USP 800: Understanding the Guidelines for Hazardous Drugs—Handling in Healthcare Settings
The United States Pharmacopeia (USP) is a non-profit organization that sets quality standards for drugs and healthcare products. USP publishes guidelines for the safe handling of hazardous drugs, known as USP 800. This standard provides guidance on the proper handling, storage, and disposal of hazardous drugs in healthcare settings.
Why is USP 800 important?
Hazardous drugs are used in many healthcare settings to treat a variety of diseases, including cancer. These drugs can be harmful to healthcare workers if they are not handled properly. Exposure to hazardous drugs can lead to acute and chronic health effects, such as skin rashes, cancer, and adverse reproductive outcomes . USP 800 provides guidelines to protect healthcare workers from exposure to these drugs.
What are hazardous drugs?
The criteria for what define Hazardous Drugs is established by the CDC’s National Institute of Occupational Safety and Health (NIOSH). HDs meet one or more of the following criteria:
- Carcinogenicity: drugs that are known or suspected to cause cancer
- Teratogenicity: drugs that are known or suspected to cause birth defects
- Reproductive toxicity: drugs that are known or suspected to harm the reproductive system
- Organ toxicity at low doses: drugs that can cause organ damage at low doses
- Genotoxicity: drugs that damage DNA or cause mutations
- Structure and toxicity profiles: drugs that have properties that pose a risk to healthcare workers, such as toxicity to skin or mucous membranes
Examples of hazardous drugs include chemotherapy drugs, antiviral drugs, and hormone therapies such as, but no limited to:
- 5-Fluorouracil
- Cyclophosphamide
- Docetaxel
- Doxorubicin
- Etoposide
- Ifosfamide
- Irinotecan
- Methotrexate
- Estradiol
- Mitomycin
NIOSH publishes a list of HDs but also requires employers to evaluate their own formularies against the NIOSH criteria to identify HDs handled by employees.
What do the USP 800 and NIOSH guidelines mean for healthcare facilities?
If you work in a healthcare facility that handles hazardous drugs, it's important to be familiar with the guidelines outlined in USP 800 and NIOSH. These guidelines cover a wide range of topics and may require changes to your facility's policies and procedures.
For example, USP 800 requires the use of PPE, such as specific ASTM D6978-05 chemotherapy-tested gloves and gowns, when handling hazardous drugs. It also requires specific engineering control (hoods, and closed-system transfer devices) when preparing these medications
In addition to these specific requirements, USP 800 also requires healthcare facilities to develop comprehensive policies and procedures for the handling of hazardous drugs. These policies should cover all aspects of employee HD exposure control from the HD receipt and storage to the disposal of waste.
Overall, USP 800 represents an important step forward in protecting healthcare workers, patients, and the environment from the risks associated with the handling of hazardous drugs. By following these guidelines and regulations, healthcare facilities can ensure that they're providing a safe and healthy workplace for their employees, while also protecting the public and the environment.
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