IPLEDGE

Infobox Website
name = iPLEDGE



caption =
url = https://www.ipledgeprogram.com/
commercial = no
type = Regulatory/Government
language =
registration =
owner = Food and Drug Administration
author =
launch date = 2005
current status =
revenue =

The iPLEDGE program is a mandatory distribution program in the United States for isotretinoin (commonly sold under the trade names Accutane, Amneesteen, Claravis or Sotret), intended to prevent the use of the drug during pregnancy due to the high risk of birth defects ("see Teratogenicity of isoretinoin"). As of March 1, 2006, patients and their doctors and pharmacists are required by the US Food and Drug Administration to register and use a web site in order to receive this medication.

Process

The program is intended to work as follows: first, the doctor prescribing the drug enters patient information on the iPLEDGE website.The stated goal is to prevent female patients "of childbearing potential" from receiving the drug if they are pregnant, and to prevent them from becoming pregnant if they are taking the drug.

Some Canadian pharmacies will honor US prescriptions, thus providing an alternate source of isotretinoin if US patients are unable to obtain it through FDA-approved procedures.

Recently the iPLEDGE program has been relaxed for males and women of non-childbearing age. Doctors can issue prescriptions a few days early if appointments do not happen to line-up with the 30 day window. A lost or unfilled prescription can also be rewritten within 30 days. Mandatory patient counseling and reporting in the online system is still required for all patients.

Criticisms

Criticisms of the iPLEDGE program include the following:

Difficulty of compliance

The time and expense of compliance with iPLEDGE is significant, and may pose a barrier to treatment if doctors do not wish to expend the effort required.

In the RxDerm dermatology user group, a physician said, "It will be easier to get a firearm, an abortion or thalidomide, than to obtain this safe and important medication." He went on to say that this program requires the pharmacist, the physician, and the patient to get online, answer personal and sensitive questions about the patients' sexual practices, urine tests, and menstrual cycles to a faceless governmental confessor, all according to a very tight schedule, just so that a patient may have her acne treated. If any of the numerous requirements are not met, the drug cannot be dispensed and further activity for the patient is delayed for 30 days."

For many patients, the iPLEDGE program has caused delays in receiving isotretinoin. Doctors may not prescribe more than a 30 day supply. A new prescription may not be written for at least 30 days. Pharmacies are also under similar restriction. No more than a 30 day supply may be filled. There is also a 7 day window in which the medication must be picked up at the pharmacy; if the prescription has not been filled within the 7th day of the doctor handing the patient the prescription, it is then voided and can not be filled/sold. If the original prescription is lost, or pick-up window is missed, the patient must wait 30 days without any medication. Doctors and pharmacists must also verify written prescriptions in an online system before patients may fill the prescription. This sequence of requirements can make it very difficult for patients to receive and take isotretinoin on the prescribed schedule. Many patients are forced to wait several days without medication.

Privacy

Some patients complain of the requirements of the iPLEDGE program and say patients must choose between privacy or treatment. Some requirements of the program include regular blood testing every thirty days and regular pregnancy tests every thirty days. Another issue is that of a potential breach in patient/doctor confidentiality. Compliance to the program requires a participating physician to reveal many aspects of a patient's sexual history including STDs, when a patient is registered into the program.

Medicare part D

Another criticism is that pharmacists are already taxed with compliance with Medicare Part D.

Criticisms of the iPLEDGE website

Some criticisms of the iPLEDGE website include the website provides no information about who administers the site or how patients' private information is secured. Another criticism is that a website is not an effective pregnancy prevention program.

The program was mandated by the FDA despite criticism from practicing medical doctors that its cumbersome nature would make the drug unavailable to deserving patients. In practice, the website has presented many problems to physicians; once information is entered, it can be difficult or impossible to change or correct it. If there is an error, the patient is locked out for 30 days and cannot receive the medication. Problems are common and take days to correct. Technical assistance by phone is available via a toll free number. The iPLEDGE presumes that the woman will not be honest about her sexual activities by requiring the pregnancy test; but at the same time assumes she will by the pledge be trustworthy to either use contraceptives or not engage in sex.

Although the goal of the program is to prevent pregnancies, male patients must also use the same program even though the questions and "Pledge" are geared towards females. This includes promising that they will not get pregnant as part of the iPLEDGE questioning. There has been no link to birth defects from Accutane associated with males using the drug, though male sexual dysfunction has been linked to the drug: Erectile dysfunction in the form of difficulty in maintaining erection was reported in several patients in a clinical study. The impotence may have been caused by the psychiatric side effects of isotretinoin. [cite journal | author = Tirado Sánchez A | coauthors = León Dorantes G. | year = 2005 | month = Nov-Dec | title = [Erectile dysfunction during isotretinoin therapy] | journal = Actas urologicas españolas. | volume = 29 | issue = 10 | pages = 974-6 | pmid = 16447596 ] Despite this, sexual dysfunction is not acknowledged as a side-effect in the official literature accompanying the medication.
http://www.ncbi.nlm.nih.gov/pubmed/16447596

References

External links

* [https://www.ipledgeprogram.com/ ipledgeprogram.com] The official iPledge program web site.
* [http://www.fda.gov/bbs/topics/NEWS/2005/NEW01218.html FDA press release] about the program
* [http://www.cdc.gov/ncbddd/bd/accutane.htm Information from the CDC] CDC and the March of Dimes [http://www.marchofdimes.com/professionals/14332_1168.asp] about Accutane and birth defects
* [http://www.medscape.com/viewarticle/525664 Medscape Medical News] , "Dermatologists Frustrated With Problematic iPledge Program", AAD 64th Annual Meeting. Focus session, March 6, 2006