Sanitizers - Hidden threat lurking behind the alcohol sanitizers in COVID‐19 outbreak

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trader32176
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Sanitizers - Hidden threat lurking behind the alcohol sanitizers in COVID‐19 outbreak

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Hidden threat lurking behind the alcohol sanitizers in COVID‐19 outbreak

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7280687/

Abstract

The ongoing COVID‐19 pandemic has made various challenges for communications all over the world. Nowadays hand hygiene practices with alcohol sanitizers are an unavoidable reality for many people, which cause skin dryness and flaking. The current short communication has been explained about monitoring the quality control of alcohol concentrations and hand rub formulation, which needs more attention and should consider meticulous in this crisis.

According to the available documents, the most important way to transmit diseases, especially in medical centers, is by hands and now we know that more than 80% of infections are transmitted by touch. As it has been documented, normal human skin is colonized by different kind of bacteria, with totally different aerobic counts (ranging from >1 × 106 colony forming units [CFU]/cm2 on the scalp to 1 × 104 CFU/cm2 on the forearm), this is while total bacterial counts on the hands of a health person is ranged from 3.9 × 104 to 4.6 × 106 CFU/cm2. 1 Along with this the hands of some health care workers may become persistently colonized by some pathogenic flora such as Staphylococcus aureus, Gram‐negative bacilli, or some other kind of microorganisms.

In the recent pandemic, COVID‐19, which is stands for “coronavirus disease 2019,” is introduced as the cause of world acute respiratory infection crisis and outbreak. 2 In this context, public health guideline recommended by World Health Organization emphasized on frequent and correct washing hands with standard hand rubs to prevent transmission and reduce the spread of the mentioned pandemic diseases. Based on these protocols and recommendations, use of alcohol‐based hand rubs has become very common around the world. Although it is true that hand hygiene is the most important way to break the infection chain transmission but using proper solution with the standard formula should be consider strongly. Although handwashing with water and soup is the most recommended procedure but due to lack of access in some situations, Ethanol‐containing hand rubs are used frequently as a substitute for mentioned method. In the recent crisis due to the fact that the consumption of hand rub solutions has greatly increased in the world, several cases of related risks have been proposed, which are discussed in this article, so evaluation the alcohol concentrations should be considered in quality control procedures meticulous. Due to the fact that handwashing can be performed with different methods and compounds, so this instruction should be considered and assay both in terms of behavior and the risk of production formula. Governments and health policy makers should encourage local production but monitoring the hand rub formulations to have enough efficiency and safety.

Another problem about hand rubs is skin complications. Due to the excitement in the world and overuse, the alcohol‐based hand rubs have caused adverse effects on the skin of many people who used it frequently. Figure ​Figure11 demonstrates a contact dermatitis in two cases and an exacerbation of atopic dermatitis on the palm. In a review study by Cristina Beiu et al, it has been mentioned that frequent handwashing for COVID‐19 prevention can cause hand dermatitis. 2 Good hand hygiene helps prevent the transmission of infections such as COVID‐19, but these preventive practices can also damage the skin. It has been proved that frequent hygenization of hands make several changes in texture of skin. These changes are ranged from development of cutaneous xerosis (dryness) up to irritant contact dermatitis (ICD) and rarely allergic contact dermatitis (ACD). These disorders are induced by different mechanisms such as physical, chemical, and immunological. Appearing hand dermatitis makes difficult situation to balance the dilemma of maintaining hand hygiene and preventing eczema flare. Based on these mechanisms, properties of hand hygiene policy, rub compounds (quality and formula), and used techniques are very important to be measured and must be considered based on the following circumstances:

1) One of the most popular hands hygiene techniques according to the recent pandemic crisis related to COVID‐19 is the use of gloves. The remarkable thing about this is prolonged wearing medical gloves, which have some side effects such as increased sweating and humidity of the hands and in the following increases the inflammatory responses and irritants which will be followed by fungal and bacterial skin infections.

2) Repeated use of soaps, surfactants, detergents, or solvents due to their capacity to remove skin surface lipids, damage to skin proteins, denature epidermal keratin, and even induce alteration of the cell membrane of keratinocytes can lead to ICD and rarely to ACD.

3) Frequent use of alcohol‐based products can result in skin dryness and irritation.

4) In addition to the above and due to the recent crisis related to COVID‐19, there are some other points that should be considered during executing the instructions.

Since the outbreak of COVID‐19, although washing with warm water and soap remains the gold standard for hand hygiene, but according to the structural characteristic of coronaviruses, (enveloped viruses with bilayer lipid) alcohol‐based products introduced as the most effective hand sanitizers. In this crisis, and due to the high volume of alcohol consumption, a number of problems are emerging, which, if not controlled in a timely manner, could create other crises for the general health of society. One of the problems with alcoholic products is the production of hand rubs with nonstandard formulas. For example, it has been cleared that methanol is used instead of ethanol in some products. While methanol itself is not a type of toxin, but when adsorbed to the human body, it metabolized by dehydrogenase enzymes into formaldehyde and formic acid. These end products are toxic and may cause metabolic acidosis, brain injury, blindness, cardiovascular instability, and death. 3 , 4 Methanol toxication most frequently results via oral, industrial inhalation, and transdermal routes.

One of the dangers of widespread use of alcoholic solutions in society especially by ordinary people is eliminating many skin normal florae that are very important for the health system, and this is because those such compounds do not differentiate between foe and friend bacteria. 5

Another important point about alcohol products is its production based on the nonstandard formula, especially situation‐based protocols. In standard alcohol‐based hand sanitizers, varying amounts (60%‐80% most effective, higher, and less are not most effective) and types of alcohols are used. In these compounds, isopropyl alcohol, ethanol (ethyl alcohol), n‐propanol, or a combination of two of these are used. 6 This group of sanitizers is found effective at killing many types of bacteria including Gram‐positive and Gram‐negative types and also different virus families including influenza A virus, rhinovirus, hepatitis A virus, HIV, and coronaviruses. However, they have virtually no activity against bacterial spores, protozoan oocysts, and very poor activity against nonenveloped (nonlipophilic) viruses. 7 , 8

Although alcohols with the mentioned points are rapidly germicidal when applied, but have no significant residual activity and regrowth of bacteria occurs after use of alcohol sanitizers. For this reason, some compounds such as chlorhexidine, quaternary ammonium compounds, octenidine, or triclosan are added to alcohol‐based formulations to increase persistent activity of hand rubs. According to the recent crisis, Food and Drug Administration released a temporary compound producing guideline for certain alcohol‐based hand sanitizer products during COVID‐19 pandemic on March 14, 2020, as the public health emergency. 9 Based on such emergency instructions, produced antiseptics solutions have not proper effect and cannot cover all introduced pathogens especially all kinds of nosocomial infections. Although this single alcohol‐based sanitizers with no persistent compounds may be effective on the infectious agent causing the 2020 crisis (SARS‐CoV‐2), according to its limited activity against certain groups of microorganisms, this will cause selection pressure on ethanol‐resistant microorganisms. This clonal selection, especially in hospital settings, will lead us to emerge and re‐emerge of some controlled microorganisms that will cause a new crisis.
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Re: Hidden threat lurking behind the alcohol sanitizers in COVID‐19 outbreak

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This is what happens to your body when you use hand sanitizer every day

https://timesofindia.indiatimes.com/lif ... d=75601875

We all are using hand sanitizers much more than ever before. Proper handwashing and using sanitizer whenever washing hands is not possible, can save all of us from bacteria and viruses. When you are outside, riding in a car, playing in a park or just shopping, it's not always possible to use soap and water to wash hands. This is where we all have to rely on our alcohol-based hand sanitizers. Especially during times like these when we are combatting the COVID-19 pandemic, frequent use of sanitizer is recommended by the government itself. But there are some unpleasant side effects of using hand sanitizer every day. We share a few

Excessive use can disrupt your microbiomes


Sanitizer is a little too good at killing bacteria and that is how it keeps us safe from a variety of illnesses. But another aspect of this is, sanitizer can affect the body's microbiomes in a few ways, which can be bad for us. Sanitizer kills off the bacteria that are beneficial for our body, which in turn can wreak havoc in our healthy bacterial community. The only solution to this is that people should use hand sanitizer with caution and only when they don't have access to soap and water.

​Excessive use can create stronger bacteria

According to the Center for Disease Control and Prevention, hand sanitizer with antibacterial ingredients can contribute to the development of antibiotic-resistance bacteria. So, in order to prevent creating those scary little microbes, washing your hands instead of reaching for the bottle of sanitizer should be practiced, as much as possible. The antibiotic-resistant bacteria can develop the ability to tolerate the drug that otherwise should be able to kill them.

Hand sanitizers cannot effectively remove dirt and grime

If your hands are visibly soiled, hand sanitizer won't work. Hand sanitizer does not remove dirt and is less effective at killing germs viruses when the hands are soiled. This rule is the same in a situation like when you change a diaper, empty the trash box or clean a dirty surface.

Excessive use can make your hands dry

If you are using hand sanitizer every day, you might have noticed your hands have become incredibly dry. The alcohol in hand sanitizer can dry out your skin, but this can be fixed by using hand moisturizer and staying hydrated. Or simply opt for soap and water to clean your hands. Are you getting the gist? Handwashing is the king, guys!

​Ingesting and inhaling sanitizer every day can increase your risk of alcohol poisoning

If you ingest hand sanitizer, which is a terrible idea, you are at a risk of alcohol poisoning. If you touch some on your lips by accident, it's not an issue. But if you gulp some mouthful, you might be in trouble. The Center for Disease Control (CDC) notes that children are particularly at risk of ingesting hand sanitizer, especially if it's scented, bright coloured or attractively packaged. So, keep it away from the reach of children.


If you work with chemicals, hand sanitizer can prove dangerous


If you work with chemicals all day, you surely want to make sure your hands are clean at the end of the shift. If you work with ultra-strong cleaning, de-greasing agents and pesticides, hand sanitizer is the last thing you should reach out for. This is because the combination of liquid gel and chemicals can be really harmful for your body. According to a study published in the Journal of Occupational and Environmental Medicine, farmworkers who used hand sanitizer had increased levels of pesticides in their bodies as opposed to those who didn't use the sanitizer.
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Re: Hidden threat lurking behind the alcohol sanitizers in COVID‐19 outbreak

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FDA says these hand sanitizers won't protect you against COVID-19

https://www.cbsnews.com/news/sanitizer- ... rotection/


For months, the Food and Drug Administration has been urging U.S. consumers to avoid a growing list of hand sanitizers that may contain toxic substances. Now the agency is warning of another problem: Some brands may not be strong enough to kill the coronavirus.

To work, sanitizers must have a sufficient amount of at least one of two kinds of alcohol. They have to have be at least 60% ethanol or 70% isopropanol, according to the Centers for Disease Control and Prevention. Those levels are also safe on human skin.

According to the FDA, the following sanitizer products are "sub-potent," meaning they lack enough of the active ingredients that protect people from infection:

Alcohol Antiseptic 62% Hand Sanitizer (Quimica Magna de Mexico)
Assured Hand Sanitizer Vitamin E and Aloe (Albek de Mexico)
Assured Hand Sanitizer Aloe Vera (Albek de Mexico)
Bernal (Quimica Magna)
Datsen (Quimica Magna)
Derma70 Hand Sanitizer (Asiaticon)
Clean Humans (DEPQ Internacional)
CleanCare NoGerm (Precision Analitica Integral)
Dgreen (DEPQ Internaciona)
Hand Sanitizer (DEPQ Internacional)
HF&N (Healthy Food and Nutrition Lab)
Medically Minded (Asiaticon)
Modesa Hand Sanitizer with Moisturizers and Aloe Vera (Albek de Mexico)
NeoNatural (Limpo Quimicos)
Next Hand Sanitizer (Albek de Mexico)
Nuuxsan Instant Hand Sanitizer (Albek de Mexico)
OZO (Estrategia Hospitalaria)
Protz Real Protection Antibacterial (Asiaticon)
UltraCruz (Santa Cruz Biotechnology, Texas)
V-KLEAN (Asiaticon)
Yakana (Grupo Yakana)
Yacana Hand Sanitizer (Grupo Yacana)

Worse, some of those sanitizers also contain methanol, which is used to make fuel and is dangerous when absorbed through the skin, inhaled or ingested.

The lack of potency is one of the reasons the FDA's list of sanitizers that people should avoid, which was expanded this week to about 100 brands and nearly 150 varieties. The list includes sanitizers made without enough ethanol, isopropanol or another active ingredient to be effective, consumer advocacy group U.S. PIRG noted.

Most recently, on August 26, the federal agency posted a recall notice by Mexico's Apodaca, Nuevo Leon, Nanomateriales involving Zanilast plus gel to contain 1-propanol, a toxin that can damage the nervous system. The substance cause death if it's absorbed through the skin, consumed or comes into contact with a person's eyes.

The recalled products were sold in 1-liter, 25-liter and 1-gallon plastic bottles in California, New Jersey and New York, the company said.
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Re: Hidden threat lurking behind the alcohol sanitizers in COVID‐19 outbreak

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COVID-19: Not all hand sanitizers work against it – here’s what you should use

https://www.thejakartapost.com/life/202 ... d-use.html

Since the outbreak of COVID-19, sales of hand sanitizers have soared. It’s become such a sought-after product that pharmacies and supermarkets have started limiting the number that people can buy at one time. New York state has even announced it will start producing its own hand sanitizer to meet demand. Though hand sanitizers can help reduce our risk of catching certain infections, not all hand sanitizers are equally effective against coronavirus.

As with other viral respiratory infections – like the common cold and flu – the novel coronavirus (called SARS-CoV-2) is mainly spread when virus-laden droplets from a person’s mouth or nose are transferred to other people. However, a recent study has suggested that it can also spread through faeces.

Aside from inhaling droplets, you can also get respiratory viruses including SARS-CoV-2 by touching anything contaminated with the virus and then touching your face, in particular your mouth or nose. We touch our faces a lot without even realising it. A study from New South Wales found that people touch their faces about 23 times an hour.

Washing with warm water and soap remains the gold standard for hand hygiene and preventing the spread of infectious diseases. Washing with warm water (not cold water) and soap removes oils from our hands that can harbour microbes.

But hand sanitizers can also protect against disease-causing microbes, especially in situations when soap and water aren’t available. They’re also proven to be effective in reducing the number and type of microbes.

There are two main types of hand sanitizers: alcohol-based and alcohol-free. Alcohol-based hand sanitizers contain varying amounts and types of alcohol, often between 60 percent and 95 percent and usually isopropyl alcohol, ethanol (ethyl alcohol) or n-propanol. Alcohol is known to be able to kill most germs.

Alcohol-free hand sanitizers contain something called quarternary ammonium compounds (usually benzalkonium chloride) instead of alcohol. These can reduce microbes but are less effective than alcohol.

Not only are alcohol-based hand sanitizers found to be effective at killing many types of bacteria, including MRSA and E coli, they’re also effective against many viruses, including the influenza A virus, rhinovirus, hepatitis A virus, HIV, and Middle East respiratory syndrome coronavirus (MERS-CoV).

Destroying viruses

Alcohol attacks and destroys the envelope protein that surrounds some viruses, including coronaviruses. This protein is vital for a virus’s survival and multiplication. But a hand sanitizer needs to be at least 60% alcohol in order to kill most viruses.

Hand sanitizers with less than 60 percent alcohol were also found to be less effective at killing bacteria and fungi and may only reduce the growth of germs rather than killing them outright.

And even hand sanitizers containing 60 percent alcohol can’t remove all types of germs. Studies have found that hand washing is more effective than hand sanitisers at removing norovirus, Cryptosporidium (a parasite that can cause diarrhea), and Clostridium difficile (bacteria which cause bowel problems and diarrhea).

With shortages leading some people to try and make their own hand sanitizers, it’s also important to know these might not be as effective as commercially available products.

If hands are visibly dirty, hand washing with soap and water is more effective than using alcohol-based hand sanitizers. Research has found that the detergent effect of soap and the friction of washing work together to reduce the number of microbes on our hands, as well as the dirt and organic materials.

Sneezing or coughing into your hands also requires more than just a pump of hand sanitizer to disinfect them. This is because if your hands are contaminated with mucous, the hand sanitizer might not work as well because mucous acts to protect microbes.

As a result, the best and most consistent way of preventing the spread of the coronavirus – and reducing your risk of contracting it – remains washing your hands with soap and water as a first choice, and avoiding touching your face as much as possible.

But alcohol-based hand sanitizers (with at least 60 percent alcohol) are a practical alternative when soap and water aren’t available. If you are using hand sanitizer then, just like when washing with soap and water, you need to make sure you cover your hands (including between your knuckles, wrists, palms, back of your hand and your fingernails) fully, rubbing it in for at least 20 seconds so it’s truly effective.
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Re: Hidden threat lurking behind the alcohol sanitizers in COVID‐19 outbreak

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Coronavirus (COVID-19) Update: FDA Reiterates Warning About Dangerous Alcohol-Based Hand Sanitizers Containing Methanol, Takes Additional Action to Address Concerning Products
Agency Urges Consumers, Health Care Professionals Not to Use Certain Products, Citing Serious Adverse Events and Death


https://www.fda.gov/news-events/press-a ... sanitizers

The U.S. Food and Drug Administration continues to warn consumers and health care professionals not to use certain alcohol-based hand sanitizers due to the dangerous presence of methanol, or wood alcohol – a substance often used to create fuel and antifreeze that can be toxic when absorbed through the skin as well as life-threatening when ingested. The agency has also taken additional action to help prevent certain hand sanitizers from entering the United States by placing them on an import alert. The FDA is proactively working with manufacturers to recall products and is encouraging retailers to remove products from store shelves and online marketplaces. As part of these actions, a warning letter has been issued to Eskbiochem S.A. de C.V. regarding the distribution of products labeled as manufactured at its facilities with undeclared methanol, misleading claims –including incorrectly stating that FDA approved these products—and improper manufacturing practices.

The FDA first warned about some of the methanol-containing hand sanitizers being sold in retail stores and online in June. The agency issued a further warning earlier this month about an increasing number of adverse events, including blindness, cardiac effects, effects on the central nervous system, and hospitalizations and death, primarily reported to poison control centers and state departments of health. The agency continues to see these figures rise.

“Practicing good hand hygiene, which includes using alcohol-based hand sanitizer if soap and water are not readily available, is an important public health tool for all Americans to employ. Consumers must also be vigilant about which hand sanitizers they use, and for their health and safety we urge consumers to immediately stop using all hand sanitizers on the FDA’s list of dangerous hand sanitizer products,” said FDA Commissioner Stephen M. Hahn, M.D. “We remain extremely concerned about the potential serious risks of alcohol-based hand sanitizers containing methanol. Producing, importing and distributing toxic hand sanitizers poses a serious threat to the public and will not be tolerated. The FDA will take additional action as necessary and will continue to provide the latest information on this issue for the health and safety of consumers.”

The agency has posted a do-not-use list of dangerous hand sanitizer products, which is being updated regularly. In most cases, methanol does not appear on the product label. However, methanol is not an acceptable ingredient in any drug, including hand sanitizer, even if methanol is listed as an ingredient on the product label. The FDA’s ongoing testing has found methanol contamination in hand sanitizer products ranging from 1% to 80%.

Importantly, the FDA is urging consumers not to use any hand sanitizer products from the particular manufacturers on the list even if the product or particular lot number are not listed since some manufacturers are recalling only certain – but not all – of their hand sanitizer products. Manufacturers’ failure to immediately recall all potentially affected products is placing consumers in danger of methanol poisoning. One of the reported deaths is associated with Blumen Hand Sanitizer, distributed by 4e North America and manufactured by 4E Global in Mexico, who recently expanded its recall to include additional lots of its hand sanitizer products. Additionally, the FDA is strongly urging distributors and retailers to stop distributing and selling hand sanitizers manufactured by the firms on the list immediately, even if the particular product is not included in a recall, due to the risk of methanol poisoning.

When identifying hand sanitizers from the FDA’s do-not-use list, consumers should look for one or more identifiers from the list that match the product’s labeling, including:

Manufacturer name
Product name
National Drug Code (NDC) number

If any of the identifiers (name, company, or NDC) match a product on the list, the FDA urges consumers to immediately stop using the hand sanitizer. Dispose of the hand sanitizer bottle in a hazardous waste container, if available, or dispose of as recommended by local waste management and recycling centers. Do not flush or pour these products down the drain or mix with other liquids.

Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although people using these products on their hands are at risk for methanol poisoning, young children who ingest these products and adolescents and adults who drink these products as an alcohol (ethanol) substitute are most at risk. Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate medical treatment for potential reversal of the toxic effects of methanol poisoning.

The FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program (please provide the agency with as much information to identify the product as possible):
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Re: Hidden threat lurking behind the alcohol sanitizers in COVID‐19 outbreak

Post by TimGDixon »

This is all really good information. The very best thing you can do is wash your hands with warm soapy water - i rarely use the alcohol sanitizers. Keep up the good work - we are building a really good source of information.
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Re: Hidden threat lurking behind the alcohol sanitizers in COVID‐19 outbreak

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Risk of poisoning from hand sanitizers sold in beverage containers

https://healthycanadians.gc.ca/recall-a ... 1a-eng.php

Summary

Product: Hand sanitizers sold in beverage containers.
Issue: Some manufacturers of hand sanitizers are using packaging that is commonly used for beverages. This could confuse some consumers, who may mistake hand sanitizer for water or other beverages.
What to do: Always follow the label directions on hand sanitizers. Store these products away from beverages, and keep them out of the reach of children. Always supervise children when they use hand sanitizer. If hand sanitizer is swallowed, call a poison control centre or seek medical attention right away.

Issue

Some manufacturers of hand sanitizers are having difficulty producing or sourcing containers normally used for medical or household products. Many companies have increased their production in response to the COVID-19 pandemic, but are finding that appropriate packaging is limited.

Some companies, such as breweries and distilleries, are using water, wine and liquor bottles for hand sanitizer. The products’ labels and branding may also be similar to the labels and branding of known alcoholic beverages or bottled water so consumers could confuse hand sanitizer for water or other beverages. Ingesting hand sanitizer could cause serious harm, particularly in children, because of the high alcohol content.

All hand sanitizer products authorized for sale by Health Canada have an eight-digit Drug Identification Number (DIN) or Natural Product Number (NPN) on the label, and are listed on the List of Hand Sanitizers Authorized by Health Canada.

As with all health products, always read and follow the directions on the product label. Hand sanitizers should never be ingested and should always be kept out of the reach of children. Always supervise children when they use hand sanitizer, because ingesting even small amounts can be dangerous or fatal. Health Canada recently issued an advisory about the risk of poisoning from hand sanitizers sold in beverage containers.

In light of global supply shortages, the Government of Canada has issued guidance to industry on acceptable packaging materials and sizes for hand sanitizer products to ensure their availability during the COVID-19 pandemic. We encourage manufacturers to consider the appearance of containers to avoid potential confusion by consumers.
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Re: Hidden threat lurking behind the alcohol sanitizers in COVID‐19 outbreak

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Recommendations for compounded hand sanitizers during COVID-19

https://www.contemporarypediatrics.com/ ... g-covid-19

The COVID-19 pandemic led to a shortage of hand sanitizers and a push to make up the gap with compounded hand sanitizer ensued. Recommendations were released to ensure their efficacy.

Early in the COVID-19 pandemic, the US supply chain was stretched thin on many necessary products, including hand sanitizer. In response to this shortage, many health systems, manufacturers, and non-traditional institutions (eg, distilleries) sought to compound hand sanitizer to meet this need. To ensure safe compounding practices, in March 2020 the US Food and Drug Administration (FDA) released guidance for the temporary compounding of certain alcohol-based hand sanitizer products during the public health emergency.1 In addition, the United States Pharmacopeia (USP) provided recommendations on compounding alcohol-based hand sanitizer during the COVID-19 pandemic.2 These guidance documents provided recommendations regarding ingredients, facilities, and labeling in accordance with the World Health Organization’s (WHO) recommended recipe.3 These documents support the use of two formulas that result in either an ethanol antiseptic topical solution containing ethanol 80% (v/v) or an isopropyl alcohol antiseptic topical solution with a final concentration of 75% (v/v).1,2,3 According to the USP guidance, compounded hand sanitizers have a beyond use date of 30 days which is significantly shorter than commercially available products.2 The FDA does not recommend the public manufacture their own hand sanitizers due to risk for poor efficacy if made incorrectly and reports of skin burns.4 The hand sanitizer should be labeled with the alcohol percentage and can be stored at controlled room temperature.1

The CDC recommends using alcohol-based hand sanitizer only when soap and water are unavailable. Therefore, it is crucial that the final concentration of hand sanitizer is at least 60% alcohol (ethanol or isopropyl alcohol) to avoid getting sick and spreading germs to others.5 Hand sanitizer should be used by covering all hand surfaces and rubbing one’s hands together, for approximately 20 seconds, or until they feel dry.6 Soap and water should be used whenever possible and always during food preparation, wound care, using the restroom, or caring for pets.6

Hand sanitizer, when used by children, must be under the direct supervision of adults to prevent accidental ingestion.5

Note from Dr. Lee: Numerous brands and types of hand sanitizers have emerged in the market place and they are NOT regulated by the FDA. It is extremely important to review all contents and their concentration to assure its effectiveness and safe use. The CDC and FDA are excellent resources for updated information for hand sanitizers (eg, potential harmful effects of methanol containing products). —Carlton Lee, PharmD, MPH, FASHP, FPPAG

References

Policy for Temporary Compounding of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency Immediately in Effect Guidance for Industry. U. S. Food and Drug Administration. https://www.fda.gov/media/136118/download. Published in March 2020, Last Updated on June 1, 2020, Accessed on July 13, 2020.
Compounding Alcohol-Based Hand Sanitizer During COVID-19 Pandemic. United States Pharmacopoeia. https://www.usp.org/sites/default/files ... andrub.pdf. Published on March 18, 2020. Last Updated on March 25, 2020. Accessed on July 13, 2020.
Guide to Local Production: WHO-recommended Handrub Formulations. World Health Organization. https://www.who.int/gpsc/5may/Guide_to_ ... uction.pdf. Last Updated in April 2010. Accessed on July 13, 2020.
Q&A for Consumers: Hand Sanitizers and COVID 19: FDA. https://www.fda.gov/drugs/information-d ... d-covid-19. Accessed on July 13, 2020.
Show Me the Science – When & How to Use Hand Sanitizer in Community Settings, Centers for Disease Control and Prevention. https://www.cdc.gov/handwashing/show-me ... tizer.html. Last Updated on March 3, 2020. Accessed on July 13, 2020.
Hand Sanitizer Use Out and About. Centers for Disease Control and Prevention. https://www.cdc.gov/handwashing/hand-sanitizer-use.html. Last Updated on April 13, 2020, Accessed on July 13, 2020.
FDA Updates on Hand Sanitizers with Methanol. U. S. Food and Drug Administration. https://www.fda.gov/drugs/drug-safety-a ... a#products. Last Updated on July 2, 2020. Accessed on July 13, 2020.
Hand Sanitizers with Methanol: FDA Updates. MedWatch - The FDA Safety Information and Adverse Event Reporting Program. http://s2027422842.t.en25.com/e/es?s=20 ... 43&elqat=1. Accessed on July 13, 2020.
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Re: Sanitizers - Hidden threat lurking behind the alcohol sanitizers in COVID‐19 outbreak

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Alcohol-free hand sanitizer works just as well as alcohol-based products to control COVID-19

12/1/20


https://www.news-medical.net/news/20201 ... ID-19.aspx


A new study from researchers at Brigham Young University finds that alcohol-free hand sanitizer is just as effective at disinfecting surfaces from the COVID-19 virus as alcohol-based products.

The BYU scientists who conducted the study suspected that the CDC's preference for alcohol sanitizer stemmed from as-yet limited research on what really works to disinfect SARS-CoV-2. To explore other options, they treated samples of the novel coronavirus with benzalkonium chloride, which is commonly used in alcohol-free hand sanitizers, and several other quaternary ammonium compounds regularly found in disinfectants. In most of the test cases, the compounds wiped out at least 99.9% of the virus within 15 seconds.

" Our results indicate that alcohol-free hand sanitizer works just as well, so we could, maybe even should, be using it to control COVID."

- Benjamin Ogilvie, lead study author

Alcohol-free hand sanitizers, which are also effective against common cold and flu viruses, have a number of advantages over their alcohol-based counterparts, Ogilvie explained.

"Benzalkonium chloride can be used in much lower concentrations and does not cause the familiar 'burn' feeling you might know from using alcohol hand sanitizer. It can make life easier for people who have to sanitize hands a lot, like healthcare workers, and maybe even increase compliance with sanitizing guidelines," he said.

In the face of shortages, "having more options to disinfect hospitals and public places is critical," added Ph.D. student Antonio Solis Leal, who conducted the study's experiments.

Switching to alcohol-free hand sanitizer is logistically simple as well.

"People were already using it before 2020," said BYU professor and coauthor Brad Berges. "It just seems like during this pandemic, the non-alcohol-based hand sanitizers have been thrown by the wayside because the government was saying, 'we don't know that these work,' due to the novelty of the virus and the unique lab conditions required to run tests on it."

Since benzalkonium chloride typically works well against viruses surrounded by lipids--like COVID--the researchers believed that it would be a good fit for disinfecting the coronavirus.

To test their hypothesis, they put COVID samples in test tubes and then mixed in different compounds, including .2% benzalkonium chloride solution and three commercially available disinfectants containing quaternary ammonium compounds, as well as soil loads and hard water.

Working fast to simulate real-world conditions--because hand sanitizer has to disinfect quickly to be effective--they neutralized the disinfecting compounds, extracted the virus from the tubes, and placed the virus particles on living cells. The virus failed to invade and kill the cells, indicating that it had been deactivated by the compounds.

"A couple of others have looked at using these compounds against COVID," said Berges, "but we're the first to actually look at it in a practical timeframe, using four different options, with the realistic circumstance of having dirt on your hands before you use it."

The team believes their findings "may actually provide a change in government directions about hand sanitizer," Berges said.

Ogilvie hopes that reintroducing alcohol-free sanitizers into the market can relieve the shortages--and reduce the chances of people encountering some potentially "sketchy" alcohol sanitizers that have cropped up in response to the demand.

"Hand sanitizer can play an especially important role in controlling COVID," he concluded. "This is information that could affect millions of people."

The study is published online in the Journal of Hospital Infection.

Source:

Brigham Young University

Journal reference:


Ogilvie, B.H., et al. (2020) Alcohol-free hand sanitizer and other quaternary ammonium disinfectants quickly and effectively inactivate SARS-CoV-2. Journal of Hospital Infection. doi.org/10.1016/j.jhin.2020.11.023.
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Re: Sanitizers - Hidden threat lurking behind the alcohol sanitizers in COVID‐19 outbreak

Post by trader32176 »

FDA takes action on alcohol-based hand sanitizers from Mexico

1/26/21


https://www.news-medical.net/news/20210 ... exico.aspx


As part of the U.S. Food and Drug Administration's continuing efforts to protect consumers from potentially dangerous or subpotent hand sanitizers, the agency has placed all alcohol-based hand sanitizers from Mexico on a countrywide import alert to help stop products that appear to be in violation from entering the U.S. until the agency is able to review the products' safety.

Over the course of the ongoing pandemic, the agency has seen a sharp increase in hand sanitizer products from Mexico that were labeled to contain ethanol (also known as ethyl alcohol) but tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin and life-threatening when ingested. Methanol is not an acceptable ingredient in hand sanitizer or other drugs.

Under the import alert, alcohol-based hand sanitizers from Mexico offered for import are subject to heightened FDA scrutiny, and FDA staff may detain the shipment. As part of their entry review, FDA staff will consider any specific evidence offered by importers or manufacturers that the hand sanitizers were manufactured according to U.S. current good manufacturing practice requirements. This marks the first time the FDA has issued a countrywide import alert for any category of drug product.


" Consumer use of hand sanitizers has increased significantly during the coronavirus pandemic, especially when soap and water are not accessible, and the availability of poor-quality products with dangerous and unacceptable ingredients will not be tolerated.

Today's actions are necessary to protect the safe supply of alcohol-based hand sanitizers. We will continue to work with our stakeholders to ensure the availability of safe products and to communicate vital information with the health and safety of U.S. consumers in mind."

- Judy McMeekin, Pharm.D., FDA Associate Commissioner for Regulatory Affairs

The FDA's analyses of alcohol-based hand sanitizers imported from Mexico found 84% of the samples analyzed by the agency from April through December 2020 were not in compliance with the FDA's regulations. More than half of the samples were found to contain toxic ingredients, including methanol and/or 1-propanol, at dangerous levels.

The agency has posted and regularly updates a list of hand sanitizer products that consumers should not use, which include those that FDA has found to contain methanol and/or 1-propanol. In most cases, methanol does not appear as an ingredient on the product label.

The agency continues to take action to help prevent potentially dangerous or violative hand sanitizers from entering the United States by placing specific products on import alert, proactively working with companies to recall products and encouraging retailers to remove violative products from store shelves and online marketplaces.

As part of these actions, the agency has also issued 14 warning letters since July 2020 for distributing hand sanitizer with undeclared methanol, inappropriate ethanol content, misleading claims—including incorrectly stating FDA approval—and improper manufacturing practices. The FDA continues to proactively work with Mexican government authorities, manufacturers and retailers to ensure potentially dangerous or violative products are not distributed to consumers.

The agency reminds manufacturers, distributors, repackagers and importers they are responsible for the quality of their products and urges manufacturers to test their raw ingredients to ensure they meet labeling specifications and are free from harmful contamination.

The FDA recently issued a guidance outlining the agency's policy for drug manufacturers and compounders to test alcohol or isopropyl alcohol for methanol contamination prior to using the alcohol to produce drugs, including hand sanitizer products.

Methanol-contaminated hand sanitizers are a serious safety concern, and the FDA is aware of adverse events, including blindness, cardiac effects, effects on the central nervous system and hospitalizations and death, primarily reported to poison control centers and state departments of health.

Methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death. Although people using these products on their hands are at risk for methanol poisoning, young children who ingest these products and adolescents and adults who drink these products as an alcohol substitute are most at risk.

Consumers who have been exposed to hand sanitizer contaminated with methanol and are experiencing symptoms should contact their local poison control center and seek immediate medical treatment for potential reversal of the toxic effects of methanol poisoning.

The FDA encourages health care professionals, consumers and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA's MedWatch Adverse Event Reporting program (please provide the agency with as much information to identify the product as possible). For more information, consumers should refer to the FDA's guidelines on safe use of hand sanitizer as well as a question and answer page.

Source:

U.S. Food and Drug Administration
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