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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
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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