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Advanced Parenterals > Exam 3 Stuff > Flashcards

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

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2
Q

What 3 things does the USP create standards for?

A

medications, healthcare technologies, and related practices

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3
Q

In the USP chapters >1000 are _____ while chapters <1000 are ____

A

informational

enforceable

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4
Q

True or false, USP chapters undergo continuous revision

A

True

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5
Q

What is the basis for The Joint Commission (TJC) and state pharmacy board inspections?

A

United States Pharmacopeia (USP)

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6
Q

When did the revised USP 797 take effect?

A

June 1, 2008

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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

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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
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9
Q

____ are a major source of contamination during the sterile compounding procedure

A

People

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10
Q

Who is responsible for determining risk level of a sterile compounded medication in an institution?

A

The pharmacist

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11
Q

What can a sterile compounded medication be contaminated with?

A

Microbes, chemicals, or other matter

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12
Q

Which risk level?

Aseptic manipulations entirely within ISO class 5 using only sterile ingredients, compounds, products, and devices are used

A

Low

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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

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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

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15
Q

Which risk level?

Ampule contents should be passed through a sterile filter to remove particles

A

Low

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16
Q

Which risk level?

Compounding piggybacks or hydration fluids in an ISO 5 laminar flow hood

A

Low

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17
Q

Which risk level?

Dual chamber parenteral nutrition container with no more than 2 additives?

A

Low

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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
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19
Q

Which risk level?

PN using manual or automated devices

A

Medium

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20
Q

Which risk level?

Filling device reservoirs with more than 3 sterile drug products and evacuation of air before dispensing

A

Medium

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21
Q

Which risk level?

Transfer of volumes from multiple ampules or vials into one or more final sterile containers

A

Medium

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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

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23
Q

Which risk level?

Nonsterile ingredients or devices used before sterilization

A

High

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24
Q

Which risk level?

Air quality inferior to ISO Class 5

A

High

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25
Q

Which risk level?

Nonsterile exposure for 6 hours before sterilized

A

High

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26
Q

Which risk level?

Storage-no more than 24 hours controlled room temperature, 3 days refrigerated or 45 days in solid frozen state

A

High

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27
Q

What temperature is considered a solid frozen state?

A

-10 to -25 degrees

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28
Q

Which risk level?

Nonsterile bulk and nutrient powders that will be sterilized (morphine, glutamine)

A

High

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29
Q

Which risk level?

Sterile ingredients in nonsterile conainers

A

High

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30
Q

Which risk level?

Bladder irrigations made from bulk powder

A

High

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31
Q

With low and medium risk, start ____ and _____; with high risk start _____ and _____

A

low/med: start sterile and maintain sterility

high: start nonsterile and make sterile

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32
Q

What are 5 immediate use CSPs? (compounded sterile preparations)

A 
Patient
Ambulance
ER
Combat zone
Code
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33
Q

True or false

Immediate use CSPs are exempt from all 797 requirements

A

True!

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34
Q

5 immediate use CSPs requirements

A
  • 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
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35
Q

True or false

With an immediate use CSP, the dose has to be labelled even when administered by the person who prepared it

A

False!

Only needs to be labelled if NOT administered by the preparer

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36
Q

How long from completion of an immediate use CSP until it must be used?

A

1 hour

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37
Q

True or false

An immediate use CSP dose must be discarded if administration has not begun within 1 hour after the start of preparation

A

True!

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38
Q

True or false

beyond use dating (BUD) = expiration date

A

False!

Expiration date applies to manufactured drug products

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39
Q

What type of data is used to determine the beyond use dating?

A

Microbiologic and chemical

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40
Q

What is it called when another pharmacy:

  • Prepares an admixture
  • Completes all compounding or certain preparations
  • Take care of waste, cost, and expiration issues?
A

Outsourcing!

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41
Q

When outsourcing, who is responsible for the product given to the patient?

A

YOU! (or the person giving it)

You should check quality records and visit compounding center to ensure quality of drug

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42
Q

When was the final revision of USP 797 published and when will it be implemented?

A

June 2019

December 1, 2019

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43
Q

What is the primary component of parenteral carbohydrates?

A

Dextrose

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44
Q

1 g of hydrated dextrose = hos many kcal?

A

3.4

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45
Q

1 L D5W = how many kcal?

A

170

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46
Q

Max rate dextrose is oxidized by an adult body?

A

4 to 7 mg/kg/min

may be higher in pediatrics

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47
Q

What concentrations of dextrose are commercially available?

A

2.5-70%

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48
Q

What does excess dextrose in the blood cause?

A
  • Hyperglycemia
  • Excess carbon dioxide formation
  • Hepatic steatosis
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49
Q

How many mOsm/L is in 5% dextrose?

A

250

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50
Q

What is the max mOsm/L tolerated peripherally?

A

900

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51
Q

What is the highest peripheral dextrose concentration available?

A

10%

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52
Q

What is glycerol?

A

Sugar alcohol

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53
Q

How many kcal is 1 g of glycerol?

A

4.3 kcal

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54
Q

True or false

Glycerol requires insulin for transport into cells

A

False!!!

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55
Q

What component is used as non-protein calorie source in ProcalAmine for short-term protein sparing therapy?

A

glycerol

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56
Q

Which are purer amino acid forms and why?

Crystalline or protein hydrolysates?

A

Crystalline! They have a known amino acid composition

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57
Q

Amino acids are reformulated from ____ to ____ salts to reduce metabolic acidosis

A

chloride to acetate

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58
Q

How many kcal is 1 g of amino acids?

A

4

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59
Q

True or false, amino acids are used for energy

A

False!!! They are used for protein synthesis

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60
Q

100 g protein = ___ g nitrogen

A

16

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61
Q

What are the 2 amino acid formulations used in pediatrics?

A

Cysteine-essential in neonates

Carnitine

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62
Q

What are aspects of the cysteine-essential amino acid formulation used in neonates?

A
  • Unstable to add at the manufacturer
  • Add to PN in pharmacy and use within 24 hours
  • Enhances Ca/P solubility
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63
Q

What are aspects of the Carnitine amino acid formulation used in the pediatric population

A
  • Transport FFA into the mitochondria
  • Decrease carnitine associated with impaired lipid metabolism
  • Routine use controversial in absence of inborn error of metabolism
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64
Q

Which component in a TPN is the source of energy and essential fatty acids?

A

IV Fat emulsion

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65
Q

What makes up the IV fat emulsion used in a TPN?

A

Long chain fatty acids containing linoleic and linolenic acid

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66
Q

What does IV fat emulsion contain as an emulsifier

A

Egg phosphatides

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67
Q

What does IV fat emulsion contain for tonicity?

A

Glycerine

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68
Q

What are the particle sizes of IV fat emulsion?

A

0.4 to 0.5 microns (similar to chylomicrons)

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69
Q

What is the biggest downside to IV fat emulsion use?

A

Good growth medium for bacteria

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70
Q

How many kcal is in 1 g of fat emulsion?

A

10

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71
Q

What is the concentration of kcal/mL in 20% fat emulsion?

A

2 kcal/mL

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72
Q

What is the concentration of kcal/mL in 30% fat emulsion?

A

2.9 kcal/mL

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73
Q

True or false

30% fat emulsion is not for direct infusing

A

True! Only for admixtures!

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74
Q

What filter size do you use when administrating an IV fat emulsion?

A

1.2 micron air eliminating

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75
Q

Clinolipid 20% contains what types of fat?

A

80% olive

20% soybean

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76
Q

Smoflipid 20% contains what types of fat?

A

Soy, medium chain, olive, and fish oils

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77
Q

Omegavan 10% contains what types of fat?

A

Fish

78
Q

Which IV fat emulsion can be used in pediatrics?

A

Omegavan 10% (fish)

79
Q

What is the definition of trace elements?

A

Minerals required in very small amounts

80
Q

What are examples of trace elements?

A 
Chromium
Copper
Manganese
Zinc
Selenium
Molybdenum
81
Q

What trace elements are metabolized through the biliary tract?

A

Manganese

Copper

82
Q

What trace elements are excreted renally?

A

Zinc, chromium, selenium molybdenum

83
Q

Electrolyte requirements depend on what factors?

A

Renal and hepatic function
Diarrhea
Vomiting

84
Q

What can affect compatibility of electrolytes?

A

Salt form

85
Q

What is the unit used for the electrolytes Na, K, Ca, Mg?

A

mEq

86
Q

What is the unit used for the electrolyte P

A

mM

87
Q

Chloride and acetate are given in the electrolytes to maintain what?

A

Acid-base balance

88
Q

What do 2-in-1 admixtures contain?

A

Dextrose and amino acids (diluted with water if necessary)

89
Q

How is fat emulsion given when a 2-in-1 admixture is given?

A

via Y-site

90
Q

What containers can 2-in-1 admixtures be stored in?

A

PVC/DEHP or EVA

91
Q

What are 4 advantages of 2-in-1 admixtures?

A
  • 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
Q

What type of filter do you use when administering a 2-in-1 admixture?

A

0.22 micron air-eliminating filter

93
Q

What is the disadvantage to a 2-in-1 admixture?

A

May have increased vein irritation vs 3-in-1

94
Q

What is a 3-in-1 admixture also known as?

A

Total Nutrient Admixture

95
Q

What does a 3-in-1 admixture contain?

A

Dextrose/lipid/amino acids with or without water

96
Q

What are 4 disadvantages to 3-in-1 admixtures?

A
  • Fewer compatible medications
  • Opaque appearance so visual inspection is difficult
  • Shorter stability than 2-in-1
  • Supports bacterial and fungal growth
97
Q

Which containers do you use for a 3-in-1 admixture and which one do you avoid?

A

Use PVC/TOTM or EVA

Do NOT use DEHP due to extraction

98
Q

What filter size should be used for a 3-in-1 admixture?

A

1.2 micron (this will NOT eliminate any bacteria present)

99
Q

How does a 3-in-1 admixture simplify regimen?

A

No line breaks for lipids (like in 2-in-1 admixtures)

100
Q

What are 5 considerations of peripheral PN?

A
  • 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
Q

What are 5 considerations of central PN?

A
  • Use large central vein (subclavian preferred)
  • Multi-lumen catheters (Hickman, Broviac)
  • Implantable ports for long-term use
  • Surgical placement
  • Radiographic confirmation
102
Q

What is the most common element in earth’s crust?

A

Aluminum

103
Q

What has no medical function but acts as a barrier in the GI tract?

A

Aluminum

104
Q

Should you add P or Ca first when adding them to an admixture?

A

P

105
Q

What do you have to watch for when adding Ca and P to an admixture?

A

Precipitation

106
Q

What will obscure your view of precipitates in an admixture?

A

Lipids

107
Q

In a 3-in-1 should you add fat or calcium first?

A

Calcium

108
Q

What are 6 things that affect Calcium and Phosphorus when added to an admixture?

A
  • Amino acid concentration
  • Amino acid product
  • pH
  • Dextrose
  • Calcium Salt
  • Temperature
109
Q

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%

A

Trophamine 2%

110
Q

Divalent cations (calcium and magnesium) does what to stabilize 3-in-1 compounding?

A

Neutralizes negative surface charge

111
Q

High or low temps stabilize 3-in-1 compounding?

A

Low

112
Q

True or false, destabilizing in a 3-in-1 admixture occurs immediately

A

False!

113
Q

How can you tell if a 3-in-1 admixture has been destabilized?

A
  • Creaming
  • Cracking
  • Visible oil layer
114
Q

Which has higher aluminum content glass or plastic?

A

Glass

115
Q

What are 4 high aluminum products?

A
  • Calcium gluconate
  • Potassium phosphates
  • Sodium phosphates (glass)
  • Cysteine HCl
116
Q

What is the goal aluminum load for patient’s

A

<5 mcg/kg/day

117
Q

____ will occur whenever the solubility of the drug is exceeded

A

precipitation

118
Q

Poorly soluble drugs are often formulated with whater miscible cosolvents like what?

A

ethanol, propylene glycol or PEG

119
Q

What are 3 examples of poorly soluble drugs?

A

Diazepam, digoxin, and phenytoin

120
Q

True or false

Dilution with water can result in precipitation

A

True!

121
Q

What can precipitation upon IV injection cause?

A

phlebitis - can be painful and long lasting

122
Q

The solubility of drugs that are weak acids or weak bases depends on what?

A

The pH of the solution

123
Q

Weak acid drugs are made into salts with ____

A

strong bases (e.g. penicillin G, Potassium, pantoprazole sodium)

124
Q

Weak base drugs are made into salts with _____

A

strong acids (morphine sulfate, isoproterenol HCl)

125
Q

Turing insoluble drugs into ___ helps to solubilize them

A

ionic form

126
Q

How do you turn a poorly soluble acid into an ionic form?

A

add a base

127
Q

How do you turn a poorly soluble base into an ionic form?

A

add an acid

128
Q

____ ions can form ____ with oppositely charged drugs and ____

A

large; complexes; precipitate

129
Q

What does TNA stand for?

A

Total Nutrient Admixture

130
Q

What 2 electrolytes have major compatibility issues in TPN?

A

Phosphate and Calcium

131
Q

What order should you mix lipids, amino acids, and dextrose?

A

Dextrose, AA, then lipids

AA are an emulsion aid for lipids

132
Q

PN emulsions are not stable below what pH?

A

5

133
Q

What cations destabilize emulsions?

A

Divalent cations (calcium and magnesium)

134
Q

Phosphate and calcium are compatible or incompatible?

A

incompatible

135
Q

True or false

Mixing order in TPN is critical

A

True!!!

136
Q

Acid salts and bicarbonate are compatible or incompatible?

A

incompatible!!!

137
Q

Drugs solubilized with cosolvents can ___ upon dilution (in a vein or vial)

A

precipitate

138
Q

What is chremophor?

A

A surfactant

139
Q

What can chremophor cause?

A

Anaphylactic shock

140
Q

What is sorption?

A

The loss of drug from the solution to be administered, into the container, administration set, or filter

141
Q

What is adsorption?

A

Surface phenomenon

142
Q

What is absorption?

A

Diffusion/penetration into the bulk

143
Q

Sorption is most significant for what concentration of drugs?

A

Low concentration (aka potent)

144
Q

____ drugs can absorb into plastic administration sets, especially those made of ___ and those that contain ____

A

Lipophilic; made of PVC; contain plasticizers (phthalates)

145
Q

____ leach plasticizers from plastic containers, which is why they should be packaged in glass containers only

A

Oil emulsions

146
Q

When a drug is dissolved in water a _____ bond breaks by an acid or base effect of the solvent medium

A

labile

147
Q

What are 4 types of chemical degradation?

A

Hydrolysis
Oxidation
Reduction (Redox)
Photolysis

148
Q

Chemical degradation is strongly dependent on what 2 things?

A

Temperature and pH

149
Q

____ and ____ are very important in chemical degradation

A

compounding and storage conditions

150
Q

Oxidation and reduction involves the exchange of ____ between ____

A

electrons; reactants

151
Q

True or false

Oxygen is the only cause of redox reactions

A

False!

152
Q

What are 3 ways to control oxidation?

A
  • Purge parenteral products with nitrogen
  • Use antioxidants
  • Use chelating agents
153
Q

What is photolysis?

A

When some drugs are degraded when exposed to light

154
Q

What is the most destructive type of light?

A

UV

155
Q

True or false

Some drugs are sensitive to visible light

A

True!

note: visible light is NOT UV light

156
Q

What type of wrapping can protect from light?

A

Aluminum wrapping (make sure to properly label wrapping too)

157
Q

When is it best to have the UV light on in a laminar flow hood to prevent photolysis of drugs?

A

When the hood is empty

158
Q

What can slow down chemical degradation and microbial growth?

A

Refrigeration

159
Q

True or false

Putting a CSP back in the refrigerator makes it like new

A

False

160
Q

Freezing parenteral preparations can do what to the pH?

A

Cause a significant pH shift

161
Q

When freezing a parenteral preparation what happens as ice is formed?

A
  • The drug gets concentrated into a very small volume of liquid water
  • Ions get concentrated and the ionic strength changes
162
Q

Freezing is particularly bad for what type of parenteral preparation?

A

Emulsions

163
Q

Critical areas (DCA) are what ISO class

A

5

164
Q

Buffer zone (clean room) is what ISO class?

A

7

165
Q

Anteroom is ISO class what?

A

7 or 8

166
Q

What does HEPA stand for?

A

High Efficiency Particulate Air (filter)

167
Q

HEPA filters meet what standards?

A

IEST RP-CC001.3 (institute of environmental science and technology) and MIL-STD 282 (military standard)

168
Q

What percentage of all air particles are removed?

A

99/97% of all air particles 0.3 um or larger

169
Q

How big are bacteria?

A

0.3 to 10 um

170
Q

How big are viruses?

A

0.005 to 1 um

171
Q

True or false

HEPA filters remove all bacteria from the air that passes through them

A

True!

172
Q

True or false

HEPA filters remove all viruses from the air that passes through them

A

False (removes some but not all because they are super tiny)

173
Q

True or false

HEPA filters removes all Pseudomonas diminuta ATCC from the air that passes through them?

A

True!

174
Q

What is laminar airflow?

A

Movement of a body of air in a single direction, with a uniform velocity

175
Q

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

A

True!

176
Q

What must the velocity of air flow be in a laminar flow hood?

A

100 ft/min

90 +/- 10%

177
Q

Type A HEPA filter removes ____ % of all air particles 0.3 um or larger

A

99.97%

178
Q

Type C HEPA filter removes ____% of all air particles 0.3 um or larger

A

99.99%

179
Q

What type of HEPA filter is used for CSP?

A

Type C

180
Q

What are the environmental requirements for the anteroom?

A
  • 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
Q

The antiroom is in direct contact with what?

A

The outside (i.e. not clean environment)

182
Q

Access to the antiroom should be restricted to who?

A

essential personnel

183
Q

Pressure difference in the antiroom is ____ which does what?

A

lower

Increased chances of particle entry

184
Q

True or false

Laminar flow hood is a sterile environment

A

FALSE!!!

185
Q

What does Rodac stand for?

A

Replicate organism detection and counting

186
Q

What 2 things do agar plates contain?

A

Polysorbate 80

Lecithin

187
Q

On an agar plate the ____is higher than the ____

A

surface is higher than the sides

188
Q

How are particles picked up on an agar plate?

A

By pressing raised agar against test surface

189
Q

True or false

Every single parenteral container (vial, ampule, bottle, etc) was inspected by a human before it left the factory

A

True!

People make mistakes tho so still be careful!

190
Q

Where should defective products be reported to?

A

FDA via MedWatch

Advanced Parenterals (2 decks)

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