Intro to Drug Lit- Krysiak

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What type of literature is this? (primary, secondary, or tertiary)

  • summarized from primary literature

  • source of answers to straight forward questions

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40 Terms

1

What type of literature is this? (primary, secondary, or tertiary)

  • summarized from primary literature

  • source of answers to straight forward questions

tertiary literature

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2

What type of literature is this? (primary, secondary, or tertiary)

  • original research

  • clinical evidence raw and most recent form

  • evaluation skills are necessary

  • synthesis addresses more complex questions

primary literature

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3

What type of literature is this? (primary, secondary, or tertiary)

  • searchable databases that enables location and retrieval of primary and tertiary resources

  • catalogue w/ indexing and filtering

secondary literature

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4

Examples of primary literature:

  • controlled trials

  • cohort studies

  • case reports

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5

Examples of secondary literature:

  • PubMed

  • Medline

  • Embase

  • IPA

  • Google Scholar

  • Web of Science

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6

Examples of tertiary literature:

  • Compendia (Micromedex, Lexicomp)

  • Textbooks

  • review article

  • clinical practice guideline

  • package insert

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7

What is the BEST method to search your literature?

a. primary lit —> secondary databases —> tertiary

b. secondary databases —> primary lit —> tertiary

c. tertiary —> secondary databases —> primary lit

d. primary lit —> tertiary —> secondary databases

c.

tertiary —> secondary —> primary

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8

Which of the following correctly describes tertiary resources?

a. provides info that is detail oriented, such as case studies

b. provides info that is summarized for a quick and easy overview

c. provides info that references the literature found in journals

d. provides info that includes details that are not yet published

b.

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9

What are the pros and cons of tertiary literature?

pros: convenient, user friendly

cons: risk of out-of-date info

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10

T/F When reading tertiary resources, you should look consult 2 or more resources as you may have different answers depending on what resource you utilize.

T

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11

Non-systematic review articles:

  • What are they used for?

  • What are they not based on?

  • Advantages:

  • Used for: general background info (like disease state and tx)

  • NOT based on predefined lit search criteria

  • advantages: updates the research on new treatment strategies that may not be in guidelines yet

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12

Describe Systematic Review, a type of tertiary literature:

  • clear and prespecified criteria for finding research and for rating quality of evidence

  • higher quality of review

  • may be considered primary considering it brings new understandings by combining earlier findings

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13

Is Meta-analysis considered a primary or tertiary literature?

PRIMARY

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14

What is a meta-analysis?

  • new research bc it mathematically combines findings of smaller studies, generating new knowledge from previously measured results

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15

Prescribing information is generally considered as _________________ literature.

TERTIARY

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16

What is the definition of Clinical Practice Guidelines?

systematically developed statements to assist practitioner and patient decisions about appropriate healthcare for specific clinical circumstances

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17

T/F Best/high quality clinical guidelines will not continually review medical literature AND summarize old evidence to inform best practice standards

F

Guidelines WILL continually review medical literature AND summarize NEW CURRENT evidence to inform best practice standards.

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18

How is a quality clinical practice guideline created?

  • transparent process is published/followed

  • specific methods used to find/synthesize evidence

  • ratings of evidence is determined beforehand and consistently applied

  • recommendations include an indicator of strength of supporting evidence

  • references provided

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19

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20

What is the name given to the compilation of information from FDA regarding safety and efficacy based on clinical trials?

Prescribing Information

  • aka the package insert,

  • prescription drug label,

  • PI,

  • product info

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21

Do package inserts contain off-label or unapproved indications?

no

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22

Where would you go to, to find package inserts?

  • DailyMed website maintained by NLM

  • Drugs@FDA website and mobile app

  • Manufacturer website

  • printed and attached to the product

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23

What does the FDA Orange Book contain? How are things rated?

  • approved drug products w/ therapeutic evidence

  • reference listed drugs and ratings of therapeutic evidence of generic products

    • AB Rating

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24

What does the FDA Purple Book contain?

  • licensed biological products w/ biosimilarity and interchangeability evaluations

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25

What is the difference between biosimilar and interchangeable?

  • biosimilar- biological product that is highly similar and has no clinically meaningful differences in terms of safety or effective from an existing FDA approved reference produce

  • Interchangeable- is BIOSIMILAR ANDDDDD approved based on info sufficient to show that it can be expected to product the same clinical result in any given patient

Think: An interchangeable is biosimilar that meets additional requirements!

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26

Which drug resources are available to use through LECOM?

  • FYI

  • lexicomp,

  • micromedex

  • natural medicine

  • UptoDate

  • +more

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27

What resource is included in Micromedex and is unique for including pricing information - average wholesale price (AWP), wholesale acquisition cost (WAC), direct price (DP), suggested retail price (SRP), and federal upper limit (FUL)?????

Pharmacy Red book

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28

What are secondary resources?

refers to literature that indexes the primary (and some tertiary) found in journals

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29

Secondary resources help the used find relevant literature through indexing and/or abstracting. What do indexing and abstracting provide?

  • Indexing provides the bibliographic citation info

  • abstracting provides a brief description

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30

What are the advantages of secondary databases?

  • enables you to retrieve compreshensive published literature specific to a topic

  • many different sources available

  • continually updated

  • easy to use

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31

What are the disadvantages of secondary databases?

  • can be costly for subscriptions

  • may have to use multiple databases

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32

If you use info found in a secondary resource… do you cite the secondary source?

  • FYI

  • no!

  • cite the info from where the secondary source found it

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33

Describe primary literature:

  • ORIGINAL research

  • FOUNDATION on which all over literature sources are built

  • published or unpublished

  • using primary literature is the final step in the literature search

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34

Unpublished or _________ literature is primary literature that contains drug info that has not been published in medical journals or resources. It also is generally not peer-reviewed.

Grey

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35

The Journal Impact Factor or JIF is based on…

based on how often the articles are cited by other publications over a 2 year period

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36

What are the components to journal quality?

  • author guidelines

    • very detailed instructions for authors to follow

  • peer review

    • ppl w/ relevent expertise review the article

    • authors must respond

  • conflict of interest

    • any financial interest must be disclosed

  • open access

    • journals are available to public at free/low cost

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37

What are some examples of grey literature?

  • FDA review information that is located on the website, but hard to find or info that is not on the website bu available by a Freedom of Information Act request

  • internal data kept private by manufacturers

  • results of studies that authors didn’t publish

  • blogs, press reports, conferences, etc

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38

When do we use primary literature?

  • if tertiary literature is conflicting/outdated

  • a clinical case is abnormal or falls outside normal parameters

  • development of standardized procedures, protocols, or guidelines

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39

Advantages of primary literature:

  • ability to obtain complete, detailed, most relevant info regarding the topic in question

  • information is current

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40

Disadvantages of primary literature:

  • requires comprehensive searches to find evidence

  • requires significant time and expertise

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