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First published April 25, 2007 as JAMIA PrePrint; doi:10.1197/jamia.M2412
Journal of the American Medical Informatics Association 2007;14(4):440-450
© 2007 American Medical Informatics Association

A more recent version of this article appeared on July 1, 2007
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Submitted on February 23, 2007
Accepted on April 9, 2007

Randomized Trial to Improve Prescribing Safety During Pregnancy

Marsha A. Raebel PharmD1*, Nikki M. Carroll MS2, Julia A. Kelleher PharmD3, Elizabeth A. Chester PharmD4, Sally Berga MD5, and David J. Magid MD, MPH6

Affiliation of the authors: 1 Kaiser Permanente Colorado Clinical Research Unit, Denver, CO; School of Pharmacy, University of Colorado at Denver and Health Sciences Center, Denver, CO ; 2 Kaiser Permanente Colorado Clinical Research Unit, Denver, CO; 3 Kaiser Permanente Colorado Pharmacy Department, Denver, CO; School of Pharmacy, University of Colorado at Denver and Health Sciences Center, Denver, CO ; 4 , Kaiser Permanente Colorado Pharmacy Department, Denver, CO; School of Pharmacy, University of Colorado at Denver and Health Sciences Center, Denver, CO ; 5 School of Pharmacy, University of Colorado at Denver and Health Sciences Center, Denver, CO ; 6 Kaiser Permanente Colorado Clinical Research Unit, Denver, CO; School of Medicine, University of Colorado at Denver and Health Sciences Center, Denver, CO

* To whom correspondence should be addressed.

Objective To determine whether a computerized tool that alerted pharmacists when pregnant patients were prescribed United States Food and Drug Administration pregnancy risk category D or X medications was effective in decreasing dispensings of these medications.

Design Randomized trial. Pharmacy, diagnostic, and laboratory data were linked to identify pregnant patients prescribed targeted medications. Women (n = 11,100) were randomized to intervention or usual care. Physicians and pharmacists collaborated on the intervention.

Measurements The primary outcome was the proportion of pregnant women dispensed a category D or X medication. The secondary outcome was the total number of first dispensings of targeted medications.

Results 2.9 percent of intervention (n = 177) and 5.5 percent of usual care (n = 276) patients were dispensed targeted medications (p < 0.001). 1.8 percent of intervention (n = 108) and 3.9 percent of usual care (n = 198) patients were dispensed only category D medication(s); 0.9 percent of intervention (n = 54) and 1.2 percent of usual care (n = 58) patients were dispensed only category X medication(s); 0.2 percent of intervention (n = 15) and 0.4 percent of usual care (n = 20) patients were dispensed both category D and X medications (p = 0.05). This resulted in intervention patients receiving 238 dispensings of unique targeted medications and usual care patients receiving 361 dispensings of unique targeted medications (p = 0.03). The study was stopped primarily due to two false positive alert types: misidentification of medications as contraindicated in pregnancy by the pharmacy information system and misidentification of pregnancy related to delayed transfer of diagnosis information.

Conclusions Coupling data from information systems with knowledge and skills of physicians and pharmacists resulted in improved prescribing safety. Systems limitations contributed to project discontinuation. Linking ambulatory clinical, laboratory, and pharmacy information to provide safety alerts is not sufficient to ensure project success and sustainability.






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