Throughout the US, 8 million healthcare workers handle hazardous drugs (HDs) and administer over 12 billion doses of HDs each year. Mishandling and improper compounding procedures can result in lasting health effects for the employees, nearby patients, and the environment. Unprotected exposure to HDs may result in cancer formation, fertility changes, and DNA and organ damage. The United States Pharmacopeia (USP) implemented chapter USP 800 to promote patient health, worker safety, and address environmental concerns.
USP 800 details proper planning and procedures for handling hazardous drugs including receiving, dispensing, compounding, administering, transporting, disposing, and cleaning to contain residues and prevent exposure. To become USP 800 compliant, facilities must identify a list of hazardous drugs, understand the types of exposure, and create an occupational safety plan detailing the standard operating procedures of personnel training, facility and engineering controls, and other safe workplace practices.
All facilities that handle HDs such as pharmacies, hospitals, patient treatment centers, physician practices, surgical centers, veterinarians, home health centers, and nursing facilities will be required to be fully USP 800 compliant by December 1, 2019.
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List of Hazardous Drugs - Each facility must identify and assess all hazardous drugs and drugs with hazardous active pharmaceutical ingredient (API) used by employees. This assessment includes completing a dosage risk assessment to determine if the drug manipulations apply to USP 800 compliance.
Types of Exposure - Understanding the areas where exposure to HDs occurs helps facilities recognize hazards and instill USP 800 compliant procedures in those areas. The following processes may expose employees to HD or contaminate surfaces with HD residue: Receiving/Unpacking, Dispensing, Compounding, Administering Medication, Patient Care, Spills, Disposal, and Transporting.
Trained Personnel - Every facility that handles HDs must assign a trained team leader in charge of implementing procedures, managing compliance, maintaining a knowledgeable team, and monitoring environmental controls for storage and compounding. Every team member that works with HDs must be trained to understand compliance practices, ways to evaluate current procedures and preserve the quality of HDs to protect patient and personnel safety.
Facilities and Engineering Controls - General safety measures such as posting hazard signs, restricting access to HD areas, and secluding the locations away from traffic properly protects other personnel, patients, and visitors from HD exposure. Each process involved in handling HDs must take place in a designated area meeting strict USP 800 guidelines.
ISO Class 7 buffer room with ISO Class 7 ante-room
Hazardous Drug List
Facility & Engineering Controls
Policies & Procedures
The USP 800 hazardous drugs list for each facility can be compiled by comparing all medications handled and compounded to the NIOSH list of antineoplastic and other HDs. The facility’s list must be reviewed every year and after the introduction of new drugs. To be considered a hazardous drug, the drug must include any HD active pharmaceutical ingredient (API) or any antineoplastic that requires HD manipulation. Drugs may be classified as hazardous if exhibiting any of these characteristics:
Certain hazardous drugs with a low-risk assessment that do not require manipulations (such as counting and packaging) may not be required to follow USP 800 guidelines. Drug risk assessment includes considering the type of HD, dosage form, risk of exposure, packaging, and manipulation. Alternative containment can be used but must be documented and reviewed yearly to ensure proper containment.