Talk:Pharmacovigilance

Wiki Education Foundation-supported course assignment
This article is or was the subject of a Wiki Education Foundation-supported course assignment. Further details are available on the course page. Student editor(s): Yohler.

Above undated message substituted from Template:Dashboard.wikiedu.org assignment by PrimeBOT (talk) 06:31, 17 January 2022 (UTC)

why the removal of the link on the pharmacoviglance article?
Sorry - a bit new here. The link was under the external links page and was to a tool that does pharmacovigilance. I am not sure why it was removed? I checked the help/faqs and it didn't look like it was innapropriate. Thomrossi 12:52, 13 August 2006 (UTC)


 * The link was to www.cartesiansoftware.com a commercial site that offers the services of a small company with a very limited scope, they are essentially selling one software. This company is one among thousands of companies offering similar services, and among tens of thousands of companies working in the field of pharmacovigilance. I see no reason to give them such a huge importance in a general article on pharmacovigilance.


 * The same applies to the link to DrugLogic, which was even in the wrong place ("See Also" insted of "External References"). (Jiankabe 15:30, 13 September 2006 (UTC))

Removed external links
I removed a number of external websites from this article; please discuss here before adding links, even those accompanied by valuable trademark symbols. Flowanda | Talk 08:46, 27 March 2008 (UTC)

Signal Detection references move here, as being primary refs...
…that are not truly, validly germane to the section's subjects. These two references are primary references that cite concepts in their introductions and discussions that are relevant to this section. But it is the secondary sources that those introductions rely on that are needed here (not, per WP, primary sources, esp. when those sources are minimally conceptually relevant, and when much better sources on the subject exist).

I would also note that there seems to be an abundance of references from the Indian literature, when these are only a small part of the broad international literature on this subject, and this needs to be considered when citations are re-added to this and other sections. Relocated citations are below. LeProf 50.179.245.225 (talk) 23:55, 25 March 2014 (UTC)


 * Gavali D., Kulkarni K.S., Kumar A., Chakraborty B.S. (2009). Therapeutic Class Specific Signal Detection of Bradycardia Associated with Propranolol Hydrochloride. Ind J Pharmacol, 41, 162-166


 * Singhal S., Chakraborty B.S. (2012). Signal Detection of Docetaxel in Canadian Spontaneous Adverse Event Reports. Journal of Pharmacy Research, 5, 1-6

Beginning of a list of possible new secondary (review) sources for Signal Detection section...
…that are either up-to-date and in highest quality sources, or that have been in the literature for a time and are highly cited. Use of these, or similar, will allow the earlier included two specific case study citations to be dispensed with. LeProf 50.179.245.225 (talk) 04:21, 26 March 2014 (UTC)


 * K Haerian, D Varn, S Vaidya, L Ena, HS Chase and C Friedman, 2012, Detection of Pharmacovigilance-Related Adverse Events Using Electronic Health Records and Automated Methods, Clinical Pharmacology & Therapeutics, 92(2), 228–234. [doi:10.1038/clpt.2012.54, http://www.nature.com/clpt/journal/v92/n2/abs/clpt201254a.html]


 * G Trifiro, A Pariente, PM Coloma, JA Kors, G Polimeni, G Miremont-Salame, MA Catania, F Salvo, A David, N Moore, AP Caputi, M Sturkenboom, M Molokhia, J Hippisley-Cox, C Diaz Acedo, J van der Lei, and A Fourrier-Reglat, on behalf of the EU-ADR group, 2009, Data mining on electronic health record databases for signal detection in pharmacovigilance: which events to monitor, Pharmacoepidemiology and Drug Safety, 18: 1176–1184 [DOI: 10.1002/pds.1836, http://scholar.google.com/scholar_url?hl=en&q=http://www.researchgate.net/publication/26815205_Data_mining_on_electronic_health_record_databases_for_signal_detection_in_pharmacovigilance_which_events_to_monitor/file/9fcfd50a557dd3266c.pdf&sa=X&scisig=AAGBfm1I0PbyK0EadFfeepUZhq-Wto1ZJA&oi=scholarr]


 * RHB Meyboom, ACG Egberts, IR Edwards, YA Hekster, FHP de Koning, FWJ Gribnau, 1997, Principles of Signal Detection in Pharmacovigilance, Drug Safety 16(6):355-365.

EPV section (preponderance of sci lit steers away from pharmacoenvironmentology
The earlier section on Pharmacoenvironmentology was modified when a critical reference was identified in a reliable, verifiable source making clear that this title term was synonymous with a much more broadly used set of terms, including the most widely cited, ecopharmacology (EPV). I therefore merged the earlier paragraph concept with the more widely equivalent literature concept of EPV, providing necessary references and more thorough subject content. LeProf 50.179.245.225 (talk) 05:31, 26 March 2014 (UTC)

Plagiarised sentence removed (Latin America subsection)
While fixing a dead citation link, I looked to improve the content of this subsection (whose content differed from parallel related subsections). In so doing I discovered that the appended sentence—removed and transferred here from the article—appears verbatim in the source cited for the sentence. That is, it was taken from the source, directly, and without paraphrase, and is used without indication that it is a quotation (and is therefore plagiarism). It is removed both for the plagiarism, and for its limited relevance to the content intended for these subsection (indication of regulatory agencies responsible for PV in various countries).

"Most Latin American countries have high or medium levels of regulatory pharmacovigilance requirements, in line with international standards."

LeProf Leprof 7272 (talk) 14:49, 28 March 2014 (UTC)

Regulatory agency list being restructured...
…to make it more consistent (e.g., Spain is currently covered twice, by EU and by a specific country heading), and to create sections for other major geographic areas. Areas are still ordered alphabetically, though smaller individual countries are groups in one section (to make less glaring the fact that many, many individual countries are missing). LeProf Leprof 7272 (talk) 15:22, 28 March 2014 (UTC)

Two sections restructured
The section on regulatory agencies was restructured, to remove redundancy (e.g., Spain heretofore was covered twice, standalone and under EU), and to group countries by geography-plus-pharma-economy. By doing the latter, guidance is provided to individuals that want to add further country regulatory agencies, and the the list's continuing to grow in one-sentence subsections with each country addition will be avoided. In addition this change identifies important gaps in content, where regulation in individual important economies has to date been shortshrifted. ''For instance, under the EU, information appears for Spain (redacted from even more voluminous earlier material), but no information appears on the UK (because there was no information on this unique EU-affiliate in the earlier article version). Moreover, there is no current information on the preeminent and critically important market of China, with its distinct drug (and so PV) regulatory apparatus,'' matters along with other gaps that should be rectified.

The section on international cooperation was reordered, in terms of primacy of the agencies. Earlier, a subordinate component of the WHO was listed before the WHO itself, a smaller professional society was listed before the WHO, etc. At the same time, the full names of the organizations are given in the subsection titles, to better define content and guide readers to the content in which they are interested.

LeProf Leprof 7272 (talk) 17:01, 28 March 2014 (UTC)


 * To meet this glaring gap, one line has been added regarding China, as a stub for further material. 50.179.245.225 (talk) 01:25, 29 March 2014 (UTC)

Section annotated as needing attention
The section on pharmacovigilance for herbal medicines was annotated as being especially in need of attention, as it is currently a series of vague and largely unsupported statements on the title subject. LeProf Leprof 7272 (talk) 17:26, 28 March 2014 (UTC)

SERIOUS QUESTION RAISED ABOUT SOURCE(S) OF LARGE BLOCKS OF THIS MATERIAL
Per WP, material on the sciences that is not common knowledge must be accompanied by a verifiable source. Very large swaths of this article appear without citations, and those that have citations are often to very large documents where precise location of the derived material is poorly specified. Cases in point are readily apparent; begin with the opening list of definitions, which appears without a single citation, and proceed to skim the reference list to see how many citations are naked URLs (most often without access date), documents cited as a whole (without page numbers), etc. Note, refs. 24-38 were added in today's editing, and are largely an exception to this incomplete/vague referencing observation; but nearly every other earlier citation is nearly useless in assigning a sentence to its actual source.

This is a serious breach in WP as it pertains to the verifiability of information. In an academic setting, the assumption would have to be one of blatant, extensive plagiarism—and I am not sure why it should be different here. The information contained seems derived from *.gov, WHO, CDC, and related documents, and appears reasonable. Regardless, it has to be verifiable, so tags were added, and I will return in 6 mos. to see that the content begins to meet WPs in terms of verifiability. It is better to have a short, well-referenced article than to have a long, complex article devoid of traceable citations. As in any regulatory area, facts change, and having the original document full of untraceable material makes its continuing editing to keep it up-to-date a near impossibility. LeProf Leprof 7272 (talk) 17:37, 28 March 2014 (UTC)


 * To accentuate and add emphasis to this issue, the content of an earlier version of the Wikipedia article has itself been lifted and appears part and parcel in a SlideShare set of "published" slides (without attribution to Wikipedia). See: http://www.slideshare.net/pharmagaurav/pharmacovigilance-31374417?qid=02fe2f76-795d-4674-89e5-beb2bcfb0b04&v=qf1&b=&from_search=2 (accessed March 28, 2014).  50.179.245.225 (talk) 01:29, 29 March 2014 (UTC)

Is Pharmacovigillance equal to Post Marketing Surveillance?
If they are same, why not to redirect one article to other? And if they are different, what is the exact difference? I am also asking this question at the talk page of article of Post Marketing Surveillance. Thanks in advance. --Abhijeet Safai (talk) 13:42, 1 April 2015 (UTC)

External links modified
Hello fellow Wikipedians,

I have just added archive links to 2 one external links on Pharmacovigilance. Please take a moment to review my edit. If necessary, add after the link to keep me from modifying it. Alternatively, you can add to keep me off the page altogether. I made the following changes:
 * Added archive https://web.archive.org/20101110015452/http://www.ich.org/cache/compo/475-272-1.html to http://www.ich.org/cache/compo/475-272-1.html
 * Added archive https://web.archive.org/20100823124028/http://estri.ich.org:80/new-icsr/index.htm to http://estri.ich.org/new-icsr/index.htm

When you have finished reviewing my changes, please set the checked parameter below to true to let others know.

Cheers.—cyberbot II  Talk to my owner :Online 17:41, 9 January 2016 (UTC)