Simply defined, iPledge is a patient safety program for patients on or intending to take isotretinoin and it is designed to prevent harm from coming to unborn children of pregnant women, as well as other potential harmful side effects if not monitored by your provider. In technical terms, it is a REMS (Risk Evaluation and Mitigation Strategy) program implemented through the FDA.
iPledge requires certain actions to be taken by providers, pharmacies, and drug manufacturers. This ensures that people taking the medication are fully aware of potential risks. We at Big Country think of this as your patient safety team.
The iPledge program is solely designed as a REMS for isotretinoin, which is a prescription medication primarily used for treating severe acne. One side effect of taking this drug during pregnancy is that it can cause birth defects and health issues. Therefore, the purpose of this program is to prevent pregnancy during treatment in anyone taking isotretinoin.
Isotretinoin is also known by many other branded names such as: Accutane, Absorica, Amnesteem, Claravis, Myorisan, and Zenatane.
Why does iPledge matter?
Because isotretinoin is known to cause birth defects, it should not be taken by pregnant women. There is also an increased risk of complications such as preterm birth or miscarriage. Women often do not know that they are pregnant for the first 3-8 weeks which is why preventative measures are crucial.
The use of isotretinoin can lead to the following birth defects:
- Abnormal looking ears, including small or absent ear canals
- An abnormally shaped skull
- Cleft palate
- Facial disfigurements
- Eye abnormalities
For those who are pregnant, using isotretinoin might lead to severe and life-threatening internal problems in the baby such as severe damage to the brain, heart issues, severe intellectual disability, inability to talk, move, walk, breath, speak and possibly think. For that reason, iPledge is designed to prevent pregnancy in those taking isotretinoin.
How does iPledge work?
The program tracks all isotretinoin transactions. This program is targeted toward patients, pharmacies, providers, and wholesalers. There is no exceptions to the iPledge guidelines.
Before providers can prescribe isotretinoin, they must have registered under the iPledge program and activated their status in the iPledge system. Pharmacies must also be registered in the iPledge system before they can obtain the medication isotretinoin or dispense it, the same goes for wholesalers. Providers, pharmacies, and wholesalers are not the only ones that register, but also patients, whether or not they have childbearing potential. Males are also registered in the iPledge system. There is no age restriction or gender restriction for iPledge.
Aside from preventing harm in unborn children, the most common side effects that are monitored are depression, joint pain, and high cholesterol levels that can be caused by the medication.
An appointment is scheduled every month with a provider for patients on isotretinoin. During the visit, they are counseled on birth defects and adverse psychiatric events among other things. Monthly visits are confirmed by the dermatologists. In the case of women with childbearing potential, they are also required to initially obtain a negative diagnostic pregnancy test and then also get a negative confirmation pregnancy test before their monthly meeting. As well as practice iPledge approved pregnancy prevention methods.
For females with child-bearing potential, before the pharmacy can dispense the medication, the patient must have contraceptive counseling, a negative pregnancy test and log into iPledge and pass the quiz on “iPledge program basics” before getting the green light to obtain their monthly supply of isotretinoin. The patient will have a 7 day window which begins and includes the day they take their pregnancy test.
Once the child-bearing potential female completes her therapy in the iPledge program and before getting pregnant, she has to conduct a pregnancy test from a reputable laboratory to confirm she did not become pregnant within the 30 days after taking the last isotretinoin pill. At this point, the patient is safe to become pregnant.
How does Big Country adhere to it?
ClaRx adheres to the strict guidelines of iPledge and works to communicate with our patients and providers to ensure everyone is on the same page. For females with the potential of becoming pregnant, they only have a 7 day window to obtain their medication. The window starts on the day the pregnancy test is taken.
As this prescription process is much more complex than an average prescription we take steps to ensure consistent service.
Our Isotretinoin Guarantee is: If a patient misses their iPledge window and it is the pharmacies fault, we will pay for their repeat lab work, provider visit, and medication. We do this because the last thing a patient or provider wants is to have to start the process over because the patient was not able to receive their prescription within the time frame.
We do this by reaching out to our patients using both phone calls, and text messages. If we do not hear back from the patient we will follow up with the patients provider to see if they have any other means to contact the patient.
We also deliver isotretinoin via fed-ex ground for free to expedite the process further.
The iPledge program is important for patients, pharmacies, and physicians. They must register through the iPledge program and activate their status.
In conclusion, iPledge is a REMS program which regulates the prescription of isotretinoin through pharmacies and providers, patients, manufacturers, and wholesalers. And claRx is giving its best to guarantee total adherence to iPledge with complete patient satisfaction.