Randomized Trial to Improve Prescribing Safety During Pregnancy
- Affiliations of the authors: Kaiser Permanente Colorado Clinical Research Unit, Denver, CO; School of Pharmacy, University of Colorado at Denver and Health Sciences Center, Denver, CO; Kaiser Permanente Colorado Pharmacy Department, Denver, CO; Colorado Permanente Medical Group, Denver, CO; School of Medicine, University of Colorado at Denver and Health Sciences Center, Denver, CO
- Correspondence and reprints: Marsha A. Raebel, PharmD, Kaiser Permanente Colorado Clinical Research Unit, PO Box 378066, Denver, CO 80237-8066; e-mail: <marsha.a.raebel{at}kp.org>
- Received 23 February 2007
- Accepted 9 April 2007
Abstract
Objective This study sought to determine whether a computerized tool that alerted pharmacists when pregnant patients were prescribed U.S. 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 A total of 2.9% of intervention (n = 177) and 5.5% of usual care (n = 276) patients were dispensed targeted medications (p < 0.001): 1.8% of intervention (n = 108) and 3.9% of usual care (n = 198) patients were dispensed only category D medication(s); 0.9% of intervention (n = 54) and 1.2% of usual care (n = 58) patients were dispensed only category X medication(s); 0.2% of intervention (n = 15) and 0.4% 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 2 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.
Conclusion 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.
Footnotes
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Supported by the Agency for Healthcare Research and Quality (1UC1HS014249), the Garfield Memorial Fund (101-9501), and by Kaiser Permanente Colorado.
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The authors thank the Associate Medical Director for Quality, Michael Chase, MD, and Kenneth Faber, MD, Physician Director for Resource Stewardship, for their support of this work. The authors thank Michael A. Bodily, MBA, for information systems expertise and Charron Long, PharmD for project coordination and clinical content support. The authors thank the pharmacy department personnel and leadership who supported and/or contributed programming, operational, or clinical skills to this initiative, Bob Rocho, RPh, Silvia Maranian, RPh, Stephanie Campbell, PharmD, and the late Kent M. Nelson, PharmD.
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Authors had access to study data, take responsibility for the integrity of the data and the accuracy of the analysis, and had authority over manuscript preparation and the decision to submit the manuscript for publication.
