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HAZARD COMMUNICATION STANDARD
(HCS)
• Passed by Congress in 1988 with feedback from
• National Institute for Occupational Safety and Health (NIOSH)
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• United States Pharmacopeia (USP)
• American Society of Health-System Pharmacists (ASHP)
• Oncology Nursing Society (ONS)
• Occupational Safety and Health Administration (OSHA)
HAZARDOUS MATERIALS
• Enforced by Occupational Safety and Health Administration (OSHA)
• Surveyed under The Joint Commission (TJC), Florida Board of Pharmacy,
Environmental Protection Agency (EPA), and others
SAFE HANDLING
DISCLAIMER
I, Kathleen Moorman, do not have (nor does any
immediate family member have) a vested interest in
or affiliation with any corporate organization offering
financial support or grant monies for this continuing
education
activity, or any affiliation with an organization whose
philosophy could potentially bias my presentation.
HAZARD COMMUNICATION STANDARD…
OR THE “RIGHT-TO-KNOW”
• Requires every employer to develop, implement and maintain a written
comprehensive hazard communication program for the workplace1, 2
• The HCS is commonly referred to as the Right-to-Know Law
• Gives employees the right to know if they are exposed to a hazardous chemicals
including drugs in their workplace
• Ensures that there are measures in place to protect employees from harm from these
chemicals
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OBJECTIVES
• Understand the components of the Hazard Communication Standard (HCS)
• Labeling requirements of hazardous of hazardous chemicals and drugs
• Describe how to handle hazardous drugs (HDs) and chemicals
HAZARD COMMUNICATION STANDARD
CONT’D
• In 2011, the HCS was revised to align with the globally harmonized system of
Classification and Labeling of Chemicals to provide the following level of
standardization
• Classification of the chemicals according to their hazard
• Explain the use of Safety Data Sheets (SDSs)
• Review the Resource Conservation and Recovery Act (RCRA) and RCRA Waste
• Summarize guidelines for safe handling of hazardous drugs
• Labeling requirements
• The format of Safety Data Sheets (SDSs)
• These have replaced Material Safety Data Sheets (MSDS)
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HAZARD COMMUNICATION PROGRAM
• Consists of policies and procedures for handling, preventing, and responding to
exposure by HDs
• Includes
• A means to identify and warn employees of hazardous chemicals, including a list of
hazardous chemicals in the workplace and labeling of containers
• Safety Data Sheet (SDSs)
• An employee information and training program
ITEMS COVERED BY THE HCS
• Substances determined hazardous by the manufacturer
• Liquids known to be corrosives, irritants, suspected carcinogens
(i.e. phenol, formalin, glacial acetic acid)
P AND U LISTED WASTE
• Designates hazardous waste pure and commercial grade formulations of
certain unused chemicals that are being disposed
• Must meet the following three (3) criteria:
• Waste must contain one of the chemicals listed on the P or U list
• Chemical in waste must be unused; and
• Chemical in waste must be in the form of a commercial chemical product
• EPA commercial chemical product: chemical is either 100% pure, technical grade or the
sole active ingredient in a chemical formulation
P-LISTED HAZARDOUS WASTE
• Acute hazardous wastes from discarded commercial chemical products
• Complete P-list can be found at 40 CFR section 261.33
• Liquid medications (i.e. antineoplastic agents) and other
medications (i.e. powdered meds) that contain hazardous
substances and are intended to be mixed before administration
• Tablets, capsules, pills, and other solid medications that contain
hazardous substances and are intended to be dissolved/crushed
before administration
ITEMS EXEMPT FROM THE HCS
• Chemicals and medications that do not contain hazardous substances
U-LISTED HAZARDOUS WASTE
• Hazardous wastes from discarded commercial chemical products
• Complete U-list can be found at 40 CFR section 261.33
• Chemicals and medications in retail establishments that are packaged for sale
to consumers
• Personal food, medications, and cosmetics intended for use or consumption in
the workplace
• Hazardous medication products in a solid form for direct administration
• Hazardous medication products in a solid form that are on occasion dissolved
or crushed for administration
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SUMMARY OF EMPLOYEE RIGHTS
• Elements of the HCS that relate to the employee’s right-to-know include the
following requirements imposed on employers that use or store hazardous
chemicals and drugs
• Employers must post a notice of employee rights (provided by the Department of
Labor)
• Employers must maintain and make readily accessible to employees, the most
current SDSs for hazardous chemicals used in the workplace
• If the SDS is not available, employee may refuse to work with the hazardous
chemicals without penalty after following appropriate organization procedure
• Appropriate labels must be maintained on containers
• Employers must provide education and training regarding hazardous chemicals to
employees. Record of training dates should be kept
SUMMARY OF EMPLOYEE RIGHTS
• Employers must inform employees of exposure to hazardous chemicals,
identify areas where hazardous chemicals are stored/handled, provide access
to the hazardous chemicals list and SDSs, and provide copies of SDSs upon
request
• Employers must provide personal protective equipment and materials for
cleanup and disposal of hazardous chemicals
• Employers may not retaliate against employees for exercising rights under the
act
• Employers may not force employees to waive any right under the act as a
condition of employment
PICTOGRAMS APPROVED FOR USE BY HCS
SAFETY DATA SHEETS (SDSs)
• Comprehensive information sheets kept on each hazardous
drug or chemical
• Provide information regarding proper handling procedures,
accident and fire prevention, potential hazardous effects,
and emergency procedures for chemicals used in the work
area
• The HCS requires SDSs to include certain information in a
specific order and format
THE RESOURCE CONSERVATION AND
RECOVERY ACT (RCRA)
• Enacted by the EPA in 1976 to provide a way for tracking hazardous waste
from the point of generation to final disposal
• Focus is on environmental and human health issues surrounding the handling
and disposal of hazardous waste
• Applies to medications and chemicals discarded by healthcare organizations
and other commercial entities
• Waste defined as hazardous under the RCRA must be collected separately
from other waste, labeled properly and disposed of per specific procedures
• Hazardous waste cannot be discarded into waste water systems (i.e. drains,
sewers) or landfills
RCRA CONT’D
• Chemicals considered hazardous under the RCRA
(meet ≥1 of the following characteristics)
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Ignitability
Toxicity
Corrosivity
Reactivity
• RCRA includes lists of specific agents classified as
hazardous
• EPA assigns each hazardous chemical a hazardous
waste number
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RCRA WASTE
• RCRA allows empty containers to be exempt from hazardous waste regulations
• Residue in container not more than 3% by weight of total capacity of the container
• Examples: empty vials, ampules, syringes, needles, IV sets, gloves, gowns, prep
pads
• Does not apply to empty containers of P-listed agents or residues from hazardous
spill cleanups
• Must be managed as RCRA hazardous waste
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Unused/partial containers of hazardous chemicals
Unused/partially used containers and IV preps of hazardous drugs
Empty containers of P-listed agents
Materials from spill cleanups
HANDLING HAZARDOUS DRUGS (HDs)
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Receiving
Storage
Compounding and Preparation
Final Product Labeling
Medication Transport and Delivery
Cleaning, Decontamination, and Housekeeping
Waste Disposal
Accidental Exposures and Spills
Medical Surveillance
Quality Assurance Documentation
RECEIVING
• Cartons and containers should be inspected for leaks or breakages
• Containers should be opened in an isolated, well-ventilated area wearing PPE
• If there is a chance of aerosolization from broken HDs containers, it is
recommended that a NIOSH-certified respirator be worn
STORAGE
• Stored separately from other medications
• Stored in a well ventilated area with limited unauthorized access
• Stored on shelves and in bins with front barriers to decrease likelihood of falls
and breakages
• HDs stored in refrigerators should be placed in separate bins designed to
prevent breakages
• Storage containers should be clearly labeled
• Chemotherapy gloves should be worn when stocking/inventorying and
selecting/gathering HDs for preparation and dispensing
COMPOUNDING & PREPARATION
• Preparation should be limited to a designated area by authorized personnel
• Compounding should be performed under negative pressure in a BSC
(biological safety cabinet), isolator, or by a robotic device designed for such a
purpose
• Exhaust air from the cabinet must be ventilated to an outside area
• Use of supplemental equipment (i.e. closed-system drug-transfer devices or
needless systems) to decrease contamination
• BCS, isolator, and robotic devices used to prepare HDs should not be used to
prepare non-HDs
• Personnel must wear PPE during compounding and preparation activities
FINAL PRODUCT LABELING
• A distinct warning label with appropriate cautions must be placed
on all HDs containers
• Solutions of vinca alkaloids must be labeled with the statement:
“For IV use only-Fatal if given by other routes”
• Syringes or IV containers of vincristine and vinblastine must be
dispensed in a labeled over-wrap with the statement: “Do not
remove covering until the moment of injection. For IV use onlyFatal if given by other routes”
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MEDICATION TRANSPORT & DELIVERY
• All HDs must be transported in appropriately labeled, clear, sealable bag or
container to prevent breakage and container leakage
• Pneumatic tubes system or other methods that produce mechanical stress on
containers should not be used to transport HDs because containers may break
or leak
• All antineoplastic agents delivered to patient care units should be placed in
areas designated for these preparations
CLEANING, DECONTAMINATION,
HOUSEKEEPING
• Personnel must wear appropriate PPE
• Surfaces within the BSC/compounding isolator should be decontaminated
before and after each activity and shift per the HDs manufacturer's
recommendation
• Work areas must be disinfected with 70% isopropyl alcohol prior to
compounding sterile preparations
• The BSC/isolator should be decontaminated after any spill during compounding
and the outside of the BSC front opening and the floor in front of the BSC
should be cleaned daily
• Contaminated equipment used in compounding should be wiped with sterile
water, decontaminated, then rinsed with sterile water
• Materials used in cleaning must be disposed of properly and staff must wash
hands before and after donning their PPE
WASTE DISPOSAL
• HDs waste must be placed in the designated containers at the facility
• Contaminated sharps must be placed in sharps containers designed for HDs
located inside the BSC or compounding isolator to minimize aerosolization
• Contaminated soft materials should be placed inside a sealable bag in BSC or
isolator and then discarded in the designated waste containers
• All HDs prepared or dispensed, but not administered, should be placed in a
sealed bag and discarded in a container for bulk HDs and documented per
policy
• HDs waste containers should be labeled with appropriate warnings as required
by policies, laws, and regulations.
• HDs waste should be picked up for disposal by designated personnel only
ACCIDENTAL EXPOSURES & SPILLS
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Spills/breakages should be cleaned up immediately
Only personnel trained in HDs may clean up HDs spills, while wearing PPE
Chemotherapy spill kit locations must be known to staff
Clean up materials must be disposed of in waste containers that meet local,
state, and federal laws and regulations
• Personnel accidentally exposed to HDs must seek official medical assistance
immediately as outlined by established policies and each incident must be
documented
• In areas where HDs are handled eyewash fountains are preferred over
manually operated bottles of flush solutions
MEDICAL SURVEILLANCE
• Personnel who are pregnant, breastfeeding, or trying to conceive a child should
not handle HDs or associated waste
• Personnel handling HDs should be monitored in an ongoing medical
surveillance program that includes a medical and exposure history, physical
examination, and appropriate laboratory tests
QUALITY ASSURANCE DOCUMENTATION
• Patient profiles must be maintained for all patients receiving injectable
hazardous drugs and the pharmacist compounding the HDs
• These profiles should be permanently maintained for future medication therapy
reference and serve as a record of drug exposure for personnel
• Daily/Monthly HDs usage reports should be kept
• BCS and compounding isolator cleaning/filter changes and other
cleaning/decontamination of areas where HDs are handled should be
documented in appropriate records
• Accidental exposures/spills must be documented in accordance with policies,
laws, and regulations
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CHEMOTHERAPY:
ADMINISTRATIVE CONTROLS
• Policies and procedures
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• Additional training
• Duty-specific training
• Medical surveillance program
• Establish janitorial policies with cleaning contractor
CHEMOTHERAPY
• Clean BSC with a deactivating agent
• Sample work surfaces periodically for HD
• Prohibit food/drink consumption in work area
• Encourage employees to report health concerns to their supervisor
SAFE HANDLING
SAFETY WITH CHEMOTHERAPY
● Engineering Controls
● Administrative Controls
● Personal Protective Equipment (PPE)
CHEMOTHERAPY:
ENGINEERING CONTROLS
● Reduce Exposures by:
● Creating a barrier
● Removing HD from the process
CHEMOTHERAPY:
PERSONAL PROTECTIVE EQUIPMENT (PPE)
• Ensure appropriate PPE is readily available
• Gloves should be ASTM certified
• Change every 30 minutes or if torn/punctured
• Double glove
• Follow OSHA standards for respiratory protection
• Ensure proper storage of respiratory equipment
• Replace when they become visibly clogged or difficult to breath through
REFERENCES
http://www.cdc.gov/niosh/hhe/reports/pdfs/2009-0148-3158.pdf
http://www.usp.org/sites/default/files/usp_pdf/EN/m7808_pre-post.pdf
https://www.epa.gov/hw/defining-hazardous-waste-listed-characteristic-andmixed-radiological-wastes
● Transport chemotherapy bags and equipment in plastic bins to minimize
exposure
● Clean the bins after each use
● Biologic Safety Cabinet (BSC) sash height
● The sash height is the opening into the BSC.
● Ensure at least 100 ft/min air flow
Many thanks to Jennifer Kim and James Powers,
University of South Florida Pharmacy Candidates Class of 2016
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