Alcohol-based hand hygiene rubs, ubiquitous in hospitals and widely praised for their efficacy and ease of use, may pose some level of risk to expectant mothers and their unborn babies, the FDA warns. As hand hygiene is performed constantly throughout a hospital workday a small level of alcohol may begin to accumulate and flow through the bloodstream. No problem for most workers, but what about those expecting?
“No known safe threshold exists for fetal alcohol exposure,” Colleen Rogers, PhD, lead microbiologist in the FDA’s Division of Nonprescription Drug Products (DNDP) said at a preliminary hearing on a recently proposed FDA rule.
The FDA is calling for a major review of the active ingredients in hospital antiseptics. As it currently stands, alcohol rubs and other healthcare antiseptics are being used in the absence of updated scientific data on the effects of prolonged exposure to healthcare workers, particularly those who are pregnant or breast-feeding. Infection preventionists have until Oct. 28, 2015 to submit comments on the controversial proposed rule by the FDA.1
“Alcohol-based healthcare antiseptics are not only used frequently in the healthcare setting, but they are also recommended for use by authoritative bodies such as the CDC,” Rodgers said. “There are no data on the effects of systemic alcohol exposure due to healthcare antiseptic use during pregnancy, but maternal alcohol ingestion is the leading known cause of developmental and cognitive disabilities in children and a preventable cause of birth defects. Based on alcohol exposure data from non-pregnant adults, ‘moderate’ hand rub use led to a maximum systemic exposure equivalent to approximately 10% of the alcohol in a glass of wine or a bottle of beer. The implications of even this low exposure are unclear.”
The FDA would have to find compelling evidence to limit the use of alcohol rubs in hospitals, as a former CDC outbreak investigator made it perfectly clear what was at stake.
“This would lead to increased healthcare-associated infection rates and take U.S. infection control backwards at least 15 to 20 years,” warned William Jarvis, MD, an independent infection control consultant who spoke on behalf of industry at the hearing.
Healthcare settings nationwide transitioned from soap and sinks to the alcohol hand rubs after the CDC recommended the move in 2002 guidelines that cited improved compliance by healthcare workers and high efficacy against nosocomial pathogens. The notable exception is C. difficile, a spore former that may require the use of soap and water. Citing the worst-case scenario, Jarvis said removing alcohol rubs and returning to the old soap and water approach would have a devastating effect on patient safety. It would require more healthcare worker time, likely undermining compliance and providing less killing power than alcohol even when workers do comply.
“[The] rest of the world has moved forward [with alcohol rubs],” he said, “The WHO has their worldwide Hand Hygiene Campaign. All of this would occur during a time when antibiotic-resistant pathogens are on the rise and infection prevention is needed more than ever. Given that hand hygiene is thought to be the most important method to decrease healthcare-associated infections, patient safety would be significantly adversely impacted.”
The FDA proposed rule requests additional scientific data to support the safety and effectiveness of certain active ingredients used in healthcare antiseptics marketed under the over-the-counter drug monograph.
“The FDA recommends that healthcare personnel continue to use these products consistent with infection control guidelines while additional data are gathered,” the agency said in a statement. “Healthcare antiseptics are primarily used by healthcare professionals in hospitals, clinics, doctors’ offices, outpatient settings and nursing homes. They include hand washes and rubs, surgical hand scrubs and rubs (with or without water), and patient preoperative skin preparations, including pre-injection preparations. The most common active ingredients in healthcare antiseptics marketed under the over-the-counter drug monograph include alcohol and iodines. These products are different from consumer antiseptics, such as antibacterial soaps and hand sanitizer rubs, which are not part of this proposed rule.”
The FDA would require manufacturers who want to continue marketing healthcare antiseptic products to provide additional data on the active ingredients’ safety and effectiveness. This would include data to evaluate absorption, potential hormonal effects, and development of bacterial resistance. Once the proposed rule is finalized, ingredients for which adequate safety and effectiveness data have been provided would continue to be available, the FDA concluded in the proposed rule.
Given the unprecedented national emphasis the last few years on reducing HAIs and staving off a post-antibiotic era, members of the antiseptic industry have been understandably taken aback by the data demands.
“First, let’s remember we’re speaking about a healthcare setting where a significant number of infections do occur. The pathogens are becoming more and more virulent, and we have fewer effective therapies. So infection prevention is critical,” Dave Mackay of GOJO Industries told the FDA. “These products have been used safely for many decades. They are the current standard of care. Despite the decades and frequency of use, there have been no identified chronic health related issues. Yet the benefit to the patient is undisputed.”
The nation’s two leading infection control healthcare epidemiology associations cautiously endorsed the FDA action while emphasizing that hand hygiene, surgical skin preps, and other antiseptics are essential to prevent HAIs, which cause 75,000 patient deaths annually. The statement by APIC and the Society for Healthcare Epidemiology of America (SHEA) reads in part:
“APIC and SHEA strongly agree with FDA’s advice that these products continue to be used consistent with infection control guidelines while additional data is being gathered. Healthcare antiseptics are an important component of infection control strategies in hospitals, clinics, and other healthcare settings, and remain a standard of care to prevent illness and spread of infection. … Since all infection prevention and control guidelines are evidence-based, it is important to stay up-to-date on safety and effectiveness data to protect healthcare personnel and their patients.”
The FDA cited new scientific information and concerns expressed by outside scientific and medical experts on FDA advisory committees. The work practices and science have changed since the FDA began reviewing healthcare antiseptics in the 1970s. Among the changes cited by the agency are its own safety standards, the frequency of use of some of the products, hospital infection control practices, new technology that can detect low levels of antiseptics in the body, and increased knowledge about the impact of widespread antiseptic use. The research paradigm is different as well, with the FDA looking for data on the effects on healthcare workers — not the traditional focus on the safety and efficacy in patients.
“This seems obvious, but it’s an important point that is very pertinent to our discussion because it results in a different benefit/risk profile than we’re used to thinking about since the benefit of the drug occurs in a different person than the risk,” Theresa Michele, MD, director of the DNDP at the FDA, said at a Sept. 4, 2014 hearing on the proposed rule.
For example, new lines of research suggest that for at least some healthcare antiseptic active ingredients, systemic exposure (full body exposure as shown by detection of antiseptic ingredients in the blood or urine) is higher than previously thought, the FDA states. The agency is particularly concerned about the effects of repeated daily exposure to antiseptic active ingredients.
The frequency of dosing is a critical area of concern for the FDA.
“I mean, if you really think about it with the healthcare antiseptics, [healthcare workers are] probably the poster child for maximal use when it comes to frequency of dosing,” said Dennis Bashaw, PhD, director of the FDA’s office of clinical pharmacology. “You use it when you come in the room. You use it when you leave the room. You use it before you start a procedure. You do it over and over again. There’s no other topical dermatological that you’re going to use as many times per shift, per 8-hour, 10-hour, 12-hour period, as you’re going to use a topical healthcare antiseptic.”
The chemicals diffuse through the skin and accumulate as they are constantly replenished, an effect that may be compounded by healthcare workers who develop irritated and chapped or broken skin. While there is little data on the effects of alcohol on healthcare workers, there is even less on the other major antiseptic ingredient, iodine.
“One small study showed an increase in urinary iodine concentration after a single day of surgical scrub use,” Bashaw said. “Although we don’t have a lot of information about absorption as a result of healthcare antiseptic use, data on iodine absorption are available. Iodine is known to cross the placenta. It is also actively concentrated in the mammary gland and secreted in breast milk.”
REFERENCE
- Food and Drug Administration. Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record. Fed Reg May 1, 2015: http://1.usa.gov/1SDshKy.
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