Article Text
Abstract
Background Errors and the incorrect use of medications are significant sources of risk and harm to children in US hospitals. The risk associated with medication infusions has led to recommendations for the adoption of technologies including computer order physician entry (CPOE) and ‘smart’ infusion pumps despite a paucity of evidence demonstrating the ability of these technologies to reduce harm to paediatric inpatients.
Objective To measure discrepancies between medication orders for infusions entered into a CPOE system and the medication being infused as measured by the programmed settings of the smart infusion pump within a paediatric intensive care unit.
Methods This study used a prospective, observational design in a 30-bed paediatric intensive care unit. Data were simultaneously collected from the medication orders in the CPOE system and the bedside smart infusion pumps by trained observers. Analysis consisted of a line-by-line comparison of order observation data with the pump observation data.
Conclusions Of 296 observations of medication infusions and 231 observations of intravenous fluid infusions, the frequency of discrepancies between orders entered and pumps programming ranged from 24.3% for observed medications to 42.4% for observed fluids. Anti-infectives (100%), concentrated electrolytes (46.7%) and anticoagulants (46.2%) were associated with greatest discrepancy between orders and programmed doses.
- Medications
- infusion pumps
- computer order entry
- pediatrics
- risk
- healthcare quality improvement
- human factors
- medication error
- medication safety
- patient safety
Statistics from Altmetric.com
- Medications
- infusion pumps
- computer order entry
- pediatrics
- risk
- healthcare quality improvement
- human factors
- medication error
- medication safety
- patient safety
Introduction
Errors and the incorrect use of medications are significant sources of risk and harm to children in US hospitals.1–3 Medication errors are classically defined as ‘any error occurring in the medication use process.’4 A study of medication errors among children found that the rate of preventable adverse drug events (ADE) was five per 10 778 (0.05%), similar to adult studies.5 However, the rate of potential adverse drug events (errors that occurred yet did not harm the patient) was three times higher in children when compared with adult rates (1.1% vs 0.35%). These potential ADEs were most common in neonatal intensive care units, a finding that is consistent with previous work demonstrating a higher number of medication errors in neonatal and paediatric intensive care units.6 7 The reported incidence of medication errors in paediatric intensive care units (ICUs) is between 22 and 55 per 1000 doses.5 8 While not all medication errors cause harm, they are sources of risk and of potential harm to children.
The use of intravenous medications has been identified as a specific source of medical risk. In one adult ICU setting, 83% of ADEs were related to medications in intravenous form.9 The risk related to intravenous medications includes those medications administered via an infusion pump. A study of infusion errors in an adult setting found that 66.9% of intravenous medications had one or more error associated with their administration, and infusion pumps accounted for up to 35% of all medication errors resulting in significant harm to patients in one children's hospital.10 11
In response to the errors and harm associated with medication infusions, recommendations have called for the adoption of a range of healthcare information technologies (HIT) including computer order physician entry (CPOE), bar-coded medication administration (BCMA) and ‘smart’ infusion pumps.10 12 13 Unfortunately, while these technologies have been associated with the elimination of errors, the available studies have yet to demonstrate that the technologies reduce harm. For instance, studies of CPOE suggest that the errors most commonly prevented are those that are least likely to cause harm.14 Furthermore, while there has been a national call for the use of CPOE based on its ability to decrease prescribing errors, examination of CPOE by both quantitative and qualitative measures has revealed its potential association with new and unanticipated errors.15–18 Similarly, ‘smart’ infusion pump technology has been identified as a means of preventing errors with little evidence to support the prevention of harm.19 20 Like adult studies, there is a paucity of evidence demonstrating the ability of these technologies to reduce harm to paediatric inpatients.21
Applying insight into work systems from the science of human factors engineering (HFE) may provide a helpful perspective through which to view the limited realised benefits of these medication safety technologies. One such model, the SEIPS model, illustrates how people (both healthcare providers and patients) use tools and technologies to perform tasks in various environments within the context of an organisation.22 23 These five components and their interactions result in the emergent properties of safety and quality of the system of care delivery. In light of such a model, what may be viewed as the simple introduction of technology (infusion pumps) may actually result in a fundamental change to systems of care delivery that impact providers and their tasks.
Further, work into the multidimensional nature of nursing workload suggests that there may be at least three types of nursing workload that exist within the context of a specific care unit. These include unit-level, job-level and task-level workloads.24 25 While the unit-level workload can be thought of as staffing ratios on a nursing unit, the job-level workload includes both general and specific demands of a given job, and the task-level work is includes the aspects of the work that is specific to a given activity. Additionally, changes to one level of workload may have unintended and negative consequences for other levels of workload. Thus, the task-level activities associated with using a new technology, such as an infusion pump, may have an impact on unit- and job-level work. Conversely, the job- and unit-level workload may influence the ability to perform task-level work.
With a model of a system of healthcare delivery and the concepts of multidimensional work in mind, the primary objective of this study was to measure discrepancies between medication orders for infusions entered in to a CPOE system and the medication (or fluid) actually being infused as indicated by the programmed settings of the smart infusion pump, in the setting of a PICU. A second objective was to interpret the findings from the study in using HFE concepts in the hopes of better understanding why any observed discrepancies may exist.
Materials and methods
Study design
This study used a prospective, observational design in a 30-bed paediatric intensive care unit (PICU), averaging 1820 admissions per year, in a free-standing children's hospital located in the Midwest. The patient population in the PICU includes children ranging from 1 day to over 18 years of age, with a wide range of disease processes including trauma, cardiothoracic surgery, respiratory failure, metabolic disease and sepsis. Trained PICU nurses perform infusion pump programming, while orders for medication infusions and intravenous fluids may be entered into the CPOE system by attending physicians, trainees (fellows and resident physicians), as well as nurse practitioners and physicians assistants. Data were gathered over a period of 24 weekdays, and approval from the hospital Institutional Review Board was obtained prior to any data collection.
Technologies
The CPOE system, Sunrise Clinical Manager Version 4.5 by Eclipsys Technologies Corporation, was implemented in September of 2000, with more than 90% of orders directly entered into the system. The ‘smart’ infusion pumps (Smith-Medex) were implemented in 2006.
Data collection
For this study, infused medications were defined as medications requiring the use of an infusion pump. These included both continuous infusions over multiple hours or days as well as single-dose infusions. Intravenous fluids were defined as total parenteral nutrition (TPN), lipids and crystalloid infusions requiring the use of an infusion pump.
Data were simultaneously collected from the medication orders in the CPOE system and the bedside smart infusion pumps by trained observers, once a day during weekdays over a period of 24 days. One observer went from bed space to bed space recording date, time, bed number and each infused medication or fluid, along with the corresponding dose or rate. A second observer reviewed existing orders by bed space, capturing the date and time of observation, and each ordered medication or fluid with its respective dose or rate. All data were then entered into a spreadsheet, which was stored in a secured manner.
No patient related-information was collected during this study. Information was simultaneously collected only from medication orders and infusion pumps, using the patient bed space as the basis for linking orders and pumps. Therefore, patients not receiving infused medications (as evidenced by the absence of pumps) were excluded from the pump observation component.
Analysis
Analysis consisted of a line-by-line comparison of order observation data with the pump observation data, matched by time and bed number. Any observations which occurred more than 15 min apart were excluded to minimise the effect of any interim changes to order or pump. For each observed medication infusion, analysis began with verifying the presence of a corresponding order. For each observed medication that had a corresponding order, the doses that were ordered and programmed were compared. Observed intravenous fluids were compared with the ordered fluids, and when corresponding orders and fluids were identified, the rate of administration was compared. The frequency of discrepancies by medication and fluid type was established.
Discrepancies were defined as follows: a medication or fluid found to be infusing without a corresponding order was categorised as an unauthorised medication or unauthorised fluid. When no medication or fluid infusion was observed despite the presence of an active order, this discrepancy was categorised as an omitted medication or omitted fluid. Finally, when the medication or fluid infusing at the bedside was observed to differ in dose or rate when compared with the active order in CPOE, this discrepancy was categorised as a wrong medication dose or wrong fluid rate.26
Results
A total of 296 observations of medication infusions and 231 observations of intravenous fluid were completed during the study period of 24 days. No observations required exclusion based on the predetermined 15 min repugnant time window for orders and programming. Seventy-two of the 296 (24.3%) observations of medications revealed order-programming discrepancies, while 97 of the 231 (42%) observations of intravenous fluid revealed order-programming discrepancies (tables 1, 2).
Of the 72 medication observations that revealed order-programming discrepancies, 62 (86.1%) of the discrepancies were due to either unauthorised medications or omitted medications, while 10 (13.9%) of the detected discrepancies were due to wrong medication dose (table 3). When the medication observations were classified by medication category, those categories with the most frequent order-programming discrepancies included anti-infectives (100%), concentrated electrolytes (46.7%) and anticoagulants (46.2%). Within the anti-infective and concentrated electrolyte groups, every discrepancy was identified as an unauthorised medication, whereas anticoagulant discrepancies were almost evenly split between unauthorised and omitted medications. None of the discrepancies observed within the anti-infective medications, concentrated electrolytes or anticoagulants were found to be due to a wrong dose.
Similar to the observed medications, 56.7% of the observed order-programming discrepancies among intravenous fluids were due to unauthorised and omitted fluids. The observed order-programming discrepancies among intravenous fluids also revealed a high frequency of incorrect rate of infusion (43.3%), whereas there were fewer observed wrong doses among the medications. The greatest number of observed intravenous fluid discrepancies was in dextrose-containing fluids (48.3%) and TPN (50%) (table 2). For both crystalloids and TPN, discrepancies were divided fairly equally between unauthorised/omitted fluids and wrong fluid rates (table 3).
Discussion
We observed a high frequency of discrepancies between medication and intravenous fluid orders within a CPOE system and programmed settings on ‘smart’ infusion pumps at the beside. The observed frequency of discrepancy (24%) between medication order and the medication infusions in our study is similar to the frequency observed by Barker et al (19%) in 2002.26 There are no published frequencies of fluid discrepancies to compare with our observed frequency of intravenous fluid discrepancies (42%). Among the medication classes of anti-infectives, concentrated electrolytes and anticoagulants, the observed frequency in order-programming discrepancies ranged from 40 to 100%. This is of particular concern because concentrated electrolytes and anticoagulants have been identified as high-risk medications.27
Why were these discrepancies present? The exact cause for any specific observed discrepancy is unclear; however, a number of potential origins have been identified. Problems with order entry include omission of entry as well as incorrect order entry. Alternatively, pump programming may be the source of the discrepancy and could be related to a lack of recognition of active orders, failure to execute programming, and incorrect programming. Regardless of the origin, it should be noted that there are inherent risks and potential for harm within the process of reconciling these discrepancies. Specifically, there is a very real risk that a nurse may discover the discrepancy between order and infusion pump, and decide to reconcile it by changing one to match the other. As long as the nurse correctly reconciles to the accurate item (order or pump), the patient does well. However, reconciliation of the incorrect item may create additional risk of patient harm.
Due to the limitations of this study, several questions remain. First, which is correct: the medication order in the CPOE system or the actual pump settings? Our study cannot answer this, as it was impossible to tell which technology reflects the intent of the prescribing physician and which technology was incorrect. Anecdotally, asking the bedside providers or physicians may not help clarify whether the order or the pump is correct because these providers typically go to the pump or order to aid their recall. A second question that remains unanswered by this study is, why might this phenomenon be occurring in the first place? This question is perhaps easier to answer by considering the flow of actions and information associated with titration of infusions of medications.
For medications that are titrated for clinical effect, such as epinephrine, the assumed process by the engineers designing CPOE and infusion technologies is as follows: Provider conceives of order → Provider enters order → Provider communicates order to nurse → Nurse reprogrammes infusion pump.
While this may happen, there are other variations of this process that appear to occur related to the patient being the point of initiating care and NOT the computer. For instance, the sequence may be: Provider conceives of order → Provider enters order → Provider fails to communicate order to nurse → Nurse does not act or acts only after later discovering order.
More commonly, an evaluation of the patient at the bedside leads to one of the following occurrences: Provider exams patient → Provider conceives of order → Provider communicates order to nurse → Nurse reprogrammes infusion pump → Provider may or may not later enter order → Nurse may or may not enter order as verbal order in the event they realise the provider failed to enter the order. Or: Provider exams patient → Provider conceives of order → Provider reprogrammes infusion pump → Provider may or may not later enter order.
In this last example, the nurse may not recognise that a pump change was made for some time.
An additional factor that likely contributed to the increased frequency of discrepancies between CPOE orders and pump programming relates to vascular access and the number and relative timing of infusions, and compatibility of medications. For example, orders within a CPOE system may indicate that multiple medications are to be given within a narrow time frame. Depending on the duration of infusion and compatibility of the various medications, it may be necessary for the bedside nurse to delay administration of one medication while another is infusing. This situation could have led to observation of either omitted or unauthorised medications under our study design, and it may help explain the high frequency of discrepancies within the anti-infective and concentrated electrolyte medication groups.
This study was based on a several concepts from the science of human factors engineering including a model of understanding systems in healthcare as well as the multidimensional nature of nursing work. The issue of nursing work is critical to this study, as nurses are the providers who program infusion pumps in the studied PICU. This task-level activity (programming a pump) is performed in a system that involves multiple prescribing physicians and clinicians who are charged with entering orders into the CPOE system. The nurses in the PICU act as one of several ‘people’ in the care delivery system who must perform the task-level action of order discovery and pump programming while also performing their job- and unit-level activities.
An additional concept that is important to this study is the understanding that errors and harm are both manifestations of flawed systems of care delivery.19 These system flaws can be identified as risks, which can then be analysed for potential impact and reduced, when appropriate. Using this concept, this project did not attempt to identify harm from medication errors. How harm might manifest in any given patient would vary by the medication or fluid involved in a discrepancy and by the cause of the error. An unauthorised medication might create harm that would be different from an omitted medication or wrong dose. The heterogeneity of diagnoses, severity of illness, comorbidities, ages and other therapies that exist in a PICU setting confound the detection of harm. Thus, the goal was to identify any discrepancy between a medication order and the actual programmed infusion that created the potential for harm to patients. Only through identifying and analysing risks can the process of risk elimination and mitigation begin.
This leads to the final question that remains unanswered by this study: how best to eliminate or mitigate this risk? The question is most difficult to answer. Because the expectation of information and work flow as envisioned by designers of technologies used in medication delivery is very different from the reality at the bedside, any solutions may serve as ‘workarounds’ that increase risk. Thus, the introduction of technologies intended to reduce risk and harm may, by virtue of inadequate understanding of the pre-existing and resultant systems of medication delivery, create increased risk. This is particularly true in ICU environments where the changes are often made at the patient's bedside. Ironically, these patients happen to be among the most ill and most complex, receiving large numbers of potentially dangerous medications.
Conclusions
Our study revealed potential risks that result from the interactions between different providers performing the tasks of ordering intravenous medications and fluids, and the programming of the infusion pumps in a paediatric intensive care unit environment that has adopted two safety technologies, CPOE and ‘smart’ infusion pumps. Both healthcare providers and designers of technology might benefit from more intensive understanding of such interactions before tampering with existing systems.
References
Footnotes
Competing interests None.
Provenance and peer review Not commissioned; externally peer reviewed.
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