Quality & Regulatory Affairs  |   November 2017
United States Pharmacopeia (USP) General Chapter <800> and the Assessment of Risk (AOR) of Oxytocin in Order to Maintain Compliance
Author Affiliations
  • Elizabeth Rebello, M.D.
    Committee on Quality Management and Departmental Administration
  • H.A. Tillmann Hein, M.D.
    Committee on Quality Management and Departmental Administration
Article Information
Obstetric Anesthesia / Patient Safety / Practice Management / Advocacy and Legislative Issues / Quality & Regulatory Affairs
Quality & Regulatory Affairs   |   November 2017
United States Pharmacopeia (USP) General Chapter <800> and the Assessment of Risk (AOR) of Oxytocin in Order to Maintain Compliance
ASA Monitor 11 2017, Vol.81, 58-60.
ASA Monitor 11 2017, Vol.81, 58-60.
United States Pharmacopeia (USP), a scientific non-profit organization, sets standards for the identity, purity, manufacturing and handling of medications that are recognized worldwide. USP General Chapter <800> Hazardous Drugs in Healthcare Settings provides standards for safe handling of hazardous drugs.1  Most of the hazardous drugs listed in the chapter are not utilized in the peri-operative environment. However, oxytocin – a drug that anesthesiologists and other members of the anesthesia care team, as well as nurses in labor and delivery suites may handle – is included in this list.
In most U.S. jurisdictions (46 states and territories), USP chapters are incorporated into statute by reference. That makes these chapters enforceable by the Centers for Medicare & Medicaid Services (CMS) and those accrediting agencies that have been granted deemed status by CMS. To maintain compliance with The Joint Commission and CMS, physicians are required to comply with USP <800>, which consists of being in compliance with all containment strategies detailed in the USP <800> or having an assessment of risk (AOR) documented on file for oxytocin administration.
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