USP General Chapter <800>: Hazardous Drugs Handling in Healthcare Settings

USP General Chapter <800> was developed to protect healthcare workers, patients, and the environment from the risks associated with exposure to hazardous drugs (HDs). The chapter provides standards for the safe handling of hazardous drugs throughout the healthcare system, including receipt, storage, compounding, dispensing, administration, and disposal.

The Purpose of USP <800>

Exposure to hazardous drugs can lead to serious health consequences, including cancer, reproductive toxicity, organ damage, and genetic mutations. Unlike traditional pharmaceutical regulations that focus primarily on patient safety, USP <800> specifically mandates requirements focused on the occupational safety of personnel handling these substances. It applies to all healthcare personnel who handle hazardous drugs, including nurses, pharmacists, technicians, physicians, and environmental services staff.

Key Definitions and Scope

The chapter defines a hazardous drug as any drug identified as hazardous by the National Institute for Occupational Safety and Health (NIOSH). A drug is considered hazardous if it exhibits one or more of the following characteristics:

• Carcinogenicity
• Teratogenicity or other developmental toxicity
• Reproductive toxicity
• Organ toxicity at low doses
• Genotoxicity
• Structure and toxicity profiles of new drugs that mimic existing drugs determined hazardous

Responsibilities and Standards

Organizations must designate a person to be responsible for the implementation of the chapters requirements. This individual is tasked with ensuring compliance, overseeing staff training, and maintaining documentation. Key areas of compliance include:

Personal Protective Equipment (PPE)

PPE is the final line of defense against exposure. The chapter specifies that personnel must use appropriate gloves, gowns, head/hair covers, shoe covers, and eye protection depending on the task being performed. For instance, gloves must be powder-free and tested for resistance to chemotherapy permeation. When compounding or administering injectable antineoplastics, double-gloving is a standard requirement.

Handling and Storage

Hazardous drugs must be clearly labeled and stored in a manner that prevents breakage or contamination. Antineoplastic HDs requiring manipulation (like crushing or splitting) and those that must be stored in a refrigerator must be kept in a dedicated storage area with appropriate ventilation. The chapter emphasizes that these drugs should not be stored in a way that allows them to be mistaken for non-hazardous medications.

Training and Competency

All personnel who handle hazardous drugs must receive comprehensive training before they begin their duties. This training must cover the risks associated with the drugs, the proper use of PPE, cleaning and deactivation procedures, and spill management. Competency must be reassessed at least every 12 months to ensure that staff remain proficient in these critical safety protocols.

Medical Surveillance

The chapter recommends, though does not strictly mandate for every facility, the establishment of a medical surveillance program. This program involves tracking the health of employees who are routinely exposed to HDs. By identifying potential exposure early through health screenings, organizations can take corrective action to improve safety controls and protect the workforce.

Conclusion

Compliance with USP <800> is not merely a regulatory burden but a vital commitment to workplace safety. By adhering to these stringent standards for facility design, PPE, training, and operational procedures, healthcare organizations significantly reduce the risk of accidental exposure. Prioritizing the health of the healthcare worker is an essential component of delivering high-quality, safe patient care.