Hazardous Drugs Flashcards
NIOSH Alert
List of hazardous drugs and tear out sheets available in Spanish
Cytotoxic drug parenteral lab
Put plastic backed baker with plastic side down in the hood
Must use Luer-locking syringes
Never recap an needle or remove it from the syringe
Never take other used materials directly out of the hood
Never reuse anything
USP 800
Hazardous drug compounding
USP 800 chapters
- Introduction and scope
- List of hazardous drugs
- Types of exposure
- Responsibilities of personnel handling HDs
- Facilities and engineering controls
5.1 Receipt
5.2 Storage
People not included in USP 800
Manufacturers, Wholesale personnel, researchers, family
Must have in hazardous drug list
Type of HD
Dosage form
Risk of exposure
Packaging
Manipulation
Types of exposure
Dermal (do not absorb)
Mucosal absorption
Inhalation
Injection
Ingestion
Designated areas required for HDs
Receipt and unpacking
Storage
Non-sterile compounding
Sterile compounding
HD unpacking area
Needs neutral and negative pressure
HD storage
Must be stored in manner to prevent spillage/breakage
HDs requiring manipulation stored separately
HD Compounding primary engineering controls
The hood
Restricted access barrier system
Must be externally vented
Must follow USP 795, 797
Should be closed system drug-transfer device
HD compounding secondary engineering controls
The room
Must be externally vented
Must be physically separated
Must be negative pressure
Must have eyewash station available
PhaSeal
Encapsulate the hazardous drug to limit need for additional garbing
Completely closed needle safe system for preparation, administration and waste handling
Features to prevent leakage
Dry connections
Pressure equalization
Chemo dispensing pin
Prevent leaks
Replaces the needle during the reconstitution process
Construction of the dispensing pin
A vented spike needle
Filter should remain at the top during the reconstitution process
Non-sterile HD compounding
Must follow USP <795>
Regulations for
—cutting, crushing
—externally vented or redundant HEPA
—containment ventilated enclosure
Environmental quality and control
Should sample routinely=initially and then every 6 months
PPE
Must define the use of PPE for handling HDs
—receipt
—storage
—transport
—etc.
Hazard communication program
All containers must be labeled
Entities must have an SDS for each chemical
SDSs must be readily accessible
Personnel must be provided information and training before job
Personnel of reproductive capability must confirm that they understand the risks of handling HDS
Personnel training
Must be trained based on their job functions
Must be assessed every 12 months
Must be trained on new HDs and equipment
Must document competencies
Transport
Must not transport liquid HDs via pneumatic tubes
HD disposal
No drugs can go down the drain
Must be labeled based on category
HD dispensing
Antineoplastics must not be placed in automated counting/packaging machines
HD compounding
Should use a CSTD for sterile compounding
Must follow 797 and 795
Chemo mat should be used
Must dedicate equipment to HDs
Administration
Must use CSTDs or protective medical devices and techniques
Must pre-prime IV tubing with non-HD solution
Must wear PPE
Must avoid manipulation (splitting, crushing, opening capsules)
HD Spills
Deactivation
Decontamination
Cleaning
Disinfecting
Spill control
Must have proper training for spill management
Must have spill kits readily available
Must dispose of materials as hazardous materials
Must address size of spills
SOPs for HDs
Must review SOPs every 12 months
Medical surveillance
Plan should be consistent with HRs plan
Identify people with HD exposure
Must quantify handling risk
Medical assessment on hire and routinely
Develop exit interview assessment strategy
What makes waste hazardous?
Ignitability
Corrosively
Reactivity
Toxicity
Or specifically listed as hazardous
Pharmaceutical waste
Expired drugs
Patient discarded medications
Waste materials containing excess drugs
Waste materials with chemo drug residue
Open containers of drugs that can’t be used
Containers that held acute hazardous waste
Drugs that are discarded
Contaminated material (spill kits, clothes, etc)
P-listed disposal
Triple rinsed
Bottle is no longer hazardous
The rinsate is managed as hazardous waste
U-listed containers are empty when
All contents are removed that can be removed through normal means
No more than 3% by weight remains
Use non PVC IV sets
Reduce the adverse effects on the environment and public health when incinerated
Ignitability
Aqueous solutions with more than 24% alcohol and flash point <140 F
Rubbing alcohol
Topical
Corrosivity
PH 2 or less or 12.5 or more
Incinerator types
Municipal
Medical waste
Hazardous waste
Storage accumulation
Provides a storage area for hazard waste while it awaits shipping
Maximum storage time 90 or 180 days
