Scaling Up Lifesaving Commodities for Women, Children, and Newborns An Advocacy Toolkit

Publication date: 2013

Scaling Up Lifesaving Commodities for Women, Children, and Newborns An Advocacy Toolkit 2 Scaling Up Lifesaving Commodities for Women, Children, and Newborns Scaling Up Lifesaving Commodities for Women, Children, and Newborns An Advocacy Toolkit This toolkit was produced under the auspices of the UN Commission on Life-Saving Commodities for Women and Children’s Advocacy Working Group and Maternal Health Technical Reference Team, through the generous support of the Norwegian Agency for Development Cooperation (NORAD), and is part of Every Woman Every Child, an unprecedented global movement to mobilize and intensify global action to improve the health of women and children around the world. Special thanks to the Reproductive Health Supplies Coalition’s (RHSC’s) Advocacy and Accountability Working Group for their support in the development of the Spotlight on Contraceptive Commodities. authors PATH: Kristy Kade, Elesha Kingshott, Ashley Latimer, Billie-Jean Nieuwenhuyus, and Michel Pacque Global Health Visions: Susan Fox and Nejla Lias contributors Reproductive Health Supplies Coalition: Nienke Blauw and Julie Solo Quirk Communications: Janie Hayes and Paul Quirk Graphic Design by Tony Frye Design acknowledgments Special thanks to the following individuals for informing the development of and reviewing the toolkit. Marta Seoane Aguilo, World Health Organization (WHO) Sono Aibe, Pathfinder International Debbie Armbruster, United States Agency for International Development (USAID) Daniela Bagozzi, PATH Siobhan Brown, PATH Heather Clark, Population Council Trish Coffey, PATH Rachel Coghlan, World Vision Lou Compernolle, RHSC Beth Fredrick, Advance Family Planning Zarnaz Fouladi, USAID Laura Frye, Gynuity Health Projects Elisha Dunn-Georgiou, Population Action International (PAI) Katie Gray, PATH Lars Gronseth, NORAD Saskia Husken, Rutgers World Population Foundation Michael Kiernan, Save the Children/Saving Newborn Lives (STC/SNL) Mary Kinney, STC/SNL Frederik Kristensen, WHO Manjari Lal, PATH Mercedes Mas de Xaxas, PAI Mutsumi Metzler, PATH Lori McDougall, Partnership for Maternal, Newborn and Child Health Khatidja Naithani, USAID Maternal and Child Health Integrated Program Kim Ochletree, PAI JoAnn Paradis, STC/SNL Saumya Ramarao, Population Council Sarah Rich, Family Care International (FCI) Nicole Shiegg, UN Foundation Joanna Skinner, Johns Hopkins Bloomberg School of Public Health, Center for Communication Programs Robyn Sneeringer, Bill & Melinda Gates Foundation Catharine Taylor, PATH Donna Vivio, USAID Benedicte Walter, United Nations Children’s Fund (UNICEF) Elizabeth Westley, FCI Rachel Wilson, PATH Scaling Up Lifesaving Commodities for Women, Children, and Newborns. Washington, DC: PATH; 2013. 3 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 3 Overview About the Toolkit Policymakers, development partners, program implementers, health professionals, private-sector leaders, civil society activists, and community members all have a critical role to play as advocates in ensuring improved and equitable access to lifesaving commodities for women, children, and newborns. This toolkit provides information about the UN Commission on Life-Saving Commodities for Women and Children (the Commodities Commission), its 13 priority commodities, and examples of how its ten recommendations to improve access and availability are being applied globally and within countries. It also provides advocacy resources for utilizing the Commodities Commission platform to raise awareness and engage stakeholders in addressing commodity-related gaps in global and national plans, policies and initiatives, as well as providing strategic input to advance implementation of the recommendations. The toolkit is organized into four major sections: What you need to know: Page 4 Background information on the Commodities Commission, including linkages with other global initiatives, an overview of country funding and support mechanisms, and analysis of the recommendations. What you can do: Page 17 Guidance on realizing the recommendations through strategic advocacy, including tangible actions and tools that advocates can adapt for use within their countries to mobilize support for the integration of the Commodities Commission recommendations and reproductive, maternal, newborn, and child health commodities into relevant plans, policies, and programs. What there is to say: Page 28 Outlines messages to inform relevant audiences about the Commodities Commission and to engage with relevant decision-makers and stakeholders. Spotlight on commodities: Page 35 Overview of maternal, child, and newborn health and contraceptive commodities, including issues and barriers to their access and use, and specific advocacy needs. If you have questions about these materials or the content, please contact the Commodities Commission’s Advocacy Working Group at UNCoLSC_AWG@path.org. “Every year, millions of women and children die from preventable causes. These are not mere statistics. They are people with names and faces.” – United Nations Secretary-General Ban Ki-moon 4 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 4 What You Need to Know “The Commodities Commission will tackle an overlooked but vital aspect of health systems, and ensure that women and children are protected from preventable causes of death and disease.” — United Nations Secretary-General Ban Ki-Moon 5 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 5 What You Need to Know Introduction In 2012, the Commodities Commission was formed to call attention to the need for increasing access to and use of critical medicines and health supplies in the countries where the most women, newborns, and children under five die each year. Specifically, the Commodities Commission, led by Co-Chairs President Goodluck Jonathan of Nigeria and Prime Minister Jens Stoltenberg of Norway, released a report which outlined a priority list of 13 reproductive, maternal, newborn, and child health (RMNCH) commodities that can prevent and treat many of the leading causes of death in these countries. In spite of the strong evidence showing their impact in saving lives, too often the 13 commodities are out of the reach of those individuals who need them. These medicines and health supplies cost just dollars, with the majority costing less than US$1 per dose. However, multiple barriers prevent people from accessing these commodities. The Commodities Commission report also outlines ten bold and innovative recommendations to catalyze changes in the way the 13 commodities are produced, distributed, and used, estimating that the effective implementation of the recommendations would result in saving the lives of six million women and children over five years. 6 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 6 What You Need to Know Reproductive Health Female Condoms Prevents STIs/HIV and unintended pregnancy Contraceptive Implants Prevents unintended pregnancy Emergency Contraception Prevents unintended pregnancy Maternal Health Oxytocin Prevents and treats postpartum hemorrhage Misoprostol Prevents and treats postpartum hemorrhage Magnesium Sulfate Treats eclampsia and pre-eclamsia Newborn Health Injectable Antibiotics Treats newborn sepsis Antenatal Corticosteroids Prevents preterm respiratory distress syndrome Chlorhexidine Prevents umbilical cord infections Resuscitation Device Treats newborn asphyxia Child Health Amoxicillin Treats pneumonia Oral Rehydration Salts Prevents dehydration from diarrhoea Zinc Treats diarrhoea >>>> Lifesaving Commodities Across the Continuum of Care 13 7 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 7 What You Need to Know The Every Woman Every Child Connection The Commodities Commission was established by the U.N. Secretary- General as part of the global Every Woman Every Child (EWEC) movement. EWEC seeks to mobilize and intensify global action to address the main treatable health challenges facing women and children in the 49 poorest countries. EWEC is guided by the Global Strategy for Women’s and Children’s Health, which includes a specific challenge to global and national leaders to increase access to and appropriate use of essential medicines, medical devices, and health supplies, or “commodities,” that effectively address the leading avoidable causes of death during pregnancy, childbirth, and early childhood. The availability and affordability of commodities underpins the success of broader RMNCH efforts, including, but not limited to, the following complementary EWEC initiatives: Progress toward the goals of EWEC (including the scale-up of RMNCH commodities) is moni- tored by an independent Expert Review Group (iERG), which is part of the UN Commission on Information and Accountability for Women’s and Children’s Health (COIA). The COIA was created by the WHO in an effort to determine the most effective international institutional arrangements for ensuring global reporting, oversight, and accountability on women’s and children’s health. The COIA created a system to track timeliness of donations, resource alloca- tions, and overall results and impact. When advocating for the inclusion of the 13 com- modities and ten recommendations within coun- try RMNCH plans and priorities, integration and/ or coordination with other global EWEC initiatives should be explored wherever possible. Every Newborn is a comprehensive action plan (cur- rently in develop- ment) that will link with other initiatives and stakeholders to accelerate national plans to reduce preventable new- born mortality, in- cluding emphasizing the important role of the four newborn health commodities. Child Survival Call to Action: A Promise Renewed (APR) was launched to revitalize global commitment to child survival as part of the wider effort behind EWEC. It focuses on three priority areas: the development of evidenced-based national action plans to scale up successful interventions; promotion of transparency and mutual accountability; and mobilization of broad- based social and political support to end preventable child deaths. Family Planning 2020 (FP2020) aims to deliver contraceptives, information, and services to a total of 120 mil- lion women and girls in develop- ing countries by 2020. This includes maximiz- ing global access to contraceptive commodities endorsed by the Commodities Commission. Integrated Global Action Plan for Prevention and Control of Pneumonia and Diarrhoea (GAPPD) is designed to inform global and national programs and policies to provide a frame- work to protect chil- dren, prevent disease, and treat children who do become sick, using proven inter- ventions—including commodities. 8 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 8 What You Need to Know Ensuring Linkages and Support for Country Implementation of the Recommendations To better coordinate and align the various RMNCH-related initiatives and funding streams, including the implementation of the Commodities Commission recommendations, and to more effectively respond to related country needs and gaps, an RMNCH Steering Committee (SC), supported by an RMNCH Fund and Strategy and Coordination Team (SCT), was established in 2013. RMNCH Steering Committee Specifically, the SC was established to: 1. harmonize and align global funding streams and initiatives to better respond to country needs and gaps. 2. clarify the respective roles and responsibilities with regards to engaging with countries to strengthen national RMNCH plans, resources, and processes. Membership on the RMNCH SC is unique in that it cuts across all RMNCH-related global initiatives under the EWEC banner. Its approximately 25 members include representation from technical and financing agencies, foundations, global health coordinating bodies, EWEC countries, nongovernmental organizations (NGOs), and the private sector. Individual governance mechanisms of specific initiatives, such as the FP2020 Reference Group, continue to function alongside the broader RMNCH SC, but will aim to take forward within their respective spheres the orientations provided during RMNCH SC discussions. A high-level champions group is also under development. 9 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 9 What You Need to Know RMNCH Fund The RMNCH Fund will support the EWEC movement by providing catalytic resources to fill critical country-identified gaps in reproductive, maternal, newborn, and child health. The SC will make recommendations on the most optimal uses of the RMNCH Fund toward these gaps. United Nations Population Fund (UNFPA) acts as the fiduciary agent dispersing funds to implementing partners and agencies. The Fund will not seek to finance large-scale service delivery interventions. Rather it will draw on a dedicated funding pool from development partners to (co-)finance the catalytic scale-up of high- impact interventions and health systems strengthening initiatives. The Fund will support country RMNCH plans, or parts thereof directly, while also seeking to leverage other multilateral or bilateral funding mechanisms in support of these same plans in a complementary fashion. Zn ORS ORS Amox 4MgSO4MgSO Oxy 10 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 10 What You Need to Know RMNCH Strategy and Coordination Team The SCT, hosted by UNICEF, with seconded staff from UNICEF, UNFPA, and WHO, is responsible for providing administrative and technical support to the SC and Fund, including developing procedures for and helping to identify country needs, plans, funding, and partners to support national RMNCH responses. The Steering Committee, and corresponding Fund and SCT, provides various levels of support for the follow-up of the Commodities Commission’s recommendations at both the country and global levels: ●● Finance support for improving availability and access to lifesaving commodities The RMNCH Fund provides support for countries to scale-up key commodities through their national RMNCH plans. These grants are meant to be catalytic (approximately one year), addressing strategic gaps, key priorities, and identified bottlenecks at the country level in order to improve and supplement existing national plans related to reducing newborn, child, and maternal mortality. In 2013, the Fund provided one-year grants to an initial group of eight pathfinder countries: Democratic Republic of the Congo (DRC), Ethiopia, Malawi, Nigeria, Senegal, Sierra Leone, Uganda, and  the United Republic of Tanzania. Additional pathfinder countries are to be identified and funded in 2014. The RMNCH Fund is not limited to commodity-related work but can also be applied in conjunction with a broader RMNCH Country Engagement process so as to ensure these funds are used in a coordinated and complementary way with other funding streams. ●● Technical support to implement the Commission recommendations The SCT oversees technical reference teams (TRTs), which roughly correspond to each of the recommendations and priority commodities, and a cross-cutting advocacy group, which are working with pathfinder countries and partners to implement the Commodities Commission’s recommendations. The TRTs develop guidance and tools to support country implementation and address global and regional barriers to accessing the 13 commodities. For each TRT, a global lead convener facilitates a broader working group comprised of stakeholders from government and NGOs. For more information on the activities of each of the TRTs, download their individual briefs. For more information on the RMNCH Steering Committee and Fund and how to become a pathfinder country, please contact Pascal Bijleveld, pbijleveld@unicef.org, Senior Executive Manager of the SCT. The initial group of eight pathfinder countries to receive catalytic funding for commodities-related activities.        11 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 11 What You Need to Know: Convener Contact Information TRT NAME CONVENING ORGANIZATIONS CONVENERS CONTACT INFORMATION Shaping global market CHAI, DFID Hema Srinivasan James Droop hsrinivasan@clintonhealthaccess.org j-droop@dfid.gov.uk Shaping delivery markets CHAI Andrew Storey astorey@clintonhealthaccess.org Innovative financing World Bank Monique Vledder mvledder@worldbank.org Quality strengthening WHO Lisa Hedman hedmanl@who.int Regulation efficiency  WHO Lisa Hedman hedmanl@who.int Supply and awareness USAID, UNFPA Jennifer Bergeson- Lockwood Kabir Ahmed jbergeson-lockwood@usaid.gov kahmed@unfpa.org Demand and awareness  USAID Zarnaz Fouladi Hope Hempstone zfouladi@usaid.gov hhempstone@usaid.gov Reaching women and children Gov. of Uganda, Save the Children Jesca Nsungwa-Sabiiti Francesco Aureli jsabiiti@infocom.co.ug; Francesco.Aureli@savethechildren.org Performance and accountability AMREF, m-Health Alliance John Nduba Patty Mechael Nduba.John@Amref.org; pmechael@mhealthalliance.org Product innovation PATH Michel Pacque mpacque@path.org Oxytocin, Magnesium Sulfate USAID Debbie Armbruster darmbruster@usaid.gov Misoprostol UNFPA Kabir Ahmed kahmed@unfpa.org Injectable antibiotics Saving Newborn Lives Steve Wall Brenden Wackenreuter steve.wall@savechildren.org bwackenreuter@savechildren.org Antenatal corticosteroids Save the Children, BMGF Joy Lawn Joel Segre joylawn@yahoo.co.uk joel.segre@gatesfoundtation.org Chlorhexidine PATH Patricia (Trish) Coffey Siobhan Brown pcoffey@path.org scbrown@path.org Newborn resuscita- tion equipment USAID Donna Vivio dvivio@usaid.gov Amoxicillin UNICEF, CHAI Mark Young Francisco Blanco myoung@unicef.org fblanco@unicef.org ORS, Zinc CHAI, UNICEF Nancy Goh Mark Young Ngoh@clintonhealthaccess.org myoung@unicef.org Female condoms UNFPA, RutgersWPF Kabir Ahmed Bidia Deperthes Saskia Husken kahmed@unfpa.org deperthes@unfpa.org s.husken@rutgerswpf.nl Contraceptive implants BMGF, DFID, RHSC Monica Kerrigan Nel Druce John Skibiak Monica.Kerrigan@gatesfoundation.org n-druce@dfid.gov.uk jskibiak@rhsupplies.org Emergency contraception WHO, FCI Mario Festin Viviana Mangiaterra Sarah Rich Elizabeth Westley festinma@who.int mangiaterrav@who.int srich@familycareintl.org ewestly@familycareintl.org Advocacy PATH Kristy Kade Billie-Jean Nieuwenhuys kkade@path.org bnieuwenhuys@path.org For more information on the Commodities Commission, please visit www.lifesavingcommodities.org. TRTs and conveners continue to merge and develop according to ongoing work plans. For more information on how to access the TRTs, contact information for each of the lead conveners is provided. The information below is current as of December 2013. 12 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 12 What You Need to Know The Pillars of the 2012 Commissioners’ Report THE NEED: COMMODITIES The Commodities Commission reviewed and selected 13 commodities based on three criteria: 1. Global burden of disease, and evidence of high impact and efficiency to reduce mobility and mortality across the RMNCH continuum of care. 2. Inadequate funding for commodities. 3. Untapped potential and opportunity for innovation and rapid scale-up in product development and market shaping. The Commodities Commission also reviewed a full range of contraceptive methods and identified three that are particularly overlooked, often unavailable when requested, and have public health benefits. It is anticipated that implementation of the Commodities Commission’s recommended actions will also increase access to other commodities through cross-cutting improvements such as regulatory efficiencies and support tools for health care workers. THE CHALLENGE: BARRIERS TO ACCESS AND USE Regulatory challenges lead to delayed registra- tion of commodities, lack of oversight on product quality, and general inef- ficiencies in low-income countries. Market failures, in which return on investment is too low to encourage manufacturers to enter the market or produce sufficient quantities of commodities. This limits global supply, which in turn affects country pricing, distribution, and commodity accessibility. Supply and demand challenges, which include limited demand for the product from health providers, women, and caregivers, local delivery problems, incorrect quantification and forecasting, and incorrect prescription and adherence. The Commodities Commission report highlights three key, interrelated barriers that affect the production, distribution, availability, and demand for commodities: 13 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 13 What You Need to Know Recommendation Global (G) and/or National (N) Examples  Shaping global markets By 2013, effective global mechanisms such as pooled procurement and aggregated demand are in place to increase the availability of quality, lifesaving commodities at an optimal price and volume. G The Recommendation 1 TRT is working with global purchasers, pathfinder countries, partners, and suppliers to compile information for the 13 commodities on ordering and pricing, procurement and forecasting, and consumption. The TRT is generating data on major suppliers in low- and middle- income countries, along with capacity and pricing information. The TRT is also working to compile information that will help create a more enabling environment for consistent supply and demand of commodities. Resources will include a web-based informational site with relevant data and research, and market- shaping frameworks and toolkits.  Shaping local delivery markets By 2014, local health providers and private- sector actors in all EWEC countries are incentivized to increase production, distribution, and appropriate promotion of the 13 commodities. G The Recommendation 2 TRT will develop a toolkit and market-shaping guidance for EWEC countries to support sustainable levels of local distribution and supply. N Nigeria is working with local manufacturers to improve quality assurance of commodities and to facilitate enhanced raw material imports. N Officials in Uganda are engaging local manufacturers to increase local production and reduce prices of commodities. Manufacturers will also receive support to meet prequalification standards. N DRC will develop an outreach and certification plan for local manufacturers, and will provide assistance for procurement planning. THE ACTION PLAN: RECOMMENDATIONS To address these barriers, the Commodities Commission defined ten practical, time-bound, cross-cutting recommendations to strengthen health systems and impact the supply, demand, and use of the 13 lifesaving commodities. These recommendations, and illustrative examples of how they are being carried forward at the global and national levels by the recommendation TRTs and pathfinder countries, are outlined below. Complete overviews of the pathfinder countries’ activities can be accessed here, while more information on the TRTs can be found here. 14 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 14 What You Need to Know Recommendation Global (G) and/or National (N) Examples  Innovative financing By the end of 2013, innovative, results-based financing is in place to rapidly increase access to the 13 commodities by those most in need and foster innovations. G The Recommendation 3 TRT will explore the use of a facility- based commodity fund that can “procure” from private or government sources. N Sierra Leone plans include innovative financing to link community health workers (CHWs) to an expanded results-based financing program. Based on pilot results, CHWs may be linked through the national Performance-Based Financing Scheme. N Malawi will establish a “ring funding mechanism” for RMNCH commodities, allocating specific resources to improve equitable access to treatment and care.  Quality strengthening By 2015, at least three manufacturers per commodity are manufacturing and marketing quality-certified and affordable products. G The Recommendation 4 TRT is conducting a survey on regulatory and quality status of key commodities in 25 countries in order to determine the quality problems experienced on the 13 commodities and offer technical support in addressing these issues. G The TRT for Recommendation 4 will support countries to implement revised WHO Essential Medicine List (EML) guidelines to improve rational use of medicines. N Leaders in DRC will promote local production and distribution of commodities by training a team of inspectors to conduct drug-quality audits and ensure continued quality assurance. N Both Nigeria and Senegal will improve post-market surveillance capacity to ensure quality products throughout the supply chain.  Regulatory efficiency By 2015, all EWEC countries have standardized and streamlined their registration requirements and assessment processes for the 13 lifesaving commodities with support from stringent regulatory authorities, the WHO, and regional collaboration. G The Recommendation 5 TRT encourages countries and stakeholders to consolidate policies around an appropriate product to reduce fragmentation in the market. The TRT also engages national and regional regulators in joint and harmonized activities to put medicines and medical devices on the market in countries. N DRC, Nigeria, Malawi, and Senegal will all update their country’s EMLs. Revised EMLs are anticipated, alongside revised treatment guidelines, to ensure that registered products are procured. N Sierra Leone plans to strengthen the Pharmacy and Poisons Board role in regulatory efforts. N Tanzania will harmonize their EML with that of the WHO and will also fast-track registration for lifesaving commodities. 15 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 15 What You Need to Know Recommendation Global (G) and/or National (N) Examples  Supply and awareness By 2015, all EWEC countries have improved the supply of lifesaving commodities and built on information and communication technology (ICT) best practices for making these improvements. G The Recommendation 6 TRT will develop guidance for quantification of RMNCH essential medicines, document and disseminate knowledge and good practices on public-private partnerships to improve supply chain management, and enhance open-source supply chain ICT systems for use in supply chain management. These activities include creation of a framework and pilot program for engaging private-sector partners to strengthen supply chain systems within countries. N Tanzania will enhance procurement efforts, improve quantification, and scale up the electronic Logistics Management Information System [LMIS] to include lifesaving commodities in mHealth monthly monitoring and in supply chain management training. This will be a country-wide rollout of the mHealth structure. N Nigeria and Sierra Leone will provide technical support for commodity quantification. N Senegal will extend electronic LMIS to 62 districts, improve supply chain management trainings, and include lifesaving commodities as key tracking indicators.  Demand and utilization By 2014, all EWEC countries in conjunction with the private sector and civil society have developed plans to implement appropriate interventions at scale to increase demand for and utilization of health services and products, particularly among under-served populations. G To support countries to accelerate current demand -generation efforts or to launch new demand-generation activities, the Recommendation 7 TRT has developed a Demand Generation Implementation Kit for Underutilized Commodities in RMNCH. The kit includes a collection of cross-cutting resources on gender, ICT/new media, and public-private partnerships, as well as commodity-specific communication strategies that are adaptable and replicable in multiple countries and a selection of commodity-related tools and resources. N DRC and Malawi will conduct research on the principle barriers to accessing family planning services and institute a social marketing plan to combat these challenges. N Nigeria plans to develop awareness campaigns, media strategies, and community activation forums to improve consumer demand and utilization of care and services. N Tanzania will improve demand by developing “demand- generation toolkits” to mobilize private-sector providers. 16 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 16 What You Need to Know Recommendation Global (G) and/or National (N) Examples  Reaching women and children By 2014, all EWEC countries are addressing financial barriers to ensure the poorest members of society have access to the lifesaving commodities. N DRC will work to reduce financial barriers to the 13 commodities by integrating them into subsidized maternal and child health kits. N Ethiopia will expand access to community-based newborn care by purchasing newborn commodities and equipment. N Senegal will improve access by integrating lifesaving commodities into user-fee exemption strategies.  Performance and accountability By the end of 2013, all EWEC countries have proven mechanisms such as checklists in place to ensure that health-care providers are knowledgeable about the latest national guidelines. G The Recommendation 9 TRT will develop job aids to improve performance among health workers, establish monitoring systems for performance measurement and accountability, and support development and integration of mobile and electronic health applications. N Tanzania is revising and disseminating job aids, checklists, and training tools for health care workers, and will establish supervision and mentorship programs to improve quality of care. N Officials in Uganda will develop e-learning curricula to disseminate the latest guidelines based on operational research and provider assessments. National integrated community case management programs will be scaled-up.  Product innovation By 2014, research and development for improved, lifesaving commodities has been prioritized, funded, and commenced. G The Recommendation 10 TRT is focused on identifying priority product improvements for the 13 commodities. The TRT will identify innovation gaps and create new target product profiles to ensure specific attributes are part of the final product. N Senegal will work to co-package ORS and zinc to improve access to both commodities. N Uganda will focus on product improvements for pedi- gentamycin, misoprostol packaging, and magnesium sulfate bundling. 17 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 17 What You Can Do “There is no doubt that lives can be saved by increasing access to affordable and effective medicines and health supplies. We must all make a difference and the time is now.” —His Excellency President Goodluck Jonathan of Nigeria, Co-Chair of the Commodities Commission 18 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 18 What You Can Do Why Advocacy? Advocacy is an important strategy for guiding the refinement or development of robust RMNCH plans that reflect the commodity needs and realities of a given country. It also plays a central role in generating system-wide support for expanding access to commodities, facilitating a strategic approach to scale- up among relevant stakeholders, promoting accountability, and ensuring related political commitments are translated into actions that reach intended beneficiaries. Advocacy Actions The Commodities Commission recommendations comprise a critical platform that advocates in both pathfinder and broader EWEC countries can utilize to increase focus and attention on commodities, to see them effectively integrated into national RMNCH priorities and plans, and encourage tangible progress on wider RMNCH initiatives. There is a range of actions advocates can take to engage with key decision-makers and stakeholders to integrate and actualize the Commodities Commission recommendations into national and subnational processes, policies, and programs. The advocacy actions outlined below are not intended as an exhaustive list. They are a menu of tangible items that can be utilized to leverage the Commodities Commission in order to advance women’s, newborns’, and children’s health. Actions may require adaptation for individual country contexts. 19 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 19 What You Can Do Advocacy in Pathfinder Countries Ministries of Health (MOH) in pathfinder countries (DRC, Ethiopia, Malawi, Nigeria, Senegal, Sierra Leone, Tanzania, and Uganda) have submitted dedicated plans/proposals to carry forward the recommendations within their country to the SC and received support from the RMNCH Fund to implement their plan. Advocates can contribute to the successful implementation of the plan/proposal through the following activities: ●❑ Review pathfinder plans/proposals to identify the specific steps and actions the MOH has committed to taking to address RMNCH commodity gaps in your country. ●❑ Identify specific advocacy activities highlighted in the plans and explore opportunities for partnership with the MOH to generate wide-spread support for the plan. ●❑ Identify additional individuals or audiences that need to be engaged to move forward the plan and determine what information is available about their knowledge and commitment to advancing commodities. Fill in knowledge gaps as appropriate. ●❑ Provide information and highlight commitments to relevant stakeholders, such as parliamentarians, Ministry of Finance (MOF) representatives, sub- national leaders and health teams, health professionals, private-sector leaders, and community members to build system support, ensure coordination and leveraging of resources, and promote accountability for the plan. ●❑ Review national and sub-national RMNCH initiatives, strategies, and frameworks and work with decision-makers to ensure that the commodities plan aligns with and is appropriately integrated to support concrete programs and results on the ground. ●❑ Identify and promote necessary policy changes at both national and sub-national levels to actualize the plan and enhance the availability and accessibility of the 13 commodities. ●❑ Educate on the need to invest resources to address funding gaps and ensure sustainability for implementation of the plan to parliamentarians, the MOF, and sub-national leaders. ●❑ Monitor and track application and progress of the plan at various levels in order to raise visibility of bottlenecks and barriers to implementation, as well as areas of low coverage and inequitable access to care for both the public and decision-makers in order to maximize accountability. ●❑ Ensure that diverse perspectives, including civil society, are represented in consultation meetings and stakeholder feedback on the implementation of the commodities plan. Civil society representatives should reflect the RMNCH spectrum. ●❑ Identify gaps in current plan/proposal and promote the development of long- term and sustainable solutions by decision-makers for ensuring expanded access and availability of commodities beyond support from the RMNCH Fund. To coordinate or connect with specific groups conducting Commission- related advocacy within pathfinder countries and to share lessons learned and ideas on commodities advocacy within EWEC countries, please contact the Commodities Commission’s Advocacy Working Group at UNCoLSC_AWG@path.org. 20 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 20 What You Can Do Advocacy in Broader EWEC Countries In order to save six million lives in five years, concentrated efforts are required in all 49 EWEC countries to scale up access to lifesaving commodities. Advocates can play a critical role in mobilizing support for the implementation of the Commodities Commission recommendations in EWEC countries through the following activities: ●❑ Organize community and private-sector outreach and social mobilization activities to increase public awareness on the importance and impact of commodities and health products to improving the health of women and children. ●❑ Highlight global efforts to advance commodities to decision-makers — including the 2013 World Health Assembly (WHA) resolution urging member states to implement the Commodities Commission recommendations — to motivate action on commodities within your country. ●❑ Disseminate up-to-date information to key decision-makers about the ten recommendations and 13 commodities to raise visibility and generate interest in addressing commodity-related issues in your country through development of a country plan/proposal as a future pathfinder country. ●❑ Identify the individuals or audiences that need to be engaged across government structures to secure buy-in and coordination for the development and implementation of a commodities plan/proposal and conduct outreach relative to the importance of commodities. ●❑ Call for a transparent and open process for the development of a commodities plan/proposal, including the creation of formal mechanisms to receive and react to stakeholder feedback. ●❑ Organize consultations with diverse stakeholders, including policymakers, health professionals, private-sector leaders, NGOs, civil society organizations, and community members to identify issues and needs to be addressed in a commodities plan/proposal. Consultations should include representatives that reflect the RMNCH spectrum. Invite and/or share findings with key decision-makers. ●❑ Review or conduct landscaping at sub-national levels to highlight health trends, major system bottlenecks, and commodity-related gaps in order to guide development of a commodities plan/proposal that reflects needs and realities throughout the country. Share broadly, including with key decision-makers. ●❑ Review national and sub-national RMNCH roadmaps and policies to identify commodity-related gaps to be addressed through a proposal/plan as a pathfinder country. ●❑ Encourage focus on the 13 commodities and integration of the Commodities Commission recommendations into any on going policy reviews of your country’s RMNCH plans, strategies, and frameworks. ●❑ Advocate for investment of resources from both international donors and domestic financing in order to support long-term access to and availability of lifesaving commodities for women, children, and newborns. Becoming a Pathfinder Country EWEC countries interested in becoming pathfinder countries and receiving short-term catalytic grants from the RMNCH Fund must develop a country implementation plan/proposal highlighting their current RMNCH context, national RMNCH plan, and key gaps on commodities. The plan should detail the commodities and recommendations that have the biggest potential for increasing access and services within the country and outline how the applicable recommendations will be carried out. The implementation plan should complement or be part of the country’s national RMNCH plan(s), focusing on unmet needs in relation to commodities. 21 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 21 What You Can Do In both pathfinder and broader EWEC countries alike, ensure that information on the Commodities Commission, the 13 priority commodities, and ten recommendations is featured at national and sub-national levels. Specifically: ●● Work with the MOH and other partners to identify key opportunities to highlight and promote the Commodities Commission recommendations and linkages with other initiatives. ●● Increase focus on access and availability of commodities. ●● Build political will for implementation. Organize disseminations of Commodities Commission recommendations and country commodities plans/proposals at sub-national levels to get the word out, answer questions, collect feedback, and explain opportunities for carrying forward the plan. There are a variety of advocacy tools available, including a draft policy brief, press release, letter of support, and advocacy strategy development template that can be adapted for use in your country to raise visibility and build momentum for addressing RMNCH commodity gaps through development and implementation of a commodities plan. Opportunities for awareness- raising may include country APR launches and Every Newborn consultations, world health days, health campaigns, and national events/meetings focused on women’s and children’s health. How to edit PDF files: Open a file in Acrobat XI. Select Tools > Content Editing. Click the Edit Text & Images tool. Click the on-page element you wish to edit, which automatically activates the tools you’ll need. Choose the tool that best fits your task. Or simply cut and paste into a word document and format as appropriate. MAR INTERNATIONAL WOMEN’S DAY 8 APR WORLD HEALTH DAY 7 JUN DAY OF THE AFRICAN CHILD 16 JUL WORLD POPULATION DAY 11 NOV WORLD PNEUMONIA DAY 12 NOV WORLD PREMATURITY DAY 17SEP GLOBAL FEMALE CONDOM DAY 16 22 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 22 What You Can Do: Draft Policy Brief Template Part 1 THE PROBLEM In [country name], too many women, newborns, and children are suffering and dying from causes that are preventable and treatable. Every year in [name of country]: ●● [Insert country-specific maternal mortality rate] women die from complications during pregnancy and childbirth. ●● [Insert number of country-specific deaths from postpartum hemorrhage] women died in [year] from obstetric bleeding (“postpartum hemorrhage”), and [insert number of country-specific deaths from pre-eclampsia/eclampsia] died from pre- eclampsia, and eclampsia —the two leading causes of maternal death. ●● [Insert country-specific newborn mortality rate if available] newborns die in the first 28 days of life. Leading causes of newborn mortality include newborn sepsis, respiratory distress syndrome in preterm babies, and newborn asphyxia. ●● [Country name] has an under-five mortality rate of [Insert under-five mortality rate]. Two leading causes of child mortality are pneumonia and diarrhoea. [Country name] cannot address these maternal, newborn, and child deaths without investing in lifesaving commodities (i.e., medicines and health supplies). Community health workers aren’t nearly as useful if they cannot provide access to modern contraception. A skilled birth attendant is not as effective during delivery if she does not have access to medicines and devices for the mother and baby. Health care clinics cannot save children’s lives without essential medicines to dispense as needed. Access to commodities leverages the impact of the rest of the health care system. Scaling-up Lifesaving Commodities to Advance Reproductive, Maternal, Newborn, and Child Health Platform for action in [country name] THE SOLUTION The solution is within reach: experts estimate that with access to basic health care and key interventions, the leading causes of maternal, newborn, and child deaths are largely preventable. There are key medicines and health supplies that are evidence-based, cost- effective, and available on the market TODAY, yet they remain largely inaccessible to the most vulnerable. [Country name] will focus on scaling up access to and use of [insert number of commodities] commodities, which are proven to save the lives of women, newborns, and children. These commodities are: [Edit below chart to delete commodities that you will not focus on in your country’s plan]. Contraceptives: Female condoms, emergency contraception, and implants for contraceptive needs Maternal Health: Oxytocin and misoprostol for postpartum hemorrhage and magnesium sulfate for eclampsia and severe preeclampsia Newborn Health: Injectable antibiotics for newborn sepsis, antenatal corticosteroids [Insert compelling maternal, newborn, or child health photo above from your country and include caption and photo credit here] 23 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 23 What You Can Do: Draft Policy Brief Template Part 2 for preterm respiratory distress syndrome, chlorhexidine for cord cleansing to prevent umbilical cord infections, and resuscitation devices for newborn asphyxia Child Health: Amoxicillin for pneumonia and oral rehydration salts and zinc for diarrhoea Despite the fact that these commodities are affordable, low-cost, and are manufactured around the world, there are still barriers that limit access. These barriers include weak supply chains, inadequate regulatory capacity to protect people from sub-standard or counterfeit products that can cause harm, and lack of awareness of how, why, and when to use them. It is essential to address these barriers to reduce [country name]’s maternal, newborn, and child mortality rates. GLOBAL ACTION The UN Commission on Lifesaving Commodities for Women and Children (the Commodities Commission) was established as part of the global Every Woman, Every Child movement which seeks to address the major health challenges facing women and children in the world’s poorest countries. The Commodities Commission identified a list of 13 essential but under-used contraceptive, maternal, newborn, and child health commodities with the aim of improving how they are produced, distributed, and used in countries where the most women, newborns, and children under five die from preventable causes. The Commodities Commission developed a set of ten recommendations on how to address common barriers to accessing these key commodities. The Commodities Commission’s recommendations are in alignment with other global initiatives that work to improving maternal, newborn, and child health. These initiatives include: ●● Child Survival Call to Action: A Promise Renewed seeks to accelerate the declines in the number of under-five and maternal deaths, enabling more countries to achieve MDGs 4 and 5 by 2015 and to sustain the progress well into the future. One of the five action items in A Promise Renewed is investing in high-impact solutions such as commodities that help prevent the major causes of maternal, newborn, and child mortality. ●● Family Planning 2020 is an initiative to increase access to modern contraceptives to 120 million additional women by 2020. ●● The Global Action Plan for the Prevention & Control of Pneumonia and Diarrhoea (GAPPD) is a resource for coordinating and integrating efforts to improve the impact of current programming for pneumonia and diarrhoea; this action plan includes the promotion of oral rehydration solution, zinc, and amoxicillin to prevent child mortality. ●● The Global Newborn Action Plan focuses on reducing preventable newborn mortality and will build on the recommendations of global initiatives including the Commodities Commission to improve access to injectable antibiotics, antenatal corticosteroids, chlorhexidine, and newborn resuscitation devices. Together these global-level initiatives help ensure there is momentum around supporting reproductive, maternal, newborn, and child health commodities. [Country name]’s COMMITMENT These global initiatives help bring attention, funding, and support for commodities; however, countries also must have national-level strategies HEADLINE Insert a relevant quote, graph, or chart 24 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 24 What You Can Do: Draft Policy Brief Template Part 3 to ensure that commodities are available at the health clinics and in the hands of trained health care workers to save lives. In (insert date), Minister [insert name of minister of health] committed to carrying out the necessary actions to ensure sustainable and equitable access to and use of lifesaving medicines and health supplies to all women and children by 2015. A national implementation plan for scaling up key commodities has been created. [Country name] has committed to work on the following areas: [Delete recommendations your country is not working on and insert sub-bullets of specific details from your country plan as appropriate.] ●● Shaping local delivery markets: By 2014, local health providers and private-sector actors are incentivized to increase production, distribution, and appropriate promotion of the commodities. ●● Innovative financing: By the end of 2013, innovative, results-based financing is in place to rapidly increase access to the commodities by those most in need and foster innovation. ●● Quality strengthening: By 2015, at least three manufacturers per commodity that are manufacturing and marketing quality- certified and affordable products. ●● Regulatory efficiency: By 2015, [country name] has standardized and streamlined registration requirements and assessment processes for the lifesaving commodities with support from stringent regulatory authorities, the World Health Organization, and regional collaboration. ●● Supply and awareness: By 2015, [country name] improves the supply of lifesaving commodities and builds on information and communication technology (ICT) best practices for making these improvements. ●● Demand and service utilization: By 2014, [country name] in conjunction with the private sector and civil society have developed plans to implement at scale appropriate interventions to increase demand for and utilization of health services and products, particularly among under-served populations. ●● Reaching women and children: By 2014, [country name] is addressing financial barriers to ensure the poorest members of society have access to the lifesaving commodities. ●● Performance and accountability: [country name] has proven mechanisms such as checklists in place to ensure that health care providers are knowledgeable about the latest national guidelines. ENSURING ACTION To move forward these commitments, the following is necessary: [Adjust and add any action needed by national and local government officials or of the national working group (if it exists). Some examples are listed below; please make sure they are adjusted to the relevant situation in your country.] ●● Recognizing that implementing these recommendations is essential to saving mothers’, newborns’, and children’s lives, prioritize financial and human resources to implement the national plan. ●● Engage stakeholders from affected communities, civil society, the private sector, donor agencies, and multilateral institutions in the planning, implementation, and monitoring of the recommendations. ●● Conduct monitoring and evaluation of the implementations plans to identify gaps and priority actions. ●● Identify the most effective strategies and where additional efforts are needed, and how to best coordinate efforts across ministries, sectors, and partners. ●● Work with regional- and district-level health officials to ensure that the implementation plans are integrated at all levels. CONTACT US For more information, please contact: [insert name, organization, and email] 25 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 25 What You Can Do: Press Release Template [Name of country] to address the leading causes of maternal and child mortality through lifesaving drugs and health supplies [City], [date] – Every year, in [country name], hundreds of women and children die of preventable or treatable causes because they cannot access affordable and effective medicines and simple health supplies. Medicines for the prevention of bleeding after childbirth and treatment of children for diarrhoea and pneumonia for example —which cost less than US$0.50 [convert to local currency] per treatment—can make the difference between life and death for mothers and their children. Simple medicines can save lives, but only if people can access them. [Country name] is no exception: [Insert country-specific statistics about maternal, newborn, and child deaths. Illustrative examples are below] ●● Each year [Insert country-specific maternal mortality data] women die from complications during pregnancy and childbirth. ●● [Insert number of country-specific deaths from postpartum hemorrhage] women died in [year] from obstetric bleeding (“postpartum hemorrhage”), and [insert number of country-specific deaths from pre-eclampsia/eclampsia] died from pre-eclampsia, and eclampsia—the two leading causes of maternal death. ●● [Insert country-specific newborn mortality data if available] newborns die in the first 28 days of life. Leading causes of newborn mortality include newborn sepsis, respiratory distress syndrome in preterm babies, and newborn asphyxia. ●● Each year, [insert under-five mortality data] in [country name] die before the age of 5. The two leading causes of child mortality are pneumonia and diarrhoea. In September 2012, the UN Commission on Life-Saving Commodities for Women and Children (the Commodities Commission) launched a report outlining ten key recommendations for improving the supply and access to 13 lifesaving and cost-effective but overlooked commodities for reproductive, maternal, newborn, and child health. In [include date], [name of country] became one of the first countries to pledge its commitment to implementing the Commodities Commission’s recommendations and ensuring sustainable and equitable access to and use of lifesaving medicines and health supplies to all women and children by 2015. Now a national implementation plan for scaling up key commodities [has been/is being] created. As part of the plan, [country name] has committed to work on the following areas: [Include specific recommendations, commodities, and partnership details from your country plan as appropriate]. “It’s a travesty that so many women are dying in childbirth and children are dying of preventable causes like diarrhoea and pneumonia in [country name]. The government’s decision to join this global commitment is a clarion call for urgent action. We know what we need to do and we have a 2017 deadline. The clock is ticking,” said [insert name and title of representative]. [Adjust quote as needed] [Highlight information on the status of the implementation plan and necessary next steps. Add information on country progress in taking action as a pathfinder country, initiation of a country consultation process, etc. You might mention the role, if any, that your organization/office has played to date in advancing essential commodities as part of the Commodities Commission.] About [name of organization] [Insert a short paragraph describing the mission and activities of your organization/office.] Press Contact [Insert phone number and email address of relevant contact person at your organization.] 26 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 26 What You Can Do: Letter of Support Template Date Name and title of recipient Address of recipient – Line 1 Address of recipient – Line 2 Address of recipient – Line 3 RE: Recommendations of the UN Commission on Lifesaving Commodities for Women and Children To the Honorable [Name], On behalf of [organization name], I urge you to act on the recommendations of the UN Commission on Lifesaving Commodities for Women and Children to improve access to and use of commodities in [country]. Despite advancements in health services and delivery, the number of women and children that continue to die from preventable causes in [country name] each year continues to be a cause for concern. Each year, [Insert some country-specific statistics about maternal and child deaths.] The majority of these deaths could be averted with improved access to 13 effective, low-cost “commodities,” which include drugs and simple health supplies. [Organization name] welcomes and endorses the recommendations set out by the Commodities Commission as a powerful means to address preventable maternal and child deaths. We [applaud you for pledging/urge you to pledge] to carry out the necessary actions to ensure sustainable and equitable access to and use of lifesaving commodities for women and children in [insert country name] through development of a national implementation plan. We recognize the need to act quickly to transform the Commodities Commission’s recommendations into a reality that saves the lives of our most vulnerable women and children. The enclosed brief [see policy brief template in toolkit to create one] provides an analysis of the situation of reproductive, maternal, newborn, and child health in [country name], including recommendations for how to maximize the Commodities Commission platform within our country’s context. [Organization name]’s input may be helpful in [developing or building support for carrying out] the national implementation plan given our experience in [provide more details]. I would be delighted to meet with you or your staff, or to help organize a meeting with key stakeholders to discuss next steps. Sincerely, Name and title Organization Telephone number and email address 27 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 27 What You Can Do: Advocacy Strategy Development Template What is the problem that needs to be addressed? What is your advocacy goal, specifically the change that is needed to address the problem? Who are the decision-maker(s) with power to make the change and their influencers? What motivates and interests your target decision-maker(s) that can help influence them toward your goal? What obstacles or opposition exist to the change you would like to see? What are your organization’s assets and gaps in advocating for the change? Who are potential partners with similar interests in achieving the change? What advocacy activities and tactics will you use to influence decision-makers? What messengers and messages will you use to reach and persuade decision-makers? What is your plan to monitor and evaluate the success of your strategy? It may be necessary to develop targeted advocacy strategies to bring about change relative to the Commodities Commission’s 13 priority commodities and ten cross- cutting recommendations in your country, including ensuring the development and effective implementation of a commodities plan. Developing a strategy will enable you to better assess options and make decisions about activities that will successfully influence advocacy targets to move toward your desired point of view. To start your advocacy strategy, answer the following questions: For more information and tools on how to develop advocacy strategies utilizing the ten-part framework, including ideas for specific activities and tactics, click here or to find out if an advocacy strategy development workshop is happening near you, email UNCoLSC_AWG@path.org Worksheet is adapted from PATH’s ten- part advocacy framework for advocacy strategy development and implementation. The framework uses data and analysis, including community perceptions and environmental landscaping, to inform advocacy planning and decision-making. Potential advocacy messages are included in the What There is to Say section. 28 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 28 What There is to Say “By increasing access to 13 overlooked lifesaving medicines and health supplies, care-givers will have a better chance to reach the women and children in greatest need. This isn’t just the right thing to do; it’s the smart thing to do. Scaling up these 13 commodities would cost less than US$2.6 billion and would save over six million lives. That is one of the ‘best buys’ in global health today.” —Anthony Lake, Executive Director, UNICEF, Vice-Chair of the Commodities Commission 29 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 29 What There is to Say Advocacy Messages Advocacy messages play a key role in ensuring the issue of commodities stays visible and a global and national priority. Compelling messaging needs to effectively communicate the problem, the solution, its impact, and call to action. Communication should demonstrate the validity of the evidence and engage the audience. As scaling up essential commodities is a significant investment that requires long-term commitment, advocacy efforts should communicate the need for a sustained investment, both politically and financially. This messaging platform can be tailored to reflect individual countries’ contexts by including current data on commodities and describing the impact of implementing the Commodities Commission recommendations. The various messages can be incorporated into relevant press releases, media advisories, op-eds, fact sheets, blogs, newsletters, social media, and speeches on various EWEC and RMNCH-related initiatives in your country. Messaging Platform The UN Commission on Life-Saving Commodities (the Commodities Commission) aims to increase access to low-cost, high-impact medicines and health products in the world’s poorest countries. The effort has laid out clear evidence-based actions with demonstrable impacts—including saving six million lives in five years—that target a range of groups, including donors, policymakers, advocates, and private-sector audiences at global and national levels. This message platform was developed to inform audiences about the Commodities Commission and, more importantly, to inspire action from decision-makers with the authority to implement the Commodities Commission’s recommendations. Topline Messages ●● The implementation of the Commodities Commission recommendations could save six million lives in five years by making 13 simple but overlooked health products and medicines available and accessible for the world’s poorest women and children. ●● Increasing access to commodities and related services is one of the most effective ways to achieve the goals of the Global Strategy for Women and Children’s Health and close the gap to reaching Millennium Development Goals (MDGs) 4 and 5. ●● The Commodities Commission’s ten recommendations aim to break down regulatory, financial, and market-based barriers. Eight countries are currently leading the charge. ●● To continue momentum, global leaders must focus on increasing financing, supporting country implementation, coordinating global efforts, and leading initiatives like operational research. National leaders must include access to commodities in their country plans and strategies, implement supportive policies, and commit to knowledge-sharing and evaluation. 30 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 30 What There is to Say Key Messages Together, we have the chance to succeed in one of the most ambitious health campaigns in history—saving the lives of 16 million women and children by the end of 2015 in the world’s poorest countries, as laid out in the 2010 Global Strategy for Women and Children’s Health. The Every Woman Every Child (EWEC) movement was established to mobilize and intensify the international and national action needed to advance this strategy. The Commodities Commission, working under the EWEC umbrella, will focus on increasing the access, availability, and quality of health products and medicines to improve the health of the world’s poorest women, children, and newborns. ●● Increasing availability and access to simple but often overlooked health products and medicines is one of the most effective ways to achieve the goals of the Global Strategy and close the gap to reaching MDGs 4 and 5. ●● Scaling up access to cost-effective and high-impact reproductive, maternal, newborn, and child health (RMNCH) products is a top “best buy” in global health. By investing $2.6 billion over the next five years to adopt the the Commodities Commission recommendations, we can save an estimated six million lives. Until now, regulatory, financial, and market-based challenges have kept many critical products out of reach. In 2012, the Commodities Commission laid out ten key actions to make these products more available and affordable, even in the most remote villages in the poorest countries. ●● Three major barriers keep these health supplies from those who need them most: insufficient supply, ineffective quality assurance, and inadequate demand. ●● Drawing on the lessons and successes of other health partnerships, the Commodities Commission made ten recommendations for country and global leaders that could remove bottlenecks to access and ensure affordability. ●● They include actions such as investing in innovative financing, generating demand and awareness, creating incentives for producers and purchasers, improving quality assurance and regulation, educating health care providers, and supporting research and development efforts to improve products. 31 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 31 What There is to Say The Commodities Commission recommenda- tions are a blueprint for country and global leaders to accelerate access, and improve availability and quality. ●● Eight countries have committed to prioritizing implementation of the Commodities Commission’s recommendations. Those leading the way include the Democratic Republic of the Congo (DRC), Ethiopia, Malawi, Nigeria, Senegal, Sierra Leone, Tanzania, and Uganda. ●● Enacting the Commodities Commission’s recommendations will take shape differently in each country, based on local partnerships, opportunities, challenges, and needs. Initiatives underway include, but are not limited to, the following: ● Senegal is working to integrate the lifesaving commodities into its user-fee exemption strategy to increase access for women and children who need them most. ● Sierra Leone’s pilot of an integrated community case management (iCCM) program is training community health workers [CHWs] to provide child health-focused commodities during home visits. ● Nigeria created incentives for ORS and zinc manufacturers, which has led to two local manufacturers commercially producing zinc and four producing ORS for diarrhoea treatment. ● Ethiopia’s new Community-Based Newborn Care (CBNC) program will educate health care providers to increase demand and utilization of maternal and newborn commodities. ● Uganda has identified innovations in mHealth, including the use of e-learning tools to disseminate the latest guidelines and SMS-based systems for real-time reporting of stock levels at health facilities. ● Tanzania is working to improve provider knowledge on contraception, including implantable contraceptives, female condoms, and emergency contraception by developing and disseminating job aids. ● Malawi will train 500 service providers per year on the insertion and removal of implantable contraceptives. ● The DRC will be working to get oxytocin integrated into the Expanded Programme on Immunization (EPI) cold chain to ensure increased distribution and efficacy of the commodity. Eight Countries Committed to Prioritizing Implementation of the Commodities Commission’s Recommendations 32 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 32 What There is to Say Demand, access, and availability of these commodities, coupled with a strong focus on health system strengthening and adequate financing, will play a critical role in the achievement of key global and country work focused on RMNCH. To reach these goals, leaders at the global and country levels all have a role to play. With these commitments, we can take immediate action to save millions more lives and accelerate progress toward the MDGs. Country leaders can: ●● Commit to the Commodities Commission’s recommendations by integrating into existing country plans specific interventions that address barriers related to local supply, regulation, product quality, and demand generation; ●● Work with development partners, the private sector, and civil society to increase political awareness and commitment for the implementation of policies that support product demand, availability, and affordability; ●● Facilitate multi-sectoral learning, knowledge-sharing, and evaluation of these initiatives; and ●● Conduct research to improve availability and accessibility of the commodities at country level. Global leaders can: ●● Provide long-term technical and financial support for country-led implementation of the Commodities Commission recommendations in alignment and coordinated with other RMNCH-related initiatives; ●● Commit and leverage funding to support product availability and support innovation in product development; and ●● Coordinate global accountability initiatives to ensure that the Commodities Commission recommendations are supported and leveraged. 33 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 33 What There is to Say > > > > MATERNAL HEALTH COMMODITIES MESSAGES The Problem Each year, approximately 287,000 women—99 percent of whom live in developing countries—die from preg- nancy and childbirth-related complications. That means one woman dies every two minutes from pregnancy- related complications. The Solution Three proven, low-cost medi- cines can treat and prevent the two main causes of death, postpartum hemor- rhage—excessive bleeding after childbirth, and pre- eclampsia/eclampsia—the dangerous elevation of blood pressure during pregnancy that can lead to seizures, kidney and liver damage, and death. Together, these condi- tions account for more than half of maternal deaths. Oxytocin and misoprostol are proven, lifesaving medicines for the treatment of postpar- tum hemorrhage. Magnesium sulfate is highly effective in treating severe pre-eclamp- sia and eclampsia. Expanding access to high- quality, affordable medicines is essential to reducing ma- ternal deaths. Improving the reliable availability of such medicines will strengthen health care systems and make frontline health work- ers more effective. Delivering a package of ser- vices, including essential supplies, is estimated to cost less than US$1.50 per person in the 75 countries where 95 percent of maternal mortality occurs. The Impact If these three medicines were available to every woman giving birth, 1.4 mil- lion women’s lives could be saved over ten years. Ensuring that these three commodities are effec- tively available to all women could dramatically reduce the 134,800 deaths due to postpartum hemorrhage, pre-eclampsia, and eclampsia each year. Since babies whose mothers die are nine times more likely to die in infancy than those whose mothers survive, sav- ing mothers will save infants’ lives too. Healthy mothers have a pow- erful ripple effect. To save a mother is to save a family. And to save a family is to lay the foundation for stronger communities. The Call to Action Maternal health supplies and medicines need to be stocked in health clinics, placed in the hands of trained health care workers, and ultimately delivered appropriately to the women who need them in order to save lives. Where a woman gives birth should not decide her fate, especially when afford- able, effective medicines to treat and prevent maternal deaths exist. Governments have a respon- sibility to protect women’s lives during pregnancy and childbirth. Policy leadership, matched with funding to scale up prov- en, low-cost maternal health supplies, can dramatically improve maternal health and save millions of lives. 34 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 34 What There is to Say CONTRACEPTIVE COMMODITIES MESSAGES > > > >The Problem An estimated 222 million women in developing coun- tries want to use contracep- tives but do not have access to them. Many women who would like to have no more children do not have access to long-act- ing and permanent methods, and those who are at risk of HIV or other sexually trans- mitted infections too often do not have access to the means for prevention of both infec- tion and pregnancy. The Solution Contraception is one of the most cost-effective public health interventions. Expanding access to high- quality, affordable contra- ceptive methods can lead to healthier timing and spacing of pregnancies and is es- sential to reducing maternal, newborn, and child deaths. A full range of methods and the ability of women to choose a method that fits within their own fertility goals and life circumstances are essential for maximizing the impact of contraceptive com- modities. This includes: ●● Contraceptive implants are a highly effective and popular method of long- lasting and reversible contraception, offering multi-year protection. ●● Female condoms are the only female-initiated method available that of- fers dual protection from pregnancy and STIs/HIV. ●● Emergency contraception is a unique method, offer- ing women an important second chance to prevent unintended pregnancy if a method fails, is not used, or sex is forced. The Impact Access to and use of contra- ceptive commodities have wide-ranging benefits, in- cluding reducing unintended pregnancies, reducing the transmission of sexually transmitted infections, in- cluding HIV, and reducing the incidence of deaths and illnesses related to compli- cations of pregnancy and childbirth. If contraceptives were avail- able to every woman who wanted to use them, an esti- mated 53 million unintended pregnancies could be avoid- ed, 90,000 women’s lives saved, and 590,000 newborn deaths averted annually.1 Reproductive health com- modities are a critical part of an integrated package of low- cost, essential health care interventions for women that can save lives, families, and communities. The Call to Action Contraceptive implants, female condoms, and emer- gency contraception can and should be widely available in all settings. Governments have a respon- sibility to protect women’s lives, including ensuring con- sistent access to contracep- tives and quality of care. Women have the right to equitable access to methods that can save their lives and protect them from disease. Every woman around the world deserves access to commodities to achieve her reproductive intentions and protect herself from STIs, including HIV. 1 Guttmacher Institute and International Planned Parenthood Federation, ‘Facts on Satisfying the Need for Contraception in Developing Countries’, In Brief, November 2010. 35 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 35 What There is to Say CHILD HEALTH COMMODITIES MESSAGES > > > >The Problem In 2012, 6.6 million children under five died, almost 1.8 million of them from pneu- monia and diarrhoea, which are both preventable and treatable. Despite substantial progress in reducing child mortal- ity rates worldwide, nearly 18,000 children under age 5 are still dying every day. Children in developing coun- tries are especially vulnerable to pneumonia and diarrhoea because they often lack ac- cess to quality, affordable care and treatment that could save their lives. The Solution The solution is within reach: three proven low-cost com- modities – oral rehydration salts (ORS), zinc, and amoxi- cillin – can treat the leading causes of mortality for chil- dren under five years old. ORS is a sodium and glucose solution widely proven to prevent deadly dehydration in children with acute diarrhoea. Zinc is a vital micronutrient that helps reduce the sever- ity of diarrhoea and can help prevent future bouts. Amoxicillin is an effective, low-cost, widely used antibi- otic that is proven to save the lives of children with pneu- monia. Child health commodities should be stocked in health clinics, in the hands of trained health care workers, and de- livered appropriately to the children who need them in order to save lives. The Impact With appropriate case man- agement, amoxicillin dis- persible tablets can reduce deaths from pneumonia by 70 percent. When used together, ORS and zinc can prevent more than 90 percent of child deaths from diarrhoea. Without urgent and coor- dinated efforts to improve availability of ORS, zinc, and amoxicillin, almost 1.8 million of the world’s most vulner- able children will continue to die from pneumonia and diarrhoea. Expanding access to qual- ity, affordable commodities is essential to accelerating progress toward eliminat- ing preventable deaths from pneumonia and diarrhoea. The Call to Action Successfully reducing pneu- monia and diarrhoea deaths requires engagement by a wide range of actors and sec- tors, the first and foremost of which are national govern- ment leaders. Child health commodities are a critical part of an integrated package of low-cost, essen- tial health care interventions for women and children that can save lives when readily accessible and available. Policy leadership, matched with funding to scale-up proven, low cost child health supplies can dramatically improve child health and save millions of lives each year. To ensure that children ev- erywhere can one day raise healthy families of their own and build thriving communi- ties, there must be continued investments in the health and well-being of children. 36 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 36 What There is to Say NEWBORN HEALTH COMMODITIES MESSAGES > > > >The Problem Annually, 2.9 million babies die in the first month of life, largely from preventable causes; 98 percent of these deaths occur in develop- ing countries. This means that nearly 8,000 newborns die each day. These deaths account for 44 percent of under-five mortality. The world has made huge progress in reducing child mortality —but the greatest remaining challenge is to save the lives of newborn babies. While the number of total child deaths worldwide declines, the proportion of newborn deaths is growing because the progress in re- ducing preventable newborn deaths has been slower than the progress made in reduc- ing child deaths. The Solution Four low-cost, highly effec- tive interventions can prevent and treat the three leading causes of neonatal deaths: prematurity, complications of childbirth (or birth asphyxia), and severe infections. To- gether, these three causes account for more than 85 percent of newborn mortality. Antenatal corticosteroid is a proven, lifesaving interven- tion to prevent respiratory distress syndrome in preterm newborns. Newborn resus- citation devices can treat the majority of cases of birth asphyxia. Chlorhexidine can prevent deadly infections in newborns, and injectable antibiotics can success- fully treat infections that can quickly kill newborns without treatment. Newborn commodities should be available in every health facility and every birth attendant should have ac- cess and be trained to use these lifesaving commodities. Improving the availability and training of how to use newborn medicines and tech- nologies will strengthen the health care system and make frontline health care workers more effective. The Impact More than one million new- born lives could be saved each year if the four newborn commodities were universally available in the 75 countries with the highest rates of newborn mortality. Most newborn deaths re- sult from preventable and treatable conditions. We can prevent up to two-thirds of newborn deaths by bringing high-impact, low-cost inter- ventions to scale. Ensuring that lifesaving medicines and supplies are stocked in the health clinics, and placed in the hands of health care workers, and ultimately deliv- ered appropriately is a critical part of preventing newborn deaths. The Call to Action Governments should fund lifesaving maternal and child health programs that include a focus on newborns. Currently, only 6 percent of global aid for maternal and child health goes to newborn- sensitive programs, and only 0.1 percent targets newborns exclusively. Where a baby is born should not determine his/her fate, especially when affordable and effective interventions exist to prevent the majority of newborn deaths. All facilities and birth atten- dants need to have uninten- terupted stock and access to lifesaving newborn com- modities. Policy leadership and invest- ments need to be made by governments and global manufacturers to increase the availability of newborn commodities that can be easily supplied and used in resource-poor settings. Adapted from Every Newborn Toolkit Key Messages 37 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 37 Spotlight on Commodities: Maternal Health “The day of birth is the most dangerous day in the life of a woman and her child. The fact that women do not get the care they need during childbirth is the most brutal expression of discrimination against women. To prevent these tragic and unnecessary deaths is not only a humanitarian urgency of highest priority, but a key investment for social and economic development.” —Prime Minister Jens Stoltenberg, Co-chair of the Commodities Commission 38 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 38 Spotlight on Commodities: Maternal Health Of the 13 essential commodities identified by the Commodities Commission, three focus on the leading causes of maternal death: oxytocin and misoprostol for postpartum hemorrhage (PPH), and magnesium sulfate (MgSO4) for pre-eclampsia and eclampsia (PE/E). All three commodities are on the WHO’s Model List of Essential Medicines. They are also eligible for the WHO Prequalification of Medicines Program. To date, however, no manufacturers have qualified under this program for the three drugs. Ensuring that these three commodities are effectively accessible to all women could dramatically reduce the combined 134,800 maternal deaths due to PPH and PE/E each year. Each commodity costs less than US$1 per dose.1 However, cross-cutting challenges such as poor or uncertain quality of unregistered products, limited funding for commodities, and supply chain issues, including weak regulatory capacity; the absence of reliable demand forecasting; poorly designed or implemented LMIS; weak infrastructure with low staffing at the district and facility levels; and a limited pool of skilled human resources at all levels of the health system, all contribute to limit their availability and compromise their impact on women’s lives. Furthermore, there are few incentives for pharmaceutical manufacturers to innovate with these commodities because of the highly competitive, marginally profitable, low-price driven nature of generic pharmaceuticals. The specific uses of the individual commodities, their benefits for women’s health, and barriers to their effective use that need to be addressed are highlighted below. Information is adapted from the March 2012 Working Paper on Medicines for Maternal Health prepared to inform the development of the Commodities Commission recommendations. Overview: Maternal Health Commodities 1 PATH. Safeguarding Pregnant Women with Essential Medicines, September 2012. 39 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 39 Spotlight on Commodities: Maternal Health What you need to know about. oxytocin Barriers to Use National STGs specify the level of health provider authorized to administer oxytocin and often unnecessarily restrict the most widely used skilled birth attendants, such as midwives, from providing the drug. Globally, more than half of women give birth at home, rather than at a facility. In most countries, birth attendants at the peripheral or community level have limited access to or are untrained to administer oxytocin. Oxytocin is temperature sensitive and loses effectiveness after three months of being stored at temperatures higher than 30 degrees Celsius (86 degrees Fahrenheit). As such, cold chain storage is recommended, though oxytocin is not commonly included in national supply cold chains. Oxytocin is commonly misused to augment labor instead of to prevent or treat PPH. Inadequate knowledge or training on the uses of oxytocin, cultural preferences for speedy births, and poor quality and infrequent supervision contribute to birth complications. Benefits of Use Oxytocin is a uterotonic that can prevent and treat PPH by causing contractions of the uterus during and after childbirth, effectively controlling excessive bleeding. It is available in 1ml glass vials containing either 5 or 10 international units (IU) and can be administered by injection into a woman’s vein or muscle. It is recommended by WHO as the first- line uterotonic drug for the prevention and management of PPH, and is the most commonly used drug for this purpose. Oxytocin is included in the vast majority of national protocols for maternal health service provision, EMLs, and standard treatment guidelines (STGs). Oxytocin takes effect sooner than most other uterotonic drugs; it is effective two to three minutes after injection, and has minimal side effects. 40 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 40 Spotlight on Commodities: Maternal Health What you need to know about. Barriers to Use Treatment for PPH with misoprostol is not included in the WHO EML as an appropriate indication. Many countries do not include misoprostol in their national EMLs. Of the 37 countries that the Maternal and Child Health Integrated Program surveyed in 2012, 16 reported that they do not include misoprostol to prevent and treat PPH on their national EML. Many countries also do not procure misoprostol, and therefore, it is often not available in public -sector health facilities. Many policymakers, providers, pharmacists, and even product manufacturers are largely ignorant of misoprostol’s use and dosing to prevent PPH and hotly contest the drug, given concern for potential off-label use for abortion, particularly in countries where it is illegal. Misoprostol is susceptible to spoilage from exposure to humidity, which can easily occur when the tablets are not stored or packaged properly. Few manufacturers produce a three-pill blister pack equaling 600 micrograms (the dosing regimen for PPH prevention), creating procurement challenges. Benefits of Use Misoprostol is a uterotonic that can prevent and treat PPH by stimulating strong contractions of the uterus, effectively stopping excessive bleeding after childbirth. It is available in oral (sublingual) tablet form.  Three tablets of 200 mcg are indicated for PPH prevention and four tablets of 200 mcg for PPH treatment. The WHO recommends misoprostol for prevention of PPH where oxytocin is not available or cannot be safely used (e.g., when skilled birth attendants are not present). Misoprostol is less heat sensitive than oxytocin, and its tablet form (as opposed to injections) make it an ideal medicine for preventing and treating PPH during home births and/or in low-resource settings where lower-level providers may find oral administration easier and more compatible to their work environment. The 2012 WHO Recommendations for the Prevention and Treatment of Postpartum Hemorrhage state a CHW, trained in its use, can distribute misoprostol for prevention of PPH. Multiple countries are piloting misoprostol distribution to women at the community level by community health workers (CHWs) with positive results. misoprostol 41 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 41 Spotlight on Commodities: Maternal Health What you need to know about. Barriers to Use National standard treatment guidelines often limit the use of magnesium sulfate to specialized care facilities.  Task-shifting occurs, nonetheless, such that untrained staff may be using the product in less than adequate facilities. Some countries have a large variety of formulations available that are not in line with WHO recommendations. For example, magnesium sulfate is available in 15 percent formulations in some countries, while the WHO recommendation is 20 or 50 percent. This creates confusion and requires providers to calculate the difference and adjust the dosage accordingly.  Magnesium sulfate is often not used by health providers because of lack of knowledge in administration with respect to timing and dosing and fears about potential toxicity, relying instead on diazepam, a less effective medication with more adverse neonatal effects. Oftentimes, because initial treatment for PE/E can take place at health centers before the patient is transferred to higher-level facilities for ongoing care, the second dose of magnesium sulfate may be missed, due to poorly functioning referral systems. Benefits of Use Magnesium sulfate is an anticonvulsant highly effective in treating PE/E, which are most often detected through an elevation of blood pressure during pregnancy, and can lead to seizures, kidney and liver damage, and death, if untreated. A loading dose is administered intravenously (IV) and maintenance regimes can be administered through IV or intramuscular (IM) injection. It is recognized by the WHO as the safest, most effective, and lowest-cost medication for preventing and treating eclampsia. Magnesium sulfate is included in the vast majority of national EMLs. magnesium sulfate 42 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 42 Spotlight on Commodities: Maternal Health The Oxytocin, Magnesium Sulfate, and Misoprostol TRTs are working together to develop tools and provide technical assistance for EWEC countries to increase the quality and appropriate use of maternal health medicines, as well as to improve access to these three lifesaving drugs by reducing key barriers. Specifically, their objectives are to: The Maternal Health Technical Reference Team ●● Improve forecasting and quantification of maternal health medicines; ●● Achieve an adequate supply of high-quality maternal health commodities available where needed; ●● Improve and adopt practices and policies for safe use; and ●● Advance innovations such as simplified packaging and presentation, as well as heat-stable formulations and easier-to-use modalities of maternal health commodities. Illustrative examples of how the combined MH TRT and the pathfinder countries are specifically applying the recommendations to address barriers to effective use and improve access and availability of maternal health supplies at the global and national levels are outlined below. These may give ideas for specific advocacy asks in your country. Other advocacy actions for maternal health commodities that correspond with the various recommendations are also included. Your advocacy strategy or agenda should be targeted and focused and does not need to encompass all actions. You may want to refine or include additional actions in your strategy depending on your individual country context. To read the pathfinder countries’ complete implementation plans/ proposals, visit here. For more information on activities of the MH TRT, download the following briefs. To join the MH TRT or to request tools and technical assistance, please contact : Deborah Armbruster, USAID darmbruster@usaid.gov Kabir Ahmed, UNFPA kahmed@unfpa.org Remember to “coordinate” and “integrate” with work being done on other priority commodities and the Commission as a whole: explore opportunities for a coordinated “ask” for all RMNCH commodities and opportunities to link with related RMNCH “asks”. 43 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 43 Spotlight on Commodities: Maternal Health Global (G) and/or National (N) Examples  Shaping global markets Global and/or National Examples G The MH TRT will analyze the status of oxytocin manufacturers that have submitted WHO prequalification applications, and will work to establish a business case for other manufacturers to do the same. Advocacy Actions Advocate for advanced market commitments or pooled procurements to incentivize manufacturers, drive down costs, and create a more sustainable market.  Shaping local delivery markets Global and/or National Examples N In Tanzania, officials are meeting with manufacturers and distributors to expand registration of magnesium sulfate. Advocacy Actions Advocate to government decision-makers to procure maternal health commodities from local manufacturers that are producing high-quality products. Request that governments provide central funding for essential maternal commodities. Map private-sector entities providing maternal health services and commodities to inform advocacy and outreach to government decision-makers on total market approaches.  Innovative financing Global and/or National Examples N Malawi will establish a “ring fencing mechanism” that will improve financing for lifesaving commodities—oxytocin, misoprostol, and magnesium sulfate included. N The Nigerian government has proposed a conditional cash transfer program for maternal and child health. Advocacy Actions Conduct advocacy with donors and the private sector for resource mobilization, particularly the need to fund innovative maternal health strategies. Identify where health budgets could/should include specific line items for maternal health commodities. Advocate for results-based financing of maternal health commodities that rewards providers when they meet performance standards for oxytocin, misoprostol, and magnesium sulfate. 44 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 44 Spotlight on Commodities: Maternal Health Global (G) and/or National (N) Examples  Quality strengthening Global and/or National Examples G The MH TRT will develop a technical brief on the integration of oxytocin into the cold chain to maintain quality and will offer technical assistance support to countries to include oxytocin in their cold chain. N In Malawi and DRC, officials are prioritizing efforts to improve supply chain management and to integrate the supply chain, including the addition of oxytocin into the cold chain. N DRC will train inspectors for drug-quality audits to improve quality control. N Several countries, including Nigeria, Senegal, and Uganda will improve post-market surveillance capacity to ensure continued safety and quality control. Advocacy Actions Advocate to decision-makers and key influencers on the importance of integrating oxytocin into the cold chain. Map local manufacturers who could achieve the WHO’s prequalification status and connect them with relevant technical assistance partners and decision-makers. Advocate to government officials to develop incentives to encourage local manufacturers to seek WHO prequalification. Collaborate with partners to identify regulatory pathways that can be improved to more fluidly deliver high-quality products and advocate to decision-makers for investment in strengthening of regulatory systems.  Regulatory efficiency Global and/or National Examples G The MH TRT is reviewing current procurement practices for pathfinder countries with the goal of ensuring that only one presentation of magnesium sulfate is used in each country. G The MH TRT is conducting a landscape analysis and record review of national EMLs in Africa and Asia and is identifying priority countries to undergo revisions of EMLs relative to the maternal health commodities. N Several countries, including Malawi, Sierra Leone, and Tanzania will be updating EML guidelines and treatment protocols. N DRC will also be revising guidelines on good pharmacy practice, post- market surveillance, and pharmacovigilance. Advocacy Actions Advocate with relevant decision-makers to update EMLs with oxytocin, misoprostol, and magnesium sulfate. Advocate with decision-makers to update STGs and national treatment protocols to help facilitate education and proper use of oxytocin, misoprostol, and magnesium sulfate among health care workers. Collaborate with partners to advocate for midwives, nurses, and lower-level providers to be able to provide misoprostol, oxytocin, and magnesium sulfate. 45 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 45 Spotlight on Commodities: Maternal Health Global (G) and/or National (N) Examples  Supply and awareness Global and/or National Examples G The MH TRT is developing a searchable web-based compendium of tools on quantification, forecasting, product use, demand, and quality of maternal health commodities. N Tanzania will include maternal commodities in its mHealth monitoring system. Advocacy Actions Identify circumstances where integrated procurements or supply chains were successful and develop advocacy briefs to highlight successes, generate evidence, and support scale-up. Collaborate with partners to identify supply chain weaknesses and bottlenecks and solutions that can be advocated to government officials to strengthen the supply chain. Develop lessons learned from examples of strong private-sector supply chains and share with decision-makers. Identify and promote opportunities where maternal health commodities can be integrated into the broader Health Management Information System (HMIS) or mHealth system to improve information management.  Demand and utilization Global and/or National Examples G The MH TRT is collaborating with the Recommendation 7 TRT to develop an adaptable communications strategy for magnesium sulfate as well as a combined strategy for oxytocin and misoprostol. N Tanzania will review evidence to create “demand-generation toolkits” to mobilize the private-sector system. N Malawi will assess barriers to the use of maternal health commodities and develop solutions to improve demand generation. Advocacy Actions Advocate to health officials to host/sponsor promotional and informational sessions throughout the year to improve community awareness and care-seeking behavior among pregnant women. Advocate to decision-makers for increased investment in demand generation campaigns for maternal health supplies. Develop promotional materials that can be used to share information and improve understanding of oxytocin, misoprostol, and magnesium sulfate. 46 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 46 Spotlight on Commodities: Maternal Health Global (G) and/or National (N) Examples  Reaching women and children Global and/or National Examples G The MH TRT will develop a knowledge translation methodology that will be used to increase the safe and appropriate use of oxytocin, misoprostol, and magnesium sulfate. N Senegal plans to reach more women and children by integrating oxytocin, misoprostol, and magnesium sulfate into the country’s user- fee exemption strategy. Advocacy Actions Work with government officials to identify most hard-to-reach communities (and populations) and ensure activities are prioritized in these areas. Compile evidence on task-shifting to advocate for the importance of CHWs in improving access to misoprostol; advocate for policies that improve access to maternal health commodities by enabling community-level distribution. Advocate for government officials to adapt/implement incentive schemes, conditional cash transfers, or insurance schemes to improve access to oxytocin, misoprostol, and magnesium sulfate. Advocate for incorporating/procuring innovative delivery technologies that allow lower-level workers to administer medicines. 47 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 47 Spotlight on Commodities: Maternal Health Global (G) and/or National (N) Examples  Performance and accountability Global and/or National Examples G The MH TRT will develop a monitoring and evaluation strategy for ongoing assessment of sustained guideline use at the national and local levels. G The MH TRT will assist with the development of a cross-cutting, multi-level implementation strategy for improving adherence to WHO guidelines related to maternal health commodities. N Several countries, including Sierra Leone, Tanzania, and Uganda will improve health worker performance by updating training materials and developing and disseminating job aids, checklists, and training tools. Advocacy Actions Organize meetings with government officials to determine responsibility and accountability for results and for monitoring and evaluation. Advocate for alignment between CSO/NGO indicators and government strategies, including common sets of indicators. Support citizens and communities to improve their health, and to hold local government accountable, through interpersonal communication, social media, and community outreach. Advocate for revised strategies and policies that support training of health providers. Advocate for updating job aids that incorporate revised treatment guidelines and global best practices. Collaborate with government officials to disseminate revised guidelines and performance policies to lowest-level health facilities.  Product Innovation Global and/or National Examples G The MH TRT will collaborate with the Recommendation 10 TRT to develop prototype packing for magnesium sulfate and misoprostol, and to potentially include time-temperature indicators on oxytocin vials. There will also be collaboration toward a simplified package and presentation for magnesium sulfate. N Uganda is exploring innovative ways to package misoprostol and to potentially bundle magnesium sulfate and calcium gluconate, which can be used to treat in cases of magnesium sulfate toxicity. Advocacy Actions Advocate for government officials to procure products with revised packaging and bundling. Advocate for government funding to support research and development of new product innovations that will contribute to increased access. Collaborate with research institutions and the national government to inform operations research to better understand user preferences and barriers. 48 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 48 Additional Resources: Maternal Health For more information to support advocacy efforts in your country, the following resources are available: Maternal Health Commodities Product Briefs, Reproductive Health Supplies Coalition, 2012 Maternal Health Supplies Advocacy Messages: A Roadmap for Success, PATH, 2012 National Programs for the Prevention and Management of Postpartum Hemorrhage and Pre-Eclampsia/Eclampsia: A Global Survey, MCHIP, 2012 Safeguarding Pregnant Women with Essential Medicines: A Global Agenda to Improve Quality and Access, PATH, 2012 Demand Generation for Underutilized Commodities in RMNCH, Johns Hopkins Bloomberg School of Public Health, Center for Communication Programs, 2013 49 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 49 Spotlight on Commodities: Contraceptives “We can save six million lives by focusing on low-cost but high-impact medicines. Family planning alone can reduce one-third of maternal deaths. Together with low-cost maternal medicines, most maternal deaths could be averted.” —Dr. Babatunde Osotimehin, Executive Director, UNFPA, Vice-chair of the Commodities Commission 50 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 50 Spotlight on Commodities: Contraceptives Of the 13 essential commodities identified by the Commodities Commission, three are underutilized contraceptive methods: contraceptive implants, female condoms, and emergency contraceptive pills (ECP). All three commodities are on the WHO Model List of Essential Medicines. Expanding access to contraceptive methods can have a dramatic impact on improving health and saving the lives of women and children. The benefits of contraceptive use include preventing unintended pregnancies, reducing the transmission of sexually transmitted infections [STIs] and HIV, and reducing the incidence of deaths and illnesses related to complications of pregnancy and childbirth. Approximately 200 million women in developing countries want to use contraceptives but do not have access. If this unmet need for contraception was fully satisfied, an additional 90,000 women’s lives would be saved and 590,000 newborn deaths averted each year. To realize the public health benefits of contraception, women must have access to a full range of methods and the ability to choose the method that best meets their fertility goals and circumstances over their lifespan. For example, women who would like to have no more children may desire long-acting and permanent methods (such as implants), while those who are at risk of HIV and AIDS or other STIs may want the means for prevention of both infection and pregnancy (such as female condoms). The Commodities Commission estimates that an ambitious scale-up of overlooked and underutilized contraceptive methods, such as implants, female condoms, and ECPs, could avert 230,000 women’s deaths over a five-year period. Cross-cutting challenges such as comparatively high costs, limited funding for commodities, low levels of awareness and/or misperceptions about acceptability and use by women and health providers, and supply chain management issues, including poor distribution and procurement networks and LMIS, contribute to use of these commodities remaining low as a percent of method mix worldwide. The specific uses of the individual commodities, their benefits for women’s health, and barriers to their effective use that need to be addressed are highlighted below. Information is adapted from the March 2012 Working Paper on Contraceptive Commodities for Women’s Health, prepared to inform the development of the Commodities Commission recommendations. Overview: Contraceptive Commodities 51 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 51 Spotlight on Commodities: Contraceptives What you need to know about. Barriers to Use Up-front commodity cost can be a barrier to both procurement and client access. However, recent reductions in price will allow for improved access. For example, in 2013, Implanon was reduced in price from $16.50 to $8.50. Implants are included in the WHO EML (2011); however, they are specified as a two-rod, levonorgestrel-releasing implant. One-rod implants are not included. Given the diversity in implant products, technical requirements for competent training in counseling, insertion, and removal of each product as well as related procurement processes are required. Implants are often combined in information systems and on procurement lists, leading to challenges in supply management. Benefits of Use Contraceptive implants are a highly effective and increasingly popular long-acting and reversible method of contraception. Implants provide sustained contraception for between three and five years by releasing a progestin hormone into the body. Implants are thin, flexible plastic rods about the size of a matchstick that are inserted just under the skin of a woman’s upper arm. There are four current products: Implanon: one-rod, effective for three years, $8.50 Jadelle: two-rod, labeled for five years of use, $8.50 Sino-Implant: two-rod, four-year duration of effective use, $8 Nexplanon: one-rod, provides protection for three years, $8.50, allows for x-ray detection. Implants are safe and highly effective (annual pregnancy rates are less than one percent). Compliance and continuation rates are higher than shorter-term methods. Implants require no regular action by the user or routine clinical follow-up after insertion. They are quickly reversible. The contraceptive effect of implants ends immediately after removal and fertility returns rapidly. Implants are more cost-effective in the long term than repeated use of short-acting methods. In some settings, policies allow task-shifting, which permits lower cadres of health care providers to insert and/or remove implants. Implants can be used to delay, space, or limit pregnancies and are becoming increasingly popular among women across the lifespan. Increases in procurement of implants have also been reported. In sub-Saharan Africa, for example, the number of implants procured increased from 132,000 in 2005 to 3.4 million in 2012. Jadelle and Implanon have achieved WHO- prequalified status and are registered in more than 47 and 80 countries respectively. Sino-Implant is in the process of obtaining prequalification. contraceptive implants 52 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 52 Spotlight on Commodities: Contraceptives What you need to know about. Barriers to Use While the WHO List of Essential Medicines includes condoms, it does not list male and female condoms separately, making it difficult for countries to enter female condoms in their national EMLs. Female condoms are relatively expensive to procure.  Average price is $0.55 for a female condom vs. $0.03 for a male condom. There is limited awareness among users and providers of the method. Governments often do not include the female condom in prevention or family planning programs. Efficacy depends on correct and consistent use by the end-user.  Proper insertion training must accompany product availability.   Currently there is very little private-sector involvement in the sale of female condoms at the country level, with the exception of small enterprises distributing through social marketing.3 The private-sector market is almost non-existent in sub-Saharan Africa. Benefits of Use Female condoms are the only female initiated method available now that offers dual protection from unintended pregnancy and STIs, including HIV. The female condom is a condom made of a soft, thin material that fits inside a woman’s vagina. When used consistently and correctly, female condoms are comparable in effectiveness in preventing HIV/STIs and pregnancy to male condoms. A growing body of evidence suggests that providing the female condom along with the male condom increases the number of protected sex acts.2 Female condoms do not require a prescription or clinician involvement and have no side effects. There are a select number of female condom products available on the market. Two products, the FC2 Female Condom (FC2) and the Cupid female condom have achieved WHO prequalified status. Several other female condom products are currently under review by the WHO to determine their suitability for public-sector purchase. Despite misperceptions on acceptability, studies conducted in more than 40 countries in Africa, Asia, Europe, Latin America, and North America have found strong initial acceptability of female condoms. female condoms 2 See amongst others: Koster W. and Groot Bruinderink M. (2012) Effective prevention without side effects: A study of male acceptance of female condoms in Lagos, Nigeria. 3 See amongst others: UAFC 2012 Annual Report, UAFC, August 2013, on social marketing experiences of female condoms by PSI affiliates in Nigeria and Cameroon. 53 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 53 Spotlight on Commodities: Contraceptives What you need to know about. Barriers to Use Of the 111 countries with available EMLs, only 54 countries are known to list ECPs. There is often opposition due to misconceptions about ECPs, including conflation with abortion. There are restrictions on access, often due to unnecessary prescription requirements. Forecasting in particular is difficult with little historical data. Globally, the majority of ECPs are purchased by women for their own use in the commercial sector. They are less available in the public sector. The majority of ECPs sold outside of Europe and the US is a two-pill formulation, which is not as easy to use as the one-pill formulation. Benefits of Use ECPs are a post-coital contraceptive option, allowing women to prevent pregnancy after intercourse has occurred. ECPs offer women an important second chance to prevent pregnancy when a regular method fails, no method was used, or sex was forced. ECPs can be used up to five days after unprotected sex but are generally more effective the sooner they are used. ECPs do not have any effects after fertilization. Depending on the formulation used and timing of use, ECPs can reduce a woman’s risk of becoming pregnant from a single act of intercourse between 75 and 89 percent.4 ECPs are registered and available commercially in more than 140 countries and can be imported with a special license in several other countries. They are regulated as an over-the-counter or non- prescription product in 72 countries. ECPs can safely be provided over the counter by pharmacists or pharmacy personnel with minimal or no training. Two manufacturers of ECPs (Gedeon Richter and HRA Pharma) have received stringent regulatory approval from the U.S. Food and Drug Administration (USFDA) or the European Medicines Agency (EMA). Gedeon Richter has achieved WHO prequalification status. emergency contraceptive pills 4 Reproductive Health Supplies Coalition. Emergency contra- ceptive pills. Caucus on New and Underused Reproductive Health Technologies: Product Brief. Updated May 2013. 54 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 54 Spotlight on Commodities: Contraceptives There are three TRTs developing tools and providing technical assistance for EWEC countries to increase access to each of the contraceptive priority commodities. Specifically, their objectives are to: Contraceptive Implants TRT ●● Ensure that a secure supply of affordable contraceptive implants is available to women in low- and middle-income countries. ●● Increase demand for and adoption of implants by women for whom they are the method of choice. ●● Ensure a dynamic and sustainable market for affordable, high-quality implants as part of a broad range of contraceptive choices. ●● Strengthen systems and capacity for delivering high-quality services through appropriate human resources and effective supply chains. ●● Ensure providers are trained in the safe insertion and removal of contraceptive implants. ●● Foster technical improvements to implants and related products and services. Female Condoms TRT ●● Raise awareness and demand for the female condom. ●● Increase availability and accessibility of the female condom. ●● Increase utilization of the female condom. ●● Strengthen capacity of national officers to deliver quality female condom programs. ●● Generate scientific evidence on the female condom’s effectiveness to prevent STIs and pregnancy. ●● Update existing and develop new tools and guidelines that expand accessibility and use of female condoms. Emergency Contraceptive Pills TRT ●● Expand access to ECPs, including among vulnerable groups. ●● Strengthen the capacity of providers and pharmacists to implement ECPs in select countries. ●● Strengthen public knowledge and demand for ECPs. ●● Strengthen quality assurance standards throughout the supply chain for ECPs. Illustrative examples of how the TRTs and the pathfinder countries are specifically applying the recommendations to address barriers and improve access and availability of contraceptives at the global and national levels are outlined below. These may give ideas for specific advocacy asks in your country. Other advocacy actions for contraceptives that correspond with the various recommendations are also included. Your advocacy strategy or agenda should be targeted and focused and does not need to encompass all actions. You may want to refine or include additional actions in your strategy depending on your individual country context. To read the pathfinder countries’ complete implementation plans/ proposals, visit here. For more information on activities of the Contraceptive TRTs, download the following briefs. To join a related TRT or to request tools and technical assistance, please contact the following: Contraceptive implants: Nel Druce, DFID n-druce@dfid.gov.uk Monica Kerrigan, BMGF monica.kerrigan@gatesfoundation.org John Skibiak, RHSC jskibiak@rshupplies.org Emergency contraceptive pills: Viviana Mangiaterra, WHO mangiaterrav@who.int Mario Festin, WHO festinma@who.int Elizabeth Westley, ICEC ewestley@familycareintl.org Sarah Rich, ICEC srich@familycareintl.org Female condoms: Bidia Deperthes, UNFPA deperthes@unfpa.org Saskia Husken, Rutgers WPF s.husken@rutgerswpf.nl Remember to “coordinate” and “integrate” with work being done on other priority commodities and the Commodities Commission as a whole: explore opportunities to coordinate RMNCH commodities requests with requests being made for similar issues. 55 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 55 Spotlight on Commodities: Contraceptives Global (G) and/or National (N) Examples  Shaping global markets Global and/or National Examples G Agreements on two major price reductions were achieved in early 2013: Bayer HealthCare will reduce the price of the Jadelle contraceptive implant by more than 50 percent over the next six years and Merck MSD will reduce the cost of the Implanon and Nexplanon by approximately 50 percent over the next six years. G The Female Health Company announced a pricing arrangement to reduce costs for the FC2 in the world’s poorest countries in addition to providing USD 14 million in training and education over the next six years. Advocacy Actions Advocate for advanced market commitments or pooled procurements at the regional/central level to incentivize manufacturers and drive down costs and create a more sustainable market. Work with partners and technical working groups to identify collaborative opportunities for pooled procurement, such as pooled procurement with social marketing organizations, service delivery organizations, and NGOs working with female condoms in your country.  Shaping local delivery markets Global and/or National Examples N Uganda will improve the national market for implants by building the capacity of the National Drug Authority to test the quality of implants and register additional suppliers. This is anticipated to increase the number of options nationally. Advocacy Actions Collaborate with regulatory groups and technical working groups to identify ways to incentivize local manufacturers in the country. Advocate to government decision-makers to procure contraceptive commodities from local manufacturers that are producing high-quality products. Advocate to smaller manufacturers to enhance capacity for quality assurance to enable national and local procurement organizations to purchase high-quality contraceptive commodities within countries.  Innovative financing Global and/or National Examples N Tanzania will roll out a nation-wide Pay-for-Performance program that provides bonuses to health facilities linked to the attainment of performance targets. Performance indicators on contraceptive commodities are included in order to motivate facility staff to ensure commodities are available and utilized. Advocacy Actions Identify where health budgets could/should include specific line items for contraceptive commodities. Identify opportunities with donors and the private sector for advocacy on resource mobilization; highlight need to fund innovative family- planning strategies. Map private-sector entities involved in contraception programs interested in funding commodities and share with decision-makers to promote total-market approaches. 56 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 56 Spotlight on Commodities: Contraceptives Global (G) and/or National (N) Examples  Quality strengthening Global and/or National Examples G The Recommendation 4 TRT is conducting a survey on regulatory and quality status of the 13 commodities in 25 countries in order to determine the quality problems and offer technical support in addressing these issues. N To reinforce market oversight, the DRC will develop and implement a quality assurance and control plan for RMNCH commodities, including contraception, and strengthen the capacity of the Department of Pharmaceuticals and Medicines to carry out quality audits of drug- manufacturing laboratories. Advocacy Actions Advocate with local government officials to develop incentives to encourage manufacturers to develop and carry out quality audits. Collaborate with partners to identify regulatory pathways for the improved delivery of high-quality products and advocate for investment in strengthening regulatory systems. Advocate for donors to provide technical assistance to support select local manufacturers in achieving the WHO’s prequalification status and incentives to encourage manufacturers to seek prequalification.  Regulatory efficiency Global and/or National Examples G The ECP TRT has developed fact sheets to support country-level registration of ECPs and the inclusion of ECPs in countries’ EMLs. G Universal Access to Female Condom (UAFC) is providing support to various female condom manufacturers on regulatory support, manufacturing support, and preparation of their dossier for WHO prequalification. N Senegal is expanding access to ECPs through several policy initiatives, including integration of ECPs into the MOH Norms and Standards, introduction of ECPs into family planning training, and adding ECPs to the EML. Advocacy Actions Where not already included, work with relevant decision-makers to add implants, female condoms, and ECPs to EMLs, STGs, and national protocols to help facilitate education and proper use among health care workers. Work with decision-makers to update STGs, and national treatment protocols on FP commodities to help facilitate education and proper use among health care workers. In the case of emergency contraception, ensure it is available to all women over the counter and included as part of standard post-rape care protocols. Identify circumstances where integrated procurements can increase access and develop case studies to highlight successes, generate evidence, and support scale-up. 57 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 57 Spotlight on Commodities: Contraceptives Global (G) and/or National (N) Examples  Supply and awareness Global and/or National Examples G The Contraceptive Implants TRT is developing a global forecast for implants, which will be supported by country-level forecasts and procurement data. G UAFC is providing market intelligence information on female condoms at the global level and supply chain management support to public and private sectors at national level to address female condom supply chain weaknesses. N Malawi will take steps to improve quantification—which is currently done at the national level based exclusively on products received (not on need)—by developing the capacity of district and health facility managers on quantification, procurement, and distribution planning for RMNCH commodities, including FP commodities, based on need. Advocacy Actions Collaborate with partners to identify supply chain weaknesses and bottlenecks and identify solutions that can be presented to government officials to strengthen the supply chain management of contraceptive commodities. Identify and promote opportunities where contraceptive commodities can be integrated into the broader HMIS or mHealth system to improve information management. Advocate for investment in strengthening supply chain systems to ensure consistent supply and delivery, including in rural areas. Advocate for integration of contraceptive commodities individually into the systems that track other health commodities, and relevant health outcomes to help strengthen information management. 58 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 58 Spotlight on Commodities: Contraceptives Global (G) and/or National (N) Examples  Demand and utilization Global and/or National Examples G The Recommendation 7 TRT is working with the Contraceptive Implants TRT to develop an evidence review on demand creation for implants and an adaptable communication strategy and online toolkit to guide development and implementation of demand-generation programs. G The Female Condoms TRT developed an assessment and a step- by-step guide to facilitate the introduction of new female condom products at the country level. The group is also working with Recommendation 7 to develop a Roadmap for Female Condom Demand Creation, including communication strategy guidance with adaptable examples for various target groups. N Nigeria recently launched a social marketing campaign through which female condoms are sold by trained hairdressers and other peer educators. Advocacy Actions Advocate to health officials to host/sponsor promotional and informational sessions throughout the year to improve community awareness and care-seeking behavior among women. Work with partners and officials to identify key opportunities to promote appropriate use of the contraceptive implants, the female condom, and emergency contraceptives. Identify relevant policy changes that will improve demand (and supply) and continue to hold meetings, roundtables, and other events to encourage policy change. Develop promotional materials that can be used to share information and improve understanding of contraception commodities among decision-makers. Advocate to include all contraceptive methods in training programs for health care providers to address misconceptions about the various methods. Develop public education and mass media campaigns to ensure that all women are aware of the range of contraceptive methods and to dispel myths. Ensure decision-makers invest in demand creation and information, education, and communication (IEC) over a period of time before drawing conclusions about acceptability or demand. 59 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 59 Spotlight on Commodities: Contraceptives Global (G) and/or National (N) Examples  Reaching women and children Global and/or National Examples G The Contraceptive Implants TRT has provided financial support to key social marketing organizations, enabling them to expand procurement and distribution of implants with the aim of reaching the most vulnerable women. Advocacy Actions Work with government officials to identify the most hard-to-reach communities (and populations) and ensure activities are prioritized in these areas. Advocate for government officials to adapt/implement incentive schemes, conditional cash transfers, or insurance schemes to improve access to contraception commodities. Support policies that enable implants to be offered at lower levels of the health system, including the community level. In Ethiopia, for example, Community Health Extension Workers have offered Implanon in communities and nurses and midwives are trained on removing them. Ensure those making procurement decisions are aware of the recently negotiated lower cost of implants.  Performance and accountability Global and/or National Examples G The ECP TRT has developed training materials for health care providers based on identified gaps and needs. N Sierra Leone will introduce and support the scale-up of implants at public health facilities, including community health centers, by developing and disseminating manuals, guidelines, protocols, and job aides. Advocacy Actions Support citizens and communities to improve their health, and to hold local government accountable, through interpersonal communication, social media, and community outreach. Advocate for revised strategies and policies that improve the reach of trained health providers at the community level. Advocate for improved and revised job aids that incorporate revised treatment guidelines and global best practices. Collaborate with government officials to disseminate revised guidelines and performance policies to lowest-level health facilities. Ensure implants, female condoms, and ECPs are included in in-service training and pre-service FP training. 60 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 60 Spotlight on Commodities: Contraceptives Global (G) and/or National (N) Examples  Product Innovation Global and/or National Examples G Product innovation in the case of all three priority contraceptive commodities has lowered prices, increased ease of use for women, and overall use. The three contraceptive commodity TRTs are working to ensure information on recent product innovations is shared widely. Advocacy Actions Advocate for more investment in research and development for contraceptive technologies to lead to more choices, as improved ease of use, comfort, and product price all influence use. Advocate for focus on specific product innovation. In the case of implants, for example, disposable trocars may make implant insertion more feasible in developing countries, enable a more decentralized provision of the method, and reduce the risk that improperly cleaned equipment could lead to transmission. 61 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 61 Additional Resources: Contraceptives For more information to support advocacy efforts in your country, the following resources are available: Reproductive Health Commodities Product Briefs, Reproductive Health Supplies Coalition, 2012 Reproductive Health Supplies Coalition. USAID │Health Policy Initiative, Task Order 1. 2007. Leading Voices in Securing Reproductive Health Supplies: An Advocacy Guide and Toolkit. Brussels, Belgium. Demand Generation for Underutilized Commodities in RMNCH, Johns Hopkins Bloomberg School of Public Health, Center for Communication Programs, 2013. Making female condoms available and accessible: a guide on implementing female condom programs, UAFC, 2011. K4Health Implants Toolkit, Knowlwdge4Health, 2013. International Consortium for Emergency Contraception. Make a move: advocating for the female condom. UAFC Advocacy Toolkit, UAFC, 2011. 62 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 62 Spotlight on Commodities: Newborn Health “Care for mother and baby in the first 24 hours of any child’s life is critical for the health and well-being of both. Up to half of all newborn deaths occur within the first day.” —Dr. Margaret Chan, Director-General, WHO 63 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 63 Spotlight on Commodities: Newborn Health Overview: Newborn Health Commodities 1 Save the Children. Surviving the First Day: State of the World’s Mothers 2013, May 2013. 2 http://www.everynewborn.org/ 3 The NeoNatalie Complete model (including the NeoNatalie simulator, resuscitator, and the penguin suction) costs US$70, and is intended to be re-used multiple times to resuscitate newborns. Of the 13 essential commodities identified by the Commodities Commission, four focus on the leading causes of death in the first 28 days of life: antenatal corticosteroids (ACS) for respiratory distress syndrome in preterm newborns, chlorhexidine for umbilical cord care to prevent neonatal infections, injectable antibiotics for the treatment of newborn sepsis, and newborn resuscitation devices to treat birth asphyxia. The WHO’s List of Essential Medicines includes chlorhexidine digluconate (7.1%), five forms of injectable antibiotics, and, in 2014, it is anticipated that oral amoxicillin will be included, as well as one form of antenatal corticosteroid. WHO is developing a specific Interagency List of Essential Medical Devices for Maternal and Newborn Health, which will include neonatal resuscitation devices. Ensuring that these four commodities are accessible and effectively administered to newborns in high-mortality countries could save the lives of approximately 1,770,000 newborns each year.1 Helping babies survive the first days and weeks of life represents the greatest remaining challenge in ending preventable childhood deaths.2 These four products are highly effective and affordable (for example, a dose of chlorhexidine can cost less than US$0.50 per application, and resuscitators are available for less than US$30 per device3). However, cross-cutting challenges such as regulatory hurdles, including omission from or limited inclusion on national essential medicines and devices lists, low provider and user awareness, and low training on the administration of these commodities contribute to limited and often undermined use. The specific use of the individual commodities, their benefits for newborns’ health, and the barriers that need to be addressed to optimize their impact are highlighted below. Information is adapted from a series of working papers prepared to inform the development of the Commodities Commission recommendations, including: Case Study on Injectable Antibiotics for Treatment of Newborn Sepsis; Case Study on Antenatal Corticosteroids for the reduction of deaths in preterm babies; Case Study on Chlorhexidine for Umbilical Cord Care; and Case Study on Newborn Resuscitation Devices. Information is also adapted from the Advocacy Toolkit to support the development of Every Newborn: An Action Plan to End Preventable Deaths. 64 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 64 Spotlight on Commodities: Newborn Health What you need to know about. Barriers to Use In many countries, product use for fetal lung maturation is often off-label (since fetal lung development has not been listed for ACS’s official use) and very few countries have both included ACS on their national EMLs and registered ACS for the indication of fetal lung maturation. Limited policymaker and provider awareness of ACS within low-income/high-burden settings is a key issue; ACS is often not included in standard treatment guidelines at the country level. Furthermore, uncertainty of gestational age makes it challenging for providers to know if labor is occurring preterm. Given minimal side effects, administration of dexamethasone should be encouraged among providers. Benefits of Use Antenatal corticosteroids (ACS) is the most effective intervention to prevent lung immaturity in preterm newborns—known as respiratory distress syndrome (RDS). RDS is a major complication in preterm infants and is the second leading cause of under-five mortality. The WHO recommends the use of ACS for the prevention of RDS as a priority intervention in the management of preterm labor. ACS can be administered as an intramuscular injection to pregnant women at risk of preterm delivery in order to initiate fetal lung maturation. There is a large body of evidence supporting the safety and efficacy of ACS in reducing newborn mortality when administered in a timely manner. There are no known adverse effects to newborns and no evidence of significant risk to mothers. Dexamethasone (an ACS) is listed on the WHO Priority Medicines for Mothers and Children for preterm indications. In 2013, the WHO added dexamethasone for the use of fetal lung development to the Model List of Essential Medicines. Dexamethasone is low-cost (on average $0.51 per course of treatment), stable at high temperatures, highly effective, and has many generic producers. Estimates indicate that approximately 400,000 lives could be saved each year if ACS were widely available in the countries with the highest rates of preterm birth. antenatal corticosteroids 65 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 65 Spotlight on Commodities: Newborn Health What you need to know about. Barriers to Use Many manufacturers are currently making chlorhexidine-based products (branded and generic) at concentrations from <1% to 20%. However, there are only a few manufacturers producing the 7.1% chlorhexidine digluconate for umbilical cord care. Currently, several manufacturers in sub-Saharan Africa are being evaluated as to their capability to produce high-quality 7.1% chlorhexidine digluconate. This will allow for regional chlorhexidine supplies to be established. There are significant misperceptions in many low-income/high-burden settings that WHO recommends dry cord care only, the previous standard of care. Many professional associations have long advocated for dry cord care and show some hesitancy to now promote chlorhexidine. Chlorhexidine for umbilical cord care is classified by national regulatory agencies as a medicine, adding a regulatory hurdle to overcome. In addition, chlorhexidine at the recommended concentration for umbilical cord care is a new intervention and therefore requires revision of standard treatment guidelines and use as well as inclusion in national EMLs. Benefits of Use Chlorhexidine is a widely used, low-cost medicine that is effective in preventing neonatal infection when used for umbilical cord care of newborns who are born at home in settings with high neonatal mortality. The appropriate formulation for cord care is 7.1% chlorhexidine digluconate aqueous solution or gel, delivering 4% chlorhexidine. Chlorhexidine has been in use since the 1950s and has a well-established safety record. Studies from three countries have shown that when 7.1% chlorhexidine digluconate was applied to the umbilical cord stump, it reduced neonatal mortality by 23 percent. In 2013, 7.1% chlorhexidine digluconate for umbilical cord care was added to the WHO Model List of Essential Medicines for Children and to the WHO Recommendations on Newborn Health. Chlorhexidine is readily available globally at low cost (a single-day application costs less than $0.50). Its low cost makes it an excellent candidate for public procurement in countries. Chlorhexidine has a long shelf life and requires no cold chain. It is easily administered with minimal training (including by family members). chlorhexidine for umbilical cord care 66 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 66 Spotlight on Commodities: Newborn Health What you need to know about. Barriers to Use Injectable antibiotics are frequently subject to stockouts in weaker health systems, particularly in remote areas. In Asia and sub-Saharan Africa, formulations at appropriate pediatric dosage may not be readily available from manufacturers. Manufacturers have cited insufficient demand as a reason for low supply in some cases. The supply of the injectable antibiotics for neonatal sepsis treatment in developing countries is currently being characterized. Some countries have these medicines on their national essential medicines lists, but little is known about national policies, availability, and use of these drugs at various levels of the health care system in developing countries. The relative expense of ceftriaxone may make it less affordable for public procurement. In many countries, there is a need for a community-based strategy and case management of neonatal sepsis in settings where referral is not possible. WHO is addressing this need and will issue new treatment guidelines in 2014. There are some associated risks with gentamicin related to toxicity (hearing and kidney damage). Resistance to ceftriaxone can develop rapidly. It is challenging to develop alternative delivery mechanisms for benzylpenicillin and ceftriaxone powders. They must be reconstituted with sterile water. Once reconstituted, benzylpenicillin and ceftriaxone must be refrigerated and used within a very short time. Benefits of Use Injectable antibiotics are effectively used to treat newborn sepsis. The WHO Model EML for Children includes the following injectable antibiotics for the treatment of neonatal sepsis: ampicillin, benzylpenicillin, procaine benzylpenicillin, gentamicin, and ceftriaxone. It is anticipated that the oral antibiotic amoxicillin will be added to be used in community treatment when referral is not possible. The WHO recommends ampicillin (or a comparable penicillin) and gentamicin as first-line therapy for presumptive treatment in newborns at risk of a bacterial infection. They also recommend ceftriaxone delivered alone for the treatment of neonatal sepsis as a second-line therapy. All generic injectable antibiotics are available throughout the world with manufacturers throughout Asia and South Asia, Europe, the Middle East, and North America. They do not require refrigeration when stored as dry powder. Procaine benzylpenicillin, amoxicillin, and gentamicin, relatively low-cost antibiotics, are an excellent option for public procurement. Assessments on community-based management of newborn sepsis show that CHWs are able to successfully identify, treat, and refer infants suspected of having bacterial infections. Innovations—such as inclusion of different doses of gentamicin in Uniject® prefilled injection system and early upstream development of microneedle patches—may enable ease of use and administration at the community level. injectable antibiotics 67 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 67 Spotlight on Commodities: Newborn Health What you need to know about. Barriers to Use Providers often lack pre- and/or in-service training on how to properly ventilate newborns correctly— studies have found that in some countries, only half of providers know how to properly ventilate a newborn. Furthermore, there is low exposure to asphyxia cases and inadequate use and retention of resuscitation skills by health workers in peripheral centers. There is not standardization in sizes of masks or a common nomenclature used to describe equipment, which leads to confusion by providers and facilities in procuring resuscitation equipment. Very few countries have standard policies or guidelines for procuring, repairing, replacing, and maintaining standards of quality for resuscitation equipment through the government health care system. With countries relying on international and regional procurement, delays in delivery, custom clearance, and additional tariffs and customs costs pose a challenge. Other major barriers that delay distribution include inadequate logistics coordination, planning, and budgeting. The low-level of facility births or use of skilled birth attendants impedes the use of resuscitation equipment. The use of newborn resuscitation equipment and at home and community health posts is non-existent. Price variations among seemingly similar products are enormous. While sourcing cheap products may be tempting, attention to quality is imperative. Due to the large quantity of manufacturers of these types of devices, quality failures occur relatively frequently, most commonly due to the quality of material used; mechanical failure during operation, mostly of valves; substandard finishing lacking precision (leakage of valves and fittings); or dust particles inside the device. The WHO draft Essential Medical Devices List for priority interventions for MNCH includes neonatal resuscitators (bag and mask), suction devices, and resuscitation training mannequins. However, it has yet to be published as a reference. Benefits of Use Neonatal resuscitation devices are a basic package of equipment used to treat birth asphyxia, which accounts for more than a quarter of newborn deaths. In addition, of the 1.2 million intrapartum stillbirths that occur each year, it is unknown how many of those were misclassified and would have been a live-born baby if neonatal resuscitation was provided. The basic neonatal resuscitation package includes a neonatal bag and mask, suction device, and a resuscitation training mannequin. Neonatal resuscitation with bag and mask for babies who do not breathe is considered an essential evidence-based intervention to reduce newborn mortality. With basic equipment and effective training, successful newborn resuscitation can prevent 30 percent of deaths in full-term newborns and avert five to ten percent of deaths in preterm births. Recently, affordable and high-quality devices have become available in developing countries. Helping Babies Breathe (HBB), a simplified evidence-based resuscitation training program, was launched in 2010 to address the lack of neonatal resuscitation skills in resource-limited areas. HBB has introduced neonatal resuscitation equipment in 60 countries, scaled up coverage of a high-quality resuscitation program, and increased demand for newborn resuscitation devices in many other countries. There is a large supplier base supporting this category of medical devices. Prices range depending on device and manufacturer. Laerdal Global Health has committed to providing NeoNatalie on a not-for-profit basis for developing countries through 2015. The NeoNatalie Complete model (including the NeoNatalie simulator, resuscitator, and the penguin suction) costs US$70 and is reusable. Updated international purchasing guides on sources, prices and quality on high- quality, affordable resuscitation products are available to international and national purchasing agents. newborn resuscitation devices continues on next page continues on next page 68 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 68 Spotlight on Commodities: Newborn Health What you need to know about. Barriers to Use continuedBenefits of Use continued newborn resuscitation devices With equipment and training, successful newborn resuscitation can be achieved at lower level health facilities and in communities. Reusable resuscitation devices are affordable and have excellent durability. Innovation efforts are focusing on development of device design and parts so that infrequent users at peripheral health centers will be better able to use the technology. Resuscitation equipment are more likely to be available in tertiary and district hospitals than in lower-level health facilities. Even when equipment is available in facilities, it may not be readily accessible in the delivery room. Resuscitation equipment is not systematically included in country essential device lists and is often not regulated by the country medical supplies and equipment regulatory board. 69 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 69 Spotlight on Commodities: Newborn Health To join a related TRT or to request tools and technical assistance, please contact the following: Antenatal Corticosteroid TRT: Joy Lawn, Save the Children joylawn@yahoo.co.uk Joel Segre, BMGF joel.segre@gatesfoundation.org Chlorhexidine TRT: Siobhan Brown, PATH scbrown@path.org Patricia Coffey, PATH pcoffey@path.org Injectable Antibiotics TRT: Steve Wall, Save the Children swall@savechildren.org Brendan Wackenreuter, Save the Children bwackenreuter@savechildren.org Neonatal Resuscitation Devices TRT: Donna Vivio, USAID dvivio@usaid.org There are four Technical Reference Teams (TRTs) developing tools and providing technical assistance for EWEC countries to increase access to and appropriate use of each of the newborn commodities. Specifically their objectives are to: Antenatal Corticosteroids TRT: ●● Aggregate known data and gather new data related to ACS use and bottlenecks to use. ●● Share evidence on effectiveness, coverage rates, common barriers, and their remedies with national and global audiences. ●● Systematically address barriers to ACS use at the global and national levels to measurably increase uptake, including direct technical support to pathfinder countries. Chlorhexidine TRT: ●● Increase awareness and use of 7.1% chlorhexidine digluconate for umbilical cord care as part of essential newborn care by policymakers, birth attendants, and families. ●● Establish local or regional manufacturing of 7.1% chlorhexidine digluconate in selected countries. ●● Develop and disseminate guidance and tools to strengthen planning and policy environment for the introduction of 7.1% chlorhexidine digluconate. Injectable Antibiotics TRT: ●● Understand and address the barriers that prevent the appropriate and timely use of injectable antibiotics to save newborn lives. ●● Establish objectives and implementation plans to address each of the specific barriers. ●● Inform policy dialogue (based on new research) about the appropriate antibiotics to be used at the community level, when referral to facilities is not possible. Neonatal Resuscitation Devices TRT: ●● Promote, at scale, sustainable procurement and maintenance of a functional set of high-quality resuscitation commodities in the hands of appropriate, competent, skilled health workers. ●● Ensure continued correct usage by promoting quality improvement during training, follow-up supervision, and/or mentoring of skilled health workers. ●● Monitor efforts in order to evaluate the impact and quality of neonatal resuscitation. The ANC and chlorhexidine TRTs maintain a resource section on the Healthy Newborn Network, intended to help inform and support increased implementation of antenatal corticosteroids and chlorhexidine around the world. Plans for similar sections for the other two TRTs are in progress. 70 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 70 Spotlight on Commodities: Newborn Health Illustrative examples of how the TRTs and the pathfinder countries are specifically applying the recommendations to address barriers and improve access and availability of newborn commodities at the global and national levels are outlined below. These may give ideas for specific advocacy asks in your country. Other advocacy actions for newborn commodities that correspond with the various recommendations are also included. Your advocacy strategy or agenda should be targeted and focused and does not need to encompass all actions. You may want to refine or include additional actions in your strategy depending on your individual country context. To read the pathfinder countries’ complete implementation plans/proposals, visit here. For more information on activities of the newborn health TRTs, download the following briefs. Remember to “coordinate” and “integrate” with work being done on other priority commodities and the Commodities Commission as a whole: explore opportunities to coordinate RMNCH commodities requests with requests being made for similar issues. Global (G) and/or National (N) Examples  Shaping global markets Global and/or National Examples G The Chlorhexidine TRT is working to facilitate the establishment of local and regional production of 7.1% chlorhexidine digluconate for umbilical cord care. Advocacy Actions Advocate for advanced market commitments at the regional/central levels to incentivize manufacturers, drive down cost, and create a more sustainable market. Advocate for large international procurement agencies to pool procurement for several EWEC countries in the same region.  Shaping local delivery markets Global and/or National Examples G Chlorhexidine TRT provides guidance to countries to determine the optimal product-acquisition strategies (local production versus regional, global procurement), distribution strategies, and product introduction strategies (phased versus national introduction). N Nigeria has begun the selection of local chlorhexidine manufacturers and is conducting market research and demand forecasting to aid effective introduction of the product. Advocacy Actions Advocate for the government to procure newborn health commodities from quality manufacturers. 71 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 71 Spotlight on Commodities: Newborn Health Global (G) and/or National (N) Examples  Innovative financing Global and/or National Examples N To ensure equitable access by the poorest Ugandans, ACS will be integrated into existing financial protection mechanisms, for example the Government’s reproductive health voucher system. Advocacy Actions Advocate for child health budgets to include specific line items for commodities (newborn and child health) that reflect the data on demand and use. Advocate for results-based financing of newborn health commodities to reward private and public providers through financial and non-financial incentives when they improve outcomes associated with use of these commodities.  Quality strengthening Global and/or National Examples G The Chlorhexidine TRT will develop a manufacturing guide and monograph/quality standards for quality 7.1% chlorhexidine digluconate production. N Senegal will evaluate the potential for local production of key commodities to stimulate and incentivize private-sector involvement in the plan. Advocacy Actions Advocate for provision of technical assistance to support select local or regional manufacturers in producing high-quality product and implement incentives to encourage manufacturers to seek prequalification. 72 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 72 Spotlight on Commodities: Newborn Health Global (G) and/or National (N) Examples  Regulatory Efficiency Global and/or National Examples G The ACS and Chlorhexidine TRTs have spearheaded efforts to include two newborn health commodities on the WHO EML: dexamethasone (an ACS) for accelerating lung maturity in preterm babies and 7.1% chlorhexidine digluconate for umbilical cord care. The inclusion of these commodities on the global list will facilitate incorporation at the country level. G The Neonatal Resuscitation Devices TRT worked with the WHO Medical Devices group to decide on specifications for quality devices. N In Uganda, there is a plan to add an addendum on EML and treatment guidelines to include injectable antibiotics (gentamicin and ceftriaxone) for neonatal sepsis management (in appropriate packaging and strengths with accompanying supplies) at all health-facility levels as appropriate. Advocacy Actions Where not already included, the four newborn health commodities should be added to national EMLs, and develop standard treatment guidelines and national protocols to help facilitate education and proper use among health care workers. Advocate for regulations to support approval and proper use of injectable antibiotics by midwives, nurses, and lower-level providers outside of the hospital setting. Advocate to the government to improve access to chlorhexidine and neonatal resuscitation devices for women who give birth at home by setting regulatory policies that allow the administration of these commodities by trained CHWs.  Supply and awareness Global and/or National Examples G The Neonatal Resuscitation Devices TRT will develop an mHealth application to help countries track supplies, quality of care, and monitoring and evaluation of this commodity. N Malawi is working to strengthen district-level quantification, procurement, and distribution planning of ACS. Because the majority of women in Malawi deliver in a health facility, improving the availability of ACS is expected to create an opportunity to shift practice on the prevention and treatment of preterm labor across the entire country quickly. Advocacy Actions Advocate the government for investments to strengthen supply chain systems to ensure consistent supply and delivery from the manufacturer to pharmacies and facilities. Advocate for integration of newborn health commodity information into trainings on maternal health and maternal health commodities to ensure all skilled birth attendants are aware and properly trained on the use of newborn commodities. Advocate for investments in and the use of technologies to help track and evaluate the impact of newborn health commodities. Advocate to integrate newborn health commodities monitoring into the systems that track other health commodities and relevant health outcomes to help strengthen information management. 73 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 73 Spotlight on Commodities: Newborn Health Global (G) and/or National (N) Examples  Demand and utilization Global and/or National Examples G The ACS TRT hosted consultations at two global conferences in 2013, which resulted in a platform for action to increase the use of ACS including 1) a focus on expanding access to dexamethasone; 2) a focus on facility use; and 3) adopting a lower threshold for administration, which means that the benefits of treatment outweigh the risks (which are minimal), so health workers should administer ACS where there is an imminent risk of preterm delivery. N Ethiopia launched a community-based newborn care program, which includes all four newborn health commodities, with a key focus on prevention and treatment of neonatal sepsis. Advocacy Actions Advocate to decision-makers for increased investment in demand- generation campaigns for newborn health supplies In countries where there are practices of improper cord care, advocate to health officials to host/sponsor events on proper umbilical cord care and the use of chlorhexidine with women’s groups, media, and community members. Identify relevant policy changes that will improve demand (and supply) and continue to hold meetings, roundtables, and other events to encourage policy change. Develop advocacy materials that can be used to share information about newborn mortality and the role that commodities can have in improving outcomes with decision-makers.  Reaching women and children Global and/or National Examples N The DRC will pilot two programs addressing the financial barriers related to the accessibility of the commodities: 1) a “family kit” with basic supplies and a subsidy coupon for health services at both the community and health-facility levels; and 2) third-party health access coupons for use at health facilities. Advocacy Actions Advocate for increased access to services and commodities through incentive schemes, conditional cash transfers, or insurance schemes that would promote antenatal care, facility births, and skilled births that would promote the use of commodities. Advocate for policies that improve access to newborn health commodities by enabling community-level distribution when facility births are not possible, and ensure all CHWs are trained on neonatal resuscitation. Provide all expectant parents with chlorhexidine and information on proper use free of charge. Advocate to eliminate user fees for antenatal care to help identify women who are at risk for preterm birth and need to access ACS. 74 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 74 Spotlight on Commodities: Newborn Health Global (G) and/or National (N) Examples  Performance and accountability Global and/or National Examples G The Injectable Antibiotics TRT will convene a consultation of global- and national-level policymakers to develop guidelines for service providers on the selection, administration, and monitoring of first-line injectable antibiotics in the treatment and management of newborn sepsis. It will develop a toolkit to help countries to bring guidelines forward, which will include job aids, training materials, and equipment specifications and quantification. N Tanzania will develop job aids on the use of ACS to support training for health care workers on improving preterm survival. Advocacy Actions Advocate for improved and revised job aids that incorporate revised treatment guidelines and global best practices; collaborate with government officials to disseminate revised guidelines and performance policies to lowest-level health facilities. Advocate with national bodies that accredit schools of nursing, midwifery, and medicine to ensure comprehensive training on newborn health and the use of newborn commodities as part of the curriculum to promote competency on identifying preterm labor, signs of sepsis, and how to resuscitate newborn babies. Hold working group meetings with government officials to determine responsibility and accountability for results and for M&E. Advocate for better vital registries and data on causes of neonatal mortality to show the need to access quality newborn health commodities.  Product innovation Global and/or National Examples G Innovations are being explored for resuscitation and injectible antibiotics: a simplified upright resuscitator and simplified delivery options of injectable antibiotics. Advocacy Actions Advocate with research institutions and the national government to conduct operations research to better understand user preferences (and barriers). Advocate for investment in research and development of innovations that increase ease of use and expand access at lower levels of the health system. Advocate to the government for the uptake of innovations around mobile technologies that help with administration and delivery of commodities. 75 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 75 Additional Resources: Newborn Health For more information to support advocacy efforts in your country, the following resources are available: Every Newborn Toolkit, the Partnership for Maternal, Newborn and Child Health, 2013. Healthy Newborn Network: Addressing Critical Knowledge Gaps in Newborn Health. A decade of change for newborn survival, policy and programmes (2000–2010): A multi-country evaluation of progress towards scale. Health Policy and Planning. Guest Editors: Joy E Lawn, Mary V Kinney and Anne Pfitzer, with Gary L Darmstadt and David A Oot. The Lancet: Series on Stillbirth, 2011. Surviving the First Day: State of the World’s Mothers. May, 2013. Save the Children. March of Dimes, PMNCH, Save the Children, WHO. Born Too Soon: The Global Action Report on Preterm Birth. Eds CP Howson, MV Kinney, JE Lawn. World Health. Demand Generation for Underutilized Commodities in RMNCH, Johns Hopkins Bloomberg School of Public Health, Center for Communication Programs, 2013. 76 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 76 Spotlight on Commodities: Child Health “Our shared promise to give every child the best possible start in life must remain the rallying cry of every society, every government, every community, and every family.for every child.” —Anthony Lake, UNICEF Executive Director 77 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 77 Spotlight on Commodities: Child Health Overview: Child Health Commodities Three of the 13 essential commodities identified by the Commodities Commission address the two leading causes of child mortality: oral rehydration salts (ORS) and zinc for diarrhoea, and amoxicillin for pneumonia. All three commodities are on the WHO’s Model List of Essential Medicines. While amoxicillin is listed for other bacterial infections, it is not specifically indicated to treat pneumonia. An update is anticipated in 2014. Overall, the world has made significant progress on reducing the rate of childhood mortality; under-five deaths have decreased from 12.6 million in 1990 to 6.6 million in 2012. However, an unacceptably high number of children continue to die each year from pneumonia and diarrhoea – diseases that are completely preventable and treatable. Of the 6.6 million children who died before age five in 2012, 1.1 million (17 percent) died from pneumonia and 600,000 (9 percent) from diarrhoea.1 ORS, zinc, and amoxicillin are highly effective and proven to save children’s lives. If children under age five in the poorest countries all had access to these commodities, almost two million children could survive episodes of diarrhoea and pneumonia. ORS, zinc, and amoxicillin are inexpensive. However, cross- cutting challenges such as limited availability, access, and demand generation in remote locations, weak supply chains, and a lack of integrated programming and services minimize their impact. Globally, only 31 percent of children with suspected pneumonia receive antibiotics; just 35 percent of children with diarrhoea receive ORS and fewer than 5 percent receive zinc.2 Targeted efforts to reach children at greatest risk and in remote locations with ORS, zinc, and amoxicillin will serve to significantly reduce the number of children dying from pneumonia and diarrhoea. Ensuring that these commodities are effectively accessible to all children could dramatically accelerate progress toward reducing preventable child deaths. The specific uses of the individual commodities, their benefits for children’s health, and barriers to their effective use that need to be addressed are highlighted below. Information is adapted from Product Profiles prepared to inform the development of the Commodities Commission recommendations. Information is also adapted from the Global Action Plan for the Prevention and Control of Pneumonia and Diarrhoea (GAPPD), published in April 2013 by WHO and UNICEF, which outlines a comprehensive integrated framework for key interventions, including ORS, zinc, and amoxicillin, to effectively prevent and treat pneumonia and diarrhoea. 1 UNICEF, WHO, The World Bank and the United Nations. Levels & Trends in Child Mortality: Report 2013. 2 UNICEF. Pneumonia and Diarrhoea: tackling the deadliest diseases for the world’s poorest children. 2012. 78 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 78 Spotlight on Commodities: Child Health What you need to know about. oral rehydration salts Barriers to Use Caregiver demand for and use of ORS is low as misperceptions about its benefits are high. (Caregivers expect it to treat the diarrhoea, rather than preventing the deadly dehydration associated with diarrhoea). As a result, many caregivers and health care providers prefer suboptimal (even harmful) products for diarrhoea such as antibiotics and anti-diarrhoeal medicines. Suppliers typically do not invest in marketing, promotion, and distribution of the product, which leads to limited access to ORS for the poorest and most remote populations of children. Some countries have been slow to disseminate diarrhoea treatment policy and translate them into training modules and job aids resulting in delayed uptake of ORS among health providers. ORS and zinc should be packaged together as they should be taken together for optimal care. Dual packaging faces unnecessary regulatory hurdles, particularly in the public sector. Benefits of Use ORS is a sodium and glucose solution (typically in powder form) widely used to prevent dehydration in children with acute diarrhoea. The WHO approved formula prevents deadly dehydration and can reduce the need for costly intravenous fluids and hospitalization by 33 percent. When combined with zinc, ORS is recommended by UNICEF and WHO as first line treatment for children with acute diarrhoea.3 ORS is included on the majority of national EMLs, and is available over-the-counter in most high-burden countries. It is manufactured globally, is low cost, and can safely be distributed by CHWS, as well as caregivers in the home. If scaled up to 100 percent coverage, ORS can reduce diarrhoea mortality by 93 percent.4 3 WHO/UNICEF Joint Statement: Clinical Management of Acute Diarrhoea. 2004 4 Munos MK, Fischer Walker CL and Black RE. The effect of oral rehydration solution and recommended home fluids on diarrhea mortality. International Journal of Epidemiology 2010;39:i75–i87 79 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 79 Spotlight on Commodities: Child Health What you need to know about. Barriers to Use Uptake of zinc has been relatively slow as there are many misperceptions about its benefits for treating diarrhoea, and zinc remains difficult to access in many countries. Many countries have placed zinc on a prescription list of treatments, thus unnecessarily limiting its availability over- the-counter and keeping it out of community health worker baskets and limiting use in the private sector. There are no WHO prequalified manufacturers of zinc, limiting quality supply for both international and national markets. Consensus on a broadly endorsed quality standard is needed. There is limited awareness among service providers about the value and benefits of zinc, and extremely limited awareness or demand from consumers which impacts procurement practices and use. Benefits of Use Supplementary zinc is a vital micronutrient that helps the body to absorb water and electrolytes to prevent dehydration and death in a child with diarrhoea.5 UNICEF and WHO recommend zinc as a complementary treatment to ORS for first line treatment of acute diarrhoea. Zinc reduces duration and severity of a diarrhoeal episode,6 and prevents subsequent infections in the two to three months following treatment. 7 Zinc sulfate tablets are easily dispersible in liquid (clean water or breast milk) and can be administered to children with a spoon. Diarrhoea mortality is reduced by 23 percent when zinc tablets are administered.8 zinc 5 WHO: http://www.who.int/elena/titles/bbc/zinc_diarrhoea/en/ 6 Bahl, R., et al., ‘Effect of zinc supplementation on clinical course of acute diarrhoea‘ – Report of a Meeting, New Delhi, 7-8 May 2001. Journal of Health, Population and Nutrition, vol. 19, no. 4, December 2001, pp. 338-346. 7 Bhutta Z.A., Black, R.E., Brown K. H., et al., ‘Prevention of diarrhoea and pneumonia by zinc supplementation in children in developing countries: Pooled analysis of randomized controlled trials’, Zinc Investigators’ Collaborative Group, Journal of Paediatrics, vol. 135, no.6, December 1999, pp. 689-697 8 Fischer Walker CL and Black RE. Zinc for the treatment of diarrhoea: effect on diarrhoea morbidity, mortality and incidence of future episodes. International Journal of Epidemiology 2010;39:i63–i69 80 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 80 Spotlight on Commodities: Child Health What you need to know about. Barriers to Use Care seeking for pneumonia is extremely low; globally, only 54 percent of children with suspected pneumonia are taken to an appropriate provider. Policy and regulatory restrictions inhibit access to amoxicillin in many countries as EMLs are not updated with amoxicillin as first-line treatment and list less effective alternative antibiotics. In many countries, there is a lack of appropriate policies and treatment guidelines to enable CHWs and lower-level providers to diagnose and treat pneumonia. Other antibiotics are often used to treat pneumonia; in many countries EMLs have not been updated to denote amoxicillin as first line treatment. The market for dispersible tablets is limited due to preference and familiarity with suspensions and capsules. Poor packaging and quality issues are a concern, especially when combined with hindrances from supply chain logistics. Benefits of Use Amoxicillin is an effective and widely- available antibiotic, and can prevent the majority of pneumonia deaths. WHO has gathered evidence on amoxicillin as first line treatment, and is updating official treatment guidelines to include amoxicillin dispersible tablets as first line treatment for pneumonia for children under age five.9 Simple to use—dispersible tablets easily dissolve in water—and low cost, amoxicillin, when provided with appropriate case management, can reduce deaths from pneumonia by 70 percent.10 amoxicillin 9 New WHO recommendations for childhood pneumonia anticipated early 2014. 10 Theodoratou E, Al-Jilaihawi S, Woodward F, et al. The effect of case management on childhood pneumonia mortality in developing countries. International Journal of Epidemiology 2010; 39:i155-i171 81 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 81 Spotlight on Commodities: Child Health To join the DPWG or to request tools and technical assistance, please contact: Nancy Goh CHAI Ngoh@clintonhealthaccess.org Mark Young UNICEF myoung@unicef.org Remember to “coordinate” and “integrate” with work being done on other priority commodities and the Commodities Commission as a whole: explore opportunities to coordinate RMNCH commodities requests with requests being made for similar issues. The Child Health Technical Reference Team The ORS, zinc, and amoxicillin TRTs have joined together into one child health TRT, under the auspices of the Diarrhoea and Pneumonia Working Group (DPWG), to provide technical assistance, resource mobilization, and monitoring and evaluation support to organizations and governments to improve access to the three commodities. Specifically, the group is working to support financing and implementation of national scale-up plans for child essential medicines in ten high burden countries, which were developed by country governments and partners and supported by the DPWG in 2012. The DPWG will work to: ●● Ensure wide availability of high-quality, affordable treatments in both the public and private sectors; ●● Secure a conducive and supportive policy and regulatory environment for treatment; ●● Ensure harmonization of efforts across partners to maximize impact of individual investments; ●● Generate demand for ORS, zinc, amoxicillin, and teaching caregivers when and where to seek treatment; and ●● Improve knowledge and skills of health providers to promote and deliver appropriate treatment and care. Illustrative examples of how the DPWG, additional TRTs, and the pathfinder countries are specifically applying the recommendations to address barriers to effective use and improve access and availability to high quality commodities at the global and national level are outlined below. These may provide ideas for specific advocacy asks that could be relevant in your country. Other advocacy actions for child health commodities that correspond with these various recommendations are also included. Your advocacy strategy or agenda should be targeted and focused and does not need to encompass all actions. You may want to refine or include additional actions in your strategy, depending on the individual country context. To read the pathfinder countries’ complete implementation plans/proposals, visit here. For more information on the related activities of the DPWG, download the following briefs. 82 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 82 Spotlight on Commodities: Child Health Global (G) and/or National (N) Examples  Shaping global markets Global and/or National Examples G The DPWG is engaging with manufacturers to increase the supply of amoxicillin dispersible tablets. Additionally, it established and launched an external review panel process to facilitate registration and developed a preliminary demand forecast. Advocacy Actions Advocate for advanced market commitments or pooled procurements to incentivize manufacturers, drive down costs, and create a more sustainable market for ORS, zinc, and amoxicillin. Request that international agencies and governments within the same region secure pooled procurement agreements for several countries and commodities at once.  Shaping local delivery markets Global and/or National Examples G The Recommendation 2 TRT will develop a toolkit and market- shaping guidance for countries based on data and experience from four African nations. G The DPWG is working to increase the availability of high-quality ORS, zinc, and amoxicillin. N Partners in Uganda and Nigeria are engaging local manufacturers to increase production and reduce prices of ORS and zinc. N In Senegal, the government will evaluate the potential for local production of amoxicillin dispersible tablets. Advocacy Actions Advocate for clear financing sources and procurement mechanisms for ORS, zinc, and amoxicillin. Advocate for government decision-makers to procure child health commodities from local manufacturers that are producing high-quality products. Advocate for elimination (or reduction) of import duties and taxes that contribute to elevated commodity prices when local production is not available. Request that government prioritize central funding for essential child health commodities. Conduct outreach to the private sector to improve understanding of market for high quality child health commodities. 83 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 83 Spotlight on Commodities: Child Health Global (G) and/or National (N) Examples  Innovative financing Global and/or National Examples N Nigeria is piloting performance-based financing in three states, enabling health facilities to purchase their own commodities from prequalified wholesale pharmacies in order to increase access to key commodities. N Malawi will establish a “ring fencing mechanism” that will improve financing for lifesaving commodities – ORS, zinc, and amoxicillin dispersible tablets included. Advocacy Actions Advocate for results-based financing of child health commodities that rewards providers when they meet performance standards for ORS, zinc, and amoxicillin. Identify opportunities with donors and the private sector for advocacy on resource mobilization and the need to fund integrated child health interventions. Advocate with governments to update national budgets and policies to include integrated child health programs, with emphasis on diarrhoea and pneumonia.  Quality strengthening Global and/or National Examples G The Recommendation 4 TRT will provide technical assistance for regulatory and quality improvement activities. Plans are also in place to support the implementation of new guidelines, EMLs, and rational use of medicine frameworks. N DRC will train inspectors for drug-quality audits to improve quality control. N Several countries, including Nigeria, Senegal, and Uganda will improve post-market surveillance capacity to ensure continued safety and quality control. Advocacy Actions Advocate for focused technical assistance to local manufacturers to achieve appropriate quality standards, as determined by WHO, for zinc and ORS. Work with government officials to incentivize manufacturers to seek appropriate quality standards, as determined by WHO, for child health commodities, especially zinc. Collaborate with partners to identify regulatory pathways that can be improved to more fluidly deliver high-quality products and advocate to decision-makers for investment in strengthening of regulatory systems. 84 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 84 Spotlight on Commodities: Child Health Global (G) and/or National (N) Examples  Regulatory efficiency Global and/or National Examples G The Recommendation 5 TRT will work with countries to consolidate policies around an appropriate treatment product to reduce fragmentation in the market. The TRT will also work with WHO, UNICEF, and UNFPA for an abbreviated regulatory process for certain pediatric health commodities. N In Sierra Leone, government officials will provide technical support to the Pharmacy and Poisons Board to strengthen the Board’s regulatory role in country. N Senegal officials will ensure child health products are registered and procured. N Several countries, including Malawi, Nigeria, and Tanzania will update EML guidelines and treatment protocols. Advocacy Actions Advocate that treatment policies and EMLs include ORS and zinc as first line diarrhoea treatment and amoxicillin dispersible tablets as first line pneumonia treatment. Where zinc is still restricted, advocate for zinc to be deregulated and made available over-the-counter. Hold meetings with relevant local government officials to advocate for regulatory policies and guidelines to be implemented at a sub-national level. Advocate for policy change that allows trained health workers at the community level to be stocked with and distribute ORS, zinc, and amoxicillin dispersible tablets. 85 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 85 Spotlight on Commodities: Child Health Global (G) and/or National (N) Examples  Supply and awareness Global and/or National Examples G Recommendation 6 TRT conveners will document and disseminate good public-private partnership practices on health supply chain management. G Recommendation 6 TRT conveners will develop a quantification guide to assist country program managers to estimate needs for essential commodities. N DRC will include child health lifesaving commodities in subsidized maternal and child health kits. N Nigeria is working to improve commodity quantification – including ORS, zinc, and amoxicillin – across states. N Tanzania and Uganda will focus on supply chain strengthening by improving mHealth applications for commodity tracking and monitoring. Advocacy Actions Collaborate with partners to identify supply chain weaknesses and bottlenecks and corresponding solutions that can be advocated to government officials to strengthen the supply chain. Advocate for child health commodities to be integrated into existing programs, platforms, and service delivery mechanisms for child health. Identify examples of strong private-sector supply chains and share with decision makers as examples of potential improvements. Identify and promote opportunities where child health commodities can be integrated into the broader LMIS or mHealth system to improve information management. Hold meetings with government officials on national health plans to ensure equity and prioritization of supply chain distribution to hardest- to-reach communities. 86 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 86 Spotlight on Commodities: Child Health Global (G) and/or National (N) Examples  Demand and utilization Global and/or National Examples G The DPWG will develop guidance and tools to inform the design and implementation of effective demand-generation programs at scale. G The Recommendation 7 TRT can provide targeted technical assistance, including capacity strengthening to measure and use data for improved demand generation programs. G The Recommendation 7 TRT, in collaboration with the DPWG, has developed an evidence review for demand and utilization of ORS/zinc and amoxicillin. N In Nigeria, the government will increase demand for child health commodities through awareness campaigns, national advocacy meetings, and community activation forums. N Officials in Senegal plan to improve demand by implementing social marketing programs and community training programs for lifesaving commodities, including ORS, zinc, and amoxicillin. Advocacy Actions Advocate for child health commodities to be included in training programs for health care workers, including those working at the community level. Work with partners to develop and implement strategies using high-impact channels (mass media campaigns, mid media, social mobilization) to ensure caregivers are aware of diarrhoea and pneumonia symptoms and know where to seek care when a child is ill. Develop promotional materials that can be used to share information and improve understanding of ORS, zinc, and amoxicillin among decision-makers, health professionals and caregivers. Advocate to decision-makers for increased investment in demand generation campaigns for child health supplies. Identify relevant policy changes that will improve demand (and supply) and continue to hold meetings to encourage policy change. 87 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 87 Spotlight on Commodities: Child Health Global (G) and/or National (N) Examples  Reaching women and children Global and/or National Examples N Ethiopia will integrate community management of child and newborn illnesses to expand access to comprehensive care. N Senegal will reach more children by integrating ORS, zinc, and amoxicillin into the country’s user-fee exemption strategy. Advocacy Actions Work with partners to identify areas of low coverage and inequitable access to care and advocate for government activities to prioritize these areas. Advocate for policies that improve equitable access to child health commodities by enabling community-level distribution. Compile evidence and develop case studies on task-shifting to show the importance of CHWs in improving access to ORS, zinc, and amoxicillin. Advocate for government officials to adapt/implement incentive schemes, conditional cash transfers, or insurance schemes to improve access to ORS, zinc, and amoxicillin. 88 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 88 Spotlight on Commodities: Child Health Global (G) and/or National (N) Examples  Performance and accountability Global and/or National Examples G The Recommendation 9 TRT will develop generic checklists and job aids to improve the performance of health workers and support task- shifting to increase the use and scale-up of lifesaving commodities, including ORS, zinc, and amoxicillin. G The DPWG has developed a core set of indicators for measuring progress on diarrhoea and pneumonia treatment scale-up. G The DPWG is developing easy-to-use adaptable resources for health care providers (physicians, pharmacists, etc.) for ORS/zinc and amoxicillin, which will be free to download on a new website. N Sierra Leone will update training materials and job aids while expanding the national community health worker program with integrated community case management. N Tanzania plans to improve health worker performance by establishing a supervisory and mentorship program. N Nigeria will develop a policy and legal framework to help expand access of amoxicillin through appropriate primary providers at community level. Advocacy Actions Organize meetings with government officials to determine responsibility and accountability for results and for monitoring and evaluation of child health programs. Advocate for alignment between CSO/NGO indicators and government strategies, including common sets of indicators. Support citizens and communities to improve their health, and to hold local government accountable, through interpersonal communication, social media, and community outreach. Advocate for revised strategies and policies that improve capacity of community health worker cadres trained in integrated case management. Advocate for revised job aids that incorporate integrated management of childhood illness algorithms. Collaborate with government officials to disseminate revised guidelines and performance policies to lowest-level health facilities. Advocate with government officials to strengthen collaboration between all levels of health care, from hospitals to community health care workers. 89 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 89 Spotlight on Commodities: Child Health Global (G) and/or National (N) Examples  Product Innovation Global and/or National Examples G The DPWG is working to create appropriate packaging and various options for dispensing amoxicillin dispersible tablets, and to improve diagnostics and prognostics for childhood pneumonia. N Senegal is exploring innovative ways to co-package ORS and zinc together for comprehensive diarrhoea treatment. Advocacy Actions Advocate for ministry officials and regulatory boards to expedite approval of co-packaged ORS and zinc to be made available over-the- counter. Advocate for governments to procure products with revised packaging and bundling. Advocate for government and global funding to support research and development of new product innovations. Encourage research institutions to carry out operations research that supports innovative packaging and service delivery. Encourage partners to develop user-friendly packaging that gives clear directions on dosage and adherence of ORS, zinc, and amoxicillin dispersible tablets. 90 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 90 Additional Resources: Child Health For more information to support advocacy efforts in your country, the following resources are available: The Global Action Plan for the Prevention and Control of Pneumonia and Diarrhoea, WHO and UNICEF, 2009. Global Action Plan for the Prevention and Control of Pneumonia and Diarrhoea Advocacy Toolkit, PATH and World Vision International, 2012. Zinc + ORS Campaign: Healthcare Professional Resources. Demand Generation for Underutilized Commodities in RMNCH, Johns Hopkins Bloomberg School of Public Health, Center for Communication Programs, 2013. 91 Scaling Up Lifesaving Commodities for Women, Children, and Newborns 91 Spotlight on Commodities: Please help to improve Scaling Up Lifesaving Commodities for Women, Children, and Newborns: An Advocacy Toolkit by taking this short survey. Your feedback on your experience using the toolkit is incredibly valuable. Thank you.

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