Compounding pt 2 Flashcards Preview

NAPLEX - OUR cards > Compounding pt 2 > Flashcards

Flashcards in Compounding pt 2 Deck (27)
Loading flashcards...
1
Q

Medications that must be prepared in a sterile manner include…

A

opthalmics, inhalations, (irrigations), and IV medications

2
Q

How is air quality defined?

A

Number of particles per volume of air

Defined by ISO

3
Q

What ISO rating corresponds to the different compounding areas

A
Primary engineering control = 5
Buffer area (air in room around PEC) = 7
Garbing area (ante area) = 7 if opens into negative pressure, 8 if opens into positive pressure
4
Q

What is primary engineering control vs secondary engineering control

A
PEC = isolator or hood, ISO Class 5
SEC = ante area and buffer area (ranges 7-8)
5
Q

Ante area must have how many air changes per hour

A

30

6
Q

What is laminar airflow?

A

Air flows in the same direction at the same speed in parallel lines

7
Q

In a horizontal LAFW, nothing should be _____ the sterile object

A

Behind

8
Q

In a vertical LAFW, nothing should be _____ the sterile object

A

Above

9
Q

Why is it important that nothing be behind (horizontal LAFW) or above (vertical LAFW) sterile objects?

A

To ensure they receive “first air” that comes out of the HEPA filter

10
Q

What are BSC’s?

A

Biological safety cabinets
They are used to compound chemo and other hazardous drugs
They are negative pressure, vertical laminar hoods that limits staff exposure to toxic drugs

11
Q

Describe isolators

A

“Glove boxes”
Hazardous drugs can be compounded in aseptic containment isolaters (CACI’s) which have negative pressure
Non hazardous drugs can be used in aseptic isolaters (CAI’s) which have positive pressure

12
Q

Options for pharmacies that do not have room for a full IV room?

A

Use segregated compounding area

Unclassified air, BUD is 12 hours

13
Q

What is the glove fingertip test?

A

Used to evaluate gloving and garbing technique
Passing requires 3 consecutive gloved fingertip samples with zero CFU’s for both hands
Required annually for personnel who compound low or medium risk CSPs
Required semiannually for those who compound high risk CSPs

14
Q

How should surfaces be cleaned?

A

With germicidal detergent and disinfected with 70% isopropyl alcohol
Clean from cleanest to dirtiest (buffer area, then ante area, then general supply area)

When cleaning hood: top to bottom, back to front, cleanest to dirtiest

  1. Ceiling (back to front)
  2. Grill (top to bottom)
  3. Side walls (back to front, wiping up and down) including IV bar and hooks
15
Q

Non-PVC bags should be used for medications that have…

A

Leaching or sorption issues

16
Q

What is the bubble point test?

A

Used to test filtering

Uses pressure to force liquid to “bubble” our of the filter to test filter integrity

17
Q

Which CSPs require sterility testing? How is it performed?

A

Certain high risk CSPs and CSPs intented for use beyond the recommended BUD

Use either tryptic soy broth (TSB) or fluid thioglycollate medium (FTM) and include bacterial endodoxin (pyrogen) testing prior to use

18
Q

What is a class I vs class II vs class III recall

A

Class I = reasonable probability that use or exposure will cause serious adverse health consequences or death

Class II = can cause temporary or reversible adverse health consequences

Class III = use or exposure is not likely to cause adverse health consequences

19
Q

Hood has to be on for how many minutes before it can be used?

A

30 minutes

20
Q

What special care should be used when injecting an IV bag with drug from an ampule?

A

Use a standard needle to draw up the medication from the ampule, but then discard the needle and change to one with a filter device before injecting into IV bag (to avoid any glass particles entering the admixture)

21
Q

Correct way to verify IV bag correct volumes were mixed

A

BEFORE the drug is injected into the bag
“syringe pull back method” is not recommended by ISMP or addressed by USP
Pharmacist should verify that the volume of drug pulled back in the syringe is correct before it is injected in the bag

22
Q

How is a BUD determined?

A

USP 797 standards and the stability/expiration date of the individual ingredients, whichever is shorter

A sterility test can be performed to determine if a longer BUD is possible

USP 797 standards determine BUD by CSP risk level and storage temperature

23
Q

Low risk BUD

A

Room temp 48 hours
Fridge temp 14 days
Freezer temp 45 days

24
Q

Low non-HD risk BUD

A

All 12 hours

25
Q

Medium risk BUD

A

Room temp 30 hours
Fridge temp 9 days
Freezer temp 45 days

26
Q

High risk BUD

A

Room temp 24 hours
Fridge temp 3 days
Freezer temp 45 days

27
Q

Immediate use risk BUD

A

Room temp 1 hour

Fridge/Freezer N/A

Decks in NAPLEX - OUR cards Class (83):