1. USP 800 Implementation in a Community Oncology Practice
Nina K. Chavez, MBA, CMPE
Chief Operating Officer,
New Mexico Oncology Hematology Consultants, Ltd.
Phone: (505)
CHOP Annual Meeting – Friday, February 10, 2017

2. Purpose of USP 800
USP <800> builds on the standards established by existing compounding chapters
<795> Nonsterile compounding
<797> Sterile
compounding
Adds in the element of containment of hazardous drugs (HDs)

3. Existing References NIOSH Alert
ASHP Guidelines on Handling Hazardous Drug
Incorporates principles of medication safety and worker protection

4. Major Changes
Elimination of the low volume allowance for facilities that prepare HDs that permits placement of a Biological Safety Cabinet (BSC) in a non-negative pressure room. All HD compounding must be done in a separate area designated for HD compounding.
Addition of an allowance in 800 for a Containment Segregated Compounding Area (C-SCA), a separate, negative pressure room with at least 12 air changes per hour for use when compounding HDs. Low- and medium-risk HD compounded sterile preparation may be prepared in a BSC or (CACI) located in a C-SCA, provided that the HD are mixed and given within 12 hours.

5. Major Changes
Revised section on list of HDs, to allow entities to perform:
an assessment of risk for non-antineoplastic drugs and final dosage forms to determine alternative containment strategies and/or work practices.
Unpacked HDs in either a neutral/normal or negative pressure area.
Use external venting or redundant high-efficiency particulate air (HEPA) filtration of containment primary engineering controls (C-PECs) used for non-sterile compounding.

6. Scope of USP 800 Protect personnel, preparations, and the environment
Scope includes entire time a hazardous drug is in
your facility: receiving through disposal
Includes both nonsterile and sterile products and preparations
Standards apply to all personnel who compound HDs preparations and all places where HDs are prepared, stored, transported, and administered

7. Potential Exposure Receipt Preparing Administration Transport Spills
Waste

8. You Need a Point Person Designated individual6
You Need a Point Person
Designated individual
Develops and implements appropriate procedures
Oversees facility compliance with this chapter and other applicable laws, regulations, and standards
Ensures competency of personnel
Assures environmental control of the
compounding areas

9. What Do You Need For Compliance?5
What Do You Need For Compliance?
Engineering controls (including primary, secondary and supplemental)
Robust work practices
Comprehensive approach to prevent worker and environmental exposure
Monitoring
Competent personnel
Availability of appropriate Personal Protective Equipment (PPE)

10. Engineering Controls

11. Containment SCA
USP <800> currently allows for a Segregated Compounding Area for HDs
Containment Segregated Compounding Area
Low- and medium-risk CSPs
C-PEC in a separate negative pressure room
At least 12 air changes per hour
Maximum beyond-use time of 12 hours
Negative
BSC or
CACI
New

12. Facility Design Restricted access Unpacking Storage
Nonsterile HD compounding
Sterile HD compounding

13. Closed System Drug-Transfer Devices
CSTDs are supplemental engineering controls
Recommended for use during compounding
Required for use during administering
tesy of BD

14. Safe Work Practices Standard Operating Procedures (SOPs)
Documentation (pharmacy keeper software)
Aseptic technique
Containment technique
Disposal
Spill control

15. SOPs for handling of HDs should include:
Hazard communication program
Occupational safety program
Labeling of HDs
Procurement of HDs
Use of proper engineering controls (e.g., C-PECs, C-SECs)
Use of PPE based on activity (e.g., receipt, transport, compounding, administration, spill, and disposal)
Decontamination/deactivation, cleaning, and disinfection
Transport
Environmental monitoring
Spill control
Medical surveillance

16. Storage Storage of sterile and non-sterile HDs may be intermingled14
Storage
Storage of sterile and non-sterile HDs may be intermingled
HD storage in a sterile compounding buffer area shall be limited to those used for sterile compounding
Separate storage
Negative pressure
Refrigerator in storage area

17. Four Step Cleaning Process
Deactivation
Decontamination
Cleaning
Disinfection

18. Deactivating, Decontaminating, Cleaning, and Disinfecting
All areas where HDs are handled and all reusable equipment and devices must be deactivated, decontaminated, and cleaned.
Additionally, sterile compounding areas and devices must be subsequently disinfected
Cleaning of non-sterile compounding areas must comply with <795> and cleaning of sterile compounding areas must comply with <797>
Written procedures for cleaning must include procedures, agents used, dilutions (if used), frequency, and documentation requirements.

19. Environmental Monitoring
Sterile preparations
Microbial monitoring
USP <797> addresses EM for microbial contamination
Hazardous preparations
Environmental sampling
Medical surveillance
USP <800> recommends wipe samples to detect rogue HD contamination

20. Personnel Training
All personnel who handle HDs must be trained based on their job functions
Personnel competency must be reassessed at least every 12 Months
Personnel must be trained prior to the introduction of a new HD or new equipment and prior to a new or significant change in process or SOP
All training and competency assessment must be documented

21. Personnel Training The training must include at least the following:
Overview of entity's list of HDs and their risks
Review of the entity's SOPs related to handling of HDs
Proper use of PPE
Proper use of equipment and devices (e.g., engineering controls)
Response to known or suspected HD exposure
Spill management
Proper disposal of HDs and trace-contaminated materials

22. Personnel Training
All personnel who perform deactivation, decontamination, cleaning, and disinfection activities in HD handling areas must be trained in appropriate procedures to protect themselves and the environment from contamination
All personnel performing these activities must wear appropriate PPE resistant to the cleaning agents used, including two pairs of chemotherapy gloves and impermeable disposable gowns (see Personal Protective Equipment).

23. Proper Personal Protective Equipment (PPE)
Gloves
Chemotherapy gloves tested to ASTM standard
Sterile gloves for sterile HD CSPs
Gowns
Impervious
Hair covers
Eye and face protection
Shoe covers
Respiratory protection

25. Resources
NIOSH Alert: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings, 2004
NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2014
ONS/ASCO/HOPA Joint Position Statement: Ensuring Healthcare Worker Safety When Handling Hazardous Drugs