![]() ![]() This includes hospitals, pharmacies, clinics, physician’s practices, and most acute care facilities.Ĭompliance requirements do not vary according to the size of the facility or the frequency with which staff compound and administer hazardous drugs. ![]() USP applies to all facilities where hazardous drugs are prepared, stored, transported, or administered. While the deadline for complying with USP is fast approaching in many regions, thousands of medical facilities are still out of compliance with USP due to the significant architectural modifications needed to bring existing st r uctures into compliance. By keeping ourselves safe, we are protecting our patients as well. While it focuses on the protection of health care workers, it’s also about patient safety. It starts with the guy on the loading dock who first receives the drugs, all the way through to the nurses who administer them. As a member of the Compounding Expert Committee which wrote UPS put it, “ The intent and scope of USP is much broader than some of the requirements found in USP. USP has been specifically designed as a legally enforceable standard, in order to protect medical staff, patients, and the environment from exposure to antineoplastic (“chemo drugs”), non-antineoplastic, and other HDs. ![]() Pharmacopeial Convention to develop USP General Chapter Hazardous Drugs-Handling in Healthcare Settings. Meanwhile, hospital staff were receiving, handling, compounding, and administering medications identified by NIOSH as hazardous drugs (HDs), without sufficient safety measures in place to protect them from reproductive harm and other serious health impacts associated with these drugs. The new USP chapters also called for buffer and ante areas for sterile compounding areas, improvements in air supply, the use of HEPA filter systems, negative air pressurization, and other safety measures which often required significant modifications of existing architecture in medical facilities.īut while USP and were far reaching, they were specifically designed to protect the health of patients. Chief among these changes was the implementation of primary engineering controls (PECs), including laminar airflow workbenches (LAFWs), compounding aseptic isolators (CAIs), biological safety cabinets (BSCs), and compounding aseptic containment isolators (CACIs). With the implementation of USP and, along with changes in staff training in the handling of compounding sterile preparations ( CSPs ) and other medications, these USP chapters also created new guidelines for the design and function of medical facilities as well when it came to the compounding of medications. These standards were the result of decades of deliberation over how best to respond to patient injuries resulting from sub-potent, super-potent, or contaminated medications. Pharmacopeial Convention published USP General Chapter Pharmaceutical Compounding - Sterile Preparations, and USP Pharmaceutical Compounding - Nonsterile Preparations. Separately available exhaust canopy and exhaust alarm accessories allow connection to an external exhaust blower.Several years ago, the U.S. Standard minihelic gauges display the pressure in both the work and interchange chambers while the standard PharmaGard™ digital monitor alerts the operator when the work chamber negative pressure has departed from its acceptable parameters. A sliding door and work tray allow the passage of items within the isolator before compounding, while the hinged front window allows easy access for maintenance. This cascade of pressure simultaneously prevents contamination into the interior and the escape of hazardous material from it. The isolator is sub-divided into an interchange chamber that is kept at a stronger negative pressure than the adjoining work chamber, which is itself at negative pressure to the room. The NU-NR800 is a Compounding Aseptic Containment Isolator (CACI) composed of a stainless-steel enclosure and polycarbonate front window with gloves that provides 20 air changes per minute of ISO Class 5 HEPA filtered air for the preparation of sterile but hazardous drugs.
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