नेपाली औषधिले पायो अमेरिकी पुरस्कार :: Nepali Medicine Wins US Prize, Read with Product specification

"he 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."

काठमाडौ, पुस २५ – नवजात शिशुको नाइटोमा हुने संक्रमण रोक्न नेपालले विकास गरेको किटनाशक औषधिले अमेरिकी सहयोग नियोगको विज्ञान तथा प्रविधि पुरस्कार पाएको छ ।
क्लोरहेक्सिडाइन डाइग्लुकोनेट सिएचएक्स मल्हमको अनुसन्धानले प्रभावकारी नतिजा निकालेको ठहर गर्दै प्रविधिका लागि युएसएडको विज्ञान तथा प्रविधि नव सिर्जना पुरस्कार प्रदान गरिएको हो ।
यो मल्हम नेपालको औषधि निर्माता कम्पनी लोमस फर्म्यसुटिकल्सले उत्पादन गरेको हो । युएसएडले हरेक वर्ष विकासका चुनौतीलाई विज्ञान, प्रविधि तथा नव प्रवर्तनको प्रयोग गरी समाधान गर्ने उत्कृष्ट प्रविधिलाई सम्मान गर्दै आएको छ । शिशुमा नाइटोको संक्रमण रोक्न प्रयोग हुने किटनाशक मल्हम सिएचएक्सको प्रयोगबाट नेपालमा नवजात शिशुमृत्युदर ३४ प्रतिशतले घटेको छ ।
यो मल्हम प्रभावकारी हुनुका साथै सस्तो पनि छ । राष्ट्रिय स्वास्थ्य इन्ष्टिच्युट र विल तथा मेलिन्डा गेट्स प्रतिष्ठानसँगको सहकार्यमा युएसएडले सिएच एक्सलाई पहिले झोलका रुपमा र पछि जेलका रुपमा परीक्षण गरेको थियो । यो मल्हमलाई एकपटक मात्र नवजात शिशुको नालमा लगाउँदा संक्रमणको खतरा निकै कम हुने गरेको पाइएको छ ।
किटनाशक जेल यो वर्षको अन्त्यसम्म नेपालका अधिकांश जिल्लामा पु¥याउने लक्ष्य छ । यसको प्रयोगले नवजात शिशुको मृत्युदर घटाएर राखिएको लक्ष्य सजिलै हाँसिल गर्न सकिने अपेक्षा गरिएको छ ।
पछिल्लो तथ्यांक अनुसार नेपालमा १ सय जना नवजात शिशुमध्ये ३ जनाले नाइटोको संक्रमणका कारण २८ दिनभित्र ज्यान गुमाउने गरेका थिए । यो मल्हम नाइजेरियाले पनि परीक्षण गर्ने योजना बनाएको छ ।

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.
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.



StrengthsChallenges
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 Listand 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. 


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