Retrospective survey of the efficacy of mandatory implementation of the Essential Medicine Policy in the primary healthcare setting in China: failure to promote the rational use of antibiotics in clinics

doi:10.1016/j.ijantimicag.2016.06.017

International Journal of Antimicrobial Agents

Volume 48, Issue 4, October 2016, Pages 409-414

https://doi.org/10.1016/j.ijantimicag.2016.06.017 Get rights and content

Highlights

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Inappropriate antibiotic use is a serious problem in primary medical institutions in China.
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Prescribers preferred to use new and broad-spectrum antibiotics.
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The Essential Medicine Policy (EMP) was implemented in 2009 after initiation of a new round of healthcare reform in China.
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Enforcing the EMP could reduce the cost of medical services.
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The EMP did not have an impact on promoting rational antibiotic use.

Abstract

The objective of this study was to understand the impact of implementation of the Essential Medicine Policy (EMP) on the rational use of antibiotics in primary medical institutions in China. A retrospective survey was conducted in 39 primary medical institutions to compare the efficacy of EMP in rational antibiotic use. All institutions completed the survey 1 year before and 1 year after implementation of the EMP. In particular, antibiotic use and its rationality were closely examined. The institutions mainly dealt with common diseases, especially non-infectious chronic diseases. Antibiotic usage was very inappropriate both before and after EMP implementation. Before and after EMP implementation, respectively, the median outpatient cost was US$6.34 and US$5.05, 52.50% (2005/3819) and 53.41% (1865/3492) of the outpatient prescriptions contained antibiotics, and 76.23% (1132/1485) and 78.83% (1106/1403) of inpatients were administered antibiotics. In addition, 98.38% (425/432) and 97.52% (512/525) of surgical inpatients were administered antibiotics, respectively, and 80.76% (638/790) and 75.19% (503/669) of patients with a cold were prescribed antibiotics, respectively. The most commonly used antibiotics were broad-spectrum and injectable agents, including cephalosporins, fluoroquinolones and penicillins. This profile showed little change following implementation of the EMP. In conclusion, inappropriate antibiotic use is a serious problem in primary medical institutions in China. Whilst enforcing the EMP reduced the cost of medical services, it had little effect on promoting the rational use of antibiotics.

Introduction

Bacterial resistance has become a public health challenge worldwide, with drug-resistant bacterial infections in patients leading to high morbidity and mortality [1]. China is one of the countries with a severe bacterial resistance problem: in 2011, the prevalences of meticillin-resistant Staphylococcus aureus (MRSA), extended-spectrum β-lactamase (ESBL)-producing Escherichia coli, and carbapenem-resistant Pseudomonas aeruginosa and Acinetobacter baumannii in tertiary hospitals were 50.5%, 71.2%, 23.4% and 56.8%, respectively [2]. Furthermore, in non-central city hospitals in 2011, the prevalences of ESBL-producing E. coli, macrolide-resistant Streptococcus pneumoniae and quinolone-resistant E. coli were as high as 64.8%, 97.1% and 57.4%, respectively [3]. Moreover, 17.4%, 25.0%, 71.2% and 44.4% of the healthy population in Nanjing carry MRSA, ESBL-producing Klebsiella pneumoniae, erythromycin-resistant S. pneumoniae and sulfamethoxazole-resistant Haemophilus influenzae, respectively, in their nasopharynx [4]. If this problem is not tackled urgently, it may lead to the disastrous situation where humankind eventually lacks effective drugs against bacterial infections. This is emphasised by the warning issued by the World Health Organization (WHO) in 2011, which stated ‘combat drug resistance: no action today, no cure tomorrow’ [1], [5], [6].

Use of antibiotics and the occurrence of bacterial resistance are closely associated. In particular, inappropriate use of antibiotics (e.g. excessive prescription and unregulated use) promotes the occurrence and spread of resistant micro-organisms [7]. In the last 10 years, Chinese regulatory agencies imposed a number of measures, which were implemented in a stepwise fashion, to regulate the use of antibiotics in general hospitals [8]. These measures successfully reduced antibiotic sales and the frequency of antibiotic-containing prescriptions in general hospitals in China. However, those measures had less involvement with the primary medical institutions of China (Chinese medical service institutions consist of three-level hospitals: primary clinical service such as described in the investigation, secondary hospitals and tertiary hospitals). These institutions provide basic healthcare services to most of the population: the National Health and Family Planning Commission of China showed that in 2012, 6.888 billion patient visits occurred nationally, of which 4.109 billion (59.65%) occurred in primary medical institutions [9]. However, these institutions tend to be relatively poorly managed and their staff less well trained than those in general hospitals. These factors mean that inappropriate use of antibiotics is more prominent in these institutions and this is likely to have a large impact on the development of bacterial resistance in China [10].

To promote rational antibiotic use, the WHO has developed a serial of strategies, including the Essential Medicine Policy (EMP), and implementation of the EMP has been shown to have had a positive effect in several countries [11], [12], [13]. Development of a National Essential Drugs List (NEDL) is the core component of the EMP. The NEDL was developed in China in 1982 for the first time but without implementation. Therefore, in 2009 the government disseminated the primary institution version of the NEDL and launched a series of actions to ensure implementation of the EMP in primary healthcare institutions following the initiation of a new round of healthcare reform [14]. To understand the impact of the EMP on the rational use of antibiotics in China, this retrospective investigation was conducted. Antibiotic usage before and after implementation of the EMP in representative urban and rural primary medical institutions in China was compared.

Section snippets

Participants

Representative primary medical institutions in China that had implemented the EMP and were located in various regions with differing levels of socioeconomic development were selected for this survey. Specifically, there were 24 rural township health centres (RTHCs) from two underdeveloped inland provinces (Jilin and Henan; four RTHCs each), three developed coastal provinces (Shandong, Jiangsu and Zhejiang; four RTHCs each) and the city of Beijing (four RTHCs). There were also 24 city community

Results

A total of 48 primary medical institutions participated in this study, of which 9 were excluded from the analysis (6 because the original data were incomplete and 3 because their data failed the quality control audits, i.e. >50% of the patient records in an institution failed quality control). Thus, 39 primary medical institutions were included in the analysis, of which 8, 6, 4, 7, 8 and 6 were from Jilin, Henan, Shandong, Jiangsu, Zhejiang and Beijing, respectively. Of the 39 institutions, 23

Discussion

Improving the rationality of antibiotic use is critical for curbing bacterial resistance. This is particularly necessary in primary medical institutions because they serve most of the patients in the population. The present study showed that there is considerable inappropriate use of antibiotics in Chinese primary medical institutions: many different antibiotics are used, antibiotics are very frequently prescribed, the antibiotic treatment duration is often unnecessarily long, the indication is

Acknowledgments

The authors thank all members of the investigational team who collected the data. They also thank all of the investigated institutions for providing information and assistance during the study.

Funding: This study was carried out with grants from the National Natural Science Foundation of China [81361138021].

Competing interests: None declared.

Ethical approval: Not required.

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Overuse and misuse of antibiotics are major factors in the development of antibiotic resistance in primary care institutions of rural China. In this study, the effectiveness of a Health Information System-based, automatic, and confidential antibiotic feedback intervention was evaluated.
A randomized, cross-over, cluster-controlled trial was conducted in primary care institutions. All institutions were randomly divided into two groups and given either a three-month intervention followed by a three-month period without any intervention or vice versa. The intervention consisted of three feedback measures: a real-time pop-up warning message of inappropriate antibiotic prescriptions on the prescribing physician's computer screen, a 10-day antibiotic prescription summary, and distribution of educational manuals. The primary outcome was the 10-day inappropriate antibiotic prescription rate.
There were no significant differences in inappropriate antibiotic prescription rates (69.1% vs. 72.0%) between two groups at baseline (P = 0.072). After three months (cross-over point), inappropriate antibiotic prescription rates decreased significantly faster in group A (12.3%, P < 0.001) compared to group B (4.4%, P < 0.001). At the end point, the inappropriate antibiotic prescription rates decreased in group B (15.1%, P < 0.001) while the rates increased in group A (7.2%, P < 0.001). The characteristics of physicians did not significantly affect the rate of antibiotic or inappropriate antibiotic prescription rates.
A Health Information System-based, real-time pop-up warnings, a 10-day prescription summary, and the distribution of educational manuals, can effectively reduce the rates of antibiotic and inappropriate antibiotic prescriptions.
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We found that the primary care facilities lack long-term effective interventions to improve antibiotic use, as reported previously [61]. A range of policies have been introduced to improve the use of antibiotics; however, studies have shown that they were ineffective at reducing the prescription of antibiotics [29,34,35]. Wei et al. [17] found that a comprehensive health education intervention for providers and caregivers achieved impressive outcomes: for children with upper respiratory tract infections, prescription of antibiotics was reduced by 29%.
The overuse and misuse of antibiotics has accelerated the rapid emergence of antibiotic resistance. The aim of the study was to review interventions conducted in China to optimize use of antibiotics in humans, animals, and the environment from a One Health perspective.
The literature review for this study was limited to English and Chinese articles published from January 1985 to May 2021. Literature review searches were conducted using Web of Science, Scopus, PubMed and three biomedical databases from China (the Chinese Scientific Journals database, the Wanfang Database, and China National Knowledge Infrastructure). We used Arksey and O’Malley's step-wise methodological framework as the basis for our scoping review.
A total of 53 studies met our inclusion criteria, of which 51 (96%) were from human healthcare settings, one from environment health that pertained to rural ponds, and no studies were found that met our criteria on interventions used to improve antibiotic use in animals. For human health, the majority of the research was related to antibiotic intervention programs performed in public institutions, and only one policy assessment study included private institutions. Interventions were classified into four broad categories: 1) Knowledge interventions; 2) decision support; 3) financial incentives; and 4) organizational/management systems. Our findings indicated that combinations of multiple interventions were more effective in promoting the rational use of antibiotics in China.
China has made major efforts on improving rational use of antibiotics in the past decades. Most policies or interventions, however, focused mainly on the human health aspect, less effort targeted toward the environment and animal health sectors. For further optimizing use of antibiotics, the cross-disciplinary and coordinated multi-faceted interventions guided by the One Health perspective should be developed and implemented. Meanwhile, the cross-departmental collaborative mechanism leading by the Chinese central government should be further strengthened to play a greater and more active role in fighting against antibiotic resistance wholly.
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In 2009, the national essential medicines and zero mark-up policy was issued to improve rational use of medicines by disengaging prescribing from profits,27,28 which is considered to be an important driver of antibiotic overuse.29 However, available evidence indicates that this policy has small or no effect on the use of antibiotics.27,28 In 2011, the Ministry of Health of China implemented the 3-year national antimicrobial stewardship programme.
Inappropriate antibiotic use greatly accelerates antimicrobial resistance. The appropriateness of antibiotic prescriptions is well evaluated, using big observational data, in some high-income countries, whereas the evidence of this appropriateness is scarce in China. We aimed to assess the appropriateness of antibiotic prescriptions in ambulatory care settings in China to inform future antimicrobial stewardship.
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The National Natural Science Foundation of China.
Effect of a computer network-based feedback program on antibiotic prescription rates of primary care physicians: A cluster randomized crossover-controlled trial
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Antibiotic resistance is a serious global health problem. Over the past decade, 50% and 80% of global antibiotic prescriptions have been inappropriately used to treat colds and acute bronchitis, respectively [1,2]. In 2007, European countries reported 400,000 multidrug-resistant bacterial infections with 25,000 attributable deaths.
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There were 82 physicians in group 1 (intervention first followed by control) and 81 in group 2 (control first followed by intervention). Baseline comparison showed no significant difference in antibiotic prescription rate between the two groups (30.8% vs 35.2%, P-value = 0.07). At the crossover point, the relative reduction in antibiotic prescription rate was significantly higher among physicians in the intervention group than in the control group (33.1% vs 20.3%, P-value < 0.001). After a further 3 months, the rate of decline in antibiotic prescriptions was also significantly greater in the intervention group compared to the control group (14.2% vs 4.6%, P-value < 0.001). The characteristics of physicians did not significantly determine the change in rate of antibiotic prescriptions.
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The survey revealed that more than 80% of physicians reported defensive medicine in the form of prescribing unnecessary diagnostic tests, drugs and therapeutic interventions [8]. Chinese health policy resulting in the ubiquitous over-prescription found in the country׳s hospitals [24]. In addition, a few Chinese doctors have moral turpitude.
To identify the changing of health policy decisions and Doctor–Patient relationship in different periods in China during 67 years (1949–2016).
We followed a systematic approach to analyze the development stage of China׳s healthcare reform and Doctor–Patient relationship over time. Based on the extant literature and statistical data, the current five issues in Chinese health policy and three aspects of Doctor-Patient Relationships are classified. The reasons for the current situation and recommendations for future policy are discussed.
There are four main problems of Chinese Health Policy: funding shortage, excessive market-oriented operation, health insurance limited reimbursement amount, and media coverage a lot of non-neutral health events. In different historical periods, these problems are not prominent, but have become increasingly serious in recent years. On the other hand, three participants contributed to the growing tense relationship between doctors and patients: doctors (hospitals), patients and governments.
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Retrospective survey of the efficacy of mandatory implementation of the Essential Medicine Policy in the primary healthcare setting in China: failure to promote the rational use of antibiotics in clinics

Highlights

Abstract

Introduction

Section snippets

Participants

Results

Discussion

Acknowledgments

Clin Microbiol Infect

Lancet

Lancet

Health Policy (New York)

Antimicrobial resistance: global report of surveillance 2014

Mohnarin report of 2011: monitoring of bacterial resistance in China

Chin J Nosocomiol

Sichuan Provincial Antimicrobial Resistant Investigation Net 2011 annual report: bacterial drug resistance surveillance in south Sichuan

Clin J Hosp Pract

Resistance analysis of the major opportunistic pathogens in community healthy adults in Nanjing, China

Chin J Clin

World Health Day brochure

Antibiotic resistance threats in the United States 2013

Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis

BMJ

Changes in Chinese policies to promote the rational use of antibiotic

PLoS Med

Health statistical yearbook 2013

A systematic review of antibiotic utilization in China

J Antimicrob Chemother

The WHO policy package to combat antimicrobial resistance

Bull World Health Organ

Impact of an essential drugs programme on availability and rational use of drugs

Lancet

Promoting rational use of medicines: core components