iPLEDGE Weaknesses: Is It Time to Address the Flaws?

January 2016 | Volume 15 | Issue 1 | Original Article | 97 | Copyright © January 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.

table 1
During a recent study of isotretinoin usage,7 we observed substantive discrepancies between patient charts and iPLEDGE documentation, leading us to formally examine congruence of these two entities. It is noteworthy that all published literature on iPLEDGE centers around its efficacy on pregnancy prevention or the obstacles providers face when attempting to use the system in clinical practice.2,3,6,8,9 iPLEDGE has never been formally evaluated as an accurate information systems database.

METHODS

Study Design and Sample

A retrospective chart review of all patients registered in iPLEDGE by the primary investigators was completed between January 2006 and November 2010 (N=553). The study population was derived from a multi-dermatologist, multi-institution investigation, involving both academic tertiary care centers (Albert Einstein College of Medicine, Bronx, NY, and SUNY Downstate Medical Center, Brooklyn, NY) and a private practice dermatology office (Austin Dermatology Associates, Austin, TX). Patients who registered but never received a single dose of isotretinoin were excluded from the sample (N=161). An additional 35 patients were eliminated due to chart deficiencies, resulting in a final sample size of 357 patients.
Data collected from the chart review included: age, gender, ethnicity, history of prior isotretinoin treatment, presence of isotretinoin restart(s) [a period where a patient has become "lost to follow-up," locked out of the iPLEDGE system, and requires re-registration in order resume therapy], treatment length, and the number and dates of office visits during the course of treatment. Data collected from iPLEDGE included: number and dates of dispensed isotretinoin. Congruence between documentation in the chart and that recorded in iPLEDGE was evaluated. Discrepancies were stratified into iPLEDGE misses or additions based on data from the chart. A "miss" was defined as a documented patient visit and prescription for isotretinoin in the medical chart without a corresponding record in iPLEDGE. Moreover, the subsequent
Close Menu