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Pharm 1 Flashcards

1
Q

Steps to bring a newly discovered drug into public use:

A
  1. Pre-clinical research2. IND/NDA–>PDUFA3. Phase 1 clin trials4. Phase 2 clin trials 5. NDA6. FDA review7. Drug hits the market8. Post market safety monitoring9. Phase 4 clinical trials
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2
Q

Investigational new drug application (IND)

A

1st contact w/ the FDA, makes it possible to test unapproved drugs in humans in accordance w/ strictly defined clinical protocols. To pass, must exhibit pharmacological activity that justifies commercial development cleared for phase 1 clin trials

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3
Q

PDUFA (Prescription Drug User Fee Act)

A

drug companies pay to support FDA resources, FDA agrees to process application in a timely manner

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4
Q

New Drug Application (NDA)

A

drug co files for this after completing phase 3 clin trials to initiate thorough review. A request to the FDA for marketing in the US. results = approved, approvable, or not approved.

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5
Q

Food, Drug, Cosmetic Act

A

-started in 1906-ensures correct labeling-ammended in 1938 to to require toxicity studies as well as NDA before promotion &distribution of new drugs- Ammended in 1962 to require proof of efficacy &documentation of safety.

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6
Q

Drug Schedules 1-5(used to classify by potential for addiction & abuse)

A

1: high potential for abuse. no accepted med use, lack of accepted safety as drug2:high potential for abuse. current accepted med use. abuse may lead to psycho or physical dependence3:less potential for abuse than 1&2. current accepted med use. mod or low potential for pays dependence, high potential for psycho dependence4. less potential for abuse than 3. current accepted med use. limited potential for dependence5. less potential for abuse than 4. current accepted med use. limited dependence possible

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7
Q

Controlled Drug Act

A

requires prescribers & dispensers to register w the DEA, pay a fee, receive a personal registration #, & keep records of all controlled drugs rx’d or dispensed.

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8
Q

Enteral routes of drug absorption

A

oral - swallowed, headed for GI sublingual - placed under tongue, dissolved/absorbed into blood stream through superior vena cava

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9
Q

Parenteral routes of drug absorption

A

IV - most common IM - aqueous soln’s absorbed quicklysubcutaneous

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10
Q

routs for drug absorption

A
  • oral- sublingual- IV- IM- subcut.- inhaled- transdermal- intrathecal- rectal- epidural
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11
Q

delayed release preps of drugs

A

have a coating or ingredients that control how quickly the drug is released into the body. advantageous b/c you don’t have to take the drug as often. should not break or chew the tablet

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12
Q

depot preps

A

allow for a slow and sustained effect of the drug. drug is suspended in a non aqueous sol’n such as polyethylene glycol. usually given IM or subcut.

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13
Q

intrathecal pumps

A

administer med directly into CSF to avoid any delay. pain meds can be administered this way in order to reduce side effects of oral meds such as nausea

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14
Q

transdermal patches

A

slow & sustained release of drug. achieves a systemic effect. rate of absorption is highly variable depending on the location of the skin (ex: nicotine patches)

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15
Q

pH sustained preps

A

drugs that are intentionally altered to maintain a pH over a long period of time in order to alter the absorption (ex: long acting insulin injections)

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16
Q

patient controlled administration (PCA)

A

IV pump that allows pt to release med on their own as needed. usually used for pain mgmt in terminally ill pts

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17
Q

bioavailability

A

amount of drug administered that goes on to reach the systemic circulation.can be affected by the route the drug is administered as well as chem/physical properties of the drug.

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18
Q

loading dose

A

the administration of a drug in a single high dose to achieve desired plasma concentration rapidly, followed by maintenance dosing/infusion. often used when a delay in reaching steady state is unacceptable.

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19
Q

most drugs are absorbed more readily in their ______ state

A

unionized

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20
Q

most drugs are either a ____acid or a ____base

A

weak

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21
Q

an acid drug will be best absorbed in the

A

stomach

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22
Q

a basic drug will be best absorbed in the

A

small intestine

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23
Q

why should drugs which are absorbed in the stomach (acidic drugs) not be taken with food?

A

if the stomach becomes more basic, such as after eating a meal, an acidic drug will be less readily absorbed (due to increased ionization) than on an empty stomach, when it has a lower pH and a higher acid environment.

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24
Q

Plasma proteins

A
  • Albumin (strongly binds acidic drugs)- Alpha 1 glycoprotein (binds lipophilic drugs)- Tracer proteins
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25
what drugs permeate plasma membranes most readily?
small, nonionized, lipid soluble drugs
26
volume of distribution
the vol that would be required to contain the administered dose if that dose was evenly distributed at the concentration measured in the plasma. NOT a measurement of actual physiologic fluid in the body
27
the use of vol of distribution
to compare the drug distribution with the fluid compartments of the body as it would not be possible to test all areas of the body, so taking the measurable plasma concentration and extrapolating from there gives you a theoretical comparison.
28
fluid compartments of body
5% plasma20% interstitial40% intracellular
29
drug binding to plasma or tissue proteins results in ____ availability of free drug
lower
30
hypovolemia's affect on the therapeutic effect of a drug
less overall body water vol means a greater drug concentration; increased therapeutic effects
31
Congestive heart failure : influence on therapeutic effect of a drug
decrease in blood flow; decreased clearance; decreased vol of distribution; no change in 1/2 life
32
morbid obesity: influence on therapeutic effect of drug
more lipid binding for lipophilic drugs --> less available free drug at any one time AND drug is staying in the body longer (diminished clearance rate)
33
hypoproteinemia: influence on therapeutic effect of a drug
less available plasma proteins --> less bound drug and more free drug --> increased therapeutic effect (must be careful so the do age does not enter toxic levels!)
34
characteristics of a drug w/ small vol of distribution
drug has largely stayed in the plasma and will readily be sent to the liver & kidneys for excretion. shorter 1/2 life in body.
35
characteristics of a drug w/ large vol of distribution
drug is eliminated when it is delivered to the liver or kidney. if drug is widely distributed, it has spread throughout all body water compartments, meaning less of it is in the blood and readily avail for delivery to the liver/kidneys. this results in the drug staying in the boy longer (increased 1/2 life, extended duration of action of the drug)
36
2 phases of liver metabolism
phase 1: drug polarity increased through redox reactions often by cytochrome P450 systemphase 2: conjugation reactions further increase polarity for highly lipophilic drugs. most common conduction is glucuronidation. most drugs are inactivated by conjugation.
37
enterohepatic cycle
drugs absorbed through the stomach are not able to take effect until they have passed through portal circulation and the liver. after first pass, the bioavailability can be measured and is a result of intestinal absorption, gastric metabolism, and hepatic metabolism
38
pro drug
an inactive drug that needs to be metabolically activated through norma pathways (a precursor to an active metabolite)
39
active drug
active form of drug after it has been processed by the body
40
inactive drug
unusable to body form of drug
41
toxic
a form of drug that has been converted to a poisonous form
42
the goal of phase 1 & 2 reactions
increased polarity
43
phase 1 metabolism:
non-synthetic lipophilic drugs are oxidized or reduced to a more polar form. this happens in the liver via the cytochrome P450 system. NADPH proton carrier noun to cytochrome P450 oxidizes or reduces the substrate
44
phase 2 metabolism:
synthetic drugs are made mrs polar by the addition of a polar group. this phase does not use the P450 system, but rather specific endogenous substrates that conjugate a polar group. The resulting polarized metabolite is normally therapeutically inactive.
45
drug induction
inducing drug is able to increase genetic expression of CYP family of isoenzymes leading to greater drug metabolism.*causes decreased plasma drug concentrations, decreased therapeutic effect of drug
46
drug inhibition
inhibitors decrease drug metabolism by CYP family of isoenzymes often through competitive binding at active site. (ex: grapefruit juice)* causes increased plasma drug concentration and increased therapeutic or toxic effects
47
phase 1 & 2 reactions substantially ______ the polarity of the drug
increase
48
drugs can be excreted via
1. urine2. feces3. respiration4. breast milk
49
3 parts that make up kidney excretion
1. glomerular filtration2. proximal tubular secretion3. tubular reabsorption (this inhibits drug excretion)
50
drugs that are weak acids can be eliminated by ____ of the urine
alkalinization (ingesting bicarb)
51
drugs that are weak bases can be eliminated by ____ of the urine
acidification (ingesting amphetamine)
52
drugs are most easily absorbed when they are:
small, lipophilic, unionized
53
drugs are most easily excreted when they are:
small, hydrophilic, ionized (+)
54
half life
time it take the body to metabolize or inactivate 1/2 the amount of drug taken in. helps to determine dose.
55
3 things that will affect 1/2 life
1. large vol of distribution: increased 1/2 life: most of drug is in the extraplasmic space & unavailable to excretory organs2. liver disease: increased 1/2 life of lipophilic drugs b/c they are not being metabolized as fast3. renal failure: increased 1/2 life of hydrophilic drugs b/c they are not bring eliminated
56
duration of action
amount of time a measurable drug effect exists. depends on many factors, both kinetic and dynamic
57
drug clearance
measure of the body's efficiency in eliminating drug from the systemic circulation
58
steady state
the amount (dose) you administer equals the amount that leaves the body
59
therapeutic range
the concentration of drug at which most pts will experience desired effect w minimal adverse effects
60
therapeutic index
ratio of toxic dose to effective dose. measure of the drug's safety, because a larger value indicates a wide margin between does that are effective and those that are toxic
61
drug-drug absorption interactions
a drug can bind to another drug in the gut, preventing its absorption. OR, can alter GI motility to affect the absorption of another drug
62
drug-drug distribution interactions
some drugs can displace other drugs from plasma proteins, and therefore increase the plasma concentration of free drugs (small effect b/c if the free drug is increased, elimination is usually increased). antibiotics can interfere w/ the enterohepatic cycle of some drugs that rely on the bacteria of the gut
63
drug-drug metabolism interactions
inducers or inhibitors of drug-metabolizing enzymes (cytochrome P450) will hang the rate of metabolism
64
drug-drug elimination interactions
drugs can alter the renal or biliary exertion of other drugs. ex: altering the renal pH can change a drug from its ionized form to its nonionized form and affects the renal excretion of that drug.
65
a drug must be ____ to be excreted from the kidney
ionized
66
pharmacodynamic mechanisms of drug-drug interactions
2 drugs have either additive or antagonist affects (either 2 drugs both affect the action of the rug at the site of the receptor OR 2 drugs are working on the same system and clinical effects re seen t the level of the organ)
67
pharmacokinetic mechanisms of drug-drug interactions
one drug causes an alteration of another drug's absorption, distribution, metabolism, or excretion from the body. (influences how the drug gets to where it is going).
68
overdosage
excess dose of a drug
69
allergy
a type 1 IgE-mediated hypersensitivity reaction to an administered drug
70
anaphylaxis
a sudden, severe allergic run which results in the release of immunological mediators either locally or throughout the body; only occurs in individuals previously sensitized to the allergen
71
idiosyncratic
an unusual response to a drug; can manifest as accelerated, toxic, or inappropriate response to the usual therapeutic dose
72
excessive pharmacologic effect
drugs can produce adverse effects by the same mechanism that is responsible for their therapeutic effect (ex: atropine may cause dry mouth and urinary retention by the same mechanism that reduces gastric acid secretion in the treatment of peptic ulcer)
73
mutagenic
a drug that causes genetic mutation
74
carcinogenic
a drug that produces cancer
75
teratogenic
a drug that adversely affects normal cellular development in the embryo or fetus
76
prototype drug
the "lead agent" in a drug class
77
receptor
any biologic molecule to which a drug binds & produces a measurable response (could be an enzyme, nucleic acid, or structural protein found intra or extracellularly)
78
agonist
receptor binding by drug causes the same response as that of the endogenous ligand
79
antagonist
receptor binding decreases/opposes the action of the endogenous ligand
80
ion channels
transmembrane proteins allowing for the exchange of ions across the cell membrane. drug binding may either increase or decrease this ion exchange resulting in changed cytosolic concentration or membrane potential. response to binding is nearly instantaneous.
81
pumps
similar to ion channels, drug interactions with transmembrane pumps will affect ion concentrations and electrochemical potentials across a cell membrane
82
drug potency
the amount of drug necessary to produce an effect of a given magnitude
83
drug efficacy
ability of a drug to elicit a response when it interacts with a receptor
84
chemical name of a drug
based on molecular structure of a drug
85
generic name
a generic name given to a pharmaceutical can be used by all who wish to refer to the substance. Prefix: differentiates drug from others in classinfix: used occasionally, further sub classifiesstem: indicates place in nomenclature scheme, drugs w/ same stem are related
86
proprietary name
trade name is owned and chosen by the firm that markets a specific product
87
bioequivalence
a value indicating the rate at which a substance enters the bloodstream and becomes available to the body
88
therapeutic equivalence
a drug that has essentially the same effect in the treatment of a disease or condition as one or more other drugs. may or may not be chemically equivalent, bioequivalent, or generically equivalent
89
drugs which have a high potential for ADR in the elderly
1. benzodiazepines2. anticholinergics3. skeletal muscle relaxants
90
START
Screening Tool to Alert doctors to Right Treatment
91
STOPP
Screening Tool for Older Persons Prescriptions (drugs that should be cautioned for use in elderly)
92
FORTA
Fit fOR The AgedClass A (absolutely)Class B(beneficial)Class C (careful)Class D (don't)
93
I Can PresCribE A Drug
IndicationContraindicationPrecautionsCost/ComplianceEfficacyAdverse EffectsDose, Duration, Direction
94
AMA Drug Evals
the AMA's reference book for drug use, like a dictionary
95
Index Medicus
comprehensive bibliographic index of medical scientific journal articles from the Nat'l Library of Medicine. Printed version of medline
96
Medline
electronic version of Index Medicus. Used to get paper abstracts
97
Iowa Drug Info System (IDIS)
Index database of articles about drugs and drug therapy in humans complex from all the major medical and pharm journals
98
Physician's Desk Reference (PDR)
compilation of package inserts for drugs organized by disease; approved doses &indications; does not tell you off-label uses
99
Facts & Comparisons
drug data; more than PDR; contains off label uses
100
AHFS Drug Info
database of drug info & off-label uses by the American Society of Health System Pharmacists
101
Drug Topics Red Book
drug pricing handbook for Rx and OTC
102
Medical Letter
peer-reviewed biweekly journal; subscription resource of non-profit drug research providing pharmaceutical evals
103
Micromedex
prescribing info; can be used on PDA or any OHSU computer; updated continuously; a good place to start for drug info after you've decided what you want to use; includes off label dosing/uses; drugdex: rx info; poisindex: how to treat overdosing; identidex: helps ID an unknown pill
104
purpose of a "black box" warning on a drug
an FDA warning for possible serious adverse effects of a drug such as injury or death.

JG (6 decks)

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