Occupational Risk of Anti Neoplastic Drugs

8/3/2019 Occupational Risk of Anti Neoplastic Drugs

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Occupational Riskof Antineoplastic

Drugs

Pharmacy Seminar

Phoebe C. Llamelo


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Objectives

Give the possible acute and chronic effect ofoccupational exposure to antineoplastic drugs

and the possible mode of action.

Discuss the methods for preventing exposureof pharmacists to antineoplastic drugs

Identify the medical monitoring necessary forhealth workers


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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 (ASHP,1990)


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Examples ofHazardous

Drugs

Antineoplastic agents

Antiviral agents Hormonal agents

Immunosuppressant agents

Some antibiotics


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Antineoplastic Drugs

- Substances that inhibit or

prevent the proliferation of

NEOPLASMS


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Recent concerns:

More cancer patients

More combinations of drugs

Higher doses of drugs

More potent drugs

New procedures/settings

antineoplastic medications

expanding into other arenas


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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 ofAction

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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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 statistically significant association between

fetal loss or miscarriages and stillbirths

and the occupational exposure (Selevan,

Lindbohm, Hornung, & Hemminki, 1985;

StOcker et al., 1990; Valanis, Vollmer, &

Steele, 1999)

increased risk of cancer exists among

exposed pharmacy technicians (Hansen &

Olsen, 1994)


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Exposure

Light-headedness

Dizziness

Nausea

Headaches

Skin and mucous membrane reactions

Hair loss

Cough

Possible allergic reactions


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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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DRUG PREPARATION

Drug dilution and transfer

Reconstitution of an IV drug

Spiking ang IV bag

Cutting, crushing, or other manipulation ofcoated or uncoated tablets and capsules

for pediatric, geriatric


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DRUG ADMINISTRATION Priming tubing

Disconnecting lines

Instillation procedures

DISPOSALOF DRUGS ANDWASTE

Emptying waste containers andcleaning contaminated areas


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CONTACT WITH CONTAMINATED

SURFACES

Drug vials, counter tops, keyboards, IV

bags, tables, chairs, waste containers

CONTAMINATIONINAREAS

THOUGHTTO BE DRUG-FREE

Locations adjacent to work areas

POSSIBLE PASSAGE THROUGHHEPAFILTERS

Vapors


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Routes of Exposure


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Activities that can cause release ofHazardous

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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Prevention of Exposure


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Primary concern is for the safety of thepatient

Drugs must be prepared aseptically

Contamination can be fatal to thepatient

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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Hazardous Drug Safety and

Health 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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Drug Preparation Precautions

Work Area. preparation should be

performed in a restricted, preferably,

centralized area. Signs restricting the

access of unauthorized personnel are to

be prominently displayed. Eating, drinking,

smoking, chewing gum, applying

cosmetics, and storing food in the

preparation area should be prohibited.

procedures for spills and emergencies,such as skin or eye contact, be available

to workers, preferably posted in the area.3


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Biological Safety Cabinet

Class II or III Biological Safety Cabinets

(BSC) that meet the current National

Sanitation Foundation

Standard49,70,72 should minimize exposure

to HD's during preparation

Use of a dedicated BSC, where only HD's

are prepared, is prudent practice.


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Personal Protective Equipment

Gloves

latex gloves should be used for the

preparation unless the drug-product

manufacturer specifically stipulates thatsome other glove provides better

protection

loves with minimal or no powder are

preferred since the powder may absorb

contamination.3,104

The above referenced sources have

noted great variability in permeability

within and between glove lots.

Therefore, double gloving isrecommended if it does not interfere


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Gowns

A protective disposable gown made of lint-

free, low-permeability fabric with a closedfront, long sleeves, and elastic or knit

closed cuffs should be worn. The cuffs

should be tucked under the gloves. If

double gloves are worn, the outer gloveshould be over the gown cuff and the inner

glove should be under the gown cuff.

When the gown is removed, the inner

glove should be removed last. Gowns and

gloves in use in the HD preparation areashould not be worn outside the HD

preparation area


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Work Equipment

work with HD's be carried out in a BSC on

a disposable, plastic-backed paper liner.

The liner should be changed after

preparation is completed for the day or

after a shift, whichever comes first. Liners

should also be changed after a

spill.103 Syringes and IV sets with Luer-lock

fittings should be used forHD's. Syringe

size should be large enough so that theyare not full when the entire drug dose is

present.

A covered disposable container should be

used to contain excess solution. A covered

sharps container should be in the BSC.


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Work Practices

Labeling

all syringes and IV bags containing

HD's should be labeled with a

distinctive warning label, such as: Needles

Priming

Prudent practice dictates that drug

administration sets be attached andprimed within the BSC, prior to addition

of the drug. This eliminates the need to

prime the set in a less well-controlled

environment and ensures that any fluid

that escapes during priming contains no


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Handling Vials Diluent should be slowly added into vial by

alternately injecting small amounts andallowing displacement of air into the

syringe. When all diluent has been added,

a small amount of additional air may be

withdrawn to create negative pressure in

the vial.To withdraw liquid from a vial, negative

pressure technique must be used. Never

push in on the plunger as this creates

positive pressure in the vial and may resultin leakage or spraying from the vial.

Extremes of positive and negative

pressure in medication vials should be

avoided

The use of large-bore needles, #18 or #20,


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Handling Ampules

dry material should be "gently tapped

down" before opening to move any

material in the top of the ampule to the

bottom quantity. A sterile gauze pad

should be wrapped around the ampule

neck before breaking the top.3 This can

protect against cuts and catch airborne

powder or aerosol. If diluent is to be

added, it should be injected slowly downthe inside wall of the ampule. The ampule

should be tilted gently to ensure that all the

powder is wet before agitating it to

dissolve the contents.


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Nonliquid HD's

The handling of nonliquid forms ofHD's

requires special precautions as well.

Tablets which may produce dust or

potential exposure to the handler should

be counted in a BSC. Capsules, i.e., gel-

caps or coated tablets, are unlikely to

produce dust unless broken in handling.

These are counted in a BSC on equipment

designated forHD's only, because evenmanual counting devices may be covered

with dust from the drugs handled.

Automated counting machines should not

be used unless an enclosed process

isolates the hazard from the employee(s).


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Spills

. Personnel Contamination.

Contamination of protective equipment or

clothing, or direct skin or eye contact

should be treated by:

Immediately removing the gloves or gown.

Immediate cleansing of the affected skin

with soap and water.

Flooding an affected eye at an eyewashfountain or with water or isotonic eyewash

designated for that purpose for at least 15

minutes, for eye exposure.

Obtaining medical attention. (Protocols for


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Clean-up of Small Spills.

Liquids should be wiped with absorbent

gauze pads; solids should be wiped withwet absorbent gauze. The spill areas

should then be cleaned three times using

a detergent solution followed by clean

water.

Any broken glass fragments should be

picked up using a small scoop (never the

hands) and placed in a "sharps" container.

The container should then go into a HD

disposal bag, along with used absorbentpads and any other contaminated waste.

Contaminated reusable items, for example

glassware and scoops, should be treated

as outlined above under Reusable Items.


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Clean-up ofLarge Spills

When a large spill occurs, the area should

be isolated and aerosol generation

avoided. For spills larger than 5 ml, liquid

spread is limited by gently covering with

absorbent sheets or spill-control pads or

pillows. If a powder is involved, dampcloths or towels should be used. Specific

individuals should be trained to clean up

large spills.

Protective apparel, including respirators,should be used as with small spills when

there is any suspicion of airborne powder

or that an aerosol has been or will be

generated. Most CD's are not volatile; '


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Spills in BSC's. Extensive spills within a

BSC necessitate decontamination of all

interior BSC surfaces after completion of

the spill cleanup. The ASHP3 recommends

this action for spills larger than 150 ml or

the contents of one vial. If the HEPA filter

of a BSC is contaminated, the unit should

be labeled and sealed in plastic until the

filter can be changed and disposed ofproperly by trained personnel wearing

appropriate protective equipment.


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Medical Surveillance


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Documents

Occupational Risk of Anti Neoplastic Drugs