Occupational Risk of Antineoplastic Drugs

7/31/2019 Occupational Risk of Antineoplastic Drugs

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Occupational Risk

of Antineoplastic

Drugs

Pharmacy Seminar

Phoebe C. Llamelo


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Objectives

Define what are antineoplastic drugs and why

they are classified as hazardous drugs.

Identify the potential groups of workers exposedto antineoplastic drugs, and then focus on

pharmacists

Determine and describe the routes and commonsources of exposure of pharmacists to

antineoplastic drugs


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Objectives

Give the possible acute and chronic effect of

occupational exposure to antineoplastic drugs

and the possible mode of action.

Discuss the methods for preventing exposure

of pharmacists to antineoplastic drugs

Identify the medical monitoring necessary forhealth workers


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Antineoplastic Drugs

- Substances that inhibit or

prevent the proliferation of

NEOPLASMS


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Hazardous Drugs

Exhibit one or more of the following sixcharacteristics in humans or animals

1. Carcinogenicity

2. Teratogenicity or other developmental

toxicity3. Reproductive Toxicity

4. Organ toxicity at low doses

5. Genotoxicity

6. Structure and toxicity profiles of new drugsthat mimic existing drugs determined

hazardous by the above criteria


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Antineoplastic Drugs

Alkylating agents

Antibiotics

Antimetabolites

Biologicals

Hormonal agents

Monoclonal

antibodies

Nitrogen mustard

derivatives Plant alkaloids

Others


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Mechanism of Action

bind directly to genetic material in the

cell nucleus or affect cellular protein

synthesis

Interferes with cell division and/ordamage (DNA), disrupt DNA replication

during synthesis, or interfere with the

repair of DNA.

cytotoxic drugs may not distinguishbetween normal and cancerous cells

.


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Recent concerns:

More cancer patients

More combinations of drugs

Higher doses of drugs

More potent drugs

New procedures/settings

antineoplastic medicationsexpanding into other arenas


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Potentially Exposed Groups

Workers in manufacturing

Pharmacists and technicians

Nursing personnel

Physicians Operating room personnel

Housekeeping and laundry personnel

Veterinarians

Retail pharmacists


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Common Sources of

Exposure


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DISPOSAL OF DRUGS ANDWASTE Emptying waste containers and

cleaning contaminated areas

CONTACT WITH CONTAMINATEDSURFACES

Drug vials, counter tops, keyboards, IVbags, tables, chairs, waste containers


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CONTAMINATION IN AREAS

THOUGHT TO BE DRUG-FREE Locations adjacent to work areas

POSSIBLE PASSAGE THROUGHHEPA FILTERS

Vapors


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Routes of Exposure


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Inhalation

drug aerosols are generated during drug

compounding and transfer from one

container to another.


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Activities that can cause release of Hazardous

Drugs aerosols:

breaking open an ampule

withdrawing a needle from a vial

transferring drug from a vial to a syringe

or other container

expelling air from a syringe

attaching intravenous (IV) tubing to IV

containers

and priming tubing

powders generated during the crushing of

tablets


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Dermal

Accidental needle prick

Most common route- contact to

contaminated surfaces and objects

Contact to body fluids of patients who

have received the medication


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Oral

hand-to-mouth after touching

contaminated surfaces


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Effects of Antineoplastic Drugs

Exposure

accidental needle prick of a finger with

mitomycin-C has been reported to cause

the eventual loss of function of that hand

(Duvall and Baumann 1980).

varying degrees of local tissue necrosis

upon direct contact (Knowles and Virden1980)


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Exposure

increased risk of cancer exists among exposed

pharmacy technicians (Hansen & Olsen, 1994)

statistically significant association between fetalloss or miscarriages and stillbirths and the

occupational exposure (Selevan, Lindbohm,

Hornung, & Hemminki, 1985; StOcker et al.,

1990; Valanis, Vollmer, & Steele, 1999)

infertility (Fransman et al., 2007; Martin, 2005)


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Exposure

acute symptoms in nurses and pharmacists

hair loss

abdominal pain

nasal sores contact dermatitis

allergic reactions

skin injury

eye injury

(Harrison, 2001)


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Primary concern is for the safety of thepatient

Drugs must be prepared aseptically Contamination can be fatal to the

patient

Secondary concern is the safety of the

healthcare worker Exposure to hazardous drugs must be

kept as low as possible

Many opportunities for exposure


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Prevention of Exposure


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Hazardous Drug Safety andHealth Plan

Establishment of a designated HD

handling area.

Use of containment devices such as

biological safety cabinets.

Procedures for safe removal of

contaminated waste.

Decontamination procedures.

Standard operating procedures relevant tosafety and health considerations to be

followed when health care workers are

exposed to hazardous drugs.


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Work area

Restricted, centralized

procedures for spills andemergencies should be

available to workers,

posted in the area.


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Biological Safety Cabinet

Class II or III Biological

Safety Cabinets (BSC)

that meet the currentNational Sanitation

Foundation Standard


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Personal Protective Equipment

GLOVES- latex, with minimal or no powder

GOWNS- protective disposable gown

made of lint-free, low-permeability fabric

with a closed front, long sleeves, and

elastic or knit closed cuffs


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Work Practices

Labeling

Priming- within the BCS

Handling of Vials- Avoid extreme + or

pressure; use large-bore needles (#18 or

#20)

Handling ampules

Cleaning spills and discarding wastes


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Continuing Exposure

Antineoplastic drugs continue to contaminate the

work spaces

Metabolites still being found in the urine of those

who handled these drugs

Wipe sampling in pharmacy and preparation

areas (cyclophosphamide, ifosfamide,

fluorouracil, methotrexate)

Air sampling (cyclophosphamide, ifosfamide,

fluorouracil)


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Drug reconstitution with needle and syringe


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Drug transfer from syringe to I.V. bag


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Possible reasons to the problem

New workers lack of awareness of the

issue

Lack of vigilance in work practices

Poor adherence and less strict

implementation of the guidelines

Potential sources of contamination that

have yet to be discovered.


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Conclusion

Despite decades of data and on adverse effects of

occupational exposure to antineoplastic drugs, and

guidelines for safe handling of these drugs, direct

exposure of health care professionals to these drugs

still exists. Stricter implementation of the guidelines and validation

of their effectiveness should be done

Each new generation of health care workers need to be

educated about the risk of handling antineoplastic drugsand well trained in handling them.


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Documents

Occupational Risk of Antineoplastic Drugs