1.  Computerized Surveillance of Adverse Drug Events in Hospital Patients

Author(s): Classen DC, Pestotnik SL, Evans RS, Burke JP

Source: JAMA: The Journal of the American Medical Association. 1991 Nov 27;266(20):2847-2851.

Summary: This prospective study develops a new method to improve the detection and characterization of adverse drug events (ADEs) in hospital patients at a tertiary care center. Each day, a list of all potential ADEs was generated from an integrated hospital information system, and a pharmacist reviewed the medical records of all patients with possible ADEs for accuracy and causality. Over 18 months, only nine ADEs were identified using traditional detection methods. Physicians, pharmacists, and nurses voluntarily reported 92 of the 731 ADEs detected using this automated system. The other 631 ADEs were detected from automated signals, the most common of which were diphenhydramine hydrochloride and naloxone hydrochloride use, high serum drug levels, leukopenia, and the use of phytonadione and antidiarrheals. We believe that screening for ADEs with a computerized hospital information system offers a potential method for improving the detection and characterization of these events in hospital patients.

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2.  Medication Dispensing Errors and Potential Adverse Drug Events Before and After Implementing Bar Code Technology in the Pharmacy

Author(s): Poon EG, Cina JL, Churchill W, Patel N, Featherstone E, Rothschild JM, Keohane CA, Whittemore AD, Bates DW, Gandhi TK

Source: Annals of Internal Medicine. 2006 Sep 19;145(6):426-434.

Summary: This paper evaluates whether implementation of bar code technology reduces dispensing errors and potential adverse drug events (ADEs) at a tertiary academic medical center. In the pre- and post-bar code implementation periods, the authors observed 115,164 and 253,984 dispensed medication doses, respectively. Of the three configurations of bar code technology studied, the two configurations that required staff to scan all doses had a 93-96% relative reduction in the incidence of target dispensing errors (P < 0.001) and 86-97% relative reduction in the incidence of potential ADEs (P < 0.001). Limitations to the study include using surrogate outcomes; not masking assessors to the purpose of study; and excluding the controlled substance fill process (a process with low error rates at baseline) from the study. The overall rates of dispensing errors and potential ADEs substantially decreased after implementing bar code technology. However, the technology should be configured to scan every dose during the dispensing process.

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3.  High Rates of Adverse Drug Events in a Highly Computerized Hospital

Author(s): Nebeker JR, Hoffman JM, Weir CR, Bennett CL, Hurdle JF

Source: Archives of Internal Medicine. 2005 May 23;165(10):1111-1116.

Summary: Numerous studies have shown that specific computerized interventions may reduce medication errors, but few have examined adverse drug events (ADEs) across all stages of the computerized medication process. We describe the frequency and type of inpatient ADEs that occurred following the adoption of multiple computerized medication ordering and administration systems, including computerized physician order entry (CPOE). Pharmacists classified inpatient ADEs from prospective daily reviews of electronic medical records from a random sample of admissions at a Veterans Administration hospital. Of all ADEs, 9% resulted in serious harm, 22% in additional monitoring and interventions, 32% in interventions alone, and 11% in monitoring alone; 27% should have resulted in additional interventions or monitoring. Medication errors associated with ADEs occurred in the following stages: 61% ordering, 25% monitoring, 13% administration, 1% dispensing, and 0% transcription. High rates of ADEs may continue to occur after implementation of CPOE and related computerized medication systems that lack decision support for drug selection, dosing, and monitoring.

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4.  A Controlled Trial of Smart Infusion Pumps to Improve Medication Safety in Critically Ill Patients

Author(s): Rothschild JM, Keohane CA, Cook EF, Orav EJ, Burdick E, Thompson S, Hayes J, Bates DW

Source: Critical Care Medicine. 2005 Mar;33(3):533-540.

Summary: Errors associated with medications administrated through intravenous infusion pumps to critically ill patients can result in adverse drug events (ADEs). The prospective, randomized time-series study sought to assess the impact of smart pumps with integrated decision support software on the incidence and nature of medication errors and ADEs. Serious medication errors included both near-misses and preventable ADEs. We found a total of 180 serious medication errors, including 14 and 11 preventable ADEs and 73 and 82 nonintercepted potential ADEs in the control and intervention periods, respectively. Violations of infusion practice during the intervention periods included 571 (25%) bypasses of the drug library. Medications were also frequently administered without documentation of physician orders in both periods (n = 823; 7.7%).  In conclusion, intravenous medication errors and ADEs were frequent and could be detected using smart pumps. Although smart pumps have great promise, technological and nursing behavioral factors must be addressed if these pumps are to achieve their potential for improving medication safety.

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5.  Improving Safety with Information Technology

Author(s): Bates DW, Gawande AA

Source: New England Journal of Medicine. 2003 Jun;348(25):2526-2534.

Summary: Health care is growing increasingly complex, and most clinical research focuses on new approaches to diagnosis and treatment. In contrast, relatively little effort has been targeted at the perfection of operational systems, which are partly responsible for the well-documented problems with medical safety.  If medicine is to achieve major gains in quality, it must be transformed, and information technology will play a key part, especially with respect to safety.  Information technology can reduce the rate of errors in three ways: by preventing errors and adverse events, by facilitating a more rapid response after an adverse event, and by tracking and providing feedback about adverse events.  Information technology can substantially improve the safety of medical care by structuring actions, catching errors, and bringing evidence-based, patient-centered decision support to the point of care to allow necessary customization. New approaches that improve customization to identify key changes in status and then notify key persons should be especially important.

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6.  Automated Surveillance for Adverse Drug Events at a Community Hospital and an Academic Medical Center

Author(s): Kilbridge PM, Campbell UC, Cozart HB, Mojarrad MG

Source: Journal of the American Medical Informatics Assocation (JAMIA). 2006 Jul-Aug;13(4):372-377 Epub 2006 Apr 18. 2006 Jul-Aug;13(4):372-377 Epub 2006 Apr 18.

Summary: This prospective cohort study compares the rates and nature of adverse drug events (ADEs) at an academic medical center and a community hospital using a single computerized ADE surveillance system. Potential events identified by the computer were reviewed in detail by medication safety pharmacists and scored for causality and severity with findings compared between the two hospitals. Over the eight month study period, there were 1,116 ADEs in 900 patients at the university hospital for an overall rate of 4.4 ADEs per 100 admissions. At the community hospital, 399 patients experienced 501 ADEs for a rate of 6.2 events per 100 admissions. Rates of antibiotic-associated colitis, drug-induced hypoglycemia, and anticoagulation-related ADEs were significantly higher at the community hospital compared with the university hospital. Operation of a common automated ADE surveillance system across hospitals permits meaningful comparison of ADE rates in different inpatient settings. Automated surveillance detects ADEs at rates far higher than voluntary reporting, and the difference may be greater in the community hospital setting.