What are the requirements for a clinician to become approved to prescribe isotretinoin (Accutane)?

From the Guidelines

To become approved to prescribe Accutane (isotretinoin), you must register with the iPLEDGE program, which is a mandatory risk management program designed to prevent pregnancy in patients taking this medication due to its severe teratogenic effects. First, create an account on the iPLEDGE website (www.ipledgeprogram.com) or call their system at 1-866-495-0654. You'll need your medical license number, DEA number, and NPI number during registration. After registering, you must complete the required training about the program's requirements and the medication's risks. Once approved, you'll receive a unique iPLEDGE number that you'll use when prescribing isotretinoin. As a prescriber, you'll be responsible for enrolling your patients in iPLEDGE, documenting two negative pregnancy tests before starting female patients of reproductive potential on the medication, ensuring monthly pregnancy testing, and verifying that patients understand the risks and contraception requirements. You'll need to enter required information into the iPLEDGE system each month before a patient can receive their prescription. This strict protocol exists because isotretinoin can cause severe birth defects if taken during pregnancy, with a risk approaching 100% if exposure occurs during critical developmental periods 1.

Some key points to consider when prescribing isotretinoin include:

• The medication is indicated for the treatment of severe recalcitrant nodulocystic acne, and is also appropriate for moderate acne that is treatment-resistant or produces physical scarring or significant psychosocial distress 1.
• The recommended dosing is 0.5-1 mg/kg/day orally in 2 divided doses with food, with a duration of dosing of 15-20 weeks 1.
• Contraindications include hypersensitivity to isotretinoin or any of its components, hypersensitivity to vitamin A, and pregnancy 1.
• Adverse effects and toxicities include cardiovascular, central nervous system, skin, endocrine, gastrointestinal, blood, hepatic, musculoskeletal, ocular, otic, and respiratory effects 1.
• Interactions with other medications, such as tetracyclines, vitamin A, methotrexate, contraceptives, and alcohol, should be considered 1.
• Baseline and ongoing monitoring, including liver function tests, pregnancy tests, and lipid panels, are necessary to minimize the risk of adverse effects 1.

It's essential to follow the iPLEDGE program's guidelines and recommendations to ensure the safe and effective use of isotretinoin, and to minimize the risk of adverse effects and birth defects 1.

From the FDA Drug Label

To prescribe isotretinoin, the prescriber must be enrolled and activated with the pregnancy risk management program iPLEDGE. Prescribers can enroll by signing and returning the completed enrollment form Prescribers can only activate their enrollment by affirming that they meet requirements and will comply with all iPLEDGE requirements by attesting to the following points: To prescribe isotretinoin, the prescriber must access the iPLEDGE system via the internet (www. ipledgeprogram. com) or telephone (1-866-495-0654) to: 1) Register each patient in the iPLEDGE REMS. 2) Confirm monthly that each patient has received counseling and education.

To become approved to prescribe Accutane (isotretinoin), a clinician must:

• Enroll in the iPLEDGE program by signing and returning the completed enrollment form
• Activate their enrollment by affirming that they meet the requirements and will comply with all iPLEDGE requirements
• Access the iPLEDGE system via the internet or telephone to register patients and confirm monthly counseling and education 2 Key steps include:
• Signing and returning the completed enrollment form
• Activating enrollment by attesting to the iPLEDGE requirements
• Accessing the iPLEDGE system to register patients and confirm counseling and education

From the Research

Becoming Approved to Prescribe Accutane

To become approved to prescribe Accutane (isotretinoin), clinicians should follow these steps:

• Familiarize themselves with the FDA guidelines and regulations for prescribing isotretinoin 3
• Complete any necessary training or certification programs for prescribing isotretinoin
• Register with the iPLEDGE program, a mandatory distribution program for isotretinoin, which requires clinicians to:
  • Register and obtain a unique identifier
  • Complete an online training module
  • Agree to follow the program's guidelines and protocols
• Meet with patients to discuss the benefits and risks of isotretinoin treatment, and to determine if it is an appropriate treatment option for their acne
• Monitor patients closely while they are taking isotretinoin, and report any adverse events or concerns to the iPLEDGE program 4

Important Considerations

When prescribing isotretinoin, clinicians should consider the following:

• The patient's medical history, including any allergies or sensitivities
• The patient's current medications, including any potential interactions with isotretinoin
• The patient's pregnancy status, as isotretinoin is contraindicated in pregnant women due to the risk of birth defects 5
• The patient's mental health status, as isotretinoin has been linked to an increased risk of depression and suicidal thoughts 3

Alternative Treatment Options

For patients who are not candidates for isotretinoin, or who prefer not to take it, alternative treatment options may include:

• Topical retinoids, such as tretinoin or adapalene
• Oral antibiotics, such as doxycycline or minocycline
• Hormonal therapies, such as combination oral contraception or spironolactone 6, 7
• Combination therapy, such as topical azelaic acid cream plus oral minocycline 5