Dosage Exam 2 Flashcards
What is included in the United States Pharmacopeia (USP)?
Standards for:
-Medications
-Healthcare technologies
-Related products
Chapters >1000 in the USP are what?
Informational
Chapters <1000 in the USP are what?
Enforceable
True or False: USP has no role in enforcement
True
What is sterile compounding?
Combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a sterile preparation
What products must be sterile?
-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
What is USP <800>?
Deals with hazardous drugs
Hazardous Drugs: Handling in Healthcare Settings
True or False: Radiopharmaceuticals are not required to comply with <797>
True
Which chapter must radipharmaceuticals comply with?
USP <829>
Radiopharmaceuticals Preparation, Compounding, Dispensing, and Repackaging
Who does USP <797> apply to?
All persons who prepare compounded sterile preparations (CSPs) and all places where CSPs are prepared
-applies to more than just pharmacists
True or False: USP <797> deals with administration of products
False, this is out of its scope
What does it mean for a compounded sterile product (CSP) to be Category 1?
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
What is the Beyond Use Date of a Category 1 CSP kept at controlled room temperature?
12 hours or less
What is the Beyond Use Date of a Category 1 CSP kept refrigerated?
24 hours or less
What does it mean for a compounded sterile product (CSP) to be Category 2?
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)
What is the Beyond Use Date of a Category 2 CSP kept at controlled room temperature?
> 12h
Maximum: 45 days
What is the Beyond Use Date of a Category 2 CSP kept refrigerated?
> 24 h
Maximum: 60 days
What is the maximum Beyond Use Date of frozen Category 2 CSP?
90 days
What does it mean for a compounded sterile product (CSP) to be Category 3?
Undergo sterility testing supplemented by endotoxin testing when applicable. Most requirements of all the categories
What are the maximum Beyond Use Dates for Category 3 CSP that have been kept at room temperature, refrigerated, and frozen?
Room Temp: 90 days max
Refrigerator: 120 days max
Freezer: 180 days max
Who must complete training in appropriate compounding principles and practices?
Personnel who compound or have direct oversight of compounding personnel
How often must compounding training be done?
Initially and then at least every 12 months
For Category 1+2: Every 6 months
For Category 3: Every 3 months
How many times must initial garbing competency be achieved?
No fewer than 3 consecutive times
How is evaluation of training for garbing/compounding competency done?
Visual Observation
Gloved fingertip and thumb (GFT) sampling of both hands
*done after garbing but before applying alcohol to gloves
How is an evaluation of competency testing in aseptic manipulation done?
Visual observation
Media-fill testing followed by gloved fingertip and thumb (GFT) sampling on both hands
ISO classes are based on what?
Particle count/cubic meter
What is an anteroom?
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
What is a buffer room?
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
What is a segregated compounding area (SCA)?
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
Category 1,2, and 3 CSPs must be compounded in at least what ISO class?
ISO Class 5 or better
What does a laminar airflow system do?
Provides ISO Class 5 or better environment
Unidirectional HEPA-filtered airflow
True or False: Beyond Use Dates (BUD) and Expiration Dates are the same?
FALSE
What is an expiration date?
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
What factors are used to establish a beyond use date?
Chemical and physical stability
Container closure system materials and compatibility with the final prep
What considerations should be made when using Single-dose containers?
-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
What considerations go into using Multiple-Dose Containers?
-Once punctured it must not be used for > 28 days
What considerations go into using Pharmacy Bulk Packages?
-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
Based on the OLD <797> guidelines, immediate use products must be administered within how much time following the start of the preparation?
No later than 1 hour
Based on the NEW <797> guidelines, immediate use products must be administered within how much time following the start of the preparation?
Within 4 hours
Which form of nutrition has more costs and complications associated with it? Parenteral or Enteral?
Parenteral
What are crystalline amino acids?
Purer amino acids than protein hydrolysates
Have known composition
The reformulation of amino acids from chloride to acetate salts produces what result?
Reduced metabolic acidosis
Which amino acid is essential to add to PN for neonates?
Cysteine
-Cannot be added at the manufacturer
-Add at the pharmacy and use within 24 hours
If a pediatric patient has impaired lipid metabolism what deficiency may be causing it?
Deficiency of the amino acid Carnitine
What mandated changes did the FDA make to the former adult vitamin standard 12 vitamin prep (MVI-12)?
Now includes 150 mcg Vitamin K
Increased levels of B-1, B-6, and C
At what age do we start using the adult vitamin formulation in kids?
> 11 years old
What is the least stable vitamin in solution?
Ascorbic Acid (Vitamin C)
*destabilizes 3-in-1 admixtures
What are the benefits to 2-in-1 Admixtures over 3-in-1?
Less potential to support bacterial growth
Longer stability
Increased number of compatible medications
What is the difference between a 3-in-1 admixture and a 2-in-1 admixture?
2-in-1 contains: Dextrose + Amino Acids
3-in-1 also contains: Proteins
What is a possible downside to 2-in-1 admixtures compared to 3-in-1?
May have increased vein irritation with peripheral administration
How long can parenteral nutrition be used for?
7-10 days
What are the requirements to be able to use peripheral parenteral nutrition?
-Short-term use
-Not fluid restricted
-Cannot have large nutritional needs
-Cannot be fluid restricted
-Osmolarity limited to 900 mOsm/L
What is an infection that neonates can get from catheter contamination or a fat emulsion environment?
Malassezia furfur
-can occur from the normal flora of adults
Which element can pose a risk with parenteral nutrition due to PN bypassing the GI barrier that normally prevents its absorption?
Aluminum
Who is at risk of being harmed by aluminum in PN?
Neonates
Impaired renal function
What is the FDA limit on aluminum in Large Volume Products (LVPs)?
25 mcg/L
which substance has the higher aluminum concentration: Glass or Plastic?
Glass
What volume should be used for Large Volume Parenterals (LVP)?
25 mcg/L
Which two electrolytes in PN can precipitate with each other to form a chalky substance?
Calcium
Phosphate
Which ingredient in PN can obscure precipitates and how does this affect the way we make 3-in-1 bags?
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
