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

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

Medicine

Research output: Contribution to journal › Article

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.

Original language	English (US)
Pages (from-to)	97-102
Number of pages	6
Journal	Journal of drugs in dermatology : JDD
Volume	15
Issue number	1
Publication status	Published - Jan 1 2016

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ASJC Scopus subject areas

Medicine(all)
Dermatology

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Cyrulnik, A. A., Gewirtzman, A. J., Blecher Paz, K., Glick, J. B., Anam, A. K., Carrasco, D. A., ... Cohen, S. R. (2016). iPLEDGE Weaknesses: Is It Time to Address the Flaws? Journal of drugs in dermatology : JDD, 15(1), 97-102.

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title = "iPLEDGE Weaknesses: Is It Time to Address the Flaws?",

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.",

author = "Cyrulnik, {Amanda A.} and Gewirtzman, {Aron J.} and {Blecher Paz}, Karin and Glick, {Jaimie B.} and Anam, {Anika K.} and Carrasco, {Daniel A.} and Shalita, {Alan R.} and Cohen, {Steven R.}",

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T2 - Is It Time to Address the Flaws?

AU - Cyrulnik, Amanda A.

AU - Gewirtzman, Aron J.

AU - Blecher Paz, Karin

AU - Glick, Jaimie B.

AU - Anam, Anika K.

AU - Carrasco, Daniel A.

AU - Shalita, Alan R.

AU - Cohen, Steven R.

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N2 - 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.

AB - 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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iPLEDGE Weaknesses: Is It Time to Address the Flaws?

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