A lack of coordination among regulating bodies, pharma manufacturers, standard development organizations, and laboratory testing device companies has muddied efforts to stop antibiotic resistance; the 21st Century Cures Act aims to fix that.
With antibiotic resistance a serious and growing concern in the medical community, there is an urgent need for health care regulators, pharmaceutical companies, standard development organizations, and laboratory device makers to be on the same page when it comes to knowing which antibiotics work against which bug and at what concentrations.
Unfortunately, that has not always been the case. Frequently, there is a disconnect between updates on medication labels and updates to the devices that test these drugs, as well as a lack of awareness about updated breakpoints set by the Clinical and Laboratory Standards Institute (CLSI). Breakpoints refer to the concentration of an antibiotic that allows a provider to discern whether a bug is susceptible or resistant to that particular antibiotic; knowing a particular drug’s susceptibility is crucial when prescribing so as to ensure optimum effectiveness and the least chance of resistance.
The good news is that Congress enacted the 21st Century Cures Act in December 2016, which, among other things, aims to align health care regulators, standard development organizations, pharmaceutical companies, and the US Food & Drug Administration (FDA) on this issue. Recently, several researchers issued a report outlining the challenges that this act is set to meet.
“Antibiotics are not benign things,” Romney Humphries, PhD, chief scientific officer at Tucson-based Accelerate Diagnostics and the author of the study, told Contagion®. “[There’s] this balance between what is safe and possible to get into a patient at the site of infection and what’s going to inhibit the bug.” Out-of-date information on breakpoints can lead to inaccurate prescribing, jeopardizing a patient’s recovery and potentially contributing to antibiotic resistance.
The 21st Century Cures Act includes the launch and maintenance of a website listing breakpoints, which were previously published on drug labels and rarely updated. The website is to be updated every 6 months to reflect new and updated breakpoints, as well as to list breakpoints set by standard development organizations. The act also addresses the fact that newer testing systems until recently have not been permitted to test off-label antibiotics, which doesn’t reflect reality. “Something like 50% of all patients in the United States in ICUs are treated with off-label antibiotics,” said Dr Humphries. To test only for conditions listed on the drug label “really stifles progress.”
According to Dr Humphries, one of the problems that the 21st Century Cures Act doesn’t address directly is the fact that manufacturers of testing systems don’t have to update those systems to reflect updated breakpoints. “There are systems sold today using standards that are almost a decade out of date,” she said. “Right now, the FDA approves or disapproves devices as they enter the market. They don’t have a mechanism for them to go back and ask, ‘Is this device still good?’ It’s...up to those manufacturers to update their systems.”
However, updating systems requires re-submission to the FDA to ensure the system works with the updated breakpoint, which is a time-consuming and costly process; there is no guarantee that companies will take it upon themselves to do this. Better legislation, said Dr Humphries, would ensure that testing systems are kept up to date for patient safety.
Ms. Saloman is a health writer with more than 20 years of experience working for both consumer- and physician-focused publications. She is a graduate of Brandeis University and the Medill School of Journalism at Northwestern University. She lives in New Jersey with her family.