1. Safe Handling of Hazardous Drugs

2. Objectives The learner will be able to: 1.Identify the potential adverse effects of handling cytotoxic and other hazardous drugs. 2.List the recommended personal protective equipment needed when caring for a client receiving a hazardous agent. 3.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

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

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

7. The spectrum of risk is mainly a function of the concentration of the hazardous drug at the time you are handling it.

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.

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)

10. Controls to Exposure 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”

11. Guidelines for PPE (Photo courtesy of Georgia Cancer Specialists, Atlanta, GA) (Photo courtesy of Sam Smith, The George Washington University Hospital, Washington, D.C.)

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

13. When Should PPE Be Used? Priming IV tubing 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. Drug Preparation In a restricted area In a Biologic Safety Cabinet, Class II device, using PPE

15. 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. Outside of transport bag should have been wiped down during preparation in the BSC. Syringes should not have attached needles (should have luer end capped).

16. 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.

17. Disposal of HDs Hospital Place in leak-proof container. Label as hazardous. Put sharps in a puncture-proof container. Seal containers when full. Decontaminate reusable equipment (IV poles). Home Send patients home with sharps container. Keep HDs away from pets and children. Follow local regulations regarding disposal.*

18. Post-Administration: Body Fluids HDs are found in urine, feces, sweat, vomitus, breast milk, and seminal fluid. Consider all bodily fluids as contaminated for at least 48 hours after completion of drug administration. 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! Wear PPE when emptying Foley catheters, urinals, etc.

19. Post-Administration: Linen Prevent exposure: Use plastic-backed disposable pads under incontinent patients. Use vinyl/plastic pillow covers. If linen becomes contaminated with any body fluid within the 48-hour post-administration period: – Don PPE. Bag as contaminated. Double wash. – If home: Double wash separately from other linen.

20. Cytotoxic Spill Management (Photo courtesy of Georgia Cancer Specialists, Atlanta, GA)

21. 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.

22. 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. – Refer to MSDS, drug insert, or emergency department. 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. – Seek emergency treatment. – Refer to MSDS, drug insert, or emergency department.

23. Medical Surveillance The collection and interpretation of longitudinal data that detect health changes in workers with potential exposure to HDs or other work hazards Its purpose is to minimize adverse health effects on the working population. Includes history and physical, laboratory studies, and ongoing biologic monitoring (such as periodic blood tests or dosimetry badges)

24. Reference Polovich, M., Whitford, J., & Olsen, M. (Eds.). (2009). Chemotherapy and biotherapy guidelines and recommendations for practice (3rd ed.). Pittsburgh, PA: Oncology Nursing Society.