ASP Scan (Weekly) for Jun 29, 2018

FDA guidance for reporting animal antimicrobial sales
VIM-CRE in Indiana hospitals
Resistant bugs in meat
UTI prophylactic antibiotics and resistance
Antibiotic stewardship financial incentives
New drug-resistant UTI treatment
Updated infectious disease lab testing guide
Letter-based antibiotic prescribing intervention
CMS proposes less hospital infection reporting

Our weekly wrap-up of antimicrobial stewardship & antimicrobial resistance scans

FDA issues antimicrobial sales reporting guidance for animal-drug makers

The US Food and Drug Administration (FDA) yesterday released guidance to help animal-drug makers meet requirements for reporting antimicrobial sales. The step follows the 2016 implementation of a final rule that revised annual reporting requirements for companies that sell or distribute antibiotics for use in food-producing animals.

Because antimicrobial use in animals contributes to emerging antimicrobial resistance that poses a threat to people, the federal government tracks annual sales of animal antimicrobials, including those that are important for use in human and veterinary medicine.

Steve Solomon, DVM, who directs the FDA Center for Veterinary Medicine, said in an FDA statement that the guidance will help ensure that the animal-drug sponsors understand their responsibilities and can comply with reporting requirements, designed to give the FDA an accurate picture of the volume of antimicrobial drugs that enter the marketplace. "Sales and distribution information are one piece of the overall picture related to antimicrobial resistance that can help to better our understanding of this critical public health issue."
Jun 28 FDA statement


Testing suggests VIM-CRE in Indiana hospitals, possible regional emergence

Enhanced surveillance for carbapenemase-producing carbapenem-resistant Enterobacteriaceae (CP-CRE) in Indiana that began in December 2015 identified Verona integron-mediated metallo-beta-lactamase (VIM)–producing types that are frequently found in southern Europe and Southeast Asia, but are rare in the United States.

Between January 2016 and December 2017, tests identified 649 CP-CRE isolates across Indiana, including 9 VIM-CRE isolates from 7 patients. VIM was the most commonly identified carbapenemase after Klebsiella pneumoniae carbapenemase, authors from the Indiana State Department of Health and the US Centers for Disease Control and Prevention (CDC) reported today in Morbidity and Mortality Weekly Report. Seven different species were found in the nine VIM-producing isolates; one was from a patient colonized or infected with three different VIM-producing organisms over a 15-month period.

None of the patients had traveled overseas in the 6 months before specimens were collected, but all had stayed overnight in an Indiana hospital, suggesting VIM transmission within Indiana health facilities.

Investigators said that though VIM is still one of the least frequently reported carbapenemases among CRE in the United States, Indiana and its neighbors account for 29 (71%) of 41 VIM-CRE isolates reported to the CDC so far, hinting at the potential for regional emergence of the resistance mechanism.
Jun 29 MMWR note from the field


Nonprofit group warns of resistant bacteria in meat, offers consumer tips

The Environmental Working Group, a nonprofit group that works to protect health and the environment, issued a report yesterday warning that resistant bacteria are common in retail meat and poultry samples and offered consumer tips on avoiding such contamination.

Based on its own analysis of 2015 data from the National Antimicrobial Resistance Monitoring System (NARMS), the EWG said that bacteria with resistance to at least one antibiotic were found in 79% of retail turkey samples, 71% of pork chops, 62% of ground beef, and 36% of chicken breasts, wings, and thighs. The percentages refer to Enterococcus faecalis, a common gut bacterium that can indicate the presence of fecal contamination.

The report notes that resistant bacteria can pass their resistance genes to other bacteria, giving rise to resistant pathogens.

“Consumers need to know about potential contamination of the meat they eat, so they can be vigilant about food safety, especially when cooking for children, pregnant women, older adults or the immune-compromised,” Dawn Undurraga, MS, RD, EWG’s nutritionist and author of the report, said in a press release from the group.

The press release includes links to a tip sheet on how to avoid resistant bacteria in meat and to a “label decoder” to help consumers understand labels on meat, dairy products, and eggs. The decoder explains the significance of labels such as “American Grassfed Association,” “Animal Welfare Approved,” “Certified Humane,” “USDA Organic,” and others.

The EWG also released a letter to the commissioner of the US Food and Drug Administration calling for more aggressive action to keep resistant bacteria out of food. 
Jun 28 EWG press release and report
June 28 EWG letter to the FDA
Oct 23, 2017, CIDRAP News story on NARMS report based on 2015 sampling


Studies find increased antimicrobial resistance with prophylaxis for UTIs

Two new studies of antibiotic prophylaxis for urinary tract infections (UTIs) found an increased risk of drug resistance in recurrent infections, one involving adults who use clean intermittent self-catheterization (CISC) to empty their bladders and the other involving children who have a history of vesicoureteral reflux.

A team from Newcastle University in the United Kingdom, writing in The Lancet Infectious Diseases, reported on a randomized open-label superiority trial that compared once-daily antibiotic prophylaxis with no prophylaxis over a 12-month period to explore the benefits, drawbacks, and cost-effectiveness of low-dose treatment in adults. Between November 2013 and January 2016, researchers enrolled 404 participants, including 203 who received prophylaxis (nitrofurantroin, trimethoprim, or cotrimoxazole) and 201 who didn't.

Continuous treatment reduced UTI frequency in CISC users and was well tolerated, but there was increased resistance, not only to the drugs used for prophylaxis but also to other antibiotics commonly prescribed for UTI treatment.

"The severity of individual patient distress from repeated UTIs and local threats from antimicrobial resistance should simultaneously be considered when appraising and implementing this evidence of benefit of treatment," the authors wrote.
Jun 28 Lancet Infect Dis report

The other study is a meta-analysis of six randomized controlled trials of children age 18 or younger who had a history of vesicoureteral reflux and did or didn't receive continuous antibiotic prophylaxis. The international research team published its findings yesterday in Pediatrics.

The studies included 1,299 patients who had 224 UTIs. Patients who got prophylactic treatment were more likely to have a multidrug-resistant infection than those not treated (33% versus 6%, P< .001) and were more likely to receive broad-spectrum antibiotics (68% versus 49%, P< .004).

The group's analysis found that patients on prophylaxis had 6.4 times the odds of developing a multidrug-resistant infection and that one multidrug-resistant infection developed for every 21 patients treated with prophylaxis.

They concluded that the findings have important implications for weighing the risks and benefits of prophylaxis as a management strategy and for selecting empiric treatment for breakthrough infections in patients on antibiotic prophylaxis.
Jun 28 Pediatrics abstract


Financial incentives helped curb unnecessary antibiotic prescribing in NHS doctors

Originally published by CIDRAP News Jun 28

A financial incentive program for United Kingdom National Health Service (NHS) local groups reduced antibiotic prescribing by general practitioners for common respiratory infections by 3%, a research team based at Imperial College London reported today in the Journal of Antimicrobial Chemotherapy.

In 2015, UK officials introduced a quality premium program to improve services at NHS locations that included financial incentives for meeting different criteria, which included measures to reduce antibiotic prescribing by 1% and reduce broad-spectrum antibiotic prescriptions by 10%. Today's report is the first to describe the impact of the plan.

In reviewing data from general practices across England from 2011 to 2017, the authors focused on antibiotic prescribing for uncomplicated respiratory tract infections (RTIs), the majority of which are caused by viruses and don't respond to antibiotics. They saw the expected seasonal peaks and troughs in incidence, but antibiotic prescribing rates decreased over the 6-year period. In April 2015, a time that marked the launch of the antibiotic-prescribing incentive plan, antibiotic prescribing rates declined by 3%, or 14.65 prescriptions per 1,000 RTIs. The team also saw a 2% relative reduction in the broad-spectrum antibiotic prescribing rate.

The greatest reductions occurred in patients who had sore throats and in younger patients, with a 6% reduction in prescribing for children, a group for whom the number of doctor visits for RTIs is higher.

Sabine Bou-Antoun, MSc, the study's first author and an epidemiologist at Imperial College London, said in a press release from the school, "It is important to reduce unnecessary and inappropriate antibiotic prescribing as it is a known driver of antibiotic resistance. It's also important to measure the impact of national interventions targeted at improving the use of antibiotics so we can evaluate and identify what is working."

The group is currently investigating whether reduced antibiotic prescribing has led to any negative impacts, including increased frequency of illnesses. Alison Holmes, MD, MPH, study coauthor who is with the National Institute for Health Research and is professor of infectious diseases at Imperial College London, said, "National-level schemes such as these are important tools in our efforts to reduce antibiotic prescribing, but it is critical that these interventions are objectively and expertly evaluated."
Jun 27 Imperial College London press release
Jun 28 J Antimicrob Chemother abstract


New antibiotic approved for drug-resistant UTIs

Originally published by CIDRAP News Jun 28

The FDA approved the use of plazomicin as a new treatment for complicated, drug-resistant urinary tract infections (UTIs).

Plazomicin, marketed under the name Zemdri, is not a new antibiotic class, but has been developed to treat drug-resistant Enterobacteriaceae, identified as one of the World Health Organization's top three difficult-to-treat superbugs.

"This new antibiotic will be a vital last-resort treatment for patients with complicated and life-threatening urinary tract infections," said Tim Jinks, head of Wellcome's drug-resistant infections program in a press release. The Wellcome Trust helped fund Zemdri's development.

Zemdri is given as an intravenous infusion, administered once daily, according to Achaogen, Inc, the drug’s manufacturer. Recent phase 3 clinical trials showed that greater than 99% of Escherichia coliK pneumoniae and Enterobacter cloacae in US surveillance are susceptible to Zemdri.

Each year, the United States sees approximately 3 million cases of complicated urinary tract infections, many caused by Enterobacteriaceae, a family of gram-negative bacteria that are becoming increasingly resistant to first-line antibiotics.
Jun 27 Wellcome press release
Jun 26 Achaogen press release


IDSA and ASM update lab diagnosis guide for health providers

Originally published by CIDRAP News Jun 28

In an update to recommendations from 2013, the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM) today unveiled their latest guide for using microbiology lab tests to diagnose infectious diseases. The full report appears in the latest edition of Clinical Infectious Diseases.

J. Michael Miller, PhD, the guide's lead author and director of Microbiology Technical Services in Dunwoody, Ga., said in an IDSA press release, "As fast as technology is moving, especially with the genetic and molecular tests, this update was necessary."

The guide details the precise steps for collecting and managing blood, urine, tissue, and other specimens and contains tables that provide detailed information on the use and limitations of tests, organized by type of infections (such as urinary tract or upper respiratory) to help health providers order the best test and collect the appropriate sample. It also includes expanded information on pediatric testing, tests for tick-borne diseases, and information on diagnostic advancements, such as nucleic acid amplification tests that can identify organisms faster and less expensively, the IDSA said.

Melvin P. Weinstein, MD, guide coauthor and chief of infectious diseases at Rutgers Robert Wood Johnson Medical School, said, "Instead of using a shotgun approach and prescribing broad spectrum antibiotics, these new rapid diagnostic tests can help health care providers target the specific organism causing the infection much sooner than traditional microbiologic tests."
Jun 28 IDSA press release
Jun 28 Clin Infect Dis 


Letter from chief medical officer cuts antibiotic prescribing

Originally published by CIDRAP News Jun 25

The Behavioural Economics Team of the Australian Government, in partnership with Australia's Chief Medical Officer (CMO) and the Department of Health, released a new report showing that targeting high-prescribing physicians with a letter from the CMO helped lower the number of antibiotic prescriptions within 6 months.

To conduct the randomized control trial, researchers identified the top 30% antibiotic prescribers by region. The CMO sent letters explaining antimicrobial resistance to one group, no letters to a control group, and letters containing information comparing the physician's prescribing behavior to his or her peers to other groups.

Six months after receiving the letters, doctors who had received a letter that included peer comparisons had reduced their prescribing by 12%.

"Compared to GPs who did not receive a letter, the peer comparison letters resulted in a 9.3 to 12.3 percent reduction in prescription rates over six months. In comparison, the education-only letter reduced antibiotic prescriptions by 3.2 percent over six months," the authors said.

The authors concluded that a peer comparison letter, signed by a respected authority, was an effective way to target antibiotic overuse.
Jun 25 Australian Department of Health report


CMS proposal would halt reporting of hospital infection, other safety issues

Originally published by CIDRAP News Jun 25

A proposed rule from the Centers for Medicare and Medicaid Services (CMS) would halt public disclosure of hospital-associated infections, including those from methicillin-resistant Staphylococcus aureus and Clostridium difficile, and other patient safety problems, a nonprofit group warned in a Jun 12 call to action that urged concerned groups to comment before the rule is finalized and takes effect in November.

The safety data are contained in the Inpatient Quality Reporting Program, established by the George W. Bush administration in 2005, when the CMS Hospital Compare website began disclosing some of the safety measures, according to a Jun 19 USA Today report.

Consumers, businesses, some health providers, and policymakers had pushed for including the information on the website as a part of more transparent system that pays hospitals receiving Medicare payment to report errors, injuries, and infections. The group that sounded alarm about the proposed rule change is Leapfrog Group, a nonprofit hospital rating organization based in Washington, DC.

A CMS official has denied that it was proposing to remove the information from Hospital Compare and emphasized that the changes are open for public comment, the USA Today report said. Though hospitals haven't pushed for the change, the American Hospital Association said that the amount of information required by different federal programs is burdensome and that the change would allow them to focus more on patient safety.
Jun 19 USA Today story
Jun 12 Leapfrog Group call to action

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