Intro to Drug Lit- Krysiak

10Q

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

• summarized from primary literature

• source of answers to straight forward questions

tertiary literature

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

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

Examples of primary literature:

• controlled trials

• cohort studies

• case reports

Examples of secondary literature:

• PubMed

• Medline

• Embase

• IPA

• Google Scholar

• Web of Science

Examples of tertiary literature:

• Compendia (Micromedex, Lexicomp)

• Textbooks

• review article

• clinical practice guideline

• package insert

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

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.

What are the pros and cons of tertiary literature?

pros: convenient, user friendly

cons: risk of out-of-date info

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

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

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

Is Meta-analysis considered a primary or tertiary literature?

PRIMARY

What is a meta-analysis?

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

Prescribing information is generally considered as _________________ literature.

TERTIARY

What is the definition of Clinical Practice Guidelines?

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

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.

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

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

Do package inserts contain off-label or unapproved indications?

no

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

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

What does the FDA Purple Book contain?

• licensed biological products w/ biosimilarity and interchangeability evaluations

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!

Which drug resources are available to use through LECOM?

• FYI

• lexicomp,

• micromedex

• natural medicine

• UptoDate

• +more

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

What are secondary resources?

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

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

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

What are the disadvantages of secondary databases?

• can be costly for subscriptions

• may have to use multiple databases

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

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

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

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

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

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

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

Advantages of primary literature:

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

• information is current

Disadvantages of primary literature:

• requires comprehensive searches to find evidence

• requires significant time and expertise