In July 2016, the Food and Drug Administration (FDA) issued a safety alert on the serious side effects associated with quinolones, a class of antibiotics that includes ciprofloxacin and levofloxacin. These drugs are convenient in many ways, notably because they treat a broad range of infections and are effective both intravenously and orally. But they have a debilitating and permanent impact on tendons, muscles, joints, nerves and the central nervous system. The drug class is also associated with a higher risk for Clostridium difficile (C. diff) and the emergence of antibiotic resistance in Staphylococcus aureus and other bacteria.

With a robust antimicrobial stewardship program already in place, Jersey City Medical Center, a member of RWJBarnabas Health, was able to respond immediately, launching an awareness campaign that included clinician education materials, a lecture series and, the campaign’s pièce de résistance, “Save the Quinolones” pins worn on the lab coats of antimicrobial stewardship team members. “I underestimated how much wearing a pin around the hospital would get people’s attention,” says Steven Smoke, PharmD, BCPS, clinical pharmacist and co-chair of Jersey City Medical Center’s antimicrobial stewardship program. “The pins were very effective as conversation starters, which was precisely the goal. We wanted clinicians to know that quinolones should be reserved for cases where alternative treatment options don’t exist.”

At the start of the campaign, quinolones were the most-used class of antibiotics at Jersey City Medical Center. The results are still preliminary, but Smoke estimates the campaign has helped cut usage of quinolones by half and made a small dent in the number of methicillin-resistant Staphylococcus aureus (MRSA) cases. This year, Smoke’s team is launching a similar awareness campaign, dubbed “Why PPI?” for proton pump inhibitors, usage of which has been linked to diarrhea associated with C. diff.

A Regulatory Requirement

Clinician education like the kind being carried out by Smoke’s team at Jersey City Medical Center is one of seven required elements in the Joint Commission’s antimicrobial stewardship standard, which went into effect in January 2017. The standard, which largely mirrors national guidelines created by the Centers for Disease Control and Prevention, also requires hospitals to elevate antimicrobial stewardship as an organizational priority, assign a multidisciplinary team to oversee the program, develop and utilize various protocols to aid in antimicrobial stewardship, and collect, analyze and report data on the effectiveness of the program.

Jason Braithwaite, PharmD, MS, BCPS, senior director of clinical pharmacy services for HealthTrust, says meeting these requirements is proving difficult for some hospitals, especially smaller ones. Challenges include finding physician leaders who have an interest in antimicrobial stewardship and educating frontline clinicians, who may not be hospital employees. By and large, the most common challenge facing antimicrobial stewardship programs is tracking metrics beyond the basics. Guidelines from the Infectious Diseases Society of America recommend hospitals track defined daily dose per 1,000 patient days.

But the Joint Commission is pushing hospitals to start incorporating more outcomes-based metrics, such as rates of C. diff, adverse events, morbidity and mortality. The problem for hospitals lies in both IT limitations and the inability to decisively attribute a clinical outcome to antimicrobial stewardship. “Facilities have some good ideas about what outcomes would be important to track, but the ability to track them is more difficult than they thought,” Braithwaite says.

Jersey City Medical Center’s Smoke is keeping track of both antibiotic use and C. diff rates as part of its antimicrobial stewardship program. Over a one-year period, antibiotic use dropped 8 percent; however, the decrease in C. diff rates was not statistically significant. And, the question remained: Was the 8 percent drop in antibiotic use due to the antimicrobial stewardship program or something else? “Any kind of outcome has so many variables that drawing definitive conclusions will always be hard, especially in a hospital setting where a randomized controlled trial simply isn’t feasible,” Smoke says. “We’re forced to rely on before-and-after studies. They can’t tell us something with certainty, but they’re the best tool we have to demonstrate what happened.” Smoke says it’s important to take the time to conduct before-and-after research with every antimicrobial stewardship initiative. “It’s natural to want to quickly move on to the next one, but if you don’t demonstrate the value of a specific initiative, you’ll struggle with justifying it down the road.”

At Jersey City Medical Center, antimicrobial stewardship initiatives started in the last year include:

  • Requiring physicians to enter a reason code with every new antibiotic prescription
  • Providing selective reporting of antibiotic susceptibility to prescribers to show the narrowest-spectrum effective agents
  • Creating an internal antimicrobial resource website for clinicians
  • Using rapid diagnostic testing in the laboratory to more quickly identify the optimal therapy
  • Focusing on the social and cultural factors that impact the prescribing of antibiotics

New Therapies Available

In 2012, the FDA created a fast-track pathway for new antibiotics, leading to the approval of a variety of antibiotics for multidrug-resistant bacteria in the past few years. Since 2015, three combination antibiotics—Zerbaxa (ceftolozane/tazobactam), Avycaz (ceftazidime/avibactam) and Vabomere (meropenem/vaborbactam)—have been approved to treat complicated intra-abdominal and urinary tract (including kidney) infections. While the introduction of these drugs is helping providers feel some measure of relief, Braithwaite cautions that antimicrobial stewardship remains crucial. “These drugs need to remain niche drugs,” he says. “We cannot use them on every patient, not daily, not even weekly. We must reserve them for times when first-line agents fail. If we instead start overusing them, we’ll again be facing a resistance scenario where we don’t have a lot of good options to treat an infection.”

As new therapies come to market, HealthTrust uses its clinical advisory board review process to determine which, if any, should be added to contract. “We’re doing that now to decide if we want to narrow choice [to one or two of the new combination antibiotics] to drive maximum cost effectiveness, or bring on all three,” Braithwaite says. “Because of the nature of resistant infections, it’s hard to predict which ones will be needed and when, so contracting for all of them may end up being our recommendation.”

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