News Scan for Aug 25, 2016

News brief

Cases of severe MERS in the Middle East likely much higher than reported

New data from the Centers for Disease Control and Prevention (CDC) shows that there were 3,250 likely cases of severe MERS-CoV in the Middle East between Sept 2012 and Jan 2016. This number is 2.3-fold higher than current laboratory confirmed cases, suggesting that the disease is more widespread than previously thought.

Researchers based their findings on a calculation that used instances of severe (requiring hospitalization) MERS-CoV (Middle East respiratory syndrome coronavirus) infection in travelers returning from either Saudi Arabia, Jordan, the United Arab Emirates, or Qatar.

By assuming travelers and local residents had similar per-day risk of infection, the number of suspected cases was calculated by multiplying severe case rate among travelers by each country’s total person-time at risk in the population. Based on those calculations, Saudi Arabia had the largest number of estimated cases at 2,269.

"Public health officials are concerned about MERS-CoV, both in the source countries and from exported cases in persons who can seed outbreaks elsewhere," the authors wrote. "By better estimating the epidemic size in the Middle East, our results can help guide public health preparedness efforts in source countries and contribute to projections of the number of cases that could occur among travelers."
Aug 24 Emerg Infect Dis study

FDA offers new FSMA guidance, pushes back some deadlines

The US Food and Drug Administration (FDA) this week published several guidance documents to help with compliance with the FDA Food Safety Modernization Act (FSMA), while also pushing back deadlines for complying with multiple components.

On Aug 23 the agency published the first 5 chapters on what will be a 14-chapter document designed to help businesses comply with Current Good Manufacturing Practice (CGMP), hazard analysis, and risk-based preventive controls for the production of human food. "The draft guidance explains FDA's current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls and includes a discussion about establishing a food safety plan," the agency said in a constituent update.

The FDA will release the other chapters of the draft guidance document for public comment as they are completed, planning to finish the document by early 2018.

The FDA also provided more time for manufacturers to comply with certain requirements of four of the seven FSMA rules: the two involving CGMP and preventive control rules for human and animal food, the rule on foreign supplier verification, and the one on produce safety.

Yesterday the FDA posted two draft guidance documents to help industry professionals implement preventive controls for the animal food rule, along with a third document to help businesses determine whether functions that they perform are within the "farm" definition used in the FSMA rules.

One of the animal food documents covers CGMP requirements, and the other covers human food by-products used for producing animal foods. The FDA will offer a webinar in late September to explain the draft documents in more detail.

In determining what business operations fall under the "farm" designation, the agency said in a constituent update, "In general, businesses that only perform activities within the 'farm' definition are not subject to the FSMA Preventive Controls for Human Food or Animal Food rules. Instead, when their activities involve covered produce, farms may be subject to the FSMA Produce Safety rule.

"Facilities conducting activities that are outside the farm definition generally need to register with the FDA as food facilities (unless other exemption(s) apply, such as the exemptions for retail food establishments and restaurants) and may be subject to the FSMA Preventive Controls for Human Food or Animal Food rule. Farms, including those subject to the Produce Safety rule, are not required to register with the FDA as food facilities."

The FSMA was enacted in 2011.
Aug 23 FDA update
Aug 24 FDA update
Aug 23 FDA statement "Compliance date extensions and clarifications for FSMA final rules"

India may have double the number of TB cases estimated

A study published yesterday in The Lancet Infectious Diseases suggests the number of tuberculosis (TB) cases in India could be drastically underreported —potentially two to three times higher than current estimates.

Researchers looked at data from TB drug sales to gain a more accurate picture of TB cases in India. Many Indians choose to use private doctors, and not the public healthcare system, to treat TB; private doctors often fail to report cases of the bacterial infection to health officials.

The researchers found evidence that there was possibly more than 2.2 million TB cases treated by private doctors in 2014, at least 1.9 million in the private sector and an additional 1.4 million cases managed by public health officials.

"On any given day, this translates on average to 1.46 million people being on tuberculosis treatment, more than 12% of the country's population," the authors wrote.

Besides an increased burden of disease, the authors of the study said antibiotics used to treat TB are a significant out-of-pocket expense for patients. "Our estimates imply that in 2014, over $59 million was spent in out-of-pocket expenditure on first-line tuberculosis drugs alone," the authors wrote.

According to a press release today from Imperial College London, India has the highest number of TB cases in the world, accounting for at least 25% of all cases worldwide.
Aug 24 Lancet Infect Dis study
Aug 25 Imperial College London release

Study: Benefits of rotavirus vaccine outweigh risk of intussusception

A study yesterday in Pediatrics looked to see if rotavirus vaccines led to increased instances of intussusception, the dangerous telescoping of the intestines, among infants. While there was some evidence of increased risk among very young infants, the authors concluded that the benefits of the rotavirus vaccine outweighed the risk of this rare side effect.

The first rotavirus vaccine, RotaShield, introduced in 1999 caused an increased risk of intussusception. That vaccine was discontinued, and in 2006 two new vaccines were introduced.

Researchers conducted a retrospective analysis of intussusception hospitalizations between 2000 and 2013, comparing rates of hospitalizations before and after the 2006 introduction of RotaTeq and Rotarix vaccines. Among children 8 to 11 weeks of age, there were increased rates of intussusception from 2007 through 2013 compared with the pre-vaccine baseline. The increased rate was an estimated 7 to 26 additional cases of intussusception annually.

But among all children less than 12 months of age, there was no overall increased risk of intussusception.

"[G]iven the magnitude of the declines in rotavirus disease compared with the small increased risk of intussusception, the public health benefits of rotavirus vaccination far exceed the increased risk of intussusception," the authors wrote.
Aug 25 Pediatrics study

Antimicrobial Resistance Scan for Aug 25, 2016

News brief

Most adults with bronchitis receive unnecessary antibiotics

A new study from the Centers for Disease Control and Prevention (CDC) has found that more than three quarters of adults diagnosed as having bronchitis receive an antibiotic, despite the fact that antibiotics are not indicated for the condition.

The study, published in the American Journal of Managed Care, analyzed three measures related to antibiotic prescribing from the Healthcare Effectiveness Data and Information Set (HEDIS), a tool used by more than 90% of the nation's health plans to evaluate performance on important dimensions of care. Two of the measures focused on the pediatric population (appropriate testing for pharyngitis and appropriate treatment for upper respiratory infections), and the third measured avoidance of antibiotics in adults with acute bronchitis.

The researchers examined data for the years 2008 to 2012, and the data set included only commercial health plans. For each measure, a higher percentage indicated a better performance.

The results indicated that health plans generally performed well on the first two measures, with an average of 77% performing appropriate testing for pharyngitis and 84% treating upper respiratory infections in children appropriately (without antibiotics).

But only 24% avoided antibiotic treatment for adults with bronchitis. And that number grew worse over time. In 2008, 26.6% of health plans avoided prescribing antibiotics for bronchitis; in 2012 antibiotic avoidance for adults with bronchitis was 22.7%. The authors concluded that interventions to improve antibiotic use should target providers who treat adults.

Geographic variations in health plan performance were observed as well, with health plans in southern states generally having lower scores than other parts of the country on all three measures. But health plans in New England had the lowest score (21.9%) when it came to avoiding antibiotic treatment for adults with bronchitis.

"Though drastic improvement is needed in the South, the data suggests that there are opportunities to improve antibiotic prescribing across the United States," Lauri Hicks, DO, co-author of the study and director of the CDC's Office of Antibiotic Stewardship, said in a statement.
Aug 17 Am J Manag Care study

Prevalence of MRSA in diabetic foot infections low, but antibiotic use high

A study yesterday suggests that antibiotic therapy targeted against methicillin-resistant Staphylococcus aureus (MRSA) may be overused in patients with diabetic foot infections (DFIs).

The study, published in PLoS One, included 318 patients treated at a Texas hospital from 2010 to 2014 for diagnosed DFIs, the leading cause of non-traumatic lower extremity amputations in the United States.

Because limited data exist to support the recommendation that DFI patients with associated risk factors be treated with antimicrobials active against MRSA, the researchers wanted to determine prevalence of MRSA DFIs at the institution and compare that with the proportion of patients who received MRSA antibiotic coverage. They also wanted to identify risk factors for MRSA DFI.

What the researchers found was that while S aureus was present in 46% of culture-positive DFIs, MRSA was present in only 15% of the infections. Yet 86% (273) of the DFI patients received MRSA antibiotic coverage, resulting in 71% unnecessary use. In a multivariable analysis, male gender and bone involvement were found to be independent risk factors for MRSA in DFIs.

The authors said knowledge of MRSA prevalence in DFI patients, as well as the factors that might make certain patients more likely to be infected by MRSA, could help guide clinician decision-making and aid in antimicrobial stewardship efforts. They also called for larger epidemiologic investigations.
Aug 24 PLoS One study