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 |
| State | Published - Jan 1 2016 |
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ASJC Scopus subject areas
- Medicine(all)
- Dermatology
Cite this
iPLEDGE Weaknesses : Is It Time to Address the Flaws? / Cyrulnik, Amanda A.; Gewirtzman, Aron J.; Blecher Paz, Karin; Glick, Jaimie B.; Anam, Anika K.; Carrasco, Daniel A.; Shalita, Alan R.; Cohen, Steven R.
In: Journal of drugs in dermatology : JDD, Vol. 15, No. 1, 01.01.2016, p. 97-102.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - iPLEDGE Weaknesses
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.
PY - 2016/1/1
Y1 - 2016/1/1
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.
UR - http://www.scopus.com/inward/record.url?scp=85020320341&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85020320341&partnerID=8YFLogxK
M3 - Article
C2 - 26741387
AN - SCOPUS:85020320341
VL - 15
SP - 97
EP - 102
JO - Journal of Drugs in Dermatology
JF - Journal of Drugs in Dermatology
SN - 1545-9616
IS - 1
ER -