Dear Editor,
Ocular exposures to ethanol can damage corneal epithelium and increase proinflammatory cytokine and chemokine expression [1]. The use of alcohol-based hand sanitizers (ABHS) increased dramatically during the COVID-19 pandemic. In April 2020, the U.S. Food and Drug Administration (FDA) identified a 79% increase in ABHS exposures reported to America’s Poison Centers compared to 2019 [2]. In November 2021, FDA issued a Drug Safety Communication warning of serious eye injuries, including severe irritation and corneal abrasions associated with ABHS [2]. Recent publications from other countries have described ABHS-associated chemical eye injuries in children [3–5].
Herein, we characterize U.S. cases reporting clinical effects following ocular exposure to ABHS in all ages. We searched America’s Poison Centers’ National Poison Data System from January 2018 to April 2021 and used a 12-month interval to describe characteristics of pre-pandemic (March 2019–February 2020) versus pandemic (March 2020–February 2021) periods. Included cases involved ABHS ocular-only exposures categorized by the poison specialist as having a related clinical effect (i.e. timing/signs/symptoms of clinical effect were consistent with ABHS exposure). We reviewed case narratives reporting intentional exposures, major effects, and hospitalizations.
From January 2018 to April 2021, America’s Poison Centers received 3642 cases (Table 1) with a related clinical effect, most of which were ocular; 409 cases received treatment/evaluation. The number of cases rose by 77% from 2018 (N = 797) to 2020 (N = 1409). Nearly all cases (98%) involved ethanol-containing ABHS.
Table 1.
Descriptive characteristics of cases with a related clinical effect from ocular-only exposure to ABHS single-substance, America’s Poison Centers’ National Poison Data System from 1 January 2018 to 30 April 2021.
| Characteristic | Entire time period |
12-month pre-pandemic subset |
12-month pandemic subset |
|||
|---|---|---|---|---|---|---|
| Jan 2018–Apr 2021 N =3642 |
Jan 2018–Apr 2021 % |
Mar 2019–Feb 2020 N =980 |
Mar 2019–Feb 2020 % |
Mar 2020–Feb 2021 N=1400 |
Mar 2020–Feb 2021 % |
|
| Age (years) | ||||||
| ≤5 | 1255 | 34.5 | 344 | 35.1 | 468 | 33.4 |
| 6–12 | 1013 | 27.8 | 314 | 32.0 | 280 | 20.0 |
| 13–19 | 279 | 7.7 | 106 | 10.8 | 66 | 4.7 |
| 20–39 | 440 | 12.1 | 104 | 10.6 | 207 | 14.8 |
| 40–59 | 241 | 6.6 | 42 | 4.3 | 136 | 9.7 |
| ≥60 | 180 | 4.9 | 30 | 3.1 | 106 | 7.6 |
| Unknown child (≤19) | 12 | 0.3 | 2 | 0.2 | 7 | 0.5 |
| Unknown adult (≥20) | 195 | 5.4 | 33 | 3.4 | 118 | 8.4 |
| Unknown age | 27 | 0.7 | 5 | 0.5 | 12 | 0.9 |
| Sex | ||||||
| Female | 2024 | 55.6 | 523 | 53.4 | 803 | 57.4 |
| Male | 1606 | 44.1 | 455 | 46.4 | 594 | 42.4 |
| Unknown | 12 | 0.3 | 2 | 0.2 | 3 | 0.2 |
| Substances | ||||||
| Ethanol | 3583 | 98.4 | 971 | 99.1 | 1364 | 97.4 |
| Isopropanol | 53 | 1.5 | 9 | 0.9 | 32 | 2.3 |
| Methanol* | 6 | 0.2 | 0 | 0 | 4 | 0.3 |
| Exposure site | ||||||
| Own or Other residence | 2271 | 62.4 | 550 | 56.1 | 1005 | 71.8 |
| School | 925 | 25.4 | 326 | 33.3 | 189 | 13.5 |
| Workplace | 197 | 5.4 | 51 | 5.2 | 83 | 5.9 |
| Public area | 128 | 3.5 | 24 | 2.4 | 69 | 4.9 |
| Health care facility | 20 | 0.6 | 6 | 0.6 | 4 | 0.3 |
| Restaurant/food service | 12 | 0.3 | 1 | 0.1 | 5 | 0.4 |
| Unknown or Other | 89 | 2.4 | 22 | 2.2 | 45 | 3.2 |
| Exposure reason | ||||||
| Unintentional | 3570 | 98.0 | 949 | 96.8 | 1380 | 98.6 |
| Intentional | 21 | 0.6 | 10 | 1.0 | 5 | 0.4 |
| Unknown or Other Reason | 51 | 1.4 | 21 | 2.1 | 15 | 1.1 |
| Management site | ||||||
| Treated/evaluated and released† | 409 | 11.2 | 115 | 11.7 | 161 | 11.5 |
| Patient lost to follow-up / left against medical advice | 123 | 3.4 | 33 | 3.4 | 52 | 3.7 |
| Patient refused referral / did not arrive at a healthcare facility | 30 | 0.8 | 9 | 0.9 | 13 | 0.9 |
| Not treated at a healthcare facility | 3080 | 84.6 | 823 | 84.0 | 1174 | 83.9 |
| Treatment‡ | ||||||
| Dilution/irrigation/wash | 3363 | 92.3 | 909 | 92.8 | 1279 | 91.4 |
| Antibiotics | 74 | 2.0 | 15 | 1.5 | 31 | 2.2 |
| Steroids | 6 | 0.2 | 2 | 0.2 | 1 | 0.1 |
| Medical outcome§ | ||||||
| Major effect | 3 | 0.1 | 2 | 0.2 | 2 | 0.1 |
| Moderate effect | 121 | 3.3 | 26 | 2.7 | 56 | 4.0 |
| Minor effect | 2048 | 56.2 | 569 | 58.1 | 779 | 55.6 |
| Unable to follow, judged as a potentially toxic exposure | 80 | 2.2 | 19 | 1.9 | 29 | 2.1 |
| Not followed, minimal clinical effects possible (no more than minor effect possible) | 1390 | 38.2 | 364 | 37.1 | 534 | 38.1 |
Exposure to methanol was not confirmed.
Five cases were coded as admitted to critical care or noncritical care units; however, none of the cases described the reason for admission or the provision of inpatient care. Therefore, we re-categorized these to treated/evaluated and released.
A case may have received one or more treatments.
National Poison Data System Overview and Data Definition, March 2019.
Major effect – The patient has exhibited symptoms as a result of the exposure which were life-threatening or resulted in significant residual disability or disfigurement.
Moderate effect – The patient exhibited symptoms as a result of the exposure which are more pronounced, more prolonged or more of a systemic nature than minor symptoms. Symptoms were not life-threatening, and the patient has returned to a pre-exposure state of well-being with no residual disability or disfigurement.
Minor effect – The patient exhibited some symptoms as a result of the exposure, but they were minimally bothersome to the patient. The symptoms usually resolve rapidly and often involve skin or mucous membrane manifestations. The patient has returned to pre-exposure state of well-being and has no residual disability or disfigurement.
Not followed, minimal clinical effects possible – The patient was not followed because, per clinical judgement, the exposure was likely to result in only minimal toxicity of a trivial nature. Cases that refused follow-up if the exposure would possibly result in minimal clinical effects and would cause no more than a minor effect may also be included.
Unable to follow, judged as a potentially toxic exposure – The patient was lost to follow-up (or the poison center neglected to provide follow-up) and per clinical judgement the exposure was significant and may have resulted in toxic manifestations with a moderate, major or death outcome.
Related ocular clinical effects were primarily irritation/pain (N = 3373) followed by red eye/conjunctivitis (N = 1146). Blurred vision occurred in 164 cases and corneal abrasion occurred in 58 cases. All abrasions were treated with dilution/irrigation/wash and most received antibiotics. Twenty-eight abrasions had a moderate effect, and one had a major effect (large area of cornea involved). Fifty percent of abrasions were in ages ≤19 years, and 21% were in ages ≤5 years.
Characteristics of pre-pandemic (N = 980) and pandemic (N = 1400) subsets are described. Most ABHS exposures occurred at a residence where handwashing with soap and water is likely more accessible. A residence was the site of exposure in 56% of the pre-pandemic group vs 72% of the pandemic group. Children ≤5 years accounted for approximately 90% of exposures in both groups. School was the exposure site in 33% of the pre-pandemic group vs 13.5% in the pandemic group. Ten pre-pandemic and five pandemic cases were coded as intentional exposures. In some cases, children purposely discharged ABHS product at their peers or forcefully pressed down on ABHS dispensers.
Consistent with the experiences of other countries, ABHS exposures and injuries in the U.S. frequently occurred in children. Potential reasons include unsupervised use of personal hand sanitizers, dispensers at or above children’s eye level, and partially clogged dispenser openings that allow misdirected spray. A higher percentage of pandemic exposures occurred at home. This is not surprising given pandemic lockdowns. Prevention efforts include supervising use, storing out of reach of children, and applying gentle pressure to the pump dispenser. When exposures occur, immediate eye irrigation and examination may decrease long-term sequelae of chemical eye injuries [2].
Acknowledgements
We acknowledge Omayma Kishk, PharmD, BCPPS and Carmen Cheng, PharmD from the Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, for their contributions.
Funding
The author(s) reported there is no funding associated with the work featured in this article.
Footnotes
Disclosure statement
No potential conflict of interest was reported by the author(s).
The work was authored as part of the Contributor’s official duties as an Employee of the United States Government and is therefore a work of the United States Government. In accordance with 17 U.S.C. 105, no copyright protection is available for such works under U.S. Law.
Contributor Information
Jenny Kim, Office of Surveillance and Epidemiology, Center for Drug and Evaluation and Research, U.S. Food and Drug Administration,, Silver Spring, MD, USA.
Karen Konkel, Office of Surveillance and Epidemiology, Center for Drug and Evaluation and Research, U.S. Food and Drug Administration,, Silver Spring, MD, USA.
Evelyn Mentari, Office of Nonprescription Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Ida-Lina Diak, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Lynda McCulley, Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
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