NAPLEX- Compounding with Hazardous Drugs

Which USP is related to sterile compounding?

797

Which USP is related to hazardous compounding and handling?

800

What entity determines which drugs are hazardous?

National Institute for Occupational Safety and Health (NIOSH)

What resource would be recommended to use to determine which medications should be handled as hazardous?

NIOSH List of Antineoplastic and Other Hazardous Drugs in Healthcare Settings

What resource would be recommended to determine what PPE, first aid procedures, and spill clean-up procedures would be recommended for a certain hazardous material?

Safety data sheet (SDS)

What are common characteristics of a drug that may make it considered hazardous? (4)

Carcinogenic

Teratogenic

Causes organ toxicity at low doses

Genotoxic (damages DNA)

What medication is considered NIOSH because it is an abortifacient?

Misoprostol, mifepristone

NIOSH - hyperthyroidism

methimazole

ptu

Which antibiotics are considered NIOSH? (2)

not on key drugs

Chloramphenicol

Telavancin

What anticoagulant is considered NIOSH?

Warfarin

Which antifungals are considered NIOSH? (2)

not on key drugs

Fluconazole

Voriconazole

Which anti-HIV medications are considered NIOSH? (4)

not on key drugs

Abacavir

Entecavir

Nevirapine

Zidovudine

Which anti-virals medications are considered NIOSH? (3)

Cidofovir

Ganciclovir

Valganviclovir

Which acne medications are considered NIOSH?

Isotretinoin, tretinoin

Which antiarrhythmic is considered NIOSH?

not on key drugs

Dronedarone

Which medications for autoimmune conditions are considered NIOSH? (5)

Acitretin

azathioprine

Leflunomide

Teriflunomide

Fingolimod

Which medications for BPH are considered NIOSH? (2)

Dutasteride

Finasteride

Which SSRI is considered NIOSH?

Paroxetine

Which medication for diabetes is considered NIOSH?

not on key drugs

Bydureon BCise (Exenatide)

Which medication for dyslipidemia is considered NIOSH?

Lomitapide

Which anti-epileptics are considered NIOSH? (5)

Carbamazepine

Oxcarbazepine

Divalproex

Fosphenytoin

Phenytoin

Topiramate

Vigabatrin

Zonisamide

Which benzodiazepines are considered NIOSH? (2)

Clobazam

Clonazepam

Triazolam

Temazepam

Which anti-gout medication is considered NIOSH?

not on key drugs

Colchicine

Which heart failure medications are considered NIOSH?

Ivabradine

Spironolactone

Which medication for hepatitis is considered NIOSH?

Ribavirin

Which hormones are considered NIOSH? (5)

Androgens (testosterone)

Estrogens

Progesterones

SERD/SERMS (raloxifene/tamoxifen, fulvestrant)

Ulipristal

Which medications for hypercalcemia of malignancy are considered NIOSH? (2)

not on key drugs list

Paliperidone

Zoledronic acid

Which medications for hyperthyroidism are considered NIOSH? (2)

not on key drugs list

Methimazole

Propylthiouracil

Which medication for migraines is considered NIOSH?

not on key drugs

Dihydroergotamine

Which medications for Parkinson Disease are considered NIOSH? (2)

not on key drugs

Apomorphine

Rasagiline

Which medications for PAH are considered NIOSH? (4)

Ambrisentan

Bosentan

Macitentan

Riociguat

Which medication for renal disease or blood dyscrasias is considered NIOSH?

not on key drugs

Darbepoetin alfa

Which medication for schizophrenia is considered NIOSH?

not on key drugs

Ziprasidone

Which medications for transplant are considered NIOSH? (4)

Cyclosporine

Mycophenolate

Tacrolimus

Sirolimus

Where must non-sterile medications be compounded?

In a space separated from dispensing area

What kind of hood is a powder containment hood?

Ventilated Compounding Enclosure (VCE)

hood and buffer rooms for HD incude the word:

Containment

NOnsterile and sterile HD compounding must have a separate space except when this criteria is met:

C-sec = iso 7 air

seperate nonsterile and sterile c pecs at least 1 meter apartT

C-PECs/C-SECs/C-SCAs must have positive/negative air pressure

Negative

Hazardous drugs should be stored in an externally ventilated room with positive/negative pressure

Negative

Non-sterile hazardous drugs must be stored in a room with at least ___ ACPH

sterile c-sec ?

c-sca?

12

30

12

the anteroom for hd drugs must be iso

iso 7

USP term for sterile hoods

Primary engineering control (PEC)

USP term for buffer room or sterile compounding room

Secondary engineering control (SEC)

USP term for isolator or glove box

Compounding aseptic isolator (CAI)

USP term for chemo hood

Class 2 biologic safety cabinet (BSC) - vertical laminar airflow

USP term for isolator or glove box for hazardous drugs

Compounding aseptic containment isolator (CACI)

USP term for an IV container > 100 mL

Large volume parenteral (LVP)

Anteroom if it opens into negative pressure SEC must be at least ISO

7

Cleaning of HD must completed in what order?

disinfection is for sterile only

deactivation + what agents

makes drugs inert/inactive

peroxide, 2% bleach

decontamination + what agents

removes hd residue

alcohol, water, peroxide, 2% bleach

cleaning + agents

remove dirt and microbial contamination

germicidal detergent

disinfection + what

Destroys microorganisms

70% IPA

C-PEC in an HD cleanroom may be either... (2)

Compounding aseptic containment isolator (CACI)

Biological safety cabinet (BSC)

cleaning of HD:

Use ___ instead of spray bottle

wear what ppe?

when is surface sampling done?

use wetted wipes

wear gloves, gown, mask

q6months

When is an external vent recommended?

HD C-PECs or HD isolator PECs (CACI) because it contains hazardous fumes/particles needing to be externally vented

Spill kit contents:

-protective gown

latex gloves (minimally)

N95 respirator mask

goggles with side shields

-HD waste bag

scoop and scraper to get spill waste into the waste bag

chemo pads to absorb hazardous liquid

-HD spill report exposure form to document HD exposure

PPE for cleaning up HD spill

gown

N95 respirator

two pairs of gloves (chemo glvoes first then heavy-duty gloves to protect from glass)

shoe covers

COntents from a HD spill go into what trash?

black (bulk)

Into which colored receptacle should trace HD waste be placed?

Yellow

Into which colored receptacle should bulk HD waste be placed?

Black

HD ppe disposal:

where are outer gloves disposed?

outer garb?

outer gloves: discard INSIDE C-PEC yellow bin

outer garb: discard INSIDE C-SEC (before exiting negative-pressure area)

HD PPE - compounding

-TWO pairs of shoe covers

-head/hair covers

-eye/face protection (if spills or working outside c-pec)

-fit-tested N95 respirator

-chemo gown

-two pairs chemo gloves

HD PPE while compounding

chemo gown requirements

HD PPE while compounding

glove requirements

TWO pair of ASTM standard d6978 chemo gloves

powder free

changed q30 min

one pair goes under cuff of gown, other goes over cuff of gown

HD PPE for administration

transport&storage

When compounding HD vials, what should you not do?

dont inject air into vial

used negative pressure or closed system transfer device

Close dsystem transfer devices have:

built in valve that equalizes air pressure when fluid is added/withdrawn

preferred method to trasnfer HDs

closed system transfer devices arer ecommended for _____, but required for?

recommended: when compounding

required: administering chemo drugs

Label required during transport of HD:

Chemotherapy - dispose of properly or something similar