Dosage Forms Exam 2 Flashcards
1
Q
What are some parenteral medication errors?
A
Incorrect ingredients
Incorrect strengths
Contamination with pathogens
Contamination with pyrogens
2
Q
What happened in 2012 with the New England Compounding Center?
A
They had an outbreak of meningitis from their product
3
Q
What did the NECC meningitis outbreak lead to?
A
The Drug Quality and Security Act
4
Q
What is USP <797> about?
A
Pharmaceutical compounding–sterile preparations
5
Q
Which numbers of the USP are mandatory?
A
<1000
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
7
Q
How are parenteral products administered (in practice)?
A
By injection
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
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
10
Q
What are the 3 requirements for parenteral products?
A
- Sterile
- Particle Free
- Pyrogen Free
11
Q
What does USP <797> reduce the risk of?
A
Harm to the patient!
- Microbial contamination
- Excessive bacterial endotoxins
- Variability in strength of ingredients
- Unintended contaminants
- Ingredients of inappropriate quality
12
Q
What does sterile mean?
A
Free of microbial organisms
13
Q
How do you sterilize something?
A
Steam (autoclave) Filtration Dry Heat Gas (ethylene oxide) Irradiation (gamma rays)
14
Q
What are pyrogens?
A
Bacterial endotoxins–produce fever, cause septic shock
15
Q
Where do pyrogens come from?
A
Remanants of microorganisms
16
Q
Does sterilization eliminate pyrogens?
A
No
17
Q
What is the risk of pyrogens?
A
Septic shock/anaphylactic shock
18
Q
What is septicemia?
A
Infection of the blood
19
Q
What is septic shock?
A
Acute reaction to bacterial endotoxins (pyrogens)
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
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
22
Q
What is a [DRUG] injection?
A
Liquid preparations that are drug substances
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
24
Q
What is a [DRUG] injectable emulsion?
A
Liquid preparation of drug substances dissolved or dispersed in a suitable emulsion medium
25
What is a [DRUG] injectable suspension
Liquid preparations of solids suspended in a suitable liquid medium
26
What is a [DRUG] for injectable suspension?
Dry solids that yield preparations that meet requirements for injectable suspensions when vehicle is added
27
Difference between purduemycin injection and purduemycin FOR injection
"For" means that it is not ready to use! Has to have vehicles added before being injected
28
What is LVP?
Large Volume Parenteral--single dose injections in a container more than 100 mL
29
What is small volume parenteral?
Injection of 100 mL or less
30
Is a mistake worse in an LVP or a small volume parenteral?
LVP
31
What is a vehicle?
Solvent/medium for the administration of therapeutic agents
32
What is the most common vehicle?
Water
33
What is the preferred vehicle?
Water
34
What are the 3 types of water used in parenteral products?
Water for injection
Sterile water for injection (SWFI)
Bacteriostatic water for injection (BWFI)
35
What is WFI?
Water for injection--pyrogen free, non sterile, single use sealed container
36
What is SWFI?
Pyrogen free, sterile, packed in sealed containers <1000mL
37
What is BWFI?
Pyrogen free, sterile with antimicrobial agent added
38
Which water shouud you use for parenterals?
SWFI
39
Can you inject plain water? Why not?
NO - it causes hemolysis because it is so hypotonic
40
What preferred tonicity of parenteral products?
Isotonic
41
What is the preferred pH of parenteral products?
Physiological
42
Can intra-spinal injections have preservatives?
No
43
What are 4 common isotonic vehicles?
0.9% NaCl Solution (NS)
D5W
Ringer's Solution (NS w/K and Ca)
D2.5W1.2NS
44
What is the ideal solvent for parenteral products?
Water
45
What are water miscible cosolvents used for?
To solubilize drugs in water vehicle
46
What are some cosolvents?
```
Alcohol
Polyethylene glycol (40%)
Propylene glycol (10%)
```
47
When are cosolvents often used?
IM injections
48
Why can PEG be used at a higher IV concentration than ethyl alcohol?
To prevent hemolysis--ethyl alcohol has a higher hemolytic potential than PEG
49
Can oil be injected into veins?
No, causes embolus
50
Can oil emulsions be injected into veins?
Sure--in small enough droplets that they won't cause embolus
51
Can oil injections be used for IM?
Yes
52
When are antimicrobial preservatives used?
With multidose preparations ONLY
53
What is the most common preservative?
Benzyl alcohol 0.9%
54
What is the second most common preservative?
Parabens--methyl and propl
55
Are antimicrobials more effective in O/W or W/O?
O/W
56
What causes some compatibility issues with antimicrobial preservatives?
Polysorbate and PVP inactive them
57
Do single use preparations have antimicrobial preservatives?
No--and they can NOT
58
What populations should benzyl alcohol NOT be used in?
Neonates--gasping syndrome
59
What populations should not contain antimicrobial preservatives?
Neonates
60
What injection route cannot contain antimicrobial preservatives?
Intra-spinal (must be single use)
61
What are some common pH buffers?
Citrates
Acetates
Phosphate
62
Which pH buffer has the potential to be fatal?
Phosphate!!
63
What is the caution with citrate buffers?
They are irritating via IM or SC rate, but safe by IV
64
Which buffer has a dangerous reaction with calcium?
Phosphate
65
When do phosphate and calcium have to be given together?
TPN preparations
66
When is it important for a parenteral product to have a physiological pH?
In a solution with a BUFFE (not in a non-buffered solution)
67
Why do unbuffered solutions NOT have to be at physiological pH?
They are quickly diliuted into physiological pH after injection--buffers are forced to remain at a different pH
68
What are some antioxidants?
Metabisulfate salts (low pH)
Bisulfite (medium pH)
Sulfite (high pH)
Ascorbic acid
69
What is the most common chelating agent?
EDTA
70
How do you inject a solution that is not isotonic?
1. Small volumes
2. Slowly
3. Into central vein
All to dilute the hypertonic solution
71
What is the best type of glass to use to contain parenteral products?
Type I
72
The containers and closures are considered ingredients of a parenteral product.
True
73
What is the draw back of a flip off cap/metal cover?
Does not guarantee sterility--just protects the rubber stopper
74
What is an ampule?
Glass, single use container; tight and uniform
75
What is the estimated number of drops per mL
15--but this isn't exactly true
76
What type of tip is required for hazardous drugs? What's the other tip?
Luer Lok
| Luer
77
How do you read the volume of a syringe?
at the final edge of the plunger piston (the bottom of the triangle)
78
How accurate are syringe readings?
To 1/2 of the smallest division
79
What is the gauge of a needle?
The diameter of the bore
80
What are the two needle measurements?
gauge and length
81
How is needle size reported?
(Gauge)G(Length)
82
How is gauge measured?
13 to 27
83
What type of needle is used for an ampule?
Filter needle
84
What USPs related to practice stands for paretneral sterility?
USP 797 and USP 800
85
What are the 2 importance components of aseptic technique?
Knowledge
| Skill
86
What are the 3 sources of contamination in sterile compounding?
PEOPLE
Environment
Equipment
87
How do we limit people's contamination?
Train them
Garb them
Make sure they develop the skill
Periodically test them
88
How do we limit equipment contamination?
Sterilize it
| Sanitize (disinfect) it
89
How do we limit environmental contamination?
Control it
90
Why are people the main source of contamination?
They are always shedding particles--and shedding even more when they are moving
91
What is the most important variable in affecting microbial contamination?
The training of the personnel (pharmacists have less contamination than technicians0
92
How is the immediate vicinity kept free of particles?
Laminar flow hood and HEPA filter
93
What is laminar flow?
Streamlines flow of fluid in which the fluid moves in layers without turbulence (occurs at low velocities)
94
What is the velocity of laminar flow?
100ft/min
95
What is HEPA filtered air?
Very clean air--no more than 100 particles >0.5 micron per cubic foot
96
What is ISO Class 5?
The standard for HEPA filtered air--no more than 100 particles >0.5 micron per cubic feet
97
What routes of CSP administration are most dangerous?
Vascular and CNS
98
What is a bolus administration?
Large amount administered at once
99
What is an infusion?
Drug gradually injected into blood, over a long period of time--keeps a consistent concentration in the blood
100
Can emulsions be used for IV?
Yes
101
Can oil-based solutions be used for IV?
No
102
What are some common venous complications when giving IV?
Phlebitis
| Thrombosis (limit veins available for future therapy, may take days/weeks to subside)
103
How many mL per day can a body void?
3000
104
How many mL/hr can a body void?
100-150
105
What is important to look out in an infusion rate?
How fast, how slow, and HOW MUCh is being administered
106
Where should a piggyback IV bag be located?
Above the large volume container
107
Is a piggyback IV intermittent or continuous?
Always intermittent with piggyback
108
What is the difference between the intermittent and continuous IV set up?
Intermittent has piggyback and a One-Way check valve
109
Why do we always inject into veins?
Arteries are more sensitive
| Arteries have a higher pressure
110
What are the maximum volumes for IM injections to deltoid, thigh, and gluteal muscles?
2mL
5mL
5mL
111
Does IM have absorption step?
Yes
112
What is the maximum volume for a SubQ administration?
1.5 mL
113
Does SubQ absorb faster or slower than IM?
Slower (lower tissue vascularization)
114
What is infusion by subcutaneous route called?
Hypodermoclysis
115
What is intrathecal administration?
Into the subarachnoid space
116
What is epidural administration?
Between the dura mater and vertebral canal
117
What special considerations are made for intra-spinal injections?
Has to be isotonic
Has to have physiological pH
No preservatives
Gauge matters
118
What is special about an epidural gauge?
It has a different tip--not angled
119
If an injection is okay for IV, is it okay for IM and SC?
Usually (but not citrates)
120
What are the 2 types of laminar flow hoods?
Horizontal and vertical flow hood
121
Which hood is easier to use?
Horizontal
122
When does a vertical flow hood have to be used?
Hazardous products (cytotoxic/vesicant)
123
What is a critical site?
Anywhere where microorganisms/contamination couuld enter a parenteral product during compounding
124
What is a critical area?
An ISO class 5 environment--space between critical site and HEPA filter--must keep First Air air flow in this area!!
125
What is a direct compounding area? (DCA)
Area in the LAFW where critical sites are exposed to HEPA filtered air
126
Is the laminar flow hood sterile?
No
127
What technique are we learning?
Aseptic
128
T/F: The laminar flow hood cleans yo shit
false
129
What is First Air?
Air leaving the HEPA filter in a unidirectional air stream; essentially particle free
130
What needs to bathe all critical sites at all times?
HEPA-filtered air
131
Why do we fill syringes upside down?
To keep the path clear--not get in the way of HEPA-filtered air
132
What are the 4 bins to remember when compounding sterile preparation?
1. Garbing
2. Hand/glove
3. Hood
4. Conduct
133
What is important for the personnel to be free of?
Skin/respiratory ailments
134
What can be warn in the cleanroom?
Only dedicated shoes, shoe covers, head and face covers (NO outdoor garments, jewelry, makeup, artificial nails, iPods), and a low-shed gown
135
Are isotonic solutions always iso-osmotic?
Yes
136
Are iso-osmotic solutions always isotonic?
No
137
What is isotonicity?
Maintaining or possessing a uniform tension or tone
138
How do hypotonic vehicles cause hemolysis?
The water flows into the cell to even out concentration gradient
139
How is osmolarity measured?
Osmometer
140
What are colligative properties used to measure osmolarity?
Freezing point
Lowering of vapor pressure
Osmotic pressure
Elevation of boiling point
141
What are colligative properties?
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
How are osmolarity/osmolality determined?
Total concentrations of solutes dissolved (Including the drug)
143
How many particles do salts have drugs dissolve into?
2
144
What is the equation for osmolarity?
Moles of solute/Liter of solution * Osmoles/1 mole
145
When are osmolarity and osmolality basically the same?
At low concentrations
146
When is it dangerous to assume osmolarity and osmolality are the same?
High concentrations--like TPN dextrose solutions
147
What is the difference between osmolality and osmolarity?
```
Osmolarity = osmoles/volume of solvent + solute
Osmolality = osmoles/wt of only solvent
```
148
What is serum osmolarity?
280-300 mOsmol/L
149
What does osmolarity refer to?
A number, not the chemical that its measuring
150
What does tonicity refer to?
Effect on a living cell--a compound can have the 'correct' osmolarity, but still not be isotonic if it affects the cell poorly
151
If you mix isotonic solutions, what do you get?
Isotonic solution
152
Are NS and D5W always interchangeable?
No--depends on compatibility with the product
153
What happens if an isotonic solution is used to dissolve a lot of drug?
It becomes hypertonic
154
What is worse--hypertonic or hypotonic?
Hypotonic (it will burst the cells)
155
What are the 2 categories of vascular access devices?
Peripheral
| Central
156
What are the 2 types of peripheral VADs?
Needle
| Over-the-needle catheter
157
What are the 2 types of central VADs?
PICC
| Surgically implanted
158
What are the 2 types of IV administration sets?
Macrodrip and Microdrip
159
When would you want to us a microdrip?
Pediatrics
For very precise volumes/closely regulated solutions
It delivers smaller amounts
160
Is a macrodrip or microdrip faster?
Macrodrip
161
What is Poiseuille's Law?
Rate = Driving Force/Resistance
162
What are the components of resistance to flow?
```
Tubing (macrobore v. microbore)
In-line filter (sometimes)
Viscosity of fluid
Length of tubing
Venous backpressure
```
163
What is the drop conversion factor number?
15 drops per mL (on IV bag)--a guess/estimate, not exact for parenteral preparations
164
What does the actual drops/mL depend on?
Viscosity of CSP
Surface tension
Density
165
When is central venous therapy used?
```
Infusion of large volumes
Multiple infusion
Long-term
Infusion of irritating medications
Infusions of hypertonic fluids
```
166
How can you dilute a parenteral product?
Inject small volumes
Inject slowly
Inject into a central vein
167
Two common names of central lines
Hickman
| Broviac
168
Does the Hickman catheter require surgical insertion?
Yes
169
What is a vascular access portal?
Portal inserted into skin, skin heals over it, allows central access
170
What are the advantages of central venous therapy?
```
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
What are risks of Central venous therapy?
Sepsis
Thrombus
Perforation of vessel and organs
Embolism
172
What are the disadvantages of central venous therapy?
Cost
| Requires more skill to insert than peripheral
173
What are complications associated with central infusion from damage to the inner lining of the vein?
Stenosis (narrowing)
Thrombus (clot)
Venous occlusion
Chemical inflammation (phlebitis) and pain
174
How is flow controlled?
Controllers (use gravity)
| Pumps (use powered devices)
175
What are infusion pumps?
Powered devices that provide pressure
176
When is the range of infusion pump pressure?
2-12 psi
| 100-600 mmHg
177
When is the high end of pressure used on an infusion pump?
intra-arterial infusions
178
What is the caution associated with high infusion pressures?
Can increase infiltration risk at the site of injection
179
What are some features of infusion pumps?
```
Volumetric delivery (independent of back-pressure, patient position, composition of inusion, or tubing resistance)
Safety features (alarms)
Smart!
```
180
Do infusion pumps make the drip chamber obsolete?
No
181
When should syringe pumps be used?
Small volume infusions
| Pediatrics
182
What are syringe pumps especially useful for?
Intermittent IV meds
183
What types of syringes do syringe pumps use?
Commercial ones
184
What is Patient-controlled analgesia? (PCA)
Pain relief obtained at a lower total dose of drug
185
What are ambulatory pumps?
Operates without an external power source, and is smaller/lighter
186
What are implantable pumps?
Used for IV, intrathecal, intra-arterial routes; reserves of 50mL, can deliver as low as 1 microliter per hour
