1. WHO to host consultation on global development and stewardship framework on February 29, regional workshops in March and April
On February 29, the World Health Organization (WHO) will host a global consultation on “options for establishing a global development and stewardship framework to fight antimicrobial resistance” at their Geneva headquarters. Member States and other stakeholders, including non-governmental and intergovernmental organizations, have been invited to participate in this meeting via Webex. The registration link to join the meeting virtually can be found here. The WHO has also posted an agenda for the consultation and background document outlining the objectives of a potential framework to be:
preservation of existing antimicrobial medicines through a stewardship framework covering control, distribution and appropriate use;
development of new health technologies for addressing antimicrobial resistance; and
promotion of affordable access to existing and new antimicrobial medicines and diagnostic tools.
The document also goes into further detail of potential mechanisms to achieve this objective, which will serve as the basis for discussion at the consultation.This consultation is being held in response to the mandate outlined in the resolution adopted by Member States at the 68th World Health Assembly in May 2015 endorsing the Global Action Plan on AMR (WHA68.7). The mandate calls for the WHO Director-General "to develop, in consultation with Member States and relevant partners, options for establishing a global development and stewardship framework to support the development, control, distribution and appropriate use of new antimicrobial medicines, diagnostic tools, vaccines and other intervention, while preserving existing antimicrobial medicines, and promoting affordable access to existing and new antimicrobial medicines and diagnostic tools, taking into account the needs of all countries, and in line with the global action plan on antimicrobial resistance.” This consultation will provide feedback to the WHO Director-General for their report on options for a global framework that will be delivered to Member States at the 69th World Health Assembly in May 2016.
Following this global consultation, the WHO will be coordinating a series of regional workshops for Member States to guide countries in developing and implementing national action plans on AMR. The Global Action Plan on AMR adopted by the World Health Assembly calls for Member States to develop these plans by 2017. These regional workshops are a first step in this process and will be organized by the WHO regional offices. Participation will be limited due to regional resource constraints, allowing for a maximum of two or four representatives from each country invited to attend. There are three confirmed meetings in March as follows:
Hosted by EMRO on March 14-17 in Casablanca, Morocco
Hosted by EURO on March 15-17 in Istanbul, Turkey
Hosted by AFRO on March 21-23 in Harare, Zimbabwe
2. United Nations General Assembly adopts resolution calling for high-level meeting on AMR
The WHO Executive Board (EB) discussed AMR, including plans for a potential United Nations (UN) high-level meeting in 2016, at its 138th meeting between January 26 and 30 under agenda item 8.5. The WHO has been exploring options for such a meeting as part of Director-General’s mandate under the adopted Global Action Plan on AMR to engage with the UN Secretary-General and other agencies to explore options for a high-level meeting on the margins of the UN General Assembly in 2016 as well as deliverables including a political declaration or resolution on AMR. There have been similar calls for UN action in different policy fora including the recent adoption of a resolution in December 2015 by the UN General Assembly that includes a decision to host a high-level meeting on AMR in September 2016.For the WHO EB agenda item 8.5 around UN engagement on AMR, the European Union submitted a statement in support of holding a high-level meeting at this year’s UN General Assembly. The statement recommends that a political declaration in the UN General Assembly should be the main outcome. This declaration would commit governments to multisectoral action in human health, animal health, agriculture, and environment. The EU suggests that the UN General Assembly would be a platform for a One Health approach discussed in the context of the Sustainable Development Goals. Médecins sans Frontières (Doctors Without Borders) also issued a statement calling for several specific outcomes from a high-level meeting. These include:
A clear overview of submitted national action plans and committed implementation resources;
Acknowledgement of the key role of vaccination affordability and coverage in reducing antibiotic use;
A review of the R&D pipelines for low-cost rapid diagnostic tools;
Discussion with Member States on implementing delinkage principles to developing novel, quality products and that such products be governed under a public health framework that conserves the effectiveness of new antibiotics as well as ensures affordability and access for those in need; and
Assurance that AMR-related research carried out under the Global Action Plan are integrated with the Consultative Expert Working Group and included in the mandate of a Pooled Fund hosted by the WHO TDR (Special Programme for Research and Training in Tropical Diseases).
Addressing AMR is also mentioned as one of the goals within the draft resolution entitled "Health in the 2030 Agenda for Sustainable Development." This resolution calls for strengthening the linkages between veterinary, medical, and environmental communities to improve surveillance, research, prevention, and training to address the threats of emerging and re-emerging diseases, including antibiotic resistant bacteria.
3. Submission deadline extended for contributions to the UN High-Level Panel on Access to Medicines
Parallel to the call for UN engagement on AMR, the UN Secretary-General’s High-Level Panel on Access to Medicines is accepting contributions from stakeholders on recommendations that will promote R&D, innovation, and improve access to medicines and other technologies. Contributions are invited from all relevant stakeholders including governments, industry, research institutions, academia, civil society, and other expert groups. The deadline for this input has been extended to February 28, 2016 and the Panel has also lifted restrictions regarding the number of contributions authors are able to submit or sign onto. Further details on the call for proposals are posted on the High Level Panel's website, which is also where proposals can be submitted. The High-Level Panel on Access to Medicines was first convened in December 2015 with the mandate to put forward solutions for “remedying the policy incoherence between international human rights law, trade rules and public health in the context of health technologies.” The Panel is seeking input for their final recommendations to the Secretary General by calling for and assessing these contributions from outside organizations as well as staging a process to further examine shortlisted proposals through two public hearings to be held in March in London, United Kingdom and Johannesburg, South Africa.The UN Development Program, which serves as the Secretariat for the High-Level Panel also convened briefing sessions in Geneva and New York in early February for Member States and other groups including industry and civil society. They invited members of both the High-Level Panel and the Expert Advisory Group, who will be reviewing submitted contributions and offering recommendations to the Panels, to give interventions on the process and its opportunities. Anthony So, Director of the Center for Livable Future at Johns Hopkins Bloomberg School of Public Health and Coordinator of the ReAct Strategic Policy Program, delivered an an intervention tying in the challenges of innovation and access related to AMR to the mandate of the Panel. In his remarks, he highlighted that as the use of antibiotics generates resistance, principles such as delinkage in divorcing return on investment from volume-based sales is necessary to address antibiotic innovation, while ensuring conservation. He also highlighted concerns around the impact of proposals such as value-based pricing on the affordability of antibiotics. More coverage of the briefing and Dr. So’s remarks can be found here.
4. Consumers International to launch AMR campaign for World Consumer Rights Day on March 15
On World Consumer Rights Day (March 15, 2016), Consumers International (CI) will call on the largest fast food companies to make global, time-bound commitments with third party auditing to stop serving meat produced with the routine use of antibiotics used in human medicine. Around 50% of the world’s antibiotics are used in animal agriculture, much of which is given routinely for growth promotion or disease prevention. McDonald’s, Subway, and KFC have 100,000 restaurants – this puts the three chains in a position to use their purchasing power to change the global supply chain for meat faster than legislative efforts alone. On February 24, CI will launch its campaign on Thunderclap, a platform that automatically share its message through social media profiles of participants once a target number of people sign up to support the campaign. The Thunderclap is set to make a single post on World Consumer Rights Day. CI additionally encourages organizations and members of the public to use the hashtag #AntibioticsOfftheMenu to further publicize the campaign. CI has created a resource guide (available in English, Spanish, French, and Arabic) and a resource pack that includes a template letter to fast food chains, template article for publicizing World Consumer Rights Day, frequently asked questions information on AMR, and a resource list on AMR. The resource guide contains suggestions on social media photo messaging and event organization. Those who are writing letters and are interested in holding follow-up meetings or phone calls are urged to contact Jack Goodall (email@example.com) at the CI London office.Subway and McDonald’s have already taken steps to reduce antibiotic use, which suggests the feasibility of global animal antibiotic use reduction. However, Subway’s commitment is limited to the US, and McDonald’s has only made a commitment for chicken products in US and Canada. To date, KFC has made no such commitment. During World Antibiotic Awareness Week in November 2015, CI initiated a letter-writing campaign to the headquarters of McDonald’s, Subway, and KFC. The results of the letter writing campaign will also be released on February 24.
5. Food and Agriculture Organization views AMR as a threat to food security
Watch Dr. Juan Lubroth, Chief Veterinary Officer of the FAO, speaks about AMR in this new short educational video
Deputy Director-General Helena Semedo of the Food and Agriculture Organization of the UN (FAO) has declared that AMR is a significant risk to food security and target for coordinated global action. While speaking to the European ministers of health and agriculture at a conference on AMR in Amsterdam, Semedo discussed how AMR not only reduces the efficacy of antibiotics in human health, but also threatens animal health, rural livelihoods, and food security. Semedo views disease management as one of the most difficult food security challenges alongside climate change and urbanization.The FAO article about Semedo's talk also mentions how oxytetracycline is used in orange trees against Huanglongbing, a bacterial disease that is fatal to citrus trees. According to the Citrus Research and Development Foundation, a citrus industry research group, streptomycin and oxytetracycline are routinely used on crops when spraying crops with copper is not sufficient to manage plant disease. FAO is working with WHO and the World Organization for Animal Health (OIE), as well as through the Codex Alimentarius, to combat AMR as part of ending hunger and rural poverty, while raising up sustainable agriculture and resilient livelihoods. Semedo praised countries like the Netherlands for reducing the quantity of antibiotics used in its livestock sector by 60% in recent years. However, she emphasized that "the real challenge for us is to translate such efforts to countries in need with poor resources." The FAO supports regulations to control the use of antibiotics, but also acknowledges that smallholder farmers do sometimes need antibiotics and that counterfeit drugs are widespread. For these reasons, the FAO has highlighted the need for improvement in hygiene, disease prevention, veterinary oversight, accurate and affordable diagnostics, and nutrition for animals to increase their overall health status. Noting that 70% of emerging infectious diseases in humans originate in animals, the FAO has reiterated its call for a One Health approach that includes "human, animal and environmental wellness."
6. Routine use of antibiotics for malnourished children does not improve recovery rates
Severe acute malnutrition affects 19 million children under the age of 5 worldwide, and bacterial infection can complicate nutritional recovery. However, researchers found that there was no difference in nutritional recovery between children who received amoxicillin and children who were given a placebo. Their study, funded by Médecins sans Frontières (Doctors Without Borders) and published in the New England Journal of Medicine, provides evidence that routine antibiotic use does not increase the likelihood of nutritional recovery for children. In a trial of 2,400 children with severe acute malnutrition in Niger, the group receiving amoxicillin did not achieve a statistically significantly higher rate of nutritional recovery, with 66% of children recovering at eight weeks compared to 63% in the placebo group. The researchers suggest that if a healthcare facility has adequate infrastructure for surveillance and complication management, it should consider removing routine antibiotic use from its treatment protocols for severe acute malnutrition.In 1999, at a time when children with severe acute malnutrition were treated as inpatients, the World Health Organization recommended the routine use of broad-spectrum antibiotics for these children regardless of clinical indications due to the high risk of healthcare-acquired infections. In 2007, the WHO and United Nations endorsed a community-based malnutrition management model, in which children are treated at home with ready-to-use therapeutic food. This model allows for active case-finding with the intent of reaching malnourished children before they experience clinical complications. Given the risk of antibiotic resistance, this study suggests that more evidence is needed to support the continued use of antibiotics for malnourished children.
7. Pharmaceutical, biotechnology, and diagnostic companies launch joint declaration on AMR
In January 2016, the pharmaceutical industry launched a declaration on combating antimicrobial resistance at the World Economic Forum in Davos, Switzerland. The signatories included 85 companies and 9 industry associations from the pharmaceutical, diagnostics, and biotechnology industries. To improve "financial and access-related predictability" for industry and healthy systems, the signatories called for proposals for business models that reduce the link between revenue and volume of antibiotic use while mitigating financial risk. Mechanisms suggested in the declaration include lump sum market entry rewards as proposed by the UK Review on AMR, insurance-like purchase models, and novel intellectual property approaches with "appropriate safeguards" (though these safeguards are not specified). The declaration also claims that such models would reduce the need for promotional activities. The declaration advises that in developed markets, new drugs and diagnostics should be reimbursed "to reflect the benefits they bring." The declaration calls on governments to fund and implement business models that enhance antibiotic conservation. To achieve this goal, the declaration recommends implementation of comprehensive stewardship programs as called for by the World Health Organization Global Action Plan, and "improved reimbursement and use of advanced diagnostics." The declaration also calls for the removal of financial incentives that rewards prescribing antibiotics in greater volumes. The declaration establishes a commitment across three areas, with updates to the declaration every 2 years:
Reducing development of AMR: The signatories commit to encouraging appropriate use of antibiotics through continued education for healthcare professionals based on the WHO Global Action Plan's stewardship principles. The declaration also supports improving infection control, reducing environmental pollution from antibiotics, and taking a "One Health" approach in reducing unnecessary antibiotic use in livestock.
Investment in R&D to meet global public health needs: The declaration emphasizes the need for work and investment into the multiple approaches to overcome the challenges of antibiotic discovery. This includes investment in innovative antibiotics, vaccines, alternative technologies, and diagnostics. The companies will continue to support research in academia, and research by small and medium enterprises on new and re-purposed antibiotics. The declaration supports public-private partnerships such as New Drugs for Bad Bugs (in partnership with Innovative Medicines Initiative and the European Commission) and collaborations funded by BARDA and NIH.
Improving access to high-quality antibiotics for all: The signatories support mechanisms to ensure affordable access to new and existing antibiotics in all parts of the world for patients in need of them, regardless of income. Recognizing the success of global access programs for HIV, Tuberculosis, and malaria, the declaration calls for a similar effort for antibiotics.
Also released at Davos, the newly published World Economic Forum Global Risks Report again mentions the threat of AMR. The report notes that deaths due to resistant bacteria have been increasing every year in the European Union and the US. The report also acknowledges that the burden in low- and middle-income countries is much higher. Given the speed at which resistant bacteria can spread, the report emphasizes strengthening health systems through effective health communication; R&D for diagnostics, drugs and vaccines; and the creation of enabling regulatory and financial environments.
8. UK Review on AMR releases report on vaccines and alternatives to antibiotics
The UK Review on AMR published a report that proposes to increase the use of existing vaccines more widely in humans and animals, invest in early research, and sustain markets for vaccines and alternatives to antibiotics products through incentives for research and development. Vaccines prevent bacterial infections that would otherwise need to be treated with antibiotics, and vaccines for viral infections can reduce inappropriate antibiotic use. In the short term, the Review calls for increased use of existing vaccines and improved delivery in communities, hospitals, and farming systems. The report praises examples like Gavi (the Vaccine Alliance) and UNICEF as examples of entities that have provided the necessary financial support to increase vaccine coverage in low-income countries. The report also points out that some high and middle-income countries lack universal coverage for large portions of their populations. The pneumococcal conjugate vaccine has potential to reduce significantly the deaths and use of antibiotics related to pneumonia. The WHO estimates that pneumonia kills over 800,000 children under the age of 5 every year. A study published in the Lancet estimated that universal global coverage for this vaccine could prevent many of these deaths and 11.4 million days of antibiotic use per year in this age group.Wider use of the rotavirus vaccine could help reduce child diarrheal disease, which is a major cause of death and a driver of antibiotic use. There are no vaccines currently in use and too few candidates in clinical trials for three urgent resistance threats identified by the US CDC: carbapenemase-producing bacteria, gonorrhea, and C. difficile. Vaccine development is economically risky, often taking over 10 years to complete. The Review proposes creating market interventions to incentivize research and development on vaccines and alternative treatments where the market is currently not attractive. These interventions include advance market commitments and market entry rewards, which reward developers for successful products rather than sharing risks in the early stages of research.
9. Fifty medical and scientific organizations call for EU-wide ban on preventive antibiotic use in animals
Representatives from 50 medical and scientific organizations have written a letter published in the Telegraph on February 15 calling for the European Union to ban the preventive use of antibiotics in farm animals by revising existing EU law on veterinary medicines. Farm animals account for nearly two thirds of all antibiotics used in 26 European countries, and 90% of farm use of antibiotics in Europe occurs through treatments of entire groups of animals. As a result of these group treatments, some animals that are not sick receive antibiotics unnecessarily. The letter points out that in October 2015, farmers' unions in the countries of Denmark, Finland, Iceland, Norway, and Sweden had recommended a ban on the prophylactic use of antibiotics. The unions asked the Ministers of the Nordic Council to advocate to the European Commission for a ban on preventive use in animals. The letter urges EU governments, European Parliament, and European Commission to implement such a ban on preventive use of antibiotics.On February 17, two days after the letter was published, the European Parliament Committee on Environment, Public Health, and Food Safety voted to approve a report on updating veterinary drug legislation to limit preventive use of antibiotics in animals and only permit administering antibiotics to single animals under veterinary control. The European Parliament recommends that farmers keep animal stocks with suitable genetic diversity, in lower-density conditions to prevent disease transmissions, and with sick animals isolated from the rest of the group. The draft report on the legislation would allow the European Commission to designate antimicrobials to be reserved for human treatment. The report also calls for enhanced innovation in new veterinary medicines. To encourage such research, the report advocates for extended protection for technical documentation on new medicines, commercial protection of innovative active substances, and protection for investments made to generate data to improve an existing antibiotic or keep it on the market. In a separate vote, the committee approved a report that would amend another law to decouple the marketing authorization for human medical products from animal medical products. Both reports will be debated and voted on in March and April during plenary sessions.
10. Kerala launches statewide antibiotic stewardship program
The Indian state of Kerala is set to adopt a comprehensive antibiotic stewardship program covering public and private health services. The stewardship program guidelines contain evidence-based treatment recommendations intended to promote behavior change through public awareness and education. Kerala is the highest consumer of drugs in India, accounting for 10-13% of drug sales despite only having 2.77% of the country's population. The first stage of the program will target physicians and pharmacists to educate them on rational use of antibiotics. According to the Times of India, the program will also introduce antisepsis management to reduce the risk of healthcare-acquired infections in hospitals with 300 to 500 beds, which will capture 32 institutions. In addition, the guidelines propose mandatory procedures for cleaning hospitals. The next stage of the program will involve addressing the veterinary use of antibiotics, prescriptions of antibiotics by ayurvedic and homeopathic doctors. The program's introduction included a series of workshops under Kerala health secretary K. Ellangovan with the participation of the Indian Medical Association and the Indian Academy of Pediatrics. On January 23rd, the Kerala State Health Department launched the stewardship program at a symposium in Kochi attended by Indian public health officials, and representatives from Imperial College, London, the Indian Council of Medical Research, and the All India Institute of Medical Sciences.
11. New diagnostic tests can accurately differentiate bacterial and viral infections
A research team at Duke University has developed a diagnostic test that differentiates bacterial, viral, and noninfectious acute respiratory infection by detecting changes in host blood gene expression. A recently published observational cohort study found that the test was correct in determining whether an illness was caused by a bacteria, virus, or noninfectious illness 87% of the time for 273 emergency department subjects presenting with a respiratory illnesses. The host gene expression test was more accurate than procalcitonin testing, the current standard test for determining whether an infection is bacterial or viral, which had 78% accuracy. This test could serve as an important clinical decisionmaking aid to reduce antibiotic overuse and ensure patients who need antibiotics receive them. However, the test currently requires up to 10 hours of lab analysis. The researchers are now attempting to adapt this test for point-of-care use and reduce the analysis time to 1 hour.The next stage of the program will involve addressing the veterinary use of antibiotics, prescriptions of antibiotics by ayurvedic and homeopathic doctors. The program's introduction included a series of workshops under Kerala health secretary K. Ellangovan with the participation of the Indian Medical Association and the Indian Academy of Pediatrics. On January 23rd, the Kerala State Health Department launched the stewardship program at a symposium in Kochi attended by Indian public health officials, and representatives from Imperial College, London, the Indian Council of Medical Research, and the All India Institute of Medical Sciences.
12. American College of Physicians and CDC release guidelines on appropriate clinical use of antibiotics
The American College of Physicians (ACP) and the US Centers for Disease Control and Prevention (CDC) has released guidelines for physicians regarding prescription of drugs for acute respiratory conditions. These guidelines arose in light of the fact that antibiotics are prescribed at more than 100 million adult ambulatory care visits per year, and 41% of these prescriptions are for respiratory conditions. Antibiotics are responsible not only for the public health threat of antibiotic resistance, but also the largest number of medication-related adverse events - antibiotics account for 1 in 5 visits to the emergency department for adverse drug reactions. The CDC estimates that 50% of antibiotic prescriptions may be unnecessary or inappropriate. To reduce overuse of antibiotics for respiratory illness, the guidelines provide four key pieces of advice:
Clinicians should not perform testing or initiate antibiotic therapy in patients with bronchitis unless pneumonia is suspected.
Clinicians should test patients with symptoms suggestive of group A streptococcal pharyngitis by rapid antigen detection test and/or culture for group A Streptococcus. They should treat with antibiotics only if the patient has confirmed streptococcal pharyngitis.
For patients with acute rhinosinusitis, clinicians should only give antibiotics when the symptoms have persisted for more than 10 days; severe symptoms or signs of high fever in addition to nasal discharge or facial pain lasting longer than 3 days, or when symptoms worsen after a typical viral illness lasting 5 days initially starts to improve.
Clinicians should not prescribe antibiotics for patients with the common cold.
The ACP is a professional society for internal medicine and the second largest physician group in the US.
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Note: The ARC Newsletter will periodically capture key meetings and developments, as well as news and resources, on antibiotic resistance for Coalition members and partners. This newsletter is prepared and published through ReAct North America/Strategic Policy Program at Johns Hopkins Bloomberg School of Public Health. The ARC Declaration on Antibiotic Resistance can be found here. Please share items for consideration for inclusion in future newsletters by writing to Reshma Ramachandran at firstname.lastname@example.org.