BAD THINGS IN SMALL PACKAGES, ANTINEOPLASTIC AND CYTOTOXIC DRUGS Daryl Lance, Pharm D, BCOP, Susan Eisberg.

BAD THINGS IN SMALL PACKAGES,

ANTINEOPLASTIC AND CYTOTOXIC DRUGS

• Daryl Lance, Pharm D, BCOP,

• Susan Eisberg

INTRODUCTION

• What is the problem?

INTRODUCTION

• Communication is important.

WHAT ARE THESE CHEMICALS AND HOW ARE

THEY USED?

WHAT ARE THESE CHEMICALS AND HOW ARE

THEY USED?

• Bone marrow suppression

• Hair loss (alopecia)

• Mucositis (mouth sores)

ALKYLATING AGENTS

• First chemotherapy drug to be produced

• Alkylation to the DNA base pairs

ALKYLATING AGENTS

• Secondary tumors

• Mutagenicity

• Sterility

ALKYLATING AGENTS

• Side effects:– Bone marrow suppression– Nausea and vomiting– Hemorrhagic cystitis– Sterility

ALKYLATING AGENTS

• Cyclophosphamide, Ifosfamide• Cisplatin, Carboplatin• Dacarbazine, Chlorambucil• Busulfan, Chlorozotocin• Streptozocin, Carmustine• Semustine, Lomustine• Melphalan, Mechlorethamine• Procarbazine, Gemcitabine

ANTIMETABOLITES

• Inhibition of enzymatic processes

• False substrates

ANTIMETABOLITES

• This was the second chemotherapy agent to be produced– Antifolates

• Special applications

ANTIMETABOLITES

• Side effects– Hair loss– Mucositis– Bone marrow suppression

ANTIMETABOLITES

• Azathioprine, Cyclosporin

• Cytarabine, Floxuridine

• Fluorouracil, Capcitabine

• Ganciclovir, Hydroxyurea

• Mercaptopurine Methotrexate

• Ribavirin, Thioguanine

• Fludarabine, Zidovudine

ANTI-TUMOR ANTIBIOTICS

• Intercalation

• Alkylation

ANTI-TUMOR ANTIBIOTICS

• Highly colored.

• Important clinically

ANTI-TUMOR ANTIBIOTICS

• Side effects– Bone marrow suppression– Mucositis– Alopecia– Cardiac toxicity– Tissue vesicant agents– Nausea, vomiting

ANTI-TUMOR ANTIBIOTICS

• Doxorubicin, Daunamycin

• Idamycin, Dactinomycin

• Mitomycin Plicamycin

• Bleomycin, Mitoxantrone

SPINDLE POISONS AND NATURAL PRODUCTS

• Natural plant products

• Microtubule inhibition

• Mitosis inhibition

• Asparaginine inhibition

SPINDLE POISONS AND NATURAL PRODUCTS

• Tumor types

• Special applications

SPINDLE POISONS AND NATURAL PRODUCTS

• Side effects– Alopecia– Bone marrow suppression– Peripheral neuropathy– Vesicants– Diabetes, Coagulopathies

SPINDLE POISONS AND NATURAL PRODUCTS

• Vinca Alkyloids- Vincristine, Vinblastine, Vinorelbine

• Podophyllotoxins- etoposide, teniposide

• Taxanes- paclitaxol (taxol), Docetaxel

• Enzymes- L-asparaginase

HEALTH CARE RISK

• Risks to health care workers- Difficulties of relative risk– measurement of exposure– Long latent period– Identification of risk groups

BIOLOGIC RISKS WITH EXPOSURE

• Reproductive outcomes

• Chromosomal changes

• Urine mutagenicity

• Acute symptoms

LITERATURE DOCUMENTATION

• Study by Falck et al– Nurses were found to have mutagenic

substances in their urine

LITERATURE DOCUMENTATION

• Study by Hemminki et al. – Spontaneous abortions and malformations in

the offspring– of nurses exposed to anaesthetic gases,

cytostatic drugs– and other potential hazards in hospitals based

on – registerd information of outcome.

LITERATURE DOCUMENTATION

• Study by Kilmodin-Hedman, et al, Urine mutagenicity– Study comparing 2 groups

• one group utilizing personal protection

• one group not using personal protection

LITERATURE DOCUMENTATION

• Study by Selevan, et al. – Study of occupational exposure to

antineoplastic drugs– and fetal loss in nurses.

LITERATURE DOCUMENTATION

• Study by Benhaamou, et al.– Mutagenicity in urine from nurses handling

cytostatic agents

LITERATURE DOCUMENTATION

• Study by Conner, et al– Study of surface contamination with

antineoplastic– agents in six cancer treatment centers in Canada– and the United States.

CHEMO/CYTOTOXIC EXPOSURE

• Absorption

• Inhalation

• Ingestion

ABSORPTION

• Can happen during preparation, administration or disposal of equipment OR while handling contaminated excreta or body fluids.

• Know that body fluids and excreta can remain contaminated up to 48 hours after the last dose.

ABSORPTIONPrevention Measures

• Through skin, eyes, mucous membranes– Wear chemo gloves– Wash hands before & after gloves are used– If skin contact, wash ASAP– If eye contact, flush with normal saline liberally

INHALATION

• Inhalation of aerosols can be very subtle and can occur without awareness from:– opening vials of the medication– clipping needles– expelling air from a syringe– splash effect when discarding contaminated

excreta or body fluids into the toilet or measuring container.

INHALATIONPrevention Measures

• Use gauze pads when breaking vials

• Don’t clip or remove needles or re-cap, dispose as a whole in the sharps containers

• Use masks and/or goggles when there is a chance of creating an aerosol

• Empty waste products into the toilet close to the water to minimize splashing

INGESTION

• Eating, drinking, chewing gum, smoking or applying cosmetics or contact lenses may increase possible exposure

INGESTIONPrevention Measures

• Keep all foods and utensils away from drugs

• Wash hands before and after contact with drug

• Avoid hand to eye or hand to mouth contact

GENERAL PRECAUTIONS

• Place waste in appropriate containers

• “Chemotherapy Precautions” should begin when chemotherapy is initiated and continue for 48 hrs. after completion.

• Staff should wear special chemotherapy gloves and gown whenever handling or administering IV, IM or subcutaneous AND whenever emptying body fluids of patients who are under “Chemo Precautions”

OSHA GUIDELINES• Basics of the guidelines - Handling CD’s

– Drug Preparation– Drug Administration– Caring for Patients– Waste Disposal– Spills– Medical Surveillance– Storage & Transport– Training & Information

OSHA GUIDELINES• Basics of the guidelines - Handling CD’s

– Drug Preparation– Drug Administration– Caring for Patients– Waste Disposal– Spills– Medical Surveillance– Storage & Transport– Training & Information

OSHA GUIDELINES• Basics of the guidelines - Handling CD’s

– Drug Preparation– Drug Administration– Caring for Patients– Waste Disposal– Spills– Medical Surveillance– Storage & Transport– Training & Information

OSHA GUIDELINES• Basics of the guidelines - Handling CD’s

– Drug Preparation– Drug Administration– Caring for Patients– Waste Disposal– Spills– Medical Surveillance– Storage & Transport– Training & Information

OSHA GUIDELINES• Basics of the guidelines - Handling CD’s

– Drug Preparation– Drug Administration– Caring for Patients– Waste Disposal– Spills– Medical Surveillance– Storage & Transport– Training & Information

OSHA GUIDELINES• Basics of the guidelines - Handling CD’s

– Drug Preparation– Drug Administration– Caring for Patients– Waste Disposal– Spills– Medical Surveillance– Storage & Transport– Training & Information

OSHA GUIDELINES• Basics of the guidelines - Handling CD’s

– Drug Preparation– Drug Administration– Caring for Patients– Waste Disposal– Spills– Medical Surveillance– Storage & Transport– Training & Information

OSHA GUIDELINES

• Website and OSHA information– www.osha.gov

EXPOSURE PREVENTION Having A Written Plan

• Standard Operating Procedures

• Criteria to determine and implement control measures– Engineering controls– PPE– Work Practices

• Requirement that protective equipment (i.e. ventilation) functions properly

Having a Written Plan

• Information & Training

• Medical Surveillance

• Designation of Responsible Person for Program

• Designation of handling area

• Use of BSC’s

• Procedures for safe removal of contaminated waste

• Decontamination Procedures

CHEMO WASTE

• Bulk Waste (i.e.-unadministered doses) should be disposed of as hazardous waste and picked up by licensed waste hauler.

• Trace Waste (empty IV bags, syringes, etc.) should be disposed of in containers specially marked for chemotherapy waste to be incinerated.

SPILL PREVENTION

• Staff education

• Handling techniques– Storage– Transport– Administration– Caring for Patients

SPILLS, UNAVOIDABLE, SO HOW DO YOU CLEAN THEM

UP?

• Steps in clean up

• Who to contact

• The spill kit and its contents

• Personnel protection kits

SPILLS, UNAVOIDABLE, SO HOW DO YOU CLEAN THEM

UP?• Getting dirty (or how to avoid getting

dirty!)

• Demonstration

STEPS IN CLEANUP• What to do immediately

– Control Traffic– Rinse exposed body parts– Send someone for spill kit– Mark spill with caution sign

• Containing the spill– Place spill pillows to prevent spread– Place absorbent towel over spill without

touching spill

STEPS IN CLEANUP• Clean

– Put on PPE (gown, gloves, mask and goggles)– Pick up towel and pillows and place in chemo

waste container– Sweep any glass fragments with scoop and

brush - place in chemo waste container– Wash all surfaces, including furniture– Absorb rinse water with 2nd towel and place in

chemo waste container– If on carpet, must be extracted

STEPS IN CLEANUP

• Follow Up– Immediately Wash hands and all exposed skin

areas with soap and water– Notify EVS for further clean-up with detergent

and rinse water– Notify Pharmacy and Safety Department of

spill– Order new spill kit

STEPS IN CLEANUP

• Document– On Incident Report:

• Date, time, location, amount of spill and drug involved

• Area of body, personnel involved and action taken

• Notification of Pharmacy and Safety Office

– On Patient’s Chart• Amount of spill and the drug

• MD notified

MEDICAL SURVEILLANCE

• Types of questions

• How frequent to survey?

• Who keeps these records?

• Where do you report the records?

SUMMARY AND QUESTIONS

• What we said

• What you missed

• What else do you want to know.