Pharm World Sci (2009) 31:413–420

DOI 10.1007/s11096-008-9269-5

RESEARCH ARTICLE

The preparation and administration of intravenous drugs before

and after protocol implementation
Mirjam Tromp Æ Stephanie Natsch Æ
Theo van Achterberg

Received: 14 February 2008 / Accepted: 9 November 2008 / Published online: 3 December 2008

The Author(s) 2008. This article is published with open access at Springerlink.com

Abstract Objectives This paper reports on a pilot study wards (T = 1.36, df = 55, P = 0.18). After the
examining the incidence of nurses’ errors in preparation and implementation of the new protocol, nurses at the inter-
administration of intravenous drugs. Furthermore, the study vention ward scored better (72) than nurses at the control
aimed to evaluate the short-term effects of implementation ward (69). The mean score at the intervention ward was
of a new protocol for preparation and administration of significantly higher than the score in nurses of the control
intravenous drugs. Setting Two nursing departments of ward (T = -2.20, df = 53, P = 0.04). Conclusions The
internal medicine at a 953 beds University Medical Centre number of errors in the preparation and administration of
in The Netherlands. Methods By means of a prospective, intravenous drugs is high. This study shows that imple-
quasi-experimental design, nurses were observed during the menting a protocol for the preparation and administration of
process of preparation and administration of intravenous these drugs can reduce the number of errors.
drugs. Observation was performed before and after the
implementation of a new protocol. Seventy-two nurses at Keywords Drug administration routes
Infusions

two nursing departments were observed during the study. Injections
Intravenous administration
Netherlands

Main outcome measure A mean pre-test and post-test Nursing research
Parenteral
Practice guideline

quality score at two departments of internal medicine. Quality assurance
Results At baseline, average quality scores for nurses at the
two departments were 64 (intervention ward) and 67
(control ward) on a 0–100 quality scale. The pre-test quality Impact of findings on practice
scores were not statistically significant for the two nursing
• Errors in preparation and administration of intravenous
drugs occur frequently and can cause irreparable dam-
M. Tromp age to patients.
Department of Internal Medicine and Nijmegen Institute • Errors in the preparation and administration of intrave-
for Infection, Inflammation and Immunity (N4i), Radboud nous drugs decrease significantly after implementation
University Nijmegen Medical Centre, Nijmegen,
The Netherlands
of a protocol, leading to improved quality of care and
patient safety.
S. Natsch (&)
Department of Clinical Pharmacy and Nijmegen Institute
for Infection, Inflammation and Immunity (N4i), Radboud
University Nijmegen Medical Centre, Internal Postal Code 864,
P.O. box 9101, Nijmegen 6500 HB, The Netherlands Introduction
e-mail: [email protected]
Patient safety is an important issue in health care today. For
T. van Achterberg the USA it was estimated that more than a million injuries
Scientific Institute for Quality of Healthcare Nursing Science
Section, Radboud University Nijmegen Medical Centre, and 44,000–98,000 deaths per year are related to subopti-
Nijmegen, The Netherlands mal care or mistakes made by health care workers [1]. Yet,

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hospitalized patients are, as a rule, vulnerable and they difficulties in the developing and maintaining of intravenous
assume that health care will improve, rather than com- therapy protocols were identified. However, attempts to
promise, their health. Therefore, improving patient safety is improve the quality of the process of preparing and
an important area for practice improvement as well as administering intravenous drugs are minimal described
research, and it covers a large variety of topics such as pre- in the international literature [15, 16]. Yet, the quality of
operative cardiac events, surgical items left in patients, this process is of vital importance in providing safe patient
pressure ulcers, hospital acquired infections, falls and fall care and attempts at quality improvement deserve to be
injuries and delirium [2]. explored.
Adverse drug events are among the most common types These clinical observations, and the motivation to
of health care errors [3–7]. In a study by Bates et al. 1% of guarantee patient safety, were the reasons to examine the
all adverse drug events were fatal, 12% were life threat- quality and the effects of an attempt towards quality
ening, 30% were serious and 57% were significant [8]. In improvement of the preparation and administration of
the same study, 40% of all events were due to mistakes in intravenous drugs in a Dutch academic hospital.
the process of administering drugs. The risk involved
seems especially high in the more complicated medication
administration processes, such as in the administration of Aims of the study
intravenous drugs.
The preparation and administration of intravenous drugs The aims of the study were:
is a series of complicated technical skills. The conse-
quences of medication preparation and administration • To evaluate the quality of the preparation and admi-
errors can be anything from relatively harmless to lethal. nistration of intravenous drugs as performed by nurses
Single site studies in the UK and USA confirm that nurses in general medicine hospital wards;
make mistakes in preparing and administering intravenous • To evaluate the effects of the implementation of a
drugs in 13–84% of all cases [9, 10]. These studies used protocol on the quality of the preparation and admi-
different definitions for ‘errors’ in preparing and adminis- nistration of intravenous drugs.
tering intravenous drugs, thus making comparisons
difficult. The study of Taxis and Barber describes the dif-
ferent stages in the process in which errors occur, as well as Methods
the clinical importance of these errors [11]. In this study,
one or more errors occurred in 49% of all cases of the The study employed a quantitative, prospective, quasi-
preparation and administration of intravenous drug doses. experimental design. The researcher observed the perfor-
Preparation errors occurred in 7%, administration errors mance of nurses during the process of preparation and
occurred in 36% and both types of errors were found in 6% administration of intravenous drugs at two nursing
of all cases. 1% of these errors were potentially severe, departments of internal medicine at a 953 beds University
29% were potentially moderately harmful and 19% were Medical Centre in The Netherlands.
considered to be minor errors. The study included data collection at baseline (pre-test:
Examples of errors observed in practice and described in 8 weeks), an intervention period while the new protocol
studies are: was implemented in one of the two wards (2 weeks), and a
• administering a bolus dose too quickly; post-implementation test (post-test: 8 weeks). Nurses’
• not inspecting the medicine for expiration date; performance in the preparation and administration of drugs
• not double-checking the prescribed drug, doses and was the main focus of the study.
corresponding patient by a colleague;
• not observing hygiene regulations [11–13]. Inclusion
In conclusion, the evidence of quality and errors in the
Nurses were eligible for the study if:
preparation and administration of intravenous drugs is rather
scarce, but points towards a potentially problematic quality • They were Registered Nurses at the departments of
of care issues. The study by Cousins et al. compares the internal medicine;
intravenous therapy protocols for hospitals in the UK, • They were fully qualified for the preparation and
Germany and France [12]. The study by Anselmi et al. administration of intravenous drugs;
verified the frequency of errors in the preparation and • They declared themselves competent in the preparation
administration of intravenous drugs in three Brazilian hos- and administration of intravenous drugs;
pitals in the States of Bahia [14]. In all hospitals, various • They gave permission for observation by the researcher.

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As nurses were also observed during the administration observation list. Nurses were aware of the observation but
of drugs, patient encounters were part of the observations. unaware of its true purpose [20, 21].
Therefore, an additional inclusion criterion for the The names of the nurses, the number of observation by
observations was: the individual nurse and the phase of the study were
registered.
• Patients receiving drugs should (be able to) give
Observation took place on different days of the week, at
informed consent for the observations by the
different times of the day and night, and at both hospital
researcher.
wards. The observer was present during a preset series of
shifts, to represent the variation of working hours in
Protocol and observation list nursing practice.
It was determined beforehand when intervention would
A multidisciplinary team including two researchers, a be necessary. The project team decided that in case of
hospital pharmacist, a nurse practitioner, a ward nurse, an preparation of the wrong drug, preparation of the wrong
infection control practitioner and an occupational hygienist dose, preparation with the wrong diluent, administration
developed the new protocol, using the knowledge of using the wrong route and administration to the wrong
experts and the evidence from the scarce literature [17–19]. patient, the researcher should not only score the errors, but
An observation list was directly derived from this protocol. also intervene by talking to the nurse about these poten-
The observation list is a specification of the protocol and tially harmful errors.
consisted of 47 variables (Appendix). The variables re-
present the steps a nurse has to take in the preparation (30) Intervention
and administration (17) of intravenous drugs. Some of the
steps during the process of preparation and administration The intervention was the implementation of the protocol
had to be repeated more than once. All 47 aspects on the regarding the preparation and administration of intravenous
list were observed during all occasions where nurses pre- drugs at one of the departments, the intervention depart-
pared and administered intravenous drugs. ment. Implementation took place, during a one-time
With the observation list the option ‘‘yes’’, ‘‘no’’, ‘‘not 45 min department meeting by means of a presentation of
applicable’’ or ‘‘missing’’ could be checked. When the the pre-test results and a 15 min film with and without the
observer was not sure of his observation then one or more presentation of errors in the preparation and administration
aspects were scored as ‘‘missing’’. If the operation of a step of intravenous drugs. In addition, questions were answered
was not complete, for example, the nurse did not wait and current practices versus the new protocol were dis-
before the disinfection solution to dry, that item was scored cussed. For instance, one of the items discussed was the
as a ‘‘no’’. All variables were given equal weights. Scores disinfecting of the hands in combination with the wearing
on the items were combined in an overall quality score to of gloves. Nurses thought that when they wore gloves they
represent the number of items that were correctly per- do not have to disinfect their hands.
formed. This overall quality score was expressed on a Following the presentation, the new protocol was
0–100 quality scale. When all 47 aspects were performed available to all the nurses at the ward. To give all the nurses
correctly, the quality score for preparation and adminis- the opportunity to study the new protocol, the post-test took
tration was 100. The scores ‘‘not applicable’’ and place 2 weeks after the introduction.
‘‘missing’’ were not used in calculating the overall quality
score. Statistical analysis
In addition, more general data such as date, department,
time of prescription and time of administration were col- At the item level, differences between the two groups and
lected. Furthermore, characteristics of the administration measurements were analyzed using cross table and chi-
process (bolus dose injections, intermittent infusion or square tests. The standard deviations for the two groups
continuous infusion) were always registered. were not statistically different. Overall quality scores were
checked for normal distributions and satisfied this condi-
Observation tion. For both pre- and post-test scores, potential
differences in nurses’ level quality score between the two
At both the pre- and post-test phases, nurses were observed departments were analyzed using the independent samples
by a single observer for a maximum number of four times, T-test for statistically significance (P B 0.05). As nurses
in order to include as many different nurses as possible. could be observed several times, clustering of data at the
During the process of preparing and administering level of nurses was present in this study. Therefore, the
intravenous drugs, nurses were observed by using the mean quality scores of nurses over 1–4 observations were

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used in the analyses of the effects of the protocol imple- (a B 0.05). The mean overall quality score during the pre-
mentation. In addition, we explored the relevance of the test was 66 for bolus dose injections (n = 38), 65 for
type of administration route for quality scores using a One intermittent infusion (n = 76) and 66 for continuous
Way ANOVA technique (P B 0.05). infusion (n = 18). The quality score for bolus dose injec-
tions differed for the two departments (T = 2.63, df = 36,
Ethical considerations P = 0.01). At the control department the quality score for
this administration route was 71, while at the intervention
Approval from the local Medical Ethics Committee was department the score was only 64. For administration by
obtained. intermittent infusion or continuous infusion, no significant
differences between the wards were found.
Fifteen variables had pre-test quality scores [90% at
Results both departments (Appendix). These variables referred to
the preparation of the correct drug, correct doses, making a
At the pre-and post-test, 132 observations were performed; calculation for the solution to be made, using the right
66 observations at each ward. Seventy-two nurses were diluent, using the prescribed quantity of this diluent, using
observed in the study. the prescribed method of preparation, applying the pre-
In 56% of the cases, the nurses were observed at the pre- scribed administration route, keeping syringe, needles and/
test as well as the post-test (45% control department, 66% or transfer needles sterile, being sure that the medication
intervention department). The demographic data are sum- completely dissolves, having—at the final stage—the pre-
marized in Table 1. There were no significant differences scribed dose of the drug to be administered, administration
in any of the demographic data for the two departments. by the nurse who prepared the drug, administrating the
All of the included nurses gave permission for obser- drug before the end of sell-by after preparation and
vation by the observer. administration of the drug to the right patient.
During the study, intervening at the intervention Eight variables had pre-test scores less than 20% at both
department was necessary on two occasions: once due to departments (Appendix). The scores referred to checking
preparation of the wrong dose during the pre-test and once the expiration date, inviting colleagues to double-check the
due to preparation of the wrong drug during the post-test. prescription, inspecting the diluent for expiration date,
In these cases, the nurses corrected their mistakes after the hand washing prior to preparation, using disinfectant gauze
observer had intervened. The mistakes were registered as to break/open the ampoule, mixing the acquired infusion
errors. Intervening at the control department was not solution by wheeling, inspecting the solution for clarity and
necessary. inspecting the intravenous catheter for phlebitis or extra-
Nurses working at the control department had a mean vasation prior to administration.
quality score of 67 during the pre-test. Nurses from the The mean quality scores of nurses at the control and
intervention department scored 64 at this point in time. Pre- intervention department are summarized in Table 2. At
test scores were not significantly different for the two post-test, nurses at the intervention department scored
nursing wards (T = 1.36, df = 55, P = 0.18). In addition, significantly better (72) than nurses at the control depart-
within each department there was no significant difference ment (69) (T = -2.20, df = 53, P = 0.04). At the
in quality scores for the administration by bolus dose intervention department, significant improvement on 8
injections, intermittent infusion and continuous infusion criteria (P \ 0.01) was found (Table 3).

Table 1 Pre-test (n = 57) and

Pre-test Post-test
post-test (n = 56) demographic
data for all nurses at the two Control Intervention Control Intervention
departments
Number of nurses 26 31 Number of nurses 29 27
Male 5 5 Male 6 3
Female 21 26 Female 23 24
Mean age 37 37 Mean age 36 35
Minimum 23 23 Minimum 23 23
Maximum 58 58 Maximum 56 57
Mean years of experience 9 9 Mean years of experience 8 7
Minimum 0 1 Minimum 0 1
Maximum 32 30 Maximum 25 30

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Table 2 The quality of preparation and administration of intravenous However, most studies described errors in the process of
drugs at pre- and post-test observations (0–100 quality range) preparation and administration of intravenous drugs and
Control department Intervention department made recommendations about how to minimize the errors
[9, 10, 22].
Pre-test Post-test Pre-test Post-test
[n] [n] [n] [n] Medication errors range from those that have little or
no impact on the patient to those with very serious
Mean quality score 67 [26] 69 [31] 64 [29] 72 [27] consequences. In this study, we did not assess the
of all nurses
clinical importance of intravenous drug errors. It is dif-
Mean quality score 67 [17] 69 [23] 65 [17] 72 [23]
ficult to identify the clinical effects of errors because of
of nurses who were (Sd. 5,9) (Sd. 5,6) (Sd. 4,6) (Sd. 5,9)
observed at both the delay between the occurrence and the identification
pre- and post-test of errors and the outcome in one patient may not reflect
the likely outcomes in groups of patients as a
In the post-test, 37% of the 27 observed nurses at the whole [23].
intervention ward, were involved the new training. We Potentially severe errors such as preparation of the
checked for the effects of ‘exposure to the intervention’ by wrong doses, choosing wrong solvents and administration
comparing the scores for nurses who did or did not attend of bolus doses within insufficient time, are examples of
the protocol introduction meeting. There was a significant intravenous drug errors that could be severe. They occurred
difference between the mean score of nurses at the inter- less frequently than previously reported [13].
vention department who were observed during the post-test There was a significant difference between the mean
and who had participated in the department meeting scores of nurses at the intervention department who had
(n = 10, score = 75) as compared to those who were participated in the department meeting as compared to
observed during the post-test but who had not attended the those who had not attended the meeting. Despite that, the
meeting (n = 17, score = 70) (T = 2.27, df = 64, post-test scores for the nurses who attended the education
P = 0.03). session are similar to the whole post-test intervention ward
group. Perhaps the availability of, and giving attention to
the new protocol to all nurses at the ward was equal to, or
Discussion more effective than the education session itself. Alterna-
tively, carry-over effect from nurses who attended the
This study describes the effect of the implementation of department meeting to nurses who were not present could
a protocol on the quality of care of preparation and explain the lack of the difference between the two
administration of intravenous drugs by nurses. After the subgroups.
implementation of the protocol, we observed a modest Possibly the short period of implementation and the
significant improvement at the intervention department, minimum investment caused the modest improvement in
whereas no quality improvement was found at the con- quality of care. To accomplish a major change in the atti-
trol ward. There are a few studies which also described tude and the competence of nurses, a more multi-faceted
the effect of an educational intervention on the quality of strategy might be needed. Only 37% of the 27 observed
care of preparation and administration of intravenous nurses at the intervention ward, were involved the new
drugs, such as using an interactive CD-ROM pro- training. Another strategy for better up take should be to
gram [15] and introduction of dedicated medication have more nurses attend the training. In addition, the
nurses [16]. implementation could be strengthened with additional

Table 3 Observation items

Variable Pre-test [n] Post-test [n] P
with significant differences for
pre- and post-test at the Inspects medication for the expiration date. 6% [52] 65% [54] 0.000
intervention ward in % of the
total number of observations; Inspects diluent for the expiration date. 0% [52] 28% [57] 0.000
n = 66 at both measurements Disinfects hands prior to preparation. 15% [66] 53% [66] 0.000
Breaks/opens ampoule with diluent using disinfectant gauze. 15% [61] 43% [65] 0.000
Disinfects the ampoule with medication. 83% [54] 98% [51] 0.010
Inspects the solution for clarity. 5% [66] 20% [66] 0.007
Informs the patient about administration of the drug. 76% [66] 94% [65] 0.004
Inspects the intravenous catheter for phlebitis 15% [55] 43% [65] 0.001
or extravasation prior to administration.

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methods such as improved working conditions and teach- Conclusions

ing and testing of technical skills. Furthermore, it is
important to consider systems approaches to reduce me- The number of errors in the preparation and administration
dication errors [24]. of intravenous drugs is high. Our study identified an
Observation methods for studying medication prepara- unobtrusive significant difference between pre-test and
tion and administration errors could have influenced the post-test quality of preparation and administration of these
results. Even when all precautions are taken to minimize drugs after the implementation of a new protocol. There-
the effects of observation, it is still possible that the pres- fore, we conclude that even with limited means and
ence of a researcher may affect nurses’ behavior [21]. investments, the quality of the preparation and adminis-
Some nurses told the observer that they miss some steps tration of intravenous drugs can be improved. The protocol
in the total process of administration when the observer is developed during the pre-intervention period contributes to
not there. Therefore, the error rate may have been even the improvement of the quality of preparation and admin-
higher in the absence of the researcher. istration of intravenous drugs in nursing practice.
This implies that scores for the quality of the preparation Given the limited quality of the preparation and
and administration of intravenous drugs in this study are administration process, investing more time and money in
probably somewhat biased towards more positive scores. attempts at improvement seems justified. Without these
As the procedure was identical for the two groups however, attempts, the need for patient safety in everyday patient
this does not threaten the validity of the effects of the care might be insufficiently met.
intervention.
Prudence is called for when generalizing the results to Acknowledgments The authors thank the nurses from the two
nursing departments of internal medicine for giving permission for
other departments or other hospitals. The two departments, observation by the researcher.
which were involved in this study, are departments where
the incidence of preparation and administration of intra- Funding No funding was received.
venous drugs is high. Both departments were internal
medicine departments where doctors and nurses often treat Conflicts of Interest There were no conflicts of interest.
patients with infectious diseases. Possibly, the nurses at Open Access This article is distributed under the terms of the
these departments are more aware of the importance of Creative Commons Attribution Noncommercial License which per-
hygiene and infection prevention than nurses at other mits any noncommercial use, distribution, and reproduction in any
departments. medium, provided the original author(s) and source are credited.

Appendix

Scores in % of all observation items per measurement and department

Variable 1st measurement 2nd measurement
N contr (%) int (%) S* N contr (%) int (%) S*

1. Correct drug 132 100 100 - 132 100 99 -

2. Correct doses 132 100 99 - 132 100 100 -
3. Inspects medication for the expiration date s 99 11 6 - 103 8 65 ?
4. Asks colleague to double-check the prescription 57 15 3 - 44 10 4 -
5. Looks up preparation procedure in a handbook 132 53 24 ? 132 50 17 ?
6. Makes a calculation for the solution to be made 4 100 100 - 2 – 50 -
7. Ask colleague to double-check calculation 4 0 67 - 1 – 100 -
8. Gets the right diluent 117 98 95 - 124 100 98 -
9. Inspects the diluent for the expiration date s 102 2 0 - 109 0 28 ?
10. Washes hands prior to preparation 132 3 14 - 132 9 24 -
11. Disinfects hands prior to preparation s 132 49 15 ? 132 38 53 -
12. Wears gloves during preparation 132 39 24 - 132 50 27 ?
13. Uses disinfectant gauze to break/open the ampoule s 102 5 15 - 115 6 43 ?
14. Disinfects the ampoule with medication s 112 86 83 - 111 87 98 -
15. Waits for the disinfection solution to dry 95 86 67 - 102 81 88 -

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Pharm World Sci (2009) 31:413–420 419

continued
Variable 1st measurement 2nd measurement
N contr (%) int (%) S* N contr (%) int (%) S*

16. Disinfects injection point of infusion bag 83 82 91 - 68 90 78 -

17. Waits for the disinfectant to dry 71 76 53 - 58 68 52 -
18. Uses the prescribed quantity of solvent 119 98 98 - 124 100 100 -
19. Uses the prescribed method of preparation 130 98 100 - 131 100 100 -
20. Uses the prescribed administration process 132 100 100 - 132 100 100 -
21. Keeps syringe, needles and/or transfer needles sterile 127 98 92 - 131 99 100 -
22. Takes care that the medicine completely dissolves 106 96 93 - 116 98 97 -
23. Mixes the acquired infusion solution by wheeling 118 11 7 - 124 24 21 -
24. Inspects the solution for clarity s 132 0 5 - 132 0 20 ?
25. Has—at the final stage—the prescribed dose of the drug to be administered 132 94 91 - 132 97 99 -
26. Puts a completely filled out label on the infusion bag/syringe 97 7 30 - 76 19 10 -
27. Gets NaCl 0.9% to flush the infusion system (because of incompatibility 30 86 96 - 37 100 100 -
of the medicine with the infusion solution)
28. Keeps syringe, needles and/or transfer needles sterile 84 100 96 - 76 100 100 -
29. Writes his/here initials in the medication administration system 132 94 86 - 130 97 97 -
30. Writes the deviate time of administration in the medication administration system 30 78 75 - 8 80 67 -
31. Administration done by the nurse who prepared the drug 131 100 94 - 129 97 100 -
32. Administrates the drug before the end of sell by after preparation 129 99 98 - 124 98 100 -
33. Inform the patient about administration of the drug s 132 71 76 - 129 72 94 ?
34. Administrates the drug to the right patient 132 100 100 - 129 100 100 -
35. Inspects the IV infusion system for phlebitis and/or extravasation prior 116 10 15 - 129 25 43 -
to administration s
36. Arranges for new infusion needle in case of phlebitis/extravasation 2 – 50 - 1 0 – -
37. Disinfects the injection point of the infusion system or the infusion needle 93 83 96 - 94 95 97 -
38. Waits for the disinfectant to dry 84 35 20 - 90 37 32 -
39. Rinses out the drip with compatible infusion solution 33 100 83 - 36 83 75 -
40. Uses a new coupling 75 67 96 ? 54 58 91 ?
41. Administrates the medication using the prescribed administration time 130 89 61 ? 128 80 66 -
42. Regulates the controller according to the described rate 85 95 87 - 69 100 100 -
43. Keeps needles, coupling and/or drip sterile 129 97 100 - 129 100 100 -
44. Administers all of the solution with medicine 113 88 96 - 108 100 97 -
45. Rinses out the drip with compatible infusion solution 109 43 63 - 89 56 76 -
46. Describes the medication administered on the patient list in case 96 82 78 - 73 80 61 -
of short stay or continued infusion
47. Stays in the patient’s room after administrating the drug 116 21 18 - 110 30 25 -
* = observation item with significant differences for the control department and the intervention department
s = observation item with significant differences for pre- and post-test at the intervention department
contr = control department
int = intervention department

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