Podcast
Questions and Answers
Name the 5 USP Risk Levels.
Name the 5 USP Risk Levels.
High, Medium, Low, Low-12 hour, Immediate
Match the preparation risk category with its factors.
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?
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?
What is the Medium Risk BUD for room temp and refrigerated?
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What is a preparation classified as low risk?
What is a preparation classified as low risk?
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What is the Low Risk BUD for room temp and refrigerated?
What is the Low Risk BUD for room temp and refrigerated?
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What factors classify a preparation as low risk-12h?
What factors classify a preparation as low risk-12h?
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What products may be classified as low risk-12h? (3 factors)
What products may be classified as low risk-12h? (3 factors)
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What situations allow a preparation to be labeled 'use immediately' and prepared outside of an ISO 5?
What situations allow a preparation to be labeled 'use immediately' and prepared outside of an ISO 5?
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Additional conditions should be met when mixing 'immediate use' preparations outside of the hood: a.NMT ___ (number) products may be used.
Additional conditions should be met when mixing 'immediate use' preparations outside of the hood: a.NMT ___ (number) products may be used.
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Mixing should be______ (manner).
Mixing should be______ (manner).
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(labeling)
(labeling)
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Must be administered w/in ___ (time).
Must be administered w/in ___ (time).
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Give 2 examples of medium risk preparations.
Give 2 examples of medium risk preparations.
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Give an example of a high risk preparation.
Give an example of a high risk preparation.
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Give a few examples of low risk preparations.
Give a few examples of low risk preparations.
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Is CRRT (Delflex) considered low risk? Why or why not?
Is CRRT (Delflex) considered low risk? Why or why not?
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Multidose vials have a BUD of ____.
Multidose vials have a BUD of ____.
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Pharmacy bulk packages have a BUD of ____.
Pharmacy bulk packages have a BUD of ____.
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Pharmacy bulk packages may be pierced a total of ____ time(s).
Pharmacy bulk packages may be pierced a total of ____ time(s).
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Single dose vials may be used for up to ____ (time) as long as ____.
Single dose vials may be used for up to ____ (time) as long as ____.
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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.
