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Fall 2024 > Dosage Exam 2 > Flashcards

Dosage Exam 2 Flashcards

1
Q

What is included in the United States Pharmacopeia (USP)?

A

Standards for:
-Medications
-Healthcare technologies
-Related products

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2
Q

Chapters >1000 in the USP are what?

A

Informational

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3
Q

Chapters <1000 in the USP are what?

A

Enforceable

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4
Q

True or False: USP has no role in enforcement

A

True

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5
Q

What is sterile compounding?

A

Combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a sterile preparation

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6
Q

What products must be sterile?

A

-Injections/infusions

-Irrigation of internal body cavities (minus mouth, rectal, and sinus)

-Opthalmic dosage forms

-Aqueous preparations for pulmonary inhalation

-Baths and soaks for live organs/tissues

-Implants

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7
Q

What is USP <800>?

A

Deals with hazardous drugs

Hazardous Drugs: Handling in Healthcare Settings

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8
Q

True or False: Radiopharmaceuticals are not required to comply with <797>

A

True

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9
Q

Which chapter must radipharmaceuticals comply with?

A

USP <829>
Radiopharmaceuticals Preparation, Compounding, Dispensing, and Repackaging

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10
Q

Who does USP <797> apply to?

A

All persons who prepare compounded sterile preparations (CSPs) and all places where CSPs are prepared

-applies to more than just pharmacists

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11
Q

True or False: USP <797> deals with administration of products

A

False, this is out of its scope

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12
Q

What does it mean for a compounded sterile product (CSP) to be Category 1?

A

Compounded under the least controlled environmental conditions

-Assigned a Beyond Use Date (BUD) of 12 h or less at controlled room temperature (RT) or 24 h or less when refrigerated

-Needs a segregated compounding area or clean suite

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13
Q

What is the Beyond Use Date of a Category 1 CSP kept at controlled room temperature?

A

12 hours or less

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14
Q

What is the Beyond Use Date of a Category 1 CSP kept refrigerated?

A

24 hours or less

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15
Q

What does it mean for a compounded sterile product (CSP) to be Category 2?

A

Require more environmental controls and testing than Category 1

-Assigned a Beyond Use Date (BUD) of >12h at controlled room temperature or > 24h if refrigerated. Must not exceed limits (Max 45 days at room temp, 60 days refrigerated, 90 days in freezer)

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16
Q

What is the Beyond Use Date of a Category 2 CSP kept at controlled room temperature?

A

> 12h

Maximum: 45 days

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17
Q

What is the Beyond Use Date of a Category 2 CSP kept refrigerated?

A

> 24 h

Maximum: 60 days

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18
Q

What is the maximum Beyond Use Date of frozen Category 2 CSP?

A

90 days

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19
Q

What does it mean for a compounded sterile product (CSP) to be Category 3?

A

Undergo sterility testing supplemented by endotoxin testing when applicable. Most requirements of all the categories

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20
Q

What are the maximum Beyond Use Dates for Category 3 CSP that have been kept at room temperature, refrigerated, and frozen?

A

Room Temp: 90 days max
Refrigerator: 120 days max
Freezer: 180 days max

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21
Q

Who must complete training in appropriate compounding principles and practices?

A

Personnel who compound or have direct oversight of compounding personnel

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22
Q

How often must compounding training be done?

A

Initially and then at least every 12 months

For Category 1+2: Every 6 months
For Category 3: Every 3 months

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23
Q

How many times must initial garbing competency be achieved?

A

No fewer than 3 consecutive times

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24
Q

How is evaluation of training for garbing/compounding competency done?

A

Visual Observation

Gloved fingertip and thumb (GFT) sampling of both hands
*done after garbing but before applying alcohol to gloves

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25
Q

How is an evaluation of competency testing in aseptic manipulation done?

A

Visual observation

Media-fill testing followed by gloved fingertip and thumb (GFT) sampling on both hands

26
Q

ISO classes are based on what?

A

Particle count/cubic meter

27
Q

What is an anteroom?

A

ISO class 8 or cleaner

-Fixed walls and doors where hand hygiene, garbing procedures, and other activities that generate high particulate levels may be performed
-Transition room between unclassified area and buffer room
-Separate clean and dirty side with a line of demarcation

28
Q

What is a buffer room?

A

ISO Class 7 or cleaner

-Where primary engineering controls that generate and maintain an ISO Class 5 environment are physically located
-Can only be accessed through the anteroom or another buffer room

29
Q

What is a segregated compounding area (SCA)?

A

Not required to be classified

-Designed with a visible perimeter
-Must contain a primary engineering control and is only for sterile compounding of Category 1 CSPs

30
Q

Category 1,2, and 3 CSPs must be compounded in at least what ISO class?

A

ISO Class 5 or better

31
Q

What does a laminar airflow system do?

A

Provides ISO Class 5 or better environment

Unidirectional HEPA-filtered airflow

32
Q

True or False: Beyond Use Dates (BUD) and Expiration Dates are the same?

A

FALSE

33
Q

What is an expiration date?

A

Date assigned by the manufacturer based on the analytical and performance testing of the sterility, chemical, and physical stability an packaging integrity of the product

-Specific to a particular formulation in its container at stated exposure of illumination and temperature

34
Q

What factors are used to establish a beyond use date?

A

Chemical and physical stability

Container closure system materials and compatibility with the final prep

35
Q

What considerations should be made when using Single-dose containers?

A

-Not required to meet antimicrobial effectiveness testing

-Only puncture in ISO 5 or cleaner air

-Use up to 12 hours after initial entry

-Opened single doe ampuls must not be stored

36
Q

What considerations go into using Multiple-Dose Containers?

A

-Once punctured it must not be used for > 28 days

37
Q

What considerations go into using Pharmacy Bulk Packages?

A

-Restricted to sterile preparation of admixtures for infusion or through a sterile transfer device, for filling empty sterile containers

-Time of use is per labeling

-Only puncture in ISO 5 or cleaner air

38
Q

Based on the OLD <797> guidelines, immediate use products must be administered within how much time following the start of the preparation?

A

No later than 1 hour

39
Q

Based on the NEW <797> guidelines, immediate use products must be administered within how much time following the start of the preparation?

A

Within 4 hours

40
Q

Which form of nutrition has more costs and complications associated with it? Parenteral or Enteral?

A

Parenteral

41
Q

What are crystalline amino acids?

A

Purer amino acids than protein hydrolysates

Have known composition

42
Q

The reformulation of amino acids from chloride to acetate salts produces what result?

A

Reduced metabolic acidosis

43
Q

Which amino acid is essential to add to PN for neonates?

A

Cysteine

-Cannot be added at the manufacturer
-Add at the pharmacy and use within 24 hours

44
Q

If a pediatric patient has impaired lipid metabolism what deficiency may be causing it?

A

Deficiency of the amino acid Carnitine

45
Q

What mandated changes did the FDA make to the former adult vitamin standard 12 vitamin prep (MVI-12)?

A

Now includes 150 mcg Vitamin K

Increased levels of B-1, B-6, and C

46
Q

At what age do we start using the adult vitamin formulation in kids?

A

> 11 years old

47
Q

What is the least stable vitamin in solution?

A

Ascorbic Acid (Vitamin C)

*destabilizes 3-in-1 admixtures

48
Q

What are the benefits to 2-in-1 Admixtures over 3-in-1?

A

Less potential to support bacterial growth

Longer stability

Increased number of compatible medications

49
Q

What is the difference between a 3-in-1 admixture and a 2-in-1 admixture?

A

2-in-1 contains: Dextrose + Amino Acids

3-in-1 also contains: Proteins

50
Q

What is a possible downside to 2-in-1 admixtures compared to 3-in-1?

A

May have increased vein irritation with peripheral administration

51
Q

How long can parenteral nutrition be used for?

A

7-10 days

52
Q

What are the requirements to be able to use peripheral parenteral nutrition?

A

-Short-term use
-Not fluid restricted
-Cannot have large nutritional needs
-Cannot be fluid restricted
-Osmolarity limited to 900 mOsm/L

53
Q

What is an infection that neonates can get from catheter contamination or a fat emulsion environment?

A

Malassezia furfur

-can occur from the normal flora of adults

54
Q

Which element can pose a risk with parenteral nutrition due to PN bypassing the GI barrier that normally prevents its absorption?

A

Aluminum

55
Q

Who is at risk of being harmed by aluminum in PN?

A

Neonates

Impaired renal function

56
Q

What is the FDA limit on aluminum in Large Volume Products (LVPs)?

A

25 mcg/L

56
Q

which substance has the higher aluminum concentration: Glass or Plastic?

A

Glass

57
Q

What volume should be used for Large Volume Parenterals (LVP)?

A

25 mcg/L

58
Q

Which two electrolytes in PN can precipitate with each other to form a chalky substance?

A

Calcium

Phosphate

59
Q

Which ingredient in PN can obscure precipitates and how does this affect the way we make 3-in-1 bags?

A

Lipids obscure precipitates

When making a 3-in-1, add calcium before the fat so you are able to see if any precipitates of calcium and phosphate form before it is obscured by lipids

Fall 2024 (16 decks)

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