iPledge for Accutane
Below is a MRR and PLR article in category Health Fitness -> subcategory Acne.
iPledge for Accutane
Introduction
iPledge is a computerized registry introduced to enhance the safety guidelines for patients taking Accutane (isotretinoin). Effective since March 31, 2006, it aims to prevent birth defects linked to the drug.
Overview
The FDA's Enhanced Measures
Accutane is a highly effective treatment for acne but comes with controversies, mainly due to its potential side effects. The most significant risk is that it can cause birth defects, making it unsuitable for women who might become pregnant.
iPledge: New Safety Protocols
To eliminate these risks, all patients, healthcare providers, and pharmacies involved in prescribing and dispensing Accutane must enroll in the iPLEDGE program, initiated on December 31, 2006.
- Patient Enrollment: All patients, male and female, must register in the iPLEDGE registry to access Accutane or its generic forms.
- Prescriber and Pharmacy Requirements: Doctors and pharmacists must also register to prescribe or dispense the medication. This ensures thorough oversight of the drug's distribution.
Specific Requirements for Women
Women have additional precautions imposed to prevent pregnancy while on Accutane:
1. Pregnancy Testing: Women must undergo laboratory or doctor-administered pregnancy tests before the initial prescription and monthly before each refill. Home tests are not accepted, and results must be logged into the iPLEDGE system. Purchases must be made within seven days of a negative test.
2. Contraceptive Measures: Women must commit to using two forms of birth control and self-register on the iPLEDGE system to confirm compliance. This step serves as an extra warning about the medication's dangers.
3. Pharmacy Verification: Pharmacists must check the database to ensure all safety protocols are followed before dispensing the medication.
Understanding the Scale
Approximately 100,000 Accutane prescriptions are filled monthly. Since its market introduction in 1982, there have been over 2,000 reported pregnancies among users, many resulting in abortion or miscarriage. However, over 160 babies have been born with defects attributed to the drug.
iPledge aims to drastically reduce these numbers by enforcing strict adherence to these safety measures.
You can find the original non-AI version of this article here: iPledge for Accutane.
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