Workshop on Monitoring Antimicrobial Consumption in Select Western Pacific Countries, Manila, Philippines, 30-31 March 2017 : meeting report

30–31 March 2017 Manila, Philippines Meeting Report WORKSHOP ON MONITORING ANTIMICROBIAL CONSUMPTION IN SELECT WESTERN PACIFIC COUNTRIES

WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR THE WESTERN PACIFIC RS/2017/GE/09(PHL) English only MEETING REPORT WORKSHOP ON MONITORING ANTIMICROBIAL CONSUMPTION IN SELECT WESTERN PACIFIC COUNTRIES Convened by: WORLD HEALTH ORGANIZATION REGIONAL OFFICE FOR THE WESTERN PACIFIC Manila, Philippines 30–31 March 2017 Not for sale Printed and distributed by: World Health Organization Regional Office for the Western Pacific Manila, Philippines August 2017 ii NOTE The views expressed in this report are those of the participants of the Workshop on Monitoring Antimicrobial Consumption in Select Western Pacific Countries and do not necessarily reflect the policies of the conveners. This report has been prepared by the World Health Organization Regional Office for the Western Pacific for those who participated in the Workshop on Monitoring Antimicrobial Consumption in Select Western Pacific Countries in Manila, Philippines from 30 to 31 March 2017. iii CONTENTS ABBREVIATIONS ............................................................................................................................................... iv SUMMARY ........................................................................................................................................................... v 1. INTRODUCTION .............................................................................................................................................. 1 1.1 Meeting organization .................................................................................................................................... 1 1.2 Meeting objectives ........................................................................................................................................ 1 2. PROCEEDINGS ................................................................................................................................................. 1 2.1 Opening session ............................................................................................................................................ 1 2.2 AMC monitoring: an important component of the global fight against AMR .............................................. 1 2.2.1 Group work ............................................................................................................................................ 2 2.3 ATC/DDD methodology and AMC monitoring ........................................................................................... 2 2.4 Value and experiences of AMC monitoring ................................................................................................. 4 2.4.1 Plenary discussions (AMC methodology and PPS) ............................................................................... 4 2.5 Use of AMC monitoring ............................................................................................................................... 5 2.5.1 Group work: commentary on the questions and the poster walk ........................................................... 6 2.6 Learning from other programmes and sectors .............................................................................................. 6 2.7 Panel discussion: long-term sustainability of AMC monitoring and synergies between human and animal sectors on AMC monitoring ............................................................................................................................... 7 3. CONCLUSIONS AND RECOMMENDATIONS ............................................................................................. 8 3.1 Closing remarks and ways forward .............................................................................................................. 8 3.2 Conclusions .................................................................................................................................................. 8 3.3 Recommendations......................................................................................................................................... 9 3.3.1 Recommendations for Member States ................................................................................................... 9 3.3.2 Recommendations for WHO ................................................................................................................. 9 ANNEXES ........................................................................................................................................................... 10 Annex 1. List of participants ............................................................................................................................ 10 Annex 2. Meeting timetable ............................................................................................................................. 13 Annex 3. Group work ....................................................................................................................................... 14 Annex 4. Presentations ..................................................................................................................................... 19 Keywords: Drug resistance, Microbial / Health personnel – education / Public health iv ABBREVIATIONS AMC antimicrobial consumption AMR antimicrobial resistance AMS antimicrobial stewardship ATC anatomical therapeutic chemical CARSS Chinese Antibacterial Resistance Surveillance System CAS Center for Antibacterial Surveillance (China) DDD defined daily dose ECDC European Centre for Disease Prevention and Control ESAC- Net European Surveillance of Antimicrobial Consumption Network IMS Intercontinental Marketing Services JIACRA Joint Interagency Antimicrobial Consumption and Resistance Analysis PBS Pharmaceutical Benefits Scheme PPS point prevalence survey SDG Sustainable Development Goal TB tuberculosis UHC universal health coverage WHO World Health Organization v SUMMARY Antimicrobial resistance (AMR) is a global public health concern that threatens the health of the population as well as the economic development of the countries. Antibiotic resistance occurs naturally, but inappropriate use of antibiotics in humans and animals is accelerating the process. Thus, regular monitoring of antimicrobial consumption (AMC) in countries and establishing reliable surveillance system are critical. The Action Agenda for Antimicrobial Resistance in the Western Pacific Region and the Global Action Plan on Antimicrobial Resistance highlight the importance of improving surveillance of AMR and monitoring of AMC. In order to do this, the World Health Organization (WHO) is assisting countries to improve their capacity to monitor AMC through a range of interventions such as development of standards and methodologies throughout the Region. The Organization is also supporting the establishment of monitoring centres as well as the inclusion of AMC in the policy and legal framework. The Workshop on Monitoring Antimicrobial Consumption in Select Western Pacific Countries, held in Manila, Philippines, from 30 to 31 March 2017 was organized by WHO, focusing on the development of standards and methodologies for AMC monitoring. Participants included technical experts and national AMR focal points from the ministries of health of nine countries and areas in the Western Pacific Region. Bringing together relevant experts and development partners provided a unique opportunity to accelerate progress towards harmonization of standards and methodologies for AMC monitoring throughout the Region. The meeting also reviewed current practices on how AMC is monitored in different country system settings and provided a forum for discussions on sharing of national data. The meeting additionally provided opportunities for exchange of lessons learnt and fostered future collaborations. Among other issues, the workshop highlighted:  the importance of generating reliable and comparable national consumption data over time and across countries;  the need for collecting information on the level of use and types of antimicrobials used;  the role of legislation and particularly its importance in balancing the access to effective antimicrobials and regulating their inappropriate use; and  the importance of interpreting and applying the AMC data to guide the AMR interventions. vi 1 1. INTRODUCTION 1.1 Meeting organization The Workshop on Monitoring Antimicrobial Consumption in Select Western Pacific Countries was held in Manila, Philippines from 30 to 31 March 2017, with 17 nominated experts from nine countries and areas from the Western Pacific Region (Australia, Brunei Darussalam, China, Hong Kong SAR (China), Japan, Macau SAR (China), Malaysia, New Zealand, and the Philippines). On the first day, WHO representatives delivered remarks to welcome participants to the workshop. Following the formal opening, the meeting was divided into six main sessions: 1) Antimicrobial consumption (AMC) monitoring as an important component of the global fight against antimicrobial resistance (AMR); 2) Anatomical therapeutic chemical (ATC)/defined daily dose (DDD) methodology and AMC monitoring; 3) Value and experiences of AMC monitoring; 4) Use of AMC monitoring; 5) Learning from other programmes and sectors; and 6) Long-term sustainability of AMC monitoring and synergies between human and animal sectors on AMC monitoring. 1.2 Meeting objectives The objectives of the workshop were: 1) to share experiences, methodology and best practices on how AMC is monitored in different country settings and identify gaps and challenges of AMC monitoring; 2) to introduce the WHO methodology for AMC monitoring; and 3) to facilitate agreement on AMC data sharing and harmonization of the methodology in the Region. 2. PROCEEDINGS 2.1 Opening session Dr Takeshi Kasai, Director of the Division of Programme Management at the WHO Regional Office for the Western Pacific, delivered the opening remarks. He welcomed the participants to the Regional Office in the Philippines. Dr Kasai highlighted that AMR is one of the most important public health agenda items and that AMC monitoring is a fundamental component of the battle against AMR. Following the opening remarks, Dr Socorro Escalante, Team Leader for Health Systems at the WHO country office in Viet Nam, also welcomed the participants and introduced the workshop objectives and agenda. She suggested that participants use the meeting as an ideal platform to share country experiences. Dr Suraya Amir Husin and Dr Hajah Rosmonaliza Haji Awang Asli were elected as co-chairpersons of the workshop. Dr Irene Farinas was appointed as a workshop rapporteur. The list of participants and meeting timetable are included as Annex 1 and 2 respectively. 2.2 AMC monitoring: an important component of the global fight against AMR 2 Dr Socorro Escalante gave a presentation on the regional strategies on AMR in the Western Pacific Region. She framed AMR as an issue on the development agenda in the context of universal health coverage (UHC), One Health and the Sustainable Development Goals (SDGs). UHC plays a vital role in protecting patients from the financial burden that can arise from AMR, and containment of AMR links directly to achieving SDGs 1, 2, 3, 6, 8, 12 and 17. Dr Escalante emphasized that the control of AMR requires coordinated strategies involving multiple sectors: human and animal health, agriculture, food production and food safety, environmental protection, and trade. She also pointed out the importance of strengthening infection prevention and control measures at all levels of health care and reducing irrational use of antimicrobials. It is of particular importance to monitor AMC and to look at knowledge, attitudes and practices on AMR among health workers and among individuals in the community. Dr Ketevan Kandelaki presented on AMC monitoring as a necessary component of the global fight against AMR. She emphasized that the misuse of antimicrobials is accelerating the development and spread of AMR. Therefore, regular AMC monitoring is critical to identify the actual amount of antimicrobials being consumed in countries. She provided an overview of global AMC initiatives as well as regional updates on the roll-out of the WHO methodology for AMC monitoring during the subregional workshops in August and October 2016. Since the workshops, the Philippines has generated the data for submission – the first country in the Western Pacific Region to do so – and Viet Nam is currently initiating action to begin AMC monitoring in the human health sector. Dr Kandelaki emphasized that further capacity-building will be provided to Member States in order to initiate actions on AMC in 2017. Dr Vera Vlahović-Palčevski spoke about the European experiences surrounding AMC from the perspective of the European Surveillance of Antimicrobial Consumption Network (ESAC-Net) and the European Centre for Disease Prevention and Control (ECDC). Dr Vlahović-Palčevski shared insight on the structure of the networks responsible for AMC monitoring in Europe and how ECDC interacts with its member states through the national coordinators responsible for institutional contacts with ECDC. She also stressed the important role of national and operational contact points responsible for strategic and operational collaboration on technical and scientific issues in specific disease areas. Dr Vlahović-Palčevski highlighted the point prevalence surveys (PPSs) conducted by ESAC-Net and the ECDC antimicrobial stewardship (AMS) indicators, which will be put in place to encourage rational antimicrobial drug prescription and use. She also mentioned upcoming projects such as defining responsible antimicrobial use, quality indicators and quantity metrics to express drug use, suggesting that AMC should be expressed at least according to two different metrics in order to capture the differences. 2.2.1 Group work Country representatives participated in the group work to undertake an AMC situation mapping in their corresponding countries. Workshop participants identified existing systems and mechanisms for AMC monitoring as well as gaps and challenges and the entry points to build on the monitoring systems (Annex 3). 2.3 ATC/DDD methodology and AMC monitoring Dr Arno Muller presented the WHO methodology for AMC monitoring and the WHO PPS protocol as well as the principles for undertaking the PPS. He pointed out that AMC applies to national levels of consumption and the PPS captures information on how antibiotics are used at a consumer/prescriber level. Dr Muller introduced the objectives for AMC monitoring, which include providing a methodology to countries for collecting and reporting reliable and comparable national AMC data as well as one that can be integrated into the global WHO surveillance programme. He outlined the principle of the ATC/DDD methodology in hospital and community settings. It was pointed out that there is no defined level for the “optimal” use of antimicrobials and that there are at least 3.4-fold differences in the levels of AMC among European member states. No significant 3 difference has been detected, however, as regards mortality in the countries with the lowest AMC levels compared to countries with the highest AMC levels, keeping in mind that the burden of infectious diseases is fairly homogenous across the European member states. Dr Hege Salvesen Blix shared the Norwegian experience of using ATC/DDD for drug utilization studies. Norway has been collecting wholesalers’ AMC data since 1974, which facilitated the further evolvement and development of the ATC/DDD methodology and eventually the establishment of the WHO Collaborating Centre for Drug Statistics Methodology. Collected AMC data are often used to guide the AMS interventions. Dr Blix highlighted that ATC/DDD data are also used as an educational tool for nurses and pharmacists at health-care centres in Norway, where ATC codes are indicated on medicine shelves. It also helps to better understand by whom, where and when the antimicrobials are used in the country. The collected data are regularly reported internationally. Importantly, they are used to provide feedback to prescribers locally. She emphasized the importance of defining the broad- spectrum antibiotics, as they may vary from country to country. She noted using ATC/DDD data to set a target to reduce the use of broad-spectrum antimicrobials, since the methodology gives an opportunity to monitor the progress and capture the patterns of antimicrobial use. Dr Irene Farinas presented on the AMC activities in the Philippines. The first AMC report was presented in 2015 at the first Philippine AMR Summit, which was followed by a training workshop on the WHO methodology for AMC monitoring in 2016. She emphasized that the Philippines is outsourcing the IMS Health Philippines data, which are incorporated into the WHO AMC monitoring tool. She highlighted the absence of baseline data and the of collecting and validating sales data as some of the main gaps and challenges. Conducting PPSs according to the WHO PPS protocol and standard guidelines as well as training of hospital staff on the use of the AMC monitoring tool were identified as next steps. Dr Hajah Rosmonaliza Haji Awang Asli gave a presentation about the gaps and challenges in AMC monitoring in Brunei Darussalam. A brief overview of health facility governance was provided. The AMC data have been collected in all four districts of the country, using dispensing records as a data source from the government/community health-care centres and hospital pharmacy dispensary stores. The collected data are used as a reference guide to estimate drug purchases and medicine distribution. Dr Asli mentioned that the data collection in Brunei Darussalam does not make use of the international ATC/DDD methodology and thus limits the possibility for comparison of data with other countries. Setting up an AMC surveillance programme according to the WHO AMC methodology and ATC/DDD classification were identified as the next steps. Dr Noraini Mohamad presented the country situation analysis on AMC in Malaysia, a case study conducted with support from WHO. She gave a brief overview of the medicines supply and distribution scheme in Malaysia and presented the objectives and findings of the study, which was conducted at four major hospitals in the states of Penang, Selangor, Kuala Lumpur and Johor. Notable was that the expenditure on antibiotics accounts for 4.5–6% of the total drug expenditure in the four study sites. It was also found that the most common oral antibiotics supplied from hospital stores to substores of outpatient pharmacy departments in 2016 were penicillin (30–70 %) and cephalosporin (5–20%), while for parenteral antibiotics in inpatient pharmacy departments cephalosporins (21–37%) were mostly supplied. The lack of full-time dedicated staff for AMS activities to ensure appropriate antimicrobial use, lack of education outreach through academic detailing to prescribers and the lack of IT capability to support the needs of AMS activities were identified as major gaps and challenges. The session highlighted the following:  There is no defined level for the “optimal” use of antimicrobials, though the AMC levels between the countries and regions are widely different.  Lack of mechanisms for collecting and validating the AMC sales data were named as the main gaps and challenges. 4  Lack of harmonized methodologies for AMC monitoring limits the possibility of data comparison over time and across the Region.  AMC data are a strong tool to guide the AMS interventions. 2.4 Value and experiences of AMC monitoring Dr Hiroyuki Noda shared experiences from Japan on AMC monitoring. Japan outsources the IMS data and applies the ATC/DDD classification. Dr Noda emphasized that some of the antibiotics used in Japan do not have assigned international ATC/DDD codes; thus, Japan often assigns its own codes. Dr Noda highlighted that the total antibiotics sales volume is not high in Japan, but the proportion of use of the three major types of broad-spectrum antibiotics (third-generation cephalosporins, quinolones and macrolides) is extremely high compared to European countries. This is of particular importance as the number of newly marketed antibiotics by ingredients in Japan had steadily decreased from 51 (between 1976 and 1995) to 9 (between 2006 and 2015) and broad-spectrum antibiotics from 29 to 2. He also underlined the lack of incentives for patients not to demand antimicrobials due to fixed prices of medical services in the list of medical insurance packages in Japan and added the difficulty of doctors/prescribers to deny the prescription and dispensing of antimicrobials. Dr Ng Ho-Leung gave a presentation on the value of AMC monitoring in Hong Kong SAR (China). He started with a short introduction of the health-care system, pointing out that 71% of primary care services are provided by the private sector while 87% of secondary/tertiary care services are provided by the public sector. AMC data are readily available in the public sector, due to well-established electronic dispensing systems, which can be traced to individual hospital and speciality levels. In the private sector, most of the general practitioners are self-employed and can provide a dispensing service in their clinics. Private practitioners are not obliged to report AMC data. Thus, AMC monitoring in the private sector largely relies on wholesale supply data. AMC data are later used at the hospital, between hospitals, between hospitals and communities, and at the national level to target the AMS interventions, provide feedback to the prescribers and consumers and guide the development of the antibiotic prescription guidelines, as well as monitor trends and improvements for rational antimicrobial use. Dr Virginia Hope shared experiences in New Zealand with community AMC surveillance and evidence-based interventions. She emphasized that New Zealand has a publicly funded system and that almost 100% of the community prescribing data go through the national pharmaceutical network and can be further linked to patient data through a unique identifier. The findings of the total antibiotics consumption data in New Zealand between 2006 and 2014 showed that penicillins and tetracycline account for the majority of antibiotics consumed, with the highest consumption of tetracycline among teenagers. Dr Hope stated that the 2014 AMC data showed an increasing pattern in the prescribing of second-generation quinolones and underlined that this helped in the development of educational massaging for prescribers and consumers. She stressed that it is particularly important to also look at how microbiology results are communicated to alter some of the prescribing behaviour. The session emphasized the following:  Different factors influence AMC, among others insurance packages, reimbursement mechanism, patient and prescriber behaviour, etc.  AMC data can be used to provide feedback to the prescribers and consumers and to guide the development of the antibiotic prescription guidelines.  AMC data can be used to develop educational messaging and to raise awareness of AMR. 2.4.1 Plenary discussions (AMC methodology and PPS) The plenary discussions highlighted the importance of submitting the list of the antimicrobials without assigned ATC/DDD codes to the WHO Collaborating Centre for Drug Statistics Methodology in 5 Norway so that the correct international codes are assigned to the medicines and drug combinations. Questions and concerns surrounding the need for population standardization of AMC data had been raised. This would mean taking into consideration the population pyramid and the assumption that ageing populations are at higher risk of infections, require longer hospitalization and thus have greater needs for antimicrobials. Discussions focused also on looking at all quantitative parameters (that is, minimum antimicrobial use based on disease data and rational use of drug guidelines in human health, as well as reduction target or prohibition of antimicrobial use as a growth enhancer in animal health) in order to set systematically targets for reducing AMC and assess the achievements. Issues raised during the plenary included:  challenges in applying existing monitoring tools, such as DDD applicability to the antimicrobials consumed by children;  lack of management support, funding gaps and how to ensure enough resources (financial, human resources and expertise);  how to interpret and link the national-level consumption data and the consumer/prescriber- level data on antibiotics used;  different capabilities between hospitals and communities in establishing the AMC monitoring systems; and  lack of mechanisms for providing feedback to prescribers to improve prescribing patterns. It was also emphasized that it is important not only to monitor overconsumption of antimicrobials but also to capture where treatment is missing, particularly in countries aiming to decrease AMC. The question is how to achieve a balance between access and excess in Western Pacific countries, particularly among vulnerable, marginalized and indigenous population groups. 2.5 Use of AMC monitoring Dr Qiwen Yang gave a presentation on AMC data as part of rational drug use policies in China. Establishing a hierarchical management approach to the clinical use of antimicrobial agents consists of three levels: non-restricted use, restricted use and special use. Dr Qiwen provided an overview on AMC surveillance networks in China. Established in 2005, the Center for Antibacterial Surveillance (CAS) has 2542 member hospitals and 192 core member institutions, and the Chinese Antimicrobial Resistance Surveillance System (CARSS) has 1412 member institutions, which are secondary or tertiary hospitals in 31 provinces, autonomous regions and municipalities in mainland China. The established networks feature dynamic, timely and accurate monitoring functions and provide technical support for containing AMR and promoting the rational use of antimicrobial agents. He highlighted that the average rate of antibacterial use among inpatients has decreased from 67.3% in 2010 to 39.1% in 2015, while the rate of antibacterial use among outpatients has decreased from 19.4% in 2010 to 9.4% in 2015. It was pointed out that CAS calculates DDDs according to the WHO DDD classification, but on a national level antibiotic use density measures are applied. Mr Graham Brown presented on antimicrobial use and appropriateness of data to inform AMS activities and interventions in Australia. Mr Brown introduced the Antimicrobial Use and Resistance in Australia surveillance system and elaborated that the system captures and coordinates resistance and usage data from a range of sources, allowing integrated analysis and national reporting. He highlighted that the collected data help to focus the stewardship efforts by looking at the causes of resistance and irrational use of antimicrobial agents, determining compliance to prescription guidelines, and targeting interventions to reduce inappropriate use. Dr Lei Sai Ian gave a presentation on the containment of AMR and AMC monitoring in Macau SAR (China). As there are no agricultural and farming practices in Macau SAR (China), AMR and AMC are solely an issue in the human health sector. Dr Ian introduced the Mandatory Declaration System, which was implemented in 2016 in line with the WHO Global Action Plan on Antimicrobial Resistance, with the objectives to strengthen surveillance of AMC and to promote the rational use of 6 antibiotics. He highlighted that in the hospital’s formulary antimicrobials are categorized as unrestricted and controlled – to be used only in special situations by selected practitioners with expertise. A multilevel approval system for requesting the supply of controlled antimicrobials in order to ensure the rational and appropriate use of antimicrobials was also presented. The following points were discussed during the session:  the role of establishing the hierarchical classification of antimicrobials;  the importance of establishing a monitoring system that captures the data source and provides the possibility for targeted interventions; and  the role of standard setting, and registration and licensing of settings and people that prescribe and use antibiotics. 2.5.1 Group work: commentary on the questions and the poster walk 2.6 Learning from other programmes and sectors Dr Arno Muller gave a presentation on the European experience in AMC monitoring in the animal sector. He emphasized that the European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) project was set up in 2010 in response to a request from the European Commission, with the objective to develop a harmonized approach for collecting and reporting data on antimicrobial veterinary medicinal products as well as ensuring the comparability with the sales/use of antimicrobials in the human health sector. Dr Muller highlighted that prior to the establishment of ESVAC, nine European countries had a pre-existing national surveillance system in place. Currently, there are 30 European Union and two European Economic Area countries submitting data. The Joint Interagency Antimicrobial Consumption and Resistance Analysis (JIACRA) was also presented. This first joint report on the integrated analysis of the relationship between available data on AMC and the occurrence of AMR in humans and food-producing animals is the result of a request from the European Commission and was prepared by experts from three agencies – ECDC, European Medicine Agency (EMA) and European Food Safety Agency (EFSA) – utilizing 2011 and 2012 data. JIACRA found that there was a relationship between AMC in the animal sector and occurrence of resistant pathogens in humans, for example between animal consumption of fluoroquinolones and occurrence of resistance in human Escherichia coli. This once again underlines the importance of AMC monitoring in both the human and animal health sectors. Dr Shalala Ahmadova shared experiences on AMC monitoring with regard to tuberculosis (TB). The global and Regional TB burden was presented, highlighting that 15% of global TB cases occur in the Western Pacific Region, of which 17% are drug resistant. Dr Ahmadova presented a case study on monitoring anti-TB drugs procurement and sales data, with the objective of identifying the availability types and quantity of anti-TB drugs in the public and private sectors from 2007 to 2011 in the Philippines. It was underlined that AMC data are valuable for monitoring medicine prices as well as for ensuring the proper functioning of drug procurement processes. Dr Elizabeth Roughead presented on AMC monitoring from the perspective of medicines pricing and access to medicines. She emphasized that the data presented come from the Pharmaceutical Benefits Scheme (PBS) system in Australia and cover community use. Currently there are 37 unique antibiotics in PBS. Access and pricing policy have a particularly strong influence on antimicrobial use, and the example of quinolone was presented. Australia has one of the lowest consumption rates of quinolones. This has been achieved through active monitoring over time and maintenance of the approval requirement and has resulted in very low use of quinolones in the outpatient setting. Dr Roughead emphasized that AMC plays an important role in listing decisions in terms of quantities supplied, the initial and ongoing decisions for unrestricted access, and restricted access or prior approval access. The session discussed the following points: 7  the importance of integrated AMC surveillance systems in human and animal sectors, for better understanding of the consumption and resistance patterns in order to guide AMS and awareness-raising interventions;  the value of using AMC to identify the availability types and quantity of the medicines; and  the role of legislation including regulation of supply chains; access and drug pricing in regulation of marketing. 2.7 Panel discussion: long-term sustainability of AMC monitoring and synergies between human and animal sectors on AMC monitoring Moderator: Dr Socorro Escalante Panellists: Dr Arno Muller, Dr Vera Vlahović-Palčevski, Dr Elizabeth Roughead and Dr Hege Salvesen Blix Acknowledging the challenges in operationalizing and sustaining a functioning AMC monitoring in a limited resource setting, panellists discussed the key elements required for an effective surveillance structure both in the human and animal sectors. The following points were discussed:  AMC information needs to be correctly captured in the “drug flow chain” in the country. o In order to capture AMC information correctly, it is important to know where the bias is and what results say over time. Data collection often results in policy shifts as the data reveal the problem and issue areas. The drug distribution chain in the country is critically important in order to overcome the barriers in setting up sustainable monitoring systems. o There is a need to establish a group/network of experts who will be able to update the ATC/DDD methodology on a yearly basis, as new antimicrobials and products enter the market and new calculations are needed. o It is important to identify tools for interpreting the data, and translating the figures to be able to understand and apply the interventions as well as to allocate resources for research to further understand and explore the data presented on the aggregated level. o AMC monitoring is an evolving and dynamic process and can be implemented in a stepwise manner starting with a single point of data collection. Setting up an AMC network within and across the countries was stressed as important, as this creates an opportunity to share experiences and facilitate data interpretation, particularly given the diversity of the Region.  Synergies between human and animal sectors on AMC monitoring  Value of comparable AMC data both on national and regional levels: o capturing the data and continuously questioning and improving the data; o initiating the data collection in the human sector is critically important; o going beyond the issue of monitoring AMR to the broader context to help sustain the system:  know the drugs in your country– what your antibiotics are;  what you want to monitor;  know your supply systems;  where these antibiotics are being distributed – in the private or public sector; and  in order to streamline where you are going to get the data;  Data across countries can only be compared after establishing a standard methodology.  Importance of knowing what the most important antibiotics used are from one country to another.  Essential antibiotics can be included in the monitoring of availability of a “basket of medicines” – using the WHO methodology to determine if people are able to access the medicines including antibiotics: 8 o Undertaking a price and availability survey for a “basket of medicines” that includes essential antibiotics, given that the prices of medicines and their availability are indicators of access to medicines and influence rational use. o Data collected are used to inform the policy-makers on the availability, price and affordability of and access to essential antibiotics. o In order to collect the data considering the diversity of available medicines across the countries, WHO will be looking at developing the “antibiotics basket”, including essential medicines (antimicrobials) that are most commonly used for the most common diseases (infections) that are expected to be available when people need them. o The aim is to develop “baskets” for primary care including around 20 antibiotics and “baskets” for hospitals and for the central drugstores including around 40–45 antibiotics for each (comprehensive – from first line to last resort).  The ATC/DDD classification is valuable not only for AMC monitoring but also for policy advocacy, health insurance reimbursement schemes for insurance packages, therapeutic comparisons, as well as drug registration systems and processes. 3. CONCLUSIONS AND RECOMMENDATIONS 3.1 Closing remarks and ways forward Dr Socorro Escalante gave the closing remarks. She noted the encouraging progress around AMC monitoring, although the capacity level and extent of AMC monitoring is different from one country to another. It was acknowledged that a lot of efforts are under way in countries, from data collection at just one department of the hospital to extensive data collection nationwide. All data are equally important and valuable while consolidating the efforts towards AMC monitoring. Varying degrees of confidence using and sharing the collected data were also noted, and it was emphasized that countries should not be discouraged to collect the data, given that the process is evolving and dynamic. Participants shared what they had learnt during the workshop and expressed their interest in continued collaboration and sharing the AMC data. Dr Socorro Escalante, expressed her appreciation to the participants for making the workshop meaningful with their high level of engagement and commended the wealth of activities currently ongoing in countries. 3.2 Conclusions The workshop provided opportunities for countries to share challenges and successes in establishing and strengthening AMC monitoring. Workshop participants pointed out the importance of a multisectoral and multidisciplinary approach. They framed AMR as a development agenda issue in the context of UHC, One Health and the SDGs. Global and regional issues as well as valuable national initiatives were presented. The complexity of AMR was acknowledged and the importance of turning the action plans into coordinated multisectoral action was highlighted. The workshop identified challenges, in particular in collective One Health approaches to governance, systems strengthening, AMC and AMR surveillance, and ultimately behaviour change at all levels and disciplines involved. This workshop served as a unique platform to consider opportunities and share challenges and solutions on AMC. The WHO methodology for AMC monitoring was introduced, and discussions on AMC data sharing and harmonization of methodologies in the Region were initiated. Questions and concerns about population standardization of AMC data were raised so that the balance between access to and excess of antimicrobials in Western Pacific countries can be addressed. Group work identified existing AMC monitoring systems in the countries, as well as critical elements/strategies for interventions establishing and strengthening the AMC monitoring systems. The ways forward in sustaining effective AMC surveillance to inform evidence-based interventions 9 were also discussed. In addition, participants discussed how to strengthen communication with the prescribers, dispensers and the general public to ensure the engagement of all relevant sectors for long-term sustainability of AMC monitoring. The challenge of governance and resource mobilization remained a topic of discussion. In regard to the role of legislation, it is important to balance the need for access to effective antimicrobials and restrict irresponsible use as well as to identify which areas require legislation. Discussions continued on using AMC to identify the accessibility, availability types and quantity of antimicrobials in the countries. Panel discussions provided an opportunity to hear expert opinions on the WHO methodology for AMC monitoring and discuss solutions for AMC monitoring as well as the ways by which the capacity of countries to monitor AMC and antimicrobial use can be improved. Highlights of the discussions included identifying the systems, structures and legal frameworks essential to sustaining multisectoral actions against AMR, in particular in relation to the use of antimicrobials. 3.3 Recommendations 3.3.1 Recommendations for Member States Member States are encouraged to undertake the following: 1. to establish monitoring and surveillance systems for antimicrobial use as a necessary element for combating AMR and support such systems with broader policies to combat AMR; 2. to review the WHO methodology for AMC monitoring and work towards its adoption as well as the alignment of current AMC methodologies with the WHO methodology; 3. to consider submission of the list of antimicrobials without ATC/DDD codes to the WHO Collaborating Centre for Drug Statistics Methodology to facilitate the data harmonization and assignment of correct indexes; and 4. to strengthen country systems in monitoring AMC in the human sector and advocate the establishment of AMC monitoring systems in the animal sector to better understand the consumption and resistance patterns in order to guide AMS and awareness-raising interventions as well as actions to effect behaviour change. 3.3.2 Recommendations for WHO The WHO Secretariat is requested to do the following: 1. to continue providing technical support for the implementation of the AMC monitoring methodology in countries in the Region; 2. to continue to facilitate the tripartite collaboration between the Food and Agriculture Organization of the United Nations (FAO), World Organisation for Animal Health (OIE) and WHO and share existing AMC monitoring tools in order to implement coordinated AMC monitoring in both the human and animal health sectors; 3. to improve the tools for AMC monitoring in health-care settings with due consideration of the contexts, availability of resources and sustainability of monitoring systems; 4. to finalize the PPS tool and provide guidance to Member States on rolling out PPS activities; 5. to develop and provide guidance to Member States on how to utilize the information, analyse and interpret AMC data and translate the data into policy action; and 6. to facilitate information sharing on AMC within and across Member States. 10 ANNEXES Annex 1. List of participants 1. PARTICIPANTS Australia Mr Graham BROWN Assistant Director, Health Protection Policy Section, Department of Health Office of Health Protection MDP5 GPO Box 9848 Canberra ACT Tel: 61 2 6289 1704 E-mail: graham.brown@health.gov.au Brunei Darussalam Dr Hajah Rosmonaliza HAJI AWANG ASLI Head of Infectious Diseases Unit, Department of Internal Medicine, Ministry of Health Bandar Seri Begawan Tel: +673 2242424 ext 6249 / +673 8779477 E-mail: rosmonaliza.asli@moh.gov.bn China Dr ZHUO Chao Deputy Director, National Surveillance Network Antimicrobial Resistance in China, Director of Clinical Microbiology Division and Principal Investigator, State Key Laboratory of Respiratory Disease Guangzhou Tel: +86 20 83062879 E-mail: chaosheep@sina.com Dr QIWEN Yang Researcher/ Associate/ Director Assistant of Department of Clinical Laboratory, Peking Union Medical College Hospital, Beijing Tel: 86-18600100521 E-mail: yangqiwen81@163.com Hong Kong SAR (China) Dr NG Ho-leung Consultant, AMR Infection Control Branch, Centre for Health Protection, Department of Health, Hong Kong Tel.: + 852 2125 2953 E-mail: cons_amr@dh.gov.hk Mr HSU Know Enoch Scientific Officer, Infection Control Branch, Centre for Health Protection, Department of Health, Hong Kong, Tel: 2125 2923 E-mail: enoch_hsu@dh.gov.hk Japan Dr Hiroyuki NODA Director of Office for AIDS Control, Tuberculosis and Infectious Diseases Control Division, Health Service Bureau, Ministry of Health, Labour and Welfare 1-2-2 Kasumigaseki Chiyoda-ku, Tokyo 100-8916; Tel: +81 3 3595 2257 E-mail: noda-hiroyukiaa@mhlw.go.jp Macau SAR (China) Mr LEI Sai Ian Division Chief, Pharmacovigilance & Pharmacoeconomics Av. Sidonio Pais No. 51, Edf. China Plaza 2 Andar, Tel: +853 85983523 E-mail: dom@ssm.gov.mo Dr Maria Filomena COELHO President of Antibiotic Committee, Centro Hospitalar Conde S. Januario Tel: ++853 66820047 E-mail:mariafilomenacoelho@gmail.com Ms Veng Va CHAU Member of the Antibiotic Committee, Centro Hospitalar Conde S. Januario, Macau, Tel: +853 839 03753 E-mail: chaugoretti@gmail.com 11 Malaysia Mrs Noraini MOHAMAD Deputy Director, Pharmaceutical Services Division Ministry of Health, Petaling Jaya Selangor, Tel: +603 784 13378 E-mail: norainimohd@moh.gov.my Dr Suraya AMIR HUSIN Senior Principal Assistant Director, Head of Infection Control Unit, Medical Care Quality Section, Ministry of Health Putrajaya Tel: +603 88831190 E-mail: drsurayaamir@moh.gov.my Mrs Mardhiyah KAMAL Principal Assistant Director, Pharmaceutical Services Division, Ministry of Health Petaling Jaya, Selangor; Tel: +603 784 13382 E-mail: mkmard@moh.gov.my New Zealand Dr Jane Ann PRYER Senior Advisor, Healthcare Associated Infection, Communicable Diseases, Ministry of Health, 133 Molesworth Street Wellington, Tel: +644 816 2404 E-mail: jane_pryer@moh.govt.nz Dr Virginia HOPE Medical Director, Health Group, ESR, Kenepuru, Porirua, Wellington, Tel: +64 27 6535681 E-mail: virginia.hope@esr.cri.nz Philippines Dr Irene FARINAS Medical Officer IV/ Section Head, Policy, Planning, Program Development and, Research Unit, Pharmaceutical Division, Office for Policy and Health Systems, Department of Health, Tel: +63 2 711 2589 E-mail: ayeenfarinasmd@gmail.com Ms Nina Isabelle TOLENTINO Pharmacist III/ AMR Program Manager, Policy, Planning, Program Development and Research Unit, Pharmaceutical Division, Office for Policy and Health Systems, Department of Health, Tel: +63 939 473 9503 E-mail: nimtolentino@gmail.com 2. OBSERVERS Asian Development Bank Mr Yuki SHIROISHI Consultant, Asian Development Bank, 6 ADB Avenue, Ortigas Center, Mandaluyong E-mail: yshiroishi.consultant@adb.org Paediatric Infectious Disease Society of the Philippines Dr Marimel PAGCATIPUNAN Pediatric Infectious Disease Society of the Philippines, Unit 4 Metro Square Townhomes, #35 Scout Tuazon corner Scout De Guia, Quezon City, Tel: +63 2 374 1855 E-mail: pidsp@uplink.com.ph / mrpagcatipunan@yahoo.com Philippine Society for Microbiology and Infectious Diseases Dr Mari Rose DELOS REYES Philippine Society for Microbiology and Infectious Diseases, 2nd Floor, PSMID Building, 116 Ninth Avenue, Cubao, Quezon City UK Fleming Fund Dr Anthony HUSZAR Regional Coordinator, The Fleming Fund, Mott MacDonald, 10 Fleet Place, London EC4M 7RB, United Kingdom, Tel: +44 20 7651 0300 E-mail: anthony.huszar@mottmac.com 12 WHO Collaborative Centre for Drug Statistics Methodology Dr Hege Salvesen BLIX Senior Researcher, Department of Pharmacoepidemiology, Norwegian Institute of Public Health, Professor School of Pharmacy University of Oslo, Norway, Tel: +4721078163 E-mail: HegeSalvesen.blix@fhi.no 3. TEMPORARY ADVISERS Australia Dr Elizabeth (Libby) ROUGHEAD Research Professor, University of South Australia, School of Pharmacy and Medical Sciences, University of South Australia Tel: +61 8 83021238 E-mail: Libby.Roughead@unisa.edu.au Croatia Dr Vera VLAHOVIĆ-PALČEVSKI Professor, Clinical Pharmacologist, University Hospital Center Rijeka, Krešimirova 42, 5100 Rijeka Tel: +385 51 658805 Fax: +385 51 211602 E-mail: vvlahovic@inet.hr 4. SECRETARIAT WHO/WPRO Dr Socorro ESCALANTE Team Leader for Health Systems at the WHO Country Office Viet Nam ; Hanoi, Viet Nam Tel: +63 2 528 9026; + 63 2 528 9001 E-mail: escalantes@who.int Dr Ketevan KANDELAKI Technical Officer, Essential Medicines and Health Technologies, World Health Organization Regional Office for the Western Pacific, United Nations Avenue, Manila, Philippines, Tel: +63 2 528 9848 E-mail: kandelakik@who.int Dr Sarah PAULIN Technical Officer, Essential Medicines and Health Technologies, World Health Organization Regional Office for the Western Pacific, United Nations Avenue, Manila, Philippines, Tel: +63 2 528 9846 E-mail: paulins@who.int Ms Uhjin KIM Technical Officer, Essential Medicines and Health Technologies, World Health Organization Regional Office for the Western Pacific, United Nations Avenue, Manila, Philippines, Tel: +632 5289028 E-mail: kimu@who.int Dr Shalala AHMADOVA Technical Officer, Stop TB and Leprosy Elimination, World Health Organization Regional Office for the Western Pacific, United Nations Avenue, Manila, Philippines, Tel: +63 2 5289720 E-mail: ahmadovas@who.int WHO/HQ Dr Arno MULLER Technical Officer, Innovation, Access and Use, World Health Organization Headquarters, Geneva Switzerland, Tel.: +41 22 791 5564 E-mail: amuller@who.int 13 Annex 2. Meeting timetable Time Day 1 –Thursday March 30 September 2017 Time Day 2 – Friday 31 March 2017 8:30–9:00 9:00–10:00 Registration Opening and welcome address Welcome messages  welcome – Dr Socorro Escalante Coordinator, Essential Medicines and Technologies, WHO WPRO  Opening remarks – Dr Takeshi Kasai Director-Programme Management, WHO WPRO Overview of the meeting objectives Dr Socorro Escalante WHO WPRO Election of Chairperson, Vice-Chair and Rapporteur Round of Introduction Group photo 09:00- 11:00 Recap of Day 1 Session 4 USE OF ANTIMICROBIAL CONSUMPTION MONITORING Moderator: Dr Vera Vlahovic Palcevski AMC data as part of rational drug use policies in China - Dr Qiwen Yang AMC data to inform Antimicrobial Stewardship activities and interventions in Australia– Mr Graham Brown AMC monitoring and patient safety experiences from Macau SAR -Dr Lei Sai Ian Group work: commentary on the questions and the poster walk 10:00–10:30 Morning Tea 11:00-11:30 Morning Tea 10:30–12:00 Session 1 ANTIMICROBIAL CONSUMPTION (AMC) MONITORING- AN IMPORTANT COMPONENT OF GLOBAL FIGHT AGAINST AMR Regional Strategies on AMR in the Western Pacific - Dr Socorro Escalante AMC Monitoring as a necessary component of the global campaign against AMR– Dr Ketevan Kandelaki Experiences in Europe ESAC –NET/ECDC - Dr Vera Vlahovic Palcevski Group work: AMC mapping- poster with questions 11:30–12:30 Session 5 LEARNING FROM OTHER PROGRAMS AND SECTORS Antimicrobial Consumption in the Animal Sector in Europe- Mr Arno Muller Monitoring of antibiotic consumption from TB perspective - Dr Shalala Ahmadova AMC from medicines pricing and access to medicines perspective - Dr Elizabeth (Libby) Roughead 12:00–13:30 Lunch Break 12:30–13:30 Lunch Break 13:30–14:30 Session 2 ANATOMICAL THERAPEUTIC CHEMICAL (ATC)/DEFINED DAILY DOSE (DDD) METHODOLOGY AND MONITORING OF ANTIMICROBIAL CONSUMPTION WHO methodology for the monitoring of AMC, Data and Template for AMC - Mr Arno Muller Norway example on how to use the ATC/DDD for drug utilization studies - Dr Hege Salvesen Blix WHO methodology and AMC monitoring experiences from the Philippines -Dr Irene Farinas AMC monitoring: gaps and challenges - Brunei Darussalam- Dr Hajah Rosmonaliza Haji Awang Asli AMC country situational analyses - Case study from Malaysia - Dr Noraini Mohamad 13:30–15:00 Session 6 Panel discussion: LONG TERM SUSTAINABILITY OF MONITORING ANTIMICROBIAL CONSUMPTION AND SYNERGIES BETWEEN HUMAN AND ANIMAL SECTORS ON MONITORING ANTIMICROBIAL CONSUMPTION Moderator: Dr Socorro Escalante Mr Arno Muller; Dr Vera Vlahovic Palcevski ; Dr Elizabeth (Libby) Roughead; Dr Hege Salvesen Blix Group work: The discussions on way forward 14:45–15:15 Afternoon Tea 15:00–15:30 Afternoon Tea 15:15–16:30 Session 3 VALUE AND EXPERIENCES OF ANTIMICROBIAL CONSUMPTION MONITORING Moderator: Dr Hege Salvesen Blix Experiences from Japan on AMC monitoring– Dr Hiroyuki Noda Value of the AMC monitoring from Hong Kong SAR - Dr NG Ho-Leung AMC to drive the evidence based interventions ,New Zealand – Dr Virginia Hope Plenary discussion: on AMC methodology and Point prevalence studies 15:30–16:30 Closing session - Plenary Review of the current materials, gaps and improvements and next steps Adoption of meeting recommendations Conclusion and Way Forward Mr Arno Muller/ Dr Socorro Escalante 18:00–19:30 Welcome reception and end of day 1 16:30 End of the Meeting YEAR AND THE DATA SOURCE (the level of data e.g. facility or national level data) METHODOLOGY APPLIED and INSTITUTION/ GROUP RESPONSIBLE FOR DATA COLLECTION FREQUENCY OF DATA COLLECTION OUTPUT (e.g. selected antimicrobials, all antimicrobials, annual report etc) DATA UTILIZATION Community consumption • National drug utilization database • Community prescription/anti infective (national) National report • AURA – first national report in 2016 Community prescribing • 2012 onwards medicines insight Hospital consumption • Hospital data/consumption data 2004 (NAUSP) Hospital prescribing • National Antimicrobial Prescribing Survey (NAPS) Pharmacy claims data, scripts and DDDs (24 million people coverage, capturing 90% of community use ) Community and hospital utilization as well as resistance data from multiple sources GP prescribing data including indications, GP electronic Medical Records (500 GPs and 2.5 million people ) National antimicrobial utilization (DDDs) surveillance programme, pharmacy dispensing . (129 hospitals, 90% of principal referral beds ) Point prevalence surveys ( 248 hospitals) • Hospital –began in 1 state in 1990, since 2012 it is national wide • GP • Aged care • Surgical 1990- present Continuous age, gender, specific (2003) onwards Annual Ongoing Monthly Annual Australian statistics on medicines, online PBS statistics Antimicrobial use, resistance Australia (AURA) Included in AURA report Included in AURA report Reports to all relevant agencies www.pbs.gov.au Hosted on website of Australian Commission on Quality and safety www.safetyandquality.gov.au Feedback to participating GPs www.aps.org.au Bimonthly reporting back to hospitals, benchmarking local QI Feedback to local facilities both public and private AUSTRALIA YEAR AND THE DATA SOURCE (the level of data e.g. facility or national level data) METHODOLOGY APPLIED and INSTITUTION/ GROUP RESPONSIBLE FOR DATA COLLECTION FREQUENCY OF DATA COLLECTION OUTPUT (e.g. selected antimicrobials, all antimicrobials, annual report etc) DATA UTILIZATION Dispensary – record from the government facility store to dispensary store; Dispensaries for immediate use/dispenses to patients/wards National data • Government facilities • Can be disaggregated to facility level Data collection covers almost 80% of use nationally Crude Data collection Responsible for Data collection: Pharmacy Division Pharmacists from each facility Head of Pharmacy Beginning of each year Each pharmacy submits drug usage data for the previous year All antimicrobials from the National Standards Drug List (NSDL) Data collected captures the quantity used per year Mainly for procurement purposes by Drug Purchasing Unit BRUNEI DARUSSALAM YEAR AND THE DATA SOURCE (the level of data e.g. facility or national level data) METHODOLOGY APPLIED and INSTITUTION/ GROUP RESPONSIBLE FOR DATA COLLECTION FREQUENCY OF DATA COLLECTION OUTPUT (e.g. selected antimicrobials, all antimicrobials, annual report etc) DATA UTILIZATION Since 2005 Sources of data: 2542 Hospitals located in 31 provinces in China 192 core member hospitals National level of data collection The Center for Antimicrobial Surveillance (CAS) which was founded by National Health and Family Planning Commission is responsible for data collection and analysis Member hospitals, especially core members, extract the data from their sites and submit to CAS Monthly • cost of antimicrobial therapy per inpatient • Rate of antimicrobial use per inpatient • Use of combination antimicrobial therapy among inpatients • Timing of the first antimicrobial prophylaxis in surgical patients • Antibiotic consumption and its costs among inpatients • Density of antimicrobial use among inpatients • Categories and classes of antimicrobial agents used among inpatients • Outpatient prescription CAS analysis the AMC data and publish the data on National level once a year The AMC data of each hospital is sent to be evolutional index of the quality of the hospital The CAS is mainly consistent of the tertiary hospitals, and lacks the secondary and community healthcare settings. Next step for CAS is to enroll more healthcare sites. CHINA YEAR AND THE DATA SOURCE (the level of data e.g. facility or national level data) METHODOLOGY APPLIED and INSTITUTION/ GROUP RESPONSIBLE FOR DATA COLLECTION FREQUENCY OF DATA COLLECTION OUTPUT (e.g. selected antimicrobials, all antimicrobials, annual report etc) DATA UTILIZATION Public Hospital (100% coverage) Department of Health Since January 2017 Include all antimicrobial s (ATC J01) Electronic dispensing data Wholesales supply data Ad- Hoc request Annually Quarterly report on broad spectrum antibiotics Report on all antibiotics; DDDs Continuous monitoring ASP Guidelines Monitor consumption trend by different sector HONG KONG SAR (China) YEAR AND THE DATA SOURCE (the level of data e.g. facility or national level data) METHODOLOGY APPLIED and INSTITUTION/ GROUP RESPONSIBLE FOR DATA COLLECTION FREQUENCY OF DATA COLLECTION OUTPUT (e.g. selected antimicrobials, all antimicrobials, annual report etc) DATA UTILIZATION Initiated in 2009 an biannual data collection (2011; 2013) Sales data from IMS -It is planned to use National Database of Health Insurance extracting the data from 2008 onwards AMR reference center DDD/1000 inhabitants/Day - Secondary data analysis Annually as secondary data analysis Oral broad-spectrum antibiotics Parenteral antibiotics Cephalosporin's - Fluoroquinolones - Macrolides Set targets for National Action Plan: • Decrease total AMC with 30% by 2020 • Decrease oral broad spectrum AMC with 50 % by 2020 • The first AMC report aimed to be issued in 2017 JAPAN YEAR AND THE DATA SOURCE (the level of data e.g. facility or national level data) METHODOLOGY APPLIED and INSTITUTION/ GROUP RESPONSIBLE FOR DATA COLLECTION FREQUENCY OF DATA COLLECTION OUTPUT (e.g. selected antimicrobials, all antimicrobials, annual report etc) DATA UTILIZATION -National level -Facility level Hospital (2001) MoH – 44 MOHE -3 Private -36 Mod- 3 Primary care(PC) (2015) MoH -225 (health clinics) Hospital: 26 IV antibiotics PC: 2 oral antibiotic Hospital: supply data PC: dispensing data Hospital: • DDD/100 patient admission • DDD/1000 patient days PC: DDD/100 patient visits MOH: teriary hospitals Private: >100 beds (ICU and all wards) PC: Clinic, Family Medicine Specialist Data collection: Manual (EXCEL) Data coverage: Hospital: 35% PC: 25 % (MOH) Private primary care GP: 0% Continuous surveillance, annual reporting Hospital: Group of antibiotics: 1. Cephalosporin's 2. Fluoroquinolones 3. Carbapenems 4. Glycopeptides 5. Polymyxins 6. Aminoglycosides 7. Penicillin's/ Betalactamasa Primary care (MOH) 1. Cefuroxime 2. Erythromycin Reporting: 1. State level, state infection and antibiotic committee 2. National level, National infection and antibiotic control committee National level antibiotic committee 1. National performance consumption (trending) 2. consumption by facility 3. Consumption by group of antibiotics 4. Top 5 high user facilities Way forward: Linking, integrating AMR – AMC MACAU SAR (China) YEAR AND THE DATA SOURCE (the level of data e.g. facility or national level data) METHODOLOGY APPLIED and INSTITUTION/ GROUP RESPONSIBLE FOR DATA COLLECTION FREQUENCY OF DATA COLLECTION OUTPUT (e.g. selected antimicrobials, all antimicrobials, annual report etc) DATA UTILIZATION Since 2011 Hospital level data collection DDD per 1000 occupied bed days Antibiotic Committee Controlled antibiotics: • Carbapenems • Colistin • Vancomycin DDD are reported annually Controlled antibiotics are reported monthly Quarterly reports provided to wards Reflects the real AMC situation to prescribers Increases the motivation for better prescribing patterns Shows the resistance patterns in the hospital MALAYSIA YEAR AND THE DATA SOURCE (the level of data e.g. facility or national level data) METHODOLOGY APPLIED and INSTITUTION/ GROUP RESPONSIBLE FOR DATA COLLECTION FREQUENCY OF DATA COLLECTION OUTPUT (e.g. selected antimicrobials, all antimicrobials, annual report etc) DATA UTILIZATION Antimicrobial community consumption report 2006-2014 (published in 2016) 2015-2016 (Published in 2017) Over the counter sales Prescription Dispensing Public/private hospital pharmacy PHARMAC • Holds prescribing information • For community TY E.S.R analyze data for MoH DDD and Pack rate usage by gender, age, ethnicity, location Limited range of antibiotics medication Bulk level data Biannual Annual report Continuous for data collection Continuous Continuous All antimicrobials Reports interactive format Pharmaceutical benefit listings Private hospital data by request Public/annual usage and/or individual project -National planning -Medical education -For information to other professional governing bodies: P.T.A.C ; Ministry for primary industry; MEDSAFE -To inform research e.g. investigating Ry by ethnicity PHARMAC managing access Organizational use currently A.M.S Can be complied at the national level NEW ZEALAND YEAR AND THE DATA SOURCE (the level of data e.g. facility or national level data) METHODOLOGY APPLIED and INSTITUTION/ GROUP RESPONSIBLE FOR DATA COLLECTION FREQUENCY OF DATA COLLECTION OUTPUT (e.g. selected antimicrobials, all antimicrobials, annual report etc) DATA UTILIZATION 2011-2013 (IMS DATA) 2014-2015 (IMS Data/ Drugstores, Hospital Data) 2016- On-going Through Subscription ATC/DDD Methodology Department Of Health Group Responsible for Data collection Yearly National AMC report including all antimicrobials -for national Antibiotic Guideline formulation -AMS programmes -IPC interventions PHILIPPINES Antimicrobial Consumption Monitoring as a Necessary Component of the Global Fights Against AMR Dr Ketevan Kandelaki Technical Officer Essential Medicines and Health Technology Division of Health Systems World Health Organization Regional Office for the Western Pacific The Workshop on Monitoring Antimicrobial Consumption in Select Western Pacific Countries 30-31 March 2017, Manila, Philippines Penicillin increased survival from 10% to 90% among patients with pneumonia & bacteria in their blood Resistance was foreseen early  Alexander Fleming, Nobel Lecture, December 1945 “The time may come when penicillin can be bought by anyone in the shops. Then there is the danger that the ignorant man may easily under dose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant” How much do we actually consume? Over decades, extensive concern & efforts to address AMR  1981 WHO Scientific Working Group on Antimicrobial Resistance report includes guidelines for the appropriate use of antibiotics) (WHO/BVI/PHA/ANT/82.1)  1959 WHO scientific group on antibiotics research recommends studies on resistance (The Work of WHO, 1959, Official Records of WHO no. 98) Extensive concern & efforts …  2001 WHO Global Strategy for containment of antimicrobial resistance (WHO/CDS/CSR/DRS/2001.2)  2011 World Health Day “Antimicrobial resistance: no action today, no cure tomorrow” policy package )  2012 The evolving threat of antimicrobial resistance Options for action 2014 WHO report “Antimicrobial resistance: global report on surveillance” • Survey data from 114 countries in all regions • Focus on selected hospital & community bacteria & antibiotic resistance patterns • Limitations • Surveillance gaps in many countries • No standard methodology • But provides best available global picture Annex 4. Presentations General Findings  Very high rates of resistance in all WHO regions for common bacteria (hospital and community acquired)  Under reporting of key concerns like Multi Drug Resistant Tuberculosis (MDR TB)  Significant gaps in surveillance & information Implication: Health  Longer illnesses & more deaths in all age groups o Europe 25,000 deaths per year o Thailand 38,000 deaths per year o USA ~2 million infections & > 23,000 deaths annually  Smaller safety net for patients o Surgery, injuries o Chronic conditions like cancer (therapy), diabetes, o Greatest impact in poorest countries (risk reversing MDG gains, SDGs) o Higher burden of infectious disease o Weaker systems o Less resource to fund more expensive alternatives Implications: Economies  Estimated costs in the US o Direct up to 20 billion USD per year o Indirect up to 35 billion USD per year  Review on Antimicrobial Resistance Chaired by Jim O’Neill (Feb 2015) projects that by 2050 o >10 million deaths per year globally (more than cancer) o Cumulative cost of 100 trillion USD Action Agenda on Antimicrobial Resistance in the Western Pacific Region endorsed at the sixty-fifth session of the WHO Regional Committee for the Western Pacific, 2014 3 Priority actions: Strengthen development and implementation of comprehensive national plans to contain AMR and raise awareness in multiple sectors Improve surveillance of AMR and monitoring of antimicrobial use Strengthen health system capacity to contain AMR Regional Action Agenda for AMR 2. Improve surveillance of AMR and monitoring of antimicrobial use Set up AMR surveillance data at a national and regional level Develop and strengthen laboratory capacity, establish harmonized standards and methodology and quality assurance for AMR surveillance testing Conduct a situational analysis of antimicrobial use in humans and animal husbandry and monitor antimicrobial use using harmonized standards and methodologies 1. Strengthen development and implementation of comprehensive national plans to contain AMR and raise awareness in multiple sectors Increase awareness, political leadership and financial commitment on AMR Increase AMR awareness and change attitudes and behavior of the public through education Establishing procedures for participation 3. Strengthen health system capacity to contain AMR Strengthen financing, procurement mechanisms and regulatory systems for equitable and universal access for all Generate and link AMR surveillance, AMC data, economic and epidemiological data to increase awareness and influence policy Increase political commitment to produce quality antimicrobials with a monitoring mechanisms and clear transparent guidelines for procurement Implement (AMS) programmes with national coverage to improve prescribing practices & responsible use of antimicrobials Develop and strengthen strategy and implantation of infection prevention and control programmes in health care facilities Health systems strengthening: framework for action CONTROL & REDUCE AMR Reduce infection Reduce inappropriate use of antimicrobials Institutional IPC Community IPC, WASH, food safety Antimicorbial stewardship Regulate access Improve prescribing Improve health literacy Monitor antimicrobial consumption KAP surveys AMR surveillance HIGH LEVEL POLITICAL ENGAGEMENT MULTISECTORAL COORDINATION Global Action Plan on AMR  In 2015, at the Sixty-eighth World Health Assembly (WHA), WHO Member States endorsed the Global Action Plan (GAP) on Antimicrobial Resistance Global Action Plan: key areas 1. Improve awareness and understanding of AMR Risk communica tion Education 2. Strengthen knowledge through surveillance and research National AMR surveillance Laboratory capacities Research and development 3. Reduce the incidence of infection IPC in health care Community level prevention Animal health: prevention and control 4. Optimize the use of antimicrobial medicines Access to qualified antimicrobi al medicines, regulation, AMS Use in veterinary and agriculture 5. Ensure sustainable investment in countering antimicrobial resistance Measuring the burden of AMR Assessing investment needs Establishing procedures for participation Antimicrobial resistance complexity  Multiple and complex causes of antimicrobial resistance • Misuse/overuse of antimicrobials in human and animal setting • Control, prevention of the dissemination of bacterial infections (in hospitals, in the community) • Lack of diagnostics • Hygiene ,Water, Environment contamination (run off from hospitals and pharmaceutical companies), Food safety • Lack of new antimicrobials • Need to work on all these domains at the same time to be effective Global Antimicrobial Resistance Surveillance System (GLASS) Goal To achieve a monitoring capacity to capture essential information on the global situation of antimicrobial resistance and inform decision making. Antimicrobial Resistance Surveillance Antimicrobial Consumption Monitoring WHO has developed a tool to monitor the AMC Main Objectives:  common methodology to the countries for AMC;  to provide reliable and comparable data over time ;  to provide information on the level and types of antimicrobials used;  methodology that can be integrated into a global WHO surveillance program. Secondary Objectives:  a methodology that can be integrated in national program on surveillance of antimicrobial use;  to provide comparable consumption data with animal and agricultural consumption data. AMC as a necessary component of the global fight against AMR  Data collected: o At local level can be used to communicate patterns to prescribers who can then accurately prescribe antimicrobials to patients. o At national and regional levels, data can be aggregated to show trends in resistance and correlations to antimicrobial consumption. o At the global level, monitoring can determine the source and contain the spread of emerging resistant microorganisms ESAC – Net results /Map  Human sector o In the European Union (EU) The European Surveillance of Antimicrobial Consumption Network (ESAC-Net) managed by The European Centre for Disease Prevention and Control (ECDC) o In the remaining part of the WHO European Region The WHO/EURO Antimicrobial Medicines Consumption Project managed by WHO/EURO  Veterinary sector o In the European Union The European Surveillance of Veterinary Antimicrobial Consumption (ESVAC) project managed by The European Medicines Agency (EMA) 3 European projects on surveillance of antimicrobial consumption Introducing WHO methodology on Monitoring AMC in WPRO  In August 2016, WHO organized a workshop on Antimicrobial Consumption Monitoring in Philippines; the first data generation was initiated in November 2016  In October 2016, WHO organized a workshop on adopting WHO methodology on AMC Monitoring. The training took place in Hanoi, Vietnam with the participation of representatives from Cambodia, Lao PDR and Viet Nam.  Viet Nam is initiating the actions on AMC monitoring.  Country capacity building on AMC – Cambodia, Lao PDR  Evaluation of antimicrobial use in Member States is necessary to establish a baseline and monitor progress towards rational antimicrobial use. The information generated can then be used to encourage policymakers to take action  Regular monitoring can help to assess the links between the use of antimicrobial agents and the development of resistant pathogens in humans and animals  examine trends in hospital antimicrobial use at state and national levels as the basis for larger-scale interventions to rationalise hospital antimicrobial prescribing  provide longitudinal antimicrobial usage data which may be used to demonstrate links between antimicrobial use and resistance The value of antimicrobial consumption data  AMC data can contribute to patient safety and quality of care  AMC data can be used to target antimicrobial stewardship interventions  AMC data can be used to obtain resources for antimicrobial stewardship activities  AMC data can be used to determine cost savings Thank you! Workshop on Monitoring Antimicrobial Consumption in Select Western Pacific Countries AMC Monitoring – an Important Component of Global Fight Against AMR Experiences in Europe – ESAC-Net / ECDC Vera Vlahović-Palčevski (ECDC consultant) On behalf of the Antimicrobial Resistance and Healthcare-Associated Infections (ARHAI) Programme, European Centre for Disease Prevention and Control Manila, Philippines, 30/31 March 2017 Conflict of interests - none to disclose Antimicrobial Resistance and Healthcare- Associated Infections (ARHAI) Networks  European Antimicrobial Resistance Surveillance Network (EARS-Net) (formerly EARSS, integrated in January 2010)  European Surveillance of Antimicrobial Consumption Network (ESAC-Net) (formerly ESAC, integrated in July 2011)  Healthcare-Associated Infections surveillance Network (HAI-Net) (formerly HELICS / IPSE, integrated in July 2008) http://www.ecdc.europa.eu/en/activities/diseaseprogrammes/ARHAI/Pages/surveillance_networks.aspx  The main mode for ECDC to interact with the 28 EU Member States, Iceland and Norway on scientific and technical work is within networks linked to Competent Bodies in the countries  In each country – Coordinating Competent Body (CCB) with a National Coordinator (NC) responsible for institutional contacts with ECDC – National Focal Points (NFPs) and Operational Contacts Points (OCP) responsible for strategic and operational collaboration on technical and scientific issues for specific diseases areas and public health functions. ECDC interactions with the Member States EARS-Net (antimicrobial resistance) Electronically, from laboratory information system (LIS) How are surveillance data collected? HAI-Net (healthcare-associated infections) In the wards, at patient bed ESAC-Net (antimicrobial consumption) Electronically, from medicines agencies / pharmacies / national insurance system ©Istockphoto/Sorapop ©Istockphoto/Sorapop Indicators Epidemic intelligence Coordination Ongoing surveillance Ad-hoc studies / projects Point prevalence survey Risk assessment : syst. reviews and guidance Communication Training ARHAI Programme: indicator-related actvities EARS-Net ESAC-Net HAI-Net Interactive database & Reports Point prevalence survey of HAI and antimicrobial use in acute care hospitals (2016 / 2017) Infection control indicators Antibiotic stewardship indicators Annual Joint Coordination Committees meeting (16/17 May 2017) Interactive database & Annual report Inter-agency report (2015/2017) •Objective: To monitor antimicrobial consumption in humans in the EU/EEA and progress towards prudent use of antimicrobials •Data collected on antimicrobial consumption in the primary care and in the hospital sector •Data reported by 28 EU Member States, Iceland and Norway •Data published in ESAC-Net reports: 2010, 2011, 2012, 2013- 2014 (in preparation) •Interactive database (on ECDC website): 1997-2015 European Surveillance of Antimicrobial Consumption Network (ESAC-Net) http://ecdc.europa.eu/en/activities/surveillance/ESAC-Net/Pages/index.aspx ESAC-Net interactive database (1997-2015) www.ecdc.europa.eu/en/activities/surveillance/ESAC-Net/database/Pages/database.aspx 7 different types of reports can be selected: - online connection to the TESSy database - always the latest data are displayed ESAC-Net interactive database (7 reports) www.ecdc.europa.eu/en/activities/surveillance/ESAC-Net/database/Pages/database.aspx 1 Country 2 Data source 3 Consumption rates 4 Distribution by overview overview by country antimicrobial groups 5 Geographical 6 Trends by 7 Quality indicators distribution country (community) WHO/HQ antimicrobial consumption tool (comparability with existing networks ?) ESAC-Net (ECDC) WHO/Euro AMC network Start July 2011 (2001‒11 EU funded ESAC project) 2011 Comparable reporting protocol Yes (based on ESAC project) Yes (based on ESAC-Net) National registry recommended mandatory Data sources Sales, reimbursement data or both Sales data only Data reported At the medicinal product level or as aggregated DDD Only at the medicinal product level Centralised data up- load (incl. validation) Yes (via TESSy) No (Excel files) Data availability Community, hospital sector Only total care data Members nominated by Competent Bodies Nat. Focal Points, Operational Contact Points (IT, epidemiology) Mainly leading pharmacists Outputs Public surveillance reports, public interactive data base LID 2014 publication, ECCMID 2014 abstracts European Surveillance of Antimicrobial Consumption Network (ESAC-Net) Country and sub-regional experiences in surveillance of antimicrobial use 1. Key factors - ESAC-Net 2017 ‒ ECDCs Strategic Plans - Disease Programme ARHAI ‒ Key indicators of the latest ESAC-Net data (2016) ‒ ESAC-Net data are used for rational use actions by stakeholders in the EU/EEA ‒ European Antibiotic Awareness Day (EAAD) utilizes ESAC-Net data 2. Current pilot of antimicrobial consumption (AMC) surveillance at hospital level 3. Developing AMC quality indicators and targets ESAC-Net – European Surveillance of Antimicrobial Use Network ECDC’s perspective SMAP, 2014‒2020 • Surveillance … will undergo substantial changes up to 2020. On the one hand the burden for deli ring data should be decreased, … requires a changing paradigm of surveillance at the European level, aligning indicator and event- based surveillance. • The SMAP contains outcome indicators and targets which refer to the achievement of strategic goals. ECDC Strategic plans and indicators: Strategic multi-annual programme (SMAP) Long-term surveillance strategy (LTSS) http://ecdc.europa.eu/en/aboutus/Key%20Documents/Strategic-multiannual-programme-2014-2020.pdf http://ecdc.europa.eu/en/publications/publications/long-term-surveillance-strategy-2014-2020.pdf LTSS, 2014‒2020 • Target 12: European surveillance data are used to monitor and evaluate prevention programmes against agreed indicators • In collaboration with Member States, the EC, ECDC supports the development of indicators to monitor implementation of Council Recommendations, European Commission …. Action Plans …. Main AMC indicator – community and hospital sector: DDD per 1000 inhabitants and per day 2014 (range: 10.6-34.0; EU/EEA 21.9) 2001 (range: 9.9-33.2; EU/EEA 20.5) Interactive database: http://ecdc.europa.eu/en/healthtopics/antimicrobial_resistance/esac-net-database/Pages/database.aspx ESAC-Net targets are not defined for this indicator Additional AMC indicator in the community No of packages per 1000 inhabitants and per day Consumption of antibiotics for systemic use (ATC J01, oral administration) in the community by antibiotic group in 21 EU/EEA countries, 2014 • No of packages ~ proxy for prescriptions • Only feasible in MS with the practise of dispensing whole packages per prescription Community: 12 consensus quality indicators (expressed as DDD per 1000 inhabitants and per day) Indicators on consumption of antibacterials for systemic use (ATC group level 3): J01 Consumption of antibacterials for systemic use J01C Consumption of penicillins J01D Consumption of cephalosporins J01F Consumption of macrolides, lincosamides and streptogramins J01M Consumption of quinolones Indicators on the relative consumption of antibacterials for systemic use (ATC level 4): J01CE_% Consumption of beta-lactamase-sensitive penicillins (J01CE) expressed as percentage of the total consumption of antibacterials for systemic use (J01) J01CR_% Consumption of combination of penicillins, including beta-lactamase inhibitor (J01CR) expressed as percentage of the total of J01 J01DD+DE_% Consumption of third- and fourth-generation cephalosporins (J01(DD+DE)) expressed as percentage of the total of J01 J01MA_% Consumption of fluoroquinolones (J01MA) expressed as percentage of the total of J01 Indicators on the ratio of broad - and narrow spectrum antibacterials: J01_B/N Ratio of the consumption of broad-spectrum penicillins, cephalosporins and macrolides (J01(CR+DC+DD+(F-FA01))) to the consumption of narrow-spectrum penicillins, cephalosporins and macrolides (J01(CE+DB+FA01)) Indicators on seasonal variation of antibacterials for systemic consumption: J01_SV Seasonal variation of the total antibiotic consumption (J01) of a 12-month period starting in July and ending the following June, expressed as percentage: [(DDD (winter quarters)/DDD (summer quarters)-1] x 100 J01M_SV Seasonal variation of quinolone consumption (J01M) of a 12-month period starting in July and ending the following June, expressed as percentage: [(DDD (winter quarters)/DDD (summer quarters)-1] x 100 Community: 12 quality consensus indicators For the quality indicators, low values of the indicator suggest better quality with the best quality being within the first quartile (i.e. p0 ≤ values ≤ p25). European Commission request for joint ECDC/EMA/EFSA report EMA: ESVAC network EFSA: AMR monitoring programme ECDC: EARS-Net FWD-Net ECDC: ESAC-Net A n ti m ic ro b ia l co n su m ti o n A n ti m ic ro b ia l re si st a n ce Joint Interagency Antimicrobial Consumption and Resistance Analysis (JIACRA) First report published Jan 2015 Second report planned for 2017 Indicators from the Joint Interagency Antimicrobial Consumption and Resistance Analysis (JIACRA) http://www.efsa.europa.eu/en/efsajournal/pub/4006 Comparison of consumption in humans and food-producing animals 15 (/26) countries: o consumption for animals < consumption for humans 3 (/26) countries: o consumptions were similar for animals and humans 8 (/26) countries: o consumption for animals > consumption for humans Total consumption in 2012 (expressed in mg/kg of estimated biomass) In humans 116.4 mg/kg (range: 56.7 – 175.8 mg/kg) In animals 144.0 mg/kg (range: 3.8 – 396.5 mg/kg) EAAD utilizes ESAC-Net data http://ecdc.europa.eu/en/EAAD/Pages/Home.aspx European Surveillance of Antimicrobial Consumption Network (ESAC-Net) 2. Current pilot of AMC surveillance at hospital level ‒ Objectives and basic elements ‒ Possible indicators and road map Pilot survey for a hospital-based protocol Objectives Sustainable hospital-based AMC surveillance in EU hospitals using hospital activity denominators • EU/EEA level: standardised AMC data - link with AMR and HAI data • National level: comparable data - framework for AMC surveillance • Hospital level: stimulus for surveillance /local stewardship programmes Actors • ECDC: collating, analysing, reporting the data at EU level. Supporting national teams in creating individual hospital reports • National team: collating hospital data -> ECDC; analysing, reporting data at national level, providing feedback to each participating hospital • Hospital Team: collecting, validating data -> national team http://www.slideshare.net/balbiger/ntiobiotc-stewardship-indicators ESAC-Net DP ARHAI tasks of WP 2016/17 for developing indicators and targets • Adding ESAC-Net surveillance data to the ECDC Surveillance Atlas for Infectious Diseases* Requests by the European Commission • Proposals for EU guidelines on the prudent use of antimicrobials in humans, published in Feb. 2017 These proposed guidelines underwent a public consultation process (http://ecdc.europa.eu/en/publications/Publications/EU-guidelines-prudent-use-antimicrobials.pdf) • Joint inter-agencies scientific opinion (ECDC, European Food Authority (EFSA) and European Medicines Agency (EMA)) Proposal for simplified indicators for AMR and antimicrobial consumption in the human and veterinary sector (Deadline 30 Sept. 2017) *: http://ecdc.europa.eu/en/data-tools/atlas/Pages/atlas.aspx • Indicators are provided in a comparative mode for the community (primary care) and the hospital sector incl. EU/EEA population weighted means • Current indicators are not linked to specific targets at EU level • DP ARHAI work plan for 2016 / 2017 foresees developing quality indicators which shall be stable over time and easy to understand • A pilot hospital-based protocol may provide options for new indicators • ARHAI DNCC meeting on 16-17 May 2017, Stockholm -> to discuss on indicators and potential targets (WHO/HQ will be invited as an observer) Summary Thank you very much ! Regional Strategies on Antimicrobial Resistance in Western Pacific Region Dr Socorro Escalante Division of Health Systems Essential Medicines and Health Technologies Unit WHO Regional Office for the Western Pacific The Workshop on Monitoring Antimicrobial Consumption in Select Western Pacific Countries 30-31 March 2017, Manila, Philippines Action Agenda on Antimicrobial Resistance in the Western Pacific Region endorsed at the sixty-fifth session of the WHO Regional Committee for the Western Pacific, 2014 3 Priority actions: Strengthen development and implementation of comprehensive national plans to contain AMR and raise awareness in multiple sectors Improve surveillance of AMR and monitoring of antimicrobial use Strengthen health system capacity to contain AMR Global Action Plan on AMR • In 2015, at the Sixty- eighth World Health Assembly (WHA), WHO Member States endorsed the Global Action Plan (GAP) on Antimicrobial Resistance Global Action Plan: key areas 1. Improve awareness and understanding of AMR Risk communication Education 2. Strengthen knowledge through surveillance and research National AMR surveillance Laboratory capacities Research and development 3. Reduce the incidence of infection IPC in health care Community level prevention Animal health: prevention and control 4. Optimize the use of antimicrobial medicines Access to qualified antimicrobial medicines, regulation, AMS Use in veterinary and agriculture 5. Ensure sustainable investment in countering antimicrobial resistance Measuring the burden of AMR Assessing investment needs Establishing procedures for participation Progress on National Action Plans on AMR 1. Completed (9): • Australia • Cambodia • China • Cook Islands • Fiji • Japan • Philippines • Republic of Korea • Viet Nam 2. In progress (11): • Hong Kong SAR (China) • Lao PDR • Mongolia • Papua New Guinea • New Zealand • Samoa • Singapore • Tonga • Vanuatu 6 Framing AMR as a development agenda UHC ‘One Health’ SDGs Containment of AMR as a Development Agenda UHC ‘One Health’ ‘One Health’ – a multisectoral approach to AMR "One Health" approach • In May 2015, Member States from World Organisation for Animal Health (OIE) adopted a resolution for combatting antimicrobial resistance • In June 2015, Food and Agriculture Organization (FAO) adopted a similar resolution • "One Health" approach • Tripartite collaboration between the 3 agencies Antimicrobials are fundamental components of all health systems Source: Antimicrobial resistance – a threat to the World’s Sustainable Development. Jasovsky et al. 2016. Dag Hammarskjold Foundation. AMR strikes hardest on the poor – treatment of resistant infections is more expensive Untreatable infections in animals threatens sustainable food production for our growing population Antibiotic residues from hospitals, pharmaceutical companies and agriculture contaminates water Cost of AMR is predicted to be US$100 trillion by 2050 Balance access, innovation and conservation of antimicrobials to contain AMR All of which require multi- stakeholder partnerships AMR is a Development Agenda - SDGs UHC ‘One Health’ SDGs GOVERNANCE OF AMR as a development agenda National, Regional and Global actions to contain AMR UHC ‘One Health’ SDGs GOVERNANCE OF AMR as a development agenda Enhance R&D (new antibiotics and diagnostics) National Regional Global Harmonization of surveillance and regulations National Action Plan on AMR National, Regional and Global actions to contain AMR Health systems strengthening: framework for action CONTROL & REDUCE AMR Reduce infection Reduce inappropriate use of antimicrobials Institutional IPC Community IPC, WASH, food safety Antimicorbial stewardship Regulate access Improve prescribing Improve health literacy Monitor antimicrobial consumption KAP surveys AMR surveillance HIGH LEVEL POLITICAL ENGAGEMENT MULTISECTORAL COORDINATION Health System Attributes Key issue to be addressed for AMR Actions to address AMR Equity Is there equitable access to measures to prevent and treat infections? Reduce burden of infection Ensure access to appropriate antibiotics Balance access and restrictions Quality Are antimicrobials of sufficient quality and used appropriately? Regulate and assure quality Train health workers continuously Efficiency Are there unnecessary expenses from overuse? Is there a need to improve prescribers behaviours? Alter financial incentives to correct overuse Monitor prescribers / hospital performance and antibiotic consumption. Accountability Are users and providers adequately informed about how to use antimicrobials and reduce the risk of resistance? Provide information on surveillance of AMR, health care associated infections and appropriate treatments compared to local or national antibiotic guidelines Sustainability and resilience How can long-term efficacy of antimicrobials be preserved? Strengthen public health services Build social coalitions with public and private sectors and the community Invest in R&D for new drugs and diagnostics 14 Building resilient health system to contain AMR - UHC Thank you! Dr Socorro Escalante escalantes@who.int www.wpro.who.int/topics/drug_resistance/en/ 15 HIS/EMP | Communications Planning HIS | EMP WHO Antimicrobial Consumption Methodology Arno Muller WHO Essential Medicines and Health Products Workshop on Monitoring Antimicrobial Consumption in Select Western Pacific Countries 30-31 March 2017, Manila, Philippines HIS/EMP | Communications Planning HIS | EMP Objectives • Main Objectives: – to provide a common methodology to the countries for collecting and reporting national antimicrobial consumption data; – to provide reliable and comparable national consumption data over time and between countries; – to provide information on the level of use and types of antimicrobials for policy makers and prescribers; – to provide a methodology that can be integrated into a global WHO surveillance program. • Secondary Objectives: – to provide, as part of a national package, a methodology that can be integrated in national program on surveillance of antimicrobial use and more generally in a national program on antimicrobial resistance; – to provide comparable consumption data with animal and agricultural consumption data. HIS/EMP | Communications Planning HIS | EMP Principle • Annual collection of data on antimicrobial consumption at national level • Using the ATC/DDD methodology • In the hospital and community sectors • In both public and private sectors HIS/EMP | Communications Planning HIS | EMP Healthcare sectors • Community sector – Primary care – General practitioners, nurses, pharmacists… – External consultation in hospital – In general, antimicrobials are delivered by pharmacies to the patients • Hospital sector – Secondary, tertiary care – Hospitalised patients – In general, antimicrobials are delivered by the hospitals to the patients HIS/EMP | Communications Planning HIS | EMP Data sources Throughout the pharmaceutical value chain • – In theory • • from production to patient data • – Practically • • import/local production/donations NGOs/International programmes (Global Fund) • • central drug stores / private wholesalers • • community pharmacies/hospital pharmacies • • Insurance funds/companies • • market research company (IMS Health) Compromise between the level of details desired and the level of resources available Possibility of using different data sources • – Import + production for domestic market • – Central drug store + private wholesalers • – Make sure to avoid counting the same antimicrobial more than once! HIS/EMP | Communications Planning HIS | EMP Antimicrobials • Antimicrobials to be collected: • – Systemic use antimicrobials (mandatory/optional): • • Antibacterials (J01) • • Antimycotics and antifungals (D01BA & J02) • • Drugs again tuberculosis (J04) • • Drugs against malaria (P01B) • • Antivirals(J05) • – Some other substances: • • Antiinfectives for intestinal tract (A07AA) • • Antiprotozoals (P01AB) HIS/EMP | Communications Planning HIS | EMP Consumption data Data to be collected • – Register of antimicrobial medicines • • ATC code, route of administration • • Content (g, DDD) per package • – Number of packages sold Consumption • – Calculation • • Content per package × number of packages • • At substance level per route of administration • – Metrics for reporting • • DDD per 1000 inhabitants per day • • mg/kg human biomass HIS/EMP | Communications Planning HIS | EMP Examples: ESAC-Net http://ecdc.europa.eu/en/healthto pics/antimicrobial _resistance/esac- net-database/Pages/database.aspx HIS/EMP | Communications Planning HIS | EMP Expanding surveillance throughout Europe • Two projects: • ESAC-Net • EURO/AMC • Two compatible methodologies • Enabling data comparison in the whole European Region Lancet Infectious Diseases 2014 Published Online, March 20, 2014 http://dx.doi.org/10.1016/S1473- 3099(14)70071-4 HIS/EMP | Communications Planning HIS | EMP Use of consumption data • Correlation with resistance data Antimicrobial drug use and resistance in Europe Van de Sande-Bruinsma et al. Emerg Infect Dis. 2008 HIS/EMP | Communications Planning HIS | EMP Use of consumption data • Evaluating awareness campaigns Evaluation of the Impact of a Public Campaign for a More Rational Use of Antibiotics in Belgium BAURAIND et al. ICAAC 2001 HIS/EMP | Communications Planning HIS | EMP Use of consumption data • Identifying new pattern of use ESAC-Net interactive database HIS/EMP | Communications Planning HIS | EMP THE WHO MONITORING SYSTEM HIS/EMP | Communications Planning HIS | EMP National level Setting-up National Team • – In charge of • • developing the monitoring system • • managing the monitoring system • • collecting, analysing and reporting consumption data including developing and maintaining the antimicrobial register • • Submitting data to WHO • • Being the focal point for antimicrobial use • – Under the responsibility of the Ministry of Health • • Some tasks could be done by other institutions (e.g: universities) • – Having links with • • National Antibiotic Committee • • Team responsible for surveillance of antimicrobial resistance • • Team(s) responsible for the animal, agricultural sectors HIS/EMP | Communications Planning HIS | EMP Submission of data to WHO National team: • – Collect data at national level from local providers • – Validate and analyse data at national level • – Submit data to WHO • – Publish/Report data at national level WHO Regional Office: • – Collect data submitted by countries • – Validate and analyse data at regional level • – Confirm data with countries • – Publish/Report data at regional level WHO Head-quarters: • – Collect data submitted by Regional Offices • – Confirm data with Regional Offices • – Analyse data at global level • – Publish/Report data at global level HIS/EMP | Communications Planning HIS | EMP WHO web site • Innovation, access and use http://www.who.int/medicines/access/en/ • Surveillance of antimicrobial use AMC methodology http://www.who.int/medicines/areas/rational_ use/AMU_Surveillance/en/ HIS/EMP | Communications Planning HIS | EMP Questions ? HIS/EMP | Communications Planning HIS | EMP Use of antimicrobials in hospitals Arno Muller WHO Essential Medicines and Health Products Workshop on Monitoring Antimicrobial Consumption in Select Western Pacific Countries 30-31 March 2017, Manila, Philippines HIS/EMP | Communications Planning HIS | EMP Surveillance of antimicrobial use • Complex issue • Different approaches • – National antimicrobial consumption • • Based on sales of antimicrobial medicines • • Complete data • • Quantitative information • – Point prevalence survey on use • • Based on prescription/purchase of antimicrobial medicines • • Sample data • • Qualitative data HIS/EMP | Communications Planning HIS | EMP Objectives • To measure antimicrobial use and to provide qualitative information on the prescription • Patient based data • Link to indication, guidelines, antibiotic stewardship measures HIS/EMP | Communications Planning HIS | EMP Methodology (1/2) • Point prevalence survey • – At one point in time • Theorically, one day • Practically, few days to 3 weeks • All inpatients – With or without antibiotics – Risk factors (age, gender…) HIS/EMP | Communications Planning HIS | EMP Methodology (2/2) • For patients on antibiotics – Antibiotic: • substance, route of administration, dose – Indication, diagnosis – Resistance – Antibiotic stewardship • Compliance to guidelines • Stop review, de-escalation… HIS/EMP | Communications Planning HIS | EMP ESAC PPS • PPS in Europe, 2009 • 172 hospitals Proportion parenteral antimicrobials. monotherapy and combination therapies HIS/EMP | Communications Planning HIS | EMP ARPEC PPS • PPS in children in 2012 • 226 hospitals Proportion of prescribed antibiotics (ATC4 level) among children (>1 month) by region HIS/EMP | Communications Planning HIS | EMP ECDC HAI-Net PPS • European CDC carried out a survey in 30 countries between 2011 and 2012 • >1000 hospitals included • 2 objectives: – Prevalence of healthcare associated infections – Prevalence of use of antibiotics • http://ecdc.europa.eu/en/healthtopics/Healthcare- associated_infections/point-prevalence- survey/Pages/Point-prevalence-survey.aspx HIS/EMP | Communications Planning HIS | EMP Diagnosis HIS/EMP | Communications Planning HIS | EMP Risk factors HIS/EMP | Communications Planning HIS | EMP Conclusion • Allows to assess quality of prescribing – To improve use of antimicrobials • Complements monitoring of antimicrobial consumption at national level • Very resource demanding activities to scale up at national level – Cannot be done on annual basis • WHO will publish a protocol for point prevalence survey on antibiotic use in hospitals in Spring 2017 HIS/EMP | Communications Planning HIS | EMP WHO methodology • WHO is developing a protocol for point prevalence surveys on antimicrobial use in hospitals • Objectives – To provide comparable and reliable baseline data on the use in hospitals worldwide – To serve as a basis for further surveys for AMS and IPC • To be released Spring 2017 • Global WHO surveys at regular interval? HIS/EMP | Communications Planning HIS | EMP WHO methodology in the community • To complement hospital surveys, WHO is working on a protocol for surveys on antimicrobial in the community • 3 layers: – Household survey – Prescriber survey (GP, clinics, dentists, A&E departments,…) – Dispenser survey (pharmacies…) • To be released in 2017 HIS/EMP | Communications Planning HIS | EMP Questions ?

ANTIMICROBIAL CONSUMPTION ACTIVITIES IN THE PHILIPPINES DR. IRENE F. FARIÑAS Pharmaceutical Division Office for Policy and Health Systems Department of Health 2 Philippine Antimicrobial Consumption Report (2011-2013) Presented in the 1st Philippine AMR Summit Training on WHO Methodology on AMU Monitoring (ATC/DDD) Input of the 2014-2015 data in the WHO Monitoring Tool Timeline: AMC in the Philippines 2015 2016 2017 3 Philippine Antimicrobial Consumption Report (2011-2013) Operational definition • Antimicrobial drug consumption – amount (units, weights or DDDs) of antimicrobial drug distributed or sold from manufacturers to wholesalers and retailers (community pharmacies and hospitals) and those allocated to the DOH National Health Programs Scope and Delimitation • Data sources: IMS Health Philippines, ARSP 2013, DOH National Health Programs • Excluded direct patient utilization measures Major findings: • Trends in antimicrobial consumption • Relationship of antimicrobial consumption and resistance 4 Source: IMS Health (NSA, June 2015) Philippine Antimicrobial Consumption Report (2011-2013) • Data collected do not represent the antimicrobials consumed on the individual or patient level. 5 Philippine Antimicrobial Consumption Report (2011-2013) Antimicrobial Consumption by Drug Class (2011-2013) Drugstore Cefuroxime- highest weights and increasing resistance (Klebsiella) Ciprofloxacin- very high resistance against Neisseria Hospital Increasing consumption of cefuroxime also correlated with high rates of resistance of Klebsiella. 6 Monitoring of antibiotic use in hospitals  Methods Guide – developed with the support of WHO; antibiotic use measured as DDD/1000 patient days from dispensing data of hospitals  Instrument - Excel- based, ready for roll-out to hospitals 7 Training on WHO Methodology on AMU Monitoring • August 2016 • Resource Speakers: • WHO Geneva and WPR • Attendees: • DOH Pharmacists • Output: • Generation of the Philippine AMU Monitoring Report using sales data 8 Input of the 2014-2015 data in the WHO Monitoring Tool • 2014-2015 sales data incorporated in the WHO Monitoring Tool 9 Gaps and Challenges • Absence of baseline data • Validity of sales data with the Philippine FDA • Difficulty in gathering data on the patient level • Inability to account sales data from “informal” drugstores • Non-adherence of patients to therapy was not addressed • No existing platform to correlate the AMC/AMU data with AMR 10 Next Steps • Conduct of Point Prevalence Survey (PPS) • Training of hospitals on the use of AMC monitoring tool • Publication of antimicrobial consumption data annually GAPS AND CHALLENGES Dr Hajah Rosmonaliza Haji Awang Asli, MBBS, MRCP(UK) Infectious Diseases Consultant RIPAS Hospital 1 Temburong District: 1 Hospital 1 Health Centre Brunei-Muara District: 1 Hospital 10 Health Centres 2 Travelling Clinics Tutong District: 1 Hospital 4 Health Centres 2 Travelling Clinics Belait District: 1 Hospital 3 Health Centres 3 Travelling Clinics Estimated Total Population: 423,200 (2015) (WHO Global Observatory) www.moh.gov.bn 2  Dispensing Records Government community health centres’ and hospitals’ pharmacy dispensary store pharmacy dispensaries  In all 4 districts 3  Total quantity transferred out for immediate use or for supply to wards in a year  Based on formulation of the drug  Total no. of capsules/tablets  Total no. of vials of injectables  Total no. of bottles of syrup medicines 4 Antibiotic Unit Total Quantity 2014 Total Quantity 2015 Total Quantity 2016 Amoxycillin 250mg capsule Capsule 817,529 808,704 765,068 Amoxycillin 125mg/5 ml syrup Bottle of 100ml 46,086 33,934 23,988 Ampicillin 500mg injection Vial 3,273 4,422 3,165 Co-amoxiclav 600mg injection Vial 25,892 5,482 4,170 Co-amoxiclav 1.2g injection Vial 47,939 38,567 62,580 5  Reference guide for drug purchasing section to procure and estimate distribution of medicines  Data can be disaggregated to community (health centres) or hospital usage  Usage trend and comparisons between facilities 6  Data collection not using global/international ATC/DDD methodology  Can only be utilised locally  Cannot be used for comparison with healthcare facilities in other countries  Training on ATC/DDD methodology required 7  Data reporting not mandated  not readily available  produced only when required No designated staff  Done by ‘available’ staff  Data not linked to antimicrobial resistance data  Not used to guide prescribing practices 8 Manpower  multitasking  no designated staff  Lack of ATC/DDD methodology ‘know-how’  Lack of proper, standardised database 9  Meet with Pharmacy Department  Set up a Surveillance Program on AMC according to ATC/DDD methodology  Have designated staffs  Get ATC/DDD methodology training/technical support from WHO  List down available antimicrobials according to ATC  Consider mandatory reporting to Statistics Unit, MOH and to include the data into yearly Health Information Booklet  To discuss with Senior Management Team, MOH  Readily available, standardised, comparable data 10 NORAINI MOHAMAD D E P UT Y D IR E C TO R P H A R M A C Y P R A C T IC E & D E V E LO P M E NT D IV IS IO N M INIS T RY O F H E A LT H M A L AY S IA n o r a i n i m o h d @ m o h . g o v. m y ANTIMICROBIAL CONSUMPTION (AMC) : COUNTRY SITUATIONAL ANALYSIS – CASE STUDY FROM MALAYSIA Malaysia’s Population : 31,993,756 millions (March 10, 2017 – 1038am) No. of healthcare facilities Hospital Primacy care Public MOH : 139 (Mac 2017) MOHE : 3 MOD : 3 3702 (Mac 2017) Private 195 (June 2016) 7349 (June 2016) Community Pharmacy 1854 (2011) MEDICINES SUPPLY & DISTRIBUTION SYSTEM IN MALAYSIA ANTIBIOTIC CONSUMPTION AND SURVEILLANCE ACTIVITIES IN MALAYSIA 1. National Surveillance on Antibiotic Utilisation • Hospital & Primary care 2. Point Prevalence Survey • Hospital & Primary care 3. Protocol on AMS Program in Healthcare Facilities 2014 4. National Antibiotic Guideline 2014 5. Antibiotic Working Committee PSD,MOH AMC MAPPING STUDY TEAM M O H • Mdm. Noraini Mohamad • Mdm. Hazimah Hashim • Mdm. Mardhiyah Kamal U SM • Prof. Dr. Mohamed Azmi • Mr. Ho Rhu Yann • Ms. Rabia Hussain • Mr. Omar • Mr. Furqan • Mr. Ashutosh • Mr. Ahmed Si te C o o rd in at o rs • Mr. Tan Chee Chin (HSA) • Ms. The Hwei Lin (HKL) • Mr. Chong Meng Fei (HPP) • Ms. Ng Poh Lee Geetha (HTAR) OBJECTIVES OF AMC MAPPING  To assess the pattern of use of antimicrobials at four major hospitals in the states of Penang, Selangor, Kuala Lumpur and Johor.  To identify the gaps in the existing hospital practice, facilities, support and feedback mechanism and policies in monitoring the use of antimicrobials. AMC = antimicrobial consumption Penang Hospital General Kuala Lumpur Hospital Tengku Ampuan Rahimah, Klang Sultanah Aminah Hospital , JB Peninsular Malaysia METHODOLOGY : STUDY SITE 4 major hospitals METHODOLOGY Period study Retrospective Jan-Dis 2016 for procurement and drug supply data from store Prospective (Consumption Data) 3-days PPS in OPDs and IPDs on three alternate days, 27 Feb 2017- 3 Mac 2017 Study tool Validated questionnaire Data collection form : 9 forms Section A, B, C, D, E, F, G, H, I Inclusion criteria Oral and parenteral Antibiotic IPD Rx from general medical wards and general surgical wards Prescription from OPD Prescription during office hours 8am- 5pm Exclusion criteria Anti-TB, antifungal, antiviral, antiprotozoal and antiparasite Peadiatrics, CCU/ICU, oncology, radiotherapy, gynecology, rehabilitation and palliative care wards PPS : Point Prevalence Survey OPD : Outpatient Pharmacy Department IPD : Inpatient Pharmacy Department TB : Tuberculosis DATA COLLECTION FORM •Section A : Facility information and statistics •Section B : Product Level Data (procurement Jan-Dis 2016) •Section C : Product Supply to Substore (OPD and IPD) •Section D : Consumption data for OPD •Section E : Consumption data for IPD (Adult General Medical and Surgical Wards) •Section F : Facility based questionnaires •Section G : Policy and Practice data •Section H : Monitoring and feedback data •Section I : Intervention towards improving antimicrobial prescribing OPD : Outpatient Pharmacy Department IPD : Inpatient Pharmacy Department RESULTS : PRESCRIBING PATTERN & ANTIBIOTIC CONSUMPTION Hospital No. of Bed Total Drug Expenditure (in MYR) Expenditure on Antibiotics (in MYR) % Expenditure on Antibiotics Oral Parenteral Total HKL 2131 134,968,019.55 3,402,624.83 4,791,414.13 8,194,038.96 6.07 HPP 1136 77,302,062.85 1,192,546.05 2,208,707.72 3,401,253.77 4.40 HSA 1206 60,190,891.36 1,485,357.96 2,513,965.10 3,999,323.06 6.64 HTAR 1194 44,876,779.16 661,544.17 1,535,198.22 2,196,742.39 4.90 Most oral antibiotics supplied from hospital stores to OPD year 2016 1. Penicillin (30%-70%) 2. Cephalosporin(5.6% - 20.0%) 3. Penicillins+ beta-lactamase inhibitors (4.9 % -22.2%) 4. Macrolides (2.5% -14.8%) 0 20 40 60 80 Penicillins Macrolides Cephalosporins Penicillins + beta… Tetracyclines Others Sulphonamides +… Quinolones Lincosamides Oxazolidonones % % oral antibiotics supplied from hospital stores to OPD year 2016 H.TAR H.SA H.PP H.KL OPD : Outpatient Pharmacy Department Most parenteral antibiotics supplied from hospital stores to IPD year 2016 1. Cephalosporins (21.2% -37%) 2. Penicillins + beta-lactamase inhibitors (19% -31.55) 3. Penicillins (14.7% -31.6%) IPD : Inpatient Pharmacy Department 0.00 10.00 20.00 30.00 40.00 Cephalosporins Penicillins Penicillins + beta… Others Carbapenems Aminoglycosides Glycopeptides Quinolones Tetracyclines Sulphonamides +… Cephalosporins + beta… Lincosamides Macrolides Polymixins Oxazolidonones % of parenteral antibiotics supplied from hospital stores to IPD year 2016 H.TAR H.SA H.PP H.KL Most oral antibiotics supplied from hospital stores to IPD year 2016 1. Penicillins(5.7% - 60.5%) 2. Cephalosporins (8.4% - 39%) 3. Penicillins + beta-lactamase inhibitors (11.2% -20%) IPD : Inpatient Pharmacy Department 0.00 20.00 40.00 60.00 80.00 Penicillins Cephalosporins Penicillins + beta lactamese inhibitors Quinolones Sulphonamides + DHFR inhibitors Tetracycline Others Macrolides Lincosamides Oxazolidonones % of oral antibiotics supplied from hospital stores to IPD year 2016 H.TAR H.SA H.PP H.KL HKL HPP HSA HTAR Total number of prescriptions received in the OPDs 2114 4724 4220 3900 Total number of prescriptions containing antibiotics 252 191 224 84 Percentage of prescriptions containing antibiotics 11.9% 4.0% 5.3% 2.2% Total number of prescriptions containing more than 1 antibiotics in a single prescription 46 0 20 0 Percentage of prescriptions containing more than 1 antibiotics in a single prescription 18.25% 0% 8.92% 0% 0 50 100 150 200 250 300 N u m b e r o f U n it Most used oral antibiotic categories dispensed by OPDs in 3 days. H.TAR H.SA H.PP H.KL Most used oral antibiotics dispensed by OPD 1. Penicillins (32.4%) 2. Penicillins + beta-lactamase inhibitors (30.1%) 3. Tetracyclines (15.8%) Top 3 parenteral antibiotics dispensed by IPD 1. Cephalosporins (27.1%-58.0%) 2. Penicillins + beta-lactamase inhibitors (15.5%-51.3%) 3. Others (4.3%-12.9%) 0 500 1000 1500 Cephalosporins Penicillins + beta-… Others Carbepenems Penicillins Glycopeptides Aminoglycosides Quinolones Macrolides Lincosamides Sulphonamides + DHFR… Cephalosporins + beta-… Polymixins Number of Unit Most used parenteral antibiotic categories dispensed by IPDs in 3 days H.KL H.PP H.SA H.TAR 0 50 100 150 Penicillins + beta-lactamese… Cephalosporins Macrolides Others Penicillins Quinolones Sulphonamides + DHRF… Lincosamides Tetracyclines Oxazolidonones Number of Unit Most used oral antibiotic categories dispensed by IPDs in 3 days H.KL H.PP H.SA H.TAR Top 3 oral antibiotics dispensed by IPD 1. Penicillins + beta-lactamase inhibitors (1.8%-43.8%) 2. Cephalosporins (6.3%-26.7%) 3. Macrolides (3.3%-53.6%) GAPS IN MONITORING OF ANTIBIOTICS USE . Paper-based Prescription & Documentations . No fulltime dedicated staffs for AMS activities for ensuring appropriate antimicrobial use. AMS team need to be well established to play their role in implementing AMS activities . All facilities do not have IT capability to support the needs of AMS activities . Policies & practices were adjusted according to feasibility of facilities GAPS IN MONITORING OF ANTIBIOTICS USE . Lack of education outreach through academic detailing to prescriber. Mostly provided by verbal. National & local antibiotic guideline also not actively promoted to staffs . Consumption of oral antimicrobials were not strictly monitored or not documented

Experiences from Japan on antimicrobial consumption monitoring Hiroyuki NODA M.D. Ph.D. Director of Office for AIDS control Tuberculosis and Infectious Disease Control Division Health Service Bureau, Ministry of Health, Labour and Welfare March 30th, 2017 Secular trend of cause specific mortality rate in Japan 0 50 100 150 200 250 300 350 1947 1952 1957 1962 1967 1972 1977 1982 1987 1992 1997 2002 2007 2012 結核 悪性新生物※ 糖尿病※ 高血圧性疾患※ 心疾患※ 脳血管疾患※ 肺炎 肝疾患※ 不慮の事故 自殺 Mortality rate Per 100,000 persons Malignant neoplasm 293.5 Heart disease 157.0 Cerebrovasular disease 91.1 Pneumonia 95.4 Accident 31.1 Suiside 19.5 Liver disease 12.5 TB 1.7 Vital Statistics (1947-2014) Mortality rate in 2014 Cross-national Comparison of Antibiotic Use for Humans In Japan, the total sales volume of antibiotics is not high; however, the proportion of use of the three major types of broad-spectrum antibiotics (third generation cephalosporins, quinolones, and macrolides) is extremely high compared to other countries. 0 5 10 15 20 25 30 35 Japan Netherlands Estonia Latvia Hungary Austria Sweden Slovenia Germany Lithuania Denmark Norway Czech Rep. Bulgaria Finland Poland Slovakia United Kingdom Spain Croatia Iceland Malta Portugal Ireland Italy Luxembourg France Cyprus Belgium Romania Greece Average daily antibiotics sales per 1,000 population セファロスポリン、その他のβラクタム キノロン マクロライド等 ペニシリン その他 Cross-national comparison of sales of antibiotics in the medical field (2010 data for Europe, 2013 data for Japan) Japan Sales (use) of antimicrobials 3 major types of broad-spectrum antibiotics 2 Cephalosporins and other beta-lactums Quinolones Maclorides, etc. Penicillins Other antibiotics Trend in number of newly marketed antibiotics by ingredients in Japan 3 23 22 5 2 3 3 4 2 5 8 4 1 1 2 8 7 6 8 5 14 19 0 10 20 30 40 50 60 2006-2015 1996-2005 1986-1995 1976-1985 1966-1975 Cephalospirins and other beta-lactams Macrolides Quinolones Penicillins The others 34 2 41 9 18 29 10 36 51 10 Yagisawa M. Antibiotics & Chemotherapy. 2016; 32:25-30. No. of ingredients  Number of newly marketed antibiotics was decreased from 51 ingredients (1976-1985) to 9 ingredients (2006-2015).  Among antibiotics with broad spectrum, the respective number was decreased from 29 to 2. 3 antibiotics with broad spectrum "National Action Plan on Antimicrobial Resistance (AMR) (2016–2020)" (Outline) •1.1 Promote public awareness-raising activities to improve public knowledge and understanding of AMR •1.2 Promote education and training on AMR of professionals involved in related fields 1. Public awareness and education •2.1 Strengthen the surveillance of antimicrobial resistance in healthcare and nursing care •2.2 Monitor the trend of the antimicrobial use at medical institutions •2.3 Strengthen surveillance and monitoring in the fields of veterinary medicine, livestock production, and aquaculture •2.4 Standardize methods of laboratory testing and strengthen testing functions of antimicrobial resistance at clinical, commercial, and public health laboratories •2.5 Implement integrated one health surveillance including humans, animals, food, and the environment 2. Survey and monitoring •3.1 Infection Prevention and Control in Healthcare and Nursing Care and Promotion of Regional Cooperation •3.2 Promote Infection Prevention and Control in Livestock Production, Aquaculture, Veterinary Medicine and Food Chain •3.3 Strengthen the Outbreak Response Capacity against Antimicrobial-resistant Infections 3. Infection prevention and control •4.1 Promote Antimicrobial Stewardship at Medical Institutions •4.2 Ensure Prudent Use of Antibiotics for Animals in the Field of Livestock Production, Aquaculture and Veterinary Medicine 4. Appropriate use of antimicrobial agents •5.1 Promote Research to Elucidate the Mechanism of the Emergence and Transmission of Antimicrobial Resistance and its Socioeconomic Impact •5.2 Promote Research on Public Awareness/Education on Antimicrobial Resistance, Infection Prevention and Control, and Antimicrobial Stewardship •5.3 Promote Clinical Research on the Optimization of Existing Methods for Prevention, Diagnosis and Treatment of Infectious Diseases •5.4 Promote Research and Development of Novel Methods for Prevention, Diagnosis and Treatment and Promote the Cooperation of Industry, Academia and Government •5.5 Promote Global Research Collaboration on Antimicrobial Resistance and Research and Development of Novel Methods for Prevention, Diagnosis and Treatment of Antimicrobial-resistant Infections 5. Research and development •6.1 Strengthen Japan's Leadership for Global Policies on Antimicrobial Resistance •6.2 Promote International Cooperation to Achieve the Global Action Plan on Antimicrobial Resistance 6. International cooperation Summary of Numerical Targets Propotion of resistant isolates of specific indicator microorganisms in humans Indicator 2014 2020 (target) Proportion of penicillin-resistance in Streptocuccus penumoniae 48% 15% or less Proportion of fluoroquinolone resistance in Echerichia coli 45% 25% or less Proportion of methicillin resistance in Staphylococcus aureus 51% 20% or less Proportion of carbapenem resistance in Pseudomonas aeruginosa 17% 10% or less Proportion of carbapenem resistant in Escherichia coli/Klebsiella pneumoniae 0.1-0.2% 0.2% or less (same level as of 2014) Antimicrobial Use for humans (average amount of antimicrobials used per day per 1,000 population) Index 2013 2020 (target) Total 15.8 Decreased by 33% Oral cephalosporins, fluoroquinolones, macrolides 11.6 Decreased by 50% Amount of intravenous antimicrobials used 1.2 Decreased by 20% Propotion of resistant isolates of specific indicator microorganisms in animals Indicator 2014 2020 (target) Proportion of tetracycline resistance in Escherichia coli 45% 33% or less Proportion of 3G (third generation) cephalosporin resistance in Escherichia coli 1.5% same level as G7 Proportion of fluoroquinolone resistance in Escherichia coli 4.7% same level as G7 5 Cross-national Comparison of Antibiotic Use for Humans In Japan, the total sales volume of antibiotics is not high; however, the proportion of use of the three major types of broad-spectrum antibiotics (third generation cephalosporins, quinolones, and macrolides) is extremely high compared to other countries. 0 5 10 15 20 25 30 35 Japan Netherlands Estonia Latvia Hungary Austria Sweden Slovenia Germany Lithuania Denmark Norway Czech Rep. Bulgaria Finland Poland Slovakia United Kingdom Spain Croatia Iceland Malta Portugal Ireland Italy Luxembourg France Cyprus Belgium Romania Greece Average daily antibiotics sales per 1,000 population セファロスポリン、その他のβラクタム キノロン マクロライド等 ペニシリン その他 Cross-national comparison of sales of antibiotics in the medical field (2010 data for Europe, 2013 data for Japan) Japan Sales (use) of antimicrobials 3 major types of broad-spectrum antibiotics 6 Cephalosporins and other beta-lactums Quinolones Maclorides, etc. Penicillins Other antibiotics Antimicrobial consumption in Japan  The Japanese antimicrobial consumption surveillance (JACS) project started to collect data nationwide on antimicrobial consumption.  The value of defined daily doses (DDDs) per 1000 inhabitants per day (DID) increased from 14.7 in 2009 to 15.8 in 2013.  Notably, oral antimicrobials accounted for 92.6% (mean of 2009, 2011 and 2013) of total consumption.  Oral third-generation cephalosporins, macrolides and fluoroquinolones accounted for 77.1% (mean of 2009, 2011 and 2013) of oral consumption.  Consumption of antimicrobials has increased during the years 2009 and 2013 regardless of the dosage form. Muraki H. et al. J Glob Antimicrob Resist. 2016;7:19-23. 1 Value of Antimicrobial Consumption (AMC) Monitoring AMR Office Centre for Health Protection Department of Health The Government of the Hong Kong Special Administrative Region of the People’s Republic of China 2 71% of service ● Western Medicine (57%) ● Chinese Medicine (15%) 87% of service ● 41 Public hospitals/ institutions under HA ● 27 041 beds 13% of service ● 12 private hospitals ● 4 098 beds Hong Kong Healthcare System 29% of service ● Hospital Authority (HA) (25%) ● Department of Health (4%) Public Sector Private Sector P ri m a ry C a re S e c o n d a ry / T e rt ia ry C a re 3 AMC Data Availability in Hong Kong Secondary care Tertiary care Hospital Authority Primary care (e.g. childhood immunisation programme, Communicable diseases prevention and treatment (TB, HIV, STD etc)) Department of Health Public Sector Private Sector GPs Health Maintenance Organizations Private Hospitals Private Practitioner AMC Data Available Wholesaler Supply Data as Proxy 4 Antibiotics used under monitoring in Public Hospital ✓Cefepime ✓Cefotaxime ✓Ceftazidime ✓Ceftriaxone ✓Ciprofloxacin ✓Levofloxacin ✓Linezolid ✓Meropenem ✓Moxifloxacin ✓Ofloxacin ✓Piperacillin ✓Sulperazon ✓Ticoplanin ✓Tienam ✓Timentin ✓Vancomycin 5 AMC Surveillance in Hong Kong Public Sector Private Sector Electronic dispensing to capture AMC data Can trace to individual hospitals and specialties Not legally required to report consumption data Self-employed Also provide dispensing service in clinic 6 Use of AMC Monitoring Data Hospital Between Hospital Hospital and Community National 7 AMC Monitoring Data Antimicrobial Stewardship Program ❖Bedside assessment to determine non- compliance Feedback ❖Objective, continuous, systematic ❖Emphasize on no-blame culture Continuous Monitoring ❖Data to be review and reported regularly ❖Senior management will be informed Intervention ❖Antibiotic-prescription guideline Use of AMC Monitoring Data Hospital 8 Use of AMC Monitoring Data Between Hospitals Benchmarking - apple-to-apple comparison ● Adjusted for difference between hospitals ○ Case-mix, epidemiology, etc... 9 Audit Program • To look for improvement or revert of trends New Intervention • To intervene undesirable trends (e.g. ASP, further education, patient empowerment ) Further Studies • To identify pressure points (e.g. which departments/sectors use what antimicrobial most) Audit Program New intervention Further Studies AMC Monitor Data Use of AMC Monitoring Data Hospital and Community 10 Use of AMC Monitoring Data National Level Prerequisite • Harmonized surveillance standard • Regular reporting Studies to identify correlation with AMR International comparison Improved AMR Control Trend monitoring Community antimicrobial consumption surveillance to inform action Dr Virginia Hope NZMN, Medical Director, Institute of Environmental Science and Research, Virginia.hope@esr.cri.nz Jane Pryer, Senior Advisor, Ministry of Health, Jane_Pryer@moh.govt.nz Aims AMC 2006-14 review Overview antimicrobial consumption in the NZ community Antimicrobial usage by demographic characteristics and geographically Assess the feasibility of using quality indicators of antimicrobial usage for geographic comparison Establish an effective and sustainable surveillance system for monitoring antimicrobial consumption in New Zealand. Williamson et al, 2016. Total antibiotic consumption (J01) in the NZ community 0 5 10 15 20 25 30 2006 2007 2008 2009 2010 2011 2012 2013 2014 D D D p er 1 0 0 0 p o p u la ti o n p er d ay Year Urinary antiseptics (J01X ) Cephalosporins and other β-lactams (J01D) Quinolones (J01M) Sulfonamides and trimethoprim (J01E) Macrolides and lincosamides (J01F) Tetracyclines (J01A) Penicillins (J01C) 25.9 DID 0 10 20 30 40 R o m an ia B el gi u m Ir e la n d P o rt u ga l Fi n la n d U n it ed … G re e ce Es to n ia N e th er la … D D D p e r 1 ,0 0 0 p o p u la ti o n p e r d ay 0 2 4 6 8 10 12 14 16 18 20 Ja n -0 6 A p r- 0 6 Ju l- 0 6 O ct -0 6 Ja n -0 7 A p r- 0 7 Ju l- 0 7 O ct -0 7 Ja n -0 8 A p r- 0 8 Ju l- 0 8 O ct -0 8 Ja n -0 9 A p r- 0 9 Ju l- 0 9 O ct -0 9 Ja n -1 0 A p r- 1 0 Ju l- 1 0 O ct -1 0 Ja n -1 1 A p r- 1 1 Ju l- 1 1 O ct -1 1 Ja n -1 2 A p r- 1 2 Ju l- 1 2 O ct -1 2 Ja n -1 3 A p r- 1 3 Ju l- 1 3 O ct -1 3 Ja n -1 4 A p r- 1 4 Ju l- 1 4 O ct -1 4 D D D p e r 1 0 0 0 p o p u la ti o n p e r d ay Month/Year Penicillins (J01C) Tetracyclines (J01A) Macrolides and lincosamides (J01F) Sulfonamides and trimethoprim (J01E) Quinolones (J01F) Cephalosporins and other β-lactams (J01D) Urinary antiseptics (J01X) Seasonal variation in antibiotic consumption, 2006 - 2014 Total antibiotic consumption (J01) by age (DID), 2014 0 5 10 15 20 25 30 35 Māori Pacific peoples Asian MELAA European or Other Total D D D p e r 1 ,0 0 0 p o p u la ti o n p e r d ay Urinary antiseptics (J01X ) Quinolones (J01M) Macrolides and lincosamides (J01F) Sulfonamides and trimethoprim (J01E) Cephalosporins and other β-lactams (J01D) Penicillins (J01C) Tetracyclines (J01A) Total antibiotic consumption (J01) by ethnicity and region, 2014 0.00 0.50 1.00 1.50 2.00 2.50 3.00 3.50 4.00 Asian European Maori Pacific MELAA NZ antibiotic consumption by deprivation quintile and ethnicity (prescriptions/1000 population/day) 1 2 3 4 5 Community antibacterial consumption in New Zealand during 2014 /2015 by ethnicity, age and level of socioeconomic deprivation Whyler, Tomlin, Tilyard & Thomas. manuscript in preparation. A platform for antimicrobial consumption surveillance in New Zealand Courtesy of Dr Mehnaz Adnan, ESR Consumption of quinolones (J01M), 2014 • Educational messaging • Selective release of microbiology results • Specific indications required for ciprofloxacin prescribing in the community 0 100 200 300 400 500 600 0 1 -J u l- 9 2 0 1 -D e c- 9 2 0 1 -M ay -9 3 0 1 -O ct -9 3 0 1 -M ar -9 4 0 1 -A ug -9 4 0 1 -J a n- 9 5 0 1 -J u n -9 5 0 1 -N ov -9 5 0 1 -A pr -9 6 0 1 -S e p -9 6 0 1 -F e b -9 7 0 1 -J u l- 9 7 0 1 -D e c- 9 7 0 1 -M ay -9 8 0 1 -O ct -9 8 0 1 -M ar -9 9 0 1 -A ug -9 9 0 1 -J a n- 0 0 0 1 -J u n -0 0 0 1 -N ov -0 0 0 1 -A pr -0 1 0 1 -S e p -0 1 0 1 -F e b -0 2 0 1 -J u l- 0 2 0 1 -D e c- 0 2 0 1 -M ay -0 3 0 1 -O ct -0 3 0 1 -M ar -0 4 0 1 -A ug -0 4 0 1 -J a n- 0 5 0 1 -J u n -0 5 0 1 -N ov -0 5 0 1 -A pr -0 6 0 1 -S e p -0 6 0 1 -F e b -0 7 0 1 -J u l- 0 7 0 1 -D e c- 0 7 0 1 -M ay -0 8 0 1 -O ct -0 8 0 1 -M ar -0 9 0 1 -A ug -0 9 0 1 -J a n- 1 0 0 1 -J u n -1 0 0 1 -N ov -1 0 0 1 -A p r- 1 1 0 1 -S e p -1 1 0 1 -F e b -1 2 0 1 -J u l- 1 2 0 1 -D e c- 1 2 0 1 -M ay -1 3 C o m m u n it y p re sc ri p ti o n s p e r 1 0 0 ,0 0 0 p o p u la ti o n p e r m o n th Community dispensing rates for topical fusidic acid and mupirocin, New Zealand, 1992 - 2013 Fusidic acid Mupirocin MuR 28% FaR 17% MuR 11% FaR 28% Williamson DA et al. Clin Infect Dis 2014 Topical antimicrobial usage in the NZ community Conclusions 2006-14 study showed: Significant increase (49%) in antibiotic consumption 2006 - 2014 Relatively high rates compared to similar developed countries with marked seasonal variation Opportunities for further investigation and action • Ethnic and geographic variation under investigation • Topical antimicrobial usage in NZ – training courses • Quinolones Need for and value of surveillance platform to inform national action 2015 and 2016 data platform in development www.moh.govt.nz Thanks Email: virginia.hope@esr.cri.nz jane_pryer@moh.govt.nz © 2017 ESR Acknowledgements: Dr Debbie Williamson; Dr Rebekah Roos; Dr Mark Thomas; Dr Mehnaz Adnan; Helen Heffernan University of Otago, PHARMAC, Doherty Institute, BPAC and ESR AMC data as part of rational drug use policies (China) Outline Bureau of medical services administration administration of the clinical use of antimicrobial agents in China National Action Plan (2016-2020) Nov, 2016. The Administration on the Clinical Use of Antimicrobial Agents and the Status Quo of Antimicrobial Resistance in China • The data used in this part are based on the figures reported by the core member institutions to the Center for Antibacterial Surveillance (CAS) under the National Health and Family Planning Commission. • CAS currently has 192 core member institutions, and all of them are tertiary hospitals (including 181 general hospitals and 11 specialized hospitals). Nov, 2016. The Administration on the Clinical Use of Antimicrobial Agents and the Status Quo of Antimicrobial Resistance in China Administration of Abx in China 1 1. Rate of average antibacterial use among inpatients According to CAS, the average rate of antibacterial use among inpatients has decreased from 67.3% in 2010 to 39.1% in 2015. Among surgical patients, it dropped from 97.3% in 2010 to 64.0% in 2015; in non-surgical patients, it dropped from 48.5% in 2010 to 25.6% in 2015. The average antibacterial use among inpatients (%; according to CAS) Administration of Abx in China 1 2. Rate of antibacterial use among outpatients According to CAS, the rate of antibacterial use among outpatients has decreased from 19.4% in 2010 to 9.4% in 2015. Rate of antibacterial use among outpatients (%; according to CAS) Administration of Abx in China 1 3. Density of antimicrobial use The density of antimicrobial use has shown a decreasing trend in hospitals since 2010. However, the decline was slightly small in 2014; in 2015, there was a slight increase but was basically equal to that in 2014. The density of antimicrobial use (2005 - 2015) (DDDs per 100 patient-days; according to CAS) Administration of Abx in China 1 4. Antibacterial use among surgical patients with different incision types The antibacterial use has shown a decreasing trend in surgical patients with different incision types since 2010. The rate of antibacterial use (including antibacterial therapy for surgical treatment) was 64.0% in surgical patients in 2015. The rate of antimicrobial prophylaxis was 59.5%, among which the rate of antimicrobial use was 45.0% for type I incisions, 79.2% for type II incisions, and 100.0% for type III incisions. The antibacterial use for surgical patients with different incision types (2010 - 2015) (%; according to CAS) Administration of Abx in China 1 5. Timing of the first antimicrobial prophylaxis in surgical patients The timing of the first antimicrobial prophylaxis in surgical patients has increasingly became reasonable. The timing of the first antimicrobial prophylaxis in surgical patients (2010 - -2015) (%; according to CAS) Administration of Abx in China 1 6. Use of combination antimicrobial therapy among inpatients The rate of combination antimicrobial therapy among inpatients has shown a decreasing trend in the core member institutions since 2010. In particular, it has dropped by over 30 percentage points (from 47.9% in 2010 to 17.8% in 2015) in the surgical inpatients; in contrast, the rate of combination antimicrobial therapy decreased from 28.1% in 2010 to 21.7% in 2015 in the non- surgical patients. Changes in Use of combination antimicrobial therapy among inpatients in core member institutions Administration of Abx in China 1 7. Antibiotic consumption and its proportions According to CAS, the increase of antibiotic consumption in the core member institutions slowed down in 2015. The top 5 antimicrobial agents with the highest consumption volume were the third- generation cephalosporins (15.68%), quinolones (13.20%), second-generation cephalosporins (12.15%), cephalosporin + enzyme inhibitors (10.36%), and penicillin + enzyme inhibitors (7.73%). The proportions of antibiotic consumption in the core member institutions in 2015 Administration of Abx in China 1 8. Proportion of antibiotic revenue in total drug revenue The proportion of antibiotic revenue in total drug revenue has declined from 19.7% in 2010 to 11.3% in 2015. It has shown a decreasing trend in the past six years. Changes in the proportion of antibiotic revenue in total drug revenue (2010 - 2015) Administration of Abx in China 1 9. Per capita antibiotic expenditure The per capita antibiotic expenditure has shown a decreasing trend both in non-surgical patients and surgical patients in the core member institutions from 2010 to 2015. Changes in the per capita antibiotic expenditure between non-surgical patients and surgical patients in core member institutions (2010 - -2015) Administration of Abx in China 1 10. Control of antimicrobial resistance According to CARSS, among 13 major drug-resistant bacteria, the isolation rate declined in 7 bacteria, remained stable in 4 bacteria, and slightly increased in 2 bacteria. Change in the antimicrobial resistance in China (2011 - 2015) specific objectives (1) Bring to the market one or two new antibacterials and 5 - 10 new diagnostic devices and reagents. (2) Prescriptions are required to buy antibacterials at almost all pharmacies. At least 50% of veterinary antibacterials must be purchased with the presentation of a veterinarian’s prescription in a province (autonomous region or municipality). (3)Improve the networks that monitor the use of antibacterials in medical institutions and antimicrobial resistance in bacteria of animal origin; build laboratories and bacteria centers to facilitate research on drug resistance; and to establish a sound evaluative system to assess the application and resistance of antibacterials. National Action Plan (2016-2020) 2 Nov, 2016. The Administration on the Clinical Use of Antimicrobial Agents and the Status Quo of Antimicrobial Resistance in China National Action Plan (2016-2020) 2 specific objectives (4)All the second and tertiary hospitals basically establish a mechanism to manage the clinical application of antibacterials; the growth rates of major drug resistant bacteria are effectively controlled. (5) Gradually phase out antibacterials that are both used in humans and animals or that are used to expedite animal growth and more likely to develop cross resistance; the growth rates of drug-resistant zoonotic pathogens are effectively controlled. (6) Train all the medical staff, front-line veterinarians, and breeding industry workers on the rational use of antimicrobial agents; popularize the knowledge about rational use of antibacterials in elementary and middle schools; launch a week-long education campaign on the rational use of antibacterials. Thanks! Antimicrobial use and appropriateness data to inform antimicrobial stewardship in Australia Graham Brown, Office of Health Protection, Australian Government Department of Health AURA Surveillance System The National AMR Strategy 2015-2019 Some of the objectives specifically relevant to antimicrobial usage and stewardship include: 2. Implement effective antimicrobial stewardship practices across human health and animal care settings to ensure the appropriate and judicious prescribing, dispensing and administering of antimicrobials. 3. Develop nationally coordinated One Health surveillance of antimicrobial resistance and antimicrobial usage. 4. Improve infection prevention and control measures across human health and animal care settings to help prevent infections and the spread of antimicrobial resistance. AURA – antimicrobial usage programs NAUSP PBS NAPS acNAPS, sNAPS MedicineInsight • 27.4 million scripts dispensed for systemic antimicrobials (2014-15 data) – 23.4 Defined Daily Doses/1000 population/day – 1164 scripts/1000 population • 10.7 million unique patients (46% of population) • High volumes of antimicrobials prescribed for upper respiratory tract infections Community Use - PBS and MedicineInsight data Update March 2016: 28.2 millions scripts 23.5 DDD/1000/day NPS MEDICINEINSIGHT PROGRAM CAP = community acquired pneumonia CI = confidence interval TG = Therapeutic Guidelines: Antibiotic URTI = upper respiratory tract infection UTI = urinary tract infection a No antibacterials recommended by Therapeutic Guidelines: Antibiotic Source: MedicineInsight Patients prescribed systemic antimicrobials for select conditions Aged care homes - acNAPS data • Over 11% of residents are on antimicrobial therapy on any given day. However, only 4.5% of residents had a suspected or confirmed infection documented. • Most prescriptions for more than 6 months were for prophylaxis rather than treatment (56.1% for prophylaxis vs. 24.1% for treatment). • For 31% of the antimicrobial prescriptions, the resident had been prescribed the antimicrobial for greater than six months. • Of the residents who did have signs and symptoms of infection, only 33% of the prescriptions issued were for infections that required treatment with an antimicrobial. • 5% of the antimicrobial prescriptions had no start date. 65% of the antimicrobial prescriptions had no review or stop date documented. Hospitals – NAPS/ NAUSP data • Antibacterial use in Australian hospitals has declined since 2010. • Appropriateness is slowly improving: 21.9% of prescriptions in 2015 deemed inappropriate compared with 23% in 2014. • In 2015, the most common indications were surgical prophylaxis (15.5%), community-acquired pneumonia (10.5%), medical prophylaxis (7.6%), sepsis (5.7%) and urinary tract infection (5.0%). • Reasons for inappropriate prescribing: antimicrobial therapy was not indicated, the spectrum was too broad, the duration, dose or frequency was incorrect. • Surgical prophylaxis had a high proportion of inappropriate use, although this is improving (down from 41.8% in 2013 to 27.4% in 2015). Stewardship priorities for Australia arising from analyses of NAPS, NAUSP and community antimicrobial usage data: • Increase compliance with prescribing guidelines in all settings – community and hospital. • Improve the appropriateness of prescribing for surgical prophylaxis. • Improve documentation of indication, stop and review dates in all settings. • Develop a more detailed understanding of the factors that contribute to variation within hospitals, and within and between states and territories. Antimicrobial Stewardship priorities AUSTRALIA’S AMS RESOURCES LEI Sai Ian Chief of Division of Pharmacovigilance and Pharmacoeconomics, Department of Pharmaceutical Affairs, Health Bureau Primary health care system Specialist /Tertiary health care system Public Private Government Health Centres Conde S. Januario Hospital Medical entities subsidized by the Government Private clinics Kiang Wu Hospital University Hospital Other hospitals considered a model practice by the WHO Ratios of Medical Professionals to Population 2015 Doctors per 1,000 population 2.6 Pharmacist per 1,000 population 0.81 Nurses per 1,000 population 3.5 A population of over 650,000 over an area of 30.5km2 • The Health Bureau, Macao SAR Government is responsible for overseeing the development and implementation of the action plan on AMR. • The main executing bodies include the Department of Pharmaceutical Affairs (usage of antimicrobials) and the Centre for Disease Control and Prevention (public health issues and challenges). • Multi-dimensional AMR strategies have been adopted across different sectors at different levels: from public sector to private sector; from primary care to secondary care; from medical service to antimicrobial products; and from prevention to management. • Current actions: AMR surveillance system and laboratory capacity, rigorous infection control, access to quality antimicrobial, antimicrobial use control and monitoring, health promotion, infection control, public education, emergency response planning, etc. Uphill battle posing a growing threat to public health. • Mainly focus on Escherichia coli, Staphylococcus aureus and Klebsiella pneumoniae. • According to the AMR surveillance data, AMR was detected in E. coli, Staphylococcus aureus and Klebsiella pneumonia in the hospital setting. • Among them, antibiotic resistance rate of Escherichia coli and Klebsiella pneumoniae against third-generation cephalosporins reached 40% and 30% respectively, while resistance rate to carbapenem was about 1%. • In Staphylococcus aureus, methicillin-resistant Staphylococcus aureus (MRSA) reached 40% while resistance to penicillin reached 90%. • A mandatory Declaration System was implemented by DAF in 2016 • In line with the WHO Global Action Plan on AMR, the objectives are: To strengthen surveillance of antibiotic consumption To promote rational use of antibiotics • Targets: Oral and injectable antibiotics Import and Distribution Prescribing Dispensing and Supply Who is involved? All hospitals, health centers, community pharmacies, drug importers and distributors, healthcare entities and private clinics. What they need to do? To declare the buy-in, consumption and balance of all oral and injectable antibiotics; to retain the invoices, prescriptions and other supporting documents for no less than 2 years. Responsible Body Department of Pharmaceutical Affairs, Health Bureau What are the tools? Online reporting system How to oversee execution? Random inspections are carried out to verify the quantity information and to check the prescription retained in the pharmacy. • Formation under the order of the hospital authority • Multidisciplinary - infectious disease physicians, surgeons, pharmacists, microbiologists, and administration as well as other relevant professionals. • Assigned authority to advise, control and limit the use of antimicrobials in the hospital • Responsibilities  To recommend antibiotics for the formulary  To develop and promote the adoption of prescribing guidelines  To monitor the frequency of AMR  To determine and execute antimicrobial usage control  To audits antimicrobial use  To evaluate the effectiveness of the policies  To establish an easily accessible platform for consultation with clinical microbiologist/infectious diseases specialists Formulary • unrestricted  effective, safe and empirical, e.g. benzyl penicillin • Controlled  to be used only in special situations by selected practitioners with expertise, for severe infection, with particular pattern of resistance, etc. AH Doctor to fill out the “Controlled Antibiotics Request Form” Patient information Diagnosis Medical/medication History Antimicrobial Treatment Plan Dose Frequency Duration Justification for Continuation Approval by Hospital Antibiotic Committee Pharmacy Department Verify and dispense the prescription Deliver medications Monitor Usage Check if continuous treatment is necessary Submit usage record for regular audit • Department of Pharmaceutical Affairs, Health Bureau is initiating pharmacoepidemiology studies to analyze antibiotic consumption and AMR in order to better inform and guide antimicrobial stewardship policies • opportunities to improve coordination across all elements, better integrate efforts to address gaps and ensure a more comprehensive response to AMR • engaging with other countries, including through the World Health Organization (WHO), to ensure alignment with key international policies and strategies and to support developing countries in our region in their efforts to prevent and contain AMR. • making contribution to the development of action plans for AMR

Monitoring of antibiotic consumption from TB perspective Dr Shalala Ahmadova Stop TB and Leprosy Elimination World Health Organization Regional Office for the Western Pacific Content • Burden of TB and DR-TB globally and at the WPR level • Antibiotics used for treatment of drug- susceptible and drug-resistant TB • Monitoring of drug procurement and sales data Estimated number of cases Estimated number of deaths 1.8 million* • .21 million children • .5 million women • 1.1 million men 10.4 million • 1 million children • 3.5 million women • 5.9 million men 480,000 580,000 All forms of TB Multidrug-resistant TB MDR/RR- TB HIV-associated TB 1.2 million (11%) 0.4 million Source: WHO Global TB Report 2016 * Including deaths attributed to HIV/TB The Global Burden of TB, 2015 250 000 MDR/RR-TB deaths TB incidence: countries and regions 27% 9% 10% 6% 5% 4% TB burden in the Western Pacific Region • 61% of global TB cases occur in the Asia Pacific Regions (WPR 15% + SEAR 46%) • WPR carries 17% of drug- resistant TB burden All estimates are for 2015. Source: Global TB Report 2016 (WHO) * Excluding death due to TB-HIV co-infection 1.59 million (86 per 100 000) 89 000 (4.8 per 100 000) Estimate number of TB (all forms) Estimated number of deaths due to TB* Multidrug-resistant TB + Rif resistant TB 100 000 HIV-associated TB 34 000 TB is preventable and curable disease! WHO TB treatment guidelines update WHO guidelines for treatment of drug- susceptible TB and patient care WHO consolidated TB management guidelines (Diagnosis, treatment and care) 2011 2016 2017 2013 2014 Meeting 11-13 July 2016 Systematic reviews 2016 Treatment of drug-susceptible TB New cases: Intensive phase: 4 FDC (RHZE 150/75/400/275 mg) Continuation phase: 2 FDC (RH 150/75 mg) Previously treated cases: Intensive phase: 4 FDC + Streptomycin Continuation phase: 3 FDC (RHE 150/75/275 mg) Group A Fluoroquinolone Levofloxacin Moxifloxacin Gatifloxacin Group B Second-line injectable Amikacin Capreomycin Kanamycin (Streptomycin) Group C Other core second-line drugs Ethionamide/Prothionamide Cycloserine/Terizidone Clofazimine Linezolid Group D Add-on agents D1 Pyrazinamide Ethambutol High-dose INH D2 Bedaquiline Delamanid D3 P-aminosalicylic acid Imipenem/meropenem Amoxacillin/Clavulanate (Thioacetazone) Ofloxacin & Macrolides are no longer drugs for treatment of MDR-TB Treatment of DR-TB In patients with  rifampicin-resistant TB or MDR-TB who have not been previously treated with second-line TB drugs and  in whom resistance to fluoroquinolones and second-line injectable agents has been excluded or is considered highly unlikely a shorter MDR-TB regimen* of 9–12 months may be used instead of the longer regimens Conditional recommendation, very low certainty in the evidence * 4-6 Km-Mfx-Pto-Cfz-Z-Hhigh-dose-E / 5 Mfx-Cfz-Z-E Shorter MDR-TB regimen Recommendation Composition of a longer regimen Recommendation (1) A regimen with at least 5 effective TB medicines during the intensive phase is recommended including: – one from Group A – one from Group B – at least two from Group C – PZA (Group D1) (conditional recommendation, very low certainty in the evidence) WHO 2016 Update Group A: Levofloxacin Moxifloxacin Gatifloxacin Group B: Amikacin Capreomycin Kanamycin (Streptomycin) Group C: Ethionamide/Prothionamide Cycloserine/Terizidone Clofazimine Linezolid Composition of a longer regimen Recommendations (2) If this is not possible, an agent from Group D2 and other agents from D3 may be added It is recommended that the regimen be further strengthened with high-dose INH and/or ethambutol (conditional recommendation, very low certainty in the evidence) Group D: D1: Pyrazinamide Ethambutol High-dose INH D2: Bedaquiline Delamanid D3: Imipenem/meropenem Amoxacillin/Clavulanate P-aminosalicylic acid (Thioacetazone) Monitoring of anti-TB drug procureme nt and sales data Monitoring of anti-TB drug procurement and sales data Objective: To identify the availability, types and quantity of anti-tuberculosis drugs in the public and private sectors from 2007 to 2011 in the Philippines. Methods: Analysis of the procurement of and sales data on anti-tuberculosis drugs from both the public and private sectors from 2007 to 2011. Public procurement of anti-tuberculosis drugs, 2007–2011 • Sufficient N of drugs to treat new TB cases 2008 to 2011, with a substantial buffer stock • Irregular procurement of drugs for retreatment TB cases • The total cost of first-line anti-TB drugs – US$2.3 million in 2007 – US$13 million in 2010. First-line anti-tuberculosis drugs (FDCs) in the private sector • A huge quantity of first-line anti-TB drugs in the private market • 38 anti-TB drug formulations (2011) • Average yearly sales -US$24 million • 58% of private procurement by chain drug stores, 18% by independent drug stores • Private hospitals, dispensing doctors and industrial facilities account for respectively 2%, 5% and 7% • FDC sales in 2007–2011 represent 81% of total sales, – 4 FDC – 43% – 3 FDC – 29% – 2 FDC- 9% 5% 58% 7% 2% 18% 10% dispensing physician Chain drug store Industrial Private hospital Independent Other First-line anti-tuberculosis drugs in the private sector • Private sector sales enough to initiate treatment for – 256 568 new TB patients (2011) – 3511 previously treated patients. • Per the standard treatment regimen, the ratio of 4FDCs to 2FDCs is 1:2. • The ratio of sales of 4FDCs to 2FDCs on the private market was 5:1. Second-line anti-tuberculosis drugs • In 2011, NTP procured second-line drugs such as capreomycin, kanamycin, levofloxacin, ofloxacin, protionamide, cycloserine and paraaminosalicylic acid (PAS) from the GDF. • Among these, IMS Health Philippines data capture only private sector sales of fluoroquinolones, which were difficult to interpret as they are widely used for diseases other than MDR-TB. • The study found that many second-line drugs were not registered with the Philippines Food and Drug Administration (http://www.fda.gov.ph/database). 0 100 000 200 000 300 000 400 000 500 000 600 000 700 000 2007 2008 2009 2010 2011 D ru g p ro cu m e n e t/ sa le s vo lu m e (e q u iv al e n t to a n u m b e r o f p a e n ts c o u ld b e t re at e d ) Private sector drug sales* Procurement by Na onal TB Programme TB cases no fied (1-year offset) Conclusion: TB drugs in the private sector market • Growing evidence on a huge private sector drug market o Public procurement sufficient for all notified TB case (Blue bar and line) o Private sector drug sales are almost equivalent to the notified TB cases (Red bar) o Five times more drugs for initial treatment relative to drugs for continuous phase • Reflecting: o A weak notification system o Incomplete treatment in the private sector o Unnecessary patient costs * Private sales was translated as a number of patients could have been initiated intensive phase of treatment with 4 fixed-dose combination tablets. (Islam, T. Tisocki, K. et al. Public Health Action 3, 337–341 (2013).) Thank you! Anti-microbial consumption from medicines pricing and access to medicines perspective Libby Roughead University of South Australia • Australia provides universal access to necessary pharmaceuticals for all Australian citizens and permanent residents • 37 unique antibiotics are currently listed on the Pharmaceutical Benefits Scheme • Australia’s Pharmaceutical Benefits Scheme started in 1950 in response to lack of access to penicillin Australia’s antibiotic use is high comparative to many other countries 0 5 10 15 20 25 30 35 G re e ce Fr an ce R om an ia B el gi u m It al y Sp ai n M al ta Ir el an d Sl o va ki a P o la n d A u st ra lia Ic el an d U K C ro at ia B ul ga ri a C ze ch … Li th u an ia Fi n la n d D en m ar k A u st ri a N o rw ay G er m an y Sl o ve n ia H u n ga ry La tv ia Sw ed en Es to n ia N et h er la n d s D D D /1 00 0/ d ay 2013 Source: OECD pharmaceutical consumption Antibiotic use in Australia is common across all age-groups 0 10 20 30 40 50 60 70 80 90 100 0-4 5-9 10-14 15-19 20-24 25-29 30-34 35-39 40-44 45-49 50-54 55-59 60-64 65-69 70-74 75-79 80-84 85-89 90-94 95-99 100 and over % p o p u la ti o n s u p p li e d a n ti b io ti c Age group Source: http://www.pbs.gov.au/info/industry/listing/participants/public-release-docs/antibiotics-oct-14-feb-15 Antimicrobial consumption in the context of access and pricing policy 3 examples • Listing quinolone antibiotics – How to list? Open access or restricted • Quantities provided and repeat prescriptions for antibiotics • Listing new antibiotics in the era of antimicrobial resistance The Quinolone story • Despite having high use of antibiotics, Australia has low use of fluoroquinolone antibiotics – This is due to our listing decisions – The very first decision to subsidise these medicines required prior approval – Active monitoring over time and the maintenance the approval requirement have resulted in very low use in the outpatient setting 44% 23% 13% 8% 5% 6% 1% Antibiotic use: Australia 2015 Penicillins Cephalosporins Macrolides Tetracyclines Sulphonamides and trimethoprim Other Fluoroquinolones 00.5 1 1.5 2 2.5 3 D D D / 1 0 0 0 / d a y 2nd generation quinolone (ciprofloxacin) use: outpatients 2009 0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 D D D / 1 0 0 0 / d a y Outpatient quinolone use 2009 Source data: J Antimicrob Chemother 2010 65: 1286–1291 doi:10.1093/jac/dkq093. Australian statistics on medicines 2011 Ciprofloxacin use: Australia 0 0.05 0.1 0.15 0.2 0.25 0.3 0.35 0.4 D D D / 1 0 0 0 / d a y Authority listing: serious infections for which no other antibiotics is appropriate Ciprofloxacin 0 0.05 0.1 0.15 0.2 0.25 0.3 0.35 0.4 D D D / 1 0 0 0 / d a y Authority listing: serious infections for which no First national edition Ciprofloxacin 0 0.05 0.1 0.15 0.2 0.25 0.3 0.35 0.4 D D D / 1 0 0 0 / d a y Authority listing: serious infections for which no other antibiotics is appropriate Authority listing: maintained requirement for written authority, when most other items went to streamlined Authority: pseudomonas aeruginosa or other gram-negative bacteria resistant to all other oral antimicrobials Treatment of joint and bone infections or epididymo-orchitis, suspected or proven to be caused by gram-negative bacteria. Norfloxacin 0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 1 9 9 4 Q 1 1 9 9 4 Q 4 1 9 9 5 Q 3 1 9 9 6 Q 2 1 9 9 7 Q 1 1 9 9 7 Q 4 1 9 9 8 Q 3 1 9 9 9 Q 2 2 0 0 0 Q 1 2 0 0 0 Q 4 2 0 0 1 Q 3 2 0 0 2 Q 2 2 0 0 3 Q 1 2 0 0 3 Q 4 2 0 0 4 Q 3 2 0 0 5 Q 2 2 0 0 6 Q 1 2 0 0 6 Q 4 2 0 0 7 Q 3 2 0 0 8 Q 2 2 0 0 9 Q 1 2 0 0 9 Q 4 2 0 1 0 Q 3 2 0 1 1 Q 2 2 0 1 2 Q 1 2 0 1 2 Q 4 2 0 1 3 Q 3 2 0 1 4 Q 2 2 0 1 5 Q 1 D D D / 1 0 0 0 / d a y Trimethoprim Norfloxacin Authority listing: maintained requirement for written authority, when most other items went to streamlined Authority listing: complicated UTI Open listing Where unrestricted listings have been used, other countries have not observed this effect • Moxafloxacin was added to the British Columbia formulary as an unrestricted listing. • 2.1% monthly increase in use of moxafloxcin per month as a result of the listing Can J Infect Dis Med Microbiol. 2014 Spring; 25(1): 27–31. Or a voluntary restriction Alberta province introduce an optional special authorisation program. Prescribers volunteered to become quinolone prescribers and signed consent forms indicating they would prescribe according to the guidelines were sent educational materials. They did not subsequently require prior authorisation. All other prescribers required prior authorisation. Only applied to ciprofloxacin, ofloxacin and levofloxacin, which had previously been unrestricted. It did not apply to norfloxacin, nor to two new additions, gatifloxacin or moxifloxacin. There was no overall effect on quinolone use. BMC Health Serv Res. 2012 Aug 30;12:290. doi: 10.1186/1472-6963-12-290. Listings are not just about price Date of download: 3/25/2017 © The Author 2010. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org (a) Comparison of the number of ciprofloxacin trade names for oral use (thick line) and the median price per DDD registered monthly in PHC in Denmark (thin line), and the influence of the introduction of generics. The arrow marks the time of introduction of generic versions of ciprofloxacin. (b) The influence of removal of 50% reimbursement and of the introduction of generics on the total use of ciprofloxacin and median price per DDD registered monthly in PHC in Denmark (thin line). Consumption (thick line) is expressed in terms of DDDs per 1000 inhabitants per day. The arrows mark the times of removal of reimbursement of ciprofloxacin and the introduction of generic versions, respectively. 100 DDK≈13 EUR. Figure Legend: J Antimicrob Chemother. 2010;65(6):1286-1291. doi:10.1093/jac/dkq093 From: Effect of generics on price and consumption of ciprofloxacin in primary healthcare: the relationship to increasing resistance Date of download: 3/25/2017 © The Author 2010. Published by Oxford University Press on behalf of the British Society for Antimicrobial Chemotherapy. All rights reserved. For Permissions, please e-mail: journals.permissions@oxfordjournals.org From: Effect of generics on price and consumption of ciprofloxacin in primary healthcare: the relationship to increasing resistance Trends in the frequency of ciprofloxacin resistance among E. coli urine isolates from PHC with 95% confidence intervals (thin line) and the consumption of ciprofloxacin by PHC patients from 1995 to 2005 in three to seven Danish counties (thick line) seen in the light of the removal of 50% reimbursement and the introduction of generics. Consumption is expressed in terms of DDDs per 1000 inhabitants per day. The arrows mark the times of removal of reimbursement of ciprofloxacin and the introduction of generic versions, respectively. Figure Legend: J Antimicrob Chemother. 2010;65(6):1286-1291. doi:10.1093/jac/dkq093 Quantities provided and the importance of drug utilisation review • In Australia, antibiotics are listed with the option for doctors to prescribe a repeat supply (and additional course should the patient require it) Antibiotic Number of original prescriptions Original prescriptions with repeats ordered as a proportion of original prescriptions Amoxycillin 3,791,822 40% Amoxycillin + Clavulanic Acid 3,014,773 68% Cephalexin 3,585,854 53% Chloramphenicol 644,486 28% Roxithromycin 1,482,688 71% Antibiotic Number of original prescriptions with repeats ordered Filled repeats as a proportion of ordered repeats Amoxycillin 1,521,208 19% Amoxycillin + Clavulanic Acid 2,064,644 20% Cephalexin 1,908,106 20% Chloramphenicol 181,681 25% Roxithromycin 1,046,601 20% Drug Form and Strength Quantity per prescription % 1st repeat supplied <10 days post original % 1st repeat supplied > 60 days post original Amoxycillin Capsule 500 mg 20 51% 19% Cephalexin Capsule 500 mg 20 57% 15% Amoxycillin/ Clavulanic acid 875 mg/125 mg tablet 10 67% 12% Roxithromycin 300mg tablet 5 75% 9% Doxycycline Tablet 50 mg 25 7% 12% Doxycycline Capsule 100 mg 7 67% 10% Clarithromycin Tablet 250 mg 14 61% 12% Trimethoprim Tablet 300 mg 7 47% 20% Erythromycin Tablet 400 mg 25 47% 14% Cefaclor Tablet 375 mg 10 72% 10% Suggested response • Options for improving appropriate use of antibiotics: – Investigating changes to medical prescribing software defaults for the number of repeats on antibiotic prescriptions. – Removing repeats from oral antibiotic listings. – Reducing the validity of oral antibiotic prescriptions to less than 12 months. – Introducing separate listings for specific indications that require higher quantities … • Stakeholder engagement is currently underway to consider these options Rifaximin: a new antibiotic listing • Rifaximin was listed on the PBS on 1 December 2013. – for the prevention of Hepatic Encephalopathy – the treatment must be in combination with lactulose, if lactulose is tolerated, and the patient must have had prior episodes of hepatic encephalopathy. – the patient must be treated by a gastroenterologist or hepatologist or in consultation with one. • A telephone authority approval must be obtained by the prescriber from the Department of Human Services. How did we get there • November 2011, the PBAC rejected a submission for a Restricted Benefit listing of rifaximin for the prevention of a further recurrence or relapse in a patient who has already had an episode of HE on the basis of high and very uncertain cost effectiveness. • July 2012, the PBAC rejected a re-submission for a Restricted Benefit listing, in combination with lactulose, for the prevention of HE in adult patients who have had prior episodes of HE on the basis of high, uncertain, and unacceptable cost effectiveness. • November 2012 meeting, the PBAC considered the re-submission. • remained concerned regarding the development of antimicrobial resistance associated with the use. The PBAC recommended that clinical advice should be sought on the following: – potential effects of long-term rifaximin use on individual and population antimicrobial resistance – impact on hospital antimicrobial resistance – monitoring requirements should a PBS listing for rifaximin be implemented – resistance endpoints • The PBAC agreed that the likely number of patients treated with rifaximin was uncertain, noting the potential for substantial leakage beyond the requested population into treatment of irritable bowel syndrome (IBS) and travellers’ diarrhoea. The decision was deferred. • April 2013 meeting, the PBAC considered the re-submission of rifaximin. The PBAC considered that the price offered in the sponsor’s pre-PBAC response addressed uncertainties and proposed a price that provided acceptable cost effectiveness for rifaximin. • The PBAC recommended the Authority Required PBS listing of rifaximin on the basis of high clinical need, improved clinical benefit over the existing treatments and acceptable cost effectiveness. The budget impact assessment Year 1 Year 2 Total number of patients treated/year 916 1,102 Total number of prescriptions/packs 10,038 12,077 Net cost to Government for the drug $4,928,327 $5,929,056 Rifaxamin use post listing 0 200 400 600 800 1,000 1,200 1,400 1,600 N u m b e r o f p re sc ri p ti o n s Month of supply Predicted use versus actual use Year 1 Year 2 Patients Predicted 916 1,102 Actual 1,297 1,977 Difference 42% 79% Prescriptions Predicted 10,038 12,077 Actual 6,909 11,998 Difference -31% -1% PBS/RPBS Benefits Predicted $4,928,327 $5,929,056 Actual $3,339,636 $5,754,070 Difference -32% -3% • The PBAC sought clinical advice on the implications of listing rifaximin for antimicrobial resistance. • The clinical advice received suggested that the risk of resistance from rifaximin use is real but difficult to quantify. • Because rifaximin is poorly absorbed, the highest selection pressure for rifamycin resistance from rifaximin is on the bacteria in the gut. Evidence suggests that rifaximin readily selects for resistance to the other rifamycins in staphylococci, Clostridium difficile and Escherichia coli; which may all be present in the gut.,, Resistance to rifamycins can develop both in the target infectious bacteria and in normal gut bacteria. • At the time of listing PBAC were also concerned use could extend beyond the requested population into treatment of irritable bowel syndrome (IBS) and travellers’ diarrhoea. • For these reasons, monitoring is ongoing Conclusion • Monitoring antimicrobial consumption is an important part of pricing and access programs. • It supports listing decisions in terms of quantities supplied, the initial and ongoing decisions for unrestricted access, restricted access or prior approval access • Monitoring needs to be occur within the context of access, price and antimicrobial resistance. www.wpro.who.int