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Pharm 2 > LE 1 > Flashcards

LE 1 Flashcards

1
Q

Pharmacology –

A

study of drugs; their action on living organisms

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2
Q

Oral drugs - Three phases:

A
  • Pharmaceutics
  • Pharmacokinetics
  • Pharmacodynamics
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3
Q

Pharmaceutics

a) Dissolution of drugs occurs, drugs must be soluble to be absorbed
b) Absorption, Distribution, Metabolism, Excretion
c) Alteration in cellular form/environment

A

a) Dissolution of drugs occurs, drugs must be soluble to be absorbed

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4
Q

Pharmacokinetics

a) Dissolution of drugs occurs, drugs must be soluble to be absorbed
b) Absorption, Distribution, Metabolism, Excretion
c) Alteration in cellular form/environment

A

b) Absorption, Distribution, Metabolism, Excretion

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5
Q

Pharmacodynamics

a) Dissolution of drugs occurs, drugs must be soluble to be absorbed
b) Absorption, Distribution, Metabolism, Excretion
c) Alteration in cellular form/environment

A

c) Alteration in cellular form/environment

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6
Q

Absorption: First-pass effect (3)

A
  • drug absorbed by small/large intestine
  • liver first metabolizes drug
  • remaining drug not sufficient to produce
    therapeutic effect
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7
Q

Factors affecting distribution:

A
  • Protein binding (free/bound drug)
  • blood flow
  • solubility (lipid-soluble drugs/ water soluble
    drugs
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8
Q

Sites of quick distribution:

A

o Heart
o Liver
o Kidneys

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9
Q

Sites of slow distribution:

A

o Internal organs
o Skin
o Muscle

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10
Q

Metabolism:

A) Absorption rate equals elimination rate
B) Body changes drug to a more or less active form for excretion
C) Elimination of drugs from the body
D) Time for drug to produce therapeutic effect

A

B) Body changes drug to a more or less active form for excretion

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11
Q

Excretion:

A) Absorption rate equals elimination rate
B) Body changes drug to a more or less active form for excretion
C) Elimination of drugs from the body
D) Time for drug to produce therapeutic effect

A

C) Elimination of drugs from the body

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12
Q

Difficulty in drug excretion:

A) Increases half-life
B) Decreases half-life

A

Increases half-life and

risk of toxicity

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13
Q

Onset of action:

a) absorption rate equals elimination rate
b) time between drug administration and beginning of therapeutic effect
c) time for drug to produce therapeutic effect

A

b) time between drug administration and beginning of therapeutic effect

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14
Q

Peak Concentration:

a) absorption rate equals elimination rate
b) time between drug administration and beginning of therapeutic effect
c) time for drug to produce therapeutic effect

A

a) absorption rate equals elimination rate

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15
Q

Duration of action:

A

c) time for drug to produce therapeutic effect

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16
Q

Pharmacodynamics:

a) desired or therapeutic effect
b) study of the drug mechanisms producing biochemical/physiologic changes in body
c) other desirable or undesirable effects

A

b) study of the drug mechanisms producing biochemical/physiologic changes in body

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17
Q

Primary effect of drug

a) desired or therapeutic effect
b) study of the drug mechanisms producing biochemical/physiologic changes in body
c) other desirable or undesirable effects

A

a) desired or therapeutic effect

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18
Q

Secondary effect of drug

a) desired or therapeutic effect
b) study of the drug mechanisms producing biochemical/physiologic changes in body
c) other desirable or undesirable effects

A

c) other desirable or undesirable effects

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19
Q

Two general MOA in pharmacodynamic phase:

A

a) Alteration in cellular form

b) Alteration in cellular environment

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20
Q

Which produces therapeutic response?

a) agonist
b) antagonist

A

agonist

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21
Q

Drugs administered during the ____ may cause teratogenic effects

a) first trimester
b) second trimester
c) third trimester

A

a) first trimester

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22
Q

Risks of smoking and drinking:

A
  • Low birth weight
  • premature birth
  • fetal alcohol syndrome
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23
Q

6 clinical problem areas

A
  1. Drug Interactions
  2. Pharmacogenetics
  3. Drug allergy
  4. Dosing modifications
  5. Monitoring plasma drug concentrations
  6. Evidence-based therapeutics
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24
Q

Drug Interactions

A

Change in the magnitude or duration of pharmacological response to a drug because of
the presence of another drug

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25
Q

Drug interaction of Ethanol

A

speeds metabolism of phenytoin,

tolbutamide, warfarin

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26
Q

Drug interaction of Chloramphenicol

A

inhibits metabolism of

hexobarbital, tolbutamide

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27
Q

Drug interaction of

Cimetidine

A

inhibits metabolism of

benzodiazepines, propranolol

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28
Q

Common Mechanisms of Drug Interactions

A

a. Acceleration/ Inhibition of drug metabolism
b. Displacement of plasma protein-bound drug
c. Impaired/Improved uptake of drug from the GI tract
d. Altered renal clearance

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29
Q

Example of Displacement of plasma protein-bound drug

A
  • Salicylates
  • NSAIDs
  • oral hypoglycemics

___

each may be displaced by other drugs that bind on same region of the plasma protein

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30
Q

Renal clearance

A

measures the volume of plasma that is cleared of drug with time

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31
Q

Examples of drugs with altered renal clearance

A
  • Probenecid

- Salicylates

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32
Q

Probenecid decreases clearance of ___ by

A

indomethacin (inhibit renal secretion)

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33
Q

Salicylates decreases clearance of ___ by

A

phenylbutazone, sulfinpyrazone, indomethacin, probenecid (inhibit renal secretion)

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34
Q

Example of drugs that irritate stomach can cause nausea, vomiting, epigastric distress, and should be given with meals

A
  • anti-inflammatory drugs

- salicylates

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35
Q

Example of drugs combine with a drug

forming an insoluble food

A

tetracycline administered with dairy

products

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36
Q

Be especially careful of drug interactions with what types of drugs? (3)

A
  • oral anti-coagulants
  • anti-diabetics
  • anti-convulsants
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37
Q

Study of variation in drug responses resulting from genetic differences in drug disposition

a) Pharmaceutics
b) Pharmacodynamics
c) Pharmacogenetics
d) Pharmacokinetics

A

c) Pharmacogenetics

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38
Q

Name one of the mechanisms by which the liver renders all the things you take in the body to become water-soluble so they get excreted; to detoxify

A

Acetylation

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39
Q

Asians are more likely to be

a) Fast Acetylators
b) Slow Acetylators

A

a) Fast Acetylators

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40
Q

Which population is more evenly split between fast and slow acetylators?

a) Americans
b) Asians

A

a) Americans

55% - Fast
45% - Slow

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41
Q

What are the variations in drug responses that can result from genetic differences in drugs disposition? (4)

A

a. Acetylation polymorphism
b. Pseudocholinesterase polymorphism
c. Cytochrome P450 monooxygenase
polymorphism
d. G6PD deficiency

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42
Q

Drugs with Acetylation polymorphism (4)

A
  • INH (isoniazid; TB drug) → peripheral
    neuropathy
  • Procanaimide & Hydralazine (anti-
    hypertensive) → lupus
  • Sulfalazine → haemolytic anemia
  • Environmental benzidine (pollutant,
    petroleum) → urinary bladder cancer
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43
Q

Toxic effect and toxic mechanism of

INH

A
  • INH (isoniazid; TB drug) → peripheral
    neuropathy

-

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44
Q

Toxic effect and toxic mechanism of

Procanaimide & Hydralazine

A

Procanaimide & Hydralazine (anti-
hypertensive) → lupus

Mechanism: Acetylation polymorphism

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45
Q

Toxic effect and toxic mechanism of

Sulfalazine

A

Sulfalazine → haemolytic anemia

Mechanism: Acetylation polymorphism

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46
Q

Toxic effect and toxic mechanism of

Environmental benzidine

A 
Environmental benzidine (pollutant,
petroleum) → urinary bladder cancer

Mechanism: Acetylation polymorphism

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47
Q

Pseudocholinesterase is an enzyme that ____or_____ [______}

A

Pseudocholinesterase – enzyme that destroys or inactivates succinylcholine

{succinylcholine, which is a depolarizing muscle relaxant given to patients about to undergo surgery}

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48
Q

What is the importance of succinylcholine?

A

depolarizing muscle relaxant given to patients about to undergo surgery

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49
Q

Toxic effect of Pseudocholinesterase polymorphism

A

Slow succinylcholine hydrolysis → prolonged

muscle relaxation → apnea (cessation of breathing)

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50
Q

Pseudocholinesterase polymorphism in Filipinos is

a) common
b) rare

A

2% worldwide, rare in Filipinos

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51
Q

Toxic effect of Cytochrome P450 monooxygenase

polymorphism

A
  • Poor metabolism of debrisoquine,
    dextrometorphan (for dry cough), phenytoin (for seizures), metoprolol (anti-hypertensive)
  • side effect is sedation
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52
Q

Dextrometorphan is used for

A

dry cough

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53
Q

Phenytoin is used for

A

seizures

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54
Q

Metoprolol is used for

A

anti-hypertensive

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55
Q

Drugs for the following conditions are susceptible to Cytochrome P450 monooxygenase
polymorphism EXCEPT FOR

a) anti-hypertensive
b) dry cough
c) seizures
d) A and B
e) NOTA

A

e) NOTA

a) anti-hypertensive - metoprolol
b) dry cough - dextrometorphan
c) seizures - phenytoin

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56
Q

Toxic effect of Glucose-6-phosphate dehydrogenase deficiency (G6PD)

A

Decreased “reduced glutathione” (oxidized
RBC) → haemolytic anemia

When you have G6PD deficiency, you lack reduced glutathione. So you have no antioxidants. Glutathione is needed in the reduced form
for it to function as an antioxidant.

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57
Q

Drugs that are contraindicated in pts with G6PD deficiency

A

Chloramphenicol Chloroquine
Primaquine
Sulfonamides

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58
Q

What is important to know about Chloramphenicol?

A
  • contraindicated in pts with G6PD deficiency
  • inhibit metabolism of
    hexobarbital, tolbutamide
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59
Q

What is important to know about phenytoin?

A
  • for seizures
  • contraindicated in pts with Cytochrome P450 monooxygenase
    polymorphism
  • metabolism is sped up by ethanol (along with tolbutamide, warfarin)
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60
Q

Salicylates are subject to which mechanism/s of drug interaction?

a. Acceleration/ Inhibition of drug metabolism
b. Displacement of plasma protein-bound drug
c. Impaired/Improved uptake of drug from the GI tract
d. Altered renal clearance
e. NOTA
f. AOTA

A

f. AOTA

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61
Q

True of drug allergies EXCEPT

a. Undesirable immunologic responses to drugs (as antigens)
b. Response occurs only with initial exposure
c. Inter-individual variation- genetic influence
d. NOTA

A

b. Response occurs only with initial exposure

Correct: Response occurs only after a previous exposure

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62
Q

Types of Drug Allergies (4)

A

a. Immediate/ Anaphylactic reaction
b. Cytotoxic/ Autoimmune responses
c. Immune complex – mediated reaction
d. Cell-mediated response

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63
Q

bronchiolar constriction, capillary dilatation, urticaria, sometimes anaphylactic shock are signs of what type of drug allergy?

a. Cell-mediated response
b. Cytotoxic/ Autoimmune responses
c. Immediate/ Anaphylactic reaction
d. Immune complex – mediated reaction

A

c. Immediate/ Anaphylactic reaction

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64
Q

cytolysis and cell
death are signs of what type of drug allergy?

a. Cell-mediated response
b. Cytotoxic/ Autoimmune responses
c. Immediate/ Anaphylactic reaction
d. Immune complex – mediated reaction

A

b. Cytotoxic/ Autoimmune responses

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65
Q

acute inflammatory reaction, serum sickness, arteritis, urticaria, and granulocytopenia are signs of what type of drug allergy?

a. Cell-mediated response
b. Cytotoxic/ Autoimmune responses
c. Immediate/ Anaphylactic reaction
d. Immune complex – mediated reaction

A

d. Immune complex – mediated reaction

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66
Q

induced hepatitis; and infiltration causes local inflammatory response are signs of what type of drug allergy?

a. Cell-mediated response
b. Cytotoxic/ Autoimmune responses
c. Immediate/ Anaphylactic reaction
d. Immune complex – mediated reaction

A

a. Cell-mediated response

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67
Q

Immune complex – mediated reaction involves

a) Drug-antibody complexes
b) Delayed type hypersensitivity involving T lymphocytes, macrophages, and neutrophils occurring primarily in skin
c) IgE antibodies produced by drugs that bind to the surface of mast cells and basophils
d) IgG and IgM antibodies

A

a) Drug-antibody complexes

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68
Q

Immediate/ Anaphylactic reaction involves

a) Drug-antibody complexes
b) Delayed type hypersensitivity involving T lymphocytes, macrophages, and neutrophils occurring primarily in skin
c) IgE antibodies produced by drugs that bind to the surface of mast cells and basophils
d) IgG and IgM antibodies

A

c) IgE antibodies produced by drugs that bind to the surface of mast cells and basophils

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69
Q

Cytotoxic/ Autoimmune responses involves

a) Drug-antibody complexes
b) Delayed type hypersensitivity involving T lymphocytes, macrophages, and neutrophils occurring primarily in skin
c) IgE antibodies produced by drugs that bind to the surface of mast cells and basophils
d) IgG and IgM antibodies

A

d) IgG and IgM antibodies

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70
Q

Cell-mediated response involves

a) Drug-antibody complexes
b) Delayed type hypersensitivity involving T lymphocytes, macrophages, and neutrophils occurring primarily in skin
c) IgE antibodies produced by drugs that bind to the surface of mast cells and basophils
d) IgG and IgM antibodies

A

b) Delayed type hypersensitivity involving T lymphocytes, macrophages, and neutrophils occurring primarily in skin

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71
Q

Possible drug allergy of Methyldopa via what response?

A
  • hemolytic anemia

- Cytotoxic/ Autoimmune responses

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72
Q

Possible drug allergy of Quinidine via what response?

A
  • thrombocytopenic purpura

- Cytotoxic/ Autoimmune responses

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73
Q

Possible drug allergy of sulfonamide via what response?

A
  • Stevens Johnson
    syndrome
  • Immune complex-mediated reaction
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74
Q

What is Stevens Johnson syndrome?

A

Drug allergy of sulfanamides due to immune complex-mediated reaction involving drug-antibody complexes

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75
Q

Possible drug allergy of halothane via what response?

A
  • induced hepatitis

- cell-mediated response

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76
Q

Liver metabolism and renal elimination of drugs are usually increased at extremes of age.

True or False

A

False

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77
Q

What is MONITORING PLASMA DRUG CONCENTRATION

A

The quantitative determination of drug concentrations in small samples of patient blood
• Made possible by development of suitably sensitive assays

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78
Q

Define Single blind study -

A

a clinical trial in which the investigators, but not the subjects, know which subjects are receiving active drug and which are receiving placebo

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79
Q

What is “a clinical trial in which neither the subjects nor the investigators know which subjects are receiving placebo; the code is held by a third party”?

A

Double-blind study -

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80
Q

Define IND -

A

Investigational New Drug - application for FDA approval to carry out new drug trials in humans; requires animal data

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81
Q

What is “application for FDA approval to to market a new drug for ordinary clinical use”?

A

NDA - New Drug Application;

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82
Q

Define Placebo -

A

a dummy medication made up to resemble the active investigational formulation as much as possible

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83
Q

What is “three parts of a clinical trial that must be carried out before submitting an NDA to the FDA”?

A

Phases I, II and III of clinical trials -

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84
Q

Define Positive control -

A

a known standard therapy, to be used along with placebo, to fully evaluate the safety and efficacy of a new drug in relation to the others available

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85
Q

What is “having an effect on the heritable characteristics of a cell or organism - a mutation in the DNA; tested in microorganisms with the Ames test”?

A

Mutagenic -

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86
Q

Define Teratogenic -

A

having an effect on the prenatal development of an organism resulting in abnormal structure or function; not generally heritable

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87
Q

What is “having an effect of inducing malignant characteristics”?

A

Carcinogenic -

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88
Q

Define Orphan Drugs

A
  • drugs developed for rare diseases in which the expected number of patients in the USA is less than 200,000; bestows certain advantages on companies that develop drugs for unusual diseases
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89
Q

What is “application for the FDA that enables patients not qualified for participation in ongoing studies to be treated using investigational drugs outside clinical trials”?

A

Treatment IND -

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90
Q

What is the GENERAL PROCESS OF DRUG DEVELOPMENT

A
  • Synthesis / isolation
  • Pre-clinical testing
  • Clinical testing
  • Review - efficacy and safety
  • Marketing
  • Post-marketing surveillance
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91
Q

The FDA approves approximately how many new compounds a year?

A

20-30

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92
Q

Federal Food and Drug Act

A
  • 1906
  • FDA designated authority
  • Est standards for strength purity
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93
Q
  • 1938

- Prohibited marketing new drugs unless with tested safety as labeled

A

Federal Food and Drugs and Cosmetics Act

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94
Q

Amendment to FFDCA

A
  • 1962

- Required manufacturer to provide scientific proof of safety and efficacy

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95
Q
  • 1970

- Control manufacture and prescribing of habit-forming drugs

A

Comprehensive Drug Abuse Prevention and Control Act

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4
5
Perfectly
96
Q

Orphan Drug Act

A
  • 1983

- Facilitated drgu development for rare diseases

How well did you know this?
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2
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97
Q
  • 1984

- Encouraged new drug applications for generic drugs

A

Drug Competition and Patent Restoration Act

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98
Q

Federal Omnibus Budget Reconciliation Act

A
  • 1990

- reduce healthcare cost from unnecessary, inappropriate, and unmonitored drug prescription

99
Q

Stages of Drug Development

A
  1. Pre-clinical Pharmacology and Toxicology
  2. Clinical trials in humans
  3. Review
  4. Large-scale clinical use surveillance
100
Q

What is the purpose and outcome of “Pre-Clinical pharmacology” stage?

A

Purpose: safety and biological activity

Outcome: Filing of IND

101
Q

What is the stage and purpose where the outcome is “Filing NDA”?

A

Stage: Clinical trial in humans

Purpose:
I (few volunteers) - safety/dosage, PK
II (hundreds) - safety/effectiveness
III (thousands) - verify effectiveness/safety long term

102
Q

In what stage and what is the outcome of the purpose of “ensure S/E; label”?

A

Stage: Review

Outcome: Approval and marketing

103
Q

What is the purpose and outcome of the stage “Large-scale clinical surveillance”?

A

Purpose: Monitor, update label; Ph FDA - PMS req

Outcome: Revision of label; withdrawal (if needed)

104
Q

Who are the subjects in preclinical testing?

a) lab and animal studies
b) 20 - 100 health volunteers
c) 100- 300 pt volunteers
d) 1,000 - 3,000 pt volunteers

A

a) lab and animal studies

105
Q

20 - 100 health volunteers are used in which stage of drug development?

a) Pre-clinical testing
b) Phase 1 of clinical trial
c) Phase 2 of clinical trial
d) Phase 3 of clinical trial

A

b) Phase 1 of clinical trial

106
Q

Who are the subjects in Phase 2 of clinical trial?

a) lab and animal studies
b) 20 - 100 health volunteers
c) 100- 300 pt volunteers
d) 1,000 - 3,000 pt volunteers

A

c) 100- 300 pt volunteers

107
Q

1,000 - 3,000 pt volunteers are used in which stage of drug development?

a) Pre-clinical testing
b) Phase 1 of clinical trial
c) Phase 2 of clinical trial
d) Phase 3 of clinical trial

A

d) Phase 3 of clinical trial

108
Q

Assesses safety & biological activity is the purpose of what stage of drug development?

a) Pre-clinical testing
b) Phase 1 of clinical trial
c) Phase 2 of clinical trial
d) Phase 3 of clinical trial

A

a) Pre-clinical testing

109
Q

The purpose of Phase 1 of clinical trial is?

a) Assesses safety & biological activity is the purpose of what stage of drug development
b) Determine safety & dosage
c) Evaluate effectiveness & side effect
d) Verify effectiveness & monitor adverse long-term use

A

b) Determine safety & dosage

110
Q

Evaluate effectiveness & side effect is the purpose of what stage of drug development?

a) Pre-clinical testing
b) Phase 1 of clinical trial
c) Phase 2 of clinical trial
d) Phase 3 of clinical trial

A

c) Phase 2 of clinical trial

111
Q

The purpose of Phase 3 of clinical trial is?

a) Assesses safety & biological activity is the purpose of what stage of drug development
b) Determine safety & dosage
c) Evaluate effectiveness & side effect
d) Verify effectiveness & monitor adverse long-term use

A

d) Verify effectiveness & monitor adverse long-term use

112
Q

What is the purpose of lab and animal studies?

a) Assesses safety & biological activity is the purpose of what stage of drug development
b) Determine safety & dosage
c) Evaluate effectiveness & side effect
d) Verify effectiveness & monitor adverse long-term use

A

a) Assesses safety & biological activity is the purpose of what stage of drug development

113
Q

Subjects used to determine safety & dosage are?

a) lab and animal studies
b) 20 - 100 health volunteers
c) 100- 300 pt volunteers
d) 1,000 - 3,000 pt volunteers

A

b) 20 - 100 health volunteers

114
Q

What is the purpose of 100- 300 pt volunteers?

a) Assesses safety & biological activity is the purpose of what stage of drug development
b) Determine safety & dosage
c) Evaluate effectiveness & side effect
d) Verify effectiveness & monitor adverse long-term use

A

c) Evaluate effectiveness & side effect

115
Q

Subjects used to verify effectiveness & monitor adverse long-term use?

a) lab and animal studies
b) 20 - 100 health volunteers
c) 100- 300 pt volunteers
d) 1,000 - 3,000 pt volunteers

A

d) 1,000 - 3,000 pt volunteers

116
Q

Phase 1 and 2 excludes what type of healthy volunteer?

A

no women of childbearing potential

117
Q

This phase “Investigates through well-controlled

studies different populations and different dosages as well as uses new drug in combination with other drugs”

A

Phase 3

118
Q

Define “orphan drug”

A

New drugs that may benefit only a small number of patients; for rare diseases - about 200T patients or less

119
Q

Name 2 orphan drugs

A
  • human growth hormone

- epoetin alfa

120
Q

What is Eprex?

A
  • orphan drug
  • generic is epoetin alfa
  • Stimulate erythropoiesis in end-stage renal disease, cancer chemotherapy
121
Q

What is Norditropin?

A
  • orphan drug
  • generic is human growth hormone
  • Treat children with deficiency
122
Q

What do you get at the end of clinical trials?

a) IND
b) NDA

A

b) NDA

123
Q

What is Treatment IND?

A
  • Application for the FDA that enables patients not qualified for participation in ongoing studies to be treated using investigational drugs outside clinical trial
  • Intended to treat serious life-threatening diseases
  • No comparable satisfactory alternative treatment
124
Q

Treatment IND is usually filed in what phase of drug Development?

A

Controlled clinical trial Phase III

125
Q

Drug Regulatory Agencies in in PH

A
  • BFDA

- FDA

126
Q

What is the legislation number of Food, Drug & Cosmetic Act

A

RA 3720; 1963

EO 175; 1987

127
Q

RA 3720; 1963
EO 175; 1987

is better known as?

A

Food, Drug & Cosmetic Act

128
Q

What is the legislation number of Universally Accessible Cheaper and Quality Medicines Act of 2008?

A

RA 9502

129
Q

Rational Drug Use (RDU) -

A

Prescribing the right drug, in adequate dose for the sufficient duration and appropriate to the clinical needs of the patient at the lowest cost

130
Q

Reasons for RDU

A
  1. Drug Explosion
  2. Efforts to prevent the development of
    resistance
  3. Growing awareness
  4. Increase in cost of treatment
  5. Consumer Protection Act
131
Q

Reasons for Irrational Drug Use

A
  1. Lack of information
  2. Faulty and inadequate training and education
    of medical graduates
  3. Poor communication between HCP and patient
  4. Lack of diagnostic facilities/ Uncertainty of diagnosis
  5. Demand from patients
  6. Defective drug supply system and ineffective
    regulation
  7. Promotional activities of pharmaceutical
    industry
132
Q
  1. Ineffective and unsafe treatment
  2. Exacerbation or prolongation of illness 3. Distress and harm to patient
  3. Increase in cost of treatment

These are

a) Hazards of Irrational drug use
b) Reasons for Irrational drug use

A

a) Hazards of Irrational drug use

133
Q

Pre-requisite of RDU

A
  • Assessment and comparison of available treatments

* Critical assessment and evaluation of benefits and use of available drugs

134
Q

Obstacles of RDU

A
  • Lack of objective information and of continuing education and training in pharmacology
  • Lack of well-organized drug-regulatory authority and supply of drugs
  • Presence of large number of drugs in the market and unethical promotion
  • Prevalent belief that “every ill has a pill”
135
Q

Steps to improve RDU

A
  1. Identify the patient’s problem based on symptoms and recognize the need for action
  2. Diagnosis of the disease.
  3. List possible intervention or treatment and
    choose the most appropriate*
  4. Start the treatment by writing an accurate
    and complete prescription
  5. Give proper information, instruction and
    warning regarding the treatment
  6. Monitor the treatment
    - Passive c/o patient - Active c/o MD
136
Q

What is Evidence Based Medicine?

A
  • Conscientious, explicit and judicious use of current best evidence in making decisions about individual patients.
  • Integration of individual clinical expertise with the best available external clinical evidence from systematic research
137
Q

What is the 5 step model of EBM approach?

A
  • Asking answerable Questions
  • Finding the best Evidence
  • Appraising the Evidence
  • Making a Decision
  • Evaluating your Performance
138
Q

4 Elements of an well-formulated answerable question

A

P - Patient or problem
I - Intervention
C - Comparison Intervention
O - Outcome

139
Q

“How would I describe a group of patients similar to mine?”

P - Patient or problem
I - Intervention
C - Comparison Intervention
O - Outcome

A

P - Patient or problem

140
Q

“Which main intervention am I considering?”

P - Patient or problem
I - Intervention
C - Comparison Intervention
O - Outcome

A

I - Intervention

141
Q

“What is the main alternative to compare with the intervention?”

P - Patient or problem
I - Intervention
C - Comparison Intervention
O - Outcome

A

C - Comparison Intervention

142
Q

“What can I hope to accomplish?”

P - Patient or problem
I - Intervention
C - Comparison Intervention
O - Outcome

A

O - Outcome

143
Q

Case-control or cohort study answers what question?

a) etiology
b) diagnosis
c) prognosis
d) therapy
e) cost-effectiveness
f) quality of life

A

a) etiology

144
Q

Diagnostic validation study answers what question?

a) etiology
b) diagnosis
c) prognosis
d) therapy
e) cost-effectiveness
f) quality of life

A

b) diagnosis

145
Q

Inception cohort study answers what question?

a) etiology
b) diagnosis
c) prognosis
d) therapy
e) cost-effectiveness
f) quality of life

A

c) prognosis

146
Q

Randomized controlled trial answers what question?

a) etiology
b) diagnosis
c) prognosis
d) therapy
e) cost-effectiveness
f) quality of life

A

d) therapy

147
Q

Economic evaluation answers what question?

a) etiology
b) diagnosis
c) prognosis
d) therapy
e) cost-effectiveness
f) quality of life

A

e) cost-effectiveness

148
Q

Qualitative study answers what question?

a) etiology
b) diagnosis
c) prognosis
d) therapy
e) cost-effectiveness
f) quality of life

A

f) quality of life

149
Q

Steps to finding the evidence in drug selection

A
  1. Formulate your PICO question
  2. Try secondary sources
  3. Choose primary database(s)
  4. Use search MEDLINE/PubMed via PICO
150
Q

Types of secondary sources

A

a) Critically appraised topics (CATs)
b) Evidence-based summaries
c) Structured abstracts
d) Health technology assessments
d) Systematic reviews

151
Q

Type of secondary source that has appraisals of evidence in response to clinical questions

a) Critically appraised topics (CATs)
b) Evidence-based summaries
c) Structured abstracts
d) Health technology assessments
d) Systematic reviews

A

a) Critically appraised topics (CATs)

152
Q

Reviews on the evidence around a specific clinical topic is found in this type secondary source

a) Critically appraised topics (CATs)
b) Evidence-based summaries
c) Structured abstracts
d) Health technology assessments
d) Systematic reviews

A

b) Evidence-based summaries

153
Q

Structured abstracts contain

a) Appraisals of evidence in response to clinical questions
b) Reviews on the evidence around a specific clinical topic
c) Appraisals of important clinical papers
d) Appraisals of the evidence of a specific intervention
d) Review of all evidence around a specific topic

A

c) Appraisals of important clinical papers

154
Q

Health technology assessments contain

a) Appraisals of evidence in response to clinical questions
b) Reviews on the evidence around a specific clinical topic
c) Appraisals of important clinical papers
d) Appraisals of the evidence of a specific intervention
d) Review of all evidence around a specific topic

A

c) Appraisals of important clinical papers

155
Q

Systematic reviews contain

a) Appraisals of evidence in response to clinical questions
b) Reviews on the evidence around a specific clinical topic
c) Appraisals of important clinical papers
d) Appraisals of the evidence of a specific intervention
d) Review of all evidence around a specific topic

A

d) Review of all evidence around a specific topic

156
Q

Steps to critically appraise guidelines for prescribing medicine

A
  1. scope and purpose of the guideline
  2. methods
  3. applicability
  4. conflicts of interest
157
Q

What is a systematic review?

A

it is a review of clearly formulated question that uses systematic and exquisite methods to identify, select, and critically appraise relevant research, and to collect and analyse data from the studies that are included in the review

158
Q

Steps to critically appraise systematic review

A
  1. is the systematic review valid
  2. are the results important
  3. can the results help you
  • how does it compare to the current standard of care
159
Q

2 questions to consider in systematic review

A

Are the results significant and precise?

Are the results applicable to your patients?

160
Q

Acronym to asses significance and applicability of drug study to pt

A

SCRAPS

o Sex
o Co-morbidities
o Race
o Age
o Pathology
o Socio-economic issue
161
Q

Steps to appraising diagnostic articles

A
  1. is the study valid
  2. are the results important
  3. can the results help you?
162
Q

(-) C+ || D-

What is the formula for sensitivity?

A

a/(a + c)

163
Q

(-) C+ || D-

What is the formula for specificity

A

d/(b + d)

164
Q

(-) C+ || D-

What is the formula for pre-test probability (prevalence)?

A

(a + c)/(a + b + c + d)

165
Q

(-) C+ || D-

What is the formula for LR for positive result

A

sens / (1 - spec)

166
Q

(-) C+ || D-

What is the formula for LR for a negative result

A

(1 - sense)/spec

167
Q

(-) C+ || D-

What is the formula for Pretest odds

A

prevalence / (1 - prevalence)

168
Q

(-) C+ || D-

What is the formula for post test odds

A

(pre-test odds)(LR)

169
Q

(-) C+ || D-

What is the formula for post test probability

A

post test odd/(post test odds + 1)

170
Q

SpPin - high specificity

a) false positive unlikely
b) false negative unlikely

A

a) false positive unlikely

171
Q

SpNOUT - high sensitivity

a) false positive unlikely
b) false negative unlikely

A

b) false negative unlikely

172
Q

For a test with high specificity,

a) If a test is positive, it rules the diagnosis in
b) If a test is positive, it rules diagnosis out

A

a) If a test is positive, it rules diagnosis in

173
Q

For a test with high sensitivity,

a) If a test is negative, it rules diagnosis in
b) If a test is negative, it rules diagnosis out

A

b) If a test is negative, it rules diagnosis out

174
Q

Steps to appraise therapy articles

A
  1. the is the study valid
  2. are the results important
  3. can the results help you?
175
Q
  1. The therapeutic index of a drug is a measure of its
A

safety

176
Q
  1. Filipino who are “fast acetlytors” usually do not develop early side effects to this drug even dose taken is more than average

a. PZA
c. Ethambutol
b. Rifampicin d. INH

A

d. INH

177
Q
  1. The fraction of unchanged drug reaching the systemic circulation following administration by route is

a. Clearance c. Biologic half life
b. Bioavailability
d. Volume of distribution

A

b. Bioavailability

178
Q
  1. A drug can easily enters through the placenta if it is

a. Highly ionized c. Molecular weight is 1000
b. Lipophilic d. Free of non protein bound

A

b. Lipophilic

179
Q
  1. The organ that extends low sensitivity to teratogenic actions until the 3rd trimester

a. Eyes and ears
c. Arms and fingers
b. Brain and heart
d. Legs and toes

A

a. Eyes and ears

180
Q
  1. Characteristic of a drug for early elimination kinetics EXCEPT

a. Ionized and polar
c. Lipophilic
b. Water soluble d. Alkaline urine for acid drug

A

c. Lipophilic

181
Q
  1. Active drugs are converted to more active form upon biotransformation. This is true of

a. Lorazepam
c. Triazolam
b. Diazepam
d. All of the above

A

b. Diazepam

182
Q
  1. Patient did not improve with tetracycline because he was taking it with milk

a. Acceleration of drug metabolism
b. Inhibition of drug metabolites
c. Displacement of plasma protein bound of drug
d. Impairment of facilitation of drug absorption
e. Decreased renal clearance

A

d. Impairment of facilitation of drug absorption

183
Q
  1. Epileptic on phenytoin suffers from seizure after a drinking spree

a. Acceleration of drug metabolism
b. Inhibition of drug metabolites
c. Displacement of plasma protein bound of drug
d. Impairment of facilitation of drug absorption
e. Decreased renal clearance

A

a. Acceleration of drug metabolism

184
Q
  1. Patient experiences prolonged effects of indomethacin for acute gout when given probenacid

a. Acceleration of drug metabolism
b. Inhibition of drug metabolites
c. Displacement of plasma protein bound of drug
d. Impairment of facilitation of drug absorption
e. Decreased renal clearance

A

e. Decreased renal clearance

185
Q
  1. Diabetic patient on tolbutamide for experiences hypoglycemia when given chloramphenicol for typhoid

a. Acceleration of drug metabolism
b. Inhibition of drug metabolites
c. Displacement of plasma protein bound of drug
d. Impairment of facilitation of drug absorption
e. Decreased renal clearance

A

b. Inhibition of drug metabolites

186
Q
  1. Patient on propranolol experiences a hypertensive episode when given cimetidine for acid peptic disease

a. Acceleration of drug metabolism
b. Inhibition of drug metabolites
c. Displacement of plasma protein bound of drug
d. Impairment of facilitation of drug absorption
e. Decreased renal clearance

A

b. Inhibition of drug metabolites

187
Q
  1. Drug interaction is the change in the magnitude or duration of drug action in the presence of another drug

true or false

A

false

188
Q
  1. All clinical drug trials should be conducted using the RDBCT design

true or false?

A

false

189
Q
  1. RDBCT (Randomized double blind controlled trials) always feasible so long as there is sufficient finds

true or false?

A

false

190
Q
  1. Therapeutic drug monitoring aims to measure urine drug concentration as an estimate of serum levels

true or false?

A

false

191
Q
  1. Therapeutic drug monitoring is necessary for high therapeutic index and therefore unsafe drugs

true or false?

A

false

192
Q
  1. We expect the liver and kidney of the newborns to function lest among all the age group

true or false?

A

true

193
Q
  1. A physician should be watchful of a drug interaction especially with anti coagulant, anti diabetics and anti ….

true or false?

A

true

194
Q
  1. A bi modal or multi modal frequency distribution of plasma drug concentration in a population is suggestive of pharmacogenetic variation

true or false?

A

true

195
Q
  1. SLPWL-001 a new agent for insomnia had just completed the entire range of test on laboratory animals which indicated it safe at a broad dose range. The next step would be

a. Pre clinical pharmacology
b. Clinical trials
c. Review
d. Orphan drug development
e. Treatment IND

A

b. Clinical trials

196
Q
  1. Nicoston, new drug for smoking cessation had completed 3 large well controlled trials in humans with good results. The next step would be

a. Pre clinical pharmacology
b. Clinical trials
c. Review
d. Orphan drug development
e. Treatment IND

A

c. Review

197
Q
  1. Dr. Martinez develops compound ALS-01 which he believes will help patients with amyotrophic lateral sclerosis, a disease occurring in 1/100,000

a. Pre clinical pharmacology
b. Clinical trials
c. Review
d. Orphan drug development
e. Treatment IND

A

d. Orphan drug development

198
Q
  1. Dr. Fernandez wishes to use BRCD-2110 for a leukemic patient but the patient does not qualify in the drug trial

a. Pre clinical pharmacology
b. Clinical trials
c. Review
d. Orphan drug development
e. Treatment IND

A

e. Treatment IND

199
Q
  1. Prof. Milano synthesize LCA-001 in his laboratory which he hopes will be better than conventional agents for lung cancer chemotherapy. His next step would be

a. Pre clinical pharmacology
b. Clinical trials
c. Review
d. Orphan drug development
e. Treatment IND

A

a. Pre clinical pharmacology

200
Q

Place in order

  1. Promulgation of the Generics Act
  2. Abolition of FDA and creation of BFAD
  3. Formulation of task force in pharmaceuticals to formulate a national drug policy
  4. Creation of the drug inspection division and division of laboratories of DOH
  5. Incorporation of effective food and drug regulatory system in sec. 12 article 3 of the Philippine constitution
A
  • Creation of the drug inspection division and division of laboratories of DOH
  • Abolition of FDA and creation of BFAD
  • Formulation of task force in pharmaceuticals to formulate a national drug policy
  • Incorporation of effective food and drug regulatory system in sec. 12 article 3 of the Philippine constitution
  • Promulgation of the Generics Act
201
Q

Place in order

  1. Dr. Ricardo gives the patient triple chemoptherapy instead because he elicited a history of blurring of vision in the patient’s previous use of Ethambutol
  2. He identifies that the patient is suffering from a reactivation pulmonary tuberculosis
  3. He gives the patient written instruction and explains them to the patient as well
  4. He carefully assess the patient to determine if it would be appropriate to give him quadriple chemotherapy, which he prefers for cases like this
  5. His objective is to treat the patient’s infection adequately.
A
  • He identifies that the patient is suffering from a reactivation pulmonary tuberculosis (A)
  • His objective is to treat the patient’s infection adequately. (B)
  • He carefully assess the patient to determine if it would be appropriate to give him quadriple chemotherapy, which he prefers for cases like this (C)
  • Dr. Ricardo gives the patient triple chemoptherapy instead because he elicited a history of blurring of vision in the patient’s previous use of Ethambutol (D)
  • He gives the patient written instruction and explains them to the patient as well (E)
202
Q

Place in order

  1. Dr. Crisanto conducts a critical appraisal of the clinical trial for validity, importance of results and its utility
  2. He searches the internet for relevant studies and eventually selects 3,000 patient randomized double blind head to head trial of Supersartan vs Irbesartan
  3. He wishes to know if the use of Supersartan, a new ARB for HTN would improve mortality in his patient vs Irbesartan
  4. He evaluates the entire process identifying what improvements he can make when the next patient comes
  5. He decides to keep his patient on Irbesartan instead
A
  • He wishes to know if the use of Supersartan, a new ARB for HTN would improve mortality in his patient vs Irbesartan (A)
  • He searches the internet for relevant studies and eventually selects 3,000 patient randomized double blind head to head trial of Supersartan vs Irbesartan (B)
  • Dr. Crisanto conducts a critical appraisal of the clinical trial for validity, importance of results and its utility (C)
  • He decides to keep his patient on Irbesartan instead (D)
  • He evaluates the entire process identifying what improvements he can make when the next patient comes (E)
203
Q

Place in order

  1. Dr. Medel notes a 70% pre test probability (or prevalence) of ovarian cancer
  2. She decides to use CA- 125 on her patient
  3. She needs to decide whether to test a patient with pelvic mass with PSA-125
  4. She notes that the sensitivity of PSA 125 for ovarian cancer in 72% and its specificity is 78%
  5. She determines that using PSA-125 will increase post test probability of ovarian cancer to 86%
A
  • She needs to decide whether to test a patient with pelvic mass with PSA-125 (A)
  • She notes that the sensitivity of PSA 125 for ovarian cancer in 72% and its specificity is 78% (B)
  • Dr. Medel notes a 70% pre test probability (or prevalence) of ovarian cancer (C)
  • She determines that using PSA-125 will increase post test probability of ovarian cancer to 86% (D)
  • She decides to use CA- 125 on her patient (E)
204
Q
  1. You decide on your P drug for a disease the moment you encounter a case of the disease

true or false

A

false

205
Q
  1. P drugs help to avoid repeated searches for good drugs in daily practices

true or false

A

true

206
Q
  1. P drugs are the same as P treatment

true or false

A

false

207
Q
  1. Deciding your P drug involves consulting drug list and guidelines

true or false

A

true

208
Q
  1. P drug refers to the name of drug you prefer for condition

true or false

A

false

209
Q
  1. Criteria for choosing P drug include efficacy, safety, suitability and cost

true or false

A

true

210
Q
  1. You should have P drugs for all medical conditions that you encounter

true or false

A

false

211
Q
  1. You should choose the P drug of your teacher as your own, especially if he is a key opinion leader

true or false

A

false

212
Q
  1. It is appropriate to start with choosing a drug group before choosing a P drug

true or false

A

true

213
Q
  1. Part of the P drug would be its active substance, dosage, dose schedule and duration of treatment

true or false

A

true

214
Q
  1. An answerable question identifies a patient or problem, intervention, competitor and outcome

true or false

A

false

215
Q
  1. The PICO should serve as a guide to evidence search strategy

true or false

A

true

216
Q
  1. Secondary source of evidence should be considered first before going to primary sources of evidence

true or false

A

true

217
Q
  1. The Cochrane library is one of the best sources of primary evidences

true or false

A

false

218
Q
  1. PubMed will provide readers with mainly secondary databases

true or false

A

false

219
Q
  1. Boolean term AND means combination of studies containing one or both terms specified

true or false

A

false

220
Q
  1. Critical appraisal of guidelines should consider scope and purpose of the guidelines, methods, applicability and conflicts of interest

true or false

A

true

221
Q
  1. Textword search should be preferred over thesaurus search

true or false

A

false

222
Q
  1. If the Medline/PubMed PICO functions yields an article use that article over others since it corresponds to the evidence that you really need

true or false

A

false

223
Q
  1. Critical appraisal of systematic reviews include assessment of validity, importance of results and applicability of results

true or false

A

true

224
Q
  1. Quality of life

a. Case control or cohort study
b. Inception cohort study
c. Randomized controlled trial
d. Qualitative study
e. None of the above

A

d. Qualitative study

225
Q
  1. Therapy

a. Case control or cohort study
b. Inception cohort study
c. Randomized controlled trial
d. Qualitative study
e. None of the above

A

c. Randomized controlled trial

226
Q
  1. Cost effectiveness

a. Case control or cohort study
b. Inception cohort study
c. Randomized controlled trial
d. Qualitative study
e. None of the above

A

e. None of the above

227
Q
  1. Prognosis

a. Case control or cohort study
b. Inception cohort study
c. Randomized controlled trial
d. Qualitative study
e. None of the above

A

b. Inception cohort study

228
Q
  1. Etiology

a. Case control or cohort study
b. Inception cohort study
c. Randomized controlled trial
d. Qualitative study
e. None of the above

A

a. Case control or cohort study

229
Q

Importance of pharmacovigilance

A
  1. Individual case safety reports (ICSRs)
  2. Signal detection
  3. Risk management
  4. Drug safety
230
Q

Main reference for drug safety reporting

A

= ICH Harmonised Tripartite Guideline –
Clinical Safety Data Management: Definitions and Standards for Expedited Reporting E2A

= European Medicines Agency: Guideline on Good Pharmacovigilance Practices (GVP)

231
Q

The science of pharmacovigilance (PV)

A

The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug- related problems.

232
Q

ADVERSE EVENT (AE)

A

keyword: does not necessarily have a causal relationship

 Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.

233
Q

ADVERSE DRUG REACTION (ADR)

A

keyword: response

 Pre-approval Clinical Experience
o All noxious and unintended responses to a
medicinal product related to any dose.
 Marketed Medicinal Products
o A response to a drug which is noxious and
unintended, and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease or for modification of physiological function.

234
Q

SIDE EFFECT

A

 Any unintended effect of a pharmaceutical product occurring at doses normally used by a patient which is related to the pharmacological properties of the drug.

235
Q

UNEXPECTED ADR

A

 An ADR, the nature and severity of which is not consistent with the applicable product information

236
Q

SERIOUS ADVERSE EVENT

A

 Any untoward medical occurrence that at any dose:

237
Q

SEVERITY

A

 Describes the intensity of a specific event.

= serves as guide for defining regulatory reporting obligations

238
Q

INDIVIDUAL CASE SAFETY REPORT (ICSR)

A

The format and content for the reporting of one or several suspected adverse reactions in relation to a medicinal product that occur in a single patient at a specific point of time.

239
Q

Minimum criteria for ICSR include:

A
  1. an identifiable reporter
  2. an identifiable patient
  3. at least 1 suspected substance/medicinal
    product and;
  4. at least one suspected adverse reaction.
240
Q

Fatal of life-threatening Unexpected ADRs

–RA should be notified (e.g., by phone, fax, in writing) ASAP but no later than ____ days

A

7 calendar

241
Q

Serious, unexpected ADRs – Reported to RA ASAP but not later than ____ days

A

15 calendar

242
Q

What is widely accepted standard for expedited AE reporting?

A

CIOMS-I

243
Q

ABC of ADEs/ADRs

A

 Anticipate
 Beacon
 Correct

244
Q

Pharmacovigilance is partnership between:

A

o Healthcare professionals
o Patients
o Industry
o FDA

Pharm 2 (1 decks)

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