71 Chlorhexidine Digulconate for Umbilical Cord Care What is chlorhexidine digluconate A broadspectrum antiseptic Commonly used worldwide for various applications Excellent safety record with topical application on humans ID: 731712
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Slide1
A summary of global introduction efforts, policy evidence, and product availability
7.1% Chlorhexidine Digulconate for Umbilical Cord CareSlide2
What is chlorhexidine digluconate?
A broad-spectrum antiseptic
Commonly used worldwide for various applications
Excellent safety record with topical application on humans
Routinely practiced in many developed-country settings throughout the 1970s and 1980s without adverse health consequences Slide3
Evidence for chlorhexidine interventionSlide4
Evidence from randomized controlled trials on chlorhexidine for cord care
All trials had neonatal mortality and omphalitis as primary outcomes. All used dry cord care as their comparison group. All trials used water-based liquid formulation of 7.1% chlorhexidine
digluconate
.
Publication
Mullany 2006
Nepal
Arifeen 2012
Bangladesh
Soofi 2012
Pakistan
Sazawal 2016
Tanzania
Semrau 2016
Zambia
Total live births
15,123
29,790
9,741
36 ,911
37,856
Schedule of application
Days 1,2,3,4,6,8,10
Within 1st 24 hours,
then daily for 7 days
Daily for 14 days
Daily until 3 days after cord drops
Daily until 3 days after cord drops
Intervention provider
Project staff
Project staff
Traditional birth attendant & mother/ caretaker
Mother or caretaker
Mother or caretaker
First application within 24 hours of birth
63%
87%
100%
94%
90%
Application of other substances to the cord
~ ½
few
~90%
N/A
~10%
% infants with birthweight <2500g
30%
33%
N/A
5%
7%
% health facility births
8%
7%
0%
54%
64%Slide5
Pooled analysis of the RCTs conducted in Bangladesh, Pakistan, and Nepal
Results showed:
A 23% reduction in all-cause neonatal mortality compared with the control.
Reduced risk of cord infection by 27%–56% depending upon severity of infection.
Cord separation time was increased by 1.7 days over dry cord care.
Washing of umbilical cord with soap and water was not advantageous compared with dry cord care in community settings.Slide6
Reduction in NMR in 5 chlorhexidine RCTs
*Statistically significant at 95% CISlide7
Evidence summary regarding use of 7.1% chlorhexidine to the umbilical cord
Use does reduce risk of omphalitis, even in low mortality settings where there is no evidence of impact on mortality risk.
Despite previously reported substantial reductions in South Asia, use did not significantly reduce NMR in study sites in Tanzania or Zambia.
This means that study results have shown an impact on mortality risk in populations with high NMR (35-40 deaths/1,000 live births) and have not shown an impact on mortality risk in populations with low NMR (≤18 deaths/1,000 live births).
In high-mortality settings, use reduced deaths regardless of whether infants were born at home or in a facility (Hodgins 2017;
Mullany
, et al. 2017). Slide8
WHO recommendation on postnatal care of the mother and newborn, 2014
RECOMMENDATION 6: Cord care daily chlorhexidine (7.1% chlorhexidine digluconate aqueous solution or gel, delivering 4% chlorhexidine) application to the umbilical cord stump during the first week of life is recommended for newborns who are born at home in settings with high neonatal mortality (30 or more neonatal deaths per 1,000 live births).
Clean, dry cord care is recommended for newborns born in health facilities and at home in low neonatal mortality settings. 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.Slide9
Inclusion of chlorhexidine in WHO Model List of Essential Medicines
In 2008, USAID and HealthTech jointly made the first application to list 7.1% chlorhexidine digluconate for umbilical cord care.
In 2013, 7.1% chlorhexidine digluconate was listed in the WHO Model List for Essential Medicines.
Facilitated the inclusion of chlorhexidine for umbilical cord care in national EMLs.
Eliminated confusion with chlorhexidine for other applications.Slide10
Programmatic decisions for context-appropriate CHX implementation
Settings for use
Home, facility, or both.
Distribution channels must align with intended setting of use.
ANC, private sector outlets (kiosk, pharmacy, etc.), TBA, and CHW.
Regimen: Single-day vs. multiple-day application
Begin application as early as possible (within first 24 hours).
Consider cultural practices around cord care.
Dosage form (gel vs. liquid)
Ensure proper use of product by selecting containers that are packaged differently from other newborn medicines commonly available in the country.
Avoid forms of primary packaging that could easily be mistaken for eye or ear care products.
Conduct formative research on preference
as part of larger market research if possible.Slide11
Country
Dosage Form
Regimen
Location
Bangladesh
Liquid
Single-day
Community and Facility
DR Congo
Liquid & Gel
Multiple-day
Community and Facility
Ethiopia
Gel
Multiple-day
Community and Facility
Kenya
Gel
Multiple-day
Community and Facility
Liberia
Liquid & Gel
Multiple-day
Community and FacilityMadagascarGelSingle-dayCommunity and FacilityMalawi GelSingle-dayFacilityMozambiqueGelSingle-dayFacility and CommunityNepalGelSingle-dayCommunity and FacilityNigeria GelMultiple-dayCommunity and FacilityPakistan GelMultiple-dayCommunity and Facility
Dosage form, regimen, and setting for use by countrySlide12
Product
availability
and
production
s
trategy Slide13
Three-pronged approach to enable access to chlorhexidine products of
high qualitySlide14
Assess Feasibility of Local Production
YES
NO
Local (or regional) production
ImportSlide15
Ensure Product Quality
Acquisition of raw materials from quality sources
Production of the finished product by good manufacturing practices (GMP)-compliant manufacturers and validation of the production process
Pre-purchase/sales inspectionsSlide16
Assuring product quality
Manufacturers should be certified with WHO cGMP. Desirable to be audited by credible international agencies.
Manufacturers must register chlorhexidine for umbilical cord care in country of sales by conforming to national drug regulatory authority standards.
Make sure that the product are tested according to proper protocols before release.
Topical solution monograph included in USP-NF.
Gel monograph to be included in the new global health section of USP-NF.
Suppliers
should be able to provide validation methods and a certificate of analysis (COA) together with the product.
Government tender documents should be clear about which dosage form they are requested (gel or liquid).
Make sure the product does not contain alcohol. Slide17
Manufacturers of 7.1% chlorhexidine digluconate for umbilical cord care
Product
Dosage form
Manufacturer
(contact information)
Country of Origin
Hexicord®
Liquid
ACI Limited
(
http://www.aci-bd.com/
)
Bangladesh
Chlorxy-G® Gel
Gel
Drugfield Pharmaceuticals Ltd.
(
http://www.drugfieldpharma.com/
)
Nigeria
Umbipro™
Gel
GSK
(http://www.gsk.com/)United Kingdom*KawachGelLomus Pharmaceutical Pvt. Ltd.(http://www.lomus.com.np/)NepalCHX GelGelUniversal Corporation Ltd.(http://ucl.co.ke/)Kenya7.1% chlorhexidine digluconate for umbilical cord care can also be purchased from the UNICEF Supply Division Catalogue (https://supply.unicef.org).* Umbipro™ received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the prevention of omphalitis (infection of the umbilical cord) in newborn infants. This application was submitted and reviewed under Article 58 of Regulation (EC) No. 726/2004, a pathway offered by EMA in co‐operation with the World Health Organization (WHO) for products exclusively intended for markets outside the European Union.(in alphabetical order).Slide18
Drugfield
Pharmaceuticals
Song
o
‐
Atta
,
Nigeria 2014
Lomu
s
Pharmaceuticals
Kathmandu
,
Nepal
2010
Galenti
c
Pharmaceuticals
Mumbai, India Available through UNICEF SupplyGlaxoSmithKline Brentford, England Received positive scientific opinion from European EMA
ACI Limited
Dhaka, Bangladesh
2015
Assessment underway
Universal Corporation
Kikuyu, Kenya, 2015
Countries which have local production
Countries which decided to import the product
Emzor Pharmaceutical Industries Ltd.
Lagos
,
Nigeria
Approved by NAFDAC. Manufacturing pending
Tuyil Pharmaceutical Industry Ltd.
Iloryn
,
Nigeria
Approved by NAFDAC. Manufacturing pending
Addis Pharmaceutical Factory
To accelerate global scale-up, CWG is supporting local and regional manufacturingSlide19
Global collaboration for country
introduction and scaleSlide20
Chlorhexidine Working Group (CWG)
An international collaboration of organizations dedicated to advancing the use of 7.1% chlorhexidine digluconate (delivering 4% chlorhexidine) for umbilical cord care through advocacy and technical assistance
.
PATH [CWG Secretariat]
ayzh
Bill & Melinda Gates Foundation
Boston University
Burnet Institute
Centre for Infectious Disease Research in Zambia
Clinton Health Access Initiative
Drugfield Pharmaceuticals Ltd. (Nigeria)
Duke University
GSK (UK)
Global Health Action
Jhpiego
John Snow, Inc.
Johns Hopkins Bloomberg School of Public Health
Johnson & Johnson (USA)
Lomus Pharmaceuticals Pvt. Ltd. (Nepal)
Maternal and Child Survival Program
Ministry of Health, DRC (Reproductive Health)
Ministry of Health, Ethiopia (Maternal & Child Health)
Ministry of Health, Kenya (Child & Adolescent Health)
Ministry of Health, Liberia (Family Health)Ministry of Health, Malawi (Reproductive Health)Ministry of Health, Mozambique (Child Health)PSIPromoting the Quality of Medicines/ United States PharmacopeiaSave the Children/Saving Newborn LivesSHOPS Plus/Abt AssociatesSystems for Improved Access to Pharmaceuticals and Services/Management Sciences for HealthUnited Nations Children’s FundUnited States Agency for International DevelopmentUniversal Corporation Ltd. (Kenya)University of Illinois at Chicago School of NursingUniversity Research Co., LLC | Center for Human ServicesWorld Health OrganizationSlide21
Coordinating global uptake
The Chlorhexidine Working Group accelerates introduction and scale up of chlorhexidine for umbilical cord care by:Slide22
2011
Implementation/scale-up
Pilot
introduction and/or policy
alignment
Expressed interest
CWG provided TA to local manufacturersSlide23
2017
Implementation/scale-up
Pilot
introduction and/or policy
alignment
Expressed interest
CWG provided TA to local manufacturersSlide24
Twelve countries have added 7.1% CHX to national Essential Medicines List (
nEML
)
Country
Year added
Nepal
2011
DRC
2014
Ethiopia
2014
Mozambique
2014
Madagascar
2014
Myanmar
2014
Mali
2015
Kenya
2016
Nigeria
2016
Pakistan2016Afghanistan2017Ghana2017Slide25
Nepal- Roadmap to Introduction
25
Page
25Slide26
Nigeria - Roadmap to Introduction
26
Market research to inform strategy for national scale-up and effort to establish local production is complete (2013-2014)
Ministry of Health prioritizes chlorhexidine as a key newborn health commodity (2013)
Page
26Slide27
Madagascar - Roadmap to Introduction
27
Pilot introduction of chlorhexidine gel in Mahabo region (2013)
Page
27Slide28
Liberia - Roadmap to Introduction
28
Due to Ebola outbreak all chlorhexidine activities were put on hold (2014)
Supply strategy assessment completed (2013)
Page
28
Efforts to introduce and scale up chlorhexidine for umbilical cord care are ongoing (2015- present) Slide29
Kenya - Roadmap to Introduction
29
Pilot introduction of chlorhexidine gel in Mahabo region (2013)
Page
29Slide30
Key Chlorhexidine Successes
Inclusion of CHX in
WHO EMLc, WHO postnatal care guidelines, LiST, MANDATE,
and the
DHS Newborn Module.
CHX available from 1
global and
7
local manufacturers.
17
countries approved
market registration
of a CHX product (Bangladesh, Benin, Cameroon, Cote d’Ivoire, DRC, Ethiopia, Ghana, Kenya, Liberia, Madagascar, Mozambique, Nepal, Niger, Nigeria, Tanzania/Zanzibar, Uganda, Zambia)
12
country and regional
stakeholder meetings
(Afghanistan, DRC, Kenya, Liberia, Madagascar, Malawi, Mozambique, Niger, Nigeria, Pakistan, Uganda, and regional meeting of Burkina Faso, Côte d’Ivoire, Niger, Senegal).
12
countries added CHX to their
national EML
(Afghanistan, DRC, Ethiopia
, Ghana, Kenya, Madagascar, Mali, Myanmar, Mozambique, Nepal, Nigeria, Pakistan) 12 countries implementing /scaling-up (Bangladesh, DRC, Ethiopia, Kenya, Liberia, Madagascar, Malawi, Mozambique, Nepal, Nigeria, Pakistan, Sierra Leone).14 countries aligning policy/piloting the intervention (Afghanistan, Benin, Cameroon, Ghana, Haiti, Mali, Myanmar, Niger, Senegal, Timor-Leste, Uganda, Yemen, Zambia, Zimbabwe).5 countries have expressed interest (Angola, Burkina Faso, Côte d’Ivoire, Lesotho, Papua New Guinea).36 journal articles.Slide31
CWG resource page on Healthy Newborn Network (HNN) website
Materials for:
Consensus building
Building evidence for implementation
Aligning policies and guidelines
Demand generation and training
Manufacturing and distribution
Monitoring and evaluation
http://www.healthynewbornnetwork.org/issue/chlorhexidine-for-umbilical-cord-care/Slide32
For additional
information,
please
visit the
chlorhexidine resource page
on the
healthy newborn network
site.