9/30/2018 1 9/30/2018 USP <800>: A Guide for Community and - PDF document

9/30/2018 1

9/30/2018 USP <800>: A Guide for Community and Long-Term Care Pharmacy NCPA 2018 Annual Convention Brenda Jensen CPhT, CNMT, MBA Compounding Consultants, LLC Disclosure Brenda Jensen is an owner of Compounding Consultants, LLC. The conflict of interest was resolved by peer review of the content. The views and opinions expressed are those of the speaker and are not endorsed by or affiliated with USP. 2

9/30/2018 Learning Objectives 1. Review important updates to USP standards and the impact on community pharmacy, particularly in the LTC space. 2. Identify common medications most likely impacted by USP <800> standards. 3. Discuss best practices for preparing your practice site for implementation. 3

9/30/2018 Timeline associated for the proposed revisions to <795> and <797> and opportunities to engage with USP and provide input. http://www.usp.org/compounding/updates-on-standards Who Does USP <800> Apply To? All facilities where hazardous drugs are handled. 4

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9/30/2018 Facility Requirements • Designated areas must be available for: -Receipt and unpacking -Storage of HDs -Nonsterile HD compounding (if performed) -Sterile HD compounding (if performed) • Certain areas are required to have negative pressure from surrounding areas to contain HDs and minimize risk of exposure. Facility Requirements • Access to areas where HDs are handled must be restricted to authorized personnel to protect persons not involved in HD handling. • HD handling areas must be located away from breakrooms and refreshment areas for personnel, patients, or visitors to reduce risk of exposure. • Signs designating the hazard must be prominently displayed before the entrance to the HD handling areas. 6

9/30/2018 Engineering Controls •Containment primary engineering control (C-PEC) is a ventilated device designed to minimize worker and environmental HD exposure when directly handling HDs. Examples: BSC, CACI. •Containment secondary engineering control (C-SEC) is the room in which the C-PEC is placed. • Supplemental engineering controls [e.g., closed-system drug-transfer device (CSTD)] are adjunct controls to offer additional levels of protection. Engineering Controls – HD Storage • C-SEC requires fixed walls, external venting, minimum of 12 ACPH and negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas. • Refrigerated antineoplastic HDs must be stored in a dedicated refrigerator in a negative pressure area with at least 12 ACPH. 7

9/30/2018 Engineering Controls – Nonsterile Compounding • C-PEC must be located in a C-SEC with fixed walls. • C-PEC used for compounding nonsterile HDs must be externally vented or have redundant HEPA filters in series. • C-SEC requires external venting, minimum of 12 ACPH and negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas. 8

9/30/2018 Designated Person • Develops and implements appropriate procedures. • Oversees compliance. • Ensures competency of personnel. • Ensures environmental control of HD areas. • Understands the rationale for risk-prevention policies. • Oversees monitoring of facility. List of Hazardous Drugs (HDs) • An entity must maintain a list of HDs, which must include any items on the current NIOSH list that it handles. • The list must be reviewed at least every 12 months. • Whenever a new agent or dosage form is used, it should be reviewed against the entity's list. 9

9/30/2018 Common Hazardous Drugs (HDs) • Table 1 Anastrazole, Letrozole, Methotrexate, Tamoxifen • Table 2 Carbemazepine, Azathioprine, Phenytoin, Spironolactone, Tacrolimus • Table 3 Clonazepam, Fluconazole, Paroxetine, Temazepam, Topiramate, Warfarin <800> Hazardous Drug SOPs • Receipt • Storage • Compounding • Dispensing • Administration • Disposal and Spill Management • Transport 10

9/30/2018 <800> Hazardous Drug SOPs For each hazardous drug handling activity include: • Location and environmental monitoring requirements. • Who is permitted to perform the activity (and what training and competency is needed). • PPE and hand-hygiene requirements. • HD handling procedure. • Cleaning procedure. <800> Hazardous Drug SOPs - Receipt In addition to the above • Use of tiered approach, starting with visual examination of the shipping container. • Handling of damaged packages. • Spill kit must be accessible in the receiving area. • Must not be done in positive pressure environment. 11

9/30/2018 <800> Hazardous Drug SOPs - Storage In addition • HDs must be stored in a manner that prevents spillage or breakage if the container falls. In areas prone to natural disasters the manner of storage must meet applicable safety precautions. • Do not store HDs on the floor. • Need AOR for storage outside of containment secondary engineering control (C-SEC). <800> Hazardous Drug SOPs - Compounding In addition • Comply with the appropriate USP standards for compounding. • Equipment must be dedicated for use with HDs. • Equipment use, maintenance and cleaning. • Need AOR for compounding outside of containment primary or secondary engineering control (C-PEC or C-SEC). 12

9/30/2018 <800> Hazardous Drug SOPs - Dispensing In addition • Counting and repackaging equipment should be dedicated for use with HDs and should be decontaminated after every use. • Antineoplastic HDs must not be placed in automated counting or packaging machines. • Pneumatic tubes must not be used to transport any liquid HDs or any antineoplastic HDs. <800> Hazardous Drug SOPs - Administration In addition • Use of protective medical devices and techniques. • Use of CSTD with antineoplastic HDs if dosage form allows. • Use of techniques/devices that minimize risk of open systems. • Avoid manipulating HDs (e.g. crushing tablets or opening capsules). If not possible, don appropriate PPE and use a plastic pouch to contain any dust or particles generated. 13

9/30/2018 <800> Hazardous Drug SOPs - Disposal In addition • Consider all PPE worn when handling HDs to be contaminated with, at minimum, trace quantities of HDs. • Place waste in an appropriate waste container and further disposed of per jurisdictional regulations. • Refer to SDS Section 13 for disposal considerations that meet federal requirements. Refer to state/local law for additional requirements. <800> Hazardous Drug SOPs – Spill Management In addition • Include clean-up of spills (address the size and scope), use of spill kit, location of spill kits and clean-up materials, PPE requirements, and specify who is responsible for spill management. • Prevention of accidental exposures or spills. • Use of Safety Data Sheets (SDS). • Response to known or suspected HD exposure. 14

9/30/2018 <800> Hazardous Drug SOPs – Transport In addition • Address appropriate shipping containers and packaging materials. • Ensure labels include storage instructions, disposal instructions, and HD category information in a format consistent with the carrier's policies. • Refer to SDS Section 14 for transport information. • Address use of exposure-reducing strategies. <800> Hazardous Drug SOPs – Recommended • Hazard communication program (required by federal law) • Occupational safety program (required by federal law) • Hand hygiene for each HD handling scenario. • Washing of contaminated non-disposable clothing. • Environmental monitoring (e.g., wipe sampling) – If performed. • Medical surveillance – If performed. 15

9/30/2018 Summary of Training Requirements • All personnel who handle HDs or who perform custodial waste removal or cleaning activities must be trained based on job functions. • Training must occur before independently handling HDs. • Personnel must be trained prior to the introduction of a new HD, new equipment, or change in process or SOP. • Effectiveness of training must be demonstrated and competency must be reassessed at least annually. Summary of Training Requirements • Overview of HDs in use and their risks • Use of Safety Data Sheets • Storage • Review of SOPs related to handling of HDs • Use of equipment and devices. • Use of PPE including use of NIOSH-certified respirators 16

9/30/2018 Summary of Training Requirements • Prevention of HD contamination • Labeling • Transport • Disposal of HDs and trace-contaminated materials • Spill management and use of a spill kit • Response to known or suspected HD exposure 17

9/30/2018 Assessment of Risk (AOR) •If AOR is not performed, all HDs must be handled with all containment strategies defined in this chapter. •AOR must, at a minimum, consider: type of HD, dosage form, risk of exposure, packaging, and manipulation. •Document alternative containment strategies and/or work practices being employed for specific dosage forms to minimize occupational exposure. •Review at least every 12 months and document review. 18

9/30/2018 Resources • USP <800> FAQ https://www.usp.org/frequently-asked- questions/hazardous-drugs-handling-healthcare-settings • USP <800> HazRx Mobile App https://www.usp.org/hazrx-app • The Chapter <800> Answer Book by Patricia Kienle https://store.ashp.org 19