Compounding pt 2

Question 1

Medications that must be prepared in a sterile manner include…

Answer 1

opthalmics, inhalations, (irrigations), and IV medications

Question 2

How is air quality defined?

Answer 2

Number of particles per volume of air

Defined by ISO

Question 3

What ISO rating corresponds to the different compounding areas

Answer 3

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

Question 4

What is primary engineering control vs secondary engineering control

Answer 4

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

Question 5

Ante area must have how many air changes per hour

Answer 5

30

Question 6

What is laminar airflow?

Answer 6

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

Question 7

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

Answer 7

Behind

Question 8

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

Answer 8

Above

Question 9

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

Answer 9

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

Question 10

What are BSC’s?

Answer 10

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

Question 11

Describe isolators

Answer 11

“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

Question 12

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

Answer 12

Use segregated compounding area

Unclassified air, BUD is 12 hours

Question 13

What is the glove fingertip test?

Answer 13

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

Question 14

How should surfaces be cleaned?

Answer 14

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

Question 15

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

Answer 15

Leaching or sorption issues

Question 16

What is the bubble point test?

Answer 16

Used to test filtering

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

Question 17

Which CSPs require sterility testing? How is it performed?

Answer 17

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

Question 18

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

Answer 18

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

Question 19

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

Answer 19

30 minutes

Question 20

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

Answer 20

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)

Question 21

Correct way to verify IV bag correct volumes were mixed

Answer 21

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

Question 22

How is a BUD determined?

Answer 22

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

Question 23

Low risk BUD

Answer 23

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

Question 24

Low non-HD risk BUD

Answer 24

All 12 hours

Question 25

Medium risk BUD

Answer 25

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

Question 26

High risk BUD

Answer 26

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

Question 27

Immediate use risk BUD

Answer 27

Room temp 1 hour

Fridge/Freezer N/A