Feds may put regulatory ‘teeth’ into national antibiotic resistance plan
September 1, 1999 8 minutes read
Feds may put regulatory teeth’ into national antibiotic resistance plan
ICPs could play key roles in sweeping plan to stem tide of drug resistance
In a move that could empower infection control programs and expand ICP responsibilities, a host of federal agencies is developing a public health action plan that may make combating antibiotic resistance a national priority backed up by regulatory mandates, Hospital Infection Control has learned.
The sweeping scope of the effort — with no fewer than 10 agencies involved, and discussions including everything from curtailing antibiotic use in agriculture to preserving vancomycin efficacy against nosocomial infections — underscores the mounting concern about an expanding array of drug-resistant pathogens. ICPs, who have been on the front lines of ongoing efforts to track and prevent drug-resistant infections, are well-positioned to play important roles in any resulting federal action plan, says Fran Slater, RN, MBA, CIC, CPHQ, manager of infection prevention and control at Methodist Hospital in Houston, and one of 70 expert consultants invited to a recent meeting with federal public health officials in Atlanta to discuss the project.
"If there is an organized process mandated by the federal government in some fashion, then it will certainly be up to the infection control professional to make sure that process flows smoothly," she tells HIC. "I look forward to the development of federal mandates regarding this, and not only impacting health care facilities, but also the [agricultural] sources. The time has come to do something more aggressive."
Indeed, while the emergence of glycopeptide (vancomycin) intermediate-resistant Staphylococcus aureus (GISA) has been the most ominous development, antibiotic resistance is developing across a broad range of bug-drug combinations.1-3 (See related story, p. 117.) Canadian investi gators recently reported increasing fluoroquinolone resistance in Streptococcus pneumoniae, a pathogen that already has established penicillin-resistant strains and is currently the most common cause of community-acquired pneumonia in the United States.4
"[GISA] was one of the more alarming events that has occurred in recent years, but there has really been a pattern of virtually all important human pathogens becoming resistant to the drugs of choice to treat them," says David Bell, MD, a co-chair of the federal task force developing the plan and one of the principals in efforts to combat antibiotic resistance at the Centers for Disease Control and Prevention’s center for infectious diseases.
Effort goes beyond warnings, guidelines
While a wide variety of federal agencies are involved in the effort — from the Department of Defense to the Health Care Financing Admini stra tion (HCFA) — the recently formed antibiotic resistance task force is spearheaded by three key agencies: the CDC, the National Institutes of Health, and the Food and Drug Administration. Public health officials are quick to point out that the effort is at a very preliminary stage, but it was clear from an ambitious array of "action options" put on the table for discussion at a July 19-21, 1999, meeting with federal officials and expert consultants in Atlanta that the effort will go well beyond the repeated warnings and guidelines that have been issued in recent years. (See options, p. 115.)
"The whole underlying concept here is that now it is time for an action plan," Bell says. "There have been a lot of blue ribbon commissions who have done excellent work: the Institute of Medicine, the ASM [American Society for Microbiology]. They’ve analyzed the problem, recommended directions forward, and now the question is, what are the federal agencies actually going to do? That is what we are trying to come up with now."
At the meeting, public health officials and invited consultants broke into work groups to brainstorm about options for action in four key areas of antibiotic resistance: surveillance, research, product development, and prevention and control. The work groups developed lists of options — without attempting to achieve consensus or establish priorities — and then the whole group ranked the importance of the options on evaluation forms that were given to task force members at the end of the meeting. The task force will use the evaluations to assist in the development of a blueprint for the activities of federal agencies to combat antimicrobial resistance.
"This is a multifaceted problem that needs to be confronted on several fronts," Bell tells HIC. "Right now we are sorting through the ideas. Down the road, there will probably be some effort to prioritize and assign tentative time frames to get some of the things done. We need to develop a draft of a plan and then we get additional public comments back. That will happen in coming months."
While the research group considered such issues as the need for affordable diagnostic tests that could rapidly discern between bacterial and viral infection, the surveillance group pondered whether a national surveillance system for antimicrobial resistance should be a uniform data collection system or a group of coordinated components. The majority of possible actions, however, fell under the prevention and control work group, which was co-chaired by Julie Gerberding, MD, MPH, director of the CDC hospital infections program. The work group listed several options in the area of health communications that address "the concept of really making antimicrobial resistance a national health priority, and using social marketing and other public health campaign approaches to promote judicious antimicrobial use," Gerberding said at the meeting. That effort could include the Sur geon General issuing a high-profile national report to underscore to the public the problem of antibiotic resistance.
Assessing potential impact on ICPs
Though it remains to be seen what measures will actually be proposed in the draft plan, the options under discussion at the meeting included several that could impact ICPs. Those include upgrading and expanding surveillance programs for resistant organisms; monitoring use of vancomycin and other important drugs; and strengthening requirements for infection control programs and training in health care settings.
Concerning the latter, one option listed calls for the task force to "mandate" that all health care facilities and systems that receive federal funds "maintain infection surveillance, prevention and control programs consistent with standards/ requirements" outlined by federal agencies, the Joint Commission on Accreditation of Healthcare Organizations, and the professional infection control associations. Such requirements could certainly bolster the perceived importance of infection control programs, but they beg the question of whether ICPs can expect any additional resources to comply with any new program responsibilities.
"Certainly, if you are going to have an effective surveillance program in place for these particular organisms, you need to have the resources to support it," Slater tells HIC. "We spoke to the fact that this needed to be in place at all levels of the health care system, not only in acute care, but long-term care, home care, and all sectors. The other thing that we talked about was tying it to accreditation, to licensing, to the NCQA [National Council of Quality Assurance] as far as managed care contracts and so forth. That’s the only way you would be able to put some teeth into it. Otherwise, it would just be paper’ compliance."
Infection control can’t do it alone
For example, Joint Commission accreditation interpretation language could emphasize the importance of providing adequate resources for antibiotic resistance efforts, Slater says. Still, while ICPs may play vital roles in any national effort, the solutions to such a multifaceted problem lie beyond the bailiwick of infection control programs, reminds Patti Grant, RN, MS, CIC, director of infection control at RHD Memorial Medical Center and Trinity Medical Center, both in Dallas.
"Antimicrobial resistance is a thread that runs through everything we do," says Grant, who reviewed some of the federal options under discussion for HIC. "But this has to be institution-owned.’ ICPs [alone] cannot control the transmission or the mutation of multiple-resistant organisms. We are a very important player, but we are not the end." While conceding the problem certainly warrants national action and a coordinated effort by public health officials, Grant was leery of attempts to regulate the use of antibiotics in medicine.
"I’m not saying [regulation] shouldn’t be done, but it will be very hard to implement," she says. "What you are dealing with here are patient care treatment practices by individual physicians. Imagine passing a federal law that is written into a HCFA rule that says you can only give vancomycin for [certain situations]. We have to be cautious not to cross that line. But we have to get really close to that line if we are going to effect change and stop these mutations [of resistant organisms]. This is definitely needed on a national level. But how invasive do we want this to be? I think education is the key vs. regulation."
An important avenue for addressing the problem in the hospital setting may be pharmacy and therapeutics committees, which typically have the most physician representation and access to drug utilization data, she notes. "As far as monitoring vancomycin use, that would be overwhelming to me as an ICP to try and incorporate that into my infection control program," Grant says. "What would be better for infection control, which would still involve a lot of empowerment, would be to make sure that we are on the quality management and P and T’ committees as active, consulting members."
Regardless, there was no attempt at this stage of the process to clarify which federal agencies would enforce any mandates, though the FDA and HCFA appeared to be the most likely candidates to give the plan regulatory teeth and/or monetary incentives to comply. Moreover, the task force could develop an action plan outlining a coordinated federal response without recommending regulatory enforcement, Bell says.
"You can have plenty of actions that facilitate or encourage voluntary measures," he says. "There may be some items that involve regulatory actions and there may be some that involve other ways to improve [antibiotic] use that are not regulatory."
New regulations or not?
Beyond that, there remains some question of whether the effort could be enforced with current regulations or whether new rules would have to be approved. For example, Sandy Kweder, MD, acting deputy director of the FDA office of drug evaluation and research, said some of the matters discussed at the meeting would require new regulation for FDA enforcement.
"FDA could develop a regulation that actually required pharmaceutical firms to provide periodic updates on product use and distribution, as well as resistance surveillance data," she told meeting attendees. "These are not current requirements. But we could, with appropriate encouragement, bolster our regulations to do that. It would require a regulation." However, Bell says the FDA "may be able to take a number of measures just within their existing authority."
Likewise, another consultant at the meeting expressed the hope that actions could be taken without passing new regulations. "I think there is probably a lot that can be done with existing authority," says Patricia Lieberman, PhD, staff scientist at the Center for Science in the Public Interest (CSPI) in Washington, DC. "We’re not suggesting a whole new structure to deal with this."
The consumer advocate group has come out strongly in favor of government action to preserve the efficacy of antibiotics. "The CSPI definitely feels that it is time for the government, either through the health care it funds or at its own hospitals, to institute the best practices in infection control, vaccinations, and prudent use of antibiotics," Lieberman tells HIC. "The system that we have thus far with practice guidelines mostly isn’t working. In order to protect the antibiotics and make sure they continue to work, it may be time for regulations and more strict control of how antibiotics are used."
References
1. Centers for Disease Control and Prevention. Reduced susceptibility of Staphylococcus aureus to vancomycin — Japan, 1996. MMWR 1997; 46:624-626.
2. Centers for Disease Control and Prevention. Staphylococcus aureus with reduced susceptibility to vancomycin — United States, 1997. MMWR 1997; 46:765-766.
3. Centers for Disease Control and Prevention. Update: Staphylococcus aureus with reduced susceptibility to vancomycin — United States, 1997. MMWR 1997; 46:813-814.
4. Chen DK, McGeer A, De Azavedo JC, et al. Decreased susceptibility of streptococcus pneumoniae. N Engl J Med 1999; 341:233-239.
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