Reports of serious eye injury due to errors in administration of Chlorhexidine gluconate (CHX) aqueous solution or gel
By: BarbraKaryne Nchinda Fobi
Chlorhexidine gluconate (CHX) is an antiseptic antibacterial agent that can be used in the prevention of skin infections and treatment of oral diseases such as gingivitis. As a topical antiseptic agent, it is used to sanitize hands prior to performing medical procedures and clean injured and uninjured skin in preparation for surgery (Chlorhexidine, 2020). Chlorhexidine for topical application is available as paste (e.g. toothpaste), creams, dressings, gels, solutions, lotions, pads, and sponges (Greene, 2017).
Chlorhexidine has an excellent safety profile and is used globally. In fact, chlorhexidine is listed in the World Health Organization (WHO) List of Essential Medicines (EML). The WHO EML is a compilation of medications considered necessary to meet the basic needs of an effective health care system (Greene, 2017 & WHO, n.d.). The list is updated biannually and can be modified on a national level based on the country’s health system needs (WHO, n.d.). Realizing the need for standardization and accessibility to pediatric medicines, in 2007, WHO developed its first list of essential medicines for children, and chlorhexidine was one of the antiseptic medicines on the list (WHO, n.d.).
Since postpartum infection is still a leading cause of newborn morbidity and mortality worldwide, WHO expanded the use of chlorhexidine to include the prevention of omphalitis in 2009 (Stewart, 2016). WHO’s decision was based on data from a community-based, cluster-randomized controlled trial in Nepal that indicated a reduction in neonatal mortality after the use of 4% chlorhexidine solution for umbilical cord care (WHO, n.d.). Countries with limited resources have a greater risk of omphalitis for infants delivered at home compared to hospital deliveries (Stewart, 2016).
For children born at home with a high risk of mortality, WHO recommends daily application of chlorhexidine aqueous solution or gel to the umbilical cord stump of newborns within the first week of life (WHO, 2019). Use of chlorhexidine in these situations may be considered only to replace application of a harmful traditional substance, such as cow dung, to the cord stump. The use of chlorhexidine is being implemented in many countries in South Asia and sub-Saharan Africa as part of a package of essential newborn interventions to reduce the incidence of omphalitis (WHO, 2019).
Correctly administered topical preparations of chlorhexidine may still lead to side effects such as blisters, itching, rashes, redness, swelling, burning sensation and peeling of the skin (Greene, 2017 & Chlorhexidine, 2020). However, incorrect administration of chlorhexidine can cause far more serious injury. For example, when inadvertently applied to the eyes, chlorhexidine can result in blindness (WHO, 2019). Injuries associated with both the liquid and gel formulations have been reported when chlorhexidine was mistaken for eye drops or ointments. Since 2015, a total of 45 reports of eye injuries have been reported due to the improper use of chlorhexidine gel (WHO, 2019). Some of these incorrect uses might be due to the medicine package (see packages below). Two of the chlorhexidine packages are in a dropper form similar to the packages of traditional eye drops. This package similarity can be misleading to the healthcare professionals and providers who may mistakenly administer chlorhexidine into the eyes.
In 2019, WHO published a safety alert on chlorhexidine indicating the occurrence of multiple eye injuries with the use of chlorhexidine in nine sub-Saharan Africa countries: Nigeria (2015), Senegal (2015), DRC (2015), Liberia (2015), Niger (2017), Mali (2018), Kenya (2018), Chad (2018) and Cameroon (2019).
The alert warned all stakeholders involved in umbilical cord care programs about the potential maladministration and risk of serious injury with chlorhexidine. Also, all healthcare professionals, caregivers and others involved in the distribution, use and/or administration of chlorhexidine 4% gel or solution, are advised to take all necessary measures and precautions to ensure its correct use and administration.
WHO published recommendations for National Neonatal and Reproductive Health Programs and/or regulators that are also applicable to young pharmacists and pharmaceutical scientists:
- Assess the components of the newborn package and select the optimal primary container form for chlorhexidine or modify the design of the container to distinguish the product from other medicines typically used for newborns (WHO, 2019).
- Young pharmaceutical scientists are in an ideal position to assess chlorhexidine product packages for appropriateness. They can design or select packages for chlorhexidine products in forms typically associated with the intended route of administration.
- Update product labels with appropriate information on safe use (WHO, 2019).
- While young pharmaceutical scientists can make sure appropriate information and warnings are on chlorhexidine package labels, young pharmacists can use auxiliary labels to highlight pertinent information on the package such as route of administration.
- Develop detailed instructions for users (posters, flyers, pictorials etc. [WHO, 2019]).
- As the most accessible healthcare practitioners, young pharmacists can develop educational documents on the proper administration of chlorhexidine in newborns that are culturally appropriate and easy to understand.
- Train health-care professionals who interact with mothers and/or provide the product (WHO, 2019).
- As medication experts, young pharmacists can educate other healthcare practitioners on different aspects of medications such as indication, route of administration, side effect, and contraindication.
Overall, young pharmacists and pharmaceutical scientists can play a vital role in preventing the inadvertent administration of chlorhexidine through proper labeling and packaging of chlorhexidine containers and kits. Young pharmacists must create communication strategies, messages, and materials that anticipate and address the issue of potential misadministration of chlorhexidine.
References
Chlorhexidine gluconate (2020). DRUGDEX® System. Retrieved March 16, 2020, from http://www.micromedexsolutions.com. Greenwood Village, CO: Thomson Micromedex.
Greene J. M. (2017). Chlorhexidine. Salem Press Encyclopedia of Health.
Stewart D., Benitz W. (September 2016). Umbilical cord care in the newborn infant. Pediatrics. 138 (3) e20162149; DOI: https://doi.org/10.1542/peds.2016-2149
WHO (May 2019). Chlorhexidine digluconate: Reports of serious eye injury due to errors in administration. WHO Pharmaceutical Newsletter. (2), 11
WHO (n.d.). Essential medicines and health products. Retrieved from https://www.who.int/medicines/publications/essentialmedicines/en/
