Consultation on a draft Global action plan to address antimicrobial resistance The questionnaire is divided into four sections. The questions are broadly framed and intended to give you the opportunity to enter into some depth and explain your organization's viewpoint. While only questions marked with * are mandatory, we would appreciate answers to as many as possible. Where a choice of answer needs to be selected please highlight your answer. Before answering the questions, please refer to our list of supporting documents. http://www.who.int/drugresistance/amr-consultation/en/index.html About you Name of individual respondent* Philip Howard 2. Email address* (preference for official email addresses) 3. Are you authorised to represent your organization or interest group?* Yes 4. Organization Name* Joint response from Royal Pharmaceutical Society UK Clinical Pharmacy Association - Pharmacy Infection Network, 5. Address of the organization* Royal Pharmaceutical Society, 1 Lambeth High Street, London SE1 7JN. UK UK Clinical Pharmacy Association - Pharmacy Infection Network, 1st Floor, Publicity House, 59 Long Street, Wigston, Leicester LE18 2AJ, UK 6. Organization website (if available) www.rpharms.com and www.ukcpa.net 7. Country* United Kingdom 8. Type of Organization* Other (please specify) - both professional associations. RPS is the professional leadership body for pharmacists in the UK. UKCPA is a professional association for clinical pharmacy in the UK 9. Main sector of interest Human health 10. Would you like to be added to our mailing list to receive updates on the development of the global action plan?* Yes Page 1
General questions 1. From the perspective of your organization, what are the most important areas of concern in AMR? From the perspective of pharmacy organisations, the major areas of concern are: Increasing antimicrobial resistance to existing agents. The lack of existing pipeline of new antibacterial agents, and the lack of access to antibiotics already available elsewhere in the world Access to antibiotics without prescription (using left over antibiotics or buying antibiotics). Patients not taking antibiotics as prescribed (not completing the course) The lack of availability of pharmaceutical quality antibiotics and the use of counterfeit antibiotics across all parts of the world. Over use of antibiotics, but especially broad spectrum agents Point of Care or rapid diagnostics for discrimination between bacterial/viral infections and for selection of appropriate agent Development of alternatives to antibiotics Ensure priority funding for antimicrobial research and development and stimulation of governmental incentives to improve the business case for new antimicrobial agents? Lack of research/trials in general for antimicrobial stewardship Clinical trials with primary endpoint of non-inferiority not helpful in placing new agents Need better dosing/pk information for current agents and those new to market especially in vulnerable patients e.g. obese, renal/hepatic dysfunction Better access to therapeutic drug monitoring results in real time for antibiotics requiring monitoring to optimise treatment Better information on antimicrobial consumption across the world 2. Is your organization currently involved in work related to AMR? Yes Both the UKCPA-PIN and RPS are closely involved in the development and establishment of antimicrobial stewardship. Pharmacist members of the UKCPA-PIN and RPS are fully integrated into key NHS advisory groups who develop policy and guidance relating to antimicrobial usage in the UK Page 2
RPS is working jointly with the other medical and nursing Royal Colleges in organising a summit in November 2014 to engage all professions in delivering the UK 5 Year Antimicrobial Resistance Strategy. RPS also works closely with the UK media to help share accurate messages to the public on AMR. The RPS has made a commitment to tackle AMR in its New Medicines Guide- A guide to Science Underpinning Pharmaceutical Practice (May 2014) www.rpharms.com/promoting-pharmacypdfs/nmbmbu---full-report.pdf UKCPA-PIN delivers education and training, and professional support to antimicrobial pharmacists in the UK and elsewhere in the world. They have developed an educational curriculum for antimicrobial pharmacists. Members of both help support the UK government bodies to develop antimicrobial stewardship standards for hospitals and community. Questions about the draft global action plan outline document Before the WHA resolution was adopted, two WHO AMR Strategic Technical Advisory Group (STAG) meetings were held in anticipation, which included members plus a large number of representatives from other organizations. These meetings identified key issues, concerns and led to the development of a draft outline. As this consultation progresses and stakeholder meetings are held, the secretariat will harvest and incorporate the input into the draft global action plan. 1. How would you rate your understanding of WHO s intention in the development of a global action plan to address AMR? Fair Additional comments The UK focus has mainly been on the delivery of the UK 5 Year Antimicrobial Resistance Strategy. 2. From the perspective of your organization, are the major issues relating to AMR outlined in the draft global action plan? Yes If No, what additional issues need to be addressed? Questions on the Building blocks described in the draft outline. You will notice, the global action plan has been constructed around building blocks in recognition that different countries will have different starting points. In this situation, countries can choose building blocks to concentrate upon. Each building block specified has been identified as a key area where specific attention, planning and work are needed to achieve progress in addressing AMR. Page 3
Through questions in this section, we would like to hear your opinions on these building blocks in more detail. I. Building block-1: Increasing awareness and understanding about AMR and of the actions and changes needed Improving public and healthcare professional understanding and awareness of AMR, and the role they can play in minimising its spread through improved infection prevention (hygiene and vaccination). Public Engagement Activities: There needs to be a fresh way of communicating a message that people have heard before and are getting wary of. We need to make it clear that bacteria are becoming resistant to antimicrobials, and not themselves who are resistant. Patients only taking antibiotics prescribed for them, and to complete the course. Decreasing antimicrobial prescribing, especially broad spectrum antibiotics. Public and healthcare professionals to understand that antimicrobial resistance is not just observed in antibacterials, but extends to antifungals antivirals and biocides (which may lead to crossresistance). Monitoring antimicrobial use and resistance in the veterinary and food sectors with a coherent message on the impact on human health and delivery of a clear action plan on antimicrobial stewardship Stakeholders: General Medical Council (GMC) (Stewardship), Advisory Committee on Antimicrobial Resistance (SACAR) Antibiotic Resistance Coordination Group (DEFRA DARC) (food/veterinary) ACMSF Antimicrobial Resistance (AMR) Working Group. Public Health England, European Centres for Disease Control, European Medicines Agency (EMA) Government agencies (NHS in UK) working closely with the media play an important role in highlighting AMR to the public. Target driven goals need to be set to drive better but less antibiotic prescribing. c) What steps have already been taken to address this priority? In the UK, antimicrobial stewardship guidelines exist for hospitals (Start Smart then Focus) www.gov.uk/government/publications/antimicrobial-stewardship-start-smart-then-focus and primary care (TARGET) http://www.rcgp.org.uk/clinical-and-research/target-antibiotics-toolkit.aspx In addition, antibiotic prescribing competencies and antimicrobial stewardship also exist. www.gov.uk/government/uploads/system/uploads/attachment_data/file/253094/arhaiprescrcom petencies 2_.pdf Page 4
There is a 5 year Antimicrobial Resistance Strategy (2013-8) for the UK www.gov.uk/government/collections/antimicrobial-resistance-amr-information-and-resources In Europe, there has been an educational programme for schoolchildren on hygiene, infections and antibiotics www.e-bug.eu Specifically for Antimicrobial Stewardship, we would like to see a worldwide definition of AMS and it components, and a recommendation for its implementation. A definition with 2 years, implemented in the developed world by 5 years, and the developing world by 10 years. For public and healthcare awareness, a partnership approach between WHO and global partners to deliver messages through all media formats. Local funding is often a barrier to effective communication. Do once in multiple languages and share. This could be achieved within 2 years for the major world languages. A measurement such as the Eurobarometer would identify if any progress has been made. A single repository of information for all healthcare professionals and the public to access needs to be established within 2 years. II. Building block-2: Identifying the most important approaches for preventing development of infections and the steps needed to move beyond guidance to more effective implementation of such approaches Improvements in personal hygiene, improving availability of clean water, and increasing vaccination uptake. Availability of counterfeit medicines. A lack of availability of sufficient healthcare professionals to oversee appropriate distribution of antibiotics and vaccines. Understanding the epidemiology of spread of resistant organisms. Again, governmental lead to improve hygiene and vaccination uptake through clearer messages through the media and national vaccination programmes with targets. Support to the developing world to provide clean water and improved sanitation, and better education on infection prevention and control. Global actions required: Introduction or revision of antimicrobial resistance, epidemiology and importance of hygiene and vaccination in curricula of medicine, veterinary, pharmacy and nursing undergraduate programmes Continuing professional development and training of qualified medical, veterinary, pharmacy and nursing staff Page 5
c) What significant work has already been done to address this? UK immunisation programme www.gov.uk/government/collections/immunisation Control of antibiotics as food additives banned in EU Development of national frameworks for the integrated monitoring of antibiotic use, with measurement of infection control indicators in both primary and secondary care and cross-sector detection of emerging pathogens within 2 years. III. Building block-3: Optimizing the use of existing antimicrobials for human and animal health and in agriculture Over use of antibiotics in humans without prescription, animal husbandry for food promotion, and agriculture for preventing crop destruction. Lack of availability of pharmaceutical grade antibiotics for treatment especially in developing countries. Counterfeit medicines which contain low doses on antibiotics which are probably more dangerous than no antibiotic at all. Development of rapid methods for detection of pathogen, discrimination between bacterial / viral / fungal infections and rapid point of care diagnostics and technologies for detecting the appropriate (if any) antimicrobial agent. National legislation to ensure that antibiotics are only prescribed for humans and animals (singular or herd) by prescription from an authorised practitioner. Enforcement of pharmaceutical legislation to stop the use of counterfeit medicines through tightening the supply chain. If we are to fully control the whole process, then a single convention on antibiotics, similar to the 1961 United Nation Convention on Narcotics would allow global control. This will be difficult to achieve, particularly due to different requirements in different parts of the world such as the developing world where the availability of health professionals is low and alternative methods of antibiotic. c) What steps have already been taken to address this priority? European legislation in 2006 for antibiotics for humans and animals to require a prescription. No routine use of antibiotics as growth promoters in food production. Introduction of AMS guidance as in 1c and 1d above in the UK. Page 6
Apart from those stated in block 1, an international convention on antibiotics within 5 years is essential. IV. Building block-4: Identifying and closing critical gaps in knowledge needed to address AMR A proper understanding of what the public understands about AMR so as to better target messages. Understanding (through highlighting emerging research in the area and formulation of a coherent response to key stakeholder and public engagement) the role of biocides (used in the domestic, veterinary, food sectors) in the contribution of antimicrobial resistance Research funded by continental or national governments to identify the levers needed to change public reliance on antibiotics. c) What steps have already been taken to address this priority? Outside of Eurobarometer surveys of public knowledge of AMR and antibiotic use, there has been research done in this area. However, in the UK, government has made available specific research funding streams specifically antimicrobial resistance and stewardship within the 5 year antimicrobial stewardship. The UK government has taken evidence on antimicrobial resistance from experts in the scientific, medical and veterinary fields. The outcome is still awaited. www.parliament.uk/business/committees/committees-a-z/commons-select/science-andtechnology-committee/inquiries/parliament-2010/antimicrobial-resistance-amr/ Research to be funded and completed with 2 years on what tools and techniques improve the public understanding of AMR and use or requesting of antibiotics. Level of funding for research, measurement of research outcome and measurement of impact (translation of basic research to changing policy etc) V. Building block-5: Developing an innovative and sustainable approach to develop and distribute critical products and technologies needed to address AMR Lack of diagnostics that can be used in real time in the clinic or pharmacy to determine susceptibility to particular antibiotics. Page 7
Lack of rapid diagnostics to rapidly identify whether infections are viral or bacterial infection across ALL patient populations. Lack of technology to measure concentrations of antibiotics at the sight of infection, especially in a real-time manner. Lack of global tracking of antimicrobials to minimise the opportunity for counterfeit antimicrobials to be distributed and used. Use of similar classes of antibiotics in humans, animals and agriculture that might increase resistance in critical drugs. Lack of equal access to new or existing agents at the same time across the world. Need for faster access through global licensing of new antimicrobials. Clinical trials for new antimicrobials need to address all patient groups where they are likely to be used eg. Very young children to the very old; those with severe renal or hepatic dysfunction; obese patients. Ideally not non-inferiority trials. A global convention on antibiotics needs to be agreed to help the enforcement of licensing and distributing of antimicrobials for all human, animal and agriculture use. The relevant agencies need to get the engagement of world leaders to make this happens. Major funding investment is required to develop new technologies and to make them available globally in affordable way. Development of national and international consensus on a business case for new antimicrobials which brings together a number of national proposals including controversial measures such as de-linking of sales and profits, to remove market-driven overuse of new and existing antibiotics. d) What steps have already been taken to address this priority? Some initial work has been done to improve the licensing processes between the EMA and FDA. The Longitude Prize 2014 in the UK is offering 10 million to create a cheap, accurate, rapid and easy-to-use point of care test kit for bacterial infections. www.longitudeprize.org/challenge/antibiotics The Wellcome Trust has spotlighted antimicrobial resistance for investment. Many grants are now available to find alternatives to antibiotics. www.wellcome.ac.uk/about-us/policy/spotlightissues/antimicrobial-resistance/index.htm Global convention on antimicrobials within 5 years, but ideally within 2 years. Investment in new antibiotics, antimicrobials and technologies within 2 years. Page 8
VI. Building block-6: Assessing the long term economic, developmental and social costs and implications of AMR as a basis for sustainable investment and action Antimicrobial resistance is already having an impact in the UK with some patients with ESBLs needing to be admitted to hospital for treatment, rather than receive treatment in the community. We are seeing increased lengths of stays in hospital, more time in ITU and higher antibiotics costs. This is in a background of the NHS trying to save 20 billion over 3 years. We are not clear what the current or future impact of AMR will be in the UK, but it will only continue to grow year on year. Again, national governments need to fund research to assess the local national health and societal costs of AMR, and build the current and potential costs into future funding. c) What steps have already been taken to address this priority? The Wellcome Trust is working with the UK Government to look at the economic impact of AMR. www.gov.uk/government/news/prime-minister-warns-of-global-threat-of-antibiotic-resistance Assessment of economic impact of AMR within 2 years at national and global level. Re-assessment at 5 years. Concluding questions 3. What contribution would your organization be able to make in implementing the global action plan? RPS has made a commitment in the New Medicines Guide for Pharmacists in the UK: Recommendation 2 - Improving Antimicrobial Stewardship and Stimulating New Antimicrobial Development Educate the public and patients on the use of antimicrobials and their place in therapy Encourage further development of antimicrobial stewardship by healthcare professionals to maintain the effectiveness of current and any future antimicrobials. Support the discovery and development of new antimicrobials or treatment methods by developing new financial incentives. The UKCPA-PIN has started working closely with other Pharmacy Antimicrobial Stewardship organisations from around the world to share learning and to increase AMS across the globe. Page 9
Both the RPS and UKCPA-PIN would be happy to work with WHO on the GAP either directly, or through the International Pharmaceutical Federation ( www.fip.org ). 4. Additional input that you feel would facilitate development of the GAP. None. All stated above. Page 10