Exam 3 Stuff Flashcards
1
Q
What type of people are in the United States Pharmacopeia (USP)
A
Volunteers with extensive science expertise from clinical practice, academia, and industry
2
Q
What 3 things does the USP create standards for?
A
medications, healthcare technologies, and related practices
3
Q
In the USP chapters >1000 are _____ while chapters <1000 are ____
A
informational
enforceable
4
Q
True or false, USP chapters undergo continuous revision
A
True
5
Q
What is the basis for The Joint Commission (TJC) and state pharmacy board inspections?
A
United States Pharmacopeia (USP)
6
Q
When did the revised USP 797 take effect?
A
June 1, 2008
7
Q
The revised USP 797 is the _____ practice and quality standards for compounding ______ of drugs and nutrients based on current scientific information and _____
A
Minimum; sterile preparations; best sterile compounding practices
8
Q
What are the 5 different risk levels according to USP 797?
A
Low Low with 12 hour or less BUD Medium High Immediate use
9
Q
____ are a major source of contamination during the sterile compounding procedure
A
People
10
Q
Who is responsible for determining risk level of a sterile compounded medication in an institution?
A
The pharmacist
11
Q
What can a sterile compounded medication be contaminated with?
A
Microbes, chemicals, or other matter
12
Q
Which risk level?
Aseptic manipulations entirely within ISO class 5 using only sterile ingredients, compounds, products, and devices are used
A
Low
13
Q
Which risk level?
No more than 3 commercially manufactured packages of sterile products and not more than 2 entries into any one sterile container or package
A
Low
14
Q
Which risk level?
Aseptically opening ampules, penetrating disinfected stoppers on vials with sterile needles and syringes and transferring sterile liquids in sterile syringes to sterile administration devices, package containers of other sterile products, and containers for storage and dispensing
A
Low
15
Q
Which risk level?
Ampule contents should be passed through a sterile filter to remove particles
A
Low
16
Q
Which risk level?
Compounding piggybacks or hydration fluids in an ISO 5 laminar flow hood
A
Low
17
Q
Which risk level?
Dual chamber parenteral nutrition container with no more than 2 additives?
A
Low
18
Q
Medium risk preparations are low risk with the addition of one or more of what 3 things?
A
- Multiple individual doses of sterile products are combined or pooled to prepare a product that will be given to multiple patients or one patient multiple times
- Complex manipulations
- Long duration of the compounding process
19
Q
Which risk level?
PN using manual or automated devices
A
Medium
20
Q
Which risk level?
Filling device reservoirs with more than 3 sterile drug products and evacuation of air before dispensing
A
Medium
21
Q
Which risk level?
Transfer of volumes from multiple ampules or vials into one or more final sterile containers
A
Medium
22
Q
- Non-sterile chemo gloves with initial and repeated disinfection w/ 70% IPA
- Sterile glvoes with initial and repeated disinfection w/ 70% IPA
Are components of what risk quality assurance procedures?
A
Medium
23
Q
Which risk level?
Nonsterile ingredients or devices used before sterilization
A
High
24
Q
Which risk level?
Air quality inferior to ISO Class 5
A
High
25
Which risk level?
Nonsterile exposure for 6 hours before sterilized
High
26
Which risk level?
Storage-no more than 24 hours controlled room temperature, 3 days refrigerated or 45 days in solid frozen state
High
27
What temperature is considered a solid frozen state?
-10 to -25 degrees
28
Which risk level?
Nonsterile bulk and nutrient powders that will be sterilized (morphine, glutamine)
High
29
Which risk level?
Sterile ingredients in nonsterile conainers
High
30
Which risk level?
Bladder irrigations made from bulk powder
High
31
With low and medium risk, start ____ and _____; with high risk start _____ and _____
low/med: start sterile and maintain sterility
high: start nonsterile and make sterile
32
What are 5 immediate use CSPs? (compounded sterile preparations)
```
Patient
Ambulance
ER
Combat zone
Code
```
33
True or false
Immediate use CSPs are exempt from all 797 requirements
True!
34
5 immediate use CSPs requirements
- Only simple aseptic manipulations
- No more than 3 sterile non-hazardous drugs (no chemo)
- No more than 2 entries in one container
- No delays/interruptions
- No contact contamination
35
True or false
With an immediate use CSP, the dose has to be labelled even when administered by the person who prepared it
False!
Only needs to be labelled if NOT administered by the preparer
36
How long from completion of an immediate use CSP until it must be used?
1 hour
37
True or false
An immediate use CSP dose must be discarded if administration has not begun within 1 hour after the start of preparation
True!
38
True or false
beyond use dating (BUD) = expiration date
False!
Expiration date applies to manufactured drug products
39
What type of data is used to determine the beyond use dating?
Microbiologic and chemical
40
What is it called when another pharmacy:
- Prepares an admixture
- Completes all compounding or certain preparations
- Take care of waste, cost, and expiration issues?
Outsourcing!
41
When outsourcing, who is responsible for the product given to the patient?
YOU! (or the person giving it)
You should check quality records and visit compounding center to ensure quality of drug
42
When was the final revision of USP 797 published and when will it be implemented?
June 2019
December 1, 2019
43
What is the primary component of parenteral carbohydrates?
Dextrose
44
1 g of hydrated dextrose = hos many kcal?
3.4
45
1 L D5W = how many kcal?
170
46
Max rate dextrose is oxidized by an adult body?
4 to 7 mg/kg/min
| may be higher in pediatrics
47
What concentrations of dextrose are commercially available?
2.5-70%
48
What does excess dextrose in the blood cause?
- Hyperglycemia
- Excess carbon dioxide formation
- Hepatic steatosis
49
How many mOsm/L is in 5% dextrose?
250
50
What is the max mOsm/L tolerated peripherally?
900
51
What is the highest peripheral dextrose concentration available?
10%
52
What is glycerol?
Sugar alcohol
53
How many kcal is 1 g of glycerol?
4.3 kcal
54
True or false
Glycerol requires insulin for transport into cells
False!!!
55
What component is used as non-protein calorie source in ProcalAmine for short-term protein sparing therapy?
glycerol
56
Which are purer amino acid forms and why?
| Crystalline or protein hydrolysates?
Crystalline! They have a known amino acid composition
57
Amino acids are reformulated from ____ to ____ salts to reduce metabolic acidosis
chloride to acetate
58
How many kcal is 1 g of amino acids?
4
59
True or false, amino acids are used for energy
False!!! They are used for protein synthesis
60
100 g protein = ___ g nitrogen
16
61
What are the 2 amino acid formulations used in pediatrics?
Cysteine-essential in neonates
| Carnitine
62
What are aspects of the cysteine-essential amino acid formulation used in neonates?
- Unstable to add at the manufacturer
- Add to PN in pharmacy and use within 24 hours
- Enhances Ca/P solubility
63
What are aspects of the Carnitine amino acid formulation used in the pediatric population
- Transport FFA into the mitochondria
- Decrease carnitine associated with impaired lipid metabolism
- Routine use controversial in absence of inborn error of metabolism
64
Which component in a TPN is the source of energy and essential fatty acids?
IV Fat emulsion
65
What makes up the IV fat emulsion used in a TPN?
Long chain fatty acids containing linoleic and linolenic acid
66
What does IV fat emulsion contain as an emulsifier
Egg phosphatides
67
What does IV fat emulsion contain for tonicity?
Glycerine
68
What are the particle sizes of IV fat emulsion?
0.4 to 0.5 microns (similar to chylomicrons)
69
What is the biggest downside to IV fat emulsion use?
Good growth medium for bacteria
70
How many kcal is in 1 g of fat emulsion?
10
71
What is the concentration of kcal/mL in 20% fat emulsion?
2 kcal/mL
72
What is the concentration of kcal/mL in 30% fat emulsion?
2.9 kcal/mL
73
True or false
30% fat emulsion is not for direct infusing
True! Only for admixtures!
74
What filter size do you use when administrating an IV fat emulsion?
1.2 micron air eliminating
75
Clinolipid 20% contains what types of fat?
80% olive
| 20% soybean
76
Smoflipid 20% contains what types of fat?
Soy, medium chain, olive, and fish oils
77
Omegavan 10% contains what types of fat?
Fish
78
Which IV fat emulsion can be used in pediatrics?
Omegavan 10% (fish)
79
What is the definition of trace elements?
Minerals required in very small amounts
80
What are examples of trace elements?
```
Chromium
Copper
Manganese
Zinc
Selenium
Molybdenum
```
81
What trace elements are metabolized through the biliary tract?
Manganese
| Copper
82
What trace elements are excreted renally?
Zinc, chromium, selenium molybdenum
83
Electrolyte requirements depend on what factors?
Renal and hepatic function
Diarrhea
Vomiting
84
What can affect compatibility of electrolytes?
Salt form
85
What is the unit used for the electrolytes Na, K, Ca, Mg?
mEq
86
What is the unit used for the electrolyte P
mM
87
Chloride and acetate are given in the electrolytes to maintain what?
Acid-base balance
88
What do 2-in-1 admixtures contain?
Dextrose and amino acids (diluted with water if necessary)
89
How is fat emulsion given when a 2-in-1 admixture is given?
via Y-site
90
What containers can 2-in-1 admixtures be stored in?
PVC/DEHP or EVA
91
What are 4 advantages of 2-in-1 admixtures?
- Clear solution so you can visualize precipitates
- Decreased potential to support bacterial growth than 3-in-1 or IVLE
- Longer stability than 3-in-1
- Increased number of compatible medications
92
What type of filter do you use when administering a 2-in-1 admixture?
0.22 micron air-eliminating filter
93
What is the disadvantage to a 2-in-1 admixture?
May have increased vein irritation vs 3-in-1
94
What is a 3-in-1 admixture also known as?
Total Nutrient Admixture
95
What does a 3-in-1 admixture contain?
Dextrose/lipid/amino acids with or without water
96
What are 4 disadvantages to 3-in-1 admixtures?
- Fewer compatible medications
- Opaque appearance so visual inspection is difficult
- Shorter stability than 2-in-1
- Supports bacterial and fungal growth
97
Which containers do you use for a 3-in-1 admixture and which one do you avoid?
Use PVC/TOTM or EVA
Do NOT use DEHP due to extraction
98
What filter size should be used for a 3-in-1 admixture?
1.2 micron (this will NOT eliminate any bacteria present)
99
How does a 3-in-1 admixture simplify regimen?
No line breaks for lipids (like in 2-in-1 admixtures)
100
What are 5 considerations of peripheral PN?
- Short term use (7-10 d)
- Pt must not be fluid restricted
- Cannot have large nutritional needs
- Osmolarity limited to 900 mOsm/L
- May have frequent IV site changes
101
What are 5 considerations of central PN?
- Use large central vein (subclavian preferred)
- Multi-lumen catheters (Hickman, Broviac)
- Implantable ports for long-term use
- Surgical placement
- Radiographic confirmation
102
What is the most common element in earth's crust?
Aluminum
103
What has no medical function but acts as a barrier in the GI tract?
Aluminum
104
Should you add P or Ca first when adding them to an admixture?
P
105
What do you have to watch for when adding Ca and P to an admixture?
Precipitation
106
What will obscure your view of precipitates in an admixture?
Lipids
107
In a 3-in-1 should you add fat or calcium first?
Calcium
108
What are 6 things that affect Calcium and Phosphorus when added to an admixture?
- Amino acid concentration
- Amino acid product
- pH
- Dextrose
- Calcium Salt
- Temperature
109
Which of the following amino acid concentration can have the highest concentration of calcium glucose and potassium phosphate without it precipitating?
Trophamine 0.8%, 1.5%, or 2%
Trophamine 2%
110
Divalent cations (calcium and magnesium) does what to stabilize 3-in-1 compounding?
Neutralizes negative surface charge
111
High or low temps stabilize 3-in-1 compounding?
Low
112
True or false, destabilizing in a 3-in-1 admixture occurs immediately
False!
113
How can you tell if a 3-in-1 admixture has been destabilized?
- Creaming
- Cracking
- Visible oil layer
114
Which has higher aluminum content glass or plastic?
Glass
115
What are 4 high aluminum products?
- Calcium gluconate
- Potassium phosphates
- Sodium phosphates (glass)
- Cysteine HCl
116
What is the goal aluminum load for patient's
<5 mcg/kg/day
117
____ will occur whenever the solubility of the drug is exceeded
precipitation
118
Poorly soluble drugs are often formulated with whater miscible cosolvents like what?
ethanol, propylene glycol or PEG
119
What are 3 examples of poorly soluble drugs?
Diazepam, digoxin, and phenytoin
120
True or false
Dilution with water can result in precipitation
True!
121
What can precipitation upon IV injection cause?
phlebitis - can be painful and long lasting
122
The solubility of drugs that are weak acids or weak bases depends on what?
The pH of the solution
123
Weak acid drugs are made into salts with ____
strong bases (e.g. penicillin G, Potassium, pantoprazole sodium)
124
Weak base drugs are made into salts with _____
strong acids (morphine sulfate, isoproterenol HCl)
125
Turing insoluble drugs into ___ helps to solubilize them
ionic form
126
How do you turn a poorly soluble acid into an ionic form?
add a base
127
How do you turn a poorly soluble base into an ionic form?
add an acid
128
____ ions can form ____ with oppositely charged drugs and ____
large; complexes; precipitate
129
What does TNA stand for?
Total Nutrient Admixture
130
What 2 electrolytes have major compatibility issues in TPN?
Phosphate and Calcium
131
What order should you mix lipids, amino acids, and dextrose?
Dextrose, AA, then lipids
| AA are an emulsion aid for lipids
132
PN emulsions are not stable below what pH?
5
133
What cations destabilize emulsions?
Divalent cations (calcium and magnesium)
134
Phosphate and calcium are compatible or incompatible?
incompatible
135
True or false
Mixing order in TPN is critical
True!!!
136
Acid salts and bicarbonate are compatible or incompatible?
incompatible!!!
137
Drugs solubilized with cosolvents can ___ upon dilution (in a vein or vial)
precipitate
138
What is chremophor?
A surfactant
139
What can chremophor cause?
Anaphylactic shock
140
What is sorption?
The loss of drug from the solution to be administered, into the container, administration set, or filter
141
What is adsorption?
Surface phenomenon
142
What is absorption?
Diffusion/penetration into the bulk
143
Sorption is most significant for what concentration of drugs?
Low concentration (aka potent)
144
____ drugs can absorb into plastic administration sets, especially those made of ___ and those that contain ____
Lipophilic; made of PVC; contain plasticizers (phthalates)
145
____ leach plasticizers from plastic containers, which is why they should be packaged in glass containers only
Oil emulsions
146
When a drug is dissolved in water a _____ bond breaks by an acid or base effect of the solvent medium
labile
147
What are 4 types of chemical degradation?
Hydrolysis
Oxidation
Reduction (Redox)
Photolysis
148
Chemical degradation is strongly dependent on what 2 things?
Temperature and pH
149
____ and ____ are very important in chemical degradation
compounding and storage conditions
150
Oxidation and reduction involves the exchange of ____ between ____
electrons; reactants
151
True or false
Oxygen is the only cause of redox reactions
False!
152
What are 3 ways to control oxidation?
- Purge parenteral products with nitrogen
- Use antioxidants
- Use chelating agents
153
What is photolysis?
When some drugs are degraded when exposed to light
154
What is the most destructive type of light?
UV
155
True or false
Some drugs are sensitive to visible light
True!
| note: visible light is NOT UV light
156
What type of wrapping can protect from light?
Aluminum wrapping (make sure to properly label wrapping too)
157
When is it best to have the UV light on in a laminar flow hood to prevent photolysis of drugs?
When the hood is empty
158
What can slow down chemical degradation and microbial growth?
Refrigeration
159
True or false
Putting a CSP back in the refrigerator makes it like new
False
160
Freezing parenteral preparations can do what to the pH?
Cause a significant pH shift
161
When freezing a parenteral preparation what happens as ice is formed?
- The drug gets concentrated into a very small volume of liquid water
- Ions get concentrated and the ionic strength changes
162
Freezing is particularly bad for what type of parenteral preparation?
Emulsions
163
Critical areas (DCA) are what ISO class
5
164
Buffer zone (clean room) is what ISO class?
7
165
Anteroom is ISO class what?
7 or 8
166
What does HEPA stand for?
High Efficiency Particulate Air (filter)
167
HEPA filters meet what standards?
IEST RP-CC001.3 (institute of environmental science and technology) and MIL-STD 282 (military standard)
168
What percentage of all air particles are removed?
99/97% of all air particles 0.3 um or larger
169
How big are bacteria?
0.3 to 10 um
170
How big are viruses?
0.005 to 1 um
171
True or false
HEPA filters remove all bacteria from the air that passes through them
True!
172
True or false
HEPA filters remove all viruses from the air that passes through them
False (removes some but not all because they are super tiny)
173
True or false
HEPA filters removes all Pseudomonas diminuta ATCC from the air that passes through them?
True!
174
What is laminar airflow?
Movement of a body of air in a single direction, with a uniform velocity
175
True or false
In order to be a true laminar flow, a number of individual velocity test points must be +/- 20% of the average of all test points
True!
176
What must the velocity of air flow be in a laminar flow hood?
100 ft/min
| 90 +/- 10%
177
Type A HEPA filter removes ____ % of all air particles 0.3 um or larger
99.97%
178
Type C HEPA filter removes ____% of all air particles 0.3 um or larger
99.99%
179
What type of HEPA filter is used for CSP?
Type C
180
What are the environmental requirements for the anteroom?
- 72 degrees +/-5
- 30-60% humidity
- 20/h air exchange
- 5-20% fresh air
- 0.01 pressure differential
- 100,000 of more than 0.5 microns/cu ft particulates
- 2.5 CFUs/cu ft environmental bioburden
181
The antiroom is in direct contact with what?
The outside (i.e. not clean environment)
182
Access to the antiroom should be restricted to who?
essential personnel
183
Pressure difference in the antiroom is ____ which does what?
lower
| Increased chances of particle entry
184
True or false
Laminar flow hood is a sterile environment
FALSE!!!
185
What does Rodac stand for?
Replicate organism detection and counting
186
What 2 things do agar plates contain?
Polysorbate 80
| Lecithin
187
On an agar plate the ____is higher than the ____
surface is higher than the sides
188
How are particles picked up on an agar plate?
By pressing raised agar against test surface
189
True or false
Every single parenteral container (vial, ampule, bottle, etc) was inspected by a human before it left the factory
True!
| People make mistakes tho so still be careful!
190
Where should defective products be reported to?
FDA via MedWatch
