iPLEDGE Weaknesses: Is It Time to Address the Flaws?
January 2016 | Volume 15 | Issue 1 | Original Article | 97 | Copyright © 2016
Amanda A. Cyrulnik MD,a,b,* Aron J. Gewirtzman MD,a,c,* Karin Blecher Paz MD,a Jaimie B. Glick MD,b
Anika K. Anam MD,b Daniel A. Carrasco MD,c Alan R. Shalita MD,b and Steven R. Cohen MD MPHa
a Unified Division of Dermatology of Albert Einstein College of Medicine, Bronx, NY
b SUNY Downstate Department of Dermatology, Brooklyn, NY
c Austin Dermatology Associates, Austin, TX
* These authors contributed equally to the preparation of this manuscript.
BACKGROUND: The observance during acne follow-ups that information stored within iPLEDGE was discordant with medical charts prompted this study.
OBJECTIVE: To evaluate the information acquired and stored within iPLEDGE as it compares to medical charts with a goal of assessing the efficacy of iPLEDGE as a database.
METHODS: This is a multicenter retrospective chart review analyzing congruence and discrepancies between medical chart documentation and iPLEDGE data for all patients who received at least a single dose of isotretinoin from the primary investigators between January 2006 and November 2010.
RESULTS: A total of 357 charts were analyzed. Overall congruence between medical chart documentation and iPLEDGE data was observed in only 73.1% of cases. The discrepancy (N=96) was due to a missed dose (prescription recorded in chart but not in iPLEDGE) in 81.4% of cases, or an addition (medication dispensed per iPLEDGE without corresponding chart documentation) in the remainder of cases. Of note, several charts had multiple discrepancies (N=249 total discrepancies).
LIMITATIONS: Retrospective chart review study.
CONCLUSION: Given the large percentage of discordant data, our findings question the efficacy of the iPLEDGE system, which is designed to monitor every dispensed isotretinoin dose.
J Drugs Dermatol. 2016;15(1):97-102.
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Since its approval by the Food and Drug Administration (FDA) in 1982, Accutane (isotretinoin) has been contraindicated during pregnancy due to its known teratogenicity in animals.1 Unfortunately, despite a designated "Category X" drug label, reports of fetal exposure and resulting birth defects ensued, forcing the FDA and Accutane's manufacturer, Hoffman La-Roche, to devise a series of risk management programs (RMP) to heighten awareness about fetal malformation and to minimize the number of pregnancies during treatment.1,2 With each new RMP, including the Pregnancy Prevention Program (PPP) and System to Manage Accutane-Related Teratogenicity (SMART), additional requirements were placed on both the physician and patient, making the prescription of isotretinoin more rigorous and burdensome (Table 1).
In February 2004, the Drug Safety and Risk Management and Dermatologic and Ophthalmic Advisory Committees created iPLEDGE in order to reduce fetal exposure to isotretinoin and monitor the prescribing, dispensing, and distribution of all isotretinoin brands.3 The main goals of iPLEDGE are to prevent pregnancies in females taking isotretinoin and to prevent pregnant females from taking isotretinoin.4 Using a performance-linked access system, the responsibility for achieving these goals are distributed among patients, physicians, pharmacies, manufacturers, and wholesalers, all of whom are required to register with iPLEDGE online or by telephone. 1,2,5 As a result of the increasing demands placed on the physician, many dermatologists viewed iPLEDGE as an assault on their freedom to practice medicine, and believed that the isotretinoin registry would hinder their patients' access to this drug and breed select "isotretinologists."5
Despite these concerns, iPLEDGE became mandatory on March 1, 2006. Many greeted the web-based system with frustration as faulty program databases and glitches, coupled with inadequate telephone support, resulted in lengthy wait times and registration delays.2,6 However, dermatologists continued to register with iPLEDGE despite these administrative burdens as there was no alternative way to legally prescribe isotretinoin in the United States.5
Successful use of iPLEDGE requires substantial coordination. Only after the web-based system verifies that physician and patient are compliant with all iPLEDGE requirements are pharmacists allowed to dispense the drug.2,4