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Florida hospital runs into trouble with feds over nosocomial infections; new drugs approved to treat this condition.
Are hospital-acquired infections a big deal? The federal government came within days of revoking Medicare certification at a Florida hospital in November because its nosocomial infection numbers were so high.
"There was a serious deficiency with infection control," said Joyce Lang, spokeswoman at the Centers for Medicare & Medicaid Services (CMS) in Atlanta. "It constituted a serious jeopardy."
"Serious jeopardy" is CMS-speak for clear and immediate danger to patient health and safety. The agency issued a termination notice after surveys in May and October uncovered multiple sanitation and patient care deficiencies at Palm Beach Gardens Medical Center.
Surveyors from CMS and the Florida Agency for Health Care Administration inspected the hospital twice following a string of patient complaints. Survey reports noted, among other problems, improperly stored surgical instruments, dirty IV pumps, soiled food preparation areas, and a ventilation system that could circulate contaminated air into spaces that are supposed to be sterile, among other problems.
Surveyors also found the hospital had discharged some patients despite symptoms of postoperative Staphylococcus infections, only to have to readmit them for treatment. The hospital is also facing more than 100 lawsuits alleging infections, most of them related to cardiac surgery and at least 20 of them fatal.
A third survey shortly before the termination deadline convinced CMS that the hospital had dealt with its infection-control problems. The federal government will continue to cover inpatient procedures for the 40% of the patients covered by Medicare. The state will also inspect the hospital at regular intervals to ensure that infection control improvements remain in place and in force.
Officials at the Tenet Healthcare-owned facility declined to discuss infection-control issues. But Palm Beach Gardens isn't unique. A senior CMS official in Atlanta said that similar Medicare termination notices, usually based at least in part on infection-control problems, are issued for two or three Florida hospitals every year. Surveys that uncover potentially dangerous conditions are usually a response to some sentinel event or a series of patient complaints, the official said.
Florida is only part of a national problem. According to the Centers for Disease Control & Prevention, nearly two million inpatients acquire an infection during a hospital stay somewhere in the United States each year. About 90,000 of them die.
Two new drug developments could help reduce mortality.
New analysis of existing phase III study data suggests that Zyvox (linezolid, Pharmacia) is more effective than vancomycin for methicillin-resistant nosocomial S. aureus pneumonia. Hospital-acquired pneumonia affects about 300,000 patients yearly in the United States, according to the CDC. The disease costs about $2 billion annually and increases hospital stays by an average of seven to nine days per patient. Mortality ranges from 30% to 33%. Zyvox produced an overall cure rate of 63% versus 35.5% for vancomycin. The data were presented at the Infectious Diseases Society of America annual meeting in Chicago.
According to Richard Wunderink, M.D., director of the research department at Methodist Healthcare in Memphis, Tenn., this is the first analysis that shows a distinct survival advantage for one drug over another in nosocomial pneumonia. Zyvox is already indicated for the treatment of nosocomial pneumonia due to methicillin-resistant and methicillin-susceptible S. aureus as well as penicillin-susceptible Streptococcus pneumoniae.
Patients got another boost in November. The Food & Drug Administration approved 750-mg Levaquin (levofloxacin, Ortho-McNeil) for the treatment of nosocomial pneumonia. The new indication is based on an open-label study comparing 750-mg Levaquin IV followed by a 750-mg oral formulation against IV Primaxin (imipenem/cilastatin, Merck) followed by oral Cipro (ciprofloxacin, Bayer). Both regimens continued seven to 15 days.
"People were using Levaquin for nosocomial pneumonia already," said James Kahn, M.D., head of infectious disease research at Ortho-McNeil. "My concern was that they were dosing it like innocent community-acquired pneumonia. We had developed the 750-mg dose specifically for the nastier bugs you see in the hospital."
The new indication covers nosocomial pneumonia due to methicillin-susceptible S. aureus, Pseudomonas aeruginosa, Serratia marcescens, Escherichia coli, Klebsiella pneumoniae, Haemophilus influenzae, or Streptococcus pneumoniae. If P. aeruginosa is the confirmed or suspected pathogen, the company recommends combination therapy with an antipseudomonal beta-lactam antibiotic.
Kahn favors combination therapy for every hospital-acquired pneumonia. "Monotherapy tends to develop resistance in any bug," he explained.
Fred Gebhart. Beware: Feds cracking down on nosocomial infections.