ID groups urge CMS to mandate antimicrobial stewardship programs
Patient's choice: Amputate leg or a lifetime of dialysis? The harsh reality of losing antibiotics
Infectious disease societies frustrated at watching antimicrobial resistance increase for decades are taking the unusual step of asking for federal regulation and oversight of clinical practice, imploring the Centers for Medicare & Medicaid Services (CMS) to require hospitals to implement antimicrobial stewardship programs.
While multidrug-resistant strains of a formidable array of bacteria have developed over the past 30 years, there has been a dramatic drop in the development of new antibiotics, warns a policy statement on antibacterial stewardship by the Society for Healthcare Epidemiology of America (SHEA), the Infectious Diseases Society of America (IDSA), and the Pediatric Infectious Diseases Society.1 The critical need for infection control goes without saying, but the call for mandatory stewardship to reign in the widespread unnecessary use of antibiotics is roughly equivalent to the first rule of holes: When finding yourself in one, stop digging.
"Our position is that clearly unless hospitals are forced to participate in antimicrobial stewardship and the government is forced to support new antibiotic drug development, then we will only be in a worse hole and a world of hurt," says Thomas G. Slama, MD, FIDSA, president of IDSA, and clinical professor of medicine at the Indiana University School of Medicine in Indianapolis.
Indeed, the world is dangerously close to the initial phases of a "post-antibiotic era," where drug resistant pathogens cause infections that cannot be treated. Antimicrobial stewardship is one of the best ways to head off the crisis, as overused and misused drugs select out resistant organisms and perpetuate the cycle.
In seeking CMS regulatory action, the position paper called for the required creation of a multidisciplinary antimicrobial stewardship team that is physician directed or supervised and includes a physician, a pharmacist, a clinical microbiologist, and an infection preventionist. "SHEA, IDSA, and PIDS recommend that the CMS require participating healthcare institutions to develop and implement antimicrobial stewardship programs," the paper states. "This can be achieved by incorporating the requirement into existing regulations via expansion of interpretive guidelines of the relevant regulation(s)."
Such regulations should not be limited to hospitals, they noted, arguing that stewardship should be required in long-term care facilities, ambulatory surgical centers, dialysis centers and other health care settings.
Informal conversations with CMS while working on the stewardship policy statement indicate support for the idea of regulating at the agency, says Neil Fishman, MD, a chief architect of the policy statement and chair of the board of directors for the SHEA Education and Research Foundation in Arlington, VA. As previously reported, the CMS does include some assessment of antibiotic stewardship as part of its new infection control inspections slated for later this year, but there is currently no regulation requiring such policies.
"CMS circulated a new draft of their interpretative guidelines for CMS surveys, and the draft does contain some questions related to antimicrobial stewardship issues, but these are not scored and there's no penalty for not addressing antimicrobial stewardship," Fishman says. "It's a way to start collecting more data."
However, the ID groups' request could fall on sympathetic ears, given the unprecedented interest CMS has taken in infection prevention in the last few years. Increasing accounts of persistent or outright untreatable infections will certainly add political pressure for action.
'My father never saw a patient die of drug resistance'
"What we are getting closer to is what it was like before antibiotics," says Jason G. Newland, MD, MEd, director of the antibiotic stewardship program and associate professor of pediatrics at the University of Missouri-Kansas City (MO) School of Medicine, Children's Mercy Hospitals & Clinics.
A second-generation doctor, Newland says his father never saw such cases in his practice 30 years ago. "My father never saw a patient die of drug resistance, but that is happening more and more now," he says. "We had a child come into the hospital with a urinary infection that took 10 days to treat intravenously, and other pediatricians could tell you worse stories than that."
Citing recent reports that about half of Klebsiella pneumoniae isolates are now resistant to carbapenems, Newland says, "essentially what that means is a person can go to the hospital, but if he has one of those infections there's only one other drug [colistin] that you can use to treat it. And the only people who really know about this problem are the infectious disease people."
As we have previously reported, colistin, a powerful antibiotic which can contribute to kidney problems, is an undesirable last-line choice for some of the rapidly emerging gram negative infections.
And undesirable choices are not limited to drugs. Consider a recent case described by Fishman, past-president of SHEA and associate chief medical officer at the University of Pennsylvania Health System in Philadelphia, PA.
"Recently, we had a patient sent here from another hospital. A 54-year-old man had an infection caused by bacteria that was sensitive to only one antibiotic, and this single antibiotic was causing renal failure in the patient," Fishman says. "This man had fallen off a roof and injured his leg. He had a lot of surgery on it, and when it became infected, ultimately all we could offer him was treatment with an antibiotic that would result in him receiving dialysis the rest of his life with no guarantee the antibiotic would work, or he could have his leg amputated. He chose amputation. It amazes me that those are the types of decisions we're faced with in 2012."
ID Groups to CMS: Act now
"A requirement of having an antimicrobial stewardship program is one of the best opportunities to limit resistance," Newland says. It's imperative that the U.S. government does not wait until a full-blown crisis emerges, as has happened in Greece, where overprescribing and lax infection control processes have contributed to something of an antimicrobial nightmare.
"How do we avoid that problem? Everyone knows if you don't use antibiotics you don't get resistance," Newland says. "We need to use antibiotics only when they need to be used."
That is, of course, not what is happening, as roughly half of all antibiotic administration is thought to be unnecessary.
The chief roadblock to new antibiotic development is financial. "The minimum it costs to develop an antibiotic is $1 billion dollars," Slama says. "And 96% of compounds developed chemically never make it to the marketplace, so the odds of pouring all of this money into a project and coming up with a successful product is very much against the producer."
As noted, antibiotics remain more potent if they are used less, which means there will be pressure on physicians not to prescribe a new drug unless it is absolutely necessary. That makes antibiotics a far less appealing marketing option to pharmaceutical companies than are treatments for chronic illnesses.
"If you couple these obstacles with the bureaucracy and hurdles that have to be crossed with the Food and Drug Administration or working with other government agencies, then you have a process that is long, complicated, bureaucratic, and expensive," Slama explains. "It's a no-win situation."
Still, new antibiotics are greatly needed, so either the federal government or nonprofit organizations will need to help out with the cost of developing them, he adds.
In the interim, the best solutions remain stringent infection control measures and antimicrobial stewardship. Studies show that antimicrobial stewardship decreases the cost of health care, which is another reason to implement such programs, Fishman says.
"I am challenged to think of any other interventions that improve the quality and safety of healthcare and decrease the cost of health care," he adds.
While cost should make stewardship more attractive to health systems, it should not be the driving force behind implementing antimicrobial stewardship programs, says Sara Cosgrove, MD, MS, an associate professor of medicine in the division of infectious diseases at Johns Hopkins University School of Medicine in Baltimore, MD. Cosgrove is on SHEA's board of directors and has conducted a recent study on antimicrobial stewardship.
If health systems make cost savings a main tenant of their stewardship programs then it will be unsustainable, Cosgrove says.
"You initially will have a cost savings, but these cannot be sustained because if you pick the cheapest drug it would be fluoroquinolones, and we do not want everyone on those drugs," she says. "Patient safety should be the chief goal."
Antimicrobial stewardship has parallels to infection control programs, which have been accepted for decades, but once were rare.
"In the 1950s, no one had infection control programs, then there were more issues and concerns, and CMS said we have to make infection control a condition of participation and accreditation surveys look at it," Cosgrove explains. "Infection control programs are funded because the national patient safety goals say they have to do this."
Reference
- Policy Statement on Antimicrobial Stewardship by the Society for Healthcare Epidemiology of America (SHEA), the Infectious Diseases Society of America (IDSA), and the Pediatric Infectious Diseases Society (PIDS) Infect Con Hosp Epi, 2012;(Special Topic Issue: Antimicrobial Stewardship)33[4]:322-327
What would a CMS antibiotic reg require? ID groups: Antibiograms, clear clinical need A policy statement by the Society for Healthcare Epidemiology of America (SHEA), the Infectious Diseases Society of America (IDSA), and the Pediatric Infectious Diseases Society includes a recommendation that "antibacterial stewardship programs should be required through regulatory mechanisms."1 The infectious disease groups made the following key points in making this unusual request for regulatory intervention into clinical practice: At present there are no national or coordinated legislative or regulatory mandates designed to optimize the use of antimicrobial therapy through antimicrobial stewardship. Legislation is also limited at the state level. California Senate Bill 739 mandated that by January 1, 2008, the California Department of Public Health (CDPH) require that all general acute care hospitals develop a process for evaluating the judicious use of antibiotics, the results of which shall be monitored jointly by appropriate representatives and committees involved in quality improvement activities. While this is the first legislative mandate of its kind, it does not specify that hospitals must intervene to improve antimicrobial use, that is, to have an antimicrobial stewardship program. Thus, the CDPH is learning that given the nonspecific wording used in the mandate, many hospitals are able to meet this requirement without having an antimicrobial stewardship program that meets the objectives as defined above. On the other hand, successful antimicrobial stewardship programs in California are varied, utilizing different combinations of staff, strategies, and criteria; therefore, changing the regulation to be too specific may prevent resource-limited hospitals from developing robust antimicrobial stewardship programs on the basis of facility-specific attributes. In a preliminary assessment of acute care hospitals in California, 23% of hospitals reported being influenced to start an antimicrobial stewardship program because of Senate Bill 739. Lessons learned from statutory requirements in California include that regulatory mandates are important in convincing hospital administration to fund and staff antimicrobial stewardship programs. It is important to use the wording "antimicrobial stewardship program" in the regulation, as defined above, but it is also important to allow hospitals the flexibility to define how their facility can best meet the objectives of an antimicrobial stewardship program. Inasmuch as current legislation is limited to a single state and focuses only on institutional evaluation of antimicrobial use in hospitals, we support broad implementation of comprehensive antimicrobial stewardship programs across all healthcare settings. SHEA, IDSA, and PIDS recommend that the Centers for Medicare and Medicaid Services (CMS) require participating healthcare institutions to develop and implement antimicrobial stewardship programs. This can be achieved by incorporating the requirement into existing regulations via expansion of interpretive guidelines of the relevant regulation(s). Minimum requirements for the program should include: A. Creation of a multidisciplinary interprofessional antimicrobial stewardship team that is physician directed or supervised. At a minimum, 1 or more members of the team should have training in antimicrobial stewardship. The number of team members may vary on the basis of the size and complexity of the facility. Team members should include but are not limited to: A physician, a pharmacist, a clinical microbiologist, an infection preventionist. B. A formulary limited to non-duplicative antibiotics with demonstrated clinical need. C. Institutional guidelines for the management of common infection syndromes. D. Additional interventions to improve the use of antimicrobials, including those designed to detect and eliminate:
E. Processes to measure and monitor antimicrobial use at the institutional level for internal benchmarking. F. Periodic distribution of a facility-specific antibiogram indicating the rates of relevant antibiotic susceptibilities to key pathogens. Reference
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Infectious disease societies frustrated at watching antimicrobial resistance increase for decades are taking the unusual step of asking for federal regulation and oversight of clinical practice, imploring the Centers for Medicare & Medicaid Services (CMS) to require hospitals to implement antimicrobial stewardship programs.
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