occupational risk of anti neoplastic drugs
TRANSCRIPT
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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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Effects of Antineoplastic Drugs
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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Effects of Antineoplastic Drugs
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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