Ch. 6: Handling Hazardous Drugs Flashcards
Hazardous drugs that require special handling to avoid toxicity to workers (Preg. X drugs, antineoplastics, 5-alpha reductase inh., hormones, transplant drugs, others)
All Pregnancy X drugs, many Category D’s and a few C’s, and paroxetine, MTX, misoprostol, mifeprostone (Mifeprex), ribavirin, valproic acid
Antineoplastics (daunorubicin)
5-alpha reductase inhibitors (dutasteride, finasteride)
Hormones (contraceptives, estradiol, testosterone)
Transplant drugs (myophenolate, tacrolimus, cyclosporine, everolimus, sirolimus)
Others: colchicine, dronedarone, fluconazole, spironolactone, risperidone, raloxifene, rasagiline, ziprasidone, ganciclovir
When USP 800 will become federally forceable
July 2018
Engineering Controls
Primary Engineering Control (CPEC) -Ventilated “hood”
Secondary Engineering Control (C-SEC)- the room where the hood is located
NIOSH
Determines which drugs are hazardous
USP 800
Sets standards on how to work safely with HDs
ASHP
Provides detailed guidance for hospital pharmacists on implementing the USP standards
Exception to HD separate room standard
Sterile and NS-HD drugs can be prepared n the same room if the room maintains ISO 7 air during NS compounding, Must be at least 1 meter apart. Particle generating activity, such as working with powders, cannot be performed when sterile compounding is being performed.
PPE required in HD compounding
Head covers, hair covers, two pairs of shoe covers, gowns, and two pairs of chemotherapy gloves
Acceptable C-PECs specific to Sterile HD compounding
Class II Biological Safety Cabinet (Class II BSC) or Compounding Aseptic Containment Isolator (CACI)
C-PEC air type vs. anteroom and buffer room
C-PEC has ISO-5 air at 12 ACPH
Anteroom and Buffer room have ISO-7 air at 30 ACPH
Closed System Transfer Devices (CSTDs)
Keep HDs contained within (inside) the device and block entry of environmental contaminants.
Recommended when compounding HDs and REQUIRED when administering antineoplastics
Staff training for handling HDs must be completed and repeated:
Annually
Repeated when a new HD, a new piece of equipment, or some type of process that involves HDs is implemented
Antineoplastics that require manipulation and all HD active pharmaceutical ingredients (i.e. progesterone) must be stored:
Stored separately from other non-HDs in an externally ventilated, negative-pressure room with at least 12 or more ACPH in order to prevent contamination and personnel exposure
Refrigerated antineoplastics must be stored:
Stored in a dedicated refrigerator (for antineoplastics) in a negative pressure area with at least 12 ACPH (such as the buffer room)
Administration of HDs must be done with:
Two pairs of chemotherapy gloves
Gowns are required when administering injectable antineoplastics and recommended when administering other HDs that are not in tablet of capsule form.
Single chemotherapy gloves are acceptable when administering intact tablets of capsules
Trace antineoplastic waste (empty vials, empty syringes, empty IV bags, IV tubes, used gowns, used gloves, used pads) are thrown:
Into yellow containers (Trace Chemo Waste Bin)
Bulk antineoplastic waste (unused or partially empty IV bags, syringes or vials) are thrown:
Into black containers (Bulk Chemo Waste Bin)
Deactivation and Decontamination agents and purpose:
2% Sterile bleach (sodium hypochloride) or Peroxide
Inactivates and removes HD residue
Cleaning agents and purpose
Germicidal detergent, such as Quat. Ammonium, Phenolics
Removes dirt and microbial contamination (organic and non-organic)
Disinfection agents and purpose
70% sterile isopropyl alcohol (IPA)
Inhibits or destroys microorganisms; required step in sterile compounding
Environmental Monitoring
Should be performed initially as a benchmark and least every 6 months
When cleaning up a large HD spill, sanitizing the undertray of a C-PEC or when there is a known or suspected airborne exposure to powders or vapors, one must wear:
A full-face piece, chemical cartridge-type respirator or powdered air-purifying (PAPR)
First air
Comes from the top of the C-PEC, so it is vertical first air
Cleanest air that is exiting the HEPA filter
Size of syringe when handling HD
Smallest syringe, as long as it is not more than 75% full when filled with the solution
When to dispose of PPE when leaving Sterile HD buffer room
Dispose of chemo gown and outer shoe cover into the yellow trace chemo waste bin before exiting the buffer room
According to USP 800, ALL HDs must be compounded in a:
Negative pressure room
Chemotherapy gloves must be changed:
Every 30 minutes or when torn, punctured, or contaminated
How to handle receiving HD packages (garb and location of unpacking):
Must be handles with one pair of chemotherapy gloves when package is covered in plastic
When package is not covered in plastic, it must be handled with one pair of chemo gloves and an elastomeric half-mask with a multi-gas cartridge and P100-filter
Must be unpacked in a negative pressure area
How to handle receiving HD packages (garb and location of unpacking):
Must be handles with one pair of chemotherapy gloves when package is covered in plastic
When package is not covered in plastic, it must be handled with one pair of chemo gloves and an elastomeric half-mask with a multi-gas cartridge and P100-filter
Must be unpacked in a neutral/negative pressure area; must not go into sterile or positive pressure areas
According to USP 800, all HDs must be prepared with this amount and type of glove:
Two-pairs of chemotherapy powder-free gloves
When should the C-PEC operate and under what circumstances?
It must operate continuously if it is supplying some or most of the negative pressure in the C-SEC
Non-sterile HDs can be compounded in:
Containment ventilated enclosures (CVEs, powder hood) or in a class I biological safety cabinet; MUST be negative pressure
How often should a chemo gown be changed?
Every 2 to 3 hours or immediately after a spill or splash
