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What is USP <800>?

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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Becoming USP <800> compliant

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.
  • Receipt – Antineoplastic and HD APIs unpacking area must be neutral or under negative pressure. This area should never be under positive pressure.
  • Storage – All HDs must be safely stored on secured shelving to prevent breaks and spills. Antineoplastic HDs that need manipulations and HD APIs have to be stored away from non-HDs in an externally ventilated room under negative pressure with 12 air changes per hour (ACPH). Sterile and nonsterile HDs can be stored together but must be separated from the sterile compounding area. Any refrigerated HDs must have a dedicated refrigerator in a negative pressure room with 12 ACPH.
  • Compounding – Engineering controls for compounding must meet specified guidelines for all primary, secondary, and supplementary devices. The USP 800 requirements for compounding vary depending on whether it is a nonsterile or sterile preparation. In addition to following USP 800 guidelines, nonsterile compounding must be compliant with USP 795 and sterile compounding compliant with USP 797. Containment Primary Engineering Control (C-PEC) entails a continuously operated and ventilated enclosure designed to minimize worker and environmental HD exposure while directly manipulating HDs. Separate C-PECs must be used for nonsterile and sterile compounding with a plastic spill mat. Containment Secondary Engineering Control (C-SEC) is the room that contains the C-PEC and must be externally vented, separated from other areas, meet air exchange guidelines, and have negative pressure of 0.01 – 0.03 inches of water column (wc). Supplementary devices, such as closed-system drug transfer systems, offer an additional level of protection from exposure to HDs. Supplementary devices cannot be used as a substitute for a C-PEC and must have the performance evaluated to ensure containment.

Engineering Controls for Nonsterile/ Sterile HD Compounding

Compounding
Device
USP 800 Device Guidelines
Nonsterile
C-PEC
  • Externally ventilated or contain redundant HEPA filters
  • Containment Ventilated Enclosure, Class I or II Biological Safety Cabinet (BSC), or Compounding Aseptic Containment Isolator (CACI).
C-SEC
  • Externally ventilated
  • 12 ACPH
  • 0.01 – 0.03 wc negative pressure
Sterile
C-PEC
  • Externally vented providing ISO Class 5 or better air qualit
  • Class II (type A2, B1, or B2) or Class III Biological Safety Cabinet (BSC) or Compounding Aseptic Containment Isolator (CACI).
C-SEC ISO Class 7 buffer room with ISO Class 7 ante-room
  • Externally ventilated
  • 30 ACPH
  • 0.01 – 0.03 wc negative pressure
Or, Unclassified containment segregated compounding area
  • Externally ventilated
  • 12 ACPH
  • 0.03 wc negative pressure
Follow UPS 797 for the beyond-use date (BUD)

Safe Practices for Handling Hazardous Drugs

  • Surface sampling every 6 months
  • Wear personal protective equipment (PPE) and dispose of properly
  • Communicate Hazards to staff
  • Implement Standard Operating Procedures for all processes handling HDs including receiving, labeling, packaging, transporting, and disposal
  • Safely administer drugs by wearing necessary PPE and using appropriate medical devices
  • Complete thorough cleaning procedures including Deactivating, Decontaminating, Cleaning, and Disinfecting (for sterile only) for all areas using compatible cleaning products
  • Train personnel for spill control procedures, use appropriate PPE and immediately clean up spills. Document all spills to ensure the health and safety of affected employees
  • Monitor personnel exposed to HDs regularly

USP <800> Compliance Checklist

Hazardous Drug List
Consider all hazardous drugs and active ingredients used in the organization by referring to the NIOSH list.
Assess the risk of exposure to HDs dosing for preparations that only require counting and separating.
Review hazardous drug list yearly and when introducing new drugs to the workplace.

Facility & Engineering Controls
Ensure receiving and storage rooms follow USP 800 guidelines.
Utilize USP 800 compliant compounding devices and rooms.
Sample surfaces every 6 months to ensure containment.
Use proper PPE during all areas of possible exposure.
Appropriately 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 proper handling procedures.
Create and implement standard operating procedures for all areas of exposure including receiving, storing, compounding, transporting, and disposal.
Set up deactivating, decontaminating, and cleaning procedures.
Establish a spill control response plan including assignment of responsible staff.
Constitute a plan to monitor staff exposed to HDs and follow up on health changes.
Plan a revision process for all procedures.

Personnel Training
Designate 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.

USP <800> Hazardous Drug List

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:

  • Ability to impact or damage DNA/genes
  • Carcinogenic
  • Causes reproductive effects such as infertility, fetus and embryo effects, or developmental abnormalities
  • Leads to organ damage
  • Similar in structure or function as other hazardous drugs

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.