Talk:Drug recall

Editing Plan
As one of the two students editing this article, I plan on talking about the history of prevalent drug recalls, specifically in the United States. I will also be adding an introduction on drug recalls, discussing the different classes and what they mean for the drug. Here is a link to my sandbox and what I have done thus far: https://en.wikipedia.org/wiki/User:Laheide/sandbox I will update the talk page once I upload my edits. Laheide (talk) 00:49, 17 March 2016 (UTC)

Editing Plans
As an assignment for the University of Michigan, myself and another student hope to add important information to the Drug Recall page. I plan to add what the timeline and steps of a drug recall would look like for the firm recalling the drug. I am also looking at trends in drug recalls, such as more OTC drugs being recalled than prescription or a certain pharmaceutical company recalling more than others. Lastly, I would like to include a brief summary of any important/substantial changes in governmental policy due to a drug recall. The proposed changes are available to preview in my sandbox: https://en.wikipedia.org/wiki/User:MorganGroendyke/sandbox MorganGroendyke (talk) 00:48, 17 March 2016 (UTC)MorganGroendyke

Peer Review
Drug recall Peer Review- Emma Heiden[edit] This group did an impressive job of turning a one-sentence stub into a comprehensive article that explains different classes of drug recalls, an example of a particular drug recall, reasons for drug recalls, 3 key steps in recalling a drug, and a few government policies that have influenced the way drugs can be recalled. While the editors were only given a limited window, I think the Wikipedia community could really benefit from more information on changes in policy, as well as more examples of famous recalls. First and foremost, the article does correspond to the Wiki standards in terms of language, content, bias and sources. The introductory section is definitely accessible for non-experts. I might suggest starting with a brief explanation, though, of why the FDA has the authority to control which drugs are recalled. It also might be helpful to introduce the hazards that follow if the recall is not taken seriously, so that amateur readers realize the importance of continuing to read. Most contents of each section justify their length, although the section header called “Changes in Government Policy” seems a tad broad compared to its very brief content. I would suggest, if possible, adding more information on policies before 1997 and between 1997 and 2015. For instance, I read online that the FDA launched an additional pilot program for notification of recalls in 2011. While FDA, various drugs, and various conditions are hyperlinked to additional Wikipedia pages, hyperlinks would also be helpful for OTC and the 21st Century Cures Act, for further reference. The highlighted example of Diethylstilbestrol (DES) is helpful and does a good job of showing the crucial importance of recalls in protecting generations of safety. Also, the content overall does not appear to be duplicative of any other content already on Wikipedia. The figure of drug recalls by class seems like original work, and provides a great visual of how drug recalls have rapidly increased in just the last 10 years. It is also helpful in interpreting the three types of classes introduced earlier on in the article. If anything, I might move this visual up in the article and make it larger instead of a thumbnail image! That said, the references are complete and well-rounded. I cross-referenced their mentioned references, and was able to find all the data featured in the article in the proper sources. Since this article was originally only a stub, the editors did a great job of creating a systematic structure and adding relevant details based on only one original sentence. The group’s edits somewhat relate to the drug discovery aspect of the class, as one of the large risks of developing a new drug may be the threat of recall if the drug causes more side effects than anticipated.

"Drug recall" Peer Review by Ariel Dellinger[edit] First and foremost, I am extremely surprised at the lack of information present in the original, one-sentence existing Wikipedia stub. Given that drug recall can be a very convoluted subject, I believe that this group did an outstanding job basically creating a new page that detailed removal of prescription and over-the-counter drugs from the market. The introductory section is brief, yet outlines the main types of class recalls by the FDA, but differentiates it from market withdrawals and medical device safety alerts. Although drug recall is different from withdrawal and alerts, if it is placed in the Wikipedia page, I believe there should be some external link or other Wikipedia page that addresses those ideas. It just feels a little out of place without further information. Also, I think the introduction could benefit why it is the FDA’s duty to recall drugs, as well as the frequency by which these drugs are reviewed. Furthermore, I think that the introduction should specify that this specific page applies only to the United States, unless it is planned on including information regarding the European counterpart. The article might also benefit from the addition of 3 more examples of a drug that was recalled, to give an example of recall class I, recall class II, recall class III, and Market withdrawal. In general, the wording of the article is unbiased, clear, and properly cited. The structure is clear, and its length appropriately justifies each heading. The only one I would consider expanding would be further changes in government policy, as there has to be more than two government policies related to drug recall throughout the 1900s. Each term and concept, like the FDA and the FDA Modernization Act of 1997, are linked appropriately to additional Wikipedia pages, but there are other ideas like medical safety withdrawals in the introduction and Effectiveness Check under Compliance & Reporting that could use external links to further explain those ideas. There are no content duplications, and this page does an impressive job of not overlapping information with the Contamination control and List of withdrawn drugs Wikipedia pages. The figure of Drug Recalls by class is easy to read, and is useful in comparing the total number of recalled drugs by class and by year. My only comment for that would be that if a legislature passed in 1997 is used, the years should go back that far as well. It does add a great visual to enhance the importance of the legislature passed in 2015. As for the references, the two that I cross-referenced were properly cited and extremely relevant to the topic. Although only 12 references are used, they are each used extensively throughout the article and come from unbiased and scientific sources. Overall, this group should be proud of the work that they put into creating this Wikipedia page, and their effort shows in the different headings, proper citations, and unbiased writing. They did a good job at taking an unaddressed and valuable topic, and providing basic knowledge for non-expert readers like myself. Minor additions could enhance the completion of this article, but the Wikipedia community will benefit from the addition of this page.

Ajdellinger (talk) —Preceding undated comment added 22:06, 25 March 2016 (UTC)

Suggestions from ChemLibrarian[edit] I agree with your peer classmates that you did a very great job in expanding this originally one-sentence article. Here are a few suggestions.

Although these is only one sentence in the current article, there had been a few attempts in the past to add to the article. Most of them were deleted for reasons like direct copy/paste from other sites or commercial links. Take a look at the editing history page to make sure you don't repeat any mistakes before. For example, under the Reasons for Drug Recall section, your list of classifications copy/pasted from the FDA site will probably be deleted since it's direct copy/paste and can be detected by machine. I understand that these are definitions from the organization but try to re-phrase them or summarize them as you did in the Lead section. There is no need to simply repeat the FDA site. Instead, summarize and illustrate each category with examples as your peers suggested would be better. It's great that you plotted the historical data on the count of the recalled drug. But I don't see you cite the source of the data. Please do that in the caption of the figure and also add that to the image page on Wikimedia Commons. Without the source of the data, people would not know if they should trust the figure. You can find more details on how to place and re-size your image and captions at Wikipedia:Picture tutorial. One more suggestion on the figure is to reverse the order of the years (to 2004 on the left). The History of Drug Recall section is a bit thin. And the tone of this sentence "The purpose of this section is to highlight significant drug recalls, specifically in the United States." needs to be improved. Something like" Some significant drug recalls, specifically in the United States, are highlighted here to illustrate the history of drug recall in the U.S. " In fact, if you are not going to write a summary of Drug recall history, I would just call this section "Highlighted Examples of Drug Recall in the U.S." and put it as the last section. I noticed that you are starting each second level sections with the sentence "The purpose of...". I understand it's probably good for your working process. But please revise them in your final draft since it doesn't fit the encyclopedia tone. You have the "nowiki" tag around your Reference and reflist syntax at the end and that's why they are showing as the syntax rather than the formatted bibliography. Very good job with the reference formatting. But reference 9 is an Wikipedia page. So, it should be referred to as an internal link. e.g. Food and Drug Administration Modernization Act of 1997 using the " " syntax in the texts instead of inserting a reference. You did that in the sub-heading. I think there is no need to cite it again. The "Changes in Government Policy" may fit better under the History section as a sub-section.

Thanks for the good work! ChemLibrarian (talk) 21:12, 29 March 2016 (UTC)

Drug recall Peer Review- Instructor[edit] 1) Content

A) Is the introductory section accessible for non-experts?

Partly, you should start by talking what drug recalls are, not by classifying them (i.e. first define the term).

B) Do the contents of each section justify its length?

Yes

C) Are all the important terms/concepts linked to their respective Wikipedia pages for further references?

Yes, although a link to the page of “list of withdrawn drugs” should be made as it is highly relevant to the current article

D) Are the highlighted examples appropriate?

“Reasons for Drug Recall” and “Recall Process” sections are well done; however, other sections are underdeveloped. For example, the “Changes in Government Policy” describes policies that are not directly dealing with “Drug Recall”. Out of the top of my head, there was “Childhood Vaccine Act” (1986) that is more relevant to the article.

The “History of Drug Recall” starts with 1971 “DES case”; however, there were some earlier cases. Either provide an overview in the historical context or discuss main milestones here. DES was not the first drug, “Mrs. Winslow’s Soothing Syrup” was denounced by the American Medical Association yet in 1912 (Sherley Amendment).

E) Is the content duplicative of any other content already on Wikipedia?

No

2) Figures

A) Are the figures original and of high quality?

Yes

B) Are the figures informative and add to the text?

The Figure can be more informative if you provide the following information: 1) Title: say that it is US drug recall that you are talking about 2) Title should include reference to the source the data is taken from

C) Are the substance and/or protein structures chemically accurate, aligned, and easy to read? N/A

3) References

A) Are the references complete?

Yes

B) Are the references inclusive of non-journal sources?

Yes

4) Overall Presentation

Overall, this article is in the spirit of the course assignment, and the group did a decent job in identifying the sources and contributing some sections such as “Reasons for Drug Recall” and “Recall Process” sections. At the same time, “Introduction” and other sections are underdeveloped and should be modified.

Response to Peer Review
Author Response - Lauren Heide[edit] Thank you to everyone who offered their feedback and advice for our article. We've taken your critiques into account and have made the following changes. The introduction was expanded to include a more precise definition of drug recalls, as well as external links to learn more about market recalls and safety alerts. The History section was modified to only highlight a few significant cases of drug recalls in the US, and features a disclaimer about its intended content with a link to a list of drug recalls on Wikipedia. Another example of a drug recall was added by the advice of out instructor. Sections using the phrase "The purpose of this section..." were edited to remove or modify the phrase. Small errors with citations were corrected. Laheide (talk) 20:56, 3 April 2016 (UTC)

Author Response - Morgan Groendyke[edit] "Thank you to everyone who offered their feedback and advice for our article. We've taken your critiques into account and have made the following changes. The introduction was expanded to include a more precise definition of drug recalls, as well as external links to learn more about market recalls and safety alerts. The History section was modified to only highlight a few significant cases of drug recalls in the US, and features a disclaimer about its intended content with a link to a list of drug recalls on Wikipedia. Another example of a drug recall was added by the advice of out instructor. Sections using the phrase "The purpose of this section..." were edited to remove or modify the phrase. Small errors with citations were corrected." - Lauren Heide

As Lauren said, we appreciate all of the genuine feedback we received. The introduction now includes a definition of drug recalls. Overall, more external links were added to the page. Any links that were suggested that we didn't include did not exist as a wikipedia page. It was reiterated that we should explain why the FDA has the authority to recall drugs, but we think that is apparent enough without saying since they are part of the US Federal governing body and specialize in food and drugs. As for Changes in Gov't Policy, we've specified that these are US policies only. I think the two current examples are relevant because they both have made it easier for drugs to pass clinical trials which will inevitably lead to more recalls. I've added the Childhood Vaccine Injury Act of 1986 as per our professor's suggestion. I did not add a suggested 2011 pilot program because it is not an official policy change. It was suggested that Gov't Policy Changes should be a subsection of History, but we renamed history so that advice is no longer applicable. I regraphed the figure to move chronologically along the x-axis. It is now more centered, larger, accurately titled, and cited. There weren't any critiques on the Recall Process, except that Drug Type did not fit under the heading. I left it there because the drug type can either complicate or aid in the recall process, as stated in the article. In the Reasons for Drug Recall, the definitions of recall classes were quoted directly from the FDA instead of paraphrased, so I removed them. Lauren had already defined them in her own terms in the introduction, so I referenced those. As Lauren addressed, minor citation errors were corrected.

Thank you all for your advice!

MorganGroendyke (talk) 06:34, 5 April 2016 (UTC)MorganGroendyke

Additional Review
Additional suggestions[edit] You may want to make it clear that this article is US focused in the Lead section. For example, adding "In the United States, " between the first sentence and second sentence. Please add a data source to your plot in the caption and also on the source page on Wikimedia commons. It will help people to justify if they should trust the data you presented in the figure. The last few sections could use more links to other Wikipedia articles. Even if there is no Wikipedia article existing, you can still add the. It will be shown as red and others may be inspired to create them. ChemLibrarian (talk) 17:25, 7 April 2016 (UTC)

Final Post
Our improvement plans were outlined in our first post on the talk page. Since we were starting from scratch, we decided the "why," "how," and some examples were most important. We wanted to cover a lot of material, but make sure we were covering it in depth enough. In deciding what was needed: a more complete introduction, reason drugs are recalled, the process of recalling a drug from the FDA’s perspective, examples of drugs that have been recalled, and changes in government policies that affect recalls. After our presentation: we hyperlinked more terms, made it clearer that the article is more US focused, and added a source to the Wikimedia commons image. The image was also captioned. Please let us know any comments, questions, or concerns you may have with the edits we've made. We've worked very hard to use valuable, credible information and stay within Wikipedia's Five Pillars and style. Thanks for reading!

MorganGroendyke (talk) 22:54, 17 April 2016 (UTC)MorganGroendyke