Safe Handling of Hazardous Drugs
Safe Handling of Hazardous Drugs Created by: • Mary Lynn Rae, MSN RN CPHON®
Learning Objectives At the conclusion of this section, learners will be able to:
Describe the occupational exposure risks of chemotherapy and biotherapy 1
List components of safe handling and disposal practices 2
Describe safe handling in the home 3
What are your biggest fears related to safe handling of hazardous drugs (HDs)?
Urban legends
Safe handling incidents
Fears
Hazardous Drugs (HDs) Include:
Antineoplastic chemotherapy
Antivirals
Biologics
Immunosuppressive agents
p. 149
Hazardous Drugs (HDs)
Require special precautions by health care workers 1
Safe levels of exposure have not been determined by a reliable method 2
Healthcare workers must adhere to safe handling practices that minimize exposure 3
p. 149
HD Resources
2
NIOSH Antineoplastic HD List and Other Hazardous Drugs in Healthcare Settings 2016 , with periodic updates every 2 years 1
Drug Package Inserts 3
Drug Formulary 4
Safety Data Sheets (SDS)
p. 149
NIOSH Tables 2 and 3 are left up
NIOSH Antineoplastic HD List and Other Hazardous Drugs in Healthcare Settings 1 2 3
to interpretation by each individual hospital for appropriate safety precautions/PPE
Each hospital must do a risk assessment
NIOSH Table 1. Group 1: Antineoplastic drugs • Highest level of precaution per (USP) <800>
NIOSH Table 2. Group 2: Non-antineoplastic drugs
NIOSH Table 3. Group 3: Non-antineoplastic drugs
p. 149
HD Institutional Oversight
Designated Individual
Develops and implements HD procedures
Oversees compliance and competency
p. 149
Occupational Safety and Health Administration (OSHA) National Institute for Occupational Safety and Health (NIOSH) American Society of Health-System Pharmacists (ASHP)
*NEW*: U.S. Pharmacopeial Convention published (USP) CHAPTER <800> HAZARDOUS DRUGS
Safe Handling Guidelines
APHON
Oncology Nursing Society (ONS)
p. 149
Specific to the United States → for other countries see notes
(USP) CHAPTER <800>
(USP) CHAPTER <800> HAZARDOUS DRUGS is “the nation’s first set of authoritative standards on handling of hazardous drugs by healthcare personnel”
Enforceable through (update here as updates occur) State Board of Pharmacy US Food and Drug Administration Potentially through: • Centers for Medicaid and Medicare Services (CMS) • Joint Commission
p. 149
HDs and Health Risks per NIOSH
Teratogenicity or developmental toxicity
Carcinogenicity
Genotoxicity
Reproductive toxicity or fertility impairment
Organ toxicity at low doses
p. 149
What are the 4 HD Routes of Exposure/Contamination?
Absorption
Injection
Ingestion
Inhalation
Contamination Example: Touching IV bag or putting IV bag on the counter
without gloves on (or with gloves on) and using those same gloves/hands to answer the phone or touch the IV pump
p. 150
What are some ways in which HDs are released into the environment?
IV Bags, Tubing, Connections
Transferring medications
Expelling air
Vesicants
Handling of bodily fluids
Disposing of HDs
Contact
Spills
Mixing
p. 150
What are some possible symptoms of acute exposure related to HDs?
Hair loss
Abdominal pain
Fatigue
Nausea
Nasal/throat irritation or sores
Contact dermatitis or erythema
Allergic reactions
Eye irritation/injury
p. 150
HDs and Healthcare Workers (HCW)
HDs are detectable in the environment
Chronic Exposure
HDs and urine of HCWs
• Phones • Counters • Elevator buttons • IV pumps
HDs and surface contamination
p. 150
Hierarchy of Exposure Routes
Administration Handling Urine Handling Feces Handling Intact Oral Pills
Compounding Spill Management
p. 150
Safe administration, storage, transport, and disposal of HDs
Hospital Policies MUST Include:
Mandatory training
Monitoring of long-term occupational exposure
HD Spill Management
Exposure prevention measures
p. 151
Engineering Controls
•Ventilation/air exchange requirements •Separate preparation/storage areas from non-HDs •Negative pressure rooms •Biological Safety Cabinets (BSCs) Pharmacy Examples: •Closed System Transfer Device (CSTD) Nursing Examples:
Figure 6.1: Hierarchy of Hazard Controls
p. 151
Review your hospital’s CSTD
Closed System Transfer Device (CSTD)
Examples: • ChemoClave • ChemoLock • Equashield II • PhaSeal • Spiros • Tesium/SmartSite • Tevadaptor • Vialshield
Prohibits transfer of environmental contaminants and the escape of HDs or vapor concentrations
(USP) CHAPTER <800> mandates the use of CSTDs for administration of ANTINEOPLASTIC HDs
p. 151
Administrative Controls
Policies and procedures
Figure 6.1: Hierarchy of Hazard Controls
Staff compliance
Scheduling
Staff Competency Validation
Staff Education
From the National Institute for Occupational Safety and Health available at https://www.cdc.gov/niosh/topics/hierarchy/
p. 152
Figure 6.1: Hierarchy of Hazard Controls
Administrative Controls Include:
• Per USP <800>: personnel who may be exposed to hazardous chemicals when working must be provided information and training before the initial assignment to work with a hazardous chemical, and also whenever the hazard changes • Per USP <800>: personnel of reproductive capability must confirm in writing that they understand the risks of handling HDs
Medical Surveillance
Risks of exposure
Reproductive Risks
Training
p. 152
Figure 6.1: Hierarchy of Hazard Controls
Environmental and Quality Controls
Wipe samples of the environment are recommended but not required per USP <800>:
Pharmacy
Equipment
Prep areas
Adjacent work areas
Patient admin areas
p. 152
Figure 6.1: Hierarchy of Hazard Controls
Personal Protective Equipment (PPE)
BEST way to prevent exposure to HCW
Primary responsibility with HCW
Includes: • Double chemo gloves • Chemo gowns • Face/eye protection • Respiratory protection
Must be worn when administering HDs
p. 152
What are some situations when PPE must be worn?
Expelling air (not recommended) or transferring medications using needles or syringes *Handling bodily fluids from patients who received hazardous drugs within the last 48 hours
Preparing oral drugs that must be compounded or crushed
Preparing or transferring medications from vials or ampules
Spiking, priming, or changing IV equipment
Having contact with leaking tubing or connection sites
Managing cytotoxic spills
Disposing of hazardous drugs; mixing materials
p. 152
PPE: Gloves
Double gloves are mandated by (USP) Chapter <800>
Tested by American Society for Testing Materials (ASTM) D6978-05 standards (2013) • Look to ASTM testing for drug penetration times Inner glove (under the gown cuff) and outer glove (over the gown cuff)
Disposable, powder-free
Hand hygiene with soap and water Alcohol gel not recommended
Longer cuffs preferred
p. 152
PPE: Gowns
Solid front with long sleeves and fitted cuffs
Disposable Lint free
Made of polyethylene- coated polypropylene or other laminate materials
Meant for single use only and should not be re-used
Must be removed before leaving the HD area to avoid contamination
Must close in the back
p. 153
PPE: Face Protection
Must be worn if there is possibility of splashing or eye exposure Goggles must be used when eye protection needed
Examples include: working above eye
A full-face shield provides eye and face protection
level, cleaning spills, surgery
Holding for lumbar punctures
Eye glasses do not protect from splashes
would also be included
p. 153
PPE: Respiratory Protection
A surgical mask does not protect against aerosols or vapors
A power air-purifying respirator (PAPR) or full faced chemical cartridge respirator is required for
An N95 respirator may be used for a barrier for airborne particles but not gas or vapors
Not recommended during routine administration of HDs
Cleaning up larger spills that cannot
be contained with a spill kit
For drugs that have the potential to produce vapors for spill cleanup
p. 153
Identified Agents That Have the Potential to Cause Vaporization Include:
Carmustine (BiCNU®)
Ifosfamide (Ifex®)
Nitrogen Mustard (Mustargen®)
Cisplatin (Platinol®)
Fluorouracil (Adrucil®)
Thiotepa (Thioplex®)
Cyclophosphamide (Cytoxan®)
Etoposide (Toposar®)
p. 153
Appropriate PPE by Route Form/Route of Administration Double Gloves Protective Gown
Face/Eye Protection
Respiratory Protection
Intact tablet/capsule No,
No
No
No
single gloves
Manipulated tablet/capsule
Yes
Yes
Yes, if possibility of liquid splash Yes, if not crushed/mixed in a control device
Oral Liquid
Yes Yes
Yes Yes
Yes, if possibility of liquid splash No
SubQ/IM Injection * DO NOT prime needle
Yes, if possibility of liquid splash If inhalation potential
Intravenous Solution Yes
Yes Yes Yes Yes
Yes, if possibility of liquid splash If inhalation potential Yes, if possibility of liquid splash If inhalation potential
Topical Drug
Yes Yes Yes
Irrigation (i.e. surgical) Inhalation (i.e. neb)
Yes Yes
Yes Yes
p. 154
Wash hands with soap and water
Inner pair of gloves
Outer pair of gloves
Face/Eye Protection
Gown
Doffing of PPE Routine (non-spill)
Demonstrate how to DOFF PPE
Labeling and Storage
Medications must be labeled clearly for content and hazardous nature
Sealable plastic bags must be used to transport medications for use
Any areas that contain chemotherapeutic materials must have locks and other devices to make the area inaccessible to children
Pneumatic tubes must not be used to transport any liquid or antineoplastic HDs
p. 153
Safe Handling: Overall Points
Know where your spill kits are & how to clean up a spill
Wash hands with soap & water vs. hand sanitizer
Wear appropriate PPE!
All drugs must be prepared in the pharmacy with engineering controls & aseptic technique
Check HDs in sealed bags and in designated areas
Always work below eye level
p. 153
Safe Handling: Overall Points
HCW must take extra precautions to decrease exposure if mixing PO, NG, GT meds
Pharmacy should not overfill syringes by more than 75% full
PO, NG, GT meds must be crushed in pharmacy A CSTD must be used on syringes and IV tubing per (USP) <800>
Do not touch HDs with bare hands
Do not express air from a syringe into the air
p. 153
Safe Handling: Overall Points
Priming of IV tubing
HD labeling and transport
Luer lock connections
IV bag spikes and tubing re-use
IV tubing labeling
Disposal
p. 154
Physical HD Check Standard • HDs should not be touched without wearing gloves • HDs should be checked through the bag if possible • If syringe label cannot be seen, must put on chemo mat • HDs should not be left to sit on: • Tables/countertops • Charts
• Bedside tables • Nurse servers
• Even touching the bag in the patient room to check it or while hanging on IV pole →need to at least wear gloves
36
Chemotherapy Mats
Use for pushing chemo
Use as work surface for mixing oral chemo
Use it to set down your supplies once the chemo is out of the bag
Disposal Guidelines: Hazardous Medical Waste Containers
Must be available where HDS are prepared & administered
*Puncture proof *Secure lid *Labeled as hazardous
Discarded items:
Hazardous medications Post-administration (i.e. IV tubing)
Transport medication bags
Gowns (do not re-use)
Gloves
Diapers
Hats/urinals
Unused medications returned to pharmacy
p. 155
Body Fluid Guidelines
Some HDs may require a longer period of protection due to half life
General rule for precautions = 48 hours
Use double gloves and disposable gown
Bed pans
Face shield: if risk of splashing
Hats
Use disposable:
Urinals
Linens: refer to hospital policies on contaminated linens
Emesis basins
Diapers
p. 155
Toilets and Flushing
Patients may use regular toilet facilities
Plastic-backed pads or covers over an open toilet?
Double Flushing?
Without lids in hospitals → may increase aerosolization
p. 155
Accidental Exposure
Seek medical treatment as soon as possible!
Refer to hospital policies
Notify a member of your leadership team
Refer to SDS
p. 155
Types of Exposures and Immediate Treatment Skin •Remove clothing & treat as hazardous (discarded) •Wash with soap and water Eyes •Know location of eye wash station •Flush eye with tap water or saline solution for at least 15 min Mucous Membranes •Flush with tap water or saline solution •Example: mouth
p. 155
Per USP <800>: Clothing Exposure
Clothing may retain HD residue from contact • Can transfer to other healthcare workers and surfaces Washing of non-disposable clothing contaminated with HD residue → refer to hospital policy
Potentially contaminated clothing must not be taken home under any circumstances
p. 155
Spill Management: Key Points
Spill kits need to be available where all cytotoxics are: •Stored •Prepared
All personnel must be trained in spill management who: •Prepare • Transport • Administer
• Transported • Administered
p. 156
Spill Management: Spill Size
A spill that requires > 2 spill kits needs further assistance
Out with the old! No longer defined by small spill (< 5 mL) vs. large spill (> 5 mL)
Hospital policies should differentiate who is responsible for cleaning up spill and decontamination based on spill volume
Bottom line there is no definition!
i.e., “X” mL can be cleaned by a nurse, but “X” mL needs to be cleaned by a designated team
p. 156
Common Contents of a Spill Kit Quantity Item 1 Poly-coated, maximum protection chemo gown 1 pair Chemical resistant shoe/leg covers (to knees) 2 pairs Chemotherapy gloves 1 pair Chemical splash goggles (side paneled) 1 NIOSH approved respirator mask 1 Disposable dust pan (scoop/scraper) 3 Spill absorbent towels 2 Chemosorb pads 2 Large, heavy duty waste disposal bags and tie wraps 1 Hazardous waste label/chemo caution sign
p. 157
Spill Management: Step by Step Process
DOFF PPE → wash hands with soap and water
USP <800> Potentially
Clean and rinse the area per your policy Dispose of equipment in puncture proof bags/waste container
Post a warning sign
contaminated clothing must not be taken home under any circumstances Treat every spill as if it was a CLABSI Mini-RCA
Designated team to re-clean area
Don full PPE
Report the spill per hospital policy
Don respirator mask or PAPR
Absorb the spill
p. 156
Doffing of PPE: Sequence Post Spill Clean Up
Outer pair of gloves
Face/eye protection
Shoe/leg coverings
Gown
Wash hands with soap and water
Inner pair of gloves
Respirator/Mask
p. 156
Seek 2 volunteers to practice cleaning up a spill Use your own hospital based spill kits/equipment
Staff Training
All personnel that handle HDs must have initial training before the employee handles HDs
Training must be re-assessed and documented yearly per (USP) CHAPTER <800>
p. 157
Annual Staff Training Must Include:
Review of hospital based standard operating procedures (SOPs)
List of hospital-specific HDs
Risks associated with HD handling
Proper use of PPE and CSTDs
Proper use of hospital based equipment & devices
HD exposure and action plans
Spill management
HD disposal
Access to safety data sheets (SDS) for HDs
Review of reproductive risks
p. 157
HDs may be administered
Compliance with OSHA or agency standards for PPE may be more difficult
in the home by caregivers and/or patients
Safe Handling in the Home
Disposal of waste products or leftover HD medications State and county regulations dictate proper disposal in the home
p. 157
Safe Handling in the Home
Written instructions required to minimize exposure
HD spill kit should be available in the home
p. 157
Safe Handling in the Home - PO Drug Education Must Include:
Safe handling
Disposal
Mixing
p. 157
Precautions for pregnant caregivers
Specific home care instructions for caregivers should include the following:
Proper use of personal protective equipment
Designated workspace for HDs
Wearing gloves when handling PO HDs
Crushing tablets or opening capsules should be avoided if possible
p. 157
Emergency interventions for accidental drug exposure Medication-specific exposure hazards Types and prevention of exposures
Specific home care instructions for caregivers should include the following:
How to clean up a spill
p. 158
Specific home care instructions for caregivers should include the following:
Containers for disposal of HDs including location
Review of disposable equipment
State and county regulations regarding disposal of HDs
Handling of body fluids
p. 158
Pearls for Practice Know which HDs are handled with cytotoxic precautions at your hospital Review your hospital policies
Wear the appropriate PPE according to route
Know how to clean up a spill
Know what to do for accidental exposure
Questions?
DOFF EM’ OFF • Need 6 volunteers • Use slides provided (see games) • Volunteers will each be given a step • In silence (the volunteers) have to put the steps in order for cleaning up a spill • Play some fun music as per below! • Audience votes
https://www.youtube.com/watch?v=XAYhNHhxN0A
SPILL DRILL • Need 9 volunteers • Use slides provided (see games) • Volunteers will each be given a step • In silence (the volunteers) have to put the steps in order for cleaning up a spill • Play some fun music as per below! • Audience votes
https://www.youtube.com/watch?v=NNiTxUEnmKI
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