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USP 800 chemotherapy administration impact: hazardous drug handling for patient and compounding staff safety

Hlavné poznatky

  • USP <800> guidelines mandate strict standards for the safe handling of hazardous drugs like chemotherapy agents to protect healthcare workers.
  • Compliance requires dedicated facilities, personal protective equipment (PPE), and safe handling of hazardous waste.
  • Pharmacies must regularly train staff and evaluate competencies to minimize exposure risks associated with chemotherapy administration.
Woman receiving chemotherapy treatment
Under USP Chapter <800> the Compounding Expert Committee has outlined standards for safe handling of hazardous drugs in healthcare settings. Here are key areas where they impact chemotherapy administration.

USP <800> standards apply to the handling of chemotherapy agents from receipt and storage through the compounding process and the administration of these hazardous drugs to patients. Concerns surrounding the compounding of hazardous chemicals, such as those used in chemotherapy agents, have been discussed since the 1970s. Chemotherapy had been originally mixed on countertops or horizontal workbenches, which allowed contaminated air into the room, exposing unprotected healthcare professionals.

Research published on these issues has identified the side effects of hazardous drug (HD) exposure resulting from little to no compounding standards, such as chromosome alteration, fertility issues, fetal teratogenicity, and secondary cancers. Today, USP <800> chemotherapy administration compliance requires the use of personal protective equipment (PPE), personnel training, safe handling of hazardous waste, and containment primary and secondary engineering controls for maintaining sterility and worker safety during compounding and medication storage.

USP <800> chemotherapy administration standards outlined

  • Pharmacies compounding hazardous drugs must adhere to the standards outlined in USP Chapter <800>. These standards apply to sterile and non-sterile compounding processes, and compliance must begin as soon as a pharmacy receives HD inventory. Some of the standards stated in USP <800> include:
  • Table 1 Antineoplastic HDs requiring manipulation and all HD Active Pharmaceutical Ingredients (APIs) must be stored in an area with 12 air changes per hour and under negative pressure. Exceptions apply to final dosage forms that are clearly labeled as HDs and have a documented assessment of risk.
  • Environmental and medical surveillance should be maintained.
  • Containment primary engineering controls must be defined for both non-sterile and sterile HD compounding.
  • Some HDs are allowed to be exempt from full containment requirements of the chapter when an assessment of risk is performed and implemented. HDs that may be exempt with an assessment of risk include final dosage forms of compounded and conventionally manufactured HDs that do not require further manipulation other than counting or repackaging.
  • Manipulation of HDs that do not produce aerosols is permitted outside of the containment primary engineering control when an assessment of risk has been performed and implemented.

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Chemotherapy drug preparation in negative-pressure spaces

Under the 2008 USP Chapter <797>, compounding facilities were permitted to compound HDs in the same buffer room as non-hazardous compounding if the HD volume being compounded was small. USP <800> changes this allowance, requiring all HD compounding to occur in a negative-pressure environment. This requirement can pose a financial and/or physical challenge for some facilities, such as oncology clinics or hospital satellite pharmacies, where negative-pressure buffer rooms may not be present.

A negative-pressure room is designed to prevent cross-contamination. A cleanroom design with a negative-pressure buffer room for hazardous compounding includes an adjoining positive-pressure anteroom and a ventilation system that prevents air from corridors or adjacent unclassified areas from entering the space. Negative-pressure buffer rooms have greater air exhaust than air supplied.

Under USP <800>, there is an alternative for organizations that lack the space to dedicate to a cleanroom suite with a negative-pressure buffer room: a containment segregated compounding area (C-SCA). A C-SCA is a space that has fixed walls, is vented to the outside, has a negative pressure between 0.01 and 0.03 to adjacent areas, and has a minimum of 12 air changes per hour. C-SCAs do not need to meet ISO standards for air quality in controlled environments for particle counts per cubic meter.

USP <800> chemotherapy administration: exposure and prevention

USP <800> lists several risk points for exposure to HDs, including dispensing, compounding, administration, and transport. Because of the potential risks, the chapter states that each facility must have a designated person who is qualified and trained to be responsible for HD storage, handling, transport, compounding, and HD waste management. The designated person can be a single person or multiple people who take on different aspects of the HD lifecycle at the facility.

To enhance safety measures for HD compounding, USP <800> also requires the use of a contaminant primary engineering control (C-PEC) for sterile and nonsterile HD compounding. A C-PEC is a ventilated device that minimizes worker and environmental exposure during HD manipulation. Additionally, the C-PEC must be used inside a containment secondary engineering control (C-SEC) room to prevent cross-contamination.

PPE must be worn by personnel to prevent exposure to HDs, such as those found in chemotherapy compounds. PPE must be worn during all stages of the HD lifecycle at the facility, from receiving through disposal. Under USP <800>, impermeable gowns are also required when administering injectable antineoplastic HDs. USP <800> hazardous drug handling chemotherapy safety standards also highlight the importance of personnel wearing PPE to reduce the potential for exposure in the event of an HD spill.

Finally, USP <800> highlights the importance of personnel training. Training must be conducted before an individual handles HDs independently. Furthermore, personnel competency must be demonstrated initially and evaluated every 12 months or upon introduction of new equipment. Simplifi 797’s USP <800> module offers pharmacy compounding Continuing Education for USP <800>, ensuring nothing falls through the cracks in your hazardous drug compounding operation.

USP <800> became official on December 1, 2019, but was not enforceable until November 1, 2023, when it became compendially applicable.

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References:

  1. United States Pharmacopeia (2020). General Chapter, ⟨800⟩ Hazardous Drugs—Handling in Healthcare Settings. USP-NF. Rockville, MD: United States Pharmacopeia.
  2. Power, Luci. "Understanding the New Proposed USP Chapter 800." Pharmacy Purchasing and Products. June 2014.
  3. Page, Michael. "USP 800: New Regulations to Protect Health Care Workers from Hazardous Drugs." Specialty Pharmacy Times. April 15, 2015.
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