USP 800

6 things that USP encompasses

receipt, storage, compounding, dispensing, administration, disposal of sterile and nonsterile products

the hazardous drug occupational safety plan includes (6)

list of HD

facility and engineering controls

competent personnel

safe work practices

proper use of PPE

policies for HD waste segregation

who determines which drugs are hazardous

NIOSH

based on NIOSH criteria, each institution is responsible to

create a list of hazardous drugs on their formulary

3 categories of HD

antineoplastics

non antineoplastics

hormonal agents

7 NIOSH criteria for hazardous drugs

carcinogenicity

teratogenicity

reproductive toxicity

organ toxicity at low dose

genotoxicity

structure/toxicity profile that mimics existing HD

labeled w special handling instructions

pre hospital HD process

RX company -> delivery -> wholesaler -> packaging -> delivery

hospital HD process

pharmacy receiving -> pharmacy compounding -> patient unit delivery -> nurse admin -> patient -> housekeeping

post hospital HD process

waste hauler/linen hauler -> waste management

who is at risk to occupational exposure to HD

clinical and non clinical persons

all healthcare workers who handle HD should be enrolled in

a medical surveillance plan

routes of unintentional entry of HD

dermal

mucosal

inhalation

injection

ingestion

access to HD areas should be

restricted

3 categories of HD engineering controls

containment primary engineering control (CPEC)

secondary engineering control (SEC)

supplemental engineering control (ex: closed system transfer devices)

CSTD

closed system transfer device

a supplemental engineering control

supplemental engineering controls are recommended for

HD sterile compounding

supplemental engineering controls are required for

HD administration

BSC

biological safety cabinet

a primary engineering control

CACI

compounding aseptic containment isolator

primary engineering control

LAFW

laminar airflow workbench

should not be the primary control for HD

CAI

compounding aseptic isolator

should not be the primary control for HD

sterile and nonsterile HD compounding must occur in

C-PEC located in SEC

SEC must be under __________ pressure

negative pressure

sterile compounding is USP

797

non sterile compounding is USP

795

HD using aseptic technique can be prepared in

ISO class 5 C-PEC

ISO class 7 buffer room

ISO class 7 anteroom

disposable PPE must not

be re used

does receipt require PPE

yes

does storage/transport of HD require PPE

yes

does administration of HD require PPE

yes

does deactivation/decontamination of HD require PPE

yes

does cleaning, disinfecting, waste control of HD require PPE

yes

fit testing NIOSH N95 is sufficient for

aerosolized particles, but not gases, splashes or vapors

chemotherapy gown should be changed

every 2-3 hours or immediately after a splash

eye protection is required if

risk for HD spill when working outside C-PEC

2 pairs of powder free gloves should be changed every

30 min

SOP

safety operating procedure for labeling, packaging, transport, and disposal

HD are prepared in a

C-PEC

what gets placed on the C-PEC deck

plastic backed mat

5 exposure reducing strategies

luer lock connectors

syringe caps

CSTD

sealed impervious plastic bags

cautionary labeling

deactivation

renders HD inert or inactive

decontamination

inactivates, neutralizes, or physically removes HD residue using absorbant wipes

cleaning

the removal of contaminants and HD residue using water, detergents, surfactants, solvents

disinfection

inhibits or destroys microorganisms

all PPE must be disposed of in

yellow containers

disposal of PPE is determined by

EPA and state/local laws

how to dispose of contaminated linens, PPE

discard directly in bin if disposal occurs in that location

or

place in ziploc bag prior to disposal

yellow bin

warning label on HD IV bags/administration sets

PPE required

handle and dispose of properyl

how to dispose of HD IV bags/administration sets

place in zip loc bag before disposal

ESI

how to dispose of HD syringes with or without needles

discard directly in bin if disposal occurs in that location

or

place in ziploc bag prior to disposal

ESI

warning label on HD syringes

PPE required

handle and dispose of properly

how to dispose of drug waste

place in zip loc bag before disposal

ESI

anteroom

waiting room

buffer room

area where PEC is located

controls for sterile HD compounding

ISO 7 positive anteroom

ISO 7 negative buffer room

BSC or CACI

controls for nonsterile HD compounding

C-PEC in negative pressure SEC

the smaller the ISO class

the fewer the particles allowed per cubic meter

if BSC is turned off, how much time should pass after turning on to compound

4 min

HD must be unpacked from shipping containers in

neutral or negative pressure

list 8 ways we can protect ourselves

Luer lock syringes

Syringe caps

Container caps

Sealed plastic bags

Impact resistant containers

Water resistant containers

Cautionary labels

Medical Surveillance Program

list 5 ways you can be exposed

receipt, storage, compounding, dispensing, waste, administration

spironolactone is

teratogenic

carcinogenic

room temp BUD for cat1

<12hr

fridge temp BUS for cat1

<24h

cat 2 aseptic without sterility testing room temp BUD

non sterile components: 1 day

sterile: 4 days

cat 2 aseptic without sterility testing fridge BUD

nonsteril: 4 days

sterile: 10 days

cat 2 aseptic without sterility testing freezer BUD

45 days

cat 2 aseptic with sterility testing room temp BUD

30 days

cat 2 aseptic with sterility testing fridge BUD

45 days

cat 2 aseptic with sterility testing freezer BUD

60 days

terminally sterilized without testing

14 days

28 days

45 days

terminally sterilized with testing

45 days

60 days

90 days