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MULTI-CENTER INDICATOR INTERVENTION RESEARCH ON
SURGICAL PHROPHYLAXIS IN 2 HOSPITALS
IN PEOPLE’S REPUBLIC OF CHINA
Wang Qing1, Wang Yuqin2, Edelisa D.Carandang3, Dennis Ross-degnan4, Tang Jingbo5
1 Center for Drug Reevaluation of State Drug Administration, P.R.China
2 Xuanwu Hospital of the Capital University of Medical Sciences, P.R.China
3 Action Programme on Essential Drugs, WHO, Geneva, Switzerland
4, Harvard Medical School and Harvard Pilgrim Health Care, Boston, USA
5. Liuhuaqiao Hospital, Guangzhou, P.R.China
ABSTRACT
OBJECTIVE
Through the intervention and comparison study of rational antibiotics use in perisurgical period,
we want to explore a set of scientific evaluation and intervention methods which are fit for
China's situation, and promote the development of rational drug use in China.
METHODS
Selected two third level general hospitals and separated them into intervention hospital and control
hospital. Gave intervention to the intervention hospital from February 2001 to August 2001, and
carried out the comparison research on the same period of inpatient surgical cases of
thryroidectomy, mastectomy, cholescystectomy, and hysteromyomectomy +appendix from 2000
to 2002.
RESULTS
The average antibiotics expenditure was cut down from 740.20 RMB to 352.03 RMB (P<0.01) in
intervention hospital from 2000 to 2001, but went back to 494.62 RMB in 2002. There was a
remarkable improvement on the rationality of antibiotics use in intervention hospital during the
intervention approaches implemented, but the situation went back after the intervention stopped.
The rationality percentages in intervention hospital are from 22.88% to 80.33% and to 20.66%.
Meanwhile, there is no difference on the rationality of control hospital.
CONCLUTION: It is practicable and effective to implement the rational drug use intervention in
the research, and they play active roles on promoting safely, effectively and economic antibiotic
use in China. Te follow-up study in 2002 also showed that the work for promoting rational drug
use is a long-term task. The intervention should be going on to keep the prescriber’s good practice.
BACKGROUND
INTRODUCTION
From 2001 to 2002, the first systematic multi-center rational drug use (RDU)
research in China was carried out by Center for Drug Reevaluation of State
Drug Administration and Xuanwu Hospital Group. The research got the
financial and technical support from WHO/EDM. This antibiotic prophylaxis
intervention study was the main part of this research.
BACKGROUND
In both the developed and the developing world, medically inappropriate,
ineffective, and economically inefficient use of pharmaceuticals commonly
occurs in health care facilities. In China, self-medication, polypharmacy,
overuse of antibiotics and injections are easy to be observed.
In 2001, a national pharmaceutical situation survey in four cities of China was
conducted by MOH and SDA of China. The survey was focused on the
information of people’s access to essential drugs and drug safety,
efficaciousness, quality and reliability as well as the proper utilization of them.
26 hospitals, 21 drug outlets, and 4 drug warehouses were included in the
survey. The results showed that irrational drug use in these four cities is
popular, especially the percentages of antibiotic and injection use are 47.82%
and 35.13% respectively. In the treatment of non-pneumonia--acute
respiratory tract infection in outpatients among 26 hospitals, the percentage of
antibiotics use is 83.5%, antipyretic/analgesic 37.7%, cough and/or cold drugs
62.7% and other drugs 48.8%. After level I assessment, the proper handlings
are only 16.5% and the improper ones are as high as 83.5%. After level II
assessment, the proper handlings are 46.5% and the improper ones are 53.5%.
BACKGROUND
Inappropriate antibiotic use increases costs and the risks of antibiotic resistance. Around 50% of top 50 drug
expenditures in hospitals in Chinese major metropolis between 1993-1995 were on antibiotics, but only 50%
of costs belong to rational use indicators. According to the survey in the Outpatient Department of Beijing
Children's Hospital from 1990 to 1993, more than 98% of the patients who were diagnosed with common
cold were given antibiotics by physicians, and more than one-third of the patients had been taking antibiotics
before coming to the hospital. Using a sensitive Staphylococcus aureus assay, it was found that 70% of blood
samples and 43% of cerebrospinal fluid samples from the patients with bacterial meningitis and pneumonia
contained antibacterial activity. Bacteria were recovered significantly less often from the samples with
antibacterial activity than from those who did not from which antibiotic was not recovered, both in blood
(5.3% vs. 12.5%) and in cerebrospinal fluid (2.5% vs. 14.8%).
And some previous studies in China had found several problems in the way that antibiotics were used during
perisurgical period: incorrect indication for prophylactic use; selection of an inappropriate antibiotic or
dosage; initiation of antibiotic therapy several days before surgery without sign of infection; and continuation
of therapy for an incorrect length of time, etc.
All of these studies indicate that antibiotic abuse is a severe problem in China and that judicious use of
antibiotics is urgently needed. In this intervention research, we made efforts to develop and implement
agreed guidelines for antimicrobial prophylaxis in surgery with the aim of promoting rational antibiotic use,
reducing antibiotic costs.
It is common that 50% of hospital revenues from the sale of drugs in China, which can lead to physicians
prescribing greater numbers of drugs and more expensive drugs. Irrational drug use has got more and more
attention from the public and medical agencies. The work of promoting rational drug use (PRDU) in China
was initiated 20 years ago, but all of the researches are separately and no comparison, the methodology
applied was not consistent. RDU has not been an important indicator for health unit evaluation now, and also
it is still not the key component of national drug policy. Therefore, We look forward to exploring an objective
and scientific evaluation and research method to promote the work of RDU in China.
MATERIALS AND METHOD
All surgical inpatient cases of thryroidectomy, mastectomy, cholescystectomy,
and hysteromyomectomy plus appendix from June 1 to July 7, 2000 and 2001in
two hospitals and the same period of cases in 2002 of intervention hospital were
collected in the study.
The data collection form was formulated before baseline data collection. And all
contents on the form were recorded in the computer, including the information
about patient and admission, information about surgery and antibiotic use, etc.
Foxpro6.0 and SPSS 10.0 were used to do the analysis.
The prophylaxis guideline was formulated to provide a framework for the
intervention, and for the guideline to have maximum effect, we implemented
within the intervention hospital in a systematic way using a variety of
educational and managerial techniques.
INTERVENTION
Interventions were focused on promoting rational antibiotic prophylaxis use
and reducing antibiotic costs.
1.Education: Training, printed educational materials and face-to-face educational methods are used to
different educational targets.
① To doctors and pharmacists:
* The antibiotic prophylaxis guideline was formulated and discussed by experts and doctors from different
departments of intervention hospital. The process of soliciting suggestions from clinical departments was
treated as an important part of guideline development.
* Several RDU workshops and seminars were conducted to introduce the RDU knowledge at the beginning
and during the research.
* Printed RDU materials. For example, "Why and what is the rational drug use?", "The situation of irrational
drug use on antibiotics", "The guideline of antibiotics use", "Rational use of antibiotics", etc.
* Several sets of reference books were disseminated to every related department of intervention hospital.
② To administrators of hospital
The administrators were moved and affected by attending PRDU semiars and many times of face to face
reports. Their understanding, supporting and assisting is one of the key factors for the success of the
research.
2. Management:
① The formulation of the standard treatment guideline
② Regular meeting of intervention hospital. All members of the study team have meetings at least two times
one month. And for the core investigators, there was at least one short meeting one week.
③ Monitor in intervention hospital was appointed to do the inspection.
Two monitors in intervention hospital were appointed to do the daily inspection. Whenever the problem
happened, the monitor would report to the director of the department, and the director of the department
would discuss or communicate with the doctor or pharmacist in the department to handle the problem.
Table 1 General information for intervention and control hospital
Intervention Hospital
Hospital/Year
Control Hospital
2000
2001
2002
2000
2001
Total cases
118
122
121
120
120
Male
17
15
19
22
16
Female
101
107
102
98
104
Average age
48.36
50.22
49.2
48.32
48.68
Thryroidectomy
38
41
36
29
32
Mastectomy
10
10
16
10
10
Cholescystectomy
34
32
33
34
32
Hysteromyomectomy +
Appendix
36
39
36
36
39
Table 2 Rationality comparison for antibiotic prophylaxis use
Intervention Hospital
Control Hospital
Rationality
2000
2001
2002
2000
2001
Rational cases
37
(31.35%)
112
(91.8%)**
64
(52.88%)
0
0
Irrational cases
81
(68.64%)
10
(8.2%)**
57
(47.12%)
120
(100%)
120
(100%)
Total
118
122
121
120
120
Incidence of postsurgical infection
0
0
0
0
0
Note: ** p<0.01
Table 3 Irrational antibiotic use analysis in intervention hospital
2000
2001
2002
Problems
Times
%(/181*)
Problems
Times
%(/200)
Antibiotic use
after 3 days of
operation
94
51.93
Incorrect
administration
route
8
4.00
Inappropriate
antibiotic use
46
25.41
Times
%(/230)
47
20.4
5
2.50
Over dosage
45
19.6
Incorrect
antibiotic use
interval
40
22.09
2
1.00
Incorrect
administration
route
9
3.9
Over dosage
38
20.99
1
0.50
Inappropriate
antibiotic use
7
3.0
Incorrect
administration
route
11
6.07
Incorrect
antibiotics
combination
4
1.7
Antibiotic use
before 24
hours of
operation
Others
2
1.10
Antibiotic use
before 24
hours of
operation
2
0.9
2
1.10
Antibiotic use
after 3 days
of operation
Others
Incorrect drug
use interval
Problems
Antibiotic use
after 3 days
of operation
Table 4 Comparison of average antibiotic cost in 2000, 2001 and 2002
Intervention Hospital
Control Hospital
Hospital/Year
Average
Antibiotic
Cost
2000
2001
2002
2000
2001
740.20
352.03**
494.62
1306.31
821.82**
Variation rate%: 52.4
Note:**P<0.01
Variation rate%:
37.1
Table 5 Antibiotics used in the intervention hospital
2000
Drug Name
Times
1 Cefuroxime
52
2 Others
129
Total
181
2001
%
2002
Drug Name
Times
28.27
1 Cefuroxime
131
71.73
2 Metronidazole
100.0
0
%
Drug Name
Times
65.50
1 Cefuroxime
88
38.26
37
18.50
2 Metronidazole
32
13.91
3 Others
32
16
3 Others
110
47.83
Total
200
100.0
0
Total
230
100.0
0
Note: Cefuroxime and Metronidazole are two recommended drugs for prophylaxis use in the guideline.
%
RESULTS AND CONCLUSIONS
Results
From the three-year data analysis, we found that there were significant differences
between the intervention and control hospital for the following indicators: rationality of
the antibiotic prophylaxis, average antibiotic cost, etc. The differences represented the
feasibility and validity of the intervention. The details were showed in the under tables.
Conclusions
The antibiotic prophylaxis guideline, education and management interventions play
active roles on promoting safely, effectively and economic drug use in intervention
hospital. Through the successful implementation of this study, we believe that it is also
effective and executive to standardize the doctor's practice by formulating and
promoting standard treatment guideline and other interventions in China. But the study
also showed that promoting rational drug use is a long-term task. National treatment
guidelines should be formulated and more researches and interventions should be
implemented to make a more rational drug use environment.