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Disease and Defense > Unit 1 > Flashcards

Unit 1 Flashcards

1
Q

Federal government roles (3)

A
  1. Safety & Efficacy of new drugs; removal of unsafe dietary supplements
  2. Equivalency generic and brand
  3. Place drugs in categories Rx and OTC and schedules
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2
Q

State government roles

A

Controls who may prescribe drugs via medical/dental board. Controlled substance needs DEA (Drug enforcement admin of department of justice)

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3
Q

Local Government Role

A

Pass laws that concern drug use in their jurisdiction

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4
Q

Phase 1 clinical trial (Goals, approximate timing, number of volunteers)

A

<100 healthy males 18-45 yrs
~ 1year
Goals: Determine if it is safe and toxicity/metabolism studies, if animal/human response differ

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5
Q

Phase 2 clinical trial (Goals, approximate timing, number of volunteers)

A

200-300 patient pools
2 years
Goals: Does it work in patients, safety and efficacy, final dosing, regimen adjust. Detect broader range of toxicity

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6
Q

Phase III clinical trial (Goals, approximate timing, number of volunteers)

A

1000-6000 patients
~3 years
Goal: Does it work double blind; efficacy, adverse reaction with chronic use
Can be skipped for high need drugs (accelerated/conditional approval)

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7
Q

ANDA Abbreviated new drug application

A

Generic drugs can bypass clinical trials, just needs to prove bioequivalency

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8
Q

Phase 4 clinical trial (Goals, approximate timing, number of volunteers)

A 
Report adverse effect
post marketing surveillance
data on mortality/morbidity
Other groups - women/older/children
Low incidence drug effects missed in phase I-III seen here
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9
Q

Dietary Supplements Define

A

Taken by mouth. Vitamins/minerals/amino acids/botanical-herbs.
Herbal: Majority of molecular entity pharmaacologic activity not known

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10
Q

Dietary supplement regulation and differ from drugs

A

Prior to 1994 - assumed safe
No need to prove safe/effective - need reasonable evidence produce is safe.
Sold first, and remove from market if harmful vs proven first, then allowed to sell

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11
Q

Pharmaceutical Equivalence

A

Same: active ingredient, dosage formulation, rout of adminstration, identical in strength/concentration. “formulation”

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12
Q

Pharmaceutical alternatives

A

Same therapeutic moiety - differ in salts, ester, complex or dosages/strengths

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13
Q

Bioequivalence

A

Extent of absorption (bioavailability) and Rate of absorption same for active ingredient. “Formulation –> drug molecules –> Cp –> target”

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14
Q

Therapeutic equivalents

A

Admin to same individual in same dosage regimen –> same efficacy and safety. Assumed bioequivalent = therapeutically equivalent. “therapeutic effects”

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15
Q

1 gram = ? grains

A

15.43

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16
Q

1 kg = ? pounds

A

2.2

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17
Q

1 ounce = ? grains = ? grams

A

437.5 grains; 28.35 grams

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18
Q

1 drop = ? mL

A

0.05

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19
Q

1 tsp = ? mL?

A

5

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20
Q

1 tbsp = ? mL

A

15

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21
Q

1 fl oz = ? mL

A

29.56 or “30”

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22
Q

1 quart = ? mL

A

946

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23
Q

1 pint = ? mL

A

473

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24
Q

1 gallon = ? L

A

3.785

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25
Q

HS

A

at bed time

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26
Q

Stat

A

immediately

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27
Q

Bid

A

twice daily

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28
Q

Ac

A

before meals

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29
Q

Prn

A

As needed

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30
Q

Tid

A

three times daily

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31
Q

Qam

A

every morning

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32
Q

Pc

A

after meal

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33
Q

IA

A

intra-arterial

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34
Q

IVPB

A

IV piggy back

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35
Q

Sc/Sq

A

subcutaneous

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36
Q

IM

A

intramuscular

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37
Q

Po

A

by mouth

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38
Q

Vag

A

vaginally

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39
Q

Iv

A

intravenous

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40
Q

Pr

A

per rectum/rectally

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41
Q

how are drugs scheduled?

A

Medical use; abuse potential; physiological dependence; psychological dependence

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42
Q

Schedule 1 drugs

A

No medical use
High abuse potential
High dependence

  • Dr cannot prescribe
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43
Q

Schedule 2 drugs

A

Yes medical use
High abuse
High dependence
- Dr prescribe in ink - cannot phone/fax

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44
Q

Schedule 3 drugs

A

Yes medical use
Moderate abuse
Mod/high dependence (phys/psych)
- Dr prescribe

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45
Q

Schedule 4 drugs

A

Yes medical
Low abuse
Low dependence
- Dr prescribe

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46
Q

Schedule 5 drugs

A

Yes medical
limited abuse
lowest dependence
- Some states do not require prescription but CO does

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47
Q

Legal components of written prescription in CO

A

Date, ID of prescriber (name, address, license, phone), PT info (name, address), Drug + strength, signature, DEA number

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48
Q

5 parts of dosage regimen

A

Drug, DOse, Rout, Frequency, Duration

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49
Q

Loading Dose vs Maintenance Dose (purpose and equation)

A

LD higher to reach desired Cp faster; MD to keep at Cpss
Cp = LD/Vd
MD/T = CL x CPss (T = dosing interval)

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50
Q

Bioavailability F (Definition + Equation)

A

Extend of absorption of drug from non-intravenous site - used to convert dosage
F = AUC route/AUC IV

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51
Q

Rate of absorption is determined by which 2 factors?

A

Tmax and Cmax

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52
Q

DIstribution Vd

A

Drug from plasma to site of action target - extent of drug movement ( dilution factor)

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53
Q

Equation for clearence depends on…

A

CL = Vd x Ke (elimination rate constant and half life)

Use also to determined interval between dosages to maintain Cpss (MD/T = CL x Cpss)

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54
Q

List routes of administration

A

Oral, IV, inhalation, Rectal, Sublingual, Intramuscular, Subcutaneous, Transdermal patch, Dermal

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55
Q

Absorption depends on which 4 drug factor

A
  1. molecular size - affected by drug -protein binding
  2. Lipid solubility - O/W
  3. Degree of ionization - Affected by tissue pH - affects lipid solubility
  4. Concentration gradient - at site of admin.
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56
Q

Methods to cross lipid bilayers

A
  1. Passive diffusion via aqueous channels - water soluble drugs, limit by size
  2. Passive diffusion via hydrophobic binding - membrane lipids
  3. Facilitated diffusion - Membrane carrier molecules
  4. Active transport
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57
Q

Routs of admin fast –> Slow (Oral, IV, Intramuscular, subcutaneous)

A

IV = Inhalation > intramuscular > subcutaneous > oral

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58
Q

Which routes have high bioavailability

A

IV, Inhalation, Subligual, Intramuscular, subcutaneous (Transdermal patch)

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59
Q

Routes with low bioavailability

A

Oral, rectal (varies)

Note: Dermal is NOT systemic

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60
Q

High/low Vd meaning?

A

Drugs spread to ECF/tissues and longer to eliminate

Drug remains in plasma - quickly eliminated

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61
Q

pH > pKa drug trapping

A

high pH = basic form dominates - traps acids because WA are ionied, WB is non ion

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62
Q

HH equation

A 
pH = pKa + log A/HA;
10^(pH-pKa) = A/HA
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63
Q

Drug - protein binding effects

A

Reduce free drug concentration
INcrease half life/prolong drug action - hinders metabolic degradation
reduce excretion
Decrease Vd and ability to enter CNS

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64
Q

Drug Drug interaction concerning if

A

displaced drug = narrow therapeutic index
displaced drug = starts in high dose
Displaced drug’s Vd = small
Response rate > distribution rate

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65
Q

Special anatomic consideration for distribution (where and why)

A

GI mucosa, blood brain barrier, placenta, renal tubules - tight junctions so drug must move through cells - lipid soluble
(fenestration in post cap venules - through openings)

66
Q

Total concentration of drug is _____ on side where ionization is greater

A

greater

67
Q

Acidic drugs are trapped in more ____ solutions

A

basic

68
Q

Drug metabolism, where, how, and goals

A

In liver via oxidation (or reduction/hydrolysis)
Smooth ER - catalyze transformation
Detox –> makes inactive (sometimes makes more active, activate, or toxic)

69
Q

Phase 1 goals:

A

Make drug more polar/water soluble

70
Q

Phase 1 process

A

Inserting/unmasking function group (OH, NH2, SH)

Oxidation, reduction, hydrolysis

71
Q

Phase 2 goal/process

A

Conjugation/ endogenous substrate + functional group –> highly polar conjugate –> readily excreted via urine

72
Q

Metabolism to more active compound example

A

codeine –> morphine

Hydrocodone –> hydropmorphone

73
Q

Metabolism inactive –> active example

A

Omeprazole –> a sulenamide
Enalapril -> analprilat
Valacyclovir –> acyclovir

74
Q

Metabolism toxic metabolite example

A

Acetaminophen –> N acetyl benzoquinoneimine

75
Q

Cytochrome P 450 dependent oxidation needs 3 parts:

A

Liver smooth ER - NADPH, Flavoprotein, O2

76
Q

Therapeutic consequence induction:

A

effect takes 48-72 hours - max effect 7-10 days:

Increase clearance of other drugs = reduce therapeutic effect/increase toxic metabolite

77
Q

Therapeutic consequence inhibition:

A

Hours
Effect on Cpss - depends on t1/2
Decrease clearance –> increase toxicity

78
Q

Clinical Examples for inhibition

A 
Cimetidine
Erythromycin/Clarithromycin
Ketoconazole/Azole antifungals
Fluoxetine
Grapefruit juice
HIV protease inhibitors
Omeprazole
79
Q

Clinical Examples for inducers

A 
Phenobarital
Phenytoin
Carbamazepine
Rifampin
Ethanol
St. John's Wort
Tobacco smoke
80
Q

Phenobarbital is a _________

A

Inducer

81
Q

Phenytoin is a _________

A

inducer

82
Q

Carbamazepine is a _________

A

inducer

83
Q

Rifampin is a _________

A

Inducer

84
Q

Ethanol is a _________

A

inducer

85
Q

St. John’s wort is a _________

A

inducer

86
Q

Tobacco smoke is a ______

A

inducer

87
Q

Cimetidine is a _________

A

inhibitor

88
Q

Erythromycin/clarithromycin is a _________

A

inhibitor

89
Q

Ketoconazole/azole antifungal is a _________

A

inhibitor

90
Q

Fluoxetine is a _________

A

inhibitor

91
Q

Grapefruit juice is a _________

A

Inhibitor

92
Q

HIV protease inhibitor is a _________

A

inhibitor

93
Q

Omeprazole is a _________

A

inhibitor

94
Q

Glomerulous (filtration rate, t1/2, size limit)

A

120 mL/min
1-4 hours
mw 69000 (>albumin)

95
Q

Glomerous filtration rate depends on ______ and ______

A

renal blood flow and renal function

96
Q

Active secretion (rate, types, t1/2)

A

120-600 mL/min; stronger acids/base in proximal tubules, 1-2 hours

97
Q

Tubular reabsorption depends on _____, _____, ____, and ____

A

concentration gradient, lipid solubility, size, non-ionized

98
Q

Decrease Urine pH

A

trap base in urine, use NH4Cl

99
Q

Increase urine pH

A

Trap acid in urine, use NaHCO3

100
Q

Enterohepatic recirculation

A

Conjugates –> bile –> intestines –> bacterial flora enzyme hydrolyze to parent drug (lipid soluble ) –> reabsorption
MW>300
Reduce elimination + prolong half life

101
Q

Factors affect drug passage from plasma to breast milk

A

Timing
milk is more acidic - basic drugs trapped
Lipid soluble –> increase milk concentration
High protein binding –> decrease milk concentration
Drugs affect milk production

102
Q

1st order half life

A

0.693/k = t1/2

103
Q

Ke definition

A

fraction of drug leaving body per unit time (via all elimination process)

104
Q

1st order constant _____ of drug removed per time

A

fraction

105
Q

0th order constant _____ of drug removed per time

A

amount

106
Q

Drug Receptor concept

A

Specificy of fit between receptor and conformation –> generate response

107
Q

Drug-response curve

A

linear at the beginning -> more drug ->more receptors occupied -> more response
Level off -> receptors are saturated, dose independent

108
Q

Potency

A

Measured by amount of drug or concentration to reach 50% of max effect
High potency = high affinity, low Kd, low EC50

109
Q

Efficacy

A

Ability to reach a response to the max biological response

110
Q

Partial agonist

A

Low efficacy

111
Q

Full agnoist

A

high efficacy

112
Q

tau&raquo_space;t1/2

A

fluctuation is max - drug effectively eliminated before next dose

113
Q

tau <= t1/2

A

fluctate less than 50% - little fluctuation

114
Q

pharmacologic antagonist

A

Binds to receptor –> no effect but blocks entrance of agoinst

115
Q

Receptor antagonist can do _______ binding or ________ binding

A

Active site; Allosteric

116
Q

Nonreceptor anatongist

A

(physiological antagonist) bind to different receptor or (Chemical antagonist) bind agonist molecule directly
Shift downwards

117
Q

Noncompetitive active site antagonist

A

Binds irreversibly/pseudoirreversibly to active site - limits number of available receptor “removed”
Shift downwards

118
Q

Noncompetitive allosteric site

A

Reversibly/irreversibly at an allosteric site - receptor unable to respond to agonist
Shift downwards

119
Q

Competitive (reversible) antagonist

A

Shift graph to the right - competes for same active site as agonist - can be outcompeted with more agonist

120
Q

Physiologic antagonist

A

activate/block a distinct receptor that mediates physiologic response opposite of agonist

121
Q

Chemical Antagonist

A 
inactivate agonist itself
EDTA (chelating agent) to iron ions
antacid base neutralize HCl
Osmotic diuretic 
Protamine
122
Q

Graded dose response curve

A

Histogram - frequency distribution of dose

123
Q

Population drug response curve

A

Summation/cumulative frequency distribution

124
Q

Therapeutic index

A

LD50/ED50 - higher is better

clinical 10-20

125
Q

Standard safety margin SSM

A

(LD1/ED99 - 1)x100

126
Q

Therapeutic window

A

arbitrary, Cp - ED99 and LD1

127
Q

Pregnancy category A

A

No risk

KCl

128
Q

Pregnancy category B

A

Risk unknown

Opioids, penicillins, erythromycin, ondansetron, acetaminophen, thiazide diuretic

129
Q

Pregnancy category C

A

Risk possible; Benefit > Risk

Pseudoephedrine, antidepressants

130
Q

Pregnancy category D

A

Positive Risk - Benefit > Risk - life threatening

Oral anticoagulants, ACE inhibitors/AT1 antagonist, diazepam-lorazepam, alprazolam paroxetine

131
Q

Pregnancy category X

A

Risk > Benefits

HMG CoA reductase inhibitor

132
Q

Pharmacokinetic drug/drug and drug/food interaction methods

A

Absorption, Distribution, Metabolism, Excretion

133
Q

Prevent absorption methods

A

Emesis, Gastric Lavage, Chemical Absorption (activated charcoal), Osmotic cathartics (laxative)

134
Q

Limitation for emesis

A

Lack of gag reflex, corrosive poison, CNS stimulant drug (Seizure), Petroleum distillate (pneumonitis), pregnancy category C
asa[p

135
Q

Gastric lavage

A

within 30 min, washing stomach with saline/removal nasogastric tube

136
Q

Activated carbon (how it works and how to use)

A

Effected without gastric emptying - binds drug in guts

10:1 ratio

137
Q

Osmotic cathartics (when to use and which to avoid)

A

> 60 min
Sorbitol 70% - give with charcoal
Magnesium citrate/sulfate - not with renal disease
Sodium sulfate - avoid in congestive heart failure/hypertension
Polyethylene glycol - use with sustained release drugs/metal ions, drug packets

138
Q

Inhibition of toxication

A

Fomepizole - blocks alcohol dehydrogenase
Ethanol –> aldehyde using alochol dehydrogenase - competitive reversible antagonist
Methanol –> formic acid; Ethylene glycol –> oxalic acid

139
Q

Enhancement of detoxication process (metabolism)

A

Acetominophen overdose

give N-acetylcysteine - precursor for glutathione synthesis (needed to detox)

140
Q

Enhancement of Elimination methods

A

Extracorporeal removal, enhanced metabolism, enhanced renal excretion, chelation of heavy metals

141
Q

Extracorporeal removal

A

Remove toxin from blood
Hemodialysis
Hemoperfusion

142
Q

Hemodialysis

A

blood through filter
- small Vd, low protein binding -
helps with fluid/electrolyte balance

143
Q

Hemoperfusion

A

Blood pumped through column of adsorbent material
- high MW
- Poor water solubility
Risk: Bleeding - removing platelets + electrolyte disturbance

144
Q

Enhanced renal excretion

A

Forced diuresis - fluid overload/protect kidney

Block reabsorption from kidney - pH/ion trapping in urine

145
Q

Chelation of heavy metal

A

Chelating agent forms complex with free metal ions

ion forms coordinate covalent bonds with proteins –> enzyme inhibition/alteration of membrane structure

146
Q

antidote for acetominophen

A

N-Acetylcysteine (Mucomyst)

147
Q

Naloxone (Narcan) antidote for ______

A

Narcotics (opiates)

148
Q

Flumazenil (Romazicon) antidote for ______

A

Benzodiazepines

149
Q

Pralidoxime/atropine antidote for _____

A

Nerve gas/insecticide

150
Q

Digoxin Fab antidote for _____

A

Digoxin

151
Q

Protamine antidote for ____

A

Heparin

152
Q

Vitamin K (Phytonadione) antidote for ________

A

Oral anticoagulants (warfarin)

153
Q

antidote for Methanol/ethylene glycol

A

Ethanol, 4-methylpyrazole (antizol)

154
Q

antidote for Iron Salts

A

Deferoxamine (Desferal)

155
Q

antidote for Arsenic, gold, mercury

A

Dimeraprol (BAL)

156
Q

antidote for for lead/mercury

A

Succimer (Chemet)

157
Q

antidote for Copper, lead, gold, mercury

A

Penicillamine (Cuprimine)

158
Q

antidote for cyanide

A

Hydroxcobalamin (Cyanokit)

159
Q

antidote for Carbon monoxide

A

oxygen

160
Q

Methylene blue antidote for ____

A

Nitrites/nitrates

161
Q

Acidic medication (active tubular secretion)

A

Penicillin, salicylate, diuretics (Thiazides, acetozaolamide, thacrynic acid)

162
Q

Basic medical (active tubular secretion)

A

Morphine, catecholamines, Histamine, hexamethonium, tolzoline

Disease and Defense (10 decks)

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