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NAPLEX 2021 > Compounding > Flashcards

Compounding Flashcards

1
Q

Who sets the standards for compounding preparations?

A

U.S. Pharmacopeia (USP)

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2
Q

USP 795 pertains to ____

A

Non-sterile compounding

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3
Q

USP 797 pertains to _____

A

Sterile compounding

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4
Q

USP 800 pertains to _____

A

Handling Hazardous Drugs

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5
Q

Sterile HDs consist of:

A

IV drugs, eye drops

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6
Q

Non-sterile HDs consist of

A

orals, topicals, nasals

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7
Q

Who determines which drugs are hazardous?

A

National Institue for Occupational Safety and Health (NIOSH)

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8
Q

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

A

American Society of Health-System Pharmacists (ASHP)

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9
Q

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

A

SDS (Safety Data Sheet)

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10
Q

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

A
  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
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11
Q

What are the four characteristics that could make a drug hazardous

A
  1. carcinogenic
  2. teratogentic
  3. organ toxicity at low doses
  4. genotoxic (damages DNA)
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12
Q

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

A

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

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13
Q

Key HDs: abortifacient

A

misoprostol

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14
Q

Key HDs: antibiotics

A

chloramphenicol

telavancin

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15
Q

Key HDs: anticoagulants

A

warfarin

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16
Q

Key HDs: antifungals

A

fluconazole

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17
Q

Key HDs: antiretrovials

A

abacavir, entecavir, nevirapine, zidovudine

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18
Q

Key HDs: antivirals

A

cidofovir, ganciclovir, valganciclovir

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19
Q

Key HDs: acne

A

isotretinoin

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20
Q

Key HDs: arrhythmias

A

dronedarone

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21
Q

Key HDs: BPH

A

finasteride, dutasteride

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22
Q

Key HDs: depression

A

paroxetine

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23
Q

Key HDs: diabetes

A

exenatide

24
Q

Key HDs: gout

A

cochicine

25
Q

Key HDs: heart failure

A

ivabradine, spironolactone

26
Q

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

A

it’s a non-sterile HD

27
Q

what is a powder containment hood?

A

Not an ISO-rate air hood

simply a box to prevent powder from contaminating the air

28
Q

what is a VCE

A

a ventilated compounding enclosure

a powder containment hood with ventilation

29
Q

what types of water are needed for non-sterile compounding

A

Potable - for hand and equipment washing

Purified - for use in formulations and rinsing equipment

30
Q

What spaces are required in a sterile compounding area?

A
  • anteroom
  • buffer area
  • primary engineering control (PEC) or segregated compounding area (SCA)
31
Q

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

A

containment!

these rooms are required for compounding HDs

32
Q

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

A

1 meter

33
Q

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

A

negative

34
Q

negative air flow means

A

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

35
Q

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

A

12 air changes per hour

36
Q

what is the minimum ACPH for sterile HD space?

A

30 ACPH

37
Q

when can a redundant HEPA filter be used?

A

non-sterile HD only

38
Q

what size counts as a LVP (large volume parenteral)

A

IV container > 100 mL

39
Q

Which is “cleaner” ISO 5 or ISO 7

A

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

40
Q

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

A

ISO class 5 or better

41
Q

what iso class must the buffer area be?

A

7

42
Q

what iso class must the anterooom be?

A

8 if opens to a postive-pressure buffer area

7 if opens into a negative-pressure buffer area

43
Q

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

A

0.3

44
Q

where is the HEPA filter in a vertical flow hood?

A

top!

45
Q

where is the HEPA filter in a horizontal flow hood?

A

back!

46
Q

how often must a HEPA filter be recertified?

A

every 6 months or anytime a PEC has been moved

47
Q

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

A

first air!

48
Q

how far inside the hood must compounding be completed in

A

6 inches

49
Q

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

A

line of demarcation

50
Q

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

A

1 hour

51
Q

when must air pressure be negative?

A

hazardous compounding, otherwise, positive is fine.

52
Q

what is a CAI?

A

Compounding aseptic isolator

“glove boxes”

53
Q

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

A

12 hours

54
Q

What goes in what? (PECs and SECs)

A

PECs go in SECs (hoods go in rooms)

55
Q

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

A

14 days

56
Q

how long are plates from a gloved fingerprint test incubated?

A

2-3 days

NAPLEX 2021 (28 decks)

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