Hand hygiene is a simple action that contributes significantly to the establishment and maintenance of safe essential health services and prevention of infection in community and health care facilities.
Alcohol-based hand rub (ABHR) has been listed in the 19th World Health Organization (WHO) Model List of Essential Medicines (April 2015) as a disinfectant. [1]
Given the global COVID-19 situation, ABHR has been heavily used in the community and health care setting to maintain hand hygiene. However, the recent lack of available ABHRs in the market has led to fraudulent production and sales of questionable, poor quality, and even “dangerous” ABHRs.
Main dangers of using low quality, adulterated ABHRs:
1) Severe systemic toxicity and even deaths by methanol-containing hand rub
The main ingredients of the WHO recommended ABHR are isopropyl alcohol 99.8% or ethanol 96%. [2] However, sporadic cases of acute poisoning using undeclared methanol has been found in the market from time to time. [3] Methanol must never be used in such a product because oral, pulmonary and/or skin exposures can result in severe systemic toxicity and even deaths.
When repeatedly used as a hand rub, skin absorption resulting in chronic toxicity (e.g., visual disturbances) occurs, particularly if methanol induced desquamation and dermatitis are present. [3,4] On the other hand, alcohol levels found in the blood were insignificant and not detectable after using ABHRs which were produced from ethanol and iso-propyl, respectfully. [5]
2) Compromised antimicrobial activity
The procurement of poor quality raw ingredients for the production of ABHRs will lead to sub-standard ABHRs in the market. Sterile distilled or boiled cold water must be used for production. [2]
Manufacturers must verify the alcohol concentration and make necessary adjustments in volume to obtain the final recommended concentration for antimicrobial activity. An alcoholmeter can be used to control the alcohol concentration of the final use solution, and hydrogen peroxide concentration can be measured by titrimetry. [2]
The lack of proper quality control in the production of ABHRs would interfere with its antimicrobial properties, giving end users a false sense of security, posing more danger to themselves and others.
The WHO-recommended local production and final concentration of ABHRs
The WHO has recommended a guide on the local production and final concentration of ABHRs, summarised below.
The recommended WHO formulations meet both European Norm (EN 1500) and the American Society for Testing and Materials (ASTM E1174). These “recipes” are being made available for those who do not have access to commercially available ABHR due to logistical or cost issues.
However, the practice of using commercially-available ABHRs should continue doing so, provided that those ABHRs meet recognised standards for microbicidal efficacy (ASTM or EN standards). [2]
The WHO-recommended materials for 10-Litre ABHR preparations
(1) WHO-recommended Formulation 1
- Ethanol 96% (8333 ml)
- Hydrogen peroxide 3%( 417 ml)
- Glycerol 98% (145 ml)
- Sterile distilled or boiled cold water
FINAL concentration for Formulation 1
Ethanol 80% v/v, Glycerol 1.45% v/v, Hydrogen peroxide (H2O2) 0.125% v/v
(2) WHO-recommended Formulation 2
- Isopropyl alcohol 99.8%(7515 ml)
- Hydrogen peroxide 3% (417 ml)
- Glycerol 98% (145 ml)
- Sterile distilled or boiled cold water
FINAL concentration for Formulation 2
Isopropyl alcohol 75% v/v, Glycerol 1.45% v/v, Hydrogen peroxide (H2O2) 0.125% v/v
The “shelf life” of the WHO-recommended formulations, produced according to the Guide to Local Production, [2] is at least two years after production.
If isopropanol is bought from a reputable company, the concentration stated should be exact and it should be achievable to make up 75% isopropanol correctly. If instead ethanol is produced locally, then checks should be undertaken to determine its exact concentration before producing the ABHR.
Sale of Drugs Act 1952 and Regulations
“The presence of an entry on the Essential Medicines List carries no assurance as to pharmaceutical quality.” [1]
Therefore, it is the responsibility of the manufacturer or the producer to ensure that each product is of appropriate pharmaceutical quality (including stability) and that it complies with the requirement of the national health regulatory authority.
An Act relating to the sale of drugs and cosmetics in Malaysia can be obtained from the WHO Essential Medicine and Health Products Information Portal [6] and the Official Portal of Pharmaceutical Services, Ministry of Health, Malaysia. [7]
The general penalty for those who commits an offence against this Act or any regulation made under this Act shall be liable to a fine or imprisonment. [6,7]
Dr Lee Yew Fong (MBBS, OHD, MHM) is a Doctoral candidate in Biomedicine, Global Health Track, at the University of Geneva, Switzerland. She is also a medical doctor affiliated with Ministry of Health, Malaysia. Information in this article does not necessarily represent the University of Geneva and the Ministry of Health, Malaysia.
REFERENCES:
- World Health Organization. 19th WHO Model List of Essential Medicines [Internet]. 2015 [cited 2020 Feb 15];Available from: [link]
- World Health Organization. Guide to local production: WHO- recommended handrub formulations [Internet]. [cited 2020 Feb 15];Available from: [link]
- Chan APL, Chan TYK. Methanol as an unlisted ingredient in supposedly alcohol-based hand rub can pose serious health risk. Int. J. Environ. Res. Public Health2018;15.
- Public Health England. Methanol- Toxicological overview [Internet]. 2015 [cited 2020 Feb 16];Available from: [link]
- World Health Organization. WHO | Alcohol-Based Handrub Risks/Hazards [Internet]. [cited 2020 Feb 15];Available from: [link]
- Act 368 – Sale of Drugs Act 1952 (Revised 1989). Incorporating Latest Amendment – Act A1084/2000 [Internet]. [cited 2020 Feb 15];Available from: [link]
- Ministry of Health Malaysia. Sale of Drugs Act 1952 and Regulations | Pharmaceutical Services [Internet]. [cited 2020 Feb 15];Available from: [link]
- This is the personal opinion of the writer or publication and does not necessarily represent the views of CodeBlue.
