Increasing drug resistance, decreasing drug pipeline create microbial storm
Increasing drug resistance, decreasing drug pipeline create microbial storm
Pharmacists should lead in stewardship
Antimicrobial stewardship programs are on everyone's minds, and the latest guidelines from national organizations have placed pharmacists at the helm of such programs in hospitals.
There are financial and reputation incentives now for focusing on these programs. For instance, The Joint Commission recently posted new requirements regarding antimicrobial stewardship, and the Centers for Medicare and Medicaid Services (CMS) has included certain health care-acquired infections as diagnoses that are no longer covered for reimbursement.
Experts who've developed, studied, and written about creating antimicrobial stewardship programs in hospital systems say the process is time-consuming and challenging, especially given the shortage of infectious disease (ID) pharmacists nationwide. But stewardship is essential since we've entered an era with increasingly drug-resistant microbes, and the antimicrobial drug development pipeline is depleted.
And there's one more problem too: Experts say pharmacists should lead the way with these programs, but there aren't enough pharmacists trained in infectious diseases to meet the increasing need.
"There are not enough pharmacists trained to fill all the positions available in the United States," says Debra A. Goff, PharmD, FCCP, a clinical associate professor at the Ohio State University College of Pharmacy in Columbus, OH, and an infectious diseases specialist at the Ohio State University Medical Center.
Goff is the program director for the infectious disease residency program at Ohio State.
"We've trained several people who now have a stewardship program," she says.
But schools like OSU are able to train only a few residents a year, Goff says.
"It's really one-on-one training," she adds. "It's an advanced post-doctorate specialty, and most programs take one year."
If a hospital is unable to hire an ID pharmacist, then another model that will work is to have a non-ID pharmacist partner with an ID physician who can mentor the pharmacist in infectious diseases issues, Goff suggests.
Another issue is that hospitals that start a stewardship program often will hire or move only one pharmacist, who may or may not be trained in infectious diseases, over to that role, leaving the program understaffed.
"It's not realistic to expect a pharmacist to add this role on to his or her already-existing job and do it well," Goff says. "The goal is to improve patient care."
Also, there should be other clinicians on the stewardship team. While pharmacists are knowledgeable about drug therapy, they need to collaborate and share knowledge with other hospital experts to create the optimal antimicrobial stewardship program, she says.
"The most important point, whether you're in a small or large hospital, is to have a collaboration with the department of pharmacy, the medical staff, infectious disease physicians, microbiology, infection control, hospital epidemiology, and what we call the information warehouse — computer and data storage of patient information," Goff explains.
At the very least, an antimicrobial stewardship program needs an infectious diseases pharmacist, an infectious diseases physician, and an information services technician to help with generating reports, says Robert C. Owens, Jr., PharmD, co-director of the antimicrobial stewardship program at Maine Medical Center in Portland, ME. Owens also is a clinical assistant professor at the University of Vermont, College of Medicine in Burlington, VT. Owens published a paper recently on antimicrobial stewardship.1
"Those are critical resources that need to be in place and should be used in a programmatic approach," Owens says. "It's no longer acceptable to have an antibiotic subcommittee that meets once a month."
Even hospital systems that have had some kind of antimicrobial stewardship program for a number of years likely will need to make changes, mostly to ramp up the program.
For instance, The Medical Center, which is part of Columbus Regional Healthcare System in Columbus, GA, has had an antimicrobial stewardship team for 10 years, but it had less stature than what the organization now has developed, says Deanne Tabb, PharmD, MT (ASCP), infectious disease specialist.
"Unless you have a very good rapport with senior leaders and you can get them on board and show the program's benefits to patients and benefits from an economic perspective, a lot of institutions weren't able to start stewardship teams," Tabb explains.
Tabb came to the pharmacy field, starting over with her college education, after working as a microbiologist. After she received her pharmacy degree, she received post-doctoral pharmacy training in infectious diseases from the Mayo Clinic.
"The whole reason I went back to pharmacy school was for training in the therapeutic aspects," Tabb says.
Bench microbiologists see only part of the microbial organism puzzle, but as an infectious diseases pharmacist she can see how all the pieces fit together, Tabb notes.
The big challenge for health care systems now is finding trained pharmacists who can help lead an antimicrobial stewardship program, says Richard Drew, PharmD, MS, BCPS, a professor of pharmacy at the Campbell University School of Pharmacy in Buies Creek, NC.
"So the issue here is there are clear gaps in the availability and, ultimately, the need for training for people to meet these demands," Drew says. "There are not enough infectious disease training programs to go around."
Some professional societies are trying to identify how they can assist in training people for stewardship positions, he notes.
"The current discussion as I understand it is to take competent pharmacists and train them in the stewardship process," Drew explains. "It wouldn't be full infectious disease training, but there'd be a minimum educational requirement and perhaps certification programs in stewardship."
Lacking formal ID training, most pharmacists working in antimicrobial stewardship are learning through on-the-job training, Drew says.
It's better than nothing, but far from the ideal of having ID-trained pharmacists in charge of the programs, he adds.
Health care organizations planning to improve or initiate stewardship programs should first review professional guidelines, including those from the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America.2
"The guidelines establish a solid review and subsequent recommendation of evidence-based procedures that deal with not only improved outcomes, but improved safety of antimicrobial use," Drew explains. "The intent was for a multidisciplinary body to examine evidence-based studies, look at interventions, and then turn around and make recommendations of what they as a group felt had established a significant body of evidence of what the guidelines were."
The guidelines establish precedence for advocacy, Drew says.
Pharmacists can meet with hospital administrators with the guidelines in hand and ask for the support and resources they'll need to establish or improve an antimicrobial stewardship program, he adds.
Each health care organization will have to select its own best strategy for protecting antimicrobials. Smaller hospitals may need to share infectious diseases physicians with other medical centers, and they might need to rely on larger hospitals for other resources, Owens says.
What likely will happen as a result of the new national focus on antimicrobial stewardship is that hospitals will no longer put one person in charge of the program and leave it at that, Owens notes.
"We're in an era when most people are speaking of a programmatic strategy that really involves resources," he says.
And the information systems or technology professional is an integral part of this strategy since this is the person who will provide better informatics and better reports, helping other members of the team to use their time more efficiently, Owens says.
A 600-bed hospital like Maine Medical Center might have 160 people on antibiotics each day, he says.
"An infectious diseases service might see 20 patients a day, and it's our task to see 160 patients," Owens adds. "ID consultation services are different from antimicrobial stewardship, and, really, the ID service at any hospital will see a much smaller number of patients."
The antimicrobial stewardship team might not see each patient each day, but they're able to identify those who most need attention.
Overuse and inappropriate use of antimicrobials, combined with a depleted new antibiotics drug research pipeline, has led to a crisis situation in the United States, the experts say.
"In Switzerland, their rate of resistance to staph is 2%," Goff says.
"Our rate of resistance to staph in the United States is 70%," Goff says. "One of the causes is decades of a very cavalier approach to antimicrobials, and we've paid a huge price because of it."
Clinicians also have become accustomed to newer, more potent drugs regularly coming on the market, and that simply isn't happening with antimicrobials anymore.
"In the drug discovery pipeline there are no new classes of antimicrobials for gram-negative organisms," Goff says. "The timeline from drug discovery to approval for the market is 10 years, so this is a real crisis."
The Infectious Diseases Society of America (IDSA) of Arlington, VA, has been lobbying for increased investment in antimicrobial drug development and has called for the end of non-therapeutic antimicrobial use in animals. The IDSA also has criticized the FDA for not providing clear guidance on study design for new drugs against community-acquired pneumonia (CAP).
The private sector has not given as much attention to antimicrobial development because the organisms mutate and become resistant so quickly that any profits realized from a new drug might be short-lived, Goff notes.
"And antimicrobials are drugs we only use for a few days," she adds. "They're not lifetime drugs like Lipitor®, so from a business perspective they're not a smart drug for a company to invest in."
For some areas, the crisis of drug resistance has grown so severe that providers are prescribing an antimicrobial drug that was discovered in the 1940s and used for decades in intravenous formulations until a high incidence of nephrotoxicity led to its being abandoned more than 20 years ago.3
Colistin, a polymyxin drug, is a cyclic basic polypeptide that until recently had been restricted to use for the treatment of lung infections due to multidrug resistant, gram-negative bacteria in cystic fibrosis patients.3
Now colistin use has made a comeback because of the prevalence of multidrug resistant bacteria that have defeated the current arsenal of antimicrobials.
"We're now using colistin because we have no other effective therapy for Pseudomonas aeruginosa and Acinetobacter baumanni," Goff says. "We're running out of effective drugs."
References
- Owens RC Jr., Shorr AF, Deschambeault AL. Antimicrobial stewardship: Shepherding precious resources. Am J Health Syst Pharm 2009;66(12 Suppl 4):515-522.
- Drew RH, White R, MacDougall C, et al. Insights from the Society of Infectious Diseases Pharmacists on antimicrobial stewardship guidelines from the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Pharmacotherapy 2009;29:593-607.
- Conly JM, Johnston BL. Colistin: The phoenix arises. Can J Infect Dis Med Microbiol 2006;17:267-269.
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