Drug project: Difference between revisions

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:  '''4.1.7'''   If the information for certain section is lacking, insert the following statement:
:  '''4.1.7'''   If the information for certain section is lacking, insert the following statement:


:::    '''''FDA Package Insert for (Drug) contains no information regarding (section).'''''
:::    '''''FDA Package Insert for (Drug) contains no information regarding (Section).'''''


====4.2 Quality Checking the Drug Chapters====
====4.2 Quality Checking the Drug Chapters====

Revision as of 21:30, 11 March 2014

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]


    By signing this agreement, I hereby acknowledge that I have read, understand,    

    and will abide by the terms of this document pertaining to the WikiDoc Drug Project.    


    PRINT NAME      __________________________________________________________


    SIGNATURE     ___________________________________________________________


    DATE (MM/DD/YYYY)     ____________________________________________________



Step 0. Formatting Basics

0.1 Pasting as Plain Text

  0.1.1   Pasting as plain text must be done by Ctrl+Shift+V in Windows OS (or Cmd+Shift+Opt+V in Mac OS).
  0.1.2   DO NOT USE CTRL+V (OR CMD+V in Mac OS) TO PASTE.

0.2 Removing Extra Line Spaces

  0.2.1   Phantom line spaces generated during copy-pasting commonly appear between paragraphs and at the top. Remove extra line spaces before moving onto the next page.

0.3 Inserting Images for Tables, Graphs, and Packages

  0.3.1   The width of inserted images should be 600px unless otherwise indicated.
  0.3.2   Use the following wikicode:
{|
| [[File:NAMEOFTHEIMAGE01.png|thumb|600px]]
|}


Step 1. Selecting Appropriate FDA Package Inserts

1.1 Generic Names, Trade Names, and Formulations

  1.1.1   Check the generic name, trade names, and formulations of the drug from both DailyMed and Drugs@FDA.
  1.1.2   Confirm the presence of Original Packager label of each available formulation (solution/tablet/spray) from DailyMed.
  1.1.3   Select the earliest available Original Packager label. Avoid using Repackager labels.
  1.1.4   Include all trade names in {{SB}} and make proper redirections.
  1.1.5   Put Patient Information link in the line between {{CMG}} and {{SB}}.
  1.1.6   Take Clopidogrel as an example:
   Clopidogrel is the generic name.
   Plavix is the trade name.
   The earliest available Original Packager label is this.
   Redirect Plavix to the Clopidogrel main page.

1.2 When More Than One Formuation Exists

  1.2.1   Confirm the presence of Patient Information pages for different formulations on WikiDoc.
  1.2.2   Visit MedlinePlus, if necessary, to collect data for Patient Information.


Step 2. Drug Template

2.1 Creating the Drug Template

  2.1.1   Search Template:(generic name of the drug, capitalize the first letter) in the search field. (For example, Template:Clopidogrel)
  2.1.2   Click on Create the page "Template:(generic name of the drug)" on this wiki!   which leads to an empty page.
  2.1.3   Go to Example Drug Template.
  2.1.4   Copy the code from the template and paste it back to the new drug template.
  2.1.5   Replace the generic and trade names in the template you've created.
  2.1.6   DO NOT REPLACE EXAMPLE DRUG TEMPLATE.

2.2 Quality Checking the Drug Template

  2.2.1   Fix any misspelling, punctuation error, or malfunctioning link.
  2.2.2   In case of multiple formulations, the links to chapters should start with the Trade names rather than the generic name.
  2.2.3   Refer to Sumatriptan as an example of a drug with multiple formulations.


Step 3. Drug Homepage

3.1 Creating/Amending the Drug Homepage

  3.1.1   Go to Example Drug Homepage.
  3.1.2   Copy the code from the example drug homepage and paste it back to the drug homepage.
  3.1.3   Replace the generic and trade names in the template you've created.
  3.1.4   DO NOT REPLACE EXAMPLE DRUG HOMEPAGE.
  3.1.5   Accommodate preexisting contents, if any, to the standard format.
  3.1.6   DO NOT REMOVE WORKS DONE BY PREVIOUS EDITORS.

3.2 Taking Alcohol with Medication

  3.2.1   Search the term Alcohol in the Package Insert on DailyMed.
  3.2.2   Place the information relating to combined alcohol use under the heading of Taking Alcohol with (Drug).
  3.2.3   If this information is lacking, insert the following statement:
   Alcohol-(Drug) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

3.3 Boxed Warning

  3.3.1   Boxed warning information must be placed under the heading of FDA Package Insert on the drug homepage.
  3.3.2   Use the following wikicode:
<font color="#F8F8FF">
{| style="border: 3px solid #696969;" align="center"
| style="background: #000000; border: 0px; padding: 0 5px; width: 800px;" |


<center>
'''BOXED WARNING'''
</center>

<center>
''See full prescribing information for complete boxed warning.''
</center>


<b>
* Item 1

* Item 2

* Item 3
</b>


|}
</font>


  3.3.3   For instance, boxed warning alert for Prasugrel will appear as:



WARNING: BLEEDING RISK

See full prescribing information for complete boxed warning.


  • Effient can cause significant, sometimes fatal, bleeding.
  • Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke.
  • In patients ≥75 years of age, Effient is generally not recommended, except in high-risk patients (diabetes or prior MI), where its use may be considered.
  • Do not start Effient in patients likely to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Effient at least 7 days prior to any surgery.
  • Additional risk factors for bleeding include: body weight <60 kg; propensity to bleed; concomitant use of medications that increase the risk of bleeding.
  • Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of Effient.
  • If possible, manage bleeding without discontinuing Effient. Stopping Effient increases the risk of subsequent cardiovascular events.



3.4 Quality Checking the Drug Homepage

  3.4.1   Headings must be arranged in proper order (Overview, Category, FDA Package Insert, Taking Alcohol with (Drug), etc).
  3.4.2   Apply appropriate categories at the bottom of the page (eg, [[Category:Cardiovascular Drugs]] and [[Category:Drugs]]).
  3.4.3   Fix any misspelling, punctuation error, or malfunctioning link.


Step 4. Drug Chapters

4.1 Creating the Drug Chapters

  4.1.1   Go to Example Drug Chapter.
  4.1.2   Copy the code from the example drug homepage and paste it back to a drug chapter.
  4.1.3   Obtain the url of the drug label from DailyMed.
  4.1.4   Create the reference wikicode and paste it back to the drug chapter.
  4.1.5   DO NOT REPLACE EXAMPLE DRUG CHAPTER.
  4.1.6   Apply appropriate categories at the bottom of the page (eg, [[Category:Cardiovascular Drugs]] and [[Category:Drugs]]).
  4.1.7   If the information for certain section is lacking, insert the following statement:
   FDA Package Insert for (Drug) contains no information regarding (Section).

4.2 Quality Checking the Drug Chapters

  4.2.1   Fix any misspelling, punctuation error, or malfunctioning link.
  4.2.2   Make sure all uploaded pictures are appearing.
  4.2.3   Remove extra line spaces and punctuation mistakes at the authorship field of each page.

Step 5. Completion

5.1 Fix all the errors before announcing the completion.

5.2 Update the status in the progress spreadsheet.

5.3 Submit the pages for peer-review and request for unlocking the next drug.