Randomized trial to improve prescribing safety during pregnancy
Raebel MA, Carroll NM, Kelleher JA, Chester EA, Berga S, Magid DJ. Randomized trial to improve prescribing safety during pregnancy. J Am Med Inform Assoc. 2007 Jul-Aug;14(4):440-50.
Objective: This study sought to determine whether a computerized tool that alerted pharmacists when pregnant patients were prescribed medications that were U.S. Food and Drug Administration pregnancy risk category D (medications for which there is evidence of fetal risk) or X (medications considered contraindicated because evidence from human or animal studies suggests that risk to the fetus outweighs therapeutic benefit) 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 and 5.5% of usual care patients were dispensed targeted medications. This resulted in intervention patients receiving 238 dispensings of unique targeted medications and usual care patients receiving 361 dispensings of unique targeted medications. 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.
J Am Med Inform Assoc. 2007;14:440–450. DOI 10.1197/jamia.M2412.
Comment: This study did reveal a decreased rate of prescribing category D or X (and both). However, under closer review, a number of medications that were prescribed may have been appropriate given certain circumstances (e.g., sulfonamide or opiate use well prior to anticipated delivery, use of medications for migranes after other agents had failed, and oral contraceptives to filled during but to begin following pregnancy). Additionally, the study cites the challenge of delayed or absent information reguarding a pregancy loss (e.g., a miscarriage) and the potential for consequentially awkard pharmacist-patient interactions. While linking the information from clinical, laboratory, and pharmacy data my be a necessary step for such saftey measures to be realized, more involved clinical decision support designs and access to more accurate real-time information will be needed.
