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Chlorhexidine (CHX)

Product Profile

Chlorhexidine (CHX)

Potential Lives Saved/Year:

Hundreds of thousands of newborns¹

>>Read the full case study (PDF)


Problem and Proposed Intervention


Globally, neonatal sepsis accounts for over 500,000 newborn deaths annually1. Many of these infections come from contamination of the umbilical cord stump. Chlorhexidine (CHX) digluconate is a widely used, low-cost antiseptic effective against major agents of neonatal infection. Since its introduction in the 1950s, it has been used regularly as a surgical, veterinary, neonatal and dental antiseptic and carefully studied for safety and efficacy. Recent community-level randomized controlled trials in Nepal2, Pakistan3,4, and Bangladesh3,4 have shown that applying a 4% CHX product (7.1% CHX digluconate) to the umbilical cord saves lives. Across the three countries, data from over 54,000 newborns showed an aggregate 23% reduction in neonatal mortality (not including deaths in the first few hours of life) and a 68% reduction in severe infections for the CHX intervention groups2,3,4. The results are some of the largest effect sizes seen in any neonatal intervention.  CHX has a long shelf life, requires no cold chain, and is extremely easy to apply with minimal training and no equipment. These factors make it suitable for hospital, health center, and home care alike. Few other interventions have demonstrated such potential for rapidly reducing newborn mortality across so many settings for such a low cost.  Action is necessary to prioritize increased use of this overlooked intervention, thereby contributing to hundreds of thousands of newborn lives saved annually.

See also the work that the Chlorhexidine Working Group is doing. 

Chlorhexidine (CHX) product characteristics:

Drug:

Chlorhexidine gluconate (also called Chlorhexidine digluconate or just Chlorhexidine)

Proposed Indication:

Antiseptic for umbilical cord care/cleansing

Formulation:

7.1% CHX digluconate aqueous solution or gel, delivering 4% CHX for umbilical cord care

Dose:

3 grams for single day application (as currently practiced in Nepal)

Avg. Cost:

Around $0.30 (as currently sold in Nepal)5





Initial Findings from Product Case Study Working Paper

 

* Note: The strengths and challenges outlined below are initial findings from a longer working paper developed to analyze the current global situation of each product.  The findings are presented below to catalyze further thinking and discussion in order to finalize a list of issues and recommendations. The full working paper texts are forthcoming.

 

 

Strengths

Challenges

Policy and Regulation

 

 

Global

* WHO has recognized CHX as a suitable antimicrobial for cord care where necessary and especially to displace harmful cord care practices6

* WHO Essential Medicines List7 and WHO Priority Medicines for Mothers and Children 20118 include CHX for umbilical cord care

 

* Misconception that the WHO guidelines advocate for exclusive use of dry cord care.

* Due to the absence of a commercially available 4% CHX product in 2009 and at the time of review for the 2011 WHO EML 17, both WHO EML 16 and 17[1] resulted in listing 20% CHX (digluconate) with an instruction to dilute for umbilical cord care use. 

National, Regional

* Nepal is the 1st country to have registered a CHX product for umbilical cord stump care. 

* Nepal has included CHX in their 2011 national list of essential medicines.

* Favorable findings from recent trials in Bangladesh and Pakistan, along with an updated EML[2] listing (if obtained), could facilitate country/regional level regulatory reviews.

* Ongoing trials in Zambia and Tanzania may provide Africa with data to support country regulation. 

* CHX for umbilical cord care is often classified by national regulatory agencies as a medicine, increasing its regulatory hurdles.

*National regulatory pathways are yet to be determined on a country by country basis.

Product specification & characteristics

* Widely used in a range of applications including surgical prep, wound care, cosmetics, oral hygiene, general disinfection, and veterinary care

* 50+ year safety track record, including several decades of use with neonates

* Long shelf-life

* Does not require cold chain

* Thoughtful combination of formulation and packaging is needed to increase the product’s adoption in communities with specific umbilical cord care practices/traditions.

Financing, Procurement & Supply

* Many manufacturers currently making CHX-based products (branded and generic), at concentrations from <1% to 20%. 

* CHX is readily available on every inhabited continent at low cost (< US$0.01 in raw materials per baby).

* Lomus Pharmaceuticals Pvt. Ltd (Nepal) is now producing a 4% CHX product commercially.

* “Best buy” in neonatal health and strong candidate for public procurement, given low cost.

 

* Until recently, there has not been a commercially available 4% CHX digluconate product, and this has resulted in an unrevised WHO EML recommendation listing that causes confusion (20% CHX (digluconate) with an instruction to dilute for umbilical cord care).

* Low-volume, low-margin product means that large pharmaceutical companies are unlikely to take an interest in independent manufacture and distribution of CHX for umbilical cord care.  Institutional buyers and large volume orders are more likely to attract the attention of potential manufacturers.

Service Provision (Rational Use)

* Easy to apply with minimal training and no equipment (suitable for hospital, health center, home care).

 

Demand

* In consumer research, mothers have shown a strong latent demand for a purpose-made antiseptic like CHX and also have demonstrated the ability to use CHX correctly.

* Even though mothers are asking for a cord care product, professional associations have been advocating for dry cord care for years and show some hesitance to switch to CHX.




[1]  Black RE, Cousens S, Johnson HL, Lawn JE, et al.  Global, regional and national causes of mortality in 2008: a systematic analysis.  Lancet 2010; 375:1969-1987.

[2] Mullany LC, Darmstadt GL, Khatry SK, et al. Topical applications of chlorhexidine to the umbilical for prevention of omphalitis and neonatal mortality in southern Nepal: a community-based, cluster-randomized trial. The Lancet. 2006;367:910–918. 

[3] Soofi S, Cousens S, Imdad A, Bhutto N, Ali N, Bhutta ZA. Topical application of chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan: a community-based, cluster-randomised trial. The Lancet. Published online February 8, 2012.

[4] El Arifeen S, Mullany LC, Shah R, et al. The effect of cord cleansing with chlorhexidine on neonatal mortality in rural Bangladesh: a community-based, cluster-randomised trial. The Lancet. Published online February 8, 2012. 

[5]  This cost estimate includes the active drug cost of less than $0.01 plus packaging costs.

[6]  World Health Organization. Care of the Umbilical Cord: A Review of the Evidence. Geneva: WHO/RHT/MSM; 1999. Available at: https://apps.who.int/rht/documents/MSM98-4/MSM-98-4.htm. 

[7]  WHO. WHO Model List of Essential Medicines (March 2011), 17th edition.  Available at:  http://whqlibdoc.who.int/hq/2011/a95053_eng.pdf.  Accessed March 26,2011

[8] WHO. Priority Medicines for Mothers and Children 2011, 3rd edition.  http://www.who.int/medicines/publications/A4prioritymedicines.pdf (Accessed March 2012).