Pharm Block 1 Cram Flashcards
1
Q
Define “Sig”
A
Let it be labeled (according to prescription)
2
Q
What are the two safety categories of medications?
A
Legend- Rx
OTC
3
Q
Who determines if a drug is a Legend or OTC?
Who controls/monitors drugs with abuse potentials?
A
FDA
DEA
4
Q
Who approves a drug as safe and effective for a specific indication?
A
FDA
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)
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
7
Q
What is another name for a drug’s Generic name?
A
US Adopted Name
8
Q
What are the 4 drug names/classifications a drug can fall under?
A
Chemical
Drug
Pharmaceutical Class
Target physiologic system
9
Q
Define “Sig”
A
Directions for use
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
11
Q
Who authorizes/controls the fact that Schedule 3-5 drugs can have 5 refills in 6mons?
A
DEA
12
Q
4 factors that promote PT non-compliance with medications?
A
Asymptomatic
Frequency
Difficult directions
Side effects
13
Q
Abbreviation for Aspirin
Abbreviation for Around the Clock
A
ASA
ATC
14
Q
Abbreviation for Bone Mineral Density
Abbreviation for Bowel Movement
A
BMD
BM
15
Q
Abbreviation for Blood Sugar Glucose
Abbreviation for Body Surface Area
A
BS/BG
BSA
16
Q
Abbreviation for Half Normal Saline
Abbreviation for Dextrose 5% in LR
A
1/2NS
D5LR
17
Q
Abbreviation for Dextrose 5% in NS
Abbreviation for Dextrose 5% in water
Abbreviation for Dextrose 10% in water
A
D5NS
D5W
D10W
18
Q
Abbreviation for Hypertension
Abbreviation for Hypotension
A
HTN
HOTN
19
Q
Abbreviation for Nausea and Vomiting
Abbreviation for Drops
A
N&V
Gtts
20
Q
Abbreviation for Before, After, Before Meal, and After Meal
A
a
p
ac
pc
21
Q
Abbreviation for Ointment
Abbreviation for Dispense as Written
A
Ung/oint
DAW
22
Q
Abbreviation for Gram
Abbreviation for Microgram
A
gm
mcg
23
Q
Abbreviation for Millequivalent
Abbreviation for Add Sufficient Quantity to Make
A
meq
qs
24
Q
Abbreviation for Apply to Affected Areas
Abbreviation for By Nebulizer
A
AAA/aaa
per neb
25
Abbreviation for Percutaneous Endoscopic Gastronomy
PEG
26
Abbreviation for Rectally
| Abbreviation for Vaginally
Rect/PR/pr
| PV/pv
27
Define Adverse Drug Reaction
Unexpected, unintended/desired response to a medication
28
Define Medication Error
Any preventable event that may cause/lead to inappropriate medication use/PT harm while medication is still in control of HCP, PT, consumer
29
Define Allergic Reaction
| What is required for this to happen?
Immunologic hypersensitivity as a result of unusual sensitivity to a medication
Sensitizing dose
30
Define Idiosyncratic Reaction
Abnormal reaction that is unique to that PT
31
How are adverse drug events reported?
FDA MedWatch
32
Who establishes the controlled substances classifications?
DoJ
| DEA: Office of Diversion Control Title 21 USC Controlled Substance Act
33
Two examples of Class I Drugs
| Two examples of Class II Drugs
LSD
Methaquolone
PCP, Cocaine
34
What is the limit of codeine for Class 3
| What is the limit of Codeine for Class 5
Greater than 90mg (Ketamine, Anabolic Steroids)
Less than 200mg/100ml
35
What are the key words in the effects of Controlled Substances?
2- severe
3- Moderate/low physical, high psychological
4- limited physical/psychological
5- limited physical/psychological
36
What is the only drug schedule that has medical use that is accepted with restrictions?
2
1- no accepted use
3-5= accepted use
37
What are the limits of Schedule 2 refills/filling?
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
38
How are emergency situations requiring the issuing of Class 2 meds handled?
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
39
What are the 3 exceptions for faxed Rxs
Class 2 compounded for direct administration
Class 2 Long Term Care Facilities
Class 2 Hospice and paid for by Medicare Title XCIII
40
What are the 5 FDA pregnancy categories?
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
41
What are the 3 subsections that are required to by placed on labels for pregnancy concerns?
Pregnancy
Lactation
Reproductive potential
42
What year/act required pharmacists/providers to have a license and pay taxes?
1914 Harrison Tax Act
43
What year/act was the FDA made?
1927- Food, Drug, Insecticide Administration
44
What year/act required drugs to be shown safe before marketing?
1938- Food, Drug, and Cosmetic Act
45
What year/act made a drugs use mandatory to be on a label?
1950- Alberty Food Product vs US
46
What year/act made defined what drugs required a prescription for dispense?
1951- Durham-Humphrey Amendment
47
What year/act made it a requirement for manufacturers to demonstrate safety and effectiveness of a drug prior to marketing?
1962- Kefauver-Harris Amendment
| Only applicable to drugs post 1938
48
What year/act made it a requirement for a drug's label to be honest and informative?
1966- Fair Packaging and Labeling Act
49
What year/act made it a requirement for meds to have child-proof packaging?
1970- Poison Preventing Packaging Act
50
What year/act made drugs fall within five specific classifications?
1970- Controlled Substance Act
51
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?
BCF- all full service
| ECF- carried if service offered
52
What is a list of pharmaceutical agents that are required to be on a local formulary?
```
Basic Core Formulary
Limited services (specialty, AD only clinics) are not required to include entire BCF
```
53
What is the requirement for an MTF that chooses to have an ECF therapeutic class on the formulary?
Must have ALL ECF medications in that class on their formulary
54
Define Non-Formulary
Medication provided at formulary cost share IF provider supplies info showing a medical necessity
55
What happens during the Pre-clinical Phase of drug development?
Animal pharmacology/toxicology data collected
| New Drug application submitted to FDA and In Vitro studies
56
Define Monograph
Package Insert
| Summary of medication info required by FDA for all medications
57
Give six examples of drugs that do not work at the receptor level?
```
Osmotic diuretics
Detergents
Antacids
Chelating agents
Chemical/Physiologic Antagonists
```
58
Chemical Antagonists are AKA ?
Neutralizing antagonists
59
What is a Physical Antagonist?
Drugs that compete by interacting with opposing regulatory pathways
60
Define Down Regulation
Dec in receptor numbers from prolonged exposure to drugs
61
Define Desensitization
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
Define Supersensitivity/Hyper-Reactivity
Enhance physiologic/biochemical response from long-term exposure to receptor antagonist followed by abrupt medication stop
63
Define Receptor Specificity
| Define Receptor Sensitivity
Drug only has one effect on all systems
| Drug prefers one receptor (Inc selectivity= fewer adverse reactions)
64
What is the general rule of a drug between its dose and selectivity?
Inc dose=dec selectivity
65
What type of receptor/channel are GABA receptors?
Major inhibitors
| Cl- channel
66
Define Non-Competitive Antagonist
Allosteric Agonist
Binds to different site on receptor, indirectly blocks agonist/reduces affinity
Can not be overcome w/ inc dose
67
Define Indirect Agonist
Inhibits molecules that usually terminate an action, potentiating an agonists activity
68
Define Irreversible Antagonist
Permanently antagonize agonist w/ covalent bonds
| Reduces efficacy of agonist
69
Define Competitive Antagonist
Binds to same receptor as agonist, preventing binding
| Reduces agonist potency, possibly efficacy
70
Define the Therapeutic Index
| A higher index = ?
Median Toxic/Lethal Dose / Median Effective Concentration
| Higher index= safer drug, less monitoring
71
Lab monitoring for small/narrow index drugs are monitoring what part of blood?
Plasma concentrations
72
Define Graded Response w/ examples
Continuous Variables- BP, enzyme activity, muscle tension
73
Define Quantal Response w/ examples
"All or Nothing" response
| Pain, Death, Number anesthetized
74
Define Potency, Efficacy and Effectiveness
```
P= amount needed to cause a response
Eff= ability to produce desired result (more important)
Effective= degree of success at producing result
```
75
What are 3 factors that effect Therapeutic Drug Monitoring?
Absorption
Vol of Distribution
Clearance
76
When is a Loading Dose used?
| When is a Maintenance Dose used?
Therapeutic plasma concentration is needed rapidly
| Replacement of lost drugs from plasma
77
When is the Dosing Interval changed?
| When is this used?
Achieve similar steady-state concentrations
| Limited dosage forms
78
When is a Change of Dose used/preferred?
Therapeutic concentration maintenance
79
When is changing a Dose and Interval used?
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
A drugs dose does not change time to steady state as long as ________?
Half life remains constant
81
How can the magnitude of fluctuations with a steady-state be controlled?
Dosing interval
| Shorter interval decreases fluctuations, longer interval increases
82
No interval/short interval = ______fluctuation
| Long interval= ______ fluctuation
Short, infusion
| More, greater fluctuation
83
If a drug's dose/interval is altered, what remains that same and what changes?
Time for steady-state= same
| Final steady-state plasma level= changes
84
If dosing interval is less than ____ half lives, accumulation will be detectable
Shorter than four 1/2 lives
85
What outside factor does not effect a drug's half life?
Concentration
86
What is the Elimination Constant Equation
K=Cl/VD
Cl= clearance rate
VD= vol of distribution
87
What is the half-life equation
```
T1/2= 0.693/k
K= elimination constant
```
88
Normal CrCl levels
```
Normal= 90 - 140
Men= 125
Women= 115
```
89
Cockcroft-Gualt equation has to be adjusted for PTs with what type of weight?
BMI greater than 18.5kg/m2
90
Re-absorption of drugs in kidneys depends on what factor?
Lipid Solubility
91
What causes ion trapping in kidneys?
Charged compounds not being reabsorbed
92
What are the two Child-Pugh Classifications
```
A/B= mild/moderate hepatic impairment, no dose adjustment
C= severe impairment, no ER tablets, IR tab/injections are reduced by 50%
```
93
What GI pathway does grapefruit juice inhibit?
CYP3A4
94
Define First Order Kinetics
Proportional to concentration; Non-linear
Rate of elimination = drug concentration
Half life same regardless of concentration
95
Define Zero Order Kinetics
Metabolism is proportional to concentration; Linear
Concentration changes w/ time - independent of concentration
No true 1/2 life (Ethanol, Phenytoin)
96
What effect do "inhibitors" have on drug metabolism?
What effect do "inducers" have on drug metabolism?
How doe Prodrugs effect this?
Inhibit CYP450
Inc drug level= Inc side effect/toxicity
Induce CYP450
Dec drug level= Therapeutic Failure
Prodrug= opposite effects for both
97
Chirality is AKA and is used for what 3 purposes
Steroisomerism
Create new drug
Reduce side effects
Extend a PT
98
CYP450 is ____ dependent
Substrate
99
Define Phase 2 of metabolism
Synthetic
Conjugation reaction, covalent bond w/ parent
Highly polar conjugate=rapid elimination
100
What are the two paths within Phase 2 /Synthetic metabolism?
Glucoronidation- Benzoic acid, meprobamate, phenol, steroids
| Sulfation
101
Define Phase 1 of metabolism
Non-Synthetic
RedOx and Hydroxylation reactions
Introduces/exposes functional group and converts parent to polar metabolite causing loss in pharmacological activity
102
Oxidation reactions involve what pathway and end in what type of elimination?
Conjugation reactions involve what path and end in what type of elimination?
CP450, metabolites/polar species eliminated in urine
| Glucuronidation= stable products, non polar species eliminated in stool
103
What effect does first pass metabolism have on drugs?
This route usually applies to what type of meds?
What can it reduce/prevent?
Reduces bioavailability
Orally ingested
Limits efficacy if clearance is large
104
Drugs with affinity for protein binding in plasma will have what type of Volume Distribution?
Reduced
105
What is the Volume of Distribution equation?
```
Vd= F Dose / C0
F= Bioavailability
D= amount of drug given
C= concentration of drug in blood/plasma
```
106
In the Two Compartment Model, what organs are in the Central Compartment?
```
Plasma
Heart
Lung
Liver
Kidney
```
107
What are the two drug transporting blood proteins?
Albumin
| Alpha1 acid glycoprotein
108
Plasma protein binding properties are important for what two types of drugs?
High binding
| Narrow therapeutic index
109
What medication route has the most rapid onset?
What route bypasses first pass metabolism?
What route is most convenient but has significant first pass?
IV
Sublingual, Transdermal
Oral
110
What are 3 modifications to navigate around First Pass Effect?
Increase dose
Alternative route
Delayed release dose
111
What are 4 factors that affect passage of drugs across biologic membranes?
Lipid-aqueous partition coefficient (non/ionized)
Specific transport
Plasma binding
Perfusion rate
112
What two factors determine bioavailability?
Extent of absorption
| First pass metabolism
113
Define Bioavailability
Fraction of unchanged drug reaching systemic circulation after oral administration
114
In the Henderson-Hasselbach equation, what do the HA and A- stand for?
HA- protonated, un-ionized form of an acid
| A- ionized, unprotonated form
115
Low pKa = ?
| High pKa = ?
```
Low= strong acid
High= strong base
```
116
Weak acid + acid medium = ?
| Weak acid + alkaline medium = ?
Shift to L, suppresses ionization
| Increased ionization
117
Weak base + acid = ?
| Weak base + alkaline medium=
Shift to L, ionization increases
| Shift to R, suppresses ionization
118
What are 5 factors that effect pharmacokinetic parameters?
```
Bioavailability
Volume of distribution
Drug Accumulation
Clearance
Elimination
```
119
What is the acronym for pharmacokinetics?
What body does to drug
| ADME
