1. Safe Handling of Hazardous Drugs

2. Objectives The learner will be able to:
Identify the potential adverse effects of handling cytotoxic and other hazardous drugs.
List the recommended personal protective equipment needed when caring for a client receiving a hazardous agent.
Describe the cytotoxic spill clean-up process.

3. Safe Handling
Hazardous drugs (HDs), are those drugs that exhibit one or more of the following characteristics:
Carcinogenicity
Teratogenicity
Reproductive toxicity
Organ toxicity at low doses
Genotoxicity
Any drug similar in structure or toxicity to drugs classified as hazardous

4. Adverse Health Effects of Occupational Exposure to Hazardous Drugs
Integumenary/Mucosal
Skin irritation or contact dermatitis
Mouth and nasal sores
Partial alopecia*; hair thinning
Neurologic
Headaches
Dizziness
Respiratory
Dyspnea
Gastrointestinal
Nausea and vomiting
Abdominal pain
Pg. 79 (Polovich, Whitford, & Olsen, 2009)
*Alopecia = hair loss
In the United States many states have laws governing how left-over drug or contaminated materials should be disposed.
Check with local authorities to determine if such laws exist in your location.

5. Adverse Health Effects of Occupational Exposure to Hazardous Drugs (con’t)
Hypersensitivity
Allergic asthma
Eye irritation
Reproductive
Infertility
Prolonged time to conception
Premature delivery/low birth weight
Ectopic pregnancy
Spontaneous abortions/miscarriages
Stillbirths
Learning disabilities in offspring
Pg. 79 (Polovich, Whitford, & Olsen, 2009)
*Alopecia = hair loss
In the United States many states have laws governing how left-over drug or contaminated materials should be disposed.
Check with local authorities to determine if such laws exist in your location.

6. Adverse Health Effects of Occupational Exposure to Hazardous Drugs and Biotherapy Agents
Malignancies
Leukemia
Non-Hodgkin’s lymphoma
Bladder cancer
Liver cancer
Biotherapy Agents - Data remain limited.
Most biologic agents do not affect DNA, including:
Antiangiogenics
Some targeted therapies
Interferon
Conjugated monoclonal antibodies
Pg. 74 (Polovich, Whitford, & Olsen, 2009)
Much of the data around biotherapy agents demonstrates that most do not affect DNA, However, longitudinal data is not yet conclusive (since these are a relatively new class of drugs); therefore, the true long-term health effects remain unknown.
Antiangiogenics
Targeted therapies
Interferon
Conjugated monoclonal antibodies = these are all different types of biotherapy agents; each of which has a mechanism of action that is different

7. The spectrum of risk is mainly a function of the concentration of the hazardous drug at the time you are handling it.
From Safe Handling of Hazardous Drugs web course, ONS.

8. Exposure Risks Studies show:
Chronic low-level exposure to HDs can lead to absorption.
Chronic low-level absorption may cause significant long-term side effects.
Acute exposure may cause acute symptoms.
The use of personal protective equipment (PPE) reduces the risk of absorption.
Chronic refers to repeated exposure, such as repeated preparation or administration of chemotherapy drugs without the use of protective gloves.
Acute exposure refers to a one-time significant exposure to drug, such as with a spill.

9. Types of Exposure Absorption (through skin, eyes, or mucous membranes)
Surface contamination has been found in every single study that has tested for it.
Unprotected skin easily can become contaminated if surfaces are contaminated.
Injection (accidental needle sticks)
Ingestion
Inhalation (sprays, aerosolization, drug dust, spills)
Surface contamination may include trays, boxes, the outside of containers that contain hazardous drugs, work surfaces, etc. It may also include areas inside the biologic safety cabinet, floors, door handles, etc. Studies have even confirmed contamination on drug vials when delivered from the manufacturers (Polovich, 2011)
Studies have demonstrated that gloves are routinely contaminated during HD handling and should be changed periodically. Guidelines recommend that gloves should be changed at least after no more than 30 minutes of use, or when soiling occurs (Polovich, 2011)
From Safe Handling of Hazardous Drugs web course, ONS.

10. Controls to Exposure Administrative Controls
Engineering (Mechanical) Controls* (Primary Engineering Controls)
Biologic safety cabinets (BSC) (Class II)
“Hoods”
Needless/needle-safe administration systems
Work Practice Controls (procedures performed to reduce exposure)
Prime IV tubing in the BSC, with saline/locking connections
Administrative Controls
Provide clear policy/procedure, education, training, and evaluation.*
Personal Controls
Personal Protective Equipment – known as “PPE”
Controls to Exposure: known as Hierarchy of Controls
OSHA defines industrial hygiene as “the science of anticipating, recognizing, eval-
uating, and controlling workplace conditions that may cause workers’ injury or ill-
ness” (OSHA, 1998).
*Biologic safety cabinet: is the most effective control short of total elimination of the hazard. It is a primary engineering control (PEC). It is an enclosed area or cabinet with a laminar flow device attached that protects the worker from exposure to a contaminate within the cabinet. Workers put protected hands into the cabinet to prepare the hazardous drugs. It is usually located in the pharmacy department, but many ICUs, clinics, and outpatient physician’s offices have them as well.
*Closed system devices, such as needleless/needle-safe preparation and administration systems, are designed to reduce the risk of accidental needlestick and exposure to hazardous drugs. The system consists of a series of interlocking plastic parts that can deliver the medication without the use of sharps and the associated risks. Only PhaSeal ® has been studied in a clinical environment.
Priming IV tubing in the BSC allows for any leaks or droplets to be contained within the BSC and therefore not potentially touched or inhaled by the worker.
Locking connections on IV tubing are a safety feature that reduces the risk of an accidental disconnection and subsequent exposure to the hazardous drug. (Polovich, 2011)
Work Practice Controls require scrutiny of workplace routines to assure that contamination with HDs is not occurring. Instances where it could be occurring include when exiting or reentering the BSC without changing gloves; inadequately cleaning spills, failing to wipe HD vials or ampules, inadequate hand washing. (Polovich, 2011)
Limiting access to the place where hazardous drugs are prepared assures that only those who are trained in reducing their risk are in the area.
Training a few people very well, rather than all individuals in a limited way, will reduce overall risks of exposure.
*Good administrative controls include clear policies and procedures, staffing and scheduling guidelines, quality staff education, training, and validation of skills, and medical surveillance.
Personal protective equipment should include gloves, gown, and face shield if splashing is possible. Although OSHA (1995) recommended changing gloves every 60 minutes or when soiled, results of permeability testing requires recommending changing gloves every 30 minutes, and remove immediately if torn or contaminated. Double gloving is recommended for all activities involving HDs ( inner glove under gown sleeve; outer glove over gown cuff).
No standards exist for the length of time a gown should be worn. Recommendations include removing gown immediately if contaminated, at the end of drug handling activities, or when leaving drug-handling area.
Face Shield- surgical masks do not provide adequate protection from splashing or aerosolized drugs.
Activities requiring respiratory protection from potential aerosolized drug require the use of a fit-tested NIOSH-approved N95 respirator (such as those worn for use with tuberculosis patients). These do not, however, protect from a gas or vapor exposure. A gas/vapor cartridge in combination with an N95 or greater particulate filter is required if gas or vapor exposure is possible.

11. Guidelines for PPE (Photo courtesy of Sam Smith, The George
Pages 74-77
Gloves
Disposable
2 pairs as shown in image
Powder-free
Tested for use with HDs
Remove and discard gloves
immediately after use
if a tear, puncture, or drug spill occurs
30 minutes of wear
Gowns
Lint-free
Solid front – no lab coats, zippers, etc.
Long sleeves with tight cuffs
Back closure
Gowns should not be re-used (NIOSH, 2004)
Respirators
NIOSH approved - NIOSH is the United State’s National Institute for Occupational Safety and Health. They have submitted recommendations for appropriate PPE.
Surgical masks do not provide respiratory protection
Eye and face protection
Wear whenever there is a possibility of splashing
(Photo courtesy of Sam Smith, The George
Washington University Hospital, Washington, D.C.)
(Photo courtesy of Georgia Cancer Specialists, Atlanta, GA)

12. When Should PPE Be Used? Introducing or withdrawing needles from vials
Transferring drugs from vials to other containers using needles or syringes
Opening ampoules
Expelling air from a drug-filled syringe
Administering HDs by any route
Spiking IV bags containing HDs and changing IV tubing
Handling urinary catheter after chemotherapy has been instilled

13. When Should PPE Be Used? Preparing to instill the chemotherapy
Handling leakage from tubing, syringe, and connection sites
Disposing of HDs and items contaminated by HDs
Handling the body fluids of a patient who received HDs in the past 48 hours
Cleaning HD spills

14. Applying PPE
Items:
Gloves
Protective gowns
Eye and face protection

15. Drug Preparation In a restricted area
In a Biologic Safety Cabinet, Class II device, using PPE
The pharmacy technician hands and the hazardous drug are inside a BSC, which is inside a restricted area. She covers her hair to avoid contamination. She is protected from splashes and eye contact by the lowered glass window of the BSC. In the background is a special hazardous waste container, with a tight-fitting lid. Note the cleaning wipes, used to wipe the outside of the ampoule prior to mixing the drug with diluent, after mixing, and prior to putting the syringe into the transport bag. Note that she wears a protective gown and two pairs of chemotherapy-tested gloves, with the outer glove extending over the cuff of the gown.
(From Safe Handling of Hazardous Drugs web course, ONS)

16. Drug Transport
Drug should arrive to you in a sealed transport bag, with a container inside.
Container AND bag should be labeled as HAZARDOUS. It should also have a label stating that you need to wear gloves to handle it.
Syringes should not have attached needles (should have luer end capped).
BSC= biologic safety cabinet, usually located in pharmacy department
Leur lock is a fitted connector with a locking mechanism to prevent leaks

17. Drug Administration
Administration guidelines are required regardless of where the drug is given, or the condition for which it is given. A HD is a HD, regardless of where you find it.
Perform all work at eye level; never over your head.*
Have a spill kit nearby.
Prepare your work area before starting.
Put on all PPE before reaching into the delivery bag to remove the drug container.
Do not reuse gowns after use.
Wash hands with soap and water, not alcohol-based gels; friction is necessary to remove HDs.
Spiking an IV bag with HDs in it while hanging from an IV pole over your head greatly increases your risk of exposure.

18. Disposal of HDs At hospital/clinic
Place in leak-proof container. Label as hazardous. Put sharps in a puncture-proof container.
Seal containers when full.
Decontaminate reusable equipment (IV poles).
Preferable not to flush intravesical chemo into a public toilet (splash contamination).
Home
Encourage patient to void for the first time at home.
Keep HDs away from pets and children.
Patient should use their own bathroom for the 1st day.
Flush urine in the toilet twice.
All disposable items with chemo-urine – bag, seal, and trash.
* In some areas of the U.S., patients must return their unused HDs to the MD office or hospital. Be sure to know your local regulations.

19. Post-Administration: Body Fluids
HDs are found in urine, feces, sweat, vomitus, breast milk, and seminal fluid.
For intravesical chemotherapy: consider only urine as contaminated for at least 6 hours after the patient’s first void.
Cover toilets without a lid before flushing to avoid spray contamination. Encourage use of toilet instead of urinal/bedpan to decrease exposure.
Protect the skin of incontinent patients.
Remember: Diapers can be contaminated too! So if family is helping the patient at home, they should have gloves.
Wear PPE when emptying Foley catheters, urinals, etc.
1=Although there is no research to support the role of double-flushing in reducing exposure, it has been suggested in the past (Brown et al., 2001; Welch & Silveira, 1997) and may be helpful with low-volume-per-flush toilets (Polovich, 2011).
2=Some metabolites of drugs can be damaging to the skin. Wash the skin with soap and water, and apply a moisture barrier after urination or defecation.

20. Post-Administration: Linen
Prevent exposure: Use plastic-backed disposable pads under incontinent patients. Use vinyl/plastic pillow covers.
If linen becomes contaminated with urine within the 6-hour post-administration period:
Handle carefully, double wash separately from other linen.

21. Cytotoxic Spill Management
Everyone who is involved or near HDs should know where a spill kit is and how to use one.
Spill kits should be available wherever HDs are stored, prepared, or administered.
In the United States, some clinics and hospitals have “Spill Teams” that are called to handle any spill
A spill kit includes:
Absorbent chemotherapy towels
2 pairs chemotherapy resistant shoe covers
2 disposable chemotherapy resistant gowns
4 pairs chemotherapy gloves
2 pairs splash goggle or face shields
2 respirator masks
1 disposable dustpan
1 puncture-proof container
1 plastic scraper
2 heavy duty waste sealable disposable bags
1 Hazardous Waste label
(Polovich, Whitford, & Olsen, 2009; Polovich, 2011)
(Photo courtesy of Georgia Cancer Specialists, Atlanta, GA)

22. Spill Management Prevent spills as much as possible!
Be prepared for one if it happens (spill kit).
Post signs where spill is located; evacuate area.
If clothes or skin are contaminated, remove clothes; wash skin with soap and water; get medical attention.
Wear full PPE, including respirator mask and shoe covers, before attempting to control spill.
Use spill kit to control spill area.
Patients receiving HDs at home should have a spill kit too, and instructions on how to use it.
Spill management generally includes:
Wiping up glass (if ampoule is broken) with plastic scoop, then wiping up liquid spill using absorbent towels. Then clean areas three times, using Surface Safe and detergent solution, then water.
Seal all items in safety bags with hazardous labels.
Remove PPE and place in hazardous waste bag.
If spill occurs on carpet, use absorbent powder, such as Green Z ™
Use a dedicated vacuum to clean spill, then clean carpet again, according to usual procedure.

23. Acute Accidental Cytotoxic Exposure: What to Do
Skin
Remove contaminated garments.
Immediately wash skin with soap and water.
Refer to MSDS, drug insert, or emergency department.
Eye
Immediately flush eye(s).
Seek emergency treatment.
Inhalation
Move away from area of exposure.
Seek emergency treatment.
Refer to MSDS, drug insert, or emergency department.
Ingestion
Do not induce vomiting unless indicated by MSDS.
Pg (Polovich, Whitford, & Olsen, 2009)
Note: some HDs will vaporize at 80.6°F–98.6°F
Reporting Procedures:
Employee exposure
Report to employee health department
Follow policy and procedures
Patient exposure
Inform patient’s healthcare provider(s)

24. Reference
Polovich, M., Olsen, M., & LeFebvre, K.B. (Eds.). (2014). Chemotherapy and biotherapy guidelines and recommendations for practice (4th ed.). Pittsburgh, PA: Oncology Nursing Society. Polovich, M. (Ed.). (2011). Safe handling of hazardous drugs (2nd ed). Pittsburgh, PA: Oncology Nursing Society.