9/27/2016
Disclosure Patricia Kienle is an employee and stockholder of Cardinal Health She is an elected member and Vice Chair of the USP Compounding...
Disclosure Patricia Kienle is an employee and stockholder of Cardinal Health She is an elected member and Vice Chair of the USP Compounding Expert Committee, but this talk is not endorsed by or affiliated with USP
Strategies to Prepare for USP
She authored the ASHP upcoming publication The 800 Answer Book and is a contributor to Competence Assessment Tools for HealthSystem Pharmacies
PAT R ICIA C. KIE NLE , R PH , M PA, FASH P DIR E CTOR , ACCR E DITAT ION AND M E DICAT ION SAFE T Y CAR DINAL H E ALT H INNOVAT IVE DE LIVE R Y SOLUT IONS
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Objectives
Patti’s Wish
Identify the three categories of hazardous drugs
Identify three things that you can improve the next day you are at work
Describe elements of an Assessment of Risk State the garbing requirements when compounding hazardous drugs Identify the steps in the cleaning process when handling hazardous drugs
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What’s All the Fuss?
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Why ? To promote patient safety, worker safety, and environmental protection when handling hazardous drugs (HDs) Addresses, but is not limited to ◦ Receipt ◦ Storage ◦ Compounding
• Dispensing • Administration • Disposal
Applies to all healthcare personnel who handle hazardous drugs Applies to all healthcare entities that store, prepare, transport, or administer hazardous drugs
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USP
How Close to Compliant is Your Facility?
USP becomes federally enforceable on July 1, 2018 It is a required standard (not a guideline)
25%
50%
75%
100%
Courtesy of United States Pharmacopeial Convention
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Hazardous Drugs in Your Facility
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Major Components of USP Facilities Assessment of Risk Other Elements
Receiving
Storing
Mixing
Administering
◦ Personnel acknowledgement ◦ Medical surveillance ◦ Education and training ◦ Personal Protective Equipment ◦ Use of closed-system drug transfer devices (CSTDs) ◦ Environmental monitoring
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Genesis of USP
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NIOSH List of Hazardous Drugs Antineoplastic Non-antineoplastic Reproductive hazards
Hazardous to personnel ◦ Different from EPA hazards www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf 11
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Your Hazardous Drug List
Your Handling Options
Review the NIOSH list of hazardous drugs Identify the drugs and dosage forms you handle
Treat all Hazardous Drugs with all containment strategies in
Document review of this list annually
Perform an Assessment of Risk 13
Your List All containment strategies in
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Assessment of Risk Drug Dosage form Risk of exposure
Alternative containment strategies
API of any Hazardous Drugs on the list
Antineoplastics you only need to count or package
Antineoplastics you have to manipulate
Non-antineoplastics
Packaging Manipulation Documentation of alternative containment strategies and/or work practices Review annually and document
Items that don’t fit your Reproductive hazards Assessment of Risk approach 15
Receipt of Hazardous Drugs Supplier should mark containers Can be received in either a neutral/normal or negative pressure area (NOT in positive pressure) Receiving personnel need to assess the integrity of the container You must provide:
◦ Separate room with fixed walls ◦ Negative pressure
Secondary
Remove and dilute the hazard
◦ The room in which the PEC is placed
◦ Vented to the outside ◦ Appropriate number of air changes per hour (ACPH)
Supplemental ◦ Closed system drug-transfer devices
These are the minimum requirements
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Design for NonSterile Compounding
Two Options for Sterile Compounding
Primary Engineering Control
Cleanroom suite ◦ Positive pressure ISO 7 anteroom opening into negative pressure ISO 7 buffer room with biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI)
Secondary Engineering Control ◦ Room that is separate from non-hazardous drugs, and is under negative pressure, vented to the outside, and has the appropriate number of air changes per hour (ACPH) Occasional nonsterile compounding can be done in the sterile compounding area; details are in USP
Containment Segregated Compounding Area ◦ Separate space with BSC or CACI ◦ Limited to 12 hour beyond-use date (BUD) ◦ NOTE: Not currently allowed by
Low volume exemption is no longer allowed
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Personnel
Work Practices
Acknowledgement of risk of handling hazardous drugs
Policies and Procedures ◦ Master Formulation Records
Training ◦ USP for nonsterile compounding ◦ USP for sterile compounding ◦ State Board regulations
Technique ◦ Negative pressure technique
Personal Protective Equipment
Monitoring
Closed-System Drug Transfer Devices
◦ Media fill test ◦ Gloved fingertip test
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Personal Protective Equipment Requirements in
Gloves for Handling Hazardous Drugs
Gloves
Chemotherapy gloves tested to ASTM D6978
Gowns
Two pairs of non-powdered gloves
Hair covers
Gloves must be sterile when compounding sterile preparations
Shoe covers Face protection Respirators
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Gowns for Handling Hazardous Drugs
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PPPMag – January 2015
Tested and shown to resist permeability by hazardous drugs Disposable Polyethylene-coated polypropylene or other laminate
Close in back (no open front) Long-sleeved Elastic or knit closed cuffs No seams or closures that could allow hazardous drugs to pass through
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Other Garb Issues
Closed System Drug-Transfer Devices
Eye protection
CSTDs mechanically prohibit the transfer of environmental contaminants into the system and the escape of HD or vapor concentrations outside the system
◦ BSC/CACI provide eye protection ◦ Use goggles when working outside a PEC
Respirators
NIOSH has published a proposed performance protocol
◦ Use when outside a PEC
All garb is required when using a CACI Photo courtesy of BD 29
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How Close to Compliant is Your Facility? What solutions do you use to clean your chemo hood?
25%
50%
75%
100%
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Three Steps Step Deactivate Decontaminate Clean Disinfect
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Monitoring Agent Properly-diluted EPAapproved oxidizer intended for use with hazardous drugs Germicidal detergent Sterile isopropyl alcohol
Personnel
Safe Workplace
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Medical Surveillance
Environment
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Occupational Exposure
Recommended by Requirement to follow organizational policies Consider ◦ Health questionnaire ◦ History of exposure to HDs ◦ Record of acute exposure (spills) ◦ CBC with diff