Implementation of an iv medication safety system - American Journal ...

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I.V. medication safety system

Implementation of an i.v. medication safety system CAROLYN K. WILLIAMS AND RAY R. MADDOX Am J Health-Syst Pharm. 2005; 62:530-6

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he medication-use process is extremely complex and involves multiple steps performed by people in conjunction with machines, and medication errors can occur in any step of this process. Medication errors associated with high-risk drugs have the greatest potential to cause significant patient harm. Many high-risk-of-harm drugs1-3 (e.g., heparin, insulin, opioids) can be delivered by i.v. infusion, and administration is the step most vulnerable to error.4 Prevention of i.v. medication administration errors at the point of care, particularly those involving continuous-drug-infusion programming errors, should be a primary focus to prevent patient harm. The use of technology is essential for changing the medicationuse system and enabling clinicians to avoid errors. Some computerized prescriber-order-entry (CPOE) systems have dose limits that pharmacists can develop to help ensure the safety of prescribed dosages. The use of bar-code medication verification can help ensure the “five rights.” However, neither technology can safeguard patients against i.v. infusion programming errors.5 The introduction of an i.v. medication safety system (a computerized i.v. infusion system with hospital-defined drug libraries with dose limits) can help safeguard patients and caregivers against i.v. administration errors. This system can also provide previously unavail-

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able data on the frequency and characteristics of high-risk medication errors averted by its use. Analysis of aggregated data from i.v. medication safety systems at 18 institutions—community and regional hospitals, as well as major medical centers—showed that in an average 350-bed hospital, the system helped avert 1.1 potentially lifethreatening and an additional 1.5 probably significant i.v. programming overdoses every 1000 patient days. Data represent 425,000 patient days and include only dose-abovemaximum alerts with subsequent reprogramming (i.e., averted doses).6 Even without an i.v. medication safety system, some infusion errors may be detected, since many patients receiving continuous infusions are closely monitored. However, other infusion errors may go undetected for extended periods, depending on the patient care area. In an acutely ill patient, an infusion-related preventable adverse drug event can easily be misattributed to disease progression. Nationwide staffing shortages of nurses and pharmacists may increase the risk of errors and decrease the probability of error detection. The CAROLYN K. WILLIAMS, B.S.PHARM., is Medication Safety Specialist, Department of Clinical Pharmacy; and RAY R. MADDOX, PHARM.D., is Director of Clinical Pharmacy, Research and Pulmonary Medicine, St. Joseph’s/Candler Health System, Savannah, GA. Address correspondence to Dr. Maddox at

Am J Health-Syst Pharm—Vol 62 Mar 1, 2005

longer an error goes undetected, the greater the likelihood of prolonged hospitalization, increased hospital costs, and patient harm. Ultimately, CPOE, bar coding, and i.v. medication safety systems are all necessary. However, few institutions have the resources to implement all of these simultaneously. Hospitals’ efforts to prioritize capital allocations for various medication safety technologies typically involve pharmacists. For this reason, pharmacists need the skills to evaluate which types of medication errors pose the greatest risk of harm and which technology can be implemented most quickly and successfully and have a tangible impact on reducing those errors. We describe the multidisciplinary, collaborative approach used by St. Joseph’s/Candler Health System (SJCHS) to evaluate and select an infusion safety system and review the differences in the potential for harm associated with i.v. and oral medication errors. The comparative “speed to impact” (costs, time, ease of implementation, and capacity to prevent high-risk medication errors) of CPOE, bedside bar coding, and an i.v. medication safety system is also reviewed. Preliminary data on averted i.v. infusion medication errors are reported. SJCHS. SJCHS comprises two tertiary care hospitals in Savannah, Georgia, and one outlying facility, totaling 675 beds. It is the largest St. Joseph’s/Candler Health System, 5353 Reynolds Street, Savannah, GA 31405 ([email protected]). Copyright © 2005, American Society of Health-System Pharmacists, Inc. All rights reserved. 1079-2082/05/0301-0530$06.00.

COMMENTARIES I.V. medication safety system

health care system in southeast Georgia and the only faith-based and locally managed facility in Savannah. St. Joseph’s Hospital and Candler Hospital are two of the oldest continuously operating hospitals in the United States. There are 23,169 patient discharges annually. Staff includes 540 community-based, private-practice physicians, 972 nurses, and 38 pharmacists. Interaction among staff and administration is characterized by a high degree of collaboration. SJCHS has promoted a nonpunitive culture for medication-error reporting and analysis for many years. Education and staff involvement in medication-error analysis and process improvements have demonstrated that to improve patient safety, the goal must be to improve processes and focus on the issues, not on the individual. In April 1999, SJCHS initiated an agreement to help develop a bedside bar-code medication and verification product with a manufacturer of automated dispensing cabinets used in our hospitals. The three-year pilot project was conducted on a 14-bed oncology medical–surgical unit. After completion of the pilot project, further development was suspended to allow investigation of the best way to approach hospitalwide implementation of bedside bar-code technology (i.e., whether to select “best of breed” or to proceed with a product that would integrate directly with existing medical information technology). At the same time, the need to focus on prevention of i.v. medication errors with a high potential for harm rather than the frequency of medication errors became apparent. Clinical and administrative staff realigned professional priorities to improve i.v. medication safety. An article published by the Institute for Safe Medication Practices (ISMP) detailing potential medication errors associated with patient-controlled analgesia (PCA) prompted in-

creased attention to i.v. medication errors.7 In 2001 a multidisciplinary team, including nurses, pharmacists, respiratory therapists, risk managers, physicians, and others at SJCHS, completed an ISMP Medication Safety Self-Assessment, which included a review of checks and balances in the medication-use process.8 The analysis prompted a focus on the administration stage of the medication-use process and on i.v. medications. Potential for harm. Numerous studies have investigated the frequency of medication errors and the stage at which they are most likely to occur. In 1995, Bates et al.9 reported that the overall incidence of medication errors in hospitals was 6.5 adverse drug events and 5.5 potential adverse drug events per 100 nonobstetrical admissions. In a related report, Leape et al.4 found that 38% of medication errors causing preventable adverse drug events occurred during drug administration, 2% of which were intercepted. Of the nonintercepted potential and preventable adverse drug events, 51% occurred during the administration stage. While it is important to work to reduce the frequency of all medication errors, pharmacists’ primary focus must be on preventing errors with the greatest potential for harm (i.e., those involving high-risk medications). The most serious outcomes of medication errors are often associated with i.v. medications (e.g., heparin, insulin, morphine, fentanyl, propofol, midazolam).10 I.V. medications have been associated with 54% of potential adverse drug events11 and 56% of medication errors.12 Data from a major teaching hospital indicate that, overall, 61% of the most serious and life-threatening potential adverse drug events occur with i.v. medications (Bates DW, personal communication, 2001 Oct). Multiple factors contribute to this increased risk of harm. Many i.v. medications are powerful and have a

low therapeutic index, which increases the potential for and risk of underdosing or overdosing. With thousands of medications currently available and more being introduced every year, clinicians need technical support and cannot rely on memory for proper dosages. Look-alike, work-alike, and sound-alike drug names further increase the possibility of error. Combination therapies are increasingly complex. I.V. medications are used in all patient care areas but most frequently in acutely ill patients who are least able to compensate for medication errors. Even a minor overdose or underdose in these patients can result in serious adverse effects. Improved i.v. medication safety. In the medication-use process, the nurse at the bedside is most vulnerable for committing an error. Control and monitoring systems, including CPOE, robotic drug dispensing, pharmacy-controlled drug-cabinet access, and bedside bar-coding systems, exist for other aspects of the process. However, none of these approaches addresses the problem of infusion-device programming errors.5 Infusion pumps have made complex i.v. medication delivery possible. However, general-purpose infusion devices may be associated with errors because they can deliver medications at any rate within a 10,000-fold range (0.1–999 mL/hr) and can be programmed for patients whose weights range from 600 g to more than 300 kg. Without safeguards, the use of these devices increases the likelihood of administration errors. For example, a clinician may inadvertently use weight-based dosing and program the delivery of i.v. medication as micrograms per kilogram per minute instead of micrograms per minute; for a 67-kg patient, this would result in a 67-fold overdose. A 24-hour dose can be programmed to be delivered over 1 hour. 13 Pressing one wrong key while programming the delivery of i.v. medication can result


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in harm to a patient. A missing decimal point or a double key press can result in a 10- or 11-fold overdose.13 Mix-ups may easily occur among the programming of dose, flow rate, and bolus or loading doses. Key elements in programming i.v. medication administration include calculations of the volume to be infused and the drug infusion rate per hour. Many drug references provide information on the maximum dose to be given over 24 hours; however, they often do not provide data on minimum or maximum doses that can be administered over 1 hour. This observation is also often true for pharmacy information systems’ software. As a result, many institutions have developed their own guidelines for i.v. drug administration.13 Medication safety technologies. CPOE. CPOE is used to initiate and transfer prescriber orders electronically. This technology may provide interactive clinical data pertinent to all medical orders and should eliminate illegible orders. Decisionsupport logic provides the real value of CPOE; yet, only 56% of CPOE systems have decision-support technology.14 Studies have shown that CPOE can reduce the rate of medication errors, potential adverse drug events, and preventable adverse drug events. 15 However, hospitals have found the implementation of CPOE systems far more complicated than expected.16 In 2002, 6.9% of hospitals had CPOE.14 Importantly, CPOE systems, even those with decision support, do not safeguard against programming errors, which occur at the bedside during the administration of i.v. medications. Bedside bar-coded medication delivery. With this technology, barcoded labels for the medication, the patient, and the person administering the medication are scanned and reconciled and then documented electronically. This process helps to ensure that the right patient gets the right drug at the right dose by the

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right route at the right time. However, implementation of a bar-code system is technically and procedurally difficult and requires support from administrative, medical, and nursing leadership.17 Bar-code systems also require integration between multiple electronic databases, including patient medical information, pharmacy medication and patient profile system, drug inventory purchasing and management, drug packaging devices, and automated drug-dispensing hardware. Logistic issues with this technology include multiple bar codes from manufacturers for the same generic product. Some hospital locations may not use bar codes because of unique patient care flow and management characteristics (e.g., the emergency department and operating room). Lack of bar-coding standards for oral and injectable medications complicates full-scale implementation of this technology in hospitals.17 In 2002, only 2% of hospitals reported using bar-code technology.14 A bar-code system is a patient care improvement that requires significant changes in nursing work processes and does not reduce the time associated with medication administration. “Workarounds” may develop and require constant nursing oversight and compliance management. Implementation of an electronic medication administration record should probably precede the initiation of bar-code medication systems, as they are highly dependent on an electronic record of all doseadministration transactions performed by nurses.17 Importantly, bar coding does not currently address infusion programming errors, including those associated with STAT orders and dosage adjustments. I.V. medication safety systems. Recently introduced i.v. medication safety systems are computerized infusion systems with i.v. medicationerror-prevention and data-collection capabilities. These devices have a


modular platform that can integrate drug infusion and monitoring in a single system at the point of care. The programming module with a computer “brain” can be integrated with up to four additional and detachable modules, including large-volume pumps, syringe pumps, PCA pumps, and pulse oximetry and end-tidal carbon dioxide modules. The use of a single interface for all modules simplifies staff training, reduces programming complexity, and increases ease of use.5 Modules not needed for a particular patient can be available for use with other patients, thereby maximizing asset utilization. The system software provides a “test of reasonableness” at the point of care before medication delivery and links each device to a common database. The software provides hospitaldefined profiles for up to 10 different patient care areas or patient types (e.g., adult critical care, oncology, adult medical–surgical, obstetrics, pediatric patients weighing less than 5 kg, pediatric patients 5–10 kg, pediatric patients 10–20 kg, and pediatric patients greater than 20 kg). Caregiver selection of a specific profile adjusts the performance characteristics of the infusion device to meet the needs of a particular patient care area or patient type. Each profile is associated with a hospital-defined drug library containing various drug-infusion parameter sets (e.g., drug name; concentration amount and diluent; and maximum, minimum, and bolus dose limits). Limits are established that correspond with patient condition, age, and weight for adult and pediatric patients. If a programmed continuous or bolus dose is outside of the preestablished limits, the software provides an alert to the clinician. Depending on the drug, alerts are programmed either as “soft” or “hard” limits. A clinician can override a soft limit warning, while a hard limit warning does not allow the clinician to continue. Software can pro-


vide alerts when an attempt is made to start a second infusion of a medication that is already hanging, preventing duplicate therapy, and provide specific dose limits based on the weight of the patient. Alerts must be addressed before an infusion can begin, thus helping to intercept serious programming errors. These devices require institutions to develop standardized concentrations, dosing units, and limits for drug indications and areas of use. Some of these systems incorporate continuous quality improvement (CQI) data logs that allow a hospital to track programming errors and near misses that have been averted and could have resulted in patient harm. Reports generated from the safety system’s CQI logs can include patient information, the device number, date, time of administration, drug name, dose, drug amount, diluent volume, dosing units, programmed dose or bolus amount, dosage limit, amount over or under the limit, warning given, and subsequent reprogramming parameters. These data can be periodically downloaded by a hardware link to the hospital’s network server in batches for CQI analysis or by radio frequency in real time for CQI analysis. This previously unavailable information can be used to identify process improvement opportunities. The recently introduced IV Medication Harm Index, developed by a multidisciplinary work group of physicians, pharmacists, and nurses, will make it possible to objectively measure harm that has been averted through the use of an i.v. medication safety system.18 Prioritizing technology implementation. SJCHS’s multidisciplinary team recognized the primary importance of averting i.v. medication programming errors, which pose the greatest risk of harm. The question then became whether to focus primarily on the continuing development of a bedside bar-code system or the implementation of either

CPOE or an i.v. medication safety system. Based on the comparative speed of implementation, as well as influence on harm, quality of care, nursing satisfaction and productivity, CQI data capabilities, and platform for future technologies, an i.v. medication safety system was selected as the best initial approach to safeguard patients against medication errors with the highest potential for harm. An i.v. medication safety system is associated with lower costs ($1.2– $1.5 million versus $3–$7.9 million with CPOE and $0.5–$2 million with bar codes) and more rapid implementation (90 days versus 1.5–5 years with CPOE and greater than six months with bar codes) in addition to ease of implementation.19-21 With staffing shortages, any need to hire additional staff is important, yet no additional personnel are required for i.v. medication safety system implementation. In addition, an i.v. medication safety system requires no changes in nursing workflow and has minimal impact on productivity. Selection of an i.v. medication safety system. An analysis was initiated to identify a single new i.v. medication safety system. As with any new technology that has such a broad impact, challenges regarding purchase and implementation of the system were encountered. The most effective way to get the support from the health system’s leadership was to involve a multidisciplinary team of hospital staff to research alternative technologies. Team members conducted a comprehensive analysis, from the information-gathering stage through final price negotiations. While time-consuming, this approach was well worth the effort and effective in obtaining leadership approval of an i.v. medication safety system. Overall, the group sought a new infusion system that would allow the health system to increase detection and prevention of errors, increase documentation of errors, develop an error detection system

with feedback loops for CQI purposes, and decrease complexity of infusion technology. The team identified and compared 25 functions and components, as well as the benefits, risks, and costs of various products. Although published after the evaluation was complete, the Emergency Care Research Institute (ECRI) health devices evaluation was a useful expert resource to identify preferred products.22 The initial ECRI evaluation of these i.v. infusion systems has since been updated by the publication of a second and more comprehensive analysis.23 In both publications, ECRI reviewed pump capabilities, features, performance, safety, human factors design, reliability, service, and support. After comparing and evaluating all smart infusion devices on the market at the time and reviewing published reports,5 a modular, computerized, integrated i.v. infusion system with medication-errorprevention and CQI data-collection software (Alaris System, formerly known as the Medley System, with Guardrails Suite of Safety Software, Cardinal Health, Alaris Products, San Diego, CA) was selected. The most notable features of this system are listed in the appendix. The combination of these features suggested a dramatically improved infusion system that promised a potentially significant reduction of infusion-related medication errors. This system is the only one of the four available smart i.v. infusion products that ECRI rates as “preferred,”22,23 which validated our decision. With assistance from materials and risk management staff, hospital leadership became convinced that this system would result in considerable cost savings over the long term and would lead to an improvement in the ability to detect and prevent medication errors. Further, it was concluded that the system would ultimately result in a universal platform across the patient care continu-


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um, which would permit a decrease in i.v. line manipulation, increase standardization of practice within and between hospitals, and, most importantly, improve patient safety. Implementation of an i.v. medication safety system. Drug libraries and hospital profiles. Clinical content experts in nursing, pharmacy, and medicine created the drug libraries for SJCHS, which included a total of 76 drugs for eight patient care areas that serve as the basis for the dosechecking software. Each entry in the library contains the drug concentration available at our hospitals. The drugs are further customized with maximum and minimum recommended administration parameters. The limit can be set using dosing units, such as milliliters per hour, milliliters per minute, milligrams per kilogram per hour, milligrams per kilogram per minute, and micrograms per kilogram per minute, for each drug. The dosing units and limits are determined by clinical personnel in the hospital and verified by literature or current practice. The type of limit, soft or hard, is determined by the clinical staff and programmed for each specific drug within each patient profile. At SJCHS, dopamine can be administered to a medical–surgical patient not in a critical care unit at a maximum rate of 5 µg/kg/min. In the critical care unit, the drug has a maximum administration rate of 30 µg/ kg/min. Factors considered when determining whether to use soft or hard limits are clinical literature, policy, and practice. As a result of this effort, dosage protocols and drug concentrations were standardized across the health system. Staff education. Once selection of the system was made, staff were educated about its benefits and how it protects the patient and caregiver from medication errors. Although initial resistance was encountered, the clinical staff has embraced the system. Nurses, pharmacists, and

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physicians realized the benefit of the safety software in preventing errors. Clinical experts for various patient care areas in each hospital were designated as trainers. In a multitiered process, staff received training on the new infusion system during expert sessions and skill classes. Training sessions combined hands-on exposure with an Internet-based training module provided by the vendor. Training on the i.v. medication safety system has since been incorporated into the hospital orientation for all new nursing staff. Installation. On October 15, 2002, the new infusion system was installed on all units in the three-hospital health system (total of 645 i.v. medication systems). Installation was completed within an eight-hour period. Clinical experts were available in each area to supervise and answer questions that day and thereafter. The vendor provided around-theclock coverage for several days after system installation. Postimplementation analysis. To obtain the maximum benefit from the new system and assess the degree to which overall goals were being met, three research areas were identified for initial analysis of CQI data: (1) number and types of medicationerror alerts, (2) relationships among alerts, the type of drug being infused, and patient profile, and (3)differences in the type of drugs associated with alerts, depending on the patient profile. A sample of 100 i.v. infusion devices was randomly selected for analysis during the initial six months of operation from two of our three hospitals. Care was taken to choose at least 4 devices from each unit of each hospital. Reports were generated using CQI data documented by the safety software. Nurses were observed to determine the extent of compliance with the use of the safety software. Medication-error alerts. For the 100 sample systems from eight patient care areas, 506 events (i.e., in-


stances in which a nurse or clinician received an automated alert before infusing a drug) were documented over six months (Figure 1). The great majority of these alerts (73%, n = 370) indicated a dosage above the maximum recommended. In 88% (n = 443) of these cases, the warning was overridden by the caregiver. The majority of these overrides involved infusion of propofol. Subsequent analysis showed that bolus doses accounted for most of these warnings. Because bolus doses of propofol are given in addition to continuous infusion in the intensive care unit, the dose-checking software was providing a “dose above maximum” warning, even though the bolus dose may have been clinically appropriate. As a result of these data, a separate bolus dosing protocol has been established for propofol. Further analysis is needed to determine why other alerts were overridden, whether these overrides were appropriate in all cases, and whether the drug library infusion dose ranges need to be adjusted. While it could be assumed that this group of warnings would not have resulted in error had the technology been absent, the warnings serve as yet another check in the system. Of the remaining 63 (12%) events, the alert led to reprogramming of the device by the clinician (n = 37), cancellation of the drug selection (n = 20), or cancellation of the process altogether (n = 6). In these cases, the system played a critical role in the prevention of potentially serious infusion errors. Most common warnings. Four drugs were most commonly associated with warnings: propofol (n = 144), heparin (n = 36), octreotide (n = 37), and atracurium (n = 34). These drugs accounted for half of all alerts during the study period. The vast majority of warnings occurred among adult critical care patients (92% [n = 466]), followed by labor and delivery patients (5% [n =


Figure 1. I.V. medication safety system warnings (n = 506). 400

370

No. Warnings

350 300 250 200 150

110

100 50 0

19 Dose above maximum

Dose below minimum

25]) and medical–surgical patients (3% [n = 15]). Among adult critical care patients, 12% (n = 56) of warnings resulted in a programming change or cancellation, while 40% (n = 6) among medical–surgical patients resulted in a programming change or cancellation. Only 8% (n = 2) of warnings among labor and delivery patients resulted in a programming change or cancellation. No alerts occurred among systems used by adult oncology or pediatric patients. Different types of drugs were associated with alerts depending on patient profiles. Among adult critical care patients, propofol was most likely to be associated with a warning. Among labor and delivery patients, magnesium sulfate was the most common. Finally, heparin was the most common drug associated with an alert among medical–surgical patients. Compliance. Direct observation revealed that nursing compliance with the safety software was 98– 100%. Positive feedback and excellent compliance are believed to result from the preimplementation education of nursing and hospital staff, coupled with the involvement of nursing staff in research and implementation of the technology. In addition, nursing leadership gives daily reinforcement to staff about the importance of using the safety software.

Drug selection canceled

4

3

Same drug infusing

Bolus dose below minimum

Risk priority score. Before implementation of the safety system, a failure mode and effects analysis (FMEA) was conducted to determine a risk priority score related to setting i.v. heparin infusion rates at SJCHS. A 10-point scale was used to assess the potential for error when setting rates with the infusion pump. During the FMEA, the severity was assigned a value of 7, indicating a high potential for harm, the occurrence was assigned a value of 5, indicating that the frequency of occurrence was moderate, and the detectability value was 6, indicating that it would be difficult to detect with the current i.v. infusion pump. Because there was no reliable mode of error detection for drug infusions, the risk priority score was 210. After the safety system was implemented, the FMEA analysis was repeated. The severity value remained 7, the occurrence value was reduced to 4 due to ease of programming, and the detection value was reduced to 2, indicating that the error was easily detectable. The risk priority score dropped from a preimplementation score of 210 to a postimplementation score of 56—nearly a fourfold reduction in risk as a result of the i.v. medication safety system. The smart infusion system provides an alert when a programming error occurs that exceeds the safety limits. The reduction in FMEA score was

achieved primarily by the improvement in the detection of programming errors. Discussion. There are a number of other ways in which this system has helped to change the medication administration process at SJCHS. CQI data analysis identified that infusion of propofol as a bolus dose caused an unnecessary error warning, which prompted the development of bolus dosing parameters. Previously, the weight-based heparin protocol contained blank fields for the pharmacist to fill in after converting the dose (units per kilogram per hour) to a rate (milliliters per hour). The protocol had to be sent to the pharmacy department by nurses via pneumatic tube, calculations had to be performed and documented on the protocol, and the protocol was then sent back to the nurse. The nurse also performed this series of calculations before programming the rate into the infusion device. The heparin protocol has been revised and the rate calculations eliminated by programming the dose (units per kilogram per hour) directly into the smart infusion system. This eliminated at least three steps in the medication-use process, numerous calculations, and multiple opportunities for error. This change improved the safety and timeliness of heparin administration by eliminating unnecessary calculations and the need to send the protocol to and from the pharmacy via pneumatic tube. It was also discovered that if i.v. drug labels were reformulated to include the total volume and amount of drug, nursing staff would be able to program the system more easily and deliver the correct dose of medication. Another unexpected use for the system that has resulted in increased efficiency involves neonatal and pediatric patients. Previously, when orders were written for drugs not frequently used, pharmacists spent time researching and compiling information to determine the correct con-


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centration for a pediatric patient. Now, they are able to quickly reference the dose-checking drug database, knowing that the information is adequately supported by current literature. Implementation of the i.v. medication safety system has resulted in significant progress in the achievement of SJCHS’s error-prevention goals. While most health care institutions continue to rely on selfreported errors, this i.v. medication safety system allows us to systematically detect and prevent errors. Averted errors, or near misses, are electronically recorded, which provides documentation that assists in CQI efforts. For SJCHS, the new system offers a true safety net for detecting medication errors. There is little doubt that patient morbidity and mortality have been reduced as a result of the investment in this system. The system continues to be refined, including reprogramming of dose ranges for selected drugs. We also recognize that it is critical to broaden our understanding and definition of averted errors, so that near misses can be traced to their source in the medication-use process. The process of transforming the i.v. infusion system at SJCHS has been both rewarding and challenging. The approach, which involved multidisciplinary collaboration and a thorough planning and review process, will guide the institution through future upgrades and additions of new technology. Integration of the programming and large-volume modules with PCA, syringe units, and pulse oximetry with end-tidal carbondioxide-monitoring modules is already under way. Ultimately, this enhancement will lead to an even more seamless error-detection and harmprevention medication system. Conclusion. SJCHS’s experience and CQI data validate the ability of an i.v. medication safety system to prevent the most harmful medica-

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tion errors and to provide actionable data for process improvements. References 1. National Coordinating Council for Medication Error Reporting and Prevention. NCC MERP taxonomy of medication errors. www.nccmerp.org/pdf/taxo200107-31.pdf (accessed 2004 Nov 1). 2. Summary of information submitted to MEDMarx in the year 2001. A human factors approach to understanding medication errors. Rockville, MD: The United States Pharmacopeia; 2002. 3. Winterstein AG, Hatton RC, GonzalezRothi R et al. Identifying clinically significant preventable adverse drug events through a hospital’s database of adverse drug reaction reports. Am J Health-Syst Pharm. 2002; 59:1742-9. 4. Leape LL, Bates DW, Cullen DJ et al. Systems analysis of adverse drug events. JAMA. 1995; 274:35-43. 5. Eskew JA, Jacobi J, Buss WE et al. Using innovative technologies to set new safety standards for the infusion of intravenous medications. Hosp Pharm. 2002; 37:117989. 6. Vanderveen T. Moving from infusion pumps to an intravenous medication safety system. HealthLeaders. 2004; 7(12 suppl):10-5. 7. Institute for Safe Medication Practices. Design flaw predisposes Abbott Lifecare PCA Plus to dangerous medication errors. www.ismp.org/Pages/Lifecare.html (accessed 2004 Nov 1). 8. Smetzer JL, Vaida AJ, Cohen MR et al. Findings from the ISMP Medication Safety Self-Assessment for hospitals. Jt Comm J Qual Saf. 2003; 29:586-97. 9. Bates DW, Cullen DJ, Laird N et al. Incidence of adverse drug events and potential adverse drug events: implications for prevention. JAMA. 1995; 274:29-34. 10. Hicks RW, Cousins DD, Williams RL. Summary of information submitted to MEDMARX in the year 2002. The quest for quality. Rockville, MD: USP Center for the Advancement of Patient Safety; 2003. 11. Kaushal R, Bates DW, Landrigan C et al. Medication errors and adverse drug events in pediatric inpatients. JAMA. 2001; 285:2114-20. 12. Ross LM, Wallace J, Paton JY. Medication errors in a paediatric teaching hospital in the UK: five years operational experience. Arch Dis Child. 2000; 83:492-7. 13. Wilson K, Sullivan M. Preventing medication errors with smart infusion technology. Am J Health-Syst Pharm. 2004; 61:177-83. 14. Pedersen CA, Schneider PJ, Scheckelhoff DJ. ASHP national survey of pharmacy practice in hospital settings: dispensing and administration. Am J Health-Syst Pharm. 2003; 60:52-68. 15. Bates DW, Leape LL, Cullen DJ et al. Effect of computerized physician order en-


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try and a team intervention on prevention of serious medication errors. JAMA. 1998; 280:1311-6. CPOE, bedside technology, and patient safety: a roundtable discussion. Am J Health-Syst Pharm. 2003; 60:1219-28. Maddox RR. Bar code medication administration: lessons learned from three years of preparation. Hosp Pharm. 2003; 38(suppl 1):S24-5. Sullivan J. I.V. medication harm index: results of a national consensus conference. Hosp Health Netw. 2004; 78(5 suppl): 29-31. Computerized physician order entry: costs, benefits, and challenges: a case study approach. Long Beach, CA: First Consulting Group; 2003 Jan. Kinninger T, Kelly J. Prioritizing capital allocation for patient safety: how healthcare leaders can evaluate information technology using evidence-based information. www.bridgemedical.com/pdf/ Allocation_White_Paper.pdf (accessed 2004 Nov 1). Data on file. ALARIS Medical Systems, Inc., San Diego, CA: 2004 Jan. General-purpose infusion pumps. Health Devices. 2002; 31:353-87. General-purpose infusion pumps. Evaluating the B. Braun Outlook Safety Infusion System. Heath Devices. 2003; 32:382-95.

Appendix—Key features of an i.v. medication safety system • Modularity of infusion channels allows for maximization of the number of infusible lines across patients • Ease of use • Internal, programmed drug calculations • Standardized drug programming with specific hard (cannot be overridden) and soft (can be overridden) dosage limits • Software that is intuitive; requires fewer key strokes in programming • Standardization of medication concentration and dosing • Continuous quality improvement (CQI) data—all programming errors and resolution • Standardized nonfiltered tubing • Confirmation of settings when system is powered on; anesthesia list “disappears” when system is unplugged • Customizable patient care profiles • Sensitivity of i.v. pressure settings • System platform adaptable for up to four detachable modules, including large-volume pumps, syringe pumps, PCA pumps, and endtidal carbon dioxide monitoring pulse oximetry, and potential future modules such as patient-controlled analgesia • Single interface for all modules—less training or opportunity for confusion • Expanded drug library lists up to 1000 drugs • Long battery life • Does not require, yet has, electronic interface with information systems to facilitate use of CQI data