Pharmacy Risk Levels Quiz

Questions and Answers

Name the 5 USP Risk Levels.

High, Medium, Low, Low-12 hour, Immediate

Match the preparation risk category with its factors.

High Risk = Made from non-sterile ingredients, Exposed to air quality inferior to ISO 5 Medium Risk = Complex manipulations, The end product will be used multiple times Low Risk = Closed or sealed system with only a few aseptic manipulations Low Risk-12h = ISO 5, in segregated area, but not in a clean room

What is the High Risk BUD for room temp and refrigerated?

24h room temp, 72h refrigerated

What is the Medium Risk BUD for room temp and refrigerated?

30 hours room temp, 9 days refrigerated Signup and view all the answers

What is a preparation classified as low risk?

Closed or sealed system with only a few aseptic manipulations Signup and view all the answers

What is the Low Risk BUD for room temp and refrigerated?

48 hours room temp, 14 days refrigerated Signup and view all the answers

What factors classify a preparation as low risk-12h?

ISO 5, in segregated area, but not in a clean room Signup and view all the answers

What products may be classified as low risk-12h? (3 factors)

Low risk, patient-specific, made in 'hood' that's not in IV room Signup and view all the answers

What situations allow a preparation to be labeled 'use immediately' and prepared outside of an ISO 5?

Emergency use, Immediate administration Signup and view all the answers

Additional conditions should be met when mixing 'immediate use' preparations outside of the hood: a.NMT ___ (number) products may be used.

3 Signup and view all the answers

Mixing should be______ (manner).

done all at once Signup and view all the answers

(labeling)

must be labeled Signup and view all the answers

Must be administered w/in ___ (time).

1 hr Signup and view all the answers

Give 2 examples of medium risk preparations.

TPNs, IV Batch (vanco, ancef, etc) Signup and view all the answers

Give an example of a high risk preparation.

Morphine prepped from non-sterile powder Signup and view all the answers

Give a few examples of low risk preparations.

LR + 40 of KCl, 1/4 Saline, Calcium gluconate in 100 mL Signup and view all the answers

Is CRRT (Delflex) considered low risk? Why or why not?

False Signup and view all the answers

Multidose vials have a BUD of ____.

28 days Signup and view all the answers

Pharmacy bulk packages have a BUD of ____.

6 hours Signup and view all the answers

Pharmacy bulk packages may be pierced a total of ____ time(s).

One Signup and view all the answers

Single dose vials may be used for up to (time) as long as .

6 hours, they are stored in ISO 5 Signup and view all the answers

Study Notes

USP Risk Levels

Five USP Risk Levels: High, Medium, Low, Low-12 hour, Immediate.

High Risk Preparations

Defined as having non-sterile ingredients or exposure to air quality inferior to ISO 5.

High Risk Beyond-Use Dates (BUD)

Room temperature: 24 hours
Refrigerated: 72 hours

Medium Risk Preparations

Involves complex manipulations and products intended for multiple uses.

Medium Risk BUD

Room temperature: 30 hours
Refrigerated: 9 days

Low Risk Preparations

Characterized by closed or sealed systems with minimal aseptic manipulations.

Low Risk BUD

Room temperature: 48 hours
Refrigerated: 14 days

Low Risk-12 hour BUD Conditions

Must be prepared in ISO 5 conditions within a segregated area, not requiring a clean room.

Criteria for Low Risk-12 hour Preparations

Must be low risk
Patient-specific
Prepared in a "hood" not situated in an IV room.

"Use Immediately" Labeling Conditions

Permitted for emergency use or when immediate administration is necessary.

Conditions for Mixing Immediate Use Preparations

No more than three products (NMT 3).
Mixing conducted all at once.
Must be appropriately labeled.
Must be administered within one hour.

Examples of Medium Risk Preparations

Total Parenteral Nutrition (TPNs)
IV Batches (e.g., vancomycin, ancef).

Example of High Risk Preparation

Morphine prepared from non-sterile powder.

Examples of Low Risk Preparations

LR + 40 of KCl
1/4 Saline
Calcium gluconate in 100 mL.

CRRT (Delflex) Risk Assessment

Classified as high risk due to typically containing more than three ingredients.

Beyond-Use Dates (BUD) for Vials

Multidose vials: 28 days.
Pharmacy bulk packages: 6 hours, may be pierced only once.
Single dose vials: usable for 6 hours if stored in ISO 5 conditions.

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Description

Test your knowledge on the five USP risk levels in pharmacy, including definitions and beyond-use dates for each category. Understand the criteria for high, medium, and low-risk preparations and their specific conditions for use. This quiz is essential for pharmacy students and professionals looking to ensure safety in compounding practices.