Talk:IPLEDGE program

Early discussions

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)

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)

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)

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)

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)

Male & Female program?

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)

I'm taking the medication right now, am male, and I did sign up for the program, but don't need to do much in it. I don't need to answer the questions every month or do the urine samples, but I do have an iPLEDGE card. - Bill3000 22:04, 30 August 2006 (UTC)

I'm also on the medication and a male. I have to have blood work done monthly, and I still have to follow the 30 days/7-day window garbage. I don't have to answer questions or anything, though, I just have to swear not to share my drugs, which, of course I wouldn't becuase I want the treatment.

I'm also on the program as a male. We just don't have to do their questions/urine tests, but we do have to have bloodwork every month and complete the initial questionaire to get into iPledge, swear not to share the drug(not that I would, as said above, I want the damned treatment!), not to get anyone pregnant, etc.

I am also on the medication and am male. There is the bloodwork, initial questionnaire, not sharing, etc. as mentioned above. Though in contrast to what's mentioned above, nowhere does it state the medication affects male reproduction, so that a male could cause pregnancy without any adverse consequences caused by the medication. The card is a necessity to get the prescription filled, and getting the medication filled in strictly regulated(you cannot get it filled even a day earlier than 30 days from the previous filling, etc.), which can be very cumbersome when trying to schedule appointments. Smeggysmeg 16:51, 28 September 2006 (UTC)

Article needs work

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)

Revamp

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)

"Males pledging not to get pregnant"

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)

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)

First, let me make the observation that sarcasm such as that above is notably noncontributory toward our supposed goal of improving articles. That said -- when iPledge was first introduced, many of us (dermatologists) asked why it was necessary to enroll male patients at all, given that the stated goal of the registry was to prevent pregnancy. The answer we received was that they didn't want men stockpiling isotretinoin and giving it to their girlfriends. We then asked how enrolling men in the registry was going to prevent that -- and received no answer. DoctorJoeE ^{talk to me!} 18:55, 5 December 2011 (UTC)

How long does Isotretinoin stay in the body?

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)

That is probably because there is no definitive consensus on the answer. The FDA has so far studiously avoided making an "official" recommendation. Isotretinoin is water soluble, and so leaves the body quickly, at least in theory. (It is undetectable in the bloodstream 48 hours after the last dose is taken.) Furthermore, it affects embryogenesis, and not chromosomes, so once it's gone it's no longer a threat -- again, at least in theory. While some have speculated about retention in the liver and elsewhere, there is no credible evidence to support it that I'm aware of. Recommendations for how long to wait after completing isotretinoin treatment before attempting pregnancy vary all over the map -- from one menstrual period to a year or more. I personally believe that one menstrual period is sufficient, but I recommend three, out of an abundance of caution (or perhaps cowardice). So if anything were to be added to the article in this regard, I would suggest something similar to the above, i.e. one month to one year, depending on who you talk to -- and I'm sure there are citations to support that. DoctorJoeE ^{review transgressions}/_{talk to me!} 21:48, 26 February 2015 (UTC)

FDA meddling with this article?

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)

Who operates the site, and HIPAA and governmental privacy considerations

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)