Dosage Exam 2

Question 1

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

Answer 1

Standards for:
-Medications
-Healthcare technologies
-Related products

Question 2

Chapters >1000 in the USP are what?

Answer 2

Informational

Question 3

Chapters <1000 in the USP are what?

Answer 3

Enforceable

Question 4

True or False: USP has no role in enforcement

Answer 4

True

Question 5

What is sterile compounding?

Answer 5

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

Question 6

What products must be sterile?

Answer 6

-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

Question 7

What is USP <800>?

Answer 7

Deals with hazardous drugs

Hazardous Drugs: Handling in Healthcare Settings

Question 8

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

Answer 8

True

Question 9

Which chapter must radipharmaceuticals comply with?

Answer 9

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

Question 10

Who does USP <797> apply to?

Answer 10

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

-applies to more than just pharmacists

Question 11

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

Answer 11

False, this is out of its scope

Question 12

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

Answer 12

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

Question 13

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

Answer 13

12 hours or less

Question 14

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

Answer 14

24 hours or less

Question 15

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

Answer 15

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)

Question 16

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

Answer 16

> 12h

Maximum: 45 days

Question 17

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

Answer 17

> 24 h

Maximum: 60 days

Question 18

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

Answer 18

90 days

Question 19

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

Answer 19

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

Question 20

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

Answer 20

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

Question 21

Who must complete training in appropriate compounding principles and practices?

Answer 21

Personnel who compound or have direct oversight of compounding personnel

Question 22

How often must compounding training be done?

Answer 22

Initially and then at least every 12 months

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

Question 23

How many times must initial garbing competency be achieved?

Answer 23

No fewer than 3 consecutive times

Question 24

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

Answer 24

Visual Observation

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

Question 25

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

Answer 25

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

Question 26

ISO classes are based on what?

Answer 26

Particle count/cubic meter

Question 27

What is an anteroom?

Answer 27

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

Question 28

What is a buffer room?

Answer 28

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

Question 29

What is a segregated compounding area (SCA)?

Answer 29

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

Question 30

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

Answer 30

ISO Class 5 or better

Question 31

What does a laminar airflow system do?

Answer 31

Provides ISO Class 5 or better environment Unidirectional HEPA-filtered airflow

Question 32

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

Answer 32

FALSE

Question 33

What is an expiration date?

Answer 33

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

Question 34

What factors are used to establish a beyond use date?

Answer 34

Chemical and physical stability Container closure system materials and compatibility with the final prep

Question 35

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

Answer 35

-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

Question 36

What considerations go into using Multiple-Dose Containers?

Answer 36

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

Question 37

What considerations go into using Pharmacy Bulk Packages?

Answer 37

-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

Question 38

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

Answer 38

No later than 1 hour

Question 39

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

Answer 39

Within 4 hours

Question 40

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

Answer 40

Parenteral

Question 41

What are crystalline amino acids?

Answer 41

Purer amino acids than protein hydrolysates Have known composition

Question 42

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

Answer 42

Reduced metabolic acidosis

Question 43

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

Answer 43

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

Question 44

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

Answer 44

Deficiency of the amino acid Carnitine

Question 45

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

Answer 45

Now includes 150 mcg Vitamin K Increased levels of B-1, B-6, and C

Question 46

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

Answer 46

>11 years old

Question 47

What is the least stable vitamin in solution?

Answer 47

Ascorbic Acid (Vitamin C) *destabilizes 3-in-1 admixtures

Question 48

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

Answer 48

Less potential to support bacterial growth Longer stability Increased number of compatible medications

Question 49

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

Answer 49

2-in-1 contains: Dextrose + Amino Acids 3-in-1 also contains: Proteins

Question 50

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

Answer 50

May have increased vein irritation with peripheral administration

Question 51

How long can parenteral nutrition be used for?

Answer 51

7-10 days

Question 52

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

Answer 52

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

Question 53

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

Answer 53

Malassezia furfur -can occur from the normal flora of adults

Question 54

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

Answer 54

Aluminum

Question 55

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

Answer 55

Neonates Impaired renal function

Question 56

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

Answer 56

25 mcg/L

Question 56

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

Answer 56

Glass

Question 57

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

Answer 57

25 mcg/L

Question 58

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

Answer 58

Calcium Phosphate

Question 59

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

Answer 59

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