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I have submitted basic information about iPLEDGE. Philiphughesmd 18:25, 6 March 2006 (UTC) I have edited it to make it more "neutral." Philiphughesmd 04:03, 7 March 2006 (UTC)[reply]
As a parent of a child that takes accutane and a victim of the iPLEDGE nightmare I vouch for the authors neutrality. He had much nicer things to say about iPLEDGE then I do. Eric Pedersen, parent. tisabooks@hotmail.com
This article is not biased! The iPLEDGE program is a disaster according to the American Academy of Dermatology. Philiphughesmd 03:49, 12 April 2006 (UTC)[reply]
While I do not necessarily support iPLEDGE (indeed, there are huge failures to the system), this article could include information about the purpose of the program, including information about the birth defects caused by accutane, the discussion leading up to the program and its governing body, and the rationalization for a governing system, while avoiding incendiary language such as "requirements to get it are intrusive, bewildering, and byzantine!" or unsubstantiated claims such as "waits "on hold" of easily 2 hours or more." Customer and dermatologist complaints notwithstanding, an obstetrician may yet say that the program is far from a disaster. I say that this article is still far from neutral. -hedge, 03:54, 19 April 2006 (UTC)
As an 18 year old participant of the iPLEDGE system, I wholeheartedly agree with this author's take on the program. Not only is this a neutral article, but a correct one. I am an extremely punctual, conscientious, and responsible person, and I have had two skip 2 months of my treatment just because of glitches and errors in this ridiculous system full of short windows of time and endless authorizational processes. This medication is changing my life - I have been on antibiotics for more than a decade, and the freedom that this gives me is beyond words. The iPLEDGE system is archaic and abusive, and needs to be removed. Anyone who thinks otherwise has clearly not had an acne problem. abateman@wisc.edu
I've completely revamped the article to make it largely NPOV, while adding relevant links, keeping all the present criticisms, and adding a few of my own. The previous version of the article was loaded with vitriolic terms and didn't really tell me what iPLEDGE was or why it was instituted. Reading the actual website makes it clear that it was badly implemented. One thing this article still needs is an actual linked quote from a named physician, the paragraph with the RxDerm reference is still presented as hearsay (though it may well be true). User:keno 19:58, 27 April 2006 (UTC)[reply]
Speaking as a pharmacist, this program was started in response to an easier program that used "qualification stickers" and had time restrictions, but was dependent on the prescriber to screen for pregnancy and counsel on the risk of birth defects. The risk of birth defects with isotretinoin is real, severe, and has happened several times. The ipledge program was created to better prevent pregnancies while people where taking isotretinoin, and was only created after the failure of the previous system. Furthermore, the use of isotretinoin for routine acne cases and not necessarily its FDA indication of "severe recalcitrant nodular acne" further exacerbates the problem of pregnancy during use. The system was also created in order to stop the down-playing of the risks that was commonly done by prescribers (cf. http://www.medscape.com/viewarticle/514558) On the pharmacy end, we only receive authorization to fill a prescription, entering only the patient's ID number and date of birth- so we don't have any knowledge of any further private information that other editors have complained about. While i certainly understand the hassle this whole system causes (we've had several patients who had to either go back to the doctor or go without for a month) it comes down to the fact that the prescriber is responsible for meeting the prescribing requirements, just as they are for any drug. If patients are having a problem with a particular doctor entering the information in a timely manner, they should perhaps consider switching to another office who is more proficient/efficient/experienced with isotretinoin prescribing and the federal requirements for the drug. The requirements are only stricter for this particular drug due to safety concerns, and the alternative for this system would be a complete withdrawal of isotretinoin from the marketplace--something that patients, prescribers, and manufacturers didn't want to see. --Edge79mi 04:26, 17 September 2006 (UTC)[reply]
I'd be interested in seeing something regarding the Bush administration's anti-abortion stance. Speaking as the partner of a woman who uses isotretinoin and being familiar with the faulty rationality behind the iPLEDGE program it's really not too difficult to see that it is not intended to better prevent pregnancies, as suggested above, but rather to better prevent abortions which would result from pregnancies by women who are using the drug. When you read the documentation associated with iPLEDGE and follow the patient's procedures for compliance it's easy to see this as a thinly veiled attempt at anti-abortion legislation by invading a woman's privacy and attemptiong to keep a very short leash on her sexual practices. If that's not the case then it's possibly just some of the worse legislation ever written. That is also the opinion of, at least, several prescribing doctors. foresme 00:22, 15 May 2007 (UTC)[reply]
From reading the article it seems like the program is mostly geared at women, and it is unclear if only women must sign up for the program? Is that the case? Myrockstar 11:32, 17 July 2006 (UTC)[reply]
At the moment, the article seems to be little more than a list of problems (however significant) with the program, moreso than a source of information on the program/website, and background history explaining its purpose and methods. --NEMT 20:50, 30 November 2006 (UTC)[reply]
I've added a new section that explains the project's previous incarnation and background, thus providing some continuity as to why it takes the current (restrictive) form it does. I added four new refs and some inlines where appropriate, but I'm still hacking on them. I'm having major issues with the whole Criticism section, because it's quite POV and completely unreferenced except for a non-critical source at the bottom. I'll see if I can't chase up some of these sources, but I'd like to go pruning on some of the most POV stuff. Bullzeye contribs 11:02, 7 February 2009 (UTC)[reply]
Is it technically possible for a male to get pregnant? Are they referring to 'trans'-men? 93.161.104.154 (talk) 14:24, 25 October 2009 (UTC)[reply]
I'm not sure if you were kidding or not, but in case you weren't, please note that males cannot become pregnant. Also, please note that if you're a male, even if you think you're a female, you still cannot become pregnant. It just won't happen. I do not have a source for this, but I've heard you need specialized organs to be able to become pregnant. They're making males pledge to not get pregnant because they don't want to make a separate questionnaire just for the males, assuming that it's obvious what they mean by it. Also note that most of the problems (if not ALL of the problems) are occurring in women anyways. I'm not familiar with the program nowadays, or if they've changed the questionnaires. Boonshofter 18:44, 5 December 2011 (UTC) — Preceding unsigned comment added by Boonshofter (talk • contribs)
How soon after one stops taking it is it safe to become pregnant again? This was not mentioned in the article. — Preceding unsigned comment added by Luvdalz68 (talk • contribs) 07:43, 26 February 2015 (UTC)[reply]
These sounds like something the FDA has written:
Due to the nature of restricted distribution programs in general, and ETASU REMS programs specifically, stakeholder burden has always been balanced against control and compliance.
The duality of prescribers' feelings about isotretinoin can be seen in the two paragraphs below, and also explain why the burden associated with the Program is warranted, given the risks to patient/fetal safety. — Preceding unsigned comment added by Rosskey711 (talk • contribs) 21:41, 17 October 2015 (UTC)[reply]
It seems a bit unclear who (i.e. what organization) is receiving and storing the information that is being provided to the site, and it seems odd to have a mandatory program that requires information to be provided, without what seems to be the usual HIPAA and federal privacy assurances and without a clear identification of who the information is being provided to. The article says that one of the criticisms of the iPLEDGE website is that "the website provides no information about who administers the site". I have confirmed that I am having some difficulty finding a clear identification of who operates the site on the website itself.
Looking at the "Terms of Use" (ToU) of the website, it seems to be phrased as an agreement between "you" and "the sponsors of the Site". I don't know whether it is really possible to have a binding contract with an unidentified party. Somewhere else in the ToU, it refers to "the companies that sponsor iPLEDGE (i.e., the manufacturers)", so perhaps "the sponsors of the Site" and presumably the administration of the site are in the hands of some group of (not clearly identified) drug manufacturers.
However, the ToU says "iPLEDGE uses your identifiable personal information to ...", so it is referring to iPLEDGE as a distinct entity. It also says that "Before information is reported to the companies that sponsor iPLEDGE (i.e., the manufacturers) or the FDA, your personal identifying information is removed." That seems to imply that "iPLEDGE" is an entity that appears to be distinct from "the companies that sponsor iPLEDGE (i.e., the manufacturers)" and is also distinct from "the FDA".
If the program is operated by the federal government, I believe there are some regulations about the need for the government to provide a privacy notice when requesting personal information. I also don't find any mention of HIPAA anywhere.
I also find a "Non-Compliance Action Policy", which is an 18-page PDF document. But the document does not seem to clearly identify who issued the document. It has no letterhead or signature. In a few places in that document, there is a mention of the "Isotretinoin Products Manufacturing Group (IPMG)". Perhaps that is the name of the entity.
—BarrelProof (talk) 19:45, 6 March 2018 (UTC)[reply]