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USP <800>

USP <800>

USP <800> - Henry Schein Medical

Safely Handle Hazardous Drugs and Protect Your Patients and Staff with Compliant Supplies from Henry Schein

For decades, the demand to ensure a quality environment for healthcare workers and patients has been a highly discussed topic. USP General Chapter <800>, a regulation implemented on December 1, 2019, addresses the safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients, and the environment. 1

The National Institute for Occupational Safety and Health (NIOSH) considers a drug to be hazardous if it exhibits one or more of the following characteristics in humans or animals: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, or structure and toxicity profiles of new drugs that mimic existing hazardous drugs. 2 USP <800> standards and procedures will eliminate the potential risk posed to patients and the healthcare workforce. 2

Who Is Affected?

In 2018, about 8 million U.S. healthcare workers—including pharmacy and nursing staffs, clinicians, operating room personnel, environmental workers, research laboratories, and veterinary care employees—were exposed to precarious drugs. 2

Handling hazardous drugs can result in life-threatening health effects for the healthcare labor force. The Centers for Disease Control and Prevention reports workplace exposures to lethal medications can cause both acute and chronic health effects such as skin rashes, adverse reproductive outcomes (including infertility, spontaneous abortions, and congenital malformations), and leukemia and other cancers. 2

Becoming USP <800> Compliant

Follow the guidelines below to ensure your facility is USP <800> compliant 3

Hazardous Drug List

  • Examine all hazardous drugs and active ingredients used in the organization by referring to the NIOSH list 2
  • Evaluate the risk of exposure to hazardous drugs dosing for provisions that require counting and separating.
  • Review hazardous drug list yearly and when presenting new drugs to the workplace.

Facility & Engineering Controls

  • Confirm receiving and storage rooms follow USP <800> guidelines.
  • Develop USP <800> compliant compounding devices and rooms.
  • Sample surfaces every six months to ensure containment.
  • Use proper PPE during all areas of possible exposure.
  • Properly dispose of soiled PPE.
  • Implement closed-system transfer devices for administration of antineoplastic drugs.

Policies & Procedures

  • Communicate with staff about the use of hazardous drugs and appropriate handling procedures.
  • Craft and implement standard operating procedures for all areas of exposure including receiving, storing, compounding, transporting, and disposal.
  • Set up deactivating, decontaminating, and cleaning procedures.
  • Create a spill control response plan including assignment of responsible staff.
  • Establish a plan to monitor staff exposed to HDs and follow up on health changes.
  • Propose a revision process for all procedures.

Personnel Training

  • Elect a trained team leader in charge of all compliance, training, and oversight.
  • Train all personnel possibly exposed to HDs on standard operating procedures and check for staff competency.

How Henry Schein Can Help Support Your USP <800> needs

With this ruling, all personnel handling, administering, or transporting any hazardous drugs within a medical facility must abide by the USP <800> regulation. Henry Schein’s vast portfolio of products and solutions can easily transition your practice to meet the USP <800> ruling requirements.