Download Pharmacology and the Nursing Process, 4th ed. Lilley/Harrington

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Program Learning Objectives
At the completion of this program, participants should be able to:
1. Describe the potential health risks of handling hazardous drugs in
oncology nursing practice.
2. Identify the appropriate PPE needed for safe handling of hazardous
drugs.
3. Review current recommendations and guidelines for safe handling
of hazardous drugs.
4. List recommended practices for the safe handling of hazardous
drugs during drug administration and disposal of drugs.
5. List recommendations for medical surveillance for nurses who
handle hazardous drugs.
6. Describe essential elements of staff education/training related to
safe handling of hazardous drugs.
3
To ensure patient and staff safety in the receipt,
storage, preparation, transport and
administration of chemotherapy as well as
during waste handling and equipment
maintenance and repair.
Definition of Hazardous Drugs
• Carcinogenic
• Teratogenic
• Reproductive toxicity
• Organ toxicity at low doses in experimental animals or
treated patients
• Genotoxic
• Structure or toxicity similar to drugs classified as hazardous
(NIOSH, 2004)
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Reproductive Effects





Increased fetal loss
Congenital malformations depending on length
of exposure
Low birth weight
Congenital abnormalities
Infertility
• Kaiser Permanente Center for Health Research
• 7,094 pregnancies of 2,976 pharmacy and nursing staff studied
• Exposure of mother to handling antineoplastic agents during
pregnancy was associated with a significant increased risk for
spontaneous abortion and stillbirth
• Increased risk for miscarriages by 40 - 50%
• Increased risk for low birth weight by 17-fold
• Increased risk for congenital malformations by 5-fold
Source: Journal of Occupational & Environmental Med Vol.41; 8: 632-638
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End Organ Damage
• Liver damage was reported in the literature on
three nurses (working 6, 8 and 16 years) with
chemotherapeutic agents
• Cardiotoxicity related to the use of anthracyclines
Source: Sotaniemi EA, Sutinen S, Arranto AJ et al. Liver damage in nurses handling cytostatic agents. Acta Med Scand. 1983; 214:181-9.
• Fetal abnormalities (Hemminki et al, 1985)
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
In response to numerous inquiries,1 OSHA
published guidelines for the management of
Cytotoxic (antineoplastic) drugs in the work
place in 1986.

Occupational
Administration
Safety
and
Mosby items and derived items © 2007, 2005, 2002 by Mosby, Inc., an affiliate of Elsevier Inc.
Health
NIOSH ALERT 2004
Preventing
Occupational
Exposures to
Antineoplastic and
Other Hazardous
Drugs in Health Care
Settings.

In order to provide recommendations
consistent with current scientific knowledge,
this informational guidance document has
been expanded to cover hazardous drugs
(HD), in addition to the cytotoxic drugs (CD)
that were covered in the 1986 guidelines.

By definition a drug is deemed hazardous if it
causes harm to organs
Mosby items and derived items © 2007, 2005, 2002 by Mosby, Inc., an affiliate of Elsevier Inc.

A number of pharmaceuticals in the health
care setting may pose occupational risk to
employees through acute and chronic
workplace exposure

This recognition prompted the American
Society of Hospital Pharmacists (ASHP) to
define a class of agents as "hazardous
drugs".
Mosby items and derived items © 2007, 2005, 2002 by Mosby, Inc., an affiliate of Elsevier Inc.
EXAMPLES OF HAZARDOUS
DRUGS
 Antineoplastic
 Antiviral
agents
agents
 Hormonal
agents
 Immunosuppressant
 Some
antibiotics
agents
Hazardous Drugs
 Each facility or hospital should create its
own list of hazardous drugs based on
specific criteria.
Exposure Opportunity is Increasing
• WHO estimates a 50% increase in cancer patients
in the next 20 years
• Use of drugs for non-malignant disease (RA, SLE)
• Anti-viral agents for HIV treatment and other viral illnesses
• Investigational (IND) Drug Development/Clinical Trials
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Cancer Risk in Workers
• Leukemia in nurses (Skov et al, 1992)
(RR = 10.65)
• Cyclophosphamide (Sessink et al, 1993)
(1.4-10 excess cases/million)
• NHL & skin cancer (Hansen & Olsen, 1994)
(SIR = 3.7)
•
Overall increased cancer risk (Martin, 2005)
(OR = 3.27)
RR = Relative Risk; SIR = Standardized Incidence Rate; OR = 16
Odds Ratio
Evidence of toxicity exposure
39 year old pharmacist suffered episodes of
painless hematuria and was found to have
cancer (papillary cell carcinoma). 12 years
before her diagnosis, she had worked full
time for 20 months in a hospital IV
preparation of Cytotoxics. She used a
horizontal laminar flow hood. Because she
was a nonsmoker and had no other known
occupational or environmental risk factors,
her cancer was attributed to her exposure to
antineoplastic drugs.(Levin et al. 1993)

The recommendations apply to all settings
where employees are occupationally exposed
to HD's, such as hospitals, physicians' offices
and home health care agencies
Mosby items and derived items © 2007, 2005, 2002 by Mosby, Inc., an affiliate of Elsevier Inc.
Scope of Affected Workers

ASHP Guidance increases scope of affected
workers to include:

Wholesale drug distribution personnel
 Healthcare facility receiving personnel
 Healthcare facility personnel involved in cleaning
and housekeeping
 Waste handling personnel
Mosby items and derived items © 2007, 2005, 2002 by Mosby, Inc., an affiliate of Elsevier Inc.
Handling Antineoplastic Drugs
(cont’d)

During care of a patient receiving these drugs,
special precautions may be implemented, depending
on facility policies


Double flushing of bodily fluids in the commode
Special hampers for disposal of all objects that contact the
patient’s body fluids
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Modes of Contact for Drug Exposure
to Healthcare Worker
• Dermal*
– Direct contact
– Contaminated surfaces
• Ingestion
– Food, gum
– Hand-to-mouth
• Inhalation
– Aerosols
– Vapors
• Injection
– Sharps
– Breakage
*Most common source of exposure (NIOSH, 2004)
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Closed System for Cytotoxic
Handling
Closed-system drug-transfer devices mechanically prevent
the transfer of environmental contaminants into the system
and the escape of drug or vapor out of the system.
ADD-Vantage and Duplex devices are closed-system drugtransfer devices currently available for injectable antibiotics
and PhaSeal for hazardous drugs .
This multicomponent system uses a double membrane to
enclose a specially cut injection cannula as it moves into a
drug vial, Luer-Lok, or infusion-set connector.
It should be noted, that PhaSeal components cannot be used
to compound all hazardous drugs.
Evidence of Exposure
• Positive florescent scans (Valanis, 1998)
• Positive urine tests for drug exposure
– 18 Published studies
• 16 detected drugs in urine
• In 4 studies, drugs were found in the urine of workers
with no direct HD contact
• Contaminated vials - 12 studies since 1992
• Surface contamination - 14 studies since 1994
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Surface Contamination of
Primary Packaging
Liege Study:
Surface of 90 vials 5-FU tested, 3
suppliers
27/90 – 5-FU above LOD (0.3ng) but
below LOQ (1ng)
3/90 – 5-FU above LOQ (4.8-18.1ng/vial)
Delporte etal EHP (1999) 5 (3) 119-121
Favier etal: External
Contamination of Vials
Vials of 5-FU, Etoposide, Ifosfamide,
Cyclophosphamide, Doxorubicin, Docetaxel.
100% had contamination on outer surfaces
Contamination/ vial ranged 0.5 – 2500ng
Differences between manufacturers
Favier et al: J Oncol Pharm Practice (2003), 9, 15-20
Preparation & Administration
Areas: Surface Contamination
Six US/Canadian centres studied
Contamination detected in 75% pharmacy
and 65% administration areas
Pharmacy; highest levels on work surface
and airfoil of BSC and floor in front of BSC
Clinic; highest levels on floor by bed
Connor etal, Am J H-S Pharm (1999),56,1427
Drug Reconstitution With Needle & Syringe
31
Transfer of Contamination from IV Bag
Photographs courtesy of L. Hampton, RN, MS, FNP;
Donayre Cancer Center, Whiteville, NC. Reproduced with permission.
32
Where Else?
Photographs courtesy of L. Hampton, RN, MS, FNP; Donayre Cancer Center, Whiteville, NC. Reproduced with permission
.
33
On the Floor…
Photograph courtesy of Libby Hampton, RN, MS, FNP; Donayre Cancer Center, Whiteville, NC. Reproduced with permission.
34
OCCUPATIONAL
MONITORING
 URINE
ANALYSIS FOR
SELECTED DRUGS
 Most
studies have been performed in
Europe
 In
18 studies, all but two studies detected
drugs in the urine
 In
four studies, drugs were found in the
urine of workers who were not handling
them

The packaging (cartons, vials, ampuls) of hazardous drugs
should be properly labeled by the manufacturer with a
distinctive identifier to wear appropriate personal
protective equipment (PPE) during their handling. Sealing
these drugs in plastic bags at the distributor level.

Visual examination of cartons for outward signs of
damage or breakage is an important first step in the
receiving process.

Labeling from Point of Receipt: Drug packages, bins,
shelves, and storage areas for hazardous drugs must bear
distinctive labels identifying those drugs as requiring
special handling precautions.

Segregation of hazardous drug
improves control and reduces the
number of staff members potentially
exposed to the danger

Storage in an area with sufficient general
exhaust ventilation to dilute and remove any
airborne contaminants

Protection from potential breakage by storage
in bins that have high fronts and on shelves that
have guards to prevent accidental falling

Wearing double gloves and using respirators when stocking and
inventorying these drugs and selecting hazardous drug packages
for further handling. Surgical masks do not provide adequate
protection from the harmful effects of these drugs.

Transporting should be done in a manner to reduce
environmental contamination in the event of accidental dropping.

During transporting, packages must be placed in sealed
containers and labeled with a unique identifier. Carts or other
transport devices must be designed with guards to protect
against falling and breakage.
Safety training that includes spill control and have spill kits
immediately accessible
 Written procedures for handling damaged packages

Notification by Drug Distributor
•Sealed tote
•External warning labels
•Chemo drugs should
be in ziplocked bags
labeled as chemotherapy
Photos courtesy of
Robert DeChristoforo, MS
Deputy Chief,
Pharmacy Dept.,
NIH Clinical Center Pharmacy
Protection of Hazardous Drugs
in Transit & Storage
• Labeling of cooler for refrigerated products
•Air pillows to protect product in transit
•High-walled shelf container
Photos courtesy of
Robert DeChristoforo, MS
Deputy Chief,
Pharmacy Dept.,
NIH Clinical Center Pharmacy
Protection of Hazardous Drugs
in Transit & Storage
Photos courtesy of
Robert DeChristoforo, MS
Deputy Chief,
Pharmacy Dept.,
NIH Clinical Center Pharmacy
1 - Written policies and standard
procedures are maintained.
2 - Orientation Program:
 Theoretical Knowledge
 Practical Training
3 - System for verifying and documenting
acceptable staff performance
4 - Information on the drug (Toxicity,
Solubility, Stability…)
⇨MSDS (Material Safety Data Sheets)
A comprehensive safety program must include a process for
monitoring and updating the MSDS database.
5- Rooms and Equipment
A)




Work Area
Biological safety
cabinets (1)
Different classes: I,
II, III
Isolators
Class II : A,B1,B2,B3
Biological safety cabinets (2)
A- Differences


Type II A : recirculating to the work room
Type II B : outside exhaust
 B1 : exhaust 70 %
 B2-B3 : exhaust 100 %

Hepafilters, UV lights
B-Certification
C-Cleaning : water for injection
D-Disinfecting : 70 % alcohol
E-Decontamination