Infection (2014) 42:119–125 DOI 10.1007/s15010-013-0531-y
CLINICAL AND EPIDEMIOLOGICAL STUDY
Antibiotic stewardship in Germany: a cross-sectional questionnaire survey of 355 intensive care units F. Maechler • F. Schwab • C. Geffers • E. Meyer • R. Leistner • P. Gastmeier
Received: 5 June 2013 / Accepted: 4 September 2013 / Published online: 18 October 2013 Ó Springer-Verlag Berlin Heidelberg 2013
Abstract Purpose Little information is available on antibiotic prescription management in German hospitals. The objective of this cross-sectional study was to determine the prevalence and components of antibiotic stewardship measures in German intensive care units (ICUs). Methods A questionnaire survey was sent to all ICUs participating in the German nosocomial infection surveillance system (n = 579) in October 2011. Data on antibiotic management structures were collected and analyzed by structural hospital and ICU factors. Results The questionnaire was completed by 355 German ICUs (response rate 61 %). Common measures used ([80 % of the ICUs) were personnel restrictions for antibiotic prescriptions, routine access to bacterial resistance data, and pharmacy reports on antibiotic costs and consumption. A small proportion of ICUs (14 %) employed physicians specialized in the prescription of antimicrobial medication. Hospitals with their own microbiological laboratory report participation in surveillance networks for antimicrobial use (34 %) and bacterial resistance (32 %) twice as often as hospitals with external laboratories (15 and 14 %, respectively, p \ 0.001). Also, non-profit and public hospitals participate more often in surveillance networks for bacterial resistance than private hospitals ([23 % vs. 11 %, p \ 0.05).
Electronic supplementary material The online version of this article (doi:10.1007/s15010-013-0531-y) contains supplementary material, which is available to authorized users. F. Maechler (&) F. Schwab C. Geffers E. Meyer R. Leistner P. Gastmeier Institute of Hygiene and Environmental Medicine, Charite´ Berlin, Hindenburgdamm 27, 12203 Berlin, Germany e-mail: [email protected]
Conclusions While the majority of ICUs report to have some antibiotic policies established, the contents and composition of these policies vary. Organizational-level control strategies to improve antibiotic management are common in Germany. However, strategies widely considered effective, such as the systematic cross-institutional surveillance of antimicrobial use and bacterial resistance in a standardized manner or the employment of infectious disease specialists, are scarce. This study provides a benchmark for future antibiotic stewardship programs. Keywords Antibiotics Prescription Management Antibiotic stewardship Cross-sectional studies
Introduction As bacterial resistance is becoming a major concern to the public worldwide, the call for improved antibiotic prescription practice has become more significant. Many different interventions have proved to be successful in changing antibiotic prescription practice for hospital patients. Restrictive methods appear to have a larger effect than other intervention strategies [1]. However, routine restriction does not necessarily prevent the overuse of available broad-spectrum antibiotics [2], and, in the long term, restrictions are not superior to persuasive methods [1]. Much effort has been directed towards the development of guidelines for antibiotic therapy [3, 4], but adherence to guidelines needs to be improved [5, 6]. To make the best use of the currently available antimicrobials and to reduce misuse of broad-spectrum antibiotics, a fundamental change in clinical thinking is needed [7]. Antibiotic stewardship (ABS) initiatives have been pursuing this goal for years. These hospital-based
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antimicrobial management programs are focused on changing and directing antimicrobial use and may employ any number of individual strategies [8]. Antimicrobial stewardship guidelines were published in 2007 by the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) [9]. Almost 6 years later, little information is available on the structure and content of antibiotic policies and formularies/drug lists in hospitals [10], particularly at the intensive care unit (ICU) level. While some European countries have strict policies regarding antibiotic therapy [11], in Germany, any licensed physician may prescribe antibiotics without further restrictions. Information on structures underlying the antibiotic prescription process is scarce, and the information available indicates a lack of antibiotic stewardship programs and infectious diseases specialists [12]. The aim of this study was to gain information about antibiotic prescription management in German ICUs and to provide baseline data against which future initiatives can be benchmarked.
Methods This survey was performed within a larger project, which investigated the structure, design and content of infection control policies for gram-negative multidrug resistant bacilli in German ICUs. The participants in the study were recruited from hospitals that were members of the ICU component of the nosocomial infection surveillance system (KISS), a voluntary reporting network of more than 1,000 acute care hospitals in Germany. The methods of the KISS system have been described in detail previously [13, 14]. In conjunction with the KISS system, an electronic survey was sent to all participating ICUs (n = 579) to determine the prevalence and components of ICU and hospital management structures that may promote antibiotic stewardship programs in Germany. The questionnaire was distributed to the infection control practitioner, medical doctor, or nurse directly responsible for the ICU module of the KISS surveillance at each hospital in October 2011. An electronic reminder was forwarded after 5 weeks if no response had been made. The questionnaire requested data on antibiotic prescribing policies at a unit-based level as well as laboratory and pharmacy surveillance policies. Data collected included the type of hospital, size of unit/ward, requirements for prescribing antibiotics, availability of individual guidelines for antibiotic therapy, whether the ward/unit had a policy for restricting the use of antibiotics, and which antibiotics
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were restricted and why. Hospital pharmacy participation in surveillance networks for antibiotic consumption and microbiologic laboratory participation in surveillance networks for antimicrobial resistance was also recorded. Federal states were pooled as geographical regions (north, east, west, south-east, and south-west). Data analysis Descriptive statistics were conducted using summary measures appropriate to the data type and distribution. In case of categorical variables, data were expressed in numbers and percentages. For continuous variables, data were expressed in medians with interquartile ranges (IQR). Univariate analysis was conducted to identify associations between key antibiotic stewardship strategies and hospital and ICU factors, including the type of hospital (university/academic teaching/other), size of hospital (B300/301–600/[600 beds), ownership (public/no-profit/ private), laboratory site (external/internal), size of ICU (\/ C12 beds), and type of ICU (medical, surgical, interdisciplinary, other). Other ICUs comprised cardiosurgical, neurosurgical, neurological, pediatric, and burn units. Differences were tested by the Chi-square test. P-values of \0.05 were considered significant. All analyses were performed using SPSS (IBM SPSS Statistics, Somers, NY, USA) and SAS (SAS Institute, Cary, NC, USA).
Results Structural and organizational characteristics of the participating ICUs A total of 355 questionnaires out of 579 were completed (response rate 61 %). Hospital type and size and ICU type and size of responding and non-responding units did not differ significantly. The respondents were mainly infection control practitioners and medical doctors (67 and 33 %, respectively). The 355 responding ICUs were from 281 hospitals. Out of these 281 hospitals, 228 (81 %) had one ICU, 40 (14 %) had two ICUs, and 13 (5 %) more than two ICUs. The largest proportion of the participating hospitals was classified as academic teaching hospitals (n = 191, 54 %), see Table 1. Antibiotic policy measures The most common measures were the routine access to annual or semiannual unit-based reports on bacterial resistance data (n = 295, 83 %) and some kind of personnel restrictions for antibiotic prescriptions (n = 297,
Antibiotic stewardship in Germany Table 1 Structural and organizational characteristics of the participating intensive care units (ICUs)
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Parameter
Category
ICU No.
Total number of units Type of hospital
Hospital ownership
Laboratory
Type of ICU
%
355
100.0
281
100.0
53.8
143
50.9
Other
119
33.5
114
40.6
University
45
12.7
24
8.5 42.7
Public
162
45.6
120
Non-profit
111
31.3
94
33.5
Private
82
23.1
67
23.8
420a
268–717b
363a
232–546b
B300
112
31.5
107
38.1
301–600
138
38.9
114
40.6
[600 East
105 64
29.6 18.0
60 48
21.4 17.1
South-east
72
20.3
55
19.6
South-west
66
18.6
53
18.9
North
65
18.3
56
19.9
West
88
24.8
69
24.6
n = 352
100.0
n = 279
100
Internal
123
34.6
77
27.4
External
226
63.7
197
70.1
Both
3
0.8
5
1.8
Surgical
61
17.2
Interdisciplinary
193
54.4
58
16.3
Median
Medical
b
Interquartile range
Otherc
Other ICUs were cardiosurgical, neurosurgical, neurological, pediatric, and burn units
No.
191
a
c
%
Academic teaching
Hospital size (number of beds)
Region
Hospital
ICU size (number of beds) \12 C12
84 %), i.e., to entrust only preselected physicians with the prescription of antimicrobial medication, see Fig. 1. Medical personnel responsible for the prescription of antimicrobial agents were specialized physicians (i.e., infectious diseases specialists, ABS experts, microbiologists, or infection control specialists, n = 50, 14 %), senior physicians (n = 67, 19 %), ward physicians only upon approval by senior physicians (n = 145, 41 %), or any ward physician without further limitation (n = 58, 16 %). Less than 25 % of the wards reported participating in a surveillance system for antibiotic use (n = 78, 22 %) or microbial resistance (n = 73, 21 %). 160 (45 %) ICUs report to have regular (e.g., weekly) antibiotic rounds defined as meetings to specifically discuss antibiotic prescriptions. 17 (5 %) ICUs reported meetings to view microbiological records only. 268 (76 %) ICUs have access to local guidelines on antimicrobial therapy. Among the ICUs with local therapy guidelines, 170 (48 %) report to have electronic access to the guidelines.
43
12.1
12a
9–16b
157 198
44.2 55.8
263 (74 %) indicated that their hospital pharmacies would not dispense certain antimicrobials without the use of preauthorization/order forms. Constraints imposed by the pharmacies were mainly based on the substances prescribed (68 %) as opposed to patient-based (e.g., patients with allergies or renal failure, 17 %) or indication-based (e.g., perioperative prophylaxis, 19 %) constraints. 60 (17 %) of the units reported no pharmacy constraints to their antimicrobial prescribing practices or not knowing if any constraints existed (n = 33, 9 %). Antimicrobial agents most commonly targeted for restriction by approval were linezolid 190 (72 %), daptomycin 167 (64 %), and polymyxin E 144 (55 %). 290 (72 %) of the ICUs received pharmacy reports on costs and consumption of antibiotics, while 44 (12 %) received reports on costs only. 208 (59 %) ICUs received antibiotic use data in packages or grams, 57 (16 %) in packages/grams per cases or patient days, 56 (16 %) in defined daily doses (DDD), 11 (3 %) in recommended daily doses, and 88 (25 %) could not answer the question.
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Fig. 1 Percentage of intensive care units (ICUs) with antibiotic policy measures (%), n = 355. a Routine laboratory data, annual or semiannual unit-based reports bStandardized crossinstitutional surveillance
Antibiotic policy measures and hospital/ICU factors
Discussion
Certain antibiotic policies differed with regard to the hospital and/or ICU type and size, hospital ownership, and whether the hospital had its own laboratory. Significant differences for the main antibiotic control strategies— antibiotic rounds, availability of guidelines for antibiotic therapy, pharmacy dispensation restrictions, and participation in surveillance networks for antimicrobial consumption and bacterial resistance—are shown in Table 2. Large hospitals reported antibiotic policies more frequently than small hospitals. This difference was significant in the case of antibiotic rounds, pharmacy restrictions, and participation in surveillance systems for antibiotic consumption (all p B 0.003) and bacterial resistance (p = 0.22). The participation in a surveillance network was also markedly influenced by the hospitals’ ownership and the integration of the microbiologic laboratory. The latter also had a significant influence on the existence of antibiotic rounds (p \ 0.05). ICUs in university hospitals reported participation in a surveillance system for bacterial resistance more often than ICUs in other kinds of hospitals (p \ 0.01, data not shown). Significant differences were found for the existence of local antibiotic therapy guidelines and antibiotic rounds (p \ 0.05). Surgical and other ICUs were more likely to have therapy guidelines and antibiotic rounds than medical and interdisciplinary ICUs. Restrictive prescribing practices were not associated with hospital factors or ICU type.
The aim of this study was to explore the antibiotic prescription management in German ICUs. The majority of ICUs report having some kind of antibiotic control measure. Still, a surprisingly large number of ICUs continue not to employ antibiotic policy measures widely considered to be successful, such as the participation in surveillance systems for antibiotic consumption and bacterial resistance [15–17]. Being members of the KISS network of hospitals, participants would be expected to be early adopters and/or current in their policies and practices [18]. Resistance patterns may be hard to change, as other factors such as transmission and multidrug-resistant organisms import from other wards and from outside the hospital play a key role [19]. However, to paraphrase Sir William Thomson (a.k.a. Lord Kelvin), to measure is to know, and you cannot improve what you cannot measure. Participation in surveillance systems to measure and compare frequencies of antibiotic consumption and bacterial resistance have proved effective in reducing multidrug-resistant organisms prevalence [17, 20, 21]. A survey conducted among all MRSA KISS participants in 2007 showed that only 44 % of the hospitals analyzed the consumption of antibiotics at the hospital level [22]. In this study, a majority of the ICUs questioned (n = 246, 69 %) reported receiving pharmacy feedback on antimicrobial consumption in contrast to feedback on costs caused by antimicrobial therapy. In contrast, the surveillance of antibiotic consumption and bacterial resistance in
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Antibiotic stewardship in Germany
123
Table 2 Antibiotic control measures and structural hospital and unit factors N
Personnel restrictions for antibiotic prescriptions
Antibiotic rounds
Guidelines for antibiotic treatment
Pharmacy dispensation restrictions
Surveillance network for antibiotic use
Surveillance network for bacterial resistance
355
297 (84)
236 (67)
268 (76)
263 (74)
78 (22)
73 (21)
Teaching Other
191 119
165 (86) 96 (81)
134 (70) 64 (54)
151 (79) 85 (71)
146 (76) 81 (68)
46 (24) 18 (15)
31 (16) 22 (18)
University
45
36 (80)
38 (84)
32 (71)
36 (80)
14 (31)
20 (44)
0.323
\0.001
0.242
0.164
0.051
\0.001
Total no. (%) Hospital type
p-Value Hospital size (beds) B300
112
89 (79)
60 (54)
81 (72)
74 (66)
9 (8)
15 (13)
301–600
138
117 (85)
83 (60)
101 (73)
99 (72)
27 (20)
28 (20)
C600
105
91 (87)
93 (89)
86 (82)
90 (86)
42 (40)
30 (29)
0.322
\0.001
0.188
0.003
\0.001
0.022
p-Value Hospital owner Public
162
135 (83)
114 (70)
119 (73)
118 (73)
41 (25)
37 (23)
Non-profit
111
93 (84)
67 (60)
82 (74)
85 (77)
27 (24)
27 (24)
82
69 (84)
55 (67)
67 (82)
60 (73)
10 (12)
9 (11)
0.986
0.226
0.328
0.769
0.050
0.048
56 (92) 159 (82)
49 (80) 115 (60)
54 (89) 137 (71)
49 (80) 141 (73)
15 (25) 39 (20)
13 (21) 37 (19)
Private p-Value ICU type Surgical Interdisciplinary
61 193
Medical
58
47 (81)
38 (66)
43 (74)
44 (76)
17 (29)
13 (22)
Other
43
35 (81)
34 (79)
34 (79)
29 (67)
7 (16)
10 (23)
0.303
0.006
0.044
0.488
0.358
0.905
p-Value
Microbiological laboratory Internal
126
105 (83)
93 (74)
100 (79)
94 (75)
43 (34)
40 (32)
External
229
192 (84)
143 (62)
168 (73)
169 (74)
35 (15)
33 (14)
0.901
0.030
0.208
0.869
\0.001
\0.001
p-Value
a surveillance network following a standardized protocol, which is a method that is not very vulnerable to bias and facilitates cross-institutional benchmarking [23], was reported by less than a quarter of the ICUs. Accordingly, the majority of the wards have access to annual or semiannual unit-based microbiologic surveillance data, while only approximately a fifth of all the ICUs surveyed report participation in an ongoing surveillance network for bacterial resistance. The German public health institute (Robert Koch Institute, RKI) guidelines have encouraged hospitals and wards to establish microbiologic surveillance of common multidrug-resistant bacteria since 2000 [24, 25]. Notably, surveillance systems for either the use of antimicrobial agents or bacterial resistance, as well as the existence of antibiotic rounds, was significantly influenced by the integration of a microbiologic laboratory into the hospital structure, which may be due to a change of attitude often observed in hospital sectors that have been outsourced for economic reasons.
While the availability of therapy guidelines was influenced by unit factors such as ICU type, other main antibiotic control strategies appear predominantly connected with hospital factors such as hospital type or size. Accordingly, ICUs from large hospitals were more likely to report antibiotic control measures than small hospitals. It is unclear whether this may be caused by their academic status rather than by their mere size, as university hospitals tend to be larger than other hospitals. More than three-quarters of the ICUs had guidelines for antimicrobial therapy, but to have guidelines does not necessarily mean to comply with them. Audits and feedback may improve adherence to guidelines, depending on baseline performance and how the feedback is provided [26]. Infectious diseases specialists and other physicians specialized in antimicrobial substances were only rarely reported to be responsible for the prescription of antibiotics, although this practice has been shown to reduce the use and costs of these agents [27–29], as well as the incidence
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of certain drug-resistant organisms in healthcare settings [28, 30, 31]. The shortage of infectious disease specialists has been reported previously [12, 32]. Our findings confirm prior reports on hospital-wide antibiotic control strategies by Kern et al. [12]. Although the sample size was smaller and the questions were asked in different ways, the results are very similar to those of our survey. More effort is required with regard to incentives for the employment of infectious diseases specialists and for the participation in surveillance networks. An update of the German Infection Prevention Act (IfSG; July 2011) became effective in August 2011. Aimed at improving the prevention and control of nosocomial infections and multidrug-resistant organisms, the law particularly emphasizes the need to optimize antibiotic prescription practices. According to § 23 paragraph 4 of the IfSG, hospitals and clinics for ambulatory surgery are obliged to establish a continuous monitoring system of antibiotic consumption [33]. Recommendations on the prudent use of antimicrobial substances provided by the RKI are considered state-of-the-art, but have not yet been published. This study may be useful as a baseline for the comparison of antibiotic control policies and practice for antimicrobial stewardship projects, as well as to analyze the impact of future RKI recommendations. Strengths of this study are the large study size, high response rate, that all respondents answered all questions, and the clear allocation of each questionnaire to a single ward, which made multiple responses impossible. Limitations We acknowledge that respondents were all KISS participants, thus increasing the risk of response bias, but this makes the paucity of strategies such as the surveillance of bacterial resistance even more surprising. In addition, this was an ICU-based rather than a hospitalbased survey. It may be easier for ICUs, as relatively small units, to adopt new procedures than for an entire hospital. The cross-sectional design of the study provides a snapshot of practice, and we did not analyze compliance with the stewardship measures. As in other surveys on antibiotic management, it was not possible to attribute cause and effect [34], and questionnaire-based surveys always bear the risk of a recall bias. The recipients of the surveys were mainly infection control practitioners. We do not know whether they were able to provide the answers on their own or if they had to ask for advice. However, participants of the KISS system are used to discuss open questions with physicians, as
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surveillance of nosocomial infections often requires consultation with the ward physicians. Previous studies have shown that institution-wide factors independent of the practices of individual clinicians may be associated with increased rates of antimicrobial resistance [18, 35]. Further investigation is needed so as to judge the relationship between antibiotic management, bacterial resistance, and clinical patient outcome. Acknowledgments We thank all physicians and nurses in the participating hospitals who provided their antibiotic management data to KISS and Alexander Gropmann for programming the questionnaire survey. This work was supported by the German Ministry of Health (grant number IIA5-2511FSB106/321-4532-04/21). Data have been generated as part of the routine work of the nosocomial infection surveillance system (NRZ KISS). Conflict of interest The authors declare that they have no conflicts of interest.
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CLINICAL AND EPIDEMIOLOGICAL STUDY
Antibiotic stewardship in Germany: a cross-sectional questionnaire survey of 355 intensive care units F. Maechler • F. Schwab • C. Geffers • E. Meyer • R. Leistner • P. Gastmeier
Received: 5 June 2013 / Accepted: 4 September 2013 / Published online: 18 October 2013 Ó Springer-Verlag Berlin Heidelberg 2013
Abstract Purpose Little information is available on antibiotic prescription management in German hospitals. The objective of this cross-sectional study was to determine the prevalence and components of antibiotic stewardship measures in German intensive care units (ICUs). Methods A questionnaire survey was sent to all ICUs participating in the German nosocomial infection surveillance system (n = 579) in October 2011. Data on antibiotic management structures were collected and analyzed by structural hospital and ICU factors. Results The questionnaire was completed by 355 German ICUs (response rate 61 %). Common measures used ([80 % of the ICUs) were personnel restrictions for antibiotic prescriptions, routine access to bacterial resistance data, and pharmacy reports on antibiotic costs and consumption. A small proportion of ICUs (14 %) employed physicians specialized in the prescription of antimicrobial medication. Hospitals with their own microbiological laboratory report participation in surveillance networks for antimicrobial use (34 %) and bacterial resistance (32 %) twice as often as hospitals with external laboratories (15 and 14 %, respectively, p \ 0.001). Also, non-profit and public hospitals participate more often in surveillance networks for bacterial resistance than private hospitals ([23 % vs. 11 %, p \ 0.05).
Electronic supplementary material The online version of this article (doi:10.1007/s15010-013-0531-y) contains supplementary material, which is available to authorized users. F. Maechler (&) F. Schwab C. Geffers E. Meyer R. Leistner P. Gastmeier Institute of Hygiene and Environmental Medicine, Charite´ Berlin, Hindenburgdamm 27, 12203 Berlin, Germany e-mail: [email protected]
Conclusions While the majority of ICUs report to have some antibiotic policies established, the contents and composition of these policies vary. Organizational-level control strategies to improve antibiotic management are common in Germany. However, strategies widely considered effective, such as the systematic cross-institutional surveillance of antimicrobial use and bacterial resistance in a standardized manner or the employment of infectious disease specialists, are scarce. This study provides a benchmark for future antibiotic stewardship programs. Keywords Antibiotics Prescription Management Antibiotic stewardship Cross-sectional studies
Introduction As bacterial resistance is becoming a major concern to the public worldwide, the call for improved antibiotic prescription practice has become more significant. Many different interventions have proved to be successful in changing antibiotic prescription practice for hospital patients. Restrictive methods appear to have a larger effect than other intervention strategies [1]. However, routine restriction does not necessarily prevent the overuse of available broad-spectrum antibiotics [2], and, in the long term, restrictions are not superior to persuasive methods [1]. Much effort has been directed towards the development of guidelines for antibiotic therapy [3, 4], but adherence to guidelines needs to be improved [5, 6]. To make the best use of the currently available antimicrobials and to reduce misuse of broad-spectrum antibiotics, a fundamental change in clinical thinking is needed [7]. Antibiotic stewardship (ABS) initiatives have been pursuing this goal for years. These hospital-based
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antimicrobial management programs are focused on changing and directing antimicrobial use and may employ any number of individual strategies [8]. Antimicrobial stewardship guidelines were published in 2007 by the Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) [9]. Almost 6 years later, little information is available on the structure and content of antibiotic policies and formularies/drug lists in hospitals [10], particularly at the intensive care unit (ICU) level. While some European countries have strict policies regarding antibiotic therapy [11], in Germany, any licensed physician may prescribe antibiotics without further restrictions. Information on structures underlying the antibiotic prescription process is scarce, and the information available indicates a lack of antibiotic stewardship programs and infectious diseases specialists [12]. The aim of this study was to gain information about antibiotic prescription management in German ICUs and to provide baseline data against which future initiatives can be benchmarked.
Methods This survey was performed within a larger project, which investigated the structure, design and content of infection control policies for gram-negative multidrug resistant bacilli in German ICUs. The participants in the study were recruited from hospitals that were members of the ICU component of the nosocomial infection surveillance system (KISS), a voluntary reporting network of more than 1,000 acute care hospitals in Germany. The methods of the KISS system have been described in detail previously [13, 14]. In conjunction with the KISS system, an electronic survey was sent to all participating ICUs (n = 579) to determine the prevalence and components of ICU and hospital management structures that may promote antibiotic stewardship programs in Germany. The questionnaire was distributed to the infection control practitioner, medical doctor, or nurse directly responsible for the ICU module of the KISS surveillance at each hospital in October 2011. An electronic reminder was forwarded after 5 weeks if no response had been made. The questionnaire requested data on antibiotic prescribing policies at a unit-based level as well as laboratory and pharmacy surveillance policies. Data collected included the type of hospital, size of unit/ward, requirements for prescribing antibiotics, availability of individual guidelines for antibiotic therapy, whether the ward/unit had a policy for restricting the use of antibiotics, and which antibiotics
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were restricted and why. Hospital pharmacy participation in surveillance networks for antibiotic consumption and microbiologic laboratory participation in surveillance networks for antimicrobial resistance was also recorded. Federal states were pooled as geographical regions (north, east, west, south-east, and south-west). Data analysis Descriptive statistics were conducted using summary measures appropriate to the data type and distribution. In case of categorical variables, data were expressed in numbers and percentages. For continuous variables, data were expressed in medians with interquartile ranges (IQR). Univariate analysis was conducted to identify associations between key antibiotic stewardship strategies and hospital and ICU factors, including the type of hospital (university/academic teaching/other), size of hospital (B300/301–600/[600 beds), ownership (public/no-profit/ private), laboratory site (external/internal), size of ICU (\/ C12 beds), and type of ICU (medical, surgical, interdisciplinary, other). Other ICUs comprised cardiosurgical, neurosurgical, neurological, pediatric, and burn units. Differences were tested by the Chi-square test. P-values of \0.05 were considered significant. All analyses were performed using SPSS (IBM SPSS Statistics, Somers, NY, USA) and SAS (SAS Institute, Cary, NC, USA).
Results Structural and organizational characteristics of the participating ICUs A total of 355 questionnaires out of 579 were completed (response rate 61 %). Hospital type and size and ICU type and size of responding and non-responding units did not differ significantly. The respondents were mainly infection control practitioners and medical doctors (67 and 33 %, respectively). The 355 responding ICUs were from 281 hospitals. Out of these 281 hospitals, 228 (81 %) had one ICU, 40 (14 %) had two ICUs, and 13 (5 %) more than two ICUs. The largest proportion of the participating hospitals was classified as academic teaching hospitals (n = 191, 54 %), see Table 1. Antibiotic policy measures The most common measures were the routine access to annual or semiannual unit-based reports on bacterial resistance data (n = 295, 83 %) and some kind of personnel restrictions for antibiotic prescriptions (n = 297,
Antibiotic stewardship in Germany Table 1 Structural and organizational characteristics of the participating intensive care units (ICUs)
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Parameter
Category
ICU No.
Total number of units Type of hospital
Hospital ownership
Laboratory
Type of ICU
%
355
100.0
281
100.0
53.8
143
50.9
Other
119
33.5
114
40.6
University
45
12.7
24
8.5 42.7
Public
162
45.6
120
Non-profit
111
31.3
94
33.5
Private
82
23.1
67
23.8
420a
268–717b
363a
232–546b
B300
112
31.5
107
38.1
301–600
138
38.9
114
40.6
[600 East
105 64
29.6 18.0
60 48
21.4 17.1
South-east
72
20.3
55
19.6
South-west
66
18.6
53
18.9
North
65
18.3
56
19.9
West
88
24.8
69
24.6
n = 352
100.0
n = 279
100
Internal
123
34.6
77
27.4
External
226
63.7
197
70.1
Both
3
0.8
5
1.8
Surgical
61
17.2
Interdisciplinary
193
54.4
58
16.3
Median
Medical
b
Interquartile range
Otherc
Other ICUs were cardiosurgical, neurosurgical, neurological, pediatric, and burn units
No.
191
a
c
%
Academic teaching
Hospital size (number of beds)
Region
Hospital
ICU size (number of beds) \12 C12
84 %), i.e., to entrust only preselected physicians with the prescription of antimicrobial medication, see Fig. 1. Medical personnel responsible for the prescription of antimicrobial agents were specialized physicians (i.e., infectious diseases specialists, ABS experts, microbiologists, or infection control specialists, n = 50, 14 %), senior physicians (n = 67, 19 %), ward physicians only upon approval by senior physicians (n = 145, 41 %), or any ward physician without further limitation (n = 58, 16 %). Less than 25 % of the wards reported participating in a surveillance system for antibiotic use (n = 78, 22 %) or microbial resistance (n = 73, 21 %). 160 (45 %) ICUs report to have regular (e.g., weekly) antibiotic rounds defined as meetings to specifically discuss antibiotic prescriptions. 17 (5 %) ICUs reported meetings to view microbiological records only. 268 (76 %) ICUs have access to local guidelines on antimicrobial therapy. Among the ICUs with local therapy guidelines, 170 (48 %) report to have electronic access to the guidelines.
43
12.1
12a
9–16b
157 198
44.2 55.8
263 (74 %) indicated that their hospital pharmacies would not dispense certain antimicrobials without the use of preauthorization/order forms. Constraints imposed by the pharmacies were mainly based on the substances prescribed (68 %) as opposed to patient-based (e.g., patients with allergies or renal failure, 17 %) or indication-based (e.g., perioperative prophylaxis, 19 %) constraints. 60 (17 %) of the units reported no pharmacy constraints to their antimicrobial prescribing practices or not knowing if any constraints existed (n = 33, 9 %). Antimicrobial agents most commonly targeted for restriction by approval were linezolid 190 (72 %), daptomycin 167 (64 %), and polymyxin E 144 (55 %). 290 (72 %) of the ICUs received pharmacy reports on costs and consumption of antibiotics, while 44 (12 %) received reports on costs only. 208 (59 %) ICUs received antibiotic use data in packages or grams, 57 (16 %) in packages/grams per cases or patient days, 56 (16 %) in defined daily doses (DDD), 11 (3 %) in recommended daily doses, and 88 (25 %) could not answer the question.
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Fig. 1 Percentage of intensive care units (ICUs) with antibiotic policy measures (%), n = 355. a Routine laboratory data, annual or semiannual unit-based reports bStandardized crossinstitutional surveillance
Antibiotic policy measures and hospital/ICU factors
Discussion
Certain antibiotic policies differed with regard to the hospital and/or ICU type and size, hospital ownership, and whether the hospital had its own laboratory. Significant differences for the main antibiotic control strategies— antibiotic rounds, availability of guidelines for antibiotic therapy, pharmacy dispensation restrictions, and participation in surveillance networks for antimicrobial consumption and bacterial resistance—are shown in Table 2. Large hospitals reported antibiotic policies more frequently than small hospitals. This difference was significant in the case of antibiotic rounds, pharmacy restrictions, and participation in surveillance systems for antibiotic consumption (all p B 0.003) and bacterial resistance (p = 0.22). The participation in a surveillance network was also markedly influenced by the hospitals’ ownership and the integration of the microbiologic laboratory. The latter also had a significant influence on the existence of antibiotic rounds (p \ 0.05). ICUs in university hospitals reported participation in a surveillance system for bacterial resistance more often than ICUs in other kinds of hospitals (p \ 0.01, data not shown). Significant differences were found for the existence of local antibiotic therapy guidelines and antibiotic rounds (p \ 0.05). Surgical and other ICUs were more likely to have therapy guidelines and antibiotic rounds than medical and interdisciplinary ICUs. Restrictive prescribing practices were not associated with hospital factors or ICU type.
The aim of this study was to explore the antibiotic prescription management in German ICUs. The majority of ICUs report having some kind of antibiotic control measure. Still, a surprisingly large number of ICUs continue not to employ antibiotic policy measures widely considered to be successful, such as the participation in surveillance systems for antibiotic consumption and bacterial resistance [15–17]. Being members of the KISS network of hospitals, participants would be expected to be early adopters and/or current in their policies and practices [18]. Resistance patterns may be hard to change, as other factors such as transmission and multidrug-resistant organisms import from other wards and from outside the hospital play a key role [19]. However, to paraphrase Sir William Thomson (a.k.a. Lord Kelvin), to measure is to know, and you cannot improve what you cannot measure. Participation in surveillance systems to measure and compare frequencies of antibiotic consumption and bacterial resistance have proved effective in reducing multidrug-resistant organisms prevalence [17, 20, 21]. A survey conducted among all MRSA KISS participants in 2007 showed that only 44 % of the hospitals analyzed the consumption of antibiotics at the hospital level [22]. In this study, a majority of the ICUs questioned (n = 246, 69 %) reported receiving pharmacy feedback on antimicrobial consumption in contrast to feedback on costs caused by antimicrobial therapy. In contrast, the surveillance of antibiotic consumption and bacterial resistance in
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Antibiotic stewardship in Germany
123
Table 2 Antibiotic control measures and structural hospital and unit factors N
Personnel restrictions for antibiotic prescriptions
Antibiotic rounds
Guidelines for antibiotic treatment
Pharmacy dispensation restrictions
Surveillance network for antibiotic use
Surveillance network for bacterial resistance
355
297 (84)
236 (67)
268 (76)
263 (74)
78 (22)
73 (21)
Teaching Other
191 119
165 (86) 96 (81)
134 (70) 64 (54)
151 (79) 85 (71)
146 (76) 81 (68)
46 (24) 18 (15)
31 (16) 22 (18)
University
45
36 (80)
38 (84)
32 (71)
36 (80)
14 (31)
20 (44)
0.323
\0.001
0.242
0.164
0.051
\0.001
Total no. (%) Hospital type
p-Value Hospital size (beds) B300
112
89 (79)
60 (54)
81 (72)
74 (66)
9 (8)
15 (13)
301–600
138
117 (85)
83 (60)
101 (73)
99 (72)
27 (20)
28 (20)
C600
105
91 (87)
93 (89)
86 (82)
90 (86)
42 (40)
30 (29)
0.322
\0.001
0.188
0.003
\0.001
0.022
p-Value Hospital owner Public
162
135 (83)
114 (70)
119 (73)
118 (73)
41 (25)
37 (23)
Non-profit
111
93 (84)
67 (60)
82 (74)
85 (77)
27 (24)
27 (24)
82
69 (84)
55 (67)
67 (82)
60 (73)
10 (12)
9 (11)
0.986
0.226
0.328
0.769
0.050
0.048
56 (92) 159 (82)
49 (80) 115 (60)
54 (89) 137 (71)
49 (80) 141 (73)
15 (25) 39 (20)
13 (21) 37 (19)
Private p-Value ICU type Surgical Interdisciplinary
61 193
Medical
58
47 (81)
38 (66)
43 (74)
44 (76)
17 (29)
13 (22)
Other
43
35 (81)
34 (79)
34 (79)
29 (67)
7 (16)
10 (23)
0.303
0.006
0.044
0.488
0.358
0.905
p-Value
Microbiological laboratory Internal
126
105 (83)
93 (74)
100 (79)
94 (75)
43 (34)
40 (32)
External
229
192 (84)
143 (62)
168 (73)
169 (74)
35 (15)
33 (14)
0.901
0.030
0.208
0.869
\0.001
\0.001
p-Value
a surveillance network following a standardized protocol, which is a method that is not very vulnerable to bias and facilitates cross-institutional benchmarking [23], was reported by less than a quarter of the ICUs. Accordingly, the majority of the wards have access to annual or semiannual unit-based microbiologic surveillance data, while only approximately a fifth of all the ICUs surveyed report participation in an ongoing surveillance network for bacterial resistance. The German public health institute (Robert Koch Institute, RKI) guidelines have encouraged hospitals and wards to establish microbiologic surveillance of common multidrug-resistant bacteria since 2000 [24, 25]. Notably, surveillance systems for either the use of antimicrobial agents or bacterial resistance, as well as the existence of antibiotic rounds, was significantly influenced by the integration of a microbiologic laboratory into the hospital structure, which may be due to a change of attitude often observed in hospital sectors that have been outsourced for economic reasons.
While the availability of therapy guidelines was influenced by unit factors such as ICU type, other main antibiotic control strategies appear predominantly connected with hospital factors such as hospital type or size. Accordingly, ICUs from large hospitals were more likely to report antibiotic control measures than small hospitals. It is unclear whether this may be caused by their academic status rather than by their mere size, as university hospitals tend to be larger than other hospitals. More than three-quarters of the ICUs had guidelines for antimicrobial therapy, but to have guidelines does not necessarily mean to comply with them. Audits and feedback may improve adherence to guidelines, depending on baseline performance and how the feedback is provided [26]. Infectious diseases specialists and other physicians specialized in antimicrobial substances were only rarely reported to be responsible for the prescription of antibiotics, although this practice has been shown to reduce the use and costs of these agents [27–29], as well as the incidence
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of certain drug-resistant organisms in healthcare settings [28, 30, 31]. The shortage of infectious disease specialists has been reported previously [12, 32]. Our findings confirm prior reports on hospital-wide antibiotic control strategies by Kern et al. [12]. Although the sample size was smaller and the questions were asked in different ways, the results are very similar to those of our survey. More effort is required with regard to incentives for the employment of infectious diseases specialists and for the participation in surveillance networks. An update of the German Infection Prevention Act (IfSG; July 2011) became effective in August 2011. Aimed at improving the prevention and control of nosocomial infections and multidrug-resistant organisms, the law particularly emphasizes the need to optimize antibiotic prescription practices. According to § 23 paragraph 4 of the IfSG, hospitals and clinics for ambulatory surgery are obliged to establish a continuous monitoring system of antibiotic consumption [33]. Recommendations on the prudent use of antimicrobial substances provided by the RKI are considered state-of-the-art, but have not yet been published. This study may be useful as a baseline for the comparison of antibiotic control policies and practice for antimicrobial stewardship projects, as well as to analyze the impact of future RKI recommendations. Strengths of this study are the large study size, high response rate, that all respondents answered all questions, and the clear allocation of each questionnaire to a single ward, which made multiple responses impossible. Limitations We acknowledge that respondents were all KISS participants, thus increasing the risk of response bias, but this makes the paucity of strategies such as the surveillance of bacterial resistance even more surprising. In addition, this was an ICU-based rather than a hospitalbased survey. It may be easier for ICUs, as relatively small units, to adopt new procedures than for an entire hospital. The cross-sectional design of the study provides a snapshot of practice, and we did not analyze compliance with the stewardship measures. As in other surveys on antibiotic management, it was not possible to attribute cause and effect [34], and questionnaire-based surveys always bear the risk of a recall bias. The recipients of the surveys were mainly infection control practitioners. We do not know whether they were able to provide the answers on their own or if they had to ask for advice. However, participants of the KISS system are used to discuss open questions with physicians, as
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surveillance of nosocomial infections often requires consultation with the ward physicians. Previous studies have shown that institution-wide factors independent of the practices of individual clinicians may be associated with increased rates of antimicrobial resistance [18, 35]. Further investigation is needed so as to judge the relationship between antibiotic management, bacterial resistance, and clinical patient outcome. Acknowledgments We thank all physicians and nurses in the participating hospitals who provided their antibiotic management data to KISS and Alexander Gropmann for programming the questionnaire survey. This work was supported by the German Ministry of Health (grant number IIA5-2511FSB106/321-4532-04/21). Data have been generated as part of the routine work of the nosocomial infection surveillance system (NRZ KISS). Conflict of interest The authors declare that they have no conflicts of interest.
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