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RESEARCH Smart Infusion Pumps Reduce Intravenous Medication Administration Errors at an Australian Teaching Hospital Rebecca KY Pang, David CM Kong, Jan-Marie deClifford, Skip S Lam, Benjamin K Leung ABSTRACT Background: Serious and life-threatening adverse drug events are often attributed to intravenous medication administration errors. Although smart infusion pumps are increasingly being adopted by hospitals to prevent such errors, data are lacking on their effectiveness in clinical practice. Aim: To measure and characterise intravenous medication administration errors and their clinical significance before and after the implementation of smart infusion pumps. Method: In the pre-intervention period, an independent observer over 41 working days recorded the prescribing and administration details of infusions administered via the IMED Gemini Volumetric Infusion Pumps. 20 months after the introduction of the smart pumps – Alaris GP Volumetric Pump with Guardrails software – a repeat audit was conducted over 27 working days. Only infusions containing drugs that were to be incorporated into Guardrails (the medication–error– prevention software of the Alaris GP pump) were evaluated. The clinical significance of the identified errors was evaluated by 2 independent assessors (pharmacist and doctor) and rated as ‘low’, ‘moderate’, ‘high’ or ‘extreme’. Results: In the pre-intervention period, 76 infusions (n = 432, 18%) had one or more errors compared to 25 infusions (n = 266, 9.4%) following the introduction of the smart pumps. Of the 165 infusions administered using Guardrails, only 6 infusions with errors (3.6%) were identified. When drugs were infused with the Alaris GP pumps without Guardrails, the number of errors post-intervention when compared with errors in the preintervention period were not statistically significant (p = 0.8). When Alaris GP pumps with Guardrails were used there were no errors of ‘extreme’ clinical significance and only 1 error of ‘high’ clinical significance compared to the pre-intervention period where 1 ‘extreme’ and 30 errors with ‘high’ clinical significance were identified. Conclusion: Alaris GP pumps with Guardrails resulted in significant reductions in the number and clinical significance of intravenous medication administration errors. J Pharm Pract Res 2011; 41: 192-5. INTRODUCTION The majority of high-alert medicines listed by the Institute for Safe Medication Practices are intravenous medications.1 Intravenous medication errors can result in significant toxicity or treatment failure.1 In an US study, Rebecca KY Pang, BPharm, MClinPharm, CGP, Clinical Pharmacist, and Intern Preceptor, Frankston Hospital, David CM Kong, BPharm, MPharm, PhD, Lecturer, Faculty of Pharmacy and Pharmaceutical Sciences, Monash University, Jan-Marie deClifford, BPharm, GradDipHospPharm, FSHP, MHA, CGP, Senior Clinical Pharmacist, and Medication Safety Officer, Skip S Lam, BPharm, FSHP, MACCP, Director of Pharmacy, Benjamin K Leung, BPharm, MBA, Deputy Director of Pharmacy/Pharmacy Manager, Frankston Hospital, Frankston, Victoria Address for correspondence: Rebecca Kwok-Yee Pang, Pharmacy Department, Frankston Hospital, Frankston Vic. 3199, Australia. E-mail: [email protected] 192 61% of the most serious and potentially life-threatening adverse drug events were attributed to intravenous medicines.2 In another US study, intravenous medications were responsible for 54% of potential adverse drug events. 3 Hunt and Rapp4 investigated factors that contribute to intravenous medication errors and reported that similar rates of errors occurred during the prescribing, preparation and administration stages. An observational study reported an error rate of 10% during the preparation and administration of intravenous medications.5 While Wirtz et al.6 reported that the most common cause of intravenous medication errors was the wrong administration rate. The strategies used to minimise or prevent medication errors include: standardisation of processes for prescribing, preparing and administering intravenous medications, ensuring pharmacy oversight and the use of technology such as smart pumps.7 Han et al.8 concluded that errors were less likely to occur if intravenous infusion control devices were used in surgical wards, especially when used with preparations requiring prolonged infusions. The US Institute for Safe Medication Practices has recommended that smart infusion pumps offer the opportunity to identify and correct pump programming errors.9 Unlike conventional infusion pumps, smart pumps are equipped with medication–error–prevention and data–capturing software. This software allows the user to establish a drug library of intravenous drugs, their standard concentrations, dosing units, and maximum and minimum infusion rates. The drug library can be tailored to different patient groups and medical conditions. If the software is bypassed, then the smart pump is no different to a conventional infusion pump. When the software is used, alerts are provided in ‘underdose’ or ‘overdose’ scenarios. The soft–limit alerts, a feature of smart pumps, notify the user that the dose selected is out of the recommended range programmed in the drug library. The user is able to override the soft– limit alerts and allow the infusion to proceed. Conversely, the hard–limit alerts notify the user that the dose selected is out of the drug library’s maximum allowable range and the software will not allow the infusion to proceed unless it is reprogrammed within the acceptable range.10 An example of a smart infusion pump is the Alaris GP Volumetric Pump with Guardrails software that includes a drug library. While the IMED Gemini Volumetric Infusion Pump is a conventional pump with software that does not include a drug library. Although smart infusion pumps have been in use for many years, their benefits have not been explored and remain unclear. Malashock et al.11 and Fields et al.12 evaluated the impact of smart pumps on reducing Journal of Pharmacy Practice and Research Volume 41, No. 3, 2011. intravenous medication administration errors by reviewing alerts and the users’ responses recorded in the device’s electronic memory. They found that smart pumps were able to alert users to overdosing or underdosing events and avert errors. Fanikos et al.13 analysed self-reported intravenous medication administration errors and reported no difference in the total number or frequency of intravenous anticoagulation errors before and after the introduction of smart pumps. All of the aforementioned studies have the same limitation, i.e. they did not prospectively audit the actual number of administration errors before and after the introduction of smart pumps. For example, Fanikos et al.13 examined the data downloaded from the smart pumps and found many soft– and hard–limit alerts that were not self-reported. A prospective randomised time–series trial to determine if smart pumps improve medication safety, identified 87 and 93 serious intravenous medication errors per 100 patients pump days pre- and postimplementation, respectively. 14 Rothschild et al. 14 analysed adverse drug events over four 8 week data collection periods and found that smart pumps did not have a statistically significant impact on serious medication error rates. They postulated that this may partly be due to the pump set-up, making it easy for nurses to bypass the drug library. In view of the limitations with published studies, and sometimes conflicting outcomes of the effectiveness of smart pumps in preventing medication errors, this study aimed to measure and characterise intravenous medication administration errors and their clinical significance before and after the introduction of smart infusion pumps. METHOD In May 2008, Frankston Hospital, Melbourne, a 380–bed acute teaching hospital replaced all of their IMED Gemini Volumetric Infusion Pumps with Alaris GP Volumetric Pumps with Guardrails software (CareFusion). The study was approved by the Peninsula Health and Monash University Human Research and Ethics Committees. Drug Library and Training In consultation with nurses and clinicians, the pharmacy department developed a total of 600 infusion protocols involving 89 medicines to form the drug library. The drug library was approved by the hospital’s Drugs and Therapeutics Committee and programmed into the Guardrails software. Drug selection by the pharmacy department was based on frequency of use at the hospital. The hard– and soft–limit alerts programmed into Guardrails for the drug infusion protocols was customised to accommodate the varied needs of the different clinical areas within the hospital. The Alaris GP pumps were introduced to the wards in tandem with staff education and promotional activities to increase uptake of Guardrails. All nursing staff were trained to use the smart pumps prior to and during their introduction. To encourage uptake of the Alaris GP pumps with Guardrail there were continuous promotional activities throughout the study period as well as during the data collection phase of the post-intervention period. Data Collection Clinical areas audited included general medical and surgical wards, intensive care unit, recovery rooms in the theatre and day surgery unit, emergency department, day oncology unit, paediatric and maternity wards. The endoscopy and cardiac angioplasty suites, operating theatre and delivery suite were excluded because of limited access. Only infusions containing drugs that were to be incorporated into Guardrails (medication–error– prevention software of the Alaris GP pump) were evaluated. Prior to the introduction of the Alaris GP pumps (preintervention period), an independent observer (pharmacy undergraduate) prospectively recorded the prescribing and administration details of infusions administered via IMED Gemini pumps over 41 days (November to December 2007) during weekday business hours. Convenience sampling was employed to capture the infusions administered. The independent observer visited the designated wards and checked all of the infusions for errors at the first ward visit. Follow-up visits were undertaken twice daily to check for new infusions. Twenty months after the introduction of the Alaris GP pumps at the hospital, a repeat audit was similarly conducted by another independent observer (pharmacy undergraduate) over 27 working days from January to February 2010. To ensure uniformity, data for the preand post-intervention periods were collected by two independent observers (pharmacy undergraduates) who underwent the same training. The observers documented the information on the infusions from medication charts (drug prescribed, dose, frequency), infusion orders (drug, dose, frequency, rate), labels on infusion bags (drug, dose, volume), infusion pumps (rate, volume) and body weight (if required to calculate the dose or administration rate) and entered the details into an Excel spreadsheet. The observers then evaluated the data for evidence of errors. The data were also reviewed independently by a pharmacist for infusionrelated errors. The errors identified by the observers and pharmacist were then compared and any discrepancies resolved by consensus. The number of infusions with administration or concentration errors was recorded. Multiple errors could occur in any drug administration. If an error was noted by the observer, the error was immediately reported to the ward pharmacist for action to ensure patient safety. Intravenous Medication Errors Medication administration errors were defined as any deviations of the rate and/or concentration set on the infusion pump when compared with the medication order on the drug chart, the Peninsula Health Parenteral Drug Administration Guidelines or the Australian Injectable Drugs Handbook.15 Clinical Significance The clinical significance of the errors was assessed by a clinical pharmacist and an emergency medicine physician not involved with data collection. The errors were assessed and designated a risk rating with respect to severity and the likelihood of recurrence. The risk matrix tool used, enabled the risk assessment to be assigned by taking into consideration the consequence (impact) of the error and likelihood of the error occurring.16 The assessors were blinded to when and where the infusions Journal of Pharmacy Practice and Research Volume 41, No. 3, 2011. 193 were given and the type of pump used. Any discrepancies in clinical significance ratings were discussed until consensus was reached. Pre-intervention period Drugs infused via IMED Gemini Volumetric Infusion Pump (n = 432) Data Analysis GraphPad, Chi square and Fisher’s test were used to determine the reduction in the error rate and risk analysis. A p value of < 0.05 was considered statistically significant. Errors with ‘low’ or ‘moderate’ clinical significance and errors with ‘high’ or ‘extreme’ clinical significance were grouped together for statistical comparison between the pre- and post- intervention periods. RESULTS The observed drug infusions were evenly distributed across corresponding clinical areas during both phases (Table 1). The distribution of the drugs infused during both phases was also similar with heparin, noradrenaline, potassium, propofol and vancomycin the most frequently infused drugs (Table 2). Of the 266 infusions observed in the post-intervention period, 165 (62%) were infused using Guardrails software. Table 1. Distribution of drug infusions in the pre- and post-intervention periods Preintervention (n = 432) General medical General surgical Emergency department 69 (16%) 91 (21%) 26 (6%) Intensive care unit Infusions with error(s) (n = 76, 18%) Post-intervention period Drugs infused via Alaris GP Volumetric Pump (n = 266) Drugs infused with Guardrails (n = 165, 62%) Drugs infused without Guardrails (n = 101, 38%) Infusions with error(s) (n = 6, 3.6%) Infusions with error(s) (n = 19, 19%) Total number of infusions with errors (n = 25, 9.4%) Other 242 (56%) 4 (0.9%) Figure 1. Distribution of errors during the pre- and postintervention periods. compared to when they were infused via the IMED Gemini pump (18%) (p < 0.001); • no statistically significant difference in the number of errors when drugs were infused via the Alaris GP pumps without Guardrails (19%) compared to the Table 2. Intravenous drugs administered in the pre- and postIMED Gemini pump (18%) (p = 0.8); and intervention periods • 81% reduction in errors (p < 0.001) when drugs were PostPreinfused via the Alaris GP pumps with Guardrails intervention intervention (3.6%) compared to infusions given via the Alaris (n = 266) (n = 432) Drugs GP pumps without Guardrails (19%). The clinical significance ratings of the infusionAnaesthetics: propofol 43 (10%) 26 (9.8%) related medication errors are presented in Table 3. 61 (14%) 54 (20%) Antibacterials, antivirals, antifungals: Infusions administered using Guardrails predominantly aciclovir, azithromycin, ciprofloxacin, had errors with ‘low’ or ‘moderate’ clinical significance dicloxacillin, fluconazole, gentamicin, linezolid, metronidazole, vancomycin while in the pre-intervention period, errors ranged from ‘low’ to ‘extreme’ clinical significance. There was a 62 (14%) 27 (10%) Anticoagulants, antiplatelets: statistically significant reduction in errors with combined abciximab, danaparoid, heparin, ‘high’ and ‘extreme’ clinical significance between the two infliximab, tirofiban phases (p = 0.03). Electrolytes: magnesium, phosphate, 109 (25%) 67 (25%) Postintervention (n = 266) 66 (25%) 64 (24%) 19 (7.1%) 114 (43%) 3 (1.1%) potassium Inotropes: adrenaline, dobutamine, milrinone, noradrenaline, vasopressin 98 (23%) 44 (16%) Analgesics: paracetamol; antidotes: acetylcysteine; cardiac: amiodarone; endocrine: octreotide; gastroenterology: pantoprazole; obstetrics and gynaecology: oxytocin, salbutamol 59 (14%) 48 (18%) Clinical significance rating Error Analysis The errors identified were analysed from four aspects (Figure 1) with the following results: • 47% reduction in errors between the pre- (18%) and post-intervention periods (9.4%) (p = 0.003); • 79% reduction in errors when drugs were infused via the Alaris GP pumps with Guardrails (3.6%) 194 Table 3. Clinical significance of the errors associated with intravenous infusions Low Moderate Pre-intervention (n = 432) 43 (10%) 2 (0.5%) Post-intervention (n = 266) 16 (6%) 5 (1.9%) 4 (1.5%) 0 Post-intervention without Guardrails (n = 101) 13 (13%) 2 (2%) 4 (4%) 0 0 0 Post-intervention with Guardrails (n = 165) 3 (1.8%) 3 (1.8%) High Extreme 30 (6.9%) 1 (0.2%) Journal of Pharmacy Practice and Research Volume 41, No. 3, 2011. DISCUSSION To our knowledge, this is the first study conducted in an Australian hospital evaluating whether smart pumps reduce infusion-related medication errors. According to our findings, the number of infusions with errors was significantly less when Guardrails software was used compared to when the IMED Gemini pumps or the Alaris GP pumps without Guardrails were used. There were also no errors of ‘extreme’ or ‘high’ clinical significance when Guardrails was used. These results complement the positive outcomes reported in earlier studies of smart pump technology.11,12 Larsen et al. 17 reported that the number of infusion-related administration errors decreased by 70% after smart pumps were introduced in an US paediatric hospital. This is similar to the 80% reduction in infusion-related medication errors found in this study when conventional pumps were compared to smart pumps with Guardrails. In the pre-intervention period, 6.9% and 0.2% of infusions had errors with ‘high’ and ‘extreme’ clinical significance, respectively. Similarly, Taxis et al.18 reported that 1% of infusions had errors which could result in severe consequences. Smart pumps will not prevent all types of infusionrelated medication errors and may introduce new types of errors. The Alaris GP pump with Guardrails requires that the user select the correct medicine from the drug library and errors can be introduced at the initial programming stage leading to adverse consequences.19 We found occasions where nurses selected the wrong drug regimen in Guardrails, e.g. frusemide was selected and then flucloxacillin was infused, and the prescribed concentration of heparin was correctly selected but the wrong concentration was prepared and administered. Incorporating strategies such as automatic drug recognition with barcode checking or radio frequency identification, and standardising admixture dose and volume, as part of the smart pump system could potentially prevent such errors. The drug library programmed into Guardrails would require regular updating to ensure clinical relevancy, and optimise the uptake of Guardrails by nurses. The uptake of Alaris GP pumps with Guardrails was lower than expected despite promotional activities and ongoing staff education for over 20 months after the smart pump system was introduced at the hospital in 2008. The fact that Guardrails was used in only 62% of the infusions in the post-intervention period, suggests there is a need for ongoing education and promotional activities. The modest uptake of Guardrails was possibly influenced by factors, such as the appointment of new nursing staff and the use of contract or casual nursing staff unfamiliar with smart pumps. As more hospitals introduce smart pumps and their use becomes widespread, the use of Guardrails is likely to increase. Furthermore, operating smart pumps requires additional data entry and programming by the user in comparison to a conventional pumps; this feature may also impact on uptake by nurses working in a busy environment. There were some limitations with the study. The study was conducted from 8.30 am to 5 pm on weekdays and excluded after hours, weekends and public holidays. The chronogram created by Fields et al.12 revealed that most infusion-related errors occurred from 3 pm to 9 pm with an unexpected peak at 6 pm. Our study could have underestimated the number and types of errors observed given that most of the observations were not conducted during times at which infusion-related errors are most likely to occur. In conclusion, the Alaris GP smart pumps with Guardrails resulted in significant reductions in the number and clinical significance of intravenous medication administration errors. Competing interests: None declared References 1. Institute for Safe Medication Practices. ISMP’s list of high-alert medications. Horsham: Institute for Safe Medication Practices; 2008. Available from <www.ismp.org/Tools/highalertmedications.pdf>. 2. Maddox RR, Danello S, Williams CK, Fields M. Intravenous infusion safety initiative: collaboration, evidence-based best practices, and “smart” technology help avert high-risk adverse drug events and improve patient outcomes. Rockville: Agency for Healthcare Research and Quality; 2008. Available from <www.ahrq.gov/downloads/pub/advances2/vol4/Advances-Maddox_38. pdf>. 3. Kaushal R, Bates DW, Landrigan C, McKenna KJ, Clapp M, Federico F, et al. Medication errors and adverse drug events in pediatric inpatients. JAMA 2001; 285: 2114-20. 4. Hunt ML Jr, Rapp RP. Intravenous medication errors. J Intraven Nurs 1996; 19 (3 suppl): S9-S15. 5. Bruce J, Wong I. Parenteral drug administration errors by nursing staff on an acute medical admissions ward during day duty. Drug Saf 2001; 24: 855-62. 6. Wirtz V, Taxis K, Barber ND. An observational study of intravenous medication errors in the United Kingdom and in Germany. Pharm World Sci 2003; 25: 10411. 7. The Joint Commission. Preventing pediatric medication errors. Sentinel event alert. Issue 39. 11 April 2008. Available from <www.jointcommission.org/assets/ 1/18/SEA_39.PDF>. 8. Han PY, Coombes ID, Green B. Factors predictive of intravenous fluid administration errors in Australian surgical care wards. Qual Saf Health Care 2005; 14: 179-84. 9. Institute of Healthcare Improvement. Reduce adverse drug events involving intravenous medications: implement smart infusion pumps. Cambridge: Institute of Healthcare Improvement; 2006. Available from <www.ihi.org/IHI/Topics/ PatientSafety/MedicationSystems/Changes/IndividualChanges/Implement SmartInfusionPumps.html>. 10. Institute for Safe Medication Practices. Proceedings from the ISMP summit on the use of smart infusion pumps: guidelines for safe implementation and use. Horsham: Institute for Safe Medication Practices; 2009. Available from <www.ismp.org/tools/guidelines/smartpumps/printerVersion.pdf>. 11. Malashock CM, Shull SS, Gould DA. Effect of smart infusion pumps on medication errors related to infusion device programming. Hosp Pharm 2004; 39: 460-9. 12. Fields M, Peterman J. Intravenous medication safety system averts high-risk medication errors and provides actionable data. Nurs Adm Q 2005; 29: 78-87. 13. Fanikos J, Fiumara K, Baroletti S, Luppi C, Saniuk C, Mehta A, et al. Impact of smart infusion technology on administration of anticoagulants (unfractionated heparin, argatroban, lepirudin, and bivalirudin). Am J Cardiol 2007; 99: 10025. 14. Rothschild JM, Keohane CA, Cook EF, Orav EJ, Burdick E, Thompson S, et al. A controlled trial of smart infusion pumps to improve medication safety in critically ill patients. Crit Care Med 2005; 33: 533-40. 15. Burridge N, editor. Australian injectable drugs handbook. 3rd ed. Melbourne: The Society of Hospital Pharmacists of Australia; 2005. 16. SHPA Committee of Specialty Practice in Clinical Pharmacy. SHPA standards of practice for clinical pharmacy. J Pharm Pract Res 2005; 35: 122-46. 17. Larsen GY, Parker HB, Cash J, O’Connell M, Grant MC. Standard drug concentrations and smart-pump technology reduce continuous-medicationinfusion errors in pediatric patients. Pediatrics 2005; 116: e21-e25. 18. Taxis K, Barber N. Ethnographic study of incidence and severity of intravenous drug errors. BMJ 2003; 326: 684-7. 19. Vicente KJ, Kada-Bekhaled K, Hillel G, Cassano A, Orser BA. Programming errors contribute to death from patient-controlled analgesia: case report and estimate of probability. Can J Anaesth 2003; 50: 328-32. Received: 24 May 2011 Revisions requested after external review: 23 June 2011 Revised version received: 20 August 2011 Accepted for publication: 22 August 2011 Journal of Pharmacy Practice and Research Volume 41, No. 3, 2011. This activity has been accredited for 1 hour of Group 2 CPD activity (or 2 CPD credits) suitable for inclusion in an individual pharmacist’s CPD plan, if online questions are completed and submitted. No: S2011/64 195