Compounding ****

Question 1

USP compounding chapters

Answer 1

US Pharmacopeia
-non-sterile hazardous: USP 795 and 800
-non-sterile non-hazardous: USP 795
-sterile non-hazardous: USP 797
-sterile hazardous: USP 797 and 800

Question 2

Hazardous Drugs on the NIODH list

Answer 2

-antineoplastic: chemo drugs
-abx: telavancin
-anticoagulants: warfarin
-antifungals: fluxanazole, voriconazole
-antiretrovirals/HIV: abacavir, entevacir, Nevirapine, Zidovudine
-antivirals: cidofovir, ganciclovir, valganciclovir
-acne: isotretinoin
-BPH: dutasteride, finasteride
-hormones: androgens (testosterone), estrogens (estradiol), progesterones
-hyperthuriodism: methimazole, proplthiouracil
-renal disease: darbepoetin alfa
-transplant: azathioprine, cycsporine, tacrolimus, sirolimus

Question 3

Physical space: hazardous drug requirements

Answer 3

-containment: C-PEC or C-SEC
*negative air pressure
–> at least 12 air changes per hour for nonsterile
–> at least 30 changes per hour for sterile

Question 4

Air quality requirements

Answer 4

-the lower the particle count/number, the cleaner the air

-ISO 5: in clean room - cleanest air
-ISO 7: in buffer room
-ISO 8/9: ambient room

-always use 70% isopropyl alcohol to clean things before bringing them into the PEC room

Question 5

Compounding room temp and testing regulations

Answer 5

-SEC room should be kept at 20C (68F) or cooler
–> fridge: 2-8C
–> freezer: -50 to -15C

-air sampling: done every 6 months
-surface sampling: w/ tryptic soy agar, polysorbate 80 and lecthin - done at the end of the say
–> action must be taken if > 3 CFUs in ISO 5 room or > 5 CFUs in ISO 7 area

Question 6

Hazardous drug compounding cleaning steps

Answer 6

Deactivation and Decontamination:
–> 2% bleach (sodium hypochlorite) or peroxide
Cleaning:
–> germicidal detergent (Quat, Ammonium, Phenolics)
Disinfection:
–> sterile 70% Isopropyl Alcohol

Question 7

Administration of Hazardous drugs

Answer 7

-2 pairs of chemotherapy gloves and a chemotherapy gown are required when administering IV drugs and are recommended when administering other HDs
-single chemotherapy gloves are acceptable when administering intact tablets or capsules
-closed system drug transfer devices MUST be used by nurses for drug admin

Question 8

Chemo waste bin colors

Answer 8

yellow: chemo waste
black: bulk chemo waste

Question 9

Sterile Hazardous Drugs garbing

Answer 9

-head covers/beard covers
-2 pairs of shoe covers
-an impermeable gown
-2 pairs of ASTM (chemotherapy) rated gloves
-a full facepiece respirator or a face shield with goggles when there is a risk for spills or splashes

Question 10

Non-sterile hazardeous drugs garbing

Answer 10

-double gloves, a gown, a mask
-disposable pad to protect the work surface

Question 11

Minimum Weighable Quantity

Answer 11

the smallest amount that can be weighed accurately

MWQ= SR/0.05

Question 12

Glass mortar used for:

Answer 12

liquids, such as suspensions and solutions, and for mixing compounds that are oily or can stain

Question 13

Wedgewood mortar used for:

Answer 13

have a rougher surface and are preferred for grinding dry crystals and hard powders

Question 14

Porcelain mortars are used for:

Answer 14

have a smoother surface and are preferred for blending powders and pulverizing gummy consistencies

Question 15

Recommended compounding ingredients are listed in a reputable source:

Answer 15

-USP National Formulary (USP-NF)
-Food Chemicals Codex
–> if a substance comes from a non-FDA registered facility- a Certificate of Analysis is needed

Question 16

What do you do if a compounding ingredient is missing an expiration date?

Answer 16

-assign a cautious date that is no more than 3 years from the date of the pharmacy received the item

Label needs: the date of receipt and the assigned expiration date

Question 17

Types of Surfactants: Suspending agent

Answer 17

-used to reduce the surface tension between an insoluble drug and a liquid
-must be shaken to redisperse the solid prior to use

Question 18

Types of Surfactants: Emulsifiers

Answer 18

-added to an emulsion to help keep the liquid droplets dispersed throughout the liquid vehicle

Question 19

Types of Surfactants: Levigating Agents

Answer 19

-a levigant such as glycerin or mineral oil is used to aid in the grinding (to make the particles smaller)
–> mineral oil is commonly used for lipophilic (oil-soluble) compounds
–> glycerin or propylene glycol are used for aqueous (water-soluble) compounds

Question 20

Types of surfactants: wetting agents

Answer 20

-when the surface tension is lowered, is it easier to grind particles down, and to mix ingredients
-So, a fine powder that will in incorporated into a suspension is wetted with a wetting agent and stirred into a thick paste prior to being put into the delivery vehicle