USP 800 Hazardous Drugs Exam

What is USP 800?

USP 800 describes the practice and quality standards for handling hazardous drugs to promote safety and environmental protection. Allows for minimal risk of exposure to healthcare employees, patients, and the environments involved.

What does handling hazardous drugs include?

the receipt, storage, compounding, dispensing, administration, and disposal of sterile and nonsterile products and preperations (handling)

What does USP 800 apply to?

All entities that store, prepare, transport, and administer HDs

What is each entity required to do?

maintain an occupational safety plan

What does the occupational safety plan include?

list of HDs, facility and engineering controls, competent personnel, safe work practices, proper use of personal protective equipment, and policies for HD waste segregation and disposal

Who determines which drugs are hazardous?

National Institute Of Safety and Health (NIOSH)

Each institution is responsible for creating a HDs list from their formulary based on NIOSH criteria, the list is categorized into what three classes?

antineoplastic drugs (chemotherapeutics), non-antineoplastic drugs, and hormonal agents

What is the NIOSH criteria for Hazardous Drugs?

Carcinogenicity, tertogenicity or other developmental toxicity, reproductive toxicity, organ toxicity at low doses, genotoxicity, structure and toxicity profiles that mimic existing HD, labeled by the manufacturer with special handling instructions

What is the hazardous drug process for pre-hospital?

Rx company--> delivery--> wholesaler--> packaging--> delivery

What is the hazardous drug process for the hospital?

dock/pharmacy receiving --> pharmacy compounding--> patient unit delivery--> nurse administration to patient--> housekeeping

What is the hazardous drug process for post-hospital?

waste/linen haulers--> waste/linen management

T/F: HDs pose a significant risk through occupational exposure

true

T/F: both clinical and nonclinical personnel are at risk for occupational exposure to HD.

True (clinical

What is the role of medical surveillance?

early detection of health problems, tracking and comparison among personnel, and a check on primary and secondary engineering controls already in use

What are the potential opportunities for exposure?

receipt, dispensing, compounding and other manipulations, administration, patient-care activities, spills, transport, waste

What are routes of unintentional entry of HDs?

dermal absorption, mucosal absorption, inhalation, injection, ingestion

HD must be handled to promote...

patient safety, personnel safety, and environmental safety

What are the three categories of engineering controls that may be employed during HD competency?

Containment- primary engineering control (C-PEC), Secondary engineering control (SEC), and supplemental engineering controls (closed system transfer devices [CSTD])

Containment primary engineering control (C-PEC)...

may be biological safety cabinet (BSC) or compounding aseptic containment isolator (CACI), should NOT be laminar airflow workbench (LAFW) or compounding aseptic isolator (CAI)

Supplemental engineering controls (closed system transfer devices [CSTD])...

are recommended to use during HD sterile compounding and are required during HD administration

Sterile and non-sterile compounding must occur within a ___ located in a ___, which must be externally vented through a _____________, physically separated from all other compounding areas, and under negative pressure.

C-PEC located in a SEC, which must be externally vented through a HEPA filter

All sterile and non-sterile compounding must follow the standards in ____ and ___

USP 797 and USP 795

T/F: HDs prepared using sterile aseptic technique in an ISO class 5 C-PEC, ISO class 7 buffer room, and ISO class 7 ante-room may use BUD as described in USP 797

True (prepared)

PPE is used to...

protect personnel from exposure to HD aerosols and residues

Can disposable PPE be reused?

NO

Reusable PPE must be...

decontaminated and cleaned after yse

What are the activities that require PPE?

Receipt, storage, transport, compounding (sterile and nonsterile), administration, deactivation/decontamination, cleaning, disinfecting, spill control, waste disposal

Required if risk for HD spill when working outside of a C-PEC

Eye protection

Must wear two pair of powder free gloves that are changed every 30 minutes. First pair is placed under the gown and second pair (sterile pair) is placed over the gown

chemotherapy gloves

Two pairs are required when compounding sterile HDs

shoe covers

Must close in the back, be long sleeved, and have closed cuffs; changed every 203 hours or immediately after a spill or splash

Disposable chemotherapy gown

Surgical N95 respirator is ideal to provide a barrier to splashes, droplets, and sprays. Fit-tested NIOSH certified N95 is sufficient against aerosolized particles but not splashes, gases, or vapors.

Face mask

___________ must be established for labeling, packaging, transport, and disposal of HDs

Standard operating procedures (SOPs)

What should be dedicated for use for HDs and decontaminated after each use?

Clean equipment (counting trays, spatulas, mortar and pestle)

Where are HDs prepared?

in a C-PEC

What should be used on the deck of the C-PEC for sterile compounding and changed regularly during compounding and whenever spills occur

a plastic backed preparation mat

Does the deck have of the C-PEC have to be decontaminated between different HDs?

yes

What are the exposure reducing strategies that should be employed to protect personnel during sterile compounding?

luer lock connectors, syringe caps, CSTD, sealed impervious plastic bags, CAUTIONARY LABELING

What are the HD transport components

sealed containers, clearly labeled medication name and HD sticker/label

_____ renders the compound inactive or inert

Deactivation

____ inactivates, neutralizes, or physically removes HD residue using absorbent, disposable materials such as wipes

Decontamination

____ involves the removal of contaminants and HD residue from surfaces and objects using water, detergents, surfactants, solvents, and/or other chemicals

Cleaning

____ inhibits or destroys microorganisms and must be done for areas intended to be sterile

Disinfection

When do spills have to be contained and cleaned?

immediately, spill kits must be readily available and be exposed of as hazardous waste

Is all PPE worn during HD compounding considered to be contaminated with HD particles?

YES

When should gloves be doffed?

inside the C-PEC before removing hands from the C-PEC and immediately discarded in the appropriate container before leaving the SEC

Where should PPE be disposed?

in yellow containers

Who determines the disposal of HD?

the EPA and state/local laws

What is the initial disposal prep for trace chemo/hazardous prep disposable (gloves, gowns, liners, alcohol pads, gauze, etc) and what waste disposal container does it go in?

If disposal is occurring in the same locations as the bin, discard directly in the bin. Otherwise, place in a zip-lock bag before disposal. Yellow bin.

What is the initial disposal prep for full, partially full, or empty hazardous IV bags or administration sets, what is the label warning, and what waste disposal container does it go in?

It should be placed in a zip-lock bag before disposal and then disposed in a black container. The warning on the label is that PPE is required and should be handled and disposed of properly. (full, partial full, or empty)

What is the initial disposal prep for full, partially full, or empty syringes of hazardous medication with or without needles, what is the label warning, and what waste disposal container does it go in?

If disposal is occurring in the same locations as the bin, discard directly in the bin. Otherwise place in a zip-lock bag before disposal and then dispose of in a black container. The warning on the label is that PPE is required and should be handled and disposed of properly. (syringes)

What is the initial disposal prep for drug waste, hazardous injections, pills, liquids, and topicals and their containers and wrappers, what is the label warning, and what waste disposal container does it go in?

It should be placed in a zip-lock bag before disposal and then disposed of in a black container. The warning on the label is that PPE is required and should be handled and disposed of properly.

Why was USP 800 created?

to promote safety and environmental protection by describing the practice and quality standards for handling hazardous drugs

List 5 ways personnel can be exposed to HD

dermal absorption, mucosal absorption, inhalation, injection, ingestion (exposure)

According to USP 8, list 8 ways we can protect ourselves and others from exposure to HD?

luer lock connectors, syringe caps, CSTD, cautionary labeling, sealed containers, sealed impervious plastic bags, clearly labeled medication name, correct donning/doffing

Hazardous drugs must be compounded in an area under ______ pressure

negative

List 2 workbenches which may be used to compound hazardous drugs...

BSC, CACI

Why is technique important in preventing hazardous medication spills?

technique helps to prevent hazardous medications from spilling if done correctly and implements ways to protect the person handling the medication if a spill does occur by getting it on something other than their body.

Which governing body provides criteria used to identify hazardous drugs?

The national institute of safety and health (NIOSH)

What color bin should expired albumin bottles be put in?

red (albumin bottles)

What color bin should packages containing crushed warfarin be put in?

Black (warfarin)

What color bin should empty IV bag and IV lines after administration of valproic acid be put in?

Black (IV bag)

What color bin should alcohol pads used during HD compounding be put in?

Yellow

What color bin should expired acyclovir vials be put in?

Red

What color bin should a full IV bag containing phenytoin compounding errors be put in?

Black