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Dosage Forms Exam 2 Flashcards

1
Q

What are some parenteral medication errors?

A

Incorrect ingredients
Incorrect strengths
Contamination with pathogens
Contamination with pyrogens

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2
Q

What happened in 2012 with the New England Compounding Center?

A

They had an outbreak of meningitis from their product

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3
Q

What did the NECC meningitis outbreak lead to?

A

The Drug Quality and Security Act

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4
Q

What is USP <797> about?

A

Pharmaceutical compounding–sterile preparations

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5
Q

Which numbers of the USP are mandatory?

A

<1000

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6
Q

What is a parenteral product?

A

Medication that is taken into the body or administered in a manner other than the digestive tract

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7
Q

How are parenteral products administered (in practice)?

A

By injection

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8
Q

What are the benefits of using a parenteral route?

A

Avoid GI tract, administer directly to specific organ/tissue to minimize systemic side effects

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9
Q

Why do parenteral products have such stringent requirements?

A

Their administration requires injury to the body/bypassing the body’s natural defense barriers

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10
Q

What are the 3 requirements for parenteral products?

A
  1. Sterile
  2. Particle Free
  3. Pyrogen Free
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11
Q

What does USP <797> reduce the risk of?

A

Harm to the patient!

  1. Microbial contamination
  2. Excessive bacterial endotoxins
  3. Variability in strength of ingredients
  4. Unintended contaminants
  5. Ingredients of inappropriate quality
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12
Q

What does sterile mean?

A

Free of microbial organisms

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13
Q

How do you sterilize something?

A 
Steam (autoclave)
Filtration
Dry Heat
Gas (ethylene oxide)
Irradiation (gamma rays)
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14
Q

What are pyrogens?

A

Bacterial endotoxins–produce fever, cause septic shock

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15
Q

Where do pyrogens come from?

A

Remanants of microorganisms

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16
Q

Does sterilization eliminate pyrogens?

A

No

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17
Q

What is the risk of pyrogens?

A

Septic shock/anaphylactic shock

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18
Q

What is septicemia?

A

Infection of the blood

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19
Q

What is septic shock?

A

Acute reaction to bacterial endotoxins (pyrogens)

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20
Q

Why do sterile preparations have to be particle free?

A

Foreign particles can trigger an immune response
Produce damage to lungs
Produce damage to kidneys
Kill people

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21
Q

What are the 6 types of parenteral products?

A

Solutions ready for injection
Dry, soluble preparations ready to be combined with a solvent before use
Suspensions ready for injection
Dry, insoluble preparations ready to be combined with a vehicle before use
Emulsions (like parenteral nutrition)
Liquid concentrates ready for dilution prior to administration

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22
Q

What is a [DRUG] injection?

A

Liquid preparations that are drug substances

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23
Q

What is a [DRUG] for injection?

A

Dry solids that need to have vehicles added to yield solutions that meet requirements for injection

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24
Q

What is a [DRUG] injectable emulsion?

A

Liquid preparation of drug substances dissolved or dispersed in a suitable emulsion medium

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25
Q

What is a [DRUG] injectable suspension

A

Liquid preparations of solids suspended in a suitable liquid medium

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26
Q

What is a [DRUG] for injectable suspension?

A

Dry solids that yield preparations that meet requirements for injectable suspensions when vehicle is added

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27
Q

Difference between purduemycin injection and purduemycin FOR injection

A

“For” means that it is not ready to use! Has to have vehicles added before being injected

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28
Q

What is LVP?

A

Large Volume Parenteral–single dose injections in a container more than 100 mL

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29
Q

What is small volume parenteral?

A

Injection of 100 mL or less

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30
Q

Is a mistake worse in an LVP or a small volume parenteral?

A

LVP

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31
Q

What is a vehicle?

A

Solvent/medium for the administration of therapeutic agents

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32
Q

What is the most common vehicle?

A

Water

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33
Q

What is the preferred vehicle?

A

Water

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34
Q

What are the 3 types of water used in parenteral products?

A

Water for injection
Sterile water for injection (SWFI)
Bacteriostatic water for injection (BWFI)

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35
Q

What is WFI?

A

Water for injection–pyrogen free, non sterile, single use sealed container

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36
Q

What is SWFI?

A

Pyrogen free, sterile, packed in sealed containers <1000mL

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37
Q

What is BWFI?

A

Pyrogen free, sterile with antimicrobial agent added

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38
Q

Which water shouud you use for parenterals?

A

SWFI

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39
Q

Can you inject plain water? Why not?

A

NO - it causes hemolysis because it is so hypotonic

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40
Q

What preferred tonicity of parenteral products?

A

Isotonic

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41
Q

What is the preferred pH of parenteral products?

A

Physiological

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42
Q

Can intra-spinal injections have preservatives?

A

No

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43
Q

What are 4 common isotonic vehicles?

A

0.9% NaCl Solution (NS)
D5W
Ringer’s Solution (NS w/K and Ca)
D2.5W1.2NS

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44
Q

What is the ideal solvent for parenteral products?

A

Water

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45
Q

What are water miscible cosolvents used for?

A

To solubilize drugs in water vehicle

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46
Q

What are some cosolvents?

A 
Alcohol
Polyethylene glycol (40%)
Propylene glycol (10%)
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47
Q

When are cosolvents often used?

A

IM injections

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48
Q

Why can PEG be used at a higher IV concentration than ethyl alcohol?

A

To prevent hemolysis–ethyl alcohol has a higher hemolytic potential than PEG

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49
Q

Can oil be injected into veins?

A

No, causes embolus

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50
Q

Can oil emulsions be injected into veins?

A

Sure–in small enough droplets that they won’t cause embolus

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51
Q

Can oil injections be used for IM?

A

Yes

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52
Q

When are antimicrobial preservatives used?

A

With multidose preparations ONLY

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53
Q

What is the most common preservative?

A

Benzyl alcohol 0.9%

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54
Q

What is the second most common preservative?

A

Parabens–methyl and propl

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55
Q

Are antimicrobials more effective in O/W or W/O?

A

O/W

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56
Q

What causes some compatibility issues with antimicrobial preservatives?

A

Polysorbate and PVP inactive them

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57
Q

Do single use preparations have antimicrobial preservatives?

A

No–and they can NOT

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58
Q

What populations should benzyl alcohol NOT be used in?

A

Neonates–gasping syndrome

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59
Q

What populations should not contain antimicrobial preservatives?

A

Neonates

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60
Q

What injection route cannot contain antimicrobial preservatives?

A

Intra-spinal (must be single use)

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61
Q

What are some common pH buffers?

A

Citrates
Acetates
Phosphate

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62
Q

Which pH buffer has the potential to be fatal?

A

Phosphate!!

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63
Q

What is the caution with citrate buffers?

A

They are irritating via IM or SC rate, but safe by IV

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64
Q

Which buffer has a dangerous reaction with calcium?

A

Phosphate

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65
Q

When do phosphate and calcium have to be given together?

A

TPN preparations

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66
Q

When is it important for a parenteral product to have a physiological pH?

A

In a solution with a BUFFE (not in a non-buffered solution)

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67
Q

Why do unbuffered solutions NOT have to be at physiological pH?

A

They are quickly diliuted into physiological pH after injection–buffers are forced to remain at a different pH

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68
Q

What are some antioxidants?

A

Metabisulfate salts (low pH)
Bisulfite (medium pH)
Sulfite (high pH)
Ascorbic acid

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69
Q

What is the most common chelating agent?

A

EDTA

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70
Q

How do you inject a solution that is not isotonic?

A
  1. Small volumes
  2. Slowly
  3. Into central vein
    All to dilute the hypertonic solution
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71
Q

What is the best type of glass to use to contain parenteral products?

A

Type I

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72
Q

The containers and closures are considered ingredients of a parenteral product.

A

True

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73
Q

What is the draw back of a flip off cap/metal cover?

A

Does not guarantee sterility–just protects the rubber stopper

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74
Q

What is an ampule?

A

Glass, single use container; tight and uniform

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75
Q

What is the estimated number of drops per mL

A

15–but this isn’t exactly true

76
Q

What type of tip is required for hazardous drugs? What’s the other tip?

A

Luer Lok

Luer

77
Q

How do you read the volume of a syringe?

A

at the final edge of the plunger piston (the bottom of the triangle)

78
Q

How accurate are syringe readings?

A

To 1/2 of the smallest division

79
Q

What is the gauge of a needle?

A

The diameter of the bore

80
Q

What are the two needle measurements?

A

gauge and length

81
Q

How is needle size reported?

A

(Gauge)G(Length)

82
Q

How is gauge measured?

83
Q

What type of needle is used for an ampule?

A

Filter needle

84
Q

What USPs related to practice stands for paretneral sterility?

A

USP 797 and USP 800

85
Q

What are the 2 importance components of aseptic technique?

A

Knowledge

Skill

86
Q

What are the 3 sources of contamination in sterile compounding?

A

PEOPLE
Environment
Equipment

87
Q

How do we limit people’s contamination?

A

Train them
Garb them
Make sure they develop the skill
Periodically test them

88
Q

How do we limit equipment contamination?

A

Sterilize it

Sanitize (disinfect) it

89
Q

How do we limit environmental contamination?

A

Control it

90
Q

Why are people the main source of contamination?

A

They are always shedding particles–and shedding even more when they are moving

91
Q

What is the most important variable in affecting microbial contamination?

A

The training of the personnel (pharmacists have less contamination than technicians0

92
Q

How is the immediate vicinity kept free of particles?

A

Laminar flow hood and HEPA filter

93
Q

What is laminar flow?

A

Streamlines flow of fluid in which the fluid moves in layers without turbulence (occurs at low velocities)

94
Q

What is the velocity of laminar flow?

95
Q

What is HEPA filtered air?

A

Very clean air–no more than 100 particles >0.5 micron per cubic foot

96
Q

What is ISO Class 5?

A

The standard for HEPA filtered air–no more than 100 particles >0.5 micron per cubic feet

97
Q

What routes of CSP administration are most dangerous?

A

Vascular and CNS

98
Q

What is a bolus administration?

A

Large amount administered at once

99
Q

What is an infusion?

A

Drug gradually injected into blood, over a long period of time–keeps a consistent concentration in the blood

100
Q

Can emulsions be used for IV?

101
Q

Can oil-based solutions be used for IV?

102
Q

What are some common venous complications when giving IV?

A

Phlebitis

Thrombosis (limit veins available for future therapy, may take days/weeks to subside)

103
Q

How many mL per day can a body void?

104
Q

How many mL/hr can a body void?

105
Q

What is important to look out in an infusion rate?

A

How fast, how slow, and HOW MUCh is being administered

106
Q

Where should a piggyback IV bag be located?

A

Above the large volume container

107
Q

Is a piggyback IV intermittent or continuous?

A

Always intermittent with piggyback

108
Q

What is the difference between the intermittent and continuous IV set up?

A

Intermittent has piggyback and a One-Way check valve

109
Q

Why do we always inject into veins?

A

Arteries are more sensitive

Arteries have a higher pressure

110
Q

What are the maximum volumes for IM injections to deltoid, thigh, and gluteal muscles?

111
Q

Does IM have absorption step?

112
Q

What is the maximum volume for a SubQ administration?

113
Q

Does SubQ absorb faster or slower than IM?

A

Slower (lower tissue vascularization)

114
Q

What is infusion by subcutaneous route called?

A

Hypodermoclysis

115
Q

What is intrathecal administration?

A

Into the subarachnoid space

116
Q

What is epidural administration?

A

Between the dura mater and vertebral canal

117
Q

What special considerations are made for intra-spinal injections?

A

Has to be isotonic
Has to have physiological pH
No preservatives
Gauge matters

118
Q

What is special about an epidural gauge?

A

It has a different tip–not angled

119
Q

If an injection is okay for IV, is it okay for IM and SC?

A

Usually (but not citrates)

120
Q

What are the 2 types of laminar flow hoods?

A

Horizontal and vertical flow hood

121
Q

Which hood is easier to use?

A

Horizontal

122
Q

When does a vertical flow hood have to be used?

A

Hazardous products (cytotoxic/vesicant)

123
Q

What is a critical site?

A

Anywhere where microorganisms/contamination couuld enter a parenteral product during compounding

124
Q

What is a critical area?

A

An ISO class 5 environment–space between critical site and HEPA filter–must keep First Air air flow in this area!!

125
Q

What is a direct compounding area? (DCA)

A

Area in the LAFW where critical sites are exposed to HEPA filtered air

126
Q

Is the laminar flow hood sterile?

127
Q

What technique are we learning?

128
Q

T/F: The laminar flow hood cleans yo shit

129
Q

What is First Air?

A

Air leaving the HEPA filter in a unidirectional air stream; essentially particle free

130
Q

What needs to bathe all critical sites at all times?

A

HEPA-filtered air

131
Q

Why do we fill syringes upside down?

A

To keep the path clear–not get in the way of HEPA-filtered air

132
Q

What are the 4 bins to remember when compounding sterile preparation?

A
  1. Garbing
  2. Hand/glove
  3. Hood
  4. Conduct
133
Q

What is important for the personnel to be free of?

A

Skin/respiratory ailments

134
Q

What can be warn in the cleanroom?

A

Only dedicated shoes, shoe covers, head and face covers (NO outdoor garments, jewelry, makeup, artificial nails, iPods), and a low-shed gown

135
Q

Are isotonic solutions always iso-osmotic?

136
Q

Are iso-osmotic solutions always isotonic?

137
Q

What is isotonicity?

A

Maintaining or possessing a uniform tension or tone

138
Q

How do hypotonic vehicles cause hemolysis?

A

The water flows into the cell to even out concentration gradient

139
Q

How is osmolarity measured?

140
Q

What are colligative properties used to measure osmolarity?

A

Freezing point
Lowering of vapor pressure
Osmotic pressure
Elevation of boiling point

141
Q

What are colligative properties?

A

Properties that depend on the quantity of particles, not the chemical nature of the particles–the type of solute doesn’t effect it, just the amount

142
Q

How are osmolarity/osmolality determined?

A

Total concentrations of solutes dissolved (Including the drug)

143
Q

How many particles do salts have drugs dissolve into?

144
Q

What is the equation for osmolarity?

A

Moles of solute/Liter of solution * Osmoles/1 mole

145
Q

When are osmolarity and osmolality basically the same?

A

At low concentrations

146
Q

When is it dangerous to assume osmolarity and osmolality are the same?

A

High concentrations–like TPN dextrose solutions

147
Q

What is the difference between osmolality and osmolarity?

A 
Osmolarity = osmoles/volume of solvent + solute
Osmolality = osmoles/wt of only solvent
148
Q

What is serum osmolarity?

A

280-300 mOsmol/L

149
Q

What does osmolarity refer to?

A

A number, not the chemical that its measuring

150
Q

What does tonicity refer to?

A

Effect on a living cell–a compound can have the ‘correct’ osmolarity, but still not be isotonic if it affects the cell poorly

151
Q

If you mix isotonic solutions, what do you get?

A

Isotonic solution

152
Q

Are NS and D5W always interchangeable?

A

No–depends on compatibility with the product

153
Q

What happens if an isotonic solution is used to dissolve a lot of drug?

A

It becomes hypertonic

154
Q

What is worse–hypertonic or hypotonic?

A

Hypotonic (it will burst the cells)

155
Q

What are the 2 categories of vascular access devices?

A

Peripheral

Central

156
Q

What are the 2 types of peripheral VADs?

A

Needle

Over-the-needle catheter

157
Q

What are the 2 types of central VADs?

A

PICC

Surgically implanted

158
Q

What are the 2 types of IV administration sets?

A

Macrodrip and Microdrip

159
Q

When would you want to us a microdrip?

A

Pediatrics
For very precise volumes/closely regulated solutions
It delivers smaller amounts

160
Q

Is a macrodrip or microdrip faster?

161
Q

What is Poiseuille’s Law?

A

Rate = Driving Force/Resistance

162
Q

What are the components of resistance to flow?

A 
Tubing (macrobore v. microbore)
In-line filter (sometimes)
Viscosity of fluid
Length of tubing
Venous backpressure
163
Q

What is the drop conversion factor number?

A

15 drops per mL (on IV bag)–a guess/estimate, not exact for parenteral preparations

164
Q

What does the actual drops/mL depend on?

A

Viscosity of CSP
Surface tension
Density

165
Q

When is central venous therapy used?

A 
Infusion of large volumes
Multiple infusion
Long-term
Infusion of irritating medications
Infusions of hypertonic fluids
166
Q

How can you dilute a parenteral product?

A

Inject small volumes
Inject slowly
Inject into a central vein

167
Q

Two common names of central lines

A

Hickman

Broviac

168
Q

Does the Hickman catheter require surgical insertion?

169
Q

What is a vascular access portal?

A

Portal inserted into skin, skin heals over it, allows central access

170
Q

What are the advantages of central venous therapy?

A 
Access to central veins
Rapid infusion of large amounts of fluid
Draw blood and measure CV pressure
Fewer repeated venipunctures
Reduced risk of vein irritation from irritating substances
171
Q

What are risks of Central venous therapy?

A

Sepsis
Thrombus
Perforation of vessel and organs
Embolism

172
Q

What are the disadvantages of central venous therapy?

A

Cost

Requires more skill to insert than peripheral

173
Q

What are complications associated with central infusion from damage to the inner lining of the vein?

A

Stenosis (narrowing)
Thrombus (clot)
Venous occlusion
Chemical inflammation (phlebitis) and pain

174
Q

How is flow controlled?

A

Controllers (use gravity)

Pumps (use powered devices)

175
Q

What are infusion pumps?

A

Powered devices that provide pressure

176
Q

When is the range of infusion pump pressure?

A

2-12 psi

100-600 mmHg

177
Q

When is the high end of pressure used on an infusion pump?

A

intra-arterial infusions

178
Q

What is the caution associated with high infusion pressures?

A

Can increase infiltration risk at the site of injection

179
Q

What are some features of infusion pumps?

A 
Volumetric delivery (independent of back-pressure, patient position, composition of inusion, or tubing resistance)
Safety features (alarms)
Smart!
180
Q

Do infusion pumps make the drip chamber obsolete?

181
Q

When should syringe pumps be used?

A

Small volume infusions

Pediatrics

182
Q

What are syringe pumps especially useful for?

A

Intermittent IV meds

183
Q

What types of syringes do syringe pumps use?

A

Commercial ones

184
Q

What is Patient-controlled analgesia? (PCA)

A

Pain relief obtained at a lower total dose of drug

185
Q

What are ambulatory pumps?

A

Operates without an external power source, and is smaller/lighter

186
Q

What are implantable pumps?

A

Used for IV, intrathecal, intra-arterial routes; reserves of 50mL, can deliver as low as 1 microliter per hour

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