Friday, May 01, 2015

FDA Calls For Better Evidence On Health Care Antiseptics


# 9997


In this age of increasing HAIs (Hospital Acquired Infections) the number of times a HCW must stop and wash (or sanitize) their hands has grown exponentially over the past decade.   As the chart above illustrates (credit WHO), every patient contact can instigate as many as five hand washings.  


It is not unusual for HCWs to stop and sanitize their hands a hundred times during a single shift, often utilizing one of several antibacterial products (alcohol rubs, phenols, Iodine benzalkonium chloride, etc.). 

While these products have been around for decades, and are considered Generally Recognized As Safe & Effective (GRASE)  by the FDA , they’ve never been used by so many people – and applied so many times each day - as they are now.  


Yesterday the FDA published a notice that they would like to see evidence of both the safety and effectiveness of a broad range of products – used primarily, but not exclusively – in the Health Care arena.   This is the first major review of these products since the early 1970s.


Categories of healthcare antiseptics to be reviewed include:

  • Health care personnel hand washes
  • health care personnel hand rubs
  • surgical hand scrubs
  • surgical hand rubs
  • patient preoperative skin preparations


Not included in this review are common consumer antiseptics, like antibacterial soaps containing Triclosan, which are under a separate review (see FDA Reviewing Safety & Effectiveness Of Antibacterial Soaps). 

Results of this review won’t be available for several years, and in the meantime the FDA recommends that hospital staff continue to use these products as they have been. 


FDA News Release

FDA issues proposed rule to address data gaps for certain active ingredients in health care antiseptics

April 30, 2015

The U.S. Food and Drug Administration today issued a proposed rule requesting additional scientific data to support the safety and effectiveness of certain active ingredients used in health care antiseptics marketed under the over-the-counter drug monograph.


Based on new scientific information and concerns expressed by outside scientific and medical experts on an FDA advisory committee, the agency is requesting additional scientific data to demonstrate that health care antiseptics in the over-the-counter drug monograph are generally recognized as safe and effective (GRASE) for their intended use to reduce bacteria that potentially can cause disease. The FDA’s request for more safety and effectiveness data for health care antiseptic active ingredients should not be taken to mean the FDA believes that these products are ineffective or unsafe.

Since the FDA began review of health care antiseptics in the 1970s, many things have changed, including the frequency of use of some of these products, hospital infection control practices, new technology that can detect low levels of antiseptics in the body, the FDA’s safety standards and the scientific knowledge about the impact of widespread antiseptic use.

Emerging science also suggests that for at least some health care 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, and existing data raise potential concerns about the effects of repeated daily human exposure to some antiseptic active ingredients. The FDA is particularly interested in gathering additional data on the long-term safety of daily, repeated exposure to these ingredients in the health care setting and on the use of these products by certain populations, including pregnant and breastfeeding health care workers, for which topical absorption of the active ingredients may be important.

“Today health care professionals use antiseptic products much more frequently than they used to, in some cases up to 100 times a day,” said Theresa Michele, M.D., director of CDER’s Division of Nonprescription Drug Products. “Today’s proposal seeks to ensure the FDA’s evaluations and determinations for all health care antiseptic active ingredients are consistent, up-to-date and appropriately reflect current scientific knowledge and patterns of use by health care professionals.”

The proposed rule does not require any health care antiseptic products to be removed from the market at this time. Instead, it requires manufacturers who want to continue marketing health care antiseptic products under the monograph to provide the FDA with additional data on the active ingredients’ safety and effectiveness, including 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.

(Continue . . .)

During the last big review of hospital antiseptics in the early 1970s, the FDA determined that one of the most commonly used antimicrobial products - Hexachlorophene – used in hospitals and in consumer products like bar soaps, cosmetics, and acne medicines – was highly toxic and could produce neurological symptoms and even death.


Its non-prescription use was pretty much abolished in 1972. 


The fact that hexachlorophene was also used in pesticides might have served as a clue to its toxicity, but this was the middle of the 20th century, when for a time you could buy cigarettes with asbestos filter tips, cribs were coated with leaded paint, kids were encouraged to handle beads of mercury in school, and you could go to a shoe store and have your feet x-rayed for fun.


And yet, somehow we still think of them as the good old days.


Giga Gerard said...

When I had a cleaning job after a year red bumps appeared on my hands: the beginning of eczema I thought. From then on I always wore gloves when using cleaning products.
I wonder what a nurse will do after she discovers red bumps on her hands from sanitizing too much. Wear gloves?

Giga Gerard said...

I'd like to add: those red bumps I got from cleaning were very itchy.