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Alcohol-based hand sanitisers: a warning to mitigate future poisonings and deaths
  1. Georgia C Richards
  1. Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
  1. Correspondence to Georgia C Richards, Centre for Evidence-Based Medicine, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; georgia.richards{at}kellogg.ox.ac.uk

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Alcohol-based hand sanitisers, if ingested, can have toxic effects and may even be lethal. Preventable deaths from ingesting hand sanitisers have been identified. This article describes two Prevent Future Death (PFD) case reports, and recommends eight actions to mitigate intentional and accidental ingestion of alcohol-based hand sanitisers in healthcare and community settings.

This article is part of the Coroners’ Concerns to Prevent Harms series1 . It covers the toxicity of alcohol-based hand sanitisers from two Prevention of Future Deaths reports.2 3

Since the COVID-19 outbreak, alcohol-based hand sanitisers have become among the most in-demand commodities globally.4 5 Panic buying left many shelves empty, and production increased to meet demands. Alcohol-based hand sanitisers are liquids, gels or foams that contain 60–95% ethyl alcohol (ethanol) or 70–95% isopropyl alcohol (isopropanol) used to disinfect hands6 (see box 1). The volume of these products now to be found around homes, hospitals, schools, workplaces and elsewhere may be a cause for concern. Warnings about the toxicity and lethality of intentionally or unintentionally ingesting alcohol-based hand sanitisers have not been widely disseminated.

Box 1

EBM facts: alcohol-based hand sanitisers6 10 18

Formulations

  • liquids

  • gels

  • foams

Ingredients

  • alcohol: ethanol (60–95%) or isopropanol (70–95%)

  • hydrogen peroxide (in selected products)

  • gelling or foaming agents, depending on formulation

  • an emollient (eg, glycerol)

  • sterile distilled or boiled water

Indications for use

  • To disinfect hands, external use only

  • In healthcare settings it should be regularly used in line with the WHO’s ‘My 5 Moments for Hand Hygiene’, except when hands are soiled then water and soap is advised.

  • In all other settings it may be used when access to water and soap are not readily accessible.

Regulations

  • In the UK, the MHRA categorises alcohol-based hand sanitisers as biocides if they claim to kill germs, disinfect, sanitise or use an active antimicrobial ingredient. If so, they are regulated through the Health and Safety Executive.

  • Other products such as liquid or solid soaps, which are primarily used to clean or moisturise hands and have a secondary antimicrobial effect, are regulated as cosmetics through the Cosmetic Production Regulation.

  • Products that claim to treat or prevent infection associated with named pathogens such as surgical scrubs in operating theatres are regulated as medicines by the MHRA.

Harms

Intended use:

  • allergic reactions

Off-label use:

  • if ingested, headache, blurred vision, nausea, vomiting, abdominal pain, loss of coordination, decreased level of consciousness, among others and, in some cases, death.

Hazards

  • flammability if exposed to high temperatures or flames

  • eye irritation if not used as intended (ie, rub hands until dry)

There was a 157% increase in poisonings from alcohol-based hand sanitisers reported to the National Poisons Information Service (NPIS) in the UK between January and September 2019 and January and September 2020 (figure 1).7 Two case studies have also described accidental poisonings from the ingestion of hand sanitisers at home by children in Australia and the USA during the SARS-CoV-2 pandemic.8 9 The US CDC reported 15 poisonings and four deaths associated with the ingestion of hand sanitisers that were intentionally made with methanol instead of ethanol or isopropanol during the COVID-19 outbreak,10 and the FDA is taking action by regularly updating their “should not use” list of hand sanitisers to protect the public from further harms (www.fda.gov/handsanitizerlist). This BMJ EBM Coroners’ Concerns to Prevent Harms article describes two deaths in England that occurred after the intentional and unintentional ingestion of alcohol-based hand sanitisers in healthcare facilities,2 3 and outlines recommendations to mitigate further harms.

Figure 1

Trends in UK alcohol-based hand sanitiser poisonings reported to the National Poisons InformationService (NPIS) between January and August in 2019 (blue) compared with 2020 (orange). There was a 157% increase in reports during this time, from 155 calls in 2019 (January 1 to September 16) to 398 in 2020 (January 1 to September 14). Data were obtained through a Freedom of Information request to Public Health England.19 Pandas,20 seaborn21 and matplotlib22 packages in Jupyter Notebooks (Python v3.8.2) were used to create the plot. The data and code are openly available at GitHub.9

Case 1: Intentional consumption

In 2013 a 30-year-old woman was admitted to a mental health facility in an English tertiary care hospital. Twenty days later she was detained under the provisions of the Mental Health Act 1983 and given venlafaxine, an antidepressant medicine. She passed away 3 days later, found in her hospital bed with a container of Purell hand sanitising gel (containing ethanol and isopropanol at 66% weight per volume) beside her. The gel was readily accessible to patients on the ward from a communal dispenser, and patients were allowed to fill cups or other containers to keep in their rooms. A post-mortem blood analysis found “214 mg of alcohol in 100 mL of blood”. The medical cause of death was “ingestion of alcohol and venlafaxine”, and the coroner concluded that the combination of these substances caused the patient’s breathing to be suppressed, resulting in death.

The coroner’s report identified four concerns (see box 2) which were addressed to the UK’s Department of Health and the NHS Trust.2 Under regulation 28 of the Coroners’ (Investigations) Regulations 2013, parties who receive the report have 56 days to respond to the coroner, outlining actions taken or proposed, with a timetable for action; otherwise, the addressees must explain why no action is proposed. The Department of Health responded 59 days later describing national guidelines and strategies to prevent suicides.11 They also alluded to data from the National Reporting and Learning System, which can only be accessed if you are a general practitioner or pharmacist or have an NHS email. Thus, no actions were undertaken or proposed by the Department of Health.

Box 2

Coroner’s concerns from Case 12

  • Patients had unlimited access to alcohol-based hand sanitiser

  • Patients were allowed to decant alcohol-based hand sanitiser into cups and other such containers

  • Patients were allowed to keep cups and containers of alcohol-based hand sanitiser in their rooms

  • Lack of awareness among hospital staff (eg, nurses, physicians) of the alcohol content of hand sanitisers, and the potential for such substances to be ingested23

At the time of writing (August 2020) and published (November 2020) this article, a response from the NHS Trust was not available on the Judiciary website, making it 6 years overdue.2 A Freedom of Information (FOI) request to the Trust revealed that a response may have been received by the Coroner’s Office which reported replacing wall-mounted sanitisers with alcohol-free alternatives, and that the Trust had taken steps to review access to and use of sanitisers, as well as raising awareness of the potential risks associated with the ingestion of alcohol-based hand sanitisers with staff.11 However, there are no mechanisms for verifying or monitoring the implementation of these actions, nor is it possible to determine whether the actions became standard practice and are still being endorsed across the Trust.

Case 2: Unintentional consumption

In 2015 a 76-year-old man developed acute ethanol toxicity after ingesting an unknown quantity of Purell Advanced Hygienic Hand Sanitising Foam, containing about 75% ethanol, which was attached to the foot of his bed while he was an inpatient in an NHS hospital in England. He had a history of agitation and depression, which was being treated with antidepressants, and had a 9-month history of increasing confusion, with some evidence that he might be developing vascular dementia. His blood ethanol concentration was 463 mg/dL (100 mmol/L) initially and 354 mg/dL (77 mmol/L) 10 hours later. He was given lorazepam and haloperidol and treated with ventilation in the intensive care unit (ICU), with a plan to allow the alcohol to be naturally metabolised. After removal of his endotracheal tube in the ICU, he developed aspiration pneumonitis and bilateral bronchopneumonia. He died 6 days later and the causes of death were recorded as: (1a) bronchopneumonia; (1b) acute alcohol toxicity; (2) acute delirium and coronary artery atherosclerosis.

The coroner’s primary concern (see box 3), addressed to NHS England, was that lessons from this incident were not widely communicated within the NHS or to the public. No response was available from NHS England at the time of writing (August 2020) and published (November 2020) this article, making it more than 3 years overdue under regulation 28 of the Coroners’ (Investigations) Regulations 2013.3 After the inquest, a news article reported that the Trust had introduced lockable dispensers and staff were carrying their own sanitisers.12 However, there are no mechanisms for verifying or monitoring these actions, nor is it possible to determine whether the imposed actions are still standard practice. In another news article the medical director of NHS England stated that they could not directly influence the public’s use of alcohol-based sanitisers, but that he would flag the risk with the Medicines and Healthcare products Regulatory Agency (MHRA), and that NHS Improvement would update the coroner on both steps as developments emerge.13 But no record of whether this communication occurred is available on the Judiciary website.3

Box 3

Coroner’s concerns from Case 23

  • The coroner first acknowledged the challenge between preventing cross-infection in hospitals and the possibility that confused patients may consume sanitisers. The coroner discussed increased public awareness of hand hygiene and the resultant increase in exposure to alcohol-based hand sanitisers outside of hospitals.

  • The coroner was concerned that key learnings from this incident had not been disseminated across the NHS and in public and private sectors.

  • The coroner recommended that such organisations need to be made aware of this potential hazard and take appropriate action, which might include making formal risk assessments when such materials are used.

Encouraging hand hygiene while mitigating harms

Hand hygiene is the cornerstone of infection control, and efforts are still needed to improve practices, particularly during the COVID-19 outbreak. In healthcare facilities the WHO’s “My 5 Moments for Hand Hygiene” should be performed, and increasing the availability of alcohol-based hand sanitisers in point-of-use areas can improve adherence.14 In most clinical settings, alcohol-based hand sanitisers are the preferred approach, unless hands have visible contamination with blood, body fluids, proteinaceous material or are exposed to spore-forming organisms, when hands should be washed with soap, water and drying agents.15 In all other settings, washing hands with soap and water is a simple and effective way to decrease the spread of pathogens and infections. If soap and water are not available, alcohol-based hand sanitisers can be used. Thus, the deaths discussed in this article should not deter the use of hand sanitisers. However, these deaths have serious safety implications for healthcare facilities, the public and other private settings. The deaths provide an opportunity to develop and implement mitigation strategies (see box 4), and are an opportunity to educate healthcare professionals and the public in harm reduction.

Box 4

Recommendations to improve hand hygiene while mitigating harms from alcohol-based hand sanitisers

All settings

  • Launch an understandable and convincing public health campaign to educate the public as well as healthcare professionals about hand hygiene, when alcohol-based hand sanitisers may be preferred over water and soap, and the potential for misuse and serious adverse health events if alcohol-based hand sanitisers are ingested, including death.

  • When supplying large volumes of alcohol-based hand sanitisers, secure bottles or contents in lockable dispensers.

  • Mandate manufacturers to display clear warning labels on products about the potential for misuse and harms if ingested.

  • Enforce and monitor the reporting and analysis of poisonings and deaths from the ingestion of alcohol-based hand sanitisers to public health authorities.

  • Alcohol-based hand sanitisers should only be used to disinfect hands and should never be swallowed. Children should be supervised when using, and products kept out of reach when not in use.

Healthcare settings

  • Develop and disseminate national guidance on where and how alcohol-based hand sanitisers should be located (i.e. in lockable dispensers or removed from rooms for high-risk patients), and how to treat people who have ingested alcohol-based hand sanitisers, tailoring the guideline to the availability of treatments, types of sanitisers available and providing contacts for local poisons information centres.

  • Track the daily volume of sanitiser being dispensed (eg, using a force-sensitive resistor and a microcontroller recording device24) to provide feedback on hand hygiene practices and to alert staff when overuse is detected.

  • For patients with alcohol use disorder or at high-risk, particularly those in geriatric, paediatric or mental health facilities, access to alcohol-based hand sanitisers should be removed to prevent intentional or accidental ingestion and staff should be provided with individual portable sanitisers.

Had appropriate actions been taken at a national level by the UK’s Department of Health in 2014, the death described in Case 2 and the hundreds of poisonings reported to the NPIS in 2019 and 2020 (figure 1) might have been prevented. The combination of increased demand and exposure to alcohol-based hand sanitisers, and the negative impacts of the COVID-19 outbreak on mental health, social supports, financial security and health services is a cause of serious concern.16 17 This complex interplay of issues may lead to a further increase in poisonings and deaths that could be mitigated if recommendations from these deaths were implemented.

While governments and public health authorities have successfully heightened our awareness of and need for better hand hygiene during the COVID-19 outbreak, they must also make the public aware of the potential harms and encourage the reporting of such harms to poisons information centres. Data reported to poisons centres should be monitored, openly shared, and used to design and implement mitigation strategies to serve patient and public safety.

References

Footnotes

  • Twitter @Richards_G_C

  • Correction notice Thia article has been corrected since it appeared Online First. In the second paragraph, 61% has been corrected to "157% increase in alcohol-based hand sanitiser poisonings from alcohol-based hand sanitisers reported to the National Poisons Information Service (NPIS)". Figure 1 caption of the same percentage has been updated from 61% to 157%.

  • Contributors GCR devised the idea for this article, identified the coroners’ reports, conducted a systematic literature search, submitted two freedom of information requests, analysed the data on calls to poisons centres, and wrote, edited and submitted the manuscript.

  • Funding The author has not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Disclaimer The views expressed are those of the author and not necessarily reflect those of the NHS, the NIHR, or the Department of Health and Social Care.

  • Competing interests GCR is financially supported by the National Institute of Health Research (NIHR) School for Primary Care Research (SPCR), the Naji Foundation and the Rotary Foundation to study for a Doctor of Philosophy (DPhil/PhD) at the University of Oxford. GCR is the Editorial Registrar of BMJ Evidence Based Medicine and is developing the preventabledeathstracker.net website.

  • Patient consent for publication Not required. The coroner reports discussed in this article are openly available at https://www.judiciary.uk/subject/prevention-of-future-deaths/

  • Provenance and peer review Commissioned; externally peer reviewed.

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