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Handling Cytotoxic Drugs;

A HEALTH AND SAFETY REVIEW


OVERVIEW
Ansell Healthcare Products LLC has an ongoing commitment to the development of quality
hand barrier products and services for the healthcare industry. This self-study, Clinical
Reference Manual: Handling Cytotoxic Drugs; a Health and Safety Review, is one in a
series of continuing educational services provided by Ansell. This educational module
examines glove use in handling cytotoxic drugs.

INTENDED AUDIENCE
The information contained in this self-study guidebook is intended for use by healthcare
professionals who are responsible for or involved in the following activities related to this
topic:
Educating healthcare workers
Establishing institutional or departmental policies and procedures
Decision-making responsibilities for hand-barrier products
Maintaining regulatory compliance with agencies such as OSHA, ANA and CDC
Managing employee health and infection prevention services

PROGRAM OVERVIEW
Upon completion of this educational activity, the learner should be able to:
Discuss hazardous drugs used in chemotherapy
Discuss standard testing method of material used in handling chemotherapy drugs
Describe steps to prepare and administer cytotoxic drugs
Describe the characteristics of good barrier protection of the different gloving
HANDLING CY TOTOXIC DRUGS

materials available
Discuss standard of practice to glove use in handling chemotherapy drugs
INSTRUCTIONS
Ansell Healthcare is a provider approved by the California Board of
Registered Nursing, Provider # CEP 15538 for 2 contact hour(s). Obtaining
full credit for this offering depends on completion of the self-study materials
on-line as directed below.
Approval refers to recognition of educational activities only and does not imply
endorsement of any product or company displayed in any form during the educational
activity. To receive contact hours for this program, please go to the "Program Tests" area
and complete the post-test. You will receive your certificate via email.
AN 85% PASSING SCORE IS REQUIRED FOR SUCCESSFUL COMPLETION
Any learner who does not successfully complete the post-test will be notified and given an
opportunity to resubmit for certification.
For more information about our educational programs please contact Ansell Healthcare
Educational Services at 1-732-3452162 or e-mail us at edu@ansellhealthcare.com.
Planning Committee Members:
Luce Ouellet, DESS, BSN, RN
Patty Taylor RN, BA
Pamela Werner, MBA, BSN, RN CNOR
As employees of Ansell; Mme Ouellet, Mrs. Taylor and Ms. Werner have declared an
affiliation that could be perceived as posing a potential conflict of interest with
development of this self-study module.
Roy Zacharius Jr., CST, BS, FAST
As an employee of The Meridian Institute, Mr. Zacharias has declared an affiliation that
could be perceived as posing a potential conflict of interest with the development of this
HANDLING CY TOTOXIC DRUGS

self-study module.
This module will include discussion of commercial products referenced in generic
terms only.

Ansell Healthcare
Products LLC
111 Wood Avenue South,
Suite 210
Iselin, NJ 08830
USA
Tel: 1-800-952-9916
www.ansellhealthcare.com
CONTENTS
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Classes of Cytotoxic Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Carcinogenic Agent Toxicology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Securing Health Professionals; Handling Hazardous Drugs . . . . . . . . . . . . . . . . . 3


H A N D L I N G C Y T O T O X I C D R U G S ; A H E A LT H A N D S A F E T Y R E V I E W

The Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Effects of Chemicals on Gloves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

Testing for Glove Permeation by Chemotherapy Drugs . . . . . . . . . . . . . . . . . . . . 5

Interpreting Breakthrough Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Glove Selection in Handling Cytotoxic Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Glove Fit and Sizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

Double Gloving . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Donning and Doffing Gloves . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Donning Techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Closed Donning Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

Open Donning Technique . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Glove Removal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Removing Examination Gloves Safely . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Glove Recommendations in Handling Cytotoxic Drugs . . . . . . . . . . . . . . . . . . . 11

Drug Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Working Securely with Cytostatics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Administering Cytostatics to Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Drug Administration; Glove use Recommendation . . . . . . . . . . . . . . . . . . . . . . . 14

Drug Clean Up and General Handling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Summary of Glove Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
INTRODUCTION Some of the other potential effects are:

According to the World Health Organization Decrease in fertility


(WHO), between now and 2030 the Fetal malformation
cancer rate is going to increase by 50% Abortion
to about 13 million new cases a year, Extra uterine pregnancy
worldwide. The predicted increase in new High toxicity for certain organs
cases will mainly be due to the existence Handling cytotoxic drugs poses potential
of a steadily aging population in both occupational risks. The occupational
developed and developing countries, but risk is highly dependent of the following
also to the current prevalence of smoking criteria4:
and the rise in numbers of those adopting
unhealthy lifestyles1. One of the most Intrinsic toxicity of cytostatic
frequently used treatments for cancer is Duration of exposure
chemotherapy. Frequency of exposure
Handling method- before, during,
Chemotherapy treatments are utilized in and after use
suppressing and/or inhibiting cell growth
and division. It is used as an adjuvant to
surgery, and/or treatment of metastatic CLASSES OF
cells. Unfortunately, it is well known that CYTOTOXIC DRUGS
cytostatic agents are potentially hazardous Traditional antineoplastic drugs, which still
for the manipulator (pharmacist, assistant, constitute most of the anticancer drugs
nurse, surgeon, pharmacy technicians, used today, generally target either the DNA
etc.)2. inside the nucleus of a cell directly, inhibit
the synthesis of new DNA strands, or stop
Cytostatics are known to be3: the mitotic processes of a cell. In the first
case, the objective is to cause physical
Mutagenic - induce or increase
changes in the DNA itself, resulting in
genetic mutations by causing changes
mutations of the DNA attempting to
in DNA.
replicate. In the second case, these agents
Carcinogenic - cancer-causing in
usually stop the synthesis of DNA by
animal models, in patient
stopping the synthesis of the necessary
population, or both.
building blocks of DNA. In the third case,
Teratogenic - causing fertility
the objective is to stop cell replication
impairment in animal studies or
in one of the stages of mitosis, often by
treated patients.
inhibiting synthesis or breakdown of the
cellular structure.5

1
I. Antineoplastic agents which directly Example:
attack DNA in the nucleus belong to the Etoposide (VePesid, VP-16)
following categories:
II. Antineoplastic agents which stop the
A. Alkylating agents: synthesis of DNA precursors are:

These agents directly alkylate or A. Folic Acid antagonists:


covalently modify the nitrogenous bases of
DNA molecules. This can result in These agents stop the formation of
H A N D L I N G C Y T O T O X I C D R U G S ; A H E A LT H A N D S A F E T Y R E V I E W

mispairing of bases, or loss of bases, or tetrahydrofolate, which is necessary for


actual splitting of the DNA backbone. the synthesis of both purines
and pyrimidines.
Examples:
Altrtamine (Hexalen) Example:
Busulfan (Myleran) Methotrexate (MTX)
Carboplatin (Paraplatin)
B. Purine antagonists:
Chlorambucil (Leukeran)
Cisplatin (Platinol) These agents are competitive inhibitors of
Cyclophosphamide enzymes in the purine nucleotide synthetic
Dacarbazine (DTIC) pathways.
Ifosfamide (Ifex)
Melphalan (Alkeran) Examples:
Oxiliplatin (Eloxatin) Mercaptopurine (Purinethol)
Procarbazene (Matulane) Thioguanine (Tabloid)
Telomozomide (Temodar)
ThioTEPA C. Pyrimidine antagonists:

B. Intercalating agents: These agents are competitive inhibitors of


enzymes in the pyrimidine nucleotide
These agents bind tightly to the DNA synthetic pathways.
double helix, preventing the unwinding of
the double helix at that point. Examples:
Floxuridine (FUDR)
Examples: Fluorouracil (5-FU)
Dactinomycin (Cosmegen) Cytarabine (Cytosar, ARA-C)
Daunorubicin (Cerubidine)
Doxorubicin (Adriamycin) D. Ribonucleotide diphosphate reductase
Plicamycin (Mithramycin) inhibitors:

C. DNA Topoisomerase inhibitors: These agents will effectively interfere with


DNA construction. These agents damage
By inhibiting this enzyme involved in cells during S phase.
supercoiling, these agents somehow
cause the actual scission or breakage of Example:
DNA strands in the nucleus. Hydroxyurea (Hydrea)

2
III. Antineoplastic agents which affect their inherent toxicity as well as the type
the synthesis or breakdown of the of exposure that may occur in the
mitotic spindles belong to the general workplace. Today that workplace
category of alkaloid antineoplastic drugs. environment may be a hospital clinic,
other patient unit, a physicians office,
A. Alkaloids exert their actions on tubulin pharmacy, or in the patients home.
synthesis/breakdown: Chemotherapy administration has also
evolved over the years. Chemotherapy
Examples:
agents are administered via intravenous
Vinblastine (Velban, Velsar)
push as well as a continuous infusion
Vincristine (Vincasar, Oncovin)
through a variety of implanted access
Pacitaxel (Taxol)
devices. Exposure, to the healthcare
worker or a family member in the home,
CARCINOGENIC may be through ingestion of food that may
AGENT TOXICOLOGY have been exposed to the drug, inhalation
of drug particles that may become
The International Agency for Research on
aerosolized during preparation, handling of
Cancer (IARC) is part of the WHO. Its major
patient excreta during home care, or direct
goal is to identify causes of cancer. The
skin contact of the drug. Studies have
most widely used system for classifying
been conducted to assess the indirect
carcinogens comes from the IARC. In the
exposure of healthcare workers, i.e.
past 30 years, the IARC has evaluated the
nurses and pharmacists, to determine if
cancer-causing potential of more than 900
there was any chromosomal damage to
likely candidates, placing them into one of
these workers that prepared and
the following groups: 6
administered these drugs. This and other
Group 1: Carcinogenic to humans
reports point to the need for excellent
(109 agents)
exposure control measures and excellent
Group 2A: Probably carcinogenic to
compliance to safe handling procedures.7
humans (65 agents)
Group 2B: Possibly carcinogenic to
humans (275 agents) SECURING HEALTH
Group 3: Unclassifiable as to PROFESSIONALS;
carcinogenicity in humans (503 agents) HANDLING
Group 4: Probably not carcinogenic to HAZARDOUS DRUGS
humans (1 agent)
The Standards
The hazards encountered during the
The FDA Glove Guidance manual offers
preparation, administration, clean up and
specific guidance for labeling exam gloves
general handling of any cytotoxic drug
used in chemotherapy;
have been well documented. Public
concern is magnified by the perception
that cancer risks are imposed upon
workers, nurses and pharmacists that are
involved in these procedures. The dangers
of handling hazardous drugs come from

3
To market the glove for use in the At the end of each batch, the outer gloves
handling and/or preparation of should be removed and sealed in a zipper-
chemotherapeutic drugs, you should label lock bag. Remove and discard the gown
the glove as a Patient examination Glove before removing the inner pair of gloves.9
or Surgeons glove and tested for use
with (name of chemotherapeutic drugs).
EFFECTS OF
We recommend that you include the CHEMICALS ON
following labeling information: GLOVES
H A N D L I N G C Y T O T O X I C D R U G S ; A H E A LT H A N D S A F E T Y R E V I E W

Chemical resistance data (test method Chemicals can penetrate, degrade, and/or
used, chemicals tested) for consumer permeate through a glove. All effects can
review, if desired. happen at once. They can let chemicals
The statement Gloves used through to skin. To understand, we must
forprotection against chemotherapy consider them one by one.
drug exposure should be selected
specifically for the type of chemicals 1. Penetration is defined as the movement
used and instructions for users to of a chemical and/or micro-organism
review drug labeling or material safety through porous materials, tears, pinholes
data sheets for the chemicals being or other imperfections or manufacturing
used to determine an adequate level of defects in a protective glove material on a
protection for the intended use.8 non-molecular level. It implies that you
can see the holes.
The Oncology Nurses Society mentions in
their standards that the use of a class II 2. Degradation is a deleterious change in
safety cabinet does not eliminate the need one or more properties of a material.
for PPE (Personal Protective Equipment). When degradation is caused by chemicals,
Because spills are possible during any the rubber swells, softens, and weakens
handling, PPE must be used to prevent and plastic shrinks, stiffens, or
workers exposure. Gowns made of becomes brittle.
materials that protect from Hazardous
Drugs (HD) permeation and double gloves, 3. Permeation is the process by which a
tested to the ASTM standard 2005, are chemical moves through a protective
universally recommended for HD handling. glove material on a molecular level. It
USP 797 requires two pair of gloves, the involves the following:
outer one sterile, for compounding sterile a. Adsorption of the molecules of the
preparations. When wearing double chemical into the contacted or outer
gloves, tuck the cuff of the inner glove surface of a material
under the gown sleeve and the cuff of the b. Diffusion of the absorbed molecules in
outer glove over the gown sleeve. Change the material.
the outer gloves immediately whenever c. Desorption of the molecules from the
contamination is suspected. Change both opposite or inner surface of the material
gloves if the outer glove is torn, punctured
or contaminated by an obvious spill.

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TESTING FOR GLOVE All chemicals
PERMEATION BY Test measurements using the palm of
CHEMOTHERAPY the glove
DRUGS Tested for up to 2 hours
Detection Limit is 0,1 g
Chemotherapy drugs can represent a
significant health risk to healthcare Every glove may react differently in terms
personnel. Some chemotherapy drugs of permeation and therefore assumptions
have been found to be carcinogenic, to are not acceptable. Every cytostatic
cause chromosomal damage and may molecule may react differently in terms of
also cause damage to normal skin and permeation. Therefore, a claim as Good
necrosis of compromised skin. The most for cytostatic handling is dangerous and
common exposures are the result of misleading. This is due to the physico-
inadvertent ingestion of a drug on food, chemical heterogeneity of the cytostatics.
inhalation of drug dusts or droplets or
direct skin contact. Proper training and The Universit Catholique de Louvain,
the use of personal protective equipment Brussels, Belgium have developed a
such as suitable gloves are critical to the unique dynamic permeation device. They
safety of healthcare workers who handle have tested gloves under dynamic
chemotherapy drugs.10 physical conditions for stretching, tension,
and rubbing.12
ASTM D 6978-05 is the test method
specifically designed to test breakthrough Not all drugs or combinations of drugs can
times of cytostatic drugs on gloves. It is be tested. Hence, Dr. Wallemcacks study
defined as Standard of Practice for advised caution when working with
Assessment of Resistance of Medical Gloves lipophilic and low molecular weight
to Permeation by Chemotherapy Drugs.11 cytotoxic agents. Lipophilic or 'lipid-loving'
Chemotherapy drugs used in testing molecules are attracted to lipids. A
incorporate a minimum of nine currently substance is lipophilic if it is able to
used clinical drugs dissolve much more easily in lipid (a class
Test measurements using the thinnest of oily organic compounds) than in water,
area of the glove between palm and i.e. Taxol, Carmustine, ThioTEPA.
the cuff
The Federal Drug Agency, Oncology
Tested for up to 4 hours
Nurses Society as well as The Canadian
Detection Limit is
Pharmacist Oncology Association
0,01 g (= 10 ng) / (cm x min)
recognizes the need to test gloves as per
The ASTM F 739-07 Resistance of ASTM D6978-05 method.
protective clothing materials to permeation
by liquids or gazes under continuous
contact is adapted to test chemicals
breakthrough times on clothing used in
the most industrial sector of activities.

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Device chamber used for permeation test It is important to note that:
cell ASTM F-739 within this method 13 Permeation results differ in time and
average permeation rate.
The risk posed by a chemical
permeating a glove is related not just to
the speed at which it can diffuse
through, but also the flow rate. A
combination of a short breakthrough
time and a low permeation rate may
H A N D L I N G C Y T O T O X I C D R U G S ; A H E A LT H A N D S A F E T Y R E V I E W

Products tested for permeation as per expose a glove wearer to less chemical
ASTM F-739 often used in the oncology than a combination of a longer
department for disinfecting are: breakthrough time and a much higher
70% isopropyl alcohol (IPA) breakthrough rate, if the glove is not
accelerated hydrogen peroxide (H2O2) changed frequently enough.
Gloves should be changed before
Products for decontamination are: permeation occurs. Since permeation
Hypochlorite sodium (bleach) breakthrough in actual end use may
Sodium Thiosulfate occur sooner than breakthrough under
Mechloretamine (chlormetine). lab test conditions, a margin of safety
should be allowed when specifying
INTERPRETING glove change intervals based on lab data.
BREAKTHROUGH TIME
Always check the material safety data
Breakthrough time will measure how sheet (MSDS) for personal protective
quickly a chemical can permeate a glove. equipment requirements in selecting
It is specific for glove material type used gloves specifically for the type of
in the test. Thinner gloves made from the chemicals used. Verify permeation time
same material will have a shorter break- and rate to choose the right glove.
through time. For tasks with inevitable As per ASTM F-739 in handling cleaning
contact, the breakthrough time is the compounds
maximum time the glove may be used As per ASTM-D6978-05 in handling
before it should be discarded. If the work chemotherapy drugs
lasts for longer than the breakthrough
time, gloves should be changed part-way Permeation test chemicals mixed at any
through. You should allow a safety margin: other concentrations will cause data to be
stretching of gloves during use may mean generated that will give invalid
that breakthrough occurs more quickly comparisons when matched against data
than in a test environment. Do not rely on obtained using the standard
touch to detect breakthrough. Skin concentrations.
exposure will occur long before any
perceptible feeling of wetness on the inner
surface of the glove.

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GLOVE SELECTION IN Glove Fit and Sizing
HANDLING CYTOTOXIC
DRUGS Having protective equipment that fits
properly is absolutely vital to the safety of
Informed use of PPE is a very critical employees. Knowing how to accurately
component of a hospitals health and measure and choose glove sizes can
safety program. Appropriate PPE includes increase safety and productivity in the
gloves, gowns, face shields, masks, eye workplace.
protection, and ventilation devices where
there is likelihood of contact with If gloves do not fit properly, it can often
potentially contaminated material. delay work or result in hand injuries. If the
hand protection is too small, it may cause
When choosing a glove, the first hand fatigue. If the protective material is
consideration should be the barrier stretched out, it is more likely to rip or tear
requirement related to the procedure or during use which is costly to replace, as
task at hand. Be aware of the level of well as dangerous for the wearer. Gloves
exposure risk that the patient-care that are too small also decrease dexterity.
activities will require. Procedures that On the other hand, gloves that are too
involve exposure to blood, bodily fluids, large create safety issues.
and other potentially hazardous material
require a glove material that provides It is imperative to understand how to
appropriate barrier protection. appropriately measure the hand in order
to get a glove that fits correctly. If the
When selecting a medical glove, the glove fits properly, it will provide the
primary considerations should be the worker with maximum protection without
barrier protection, the fit and allergen compromising dexterity.
content. If a glove does not provide an
intact barrier, it is not doing its job. To To find the appropriate glove size, use a
maximize barrier effectiveness, you may tape measure to measure around the
wish to choose a glove manufacturer that knuckles of the dominant hand. The inch
is reliable and experienced, so that your measurement of your hand should
gloves will be of consistent quality and correspond directly to the numbered sizes
regularly available. of the glove. For example, if you measure
your hand to be 8 inches, you would wear
In handling chemotherapy drugs with the a size 8 glove. If your hand measures over
current guidelines on double gloving, 8 inches it is wise to choose the next size
insuring a proper fit to the personnel may up to avoid hand fatigue or discomfort
become a task in itself. from a glove that is too small. Some
gloves come in lettered sizes such as XS,
S, M, L, and XL. These can easily convert
to a numerical size for simple selection.

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See the table for numerical and lettered sizing relation.

Mens Women
Inch cm Inch cm
XS 7 18 XS 6 15
S 7 1/2-8 20 S 6 1/2 17
M 8 1/2-9 23 M 7 18
L 9 1/2-10 25 L 7 1/2 19
XL 10 1/2-11 28 XL 8 20
H A N D L I N G C Y T O T O X I C D R U G S ; A H E A LT H A N D S A F E T Y R E V I E W

DOUBLE GLOVING
Is there a proper technique for double The vast majority of end-users have
gloving? While double gloving sizing developed the habit of putting on gloves
depends on individual needs, today three for work involving hazardous substances.
practices are common. Some people find However, we are now seeing a problem of
that a larger glove inside with a smaller people not taking off gloves when they
one outside works for them, or vice versa really should have done so. Although
and others use the same size glove for wearing gloves can prevent skin contact
both inside and outside glove. The with hazardous chemicals, not taking
aforementioned study published in the them off at the right time may actually
European Journal of Cardiothoracic turn the used gloves into a source of
Surgery found almost an equal distribution contamination, and increase the risk of
of glove sizes used by surgeons for double hazardous chemical exposure for the
gloving: larger glove inside 31%, smaller wearer and the environment. 15-16
glove inside 35% and both gloves the
same size 31%.14
DONNING
Donning and Doffing Gloves TECHNIQUES
There are two techniques for donning
Gloves made of various materials form an
sterile gloves, "Closed Donning" and
important part of our safety practices.
"Open Donning".
End-users rely on gloves to protect their
hands against corrosive or toxic Closed Donning Technique
chemicals, and potential infectious
pathogens. We have repeatedly 1. Peel open the outer pack from the
emphasized the importance of choosing corners. The inner pack is sterile. Gripping
gloves made of material appropriate for it through your gown, open it to display
the hazardous substance(s) being handled. the gloves.
Users must also consider the level of
dexterity needed for the anticipated
manipulation.

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2. With your gown covering your fingers, hand should only touch the folded cuff -
use your right hand to remove the left the rest of the glove remains sterile.
glove. Hold your left hand palm up, fingers
straight. Lay the glove on your left wrist,
and grip the cuff with your left thumb.

2. Slide your right fingertips into the folded


cuff of the left glove. Pull out the glove
and fit your right hand into it.
3. Place your right thumb inside the top
cuff edge. Make a fist with your right hand
and stretch the glove over your left
fingertips.

3. Unfold the cuffs down over your gown


sleeves. Make sure your gloved fingertips
do not touch your bare forearms or wrists.

4. Keeping your left fingers straight, pull


down the glove.

Glove Removal

The key to removing both sterile and non-


5. Repeat the above procedure to don the sterile gloves is
other glove, that is: use your gloved left
"Dirty to Dirty - Clean to Clean"
hand to lay the right glove on your right
wrist. Slide your left thumb inside the top Contaminated surfaces only touch other
of the cuff, make a fist, and stretch the contaminated surfaces: your bare hand,
cuff over your right fingertips. Pull down which is clean, touches only clean areas
the sleeve and glove together. inside the other glove.

Open Donning Technique 1. Take hold of the first glove at the wrist.

1. Pick up the cuff of the right glove with


your left hand. Slide your right hand into
the glove until you have a snug fit over the
thumb joint and knuckles. Your bare left

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2. Fold it over and peel it back, turning it 1. With right hand, pinch palm of glove on
inside out as it goes. Once the glove is left hand and pull left glove down and off
off, hold it with your gloved hand. fingers. Form left glove into a ball and hold
in fist of right hand.
H A N D L I N G C Y T O T O X I C D R U G S ; A H E A LT H A N D S A F E T Y R E V I E W

3. To remove the other glove, place your


bare fingers inside the cuff without
touching the glove exterior. Peel the glove
off from the inside, turning it inside out as
it goes. Use it to envelope the other glove.

REMOVING
EXAMINATION
GLOVES SAFELY 2. Insert one or two fingers of left
ungloved hand under inside rim of right
As you remove the gloves, avoid allowing glove on palm side; push glove inside out
the outside surface of the gloves to come and down onto fingers and over balled
in contact with your skin, because the left glove.
outer surface may have become
contaminated. Avoid letting gloves snap,
as this may cause contaminants to fly into
your eyes or mouth or onto your skin or
other people in the area. Remove used
gloves before touching anything. Counter
tops, faucets, pens and pencils are often
contaminated because workers wearing
gloves touch them.

The following is a common way of safely


removing gloves.

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3. Grasp gloves, which are now together clean glove over the cuff of the gown.
and inside out, with left hand and remove Before handling chemotherapy drugs,
from right hand. always inspect gloves for holes, tears or
any type of defect. Unless the film is
intact, it cannot provide a barrier.
Although surgical gloves are
recommended for preparation,
administration, clean up and general
handling, sterility is not always required,
4. Discard gloves in plastic bag and seal bag. as for example, direct patient care,
handling laundry, and housekeeping
5. Wash hands thoroughly. procedures.17 Gloves are available in
non-sterile presentations for these
GLOVE purposes.
RECOMMENDATIONS
IN HANDLING DRUG PREPARATION
CYTOTOXIC DRUGS
Working Securely with Cytostatics
Powder-free neoprene and nitrile
examination gloves tested for D6978-05 As the number of cancer patients rises, so
are the best recommended choices does the use of chemotherapy treatment.
during all activities around handling While effective in treating disease, these
chemotherapy drugs as they also have drugs are also potentially hazardous for
better resistance to disinfecting and the oncology nurses, pharmacists and
decontamination products than latex. other healthcare professionals who handle
Surgical neoprene, nitrile, natural rubber, them. Yet worldwide research indicates
and polyisoprene gloves, tested using that insufficient care is being taken with
ASTM D-6978-05, are recommended cytostatic agents. Studies report
when preparing and handling widespread, low-level contamination of
chemotherapy drugs. Please use a areas where cytostatic drugs are used.
glove rated for the handling of specific Traces of cytostatic drugs have been
chemotherapy drugs. found on workbenches, floors, vials and
Polyvinyl chloride (PVC) gloves are NOT exterior surfaces of safety cabinets and
recommended for handling isolators even on the floor outside
chemotherapy drugs. preparation rooms. Once contamination
Always use powder-free gloves. The with cytostatic drugs has occurred it is
dispersing of chemotherapy drugs into extremely difficult to eradicate.18
the surrounding air and the possibility of
inhalation is a serious matter and should To better protect healthcare workers,
be treated as such. Also, glove powders heightened awareness of this serious
may contaminate chemotherapy work problem must be combined with both
areas. improved cytostatic handling procedures
If double gloving, insert first glove under and the use of appropriate hand
the cuff and place the second glove over protection. Here is a step by step guide to
the cuff. If single gloving, place the the safe preparation and administration of

11
cytostatic mixtures, as well as Similar care should be taken in the
recommendations for suitable hand preparation, administration and disposal of
protection. chemotherapy drugs. In addition to
healthcare professionals, patients and
Before actually preparing the cytostatic persons that are directly involved in home
mixture, the following activities have care should also be taught these safety
been identified. These may be standards and guidelines.
influenced by ruling protocols Always wear gloves when handling the
Don special protective clothing including drug.
H A N D L I N G C Y T O T O X I C D R U G S ; A H E A LT H A N D S A F E T Y R E V I E W

non-sterile examination gloves. Avoid touching the drug.


[Photo 1] Wash hands before putting gloves on
Unpack all material. During the and after wearing gloves.
unpacking or handling of the vials, the Gloves used for protection against
healthcare workers hand should be chemotherapy drugs must be selected.
protected as the outside surface of the specifically for the type of chemicals
vials might be contaminated with used.
cytostatic drugs. [Photo 2] Use medical grade, sterile or non-sterile,
Disinfect the work area. [Photo 3, 4] gloves depending on the technique
Assemble and disinfect all material recommended by your healthcare
necessary to prepare the cytostatic facility.
drugs. [Photo 5, 6, 7] Always use powder-free gloves.
- Glove powders may contaminate
chemotherapy work area.
Choose a natural rubber latex, nitrile or
neoprene glove - Polyvinyl chloride
(PVC) gloves are not recommended for
handling chemotherapy drugs.
Use ASTM D6978-05 tested gloves that
extend over the cuff of the protective
gown. Please use a glove rated for the
handling of the specific chemotherapy
drugs.
Double gloving is strongly advised when
there is a risk of exposure during
preparation or administration of
chemotherapy drugs.

Similar care should be taken in the Similar

12
- If double gloving, insert first glove under
the cuff and place the second glove over
the cuff.
Before handling chemotherapy drugs
- Observe gloves for any break in barrier.
- Change gloves after each use, tear, and
puncture or medication spill or after 30
minutes of wear.
Upon removal, both gloves need to be
turned inside out
Never flick, snap, or toss your gloves.
Follow recommendations implemented
by your healthcare facility for the
disposal of gloves.

Now you are ready for the


reconstitution of the cytostatic mixture
and transfer it to the perfusion set.
Don sterile gloves. [Photo 8, 9, 10, 11]
Disinfection of procedure material.
[Photo 12]
Reconstitution of the cystostatic mixture.
[Photo 13, 14, 15, 16] and,
[Photo 17, 18, 19, 20]
Perform a final disinfection of end product.
[Photo 21, 22]
Pack the product and label it.
[Photo 23, 24]

13
ADMINISTERING Drug Clean Up and General Handling
CYTOSTATICS TO Wear high quality gloves that have been
PATIENTS tested for use with chemotherapy drugs
when dealing with blood, vomitus,
Once the cytostatic mixture has been excreta and other bodily fluids from
prepared, it is administered to the chemotherapy treated patients.
patient following established Discard gloves after each use.
guidelines. (Photo 25, 26) Laundry personnel coming into contact
with linen contaminated with
H A N D L I N G C Y T O T O X I C D R U G S ; A H E A LT H A N D S A F E T Y R E V I E W

chemotherapy drug patients body fluids


should wear high quality gloves that
have been tested for use with
chemotherapy drugs.
Housekeeping personnel should wear
high quality gloves that have been
tested for use with chemotherapy drugs
when handling waste containers.
Spills should only be cleaned up by
personnel wearing a double layer of
gloves.
Spill kits for use in responding to spills
Drug Administration; Glove Use
should include two (2) pairs of gloves;
Recommendation
one outer pair of utility gloves and one
Inspect glove for visible defects.
inner pair of latex or synthetic gloves.
Wear high quality gloves that have been
All personnel involved in any aspect of
tested for use with the specific
handling chemotherapy drugs must
chemotherapy drugs to be used.
receive an orientation on chemotherapy
Double gloving is recommended.
drugs including proper use of protective
Wash hands before putting on gloves.
equipment.
Change contaminated gloves
immediately.
Wash hands after removing gloves.
Dispose of gloves according to proper
hospital toxic waste procedures.

14
Summary of Glove Use

AREAS OF GLOVE USE

Open packaging
Storage
Sterile drug preparation
Intramuscular or subcutaneous injections
Intravenous drug administration
Percutaneous drug administration
Oral and nasal enteral tube drug administration
Intraocular drug administration
Garbage disposal
Post drug delivery patient care delivery - 2 days
Patient care
Spills
Cleanroom housekeeping
Cabinet cleaning
Departemental housekeeping
Handling linen

15
REFERENCES
1 http://www.who.int/gho/publications/world_health_statistics/EN_WHS2012_Full.pdf
2
American Society of health system pharmacists,2006.ASHP guidelines on handling
hazardous drugs, American journal of health system Pharmacists, 63,1172-1193
3
Occupational health and safety Administration(1999) OSHA technical manual,
H A N D L I N G C Y T O T O X I C D R U G S ; A H E A LT H A N D S A F E T Y R E V I E W

Categorization of drugs as hazardous retrieved from http://www.osha.gov/dts/osta/otm_


vi/otm_vi_2.htlm#2
4
Polovich M Ed. (2011) Safe handling of hazardous drugs (2nd ed.) Pittsburg, PA:
Oncology Nursing Society.
5
Occupational health and safety Administration(1999) OSHA technical manual,
Categorization of drugs as hazardous retrieved from http://www.osha.gov/dts/osta/otm_
vi/otm_vi_2.htlm#2
6
http://monographs.iarc.fr/ENG/Classification/index.php
7
Polovich M Ed. (2011) Safe handling of hazardous drugs (2nd ed.) Pittsburg, PA:
Oncology Nursing Society.
8
FDA Medical Glove guidance manual (2008) pg. 22-23
9
Polovich M Ed. (2011) Safe handling of hazardous drugs (2nd ed.) Pittsburg, PA:
Oncology Nursing Society.
10
National Institute for Occupational safety and health (2004) Preventing occupational
exposure to antineoplastic and other hazardous drugs in health care settings. Retrieved
from http://www.cdc.gov/niosh/docs/2004-165
11
American safety and testing method; ASTM D-6978-05 Practice for Assessment of
Resistance of Medical Gloves to Permeation by Chemotherapy Drugs (2005)
12
P.Wallemacq, PhD et al. Permeation of 13 cytotoxic agents through 13 different gloves
under controlled dynamic conditions, AJHP March 15, 2006 Vol. 63, # 6 pg. 547-56
13
Ansell 8th edition Chemical resistance guide, Permeation and degradation data pg4
14
Hollaus PH, et al. Glove perforation rate in open lung surgery. European Journal of
CardioThoracic Surgery. 1999; 15:461-464

16
15
Fransman,W.,Vermeulen,R.,Kromhout, H., Occupational dermal exposure to
cyclophosphamide in Dutch hospital: a Pilot study. Annals of Occupational Hygiene
(2004) 48,237-44
16
Fransman,W.,Vermeulen,R., Kromhout, H., Dermal exposure to cyclophosphamide in
hospitals during preparation, nursing and cleaning activities. International Archives of
Occupational and Environmental Health (2005) 78, 403-12
17
Occupational safety and health Administration (2002) Guidelines for laundry in health
care facilities retrieved from http//www.osha.gov/od/ohs/otm_vi.2.htlm
18
By Celeste Caskey, Daniel J. Hurley, Raymond R. Liguori, Assessing environmental
contamination by cytoxic drugs ; Chemical Health & Safety, September/October 2005;
26-28

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