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Research Assistant Professor, Department of Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA
Drug Information Pharmacist, University of Pittsburgh Medical Center; Instructor, Drug Information Center, School of Pharmacy, University of Pittsburgh
Director, Drug Use and Disease State Management Program, University of Pittsburgh Medical Center; Assistant Professor, Department of Pharmacy & Therapeutics, School of Pharmacy, University of Pittsburgh
Vice Chair of Quality Improvement and Patient Safety, Department of Medicine; Assistant Professor of Medicine and Psychiatry, School of Medicine, University of Pittsburgh
Reprints: Dr. Sheth, Department of Medicine, 3504 Fifth Ave., Ste. 200, Pittsburgh, PA 15213-2582, fax 412/383-4898, shethh{at}msx.dept-med.pitt.edu
BACKGROUND: Prochlorperazine and droperidol were commonly used antiemetics at the University of Pittsburgh Medical Center-Presbyterian Hospital until a shortage of prochlorperazine occurred and a black box warning was added to droperidol prescribing information. Subsequently, promethazine was selected as the approved intravenous antiemetic for therapeutic interchange in December 2001. Promethazine use and adverse drug events (ADEs) were investigated following review of a serious ADE that identified promethazine use as a probable contributing factor.
OBJECTIVE: To illustrate ADEs associated with promethazine and characterize high-risk patients.
METHODS: An ADE database analysis identified promethazine ADEs reported from 2000 to 2003. Promethazine utilization and ADEs were compared with those of other antiemetics during the pre- and post-interchange periods.
RESULTS: Promethazine utilization increased significantly during the
post-interchange period compared with all other antiemetics (p < 0.001).
Promethazine ADEs increased from one event during the pre-interchange period
to 13 events during the post-interchange period. Causality assessment using
the Naranjo algorithm ranged from possible to probable. The promethazine ADE
rate per 10 000 doses was significantly higher than the combined ADE rate for
all other antiemetics (p < 0.001; incident rate ratio [IRR] 4.32). Elderly
patients (aged 
65 y) experienced more promethazine ADEs than younger
patients (p = 0.005; IRR 4.68). Concurrent use of opioids and/or sedating
drugs contributed to promethazine ADEs in 11 of 14 (78.6%) patients.
CONCLUSIONS: Geriatric status is a significant risk factor for promethazine ADEs. Concomitant use of sedating drugs may further increase the risk for ADEs. Therapeutic interchange programs should be monitored for both ADEs and utilization.
Key Words: adverse drug reaction reporting systems, hospital formularies, promethazine, therapeutic interchange
Published Online, January 11, 2005. www.theannals.com, DOI 10.1345/aph.1E361
This article has been cited by other articles:
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  D. B. Ludwin and S. L. Shafer CON: The Black Box Warning on Droperidol Should Not Be Removed (But Should Be Clarified!) Anesth. Analg., May 1, 2008; 106(5): 1418 - 1420. [Full Text] [PDF]
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 A. S Habib, T. W Breen, and T. J Gan Comment: promethazine adverse events after implementation of a medication shortage interchange Ann. Pharmacother., July 1, 2005; 39(7): 1370 - 1370. [Full Text] [PDF]
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