Infection Control Today

OCT 2018

ICT delivers to infection preventionists & their colleagues in the operating room, sterile processing/central sterile, environmental services & materials management, timely & relevant news, trends & information impacting the profession & the industry

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1. 2. 5. 24 ICT October 2018 www.infectioncontroltoday.com The AMR Industry Alliance, comprised of more than 100 biotech, diagnostics, generics and research-based biopharmaceutical companies and trade associations, recently issued a report showing that in 2016, 22 Alliance companies invested at least $2 billion in R&D dedicated to AMR-related products. The funds cover costs for early-stage R&D, exploring new product classes, 10 antibiotics in late -stage clinical development, 13 clinical bacterial vaccine candidates, 18 AMR-relevant diagnostic products, and other preventive therapies. More than two out of three Alliance companies surveyed with marketed AMR products, have strategies, policies or plans in place to improve access to their AMR-relevant products. While vast amounts of antimicrobials, especially antibiotics, go to waste on patients and animals who do not need them, almost 6 million people die each year from infections, because they lack access to these medicines. The Alliance says supports protecting the effcacy of antibiotics and making them available, where necessary, to every human being. More than two out of three Alliance companies surveyed with marketed AMR products have strategies, policies or plans in place, which include principles or efforts to improve access to their AMR-relevant products. A similar number of companies are engaged in dialogue with external stakeholders on improving access to their AMR relevant products. Many of the Alliance generics and R&D-based biopharmaceutical companies with AMR-relevant products believe more work is needed to determine how to balance expanding access with appropriate use, reduce falsifed products, and work with other stakeholders to address access issues in low and middle-income countries. The AMR Alliance report found that more than 80 percent of all responding companies are engaged in activities to support appro- priate use, while nearly half of the responding companies have a formal appropriate use strategy in place. Nearly 90 percent of responding companies – and 70 percent of those with AMR-relevant marketed products – are planning to, currently collecting or support the collection of surveillance data. More than half of the responding companies are planning to, or are currently engaged in, stewardship education activities, directly or collaboratively. This number increases to 70 percent for those companies with a marketed AMR-relevant product. However, it is broadly acknowledged that there is a considerable way to go, and the potential of vaccines and diagnostics is not yet fully explored. The Alliance is appealing to policy-makers to draw from the evidence provided in the report and invites stakeholders to work more systematically with the life sciences industry, to fnd sustainable solutions to tackling antimicrobial resistance. Legislative efforts are underway but as of the time of writing, a key piece of legislation, the Strategies to Address Antimicrobial Resistance (STAAR) Act, introduced in the U.S. Senate on March 1, 2018 by Sen. Sherrod Brown (D-OH), is stuck in Congress. The STAAR Act would strengthen the federal response to antimicrobial resistance by: Promoting Prevention ✦ Intensifies and expands academic public health partnerships through the CDC's current Prevention Epi-Centers to support evaluation of interventions to prevent or limit resistance. ✦ Establishes regional prevention collab- oratives that partner CDC with state health departments to interrupt and prevent the transmission of signifcant antibiotic-resistant pathogens being transmitted across healthcare settings in a geographic region. Tracking Resistant Bacteria ✦ Improves data collection for human antimicrobial drug consumption and resistance. ✦ Directs CDC to report every two years on resistance trends, threats and antibiotic use. ✦ Builds upon CDC's existing intramural and extramural programs by autho- rizing the Antimicrobial Resistance Surveillance and Laboratory Network to intensify, strengthen and expand the national capacity to monitor the emergence and changes in the patterns of antimicrobial resistant pathogens, support education of the public and providers, and assist local response to outbreaks. 3. Improving Use of Antibiotics ✦ Authorizes grant s to healthcare facilities to study the development and implementation of antimicrobial stewardship programs and directs the piloting and testing of antibiotic appropriate use quality measures. 4. Enhancing Leadership, Coordination and Accountability ✦ Reauthorizes the Antimicrobial Resistance Task Force and establishes benchmarks to monitor progress of implementing Task Force recommendations. ✦ Establishes an advisor y board of outside experts to provide input from clinicians and others regarding emerging resistance around the country. ✦ I d entifie s a dire c tor w ithin the Department of Health and Human Services to oversee the Task Force and coordinate efforts in combatting antimicrobial resistance. Supporting Research ✦ Directs the National Institutes of Health (NIH) to work with other agencies and experts to create a strategic research plan for antimi- crobial resistance to provide a detailed path for ward for future funding of epidemiological, interventional, clinical, behavioral, translational, and basic research efforts. ✦ Codifes in statute the recently created National Institute for Allergy and Infectious Disease (NIAID) Clinical Trials Network on Antibacterial Resistance. References: AMR Industry Alliance. Progress report: https:// www.amrindustryalliance.org/progress-report/ Centers for Disease Control and Prevention (CDC). Antibiotic Resistance Threats in the United States, 2013. April 23, 2013. Frieden T. Foreword in: Antibiotic Resistance Threats in the United States, 2013. CDC. April 23, 2013. Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America Guidelines for Developing an Institutional Program to Enhance Antimicrobial Stewardship. Clinical Infectious Diseases. Vol. 44, No. 2. Pages 159-177. Jan. 15, 2007. Lines TH, Nesbitt WJ and Nelson GE. Driving antimicrobial use improvement: attitudes of providers of adult hospital care on optimal attribution and feedback. Infect Control Hosp Epidemiol. Online June 7, 2018. Policy Statement on Antimicrobial Stewardship by the Society for Healthcare Epidemiology of America (SHEA), the Infectious Diseases Society of America (IDSA), and the Pediatric Infectious Diseases Society (PIDS). Online Jan. 2,2015. Pulcini C, Defres S, Aggarwal I, et al. Design of a 'day 3 bundle' to improve the reassessment of inpatient empirical antibiotic prescriptions. J Antimicrob Chemother 2008;61(6):1385. Rice LB. Antimicrobial Stewardship and Antimicrobial Resistance. Medical Clinics of North America. Vol. 102, No. 5, Pages 805-818. September 2018. Septimus EJ. Antimicrobial Resistance: An Antimicrobial/Diagnostic Stewardship and Infection Prevention Approach. Medical Clinics of North America. Vol. 102, No. 5. Pages 819-829. September 2018. So AD and Shah TA. New business models for antibiotic innovation. Ups J Med Sci. 2014 May; 119(2): 176-180. May 19, 2014. 1 2 3 4 5

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