Compounding

Question 1

Who sets the standards for compounding preparations?

Answer 1

U.S. Pharmacopeia (USP)

Question 2

USP 795 pertains to ____

Answer 2

Non-sterile compounding

Question 3

USP 797 pertains to _____

Answer 3

Sterile compounding

Question 4

USP 800 pertains to _____

Answer 4

Handling Hazardous Drugs

Question 5

Sterile HDs consist of:

Answer 5

IV drugs, eye drops

Question 6

Non-sterile HDs consist of

Answer 6

orals, topicals, nasals

Question 7

Who determines which drugs are hazardous?

Answer 7

National Institue for Occupational Safety and Health (NIOSH)

Question 8

What do hospital pharmacists rely on for detailed guidance on implementing USP standards?

Answer 8

American Society of Health-System Pharmacists (ASHP)

Question 9

What provides drug-specific safety information including PPE, first aid procedures, and spill clean-up?

Answer 9

SDS (Safety Data Sheet)

Question 10

What are the four primary reasons non-sterile compounding is used for?

Answer 10

1. change the formulation of a medication
2. avoid excipient due to intolerance
3. prepare a dose or formulation that’s not commercially available
4. add flavor

Question 11

What are the four characteristics that could make a drug hazardous

Answer 11

1. carcinogenic
2. teratogentic
3. organ toxicity at low doses
4. genotoxic (damages DNA)

Question 12

Prior to handling HDs what must men and women of reproductive capability do?

Answer 12

confirm in writing that they understand the risks associated with handling HDs

Question 13

Key HDs: abortifacient

Answer 13

misoprostol

Question 14

Key HDs: antibiotics

Answer 14

chloramphenicol

telavancin

Question 15

Key HDs: anticoagulants

Answer 15

warfarin

Question 16

Key HDs: antifungals

Answer 16

fluconazole

Question 17

Key HDs: antiretrovials

Answer 17

abacavir, entecavir, nevirapine, zidovudine

Question 18

Key HDs: antivirals

Answer 18

cidofovir, ganciclovir, valganciclovir

Question 19

Key HDs: acne

Answer 19

isotretinoin

Question 20

Key HDs: arrhythmias

Answer 20

dronedarone

Question 21

Key HDs: BPH

Answer 21

finasteride, dutasteride

Question 22

Key HDs: depression

Answer 22

paroxetine

Question 23

Key HDs: diabetes

Answer 23

exenatide

Question 24

Key HDs: gout

Answer 24

cochicine

Question 25

Key HDs: heart failure

Answer 25

ivabradine, spironolactone

Question 26

Non-sterile compounding should not take place in sterile space unless:

Answer 26

it's a non-sterile HD

Question 27

what is a powder containment hood?

Answer 27

Not an ISO-rate air hood | simply a box to prevent powder from contaminating the air

Question 28

what is a VCE

Answer 28

a ventilated compounding enclosure | a powder containment hood with ventilation

Question 29

what types of water are needed for non-sterile compounding

Answer 29

Potable - for hand and equipment washing | Purified - for use in formulations and rinsing equipment

Question 30

What spaces are required in a sterile compounding area?

Answer 30

- anteroom - buffer area - primary engineering control (PEC) or segregated compounding area (SCA)

Question 31

What does the C in C-PEC and C-SEC stand for?

Answer 31

containment! | these rooms are required for compounding HDs

Question 32

how far apart must sterile and non-sterile C-PECs be if non-sterile HDs are going to be compounded within a C-PEC

Answer 32

1 meter

Question 33

C-PECS and C-SECs must have _____ air pressure

Answer 33

negative

Question 34

negative air flow means

Answer 34

air is flowing into the hood and away from the person compounding

Question 35

what is the minimum ACPH for non-sterile HD storage?

Answer 35

12 air changes per hour

Question 36

what is the minimum ACPH for sterile HD space?

Answer 36

30 ACPH

Question 37

when can a redundant HEPA filter be used?

Answer 37

non-sterile HD only

Question 38

what size counts as a LVP (large volume parenteral)

Answer 38

IV container > 100 mL

Question 39

Which is "cleaner" ISO 5 or ISO 7

Answer 39

ISO 5! means fewer particles of smaller size per volume of air

Question 40

what ISO class must critical areas (sterile hood) in sterile compounding be?

Answer 40

ISO class 5 or better

Question 41

what iso class must the buffer area be?

Answer 41

7

Question 42

what iso class must the anterooom be?

Answer 42

8 if opens to a postive-pressure buffer area | 7 if opens into a negative-pressure buffer area

Question 43

HEPA filters are >99.99% efficient in removing particles as small as ___ microns

Answer 43

0.3

Question 44

where is the HEPA filter in a vertical flow hood?

Answer 44

top!

Question 45

where is the HEPA filter in a horizontal flow hood?

Answer 45

back!

Question 46

how often must a HEPA filter be recertified?

Answer 46

every 6 months or anytime a PEC has been moved

Question 47

where must the injection port of a vial and syringe be kept while compounding in a PEC?

Answer 47

first air!

Question 48

how far inside the hood must compounding be completed in

Answer 48

6 inches

Question 49

what is the line that runs down the center of an anteroom called?

Answer 49

line of demarcation

Question 50

what is the BUD for a compound prepared stat in suboptimal conditions?

Answer 50

1 hour

Question 51

when must air pressure be negative?

Answer 51

hazardous compounding, otherwise, positive is fine.

Question 52

what is a CAI?

Answer 52

Compounding aseptic isolator | "glove boxes"

Question 53

what is the max BUD for CSPs made in an isolator?

Answer 53

12 hours

Question 54

What goes in what? (PECs and SECs)

Answer 54

PECs go in SECs (hoods go in rooms)

Question 55

how long must liquid stay clear after a media-fill test before the compounded passes?

Answer 55

14 days

Question 56

how long are plates from a gloved fingerprint test incubated?

Answer 56

2-3 days