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.

pregnancies in females taking isotretinoin and to prevent pregnant females from taking isotretinoin," iPLEDGE "monitors all prescriptions and dispensed doses of the medication." As this monitoring requires significant effort by various parties (physician, office staff, patient, and pharmacist), simple improvements could be incorporated into the system design that would directly benefit patient care. Moreover, an important question still remains: why are men and post-menopausal women required to abide by the rules of iPLEDGE when the stated goal is to prevent teratogenic exposures in pregnancy? Perhaps excluding these patients from iPLEDGE would significantly decrease the burden on all involved parties and encourage more patients and providers to use isotretinoin.
In addition to removing the requirements on non-childbearing patients, we suggest when a patient is "lost to follow-up" and re-registered, or when a patient repeats a course of therapy, that all previous data of dispensed isotretinoin remain accessible to the provider and not hidden. Moreover, reporting the number of days for which isotretinoin is prescribed would have much greater utility if the actual dose of drug and number of pills dispensed were recorded and available. Since isotretinoin is generally prescribed with a cumulative dose target in mind, access to this extra data would create a built-in resource to corroborate information documented in the medical chart, should a question arise during a patient encounter. These changes would help not only to ensure medical record accuracy, but also would be especially useful for the patient who changes practitioners during or following a course of isotretinoin. The transfer of medical records between physicians is frequently suboptimal, and these enhancements would serve to minimize unnecessary challenges.
Another avenue of improved documentation likely rests on the complete transition from paper charts to an EMR. Though it stands to reason that the lower discrepancy rate at the Austin site is predominantly due to an electronic charting system, further studies are needed to assess the accuracy of electronic versus paper charts. It would be interesting to compare the health records of private practices utilizing paper charts versus those with EMR, as well as academic centers utilizing both types of health records.
Has iPLEDGE accomplished its ultimate goal of pregnancy prevention? Perhaps the most widely quoted study concluded neither the iPLEDGE program nor any of the previous RMPs have decreased the rate of fetal exposures to isotretinoin in females of childbearing potential.8 Yet it seems a virtual certainty that iPLEDGE or a future RMP will be required for prescribing isotretinoin, and therefore its utility should be optimized. Notwithstanding its current flaws, iPLEDGE has the potential to improve patient outcomes by functioning as a complete database. This would undoubtedly enhance provider effectiveness in dealing with the challenges of both isotretinoin and iPLEDGE.

DISCLOSURES

The authors have no conflict of interests to declare.

REFERENCES

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AUTHOR CORRESPONDENCE

Steven R. Cohen MD MPHsteven.cohen@aya.yale.edu
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