USP Chapter <800> Flashcards
What is USP 800?
it is an independent, scientific nonprofit organization that provides standards setting in compounding, biologics, pharmaceutical manufacturing, and other fields.
When did USP 800 become official?
Dec. 1st, 2019
What does USP 800 cover?
It describes practice and quality standards for handling hazardous drugs
What is NIOSH?
National Institute for Occupational Safety –it maintains a list of antineoplastic and other HDs used in healthcare. Reviewed every 12 months
What are the criteria a hazardous drug must fall under?
-carcinogenicity
-teratogenicity or other developmental toxicity
-reproductive toxicity
-organ toxicity at low doses
-genotoxicity
–a new drug that has a structure and toxicity profile that mimics an existing hazardous drug
NIOSH categories
-antineoplastic drugs
-non-antineoplastic drugs
-non-antineoplastic drugs primarily have adverse reproductive effects
Antineoplastic drugs
fluorouracil
hydroxyurea
megestrol
methotrexate
tamoxifen
non-antineoplastic drugs
carbamazepine
estrogens
progesterone
phenytoin
spironolcatone
drugs with reproductive effects
clonazepam
fluconazole
paroxetine
testosterone
topiramate
warfarin
What does an assessment of risk consider?
-type of HD (antineoplastic, non-antineoplastic, reproductive risk)
-dosage form (tablet, capsule)
-risk of exposure
-packaging
-manipulation
-documentation of alternative containment strategies and/or work practices
-Reviewed annually, documented
What is PPE?
personal protective equipment (PPE)
What is PPE used for?
-PPE provides protection to reduce exposure to HD aerosols and residues
-Disposable PPE not reused
-sterile and nonsterile compounding
Gloves
2 pairs of powder-free that meet American Society for Testing and Materials (ASTM) standard D6978. After compounding, outer glove can be removed to prevent contamination of the container when labeling or handling the completed compound.
-For sterile compounding, outer glove must be STERILE
-replace gloves every 30 minutes
Gowns
-must be poly-coated, disposable, with long sleeves and knitted or elastic cuffs
Gowns must close in the back, not the front
-regular gown worn beneath HD gown for compounding in a cleanroom suite
-washable gowns NOT permitted for use with HDs
-Replace gowns every 2-3 hours, or immediately after a spill or splash
Head, hair, shoe, and sleeve covers
wear full-coverage head and hair covers
2 pairs of shoe covers
shoe covers worn in HD handling area not worn in other areas
Eye and Face Protection
wear full face shield to protect the eyes from splashes
add goggles if compounding outside of a C-PEC or containment isolator
eyeglasses or safety glasses do not protect eyes adequately from splash
Respiratory Protection
Wear a fit-tested NIOSH-certified N95 respirator mask to protect against airborne particles and provide a barrier to splashes, droplets, and sprats around the nose and mouth -may wear regular face mask if biological safety cabinet (BSC) or containment isolator is being used
PPE disposal
-trace contamination
-appropriate waste container
-disposal regulations– local, state, federal
-removal before leaving the area to limit contamination of other area
Personnel Training
-all must be trained
-must occur before handling HDs independently
-Each employee must demonstrate
-Reassessed every 12 months; when new HD or new equipment used; w/ a new or significance change in process or SOP
What does the training include?
-overview of entity’s. list of HDs and their risks
-review of the entity’s SOP related to the handling of HDs
-Proper use of PPE
-Proper use of equipment and devices (e.g., engineering controls)
-Response to known or suspected HD exposure
-Spill management
-Proper disposal of HDs and trace-contaminated materials
Deactivation
-used to render compound inert or inactive
-Environmental Protection Agency (EPA)-registered oxidizers –peroxide formulations; sodium hypochlorite
Decontamination
-purpose to remove HD residue
-alcohol; water; peroxide; sodium hypochlorite
Cleaning
-used to remove organic and inorganic material
—germicidal detergent
