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pharmacology block 1 > lectures 1-3 > Flashcards

lectures 1-3 Flashcards

1
Q

what government body regulates most prescription drugs? exception?

A

FDA- CDER, exception is biologics (vaccines, recombinant proteins, gene therapy) are regulated by CBER

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2
Q

what is the “STEPS” approach to prescribing medication?

A

Safety, tolerability, efficacy, price, simplicity

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3
Q

steps in the FDA approval process (6)

A 
1- pre-clinical research 
2- IND application 
3- clinical testing (phase I-III)
4- NDA filed 
5- FDA review/approval 
6- phase IV (post-market surveillance)
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4
Q

describe phases I, II, III of clinical testing

A

phase I- healthy subjects, for safety, pharmacokinetics and dose range
phase II- effectiveness in target pop, 100-300 subjects
phase III- randomized/blinded, placebo-controlled for specific indications

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5
Q

what is the “gold standard” of clinical trials? what is “slightly better”?

A

double-blind, randomized, controlled trials; meta analysis (cochrane review) is superior to one study alone

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6
Q

example of RRR

A

the treated group had 34% fewer MI than control group

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7
Q

example of ARR

A

2.7% in the treated group had MI vs. 4.1% in the control group

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8
Q

example of NNT

A

medicine will prevent 1 in 71 taking med, from having MI

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9
Q

example of ARI

A

4% in treated group had adverse effect vs. 2% in control group

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10
Q

example of NNH

A

medicine will cause 1 in 21 to have adverse event

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11
Q

equation for RRR

A

RRR = (CER - EER)/CER

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12
Q

equation for ARR

A

ARR = CER- EER

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13
Q

equation for NNT

A

NNT = 100/ARR

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14
Q

equation for ARI

A

ARI = EAE - CAE

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15
Q

equation for NNH

A

NNH = 100/ARI

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16
Q

define p-value

A

the probability that an observed outcome is due to chance, lower p-value is better, less than 0.05 is considered statistically significant

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17
Q

define confidence interval

A

range of plausible results, usually reported as 95%, meaning that the actual value falls in the range 95% of the time, smaller CI is better

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18
Q

pharmacokinetics is the effect of the…

A

body on the drug

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19
Q

pharmacodynamics is the effect of the …

A

drug on the body

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20
Q

which route of administration is subject to the 1st pass effect?

A

oral

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21
Q

which 2 forms of administration have variable/erratic absorption?

A

oral and rectal

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22
Q

limited volume and pain are disadvantages to which 2 routes of admin

A

SC and IM

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23
Q

what can increase the systemic absorption of a med applied topically?

A

application over inflamed skin

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24
Q

difference between topical and transdermal

A

topical is applied to the skin and is intended to treat the skin, transdermal is applied to the skin but is intended to have systemic absorption

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25
Q

for drugs that are absorbed by passive diffusion, what determines the rate of absorption? when will absorption stop?

A

concentration gradient, absorption will continue until [intracellular ] = [extracellular]

26
Q

example of an uptake transport protein

A

OATP (organic anion transport protein)

27
Q

example of an efflux transport protein

A

P-glycoprotein - actively removes drug from epithelial cells and prevents absorption

28
Q

describe ion trapping

A

drugs can cross membranes best when they are in their non-ionized forms. Weak acids (low pKa) will be unionized at low pH and ionized at high pH. Weak bases (high pKa) will be unionized at high pH and ionized at low pH

29
Q

example of how to treat amphetamine OD

A

amphetamine is a weak base, therefore to prevent absorption and hasten excretion in urine, both the stomach and urine should be acidified to trap amphetamine in its BH+ form

30
Q

difference between enteric coated and controlled release

A

enteric coated has a protective coating that dissolves at high pH (duodenum) to protect the stomach, controlled release is designed to have a slow release of drug as it transits the GI tract (good for drugs with short T1/2)

31
Q

what is the effect on drugs that are subject to the first pass effect?

A

drugs that experience the first pass effect are metabolized in the liver before reaching the systemic circulation and will have decreased oral bioavailability and increased hepatic extraction

32
Q

how are most drugs absorbed into cells?

A

passive diffusion

33
Q

6 drugs that high first pass extraction

A

propanolol, verapamil, morphine, merperidine, lidocaine and nitroglycerin

34
Q

what 4 tissues are highly perfused and therefore have fast drug distribution?

A

liver, kidney, lung, heart

35
Q

what 4 tissues have poor perfusion and therefore slow drug distribution?

A

skin, fat, bone, prostate

36
Q

what is the effect of decreased plasma protein concentration on drug levels?

A

serum levels of free drug are increased when plasma protein levels are decreased

37
Q

what is the apparent volume of distribution?

A

volume of fluid (L) a drug would need to be dissolved in to have the same concentration as plasma

38
Q

equation for Vd

A

Vd = (amount in body/dose) / (desired serum concentration)

39
Q

4 fluid volumes for a 70 kg adult

A

plasma = 0.04 L/Kg (2.8L)
extracellular fluid = 0.25 L/Kg (17.5 L)
intracellular fluid = 0.35 L/Kg (24.5 L)
total body water = 0.6 L/Kg (42 L)

40
Q

contrast a drug A with Vd = 5L vs. drug B with Vd = 100 L

A

drug A has low Vd, mainly in plasma

drug B has very high Vd, highly distributed in tissues and fat

41
Q

when is it necessary to give a loading dose?

A

when a drug has a long half-life and is it important to reach steady state quickly

42
Q

how can Vd be used to calculate a loading dose?

A

Loading dose = Vd x desired plasma concentration x weight (Kg)

43
Q

what are the 4 “phase I” reactions? purpose?

A

hydrolysis, oxidation, acetylation and reduction

purpose is to increase water solubility

44
Q

what are the 3 “phase II” reactions? purpose?

A

sulfation, glucuroidation, glutathionation and amino acid conjugation

45
Q

what group of enzymes is responsible for most phase I reactions?

A

CYP450

46
Q

what are the 5 CYP450 types that carry out 90% of phase I reactions?

A

1A2, 2C9, 2C19, 2D6, 3A4

47
Q

what is biliary excretion subject to?

A

enterohepatic cycling

48
Q

define clearance

A

the volume of plasma from which drug is eliminated per unit time (includes clearance of drugs metabolized by both liver and kidney)

49
Q

what is the elimination rate?

A

amount of drug (mg) removed per hour

50
Q

elimination rate equation

A

elimination rate = clearance (L/hr) x drug concentration in the plasma at steady state (mg/L)

51
Q

cockroft-gault formula, correction for females

A

CrCl = ([140 - age] x IBW) / (Scr x 72)

for females, multiply by 0.85

52
Q

describe zero order elimination

A

rate of elimination is constant, regardless of drug concentration, and is due to saturation of binding sites on metabolic enzymes

53
Q

what drugs exhibit zero order elimination?

A

high doses of: Phenytoin, Ethanol, Aspirin (PEA)

54
Q

describe first-order elimination

A

rate of elimination is proportional to plasma drug concentration (increased drug concentration = increased rate of elimination)

55
Q

what is the elimination rate constant (Ke)?

A

Ke is the fraction of drug eliminated per unit time

56
Q

Ke equation

A

Ke = Cl /Vd

57
Q

what is the relationship between T1/2 and Ke?

A

T1/2 = 0.7/Ke = 0.7Vd/Cl

58
Q

what does T1/2 vary slightly per person?

A

because T1/2 depends on Vd and Cl

59
Q

what is the definition of steady state?

A

steady state is when the rate of administration equal the rate of elimination

60
Q

how many half-lives to reach steady state?

A

about 5, in the absence of a loading dose

61
Q

describe a clinical application for understanding that it takes 5 half-lives to reach steady state?

A

can be used to determine if a sx is a SE from a drug (wait 5 T1/2, if sx resolves then possibly from drug, if sx persists then not fro drug)

62
Q

define bioavailability in terms of AUC

A

bioavailability = AUC-PO / AUC-IV

pharmacology block 1 (5 decks)

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