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Multicenter Study
. 2016 Jan;15(1):97-102.

iPLEDGE Weaknesses: Is It Time to Address the Flaws?

Amanda A Cyrulnik, Aron J Gewirtzman, Karin Blecher Paz, Jaimie B Glick, Anika K Anam, Daniel A Carrasco, Alan R Shalita, Steven R Cohen
  • PMID: 26741387
Multicenter Study

iPLEDGE Weaknesses: Is It Time to Address the Flaws?

Amanda A Cyrulnik et al. J Drugs Dermatol. 2016 Jan.

Abstract

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.

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