NIGERIA BEST PRACTICE PNEUMONIA DEMONSTRATION PROJECTS DRAFT PROPOSAL OF THE PNEUMONIA AND DIARRHEA WORKING GROUP1 in support of THE SAVING ONE MILLION LIVES INITATIVE THE UNITED NATIONS COMMISSION ON LIFE-SAVING COMMODITIES FOR WOMEN AND CHILDREN THE INTEGRATED GLOBAL ACTION PLAN FOR PNEUMONIA AND DIARRHOEA April, 2013 THE CHALLENGE In 2011, 756,000 children in Nigeria did not reach their 5th birthdays putting Nigeria at #2 on the list of countries with the highest burdens of child mortality. Pneumonia caused approximately 130,000 (17%) of these deaths and an estimated 13 million episodes of sickness every year at an enormous cost to children and families2. While it is true that the majority of of under-five in Nigeria child pneumonia deaths can beCauses prevented with costmortality effective vaccines and low cost antibiotics, Meningitis the majority of children in NigeriaMeasles do not receive either. 3% causes of pneumonia – the HIV/AIDS1% Hib and pneumococcal 4% The vaccines that prevent the leading vaccines – are not yet available to all Nigerian children but are in the process of being introduced in select states, and currently just 23% of all Pneumonia Other Injuries children with suspected pneumonia are treated 17% with antibiotics. 3% 15% In addition, Nigeria’s relatively low rates of exclusive breastfeeding (13%), access Diarrhea to improved sanitation (31%) and high rate of 12% undernutrition (41% of sepsis children are stunted) are all factors contributing to the large number of Neonatal 6% 3 child pneumonia deaths. With concerted and coordinated action on these fronts most of the Congenital 130,000 child pneumonia anomalies deaths could be 1% Prematurity Millennium Development Goal 4 (MDG4).4 Birth asphyxia 10% 8% 1 Malaria averted 20% taking Nigeria one big step closer to achieving The Pneumonia and Diarrhea Working Group is chaired by UNICEF and the Clinton Health Access Initiative to support the ten countries with the highest burdens of child mortality to implement Essential Medicines Scale-Up Plans to increase access to pneumonia, diarrhea and malaria treatment. The Projects are consistent with the Declaration on Scaling Up Treatment of Diarrhea and Pneumonia in the Highest Burden Countries endorsed by the Child Survival, Call to Action in June 2012, the recommendations of the UN Commission on Life Saving Commodities for Women and Children and the Integrated Global Action Plan for Pneumonia and Diarrhoea, released by WHO/UNICEF in April 2013, and are in support of the United Nations Secretary-General’s, Every Woman, Every Child movement 2 See Committing to Child Survival: A Promise Renewed. Progress Report, 2012, UNICEF 3 See Pneumonia and Diarrhea. Tackling the Deadliest Diseases for the World’s Poorest Children, 2012, UNICEF 4 MDG4 requires a two-thirds reduction in the 1990 Child Mortality Rate by 2015 1 Source: Countdown to 2015: Maternal, Newborn and Child Survival. Nigeria: The 2012 Report. THE OPPORTUNITY To accelerate progress to MDG4 in the three years remaining to 2015, the Government of Nigeria is driving progress on both the prevention and treatment sides of the pneumonia challenge. The Hib vaccine (one of the five vaccines included in the Pentavalent vaccine) is in the process of being introduced in select Nigeria States and the pneumococcal vaccine is scheduled for introduction in 2013 in three phases. 5 On the pneumonia treatment side, the Ministry of Health’s National Primary Health Care Development Agency (NPHCDA) has prepared and endorsed an Essential Medicines Scale-Up Plan which outlines the actions needed to dramatically increase the numbers of children with suspected pneumonia who are treated with antibiotics to 80% by 2015, in the context of expanding integrated Community Case Management. Key elements of the Plan include: PRIORITY ACTIONS TO SCALE-UP ACCESS TO PNEUMONIA TREATMENT IN NIGERIA 1) Educating Families & 2) Supporting Private Sector 3) Supporting Public Sector Caregivers Provision Provision -Teach families and caregivers -Train private health providers -Train and equip Community about pneumonia, the particularly Proprietary Health Extension Workers seriousness of the infection, Patent Medicine Vendors (CHEWs) to diagnose and 5 Phase 1 vaccine introduction in Kebbi, Kaduna, Bauchi, Taraba, FCT, Kwara, Kogi, Edo, Ekiti, Rivers, Lagos, Anambra and Enugu; phase 2 in Kano, Jigawa, Gombe, Adamawa, Plateau, Benue, Osun, Ondo, Cross River, Ebony, Imo, Akwa-Ibom, Ekiti and Lagos and phase 3 in remaining states. 2 and how to recognize the (PPMVs) to better manage treat pneumonia with danger signs (fast breathing childhood pneumonia (40% of amoxicillin dispersible tablets and chest “indrawing”) sick children are treated in -Improve forecasting, the private sector) procurement and distribution care outside the home from -Increase the supply and of quality, affordable amoxicillin qualified health providers affordability of amoxicillin dispersible tablets in the public quickly (currently 30% of dispersible tablets sector (75% of Public Health children with pneumonia are -Increase the relative Centers report antibiotic treated at home) affordability of amoxicillin stockouts) -Educate families about dispersible tablets compared -Train and equip hospital and amoxicillin dispersible tablets, to other antibiotics (e.g. facility staff to treat severe how they work and the cotrimoxazole) and common pneumonia with recommended importance of completing a pneumonia treatments antibiotics and oxygen where -Encourage families to seek full course of treatment necessary -Introduce behavior change -Upgrade hospitals and facilities campaigns targeted to the to treat severe pneumonia and most vulnerable families and increase access to pulse to the health providers who oximeters and oxygen treat the majority of concentrators pneumonia cases -Support programs that empower mothers to improve the health of their children 4) Diagnostics 5) Local Manufacturing 6) Regulatory & Policy Changes -Increase use of easy-to-use, -Work with pharmaceutical -Allow CHEWs to dispense effective respiratory rate companies to increase local amoxicillin dispersible tablets counters in public and private manufacturing, marketing and -Disseminate pneumonia sectors distribution of quality, policies, standards and -Increase use of pulse affordable amoxicillin treatment guidelines oximetry in facilities and dispersible tablets throughout the public and access to oxygen -Offer fast track registration private sectors -Train and equip public and for locally manufactured -List amoxicillin dispersible private health outlets to amoxicillin dispersible tablets tablets on all Essential administer Rapid Diagnostic that meet quality and price Medicines and Drug Lists Tests (RDTs) for malaria targets -Better monitor the quality of (currently tests are only -Offer “umbrella brand antibiotics being used to treat available in fewer than 30% endorsement” for locally child pneumonia of health facilities) manufactured amoxicillin -Explore responsible strategies -Train and equip health dispersible tablets that meet for community-based outlets to dispense amoxicillin quality and price targets distribution of dispersible tablets to children -Work with manufacturers to dispersible tablets by PPMVs amoxicillin 3 whose RDT results are distribute dispersible -Remove regulatory barriers to negative and who exhibit amoxicillin tablets to rural local pharmaceutical production symptoms of pneumonia areas of amoxicillin dispersible tablets -Improve coordination across Government programs and processes relating to child survival (e.g. vaccines, community case management, HIV/AIDS, malaria, nutrition, newborn etc) Further, the Nigerian Minister of State for Health, Dr Muhammad Pate, has brought new vaccine delivery together with improved access to essential medicines for the treatment of pneumonia, diarrhea and malaria in the Saving One Million Lives Initiative, which was launched in Nigeria in October 2012. The Initiative sets a target of saving the lives of one million women and children by 2015 and lays out specific plans to reach that goal. As the second leading cause of death for children under 5 in Nigeria, pneumonia is a critical plank of the plan. Saving One Million Lives is also an opportunity for Nigeria to implement the recommendations of the United Nations Commission on Life-Saving Commodities for Women and Children that relate to pneumonia, specifically to increase access to the antibiotic amoxicillin in dispersible tablet form as the first-line treatment for children with suspected pneumonia and also to increase access to ORS, zinc and other commodities (e.g. chlorhexidine to reduce newborn infection). The President of Nigeria co-chaired the Commission and has signaled the Government’s intention to introduce amoxicillin dispersible tablets as the preferred treatment for childhood pneumonia. There is now an opportunity to combine new vaccine introduction with access to essential medicines for pneumonia, diarrhea and malaria across several States to accelerate achievement of the goals of Saving One Million Lives. BEST PRACTICE PNEUMONIA DEMONSTRATION PROJECTS To support the introduction of new vaccines and the implementation of the Government’s Essential Medicines Scale-Up Plan in the context of Saving One Million Lives, we propose that Best Practice Demonstration Projects be considered in Nigeria. By combining the most effective pneumonia prevention, diagnosis and treatment interventions in the geographic 4 areas with the highest concentrations of child deaths, the Projects will seek to demonstrate how to accelerate child mortality reductions and achieve efficiencies in the delivery of healthcare to children through better coordination across child survival programs. The Projects are also an opportunity to strengthen integrated Community Case Management of pneumonia, malaria and diarrhea in Nigeria and incorporate other high impact interventions to reduce newborn mortality (e.g. chlorhexidine) and malnutrition (e.g. expansion of Community Management of Acute Malnutrition). Target States could include those that will introduce the pneumococcal vaccine first; those that have the highest concentrations of under 5 deaths, and/or those targeted by the Government for introduction or expansion of integrated Community Case Management. The States that will introduce the new vaccines first include Kaduna and Kebbi (North West Zone), Bauchi and Taraba (North East Zone), Kwara and Kogi (North Central), Ekiti (South West), Edo (South South) and Anambra (South East). Of these States, child deaths are highest in Kaduna, Bauchi, Kebbi, Taraba and Anambra and a focus on these States would potentially have the biggest impact on child survival. The Government may prefer a mix of sites to test different approaches and evaluate the outcomes. For maximum impact, it is important that the Projects: (a) be at significant scale (i.e. across several States), (b) better coordinate the delivery of vaccines with integrated Community Case Management of pneumonia, diarrhea and malaria, (c) stimulate the development of local manufacturing of amoxicillin dispersible tablets, (d) target the providers of pneumonia treatment who provide care for the majority of children, (e) test best practice approaches to the differential diagnosis of malaria and pneumonia and measure impact on treatment outcomes and healthcare costs (e.g. by reducing wastage of malaria medicines), (f) test innovations in pneumonia prevention, diagnosis and treatment (e.g. respiratory rate counters, pulse oximeters, oxygen concentrators and user-friendly packaging of amoxicillin dispersible tablets) and g) rigorously and independently monitor and measure impact. Specifically the Projects in Nigeria could: 1. Education and Care Seeking Increase awareness of the danger signs of pneumonia among families and caregivers (targeting the health care decision makers in families) Encourage families to seek medical care quickly if a child displays these danger signs Increase understanding of the difference between the symptoms of malaria and pneumonia Explain to families the importance of having children immunized with the measles, pentavalent and pneumococcal vaccines Educate families about amoxicillin dispersible tablets – what they do and how important it is to complete a course of treatment Reduce the costs of seeking care for suspected pneumonia through provision of free 5 services in the public sector and, where appropriate, incentives (e.g. vouchers, conditional cash transfers) for seeking care from private providers 2. Prevention Increase coverage of the measles, pentavalent and pneumococcal vaccines, particularly amongst the most vulnerable children Offer information to families about pneumonia prevention and other healthy behaviors at the point of vaccination (e.g. exclusive breastfeeding, proper child nutrition, hand washing with soap, reduction of household air pollution etc) Distribute select prevention and treatment commodities, where appropriate, at the point of vaccination (e.g. nutritional supplements for severely malnourished children, Vitamin A, ORS, zinc supplements, chlorhexidine, insecticide treated bed nets, soap etc) Maximize uptake of prevention commodities with proven strategies (e.g. free trials, time payments, rights to return and rights to stop payments) 6 3. Treatment Introduce quality, affordable amoxicillin dispersible tablets, locally manufactured where possible Train and equip CHEWs and PPMVs to better manage childhood pneumonia with amoxicillin dispersible tablets Provide easy-to-use, effective respiratory rate counters to health providers Train public and private health workers to refer very sick children to facilities where community case management is not appropriate and empower them to support families to seek treatment in facilities (e.g. by reducing transportation costs) Train facility based staff to effectively treat children with pneumonia including better access to pulse oximetry and oxygen and community-based services to treat acute malnutrition Introduce community-based monitoring of public and private healthcare providers to improve service utilization and health outcomes for children 7 4. Malaria Improve differential diagnosis of malaria and pneumonia by increasing coverage of Rapid Diagnostic Tests and training health workers in their proper use 6 David Levine and Carolyn Cotterman found large increases in uptake of an improved cookstove (from 5% to 45%) among residents of Kampala after free trial, time payments, the right to return the stove and the right to stop the payments were introduced as part of the offer. See What Impedes Efficient Adoption of Products? Evidence from Randomized Variation in Sales Offers for Improved Cookstoves in Uganda, Working Paper Series, Institute for Research on Labor and Employment, UC Berkeley, 2012 7 Martina Björkman and Jakob Svensson found large increases in utilization of public primary health care services and a 33% reduction in child mortality in communities that held service providers accountable for the quality of care provided in a randomized field experiment conducted across 50 communities in 9 districts in Uganda. See Power to the People: Evidence from a Randomized Field Experiment on Community-Based Monitoring in Uganda, forthcoming 6 Train and equip testers to administer amoxicillin dispersible tablets when the results of RDTs are communicated so that children who test negative can be treated for suspected bacterial pneumonia on the spot 5. Innovation Test the introduction of innovations to improve the diagnosis of pneumonia (e.g. respiratory rate counters), the diagnosis of hypoxemia (e.g. pulse oximetry), the treatment of pneumonia (e.g. rapid acting bronchodilators and oxygen concentrators) and adherence with antibiotic treatment (e.g. user-friendly packaging of amoxicillin and simple, clear instructions for caregivers) 6. Impact Rigorously and independently monitor and measure impact on treatment outcomes and healthcare costs (including the impact on malaria medicines) of the various approaches POTENTIAL PARTNERS The most effective investments in terms of children’s lives saved will be those that combine key demand, supply and distribution elements at scale in the highest burden States and mobilize the right set of public and private partners to drive uptake on both the prevention, diagnosis and treatment sides – working together for collective impact.8 To maximize collective impact, partners for the Demonstration Projects should include all relevant levels of government, organizations driving new vaccine introduction and those with experience in scaling-up access to essential medicines and with the introduction and expansion of integrated Community Case Management. In addition to the partners sponsoring this proposal, other potential partners include: Absolute Return for Kids (ARK) , BBC Media Action, bilateral development agencies (e.g. NORAD, CIDA, 9 DfID), Bill and Melinda Gates Foundation, Children’s Investment Fund Foundation, Clinton Health Access Initiative, Federation of Moslem Women’s Associations of Nigeria, GAVI, Global Fund, Health Partners International, International Vaccine Access Center, John Snow International, Malaria Consortium, Malaria No More, Medical Women’s Association of Nigeria, National 8 Mark Kramer and John Kania argue that large-scale social change requires broad cross-sector coordination and that substantially greater progress could be made in alleviating many of our most serious and complex social problems if nonprofits, governments, businesses, and the public were brought together around a common agenda to create collective impact. See Stanford Social Innovation Review, Winter 2011. 9 ARK is currently investing in an integrated diarrhea prevention and treatment project in Zambia involving introduction of the rotavirus vaccine, access to ORS and zinc and other interventions. This is one of the few projects aiming to increase the number of children’s lives that can be saved by coordinating new vaccine introduction with access to treatment. 7 Association of Community Pharmacists, National Association of Patent and Proprietary Medicine Distributors, Nigerian Interfaith Action Association, Nigerian Medical Association, Nigerian Primary Health Center Development Agency, Nigerian Private Sector Health Alliance, Partnership for Reviving Routine Immunization in Northern Nigeria, Pediatric Association of Nigeria, PATH, Nigerian pharmaceutical companies (e.g. CHI, Emzor, May and Baker), Pharmaceutical Manufacturing Group, Save the Children, Sesame Workshop, Society for Family Health, UN Special Envoy for Malaria, Wellbeing Foundation and the World Bank. This proposal was prepared by the Members of the Amoxicillin Sub-Group of the Pneumonia and Diarrhea Working Group including UNICEF (Chair), Clinton Health Access Initiative, Bill and Melinda Gates Foundation, USAID, PATH, John Snow Inc, World Health Organization, Management Sciences for Health, Save the Children, FHI-360 and the MDG Health Alliance 8