The concept of safety in drug use has experienced changes in recent years. The errors that occur in any of the phases of the drug utilization circuit result in important patient morbidity–mortality.1,2 In this regard, administration errors are the errors that prove most difficult to intercept,3 and their potential impact upon the patient depends on the administration route involved, the drug type and dose, and the characteristics of the patient. When high risk drugs are administered via the intravenous route in critically ill pediatric patients, the likeliness of damage in the event of error is seen to multiply.4 Guaranteeing safety in this scenario therefore should constitute a priority concern, and in this regard the use of smart infusion pumps (SIPs) may play an important role.

An intelligent (smart) infusion system is a conventional infusion system equipped with safety software that contains a drug library specific of each Unit, and which constitutes a list of drugs with concrete concentration, maximum and minimum dose, and infusion time specifications for each of them. The relationship between the dose and infusion time determines the administration rate, for which absolute and relative limits (both upper and lower) are established with the purpose of intercepting errors attributable to over- and under-dosing, respectively. In this way, if programming error breaches a relative limit, the user is alerted to the fact that the infusion rate might not be adequate for a given patient. However, the alert can be ignored and infusion can be continued, after checking that programming has indeed been correct. In contrast, the accidental breaching of an absolute limit generates an alert that cannot be obviated, and the user in this case must reprogram administration of the drug.5

Different organizations acknowledge the increased safety afforded by SIP technology, and advocate replacing conventional infusion systems with smart systems.6–8

However, the published information on the true impact of these systems in terms of the interception of programming error is still limited.8

The present study examines the impact of implementing SIP technology in the administration phase of intravenous drugs in a Pediatric Intensive Care Unit (PICU) in terms of the number and types of programming errors intercepted.

An exhaustive review of the alerts generated during the 62 months of utilization of the SIPs in the PICU identified 283 real programming errors that led to cancelation and/or reprogramming of the drug infusion – with the consequent avoidance of potential adverse effects in the patient.

The greatest incidence of alerts per hour of the day corresponded to the intervals 11:00–14:00h and 17:00–18:00h. With regard to the distribution per month of the year, the periods from June to August, December and January, as well as March and April yielded the largest number of alerts due to programming errors.

Percentage utilization of the safety software for the programming of infusions during the entire study period was 84% (840,223 infusions were started through the drug library out of a total of 997,723 programmed infusions using volumetric pumps and syringe pumps). Programmed administrations with volumetric pumps represented 11% of the total, while the remaining 89% involved the use of syringe pumps. Adherence to the drug library was 49.6% in the case of the volumetric pumps and 89.4% in the case of the syringe pumps, with a variation of ±1% over the entire study period.

The ratio between the number of alerts and the number of programmed infusions was 0.76%, while the percentage of alerts due to ignored relative limits was 68%, versus a 32% incidence of alerts due to relative limits that implied reprogramming of the infusion.

High risk drugs were implicated in 164 of the 283 intercepted programming errors (58%), involving mainly attempts to exceed an absolute upper limit (Table 1).

Table 2 (online supplementary material) shows the remaining drugs, not regarded as high risk substances, related to programming errors.

Guaranteeing safe drug use in patients is one of the main responsibilities of healthcare professionals. In order to assess the impact of the introduction of SIP technology in relation to the safety of intravenous drug administration, a distinction must be made between “medication error” and “adverse event”24,25:

Medication error is understood to be “any avoidable incident that can cause damage to the patient or give rise to inadequate medication use”.

An adverse event is defined as “any damage, whether mild or severe, caused by the use of a medication, or any damage resulting from the clinical use of a medication”. Adverse events in turn can be classified as avoidable (associated to medication error) or unavoidable (related to adverse reactions).

It should be noted that the programming errors intercepted by SIP technology reported in this study were avoidable incidents that did not reach the patient, but which could have caused an adverse event had they reached the patient.

In order to guarantee the contribution of this technology to safe drug use, a continuous evaluation program should be established in order to identify opportunities for improvement and thus optimize each phase of the project.26,27

The introduction of SIP technology in our PICU has achieved a drug library adherence rate of 84%, which is similar to the 92% adherence rate reported by some authors28 and far higher than the rates described in other studies (in the range of 30–40%).26,29

It is important to note that the drug library was the same with both the volumetric pumps and the syringe pumps, with the sole exception of fluid therapy, which was only available for the volumetric pumps, since these are the main systems used in the administration of fluids. In this regard, and because of problems in configuring the fluid therapy profile, for some time we were unable to start infusions through the database, and adherence with these devices was very low (49.6%). This had a negative impact upon overall adherence of SIP technology, since the safety software adherence rate was 89.4% when only considering the syringe pumps.

The fact that a drug library is incorporated to the infusion systems does not oblige the user to program administration through the library, and this is the most important limitation of the technology. However, in a certain sense the possibility of deciding whether or not to use the drug library may be an advantage in some situations, such as for example when intending to infuse a medication not included in the drug library, or in emergency scenarios requiring rapid patient stabilization, where we do not have the seconds needed to search the database for the drug to be programmed. Thus, reinforcing training and promoting safety culture among the nursing personnel are key elements for improving adherence to SIP technology.21

With regard to the distribution of alerts according to the time of day, the hourly intervals exhibiting the largest number of alerts, namely 11:00–14:00h and 17:00–18:00h, coincide with the hours in which medication is administered in the Unit, and where the probability of error is therefore greater. Fanikos et al.30 found the time interval with the largest number of alerts to be between 14:00–16:00h, coinciding with the changing of shift in the Unit.

On the other hand, an analysis of the distribution of alerts over the different months of the year shows the vacation months to accumulate a greater proportion of alerts. This is probably explained by the incorporation of substituting personnel members who are less familiarized with the systems and the protocols used in the Unit.

In our study, the percentage reprogramming rate due to the breaching of relative limits was very high when compared with the 4–6% reported by Breland,26 but lower than the 43.2% documented by Fanikos et al.30

In any case, and as also evidenced by other authors,31 the data obtained question the usefulness of relative limits, since they tend to be ignored. This is in contrast to absolute limits, which oblige infusion reprogramming and are therefore more directly implicated in the interception of errors.29,32 In our study, the breaching of relative limits did not result in potentially serious errors (referred to either the magnitude of the error or the type of drug involved). Nevertheless, periodic revision of these limits makes it possible to optimize their performance.

The implementation of this technology allowed the interception of 283 programming errors of different kinds during 62 months of SIP use in our PICU.

Estimation of the potential seriousness of an intercepted error and of the probability of causing an adverse event if the error had reached the patient is usually based on clinical judgment. The lack of a validated universal method for establishing the potential or real causal relationship of a medication error and of an adverse event often results in great variability in the classifications.33 Since these are avoided medication errors, it is difficult to estimate the damage they would have caused had they reached the patient. Nevertheless, the fact that 58% of the drugs implicated in these errors were high risk substances reasonably suggests that the potential damage would have been greater. In this regard, it must be taken into account that the high risk drug classification published by the ISMP makes no distinction between the adult and pediatric populations; as a result, there is an information gap regarding the safety profile of drugs used in children. With the purpose of casting some light on this issue, in 2013 the official journal of the Spanish Association of Pediatrics published a list of high risk drugs used in the pediatric population. In addition to the drugs cited by the ISMP, the list also contains some other substances of special interest in the pediatric population, such as paracetamol, antiepileptic drugs, immunosuppressors, diuretics and aminoglycoside and glycopeptide antibiotics.23 According to the information published in this article, the percentage of intercepted errors involving a high risk drug increased from 43.8% when only considering the ISMP classification to 58% when also considering high risk drugs in the pediatric population.

Likewise, the age of the patients (pediatric subjects in our case) is crucial for determining the potential seriousness of the intercepted administration errors, as evidenced by Folli et al.34 The administration of incorrect doses as a consequence of overdose was the most frequent error in the mentioned article, in coincidence with our own study, where most intercepted errors corresponded to the programming of doses or infusion rates far higher than those recommended for a given patient.

The main pharmacotherapeutic groups associated to programming error were adrenergic agonists and antagonists, sedating agents, analgesics, neuromuscular blockers and opioid narcotics, together with insulin and potassium.

In relation to antibiotics, it should be mentioned that although most of them are not included in the proposed lists of high risk drugs, they are associated to a large number of programming errors (representing 33.6% of the errors involving drugs not considered to be high risk substances).

Although most of the intercepted errors corresponded to overdose or the infusion of the correct dose in less than the recommended time, we found that a dose lower than the recommended dose had been programmed in two cases, corresponding to acyclovir and amikacin.

Other drugs not considered to be high risk substances, but which were related to programming errors intercepted in our study were metamizol, octreotide, omeprazole and ranitidine.

Practically all the programming errors identified in our study corresponded to alerts produced by the breaching of absolute upper limits. Other investigators have described programming errors due to the breaching of relative upper limits, with consequent reprogramming of the infusion.26,35 The drugs involved include propofol, fentanyl and vecuronium, i.e., analgesic-sedating agents; inotropic drugs such as dopamine and noradrenalin; insulin; and antibiotics such as vancomycin and linezolid. This error profile referred to the type of drug is consistent with that recorded in our own study. Fanikos et al.30 in turn underscored the importance of implementing SIP technology with a view to reducing anticoagulant drug programming errors.

Although some studies point to the potential of SIP technology in reducing the incidence of administration errors due to incorrect programming,31,36 some authors question its usefulness. Rothschild et al. concluded that the implementation of SIPs in critical care has no effect upon the number of avoided serious errors. The reason for this apparent failure of SIP technology to lower the number of errors is the scant utilization of the safety software observed by the reports. In this case, in the event of an error in programming an infusion, the system would not generate the corresponding alert, and the medication error could therefore reach the patient.29 The authors considered that despite the promising error-detecting potential of these systems, the factor limiting their success is acceptance of such technology by the nursing personnel – these being the professionals that handle such systems on a daily basis.

Likewise, different studies have reported that when SIP technology is used on an isolated basis in the healthcare setting, its capacity to detect errors is limited.37,38 It must be taken into account that of the “5 correct criteria” that must be met to guarantee safety of the drug administration process (i.e., correct patient, drug, dose, administration route and timing), only correct dosing can be ensured with this technology,39 and possible errors, such as inadequate identification of the patient, administration of the wrong medication, or the use of an incorrect administration route or timing, can still happen.

As long as those hospitals that use SIPs for the administration of intravenous drugs fail to develop an interface to connect the different technologies, certain types of errors will continue to occur within the drug utilization circuit – with possible consequences for the patients.

The implementation of SIP technology in a PICU has been shown to have a great impact in our hospital, since it is able to intercept programming errors related to high risk drugs.

The results obtained in our study may serve as the basis for extending this technology to other Units (with both adult and pediatric patients) that might benefit from it in the same measure as in the PICU. Nevertheless, due consideration is required of the limitations of this technology when it is used on an isolated basis. Collaboration among the different healthcare professionals – physicians, pharmacists, nursing personnel – and computing and software specialists is essential in order to guarantee the success of the project and make this tool easy to use and effective in avoiding errors.

The authors agree with the contents of the present manuscript and declare that they have no conflicts of interest.