Ensuring Safe Handling of Hazardous Drugs in Hospitals: USP 797 and USP 800 Regulations

Written By Lauren Davis, BS, CPT

Summary

  • Hazardous drugs in hospitals must be properly stored and handled to protect the health and safety of patients, staff, and the environment.
  • The USP 797 and USP 800 Regulations outline specific requirements for the storage and handling of hazardous drugs in hospitals.
  • Hospitals must ensure compliance with these Regulations to maintain a safe and effective healthcare environment.

Introduction

Hospitals in the United States are responsible for managing a wide range of medical supplies and equipment to ensure the health and safety of patients. Among these supplies are hazardous drugs, which can pose risks to both patients and healthcare workers if not handled properly. In this article, we will discuss the current Regulations regarding the storage and handling of hazardous drugs in hospitals in the United States.

USP 797 Regulations

The United States Pharmacopeia (USP) chapter 797 outlines the guidelines for the safe handling of hazardous drugs in healthcare settings. These Regulations are designed to protect patients, healthcare workers, and the environment from the potential dangers associated with these drugs. Some key requirements of USP 797 include:

  1. Establishing a designated clean area for compounding hazardous drugs
  2. Using appropriate personal protective equipment (PPE) when handling hazardous drugs
  3. Implementing proper decontamination procedures for equipment and surfaces
  4. Regularly monitoring air quality in compounding areas

Compliance with USP 797

Hospitals must ensure compliance with USP 797 to maintain a safe working environment for their staff and patients. Failure to meet these Regulations can result in fines, penalties, or even legal action. Regular audits and inspections are conducted to verify that hospitals are following the guidelines outlined in USP 797.

USP 800 Regulations

In addition to USP 797, the USP chapter 800 specifically addresses the handling of hazardous drugs in healthcare settings. USP 800 provides more detailed requirements for the safe storage, handling, and disposal of hazardous drugs to minimize the risks associated with these substances. Key requirements of USP 800 include:

  1. Using closed-system drug transfer devices when compounding hazardous drugs
  2. Implementing proper ventilation systems in areas where hazardous drugs are handled
  3. Providing training for healthcare workers on the safe handling of hazardous drugs
  4. Establishing protocols for cleaning up spills and leaks of hazardous drugs

Implementation of USP 800

Hospitals are required to implement the guidelines outlined in USP 800 to ensure the safe handling of hazardous drugs. This includes updating their policies and procedures, providing training for staff, and ensuring that the necessary equipment and facilities are in place to comply with the Regulations.

Challenges in Compliance

While the Regulations set forth by USP 797 and USP 800 are designed to protect the health and safety of patients and healthcare workers, compliance can present challenges for hospitals. Some common challenges include:

  1. Cost of implementing new equipment and facilities
  2. Training staff on proper handling procedures
  3. Maintaining compliance with evolving Regulations
  4. Ensuring consistent adherence to guidelines across all departments

Addressing Compliance Challenges

To overcome these challenges, hospitals can take a proactive approach to compliance by:

  1. Investing in necessary equipment and facilities to meet regulatory requirements
  2. Providing ongoing training and education for staff on the safe handling of hazardous drugs
  3. Staying informed about updates to Regulations and making adjustments as needed
  4. Implementing a system for monitoring and enforcing compliance within the organization

Conclusion

Ensuring the safe storage and handling of hazardous drugs in hospitals is essential to protect the health and safety of patients, healthcare workers, and the environment. By adhering to the Regulations outlined in USP 797 and USP 800, hospitals can create a culture of safety and compliance that benefits everyone within the healthcare system.

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Lauren Davis, BS, CPT

Lauren Davis is a certified phlebotomist with a Bachelor of Science in Public Health from the University of Miami. With 5 years of hands-on experience in both hospital and mobile phlebotomy settings, Lauren has developed a passion for ensuring the safety and comfort of patients during blood draws. She has extensive experience in pediatric, geriatric, and inpatient phlebotomy, and is committed to advancing the practices of blood collection to improve both accuracy and patient satisfaction.

Lauren enjoys writing about the latest phlebotomy techniques, patient communication, and the importance of adhering to best practices in laboratory safety. She is also an advocate for continuing education in the field and frequently conducts workshops to help other phlebotomists stay updated with industry standards.

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