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8/4/2019 02 Safe Handling of Cytotoxic Drugs
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Lee Sing Chet
Oncology PharmacistTaiping Hospital
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What is Cytotoxic Drugs (CDs)?
Antineoplastic, anticancer or cancer
chemotherapy drugs
Ability to kill or arrest the growth of living cells
(both cancer cells and normal cells)
Hazardous drugs
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A drugs is considered hazardous if it exhibits 1 or more ofthe following 5 characteristics in humans or animals:
1. Carcinogenicity2. Teratogenicity or other developmental toxicity3. Reproductive toxicity4. Organ toxicity at low doses
5. GenotoxicityASHP
ASHP = American Society of Health-System Pharmacists
Hazardous Drugs
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List of Cytotoxic Drugs Available in HTPG
Fluorouracil (5-FU)250mg/5ml, 1g/20ml
Gemcitabine 200mg/vial, 1g/vial
Ifosfamide 1g/vial Methotrexate 50mg/2ml
Mitomycin-C 10mg/vial
Paclitaxel 30mg/5ml,100mg/17ml, 250mg/41.7ml
Vincristine 1mg/1ml
Oxaliplatin 50mg/25ml
Injection Forms
Bleomycin HCl 15mg/vial
Carboplatin 150mg/15ml,450mg/45ml
Cisplatin 10mg/ml, 50mg/50ml
Cyclophosphamide 200mg/vial,1g/vial
Docetaxel 20mg/vial, 80mg/vial
Doxorubicin 10mg/5ml
Epirubicin 10mg/5ml, 50mg/25ml
Etoposide 100mg/5ml
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Non-Cytotoxic Drugs
Injection Filgrastim (Neupogen) 300mcg/1ml(30IU/1ml)
Injection Folinic Acid (Leucovorin) 50mg/5ml
Injection Granisetron (Kytril) 3mg/3ml
Injection Ondansetron (Zofran) 8mg/4ml
Injection Pamidronate 30mg/vial
Injection Zoledronic acid 4mg/ml
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Potential Hazard From Cytotoxic Drugs
Since 1970s, a growing concern on the safety aspect ofhandling cytotoxic drugs
Acute Effects
- Severe soft tissue injury
- Dizziness, light-headedness, nausea
- Eye irritaion
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Chronic Effects
- Little is known of the long-term effects of exposureto small quantities of cytotoxic drugs over anextended period of time
- No exposure limits set for CDs
- Carcinogenic
- Teratogenicity
- Reproductive toxicity
- Genotoxicity
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- should be made aware of the potential risks
- where possible, be offered alternative duties
Pregnant Breast Feeding Planning Parenthood
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Evidence For Health Effects
Developmental & Reproductive Effects
A review of 14 studies :- exposure to antineoplastic drugs & adverse
reproductive effects association [Harrison 2001]
- major reproductive effects: fetal loss [Selevan et al. 1985; Stcker et al. 1990]
: congenital malformations depending on thelength of exposure [Hemminki et al. 1985]
: low birth weight and congenital abnormalities[Peelen et al. 1999]
: infertility [Valanis et al. 1999]
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Evidence For Health Effects
Cancer
A significantly risk of leukemia among oncology nurses- in the Danish cancer registry 1943-1987 [Skov et al. 1992]
A significantly risk of leukemia- among physicians employed for at least
6 months in a department where patientswere treated with antineoplastic drugs [Skov et al. 1990]
Estimated cyclophosphamide causes an additional1.4-10 cases of cancer per million workers each year.[Sessink et al. 1995]
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Who is at risk?
Manufacturers and shipping personnel
Pharmacists and pharmacy assistants
Doctors, medical assistants and nurses
Hospital attendants
Housekeeping
Family members and caregivers11
Everyone involved in handling CDs
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Exposure Routes
Inhalation of aerosols, particulates and droplets
Dermal contact/absorption
Unintentional ingestion from
hand to mouth contact
Unintentional injection
through a needlestick injury
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needlestick
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Reconstitutingpowdered CDs and further dilutingeither the reconstituted powder or concentratedliquid forms of CDs
Crushing tablets to make oral liquid doses
During the administration of drugs, either by directIV push or by IV infusion
Touch the outer vial of un-opened cytotoxic drugs
Will These Conditions Increase Risk of Exposure?
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Handlingpatientsbody fluids, clothing, dressings,linens, and other materials
Handling used IV line & branula
Expelling air from syringe filled with hazardous drugs
Removing and disposing of personal protective
equipment (PPE) after administration of chemotherapy
Sharing the toilet with chemotherapy patients
Will These Conditions Increase Risk of Exposure?
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1990, ASHP (American Society of Health-System Pharmacists)
: technical assistance bulletin (TAB)
: handling cytotoxic and hazardous drugs in 1990
1995, OSHA (Occupational Safety and Health Administration)
: new guideline
: occupational exposure to hazardous drugs
Guidelines
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Guidelines
2004, NIOSH (National Institute
Of Occupational Safety & Health)
: NIOSH Alert: recommendations for the
safe handling of hazardous
drugs
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Safety procedure at work
Preparation & dispensing
Administration
Storage & transport
Spill management
Waste management
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Preparation & Dispensing
Facilities
Cytotoxic cleanroom
- High Efficiency Particulate Air (HEPA) filters- Ventilated biological safety cabinet (BSC)
or isolator
- On-time maintenance
Restricted access & warning signs
- Anteroom and pass-through hatches
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Biological Safety Cabinet(BSC)
Isolator
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A. front opening
B. sash
C. exhaust HEPA filter
D. supply HEPA filter
E. negative pressureexhaust plenum
F. blower
Biological Safety Cabinet (BSC) Type II
Carbon Filters
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Personnel
Trained and validated personnel
Personnel Protective Equipment (PPE)
Not to be worn outside preparation area Stringent aseptic technique
- in conjunction with negative
pressure technique
Syringe should not be more than
three-fourths full when filled with the solution
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Personnel Protective Equipment (PPE)
Gloves
Double layer (chemo glove, powder free)
Change every 30 min and if theres a spill
Coverall or gown Chemo gown (disposable)
Respiratory protective device
NOT surgical mask
NIOSH certified N95
or more protective respirator
Face mask
N95 mask
Chemo gloves
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Others
Hair cover, eg bouffant cap or tudung cap
Boot cover or shoe cover
Eye and face protection
Should be used whenever there is a possibility
of exposure from splashing
Face shield is preferred over safety
glasses/goggles
Shoe cover Boot cover Bouffant cap
Safety goggles
Face shield
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Other specific methods of control
Luer-lock syringe Chemo Spike0.2 micron air venting filter
To ensure betterconnection of syringe
and needleTo capture aerosolization
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Special Device
"A device that mechanically prohibits the transfer ofenvironmental contaminants into the system and the
escape of hazardous drug or vapor concentrationsoutside the system.
......NIOSH
(closed system drug-transfer device, CSTD)
NIOSH = National Institute Of Occupational Safety & Health
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Special Device
Protect : the operator during preparation
: the administrator during drug administration
Eg. PhaSeal, CLAVE connector, TEVADAPTOR
MOH recommended
: use of PhaSeal system
: until hospital is equipped with clean room and BSC
BSC = biological safety cabinet
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CLAVE connector
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Special Device
MOH Health Technology Assessment Report
: PhaSeal system
- safe and effective in reducing contamination: Training of personnel
- to ensure the correct technique
: Drawback
- expensive
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Preparation & Dispensing
Drug packaging & transport
Tip of the syringes should be capped- with combi-stopper
- not with needles in place- to prevent puncturing the
leak-proof and sealed bag
Properly labelled
Sealed, leak-proof plastic bag
In a robust, hard-walled and securely closed container
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Preparation & Dispensing
Drug packaging & transport
Protected from light (not all but most)
Visually examine before removing it from theplastic bag/container
The transport container
- dedicated for cytotoxic drugs only- clearly labelled For Cytotoxic Drugs Only
Drug collection by well trained personnel only
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Storage of CDs
Dedicated storage area, separate from other drugs,
including fridge
Clearly labelled area with warning signs
Storage must be designed in a manner that will prevent
containers of CDs from falling
Storage conditions must be proper,
- eg. 5-fluorouracil and etoposide may precipitate if
refrigerated
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Oral Cytotoxic Drugs
Oral agents :
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Hydroxyurea 500mg
Letrozole 2.5mg
Methotrexate 2.5mg
Tamoxifen 20mg
Thioguanine 40mg
Oral Cytotoxic Drugs
Anastrozole 1mg
Bicalutamide 50mg
Capecitabine 500mg
Clodronate 800mg
Cyclophosphamide 50mg
Cyproterone 50mg
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Administration of Oral CDs
Wear gloves
Non-touch technique
: tablets/capsules are tipped from their container orenvelope directly into a disposable medication cup
Separate counting tray to be used
Not recommended to cut/crush tablets After administration, discard glove as cytotoxic waste
and wash your hands
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References
ISOPP Standards of Practice J Onco Pharm Practice (2007) Supplementto 13: 1-81
NIOSH Alert (CDC) : Preventing occupational exposures toantineoplastics & other hazardous drugs in health care settings 2004
Guide 2008: Cytotoxic drugs and related waste, Workcover New SouthWales, Australia
ASHP (US) Guidelines on Handling Hazardous Drugs, Am J Health-SystPharm. 2006; 63:1172-93
OSHA (US) Technical Manual Section VI: Chapter 2 Controlling
Occupational Exposure To Hazardous DrugsHealth and Safety Executive(HSE): Safe Handling of Cytotoxic Drugs, UK
Occupational Health and Safety Division, Canada : Cytotoxic Drugs, 1999
PhaSeal System For Chemopreparation, Health Technology AssessmentReport. 2008. Medical Development Division, MOH Malaysia.
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Thank you!