Original articleThe impact of the iPLEDGE program on isotretinoin fetal exposure in an integrated health care system
Section snippets
Methods
This study was conducted at KPSC and KPNC. Kaiser Permanente is a nonprofit, managed care organization that provides integrated health care services to more than 6 million members in California. The linked patient databases available at KPSC and KPNC were used as the primary data source. The database contains patient-level information on pharmacy prescription records, laboratory results, and outpatient and inpatient procedure and diagnosis codes. All patient information is linked by a distinct
Results
Between March 1, 2004, and February 29, 2008, a total of 8344 FCBP received 9912 treatment courses of isotretinoin. There were 5788 treatment courses during the SMART program, and 4124 treatment courses during the iPLEDGE program. Overall there was a 29% reduction in number of treatment courses and patients treated after the implementation of iPLEDGE. Slightly less than half (46.5%) of patients were from KPSC. The mean patient age was 24.2 years and 67.2% of patients were in the 18- to 39-year
Discussion
In this study we analyzed 9912 courses of treatment and found no evidence that the iPLEDGE program lowered the risk of fetal exposures to isotretinoin. Results from both the unadjusted analysis of fetal exposure rates (3.11 before vs 2.67 fetal exposures per 1000 treatment courses after, P = .69) and the adjusted Cox proportional hazard model (HR = 0.76, 95% CI 0.36-1.61) failed to show a benefit after implementation of the iPLEDGE program.
In 5 of the potential cases, fetal exposure could not
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Cited by (0)
Supported by Kaiser Permanente Southern California Regional Research Committee and Kaiser Permanente Northern California Community Benefit.
Disclosure: Dr Cheetham has a first-degree relative employed by Allergan (compensated by salary and stock options). Dr McCombs is an investigator for Eli Lilly (compensated by grants), Bristol-Myers Squibb (compensated by grants and honoraria), and Wyeth (compensated by grants). Dr Shin is a consultant for Bristol-Myers Squibb (compensated by grants). Drs Wong, Kass, Yoshinaga, and Sidney; Ms Niu; and Mr Sorel have no conflicts of interest to declare.