A SELF STUDY GUIDE

®

HANDLING CYTOTOXIC DRUGS:A HEALTH AND SAFETY REVIEW

Registered Nurses

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OVERVIEWAnsell 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 AUDIENCEThe information contained in this self-study guidebook is intended for use by healthcareprofessionals 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 OVERVIEWUpon 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 glovingmaterials available

• Discuss standard of practice to glove use in handling chemotherapy drugs

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INSTRUCTIONSAnsell is a Recognized Provider of continuing education by the California Board of Registered Nursing, provider #CEP 15538 and the Australian College of Perioperative Nurses (ACORN). This course has been accredited for 2 (two) contact hours. 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 by e-mail 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 self-study module.

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

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CONTENTS Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

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

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

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

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

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INTRODUCTION According to the World Health Organization (WHO), between now and 2030 the cancer rate is going to increase by 50% to about 13 million new cases a year, worldwide. The predicted increase in new cases will mainly be due to the existence of a steadily aging population in both developed and developing countries, but also to the current prevalence of smoking and the rise in numbers of those adopting unhealthy lifestyles1. One of the most frequently used treatments for cancer is chemotherapy.

Chemotherapy treatments are utilized in suppressing and/or inhibiting cell growth and division. It is used as an adjuvant to surgery, and/or treatment of metastatic cells. Unfortunately, it is well known that cytostatic agents are potentially hazardous for the manipulator (pharmacist, assistant, nurse, surgeon, pharmacy technicians, etc.)2.

Cytostatics are known to be3:

• Mutagenic - induce or increasegenetic mutations by causing changesin DNA.

• Carcinogenic - cancer-causing inanimal models, in patientpopulation, or both.

• Teratogenic - causing fertilityimpairment in animal studies ortreated patients.

Some of the other potential effects are:

• Decrease in fertility• Fetal malformation• Abortion• Extra uterine pregnancy• High toxicity for certain organs

Handling cytotoxic drugs poses potential occupational risks. The occupational risk is highly dependent of the following criteria4:

• Intrinsic toxicity of cytostatic• Duration of exposure• Frequency of exposure• Handling method- before, during,

and after use

CLASSES OF CYTOTOXIC DRUGSTraditional antineoplastic drugs, which still constitute most of the anticancer drugs used today, generally target either the DNA inside the nucleus of a cell directly, inhibit the synthesis of new DNA strands, or stop the mitotic processes of a cell. In the first case, the objective is to cause physical changes in the DNA itself, resulting in mutations of the DNA attempting to replicate. In the second case, these agents usually stop the synthesis of DNA by stopping the synthesis of the necessary building blocks of DNA. In the third case, the objective is to stop cell replication in one of the stages of mitosis, often by inhibiting synthesis or breakdown of the cellular structure.5

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I. Antineoplastic agents which directlyattack DNA in the nucleus belong to thefollowing categories:

A. Alkylating agents:

These agents directly alkylate or covalently modify the nitrogenous bases of DNA molecules. This can result in mispairing of bases, or loss of bases, or actual splitting of the DNA backbone.

Examples: • Altrtamine (Hexalen)• Busulfan (Myleran)• Carboplatin (Paraplatin)• Chlorambucil (Leukeran)• Cisplatin (Platinol)• Cyclophosphamide• Dacarbazine (DTIC)• Ifosfamide (Ifex)• Melphalan (Alkeran)• Oxiliplatin (Eloxatin)• Procarbazene (Matulane)• Telomozomide (Temodar)• ThioTEPA

B. Intercalating agents:

These agents bind tightly to the DNA double helix, preventing the unwinding of the double helix at that point.

Examples: • Dactinomycin (Cosmegen)• Daunorubicin (Cerubidine)• Doxorubicin (Adriamycin)• Plicamycin (Mithramycin)

C. DNA Topoisomerase inhibitors:

By inhibiting this enzyme involved in supercoiling, these agents somehow cause the actual scission or breakage of DNA strands in the nucleus.

Example: • Etoposide (VePesid, VP-16)

II. Antineoplastic agents which stop thesynthesis of DNA precursors are:

A. Folic Acid antagonists:

These agents stop the formation of tetrahydrofolate, which is necessary for the synthesis of both purines and pyrimidines.

Example: • Methotrexate (MTX)

B. Purine antagonists:

These agents are competitive inhibitors of enzymes in the purine nucleotide synthetic pathways.

Examples: • Mercaptopurine (Purinethol)• Thioguanine (Tabloid)

C. Pyrimidine antagonists:

These agents are competitive inhibitors of enzymes in the pyrimidine nucleotide synthetic pathways.

Examples: • Floxuridine (FUDR)• Fluorouracil (5-FU)• Cytarabine (Cytosar, ARA-C)

D. Ribonucleotide diphosphate reductaseinhibitors:

These agents will effectively interfere with DNA construction. These agents damage cells during S phase.

Example: • Hydroxyurea (Hydrea)

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III. Antineoplastic agents which affectthe synthesis or breakdown of themitotic spindles belong to the generalcategory of alkaloid antineoplastic drugs.

A. Alkaloids exert their actions on tubulinsynthesis/breakdown:

Examples: • Vinblastine (Velban, Velsar)• Vincristine (Vincasar, Oncovin)• Pacitaxel (Taxol)

CARCINOGENIC AGENT TOXICOLOGYThe International Agency for Research on Cancer (IARC) is part of the WHO. Its major goal is to identify causes of cancer. The most widely used system for classifying carcinogens comes from the IARC. In the past 30 years, the IARC has evaluated the cancer-causing potential of more than 900 likely candidates, placing them into one of the following groups: 6 • Group 1: Carcinogenic to humans

(109 agents)• Group 2A: Probably carcinogenic to

humans (65 agents)• Group 2B: Possibly carcinogenic to

humans (275 agents)• Group 3: Unclassifiable as to

carcinogenicity in humans (503 agents)• Group 4: Probably not carcinogenic to

humans (1 agent)

The hazards encountered during the preparation, administration, clean up and general handling of any cytotoxic drug 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

their inherent toxicity as well as the type of exposure that may occur in the workplace. Today that workplace environment may be a hospital clinic, other patient unit, a physician’s office, pharmacy, or in the patient’s home. Chemotherapy administration has also evolved over the years. Chemotherapy agents are administered via intravenous push as well as a continuous infusion through a variety of implanted access devices. Exposure, to the healthcare worker or a family member in the home, may be through ingestion of food that may have been exposed to the drug, inhalation of drug particles that may become aerosolized during preparation, handling of patient excreta during home care, or direct skin contact of the drug. Studies have been conducted to assess the indirect exposure of healthcare workers, i.e. nurses and pharmacists, to determine if there was any chromosomal damage to these workers that prepared and administered these drugs. This and other reports point to the need for excellent exposure control measures and excellent compliance to safe handling procedures.7

SECURING HEALTH PROFESSIONALS; HANDLING HAZARDOUS DRUGSThe Standards

The FDA Glove Guidance manual offers specific guidance for labeling exam gloves used in chemotherapy;

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“To market the glove for use in the handling and/or preparation of chemotherapeutic drugs, you should label the glove as a “Patient examination Glove” or “Surgeon’s glove” and tested for use with (name of chemotherapeutic drugs).

We recommend that you include the following labeling information: • Chemical resistance data (test method

used, chemicals tested) for consumerreview, if desired.

• The statement “Gloves usedforprotection against chemotherapydrug exposure should be selectedspecifically for the type of chemicalsused” and instructions for users toreview drug labeling or material safetydata sheets for the chemicals beingused to determine an adequate level ofprotection for the intended use.8

The Oncology Nurses Society mentions in their standards that “the use of a class II safety cabinet does not eliminate the need for PPE (Personal Protective Equipment).” “Because spills are possible during any handling, PPE must be used to prevent worker’s exposure.” Gowns made of materials that protect from Hazardous Drugs (HD) permeation and double gloves, tested to the ASTM standard 2005, are universally recommended for HD handling. USP 797 requires two pair of gloves, the outer one sterile, for compounding sterile preparations. When wearing double gloves, tuck the cuff of the inner glove under the gown sleeve and the cuff of the outer glove over the gown sleeve. Change the outer gloves immediately whenever contamination is suspected. Change both gloves if the outer glove is torn, punctured or contaminated by an obvious spill.

At the end of each batch, the outer gloves should be removed and sealed in a zipper-lock bag. Remove and discard the gown before removing the inner pair of gloves.”9

EFFECTS OF CHEMICALS ON GLOVESChemicals can penetrate, degrade, and/or permeate through a glove. All effects can happen at once. They can let chemicals through to skin. To understand, we must consider them one by one.

1. Penetration is defined as the movementof a chemical and/or micro-organismthrough porous materials, tears, pinholesor other imperfections or manufacturingdefects in a protective glove material on anon-molecular level. It implies that youcan see the holes.

2. Degradation is a deleterious change inone or more properties of a material.When degradation is caused by chemicals,the rubber swells, softens, and weakensand plastic shrinks, stiffens, orbecomes brittle.

3. Permeation is the process by which achemical moves through a protectiveglove material on a molecular level. Itinvolves the following:a. Adsorption of the molecules of the

chemical into the contacted or outersurface of a material

b. Diffusion of the absorbed molecules inthe material.

c. Desorption of the molecules from theopposite or inner surface of the material

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TESTING FOR GLOVE PERMEATION BY CHEMOTHERAPY DRUGSChemotherapy drugs can represent a significant health risk to healthcare personnel. Some chemotherapy drugs have been found to be carcinogenic, to cause chromosomal damage and may also cause damage to normal skin and necrosis of compromised skin. The most common exposures are the result of inadvertent ingestion of a drug on food, inhalation of drug dusts or droplets or direct skin contact. Proper training and the use of personal protective equipment such as suitable gloves are critical to the safety of healthcare workers who handle chemotherapy drugs.10

ASTM D 6978-05 is the test method specifically designed to test breakthrough times of cytostatic drugs on gloves. It is defined as “Standard of Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs”.11 • Chemotherapy drugs used in testing

incorporate a minimum of nine currentlyused clinical drugs

• Test measurements using the thinnestarea of the glove between palm andthe cuff

• Tested for up to 4 hours• Detection Limit is

0,01 µg (= 10 ng) / (cm² x min)

The ASTM F 739-07 “Resistance of 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.

• All chemicals• Test measurements using the palm of

the glove• Tested for up to 2 hours• Detection Limit is 0,1 µg

Every glove may react differently in terms of permeation and therefore assumptions are not acceptable. Every cytostatic molecule may react differently in terms of permeation. Therefore, a claim as “Good for cytostatic handling” is dangerous and misleading. This is due to the physico-chemical heterogeneity of the cytostatics.

The Université Catholique de Louvain, Brussels, Belgium have developed a unique dynamic permeation device. They have tested gloves under dynamic physical conditions for stretching, tension, and rubbing.12

Not all drugs or combinations of drugs can be tested. Hence, Dr. Wallemcack’s study advised caution when working with lipophilic and low molecular weight cytotoxic agents. Lipophilic or 'lipid-loving' molecules are attracted to lipids. A substance is lipophilic if it is able to dissolve much more easily in lipid (a class of oily organic compounds) than in water, i.e. Taxol, Carmustine, ThioTEPA.

The Federal Drug Agency, Oncology Nurses Society as well as The Canadian Pharmacist Oncology Association recognizes the need to test gloves as per ASTM D6978-05 method.

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Device chamber used for permeation test cell ASTM F-739 within this method 13

Products tested for permeation as per ASTM F-739 often used in the oncology department for disinfecting are: • 70% isopropyl alcohol (IPA)• accelerated hydrogen peroxide (H2O2)

Products for decontamination are: • Hypochlorite sodium (bleach)• Sodium Thiosulfate• Mechloretamine (chlormetine).

INTERPRETING BREAKTHROUGH TIME Breakthrough time will measure how quickly a chemical can permeate a glove. It is specific for glove material type used in the test. Thinner gloves made from the same material will have a shorter break-through time. For tasks with inevitable contact, the breakthrough time is the maximum time the glove may be used before it should be discarded. If the work lasts for longer than the breakthrough time, gloves should be changed part-way through. You should allow a safety margin: stretching of gloves during use may mean that breakthrough occurs more quickly than in a test environment. Do not rely on touch to detect breakthrough. Skin exposure will occur long before any perceptible feeling of wetness on the inner surface of the glove.

It is important to note that: • Permeation results differ in time and

average permeation rate.• The risk posed by a chemical

permeating a glove is related not just tothe speed at which it can diffusethrough, but also the flow rate. Acombination of a short breakthroughtime and a low permeation rate mayexpose a glove wearer to less chemicalthan a combination of a longerbreakthrough time and a much higherbreakthrough rate, if the glove is notchanged frequently enough.

• Gloves should be changed beforepermeation occurs. Since permeationbreakthrough in actual end use mayoccur sooner than breakthrough underlab test conditions, a margin of safetyshould be allowed when specifyingglove change intervals based on lab data.

Always check the material safety data sheet (MSDS) for personal protective equipment requirements in selecting gloves specifically for the type of chemicals used. Verify permeation time and rate to choose the right glove. • As per ASTM F-739 in handling cleaning

compounds• As per ASTM-D6978-05 in handling

chemotherapy drugs

Permeation test chemicals mixed at any other concentrations will cause data to be generated that will give invalid comparisons when matched against data obtained using the standard concentrations.

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GLOVE SELECTION IN HANDLING CYTOTOXIC DRUGS Informed use of PPE is a very critical component of a hospital’s health and safety program. Appropriate PPE includes gloves, gowns, face shields, masks, eye protection, and ventilation devices where there is likelihood of contact with potentially contaminated material.

When choosing a glove, the first consideration should be the barrier requirement related to the procedure or task at hand. Be aware of the level of exposure risk that the patient-care activities will require. Procedures that involve exposure to blood, bodily fluids, and other potentially hazardous material require a glove material that provides appropriate barrier protection.

When selecting a medical glove, the primary considerations should be the barrier protection, the fit and allergen content. If a glove does not provide an intact barrier, it is not doing its job. To maximize barrier effectiveness, you may wish to choose a glove manufacturer that is reliable and experienced, so that your gloves will be of consistent quality and regularly available.

In handling chemotherapy drugs with the current guidelines on double gloving, insuring a proper fit to the personnel may become a task in itself.

Glove Fit and Sizing

Having protective equipment that fits properly is absolutely vital to the safety of employees. Knowing how to accurately measure and choose glove sizes can increase safety and productivity in the workplace.

If gloves do not fit properly, it can often delay work or result in hand injuries. If the hand protection is too small, it may cause hand fatigue. If the protective material is stretched out, it is more likely to rip or tear during use which is costly to replace, as well as dangerous for the wearer. Gloves that are too small also decrease dexterity. On the other hand, gloves that are too large create safety issues.

It is imperative to understand how to appropriately measure the hand in order to get a glove that fits correctly. If the glove fits properly, it will provide the worker with maximum protection without compromising dexterity.

To find the appropriate glove size, use a tape measure to measure around the knuckles of the dominant hand. The inch measurement of your hand should correspond directly to the numbered sizes of the glove. For example, if you measure your hand to be 8 inches, you would wear a size 8 glove. If your hand measures over 8 inches it is wise to choose the next size up to avoid hand fatigue or discomfort 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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DOUBLE GLOVINGIs there a proper technique for double gloving? While double gloving sizing depends on individual needs, today three practices are common. Some people find that a larger glove inside with a smaller one outside works for them, or vice versa and others use the same size glove for both inside and outside glove. The aforementioned study published in the European Journal of Cardiothoracic Surgery found almost an equal distribution of glove sizes used by surgeons for double gloving: larger glove inside 31%, smaller glove inside 35% and both gloves the same size 31%.14

Donning and Doffing Gloves

Gloves made of various materials form an important part of our safety practices. End-users rely on gloves to protect their hands against corrosive or toxic chemicals, and potential infectious pathogens. We have repeatedly emphasized the importance of choosing gloves made of material appropriate for the hazardous substance(s) being handled. Users must also consider the level of dexterity needed for the anticipated manipulation.

The vast majority of end-users have developed the habit of putting on gloves for work involving hazardous substances. However, we are now seeing a problem of people not taking off gloves when they really should have done so. Although wearing gloves can prevent skin contact with hazardous chemicals, not taking them off at the right time may actually turn the used gloves into a source of contamination, and increase the risk of hazardous chemical exposure for the wearer and the environment. 15-16

DONNING TECHNIQUES

There are two techniques for donning sterile gloves, "Closed Donning" and "Open Donning".

Closed Donning Technique

1. Peel open the outer pack from thecorners. The inner pack is sterile. Grippingit through your gown, open it to displaythe gloves.

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Mens WomenInch cm Inch cm

XS 7 18 XS 6 15S 7 1/2-8 20 S 6 1/2 17M 8 1/2-9 23 M 7 18L 9 1/2-10 25 L 7 1/2 19

XL 10 1/2-11 28 XL 8 20

See the table for numerical and lettered sizing relation.

2. With your gown covering your fingers,use your right hand to remove the leftglove. Hold your left hand palm up, fingersstraight. Lay the glove on your left wrist,and grip the cuff with your left thumb.

3. Place your right thumb inside the topcuff edge. Make a fist with your right handand stretch the glove over your leftfingertips.

4. Keeping your left fingers straight, pulldown the glove.

5. Repeat the above procedure to don theother glove, that is: use your gloved lefthand to lay the right glove on your rightwrist. Slide your left thumb inside the topof the cuff, make a fist, and stretch thecuff over your right fingertips. Pull downthe sleeve and glove together.

Open Donning Technique

1. Pick up the cuff of the right glove withyour left hand. Slide your right hand intothe glove until you have a snug fit over thethumb joint and knuckles. Your bare left

hand should only touch the folded cuff - the rest of the glove remains sterile.

2. Slide your right fingertips into the foldedcuff of the left glove. Pull out the gloveand fit your right hand into it.

3. Unfold the cuffs down over your gownsleeves. Make sure your gloved fingertipsdo not touch your bare forearms or wrists.

Glove Removal

The key to removing both sterile and non-sterile gloves is

"Dirty to Dirty - Clean to Clean"

Contaminated surfaces only touch other contaminated surfaces: your bare hand, which is clean, touches only clean areas inside the other glove.

1. Take hold of the first glove at the wrist.

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2. Fold it over and peel it back, turning itinside out as it goes. Once the glove isoff, hold it with your gloved hand.

3. To remove the other glove, place yourbare fingers inside the cuff withouttouching the glove exterior. Peel the gloveoff from the inside, turning it inside out asit goes. Use it to envelope the other glove.

REMOVING EXAMINATION GLOVES SAFELY

As you remove the gloves, avoid allowing the outside surface of the gloves to come in contact with your skin, because the 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.

1. With right hand, pinch palm of glove onleft hand and pull left glove down and offfingers. Form left glove into a ball and holdin fist of right hand.

2. Insert one or two fingers of leftungloved hand under inside rim of rightglove on palm side; push glove inside outand down onto fingers and over balledleft glove.

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3. Grasp gloves, which are now togetherand inside out, with left hand and removefrom right hand.

4. Discard gloves in plastic bag and seal bag.

5. Wash hands thoroughly.

GLOVE RECOMMENDATIONS IN HANDLING CYTOTOXIC DRUGS

• Powder-free neoprene and nitrileexamination gloves tested for D6978-05are the best recommended choicesduring all activities around handlingchemotherapy drugs as they also havebetter resistance to disinfecting anddecontamination products than latex.

• Surgical neoprene, nitrile, natural rubber,and polyisoprene gloves, tested usingASTM D-6978-05, are recommendedwhen preparing and handlingchemotherapy drugs. Please use aglove rated for the handling of specificchemotherapy drugs.

• Polyvinyl chloride (PVC) gloves are NOTrecommended for handlingchemotherapy drugs.

• Always use powder-free gloves. Thedispersing of chemotherapy drugs intothe surrounding air and the possibility ofinhalation is a serious matter and shouldbe treated as such. Also, glove powdersmay contaminate chemotherapy workareas.

• If double gloving, insert first glove underthe cuff and place the second glove overthe cuff. If single gloving, place the

clean glove over the cuff of the gown. • Before handling chemotherapy drugs,

always inspect gloves for holes, tears orany type of defect. Unless the film isintact, it cannot provide a barrier.

• Although surgical gloves arerecommended for preparation,administration, clean up and generalhandling, sterility is not always required,as for example, direct patient care,handling laundry, and housekeepingprocedures.17 Gloves are available innon-sterile presentations for thesepurposes.

DRUG PREPARATION

Working Securely with Cytostatics

As the number of cancer patients rises, so does the use of chemotherapy treatment. While effective in treating disease, these drugs are also potentially hazardous for the oncology nurses, pharmacists and other healthcare professionals who handle them. Yet worldwide research indicates that insufficient care is being taken with cytostatic agents. Studies report widespread, low-level contamination of areas where cytostatic drugs are used. Traces of cytostatic drugs have been found on workbenches, floors, vials and exterior surfaces of safety cabinets and isolators – even on the floor outside preparation rooms. Once contamination with cytostatic drugs has occurred it is extremely difficult to eradicate.18

To better protect healthcare workers, heightened awareness of this serious problem must be combined with both improved cytostatic handling procedures and the use of appropriate hand protection. Here is a step by step guide to the safe preparation and administration of

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cytostatic mixtures, as well as recommendations for suitable hand protection.

Before actually preparing the cytostatic mixture, the following activities have been identified. These may be influenced by ruling protocols • Don special protective clothing including

non-sterile examination gloves.• Unpack all material. During the

unpacking or handling of the vials, thehealthcare worker’s hand should beprotected as the outside surface of thevials might be contaminated withcytostatic drugs.

• Disinfect the work area.• Assemble and disinfect all material

necessary to prepare the cytostaticdrugs.

Similar care should be taken in the preparation, administration and disposal of chemotherapy drugs. In addition to healthcare professionals, patients and persons that are directly involved in home care should also be taught these safety standards and guidelines. • Always wear gloves when handling the

drug.• Avoid touching the drug.• Wash hands before putting gloves on

and after wearing gloves.• Gloves used for protection against

chemotherapy drugs must be selected.specifically for the type of chemicalsused.

• Use medical grade, sterile or non-sterile,gloves depending on the techniquerecommended by your healthcarefacility.

• 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 forhandling chemotherapy drugs.

• Use ASTM D6978-05 tested gloves thatextend over the cuff of the protectivegown. Please use a glove rated for thehandling of the specific chemotherapydrugs.

• Double gloving is strongly advised whenthere is a risk of exposure duringpreparation or administration ofchemotherapy drugs.

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- If double gloving, insert first glove underthe cuff and place the second glove overthe 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 30minutes of wear.

• Upon removal, both gloves need to beturned inside out

• Never flick, snap, or toss your gloves.• Follow recommendations implemented

by your healthcare facility for thedisposal of gloves.

Now you are ready for the reconstitution of the cytostatic mixture and transfer it to the perfusion set. • Don sterile gloves.• Disinfection of procedure material.• Reconstitution of the cystostatic mixture.• Perform a final disinfection of end product. • Pack the product and label it.

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ADMINISTERING CYTOSTATICS TO PATIENTS

Once the cytostatic mixture has been prepared, it is administered to the patient following established guidelines.

Drug Administration; Glove Use Recommendation• Inspect glove for visible defects.• Wear high quality gloves that have been

tested for use with the specificchemotherapy drugs to be used.

• Double gloving is recommended.• Wash hands before putting on gloves.• Change contaminated gloves

immediately.• Wash hands after removing gloves.• Dispose of gloves according to proper

hospital toxic waste procedures.

Drug Clean Up and General Handling • Wear high quality gloves that have been

tested for use with chemotherapy drugswhen dealing with blood, vomitus,excreta and other bodily fluids fromchemotherapy treated patients.

• Discard gloves after each use.• Laundry personnel coming into contact

with linen contaminated withchemotherapy drug patients’ body fluidsshould wear high quality gloves thathave been tested for use withchemotherapy drugs.

• Housekeeping personnel should wearhigh quality gloves that have beentested for use with chemotherapy drugswhen handling waste containers.

• Spills should only be cleaned up bypersonnel wearing a double layer ofgloves.

• Spill kits for use in responding to spillsshould include two (2) pairs of gloves;one outer pair of utility gloves and oneinner pair of latex or synthetic gloves.

• All personnel involved in any aspect ofhandling chemotherapy drugs mustreceive an orientation on chemotherapydrugs including proper use of protectiveequipment.

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Summary of Glove Use

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AREAS OF GLOVE USE

Open packagingStorageSterile drug preparationIntramuscular or subcutaneous injectionsIntravenous drug administrationPercutaneous drug administration Oral and nasal enteral tube drug administration Intraocular drug administrationGarbage disposalPost drug delivery patient care delivery - 2 daysPatient careSpillsCleanroom housekeepingCabinet cleaningDepartemental housekeepingHandling linen

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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, 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

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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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