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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


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


MULTI-HOSPITAL WIPE TESTING1


• 584 samples obtained


• 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


• 525 samples obtained


• 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


• 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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• Not all chemo gloves are alike:

Found on actual box of “chemotherapy” gloves


• 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


• 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®)

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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

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ONGUARD® (B BRAUN)


• 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)


• 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)


• 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

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CSTD DIRECT SPIKES

• Allows for direct connection to HD bag using CSTD on tubing

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CSTD DIRECT SPIKE EXAMPLE

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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


• Education meets the requirements:

Occurs prior to HD handling

Documented

Performed annually



• 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


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CSTD are in place for antineoplastic HD

administration

Documentation that staff have been trained

Staff are using the device


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?

[email protected]

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