Pharm Section 1 Flashcards

1
Q

Ways to save on drug costs

A

lifestyle changes, older or generic drugs (newer isn’t always best), insurance plan & formularies (buy in bulk, etc.)

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2
Q

PAP

A

patient assistance programs by pharmaceutical manufacturers–help people who cannot afford their meds

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3
Q

anticipated increase in drug spending will be driven by…

A

expensive new drugs, aging populations, and increased generic drug use in developing countries

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4
Q

prescription drugs account for about ___% of over US health expenditures

A

11%

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5
Q

Tennessee Health Care Innovation Initiative

A

shift from fee-for-service payment to outcomes-driven reimbursement for physicians

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6
Q

____% of americans are on at least 1 prescription drug; _____% take two; and ____% are on five or more prescription meds

A

70%; 50%; 20%

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7
Q

non-adherence

A

people not taking meds as directed. nearly 3/4 consumers admit they don’t take as they should (forget to take, don’t fill Rx, take less than recommended, substitute OTC meds instead)

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8
Q

More than _____% of drug Rxs not filled within 9 months. Highest non adherence for ______ kinds of drugs

A

more than 30%; expensive or chronic preventive drugs.

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9
Q

only _____ drugs are sampled

A

branded, patent-protected

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10
Q

pros/cons of drug samples

A

pros: allows pt to test drug before committing to full rx worth (cost savings)
cons: pts start on more expensive samples, then can’t afford when they have to buy full Rx (adds to cost later, might have to change meds which can be difficult on body)

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11
Q

FDA def drug (and why they changed it)

A

“an article (other than food) intended to affect the structure or any function of the body.” Changed it in an effort to control nicotine.

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12
Q

clinical def drug

A

any substance used in the dx, tx, cure, or prevention of disease or health condition

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13
Q

pharmacology

A

study of actions and effects of drugs within a living system (legal, illegal, Rx, non-rx drugs)

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14
Q

pharmacokinetics

A

study of drug absorption, distribution, metabolism, and excretion (ADME) (“How they get in, move around, and leave the body”)

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15
Q

pharmacodynamics

A

study of drug interactions within body tissues and how drugs produce their specific effects (“how they work”)

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16
Q

pharmacogenetics

A

study of the variability in drug response and toxicity due to genetic factors

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17
Q

pharmacogenomics

A

information gained from pharmacogenetics applied to the development and use of medications. aka precision or individualized medicine

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18
Q

how is information from the US Human Genome Project being incorporated into pharmacology?

A

pharmacogenetic/genomic information included in warnings of over 100 drugs; genetic profiles may be used to choose medications with minimal side effects (CYP450 enzymes)

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19
Q

polymorphisms

A

tiny discrepancies in human genomes that can be important markers of disease risk

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20
Q

indication

A

an illness or disorder for which a specific drug has documented usefulness

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21
Q

contraindication

A

when there is evidence that a drug should not be used to treat a particular disease or disorder

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22
Q

action

A

the chemical changes or effects a drug has on body cells. may be reversible or irreversible.

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23
Q

agonist

A

drug that has an affinity and intrinsic activity for a receptor site–acts to illicit a specific effect

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24
Q

antagonist

A

drug that has an affinity for a receptor site, but does not illicit and effect (“blocks” the receptors)

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25
Q

toxicity

A

a measure of the difference between effective and lethal/toxic doses

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26
Q

therapeutic index

A

LD50/ED50 or TD50/ED50 (measure of the margin of safety for a drug…ratio of the effective dose and the toxic/lethal dose)

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27
Q

narrow therapeutic index (NTI) drugs

A

drugs that have a small margin of safety for therapeutic index…require measurement of serum plasma levels to avoid adverse effects

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28
Q

therapeutic drug monitoring

A

measuring serum plasma levels of drugs to assure

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29
Q

peak level

A

highest level of drug in serum plasma

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30
Q

trough level

A

lowest level of drug in serum plasma

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31
Q

how many half-lives does it generally take to achieve steady state serum concentrations?

A

usually after 5 half-lives for most drugs

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32
Q

OTC drugs

A

over the counter drugs. Rx not required

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33
Q

BTC drugs

A

behind the counter drugs. Restricted to pharmacies, but don’t require a prescription. E.g. pseudophed

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34
Q

Rx drugs (legend drugs)

A

require a prescription to be dispensed

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35
Q

orphan drugs

A

drug that has potential use in only a small number of people with particular conditions (not significant enough for FDA to provide incentives for drug development. controversial b/c “no reasonable expectation of profitability”).

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36
Q

drugs possess ______ actions and effects

A

multiple

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37
Q

__________ is a fact of life as evidenced by the normal curve of distribution

A

biological variation

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38
Q

all drugs are _______

A

toxic, only the toxicities and doses required differ.

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39
Q

placebo effect

A

beneficial effect produced by a drug or treatment that cannot be attributed to the properties of the placebo itself, but to the patients belief in the treatment instead (though to be the result of the body’s production of endorphins when pt believes in the drug)

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40
Q

cost may have a _____ effect

A

placebo. more expensive drugs thought to have greater effect

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41
Q

potency

A

how much of a drug is required to illicit a pharm effect (more potent drug just means to have to use more of it). potency does not equal efficacy.

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42
Q

efficacy

A

how well a drug actually accomplishes the effect it is supposed to produce (i.e. how well it actually works)

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43
Q

chronotherapeutics

A

delivery of medications in varying amounts during the day, taking temporal patterns in the risk of disease/change in symptoms/pt tolerance into account

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44
Q

EBP/EBM

A

evidence-based practices or medicine. interdisciplinary approach to clinical medicine. research best practices and put them into clinical practice

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45
Q

evidence

A

research findings derived from the systemic collection of data through observation and experiment and the formation of questions and testing of hypotheses.

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46
Q

dosage forms

A

how drugs are delivered. include: liquids, tablets, capsules, transdermals, buccal films, implants, pumps, topical, aerosols, and parenterals,

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47
Q

controlled release dosage forms

A

LA (long acting), SR (sustained release), XL, and CR (controlled release) drugs.

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48
Q

what kind of dosage forms should not be crushed?

A

enteric coated tablets and controlled release dosage forms

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49
Q

chemicals (drugs) break down in the presence of _____, ____, and ____

A

heat, light, and moisture

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50
Q

all states require that medications be packaged/dispensed in _________ containers

A

child-resistant

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51
Q

all original packages must include an ________

A

expiration date

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52
Q

shelf life

A

the timeframe in which the manufacturer state that the drug will maintain its full potency

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53
Q

what kind of drugs are labeled with “beyond use” dates? how long are these dates (usually)?

A

repackaged drugs. Generally 1 year or less from the repackaging date.

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54
Q

can drugs be used past their expiration dates?

A

drugs may be stable after their expiration dates (generally are), but that date is how long drug manufacturers can guarantee drugs will remain stable based on testing. When no substitute is available, outdated drugs may be effective. Potency and efficacy varies with the drug, batch, preservatives used, and storage.

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55
Q

expiration dates are generally set for _______ months after production

A

12-60 months.

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56
Q

destruction of drugs

A

used to flush down toilet, but started seeing in water systems. Now, “drug take-back programs” at pharmacies and other participating locations for proper disposal. If not possible, remove from vials, mix with coffee grounds or kitty litter, and put in sealed bag.

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57
Q

generic drugs

A

drugs modeled after a single, brand-name drug that performs approximately the same in the body as the brand name drug. Slight, but not medically important variations from original drug.

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58
Q

generic drugs now make up _____% of the pharmaceutical market volume

A

~84%

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59
Q

brand name drugs account for ____% of all dollars spent on prescription drugs

A

75%

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60
Q

average time brand name drugs stay in market without generic competition?

A

12.8 years

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61
Q

GPhA suggests that use of generics has reduced US healthcare spending by _____ over past decade

A

1 trillion

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62
Q

comparison of cost between Rx and generics

A

Rx ~$84, generic ~$25

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63
Q

drug nomenclature includes

A

chemical name, generic (nonproprietary) name, and trade name

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64
Q

guidelines for substituting generic for brand name drug?

A

can substitute generic for brand name if the generic is deemed “A” rated to be bioequivalent to brand name

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65
Q

bioequivalent

A

generic drugs that are synthesized to be chemically equal to brand name drugs

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66
Q

biosimilar

A

“generic” biological drugs. called biosimilar instead of generics because they’re made from living organisms, which can’t be copied exactly.

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67
Q

What is the name of the FDA publication that lists therapeutic equivalent (bioequivalent) drugs?

A

The “orange” book

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68
Q

What FDA publication lists biosimilar agents?

A

the “purple” book

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69
Q

what are the FDA guidelines for bioequivalence?

A

drug must exhibit bioavailability properties similar to the produce its being compared to. Requires that the 90% confidence interval of these properties fall with the 80-125% range of the brand product in three categories: max concentration, time to mac concentration, and area under the curve.

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70
Q

80-125% rule does NOT refer to:

A

amount of drug in the product or amount of drug absorbed/avg blood levels

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71
Q

DTCA pros/cons

A

direct-to-consumer advertising

pros: informing patient about options
cons: cost

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72
Q

STEPS for evaluating a new drug

A
S: safety
T: tolerability
E: effectiveness
P: price
S: simplicity
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73
Q

Primary function of the FDA

A

to write the label for every drug it approves

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74
Q

drugs must be proven _____ and _____ before FDA will approve them, companies can market them

A

safe and effective

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75
Q

FDA makes judgments about whether or not a drugs ______ outweigh ______

A

benefits outweigh risks

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76
Q

new FDA emphasis?

A

used to focus on safety, non inferiority, and effectiveness, now moving toward outcomes and superiority over existing drugs

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77
Q

off-label drug use

A

when drugs are used to treat illnesses/conditions/populations they are not FDA approved to treat. occurs when MDs depart from approved use, dosage, dosage form/administration, or patient population.

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78
Q

most common off-label drug use?

A

pediatrics

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79
Q

types of review for new drug applications

A

standard (drugs with therapeutic qualities similar to one or more already on market); priority (drugs appear to be significantly better than those on market); and “Animal Testing” (don’t require human clinical trials bc dangerous, only require human safety trials)

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80
Q

estimated average cost of developing new drugs?

A

$4 billion

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81
Q

animal studies are conducted to…

A

determine toxicity/therapeutic index/margin of safety (lethal dose only in animals) and pharmacokinetic information

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82
Q

human studies are conducted to…

A

aka clinical trials. determine safety, dosage range, side effects, effectiveness, compare to current drugs

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83
Q

IND

A

investigational new drug exemption

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84
Q

clinical trails

A

usually RCTs that are double blind, placebo-controlled, cross-overs, etc. Not all have placebo arm (standard of care vs. new drug)

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85
Q

NDA

A

new drug application

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86
Q

ANDA

A

abbreviated new drug application (basically for generics)

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87
Q

patent rights

A

15-20 years from IND (varies depending on a number of factors)

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88
Q

Phase I clinical trials

A

20-80 people; tests for safety, safe dose range, identify side effects

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89
Q

Phase II clinical trials

A

100-300 people; tests for effectiveness and safety in larger population

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90
Q

Phase III clinical trials

A

1000-3000 people; confirms effectiveness, monitors side effects, compares to commonly used drugs on market, collects info for how to use safely

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91
Q

Phase IV clinical trials

A

post-market studies. continues studies on adverse effects, risks, benefits, optimal use

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92
Q

REMS

A

risk evaluation and mitigation strategies. system to help manage medication risks/safety issues. 1/2 strategies provide info; 1/2 require additional training for prescribers.

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93
Q

legacy drugs

A

drugs that have “grandfathered in” approach by FDA until they can be tested. allowed to remain on the market despite lack of FDA approval.

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94
Q

drug pedigree

A

tracks drugs from original manufacturer through subsequent sales to attempt to control counterfeiting

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95
Q

“track and trace”

A

pedigree and tracking (RFID chip) requirements for drugs to try and mitigate counterfeiting

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96
Q

FAA regulations

A

“bottle to throttle” rules: can’t consume alcohol within 8 hours of flight, must wait 6 hours for viagra (b/c alters blue/green color perception)

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97
Q

pharmacognosy

A

study of plant-based drugs (aka phytopharmaceuticals)

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98
Q

chemical synthesis of drugs started in the…

A

1950s. (also discovery of DNA by wanton/crick)

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99
Q

biotechnology era….

A

1980s (1st biotech drug developed was human insulin in ‘83)

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100
Q

gene therapy

A

drugs tailored to people based on their human genome

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101
Q

1906 Food & Drug act

A

instituted labelling requirements for drug manufacturers

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102
Q

1914 Harrison Narcotic Act

A

set up taxation for opiates

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103
Q

1938 Federal Food, Drug & Cosmetic Act

A

1st safety testing requirements (following sulfanilamide disaster that killed 107 people mostly kids)

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104
Q

1952 drug legislations

A

further distinguished between Rx and OTC drugs

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105
Q

1962 Kefauver-Harris Amendment

A

1st requirements for efficacy testing (in response to thalidomide birth defects crisis)

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106
Q

1970 Controlled Substances Act

A

established schedules/ classes of drugs based on potential for abuse

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107
Q

animal testing for controlled substances

A

test to see if animal will self-administer drug and continue taking it rather than taking food/water

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108
Q

5 schedules for drugs

A

Schedule I-V

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109
Q

Schedule I drugs

A

no legitimate medical use in the US. examples: LSD, heroin, marijuana

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110
Q

Schedule II drugs

A

have high potential for abuse that may lead to severe dependence. Cannot get refills. E.g. morphine, oxycodone, hydrocodone

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111
Q

Schedule III drugs

A

potential for abuse, but less than CII. abuse may lead to moderate-low dependence. can refill 5x in 6mo. E.g. codeine with tylenol, steroids

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112
Q

Schedule IV drugs

A

lower potential for abuse than CIII. abuse may lead to limited dependence. Can refill 5x in 6 mo. e.g. benzos, tramadol

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113
Q

Schedule V drugs

A

Lowest potential for abuse, dependence. Can be Rx or OTC. e.g. codeine cough syrups, Lomotil (high doses have opiate like effect)

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114
Q

Top 10 prescribed controlled substances in TN (2015)

A

hydrocodone (Vicodin, Lortab), alprazolam (Xanax), oxycodone (OxyContin, Percocet), zolpidem (Ambien), tramadol (Ultram), clonazepam (Klonopin), lorazepam (Ativan), diazepam (Valium), morphine (MS Contin), buprenorphine (Suboxone, Subutex)

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115
Q

TCSMD

A

Tennessee Controlled Substance Monitoring Database–includes info on prescriber, date Rx, when filled, who filled, new rx or refill, basic patient info, name + form of med, source of payment

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116
Q

when do prescribers check TCSMD?

A

before prescribing opioids, benzos (and annually for patients on those meds)

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117
Q

exemptions for checking TCSMD

A

hospice, surgical procedures in licensed healthcare facility, quantity doesn’t exceed max for 7 day tx pd and doesn’t allow refills, vets

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118
Q

interstate sharing of CS data?

A

problematic. cannot share across states yet, some states don’t even have systems. but that is the goal.

119
Q

no Rx or any opiod or benzos may be dispensed in quantities greater than _______

A

a 30 day supply

120
Q

side effects

A

additional effects of drug that are not the primary purpose of giving the drug (desirable and undesirable)

121
Q

average number of side effects listed on meds

A

avg = 70 per medication

122
Q

adverse reactions

A

unintended and undesirable responses to meds. Directly related to the drug.

123
Q

package insert

A

list of side effects and potential adverse effects of drugs

124
Q

Dear Healthcare Professional Letter

A

if enough instances of adverse event happen, manufacturers send this letter to warn prescribers in hopes of reducing instances of that particular adverse event or side effect

125
Q

Black box or boxed warning

next step?

A

if letter does’t reduce instances of new side/adverse effect, must include a black box warning on the medication that lists the unwanted side/adverse effect. strongest warning the FDA can require. next step: pull drug from market

126
Q

warning fatigue

A

too many warnings for things, pay attention to them less/don’t take as seriously. e.g. peanut warning on peanuts

127
Q

two ways side effect/adverse events reach the FDA

A

voluntary reports by prescribers/consumers and reports by manufacturers (must report serious events within 15 days of hearing about it)

128
Q

US deaths caused by drug use more common than_______

A

automobile accidents and either alcohol-induced or firearm-related deaths

129
Q

Adverse Events Reporting System

A

FDA mechanism for reporting adverse events

130
Q

CDC estimate for # ED visits due to medication errors

A

700K

131
Q

examples of medication errors that lead to ED visits

A

taking multiple OTC drugs that contain similar/same products, mixing eye drops with ear drops, chewing non-chewable, splitting pills you shouldn’t split, using household spoon to measure dosage, missing or doubling doses

132
Q

drugs in hospitals administered wrongly?

A

4 in 10.

133
Q

most common medication errors in hospitals/with nurses

A

giving patients meds earlier or later than meant to, failing to flush tubes between administrations, using wrong syringes to inject meds into feeding tubes

134
Q

medical errors are the ______ leading COD in the US

A

third

135
Q

initiation of drug therapy must consider…?

A

the fish curve (aka the dose-response curve of beneficial vs. harmful effects). At some point, drugs do more harm than good

136
Q

IOM recommendations for reducing medication errors

A

electronic prescribing, hospitals have std. bar code system for checking/admin drugs, patients seek info about drug risks, DO NOT USE ABBREV.

137
Q

fetotoxic

A

toxic to the fetus

138
Q

teratogenic

A

causes birth defects

139
Q

women take and average of ______ prescriptions during pregnancy

A

3-5

140
Q

old FDA system for categorizing risk during pregnancy

A

A (safe for use during) B (not unsafe), C (can’t determine risk), D (evidence of risk), and X (contraindication–never use)

141
Q

new FDA system for relaying pregnancy risk info

A

labels must include categories for risk to: pregnancy, lactation, and female/male reproductive potential. pregnancy and lactation sections include 3 subsection: risk summary, clinical considerations, and data

142
Q

SALAD drugs

A

sound-alike-look-alike drugs. drugs with names that are easy to mix up.

143
Q

FDA guidelines for naming drugs

A

can’t name drugs things that imply efficacy/make medical claims, or suggest use that it’s not approved for, or promise more than drug delivers

144
Q

drugs ending in -oxetine belong to what class?

A

antidepressants

145
Q

drugs ending in -sartan belong to what class?

A

blood-pressure lowering drugs

146
Q

drugs ending in -afil belong to what class?

A

erectile dysfunction drugs

147
Q

drugs ending in -lukast belong to what class?

A

anti-asthma drugs

148
Q

drugs ending in -azepam belong to what class?

A

anti-anxiety drugs

149
Q

drugs ending in -coxib belong to what class?

A

anti-inflammatory pain relievers

150
Q

drugs ending in -dronate belong to what class?

A

drugs that prevent calcium loss

151
Q

drugs ending in -formin or -glitazone belong to what class?

A

diabetes drugs

152
Q

drugs ending in -prazole belong to what class?

A

stomach acid reducers

153
Q

drugs ending in -conazole belong to what class?

A

anti-fungals

154
Q

drugs ending in -vir belong to what class?

A

antivirals

155
Q

antiviral subclasses:

  • amivir for…
  • ciclovir for…
  • navir for…
A
  • amivir for anti flu drugs
  • ciclovir for herpes drugs
  • navir for HIV treatment drugs
156
Q

drugs ending in -stat belong to what class?

A

enzyme inhibitors. have a bunch of subclasses.

157
Q

-mab suffix refers to…?

A

monoclonal antibody drugs

158
Q

-imod suffix refers to…?

A

immunomodulators

159
Q

-sertib suffix refers to…?

A

serine/threonine kinase inhibitors

160
Q

-mer suffix refers to…?

A

polymers

161
Q

drug names in other countries

A

are often entirely different (brand and generic) than in the US

162
Q

10 second interventions for SALAD drugs

A

tell patient what drug is supposed to treat or ask patient why they were prescribed that drug

163
Q

how to reduce medication errors?

A

prescriber should take great care when writing/dispensing Rx. Ask prescribers to write indication/reason for taking drug in directions. patients should be encouraged to talk to pharmacist

164
Q

three phases in how body handles drug:

A

pharmaceutical phase (how drug gets into body i.e. dosage form), pharmacokinetic phase (ADME), and pharmacodynamic phase (cellular mechanism by which it works)

165
Q

drug receptor interaction theory

A

assumes drug has high affinity for a specific chemical group or particular constituent of a cell

166
Q

receptor

A

particular reactive cellular site which which the drug may interact to produce desired effect/response

167
Q

drug enzyme reaction

A

drug may increase or inhibit enzymes which control all biochemical reactions in cells

168
Q

nonspecific drug interaction

A

drug that exerts more general effects on cell membrane and processes (no specific action can be elicited)

169
Q

pharmocokinetic bell curve

A

drug administration > absorption on uphill > peak level at top > elimination on downhill.

170
Q

duration of action

A

time when drug is at minimally effective concentration or more (time when drug is working to produce effect)

171
Q

drugs are best absorbed in….

A

non-ionized, lipid-soluble form

172
Q

only way to bypass absorption:

A

IV or spinal tap

173
Q

pKa =

A

pH where 1/2 of the drug is ionized

174
Q

absorption of drug depends on the….

A

absorbing surface

175
Q

drugs with less ionization, more lipid solubility…

A

cross membranes quicker, work faster/better

176
Q

drugs exist as ______ or _____ and may be ______ or ______.

A

weak acids or weak bases and may be water-soluble (cannot pass through membranes) or lipid-soluble (pass through membranes)

177
Q

factors to consider when administering meds via enteral tubes:

A

type of tube, location of tube, liquid meds, bulk-forming or things that clog tubes, crushing tablets!!, enteral feedings may alter absorption

178
Q

how are drugs distributed through body?

A

either free or bound to plasma proteins like albumin

179
Q

drugs that are highly bound to plasma proteins may be displaced by…

A

other concurrently administered drugs with higher affinity for binding sites. displacement increases distribution of free particles, which increases the pharm activity of the displaced drug.

180
Q

metabolism

A

aka biotransformation, prepared drug for excretion. not all drugs undergo biotransformation (e.g. penicillin and WWII soldiers urine)

181
Q

what kind of drugs must be biotransformed before they can be excreted?

A

water-soluble drugs

182
Q

metabolism usually takes place @ ______ and excretion @ ________.

A

liver; kidneys

183
Q

CYP450 enzymes

A

partially responsible for drug metabolism. most commonly found in liver. each enzyme = isoform (derived from different genes). can either be induced or inhibited by chemicals in drugs, food (aka grapefruit as inhibitor).

184
Q

how does pharmacogenomics play role in metabolism?

A

some people metabolize drugs faster, slower than others. pharmacogenomics can be used to personalize drug therapy based on genes. e.g. 1-7% of population rapid codeine metabolizers (29% in Ethiopians)

185
Q

enzyme induction

A

drug that induces enzyme to increase metabolism or excretion of drug, lowering its blood level/pharm effect

186
Q

enzyme inhibitor

A

drug that inhibits enzymes metabolism/excretion of drug, increasing its blood level and pharm effect

187
Q

hepatic first pass effect

A

some drugs are immediately transported to liver and metabolized extensively on “first pass.” can bypass this effect by administering any way other than orally.

188
Q

examples of drugs that undergo hepatic first pass effect

A

morphine, nitroglycerin (given higher doses orally or by other routes of administration)

189
Q

prodrug or progenitor drug

A

a drug that is metabolized to another active drug/active metabolite e.g. clopidrogel/Plavix

190
Q

metabolite

A

end product of metabolism. may be active or inactive.

191
Q

zero-order

A

drugs that are metabolized at a constant amount per time / “flat rate” / e.g. alcohol. On graph: straight diagonal line

192
Q

first-order

A

drugs that are metabolized at a constant proportion per time (@ each half life, 50% eliminated). On graph: curved line

193
Q

half-life

A

T1/2 = the time it takes for the plasma concentration of a drug to be reduced by 50%

194
Q

it generally takes _______ half lives to achieve steady state concentrations or to reduce the drug to an insignificant level

A

3-5 half-lives

195
Q

loading dose

A

amount of a drug it takes to reach therapeutic range/minimally effective dose in circulation

196
Q

maintenance dose

A

amount of drug it takes to maintain steady state concentration in circulation

197
Q

drug interactions

A

many drugs interact as a result of enzyme induction or inhibition of enzymes. can result in larger or smaller response.

198
Q

primary excretion

A

renal system/urine

199
Q

urinary pH affects…

A

excretion (esp. amphetamines)

200
Q

best way to measure renal function

A

creatinine clearance–cockroft-galt equation (common way). takes into account serum creatinine levels, age, weight, and gender.

201
Q

other ways to measure renal function

A

serum creatinine levels (misleading, low doesn’t alway indicate good kidney function) or glomerular filtration rate (GFR–recommended for evaluating renal function for patients with chronic kidney disease)

202
Q

normal serum creatinine level?

A

0.5 or 0.6-1.1 to 1.2

203
Q

recommended way to test renal function in patients with chronic kidney disease?

A

GFR

204
Q

factors that modify a drug’s effect…

A

variable (food), fixed (genetic)

205
Q

drug-related problems

A

carcinogenicity, dependence and addiction, resistance, drug interactions, teratogenicity and fetotoxicity, extraversion and infiltration, adverse response/reactions

206
Q

tolerance

A

state of adaptation in which exposure to drug induces changes that result in reduced effect of drug over time

207
Q

tachyphylaxis

A

rapidly developing tolerance

208
Q

physical dependence

A

involves symptoms of withdrawal related to abruptly stopping or rapidly reducing dose

209
Q

addiction

A

impaired control over drug use/compulsive use despite harm/ craving

210
Q

extravasion/infiltration

A

injury to tissue caused by leakage of solution from vein into surrounding tissue during IV administration. can cause extensive damage that may/may not be repairable.

211
Q

adverse reactions include…

A

hypersensitivity reactions, idiosyncratic responses, hematologic effects, hepatotoxicity, nephrotoxicity, ototoxicity, ocular tonicity, emotional disorders, sexual dysfunction, taste disturbances/dysguesia

212
Q

weird adverse effect of amiodarone

A

“smurf effect” where skin appeared bluish

213
Q

idiosyncratic effect

A

a totally unexpected or unrelated reaction. unusual response “we have no idea why”

214
Q

blood dyscrasias

A

abnormal or disordered state

215
Q

ototoxicity…which cranial nerve?

A

8

216
Q

dysguesia

A

foul, salty, rancid, metallic sensation persists

217
Q

type I/ immediate hypersensitivity reaction

A

IgE mediated. Mast cells and basophils release histamine etc. in response to antigen. relatively rare. reaction develops rapidly, stronger with repeated exposure

218
Q

type II/ delayed hypersensitivity

A

CARPA. pseudoallergy. from mild flushing to severe rxns with bronchospasm, hypotension. reaction on first exposure, can improve/resolve with subsequent exposures

219
Q

most cutaneous drug rxns are related to…

A

drug hypersensitivity (drug specific activation of immune response). drug acts as antigen/hapten.

220
Q

estimated ___% of population are allergic to one or more meds, but ____% think they are allergic due to adverse effects

A

5%; 15%

221
Q

how can you determine if pt really has allergy or not?

A

ask CLARIFYING questions when patients say they have allergies to meds: age, time of reaction, characteristics of reaction, low long after med admin did run begin, what other meds/exposures around same time? what happened when discontinued?

222
Q

5 classes of meds that comprise majority of all allergic/pseudoallergic reaction reports?

A

antibiotics and sulfaonamides, NSAIDs/analgesics, contrast media, anticonvulsants, anticoagulants

223
Q

anaphylaxis

A

occurs within 30 minutes. Breathing/bronchospasm, rash, swelling, cardiac issues, BP drop, shock. Req. rapid tx for survival. tx = epinephrine (an dyphenylhydramine if have it)

224
Q

angioedema/urticaria

A

occurs minutes to days after therapy. symptoms may include mucosal lesion involvement, hives, facial swelling, resp. distress, cardiovascular collapse.

225
Q

serum sickness

A

occurs 1-2 weeks after initiation of therapy. delayed onset b/c immune complexes have to form. symptoms: fever, arthralgia (joint pain), and morbilliform lesions

226
Q

steven-johnson syndrom (SJS)

A

usually related to sulfa drugs and viral infections, occurs 1-3 weeks after initiation of therapy, symptoms: eruptions, blisters, detachment of

227
Q

toxic epidermal necrolysis (TEN)

A

occurs 1-3 weeks after therapy. erosions at 2+ mucosal sites, outer layer of epidermis separating from basal layer, large sheets of necrosis, totally detachment of >30% body surface area, sepsis most common COD.

228
Q

acute generalized exanthematous pustulosis (AGEP)

A

“Pustular drug eruption” and “toxic pustuloderma”. sudden eruptions appearing avg 5 days after therapy. many drugs carry this warning.

229
Q

fixed drug eruption

A

occurs 30 min- 8 hours after preexposure to drug. swollen lesions, reddening of skin/patches (erythema), darkens to deep purplish color. usually resolve 2-3 weeks after stop tx.

230
Q

management of anaphylaxis

A

0.01 ml/kg IM epinephrine 1:1,000. Followed by adjust of diphenhydramine (Benadryl), arrange for rapid transport. Hospitalization or at least 12 hour monitoring.

231
Q

pharmacokinetic changes associated with geriatrics

A
  • changes in body composition alter distribution of drugs
  • hepatic drug metabolism less efficient (increased serum concentrations)
  • some degree of renal impairment (excretion probs)
232
Q

pharmacodynamic changes associated with geriatrics

A

physical changes in old age may affect responses to drugs. fall risks increased with sedating drugs.

233
Q

americans over the age of 65 account for ____% of the population, but consume ____% of Rx drugs and ____% of OTC drugs

A

13%; 30%; 40%

234
Q

barriers to adherence in elderly population

A

forgetfulness, side effects, feel meds not needed, difficulty paying for meds, chronic conditions, med-related problems, difficulty with vision/reading instructions, hearing loss (hearing instructions, etc.)

235
Q

____% medicare beneficiaries not adherent to meds

A

30%

236
Q

elderly to age 70 are _____x more likely to experience adverse rxns than young adults and after 70 it increases to ______x more likely.

A

2-3x; 4-6x

237
Q

____ of people who die in hospital from adverse reactions are elderly.

A

1/2

238
Q

PIMS in elderly

A

potentially inappropriate medications; includes common meds like ibuprofen or digoxin. Listed in publications like “beers list”, “zhan’s list”, public citizens lists. Screening tools include STOPP and START.

239
Q

Beer’s list

A

guide for drugs to avoid in nursing home patients to reduce drug problems. Many drugs have anticholinergic or sedative effects that cause drowsiness, cognitive impairment, increase falls risk.

240
Q

Zhan’s list

A

categorizes beers list into “always avoid”, “rarely appropriate”, and “some indications” groups.

241
Q

STOPP

A

Screening Tool of Older Persons potentially inappropriate Prescriptions. helps define PIMS and reduce adverse events in elderly.

242
Q

START

A

Screening Tool to Alert doctors to Right Treatment. quality of care indicators. situations where meds are indicated.

243
Q

Public Citizen’s list of PIMS for elderly

A

lists 136 meds that cause confusion in elderly. includes diphenhydramine (Benadryl), benzos, Detrol for overactive bladder, etc.

244
Q

drugs and confusion in elderly

A

a number of drugs cause confusion in elderly pts. If elderly pt confused, sedated, ataxic…check meds. Reduce meds to see if signs/symptoms improve

245
Q

5 things to question with geriatric patients

A

feeding tubes, antipsychotics, hemoglobin A1c >7.5% (moderate control better), benzodiazepines, antimicrobials for bacteriuria

246
Q

team approach to care for elderly

A

functionality (PT/OT), social environment (social workers), medications (pharmacists/MD)…review all meds for interactions!

247
Q

“backing off”

A

less is more approach to drugs in the elderly now favored over aggressive medicating. Reduce med burden to help improve quality of life.

248
Q

Number of elderly at risk for major drug-drug event _____

A

doubles. more elderly pts using 5+ drugs, many with the potential for major interactions. Carefully consider meds, interactions, potential for adverse effects

249
Q

therapeutic orphans

A

children. b/c little incentive to manufacture kids drugs, FDA doesn’t approve many kids drugs (issues with clinical trials and kids)

250
Q

only ____% drugs approved have FDA approval to use in kids

A

25%

251
Q

FDA regulations for packaging OTC liquid drugs

A

measuring device must be included, devices and directions should have consistent abbrevs/units, dose devices can’t hold more than max dose, abbreviations should be std and defined.

252
Q

reasons kids not included in many drugs studies

A

1) vulnerable populations

2) informed consent issues

253
Q

children’s medications are dosed by…

A

weight and age (weight most important)

254
Q

administration of OTC products to kids…

A

significant number of caregivers giving improper doses to kids (probe with calculating, measuring, delivering)

255
Q

Rxs for these kids conditions have increased

A

diabetes, asthma, ADHA, antihyperlipidemics, hypertension, antidepressants (childhood obesity culprit for most of these)

256
Q

Rx categories that have declined in kids

A

allergy meds, cough/cold meds, pain, abx

257
Q

formularies

A

list of what drugs are/are not covered for insurance/MCO. Often have PDL (preferred drug lists)…subject to change often! Some drugs require prior approval.

258
Q

Drug info sources

A

Pharmacological Basis of Therapeutics (Goodman/Gilman); Physicians Desk Reference; US Pharmacopeia; epocrates.com; medscape.com; MICROMEDEX (free for UT students)

259
Q

CAM

A

complementary and alternative medicine (herbal, supplements)

260
Q

3 compounds intended for human consumption

A

drugs, food, supplements

261
Q

difference between supplements and approved drugs?

A

regulatory status. drugs require safety and efficacy testing; supplements just have to make no health claims and are not proven unsafe.

262
Q

DSHEA

A
  1. amended food, drug, cosmetic act to define supplements, set regulations (no health claims, not unsafe), requires statement that supplements are not FDA regulated/approved. Are allowed to make statements about structure/function of body.
263
Q

dietary supplement is defined as…

A

product (other than tobacco) used orally and intended to supplement the diet that bears/contains one or more of the following: a vitamin, mineral, herb/botanical, amino acid, dietary substance to increase total dietary intake, concentrate/metabolite/constituent/extract/combinations.

264
Q

FDA and supplements

A

cannot regulate, but can take enforcement actions after drug is on the market. Has new Office of Dietary Supplement Programs.

265
Q

USP verified mark…

A

assures that labeling is correct, product doesn’t contain harmful levels of contaminants, product will break down and release in body, and that they used good manufacturing practices (GMP) to make it.

266
Q

________ should not be considered inactive or benign.

A

Natural or Herbal supplements

267
Q

St. John’s wart

A

MAOI/SSRI properties (antidepressants)…increased risk of serotonin syndrome (mild to severe symptoms, fatal if not treated)

268
Q

Kava

A

hepatotoxic (7% of cases required liver transplant)

269
Q

Ginkgo biloba

A

inhibits platelet activating factor (don’t use with aspirin/blood thinners)

270
Q

Commission E

A

German Regulatory Authority’s herbal watchdog agency. probably best source for info on herbal/supplements.

271
Q

poison control phone #

A

1-800-222-1222

272
Q

drug toxicity in toddlers

A

1-2 tablets of a drug can kill a toddlers. some more deadly than others.

273
Q

beta-blockers, Ca2+ channel blockers, clonidine and toddlers

A

1-2 tablets can be fatal

274
Q

fatal dose of aspirin in toddlers

A

at least 6 extra strength tablets (methyl salicylate much more concentrate…1 tsp = 14 XS aspirins)

275
Q

most common cause of fatal overdose in children

A

iron. make specific antidote for it. 10 tablets lethal to toddlers. esp important with prenatal vitamins and other iron containing supplements

276
Q

methods of drug removal from GI tract

A

syrup of ipecac (not recommended anymore), activated charcoal, gastric lavage (stomach pump), whole bowel irrigation (laxatives)

277
Q

recommended dose of activated charcoal

A

25-100grams (depends on body weight) strive for 10:1 charcoal to toxin ratio

278
Q

what can be used to lower the systemic level of some drugs?

A

multi-dose activated charcoal (MdAC)

279
Q

two types of drug tests?

A

preliminary (highly sensitive) and confirmatory (more specific)

280
Q

immunoassays for drug testing

A

RIA, EMIT, FPIA, ELISA

281
Q

confirmatory testing for drugs

A

GC/MS (gas chromatography/mass spec)

282
Q

most used test for drugs

A

urine. easily obtained and drug concentrations usually relatively high

283
Q

specimen for drug test that useful for quantitative determinations

A

blood

284
Q

specimen for drug test that can be used to roughly gauge time of drug use/regular use

A

hair (but cannot detect if use occurred within just a couple days of testing).

285
Q

drug testing often used in detox programs

A

hair testing

286
Q

some drugs cause false positives on _______, but its ruled out using _____

A

screening tests; confirmatory tests

287
Q

pseudoephedrine shows up on drug tests as…

A

amphetamines

288
Q

rifampin or levofloxacin (like cipro) show up on drug tests as…

A

opiates

289
Q

poppy seeds contain _____ and _____ and therefore show up on drug tests as _____ when eaten in mass quantities

A

morphine and codeine; opioids

290
Q

PPI pantoprazole (Protonix) shows up on drug tests as…

A

cannabis

291
Q

Sertaline (Zoloft) shows up on drug tests as…

A

benzodiazepines

292
Q

how long after use can you detect amphetamines, heroin, cannabis, or PCP?

A

amphetamines and heroin: 1-3 days

cannabis or PCP: about a week unless chronic user

293
Q

niacin (vitamin B3) and drug testing

A

urban legend that it helps you pass drug tests (increases metabolism of drugs). No evidence of this. Excessive doses can be toxic (c/c “I’m on fire”)