Original contribution

Does the clinical use of ethanol-based hand sanitizer elevate blood alcohol levels? A prospective study

Michael A. Miller MD^a,b,*, Alex Rosin MD^a, Marc E. Levsky MD^a, Manish M. Patel MD^c,

Timothy J.D. Gregory MD^a, Chad S. Crystal MD^a

^aDepartment of Emergency Medicine, C.R. Darnall Army Medical Center, Hood, TX 76544, USA

^bCentral Texas Poison Control Center, Temple, TX 76508, USA

^cDepartment of Emergency Medicine, Emory University School of Medicine, Atlanta, GA 30322, USA

Received 4 March 2006; revised 1 May 2006; accepted 7 May 2006

Abstract

Background: Ethanol-based hand sanitizers (EBHSs) are used in most health care facilities in the United States. Infection control personnel advocate the use of generous quantities of EBHS before and after contact with patients. Although it is assumed that little systemic absorption of ethanol occurs during EBHS use, many alcohols are absorbed to varying degrees via the transdermal route. ethanol intoxication by employees in the medical workplace is a potentially serious finding, and it is of forensic and medical-legal importance to elucidate the effects of frequent use of EBHS upon serum blood ethanol levels (BELs). To investigate the effect of frequent use of EBHS upon serum blood ethanol concentrations, we prospectively studied 5 volunteers undergoing frequent application of EBHS. Methods: Enrolled subjects applied 5 mL of the product (62% denatured ethyl alcohol manufactured by Kimberley-Clark, Roswell, GA) to both hands and rubbed until dry. This activity was repeated 50 times over 4 hours. Participants had their Blood drawn before as well as after completing the study. Each participant was without alcohol exposure during the 12 hours preceding the study.

Results: Five volunteers were enrolled. All had an initial blood ethanol level of less than 5 mg/dL. All 5 participants completed the 4-hour study. There were no noted adverse reactions during the study. Blood ethanol level upon completion of the 50 applications of EBHS was less than 5 mg/dL in all 5 study participants.

Conclusion: The results of this study demonstrate that use of ethanol-based hand sanitizers, when frequently used in accordance with labeling, do not raise serum blood ethanol levels.

D 2006

* Corresponding author. C.R. Darnall Army Medical Center, Ft. Hood TX, USA. Tel.: +1 254 288 8303.

E-mail address: [email protected] (M.A. Miller).

Introduction

Ethanol-based hand sanitizers (EBHSs) are used in most health care facilities in the United States. Infection control personnel advocate the use of generous quantities of EBHS before and after contact with patients [1]. This translates to the use of these products 10 to 25 times per hour, depending

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816 M.A. Miller et al.

upon the task being performed. Although it is assumed that little systemic absorption of ethanol occurs during EBHS use, many alcohols are absorbed to varying degrees via the transdermal route [2]. Because dermal absorption of alcohols has been demonstrated in a previous study, and ethanol intoxication by employees in the medical workplace is a potentially serious finding, it is of forensic and medical- legal importance to elucidate the effects of frequent use of EBHS upon serum blood ethanol levels (BELs).

To investigate the effect of frequent use of EBHS upon serum blood ethanol concentrations, we studied 5 volunteers undergoing frequent application of EBHS.

Methods

Study design

This was a prospective, nonblinded study. The institu- tional review board at our institution approved the study.

Study protocol

Participants were the investigators and associate inves- tigators of the study. All are employees in the emergency department at the study institution. Enrolled subjects applied

5 mL of the product (62% denatured ethyl alcohol manufactured by Kimberley-Clark) to both hands and rubbed until dry. This activity was repeated 50 times over 4 hours. Participants had their blood drawn before as well as after completing the study. No laboratory tests were performed other than the ethanol levels. Prestudy blood ethanol levels were ordered to ensure a prestudy level of less than 5 mg/dL. All participants were adults between the ages of 18 and 50 years, without history of hepatic or renal disease. Each participant had no Alcohol intake or exposure during the 12 hours preceding the study, including EBHS. Other exclusion criteria included allergy to EBHS or any of its ingredients, any rash on the extremities, and current use of disulfiram or any drug known to have disulfiram-like reactions with ethanol intake.

Data analysis

In this study, the independent variable was time in relation to frequent use of hand sanitizer. The dependent variable was blood ethanol concentration, measured as milligrams per deciliter. The null hypothesis was that frequent use of alcohol-based sanitizers does not raise blood alcohol levels. A paired t test was used for analysis. The expected blood ethanol level before the frequent use of alcohol-based sanitizer was 0 to 5 mg/dL, which is deemed undetectable by the assay used by our laboratory. This is equivalent to a mean F SD of 2.5 F 1.25 for those with undetectable blood ethanol levels. An increase to 5 mg/dL would be statistically significant (an effect size of 2.5/ 1.25 = 2 SD). The sample size was adjusted with 1000

iterations of a Monte Carlo simulation until the power was between 80% and 85% with a level of confidence of 95%. According to this method, 5 subjects acting as their own controls would be needed to detect a 2 SD effect size with a level of confidence of 95% and a power of 80%.

Results

A total of 5 volunteers were enrolled. All had an initial BEL of less than 5 mg/dL. All 5 participants completed the 4-hour study. There were no noted adverse reactions during the study. Blood ethanol level upon completion of the

50 applications of EBHS was less than 5 mg/dL in all 5 study participants.

Discussion

Ethanol is the most frequently abused intoxicant in the United States [3]. The proliferation of work-related Drug testing programs, integration of EBHS into health care facilities, and the widespread abuse of ethanol make it imperative to define what, if any, contribution the use of ethanol-based hand sanitizers have on the BEL of users of such products. Medical review officers (MROs) may be asked to review an employee’s claim that he or she was not using ethanol, and the MRO must use the best available evidence to guide these important, life-altering decisions. The MRO involved in evaluating such reports relies on past case reports, knowledge of laboratory analytical techniques, and other scientific evidence to validate or negate claims of drug use in the workplace. We have previously reported a case report of a negative BEL after frequent use of EBHS [4]. Before that report, no human reports of serum ethanol levels after frequent clinical use of EBHS had been reported. This study, which demonstrates negative serum ethanol levels with extremely frequent use of EBHS, concludes that the contribution to BEL of EBHS is negligible and can be discounted by the involved reviewing authority in cases where cause of elevated BEL is unclear. Because of the heavy and consistent use of EBHS in this study, these results are likely to be reproducible in all clinical settings.

Limitations

This study tested the ability of EBHS to elevate BEL in healthy, adult males. Although the findings likely apply to other human populations, this cannot be proven from our data. Furthermore, we dealt only with EBHS being used as intended. This study does not rule out BEL elevation by EBHS that has been misused in some manner, such as through ingestion or application to mucous membranes. An important remaining question is whether EBHS may contribute to or cause disulfiram-alcohol reactions in

Does the clinical use of ethanol-based hand sanitizer elevate blood alcohol levels? 817

susceptible individuals. The finding of a negative BEL does not preclude the possibility that EBHS may cause such reactions. topical application of products containing alde- hyde-dehydrogenase inhibitors has been noted to cause such reactions in persons taking oral ethanol [5]. Because of the requirements set forth by the institutional review board, we were unable to study the effects of EBHS upon patients at risk for disulfiram-ethanol reactions. This is an important topic, worthy of future research.

Conclusion

The results of this study demonstrate that use of ethanol- based hand sanitizers, when frequently used in accordance with labeling, does not raise serum blood ethanol levels.

References

1. Hilburn J, Hammond BS, Fendler EJ, Groziak PA. Use of alcohol hand sanitizer as an infection control strategy in an acute care facility. Am J Infect Control 2003;31(2):109 - 16.
2. Turner P, Saeed B, Kelsey MC. Dermal absorption of Isopropyl alcohol from a commercial hand rub: implications for its use in hand decontamination. J Hosp Infect 2004;56(4):287 - 90.
3. Compton WM, Conway KP, Stinson FS, Colliver JD, Grant BF. Prevalence, correlates, and comorbidity of DSM-IV antisocial person- ality syndromes and alcohol and specific Drug use disorders in the United States: results from the national epidemiologic survey on alcohol and related conditions. J Clin Psychiatry 2005;66(6):677 - 85.
4. Miller MA, Crystal CS, Rosin A. Alcohol based hand sanitizer: can frequent use cause an elevated blood alcohol level? Am J Infect Control 2006;34(3):150 - 1.
5. Plouvier B, Lemoine X, De Coninck P, Baclet JL, Francois M. Antabuse effect during the administration of a topical drug based on monosulfiram. Nouv Presse Med 1982;11(43):3209.