Wikipedia:WikiProject Medicine/Good Practice Procedure task force

Welcome to the Good Practice Procedure task force of Medicine.

Scope
This procedure describes a best-practice approach to updating Wikipedia articles about prescription medicines. It does not cover medicine classes, disease information or healthcare topics in general, although the principles could be applied to other types of articles.

In developing this procedure we have focused on the English language version of Wikipedia, although the process could apply equally well to other language versions.

Assumptions

 * 1) Wikipedia is a global encyclopaedia.  The different language versions are language-specific but not country-specific.  So for example the English, Spanish and French language versions are not specific to England, Spain and France, but rather they are global resources presented in those languages.  This is an important distinction when considering articles about medicines because a given drug may be licensed for different conditions in different countries.  The Wikipedia article should be written from a global point of view, so that it covers all countries and relevant licences known by the editor at the time of writing.
 * 2) Wikipedia is for everyone – there is no specific target audience.  As such, an article should be based on factual information where at least the introductory text can be understood by the general public.
 * 3) Wikipedia’s standards do not allow for promotion or advertising within articles.  The content of an article about a medicine consists of factual information that must be supported by other credible reference sources.
 * 4) If the procedure and standards outlined in this document are followed, we do not consider that creating or updating medicine articles can be considered as ‘promotion of prescription medicines to the public’.  Wikipedia is an encyclopaedia, is global and, by its own standards, articles must not contain promotion.
 * 5) This procedure does not advocate creating country-specific articles or making ‘product claims’ or using promotional language about medicine.  If you choose to do this, it is outside this procedure.
 * 6) It is up to individual regulators, authorities and companies to determine whether a specific article is in breach of any national or international rules.  We, as authors of this procedure, do not take responsibility for the articles created or updated by others who choose to follow it.  The content of a Wikipedia edit is the responsibility of the editor concerned.

Information for editors
For a good quality result, editors should undertake the following activities when creating or updating Wikipedia medicine articles:


 * 1) Research
 * 2) Writing and creating content
 * 3) Checking content for accuracy
 * 4) Content uploading
 * 5) Update annotation

These activities may be performed by one or several individuals. All individuals involved should have a user profile on Wikipedia and be identified as associated with the article in a number of ways:


 * 1) Always include a note in the 'edit summary' field of any update which automatically updates the history page including a link to their user profile
 * 2) On the article Talk page listing all contributors, giving a concise description of the role of each contribution
 * 3) On their Talk page and/or on a ‘My work’ page linked from user profile with:
 * a list of all articles they have been involved in
 * the involvement of other contributors
 * clarification if updating on behalf of an organisation

Editors may be interested in joining the WikiProject Medicine and the Wikipedia Pharmacology Group. Editors must adhere to The Five Pillars of Wikipedia and all Wikipedia Policies Wikipedia Policies.

Payment for updates
Wikipedia does not currently prevent editors being paid for article updates, nor does it prevent editors updating articles where there is a potential conflict of interest. Where an editor is being paid to update Wikipedia, the editor must ensure they carefully follow the guidance at Wikipedia Conflict of Interest and Wikipedia’s Neutral Point of View policy. For more information and guidance on this see Wikipedia Conflicts of Interest (Medicine).

The procedures outlined here follow all these policies and guidance. In particular, they require that the conflict of interest is declared and the editor(s) of an article is(are) identified.

In addition, the following applies where an organisation or individual (the Funding Body) pays for an update:


 * 1) The Funding Body has a page on Wikipedia
 * 2) The Funding Body is identified by a note in the edit summary of any update with a link to their page
 * 3) The Funding Body has a list on their Talk page (or ‘My work’ page) of the contributions to Wikipedia entries they have funded

Procedures
The WP:MGPP consists of 3 procedures which can be used independently or combined:


 * 1) Medicine article creation: the initial creation of a medicine article
 * 2) Medicine article update: one-off review and update/review of an existing medicine article
 * 3) Medicine article monitoring: ongoing review of existing medicine article within a specified time frame

Medicine article creation
This process is for the initial creation of a medicine article. Recommendation: a medicine article should be created when a drug compound enters Phase III trials and is therefore likely to become known to the general public.


 * 1) The editor conducts research using appropriate resources, taking guidance from the Wikipedia article Reliable_sources_(medicine-related_articles)*
 * 2) The editor creates a parent article titled with the generic medicine name, ensuring that it is structured in line with the Manual of Style for Medicine-Related Articles
 * 3) The editor should include an InfoBox containing drug summary information.  A template for this can be found on Wikipedia at Template:Drugbox
 * 4) The editor writes the content and adds citations/references, ensuring the standards of  Neutral Point of View, Notability and Recentism are followed
 * 5) The content is checked for accuracy and completeness
 * 6) The editor uploads the content to Wikipedia while ‘logged in’; therefore, any articles the editor has updated are clearly identifiable as having been uploaded by the editor
 * 7) The editor adds a comment on the Talk/Discussion page of the article noting and linking to the Wikipedia page/articles for:
 * 8) user ids of any additional contributors
 * 9) any funding providers
 * 10) the fact that this procedure has been followed
 * 11) The editor updates their Talk page and/or ‘My work’ page indicating they have contributed to this article

As per Wikipedia’s guidance, the focus should be on secondary sources (eg review publications, product prescribing information, international clinical guidelines) and avoiding where possible primary sources (eg company press releases, clinical trial databases, primary manuscripts). This will help avoid concerns about Recentism and ensure the article reflects current opinion.

Medicine article update
This process is for one-off review and update/review of an existing medicine article. This may be combined with the process for continued monitoring of the article.


 * 1) The editor checks and, where necessary, updates an existing medicine article, ensuring that it is structured in line with the Manual of Style for Medicine-Related Articles
 * 2) The editor conducts research using appropriate resources taking guidance from the Wikipedia: Reliable Sources for Medicine Articles, with a focus on secondary sources as detailed above
 * 3) The editor makes the following changes (with appropriate citations)
 * 4) Adds missing information
 * 5) Corrects inaccurate information
 * 6) Removes vandalism, irrelevant content or spam, according to the guidance in Wikipedia: Content Removal
 * 7) If content without citation is found, the following procedure applies:
 * 8) The editor seeks substantiation from appropriate sources – see Wikipedia: Reliable Sources for Medicine Articles
 * 9) If a credible source is found, a citation is added to the information
 * 10) If a credible source is not found, a ‘Request to Improve’ Template will be placed in the relevant section
 * 11) If a citation is not added within 4 weeks, the editor chooses from the following options: Option 1: If the editor believes the content to be factually correct, the Request to Improve Template is left in place. Option 2: If the editor believes the content to be factually incorrect, the content is removed
 * 12) The editor amends the content while ‘logged in’; therefore, any articles the editor has updated are clearly identifiable as having been changed by the editor
 * 13) If it is not present, the editor should add an InfoBox containing drug summary information.  A template for this can be found on Wikipedia at Template:Drugbox
 * 14) The editor adds a comment on the Talk/Discussion page of the article noting and linking to the Wikipedia page/articles for:
 * 15) user ids of any additional contributors
 * 16) any funding sources
 * 17) the fact that this procedure has been followed
 * 18) The editor updates their Talk page and/or ‘My work’ page indicating they have contributed to this article

Medicine article monitoring
This process is for ongoing review of existing medicine article within a specified time frame. Recommendation: If an editor has created or updated an article, the editor should monitor it to ensure the content remains accurate and complete.


 * 1) The editor updates the Talk page for the article, indicating the period of monitoring and any rationale for monitoring (eg known vandalism)
 * 2) The editor then watches the page WP:WATCH
 * 3) If any changes are made, the editor follows the procedure for Medicine Article Update

Special considerations
Special considerations when medicine articles or medicine article updates are funded by the pharmaceutical industry.

The Wikipedia Manual of Style for Medicine-Related Articles Wikipedia:MED, which editors using this procedure should follow, includes sections called Legal status and Research which are likely to include content that may be considered ‘off-label’ by the pharmaceutical industry and its regulators.

The industry is not permitted to promote ‘off-label’ or unlicensed/unapproved uses of its medicines (Companies are not generally prohibited from providing non-promotional information about such uses; however, many companies err on the side of extreme caution and choose not to mention unlicensed uses in any context).

The problem for users of Wikipedia is that Wikipedia is about fact, and it is a fact that some drugs are used for purposes other than that for which they are licensed.

Some examples of this include:


 * Drug A, licensed for condition X, may be extensively used ‘off-label’ to treat condition Y
 * Drug A, while licensed for healthcare condition X, might be under investigation in clinical trials as a potential treatment for healthcare condition Y
 * Drug A may be used for illegal recreational purpose Z

All of these facts may be well reported and citable, but a pharmaceutical company may not want to be associated with communicating them because doing so may be interpreted as ‘promoting off-label use’ and breaching industry guidelines.

In these cases, and if the editor is being funded by a pharmaceutical company, even assuming the pharmaceutical company does not influence the edited content, it is prudent to follow this procedure for content in the ‘Legal’ or ‘Research’ sections of the article or any content elsewhere in the article that may appear to be referring to ‘off-label’ usage.

In an existing article that the editor is updating:


 * If there is an unlicensed ‘off-label’ usage reference without any citation, delete it. If it is subsequently re-instated by another editor and you are monitoring the article, follow the procedure for unsubstantiated information in the ‘updating a medicine article’ section
 * If there is an ‘off-label’ usage reference with a reliable citation, note in the edit notes that this reference pre-existed the sponsored edit, and leave it in place
 * Add a comment to the Talk page for the article explaining the situation and the pre-existence of the information. It may be appropriate to insert a reference to the licensed usage of the drug immediately after the ‘off-label’ reference in the main article to aid clarity.

Whether updating or creating an article, the editor funded by the pharmaceutical industry should follow these guidelines with regard to unlicensed references:


 * Do not add any ‘off-label’ references relating to current use of the medicine. This may mean that you are not including all the information you have, but it is incumbent on you to work within the regulations of the industry that you are funded by, even if editing independently
 * It is acceptable to refer to clinical trials investigating new indications, provided the reference is well cited with at least two notable sources, with at least one reference in the public domain. If in doubt about the notability of the information, the editor should omit it. The editor may wish to add a comment in the Talk page saying why the clinical trial information is notable enough to be included.
 * In the introductory paragraph for the article and again in the Legal and Research sections the editor should refer to the approved use of the product and if appropriate add references linking to the ‘patient leaflet’ or ‘fast text’ for the drug in major countries.

Note: Disclaimers
All articles are subject to the Wikipedia Medicine Disclaimer Wikipedia : Medicine Disclaimer, so the editor should not add a disclaimer to the article or attempt to give advice or address healthcare professionals or patients directly in any way. Refer to MEDMOS for details.