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TRANSCRIPT
11/6/2017
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PREPARING FOR USP <800>
Seth Eisenberg RN, OCN®, BMTCN®
Professional Practice Coordinator, Infusion Services
Seattle Cancer Care Alliance
Seattle, WA
October 2017 NCCS
HAZARDOUS DRUG DEFINITION
• Defined by NIOSH as having any of the following characteristics:
• Carcinogenicity
• Teratogenicity or other developmental toxicity
• Reproductive toxicity
• Organ toxicity at low doses
• Genotoxicity
• Structure mimicking existing HDs
NIOSH 2016 DRUG LIST
NIOSH HD GROUPS
NIOSH, 2016
Group Comments
1 Antineoplastics
Antineoplastics (chemotherapy) Does not include non-conjugated monoclonal antibodies
2Non-antineoplastics
Non-Antineoplastics
3Reproductive risks
Reproductive hazards for personnel attempting to conceive, or breast feeding
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HAZARDOUS BUT NOT EQUAL
• While all HDs on the NIOSH list are hazardous, different precautions may be needed depending on the handling activity and formulation
• Example:
• “Unopened, intact tablets and capsules may not pose the
same degree of risk as IV medications. Cutting, crushing,
or otherwise manipulating tablets and capsules will
increase the exposure.”
NIOSH, 2016
TIMELINE
Positive urine mutagenicity (Ames Test) in nurses and
pharmacists handling chemotherapy
Falck, K. et al 1979 Lancet
HAZARDOUS DRUG GUIDELINES
ASHP ASHP ONS OSHANIOSH Alert
1981 1983 1984 1986 2004
ASHP ASHP ONS OSHAASHP ASHP ONS
2004 NIOSH ALERT
• Summarized literature on hazardous
(HD) exposure
• Made specific recommendations
for safe handling based on studies
and professional organizations
(ASHP, ONS)
• Covered chemotherapy and non-
chemotherapy agents
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CHEMOTHERAPY IS NOT GOING AWAY
RECENT STUDIES
WIPE TESTING
• 6 Canadian hospitals
• Wipe testing for cyclophosphamide (Cy)
• 438 surfaces in pharmacy and administration areas
Hon C., et al., 2013
WIPE TESTING EXAMPLE
Photo credit: Seth Eisenberg
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WIPE TESTING
• IV hooks
• IV pumps
• Calculators
• Carts
• Chairs
• Computer mice
• Countertops
• Pens
• Printers
• Patient bedside tables
• Elevator buttons
• Sink handles
• Examples of contaminated objects:
• 36% of all samples were above level of detection
HAND CONTAMINATION
• N = 110
• 225 wipe samples collected
• Sample included nurses, oncologists, dietitians, ward
clerks, volunteers, housekeeping
• 20% of the samples were positive
• Highest level of contamination on non-nurses
• Hand-washing did not prevent positive results
Hon C., et al., 2014
URINARY EXCRETION
• N = 103 disciplines
• 201 (24hr) samples collected
• 55% were positive for Cy
• Highest concentration in unit clerks and other
departments that did not prepare or administer
• No correlation between levels and known contact with Cy
Hon C., et al., 2015
MULTI-HOSPITAL WIPE TESTING1
• 51 Canadian hospitals
• 584 samples obtained
• 50% were positive for Cy
• Contamination found in pharmacy and patient care
areas including infusion chairs and on the counter
Janes A., et al., 2015
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MULTI-HOSPITAL WIPE TESTING2
• 48 Canadian hospitals
• 525 samples obtained
• 34% were positive for Cy
• Contamination found in pharmacy and patient care
areas including infusion chairs and on the counter
Poupeau C., et al., 2016
CHROMOSOMAL DAMAGEFLUORESCENT IN SITU HYBRIDIZATION (FISH)
• 3 US cancer centers
• N = 109 (includes 46 control)
• Abnormalities seen for chromosome 5 in exposed
versus non-exposed (p=.01)
• Increased incidence of chromosome 5 abnormalities
seen with increased drug handling
• Hazard Ratio 8.54 (p=.01) for alkylating agents
McDiarmid, M. et al, (2010) JOEM
CHROMOSOMAL DAMAGEMN (MICRONUCLEI) AND CA (CHROMOSOMAL ABERRATIONS)
• 5 hospitals in Italy
• N = 148 (71 study, 77 control)
• Signi cant increase in MN frequency (5.30 ± 2.99
and 3.29 ± 1.97; (p < 0.0001)
• CA detection (3.30 ± 2.05 and 1.84 ± 1.67; p < 0.0001)
Moretti, C. et al, (2015)
© 2016 Seth Eisenberg
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EXPOSURE ROUTE HIERARCHY
Handling Intact O
ral A
gents
Handling Feces
Spill M
anagement
Administration
Handling U
rine
Compounding
© 2017 S. Eisenberg
HOW EXPOSURE OCCURS
• Compounding in biologic
safety cabinet (BSC)
using needles
Courtesy of S. Eisenberg
HOW EXPOSURE OCCURS
• Spiking and unspiking at the bedside
Polovich, M. 2011 ONS Photos Courtesy of S. Eisenberg
HOW EXPOSURE OCCURS
• Connecting and
disconnecting
syringes and tubing
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HOW EXPOSURE OCCURS
• Priming IV tubing
Photo Courtesy of S. Eisenberg
HOW EXPOSURE OCCURS
• Touching the
exterior of the IV
bag
Photo Courtesy of S. Eisenberg
HOW EXPOSURE OCCURS
• Wearing improper PPE
HOW EXPOSURE OCCURS
• Handling excreta
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HOW EXPOSURE OCCURS
• Spills and leaks
Photos Courtesy of S. Eisenberg
NIOSH HD SURVEY• N = 1954 nurses
Survey Item %
Primed tubing with hazardous drug 6
Crushed tables or opened capsules (n=494) 13
Touched IV pump or bed controls while wearing chemotherapy gloves 61
Used pens or pencils while wearing chemotherapy gloves 26
Touched doorknobs or cabinets while wearing chemotherapy gloves 20
Never used a Closed System Transfer Device (CSTD) 47
Always wear double gloves 20
Always wear recommended gown 58
Reported a spill within prior week 12
Spills not always cleaned up 10
Boiano, Steege & Sweeney, 2014
HD GUIDELINES
US Pharmacopeial Convention
ASHP ASHP ONS OSHANIOSH Alert
1981 1983 1984 1986 2004
USP
2016*
ASHP ASHP ONS OSHAASHP ASHP ONS
UNITED STATES PHARMACOPEIA (USP)
• Most nurses have never
heard of USP but we’ve
seen their logo
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UNITED STATES PHARMACOPEIA (USP)
• The mission of USP is to set standards “for the
identity, strength, quality, and purity of
medicines…”
GUIDELINES VS. STANDARDS
Guidelines
• Recommended practice
• Evidence-based
• What “should” be
• Example:
• ONS Chemotherapy
Guidelines
Standards
• Expectations for practice
• Evidence-based
• What “must” be
• Example:
• The Joint Commission
USP CHAPTER 800 (USP <800>)
• Includes standards for:
• HD delivery and storage
• Education
• Compounding
• Administration
• Disposal
** Photo courtesy of Seth Eisenberg
*
* Photo courtesy of Fred Massoomi
**
USP <800>
Revised compliance date: December 1, 2019
• Is enforceable by each state’s Board of
Pharmacy or designated agency (e.g.,DOH),
the FDA and CMS (through USP <797>)
• CMS currently has COPs with USP for USP <797>
*CMS Standard §482.25(a) (https://www.cms.gov/Regulations-and-Guidance/Legislation/CFCsAndCoPs/Hospitals.html)
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USP <800> REQUIREMENTS
USP <800> REQUIRED EDUCATION
• All employees must have access to and understand the
organization’s HD list
• Education must be provided for all staff handling HDs
before performing any HD-related duties
• Assessment of competency must be performed
annually and documented
• All staff of reproductive capability must sign an
acknowledgement of the risks of HDs
PERSONAL PROTECTIVE EQUIPMENT
• Double-gloves
• BOTH pair must be chemotherapy tested to
ASTM D6978-05 standards
Photo courtesy of Seth Eisenberg
PERSONAL PROTECTIVE EQUIPMENT
• Not all chemo gloves are alike:
DrugMinimum breakthrough
time (minutes)
Cardinal Cool Blue Cardinal Esteem
Carmustine (BCNU) 7.28 17.14
Cisplatin >240 >240
Cyclophosphamide >240 >240
Doxorubicin >240 >240
Etoposide >240 >240
5FU >240 >240
Methotrexate >24 Not Tested
Paclitaxel >40 >240
Thiotepa 2.67 1.16
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PERSONAL PROTECTIVE EQUIPMENT
• Not all chemo gloves are alike:
Found on actual box of “chemotherapy” gloves
PERSONAL PROTECTIVE EQUIPMENT
• Chemotherapy-resistant gown
• “Single-use” and disposable
• Solid front and elastic or knit cuffs
• Shown to resist HD permeability
• There are no current standards for gowns; ask the
manufacturer to provide proof of HD resistance
Eisenberg, S. 2017, Clinical Journal of Oncology Nursing
PERSONAL PROTECTIVE EQUIPMENT
• Worn during:
Preparation
Administration
DisposalManaging
Spills
Photos courtesy of Seth Eisenberg
SPILL MANAGEMENT
• Spill training with appropriate respiratory protection
for drugs that vaporize at room temperature
• Carmustine
• Etoposide
• Cyclophosphamide
• Thiotepa
• Nitrogen Mustard
• 5-FU
• Cisplatin
• Ifosfamide
Connor, Shults & Fraser, 2000; Kiffmeyer et al, 2002
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VAPORS AND AEROSOLS
• Vapors: small particles (e.g., perfume)
• Aerosols: larger particles (e.g., Windex™)
• N95 or N100 are for aerosols and particulates
• Vapors require a canister respirator or PAPR
(Powered Air Purifying Respirator) with organic
vapor cartridge
DHHS (NIOSH) Publication No. 2009–106; USP<800> 2016
Full Face Respirator with OV canister
PAPR (Powered Air Purifying Respirator) with OV cartridge
VAPORS AND AEROSOLS
Photos courtesy of Seth Eisenberg
CLOSED SYSTEM TRANSFER DEVICE
• A Closed System Transfer Device (CSTD) will be required for administration of antineoplastic HDs
• Designed to “restrict hazardous drug liquid or vapor from escaping into the environment.”
• CSTDs are recommended for compounding
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7 CSTD SYSTEMS AVAILABLE
• Halo (Corvida)
• Phaseal (BD)
• Equashield (Equashield Medical)
• OnGuard (B Braun)
• ChemoLock (ICU Medical)
• ChemoClave (ICU Medical)
• Chemo Safety System [Texium]
(CareFusion/BD)
• Used at the end tubing
(secondary tubing
and/or primary)
CSTDs
Eisenberg, S. (2014) PPPmag.comPhotos courtesy of S. Eisenberg
• For administering drugs
in a syringe (IVP, SC,
IM)
• On all IV chemotherapy
bags if attaching at
bedside or
disconnecting bag from
tubing
CSTDs
Photo courtesy of S. Eisenberg
CSTD DESIGNS
• B Braun On Guard• BD Phaseal• Corvida Halo• Equashield• ICU ChemoLock (needless)
• ICU Spiros• CareFusion Texium
Illustration © 2017 S. Eisenberg
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MEMBRANE TO MEMBRANE DEVICES & ADAPTORS
©2016 S. Eisenberg
CSTD SYSTEMS
PHASEAL® (BD)
• First system on the market (1999)
• Membrane-to-membrane
• Requires adaptor for use with
Luer devices
• External chamber to trap vapors
• Push / turn / push “Injector” to
engage needle
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CHEMO SAFETY SYSTEM (BD/CAREFUSION)
• Luer-to-luer system (needleless)
• Designed to work with CareFusion
Smartsite™ valve
• Texium™ has internal valve designed to
open when connected to SmartSite™
• VialShield has external balloon
to trap vapors
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CHEMOCLAVE® (ICU MEDICAL)
• Luer-to-Luer design (needleless)
• No adaptors required
• Vial Spike (CH-80S) has external
polyethylene lined/metallized
nylon balloon to equalize pressure
• Spiros® closed male luer has
internal valve is activated only
after attaching to a luer device
(e.g. Clave®)
57
CHEMOLOCK® (ICU MEDICAL)
• Membrane-to-membrane design
(needleless)
• Requires adaptor for use with luer
devices
• Vial spike (CL80) has external
polyethylene lined/metallized nylon
balloon to equalize pressure
• ChemoLock pushes on with audible
click to engage
• Press clip for automatic disconnect
58
ONGUARD® (B BRAUN)
• Membrane-to-membrane
• Requires adaptor for use with luer
devices
• Uses dual-layer micro-filter to trap
particles and filter vapors
• Pushes on with audible click
• Press wings to pull off
EQUASHIELD® (EQUASHIELD MEDICAL)
• Membrane-to-membrane
• Requires adaptor for use with
luer devices
• Uses dual-chamber syringes to
vent vapors back into rear of
syringe
• Push on / pull off
60
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HALO® (CORVIDA MEDICAL)
• Membrane-to-membrane
• Requires adaptor for use
with luer devices
• Syringe locks on to device
• Has external circumferential
balloon which extends from
vial adaptor
• New
CSTD SIZE COMPARISON
CSTD DIRECT SPIKE
• Allows for connecting tubing at the bedside
• Eliminates the need to prime tubing in pharmacy
• Reduces opportunity for tubing contamination in the BSC
• Saves pharmacy time and space
• Available from all CSTD manufacturers
63
CSTD DIRECT SPIKES
• Allows for direct connection to HD bag using CSTD on tubing
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CSTD DIRECT SPIKE EXAMPLE
65
Bag arrives with CSTD Direct Spike
CSTD DRY SPIKE EXAMPLES
• Similar to Direct Spike, but designed to use existing tubing.
• Allows for spiking of tubing at the bedside without risk of puncturing the IV bag
• Eliminates the need to prime tubing in pharmacy, and reduces opportunity for tubing contamination in the BSC
• Available from all CSTD manufacturers
CSTD DRY SPIKE EXAMPLES
ICU ChemoLock BD Phaseal
Photos courtesy of S. Eisenberg
CSTD CIRCLE PRIMING
• Allows for priming IV tubing while maintaining a
completely closed system
• Can be done in pharmacy and/or at the bedside
without risk of HD exposure
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CSTD CIRCLE PRIMINGHYBRID CSTD SECONDARY SET
EXAMPLE
70
CL3011
CSTD EFFECTIVENESS
• Still no standardized test for effectiveness
• NIOSH is working on a second draft protocol for testing
• Products that passed 1st protocol:
• ChemoLock
• Phaseal
• Equashield
• OnGuard
WHAT CAN YOU DO?USP<800>
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DETERMINE WHO’S IN CHARGE
• All aspects of HD safety must be overseen by an
individual responsible for
• development of any additional HD policies and
procedures
• monitoring for compliance with USP <800> and state
and Federal regulations
• Should work with members of an interdisciplinary
team
IDENTIFY AREAS OF VULNERABILITY
• Perform a gap analysis between USP <800>
and current policies and practice
• Determine if:
Gloves meet the ASTM 6978 standard
Gowns meet the USP <800> requirements
Disposal meets USP <800> requirements
Eisenberg, S. 2016; Walton, A. 2012
IDENTIFY AREAS OF VULNERABILITY
• Education meets the requirements:
Occurs prior to HD handling
Documented
Performed annually
Eisenberg, S. 2016; Walton, A. 2012
IDENTIFY AREAS OF VULNERABILITY
• Spill Management
Staff trained to manage a spill
Are available whenever HDs are administered
Have the requisite respiratory protection for drugs
that vaporize
Treat every spill as if it was MRSA
Eisenberg, S. 2016; Walton, A. 2012
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IDENTIFY AREAS OF VULNERABILITY
CSTD are in place for antineoplastic HD
administration
Documentation that staff have been trained
Staff are using the device
Eisenberg, S. 2016; Walton, A. 2012
IDENTIFY BARRIERS FOR SAFETY COMPLIANCE
• Poor staffing (workload)
• Lack of education about HD dangers
• PPE not meeting staff needs (e.g., gowns or
gloves that do not fit)
• Workplace culture does not support HD safety
Callahan 2016; Polovich & Clark 2012
IDENTIFY WORKPLACE CULTURE
• Find Hazardous Drug champions on your units!
• Staff nurses
• Advanced Practice Nurses
• Clinical educators
• Department manager
• Pharmacy manager
• Department medical director
• Risk manager
Eisenberg, S. 2016
IDENTIFY WORKPLACE CULTURE
Eisenberg, S. 2016
• Adopt a zero-tolerance approach to preventing
exposure within the workplace
• Increase nursing awareness of the risks associated with
hazardous drugs through multiple mediums and
methods
• Staff meetings
• Local chapter presentations
• Newsletters
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SUMMARY
• Become familiar with the steps we can take to
protect ourselves against HD exposure
• Be aware that changes in safety culture and
practice may be required
QUESTIONS?