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Guide to DI (Exam 1) Flashcards

1
Q

Drug Information

A

Facts or advice on drugs

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2
Q

Drug Information Center

A

A physical location where pharmacists have the resources to provide drug information

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3
Q

Drug Information Service

A

A professional service providing drug information

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4
Q

Optimal drug development requires a balance between achieving ________ and eliciting desired ______.

A

therapeutic concentrations (PK)

therapeutic effects (PD)

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5
Q

Pharmacokinetics (PK)

A

Body on drug
ADME

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6
Q

Pharmacodynamics (PD)

A

Drug on body
Drug-receptor interactions
MOA
Dose-response relationship

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7
Q

Drug Development Stages

A

Pre-clinical
Phase 1
Phase 2
Phase 3
FDA approval
Phase 4

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8
Q

Pre-clinical testing

A

In vitro/vivo studying on cells and animals

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9
Q

Phase 1

A

Safety and tolerability of drug in 20-100 healthy humans

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10
Q

Phase 2

A

Effect of drug in 100-200 patients with target disease
Efficacy and dosing

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11
Q

What percent of drugs will enter phase 3?

A

25%

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12
Q

Phase 3

A

Effect of drug in a few thousand patients with target disease
Double-blind design

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13
Q

Applying for FDA Approval

A

NDA reviewed by FDA and approved/denied

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14
Q

Phase 4

A

Post-marketing monitoring

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15
Q

MedWatch

A

Collects reports about unexpected side effects, quality issues, medication errors, and therapeutic failures
Voluntary

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16
Q

FAERS

A

FDA Adverse Event Reporting System
Information on drug and biologic reports

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17
Q

VAERS

A

CDC Vaccine Adverse Event Reporting System

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18
Q

Prescribing Information (PI)

A

Package insert, prescribing information, prescription drug labeling, product label
NO “off-label” indications

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19
Q

Which phase of FDA drug development is most concerned with human pharmacodynamic parameters of the drug?

A

Phase 1

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20
Q

What is the primary objective of Phase 4 clinical trials in FDA drug development?

A

Gather additional safety data in real-world setting

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21
Q

Black Box Warning (BBW)

A

Contraindications
Warnings and Precautions
Adverse Reactions

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22
Q

Drugs with serious safety concerns may require enrollment in _____ to manage.

A

Risk Evaluation and Mitigation Strategies (REMS)

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23
Q

Risk Evaluation and Mitigation Strategies (REMS)

A

FDA required safety programs for meds with specific serious adverse effects
Ex. Clozapine REMS

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24
Q

Adverse Drug Event

A

Harm caused by appropriate OR inappropriate use of drug
includes adverse drug reactions

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25
Q

Adverse Drug Effect

A

potentially harmful effect due to use of drug discovered during clinical exam or lab value

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26
Q

Adverse Drug Reaction

A

Harm directly caused by drug under appropriate use and normal conditions

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27
Q

Common Terminology Criteria for Adverse Events (CTCAE)

A

System used for reporting and grading severity of adverse events
Grade 1-5

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28
Q

Grade 1 Mild

A

Asymptomatic or mild symptoms
No intervention

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29
Q

Grade 2 Moderate

A

Minimal, local, noninvasive intervention
Limits daily activities

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30
Q

Grade 3 Severe

A

Medically significant but not life threatening
Hospitalization required

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31
Q

Grade 4 Life-threatening

A

Urgent intervention
ICU

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32
Q

Grade 5

A

Death :o

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33
Q

Full Prescribing Information (PI)

A

Drug Interactions
Drug Abuse and Dependence
Overdosage
References

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34
Q

Drug Interactions vs Drug Incompatibilities

A

Interactions - in body
Incompatibility - in vitro

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35
Q

Electronic “Drug ID” Tool

A

Drug identification
Enter letters and numbers from pill

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36
Q

Drug Instability

A

Eventual drug incompatibility or degradation

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37
Q

Where clinical trials can register to provide the public with transparent information?

A

ClinicalTrials.gov

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38
Q

Where to find PI?

A

DailyMed
Product Website
Manufacturer’s Website
Drugs@FDA
OTC Monographs@FDA
Paper label attachment
NO GOOGLE

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39
Q

Types of DI Resources

A

Primary
Secondary
Tertiary

40
Q

Tertiary Resource

A

Summaries of available info

41
Q

Secondary Resource

A

Databases which link primary sources

42
Q

Primary Resource

A

Present new/original material

43
Q

Which resource is the best starting point for gathering information?

44
Q

Drug Monograph

A

Structured document that reviews major features of a drug product
Limited to FDA-approved info

45
Q

Monograph vs monogram

A

idk just remember to look for the word monoGRAPH probs a true/false question
edit: monogram is a t-shirt print with initials

46
Q

Drug Monograph Body Contents

A

Indications (off-label as well)
Guidelines
Cost comparison

47
Q

Drug Monograph Sources

A

PI, Package Insert, NDA, ANDA

48
Q

Drug Compendia

A

sources for use in determining medically-accepted indication of drugs and biologicals used off-label in an anti-cancer chemo regimen

49
Q

Types of Compendia

A

AHFS DI
Micromedex
Lexicomp
Clinical Pharmacy
NCCN Drugs and Biologics

50
Q

AHFS DI

A

“Need to know” about drugs

51
Q

Micromedex

A

Summary info
Links to REDBOOK and Trissel’s

52
Q

Lexicomp/drug

A

Quick look up
Links to AHFS DI, Briggs, and Trissel’s

53
Q

Clinical Pharmacology

A

“Find by” feature
Links to AHFS DI, Harriet Lane, Trissel’s

54
Q

NCCN Drugs and Biologics

A

Decision-making for patients’s w cancer

55
Q

Which compendium provides access to Harriet Lane Handbook?

A

Clinical Pharmacology

55
Q

Disease Oriented Resources for Therapeutics

A

Koda-Kimble and Young’s
Applied Therapeutics
Pharmacotherapy (Dipiro)

56
Q

Disease Oriented Resources for Symptoms and Diagnosis

A

Goldman’s
Harrison’s

57
Q

Disease Oriented Resources for General Background Websites

A

Pharmacist’s Letter
Dynamed / dynamedex
UpToDate
Epocrates
Merck Manual
Medscape

58
Q

Disease Oriented Resources for Pharmacology

A

Brody’s
Basic & Clinical (Katzung)
Goodman $ Gilman’s

59
Q

Specialty Resources for Compounding and IV Stability

A

King Guide
Trissel’s
IJPC
Compounding Today
Remington
US Pharmacopoeia

60
Q

Specialty Resources for Drug Shortages

A

ASHP and FDA Drug shortages

61
Q

Specialty Resources for OTC

A

Handbook of Nonprescription Drugs
OTC Monographs@FDA

62
Q

Specialty Resources for Drug Interactions

A

Stockley’s
Liverpool
Hansten and Horn

63
Q

Specialty Resources for ADRs

A

FAERS and VAERS
MedWatch
Meyler’s
Reactions Weekly
Side effects of Drugs Annual

64
Q

Specialty Resources for Toxicology

A

Posion Control Center
PoisinDex
Lexi-Tox
ToxEd
Goldfrank’s
Casarett & Doull’s

65
Q

Specialty Resources for Pharmaceutical Industry

66
Q

Is IV compatibility the same as absence of drug interaction?

67
Q

Number for poison control

A

1-800-222-1222

68
Q

Specialty Resources for Veterinary

A

Merck Manual
Plumb’s

69
Q

Specialty Resources for Pediatrics

A

Harriet Lane
Neofax
TeddyBear

70
Q

Specialty Resources for Pharmacogenomics

A

Pharmacogenomics and Lab Tests
CPIC
PharmGKB
RxPgx

71
Q

Specialty Resources for Pregnancy/Lactation

A

Brigg’s
LactMed

72
Q

Specialty Resources for Geriatrics

A

Beers Criteria

73
Q

Specialty Resources for infectious Disease

A

Sanford Guide

74
Q

Specialty Resources for Immunizations

A

CDC Immunization Schedule
Immunization Action Coalition

75
Q

Specialty Resources for Drug Information

A

Drug Information
RxList.com

76
Q

Specialty Resources for International

A

Martindale
Index Nominum
WHO
European Med Agency

77
Q

Specialty Resources for Herbal Therapies

A

Natural Medicines Database
Examine.com
NIH Office
About Herbs

78
Q

Specialty Resources for Enteral Administration

A

Handbook of Drug Administration via Enteral Feeding Tubes

79
Q

Green Book

A

Animal Products

80
Q

Orange Book

A

Therapeutic Equivalence

81
Q

Purple Book

A

Biosimilars

82
Q

Pink Book

A

Vaccine-Preventable Diseases

83
Q

REDBOOK

A

Pricing Info

84
Q

American Academy of Pediatrics Red Book

A

Pediatric Infectious Disease

85
Q

Yellow Book

A

Travelers’ Health Info

85
Q

What do most health care professionals use to search information?

A

Specific medication website/apps

86
Q

Systematic Approach to Answering DI Questions

A
  1. Receive
  2. Expand
  3. Classify
  4. Search
  5. Evaluate
  6. Formulate
  7. Communicate
  8. Follow-up
87
Q

Why does complexity matter when searching databases?

A

Obvious search terms for low-mid complexity
Specific search terms for mid-high complexity

88
Q

Secondary resource strategies

A

Select appropriate search terms
Determine what filters need to be placed

89
Q

Assess primary literature by

A

Validity of journal
Date published
Target audience
Author credentials

90
Q

Formulating a response includes

A

Patient factors
Disease factors
Medication factors
Background info
Special circumstances

91
Q

Analysis vs. Synthesis

A

Analysis: breaking down into component parts
Synthesis: Process of combining varied and diverse ideas into a coherent whole

92
Q

When providing a response

A

List all resources searched
Provide facts
Summarize

93
Q

Which reference style do we use?

94
Q

AMA Style

A

Author(s),Title, Journal name Year;vol(issue No.):inclusive pages. DOI

95
Q

Citing package insert

A

Medication name. Package insert. Publisher; Year. Accessed month, day, year. doi/url

Drug Information (4 decks)

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