BMJ Open · than by the patient’s underlying disease that results in a prolonged hospital stay, temporary or permanent disability, or death.[2] The national Dutch Hospital Patient

For peer review only

Protocol compliance of administering parenteral medication in Dutch hospitals: an evaluation and cost-estimation of the

implementation

Journal: BMJ Open

Manuscript ID: bmjopen-2014-005232

Article Type: Research

Date Submitted by the Author: 10-Mar-2014

Complete List of Authors: Schilp, Janneke; Netherlands Institute for Health Services Research (NIVEL), Boot, Sanne; Netherlands Institute for Health Services Research (NIVEL),

de Blok, Carolien; Netherlands Institute for Health Services Research (NIVEL), Spreeuwenberg, Peter; Netherlands Institute for Health Services Research (NIVEL), Wagner, Cordula; Netherlands Institute for Health Services Research (NIVEL),

<b>Primary Subject Heading</b>:

Medical management

Secondary Subject Heading: Pharmacology and therapeutics

Keywords:

Protocols & guidelines < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, Quality in health care < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, Health & safety < HEALTH SERVICES

ADMINISTRATION & MANAGEMENT, Adverse events < THERAPEUTICS

For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml

BMJ Open on January 25, 2020 by guest. P

rotected by copyright.http://bm

jopen.bmj.com

/B

MJ O

pen: first published as 10.1136/bmjopen-2014-005232 on 30 D

ecember 2014. D

ownloaded from

http://bmjopen.bmj.com/


1

Protocol compliance of administering parenteral medication in

Dutch hospitals: an evaluation and cost-estimation of the

implementation

Corresponding author: Janneke Schilp

Postal address: NIVEL. P.o. box 1568, 3500 BN Utrecht, The Netherlands.

Email: [email protected]

Janneke Schilp,1* Sanne Boot,1 Carolien de Blok,1 Peter Spreeuwenberg,1 Cordula Wagner1,2

1NIVEL, Netherlands Institute for Health Services Research, Utrecht, The Netherlands.

2 Department of Public and Occupation Health, EMGO+ Institute for Health and Care Research, VU

University Medical Center (VUmc), Amsterdam, The Netherlands.

Telephone: +31 302 729 843

Fax: +31 302 729 729

Running title: Protocol compliance parenteral medication in hospitals

Keywords: patient safety, adverse drug events, protocol, implementation, cost estimation

Word count main text: 4012

Page 1 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960

on January 25, 2020 by guest. Protected by copyright.

http://bmjopen.bm

j.com/

BM

J Open: first published as 10.1136/bm

jopen-2014-005232 on 30 Decem

ber 2014. Dow

nloaded from



2

Abstract

Objectives: Preventable adverse drug events (ADEs) are most related to administration processes of

parenteral medication. The Dutch Patient Safety Program provided a protocol for administering

parenteral medication to reduce the amount of ADEs. The execution of the protocol was evaluated and

a cost estimation was performed to provide insight in the associated costs of protocol compliance.

Methods: A longitudinal evaluation study was performed in secondary care. A total of 2154

observations of the administration process of parenteral medication were performed within 10

measurements in 19 hospitals between November 2011 and December 2012. The total time needed for

the process was measured in a sample of 5 hospitals. Multilevel linear and logistic regression analyses

were used to analyze the trend over time of the implementation and to assess the association between

hospital and administrion characteristics and compliance of the protocol. A cost estimation provided

insight in the costs of performing a complete administration process and the costs at department level

for one year.

Results: The complete protocol was performed in 19% of the observations. The proceeding ‘check by

a second nurse’ was least performed. Large differences were found between individual hospitals in

performing the administration protocol. The compliance of the protocol was negatively influenced in

case of disturbance of the administrator. The overall trend over time of completely performing the

protocol fluctuated during the study period. On average 3 min. 26 sec. was needed to perform the

complete protocol, which costs €2.42. Extrapolating the costs to department level, including cost for

clinical lessons, the difference in costs in performing the complete protocol and an incomplete

protocol was €7.891 for one year.

Conclusions: The protocol for administering parenteral medication is still not implemented

completely, therefore an investment in time and euros is needed.

Page 2 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



3

Strengths and limitations of this study

• This study analyses the trend over time of protocol compliance of administering parenteral

medication including a large representative sample of Dutch hospitals.

• This study provides insight into the characteristics contributing to complete protocol compliance

and provides a cost estimation of complete compliance.

• Only process indicators were measured in the evaluation study to provide insight in the

implementation, whereby the effect of the implementation on the occurrence of ADEs could not

be evaluated.

Page 3 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



4

Introduction

Despite the importance of patient safety in healthcare, preventable adverse events (AEs) continue to

occur in hospitals.[1] An adverse event is unintentional harm caused by healthcare management rather

than by the patient’s underlying disease that results in a prolonged hospital stay, temporary or

permanent disability, or death.[2] The national Dutch Hospital Patient Safety Program (Safety

Program) started in 2008 to support hospitals to increase patient safety and to reduce the high number

of preventable AEs by the introduction of a safety management system and ten medical improvement

themes.[3] After surgical AEs, Adverse Drug Events (ADEs) are the most common healthcare-related

AEs that occur during hospital admissions [2,4] and result in an excess length of hospital stay and high

direct medical costs.[5] In the Netherlands, the average costs of one preventable ADE was estimated to

be €6009.[6]

From the Dutch Central Medication error Registration (CMR), in which all hospital-related

ADEs must be reported, can be concluded that most ADEs are related to parenteral medication.[7]

Parenteral medication is provided with intravenous, subcutaneous or intramuscular injections. Most

parenteral medication involve high risk medications such as antibiotics, which increases the risk of

causing significant injury to patients, when used inappropriately.[8] Three stages can be identified in

the process of ensuring the appropriate medication is given to the patient: prescription, preparation and

administration of parenteral medication. In every stage of the process there is a possibility for ADEs to

occur, but analysis of Central Medication-incident Registration (CMR) showed that most of the

reported ADEs (46%) are related to the administration.[7] During the stage of administration, five

types of errors can be distinguished attributing to medication errors: wrong dose, wrong drug, wrong

route, wrong time and missed medication.[9] Since most errors appear in the stage of administration,

the present study will focus on this specific part of the medication process.

Protocols provide support to health care providers by describing interventions to reduce

ADEs. Earlier research showed that using a protocol for preparing and administering parenteral

medication resulted in less ADEs in hospitals.[10-12] By preventing ADEs, adverse consequences

such as medical burden for the patient and economic burden for the society will be decreased.[13,14]

Page 4 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



5

Within the Dutch Safety Program a protocol containing the proceedings of the preparation and

administration of parenteral medication, was developed by an expert team of hospital pharmacists,

doctors, ICU nurses and an anesthesiologist. This protocol was available for all hospitals within the

module ‘High Risk Medication: Preparation and administration of parenteral medication’.[15]

Education and several practical recommendations for successful implementation of the protocol were

offered to the hospitals.[15] With education, such as clinical lessons, it was expected to generate

support among nurses to execute the protocol completely.[16,17] Accurate implementation of the

protocol is essential because preventable ADEs may only be reduced when the protocol is strictly

followed.[10,11] Insight in the actual degree of implementation of the protocol is important, because

earlier research showed that successful implementation of guidelines is complex in clinical practice

and that guideline adherence is not high without specific intervention.[18-20] Based on the goals of

the Safety Program, it was expected that the protocol compliance would improve during the final year

of the program as hospitals approached the public deadline at the end of 2012.

Besides the characteristics of the guideline and the implementation strategy, also

characteristics of professionals, characteristics of patients and environmental characteristics influence

the implementation of guidelines.[21] In the present study the influence of characteristics of the

environment will be investigated by determining the associations of hospital characteristics and

administration characteristics with the execution of the protocol.

Successful implementation of an intervention in an organization requires investment of time

and money. Despite of these spending costs, performing the protocol for administering parenteral

medication might be cost-effective or even cost saving if a reduction of the number of ADEs is

realized.[6] Cost reduction might be an economic incentive for hospitals to invest in various types of

patient safety interventions.[13] Since the costs of the implementation of the protocol for

administering parenteral medication are still unknown, a cost-estimation will provide more insight into

the costs of complete protocol compliance.

The aim of the present study was to evaluate the execution and implementation of the protocol

of administering parenteral medication in Dutch hospitals, whether protocol compliance has changed

over time, and to investigate which hospital characteristics and administration characteristics

Page 5 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



6

contributed to a complete protocol compliance. Furthermore, the average time and associated costs

required for nurses to perform the protocol completely were estimated and extrapolated to department

level.

Methods

Study design

Data was collected within a large longitudinal evaluation study during the final year of the Dutch

Hospital Safety Program between November 2011 and December 2012.[22] Aim of the evaluation

study was to provide insight in the degree of implementation of ten patient safety themes in Dutch

hospitals. Hospitals were randomly selected using a stratified representative sample based on area and

type of hospital. Data for the present study was collected within 19 hospitals (2 academic, 6 tertiary

teaching and 11 general hospitals). In each participating hospital approximately 15-20 observations

were performed every 4 to 6 weeks during one year, resulting in a total of 10 measurement moments

per hospital. The observations were conducted for patients >18 years in four different types of

departments: general surgery, internal medicine, Intensive Care Unit (ICU) and other departments

administering parenteral medication such as neurology, pulmonary diseases and day admission. All

types of parenteral intravenous medication, except cytostatic, were included for the observations. 14

trained research assistants observed the nurses executing the administration protocol during the

measurement days. A maximum of three processes a day were observed for each administrating nurse,

to correct for between-person variation. Nurses were unaware of the true purpose of the observations.

The study has been approved by the Medical Ethics Committee of the VU Medical Centre Amsterdam.

Observation administration protocol

An observation list was used to evaluate the execution of the proceedings included in the protocol of

administering parenteral medication (box 1). The list included the 9 most important and identifiable

administration proceedings determined by the expert team. All completely performed proceedings

were marked on the observation list, whereby insight was obtained in the compliance with the

Page 6 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



7

individual proceedings. The total amount of performed proceedings was calculated to show the

compliance to the protocol (score 0 to 9). Compliance with the protocol was dichotomized into

complete (9 proceedings) and not complete (≤8 proceedings).

Factors associated with compliance of the protocol

Both hospital and administration characteristics possibly associated with complete protocol

compliance were measured. Determined hospital characteristics were: type of hospital (academic,

tertiary teaching and general), size of hospital (number of beds) and type of department (general

surgery, internal medicine, ICU and other departments). Determined administration characteristics

were: moment of administering parenteral medication (morning from 8.00 till 12.00 am, afternoon

from 12.00 till 6.00 pm and evening/night from 6.00 pm till 8.00 am), disturbance of nurses during the

administration processes (yes or no) and recognizability of nurses by wearing a medication safety

jacket during the administration process (yes or no). Wearing a safety jacket was advised in the

module ‘High Risk Medication’ to ensure that the administrator may not be disturbed.

Cost estimation of the administration protocol

Five hospitals (three tertiary teaching hospitals and two general hospitals) participating in the

evaluation study were selected for additional data collection to estimate the costs of complete protocol

compliance. In these hospitals, the time duration (in seconds) of administering parenteral medication

was examined by observing and registering time of the administration process. Time was started when

the administrator started the first proceeding of the administration process and ended when the process

was finished. If the administrator performed other activities during the administration process which

led to interruptions, this time was not included. The total time was doubled if the proceeding ‘check by

a second nurse’ was executed, because then two nurses spent time to the administration process. To

determine the time investment to become familiar with the protocol an assumption was made that the

average duration of a clinical lesson takes one hour.[11] The time for a teaching nurse of preparing

and providing a clinical lesson for ten nurses was based at two hours. The total time for preparing,

providing and following a clinical lesson was thereby estimated at 72 minutes per nurse.

Page 7 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



8

The cost valuation of the time of the administration protocol was based on a bottom-up

approach.[23] Following this approach the total duration of time of the administration process was

multiplied with the costs per time unit for a nurse (€42.42), calculated by using the Dutch Manual for

Costing in Economic Evaluation.[23] For the clinical lessons, the staff hourly wage of €32,88 was

used. In case of incomplete performance of the protocol no costs for clinical lessons were counted.

The total duration of time and costs for the administration process were extrapolated to mean

department level for one year. The calculation of this extrapolated time and associated costs was based

on thirty employed nurses and twenty administration processes per day (24 hours) at one department.

Statistical analysis

The mean of the performed proceedings and the percentages performed individual proceedings were

calculated for the ten measurements. Additionally, mean percentages for disturbance and

recognizability of the administrator were calculated. Differences between hospital types in percentages

were tested with one-way ANOVA test.

A multilevel linear regression analysis was conducted to analyze the trend over time of the

implementation of the protocol. The outcome variable was the mean of the total amount of performed

proceedings of the protocol (continuous: 0 to 9). This variable was approximately normally distributed

based on the results of the distribution of residuals. A three-level multilevel structure was used,

whereby the observations were clustered within departments and the departments within hospitals.

Time was modeled by adding ten indicator variables for the moments (removing the intercept from the

model) and trends were tested using polynomial contrasts (to the 4th order) to study development over

time. For each measurement an average score was estimated, which was corrected for the three-level

structure and time indicator.

The Intraclass Correlation Coefficient (ICC) was calculated to indicate the correlation of the

observations within the same department and same hospital.[24]

To assess the association between the hospital and administration characteristics and complete

compliance (9 proceedings), separate univariate multilevel logistic regression analyses were performed

using complete compliance (yes/no) as dependent variable and the characteristics as independent

Page 8 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



9

variables. Categorical independent variables were analyzed by adding separate indicator variables for

the categories to the model.

Descriptive analyses were performed using Stata version 12.1 and the multivariate analyses

were executed with MlwiN version 2.24. For all analyses, P-values ≤.05 were considered statistically

significant.

Results

A total of 2154 observations of administration processes of parenteral medication were included in the

evaluation study. The descriptive hospital and administration characteristics are shown in Table 1.

Most observations were performed at the general surgery department (36%) and most observed

administration processes were executed in the afternoon (58%). The administrator was disturbed in

12% of the administration processes and only 3% of the nurses followed the advice on recognizability

by wearing a medication safety jacket during the administration.

Table 2 shows a comparison between the three hospital types in performing the administration

protocol. The mean estimate of performed proceedings of the protocol during the total study period

was 7.3 (SD 1.3) and the protocol was executed completely in 19.4% of all observations. A small but

statistically significant difference in the amount of performed proceedings was found between the

three types of hospital, with the highest amount in general hospitals. The percentage observations with

a complete protocol was also the highest in general hospitals. In academic hospitals administrators

were most often disturbed during the administration process. The amount of disturbances decreased

statistically significantly during the study period (p<0.001): 15% disturbance at the beginning

(measurements 1-3) 12% in the middle (measurements 4-7) and 8 % at the end (measurements 8-10)

of the study. In case of disturbance, statistically significantly less (p<0.001) proceedings of the

protocol were performed compared to no disturbance (6.9; SD 1.3 vs 7.4; SD 1.3). The recognizability

of the administrator was highest in tertiary teaching hospitals. No statistically significant difference

Page 9 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



10

was found in performing the protocol in case of recognizability or no recognizability of the

administrator (7.1; SD 1.5 vs 7.3; SD 1.3).

Figure 1 shows the percentages for executing the individual proceedings. The proceeding

‘check by a second nurse’ was least often performed (52%), followed by the proceeding ‘identify

patient’ (61%) and ‘hand hygiene’ (62%). A deterioration occurred on half of the study period for

these proceedings. The six remaining proceedings were more often performed and during the study

period an increase was visible. At the final three measurements the proceedings ‘check medication’

and ‘collect materials of medication’ were executed in all administration processes.

Multi-level analysis: time trend

Figure 2 shows the multilevel trend over time for the total amount of performed proceedings of the

protocol of administering parenteral medication. The mean estimate of the measurements ranged

between 7.0 and 7.7. A statistically significant trend was found over the study period (second and

fourth order multilevel, p<0.001). The trend was not linearly, a decrease of performed proceedings

was observed in the middle of the study, followed by an increase of the proceedings to the end of the

study. The multi-level analysis shows that 20% of the total variance in performed proceedings of the

administration protocol (ICC=20.06) was caused by differences between individual hospitals, 10% of

the variance in protocol compliance (ICC=9.55) was caused by differences between individual

departments.

Hospital and administration related factors associated with complete protocol compliance

The univariate association between potential explanatory factors and complete protocol compliance

was investigated. An association was found between type of department and complete protocol

compliance (Table 3). Other departments such as neurology, pulmonary diseases and day admission,

had a positive significant association with complete protocol compliance (p<0.01), meaning that a

complete protocol compliance was more often performed in these departments compared to the

reference general surgery department. 34% (ICC=33.63) of the total variance in the association

between department and complete protocol compliance was caused by differences between individual

Page 10 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



11

hospitals and 13% (ICC=13.01) by individual departments. Other investigated hospital and

administration related factors were not associated with complete protocol compliance.

Cost estimation protocol compliance

A total of 120 observations of administration processes were performed for the cost estimation in

tertiary teaching (n=78) and general hospitals (n=42). The mean performed proceedings was

comparable to the evaluation study (7.3; SD 0.88). Table 4 shows the estimation of the mean estimated

time and costs for administering parenteral medication for one administration process and extrapolated

to a department in one year. More time was needed when more proceedings were performed

(p=0.004). The entire protocol was completed in 7% (n=8) of the observations. Performing all

proceedings of the administration protocol (3 min/ 26 sec) requires 60% more time compared to

performing eight or less proceedings of the protocol (2 min/ 8 sec). An additional analysis showed that

nurses in general hospitals needed statistically significantly (p<0.001) more time to administer

parenteral medication (3 min/ 7 sec) than their colleagues in tertiary teaching hospitals (1 min/ 50 sec),

but this was mainly caused by the high compliance in general hospitals (55%) to the proceeding

‘check by a second nurse’, whereby time was doubled, compared to the tertiary teaching hospitals

(5%). The duration was statistically significant shortest (p=0.001) at ICU-departments (1 min/ 32 sec)

and longest in other departments (3 min/ 15 sec). Administering parenteral medication in the evening

took statistically significantly (p=0.04) more time (3 min/ 15 sec) compared to the morning and

afternoon (2 min/ 5 sec).

The total costs of following, preparing and providing a clinical lesson for one nurse was

estimated on €39.46. The average costs of one complete administration protocol were €2.42. In case of

an incomplete protocol, the costs were on average €1.51. The extrapolated total costs of administering

parenteral medication according the protocol were €18.899 per year per department. When the

protocol was incomplete performed and nurses received no education, the extrapolated total costs were

€11.007. The difference of the explored costs for performing the complete protocol or not was €7.891

per department per year.

Page 11 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



12

Discussion

The aim of the present study was to evaluate the implementation of the protocol of administering

parenteral medication and to investigate possible characteristics contributing to complete protocol

compliance. The complete protocol was performed in only 19% of all observations. The total amount

of performed proceedings slightly decreased to the median of the study period and slightly increased at

the end. Differences were found between types of hospitals and departments. The proceeding ‘check

by a second nurse’ was least performed followed by ‘identification of patient’. Disturbance of the

administrator influenced the protocol compliance negatively. A cost-estimation showed that on

average 3 min. 26 sec. was needed to perform the complete protocol, which costs €2.42. The

extrapolation of the average costs to department level for one year showed a difference of €7.891

between a complete and incomplete administration protocol. These costs are comparable to the costs

of one preventable ADE (€6009). Therefore, beside the potential effect of implementation of the

protocol on the patients in diminishing the harm due to an ADE, the investment in money for hospitals

is also relatively low in perspective to the output.

In only one out of five administration processes all proceedings of the protocol were

performed. On average 7.3 proceedings of the protocol were executed during the entire study period.

Possible explanations for the limited implementation of the protocol may be the sticking to old habits,

insufficient staff and lack of urgency. Earlier studies showed already the difficulty of implementing

guidelines in clinical practice.[18] Several factors influence the implementation of guidelines:

characteristics of the guideline, the implementation strategy, characteristics of professionals,

characteristics of patients and environmental characteristics.[21] The used observation method could

have overestimated the results due to the Hawthorne-effect.[25] Even when all precautions are taken to

minimize the effects of observation, it is still presumable that more attention (by the researchers)

during the administration process affects the nurses’ behavior. The evaluation study showed that

nurses working at academic hospitals less often performed the protocol than nurses working in general

or tertiary teaching hospitals. Major differences in compliance to the protocol were found between

individual hospitals. Some hospitals were performing all proceedings of the protocol in the majority of

Page 12 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



13

the administration processes, while in other hospitals in none of the processes all proceedings were

executed. These findings may be explained by earlier findings that successful implementation of the

protocol is possible when the appropriate preconditions and support are available.[11] During the

study period, the total amount of performed proceedings of the protocol decreased to the median and

increased at the end of the study period. The lower degree of compliance to the protocol may possibly

be the result of the summer season. In this period the attention may be weakened by increased

workload or replacement of personnel who are not familiar with the protocol.

Remarkable differences were found between the individual proceedings of the protocol. In

particular the ‘check by a second nurse’ was not often performed in most hospitals. This is an

important proceeding, because a second nurse can intervene when the administrator is heading for

making an error. An overestimation of this percentage is likely, because the ‘check by a second nurse’

was difficult to determine. ‘Identification of the patient’ was also not often performed. Possibly,

nurses did not identify the patient because they cared such a long time for the patient and knew the

patient well.

A noticeable outcome of the study was the degree of disturbance (12%) on performing the

proceedings of the protocol. Disturbance of the administrator resulted in less performed proceedings,

which may increase the risk of an error in the administration process. A reduction of errors in the

administration process will contribute in a reduction of ADEs.[10] Therefore, preventing disturbance

during administering parenteral medication seems to be a simple way of reducing ADEs. A possibility

to avoid disturbance during administering parenteral medication is to increase the recognizability of

nurses by wearing a medication safety jacket.[26-29] During the study period, administrators were

recognizable by wearing a medication safety jacket in only 3% of the observations. Several studies

have shown that the use of a medication jacket results in less interruptions.[26-29] However in this

study, in 29% of these observations the administrator was still disturbed during administration while

wearing a medication jacket. This percentage of interruptions was higher compared to nurses who

were not recognizable, which is contrary with previous published studies. Insufficient introduction and

clarification of the importance of the medication jacket might be an explanation for this result.

Page 13 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



14

Patients, visitors and staff members might be questioning the function of the jacket, which leads to

interruptions.

Performing all proceedings of the administration protocol requires 60% more time compared

to performing eight or less proceedings of the protocol. This is most likely due to the ‘check by a

second nurse’ which takes most time and was least performed. Nurses employed in general hospitals,

needed on average more time to administer parenteral medication than nurses in tertiary teaching

hospitals. However, in one general hospital the proceeding check by a second nurse was in the

majority of the administration process performed in contrast to other individual hospitals. The

proceeding requires time investment, but apparently execution of this proceeding is possible

whenever appropriate preconditions are available. The result mentioned above might be explained due

to large differences between the five individual hospitals and not as a result of differences between

types of hospitals. This is also reflected in the high ICC of the association between type of hospital

and complete protocol compliance, showing that 28% of the total variance in the association between

type of hospital and complete protocol compliance was caused by differences between individual

hospitals.

Strengths and limitations

A strength of this study was the large amount of participating hospitals including all departments.

Because the observations were performed on different time points a trend over time in compliance of

the protocol could be determined. The large representative sample of hospitals ensures the results may

be generalized to the national hospital population. Due to the large amount of observations a

distinction could be made between different types of hospitals. Another strength of the study was that

a maximum of three processes were observed within each nurse, to take variation into account.

Some limitations should also be mentioned. A potential weakness of an observational design is

the presence of observation bias. In this study, nurses presumably perform the protocol better or

administer medication different due to the observer effect. To avoid this type of bias as much as

possible, observations were conducted on different days, administration moments and nurses. Several

research assistants executed the observations which might have led to variation in the observations.

Page 14 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



15

Therefore, this bias effect was avoided as much as possible by training the research assistants,

checking the data input and using a standardized observation list. A final limitation of the study was

that the effect of the implementation of the protocol on the occurrence of ADEs could not be

evaluated. However, this is a consequence of the design of the evaluation study as only process

indicators were measured to provide insight in the degree of implementation of patient safety themes.

Future studies are needed to investigate the effect of the implementation of the protocol on reducing

ADEs.

Conclusion

The protocol for administering parenteral medication to patients was not completely implemented in

Dutch hospitals. Disturbance during the administration process had a negative influence on the

execution of the protocol. Large differences were found between individual hospitals in performing

the administration protocol. Future research may provide detailed information about the economic

benefits of this protocol, since the causal relation of performing the complete protocol and occurrence

of ADEs and associated costs was not determined. Extrapolating our results to department level, we

showed a difference of €7.891 between a complete and incomplete administration protocol per

department per year, which is comparable to the costs of one preventable ADE.

Page 15 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



16

Box 1: Checklist proceedings of the protocol for administrating parenteral medication.[15]

Proceeding Explanation

1. Check medication Check of drug on the basis of a medication list or distribution list.

2. Prepare administration Preparation of administration: set pump and speed of injection

3. Collect materials Gathering the needed materials and check the administration label.

4. Identify patient Take time to identify it is the right patient, electronically or by

checking the name, date of birth, patient number and type of

medication.

5. Hand hygiene Hand disinfection before administration / wearing gloves during

administration.

6. Check flow infusion Check the intravenous medication line, before administering the

medication.

7. Check pump mode Check or set the pump mode before administering medication.

8. Check by a second nurse A second nurse checks if it is the right order, medication, dosage,

administration route, administration rate, patient and time of

administration.

9. Sign medication order Administrator signs the medication order.

Page 16 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



17

Table 1. Descriptive characteristics of the study sample (N=2154)

Characteristic Observations N (%)

Hospital characteristics

Type of hospital

Academic

Tertiary teaching

General

297 (13.8)

750 (34.8)

1107 (51.4)

Size of hospital (number of beds), mean (SD) 615.7 (250.0)

Type of department

General surgery

Internal medicine

Intensive Care Unit

Other departments

771 (35.8)

643 (29.9)

671 (31.2)

69 (3.2)

Administration characteristics

Moment of administration

Morning

Afternoon

Evening/night

770 (35.8)

1256 (58.3)

126 (5.9)

Disturbance administrator 255 (11.8)

Recognizable administrator 58 (2.7)

Data is presented as N (%) unless stated otherwise

Page 17 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



18

Table 2. Comparison of hospital types in performing the administration protocol

Characteristic Total

N=2154

General

hospitals

N=1107

Tertiary

teaching

hospitals

N=750

Academic

hospitals

N=297

P

Performed proceedings, mean (SD) 7.32 (1.3) 7.45 (1.4) 7.25 (1.3) 6.98 (1.1) <0.001b

Complete protocol compliance, % 19.4 25.0 16.1 6.73 <0.001a

Disturbance administrator, % 11.8 12.8 9.5 14.1 <0.001a

Recognizable administrator, % 2.7 1.2 5.5 1.4 <0.001a

a Tested by chi-square test

b Tested by one-way anova

Page 18 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



19

Table 3. Multi-level analysis of the association between types of departments and complete protocol

compliance (n=2154)

N Estimate (SE)

Fixed effects

Complete protocol compliance (constant) -2.26 (0.44)

Type of department

General surgery 771 Reference

Internal medicine 643 -0.19 (0.40)

Intensive Care Unit 671 0.46 (0.38)

Other departments 69 1.83 (0.70)**

Random effects

ICC

Hospital level variance

33.63

2.07 (0.86)*

ICC

Department level variance

13.01

0.80 (0.29)**

*P <0.05, **P<0.01

Page 19 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



20

Table 4. Time and costs of one administration process and extrapolated to department level

One administration process Department in one year

Time (min) Costs (€)a Time (hours) Costs (€)b

Fixed (clinical lesson)a

No complete protocol

Complete protocol

-

72 min

-

€39,46

-

36 h

-

€1.183,95

Variable (administering medication)


Complete protocol

2 min 8 sec

3 min 26 sec

€1,51

€2,42

259 h 33 min

417 h 43 min

€11.007,23

€17.714,76

Total


Complete protocol

259 h 33 min

453 h 43 min

€11.007,23

€18.898,71

a Calculated for one nurse, no allowance for irregular hours included and based on two hours of

preparing and providing a clinical lesson to ten nurses.

b Extrapolation was based on thirty employed nurses, assuming that twenty administration processes

were performed in twenty-four hours in one department.

Page 20 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



21

Figure legends

Figure 1. Percentage administration processes with performed individual proceedings

Figure 2. Overall trend of amount performed proceedings resulting from the multilevel analysis

Page 21 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



22

Acknowledgements

The authors gratefully acknowledge all participating hospitals and the research assistants and research

nurses for collecting data for this study.

Contributors

CB, CW and SB designed the study, organized the data collection and developed the study protocol.

JS, SB and PS performed statistical analyses and interpreted the analytical results. JS and SB wrote the

manuscript. All authors made critical revision and approved the final version of the manuscript.

Funding

This work was supported by the Dutch Hospital Patient Safety Program.

Competing interests

None.

Ethics approval

This study has been approved by the Medical Ethics Committee of the VU Medical Centre

Amsterdam, with protocol number 2011/359.

Provenance and peer review

Not commissioned; externally peer reviewed.

Data sharing statement

No additional data are available.

Page 22 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



23

References

1. Baines RJ, Langelaan M, de Bruijne MC, et al. Changes in adverse event rates in hospitals over

time: a longitudinal retrospective patient record review study. BMJ QualSaf 2013;22(4):290-98.

2. Zegers M, de Bruijne MC, Wagner C, et al. Adverse events and potentially preventable deaths in

Dutch hospitals: results of a retrospective patient record review study. QualSaf Health Care

2009;18(4):297-302.

3. VMS Safety Program. www.vmszorg.nl.

4. de Vries EN, Ramrattan MA, Smorenburg SM, et al. The incidence and nature of in-hospital

adverse events: a systematic review. QualSaf Health Care 2008;17(3):216-23.

5. Hoonhout LH, de Bruijne MC, Wagner C, et al. Nature, occurrence and consequences of

medication-related adverse events during hospitalization: a retrospective chart review in the

Netherlands. Drug Saf 2010;33(10):853-64.

6. Leendertse AJ, van den Bemt PM, Poolman JB, et al. Preventable hospital admissions related to

medication (HARM): cost analysis of the HARM study. ValueHealth 2011;14(1):34-40.

7. CMR. Annual report Central Medication Registration 2008, 2009.

8. Federico F. Preventing harm from high-alert medications. Joint Commission Journal on Quality and

Patient Safety 2007;33(9):537-42.

9. Valentin A, Capuzzo M, Guidet B, et al. Errors in administration of parenteral drugs in intensive

care units: multinational prospective study. BMJ 2009;338:b814.

10. Roelofsen EE, Schuitenmaker MG, Swart EL, et al. Veiligheid op recept: een protocol voor

toediening gereed maken van parenteralia voor verpleegkundigen. Pharm Weekbl 2007;142:1162-66.

11. Tromp M, Natsch S, van Achterberg T. The preparation and administration of intravenous drugs

before and after protocol implementation. Pharm World Sci 2009;31(3):413-20.

12. Van Den Bemt PM, Fijn R, van der Voort PH, et al. Frequency and determinants of drug

administration errors in the intensive care unit*. Critical care medicine 2002;30(4):846-50.

13. Hoonhout LH, De Bruijne MC, Wagner C, et al. Direct medical costs of adverse events in Dutch

hospitals. BMC Health Services Research 2009;9(1):27.

Page 23 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



24

14. Van den Bemt PMLA, Egberts ACG. Drug related problems: definitions and classification.

European Journal of Hospital Pharmacy Practice 2007;2007(13):62-64.

15. VMS. High Risk Medication: Preparation and administration of parenteralia. Utrecht, The

Netherlands, 2009.

16. Greengold NL, Shane R, Schneider P, et al. The impact of dedicated medication nurses on the

medication administration error rate: a randomized controlled trial. ArchInternMed

2003;163(19):2359-67.

17. Schneider PJ, Pedersen CA, Montanya KR, et al. Improving the safety of medication

administration using an interactive cd-rom program1. Nederlands Tijdschrift voor Evidence Based

Practice 2007;5(1):12-13.

18. Bauer MS. A review of quantitative studies of adherence to mental health clinical practice

guidelines. Harvard review of psychiatry 2002;10(3):138-53.

19. Grimshaw JM, Thomas RE, MacLennan G, et al. Effectiveness and efficiency of guideline

dissemination and implementation strategies. Health technology assessment (Winchester, England)

2004;8(6):iii-iv, 1-72.

20. Hakkennes S, Dodd K. Guideline implementation in allied health professions: a systematic review

of the literature. Quality & safety in health care 2008;17(4):296-300.

21. Francke AL, Smit MC, de Veer AJ, et al. Factors influencing the implementation of clinical

guidelines for health care professionals: a systematic meta-review. BMC medical informatics and

decision making 2008;8:38.

22. De Blok C, Koster E, Schilp J, et al. Implementation VMS Safety Program: Evaluation study in

Dutch hospitals (in Dutch: Implementatie VMS Veiligheidsprogramma: Evaluatieonderzoek in

Nederlandse ziekenhuizen). Utrecht/Amsterdam, 2013.

23. Hakkaart-Roijen L, Tan SS, Bouwmans CAM. Handleiding voor kostenonderzoek. Methoden en

standaard kostprijzen voor economische evaluaties in de gezondheidszorg, 2010.

24. Twisk JW. Applied multilevel analysis: a practical guide: Cambridge University Press, 2006.

25. Wickstrom G, Bendix T. The" Hawthorne effect" what did the original Hawthorne studies actually

show? Scandinavian journal of work, environment & health 2000:363-67.

Page 24 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



25

26. Fore AM, Sculli GL, Albee D, et al. Improving patient safety using the sterile cockpit principle

during medication administration: a collaborative, unit-based project. JNursManag 2013;21(1):106-11.

27. Johari H, Shamsuddin F, Idris N, et al. Medication Errors Among Nurses in Government Hospital.

IOSR-JNHS 2013;1(2):18-23.

28. Relihan E, O'Brien V, O'Hara S, et al. The impact of a set of interventions to reduce interruptions

and distractions to nurses during medication administration. Quality and Safety in Health Care

2010;19(5):1-6.

29. Tomietto M, Sartor A, Mazzocoli E, et al. Paradoxical effects of a hospital-based, multi-

intervention programme aimed at reducing medication round interruptions. JNursManag

2012;20(3):335-43.

Page 25 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



169x121mm (96 x 96 DPI)

Page 26 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



109x95mm (96 x 96 DPI)

Page 27 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



1

STROBE Statement—checklist of items that should be included in reports of observational studies

Item

No Recommendation

Title and abstract 1 (a) Indicate the study’s design with a commonly used term in the title or the abstract X

(b) Provide in the abstract an informative and balanced summary of what was done

and what was found

X

Introduction

Background/rationale 2 Explain the scientific background and rationale for the investigation being reported X

Objectives 3 State specific objectives, including any prespecified hypotheses X

Methods

Study design 4 Present key elements of study design early in the paper X

Setting 5 Describe the setting, locations, and relevant dates, including periods of recruitment,

exposure, follow-up, and data collection

X

Participants 6 (a) Cohort study—Give the eligibility criteria, and the sources and methods of

selection of participants. Describe methods of follow-up

Case-control study—Give the eligibility criteria, and the sources and methods of

case ascertainment and control selection. Give the rationale for the choice of cases

and controls

Cross-sectional study—Give the eligibility criteria, and the sources and methods of

selection of participants

X

(b) Cohort study—For matched studies, give matching criteria and number of

exposed and unexposed

Case-control study—For matched studies, give matching criteria and the number of

controls per case

Variables 7 Clearly define all outcomes, exposures, predictors, potential confounders, and effect

modifiers. Give diagnostic criteria, if applicable

X

Data sources/

measurement

8* For each variable of interest, give sources of data and details of methods of

assessment (measurement). Describe comparability of assessment methods if there is

more than one group

X

Bias 9 Describe any efforts to address potential sources of bias X

Study size 10 Explain how the study size was arrived at X

Quantitative

variables

11 Explain how quantitative variables were handled in the analyses. If applicable,

describe which groupings were chosen and why

X

Statistical methods 12 (a) Describe all statistical methods, including those used to control for confounding X

(b) Describe any methods used to examine subgroups and interactions X

(c) Explain how missing data were addressed X

(d) Cohort study—If applicable, explain how loss to follow-up was addressed

Case-control study—If applicable, explain how matching of cases and controls was

addressed

Cross-sectional study—If applicable, describe analytical methods taking account of

sampling strategy

NA

(e) Describe any sensitivity analyses

Continued on next page

Page 28 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



2

Results

Participants 13* (a) Report numbers of individuals at each stage of study—eg numbers potentially eligible,

examined for eligibility, confirmed eligible, included in the study, completing follow-up,

and analysed

X

(b) Give reasons for non-participation at each stage NA

(c) Consider use of a flow diagram X

Descriptive

data

14* (a) Give characteristics of study participants (eg demographic, clinical, social) and

information on exposures and potential confounders

X

(b) Indicate number of participants with missing data for each variable of interest X

(c) Cohort study—Summarise follow-up time (eg, average and total amount)

Outcome data 15* Cohort study—Report numbers of outcome events or summary measures over time

Case-control study—Report numbers in each exposure category, or summary measures of

exposure

Cross-sectional study—Report numbers of outcome events or summary measures X

Main results 16 (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their

precision (eg, 95% confidence interval). Make clear which confounders were adjusted for

and why they were included

X

(b) Report category boundaries when continuous variables were categorized X

(c) If relevant, consider translating estimates of relative risk into absolute risk for a

meaningful time period

NA

Other analyses 17 Report other analyses done—eg analyses of subgroups and interactions, and sensitivity

analyses

X

Discussion

Key results 18 Summarise key results with reference to study objectives X

Limitations 19 Discuss limitations of the study, taking into account sources of potential bias or

imprecision. Discuss both direction and magnitude of any potential bias

X

Interpretation 20 Give a cautious overall interpretation of results considering objectives, limitations,

multiplicity of analyses, results from similar studies, and other relevant evidence

X

Generalisability 21 Discuss the generalisability (external validity) of the study results X

Other information

Funding 22 Give the source of funding and the role of the funders for the present study and, if

applicable, for the original study on which the present article is based

X

*Give information separately for cases and controls in case-control studies and, if applicable, for exposed and

unexposed groups in cohort and cross-sectional studies.

Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and

published examples of transparent reporting. The STROBE checklist is best used in conjunction with this article (freely

available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/, Annals of Internal Medicine at

http://www.annals.org/, and Epidemiology at http://www.epidem.com/). Information on the STROBE Initiative is

available at www.strobe-statement.org.

Page 29 of 29


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



Protocol compliance of administering parenteral medication in Dutch hospitals: an evaluation and cost-estimation of the

implementation

Journal: BMJ Open

Manuscript ID: bmjopen-2014-005232.R1

Article Type: Research

Date Submitted by the Author: 28-Oct-2014

Complete List of Authors: Schilp, Janneke; Netherlands Institute for Health Services Research (NIVEL), Boot, Sanne; Netherlands Institute for Health Services Research (NIVEL),

de Blok, Carolien; Netherlands Institute for Health Services Research (NIVEL), Spreeuwenberg, Peter; Netherlands Institute for Health Services Research (NIVEL), Wagner, Cordula; Netherlands Institute for Health Services Research (NIVEL),

<b>Primary Subject Heading</b>:

Medical management

Secondary Subject Heading: Pharmacology and therapeutics, Medical management, Health economics

Keywords:

Protocols & guidelines < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, Quality in health care < HEALTH SERVICES ADMINISTRATION & MANAGEMENT, Health & safety < HEALTH SERVICES

ADMINISTRATION & MANAGEMENT, Adverse events < THERAPEUTICS


BMJ Open on January 25, 2020 by guest. P

rotected by copyright.http://bm

jopen.bmj.com

/B

MJ O

pen: first published as 10.1136/bmjopen-2014-005232 on 30 D

ecember 2014. D

ownloaded from



1



implementation








Telephone: +31 302 729 843

Fax: +31 302 729 729




Page 1 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



2

Abstract












for one year.











Page 2 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



3








be evaluated.

Page 3 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



4

INTRODUCTION








AEs occuring during hospital admissions [2, 4] and result in an excess length of hospital stay and high

direct medical costs.[5] In the Netherlands, the average costs of one preventable ADE was estimated to

be €2876 (95% CI €976-€5080).[5]

From the Dutch Central Medication incidents Registration (CMR), in which all hospital-

related medication errors must be reported, can be concluded that most reported medication errors are

related to parenteral medication.[7] Parenteral medication is provided with intravenous, subcutaneous

or intramuscular injections. Most parenteral medication involve high risk medication, which has a low

therapeutic index and increases the risk of causing significant injury to patients, when used

inappropriately.[8] Three stages can be identified in the process of ensuring the appropriate medication

is given to the patient: prescription, preparation and administration of parenteral medication. In every

stage of the process medication errors may possibly occur, but analysis of CMR showed that most of

the reported medication errors (44%) are related to the administration.[7, 9] During the stage of

administration, five types of errors can be distinguished attributing to medication errors: wrong dose,

wrong drug, wrong route, wrong time and missed medication.[10] Since most errors appear in the

stage of administration, the present study will focus on this specific part of the medication process.



medication and training contributed to a reduction in medication errors in hospitals.[11-15] By

preventing medication errors, adverse consequences such as medical burden for the patient and

economic burden for the society will be decreased.[16, 17] Within the Dutch Safety Program a

Page 4 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



5

protocol containing the proceedings of the preparation and administration of parenteral medication,

was developed by an expert team of hospital pharmacists, doctors, ICU nurses and an anesthesiologist.

This protocol was available for all hospitals within the module ‘High Risk Medication: Preparation

and administration of parenteral medication’.[3] Education and several practical recommendations for

successful implementation of the protocol were offered to the hospitals. With education, such as

clinical lessons, it was expected to generate support among nurses to execute the protocol

completely.[18, 19] Accurate implementation of the protocol is essential, because preventable ADEs

may only be reduced when the protocol is strictly followed.[13, 15] Insight in the actual degree of

implementation of the protocol is important, because earlier research showed that successful

implementation of guidelines is complex in clinical practice and that guideline adherence is not high

without specific intervention.[20-22] Based on the goals of the Safety Program, it was expected that

the protocol compliance would improve during the final year of the program as hospitals approached

the public deadline at the end of 2012.












the costs of implementing this protocol.




Page 5 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



6



level.

Methods

Study design











types of parenteral intravenous medication, except cytostatic, were included for the observations. A

total of 14 research assistants, having experience with practicing research (completed university

education) and/or with hospital procedures (completed nursing education), were trained in the research

protocol and the observation method during a training day. Follow-up trainings were organized to

repeat the training and to discuss common practice situations. During a measurement day the research

assistants observed the nurses executing the administration protocol. Thereby, a minimum of three

nurses per department and a maximum of three processes a day for each administrating nurse were

observed, to correct for between-person variation. Nurses were unaware of the true purpose of the

observations. The study has been approved by the Medical Ethics Committee of the VU Medical

Centre Amsterdam.

Page 6 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



7


The evaluation study focused on the degree of implementation of the protocol of administering

parenteral medication by measuring the process indicator ‘percentage completely performed

administration proceedings’. An observation list was used to evaluate the execution of the proceedings

included in the protocol of administering parenteral medication (box 1). The list included the 9 most

important and identifiable administration proceedings determined by the expert team. All completely

performed proceedings were marked on the observation list, whereby insight was obtained in the

compliance with the individual proceedings. The total amount of performed proceedings was

calculated to show the compliance to the protocol (score 0 to 9). Compliance with the protocol was

dichotomized into complete (9 proceedings) and not complete (≤8 proceedings).










module ‘High Risk Medication’ to prevent disturbance of the administrator.







Page 7 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



8



a second nurse’ was executed, because in that administration process two nurses spent time. To

determine the investment of time to become familiar with the protocol, the average duration of a

clinical lesson was assumed one hour.[13] The time for a teaching nurse of preparing and providing a

clinical lesson for ten nurses was assumed two hours. The total time for preparing, providing and

following a clinical lesson was thereby estimated at 72 minutes per nurse.





















Page 8 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



9












significant.

Results





12% of the administration processes and in only 3% of the observations nurses followed the advice on

recognizability by wearing a medication safety jacket during the administration.






a complete protocol was also the highest in general hospitals. Administrators were most often

disturbed during the administration process in academic hospitals. The amount of disturbances

Page 9 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



10

decreased statistically significantly during the study period (p<0.001): 15% disturbance at the

beginning (measurements 1-3) 12% in the middle (measurements 4-7) and 8 % at the end

(measurements 8-10) of the study. In case of disturbance, statistically significantly less (p<0.001)

proceedings of the protocol were performed compared to no disturbance (6.9; SD 1.3 vs 7.4; SD 1.3).

The recognizability of the administrator was highest in tertiary teaching hospitals. No statistically

significant difference was found in performing the protocol in case of recognizability or no

recognizability of the administrator (7.1; SD 1.5 vs 7.3; SD 1.3).

Figure 1 shows the percentages for the execution of the individual proceedings. The

proceeding ‘check by a second nurse’ was least often performed (52%), followed by the proceeding

‘identify patient’ (61%) and ‘hand hygiene’ (62%). A deterioration occurred on half of the study

period for these proceedings. The six remaining proceedings were more often performed and during

the study period an increase was visible. At the final three measurements the proceedings ‘check

medication’ and ‘collect materials of medication’ were executed in all administration processes.

Multi-level analysis, time trend



between 7.0 and 7.7. A statistically significant non-linear trend was found over the study period

(second and fourth order multilevel, p<0.001). A decrease of performed proceedings was observed in

the middle of the study, followed by an increase of the proceedings to the end of the study. The multi-

level analysis shows that 20% of the total variance in performed proceedings of the administration

protocol (ICC=20.06) was caused by differences between individual hospitals, 10% of the variance in

protocol compliance (ICC=9.55) was caused by differences between individual departments.





Page 10 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



11


complete protocol compliance was more often performed on these departments compared to the


























Page 11 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



12




Page 12 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



13

Discussion





the end. Differences were found between type of hospitals and departments. The proceeding ‘check by

a second nurse’ was least performed followed by ‘identification of patient’. Disturbance of the




between a complete and incomplete administration protocol. Comparing these extrapolated costs with

the costs of one preventable ADE (€2876), the costs correspond to approximately three ADEs yearly

on department level. Therefore, beside the potential effect of implementation of the protocol on the

patients in diminishing the harm due to an ADE, the investment in money for hospitals is also

relatively low in perspective to the output.











nurses working at academic hospitals performed less often the protocol than nurses working in general

or tertiary teaching hospitals. Major differences in compliance to the protocol were found between

Page 13 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



14

individual hospitals. Some hospitals were performing all proceedings of the protocol in the majority of

the administration processes, while in other hospitals in none of the processes all proceedings were

executed. These findings may be explained by earlier findings that successful implementation of the

protocol is possible when the appropriate preconditions and support are available.[13] During the

study period, the total amount of performed proceedings of the protocol decreased to the median and

increased at the end of the study period. The lower degree of compliance to the protocol may possibly

be the result of the summer season. In this period the attention may be weakened by increased

workload or replacement by personnel not familiar with the protocol.


particular the ‘check by a second nurse’ was little performed in most hospitals. This is an important

proceeding, because this enables intervention of a second nurse to prevent a medication error of the

administrator. An overestimation of this percentage is likely, because the ‘check by a second nurse’

was difficult to determine. ‘Identification of the patient’ was also not often performed. Possibly,

nurses did not identify the patient because they cared a longer time for the patient and knew the patient

well.














Page 14 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



15


interruptions.









to large differences between the five individual hospitals and not as a result of difference between type

of hospitals. This is also reflected in the high ICC of the association between type of hospital and

complete protocol compliance, showing that 28% of the total variance in the association between type

of hospital and complete protocol compliance was caused by differences between individual hospitals.


A strength of this study was the large amount of participating hospitals including all planned

departments. Because the observations were performed on different time points a trend over time in

compliance of the protocol could be determined. The large representative sample of hospitals ensures

the results may be generalized to the national hospital population. Due to the large amount of

observations a distinction could be made between different types of hospitals. Another strength of the

study was that a maximum of three processes were observed within each nurse, to take variation into

account.




possible, observations were conducted on different days, administration moments and nurses. Due to

privacy reasons, we do not have information about the nurses executing the administration protocol

Page 15 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



16

and could not include nurse level to the multilevel analysis. Several research assistants executed the

observations which might have led to variation in the observations. Therefore, this bias effect was

avoided as much as possible by training the research assistants, checking the data input and using a

standardized observation list. A final important limitation of the study was that the effect of the

implementation of the protocol on the occurrence of ADEs could not be evaluated. However, this is a

consequence of the design of the evaluation study as only process indicators were measured to provide

insight in the degree of implementation of patient safety themes. Outcome indicators as medication

errors were not included in the observation protocol and could therefore not be evaluated. Future

studies are needed to investigate the effect of the implementation of the protocol on reducing

medication errors and ADEs.

Conclusion






of medication errors and ADEs and associated costs was not determined. Extrapolating our results to

department level, we showed a difference of €7.891 between a complete and incomplete

administration protocol per department per year, which is comparable to the costs of three preventable

ADEs.

Page 16 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



17

Acknowledgements



Contributors




Funding


Competing interests

None.

Ethics approval







Page 17 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



18








medication.


administration.


medication.




administration.


Page 18 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



19




Type of hospital

Academic

Tertiary teaching

General

297 (13.8)

750 (34.8)

1107 (51.4)


Type of department

General surgery

Internal medicine

Intensive Care Unit

Other departments

771 (35.8)

643 (29.9)

671 (31.2)

69 (3.2)



Morning

Afternoon

Evening/night

770 (35.8)

1256 (58.3)

126 (5.9)




Page 19 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



20



N=2154

General

hospitals

N=1107

Tertiary

teaching

hospitals

N=750

Academic

hospitals

N=297

P







Page 20 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



21


compliance (n=2154)

N Estimate (SE)

Fixed effects


Type of department





Random effects

ICC


33.63

2.07 (0.86)*

ICC


13.01

0.80 (0.29)**

*P <0.05, **P<0.01

Page 21 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



22






Complete protocol

-

72 min

-

€39,46

-

36 h

-

€1.183,95



Complete protocol

2 min 8 sec

3 min 26 sec

€1,51

€2,42

259 h 33 min

417 h 43 min

€11.007,23

€17.714,76

Total


Complete protocol

259 h 33 min

453 h 43 min

€11.007,23

€18.898,71





Page 22 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



23

Figure legends



Page 23 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



24

References





2009;18(4):297-302.


Netherlands, 2009.










Patient Safety 2007;33(9):537-42.

9. Cheung KC, van den Bemt PM, Bouvy ML, et al. A nationwide medication incidents reporting

system in The Netherlands. JAMIA 2011;18(6):799-804.



11. Chedoe I, Molendijk H, Hospes W, et al. The effect of a multifaceted educational intervention on

medication preparation and administration errors in neonatal intensive care. Archives of disease in

childhood Fetal and neonatal edition 2012;97(6):F449-55.

Page 24 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



25

12. Nguyen HT, Pham HT, Vo DK, et al. The effect of a clinical pharmacist-led training programme

on intravenous medication errors: a controlled before and after study. BMJ QualSaf 2014;23(4):319-

24.



14. Van den Bemt PM, Fijn R, van der Voort PH, et al. Frequency and determinants of drug

administration errors in the intensive care unit. Critical care medicine 2002;30(4):846-50.








medication administration error rate: a randomized controlled trial. Arch Intern Med

2003;163(19):2359-67.



Practice 2007;5(1):12-13.





2004;8(6):iii-iv, 1-72.


of the literature. QualSaf Health Care 2008;17(4):296-300.

Page 25 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



26













during medication administration: a collaborative, unit-based project. J Nurs Manag 2013;21(1):106-

11.


IOSR-JNHS 2013;1(2):18-23.


and distractions to nurses during medication administration. QualSaf Health Care 2010;19(5):1-6.


intervention programme aimed at reducing medication round interruptions. J Nurs Manag

2012;20(3):335-43.

Page 26 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



1



implementation








Telephone: +31 302 729 843

Fax: +31 302 729 729




Page 27 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



2

Abstract












for one year.











Page 28 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



3








be evaluated.

Page 29 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



4

INTRODUCTION








AEs that occuroccuring during hospital admissions [2, 4] and result in an excess length of hospital stay

and high direct medical costs.[5] In the Netherlands, the average costs of one preventable ADE was

estimated to be €60092876 (95% CI €976-€5080).[6].[5]

From the Dutch Central Medication incidents error Registration (CMR), in which all hospital-

related medication errorsADEs must be reported, can be concluded that most ADEs reported

medication errors are related to parenteral medication.[7] Parenteral medication is provided with

intravenous, subcutaneous or intramuscular injections. Most parenteral medication involve high risk

medications, which has a low therapeutic index and such as antibiotics, which increases the risk of

causing significant injury to patients, when used inappropriately.[8] Three stages can be identified in

the process of ensuring the appropriate medication is given to the patient: prescription, preparation and

administration of parenteral medication. In every stage of the process medication errors there is amay

possibly possibility for ADEs to occur, but analysis of Central Medication-incident Registration

(CMR) showed that most of the reported ADEs medication errors (446%) are related to the

administration.[7, 9] During the stage of administration, five types of errors can be distinguished

attributing to medication errors: wrong dose, wrong drug, wrong route, wrong time and missed

medication.[10] Since most errors appear in the stage of administration, the present study will focus on

this specific part of the medication process.



medication and training contributed to a reduction in medication errorsresulted in less ADEs in

Page 30 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



5

hospitals.[11-15] By preventing ADEsmedication errors, adverse consequences such as medical

burden for the patient and economic burden for the society will be decreased.[16, 17] Within the

Dutch Safety Program a protocol containing the proceedings of the preparation and administration of

parenteral medication, was developed by an expert team of hospital pharmacists, doctors, ICU nurses

and an anesthesiologist. This protocol was available for all hospitals within the module ‘High Risk

Medication: Preparation and administration of parenteral medication’.[3] Education and several

practical recommendations for successful implementation of the protocol were offered to the hospitals.

With education, such as clinical lessons, it was expected to generate support among nurses to execute

the protocol completely.[18, 19] Accurate implementation of the protocol is essential, because

preventable ADEs may only be reduced when the protocol is strictly followed.[13, 15] Insight in the

actual degree of implementation of the protocol is important, because earlier research showed that

successful implementation of guidelines is complex in clinical practice and that guideline adherence is

not high without specific intervention.[20-22] Based on the goals of the Safety Program, it was

expected that the protocol compliance would improve during the final year of the program as hospitals

approached the public deadline at the end of 2012.












the costs of implementing this protocol.

Page 31 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



6






level.

Methods

Study design











types of parenteral intravenous medication, except cytostatic, were included for the observations. A

total of 14 trained research assistants, having experience with practicing research (completed

university education) and/or with hospital procedures (completed nursing education), were trained in

the research protocol and the observation method during a training day. Follow-up trainings were

organized to repeat the training and to discuss common practice situations. During a measurement day

the research assistants observed the nurses executing the administration protocol during the

measurement days. Thereby, aA minimum of three nurses per department and a maximum of three

processes a day were observed for each administrating nurse were observed, to correct for between-

Page 32 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



7

person variation. Nurses were unaware of the true purpose of the observations. The study has been

approved by the Medical Ethics Committee of the VU Medical Centre Amsterdam.


The evaluation study focused on the degree of implementation of the protocol of administering

parenteral medication by measuring the process indicator ‘percentage completely performed

administration proceedings’. An observation list was used to evaluate the execution of the proceedings

included in the protocol of administering parenteral medication (box 1). The list included the 9 most

important and identifiable administration proceedings determined by the expert team. All completely

performed proceedings were marked on the observation list, whereby insight was obtained in the

compliance with the individual proceedings. The total amount of performed proceedings was

calculated to show the compliance to the protocol (score 0 to 9). Compliance with the protocol was

dichotomized into complete (9 proceedings) and not complete (≤8 proceedings).










module ‘High Risk Medication’ to prevent disturbance of ensure that the administrator may not be

disturbed.


Page 33 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



8








a second nurse’ was executed, because then in that administration process two nurses spent time to the

administration process. To determine the investment of time investment to become familiar with the

protocol, an assumption was made that the average duration of a clinical lesson was assumedtakes one

hour.[13] The time for a teaching nurse of preparing and providing a clinical lesson for ten nurses was

based atassumed two hours. The total time for preparing, providing and following a clinical lesson was

thereby estimated at 72 minutes per nurse.














Page 34 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



9



















significant.

Results





12% of the administration processes and in only 3% of the observations nurses followed the advice on

recognizability by wearing a medication safety jacket during the administration.

Page 35 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



10






a complete protocol was also the highest in general hospitals. In academic hospitals Aadministrators

were most often disturbed during the administration process in academic hospitalsduring the

administration process. The amount of disturbances decreased statistically significantly during the

study period (p<0.001): 15% disturbance at the beginning (measurements 1-3) 12% in the middle

(measurements 4-7) and 8 % at the end (measurements 8-10) of the study. In case of disturbance,

statistically significantly less (p<0.001) proceedings of the protocol were performed compared to no

disturbance (6.9; SD 1.3 vs 7.4; SD 1.3). The recognizability of the administrator was highest in

tertiary teaching hospitals. No statistically significant difference was found in performing the protocol

in case of recognizability or no recognizability of the administrator (7.1; SD 1.5 vs 7.3; SD 1.3).

Figure 1 shows the percentages for the executionng of the individual proceedings. The

proceeding ‘check by a second nurse’ was least often performed (52%), followed by the proceeding

‘identify patient’ (61%) and ‘hand hygiene’ (62%). A deterioration occurred on half of the study

period for these proceedings. The six remaining proceedings were more often performed and during

the study period an increase was visible. At the final three measurements the proceedings ‘check

medication’ and ‘collect materials of medication’ were executed in all administration processes.

Multi-level analysis, time trend



between 7.0 and 7.7. A statistically significant non-linear trend was found over the study period

(second and fourth order multilevel, p<0.001). The trend was not linearly, aA decrease of performed

proceedings was observed in the middle of the study, followed by an increase of the proceedings to the

end of the study. The multi-level analysis shows that 20% of the total variance in performed

Page 36 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



11

proceedings of the administration protocol (ICC=20.06) was caused by differences between individual

hospitals, 10% of the variance in protocol compliance (ICC=9.55) was caused by differences between

individual departments.






complete protocol compliance was more often performed in on these departments compared to the


















Page 37 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



12












Page 38 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



13

Discussion





the end. Differences were found between types of hospitals and departments. The proceeding ‘check

by a second nurse’ was least performed followed by ‘identification of patient’. Disturbance of the




between a complete and incomplete administration protocol. Comparing these extrapolated costs with

the costs of one preventable ADE (€2876), the costs correspond to approximately three ADEs yearly

on department level. These costs are comparable to the costs of one preventable ADE (€6009).

Therefore, beside the potential effect of implementation of the protocol on the patients in diminishing

the harm due to an ADE, the investment in money for hospitals is also relatively low in perspective to

the output.











nurses working at academic hospitals less often performed less often the protocol than nurses working

Page 39 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



14

in general or tertiary teaching hospitals. Major differences in compliance to the protocol were found

between individual hospitals. Some hospitals were performing all proceedings of the protocol in the

majority of the administration processes, while in other hospitals in none of the processes all

proceedings were executed. These findings may be explained by earlier findings that successful

implementation of the protocol is possible when the appropriate preconditions and support are

available.[13] During the study period, the total amount of performed proceedings of the protocol

decreased to the median and increased at the end of the study period. The lower degree of compliance

to the protocol may possibly be the result of the summer season. In this period the attention may be

weakened by increased workload or replacement of by personnel who are not familiar with the

protocol.


particular the ‘check by a second nurse’ was not oftenlittle performed in most hospitals. This is an

important proceeding, because this enables intervention of a second nurse can intervene whento

prevent a medication error of the administrator is heading for making an error. An overestimation of

this percentage is likely, because the ‘check by a second nurse’ was difficult to determine.

‘Identification of the patient’ was also not often performed. Possibly, nurses did not identify the

patient because they cared such a longer time for the patient and knew the patient well.












Page 40 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



15




interruptions.









to large differences between the five individual hospitals and not as a result of differences between

types of hospitals. This is also reflected in the high ICC of the association between type of hospital

and complete protocol compliance, showing that 28% of the total variance in the association between

type of hospital and complete protocol compliance was caused by differences between individual

hospitals.


A strength of this study was the large amount of participating hospitals including all planned

departments. Because the observations were performed on different time points a trend over time in

compliance of the protocol could be determined. The large representative sample of hospitals ensures

the results may be generalized to the national hospital population. Due to the large amount of

observations a distinction could be made between different types of hospitals. Another strength of the

study was that a maximum of three processes were observed within each nurse, to take variation into

account.



Page 41 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



16


possible, observations were conducted on different days, administration moments and nurses. Due to

privacy reasons, we do not have information about the nurses executing the administration protocol

and could not include nurse level to the multilevel analysis. Several research assistants executed the

observations which might have led to variation in the observations. Therefore, this bias effect was

avoided as much as possible by training the research assistants, checking the data input and using a

standardized observation list. A final important limitation of the study was that the effect of the

implementation of the protocol on the occurrence of ADEs could not be evaluated. However, this is a

consequence of the design of the evaluation study as only process indicators were measured to provide

insight in the degree of implementation of patient safety themes. Outcome indicators as medication

errors were not included in the observation protocol and could therefore not be evaluated. Future

studies are needed to investigate the effect of the implementation of the protocol on reducing

medication errors and ADEs.

Conclusion






of medication errors and ADEs and associated costs was not determined. Extrapolating our results to

department level, we showed a difference of €7.891 between a complete and incomplete

administration protocol per department per year, which is comparable to the costs of threeone

preventable ADEs.

Page 42 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



17

Acknowledgements



Contributors




Funding


Competing interests

None.

Ethics approval







Page 43 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



18








medication.


administration.


medication.




administration.


Page 44 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



19




Type of hospital

Academic

Tertiary teaching

General

297 (13.8)

750 (34.8)

1107 (51.4)


Type of department

General surgery

Internal medicine

Intensive Care Unit

Other departments

771 (35.8)

643 (29.9)

671 (31.2)

69 (3.2)



Morning

Afternoon

Evening/night

770 (35.8)

1256 (58.3)

126 (5.9)




Page 45 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



20



N=2154

General

hospitals

N=1107

Tertiary

teaching

hospitals

N=750

Academic

hospitals

N=297

P







Page 46 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



21


compliance (n=2154)

N Estimate (SE)

Fixed effects


Type of department





Random effects

ICC


33.63

2.07 (0.86)*

ICC


13.01

0.80 (0.29)**

*P <0.05, **P<0.01

Page 47 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



22






Complete protocol

-

72 min

-

€39,46

-

36 h

-

€1.183,95



Complete protocol

2 min 8 sec

3 min 26 sec

€1,51

€2,42

259 h 33 min

417 h 43 min

€11.007,23

€17.714,76

Total


Complete protocol

259 h 33 min

453 h 43 min

€11.007,23

€18.898,71





Page 48 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



23

Figure legends



Page 49 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



24

References





2009;18(4):297-302.


Netherlands, 2009.










Patient Safety 2007;33(9):537-42.

9. Cheung KC, van den Bemt PM, Bouvy ML, et al. A nationwide medication incidents reporting

system in The Netherlands. JAMIA 2011;18(6):799-804.



11. Chedoe I, Molendijk H, Hospes W, et al. The effect of a multifaceted educational intervention on

medication preparation and administration errors in neonatal intensive care. Archives of disease in

childhood Fetal and neonatal edition 2012;97(6):F449-55.

Page 50 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



25

12. Nguyen HT, Pham HT, Vo DK, et al. The effect of a clinical pharmacist-led training programme

on intravenous medication errors: a controlled before and after study. BMJ QualSaf 2014;23(4):319-

24.



14. Van den Bemt PM, Fijn R, van der Voort PH, et al. Frequency and determinants of drug

administration errors in the intensive care unit. Critical care medicine 2002;30(4):846-50.








medication administration error rate: a randomized controlled trial. Arch Intern Med

2003;163(19):2359-67.



Practice 2007;5(1):12-13.





2004;8(6):iii-iv, 1-72.


of the literature. QualSaf Health Care 2008;17(4):296-300.

Page 51 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



26













during medication administration: a collaborative, unit-based project. J Nurs Manag 2013;21(1):106-

11.


IOSR-JNHS 2013;1(2):18-23.


and distractions to nurses during medication administration. QualSaf Health Care 2010;19(5):1-6.


intervention programme aimed at reducing medication round interruptions. J Nurs Manag

2012;20(3):335-43.

Page 52 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



182x117mm (300 x 300 DPI)

Page 53 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



121x90mm (300 x 300 DPI)

Page 54 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



1

STROBE Statement—checklist of items that should be included in reports of observational studies

Item

No Recommendation

Title and abstract 1 (a) Indicate the study’s design with a commonly used term in the title or the abstract X

(b) Provide in the abstract an informative and balanced summary of what was done

and what was found

X

Introduction

Background/rationale 2 Explain the scientific background and rationale for the investigation being reported X

Objectives 3 State specific objectives, including any prespecified hypotheses X

Methods

Study design 4 Present key elements of study design early in the paper X

Setting 5 Describe the setting, locations, and relevant dates, including periods of recruitment,

exposure, follow-up, and data collection

X

Participants 6 (a) Cohort study—Give the eligibility criteria, and the sources and methods of

selection of participants. Describe methods of follow-up

Case-control study—Give the eligibility criteria, and the sources and methods of

case ascertainment and control selection. Give the rationale for the choice of cases

and controls

Cross-sectional study—Give the eligibility criteria, and the sources and methods of

selection of participants

X

(b) Cohort study—For matched studies, give matching criteria and number of

exposed and unexposed

Case-control study—For matched studies, give matching criteria and the number of

controls per case

Variables 7 Clearly define all outcomes, exposures, predictors, potential confounders, and effect

modifiers. Give diagnostic criteria, if applicable

X

Data sources/

measurement

8* For each variable of interest, give sources of data and details of methods of

assessment (measurement). Describe comparability of assessment methods if there is

more than one group

X

Bias 9 Describe any efforts to address potential sources of bias X

Study size 10 Explain how the study size was arrived at X

Quantitative

variables

11 Explain how quantitative variables were handled in the analyses. If applicable,

describe which groupings were chosen and why

X

Statistical methods 12 (a) Describe all statistical methods, including those used to control for confounding X

(b) Describe any methods used to examine subgroups and interactions X

(c) Explain how missing data were addressed X

(d) Cohort study—If applicable, explain how loss to follow-up was addressed

Case-control study—If applicable, explain how matching of cases and controls was

addressed

Cross-sectional study—If applicable, describe analytical methods taking account of

sampling strategy

NA

(e) Describe any sensitivity analyses

Continued on next page

Page 55 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from



2

Results

Participants 13* (a) Report numbers of individuals at each stage of study—eg numbers potentially eligible,

examined for eligibility, confirmed eligible, included in the study, completing follow-up,

and analysed

X

(b) Give reasons for non-participation at each stage NA

(c) Consider use of a flow diagram X

Descriptive

data

14* (a) Give characteristics of study participants (eg demographic, clinical, social) and

information on exposures and potential confounders

X

(b) Indicate number of participants with missing data for each variable of interest X

(c) Cohort study—Summarise follow-up time (eg, average and total amount)

Outcome data 15* Cohort study—Report numbers of outcome events or summary measures over time

Case-control study—Report numbers in each exposure category, or summary measures of

exposure

Cross-sectional study—Report numbers of outcome events or summary measures X

Main results 16 (a) Give unadjusted estimates and, if applicable, confounder-adjusted estimates and their

precision (eg, 95% confidence interval). Make clear which confounders were adjusted for

and why they were included

X

(b) Report category boundaries when continuous variables were categorized X

(c) If relevant, consider translating estimates of relative risk into absolute risk for a

meaningful time period

NA

Other analyses 17 Report other analyses done—eg analyses of subgroups and interactions, and sensitivity

analyses

X

Discussion

Key results 18 Summarise key results with reference to study objectives X

Limitations 19 Discuss limitations of the study, taking into account sources of potential bias or

imprecision. Discuss both direction and magnitude of any potential bias

X

Interpretation 20 Give a cautious overall interpretation of results considering objectives, limitations,

multiplicity of analyses, results from similar studies, and other relevant evidence

X

Generalisability 21 Discuss the generalisability (external validity) of the study results X

Other information

Funding 22 Give the source of funding and the role of the funders for the present study and, if

applicable, for the original study on which the present article is based

X

*Give information separately for cases and controls in case-control studies and, if applicable, for exposed and

unexposed groups in cohort and cross-sectional studies.

Note: An Explanation and Elaboration article discusses each checklist item and gives methodological background and

published examples of transparent reporting. The STROBE checklist is best used in conjunction with this article (freely

available on the Web sites of PLoS Medicine at http://www.plosmedicine.org/, Annals of Internal Medicine at

http://www.annals.org/, and Epidemiology at http://www.epidem.com/). Information on the STROBE Initiative is

available at www.strobe-statement.org.

Page 56 of 56


BMJ Open

123456789101112131415161718192021222324252627282930313233343536373839404142434445464748495051525354555657585960


http://bmjopen.bm

j.com/

BM



ber 2014. Dow

nloaded from


Documents

BMJ Open · than by the patient’s underlying disease that results in a prolonged hospital stay, temporary or permanent disability, or death.[2] The national Dutch Hospital Patient