Pharm Block 1 Cram Flashcards

1
Q

Define “Sig”

A

Let it be labeled (according to prescription)

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2
Q

What are the two safety categories of medications?

A

Legend- Rx

OTC

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3
Q

Who determines if a drug is a Legend or OTC?

Who controls/monitors drugs with abuse potentials?

A

FDA

DEA

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4
Q

Who approves a drug as safe and effective for a specific indication?

A

FDA

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5
Q

PA school grads are privileged to write prescriptions that have been approved and recommended by whom?

A

Pharmacy and Therapeutics Committee (P&T)

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6
Q

Who assigns the Trade/Brand name and Generic name?

A

Trade/Brand: by company/manufacturer trademark

Generic: FDA, not protected under trademark law

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7
Q

What is another name for a drug’s Generic name?

A

US Adopted Name

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8
Q

What are the 4 drug names/classifications a drug can fall under?

A

Chemical
Drug
Pharmaceutical Class
Target physiologic system

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9
Q

Define “Sig”

A

Directions for use

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10
Q

Schedule 2 drugs can have how many refills?

Schedule 3-5 can have how many refills?

A
2= 0 
3-5= 5 in 6mon AFTER date on Rx
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11
Q

Who authorizes/controls the fact that Schedule 3-5 drugs can have 5 refills in 6mons?

A

DEA

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12
Q

4 factors that promote PT non-compliance with medications?

A

Asymptomatic
Frequency
Difficult directions
Side effects

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13
Q

Abbreviation for Aspirin

Abbreviation for Around the Clock

A

ASA

ATC

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14
Q

Abbreviation for Bone Mineral Density

Abbreviation for Bowel Movement

A

BMD

BM

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15
Q

Abbreviation for Blood Sugar Glucose

Abbreviation for Body Surface Area

A

BS/BG

BSA

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16
Q

Abbreviation for Half Normal Saline

Abbreviation for Dextrose 5% in LR

A

1/2NS

D5LR

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17
Q

Abbreviation for Dextrose 5% in NS
Abbreviation for Dextrose 5% in water
Abbreviation for Dextrose 10% in water

A

D5NS
D5W
D10W

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18
Q

Abbreviation for Hypertension

Abbreviation for Hypotension

A

HTN

HOTN

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19
Q

Abbreviation for Nausea and Vomiting

Abbreviation for Drops

A

N&V

Gtts

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20
Q

Abbreviation for Before, After, Before Meal, and After Meal

A

a
p
ac
pc

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21
Q

Abbreviation for Ointment

Abbreviation for Dispense as Written

A

Ung/oint

DAW

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22
Q

Abbreviation for Gram

Abbreviation for Microgram

A

gm

mcg

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23
Q

Abbreviation for Millequivalent

Abbreviation for Add Sufficient Quantity to Make

A

meq

qs

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24
Q

Abbreviation for Apply to Affected Areas

Abbreviation for By Nebulizer

A

AAA/aaa

per neb

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25
Q

Abbreviation for Percutaneous Endoscopic Gastronomy

A

PEG

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26
Q

Abbreviation for Rectally

Abbreviation for Vaginally

A

Rect/PR/pr

PV/pv

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27
Q

Define Adverse Drug Reaction

A

Unexpected, unintended/desired response to a medication

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28
Q

Define Medication Error

A

Any preventable event that may cause/lead to inappropriate medication use/PT harm while medication is still in control of HCP, PT, consumer

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29
Q

Define Allergic Reaction

What is required for this to happen?

A

Immunologic hypersensitivity as a result of unusual sensitivity to a medication
Sensitizing dose

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30
Q

Define Idiosyncratic Reaction

A

Abnormal reaction that is unique to that PT

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31
Q

How are adverse drug events reported?

A

FDA MedWatch

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32
Q

Who establishes the controlled substances classifications?

A

DoJ

DEA: Office of Diversion Control Title 21 USC Controlled Substance Act

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33
Q

Two examples of Class I Drugs

Two examples of Class II Drugs

A

LSD
Methaquolone

PCP, Cocaine

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34
Q

What is the limit of codeine for Class 3

What is the limit of Codeine for Class 5

A

Greater than 90mg (Ketamine, Anabolic Steroids)

Less than 200mg/100ml

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35
Q

What are the key words in the effects of Controlled Substances?

A

2- severe
3- Moderate/low physical, high psychological
4- limited physical/psychological
5- limited physical/psychological

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36
Q

What is the only drug schedule that has medical use that is accepted with restrictions?

A

2
1- no accepted use
3-5= accepted use

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37
Q

What are the limits of Schedule 2 refills/filling?

A

Requires original Rx signed by practitioner to be presented prior to dispensing
No limit, usually 30 day (90 day maintenance)
No time limit
No refills

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38
Q

How are emergency situations requiring the issuing of Class 2 meds handled?

A

Telephoned Rxs allowed
Pharmacist may give quantity limited to treatment amount for emergency period
Written and signed Rx must be provided w/in 7 days

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39
Q

What are the 3 exceptions for faxed Rxs

A

Class 2 compounded for direct administration
Class 2 Long Term Care Facilities
Class 2 Hospice and paid for by Medicare Title XCIII

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40
Q

What are the 5 FDA pregnancy categories?

A

A- Adequate studies show no risk to fetus
B- adequate animal studies show no harm, no adequate studies in humans
C- animal studies show adverse, no human studies, benefits may out weigh the risks
D- marketing/human studies show evidence of fetal risk, benefits may still outweigh risks
X- Risks in use outweigh benefits

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41
Q

What are the 3 subsections that are required to by placed on labels for pregnancy concerns?

A

Pregnancy
Lactation
Reproductive potential

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42
Q

What year/act required pharmacists/providers to have a license and pay taxes?

A

1914 Harrison Tax Act

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43
Q

What year/act was the FDA made?

A

1927- Food, Drug, Insecticide Administration

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44
Q

What year/act required drugs to be shown safe before marketing?

A

1938- Food, Drug, and Cosmetic Act

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45
Q

What year/act made a drugs use mandatory to be on a label?

A

1950- Alberty Food Product vs US

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46
Q

What year/act made defined what drugs required a prescription for dispense?

A

1951- Durham-Humphrey Amendment

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47
Q

What year/act made it a requirement for manufacturers to demonstrate safety and effectiveness of a drug prior to marketing?

A

1962- Kefauver-Harris Amendment

Only applicable to drugs post 1938

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48
Q

What year/act made it a requirement for a drug’s label to be honest and informative?

A

1966- Fair Packaging and Labeling Act

49
Q

What year/act made it a requirement for meds to have child-proof packaging?

A

1970- Poison Preventing Packaging Act

50
Q

What year/act made drugs fall within five specific classifications?

A

1970- Controlled Substance Act

51
Q

What level of formulary must be carries at all full service MTFs?
What level applies only to medications of a service IF offered at a hospital?

A

BCF- all full service

ECF- carried if service offered

52
Q

What is a list of pharmaceutical agents that are required to be on a local formulary?

A
Basic Core Formulary
Limited services (specialty, AD only clinics) are not required to include entire BCF
53
Q

What is the requirement for an MTF that chooses to have an ECF therapeutic class on the formulary?

A

Must have ALL ECF medications in that class on their formulary

54
Q

Define Non-Formulary

A

Medication provided at formulary cost share IF provider supplies info showing a medical necessity

55
Q

What happens during the Pre-clinical Phase of drug development?

A

Animal pharmacology/toxicology data collected

New Drug application submitted to FDA and In Vitro studies

56
Q

Define Monograph

A

Package Insert

Summary of medication info required by FDA for all medications

57
Q

Give six examples of drugs that do not work at the receptor level?

A
Osmotic diuretics
Detergents
Antacids
Chelating agents
Chemical/Physiologic Antagonists
58
Q

Chemical Antagonists are AKA ?

A

Neutralizing antagonists

59
Q

What is a Physical Antagonist?

A

Drugs that compete by interacting with opposing regulatory pathways

60
Q

Define Down Regulation

A

Dec in receptor numbers from prolonged exposure to drugs

61
Q

Define Desensitization

A

Dec receptor response to signaling molecule when agonist is exposed to same concentration
Inc drug concentration req’d to produce an effect of the same magnitude as initial exposure on smaller drug concentration

62
Q

Define Supersensitivity/Hyper-Reactivity

A

Enhance physiologic/biochemical response from long-term exposure to receptor antagonist followed by abrupt medication stop

63
Q

Define Receptor Specificity

Define Receptor Sensitivity

A

Drug only has one effect on all systems

Drug prefers one receptor (Inc selectivity= fewer adverse reactions)

64
Q

What is the general rule of a drug between its dose and selectivity?

A

Inc dose=dec selectivity

65
Q

What type of receptor/channel are GABA receptors?

A

Major inhibitors

Cl- channel

66
Q

Define Non-Competitive Antagonist

A

Allosteric Agonist
Binds to different site on receptor, indirectly blocks agonist/reduces affinity
Can not be overcome w/ inc dose

67
Q

Define Indirect Agonist

A

Inhibits molecules that usually terminate an action, potentiating an agonists activity

68
Q

Define Irreversible Antagonist

A

Permanently antagonize agonist w/ covalent bonds

Reduces efficacy of agonist

69
Q

Define Competitive Antagonist

A

Binds to same receptor as agonist, preventing binding

Reduces agonist potency, possibly efficacy

70
Q

Define the Therapeutic Index

A higher index = ?

A

Median Toxic/Lethal Dose / Median Effective Concentration

Higher index= safer drug, less monitoring

71
Q

Lab monitoring for small/narrow index drugs are monitoring what part of blood?

A

Plasma concentrations

72
Q

Define Graded Response w/ examples

A

Continuous Variables- BP, enzyme activity, muscle tension

73
Q

Define Quantal Response w/ examples

A

“All or Nothing” response

Pain, Death, Number anesthetized

74
Q

Define Potency, Efficacy and Effectiveness

A
P= amount needed to cause a response
Eff= ability to produce desired result (more important)
Effective= degree of success at producing result
75
Q

What are 3 factors that effect Therapeutic Drug Monitoring?

A

Absorption
Vol of Distribution
Clearance

76
Q

When is a Loading Dose used?

When is a Maintenance Dose used?

A

Therapeutic plasma concentration is needed rapidly

Replacement of lost drugs from plasma

77
Q

When is the Dosing Interval changed?

When is this used?

A

Achieve similar steady-state concentrations

Limited dosage forms

78
Q

When is a Change of Dose used/preferred?

A

Therapeutic concentration maintenance

79
Q

When is changing a Dose and Interval used?

A

Substantial dose adjustment or for narrow index drugs w/ target concentrations
If given more than once a day, change interval
If given once daily or less, adjust dose

80
Q

A drugs dose does not change time to steady state as long as ________?

A

Half life remains constant

81
Q

How can the magnitude of fluctuations with a steady-state be controlled?

A

Dosing interval

Shorter interval decreases fluctuations, longer interval increases

82
Q

No interval/short interval = ______fluctuation

Long interval= ______ fluctuation

A

Short, infusion

More, greater fluctuation

83
Q

If a drug’s dose/interval is altered, what remains that same and what changes?

A

Time for steady-state= same

Final steady-state plasma level= changes

84
Q

If dosing interval is less than ____ half lives, accumulation will be detectable

A

Shorter than four 1/2 lives

85
Q

What outside factor does not effect a drug’s half life?

A

Concentration

86
Q

What is the Elimination Constant Equation

A

K=Cl/VD
Cl= clearance rate
VD= vol of distribution

87
Q

What is the half-life equation

A
T1/2= 0.693/k
K= elimination constant
88
Q

Normal CrCl levels

A
Normal= 90 - 140
Men= 125
Women= 115
89
Q

Cockcroft-Gualt equation has to be adjusted for PTs with what type of weight?

A

BMI greater than 18.5kg/m2

90
Q

Re-absorption of drugs in kidneys depends on what factor?

A

Lipid Solubility

91
Q

What causes ion trapping in kidneys?

A

Charged compounds not being reabsorbed

92
Q

What are the two Child-Pugh Classifications

A
A/B= mild/moderate hepatic impairment, no dose adjustment
C= severe impairment, no ER tablets, IR tab/injections are reduced by 50%
93
Q

What GI pathway does grapefruit juice inhibit?

A

CYP3A4

94
Q

Define First Order Kinetics

A

Proportional to concentration; Non-linear
Rate of elimination = drug concentration
Half life same regardless of concentration

95
Q

Define Zero Order Kinetics

A

Metabolism is proportional to concentration; Linear
Concentration changes w/ time - independent of concentration
No true 1/2 life (Ethanol, Phenytoin)

96
Q

What effect do “inhibitors” have on drug metabolism?
What effect do “inducers” have on drug metabolism?
How doe Prodrugs effect this?

A

Inhibit CYP450
Inc drug level= Inc side effect/toxicity

Induce CYP450
Dec drug level= Therapeutic Failure

Prodrug= opposite effects for both

97
Q

Chirality is AKA and is used for what 3 purposes

A

Steroisomerism
Create new drug
Reduce side effects
Extend a PT

98
Q

CYP450 is ____ dependent

A

Substrate

99
Q

Define Phase 2 of metabolism

A

Synthetic
Conjugation reaction, covalent bond w/ parent
Highly polar conjugate=rapid elimination

100
Q

What are the two paths within Phase 2 /Synthetic metabolism?

A

Glucoronidation- Benzoic acid, meprobamate, phenol, steroids

Sulfation

101
Q

Define Phase 1 of metabolism

A

Non-Synthetic
RedOx and Hydroxylation reactions
Introduces/exposes functional group and converts parent to polar metabolite causing loss in pharmacological activity

102
Q

Oxidation reactions involve what pathway and end in what type of elimination?
Conjugation reactions involve what path and end in what type of elimination?

A

CP450, metabolites/polar species eliminated in urine

Glucuronidation= stable products, non polar species eliminated in stool

103
Q

What effect does first pass metabolism have on drugs?
This route usually applies to what type of meds?
What can it reduce/prevent?

A

Reduces bioavailability
Orally ingested
Limits efficacy if clearance is large

104
Q

Drugs with affinity for protein binding in plasma will have what type of Volume Distribution?

A

Reduced

105
Q

What is the Volume of Distribution equation?

A
Vd= F Dose / C0
F= Bioavailability
D= amount of drug given
C= concentration of drug in blood/plasma
106
Q

In the Two Compartment Model, what organs are in the Central Compartment?

A
Plasma
Heart
Lung
Liver
Kidney
107
Q

What are the two drug transporting blood proteins?

A

Albumin

Alpha1 acid glycoprotein

108
Q

Plasma protein binding properties are important for what two types of drugs?

A

High binding

Narrow therapeutic index

109
Q

What medication route has the most rapid onset?
What route bypasses first pass metabolism?
What route is most convenient but has significant first pass?

A

IV
Sublingual, Transdermal
Oral

110
Q

What are 3 modifications to navigate around First Pass Effect?

A

Increase dose
Alternative route
Delayed release dose

111
Q

What are 4 factors that affect passage of drugs across biologic membranes?

A

Lipid-aqueous partition coefficient (non/ionized)
Specific transport
Plasma binding
Perfusion rate

112
Q

What two factors determine bioavailability?

A

Extent of absorption

First pass metabolism

113
Q

Define Bioavailability

A

Fraction of unchanged drug reaching systemic circulation after oral administration

114
Q

In the Henderson-Hasselbach equation, what do the HA and A- stand for?

A

HA- protonated, un-ionized form of an acid

A- ionized, unprotonated form

115
Q

Low pKa = ?

High pKa = ?

A
Low= strong acid
High= strong base
116
Q

Weak acid + acid medium = ?

Weak acid + alkaline medium = ?

A

Shift to L, suppresses ionization

Increased ionization

117
Q

Weak base + acid = ?

Weak base + alkaline medium=

A

Shift to L, ionization increases

Shift to R, suppresses ionization

118
Q

What are 5 factors that effect pharmacokinetic parameters?

A
Bioavailability
Volume of distribution
Drug Accumulation
Clearance 
Elimination
119
Q

What is the acronym for pharmacokinetics?

A

What body does to drug

ADME