A group that includes members of four different medical societies has recommended dropping three antibiotics for monotherapy and 27 for combination therapy from a government list of possible treatments for severe sepsis or septic shock.
In a paper published in Clinical Infectious Diseases, the group largely cited antibiotic resistance among reasons for suggesting that the drugs and certain drug combinations be removed from the CMS tables.
Those tables were included in the Early Management Bundle, Severe Sepsis/Septic Shock (SEP-1) performance measure, which CMS adopted in July 2015. The physicians’ group recommending the exclusions — the Modification of Antibiotic Tables for SEP-1 Workgroup (MATS WG) — convened in May 2016.
“We appreciate the effort CMS has made to address the serious issue of sepsis and hope that consideration will be given to our proposed modifications,” the paper’s authors wrote. “We welcome further discussion with CMS and other stakeholders on these matters related to the SEP-1 measure.”
The MATS WG comprised six members altogether of the American College of Emergency Physicians, the Society of Critical Care Medicine, the Infectious Diseases Society of America and the Society of Hospital Medicine. They and six non-MATS WG members who are nonetheless members of those medical societies completed a drug survey on the SEP-1 table of monotherapy antibiotics and a survey on its table of combination therapy options.
The work group’s rejection of 27 individual antibiotics left 18 to be used in various combinations. The group recommended removing all four brands of ciprofloxacin, all nine macrolides and five of eight cephalosporins on the SEP-1 table, among others. The deletions, if adopted by CMS, would bring the number of possible antibiotic combinations in SEP-1 from 21 to 10.
The MATS WG cited studies showing resistance to the combination therapy drugs in various organisms.
“With the efficacy of available antibiotics diminishing and the dearth of development of new antibiotics, restricting the use of effective antibiotics with relatively low resistance rates is imperative to preserve an efficacious antibiotic pipeline,” the group members wrote.
The SEP-1 monotherapy table included 14 antibiotics. Of those, nine were approved by most of the survey participants.
Another three — ampicillin/sulbactam, levofloxacin and moxifloxacin — were rejected by a majority.
“Escherichia coli resistance to ampicillin/sulbactam has been observed in numerous studies,” the authors wrote. “Levofloxacin has been shown to be efficacious against many pathogens, namely pneumonia caused by the Haemophilus species. However, levofloxacin resistance has been observed in H. influenzae, Pseudomonas aeruginosa and E. coli. Similarly, moxifloxacin has been shown to have very high rates of resistance in Clostridium difficile isolates.”
The remaining two antibiotics — Invanz (ertapenem, Merck) and Timentin (ticarcillin/clavulanate, GlaxoSmithKline) — each received an equal number of approvals and rejections. Use of ticarcillin/clavulanate was eventually discontinued because of safety concerns. After a second survey on ertapenem to break the tie on that drug, it was approved by the majority.
The MATS WG recommended adding two antibiotics — Avycaz (ceftazidime/avibactam, Allergan) and Zerbaxa (ceftolozane/tazobactam, Merck) — to the table. – by Joe Green
Disclosure: Septimus reports no relevant financial disclosures. Please see the full paper for all other authors’ relevant financial disclosures.