From the Guidelines
Isotretinoin is the acne treatment that may only be prescribed by healthcare providers registered in the iPledge program. This oral retinoid medication is typically prescribed for severe, recalcitrant nodular acne that has not responded to other treatments. The iPledge program is a strict risk management program designed to prevent pregnancy during isotretinoin treatment due to the medication's severe teratogenic effects, which can cause serious birth defects, as noted in the guidelines of care for the management of acne vulgaris 1.
Key Points
- All patients, regardless of gender, must register in the iPledge program, but female patients of reproductive potential have additional requirements including monthly pregnancy tests and using two forms of effective contraception, as outlined in the guidelines 1.
- Providers must verify these requirements are met before each 30-day prescription can be filled, ensuring compliance with the iPledge program's strict regulations 1.
- Isotretinoin works by reducing sebum production, decreasing inflammation, normalizing skin cell shedding, and inhibiting the growth of acne-causing bacteria, as described in the prescribing information for isotretinoin 1.
- A typical treatment course lasts 15-20 weeks with dosing based on body weight, and patients require regular monitoring for potential side effects including dry skin, lips, and eyes, as well as potential liver function changes and lipid level alterations, as recommended in the guidelines 1.
Monitoring and Side Effects
- Regular monitoring of liver function tests, serum cholesterol, and triglycerides at baseline and again until response to treatment is established is recommended, as noted in the guidelines of care for the management of acne vulgaris 1.
- Patients should be educated about the potential risks with isotretinoin, including inflammatory bowel disease and depressive symptoms, and monitored for any indication of these conditions, as advised in the approaches to limit systemic antibiotic use in acne 1.
Conclusion is not allowed, so the answer will be ended here.
From the FDA Drug Label
Isotretinoin must only be prescribed by prescribers who are enrolled and activated with the iPLEDGE REMS. The answer is d. isotretinoin 2.
- The iPledge program is a requirement for prescribing isotretinoin.
- Isotretinoin is the only acne treatment mentioned that has this requirement.
- Providers must be registered in the iPledge program to prescribe isotretinoin.
From the Research
Acne Treatment and the iPledge Program
The iPledge program is a restricted distribution program that regulates the use of certain acne treatments due to their potential to cause birth defects.
- The program requires providers to be registered in order to prescribe these treatments.
- One such treatment is isotretinoin, which is a highly efficacious medication for the treatment of acne vulgaris 3, 4, 5, 6, 7.
Isotretinoin and the iPledge Program
Isotretinoin is a teratogen that can cause profound birth defects, and its distribution is regulated by the iPledge program in the United States.
- The program requires female patients capable of becoming pregnant to use two forms of contraception or commit to abstinence while using this therapy 5.
- Recent changes to the iPledge platform have made isotretinoin virtually inaccessible for many patients, highlighting the need for alternative treatments 4, 7.
Answer to the Question
Based on the evidence, the correct answer is: d. isotretinoin