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SAFE HANDLING
OF HAZARDOUS DRUGS
Presented by
Ph Waël ABI GHANEM
Chief Pharmacist
Saint George Hospital
University Medical Center
Hazardous Drugs
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Carcinogenicity
in animal models, in patient
population or both.
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Teratogenicity
in animal studies or in treated
patients.
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Fertility impairement
Genotoxicity (mutagenicity)
Evidence of serious organ, or other,
toxicity at low doses.
Hazardous Drugs
 Each facility or hospital should create its
own list of hazardous drugs based on
specific criteria.
 Examples :
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All Antineoplastic agents
Immunosuppressant agents
Antiviral agents
Routes of Exposure
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Via the lungs (Inhalation)
Via the digestive tract (Ingestion of
contaminated food stuffs)
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Via the skin and mucous membranes
(Mouth contact with hands)
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Via injection due to needle stick injuries
Possibility of Exposure
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Reconstituting powdered dugs
Administering hazardous drugs
Counting uncoated oral doses
Handling unused hazardous drugs
Decontaminating and cleaning drug
preparation or clinical areas
Removing and disposing PPE
Types of toxicity
Immediate :
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Personnel involved in preparation
Personnel involved in administration
Patient
Delayed :
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Personnel
Patient
Evidence of toxicity exposure
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Case reports in the literature range from skin-related and
ocular effects to flu-like symptoms and headache.
Reproductive studies on health care workers have shown
an increase in fetal abnormalities, fetal loss, and fertility
impairment resulting from occupational exposure.
A study done by Sessink et al. estimated that
Cyclophosphamide causes an additional 1.4 – 10 cases of
cancer per million workers each year.
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)
NIOSH ALERT 2004
Preventing
Occupational
Exposures to
Antineoplastic and
Other Hazardous
Drugs in Health Care
Settings.
NIOSH ALERT
WARNING!
Working with or near hazardous drugs
in health care settings may cause skin
rashes, infertility, miscarriage, birth
defects, and possibly leukemia or other
cancers.
Recommendations
Policies and Procedures for the safe
handling of Hazardous Drugs must be in
place for all situations in which these
drugs are used throughout a facility.
Recommendations
Developing a “Safety Program” with the following
goals:
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Protect and secure packages of hazardous drugs
Inform and educate all involved personnel about
hazardous drugs
Do not let the drugs escape from containers when they
are manipulated
Eliminate the possibility of inadvertent ingestion or
inhalation and direct skin or eye contact with the drug
Recommendations
TWO GOALS:
 Maintaining physical integrity of
packages
 Safe Handling Procedures
GOAL 1 : Maintaining physical
integrity of packages
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Access to all areas where hazardous drugs are stored
is limited to specific authorized staff
A method should be present for identifying to
personnel those drugs (WARNING LABEL )
Methods for identifying shipping cartons required
from distributors
Written procedures for handling damaged packages
Facilities for storing hazardous drugs are designed to
prevent breakage
Methods for transporting
Goal 2
Safe Handling
Procedures
-1-
Written policies and standard procedures
are maintained.
-2Orientation Program:
 Theoretical Knowledge
 Practical Training
-3System for verifying and documenting
acceptable staff performance
-4Information on the drug (Toxicity,
Solubility, Stability…)
⇨MSDS (Material Safety Data Sheets)
5- Rooms and Equipment
A) Work Area
5- Rooms and Equipment (ct’d)
B) Make ready room
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Materials needed for the preparation
Solutions ready for dispatch
C) Air Lock
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One room
Two separate rooms
Windows integrated in the door
Sliding mechanism to open the window to the
preparation room
5- Rooms and Equipment (ct’d)
D) Preparation room (1)
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Room size : min 10 m²
Height
: min 2.50m
Walls, ceilings and floors
Cleanness of the room
E) Preparation room (2)
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Safety workbench
Two way intercom
Storage facilities for limited quantities of drugs
Cleaned seatings
Waste containers
Decontamination kit
Possibility of direct documentation of the preparation
F) Safety work
Benches
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Biological safety
cabinets
(Ventilated
Cabinets)
Biological safety cabinets (1)
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Different classes: I, II, III
Isolators
Class II : A,B1,B2,B3
Isolators
What is recommended?
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BSC Type II B Class B2 or B3
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Isolators
6- Personal Protective
Equipment
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It is the third measure to be taken in
addition to organizational measures and
the technical equipment
Personal Protective Equipment
A) Overall/Protective gown
 Used for: compounding,
administration, spill
control, waste
management
 Closed up to neck
 Long sleeves with closefitting cuffs
 Lint free
 Liquid repellent
 Single-use
Personal Protective Equipment
B) Single-use gloves
 To be worn at all times
 Suitable gloves or glove
combinations
 Sterile, powder free
 Criteria for selecting gloves:
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Material properties
Size and fit
Safety during use (grip)
Tested for freedom from holes
Detectability of any damage
Health of the personnel
Personal Protective Equipment
C) Additional PPE
 Eye & Face protection: Face shield
 Respirators: Fit tested, based on OSHA
standards.
 Shoe & Hair covering
7- Technical Equipment
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3-layer work underlay
Sterile compresses and swabs
Single-use syringes
Cannulas (needles)
Container for discarded cannulas
Waste container
Closed system, Drug-transfer devices (Mixing
adaptor, phaseal,…)
8- Manipulative Procedures
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General Techniques (Use of luer-lock
syringes….)
Aseptic & Negative pressure Techniques
Validation:
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Rooms with respect of cleaning and hygiene
Cytostatics workbench
Work materials
Starting materials
Aseptic Technique: Demonstration of Competence
9-Requisition of cytostatic
solutions
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Requisition form:
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Name & gender
Body weight, height and /or BSA
Cytostatic prescribed
Dosage
Type of carrier solution
Volume of the ready-to-administer solution
Required administration time
Signature of doctor, date
Etc….
10-Preparation
A-Work Sheet for the Drug
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Name of cytostatic
Kind and name of finished drug to be used
Types and names of medical devices
Method of proper preparation
Kind of packaging
Information on label
10-Preparation (ct’d)
B-Documentation
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Time at which the preparation started
Batch number of the finished drug used (
cytostatics, solvents,..)
Quantity of cytostatics used
Unusual incidents during the preparation
Name and signature of the person
Etc…
10-Preparation (ct’d)
C-Label
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Name of the pharmacy
Name of the patient
Ward, bed number
Name and quantity of the cytostatic
Type and volume of carrier solution
Method of administration
Required time of administration
Storage conditions
Date of expiry
11- Administration
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General Recommendations
IV Cytotoxic chemotherapy should be
administered by nursing personnel who
have received specialized education and
training, and they should be able to
demonstrate their competency on a
regular basis.
11- Administration
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Oral Preparations
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PPE: Gloves, Gowns
Number of tablets to be given should be
shaken from the bottle into a medicine
cup, without skin contact.
Cytotoxic tablets and capsules must never
be crushed, powdered or opened in any
way, for ease of administration.
11- Administration
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IV Preparations
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PPE: Gloves, Gowns, Eye protection
Staff should check the blood return in the
catheter to confirm the patency prior to
administration.
On completion of administration, an
appropriate solution should be infused to
flush any remaining cytotoxic out of the
line, then the line may be disconnected.
What to Check before
Administration
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Review the Physician Order
Read the label on the infusion bag:
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Check for
Check for
order)
Check for
Check for
Check for
Check for
the name of the patient
the name of drug (same as
the dose
the Administration route
the rate of infusion
any special handling conditions
What to Check before
Administration
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Pre-Infusion parameters have to be met
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Required laboratory tests
Echocardiogram
All pre-medications are given
Etc…
Personnel Protection
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Strict adherence to safe working practices.
Personal Protective Equipment
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Gown (of impermeable material)
Gloves (the gloves must cover the gown on the
wrist)
Mask
Use a new pair of gloves for each patient.
Change the gloves if damaged or significant
contamination occurs
Any cuts or scratches on the nurse’s hands
should be covered with waterproof dressings
to prevent infiltration of the site.
Personnel Protection
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Nurses should take precautions to
prevent skin contact with the Cytotoxic
drug that they are administering
without causing unnecessary alarm to
patients.
Always disinfect hands before the
administration procedure.
Wash hands with soap and water after
finishing the drug administration.
General Guidelines
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Be careful while giving injections in order to
prevent extravasations.
Be careful during the
connection/disconnection of the bag or
syringe to the administration device.
Never remove the tubing from an IV bag
containing a Cytotoxic drug, and don’t
disconnect the tubing at other points in the
system until the tubing has been flushed well
with a non toxic solution.
12- Spill Management
Policies & Procedures:
 To attempt to prevent spills
 To govern cleanup of spills (size,
location,…)
 To define the responsibility of spill
management
12- Spill Management
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A spill kit should be present at the
nursing unit where administration takes
place.
The concerned personnel should be
trained to the use of the kit.
Do not forget to report any accidental
spillage.
Decontamination Set-Spill kit
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Instructions for use
Emergency signs
Single-use overall or gown
Overshoes
Respiratory protection mask
Protective gloves
Disposable clothes
Water and ethanol
Waste containers
Documentation forms
13-Waste Management
Cytotoxic waste is considered to be all those
materials which have come into contact with
cytotoxic drugs during reconstitution and
administration:
 Syringes, needles, transfusion sets…
 Empty or partially used vials
 PPE
 Materials used for clean up
 Air filters
 Expired drugs
13-Waste Management
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Cytotoxic waste must be segregated,
packaged and disposed of in a way that
personnel and environment are not
contaminated.
Cytotoxic waste must be incinerated in
a facility approved by an environmental
protection authority.
Guidelines on hazardous drugs
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American society of health system pharmacists
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1985,1990
2005: guidelines on handling hazardous drugs
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NIOSH (Natl. Institutes of Occupational Safety and Health)
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2004:NIOSH Hazardous Drug Alert
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http://www.ashp.org/bestpractices/new/HD-Prepub-final.pdf
Appendix A: Sample list
http://www.cdc.gov/niosh/docs/2004-165/
ISOPP Standards
International Society of Oncology Pharmacy Practitioners
OSHA (Occupational Safety and Health Administration)
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1986
1995: Controlling Occupational Exposure to Hazardous Drugs
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http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
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