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ASSESSMENT OF

ANTIMICROBIAL STEWARDSHIP IMPLEMENTATION AT THE NATIONAL LEVEL

*Guided by the World Health Organization’s National Assessment Tool on integrated antimicrobial stewardship programs

Hanoi, Vietnam October 2023

In Collaboration With:

TABLE OF CONTENT EXECUTIVE SUMMARY Pillar 1. Pillar 2. Pillar 3. Pillar 4. Pillar 5. Conclusions

Establish and develop national coordination mechanisms for antimicrobial stewardship and develop guidelines Ensure access to and regulation of antimicrobials Improve awareness, education and training Strengthen water, sanitation and hygiene, and infection prevention and control Surveillance, monitoring and evaluation

INTRODUCTION

METHODS

RESULTS

Pillar 1. Domain 1. Item 1.1. Item 1.2. Item 1.3. Item 1.4. Item 1.5. Item 1.6.

Establish and develop national coordination mechanisms for antimicrobial stewardship and develop guidelines Establish and maintain a national coordinating mechanism for AMS that is functional at national, subnational and district levels Is there a national policy on integrated AMS? Is there a central national coordination unit at the ministry of health or designated agency or institution focused on AMS? Has the central national coordination unit established a national coordination mechanism for integrated AMS activities with diverse membership, including civil society and the private sector? Have similar coordination mechanisms with diverse members, including from civil society and the private sector, been established at subnational and district levels? Are there clear reporting lines and feedback mechanisms from subnational mechanisms to the national coordination mechanism on integrated AMS activities? Is there funding allocated for the national coordinating unit and the national, subnational and district coordination mechanisms?

Oxford University Clinical Research Unit

Assessment report of AMS implementation at the national level

Item 1.7. Does the national coordination unit have clear terms of reference (TOR)? Item 1.8. Is there a linkage to other relevant stakeholders e.g. from tuberculosis (TB), infection protection and control (IPC), water, sanitation and hygiene (WASH) or universal health coverage (UHC)? Item 1.9. Is there a monitoring and evaluation (M&E) framework and have national targets been set for AMS activities based on nationally and internationally agreed indicators? Item 1.10. Have other programmes, such as IPC, WASH, TB, malaria, HIV, UHC and primary health care (PHC), integrated AMS activities within their action plans? Domain 2. Item 2.1. Item 2.2. Item 2.3. Item 2.4. Item 2.5. Item 2.6. Pillar 2. Domain 3. Item 3.1. Item 3.2. Item 3.3.

Develop national treatment and stewardship guidelines, standards and implementation tools Have the national treatment guidelines for the management of infections been updated within the last 3–5 years? Do the national treatment guidelines include AMS principles? Is there monitoring of implementation and compliance to treatment guidelines? Is there coordinated guidance and interventions to improve availability and appropriate use of diagnostics to guide therapeutic decisions? Are there specific standard operating procedures for AMS activities in health-care facilities and in community settings? Are there mechanisms and activities for the dissemination of guidelines, standards and implementation tools on AMS activities? Ensure access to and regulation of antimicrobials

Improve access to essential, quality-assured, safe, effective and affordable antimicrobials Has the WHO Model List of Essential Medicines (EML) and Access, Watch, Reserve (AWaRe) system been incorporated into the national EML formulary and health-care facility treatment guidelines? Is there a system in place to monitor access to essential, quality-assured, safe, effective and affordable antimicrobials? Is there a system to periodically identify availability of affordable antibiotics at health-care facilities? ii

TABLE OF CONTENT (cont.) Item 3.4. Item 3.5. Item 3.6. Domain 4. Item 4.1.

Is there a mechanism in place to report shortages and stock-outs of antibiotics in the country? Is there a mechanism to report the antibiotics used by patients? Is there a process to report the antibiotics used in the AWaRe system? Regulate social triggers and remuneration policies that promote responsible antimicrobial prescription and dispensing behaviors Are health worker behavioral change principles incorporated into policies addressing diagnosis, prescription, dispensing and administration of antimicrobials?

Domain 5. Legislate and regulate responsible and appropriate use and disposal of antimicrobials Item 5.1. Item 5.2. Item 5.3. Item 5.4. Pillar 3. Domain 6. Item 6.1. Item 6.2. Item 6.3. Item 6.4.

Is there a regulation on prescription-only sale/ dispensing of antibiotics? Are regulations on dispensing antibiotics by prescription only being enforced (where access is not an issue)? Is there an enforceable regulatory mechanism to prohibit sale of substandard and falsified drugs? Are there standards and criteria for responsible manufacturing and disposal of antimicrobial agents? Improve awareness, education and training

Improve awareness and engagement to support behavioral change of antimicrobials use Have studies on determinants of behavior in health professionals and other stakeholders, including the general public, been completed to support design of awareness campaigns? Does the country hold World Antimicrobial Awareness Week (WAAW) activities annually? Does the country have regular public awareness campaigns on the responsible and appropriate use of antibiotics? Are tailored AMS messages integrated into broader health promotion, prevention, treatment and rehabilitation services and initiatives such as World Water Day, World Toilet Day, World Children’s Day, immunization campaigns, World AIDS Day, World TB Day, World Malaria Day and World Nutrition Week for sustained action?

Oxford University Clinical Research Unit

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Assessment report of AMS implementation at the national level

Item 6.5. Is regular assessment/evaluation of the impact of education and awareness campaigns on knowledge attitudes and behaviors of health workers and the public conducted? Domain 7. Item 7.1. Item 7.2. Item 7.3. Pillar 4.

Strengthen health worker capacity through the provision of tailored education and training packages according to health worker roles and functions Are AMS principles and strategies included in the educational curriculum of pre-service healthcare professionals? Is there access to in-service training, including continuous professional development (CPD) on antimicrobial prescribing and AMS for all healthcare professional groups in the country? Are AMS concepts and principles incorporated within the curriculum of other complementary disciplines e.g. the curriculum for IPC professionals Strengthen water, sanitation and hygiene and infection prevention and control

Domain 8. Item 8.1. Item 8.2.

Enhance WASH in health facilities and communities Is there representation of the AMS coordinating unit on the WASH programmes and vice versa? Is the WHO WASH Facility Improvement Tool (FIT) being promoted to assess WASH in healthcare facilities?

Domain 9. Item 9.1. Item 9.2.

Implement IPC core components in health facilities Is there representation of the AMS coordinating unit on the IPC programmes and vice versa? Are there systems linking the monitoring and reporting of healthcare-associated infections (HAIs), antimicrobial use, AMR, patient outcomes and quality of care?

Pillar 5.

Surveillance, monitoring and evaluation

Domain 10. Surveillance of antimicrobial use and consumption Item 10.1. Is there a national surveillance programme for antimicrobial resistance, use and consumption with defined structures, governance and work objectives (i.e. data collection, validation, analysis, reporting and data sharing with all stakeholders)?

TABLE OF CONTENT (cont.) Item 10.2. Are there guidelines/standard operating procedures for the use of (a) antimicrobial medicines use (AMU), (b) antimicrobial medicines consumption (AMC), and c) AMR data to inform action for national and institutional decision-making to inform action for national and institutional decision-making? Domain 11. Surveillance of AMR Item 11.1. Is there a plan to strengthen laboratory capacity to support accurate diagnosis for decision-making? Domain 12. Monitoring and evaluation of AMS activities Item 12.1. Is there a national M&E framework, including internationally and locally agreed key performance indicators for integrated AMS interventions and activities in human health? Item 12.2. Is there an accountability mechanism put in place at the local level which includes positive feedback and recognition of local leadership?

CONCLUSIONS AND RECOMMENDATIONS

REFERENCES

Oxford University Clinical Research Unit

Assessment report of AMS implementation at the national level

Photo: National Antimicrobial Stewardship Workshop, organized on 30 August 2023 by OUCRU Hanoi in collaboration with Ministry of Health, World Health Organisation (WHO) Vietnam and National Hospital for Tropical Diseases.

EXECUTIVE SUMMARY Antimicrobial stewardship (AMS) is one of the key strategies in the global and national action plans to control antimicrobial resistance (AMR). In response to the increasing burden of AMR, Vietnam developed its first National Action Plan on AMR in 2013 for the period of 2015-2020, and currently is prepared the National Strategy on AMR Control for the period of 2022–2030, with a vision to 2035. In parallel, Guidelines for the Implementation of AMS Programs in Healthcare Facilities and Antibiotic Treatment Guidelines were also developed by the Vietnam Ministry of Health (MoH) to support hospitals in implementing AMS programs. In this analysis, we used the World Health Organization (WHO)’s national assessment tool from the WHO policy guidance on integrated antimicrobial stewardship activities to evaluate AMS implementation at the national level with five pillars, 12 domains and 44 items (Figure 1). The 12 domains represent 12 packages of interventions and activities that need to be considered and implemented to create a strong backbone for an integrated AMS approach to preserve antimicrobials. The policy guidance also seeks synergy and efficiency for the implementation of comprehensive interventions across key sectors and at all levels. The project aims to identify successes and achievements, areas for improvement, driving factors, and barriers to program implementation to inform further actions to improve the current status at the national level in Vietnam. Below we summarise the overall state of national-level AMS implementation and the key findings from this assessment under each pillar.

Oxford University Clinical Research Unit

Assessment report of AMS implementation at the national level

Acronyms AMR

Antimicrobial Resistance

AMS

Antimicrobial Stewardship

AMU

Antimicrobial Use

AWaRE

Access - Watch - Reserve

CPD

Continuous Professional Development

EML

Essential Medicines List

FIT

Facility Improvement Too

HAI

Healthcare-Associated Infection

HCF

Healthcare Facility

Health Worker

IPC

Infection Prevention and Control

M&E

Monitoring & Evaluatation

MoH

Ministry of Health

NCM

National Coordination Machanism

PHC

Primary Health Care

SOP

Standard Operating Procedure

Tuberculosis

TOR

Terms of Reference

UHC

Universal Health Coverage

WAAW

World Antimicrobial Awareness Week

WASH

Water, Sanitation and Hygiene

WHO

World Health Organization

Figure 1. Overall state of AMS implementation at the national level

Pillar

Domain

# 1.1 1.2 1.3 1.4

1. Establish and maintain a NCM for AMS that is functional at national, subnational and district levels

1.5 1.6

1.7

Establish and develop NCMs for AMS and develop guidelines

1.8 1.9 1.10 2.1 2.2 2.3 2. Develop national treatment and stewardship guidelines, standards and implementation tools

2.4 2.5 2.6

Oxford University Clinical Research Unit

Assessment report of AMS implementation at the national level

Item

Vietnam

Is there a national policy on integrated AMS activities?

Is there a central national coordination unit at the MoH or designated agency or institution focused on AMS?

Has the central national coordination unit established a NCM for integrated AMS activities with diverse membership, including civil society and the private sector?

Have similar coordination mechanisms with diverse members, including from civil society and the private sector, been established at subnational and district levels?

Are there clear reporting lines and feedback mechanisms from subnational mechanisms to the NCM on integrated AMS activities?

Is there funding allocated for the national coordinating unit and the national, subnational and district coordination mechanisms?

Does the national coordination unit have clear terms of reference (TOR)?

Is there a linkage to other relevant stakeholders e.g. from TB, IPC, WASH or UHC?

Is there a M&E framework and have national targets been set for AMS activities based on nationally and internationally agreed indicators?

Have other programmes, such as IPC, WASH, TB, malaria, HIV, UHC and primary health care (PHC), integrated AMS activities within their action plans?

Have the national treatment guidelines for the management of infections been updated within the last 3–5 years?

Do the national treatment guidelines include AMS principles?

Is there monitoring of implementation and compliance to treatment guidelines?

Is there coordinated guidance and interventions to improve availability and appropriate use of diagnostics to guide therapeutic decisions?

Are there specific standard operating procedures for AMS activities in health-care facilities and in community settings?

Are there mechanisms and activities for the dissemination of guidelines, standards and implementation tools on AMS activities?

Figure 1. Overall state of AMS implementation at the national level (cont.)

Pillar

Domain

# 3.1 3.2

3. Improve access to essential, quality-assured, safe, effective and affordable antimicrobials

3.3 3.4

Ensure access to and regulation of antimicrobials

3.5 3.6

4. Regulate social triggers and remuneration policies that promote responsible antimicrobial prescription and dispensing behaviours

4.1 5.1 5.2

5. Legislate and regulate responsible and appropriate use and disposal of antimicrobials

5.3 5.4

No/ Not implementing

Partially implemented

No, but a priority

Fully implemented

Planned but not started

Oxford University Clinical Research Unit

Assessment report of AMS implementation at the national level

Item

Vietnam

Has the WHO Model List of Essential Medicines (EML) and AWaRe system been incorporated into the national EML formulary and HCF treatment guidelines?

Is there a system in place to monitor access to essential, quality-assured, safe, effective and affordable antimicrobials?

Is there a system to periodically identify availability of affordable antibiotics at health-care facilities?

Is there a mechanism in place to report shortages and stock-outs of antibiotics in the country?

Is there a mechanism to report the antibiotics used by patients?

Is there a process to report the antibiotics used in the AWaRe system?

Are HW behavioural change principles incorporated into policies addressing diagnosis, prescription, dispensing and administration of antimicrobials?

Is there a regulation on prescriptiononly sale/ dispensing of antibiotics?

Are regulations on dispensing antibiotics by prescription only being enforced (where access is not an issue)?

Is there an enforceable regulatory mechanism to prohibit sale of substandard and falsified drugs?

Are there standards and criteria for responsible manufacturing and disposal of antimicrobial agents?

Pillar

Domain

# 6.1 6.2

6. Improve awareness and engagement to support behavioural change of AMU

6.3 6.4

Improve awareness, education and training

6.5 7.1

7. Strengthen HW capacity through the provision of tailored education and training packages according to HW roles and functions

7.2 7.3 8.1

8. Enhance WASH in health facilities and communities 4

8.2

Strengthen WASH and IPC

9.1

9. Implement IPC core components in health facilities 9.2 10.1

10. Surveillance of AMU and AMC 10.2 5

Surveillance, M&E

11. Surveillance of AMR

11.1 12.1

12. M&E of AMS activities 12.2 7

Assessment report of AMS implementation at the national level

Item

Vietnam

Have studies on determinants of behaviour in health professionals and other stakeholders, including the general public, been completed to support design of awareness campaigns?

Does the country hold World Antimicrobial Awareness Week (WAAW) activities annually?

Does the country have regular public awareness campaigns on the responsible and appropriate use of antibiotics?

Are tailored AMS messages integrated into broader health promotion, prevention, treatment and rehabilitation services and initiatives for sustained action?

Is regular assessment/evaluation of the impact of education and awareness campaigns on knowledge attitudes and behaviours of HWs and the public conducted?

Are AMS principles and strategies included in the educational curriculum of pre-service healthcare professionals?

Is there access to in-service training, including continuous professional development (CPD) on antimicrobial prescribing and AMS for all healthcare professional groups in the country?

Are AMS concepts and principles incorporated within the curriculum of other complementary disciplines e.g. the curriculum for IPC professionals?

Is there representation of the AMS coordinating unit on the WASH programmes and vice versa?

Is the WHO WASH Facility Improvement Tool (FIT) being promoted to assess WASH in healthcare facilities?

Is there representation of the AMS coordinating unit on the IPC programmes and vice versa?

Are there systems linking the monitoring and reporting of healthcare-associated infections (HAIs), antimicrobial use, AMR, patient outcomes and quality of care?

Is there a national surveillance programme for AMR, AMC and AMU with defined structures, governance and work objectives (i.e. collection, validation, analysis, reporting and sharing)?

Are there guidelines/SOPs for the use of (a) AMU, (b) AMC and (c) AMR data to inform action for national and institutional decision-making?

Is there a plan to strengthen laboratory capacity to support accurate diagnosis for decision making?

Is there a national M&E framework, including internationally and locally agreed key performance indicators for integrated AMS interventions and activities in human health?

Is there an accountability mechanism put in place at the local level which includes positive feedback and recognition of local leadership?

0 8

PILLAR 1. Establish and develop national coordination mechanisms for antimicrobial stewardship and develop guidelines The MoH has established national coordination mechanisms for AMR control with sub-committees to provide oversight and coordinate the activities on specific subject areas including antibiotic use. There is no separate AMS sub-committee under this structure. The coordination of AMS programs is assigned to key staff of the Department of Medical Service Administration to collaborate with other departments. Guidelines have been developed to support healthcare facilities to implement AMS programs including antibiotic treatment guidelines. However, the antibiotic treatment guidelines currently in use was released in 2015 and needs to be updated. Due to the occurrence of COVID-19 pandemic, the functions and activities of the sub-committees as well as the updates of the treatment guidelines has been delayed. The MoH’s coordination unit fo AMR control is currently working with hospitals and partners to develop the Draft National Strategy on AMR Control in Vietnam for the period of 20222030, with a vision to 2035, which is currently being submitted to the Prime Minister for approval. The main challenges for and gaps in implementation of the interventions under this domain include: • The current lack of funding allocated for the national coordination unit and coordination mechanisms in all levels; • Guidance and clarifications are required on the feedback mechanisms for AMS programs from central to local levels; • Diagnostic and laboratory infrastructure and capacity are limited and should be improved at district-level hospitals; • Linkages and integration of AMS principles in existing interconnected programs including WASH, TB, HIV, malaria, UHC and PHC are currently weak and should be identified and strengthened; • There need to be additional and specific guidelines and information to support AMS activities in community settings.

Oxford University Clinical Research Unit

Assessment report of AMS implementation at the national level

PILLAR 2. Ensure access to and regulation of antimicrobials

Vietnam has issued a number of guidance documents to ensure the supply of essential antimicrobials with high quality, safety, effectiveness, and affordable prices. The list of essential medicines (EML) is included in the national formulary and is used for developing treatment guidelines at health facilities. Existing policy and regulatory structures on pharmacy practices also apply to antimicrobials, regulating the acts of trading in pharmaceuticals, including counterfeit drugs, ingredients for making counterfeit drugs, substandard medicinal ingredients and substandard drugs, retailing prescription drugs without prescriptions, and selling drugs higher than declared prices. Regulations on sale and dispensing of prescription-only antibiotics are also emphasized under several specific regulatory docments. Regulations on dispensing antibiotics by prescription only are effective in registered pharmacies and healthcare facilities. However, dispensing over-the-counter medicines that require prescription by physicians still exists, and greater regulatory measures are needed to reduce inappropriate antibiotic use in community settings. Finally, the sale of substandard and falsified drugs is strictly prohibited under the Vietnamese law, and the standards and criteria for responsible manufacturing and disposal of antimicrobial agents have also been established. Main gaps remain in this area include: • Challenges exist in monitoring implementation and compliance to regulations because of the lack of a central electronic system in place that monitors and updates the situation accurately and continuously. Such system is needed in order to ensure the access and availability of essential, quality-assured, safe, effective, and affordable antimicrobials for patients. • There is currently no system in place to periodically identify the availability of affordable antibiotics at healthcare facilities to allow for prompt intervening actions when required. Despite antibiotic use is recorded and reported at healthcare facility level, there is no nationwide system to monitor antibiotic use in healthcare facilities or in community settings. • Vietnam’s healthcare system has not applied the WHO AWaRe for antibiotic classification and selecton framework in the reporting process of healthcare facilities. The application of such classification can help strengthen national pharmaceutical supply chains, financing and reimbursement mechanisms and pharmaceutical information management systems to ensure availability of affordable medicines at all levels of care. • Actions are required to address the disconnection in policies and guidelines on diagnosis, prescription, dispensing, and use of antibiotics in terms of behavioral change principles and interventions in the practices of health workers to improve their antibiotic prescribing and dispensing. 10

PILLAR 3. Improve awareness, education and training

The key national achievement in this area are the annual nationwide awareness raising campaigns and related activities organized within and around the World Antimicrobial Awareness Week, often jointly by different sectors and partners including the MoH, Ministry of Agriculture and Rural Development, WHO, and other relevant ministries. Multisectoral agreement has also been formed, specifically between the MoH, the Ministry of Agriculture and Rural Development, the Ministry of Trade, and the Ministry of Natural Resources and Environment through a Memorandum of Understanding (Aide Memoire) demonstrating their strong commitment and coordination to address the problem of AMR. AMS has also been integrated in the clinical pharmacy work roles of clinical pharmacists in hospital settings, and therefore there have been formal training curricula developed for students at the universities of pharmacies. AMS implementation in a number of national and provincial hospitals have been led by their clinical pharmacy teams and showed promising outcomes (examples include, but are not limited to, Bach Mai Hospital, Huu Nghi Hospital, Hue Central Hospital, and Hospital for Tropical Diseases in Ho Chi Minh City). Main areas for improvement in this pillar are: • There should be evaluations of impact of awareness raising campaigns, as well as a systematic surveillance of behavioural and related factors such as knowledge, attitudes, and practices to monitor these indicators over time, providing evidence for the planning and evaluation of effectiveness of antibiotic awareness, and AMR interventions. • Tailored AMS messages should be integrated into broader health promotion, prevention, treatment, and rehabilitation services and initiatives and AMS concepts and principles need be integrated into the curricula of other complementary disciplines and as part of the continuous professional education for key healthcare staff.

Oxford University Clinical Research Unit

Assessment report of AMS implementation at the national level

PILLAR 4. Strengthen water, sanitation and hygiene, and infection prevention and control Despite the implementation of WASH has been promoted in Vietnam for over two decades, there has been no linkages between AMS and WASH programs locally. There is currently no representation of the AMS coordinating unit within the WASH programs, and vice versa. The WHO WASH Improvement Tool (FIT) is not currently used to assess WASH in healthcare facilities. On the other hand, IPC procedures and implementation have been integrated into the guidelines for the implementation of the AMS program in healthcare facilities according to the most updated guidelines issued in the Decision 5631 QD-BYT on December 31st 2020. The guidelines state the inclusion of infection prevention and control staff roles in the membership representation of the AMS Team. Annual reports on healthcare-associated infections, antimicrobial use, AMR, patient outcomes, and quality of care are submited to the MoH for synthesis and monitoring. The areas for improvement under this pillar, as recommended by the WHO, are: • To ensure every healthcare facility has safely managed WASH and waste management facilities and implements effective, evidence-based interventions and practices to prevent infections in health workers, patients and all facilities users. • To improve WASH and IPC practices in communities to help reduce the incidence of infections, use of antimicrobials and transmission of drugresistant infections. The WHO core components for effective IPC programmes should be promoted to ensure that at least the minimum requirements are in place.

PILLAR 5. Surveillance, monitoring and evaluation

Vietnam has successfully established a national surveillance program for AMR with support from international partners, entitled Viet Nam Antimicrobial Resistance Surveillance System – VNASS (Decision 6211/QD-BYT, 17 October 2016), that include 16 key laboratories in this surveillance network during the initial phase of implementation. The objectives of VNASS are to collect, analyze, report, and share data to make recommendations for decision-making at the local level, as well as at the national and global levels, in order to reduce AMR. Important gaps and areas for improvement in this pillar are: • There is currently no official system to monitor antimicrobial use and consumption; only annual reports on these data are compiled and submited to MoH by each healthcare facility. • Data on surveillance of antimicrobial use and consumption is not currently shared with stakeholders. • There are no guidelines or standard operating procedures for the use of AMU, AMC, and AMR data to inform action for decisionmaking at the national and healthcare levels. • There are currently no systematic plans to strengthen laboratory capacity to support accurate diagnosis in healthcare facilities. • Regarding AMS, the Guidelines for the implementation of AMS programs include a description for the key performance indicators for M&E of AMS interventions in hospitals. However, no specific accountability mechanism related to the implementation of AMS programs are defined at the local level. Nevertheless, accountability, positive feedback, and recognition of individual and collective contributions shall comply with the general provisions of Vietnamese law (Decree 59/2019/ND-CP issued on July 1st, 2019 and The Law on Emulation and Commendation (Law No. 06/2022/QH15 dated on June 15th, 2022).

Oxford University Clinical Research Unit

Assessment report of AMS implementation at the national level

CONCLUSIONS In conclusion, Vietnam has achieved a number of key milestones and successes in the process toward an integrated AMS framework at the national level to ensure responsible use of antimicrobials and contribute to the control of AMR burden. These include the available regulatory and coordination structures in most required domains needed for the initial set-up, administration and operation of AMS programs in healthcare facilities, the integration of AMS into clinical pharmacy training and workplace roles, the linkages with IPC practices in hospitals, and the establishment of the national AMR surveillance network to monitor and track resistance over time for timely actions. Many challenges and gaps exist in this implementation at the national level. These challenges and gaps pinpoint the main areas and opportunities for improvement in future including: • • • • • • • • • • •

Increase effective coordination mechanisms with sustainable and adequate funding and with technically competent human resources and accountability mechanisms. Review and update national treatment guidelines on infections and infectious diseases based on local and global evidence and guidelines. Improve diagnostic capacity to rapidly and reliably detect specific pathogens and their antimicrobial susceptibilities to improve patient outcomes across the continuum of care. Apply AWaRe classifications as a selection framework to strengthen national pharmaceutical supply chains, financing and reimbursement mechanisms and pharmaceutical information management systems. Develop systems to monitor shortage or unavailability of the first-line drugs and substandard and falsified medical products to ensure access to qualityassured antimicrobials. Continue to develop and stringently enforce legal and regulatory instruments, frameworks and oversights at every step in the life cycle of antimicrobials. Prioritize tailored public communication activities, include AMS and IPC principles within schools’ curricula, and integrate AMR as a core component of professional education and training. Strengthen WASH and IPC in healthcare facilities and communtiies, ensuring the interconnectedness with the AMS program and between AMS and other health programs. Establish surveillance systems and systematic documentation and reporting of antimicrobial use and consumption in healthcare facilities and communities. Continue to strengthen and expand the national AMR surveillance network to inform the planning and implementation of integrated AMS activities and implement laboratory strengthening efforts. Conduct regular monitoring and evaluation of AMS programs to assess the quality, effectiveness, coverage and delivery of integrated AMS activities. 14

INTRODUCTION The global spread of antimicrobial resistance (AMR) and its effects has been widely documented1, with an estimation of about 10 million deaths per year due to AMR by 20502. Controlling AMR is an important societal priority as it is a crosscutting and transdisciplinary issue that can negatively impact the achievements in human health, food and environmental security, as well as our collective targets in achieving the Sustainable Development Goals (SDGs)3. The use of antibiotics is directly contributing to the development and spread of AMR4. Antimicrobial stewardship (AMS) is one of the key strategies in the global AMR Action Plan, and has been shown to be effective in reducing the inappropriate use of antimicrobials and therefore helping to reduce AMR5-8. Vietnam and most other low- and middle-income countries are facing an alarming increase in many antimicrobial-resistant bacteria, with the highest resistance rates in Asia and the world9-11. Vietnam is the first country in the region to develop a National Action Plan on AMR in the period of 2015–2020 with the objectives of promoting AMR prevention and control activities in order to improve the quality and effectiveness of the programmes and to protect and improve people’s health12 13. In the next phase, the Ministry of Health (MoH) is currently developing a National Strategy on AMR Control in Vietnam for the period of 2022–2030, with a vision to 2035. The MoH has issued Guidelines for the Implementation of AMS Programs in Healthcare Facilities under Decision 5631/QD-BYT in 2020 (replacing the guidance in Decision 772/QD-BYT in 2016) and the Antibiotic Treatment Guidelines in 2015 to support hospitals in implementing the AMS program. AMS teams have been formed in 48% of the 315 surveyed hospitals, as shown in a recent MoH report in 2019. The main AMS-related activities reported were hospital-specific guidelines on antimicrobial use (22%), and pre-authorization policies (41%). On the other hand, limited data are available on the impact of AMS programs locally; only a few studies indicated AMS activities could improve patient outcomes14-17. Recently, a new Guidelines for AMS implementation in district-level hospitals has also been released to support the activities in these less-resourced settings (Decision 2115/QD-BYT, dated 11 May 2023). In 2021, the World Health Organization (WHO) developed a toolkit to evaluate the implementation of the AMS program at the national level7. In this project, we used the WHO Toolkit to identify areas of successes and achievements, areas for improvement, driving factors, and barriers to program implementation in order to assess and inform further actions to improve the current status at the national level. This assessment was performed within the multi-country project 46HN: “Understanding variations in antimicrobial stewardship (AMS) programs in hospital networks in Asia through a newly developed context-specific tool” under the funding support of Centers for Disease Control and Prevention of the United State (BAA75D30121C11957). Oxford University Clinical Research Unit

Assessment report of AMS implementation at the national level

Photo: Focus group discussion on National workshop on AMS implementation in Hanoi - Vietnam

METHODS We used the WHO toolkit to review current AMS implementation at the national level18 using the specific questions categorized in below five key domains to guide our data collection, and analysis and synthesis of the results: A. Establish and develop national coordination mechanisms for antimicrobial stewardship and develop guidelines. B. Ensure access to and regulation of antimicrobials. C. mprove awareness, education, and training. D. Strengthen water, sanitation, hygiene, and infection prevention and control. E. Surveillance, monitoring, and evaluation For each question, a rating of the current state of AMS implementation items is chosen together with justifications given for the response as well as an eloboration on the contextual factors that has contributed to the achievements and challenges. Following are the 5 options of response for each question, the responder were instructed to select one of these options as the final response in each question during the data collection process: 1 = No (or Not implementing); 2 = No, but a priority; 3 = Planes but not started; 4 = Partially implemented; 5 = Fully implemented. The review took place from March 2022 and was based on following sources of information: • Review of policy documents since the first development of the National Action Plan for AMS control in Vietnam in 2013 in all aspects reviewed in the WHO assessment tool including the guidelines for AMS implementation, guidelines related to the supply, management and use of (antibiotic) medicines, reports on implementation of AMR actions from onehealth approach, etc.

Oxford University Clinical Research Unit

Assessment report of AMS implementation at the national level

•

Indepth interviews of two key informants who are experts in AMS and AMR fields in Vietnam: ο one former staff of Ministry of Health who had coordinated the national MoH actions on AMR and AMS between the period of 2013-2018 to provide the description of the implementation up until the most recent stage of AMS implementiton from the government’s perspective; due to the incidence of the Covid-19 pandemic, no interviews were conducted with the new MoH staff who has just been assigned to take over the coordination role for AMS activities. Responses of this key informant were used to form the initial ratings for the implementation items; these were then validated and updated based on subsequent review of policy documents and discussions with current staff with AMS roles at MoH; ο one staff of an international non-governmental organization to represent the perspective of non-government sectors for contextual understanding. This staff was selected in the capacity of a person who has worked closely with MoH and partners in AMR control and actively joined the local AMR network and the process of reviewing the draft National Strategy on AMR Control in Vietnam for the period of 2022–2030, with a vision to 2035.

•

Outcomes of the national stakeholder workshop on AMS implementation in 2019 co-chaired by MoH and WHO with support from Oxford University Clinical Research Unit (OUCRU) Vietnam15.

•

Outcomes of the national workshop on AMS implementation in August 2023 with a focus on the use of WHO national assessment tool to review the current status of AMS implementation at the national level which will be cochaired by MoH and WHO and with technical support from National Hospital for Tropical Diseases and OUCRU Vietnam.

•

Outcomes of the Regional Workshop on AMS implementation with participation of national representatives from MoH and hospitals from Vietnam to review and provide further details to update the results of the assessment at the national and healthcare facility level.

•

OUCRU participation in the MoH network meetings to review the draft National Strategy on AMR Control in Vietnam for the period of 2022–2030, with a vision to 2035. The aims of these meetings were to discuss the content of the draft in reflecting the current understanding of AMR control actions and the targets for implementation outcomes in the next time periods.

RESULTS

PILLAR 1. Establish and develop national coordination mechanisms for antimicrobial stewardship and develop guidelines Photo: National Antimicrobial Stewardship Workshop,30 August 2023

DOMAIN 1

Establish and maintain a national coordinating mechanism for AMS that is functional at national, subnational and district levels

Item 1.1.

Is there a national policy on integrated AMS?

Current status: Partially implemented

AMS activities are an important part of the National Action Plan on AMR Control in the period of 2015-2020 and the recently released National Strategy on AMR Control in Vietnam for the period of 2022-2030, with a vision to 2045 (1121/ QĐ-TTg dated 25 Septermber 2023). In the Strategy for the period 20222030, AMS in healthcare facilities is emphasized, in parallel with the role of management, assessment and awareness raising on antimicrobial use in the community, agriculture and environment. Additionally, the MoH has issued specific guidelines on the implementation of AMS programs in healthcare facilities, including the guidelines mentioned in Decision 5631/QD-BYT in 2020 (dated 31 Dec 2020, replacing the guidance in Decision 772/QD-BYT dated 04 March 2016), Handbook on AMS implementation for district hospitals (2115/ QĐ-BYT, dated 11 May 2023) and the Antibiotic Treatment Guidelines in 2015 (currently under review for updates).

Item 1.2.

Is there a central national coordination unit at the Ministry of Health or designated agency or institution focused on AMS?

Current status: Partially implemented

Currently, there is no separate central national coordination unit for AMS at the MoH. The coordination of AMS programs is assigned to key staff of the Department of Medical Service Administration to collaborate with other departments. In addition, AMS programs are important parts of the National Action Plan on AMR Control for the period of 2015–2020 and the National Strategy on AMR Control in Vietnam for the period of 2022–2030, with a vision to 2045. Within the National Action Plan, MoH has issued decisions to establish a National Steering Committee on AMR for the period from 2013 to 2020 (Decision 879/QD-BYT on March 13th 2014; to establish a National AMR Supervision Unit under the Medical Services Administration (Decision 3391/QD-BYT on August 14th 2015); to establish the sub-committees for AMR monitoring from 2013 to 2020 (Decision 2888/QD-BYT on August 5th 2014); to establish and regulate the functions and tasks of antibiotic-resistant bacteria surveillance networks at healthcare facilities (Decision 6211/QD-BYT on October 17th 2016); to establish a National Surveillance System on AMR (Decision 2775/QD-BYT on October 10th 2022); Decision 4178/QD-BYT on October 5th 2020 on the accreditation of the National Reference Laboratory for AMR Surveillance; and Decision 2115/QD-BYT on May 11th 2023 issued “Handbook for implementation of antibiotic stewardship program for district hospitals”.

Item 1.3. Has the central national coordination unit established a national coordination mechanism for integrated AMS activities with diverse membership, including civil society and the private sector? Current status: Partially implemented

There is currently no separate central national coordination unit. The national coordination mechanism for AMR monitoring is being integrated into the existing coordination mechanisms of committees and sub-committees, with the participation of relevant departments representing hospitals, prevention, agriculture, the environment, and veterinary medicine, but without the participation of non-governmental and private organizations.

Item 1.4. Have similar coordination mechanisms with diverse members, including including from civil society and the private sector, been established at subnational and district levels? Current status: Partially implemented

According to the guidelines of the MoH, similar coordination mechanisms are established at the subnational and district levels. Thus, there is no separate central national coordination unit for AMR monitoring but integrated with sub-committees for AMR monitoring or sub-committees with related roles (e.g., Drug and Therapeutics Committee in hospitals, Infection Prevention and Control Team) and without the participation of representatives of non-governmental and private organizations.

Item 1.5.

Are there clear reporting lines and feedback mechanisms from subnational mechanisms to the national coordination mechanism on integrated AMS activities?

Current status: Partially implemented

Reporting mechanisms are guided by decisions issued related to the establishment of AMR monitoring committees and sub-committees; however, there is no specific regulation related to feedback mechanisms on AMS activities in general.

Item 1.6. Is there funding allocated for the national coordinating unit and the national, subnational and district coordination mechanisms? Current status: No

Pillar 1

There are currently no guidelines or regulations on funding allocated to coordinating units and coordination mechanisms at all levels related to AMR surveillance in general and AMS in particular.

Assessment report of AMS implementation at the national level

Item 1.7. Does the national coordination unit have clear terms of reference (TOR)? Current status: Partially implemented

The decision on the establishment of sub-committees for AMR surveillance for the period 2013–2020 (Decision 2888/QD-BYT on August 5th 2014) stipulates the tasks of the sub-committees, including: planning activities and reporting to the National Steering Committee on AMR – Department of Medical Service Administration; proactively mobilizing resources to implement the plans; monitoring and evaluating; periodically reporting; and proposing appropriate solutions to prevent the increase and spread of AMR microorganisms. The next phase currently has no updates.

Item 1.8. Is there a linkage to other relevant stakeholders e.g. from tuberculosis (TB), infection protection and control (IPC), water, sanitation and hygiene (WASH) or universal health coverage (UHC)? Current status: Partially implemented

AMS is an important part of the drug management process in healthcare facilities, and its implementation requires the involvement of relevant stakeholders. In hospitals, there is linkage between AMS and other relevant departments, clinical sectors, and existing programs such as TB, Infection prevention and Control and universal health coverage. However, this linkage is only available in healthcare facilities where implement AMS activities regularly.

Item 1.9.

Is there a monitoring and evaluation (M&E) framework and have national targets been set for AMS activities based on nationally and internationally agreed indicators?

Current status: Partially implemented

The National Action Plan on AMR for the period 2015–2020 sets out general and specific objectives related to AMR activities, including the management of antimicrobial use and access to antimicrobials. The National Strategy on AMR Control in Vietnam for the period of 2022–2030, with a vision to 2045, has more specific objectives to support monitoring and assessing AMS activities. Additionally, the Vietnamese health system has monitored and evaluated the implementation of its objectives and goals in One Health, which is a national strategic plan for the prevention and control of zoonotic diseases for the period 2016–2020. Besides, AMR surveillance is one of the seven focus areas of this strategic plan. However, implementation of One Health and monitoring this implementation has been limited due to lack of staffing capacity in local levels especially for non-health sectors.

Item 1.10. Have other programmes, such as IPC, WASH, TB, malaria, HIV, UHC and primary health care (PHC), integrated AMS activities within their action plans? Current status: No

Currently, AMS activities are not integrated into the action plans of other programs such as IPC, WASH, TB, malaria, HIV, UHC, and PHC.

DOMAIN 2

Develop national treatment and stewardship guidelines, standards and implementation tools

Item 2.1. Have the national treatment guidelines for the management of infections been updated within the last 3–5 years? Current status: No

National guidelines for antibiotic treatment have not been updated in the past 3-5 years due to the COVID-19 epidemic. Currently, healthcare facilities are using national treatment guidelines that have been issued together with Decision 708/QD-BYT on March 2nd 2015 of the MoH.

Item 2.2. Do the national treatment guidelines include AMS principles? Current status: Fully implemented

The AMS principles are set out in the Guidance on the implementation of AMS in healthcare facilities (Decision 5631/QD-BYT on December 31st 2020).

Item 2.3. Is there monitoring of implementation and compliance to treatment guidelines? Current status: Partially implemented

The guidance on the implementation of AMS in healthcare facilities contains instructions for monitoring compliance with treatment guidelines at the hospital level. This monitoring has been implemented in a small number of hospitals with regular AMS programs in the forms of monitoring antibiotic prescription and audit-feedback of antibiotic use. Additionally, the MoH collaborated with WHO and Hanoi University of Pharmacy to conduct surveys to assess the current status of AMS implementation in hospitals in the period from 12/2018 to 5/2019, and monitoring of the implementation of treatment guidelines was included as one of the main objectives.

Item 2.4. Is there coordinated guidance and interventions to improve availability and appropriate use of diagnostics to guide therapeutic decisions?

Current status: Partially implemented

Pillar 1

The MoH has issued “Guidelines for diagnosis and treatment of infectious diseases” (Decision 5642/QD-BYT on December 31st 2015), which includes guidance on clinical and subclinical diagnostic procedures for each disease. In addition, the MoH also issued a number of specialized documents guiding the diagnosis and treatment of specific diseases and groups of diseases. Some recently issued guidelines include for example, guideline for diagnosis and treatment of adults with community-acquired pneumonia (Decision 4815/QD-BYT on November 20th 2020), guideline for diagnosis and treatment of

Assessment report of AMS implementation at the national level

Item 2.4.

invasive fungal infections (Decision 3429/QD-BYT on July 14th 2021), guideline for diagnosis and treatment of asthma in adults and children over 12 years old (Decision 1851/QD-BYT on April 24th 2020).

In parallel with the issuance of guidelines, healthcare facilities have also been equipped with and developed diagnostic and laboratory techniques for specific areas, and participated in trainings and short courses organized by MoH and international organizations. However, this implementation is mainly concentrated in central and provincial hospitals, less so at the district level. In addition, effective and appropriate application of diagnostics and tests in antimicrobial prescription is needed. The results of quantitative and qualitative studies in some healthcare facilities show that doctors mainly prescribed antimicrobials empirically, and there was a lack of practices of taking microbiological culture samples before using antimicrobials or as early as possible immediately after use (conducted by OUCRU/National Hospital for Tropical Disease). Item 2.5.

Are there specific standard operating procedures for AMS activities in health-care facilities and in community settings?

Current status: Partially implemented

The Guidance on the implementation of AMS in healthcare facilities (Decision 5631/QD-BYT on December 31st 2020) provides specific standard operating procedures for a number of key AMS activities. These include a list of restricted antibiotics requiring approval by a designated team or person (pre-authorization), standard operating procedure for approval of restricted antibiotic, criteria for IV-Oral switch of antibiotics based on clinical assessment, flowchart of IV-Oral switch of antibiotics based on clinical assessment, list of antibiotics for IV-Oral switch of antibiotics, and a assessment checklist for AMS activities. In some healthcare facilities with active AMS programs, there were facilityspecific standard operating procedures developed locally for specific activities and interventions such as audit-feedback of antimicrobial prescriptions and guidelines on assessing risks of infection with antibiotic-resistant microorganisms. There are currently no specific standard operating procedures for AMS activities in community settings.

Item 2.6.

Are there mechanisms and activities for the dissemination of guidelines, standards & implementation tools on AMS activities?

Current status: Partially implemented

The MoH has organized a number of trainings on AMS, which have been so far focused on the central and provincial levels. With the issuance of the “Handbook for implementation of antibiotic stewardship program for district hospitals” in 2023, it is expected that MoH will organize trainings for district hospitals in near future to help disseminate and facilitate the AMS implementation at this level.

RESULTS

PILLAR 2. Ensure access to and regulation of antimicrobials Photo: Unsplash

DOMAIN 3

Improve access to essential, quality-assured, safe, effective and affordable antimicrobials

Item 3.1. Has the WHO Model List of Essential Medicines (EML) and Access, Watch, Reserve (AWaRe) system been incorporated into the national EML formulary and health-care facility treatment guidelines? Current status: Partially implemented

The list of essential medicines (EML) is included in the national formulary and is used for developing treatment guidelines at health facilities (Circular 19/2018/ TT-BYT on August 30th 2018). Vietnam’s healthcare system has not applied the WHO AWaRe for antibiotic classification yet. There is a need to provide more information for healthcare staff and policy makers about AWaRe and its importance for AMR control work, as expressed by participants in the national workshop in August 2023.

Item 3.2.

Is there a system in place to monitor access to essential, quality- assured, safe, effective and affordable antimicrobials?

Current status: Planned, but not started

There is a number of guidance documents that have been issued to ensure the supply of essential antimicrobials with high quality, safety, effectiveness, and affordable prices, including: • Decision 29/QD-BYT on January 5th 2022, on monitoring of adverse drug reactions (ADR) in healthcare facilities; • Circular 25/2021/TT-BYT on December 13th 2021, on preparing statistical reports on prescribing in the field of pharmacy and cosmetics, including reporting requirements on the use of domestically produced and imported medicines, medicine quality, and medicines used every six months and annually; • Circular 36/2013/TTLT-BYT-BTC on November 11th 2013, amending and supplementing a number of articles of the Joint Circular 01/2012/TTLT-BYTBTC on January 19th 2012, guiding the bidding for medicine purchases by medical establishments; • Circular 06/2013/TT-BYT on February 8th 2013, guides experiments in drug price management by the maximum wholesale surplus in a cycle, applicable to the drugs covered by the state budget and health insurance; • Decree 176/2013/ND-CP on November 14th 2014, penalties for administrative violations against medical laws; • Circular 06/2023/TT-BYT on March 12th 2023, provides amendments to Circular 15/2019/TT-BYT on July 11th 2019 of the Minister of Health to guide bidding for the supply of drugs for public health facilities; • Directive 06/CT-BYT on June 14th 2013 on enhancing management and supervision of bidding activities for drug supply in health facilities; • Joint Circular 50/2011/TTLT- BYT-BTC-BCT on December 30th 2011 guides the state management of the prices of medicines for human use.

Item 3.2

However, a system for monitoring the implementation is not yet in place because of the lack of a central electronic system that monitors and updates the situation accurately and continuously in order to ensure the access and availability of essential, quality-assured, safe, effective, and affordable antimicrobials for patients.

Item 3.3.

Is there a system to periodically identify availability of affordable antibiotics at health-care facilities?

Current status: No

There is currently no system in place to periodically identify the availability of affordable antibiotics at healthcare facilities to allow for prompt intervening actions when required.

Item 3.4.

Is there a mechanism in place to report shortages and stock-outs of antibiotics in the country?

Current status: No

There is currently no system in place to periodically monitor and identify problems related to the shortages and stock-outs of antibiotics at affordable prices at healthcare facilities and promptly have solutions when required. One suggestion in the national workshop was to monitor through the drug bidding cycles through the national system or local systems.

Item 3.5. Is there a mechanism to report the antibiotics used by patients? Current status: Partially implemented

Antibiotics used in healthcare facilities are fully reported according to each facility’s system. However, there is no nationwide system to monitor antibiotic use in healthcare facilities or in community settings. There are reporting requirements from MoH on antibiotic use annually, there are manually done without any feedback on data compilation, quality and use.

Item 3.6. Is there a process to report the antibiotics used in the AWaRe system? Current status: No

Pillar 2

Currently, the WHO AWaRe classification of antibiotics has not been applied in the reporting process in healthcare facilities of the Vietnam’s health system. 27

Assessment report of AMS implementation at the national level

DOMAIN 4

Regulate social triggers and remuneration policies that promote responsible antimicrobial prescription and dispensing behaviors

Item 4.1. Are health worker behavioral change principles incorporated into policies addressing diagnosis, prescription, dispensing and administration of antimicrobials? Current status: Partially implemented

Currently, policies and guidelines on diagnosis, prescription, dispensing, and use of antibiotics incorporate principles of behavioral change for health workers to improve the practices of prescribing and dispensing antibiotics to some extent. For example, there are policies from health insurance with punishments for incorrect prescribing and treatment indications and the list of antibiotics that require pre-authorization by management and staff in charge. These could help hospital staff to improve antibiotic prescribing practices in restrictive behaviour change pathways.

DOMAIN 4

Legislate and regulate responsible and appropriate use and disposal of antimicrobials

Item 5.1. Is there a regulation on prescription-only sale/ dispensing of antibiotics? Current status: Fully implemented

These are stipulated at Point a, Clause 5, Article 6 of the Law on Pharmacy 2016 for acts of trading in pharmaceuticals, including counterfeit drugs, ingredients for making counterfeit drugs, substandard medicinal ingredients and substandard drugs, retailing prescription drugs without prescriptions, and selling drugs higher than declared prices. Regulations on sale and dispensing of prescription-only antibiotics are stated under several docments. These include Decision 4041/QD-BYT on September 7th 2017 of the Minister of Health approving the Project on strengthening control of prescription and sale of prescriptiononly drugs for the period 2017-2020. In addition, Decision 4448/QDBYT on October 3rd 2017 was released to elaborate on the Plan on implementation of the Project on strengthening control of prescription and sale of prescription-only drugs for the period 2017-2020 following Decision 4041/QD-BYT on September 7th 2017.

Pillar 2

Item 5.2.

Are regulations on dispensing antibiotics by prescription only being enforced (where access is not an issue)?

Current status: Partially implemented

Regulations on dispensing antibiotics by prescription only are in effect and are in place in all registered pharmacies and healthcare facilities. However, dispensing over-the-counter medicines that require prescription by physicians still exists (according to the results of several small-scale community studies), and greater regulatory measures are needed to reduce inappropriate antibiotic use in community settings.

Assessment report of AMS implementation at the national level

Item 5.3.

Is there an enforceable regulatory mechanism to prohibit sale of substandard and falsified drugs?

Current status: Fully implemented

The sale of substandard and falsified drugs is strictly prohibited under the Vietnamese law, as reflected in the following: • Stipulated at Point a, Clause 5, Article 6 of the Law on Pharmacy 2016 for acts of trading in pharmaceuticals, including counterfeit drugs, ingredients for making counterfeit drugs, substandard medicinal ingredients and substandard drugs, retailing prescription drugs without prescriptions, and selling drugs higher than declared prices and list prices; • Stipulated at Article 194 of the Vietnam Criminal Code 2015 (amended by Point a, Clause 44, Article 1 of the Law amending the Vietnam Criminal Code 2017) for the act of producing and trading counterfeit goods that are medicines for treatment and prevention; • Stipulated at Article 9 of Decree 98/2020/ND-CP and amended by Clause 5 and Article 13 of Decree 17/2022/ND-CP for the act of trafficking of counterfeit goods in terms of use value and utility.

Item 5.4.

Are there standards and criteria for responsible manufacturing and disposal of antimicrobial agents?

Current status: Fully implemented

The standards and criteria for responsible manufacturing and disposal of antimicrobial agents are stipulated in the following: • Circular 11/2018/TT-BYT of the Ministry of Health issued on May 4th 2018, regulating the quality of drugs and medicinal ingredients; • Circular 03/2020/TT-BYT amends and supplements a number of articles of Circular 11/2018/TT-BYT on May 4th 2018, by the Minister of Health, regulating the quality of drugs and medicinal ingredients. Accordingly, Clause 12, Article 1, of Circular 03/2020/TT-BYT adds that the recalled drug must be destroyed as specified in Clause 2, Article 15, of Circular 11/2018/TT-BYT. Accordingly, Clause 12, Article 1, of Circular 03/2020/TT-BYT adds that the recalled drug must be disposed of, which was specified in Clause 2, Article 15, of Circular 11/2018/TT-BYT; • Circular 35/2018/TT-BYT issued on November 22nd 2018 on good manufacturing practices for pharmaceutical products and pharmaceutical original materials; • Standard TCVN 9775:2013 on limiting and minimizing antibiotic resistance levels in foods from animals.

RESULTS

PILLAR 3. Improve awareness, education and training Photo: PhotoVoice exhibition in Nam Dinh province (2021)

Assessment report of AMS implementation at the national level

DOMAIN 6

Improve awareness and engagement to support behavioral change of antimicrobials use

Item 6.1.

Have studies on determinants of behavior in health professionals and other stakeholders, including the general public, been completed to support design of awareness campaigns?

Current status: Partially implemented

There have been small-scale studies in communities and healthcare facilities on knowledge, attitudes, and practices (KAP), as well as associated factors of health workers’ and community behaviors in antimicrobial prescription, antimicrobial use, and AMR. Most of these studies were carried out by research institutes and non-governmental organizations (NGOs) in collaboration with healthcare facilities and universities, including OUCRU, Woolcock, Hanoi Medical University, Hanoi University of Pharmacy, the National Institute of Hygiene and Epidemiology, and the National Hospital for Tropical Diseases. Those studies were often conducted in a short time frame with limited funding. The results have been used to design awareness-raising activities and behavioral change programs, although limited data on the effectiveness of these activities. Hence, a systematic surveillance of knowledge, attitudes, practices, and related factors is needed in order to increase representativeness and track indicators over time, providing evidence for the planning and evaluation of effectiveness of antibiotic awareness, and AMR interventions. National workshop participants also suggested to have more studies targeting individuals at community health care centers and private sectors for antibiotic use practices.

Item 6.2. Does the country hold World Antimicrobial Awareness Week (WAAW) activities annually? Current status: Partially implemented

Annually, activities to respond to World Antimicrobial Awareness Week are organized by MoH, Ministry of Agriculture and Rural Development, WHO, and other relevant ministries. On the other hand, in 2015, the MoH, the Ministry of Agriculture and Rural Development, the Ministry of Trade, and the Ministry of Natural Resources and Environment signed a Memorandum of Understanding (Aide Memoire) demonstrating their strong commitment and coordination to address the problem of AMR. However, these have been only implemented at central and major cities, not covering the remote areas and smaller cities.

Item 6.3.

Does the country have regular public awareness campaigns on the responsible and appropriate use of antibiotics?

Current status: Partially implemented

National campaigns to raise public awareness on the responsible and appropriate use of antibiotics are carried out in response to the World Antimicrobial Awareness Week organized by MoH and WHO in collaboration with other ministries and departments. The workshop participants considered the outcomes of the awareness campaigns were limited to date, not yet reaching all relevant target audiences.

Item 6.4.

Are tailored AMS messages integrated into broader health promotion, prevention, treatment and rehabilitation services and initiatives such as World Water Day, World Toilet Day, World Children’s Day, immunization campaigns, World AIDS Day, World TB Day, World Malaria Day and World Nutrition Week for sustained action?

Current status: Partially implemented

Currently, tailored AMS messages are only integrated into some programs and initiatives in TB, HIV/AIDS and malaria.

Pillar 3

There are some evaluations of the effectiveness of training and awareness campaigns on the knowledge, attitudes, and practices before and after training, for example, however these are not regular and not reaching all relevant groups of health workers and communities throughout the country.

Assessment report of AMS implementation at the national level

DOMAIN 7

Strengthen health worker capacity through the provision of tailored education and training packages according to health worker roles and functions

Item 7.1.

Are AMS principles and strategies included in the educational curriculum of pre-service healthcare professionals?

Current status: Partially implemented

The curriculum of Hanoi University of Pharmacy includes content related to AMS. This content should be included in the curriculum of other pharmacy and medical universities across the country.

Item 7.2.

Is there access to in-service training, including continuous professional development (CPD) on antimicrobial prescribing and AMS for all healthcare professional groups in the country?

Current status: Partially implemented

MoH and other institutions with national and provincial training functions have organized periodic training courses for groups of health workers on antibiotic prescribing and AMS in various formats. Health workers are supported to take part, but depending on the actual conditions in their healthcare facilities and on appropriate professional contents, some of the staff have not been trained in time due to different factors. Additionally, they also have accessed to training courses organized by pharmaceutical companies, universities, other non-governmental organizations, and development partners. Access to training and CPD is only available for major facilities, not yet for local health facilities, pharmacies and drug salers.

Item 7.3. Are AMS concepts and principles incorporated within the curriculum of other complementary disciplines e.g. the curriculum for IPC professionals? Current status: Partially implemented

Currently, AMS concepts and principles have not been included in the curricula of IPC, but with very limited content.

RESULTS

PILLAR 4. Strengthen water, sanitation and hygiene and infection prevention and control

Assessment report of AMS implementation at the national level

DOMAIN 8

Enhance WASH in health facilities and communities

Item 8.1. Is there representation of the AMS coordinating unit on the WASH programmes and vice versa? Current status: Partially implemented

There is currently representation of the AMS coordinating unit on the WASH programs in some hospitals with hand hygiene programs only.

Item 8.2.

Is the WHO WASH Facility Improvement Tool (FIT) being promoted to assess WASH in healthcare facilities?

Current status: No

The WHO WASH Improvement Tool (FIT) is not currently used to assess WASH in healthcare facilities.

DOMAIN 9

Implement IPC core components in health facilities

Item 9.1.

Is there representation of the AMS coordinating unit on the IPC programmes and vice versa?

Current status: Partially implemented

IPC procedures and implementation are integrated into the guidelines for the implementation of the AMS program in healthcare facilities according to Decision 5631 QD-BYT on December 31st 2020. Under this guideline, the sub-committee on monitoring of antimicrobial use and monitoring of AMR of microorganisms (which is part of the Drug and Therapeutics Committee) in collaboration with hospital’s AMS team, and the Drug and Therapeutics Committee in collaboration with the Infection Prevention and Control Department should aim to develop an AMS program and organize its implementation in each hospital. In this process, where the head or staff in charge of infection prevention and control is one of the members of the AMS Team. Nonetheless, as expressed by workshop participants, the collaboration and role of IPC in AMS was very weak in practice in most hospitals due to lack of commitment from leadership and limited capacity of the IPC group. It was also suggested that IPC and AMS practices should be added to the hospital quality audit checklist, and clinical microbiology and IPC should be delegated the tasks of providing consultation for microbiology results to clinicians, especially for multidrug resistant organisms.

Pillar 4

Item 9.2.

Are there systems linking the monitoring and reporting of healthcare-associated infections (HAIs), antimicrobial use, AMR, patient outcomes and quality of care?

Current status: Partially implemented

Annual reports on healthcare-associated infections (HAIs), antimicrobial use, AMR, patient outcomes, and quality of care are submited to MoH for synthesis and monitoring, but there is no systematic system to link these surveillance report data. Report formats are also not consistent across hospitals.

Assessment report of AMS implementation at the national level

Focus group discussion at Chiangrai Prachanukroh Hospital

PILLAR 5. Surveillance, monitoring and evaluation

Photo: Point Prevalence Survey Training at B.P. Koirala Institute of Health Sciences

Assessment report of AMS implementation at the national level

DOMAIN 10

Surveillance of antimicrobial use and consumption

Item 10.1.

Is there a national surveillance programme for antimicrobial resistance, use and consumption with defined structures, governance and work objectives (i.e. data collection, validation, analysis, reporting and data sharing with all stakeholders)?

Current status: Partially implemented

Currently, Vietnam has just established a national surveillance program for AMR. However, there is no official system to monitor antimicrobial use and consumption; only annual reports on these data are compiled and submited to MoH by each healthcare facility. Data on surveillance of antimicrobial use and consumption is not currently shared with stakeholders. Viet Nam Antimicrobial Resistance Surveillance System - VNASS: On October 17, 2016, the MoH issued Decision 6211/QD-BYT on establishing and regulating the functions and tasks of antibiotic-resistant bacteria surveillance networks at healthcare facilities. This decision is a foundation for establishing surveillance systems for antibiotic-resistant bacteria in healthcare facilities, including 16 key laboratories in this surveillance network during the initial phase of implementation. Subsequently, the National Surveillance Guidelines on AMR issued under Decision 127/QD-BYT on January 15th, 2019 clearly states that the objectives of VNASS are to collect, analyze, report, and share data to make recommendations for decision-making at the local level, as well as at the national and global levels, in order to reduce AMR. Key objectives of VNASS include: • Determining the characteristics of pathogens at hospitals; • Monitoring any changes in the models of antimicrobial resistance over a specific period and identifying new antimicrobial-resistant pathogens; • Increasing the capacity of microbiology laboratories to conduct identification and antimicrobial susceptibility tests to detect pathogens; • Providing information on national policy on infection control; • Implementing infection control activities following objectives at hospitals based on local antimicrobial resistance data; • Analyzing and sharing national and international AMR data by reporting to GLASS, the Global Antimicrobial Resistance Surveillance System of the WHO.

To implement the VNASS and reach their objectives, the MoH issued guidelines on AMR surveillance. This document provides solutions for the early adoption of standardized AMR surveillance in Vietnam, including methods, roles and responsibilities at the local, regional, and national levels, and requirements for data collection, management, and reporting. This document targets 16 key laboratories that participated in this surveillance network during the initial phase of implementation. The Antimicrobial Resistance Surveillance Unit (referred to as the “AMR Unit”) at Vietnam Medical Services Administration is the central national coordination unit of VNASS. The AMR Unit includes experts in infectious diseases, epidemiology, microbiology, and information technology and is responsible for: • Developing surveillance methods and requirements for AMR surveillance reports; • Verifing compliance with internal and external quality assessment programs and reviewing the results of the external quality assessment of laboratories under the surveillance network; • Receiving and managing surveillance data from all of the laboratories in the network; • Responding to the requests of the laboratories; • The AMR Unit satisfies requirements relating to training and technical support for the laboratories in the surveillance network. Besides, the AMR Unit cooperates with domestic and international microbiology experts or national AMR technical teams to develop policies, decisions, and guidelines on AMR surveillance.

Item 10.2. Are there guidelines/standard operating procedures for the use of (a) antimicrobial medicines use (AMU), (b) antimicrobial medicines consumption (AMC), and c) AMR data to inform action for national and institutional decision-making to inform action for national and institutional decision-making? Current status: No

Pillar 5

There are no guidelines or standard operating procedures for the use of AMU, AMC, and AMR data to inform action for decision-making at the national and healthcare levels. The WHO, in collaboration with the MoH, assessed the feasibility of antimicrobial use data from the health insurance database, however this was not feasible as there is no open data access or data sharing to health insurance data.

Assessment report of AMS implementation at the national level

DOMAIN 11

Surveillance of AMR

Item 11.1. Is there a plan to strengthen laboratory capacity to support accurate diagnosis for decision-making? Current status: Partially implemented

DOMAIN 12

There are currently no plans to strengthen laboratory capacity to support accurate diagnosis in healthcare facilities. Laboratories under the VNASS are required to ensure quality standards according to the National Surveillance Guidelines on AMR issued under Decision 127/QD-BYT on January 15th 2019. Additionally, over the years, the US CDC has supported laboratory capacity strengthening in a number of national and provincial hospitals, including those under the VNASS.

Monitoring and evaluation of AMS activities

Item 12.1.

Is there a national M&E framework, including internationally and locally agreed key performance indicators for integrated AMS interventions and activities in human health?

Current status: Planned, but not started

The Guidelines for the implementation of AMS program in healthcare facilities according to Decision 5631 QD-BYT on December 31st 2020 include a description for the key performance indicators for M&E of AMS interventions in hospitals. However, the implementation of the framework with the AMS indicators has not been in place.

Item 12.2. Is there an accountability mechanism put in place at the local level which includes positive feedback and recognition of local leadership? Current status: No

There is currently no specific accountability mechanism related to the implementation of AMS programs at the local level. However, accountability, positive feedback, and recognition of individual and collective contributions shall comply with the general provisions of Vietnamese law, including: • Decree 59/2019/ND-CP issued on July 1st, 2019 stipulates the general accountability of agencies, organizations, and individuals to clarify information, promptly explain their decisions, and fully justify their actions while performing their tasks and assigned duties. • The Law on Emulation and Commendation (Law No. 06/2022/QH15 dated on June 15th, 2022) stipulates the subjects, scope, principles, types, criterias, competence, and procedures for emulation and reward applied to individuals and collectives with excellent achievements in completing assigned tasks. 42

CONCLUSIONS & RECOMMENDATIONS The WHO policy guidance for an integrated approach to AMS promotes the principles of synergy and efficiency for the implementation of AMS programs at all levels. Following this guidance, national and local context and the structure of the health system need to be considered when carrying out AMS activities while focus our efforts on activities that are likely to provide the greatest benefits based on needs assessment. We also need to strengthen and use existing national and subnational platforms and coordinating mechanisms and resources to implement integrated AMS activities. It is important to build strong and effective linkages and synergies between the relevant areas and disciplines related to AMR. For Vietnam, the key strengths and opportunities include the available regulatory and coordination structures in most required domains needed for the initial set-up, administration and operation of AMS programs in healthcare facilities, the integration of AMS into clinical pharmacy training and workplace roles, the linkages with IPC practices in hospitals, and the establishment of the national AMR surveillance network to monitor and track resistance over time for timely actions. However, many challenges and gaps exist in this implementation at the national level. Following are the critical domains that need to

Oxford University Clinical Research Unit

be further developed for an effective integrated AMS program implementation in Vietnam: • Increase effective coordination mechanisms to scale up the implementation of integrated AMS activities, with sustainable and adequate funding and with technically competent human resources and accountability mechanisms. • Review and update national treatment guidelines on infections and infectious diseases based on local and global evidence and guidelines, including diagnosis, selection of the optimal drug regimen, dosing, duration and route of administration. • Improve diagnostic capacity to rapidly and reliably detect specific pathogens and their antimicrobial susceptibilities to improve patient outcomes across the continuum of care. • Promote and apply AWaRe classifications as a selection framework to strengthen national pharmaceutical supply chains, financing and reimbursement mechanisms and pharmaceutical information management systems that will ensure availability of affordable antimicrobial medicines at all levels of care. • Develop systems to monitor shortage or unavailability of the first-line drugs and substandard and falsified medical products to ensure access to quality-assured antimicrobials.

Assessment report of AMS implementation at the national level

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Continue to develop and stringently enforce legal and regulatory instruments, frameworks and oversights at every step in the life cycle of antimicrobials. Prioritize tailored public communication activities that target different audiences using communication and behaviour change strategies, include within schools’ curricula the appropriate use of antimicrobial agents, IPC and drug-resistant infections from an early age, and integrate AMR as a core component of professional education, in-service trainings and certifications, and other continuing education programmes in the human health, veterinary and agricultural practice sectors. Strengthen WASH and IPC in healthcare facilities and communtiies, ensuring the interconnectedness between AMS and the other complementary programs. Establish surveillance systems and systematic documentation and reporting of antimicrobial use and consumption in healthcare facilities and communities to monitor the impact of AMS related decisions and follow-up interventions. Continue to strengthen and expand the national AMR surveillance network to inform the planning and implementation of integrated AMS activities. Continue to implement laboratory

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strengthening efforts to ensure that there is adequate infrastructure for conducting quality microbiological practices, including isolation, identification and susceptibility testing. Conduct regular monitoring and evaluation of AMS programs to assess the quality, effectiveness, coverage and delivery of integrated AMS activities and to make the necessary adjustment following a continuing quality improvement cycle. This can be facilitated by applying the existing AMS assessment tools at the national, subnational and health-care facility levels.

In conclusion, Vietnam has achieved a number of key milestones and successes in the process toward an integrated AMS framework at the national level to ensure responsible use of antimicrobials and contribute to the control of AMR burden. Multiple contextual factors influence implementation of AMS programs, and AMS activities should be carried out in an integrated way to optimize antimicrobial prescribing and ensure patient and public safety. The key role of the central coordination unit needs to be underlined and strengthened to take the lead, and engage relevant stakeholders in strategic policy development and planning to identify the priorities for AMS implementation in the years to come.

References 1. Murray CJL, Ikuta KS, Sharara F, et al. Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis. The Lancet 2022;399(10325):629-55. doi: 10.1016/S0140-6736(21)02724-0 2. de Kraker MEA, Stewardson AJ, Harbarth S. Will 10 Million People Die a Year due to Antimicrobial Resistance by 2050? PLOS Medicine 2016;13(11):e1002184. doi: 10.1371/journal.pmed.1002184 3. World Health Organization. Regional Office for Europe. Antimicrobial resistance: fact sheet on Sustainable Development Goals (‎SDGs)‎ health targets, 2017. 4. Costelloe C, Metcalfe C, Lovering A, et al. Effect of antibiotic prescribing in primary care on antimicrobial resistance in individual patients: systematic review and meta-analysis. BMJ 2010;340 5. Davey P, Marwick CA, Scott CL, et al. Interventions to improve antibiotic prescribing practices for hospitals inpatents. Cochrane Database Syst Rev 2017;2: CD003543 doi: 10.1002/14651858.CD003543.pub4. 6. Schuts EC, Hulscher MEJL, Mouton JW, et al. Current evidence on hospital antimicrobial stewardship objectives: a systematic review and meta-analysis. Lancet Infect Dis 2016;16(7):847-56. doi: 10.1016/ S1473-3099(16)00065-7 7. Lee CF, Aso H, Fukuda K, et al. Impact of antibiotic stewardship programmes in Asia: a systematic review and meta-analysis. J Antimicrob Chemother 2018;73(4):844-51. doi: 10.1093/jac/dkx492 8. Honda H, Ohmagari N, Tokuda Y, et al. Antimicrobial Stewardship in Inpatient Settings in the Asia Pacific Region: A Systematic Review and Meta-analysis. Clin Infect Dis 2017;64(suppl_2):S119-S26. doi: 10.1093/ cid/cix017 9. Song JH, Jung SI, Ko KS, et al. High prevalence of antimicrobial resistance among clinical Streptococcus pneumoniae isolates in Asia (an ANSORP study). Antimicrob Agents Chemother 2004;48(6):2101-7. 10. Dung VTV, et al. Antimicrobial susceptibility testing results from 13 hospitals in Viet Nam: VINARES 20162017. Antimicrob Resist Infect Control 2021 doi: 10.1186/s13756-021-00937-4

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Assessment report of AMS implementation at the national level

11. Vu TVD, Do TTN, Rydell U, et al. Antimicrobial susceptibility testing and antibiotic consumption results from 16 hospitals in Viet Nam: The VINARES project 2012–2013. J Glob Antimicrob Resist 2019;18:269-78. doi: https://doi.org/10.1016/j.jgar.2019.06.002 12. Wertheim H, Chandna A, Phu V, et al. Providing impetus, tools and guidance to strengthen national capacity for antimicrobial stewardship in Viet Nam. PLoS Med 2013;10(5):e1001429. doi: 10.1371/journal. pmed.1001429 13. Kinh NV, Wertheim HFL, Thwaites GE, et al. Developing an antimicrobial resistance reference laboratory and surveillance programme in Vietnam. Lancet Glob Health 2017;5(12):e1186-e87. doi: 10.1016/S2214109X(17)30370-4 14. Son NT, Tra TT, Thao PTN. Antimicrobial Stewardship Program at a tertiary teaching hospital in Vietnam: A longitudinal observational study. Clin Microbiol Infect Dis 2017;2:in press. doi: 10.15761/CMID.1000121 15. Huong VTL, Ngan TTD, Thao HP, et al. Assessing feasibility of establishing antimicrobial stewardship programmes in two provincial-level hospitals in Vietnam: an implementation research study. BMJ Open 2021;11(10):e053343. doi: 10.1136/bmjopen-2021-053343 [published Online First: 2021/10/03] 16. Khoa NT. Thực trạng sử dụng kháng sinh hợp lý và hiệu quả can thiệp tại một số bệnh viện đa khoa tuyến tỉnh. Hà Nội: Viện Vệ sinh Dịch tế Trung ương, 2021. 17. Huong VTL, Ngan TTD, Thao HP, et al. Improving antimicrobial use through antimicrobial stewardship in a lower-middle income setting: a mixed-methods study in a network of acute-care hospitals in Viet Nam. J Glob Antimicrob Resist 2021;27:212-21. doi: 10.1016/j.jgar.2021.09.006 [published Online First: 2021/10/04] 18. World Health Organization. WHO policy guidance on integrated antimicrobial stewardship activities. Geneva: World Health Organization, 2021.

About OUCRU The Oxford University Clinical Research Unit (OUCRU) is a large-scale clinical and public health research unit with site offices in Viet Nam, Indonesia, and Nepal. Part of the Centre for Tropical Medicine and Global Health at the University of Oxford (UK), OUCRU was first established in Ho Chi Minh City in 1991, hosted by the Hospital for Tropical Diseases (HTD), Viet Nam. In 2003, OUCRU Nepal was established in Kathmandu, Nepal, hosted by Patan Hospital and the Patan Academy of Health Sciences. OUCRU Ha Noi was established in 2006 in partnership with the National Hospital of Tropical Diseases (NHTD), Viet Nam. In 2008, OUCRU Indonesia was established in Jakarta, Indonesia, in partnership with the Faculty of Medicine University of Indonesia. Our vision is to have a local, regional and global impact on health by leading a locally-driven research programme on infectious diseases in Southeast Asia. Our research programme covers clinical and laboratory research with hospital and community-based patient populations, including epidemiology, immunology, host and pathogen genetics, molecular biology, microbiology and virology, mathematical modelling, bioinformatics, biostatistics, and social science. This work is supported by an extensive clinical trials unit and data management centre compliant with national and international regulations and comprehensive management, finance, public engagement, and administrative support offices. OUCRU receives considerable support from Wellcome as part of the Africa and Asia Programmes. Together with our partners, we have led a highly successful effort in enhancing the infrastructure and capacity to perform clinical trials and basic scientific research in Viet Nam, Indonesia, and Nepal. Website: www.oucru.org

Assessment report of AMS implementation at the national level

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