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FDA Antibiotic Stewardship Tool Offers Centralized Data Resource

The FDA’s new online antibiotic stewardship system will help providers improve patient safety and potentially reduce bacteria resistance.

Patient safety and antibiotic stewardship

Source: Thinkstock

By Jessica Kent

- The FDA has launched a new antibiotic stewardship system that will serve as a centralized data resource for antimicrobial drugs while providing physicians with the most up-to-date information to improve patient safety.

The web pages offer the latest updates on Susceptibility Test Interpretive Criteria (STIC), the criteria used to identify whether bacteria or fungi are susceptible or resistant to a particular drug.

With bacteria and fungi continually changing, laboratories and antimicrobial susceptibility testing (AST) device manufacturers need to be able to deliver current information to physicians to ensure appropriate treatment choices.

The FDA’s new system hopes to offer improved decision support to providers by centralizing access to up-to-date data.

Traditionally, each drug manufacturer was responsible for updating its labeling with new STIC. Device manufacturers could only update their recommendations after this relabeling had occurred.

This process of continually updating and re-updating labeling for drug and device products was not only inefficient, but also problematic for patients.

Healthcare providers couldn’t receive the most current information on how to treat infections, or they might be delayed in learning that a certain bacteria or fungi had become drug-resistant.

The FDA hopes the modernized process will help providers quickly choose the correct antimicrobial drug for a patient’s infection and increase the chance that patients will get the treatment required for them to get well.

The new online resource is a result of the 21st Century Cures Act, which, among other things, addresses the serious problem of patient safety and antibiotic resistance.

The Cures Act aims to decrease the overuse of antibiotics by introducing new regulations to ensure promising drugs aren’t overused.

Overuse of antibiotics and poor antibiotic stewardship, which can lead to antibiotic resistance and superbugs, have become something of an epidemic in healthcare.

The Center for Disease Control (CDC) recently found that one-third of the 154 million prescriptions written for patients each year are considered unnecessary.

Antibiotics are crucial in healthcare and used to treat many life-threatening infections. Patient resistance to these drugs means a higher risk of death, or of contracting untreatable infections while in hospitals. It threatens both patient safety and hospital quality.

The Cures Act is not the healthcare industry’s first attempt to crack down on excessive antibiotic use. In 2016, CMS proposed a rule to require antibiotic stewardship programs (ASPs) in hospitals. This rule would require hospitals to have organization-wide infection prevention and control protocols, and ensure appropriate antibiotic use.

The proposed ASP rule was formulated in response to the development of drug-resistant superbugs and the increasing financial penalties for hospital acquired infections (HAIs).

Prior to this, in 2015 the White House developed The National Action Plan for Combating Antibiotic-Resistant Bacteria, a program implemented by the CDC. It aims to decrease unnecessary antibiotic prescription rates by at least half by 2020.

The program’s features include research promotion, provider and patient resistance education and advanced outbreak detection strategies.

Some physicians have been monitored for overprescribing antibiotics as well. These stewardship interventions are effective in reducing rates of unnecessary antibiotics prescriptions when they are active.

However, a 2014 study by the CDC found that once these interventions end, antibiotic prescription rates increase by 10 percent.

The FDA’s new system hopes to make significant progress with combating antibiotic resistance. Providing physicians with the most current information on STIC means discovering the best treatment options for patients much more quickly. This updated process could result in improved patient safety and hospital quality.


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