Medication errors are common in hospital intensive care units (ICUs), occurring at a median rate of 106 per 1,000 patient-days for all routes of administration.1 Errors in this environment are particularly concerning because of the elevated risk of adverse drug events (ADEs) due to the inherent vulnerability of critically ill patients. Research indicates that patients within an ICU setting experience 19 adverse events per 1,000 patient-days, nearly double the amount of ADEs experienced by non-ICU patients. This reality becomes clearer in light of the fact that ICU patients often receive twice the number of medications as non-ICU patients.2
The environment of the ICU lends itself to higher rates of ADEs and medication errors than a general medical unit largely because of the complexity of patient care and trends toward polypharmacy in the ICU.1 In the latter case, not only does an elevated number of administered medications create risk, but the capacity for a medication to be used incorrectly or cause an error also is exacerbated, as many of the medications prescribed for critically ill patients are considered to be high-risk.3 Furthermore, ICU patients with conditions, such as acute kidney injury or thrombocytopenia, are already associated with a heightened risk of ADEs, notwithstanding the potential for multiple IV medications being administered at the same time.4 In addition to the risks posed by polypharmacy and enhanced by patient sensitivity, there are other factors specifically related to the ICU environment that can contribute to an increased risk for medication errors and/or ADEs. These factors, which tend to influence human process errors, include the fast pace of care, distracting noises, unexpected work interruptions, communication obstacles, and a lack of technology often found in the ICU. In order to address the risks associated with medication administration in the ICU—especially those related to IV medications—hospital pharmacies must first quantify the volume and ramifications of these errors and then develop prevention strategies to mitigate them.
Errors and ADEs Associated with IV Drug Administration
In the ICU setting, medications are most commonly administered intravenously, either by bolus or through continuous infusion.4,5 This is significant because the number of IV medications being administered to a single patient is directly proportional to an increased risk for ADEs in the ICU, while oral drug administration does not have the same effect.4 The majority of ICU patients do receive multiple IV medications that, in turn, require multiple catheters and infusion pumps, introducing more opportunities for error as the number of administration steps increase. Coincidentally, the error rate associated with continuous IV medication infusions only is a notable 105.9 per 1,000 patient-days when compared to the baseline medication error rate of 35 per 1,000 patient-days for any route of drug administration.5,6 Further to this, errors involving continuous infusions occur more frequently when the medication is weight based and requires a calculation to determine the appropriate dose.5
In order to delve more deeply into the specific reasons for such higher numbers, one study reviewed the frequency, type, and severity of IV medication errors involving 107 nurses at two hospitals who prepared and administered IV medications.7 During this study, 568 IV medications were prepared and administered, and of these, 70% were associated with at least one clinical error, 26% of which were considered serious. Incorrect rate of administration was the most common—accounting for 94% of serious errors—and administration of medications via IV bolus was found to have significantly higher error rates than infusions—77.2% versus 47.7%, respectively. Classes of medications by error rate also were analyzed and the top three classes of medications with the highest percentage of administrations with at least one IV error were antiulcerants (93.3%), antiemetics (75%), and anti-infectives (67%). In a separate study, the USP MEDMARX program performed an analysis on IV administration errors reported over a five-year period.8 This analysis covered 73,769 reported IV administration errors and revealed that 3% to 5% (or 2,213 to 3,689 errors) were harmful. While these descriptions of harm associated with medication errors is highly concerning, the numbers are still likely underestimated since MEDMARX is a voluntary reporting program and voluntary reports consistently underestimate the actual rate of medication errors and ADEs.
Financial Impact of ADEs
Not only are IV-related medication errors more harmful to patients, they also are associated with increased costs. Another study focusing on this topic found that IV medication errors increased total hospitalization costs by $6,647 (53%) within an academic ICU setting, post event.9 Of note, these financial consequences were not upheld in a nonacademic institution during the study, which is curious. We propose that this could be due to practice differences found in academic versus nonacademic institutions. Length of stay for patients that experienced an ADE as the result of an IV-related medication error was remarkably longer as well, with an increase of 4.8 days.
These increases in patient harm, total hospitalization costs, and length of stay caused by IV-related medication errors signify the need for appropriate prevention strategies. Pharmacists are in a prime position to contribute to the identification and prevention of ADEs by reviewing written orders, participating in patient care rounds, identifying inappropriate therapy, streamlining complex drug regimens, and suggesting enteral therapies when possible. The involvement of a pharmacist in patient care rounds has been shown to substantially lower the rate of preventable ADEs by 66%, and as a result, contributes to cost containment.7
The 30-minute Rule
Ensuring patient safety is always paramount, and organizations such as ISMP and CMS also are taking steps to promote safe IV medication practices. In light of another common error type in the ICU—omission mistakes or delayed drug administrations10—CMS have updated their stance on medication administration in regard to the so-called 30-minute rule.11 In the past, CMS mandated that medications must be administered within 30 minutes, either before or after, of the scheduled time. However, beginning in November 2011, the 30-minute rule was rescinded because it is no longer recognized as the standard of practice within the hospital setting. The removal of the 30-minute rule was largely due to survey results published by ISMP, which included responses from nearly 18,000 registered nurses. Those respondents specified that in order to adhere to the 30-minute requirement for administration of all medications, a large number of workarounds and unsafe practices were being utilized.
Through a combined effort from several national organizations, ISMP has since published its Acute Care Guidelines for Timely Administration of Scheduled Medications.12 In kind, CMS also updated their guidance involving the 30-minute rule and now permits hospitals to create their own medication administration policies and procedures (P&Ps), as long as those P&Ps are followed consistently. This change in guidance provides hospitals with the opportunity to determine which medications require precise timing of administration and which do not. Essential to making this process useful is pharmacy’s consideration of the impact of rapid medication administration on patient outcomes. For example, IV antibiotic administration should be a consideration, as published reports—including the Surviving Sepsis Campaign—have described an association between timely administration and mortality.13,14 Accordingly, complying with appropriate medication administration P&Ps deserves priority in critically ill populations.
Pharmacists are commonly involved in education efforts to optimize drug utilization, often establishing in-services delivered as didactic lectures. Simulation involving high-fidelity mannequins to illustrate practical examples with real-life scenarios is one method that has been used for in-service education. Notably, modifying teaching techniques to include patient simulations when conducting medication error education for nurses has demonstrated a substantial reduction in medication errors (25%).10 This study revealed that didactic lectures did not yield the same positive results in error reduction that actual patient simulation did. As such, pharmacists should explore the option of employing patient simulation as a medication error prevention strategy.
Standardization and Ready-to-Use Products
IV medication administration is generally considered more complicated and prone to error than other routes of administration because of the nature of access, delivery, preparation, and monitoring. For example, dispensing errors can occur for a variety of reasons, but most often, they take place during product preparation. These types of errors include selection of the wrong drug, wrong administration rate, wrong mixture, wrong volume, or incompatibility.7 In addition, the wrong diluents may be used.15 To compound this problem, there are several challenges that further compromise safe IV medication use; the lack of standardization for IV medication treatments, including drug nomenclature, dosing units, and infusion rates, is among them. This lack of standardization clearly indicates that compliance and accountability among members of different health care disciplines remains an issue.16
In order to remedy this situation, it is important to look closely at the benefits and limitations of existing drug delivery systems. Manufacturer prepared or ready-to-use parenteral medications can solve many of the issues listed above. Ready-to-use products help standardize drug regimens, streamline workflow, reduce the number of steps involved in IV preparation, have a low contamination risk, and help reduce waste.17,18 Developing a specific protocol for administration of these agents further reduces the rate of medication errors.10 One effective approach for protocol design is to develop an electronic drug administration guide for all IV medications. Allow the nurses to access the guide from the electronic medication administration record to obtain needed information about the drug, dose, and infusion rate.
Technology—Now and for the Future
Over the past two decades, the introduction of technology-based medication safety initiatives has been an iterative process. While each new process has not eliminated all errors, the number of adverse events has been significantly reduced (see Figure 1).19 However, these results suggest that health technology improvements will always require modifications and continuous improvement efforts.
Moving forward, medication safety initiatives are expected to remain focused on the collation of health information via technological systems, with an emphasis on integrating that information across the continuum of care.20,21 In the acute care setting, this means integrating devices and practitioner computer modules to ensure constant monitoring of medication use. By enabling the collection of real-time data, clinicians can readily respond with dose or infusion rate changes and direct medication changes in order to prevent ADEs.22 Likewise, mobile devices are certain to assist in processing information flow and providing information to clinicians at a local level. Pharmacists should actively partake in this integration of storage systems, dispensing systems, and robotic compounding systems with drug infusion devices and electronic medication administration records.23 Creating an interface that connects clinical applications and data with pharmacy systems is becoming more and more important for the adoption and implementation of new technologies and their beneficial impact on patient safety. Nowhere is this more vital to medication error prevention than in the ICU.
IV Safety Must Be a Team Effort
Today, numerous health care practitioners and regulatory agencies are stakeholders in improving IV medication safety. To capture and make use of input from these stakeholders, a multidisciplinary team of physicians, pharmacists, nurses, respiratory therapists, and risk managers, as well as ad hoc members of senior hospital leadership, should be convened to discuss strategies and solutions. This team should be assigned responsibility for assessing IV medication safety technologies and determining the staff resources, time required for implementation, cost burden, and potential for reducing the risk of harm to patients necessary for those technologies to be effective in the context of quality care. Furthermore, the impact of new technology and systems on staff satisfaction and productivity must not be overlooked.
The time required to implement an IV safety system is one component that deserves extra attention, as it invariably will be a process that must be applied over several years. Therefore, pharmacy leadership should have a critical role on this team in evaluating drug delivery systems and identifying those that enhance safety, determining what is affordable from the hospital’s perspective, educating other staff, and contributing to the hospital’s culture of promoting greater medication safety. Ultimately, successful teams always embrace communication, compromise, consensus, respect, collaboration, and a shared vision toward a mutual goal.
Regardless of whether a hospital has tools to determine the frequency and severity of IV medication errors in the ICU, we know these errors occur frequently, so it behooves all hospitals to seek out methods to gain control over medication use processes. Given that IV medications are innately more likely to cause an ADE as compared to oral medications, and as ICU patients are particularly vulnerable to errors and ADEs, special attention must be paid in this area. IV-related medication errors are directly associated with increases in patient harm, total hospitalization costs, and length of stay, all concepts anathema to a well-run pharmacy operation.
To counteract the risks associated with IV medications, numerous safeguards are being promoted and implemented in hospitals across the country, including dynamic education on error types, increased utilization of ready-made preparations (eg, single dose vials) and ready-to use products, and continued adoption of CPOE, BCMA, and smart pumps. National organizations are also taking a stance and updating guidelines to support safe practices, and those guidelines should be seen as practice necessities, not options. Ultimately, the greatest principal safeguard in ensuring patient safety will be the ability of all health care providers to access patient information across the continuum of care. With a clear picture, even the most vulnerable and endangered patients can be assured that they will be cared for in the best possible way.
- Kane-Gill SL, Jacobi J, Rothschild JM. Adverse drug events in intensive care units: Risk factors, impact, and the role of team care. Crit Care Med. 2010;38:S83-S89.
- Cullen DJ, Sweitzer BJ, Bates DW, et al. Preventable adverse drug events in hospitalized patients: a comparative study of intensive care and general care units. Crit Care Med. 1997;25:1289-1297.
- Institute for Safe Medication Practices. ISMP’s List of High-Alert Medications. Available at: http://www.ismp.org/Tools/highalertmedications.pdf [Accessed October 8, 2012].
- Kane-Gill SL, Kirisci L, Verrico MM, et al. Analysis of risk factors for adverse drug events in critically ill patients. Crit Care Med. 2012;40:823-828.
- Herout PM, Erstad BL. Medication errors involving continuously infused medications in a surgical intensive care unit. Crit Care Med. 2004;32:428-432.
- Leape LL, Cullen DJ, Clapp MD, et al. Pharmacist participation on physician rounds and adverse drug events in the intensive care unit. JAMA. 1999;282:267-270.
- Westbrook JI, Rob MI, Woods A, et al. Errors in the administration of intravenous medications in hospital and the role of correct procedures and nurse experience. BMJ Qual Saf. 2011;20:1027-1034.
- Hicks RW, Becker SC. An overview of intravenous-related medication administration errors as reported to MEDMARX, a national medication error-reporting program. J Infus Nurs. 2006;29:20-27.
- Nuckols TK, Paddock SM, Bower AG, et al. Costs of intravenous adverse drug events in academic and nonacademic intensive care units. Med Care. 2008;46:17-24.
- Ford DG, Seybert AL, Smithburger PL, et al. Impact of simulation-based learning on medication error rates in critically ill patients. Intensive Care Med. 2010;36:1526-1531.
- CMS. Updated Guidance on Medication Administration, Hospital Appendix A of the State Operations Manual. Available at: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter12_05.pdf [Accessed October 8, 2012].
- Institute for Safe Medication Practices. ISMP Acute Care Guidelines for Timely Administration of Scheduled Medications. Available at: http://www.ismp.org/Tools/guidelines/acutecare/tasm.pdf [Accessed October 8, 2012].
- Meehan TP, Fine MJ, Krumholz HM, et al. Quality of care, process, and outcomes in elderly patients with pneumonia. JAMA. 1997; 278:2080–2084.
- Dellinger RP, Carlet JM, Masur H, et al. Surviving Sepsis Campaign guidelines for management of severe sepsis and septic shock. Crit Care Med. 2004;32:858-873.
- Cousins DH, Sabatier B, Begue D, et al. Medication errors in intravenous drug preparation and administration: a multicentre audit in the UK, Germany, and France. Qual Saf Health Care. 2005;14:190–195.
- ASHP Reports: Proceedings of a summit on preventing patient harm and death from i.v. medication errors. Am J Health-Syst Pharm. 2008;65:2367-2379.
- Borthwick M, Keeling S, Keeling P, et al. Towards standardisation of drug infusion concentrations in UK critical care units. TICS. 2009:10:197-200.
- Maddox RR. Intravenous infusion safety initiative prevents medication errors, leading to cost savings and high nurse satisfaction. Agency for Healthcare Research and Quality. Available at: http://www.innovations.ahrq.gov/content.aspx?id=2375 [Accessed October 25, 2011].
- Poon EG, Keohane CA, Yoon CS, et al. Effect of bar-code technology on the safety of medication administration. N Engl J Med. 2010. 362:1698-1707.
- Crosson FJ. 21st-century health care—the case for integrated delivery systems. N Engl J Med. 2009; 361:1324-1325.
- The Food and Drug Administration. The future of drug safety—promoting and protecting the health of the public. Available at: http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM171627.pdf [Accessed October 8, 2012].
- Kane-Gill SL, Visweswaran S, Saul MI, et al. Computerized detection of adverse drug reactions in the medical intensive care unit. Int J Med Inform. 2011;80:570-578.
- Murtuza A, Summerfield M. Using robotic IV syringe preparation to enhance pharmacy operations. Pharm Purch Prod. 2009;6:44-47.
Tiffany R. Chapman, PharmD, BCPS, is the PGY2 medication use safety pharmacy resident at the University of Pittsburgh Medical Center (UPMC) in Pittsburgh, Pennsylvania. She completed her PGY1 pharmacy residency training at NorthShore University HealthSystem in Highland Park, Illinois, and earned her PharmD from South Dakota State University in Brookings, South Dakota.
Sandra L. Kane-Gill, PharmD, MS, FCCM, FCCP, is associate professor of pharmacy and therapeutics at the University of Pittsburgh School of Pharmacy. In addition to her academic appointments, Sandra is the critical care medication safety officer in the department of pharmacy at UPMC. She received her BS in pharmacy from Wayne State University in Detroit, Michigan, her PharmD from the University of Toledo in Toledo, Ohio, and her MS in pharmacy administration from The Ohio State University in Columbus, Ohio.
John Fanikos, MBA, RPh, is director of pharmacy business and financial services at Brigham & Women’s Hospital in Boston. He also is assistant professor of clinical pharmacy practice at Northeastern University and at the Massachusetts College of Pharmacy (MCP).
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