USP 800 Implementation in a Community Oncology Practice Nina K. Chavez, MBA, CMPE Chief Operating Officer, New Mexico Oncology Hematology Consultants, Ltd. Phone: (505) 828-3783 Email: ninac@nmohc.com CHOP Annual Meeting – Friday, February 10, 2017

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)

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

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.

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.

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

Potential Exposure Receipt Preparing Administration Transport Spills Waste

You Need a Point Person Designated individual 6 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

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)

Engineering Controls

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

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

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

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

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

Storage Storage of sterile and non-sterile HDs may be intermingled 14 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

Four Step Cleaning Process Deactivation Decontamination Cleaning Disinfection

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.

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

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

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

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).

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

Resources NIOSH Alert: Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings, 2004 www.cdc.gov/niosh/docs/2004-165/pdfs/2004-165.pdf NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings, 2014 www.cdc.gov/niosh/docs/2014-138/pdfs/2014-138.pdf ONS/ASCO/HOPA Joint Position Statement: Ensuring Healthcare Worker Safety When Handling Hazardous Drugs www.ons.org/advocacy-policy/positions/practice/hazardous-drugs