstract: Antimicrobial stewardship is an activity that optimizes patient care through selection of the most appropriate antimicrobial therapy. Antimicrobial stewardship programs strive to enhance patient care and reduce preventable consequences of antimicrobial use. They are also vital in monitoring for the development of adverse events occurring as a result of antimicrobial therapy, although literature reviews of this activity are scarce. Although randomized controlled trials are considered the gold standard to study the efficacy of a medication, these trials are not designed to test safety end points and often are only able to identify the most commonly occurring and acute adverse events. In addition, prior to a drug going to market, it is difficult to detect rare adverse events because the associated costs are economically untenable given the limited pipeline of novel agents. These limitations in some ways may be resolved with the use of postmarketing surveillance and spontaneous reporting systems such as the United States Food and Drug Administration Adverse Event Reporting System. The focus of this commentary is to highlight the importance of adverse event reporting by antimicrobial stewardship programs to spontaneous reporting systems as a means to improve patient care.
authors.affiliation: Department of Pharmacy, University of Rochester Medical Center, Rochester, New York.
authors.forename: Charles
authors.initials: C
authors.lastname: Hoffmann
authors.forename: Tina
authors.initials: T
authors.lastname: Khadem
authors.forename: Anne
authors.initials: A
authors.lastname: Schweighardt
authors.forename: Jack
authors.initials: J
authors.lastname: Brown
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration / Q000639:trends; D000890:Anti-Infective Agents / Q000009:adverse effects*; D011358:Product Surveillance, Postmarketing / Q000379:methods; D016032:Randomized Controlled Trials as Topic / Q000379:methods; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000890:Anti-Infective Agents
keywords: adverse event reporting; antimicrobial stewardship; postmarketing surveillance