Friday 21 November 2014 Ms Jacinta Holdway Director, Health Protection Policy Section Office of Health Protection Department of Health GPO Box 9848, Canberra ACT 2601, Australia By email: amr@health.gov.au Dear Ms Holdway, Re: Developing a National Antimicrobial Resistance Strategy for Australia On behalf of Animal Medicines Australia, I provide the attached submission relating to the discussion paper from the Australian Antimicrobial Resistance Prevention and Containment Steering Group, entitled Developing a National Antimicrobial Resistance Strategy for Australia. Please do not hesitate to contact me or Animal Medicines Australia s Director of Corporate Affairs and Regulatory Policy, Mr Michael Wright, if you should require any further information in relation to any aspect of this submission. Yours Sincerely, Duncan Bremner Chief Executive Officer
SUBMISSION IN RESPONSE TO Developing a National Antimicrobial Resistance Strategy for Australia DISCUSSION PAPER 21 November 2014 2
INTRODUCTION Animal Medicines Australia is the peak industry body representing the leaders of the animal health industry in Australia. Animal Medicines Australia member companies are the innovators, manufacturers, formulators and registrants of a broad range of veterinary medicine products that prevent, control and cure disease across the companion animal, livestock and equine sectors. In the livestock sector, member company products are improving agricultural yield while delivering improved environmental, health, safety and animal welfare outcomes. In the companion animal sector, veterinary medicines produced by member companies are facilitating longer partnerships between humans and animals. Animal Medicines Australia works closely with a variety of industry organisations to promote an evidence based approach to public policy. Animal Medicines Australia is a member of the International Federation for Animal Health (IFAH), an official observer on VICH, and a member of the National Farmers Federation (NFF). Animal Medicines Australia and its member companies promote the responsible use of all veterinary medicines. Responsible use entails using products as little as possible and as much as necessary, for the correct duration and in accordance with the APVMA-approved usage pattern. Animal Medicines Australia and its member companies participate in industry stewardship activities including drummuster, ChemClear and Agsafe Accreditation and Training. RESPONSE TO SPECIFIC SECTIONS OF DISCUSSION PAPER STRATEGY GOAL AND OBJECTIVES Goal: To slow the development and spread of AMR and conserve the effectiveness of antimicrobials Objectives: To achieve this goal, we will focus our efforts on: 1. preventing infections and the spread of resistant infections 2. improving surveillance, and 3. improving the appropriate use of antimicrobials Is this an appropriate and realistic goal for Australia to commit to working towards? Although we recognise the proposed goal is similar to that outlined by PCAST (2014) we believe that a more tangible goal is TO CONSERVE AND OPTIMISE THE EFFECTIVENESS OF ANTIMICROBIALS IN HUMANS AND ANIMALS. Achievement of this goal can be assessed at the patient level (for example, refer to the action plan goals of the WHO global action plan, WHO 2014) and by a greater number of indices than those needed to monitor the speed and spread of AMR. While AMR will be a major component challenging the success of this goal it is not the only factor and other measures such as improved use regimens based on better evidence of effectiveness need to be encouraged and their value assessed. The proposed objectives of the Strategy are to prevent infections and the spread of resistant infections, improve surveillance, and improve the appropriate use of antimicrobials through action 1
across the seven key elements of IPC, surveillance, AMS, communication and education, international engagement, research and development and governance. Are these proposed objectives and the scope of the key elements sufficient to enable Australia to achieve the goal of the Strategy? If not, what additional objectives or key elements are needed to ensure a comprehensive national response to AMR? While each of the proposed objectives is important we believe that surveillance alone cannot solve the problem of AMR but is necessary to ensure that progress is being made. Surveillance can be viewed as a measurement tool and in that respect is subsidiary to those objectives that can help the goal to be attained. We therefore propose that the order of the objectives be modified as follows: 1. preventing infections and the SELECTION AND spread of resistant infections 2. improving the appropriate use of antimicrobials 3. improving surveillance In order to assess the sufficiency of the proposed objectives, we have reviewed key AMR management and containment plans published by various global and national bodies, including WHO, CDC, the Governments of Australia, England and the USA. A summary of the key needs for resistance containment is presented in the following table. 2
STRATEGY TO CONTAIN RESISTANCE NEED JETACAR 1999; Ryan et al 2013 IDSA 2011, 2012 Gottlieb & Nimmo 2011 CDC 2013 WHO 2012 DoH & DEFRA 2013 PCAST 2014 WHO 2014; Shallcross & Davies 2014 National Strategy 2014 Australia USA Australia USA Global UK USA Global Australia Commitment, sustained political Leadership Coordination Surveillance (antimicrobial use & antimicrobial resistance) Stewardship Education Research Product development (including economic incentives & new regulatory approaches) Diagnostics, improved (including point of care) Pre & post approval risk evaluation & mitigation strategies (REMS) Inappropriate use, define & eliminate Infection prevention & control International collaboration 3
The proposed National AMR Strategy for Australia is very comprehensive and addresses almost all essential needs of AMR containment. As a participant in the National Summit on Antibiotic Resistance (Sydney, 30-31 May 2001) that was jointly sponsored by the Commonwealth Minister for Agriculture, Fisheries and Forestry and the Commonwealth Minister for Health and Aged Care, AMA is very aware of the critical and fundamental importance of sustained high level political commitment to the national AMR strategy. It will take a long and concerted investment in significant resources to attain the goal and this will only be possible if the implementation of each element of the strategy is not interrupted by loss of resources and funding. We recognise the recent significant investment and commitment of the Australian Government. If support for the National AMR Strategy can be secured long term this commitment will be repaid by a healthier and longer lived Australian population. AMR is commonly attributed to the inappropriate use of antibiotics. Sometimes inappropriate use is also called misuse, abuse or overuse. These descriptions are so widely used that in the absence of a universally agreed definition they have accumulated a multitude of subjective meanings. As one goal of the National AMR Strategy relies on improving appropriate use it is essential to define inappropriate use. In some cases particular use patterns have been described as inappropriate even though the use pattern was following the directions set out on a registered product label. Importantly, we believe that the objectives and goals should be focused on an ambitious but achievable vision that describes what the national strategy can realistically be expected to deliver at a particular time point. 4
KEY ELEMENTS INFECTION PREVENTION AND CONTROL (IPC) AMA has a special interest in IPC and amongst the membership of AMA are the global leaders in veterinary vaccine research, development and manufacture. Currently in Australia there are 116 vaccine antigens included in more than 200 registered vaccines providing protection against 86 diseases of animals. Many of these diseases have high morbidity and mortality if not prevented. Furthermore, a number of these diseases are immunosuppressive and predispose affected animals to secondary bacterial infections. Vaccines against the agents of bovine respiratory disease and porcine respiratory disease lead to significant reduction in the need for antibiotic treatment. In food producing animals in particular there is a major focus on effective IPC supporting production practices that aim to maximise the health and welfare of farmed animals. Continuing research and development of vaccines to provide enhanced protection against existing diseases or to provide vaccines against new and emerging diseases is a subject of major investment, both in Australia and overseas. In addition to providing vaccines and other IPC medicines AMA recognises and supports the ongoing development of biosecurity measures to protect animals from exposure to infections and the improvements in nutrition, genetics and husbandry that allow animals to develop robust immune systems providing protection against pathogen challenge. 1. Are the identified IPC gaps an accurate reflection of the current situation in Australia? Are there other gaps that have not been captured here? We support the need for evidence-based best practice IPC measures and believe that an audit of IPC measures across livestock and companion animal practices is likely to be the most thorough approach to identifying important gaps. 2. Are the proposed actions for IPC appropriate to address the identified gaps? What other actions should be considered? There are many opportunities for sharing experiences in IPC across professions, especially the approaches to improving hand hygiene compliance and approaches to monitoring the effectiveness of IPC practices. 3. How could each action best be progressed? Which organisations and/or professional groups should be involved in progressing these actions? What role could your organisation or profession play in implementing and/or supporting the actions described above? We recommend consideration of cross professional approaches to IPC and highlight the benefits of including experts in behaviour change and communication. 4. How can progress on actions be monitored? What specific targets, performance indicators or outcome measures could be used to indicate success? We support the initiatives of the AVA in developing and implementing combined IPC-AMS programmes. Monitoring and assessment of actions and performance is an inherent part of these programmes and provides for the benchmarking of participants. A key need is approaches that encourage adoption of IPC-AMS programmes and here again there are opportunities for professional cross fertilisation. 5. Are you aware of other existing IPC initiatives that should be considered in the development of the Strategy? 5
In addition to a national audit it would be valuable to survey global practices and consider the adoption or local adaptation of other IPC initiatives with evidence based success. 6
SURVEILLANCE While measurement of the total mass of antimicrobial agents sold is readily collected it is a crude estimate of use and is widely misinterpreted and overinterpreted. It would be preferable to measure the quality of antibiotic use and this is likely to be increasingly possible as antimicrobial stewardship programmes are developed and implemented. 1. What levers, incentives or mechanisms are required to maximise participation in national surveillance of AMR and AU in humans, animals, the agricultural or food sector? We believe that an inclusive process of design, implementation and analysis of surveillance or AMR and AU with clear objectives is most likely to maximise participation. The near 100% voluntary participation in the most recent APVMA survey of antimicrobial use (APVMA 2014) indicates that there is a strong spirit of cooperation and willingness to participate. 2. Are you aware of other surveillance activities not reflected in this discussion paper that should be considered in the development of the Strategy? AMA conducts a survey each year of its members to obtain commercially sensitive data on product sales. This data includes the sales of antimicrobial products. AMA is examining how this data can be made available to add value to the surveillance of antimicrobial use whilst protecting the confidentiality of its members. 7
ANTIMICROBIAL STEWARDSHIP AMA is actively supportive of antimicrobial stewardship (AMS) and believes that AMS principles can be most effective if acknowledged and understood at all levels of antimicrobial use, from the community, to include consumer/client/patient, prescribers, regulators, manufacturers and distributors. Many attempts at improved antimicrobial use have not been successful and new approaches are necessary that if successful will enhance the effectiveness of AMS programmes. An understanding of current prescribing practices and the science of behaviour change will be a critical underpinning of any successful attempts to implement new and effective approaches to refine prescribing of medical (Broom et al 2014; Chaudoir et al 2013; Flanders and Saint 2014; Harris 2013; 2014; Loffler et al 2014; McAteer et al 2014; Meeker et al 2014; Prior et al 2014; Shea et al 2014; Spellberg 2014) or veterinary practitioners (De Briyne et al 2013; Higgins et al 2012, 2013a,b; Mateus et al 2014; McKenzie 2014; Moreno 2014; Summers et al 2014). As the elements of human behaviour are shared across professions there should be significant benefits in joint review of what is known and research of improved approaches. Prescribing practices in the future could advance following an assessment of the best evidence from sociological and psychological studies maybe an understanding of human nature could ultimately lead to a willingness, even enthusiasm, to constantly improve antimicrobial prescribing. 1. What would be the optimal characteristics of AMS programmes to be developed or enhanced in: Primary health care settings? Residential aged care facilities? Small animal practice? Food animal practice? Agriculture? Optimal characteristics will be defined by examination of those examples of successful AMS programmes. It will also be necessary to define what constitutes a successful outcome. Until AMS programmes are developed, implemented and monitored the features of high achieving teams will not be known. There will be many opportunities for successful AMS programmes in any one setting to inform and guide the operation of other AMS programmes. 2. How would AMS programmes best be implemented in these settings? What existing arrangements could be used to support the rollout of AMS programmes in these settings? What key professional institutions would be involved/could lead? See above. 3. Are there opportunities to improve the regulation that supports the appropriate use of antibiotics? There is already substantial regulatory activity related to the availability and use of antibiotics in veterinary practice. What is needed, as discussed elsewhere, is behaviour change. This is likely to be a complex and challenging task, but what is gleaned for one prescribing profession is expected to benefit all prescribers. The role of sociologists, psychologists, communication experts and others will be critical to the success of the goal of increased appropriate prescribing. 8
4. Is there a need to develop national prescribing guidelines, similar to those in human health, for animal health and agriculture? The AMA supports the initiatives of its members and of the AVA developing prescribing guidelines. The principles of good prescribing practice (GPP) are readily available. The key is to actively follow GPP. For example, it is recognised that there have been human health therapeutic guidelines for antibiotic prescribing in human health for more than 20 years. Ironically and inexplicably, according to a report earlier this year (Van Boeckel et al 2014), Australia appears to have one of the world s highest antibiotic use rates in humans. Significant focus on obstacles to GPP and how to encourage GPP is clearly necessary. 5. Should the use of antibiotics as growth promoters in food animals be more closely regulated, reduced or phased out completely? According to the results of the most recent APVMA survey of antimicrobial sales (APVMA 2014) the quantity of antibiotic growth promoters sold in 2009-2010 was approximately 4% of the total quantity of food animal antimicrobials sold. The only class of antibiotic used as an AGP that has uses in human medicine was the macrolide class. Since the APVMA survey was completed the macrolide tylosin has been rescheduled and is now only available on prescription. This recent regulatory change is likely to decrease if not eliminate the use of macrolides as growth promotants. The use of AGPs is declining principally for commercial reasons and in response to public preference. From a public health perspective further regulation does not appear warranted and is unlikely to yield a public health benefit, principally because use is decreasing and the use that does remain involves antibiotic classes with no human medicine equivalent. However, in support of the overriding principal of the national AMR strategy for evidence based decision making, we fully support the application of risk assessment to guide decisions on changes in use. 9
COMMUNICATION AND EDUCATION AMA recognises the fundamental importance of communication and education and the opportunities for inter-professional collaboration. Many of the messages and principles of IPC and antimicrobial use are common to the medical and veterinary worlds. It is important that communication experts are recruited and actively involved in communication plans. Similarly it is vital that education experts are included in the development, implementation and assessment of education programmes. It is clear from other experiences with communication that a clear and consistent message, based on best available evidence is essential. Public trust in the messages conveyed is critically important if behaviours are to be influenced beneficially. We recommend a communication and education review should be undertaken and that the findings should guide the development of a communication and education strategy. There is a massive literature on these subjects as they apply to IPC and AMR and considerable national and global experience and expertise which should be harnessed to increase the likelihood of first time success. IPC and AMR should also be placed in the context of food animal production. There has been a growing gap in knowledge and understanding of how food is produced and part of the communication and education programme should seek to close this gap. 10
INTERNATIONAL ENGAGEMENT Animal Medicines Australia is a member of the International Federation of Animal Health (IFAH) with other member organisations throughout Asia (ASOHI in Indonesia, INFAH in India, JVPA in Japan, Agcarm in New Zealand, AHPA in Thailand, KAHPA in Korea, and the Asian Animal Health Association or AAHA), the Americas (Caprove in Argentina, SINDAN in Brazil, CAHI in Canada, ALAVET in Chile, INFARVET-CANIFARMA in Mexico, and AHI in the US), Africa (SAAHA in South Africa), and Europe (PHARMA.BE in Belgium, VIF in Denmark, SIMV in France, BfT in Germany, APHA in Ireland, AISA in Italy, FIDIN in the Netherlands, APIFARMA in Portugal, Veterindustria in Spain, LIF in Sweden, Scienceindustries in Switzerland, and NOAH in the UK). IFAH is committed to overcoming barriers to animal disease prevention and control, and contributing to economic growth, food security, sustainability and public health. AMA continues to contribute to the IFAH strategy to contain AMR and remains a conduit for communication with the global animal health industry. 11
RESEARCH AND DEVELOPMENT The draft Global action plan on antimicrobial resistance (WHO 2014) contains a useful summary of the core needs in relation to strengthening the knowledge and evidence base through research and surveillance. These needs are summarised as follows: Epidemiological data on AMR is needed to guide treatment of patients and to inform actions at local, national and regional levels. The same information over time is essential for monitoring the effectiveness of interventions. Understanding the impact of AMR on health systems and the economy will lead to appropriate investment decisions. Robust evidence on the mechanisms of resistance development, spread and other risk factors is vital if new tools are to be developed and new policies and regulations implemented to combat AMR. An understanding is needed of the circulation of resistance within and between humans, animals, food, water and the environment, and of the impact that resistance in one has on the others. Particular research is needed to quantify the scale and impact of antibiotic use on resistance in animal and zoonotic pathogens and the impacts of AMR on agriculture, food animal production and food security. Conversely, research is needed on the impacts of agricultural practices on AMR development and spread. Newly emerged resistance or mechanisms for resistance must be rapidly identified and characterized. Research to assess the benefits and harms of non-therapeutic uses of antimicrobials in agriculture and aquaculture, including use for growth promotion and crop protection, and to identify alternative means to achieve these benefits Economic research, including the development of economic models to assess the cost of AMR and the cost and benefits of taking action as set out in this plan. 1. For your area of expertise, what are the AMR research and development priorities? As summarised above, AMA believe the following are key areas of AMR research: Risk assessment building capacity, building expertise Diagnosis at the point of need Novel antimicrobial and immunological approaches to infectious disease prevention and treatment 2. Who may be best placed to lead a priority-setting process and the development and coordination of a national research agenda for AMR? There are many important animal health research questions and it is essential that a cross disciplinary process is put in place with a long term vision and commitment to supporting research. 3. How can greater private sector investment in AMR-related research and development, including research taking a One Health approach, be supported and encouraged? Already there is substantial investment in AMR-related R&D by members of AMA and others in the private sector. Risk sharing by provision of publicly funded grants and development of models of partnership like that of the Innovative Medicines Initiative (IMI) in Europe are likely to help increase investment. Australian research definitely can play a major role in tackling a global issue, but it is also important to consider an appropriate level of coordination and integration of research projects. 12
4. How can the sharing of AMR research findings, particularly with the private sector and internationally, be better supported so that new knowledge is actively converted to better practices, policies and new technologies? This should be an important part of the communication strategy referred to earlier. 5. What mechanisms are available, or could be developed, to support increased investment in the discovery and development of new antibiotics and other technologies? IFAH estimates that it costs approximately US$200 million to bring a new veterinary medicine to market and takes 7-10 years (http://www.ifahsec.org/ifah-annual-report-2013/). Because of the critical need for truly novel mode of action antibiotics in human medicine it is unlikely that a novel antibiotic will be developed for use in animals in the foreseeable future. However, investment in R&D of vaccines and emerging technologies remains of paramount importance. R&D in this field is high risk, expensive and there are significant and challenging regulatory barriers to approval. Reducing the risk by cost sharing and developing new commercial models (for example, those presented by PCAST 2014) for partnership and return on investment are likely to encourage investment. 13
GOVERNANCE AMA supports the IFAH objective of global regulatory harmonisation of innovation friendly, evidence based regulation. There is considerable experience of effective self-regulation in the animal health area and we believe that the most sustained support of the national AMR strategy will arise from a collaborative and inclusive approach. Good governance will be supported by the widespread adoption of IPC-AMS programmes. Having broad membership of the governing body to include representatives from the community to professional and industry groups is likely to yield the most long-lived, motivated and active support. 14
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