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Disease and Defense > Unit 1 > Flashcards

Unit 1 Flashcards

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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
HS
at bed time
26
Stat
immediately
27
Bid
twice daily
28
Ac
before meals
29
Prn
As needed
30
Tid
three times daily
31
Qam
every morning
32
Pc
after meal
33
IA
intra-arterial
34
IVPB
IV piggy back
35
Sc/Sq
subcutaneous
36
IM
intramuscular
37
Po
by mouth
38
Vag
vaginally
39
Iv
intravenous
40
Pr
per rectum/rectally
41
how are drugs scheduled?
Medical use; abuse potential; physiological dependence; psychological dependence
42
Schedule 1 drugs
No medical use High abuse potential High dependence - Dr cannot prescribe
43
Schedule 2 drugs
Yes medical use High abuse High dependence - Dr prescribe in ink - cannot phone/fax
44
Schedule 3 drugs
Yes medical use Moderate abuse Mod/high dependence (phys/psych) - Dr prescribe
45
Schedule 4 drugs
Yes medical Low abuse Low dependence - Dr prescribe
46
Schedule 5 drugs
Yes medical limited abuse lowest dependence - Some states do not require prescription but CO does
47
Legal components of written prescription in CO
Date, ID of prescriber (name, address, license, phone), PT info (name, address), Drug + strength, signature, DEA number
48
5 parts of dosage regimen
Drug, DOse, Rout, Frequency, Duration
49
Loading Dose vs Maintenance Dose (purpose and equation)
LD higher to reach desired Cp faster; MD to keep at Cpss Cp = LD/Vd MD/T = CL x CPss (T = dosing interval)
50
Bioavailability F (Definition + Equation)
Extend of absorption of drug from non-intravenous site - used to convert dosage F = AUC route/AUC IV
51
Rate of absorption is determined by which 2 factors?
Tmax and Cmax
52
DIstribution Vd
Drug from plasma to site of action target - extent of drug movement ( dilution factor)
53
Equation for clearence depends on...
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)
54
List routes of administration
Oral, IV, inhalation, Rectal, Sublingual, Intramuscular, Subcutaneous, Transdermal patch, Dermal
55
Absorption depends on which 4 drug factor
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.
56
Methods to cross lipid bilayers
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
57
Routs of admin fast --> Slow (Oral, IV, Intramuscular, subcutaneous)
IV = Inhalation > intramuscular > subcutaneous > oral
58
Which routes have high bioavailability
IV, Inhalation, Subligual, Intramuscular, subcutaneous (Transdermal patch)
59
Routes with low bioavailability
Oral, rectal (varies) | Note: Dermal is NOT systemic
60
High/low Vd meaning?
Drugs spread to ECF/tissues and longer to eliminate | Drug remains in plasma - quickly eliminated
61
pH > pKa drug trapping
high pH = basic form dominates - traps acids because WA are ionied, WB is non ion
62
HH equation
``` pH = pKa + log A/HA; 10^(pH-pKa) = A/HA ```
63
Drug - protein binding effects
Reduce free drug concentration INcrease half life/prolong drug action - hinders metabolic degradation reduce excretion Decrease Vd and ability to enter CNS
64
Drug Drug interaction concerning if
displaced drug = narrow therapeutic index displaced drug = starts in high dose Displaced drug's Vd = small Response rate > distribution rate
65
Special anatomic consideration for distribution (where and why)
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
Total concentration of drug is _____ on side where ionization is greater
greater
67
Acidic drugs are trapped in more ____ solutions
basic
68
Drug metabolism, where, how, and goals
In liver via oxidation (or reduction/hydrolysis) Smooth ER - catalyze transformation Detox --> makes inactive (sometimes makes more active, activate, or toxic)
69
Phase 1 goals:
Make drug more polar/water soluble
70
Phase 1 process
Inserting/unmasking function group (OH, NH2, SH) | Oxidation, reduction, hydrolysis
71
Phase 2 goal/process
Conjugation/ endogenous substrate + functional group --> highly polar conjugate --> readily excreted via urine
72
Metabolism to more active compound example
codeine --> morphine | Hydrocodone --> hydropmorphone
73
Metabolism inactive --> active example
Omeprazole --> a sulenamide Enalapril -> analprilat Valacyclovir --> acyclovir
74
Metabolism toxic metabolite example
Acetaminophen --> N acetyl benzoquinoneimine
75
Cytochrome P 450 dependent oxidation needs 3 parts:
Liver smooth ER - NADPH, Flavoprotein, O2
76
Therapeutic consequence induction:
effect takes 48-72 hours - max effect 7-10 days: | Increase clearance of other drugs = reduce therapeutic effect/increase toxic metabolite
77
Therapeutic consequence inhibition:
Hours Effect on Cpss - depends on t1/2 Decrease clearance --> increase toxicity
78
Clinical Examples for inhibition
``` Cimetidine Erythromycin/Clarithromycin Ketoconazole/Azole antifungals Fluoxetine Grapefruit juice HIV protease inhibitors Omeprazole ```
79
Clinical Examples for inducers
``` Phenobarital Phenytoin Carbamazepine Rifampin Ethanol St. John's Wort Tobacco smoke ```
80
Phenobarbital is a _________
Inducer
81
Phenytoin is a _________
inducer
82
Carbamazepine is a _________
inducer
83
Rifampin is a _________
Inducer
84
Ethanol is a _________
inducer
85
St. John's wort is a _________
inducer
86
Tobacco smoke is a ______
inducer
87
Cimetidine is a _________
inhibitor
88
Erythromycin/clarithromycin is a _________
inhibitor
89
Ketoconazole/azole antifungal is a _________
inhibitor
90
Fluoxetine is a _________
inhibitor
91
Grapefruit juice is a _________
Inhibitor
92
HIV protease inhibitor is a _________
inhibitor
93
Omeprazole is a _________
inhibitor
94
Glomerulous (filtration rate, t1/2, size limit)
120 mL/min 1-4 hours mw 69000 (>albumin)
95
Glomerous filtration rate depends on ______ and ______
renal blood flow and renal function
96
Active secretion (rate, types, t1/2)
120-600 mL/min; stronger acids/base in proximal tubules, 1-2 hours
97
Tubular reabsorption depends on _____, _____, ____, and ____
concentration gradient, lipid solubility, size, non-ionized
98
Decrease Urine pH
trap base in urine, use NH4Cl
99
Increase urine pH
Trap acid in urine, use NaHCO3
100
Enterohepatic recirculation
Conjugates --> bile --> intestines --> bacterial flora enzyme hydrolyze to parent drug (lipid soluble ) --> reabsorption MW>300 Reduce elimination + prolong half life
101
Factors affect drug passage from plasma to breast milk
Timing milk is more acidic - basic drugs trapped Lipid soluble --> increase milk concentration High protein binding --> decrease milk concentration Drugs affect milk production
102
1st order half life
0.693/k = t1/2
103
Ke definition
fraction of drug leaving body per unit time (via all elimination process)
104
1st order constant _____ of drug removed per time
fraction
105
0th order constant _____ of drug removed per time
amount
106
Drug Receptor concept
Specificy of fit between receptor and conformation --> generate response
107
Drug-response curve
linear at the beginning -> more drug ->more receptors occupied -> more response Level off -> receptors are saturated, dose independent
108
Potency
Measured by amount of drug or concentration to reach 50% of max effect High potency = high affinity, low Kd, low EC50
109
Efficacy
Ability to reach a response to the max biological response
110
Partial agonist
Low efficacy
111
Full agnoist
high efficacy
112
tau >>t1/2
fluctuation is max - drug effectively eliminated before next dose
113
tau <= t1/2
fluctate less than 50% - little fluctuation
114
pharmacologic antagonist
Binds to receptor --> no effect but blocks entrance of agoinst
115
Receptor antagonist can do _______ binding or ________ binding
Active site; Allosteric
116
Nonreceptor anatongist
(physiological antagonist) bind to different receptor or (Chemical antagonist) bind agonist molecule directly Shift downwards
117
Noncompetitive active site antagonist
Binds irreversibly/pseudoirreversibly to active site - limits number of available receptor "removed" Shift downwards
118
Noncompetitive allosteric site
Reversibly/irreversibly at an allosteric site - receptor unable to respond to agonist Shift downwards
119
Competitive (reversible) antagonist
Shift graph to the right - competes for same active site as agonist - can be outcompeted with more agonist
120
Physiologic antagonist
activate/block a distinct receptor that mediates physiologic response opposite of agonist
121
Chemical Antagonist
``` inactivate agonist itself EDTA (chelating agent) to iron ions antacid base neutralize HCl Osmotic diuretic Protamine ```
122
Graded dose response curve
Histogram - frequency distribution of dose
123
Population drug response curve
Summation/cumulative frequency distribution
124
Therapeutic index
LD50/ED50 - higher is better | clinical 10-20
125
Standard safety margin SSM
(LD1/ED99 - 1)x100
126
Therapeutic window
arbitrary, Cp - ED99 and LD1
127
Pregnancy category A
No risk | KCl
128
Pregnancy category B
Risk unknown | Opioids, penicillins, erythromycin, ondansetron, acetaminophen, thiazide diuretic
129
Pregnancy category C
Risk possible; Benefit > Risk | Pseudoephedrine, antidepressants
130
Pregnancy category D
Positive Risk - Benefit > Risk - life threatening | Oral anticoagulants, ACE inhibitors/AT1 antagonist, diazepam-lorazepam, alprazolam paroxetine
131
Pregnancy category X
Risk > Benefits | HMG CoA reductase inhibitor
132
Pharmacokinetic drug/drug and drug/food interaction methods
Absorption, Distribution, Metabolism, Excretion
133
Prevent absorption methods
Emesis, Gastric Lavage, Chemical Absorption (activated charcoal), Osmotic cathartics (laxative)
134
Limitation for emesis
Lack of gag reflex, corrosive poison, CNS stimulant drug (Seizure), Petroleum distillate (pneumonitis), pregnancy category C asa[p
135
Gastric lavage
within 30 min, washing stomach with saline/removal nasogastric tube
136
Activated carbon (how it works and how to use)
Effected without gastric emptying - binds drug in guts | 10:1 ratio
137
Osmotic cathartics (when to use and which to avoid)
> 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
Inhibition of toxication
Fomepizole - blocks alcohol dehydrogenase Ethanol --> aldehyde using alochol dehydrogenase - competitive reversible antagonist Methanol --> formic acid; Ethylene glycol --> oxalic acid
139
Enhancement of detoxication process (metabolism)
Acetominophen overdose | give N-acetylcysteine - precursor for glutathione synthesis (needed to detox)
140
Enhancement of Elimination methods
Extracorporeal removal, enhanced metabolism, enhanced renal excretion, chelation of heavy metals
141
Extracorporeal removal
Remove toxin from blood Hemodialysis Hemoperfusion
142
Hemodialysis
blood through filter - small Vd, low protein binding - helps with fluid/electrolyte balance
143
Hemoperfusion
Blood pumped through column of adsorbent material - high MW - Poor water solubility Risk: Bleeding - removing platelets + electrolyte disturbance
144
Enhanced renal excretion
Forced diuresis - fluid overload/protect kidney | Block reabsorption from kidney - pH/ion trapping in urine
145
Chelation of heavy metal
Chelating agent forms complex with free metal ions ion forms coordinate covalent bonds with proteins --> enzyme inhibition/alteration of membrane structure
146
antidote for acetominophen
N-Acetylcysteine (Mucomyst)
147
Naloxone (Narcan) antidote for ______
Narcotics (opiates)
148
Flumazenil (Romazicon) antidote for ______
Benzodiazepines
149
Pralidoxime/atropine antidote for _____
Nerve gas/insecticide
150
Digoxin Fab antidote for _____
Digoxin
151
Protamine antidote for ____
Heparin
152
Vitamin K (Phytonadione) antidote for ________
Oral anticoagulants (warfarin)
153
antidote for Methanol/ethylene glycol
Ethanol, 4-methylpyrazole (antizol)
154
antidote for Iron Salts
Deferoxamine (Desferal)
155
antidote for Arsenic, gold, mercury
Dimeraprol (BAL)
156
antidote for for lead/mercury
Succimer (Chemet)
157
antidote for Copper, lead, gold, mercury
Penicillamine (Cuprimine)
158
antidote for cyanide
Hydroxcobalamin (Cyanokit)
159
antidote for Carbon monoxide
oxygen
160
Methylene blue antidote for ____
Nitrites/nitrates
161
Acidic medication (active tubular secretion)
Penicillin, salicylate, diuretics (Thiazides, acetozaolamide, thacrynic acid)
162
Basic medical (active tubular secretion)
Morphine, catecholamines, Histamine, hexamethonium, tolzoline

Disease and Defense (10 decks)

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