News Scan for Feb 10, 2016

Antibiotic prescribing intervention
Pneumonia drug looks promising
Lyme disease in Hispanics
FDA budget request

Study: Behavioral cues reduce inappropriate antibiotic prescriptions

Behavioral interventions that made clinicians justify prescriptions, offered alternatives to antibiotic treatment, or compared prescription rates with peers reduced rates of inappropriate antibiotic prescribing, according to findings reported yesterday in the Journal of the American Medical Association (JAMA).

Researchers from the University of Southern California conducted an 18-month cluster randomized clinical trial in 49 practices in Los Angeles and Boston. The 248 clinicians, who were randomly assigned to a control group or one or more interventions, collectively saw 16,959 patients with acute respiratory infections (ARIs) during the study period.

Behavioral interventions, or "nudges," included sending clinicians a weekly e-mail ranking their number of inappropriate antibiotic prescriptions next to their colleagues (“peer comparison”), prompting clinicians to provide a written justification for antibiotic treatment in a patient's electronic chart (“accountable justification”), and displaying a pop-up box suggesting non-antibiotic treatment when prescriptions were entered electronically (“suggested alternatives”).

Accountable justification, alone or in combination with other interventions, resulted in the most substantial decrease in inappropriate antibiotic prescriptions, from a rate of 23.2% to 5.2%. Peer comparison caused a decrease in inappropriate prescriptions from 19.9% to 3.7%. Suggested alternatives also were associated with a decline in inappropriate prescriptions, from 22.1% to 6.1%, though this difference was not statistically significant.

One significant limitation of the study involves the higher rate of patients returning for probable bacterial infections in the clinician group that received the accountable justification plus peer comparison intervention, highlighting the possibility that antibiotic prescriptions were indicated in these cases. In a random sample of 33 cases, investigators found that 13 patients for whom antibiotics were deemed inappropriate would actually have been helped by an antibiotic prescription.

The researchers said 22 million antibiotic prescriptions are written annually for inappropriate reasons, such as viral illness, potentially leading to antibiotic resistance and adverse/allergic reactions.
Feb 9 JAMA study


Positive phase 3 trial results for next-generation macrolide antibiotic

A research team from Cempra, a pharmaceutical company based in Chapel Hill, N.C., recently reported positive phase 3 trial findings for its next-generation macrolide antibiotic, solithromycin, against community-acquired bacterial pneumonia (CABP).

The study compared the drug with moxifloxacin, another macrolide antibiotic, and the results were published in the Feb 4 online edition of The Lancet Infectious Diseases.

The trial took place at 114 centers in North America, Latin America, Europe, and South Africa. Between Jan 3, 2013, and Sep 24, 2014, 860 patients were randomly assigned to receive solithromycin or moxifloxacin.

In looking at early clinical responses, researchers found that solithromycin was noninferior to moxifloxacin: 78.2% of solithromycin recipients showed an early response, compared with 77.9% in the moxifloxacin group (difference, 0.29 percentage points; 95% confidence interval, -5.5 to 6.1). Both drugs showed a similar safety profile.

Carlos Barrera, MD, one of the principal investigators with Baptist Hospital of Miami, said in a Cempra statement that the management of CABP is complicated by increasing antibiotic resistance, which is approaching 50% in the United States. "The results of this study are exciting because solithromycin demonstrated efficacy comparable to moxifloxacin, with a safety profile similar to the most widely-used macrolide antibiotics. This shows the potential to restore the use of macrolide monotherapy for CABP," he said.

Last October the company reported similar positive findings for an intravenous formulation of solithromycin. Cempra said it has plans to submit an application to the Food and Drug Administration (FDA) for both products in the first half of 2016. The FDA has already granted fast-track review for the two solithromycin formulations and has given them the Qualified Infectious Disease Product designation.

In 2013 Cempra received a federal contract worth up to $58 million to develop an antibiotic that could be used to treat children with anthrax, tularemia, or CABP.
Feb 5 Cempra press release
Feb 4 Lancet Infect Dis
May 29, 2013, CIDRAP News scan "
BARDA contract to support antibiotic for anthrax, tularemia"


US Hispanics have low Lyme disease rate but more complications

Compared with other groups, Hispanic people in the United States have a lower incidence of Lyme disease but are more likely to be diagnosed with disseminated infection, which can cause arthritis, facial palsy, heart problems, and meningitis, according to a study today in Emerging Infectious Diseases (EID).

Outdoor work is associated with a greater risk of exposure to ticks that carry Lyme disease, and approximately 43% of the outdoor (grounds maintenance, farming, fishing, and forestry) workforce in the US is Hispanic, the reportsays.

Researchers from the Centers for Disease Control and Prevention (CDC) evaluated 148,444 cases of Lyme disease with information about the patient's ethnicity reported between 2000 and 2013. Hispanic people had a lower annual incidence of Lyme disease (0.8 cases per 100,000 population) compared with non-Hispanics (4 cases per 100,000).

From 2000 to 2001, Hispanics represented 2.8% of all people with Lyme disease, though this rate rose as high as 4.9% between 2009 and 2013.

Hispanic people with Lyme disease were more likely to be diagnosed during the fall months and to have disseminated disease. Hispanics were 1.74 times more likely than non-Hispanics to have facial palsy (95% confidence interval [CI], 1.58-1.91), 1.26 times more likely to report atrioventricular block (95% CI, 0.91-1.76), 1.17 times more likely to have meningitis (95% CI, 0.84-1.63), and 1.11 times more likely to experience arthritis (95% CI, 1.05-1.18).

Hispanics with Lyme disease were less likely to report erythema migrans (the bullseye rash), and were also less likely to live in a state with a high incidence of Lyme disease. Nearly half of the Hispanics diagnosed from 2000 to 2013 resided in New York or New Jersey.

Researchers said that many Hispanics with Lyme disease may go undiagnosed or may be diagnosed at later stages of the disease because of lack of access to healthcare and health insurance, language barriers to care or information, and lack of awareness about the disease.
Feb 10 EID study


FDA seeks 2017 budget increase for food safety

The US Food and Drug Administration (FDA) yesterday requested an 8% budget increase for fiscal year 2017, citing the need to fund initiatives aimed at food safety, medical product quality, and cancer research.

The agency is requesting $1.5 billion for food safety, an increase of $211.6 million (including $193.2 million in user fees) over the enacted 2016 level, according to its budget document and a press release. Food safety funding priorities include implementing an enhanced system under the Food Safety Modernization Act, developing methods for greater accountability and safety among food importers and foreign facilities, and enforcing safety standards for domestic produce farms.

In the category of medical product safety and availability, the FDA requested an increase of $41.2 million (including $38 million in user fees) in funds for evaluating personalized diagnostic and treatment tools, holding compounded pharmaceuticals to enhanced safety and inspection standards, and addressing the intersections between antibiotic use in animals and antibiotic resistance in humans.

Mandatory funding of $75 million for the vice president's recently announced “National Cancer Moonshot” initiative will be directed primarily at establishing a “virtual Oncology Center of Excellence,” aiming to increase the number and effectiveness of cancer diagnostic methods and treatments.

The FDA's total requested budget for fiscal 2017 (Oct 1, 2016, to Sept 30, 2017) is $5.1 billion.
Feb 8 FDA press release
Proposed 2017 FDA budget

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