Compounding and Hazardous Drugs Flashcards

Exactly 200 vocabulary flashcards covering the definitions, regulations (USP 800, NIOSH), PPE, engineering controls, and safety protocols for compounding hazardous drugs.

Hazardous Drugs (HDs)

Drugs that can cause toxicity to healthcare workers, including effects like carcinogenicity, teratogenicity, reproductive toxicity, genotoxicity, and organ toxicity at low doses.

National Institute for Occupational Safety and Health (NIOSH)

The organization that determines which drugs are hazardous and maintains a list of antineoplastic and other hazardous drugs used in healthcare settings.

USP General Chapter $800$

The set of standards established by the U.S. Pharmacopeia specifically for the safe handling of hazardous drugs.

USP General Chapter $795$

The standards for nonsterile compounding that must be followed in addition to USP $800$ when handling hazardous drugs.

USP General Chapter $797$

The standards for sterile compounding that must be followed in addition to USP $800$ when handling hazardous drugs.

Carcinogenic

A drug property that describes a substance's capability to cause cancer.

Teratogenic

A drug property describing the capability to cause congenital abnormalities or developmental toxicity.

Genotoxic

A property of a drug or chemical that damages DNA, which can subsequently cause cancer.

Antineoplastic Drugs

A category of drugs, commonly known as chemotherapeutics, that are used to treat cancer and are considered hazardous.

$5$ Alpha-Reductase Inhibitors

A category of non-antineoplastic hazardous drugs that includes medications like dutasteride and finasteride.

Dutasteride

A $5$ alpha-reductase inhibitor listed by NIOSH as a hazardous drug.

Finasteride

A $5$ alpha-reductase inhibitor listed by NIOSH as a hazardous drug.

Abortifacients

A category of hazardous drugs used to terminate pregnancies, including mifepristone and misoprostol.

Mifepristone

An abortifacient drug classified as hazardous by NIOSH.

Misoprostol

An abortifacient drug classified as hazardous by NIOSH.

Warfarin

An anticoagulant medication that is classified as a hazardous drug by NIOSH.

Cidofovir

An antiviral medication classified as a hazardous drug by NIOSH.

Ganciclovir

An antiviral medication classified as a hazardous drug by NIOSH.

Valganciclovir

An antiviral medication classified as a hazardous drug by NIOSH.

Carbamazepine

An antiseizure medication classified as a hazardous drug by NIOSH.

Oxcarbazepine

An antiseizure medication classified as a hazardous drug by NIOSH.

Fosphenytoin

An antiseizure medication classified as a hazardous drug by NIOSH.

Phenytoin

An antiseizure medication classified as a hazardous drug by NIOSH.

Topiramate

An antiseizure medication classified as a hazardous drug by NIOSH.

Valproate

An antiseizure medication classified as a hazardous drug by NIOSH.

Clonazepam

A benzodiazepine medication classified as a hazardous drug by NIOSH.

Temazepam

A benzodiazepine medication classified as a hazardous drug by NIOSH.

Exenatide

A diabetes medication classified as a hazardous drug by NIOSH.

Lomitapide

A dyslipidemia medication classified as a hazardous drug by NIOSH.

Spironolactone

A heart failure medication classified as a hazardous drug by NIOSH.

Ribavirin

A hepatitis medication classified as a hazardous drug by NIOSH.

Ambrisentan

A PAH medication (Pulmonary Arterial Hypertension) classified as a hazardous drug by NIOSH.

Bosentan

A PAH medication classified as a hazardous drug by NIOSH.

Macitentan

A PAH medication classified as a hazardous drug by NIOSH.

Riociguat

A PAH medication classified as a hazardous drug by NIOSH.

Tretinoin

A retinoic acid derivative classified as a hazardous drug by NIOSH.

Paroxetine

An SSRI (Selective Serotonin Reuptake Inhibitor) classified as a hazardous drug by NIOSH.

Methimazole

A thionamide medication classified as a hazardous drug by NIOSH.

Propylthiouracil

A thionamide medication classified as a hazardous drug by NIOSH.

Cyclosporine

A transplant medication classified as a hazardous drug by NIOSH.

Mycophenolate

A transplant medication classified as a hazardous drug by NIOSH.

Tacrolimus

A transplant medication classified as a hazardous drug by NIOSH.

Sirolimus

A transplant medication classified as a hazardous drug by NIOSH.

Acitretin

A treatment for autoimmune conditions classified as a hazardous drug by NIOSH.

Azathioprine

A treatment for autoimmune conditions classified as a hazardous drug by NIOSH.

Fingolimod

A treatment for autoimmune conditions classified as a hazardous drug by NIOSH.

Leflunomide

A treatment for autoimmune conditions classified as a hazardous drug by NIOSH.

Teriflunomide

A treatment for autoimmune conditions classified as a hazardous drug by NIOSH.

Testosterone

An androgen hormonal agent classified as a hazardous drug by NIOSH.

Estradiol

An estrogen hormonal agent classified as a hazardous drug by NIOSH.

Oxytocin

A hormonal agent classified as hazardous by NIOSH.

Medroxyprogesterone

A progestin hormonal agent classified as hazardous by NIOSH.

Fulvestrant

A SERD (Selective Estrogen Receptor Degrader) classified as hazardous by NIOSH.

Raloxifene

A SERM (Selective Estrogen Receptor Modulator) classified as hazardous by NIOSH.

Tamoxifen

A SERM classified as hazardous by NIOSH.

Ulipristal

A hormonal agent classified as hazardous by NIOSH.

Safety Data Sheets (SDS)

Documents required by OSHA to be accessible to all employees, providing drug-specific safety info including PPE, first aid, and spill clean-up.

Occupational Safety and Health Administration (OSHA)

The agency that requires facilities to maintain accessible Safety Data Sheets for all hazardous materials.

Hazard Communication Program

A facility's written plan detailing the implementation of HD safety procedures, training, competency assessment, and documentation.

Assessment of Risk (AoR)

A process a pharmacy can conduct to determine if certain activities or drugs of lower risk can be exempt from full USP $800$ requirements.

Containment-primary engineering control (C-PEC)

A ventilated device (hood) designed to minimize exposure to hazardous drugs during compounding.

Containment-secondary engineering control (C-SEC)

The room in which the C-PEC is placed, which must be designed to contain hazardous contamination.

Containment-segregated compounding area (C-SCA)

A separate, ventilated room used for compounding hazardous drugs with negative air pressure.

Compounding aseptic containment isolator (CACI)

A closed-front C-PEC, commonly called a glovebox, designed specifically for hazardous drug compounding.

Biological safety cabinets (BSCs)

Hoods with unidirectional vertical laminar airflow used for sterile HD compounding (must be Class II or III).

Containment ventilated enclosures (CVEs)

Negative-pressure powder containment hoods with HEPA-filtered air used for nonsterile compounding only.

Antechamber

The part of an isolator where staff move items in and out, maintained with negative air pressure.

Yellow Waste Bucket

Used for trace hazardous drug waste, such as empty vials and syringes.

ISO $7$ Air Quality

The required cleanroom air standard for a C-SEC and an anteroom used for sterile hazardous drug compounding.

$1$ meter

The minimum distance required between separate sterile and nonsterile C-PECs if they are located in the same C-SEC.

Negative Air Pressure

Air pressure inside a space that is lower than the outside pressure to prevent contaminated air from flowing out.

Anteroom

The room where staff don PPE before entering the C-SEC; it has positive air pressure relative to the cleanroom.

Air Changes Per Hour (ACPH)

The number of times per hour that the air in a room is replaced to prevent contamination buildup.

$12$ ACPH

The minimum number of air changes per hour required in a space where nonsterile HDs are compounded or stored.

$30$ ACPH

The minimum number of air changes per hour required in a sterile C-SEC.

External Exhaust

A ventilation system where contaminated air is moved out of the building and not recirculated.

Redundant HEPA Filters

An alternative to external exhaust for nonsterile HD compounding where air passes through two or more filters before returning to the room.

NIOSH-certified N95 respirator

The standard respiratory protection appropriate for most activities involving hazardous drugs.

Surgical N95 respirator

A respirator that provides the protection of an N95 mask plus some protection against splashes and droplets.

Powered air-purifying respirator (PAPR)

A battery-operated mask that blows filtered air to the user, used for activities with higher exposure risk.

ASTM D6978

The specific American Society for Testing and Materials standard that chemotherapy gloves must meet.

Powder-free gloves

The required type of gloves for handling hazardous drugs to prevent the spread of particles.

$30$ minutes

The maximum duration chemotherapy gloves should be worn before they must be changed during HD activities.

Two pairs of gloves

The number of chemotherapy gloves required when compounding or administering antineoplastic hazardous drugs.

Chemotherapy Gown

A disposable, impermeable gown made of polyethylene-coated polypropylene that must close in the back and have closed cuffs.

$2-3$ hours

The recommended frequency for changing a chemotherapy gown if the manufacturer's schedule is unknown.

Two pairs of shoe covers

The requirement for foot protection when compounding hazardous drugs.

Gas mask

A fit-tested respirator mask with attached gas canisters used for high-risk HD exposure to gases or vapors.

Elastomeric half-mask

A mask worn with a multi-gas cartridge and P$100$-filter when unpacking HDs that are not contained in plastic.

Pneumatic tube systems

Transportation systems that cannot be used for any liquid HDs or any antineoplastics due to breakage risk.

Negative-pressure technique

A method used when withdrawing HDs from a vial where air is not initially injected to prevent spraying.

Closed-system transfer device (CSTD)

Vial transfer systems with built-in valves that equalize air pressure, used to keep HDs contained during transfer.

Bulk Hazardous Waste

Unused or partially full IV bags, syringes, and vials that must be discarded in a black container for incineration.

Black Waste Container

The designated bin for bulk hazardous drug waste intended for destruction by incineration.

Trace Hazardous Waste

Empty vials, empty syringes, empty IV bags, IV tubes, and used PPE, which are discarded in a yellow container.

Yellow Waste Container

The designated bin for trace hazardous drug waste intended for destruction by incineration.

Red Waste Bin

The container used for infectious waste and nonhazardous sharps.

Sanitization

The collective process of deactivating, decontaminating, and cleaning areas used for handling hazardous drugs.

Deactivation

The first step of sanitization using peroxide or $2$% bleach to make a compound inert/inactive.

$2$% bleach

A concentration of sodium hypochlorite commonly used for deactivation and decontamination of HD surfaces.