Quantification of Health Commodities - RMNCH Supplement for Forecasting Consumption of Select Reproductive, Maternal, Newborn, and Child Health Medical Products - March 2025

Publication date: 2025

Quantification of Health Commodities RMNCH Supplement for Forecasting Consumption of Select Reproductive, Maternal, Newborn, and Child Health Medical Products March 2025 RECOMMENDED CITATION This report may be reproduced if credit is given to MSH/MTaPS. Please use the following citation. MSH 2025. Quantification of Health Commodities: RMNCH Supplement Forecasting Consumption of Select Reproductive, Maternal, Newborn and Child Health Medical Products, Updated 2025 In this version, one chapter on post-partum hemorrhage was updated with funding from the Gates Foundation. The remainder of the document remains the same as the 2022 version revised by the US Agency for International Development (USAID) Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program and the current update by Management Sciences for Health ABOUT THE USAID MTAPS PROGRAM The United States Agency for International Development (USAID) Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program enables low- and middle-income countries to strengthen their pharmaceutical systems, which is pivotal to higher-performing health systems. MTaPS focuses on improving access to essential medical products and related services and on their appropriate use to ensure better health outcomes for all populations. The program brings expertise honed over decades of seminal pharmaceutical systems experience across more than 40 countries. The MTaPS approach builds sustainable gains in countries by including all actors in health care—government, civil society, the private sector, and academia. The program is implemented by a consortium of global and local partners and led by Management Sciences for Health (MSH), a global health nonprofit. This version updates the previous versions: MTaPS 2022. Quantification of Health Commodities: RMNCH Supplement Forecasting Consumption of Select Reproductive, Maternal, Newborn and Child Health Medical Products, Updated 2022. Submitted to the US Agency for International Development by the Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program. Arlington, VA: Management Sciences for Health. JSI and SIAPS. 2015. Quantification of Health Commodities: RMNCH Supplement Forecasting Consumption of Select Reproductive, Maternal, Newborn and Child Health Commodities. Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health. Submitted to the United Nations Children’s Fund by JSI, Arlington, VA: JSI Research & Training Institute, Inc. and is based on Quantification of Health Commodities developed by the USAID | DELIVER PROJECT and is modeled on other “Companion Guides” written by the Project for ARVs, HIV Test Kits, Laboratory Commodities, and Contraceptives, and on the Manual for Quantification of Malaria Commodities published by the Strengthening Pharmaceutical Systems Program. Parts of this document were originally published in: USAID | DELIVER PROJECT, Task Order 4. 2011. Quantification of Health Commodities: Contraceptive Companion Guide. Forecasting Consumption of Contraceptive Supplies. Arlington, Va.: USAID | DELIVER PROJECT, Task Order 4 and USAID | DELIVER PROJECT, Task Order 1. 2008. Quantification of Health Commodities: A Guide to Forecasting and Supply Planning for Procurement. Arlington, Va.: USAID | DELIVER PROJECT, Task Order 1 They are reprinted with permission. This document is made possible in part by the generous support of the American people through the US Agency for International Development (USAID) contract no. 7200AA18C00074. The contents are the responsibility of Management Sciences for Health and do not necessarily reflect the views of USAID or the United States Government One chapter of this RMNCH Supplement for Forecasting Consumption of Select Reproductive, Maternal, Newborn, and Child Health Medical Products was prepared for the Gates Foundation. The findings and conclusions contained within are those of the authors and do not necessarily reflect positions or policies of the Gates Foundation Page | iv ACKNOWLEDGMENTS This revised version includes an update of the chapter on post-partum hemorrhage developed by Management Sciences for Health with funding from the Gates Foundation. This document is revised from the original, Quantification of Health Commodities: RMNCH Supplement for Forecasting Consumption of Select Reproductive, Maternal, Newborn, and Child Health Commodities, which was developed under the Supply Chain Technical Resource Team of the UNCoLSC, co-convened by Sharmila Raj (USAID) and Kabir Ahmed (UNFPA). It was next updated in 2022 by the United States Agency for International Development (USAID) Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program. Authors of this 2025 update: Management Sciences for Health: Andualem Oumer, Jane Briggs, and Lauren Herzog The authors would like to thank the following individuals for their valuable technical contributions in the revision and/or review of this updated version: Cammie Lee and Amy Schellpfeffer (Gates Foundation), Jeff Jacobs (Merck for Mothers), Oleg Zhurov and Vishal Shah (Ferring), Samantha Durdock and country colleagues from R4D, Patricia Coffey and Besty Wilskie (PATH), Andrew Storey and country colleagues from CHAI, Naoko Doi and Daisy Ruto (JHPIEGO), Alan George (GHSC-PSM), Milka Dinev (MHSC of RHSC) and Ioannis Gallos and Mariana Widmer (WHO). The following individuals were acknowledged in the 2022 revision: Afua Aggrey (GHSC-PSM), Laila Akhlaghi (JSI), Fernando Althabe (WHO), Deborah Armbruster (USAID), Hillary Bracken (Gynuity), Devon Cain (CHAI), Atoyese Dehinbo (GHSC-PSM), Patricia Coffey (PATH), John Durgovich (GHSC-PSM), Tom Easterling (retired from University of Washington), Jane Feinberg (JSI), Patrick Gaparayi (UNICEF Supply Division), Alan George (GHSC-PSM), Leah Greenspan (USAID), Javier Guzman (previously of USAID/MTaPS), Alexis Heaton (JSI), Jeff Jacobs (Merck for Mothers), Patricia Jodrey (USAID), Smita Kumar (USAID), Philip Li (Ferring), Chia-Ying Lin (R4D), Helen Petach (previously of USAID), Megan Rauscher (GHSC-PSM), Mariya Saleh (GHSC-PSM), Gashaw Shiferaw (USAID/MTaPS), Manjari Quintanar Solares (PATH), Steve Wall (Save the Children), Charlotte Warren (Population Council), Mariana Widmer (WHO), Beth Yeager (USP/PQM+), and Oleg Zhurov (Ferring). The authors would also like to acknowledge the role of the Global Health Supply Chain Procurement and Supply Management (GHSC-PSM) Task Order 4 team: Megan Rauscher and Sweta Basnet and the country PSM teams from Nepal, Pakistan, Ethiopia, Ghana, and Nigeria for their role in validating the forecasting supplement and for providing helpful feedback for its further improvement. Page | v TABLE OF CONTENTS Acronyms . vi Summary . vii Introduction .1 1. Reproductive Health: Family Planning and Prevention of STIs . 13 2. Postpartum Hemorrhage: prevention, diagnosis, and treatment. 29 3. Prevention and Treatment of Hypertensive Disorders in Pregnancy . 51 4. Reduction of Risk of Respiratory Distress Syndrome in Preterm Births . 73 5. Newborn Resuscitation and Essential Care around the Time of Birth . 79 6. Newborn Cord Care . 86 7. Treatment of Possible Serious Bacterial Infection (PSBI) or Very Severe Disease in Newborns and Young Infants (0–59 days) . 93 8. Treatment of Pneumonia in Children 2–59 Months . 107 9. Treatment of Diarrhea in Children under 5 Years . 121 Glossary . 134 Tools and resources for quantification . 136 Annexes . 141 Page | vi ACRONYMS ACS antenatal corticosteroids ANC antenatal care CBR crude birth rate CHW community health worker CPR contraceptive prevalence rate CSO Central Statistics Office CSW commercial sex worker CYP couple years of protection DHS Demographic and Health Survey DT dispersible tablet EC emergency contraception ECP emergency contraceptive pill EML essential medicines list FP family planning HF health facility HMIS health management information system HSC heat-stable carbetocin IM intramuscular IV intravenous LMICs low- and middle-income countries MgSO4 magnesium sulfate MICS multiple indicator cluster survey MNCH maternal, newborn, and child health MOH Ministry of Health NGO nongovernmental organization ORS oral rehydration salts PGR population growth rate PPH postpartum hemorrhage PSBI possible serious bacterial infection QAT Quantification Analytics Tool RH reproductive health RHS reproductive health survey RMNCH reproductive, maternal, newborn, and child health SAM severe acute malnutrition STG standard treatment guideline STI sexually transmitted infection TXA tranexamic acid UNCoLSC United Nations Commission on Life-Saving Commodities WHO World Health Organization WRA women of reproductive age Page | vii SUMMARY This updated forecasting supplement will assist technical experts and program managers when conducting quantification of needs for specific essential reproductive, maternal, newborn, and child health (RMNCH) medical products. The RMNCH forecasting supplement can be used with the main guide—Quantification of Health Commodities: A Guide to Forecasting and Supply Planning for Procurement,1 which provides general guidance on quantification. This supplement describes the steps in forecasting consumption of these medical products based on the morbidity/demographic method of forecasting. To complete quantification, users should refer to the main quantification guide for the supply planning phase. It builds on the document produced under the United Nations Commission on Life-Saving Commodities Supply Chain Technical Resource Team and includes updated guidance from the World Health Organization (WHO). Page | viii REFERENCE 1. John Snow, Inc. 2017. Quantification of Health Commodities: A Guide to Forecasting and Supply Planning for Procurement. Arlington, Va.: John Snow, Inc. Page | 1 INTRODUCTION BACKGROUND Increasing access to and appropriate use of RMNCH medical products could save the lives of more than six million women and children per year.1 In 2012, the United Nations Commission on Life-Saving Commodities (UNCoLSC) for Women and Children, a part of the “Every Woman, Every Child” initiative, focused on a set of priority medical products for RMNCH with diverse characteristics. Some were new products in the process of being introduced at scale, while others have been in use for many years but are underused or unavailable when needed or in the recommended formulation. A major component of access is availability, and to ensure availability, accurate and timely estimates/quantifications of supply requirements are needed. For the sake of discussions in this document, quantification is defined as the process involving both forecasting and supply planning. See the section “Key Concepts and Considerations in Quantification” for more details. At the national level, results of quantifications are essential for budgeting, resource allocation and mobilization, and planning for procurement and supply chain operations. At the global level, donors and manufacturers can use the information to plan for resources, procurement, and production. In addition, aggregated estimates of future requirements can be used by donors, international procurement agents, and other agencies to negotiate framework agreements and unit prices. This supplement (an update of the 2022 version) provides practical guidance on estimating the quantities of supplies needed by programs as part of a national quantification exercise. While this guidance was developed primarily for the public sector, including where support is provided by nongovernmental organizations (NGOs), the methodology is also relevant for the private sector to forecast medical product needs if the morbidity method of forecasting is to be applied. MEDICAL PRODUCTS IN THIS SUPPLEMENT The priority medical products considered in this supplement fall into four categories: reproductive health (RH), maternal health, newborn health, and child health. The initial UNCoLSC list, which was utilized in the 2016 version of the forecasting supplement, has been expanded to include new medical products recently recommended by WHO and other essential medical products that were not considered by the UNCoLSC. While recognizing that diagnostic reagents, supplies, and equipment (e.g., blood pressure machines, respiratory rate timers, pulse oximeters) are important in the management of the conditions addressed in this supplement, they are not included in this forecasting guidance. REPRODUCTIVE HEALTH PRODUCTS: FAMILY PLANNING AND PREVENTION OF SEXUALLY TRANSMITTED INFECTIONS Emergency contraceptive pills, female condoms, and contraceptive implants are the three RH medical products included in this supplement. Other family planning (FP) medical products are sufficiently covered in other resources.2 Page | 2 MATERNAL HEALTH PRODUCTS The three UNCoLSC maternal health medical products—oxytocin and misoprostol (for preventing or treating postpartum hemorrhage [PPH]) and magnesium sulfate (for eclampsia and severe pre-eclampsia in pregnancy)— are included. In addition, this supplement includes other newly recommended medical products: heat-stable carbetocin (HSC) (for prevention of PPH) and tranexamic acid (for management of PPH as an adjunct treatment), calcium gluconate (to treat toxicity of magnesium sulfate [MgSO4]), antihypertensive medicines such as hydralazine and methyldopa (for management of severe hypertension in pregnancy), and calibrated drapes (for measuring the level of blood loss during and after delivery to determine PPH). NEWBORN HEALTH PRODUCTS The four groups of newborn health products included in this supplement are antenatal corticosteroids (ACS) (for reduction of the risk of respiratory distress syndrome in preterm births); chlorhexidine (for newborn cord care); antibiotics (for possible serious bacterial infection or very severe disease that could also affect the post- neonatal period); and resuscitation equipment (to assist breathing for babies with apnea or bradycardia [i.e., babies who are not breathing or not crying]). CHILD HEALTH PRODUCTS Three child health products included in this supplement are amoxicillin (to treat pneumonia) and oral rehydration salts (ORS) and zinc (to manage diarrhea). Although a limited number of priority RMNCH health products, as listed above, are covered in this forecasting supplement, quantification teams need to use other complementary resources, also referenced in this document, to quantify any additional commodities needed for the management of the conditions addressed. Once they master the document, quantification teams can apply the principles and calculation steps to other products. PURPOSE OF THIS SUPPLEMENT This supplement was developed to assist those involved in quantification of RMNCH medical products using best practice morbidity/demographic-based forecasting methodologies, based on demographic; morbidity (prevalence, incidence); and service data, to improve the quality of national-level forecasts of life-saving RMNCH medical products. Logistics/consumption-based methodologies that use consumption data may also be used in triangulating forecasts, but they are not covered in this supplement. This document should be used in conjunction with Quantification of Health Commodities: A Guide to Forecasting and Supply Planning for Procurement3 (hereafter referred to as Quantification of Health Commodities). A typical forecasting exercise should cover two to three years and be revised annually. It is also strongly recommended that annual forecasts be revised every six months in line with prevailing service uptake or consumption trends. This supplement does not provide general guidance on managing RMNCH programs, nor does it offer programmatic guidance on selecting or administering the products used in a country. Though it indicates WHO’s recommendations for the treatment of health conditions covered, quantification teams need to rely on local standard treatment guidelines (STGs) and actual practice in forecasting for the conditions. Page | 3 The output from the forecasting process—a list of specific products with estimates of consumption quantities that are outlined in this document—should not be used directly for procurement. Supply planning must be carried out to determine scheduling and quantity of each product that should and can be procured to ensure optimal availability of the products. Once a forecast is prepared using this supplement, the quantification team should refer to the Quantification of Health Commodities3 for guidance on how to conduct supply planning. BASIC CONTENTS This supplement is organized by health conditions and services, including: 1. Reproductive Health: Family Planning and Prevention of STIs 2. Prevention and Treatment of Postpartum Hemorrhage 3. Prevention and Treatment of Hypertensive Disorders in Pregnancy 4. Reduction of Risk of Respiratory Distress Syndrome in Preterm Births 5. Newborn Resuscitation and Essential Care around the Time of Birth 6. Newborn Cord Care 7. Treatment of Possible Serious Bacterial Infection (PSBI) or Very Severe Disease in Newborns and Young Infants (0–59 days) 8. Treatment of Pneumonia in Children 2–59 Months 9. Treatment of Diarrhea in Children under 5 Years The supplement provides background on the description/definition of each health condition, its global and regional incidence, and the WHO-recommended medical products and dosages for its management. In addition, the supplement provides information and guidance on the medical products used for the management of the respective condition, including: ■ Product characteristics and other forecasting considerations, including common presentations, indications, administration, storage conditions and requirements, and total shelf life ■ Other supply chain aspects, including program-specific factors that need to be considered when forecasting needs ■ Additional supplies, consumables, or equipment required to administer the medical products to be considered in quantification exercises ■ Recommended level of use according to the latest WHO guidelines ■ Types of data needed for forecasting and potential sources of those data ■ A sample forecasting algorithm for the morbidity method using demographic/morbidity and/or service data with calculation steps and formulae ■ A list of proxy data and respective sources that can be used when local data are not available ■ An example of the application of the assumptions, steps, and calculation formulae for the forecast of the medical products This supplement also includes definitions of quantification (i.e., forecasting and supply planning) and related concepts, descriptions of processes followed during quantification, types of data for forecasting, other general considerations for quantification, references, and an inventory of tools that can be applied in quantification. Page | 4 HOW TO USE THIS SUPPLEMENT This supplement is intended to help program managers, supply chain technical experts, and service providers use what they know about the products they manage and the programs they implement to estimate the quantities of products that will be needed to serve their programs’ clients in a given time period. Prior to a quantification exercise for any of the priority medical products, facilitators and technical staff should review the relevant sections of this document to inform data definition, collection, and exercise planning. The references/links included in the document can also be used as additional resources to capture more detailed and region/country-specific data useful for the quantification exercise. During the quantification exercise, this supplement can serve as a reference to build assumptions and undertake the actual forecasting. The algorithms and examples provide standard processes and steps to calculate the quantities of each product expected to be consumed during the forecast period. However, the quantification teams will need to adapt the sample forecasting assumptions, algorithms, calculation steps, formulae, and examples to fit the local context and the scope of the forecast being undertaken. The document can also be used to identify additional resources, such as general and program-specific quantification guides/manuals, that provide more detailed guidance on quantification processes and methodologies and tools and can be used to carry out the actual quantification of the medical product groups, including supply planning. In addition, the WHO recommendations referred to in the guide may be used to advocate for revisions to national RMNCH treatment protocols. KEY CONCEPTS AND CONSIDERATIONS IN QUANTIFICATION The following definitions are provided to harmonize vocabulary used in this document. These definitions are consistent with those used in the Quantification of Health Commodities.3 Quantification is the process of estimating the quantities and costs of the products required for a specific health program (or service) and determining when orders should be placed and delivered to ensure optimal availability of the products. It answers the questions, “What will be required by the program? What quantity of each product is estimated to be consumed? What needs to be procured and at what quantity and cost? When should it be ordered, and when should it be delivered?” The two main sub-processes of quantification are: ■ Forecasting: The process of estimating quantities of products required to meet demand (to be used/consumed) during a particular time frame. It answers the question, “How much is needed, in quantities, to meet the health demand of a defined group or population during a specific period?” ■ Supply planning: The process of estimating quantities and total costs of products required for procurement and determining order quantities and desired receipt dates of shipments. Supply plans require forecast quantities from the first subprocess (forecasting) and knowledge of lead times, system inventory requirements (such as minimum and maximum and desired stock levels), preferred order intervals, stock on hand, remaining shelf life of existing stock, stock on order (pending shipment quantities) and arrival dates, total shelf life, wastage rates, freight and logistics costs, available budget, warehouse space, and other factors. It is the final output of the quantification and answers the questions, “What needs to be procured? How much of each product can/needs to be procured? What is the total cost of acquiring products? When should orders be made, and when should products be received?” Page | 5 For definitions of additional terms related to quantification, consult the glossary at the end of this document. TYPES OF DATA FOR FORECASTING Availability and quality of historical and projected data is critical for forecasting. Data needed for forecasting can generally be classified into four types. 1. Consumption data: Quantities of individual medical products dispensed to users or issued to lower supply chain levels (proxy consumption) in a specific time frame. Issue quantities from stores/warehouses are used as proxy data when data on dispensed quantities to users from health facilities (HFs) are not available. 2. Demographic data: Information on population size and projections disaggregated by age, gender, awareness about health services, physical access to health service, etc. 3. Morbidity data: Information on incidence and/or prevalence estimates by condition. 4. Services data: Number of cases diagnosed, treated, or served by condition or subcondition. When such data are not available locally, informed assumptions shall be formulated based on research/survey data; similar countries’ experiences; and the knowledge and experience of program managers, implementing partners, service providers, and technical experts. The forecasting assumptions and results should be formulated, agreed upon, and vetted by key decision makers, implementers, and service providers who will be responsible for managing and providing the specific services and products. The nature of some of these medical products suggests that they are not currently used or available in sufficient quantities to achieve their maximum health impact, suggesting that historical data, either service or consumption, would often underestimate the potential demand. Thus, demographic and morbidity (prevalence and incidence) data and assumptions tempered with realistic service capacity, service readiness and the need for emergency medications, coverage targets and supply chain performance measures such as allocation and distribution, and product expiration shall be used to develop forecasts for these products in most developing country settings. There may be a need to account for data that are missing, unreliable, outdated, or incomplete. How severely accuracy is affected and how this influences decision will depend on the seriousness of the data gap and should be noted. Limitations require a closer review of the available data, assumptions, and results and an understanding of the deficiencies and risks—financial and other—of using such assumptions, data, and results. Data and data sources required for forecasting the medical products considered in this supplement are detailed below and in each section of the document. It is important to note that quantification teams need to consider potential interventions/factors affecting future changes in demand (e.g., scale up plans). DATA FOR FORECASTING AND SOURCES A number of data are required to forecast demands of the medical products included in this supplement. Table 1 summarizes the type of data required to conduct forecasting using the morbidity/demographic method that is common to many of the conditions/products considered in this supplement. Condition/product-specific data needs and potential sources are provided in the respective sections. Page | 6 Table 1: Common data and potential sources for forecasting using morbidity/demographic method NO DATA CONDITION/PRODUCT SOURCE NOTES 1 Total population per year All conditions/products National census and projections, Demographic and Health Survey (DHS), US Census Bureau International Programs Database, UN world population projections, special survey reports May be outdated; may need to apply estimated annual growth rate to project to forecast years; may not be reported as needed 2 Proportion/number of women 15–59 years Female condoms 3 Proportion/number of sexually active women 15–59 years Female condoms 4 Proportion/number of women of reproductive age (WRA) (15–49 years) or married women of reproductive age* Emergency contraceptive pills (ECPs), contraceptive implants 5 Proportion/number of female commercial sex workers (CSWs) Female condoms 6 Proportion/number of pregnant women per year Maternal health conditions: PPH and hypertensive disorders of pregnancy DHS, health management information system (HMIS), national maternal morbidity and mortality surveys, special surveys, program strategic plans DHS data may be outdated; HMIS data may not be complete; HMIS does not collect data from the private sector 7 Proportion/number of deliveries by level/ sector (e.g., home, public HFs, private HFs) 8 Crude birth rate (CBR) Single-use resuscitation device, possible severe bacterial infection (PSBI) or very severe disease, chlorhexidine di gluconate DHS, HMIS, RMNCH program reports, national maternal morbidity and mortality surveys, special surveys, program strategic plans 9 Proportion/number of live births by sector/level of care (births attended by sector): Community/home, public HFs, private HFs 10 Proportion/number of children under 5 years Pneumonia, diarrhea National census and projections, DHS, US Census Bureau International Programs Database, UN world population projections May be outdated; may need to apply estimated annual growth rate to project for forecast years 11 Types and number of public HFs in the country (e.g., regional, provincial, and district hospitals; health centers; health posts) Resuscitation and suction devices, MgSO4, calcium gluconate Program reports, Ministry of Health (MOH), regional health bureaus, district medical offices, strategic plans/program targets; WHO maintains a database of HFs from selected countries that can be found at https://data.humdata.org/dataset/health-facilities-in- sub-saharan-africa?force_layout=desktop May be outdated and could be different depending on the source of information. Obtain information from higher- and lower-level sources and verify. 12 Interventions/factors affecting future changes in demand (e.g., scale up plans) All conditions/products Maternal, newborn, and child health (MNCH) program; HIV program; strategic plans If strategies to increase awareness and health service seeking behavior are under way, the forecast should consider these; ensure that funding and appropriate human resources are available to support the program plans and are in place before increases in consumption are forecast *The “married women of reproductive age group” should be used instead of the “all WRA group” in countries where extramarital relations are seen as nonpermissible for cultural or religious reasons. https://data.humdata.org/dataset/health-facilities-in-sub-saharan-africa?force_layout=desktop https://data.humdata.org/dataset/health-facilities-in-sub-saharan-africa?force_layout=desktop Page | 7 FORECASTING METHODOLOGIES In general, forecasting methods can be classified into two broad groups—the consumption method and the morbidity method. Table 2 provides a comparison of the two methods. Table 2: Comparison of the forecasting methods CONSUMPTION METHOD MORBIDITY METHOD Definition Forecast based on the past usage trend of individual products Forecast based on past trends of cases served/treated coupled with rate of use of medical products per case as defined by STGs or actual prescribing practices Data needs Consumption data coupled with stock-out days Demographic, morbidity, and service data coupled with regimens and dosages/usage rates IMPORTANT NOTES: ◼ The morbidity method is sometimes referred as the demographic method when it is applied to conditions such as FP or when demographic data are applied to calculate estimated number of cases; however, the methodology is the same (i.e., considers estimated number of cases and average quantity of each product used to manage one case to calculate the estimated quantity of each medical product by condition/subcondition). ◼ If complete, recent, and accurate service data are available, morbidity-based forecasting can be carried out without the need for general demographic and prevalence/incidence data. Selection of forecasting methods is mainly dependent on availability and quality of data required for the respective method; however, use of multiple methods and comparison of results is recommended to allow validation of results and further refining. For new programs where past consumption or service data are not available, or for programs with significant scale up and changes in management of conditions, it is more appropriate to use demographic and morbidity data (incidence and prevalence data) with program assumptions on service coverage. For mature programs where complete and reliable consumption and service data are available, it is advisable to use the consumption and morbidity methods based on service data to estimate needs, compare results of the two, and decide which to use. Refer to Annex A for a description of each type of data and related forecasting methodology and to the Quantification of Health Commodities3 for a detailed review of data types and the merits of different methodologies. For FP products, the sources of data, strengths, and challenges associated with each forecasting method are further discussed in the Quantification of Health Commodities: Contraceptive Companion Guide.4 QUANTIFICATION PROCESSES Quantification should be carried out regularly in a timely and coordinated manner, following the recommended steps and processes described below and shown in figure 1, to increase the quality, reliability, and use of results. Timing of the quantification exercise should also be aligned with the national budget planning cycle to mobilize needed resources. The formation of program-specific coordination committees is recommended. The coordination committees should include program representatives and logistics officers from the public sector, implementing partners familiar with the products and plans, logistics and warehousing staff, procurement staff, clinicians, pharmacy unit staff, technical experts, and donors/funders.5 Engaging stakeholders ensures better sharing of information and coordinated decision making. In addition, at least one member of the quantification team should be comfortable using Microsoft Excel or other software applications used to manage the forecasting data and calculations. Page | 8 The quantification process involves the following major phases/steps, which need to be carried out sequentially: Preparation: Proper planning and preparation is the first step in the quantification process. During this step, members of the coordination/quantification committee need to define the scope of the quantification exercise, including conditions and medical products to be considered, geographic area, time frame, data type and sources, and methods of quantification. Then they need to collect, organize, and assess the quality of the available data. Usually, a consultative workshop is conducted after analysis of the collected data to validate and refine the data and assumptions obtained during the preparation phase of quantification and/or add more data and assumptions as necessary before the forecasting step starts; the consultation can also be carried out at the end of the quantification exercise. Forecasting: During this phase of quantification, the agreed forecast assumptions are used to develop estimated consumption/demand forecasts for each medical product. Electronic tools such as Quantimed®, the newly developed Quantification Analytics Tool (QAT) (both used for multiple product/condition groups), and Reality√® (used for forecasting FP medical products) are often used to carry out forecasting. The tools make it much easier to prepare forecasts by providing a structured and standardized way to organize and validate data and produce forecast results. The results of the forecasting step include a list of specific medical products with quantities needed for a specific time period. Some tools, such as Quantimed and QAT, can also be used to calculate quantity per case and cost per episode. These two phases/steps of quantification, especially forecasting, are covered in detail in this supplement. Figure 1, which is from Quantification of Health Commodities,3 illustrates the steps in quantification (for another view of the quantification process, including the inputs and outputs for each step, refer to Annex B). Users of this supplement should refer to Quantification of Health Commodities3 to prepare supply plans for each product. Changes related to supply chain management, including shipment delivery times, wastages, unit costs of medical products, logistic costs, and actual consumption, happen continuously, and this requires commensurate realignment of medical product supplies. This requires frequent reviews and revisions of quantification as more data become available to either validate the assumptions that were made or revise them and adjust the forecast and supply plan as needed. We recommend that quantification exercises be carried out at least every year, with supply planning revisions at least every quarter. More frequent revisions of the forecast and supply plans are particularly important for new or emerging programs/products where historical data are weak and forecasts are heavily dependent on expert opinions. http://siapsprogram.org/tools-and-guidance/quantimed/ https://www.ghsupplychain.org/quantificationanalyticstool https://www.engenderhealth.org/pubs/family-planning/reality-check/ Page | 9 Figure 1: Steps in quantification3 Page | 10 OTHER GENERAL FORECASTING CONSIDERATIONS FORECASTING REQUIREMENTS BY OTHER SECTORS Although the primary focus of this supplement is the public sector, NGOs, social marketing programs, and even the private sector may get products from the public sector for free or with subsidies; in cases where countries are using the public platform as a single market approach to fund and procure products, including for use in the social marketing and/or private sectors, it is important to engage private-sector stakeholders and quantify for both the public and private sectors. Additionally, the private sector could use the guidance in this supplement to understand how the public sector quantifies and the gap that the private sector should fill. PRODUCT (BRAND) MIX If the same product appears in different forms in the country (e.g., different brands or formulations) such that the quantification team believes that programmatic efforts or other drivers of use might affect the rate of consumption of different brands or formulations, it might be necessary to separate the forecast by brand/formulation so that separate assumptions can be applied to each. Similarly, brands may be procured from different vendors. Depending on the product, the brand choices may be driven by health programs, providers, or client preferences. Programs managing different brands/formulations may also have different plans for demand creation, provider capacity building, provision of equipment to facilities, or assignment of mobile units for more complex procedures. Therefore, the quantification team may need to build separate assumptions about growth (or decline) by brand/formulation. SOURCE MIX Utilization of related services offered by the public, social marketing, and private sectors may differ significantly, and this can affect estimates. If more than one programmatic source (e.g., public sector, social marketing, private sector) provides these medical products in the country, it will likely be necessary to break out the estimated number of clients/cases (for the morbidity method) or estimated proportion of use of each medical product (for the consumption method) by source of products—at a minimum to specify the number of clients who will be served or cases that will be treated in each sector included in the forecasting exercise. If the public sector is the only program considered in the quantification, the quantification team only needs to calculate the number of clients to be served or cases to be treated by that sector; clients or cases to be treated in other sectors should be excluded. Note that the composition and needs of groups of clients who frequent different sources for their services may vary considerably. AVAILABILITY Most of the products considered in this supplement are included in WHO’s Model List of Essential Medicines, including the WHO Model List of Essential Medicines for Children; they are also part of the national essential medicines lists (EMLs) of many low- and middle-income countries (LMICs). In addition, many of these products have WHO prequalified suppliers. For a full list of WHO prequalified products and supplies, refer to the WHO website. Quantification teams are advised to consider their national EMLs and list of products that are registered in the respective country when conducting quantification exercises. The possibility of obtaining waivers for importation should also be considered for products that are not registered. You only need to calculate the number of cases to be served by the sector(s) in scope for the forecast; cases to be served in other sectors should be excluded. https://www.who.int/medicines/publications/essentialmedicines/en/ https://extranet.who.int/prequal/content/prequalified-lists/medicines https://extranet.who.int/prequal/content/prequalified-lists/medicines Page | 11 PRICES Unit prices of many of the products considered in this supplement are available from the UNICEF catalogue and UNFPA catalogue; they may also be available from MSH’s International Medical Products Price Guide. These resources can be used if local data on prices are not available. CONSIDERATIONS FOR MULTIUSE PRODUCTS Some of the RMNCH medical products considered in this supplement are used to manage several conditions (e.g., amoxicillin can be used for pneumonia, PSBI, severe acute malnutrition [SAM], and otitis media). The quantification team should consider forecasting the needs for all relevant conditions to estimate the total needs of a specific medical product. ENTRY OF PERCENTAGE VALUES When calculations involve multiplications of a number by a percentage (%), users of the supplement should interpret the percentage as a fraction. There are two options for carrying out the calculations: 1. Interpret the percentage as a fraction (e.g., 20% is actually 0.2) and in Excel, the % sign after the percentage value interprets the value as a fraction (i.e., 50 x 20% = 10) 2. Change the percentage value to a fraction before multiplying the percentage value (i.e., change 20% to a fraction by dividing 20 by 100 = 0.2 and then multiply the fraction by the number; 50 x 0.2 = 10 [this can be the case when using a tool such as Quantimed that does not provide functionality to use the % sign with the percentage value]) PROXY DATA Users of this supplement are provided with global and/or regional data when available that can be used as proxy data (e.g., on incidence of conditions). However, the use of proxy data is recommended only when it is not possible to find local data on the specific variable. In addition, it is important for users to refer to the sources of data provided as reference for proxy data since most of them have country- or region-specific data that can be used for the region or country under consideration instead of the global average. The proxy data provided in this document are from the pre-COVID-19 pandemic period and may not reflect the current context. https://supply.unicef.org/all-materials.html https://www.unfpaprocurement.org/products https://www.msh.org/resources/international-medical-products-price-guide Page | 12 REFERENCES 1. UN Commission on Life-Saving Commodities for Women and Children. Commissioners’ Report, September 2012 2. USAID | DELIVER PROJECT, Task Order 4. 2011. Quantification of Health Commodities: Contraceptive Companion Guide. Forecasting Consumption of Contraceptive Supplies. Arlington, Va.: USAID | DELIVER PROJECT, Task Order 4. Available at: https://apps.who.int/medicinedocs/documents/s21863en/s21863en.pdf Accessed on March 20 2020 3. John Snow, Inc. 2017. Quantification of Health Commodities: A Guide to Forecasting and Supply Planning for Procurement. Arlington, Va.: John Snow, Inc. 4. Quantification of Health Commodities: Contraceptive Companion Guide; Forecasting Consumption of Contraceptive Supplies. Available at: https://www.psmtoolbox.org/en/tool/quantification/reproductive- health/reproductive-health-products/quantification-of-health-commodities-contraceptive-companion-guide/ 5. JSI Research & Training Institute, Inc. 2014. Guidance and Resources for Inclusion of Reproductive, Maternal, Newborn, and Child Health (RMNCH) Commodities in National Commodity Supply Coordination Committees. Arlington, Va: JSI Research & Training Institute, Inc., for the UN Commission on Life-Saving Commodities for Women and Children, Supply and Awareness Technical Reference Team https://apps.who.int/medicinedocs/documents/s21863en/s21863en.pdf https://www.psmtoolbox.org/en/tool/quantification/reproductive-health/reproductive-health-products/quantification-of-health-commodities-contraceptive-companion-guide/ https://www.psmtoolbox.org/en/tool/quantification/reproductive-health/reproductive-health-products/quantification-of-health-commodities-contraceptive-companion-guide/ Page | 13 1. REPRODUCTIVE HEALTH: FAMILY PLANNING AND PREVENTION OF STIS INTRODUCTION Contraceptive prevalence is defined as the percentage of women of reproductive age (15–49 years) who are currently using, or whose sexual partner is currently using, at least one method of contraception, regardless of the method used.1 Globally, modern contraceptive method prevalence (i.e., the proportion of women of reproductive age who have their need for modern contraception methods satisfied) increased slightly, from 74% in 2000 to 76% in 2019.2 However, significant differences exist in modern contraceptive prevalence rates across countries and regions. For example, the achievement is only 55% in sub-Saharan Africa and Western Asia and just 51% in Oceania (excluding Australia and New Zealand).2 The female condom, contraceptive implants, and ECP were classified by the “Every Woman, Every Child” movement as three underutilized RH products. Other resources, such as guides, manuals, and tools, exist for quantifying other more frequently used FP medical products, such as male condoms, injectables, intra-uterine devices, and oral contraceptives,3 so the product-specific section below will focus only on ECPs, contraceptive implants, and female condoms. PRODUCT CHARACTERISTICS AND OTHER FORECASTING CONSIDERATIONS EMERGENCY CONTRACEPTIVE PILLS ECPs are oral contraceptives indicated for use to prevent pregnancy after unprotected or inadequately protected sex.4 Most ECPs can be taken up to five days after unprotected intercourse. In general, ECPs are available in three types—levonorgestrel tablets, ulipristal acetate tablets, and mifepristone tablets. In developing countries, the levonorgestrel-only formulations are most widely available. This supplement covers the levonorgestrel-only formulations, although the methodology could also apply to the other types. ECPs can be important not only for couples who need contraceptive methods after no or incorrect use of contraceptives or after method failure4 but also for women who experience sexual assault.5 Regardless of their importance and efficacy, awareness continues to be an important barrier to uptake since ECP is one of the least known, least available, and least used modern FP methods in developing countries; most women have never heard of this safe and effective pill.6 The population that uses ECPs is likely a subset of the total population interested in using—or already using—a modern contraception method. In addition, ECPs may be offered via traditional and nontraditional outlets such as hospital emergency rooms, refugee and internally displaced persons camps, pharmacies, prisons, and schools where use/dispensing may not be completely or accurately reported. Access and availability can be influenced by many issues, including licensing and registration of products and whether clients can obtain the method without a prescription. Further, not every recent DHS has included ECP as a method. These factors make ECP difficult to forecast. ECP demand forecasts should be realistically aligned with programmatic plans and capacity for introducing or expanding the provision of ECPs in a given sector, especially if ECP is well established in other sectors. For example, if the private sector plays an established role in providing ECPs, quantification teams should use caution in extrapolating private-sector demand for ECPs to the public sector, where the user profile may be significantly different. Page | 14 FEMALE CONDOMS Female condoms are barrier devices inserted inside the vagina before sexual intercourse to prevent unintended pregnancy and/or STIs. Female condoms do not require a prescription or clinician involvement beyond initial insertion training. Women of all ages can use female condoms; however, they are particularly attractive to women who experience side effects from hormonal methods; high-risk behavior groups, such as female sex workers and other women with multiple sexual partners; men who dislike the use of male condoms; women who cannot negotiate the use of male condoms; and people who are allergic to latex (most female condoms are made from polyurethane and synthetic latex, which have a lower incidence of allergic reactions). Since male and female condoms prevent both pregnancy and transmission of STIs, including HIV, distinction by program and separate estimation and management by programs are common; however, this may hamper access to condoms. Conducting a coordinated quantification of requirements for FP and prevention of STIs is recommended. This will help each program avoid duplication, minimize overstocking and shortages, and plan for the transfer of products among programs if there are stock-outs/overstocks and potentials for expiry. It also allows sharing data and information for making better assumptions. An appropriate quantity of female condoms needs to be available to users regardless of their purpose. A caution on using demographic data for forecasting both male and female condoms: the data will not reflect additional use of condoms for HIV and STI prevention if the user has already indicated the use of another contraceptive method. CONTRACEPTIVE IMPLANTS Contraceptive implants are a highly effective hormonal FP method used by WRA to prevent pregnancy. The product is a small, flexible, plastic, matchstick-sized rod (or rods) inserted under the skin of a woman’s upper arm that releases a progestin hormone over the course of the implant lifespan (three–five years). Based on the 2015 WHO medical eligibility criteria for contraceptive use,7 implants are suitable for nearly all women. Implant insertion and removal requires competency-based training. Page | 15 Table 3: Summary of product characteristics: ECPs, female condoms, and contraceptive implants PARAMETER ECPS FEMALE CONDOMS CONTRACEPTIVE IMPLANTS Protocol/usage rates/couple years of protection (CYP)8 ▪ 1.5 mg levonorgestrel tablet – 1 blister of 1 tablet per case ▪ 0.75 mg levonorgestrel tablets – 1 blister of 2 tablets per case ▪ 1 condom per sexual intercourse ▪ CYP factor: 120 (120 female condoms per women per year) ▪ 1 contraceptive implant can serve for 3 to 5 years ▪ CYP ○ Levonorgestrel 75 mg/rod, 2-rod-5-year = 3.8 years ○ Levonorgestrel 75 mg/rod, 2-rod-3-year = 2.5 years ○ Etonogestrel 68 mg/rod, 1-rod-3-year = 2.5 years Presentation ▪ 1 tablet of levonorgestrel 1.5 mg tablets ▪ 2 tablets of levonorgestrel 750 microgram (0.75 mg) tablets ▪ Latex sheath with inner retention ring, with or without fragrance, of 1 piece ▪ Nitrile sheath with inner retention ring, with or without fragrance, of 1 piece ▪ Levonorgestrel 75 mg/rod, 2-rod-5-year with disposable trocars ▪ Levonorgestrel 75 mg/rod, 2-rod-3-year with disposable trocars ▪ Etonogestrel 68 mg/rod, 1-rod-3-year with disposable trocars Annual failure rate9 ▪ Oral pills = 5.5% (3.5–7.3%)* ▪ Injectables = 1.7% (0.6–2.9%)* ▪ Condoms = 5.4% (2.3–8.7%)* ▪ Not applicable Annual discontinuation rate10 ▪ Not applicable because it is not considered a regular method ▪ 50% ▪ Levonorgestrel 75 mg/rod, 2-rod-5-year = 28% ▪ Levonorgestrel 75 mg/rod, 2-rod-3-year = 33% ▪ Etonogestrel 68 mg/rod, 1-rod-3-year = 42% Administration ▪ Oral ▪ Intravaginal ▪ Subdermal Storage condition11 ▪ Do not store above 30°C, protect from light ▪ Store in well ventilated, dry conditions away from direct sources of heat, including sunlight ▪ Long-term average storage ▪ Do not store above 30°C ▪ Do not store above 30°C, protect from light Additional supplies required for administration ▪ No additional supplies are required to administer ECPs or female condoms ▪ Insertion and removal procedures require instruments, expendable medical supplies, and infection prevention supplies Level of use ▪ Can be self-administered by users after initial demonstration/advice by community health workers (CHWs) or HF staff ▪ Need to be administered at HF level or rarely by trained CHWs in home settings; 11% of surveyed countries indicated the use of CHWs to administer contraceptive implants12 Supply chain considerations ▪ Do not require cold chain ▪ Shelf life of 24–36 months ▪ Do not require cold chain ▪ Shelf life of 36–72 months ▪ Do not require cold chain ▪ Shelf life of 60 months *Failure rates of short-acting modern methods are used in the calculation of ECP requirement REQUIRED DATA AND POTENTIAL SOURCES: MORBIDITY/DEMOGRAPHIC METHOD OF FORECASTING A number of data points are required to forecast demand for ECPs, contraceptive implants, and female condoms. Table 4 summarizes the main data types and potential sources for this method of forecasting, in addition to the common data provided in the introduction of this supplement. Page | 16 Table 4: Data and potential sources for forecasting ECPs, contraceptive implants, and female condoms using morbidity/demographic method DATA CONDITION/ PRODUCT SOURCE NOTES Contraceptive prevalence rate by method, method mix ECPs, contraceptive implants, female condoms Family health surveys, DHS, reproductive health survey (RHS), national health surveys, performance monitoring for action Survey data may be outdated; may need to apply estimated annual growth rate to project to forecast years Short-term method specific failure rates ECPs DHS, special surveys, data from the Global Library of Women’s Medicine Survey data may be outdated; local data may not be available Unmet needs for contraceptives ECPs, contraceptive implants, female condoms DHS, multiple indicator cluster survey (MICS), RHS, national health surveys, census data Data quality is not always known; may be outdated Incidence of rape ECPs DHS, national health surveys, census data May be outdated; may need to apply estimated annual growth/reduction rate to project to forecast years Proportion/number of women in need of ECPs or female condoms who are aware of the products ECPs, contraceptive implants, female condoms DHS, HMIS, special surveys; data from International Consortium for Emergency Contraception can be used in the absence of local data DHS data may be outdated; HMIS data may not be complete; may need to apply estimated annual growth/reduction rate Proportion/number of women who are aware of and have access to ECPs or female condoms (separately) by sector (public, social marketing, private): source mix ECPs, female condoms DHS, HMIS, special surveys; data from International Consortium for Emergency Contraception can be used in the absence of local data Method-specific discontinuation rates Contraceptive implants DHS; special surveys; Reality√: A planning and advocacy tool for strengthening FP programs, user’s guide May not reflect country-specific situation, survey data may be outdated Annual failure rate ECPs DHS, special surveys, Contraceptive Failure Rates in the Developing World-2016 CYP factor/usage rate per year ECPs, contraceptive implants, female condoms MEASURE Evaluation FPRH Family Planning and Reproductive Health Indicators Database CYP is affected by counseling, age, intentions of the user, and availability of skilled providers for removal. The CYP factor for ECP is 20 doses, which may overestimate quantities needed if WRA use ECPs only for episodic, and not annual, protection. Usage rate of female condoms for prevention of STIs could be very different from CYP for prevention of pregnancy. Product mix ECPs, contraceptive implants, female condoms MOH reports, logistics management information system records, facility records, DHS, MICS Not always complete; data quality not always known; may be outdated or not collected; shipment information by product/brand is not a direct proxy for dispensed-to user information Note: All three methods of contraception dealt with here are available from multiple sectors—public, private/commercial, NGO, and social marketing. However, there are differences in relative availabilities. For example, ECPs are more likely to be found in the commercial sector, and implants and female condoms are more likely to be offered in the public and NGO sectors.12 The contribution of the private sector is expected to grow further; in 2017, 94% of surveyed countries reported having polici es that enable the private sector to provide contraceptive methods. This has increased significantly from 73% in 2015.12 https://www.pmadata.org/ https://www.pmadata.org/ https://www.pmadata.org/ https://www.glowm.com/section_view/heading/Contraceptive%20Efficacy/item/374#32665;DHS, Special surveys https://www.glowm.com/section-view/heading/Contraceptive%20Efficacy/item/374#32665 https://www.glowm.com/section-view/heading/Contraceptive%20Efficacy/item/374#32665 https://www.glowm.com/section-view/heading/Contraceptive%20Efficacy/item/374#32665 https://www.cecinfo.org/country-by-country-information/status-availability-database/ec-knowledge-and-ever-use-among-women-of-reproductive-age-by-country/) https://www.cecinfo.org/country-by-country-information/status-availability-database/ec-knowledge-and-ever-use-among-women-of-reproductive-age-by-country/) https://www.cecinfo.org/country-by-country-information/status-availability-database/ec-knowledge-and-ever-use-among-women-of-reproductive-age-by-country/) https://www.cecinfo.org/country-by-country-information/status-availability-database/ec-knowledge-and-ever-use-among-women-of-reproductive-age-by-country/) https://www.cecinfo.org/country-by-country-information/status-availability-database/ec-knowledge-and-ever-use-among-women-of-reproductive-age-by-country/) https://www.cecinfo.org/country-by-country-information/status-availability-database/ec-knowledge-and-ever-use-among-women-of-reproductive-age-by-country/) file:///C:/Users/aoumer/Desktop/RMNCH%20Manual%20revision/RMNCH%20Manual%20reviewed/Data%20and%20Sources%20Compiled.xlsx%23RANGE!_ftn1 https://www.engenderhealth.org/article/reality-check-and-pipeline-two-complementary-tools-for-planning-and-contraceptive-forecasting file:///C:/Users/aoumer/Desktop/RMNCH%20Manual%20revision/RMNCH%20Manual%20reviewed/Data%20and%20Sources%20Compiled.xlsx%23RANGE!_ftn1 https://www.guttmacher.org/report/contraceptive-failure-rates-in-developing-world https://www.guttmacher.org/report/contraceptive-failure-rates-in-developing-world https://www.measureevaluation.org/prh/rh_indicators/family-planning/fp/cyp https://www.measureevaluation.org/prh/rh_indicators/family-planning/fp/cyp Page | 17 Figure 2: Forecasting algorithm for ECP based on morbidity/demographic method Page | 18 IMPORTANT NOTES: ◼ WRA with unmet contraception need are not using another method and may choose to use ECPs if they have unprotected intercourse. In the sample algorithm, these women are included in the flow at “need for ECP” and filtered by awareness of and access to emergency contraception (EC). Some people might argue that women with an unmet need for contraception may not be able to access EC either. If agreement is reached on this based on local information, the quantification team may eliminate WRA with unmet need from the calculations. ◼ One episode per year is assumed for the calculation of H. Figure 3: Forecasting algorithm for contraceptive implants based on morbidity/demographic method Page | 19 Figure 4: Forecasting algorithm for female condoms based on morbidity/demographic method *Sexually active women are assumed to be 15–59 years of age. **CYP provided here is a global average for the general population mainly based on male condom use. The CYP rate for female c ondoms and especially for female CSW use could be significantly different. Page | 20 PROXY DATA AND SOURCES If local data are not available, quantification teams may use the following data as proxy. Table 5: Summary of proxy data and sources PARAMETER VALUE 1 Usage rates (CYP factors)8 ▪ ECPs ▪ 1 tablet of 1.5 mg levonorgestrel (blister): 1 blister per case per year ▪ 2 tablets of 0.75 mg levonorgestrel tablets (blister): 1 blister per case per year ▪ Female condoms ▪ 120 condoms per women per year ▪ Contraceptive implants ▪ Levonorgestrel 75 mg/rod, 2-rod-5-year = 3.8 years ▪ Levonorgestrel 75 mg/rod, 2-rod-3-year = 2.5 years ▪ Etonogestrel 68 mg/rod, 1 rod-3-year = 2.5 years 2 Discontinuation rates of contraceptive implants9 ▪ Levonorgestrel 75 mg/rod, 2-rod-5-year = 28% ▪ Levonorgestrel 75 mg/rod, 2-rod-3-year = 33% ▪ Etonogestrel 68 mg/rod, 1-rod-3-year = 42% 3 Failure rates10 ▪ Condoms = 5.4 % (2.3–8.7%) ▪ Injectables = 1.7% (0.6–2.9%) ▪ Oral pills = 5.5 % (3.5–7.3%) IMPORTANT NOTES: ◼ If data on incidence of rape are not available, the quantification team might choose to use data on the proportion of women at risk of gender-based violence as a proxy. ◼ Quantification teams are advised to refer to the sources of data provided as references for the proxy data as most have country- or region-specific data that can be used for the region or country under consideration instead of the global average. Page | 21 BOX 1. EXAMPLE OF COUNTRY FORECAST FOR ECPS BASED ON MORBIDITY/ DEMOGRAPHIC METHOD Country X would like to estimate the quantities of ECPs to be consumed by clients of its public-sector reproductive health/FP program as well as a social marketing program over the next two years. The following data and assumptions were discussed and agreed to be used for the forecast. The quantification team has agreed to use global averages as proxy when local data are not available. Available data and assumptions ▪ Total population as of current year (Central Statistics Office [CSO]: census): 20,000,000 ▪ Annual population growth rate (CSO): 2% ▪ Percentage of WRA group (15–49 years) (based on census report): 25%; estimated to remain the same during the quantification period ▪ Percentage of WRA with unmet need for contraception (DHS): 27%; estimated to remain the same ▪ Percentage of WRA using a modern method of contraception): 44%; the quantification team has estimated that contraceptive prevalence rate (CPR) for modern methods will increase by 1% annually (based on DHS and projections using current trends) ▪ Based on DHS data, trends, and program objectives, the quantification team has also estimated current CPR by method and annual increase in CPR of short-acting modern methods as follows: ○ Percentage of WRA using male condom (DHS): 2.70%; annual increase: 0.1% ○ Percentage of WRA using female condom (DHS): 0.10%; annual increase: 0.01% ○ Percentage of WRA using oral contraceptives (DHS): 10.00%; annual increase: 0.20% ○ Percentage of WRA using injectables (DHS): 18.50%; annual increase: 0.30% ▪ Method-specific failure rates: (proxy) ○ Condoms (male and female): 5.4% ○ Oral pills: 5.5% ○ Injectables: 1.7% ▪ WRA at risk of pregnancy due to rape: 4% (gender-based violence used as proxy) ▪ Percentage of WRA in need of ECPs who are aware of ECPs (DHS): 20% (current year); it is estimated that it will increase to 21% in year 1 and 22% in year 2 ▪ Estimated percentage of WRA who are aware of and have access to ECPs: 60% (estimated based on DHS and expert opinion) ▪ Percentage of clients accessing ECPs by source (based on DHS): ○ Public sector: 35% ○ Social marketing sector: 50% ○ Private sector: 15% ▪ Percentage of product (brand) mix and source mix (based on DHS); is assumed to be unchanged in the forecast period ○ Public sector: ─ Levonorgestrel 1.5 mg of 1 tab: 100% ○ Social marketing sector: ─ Levonorgestrel 1.5 mg of 1 tab: 65% ─ Levonorgestrel 0.75 mg of 2 tabs: 35% ▪ Episodic use: 1 episode per year and 1 dose per episode Calculate the quantity of ECPs required over the next two years Page | 22 Example: ECPs PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 Total population (A) A: Population = population of the previous year + (population of the previous year x PGR) (annual population growth rate (PGR) is 2%) 2% 20,000,000 20,400,000 20,808,000 Total number of WRA (15–49 years) (B) B = A x % of WRA 25% 5,000,000 5,100,000 5,202,000 CPR of male condoms (% of users out of WRA) Annual increase in CPR: Male condoms 0.10% 2.70% 2.80% 2.90% CPR of female condoms (% of users out of WRA) Annual increase in CPR: Female condoms 0.01% 0.10% 0.11% 0.12% CPR of oral pills (% of users out of WRA) Annual increase in CPR: Oral pills 0.20% 10.00% 10.20% 10.40% CPR of injectables (% of users out of WRA) Annual increase in CPR: Injectables 0.30% 18.50% 18.80% 19.10% Number of male condom users (C1) C1 = WRA (B) x CPR of male condoms in % 135,000 142,800 150,858 Number of female condom users (C2) C2 = WRA (B) x CPR of female condoms in % 5,000 5,610 6,242 Number of oral pill users (C3) C3 = WRA (B) x CPR of oral pills in % 500,000 520,200 541,008 Number of injectable users (C4) C4 = WRA (B) x CPR of injectables in % 925,000 958,800 993,582 Number of failures: Male condom users (D1) D1= C1 x failure rate in %: Male condoms 5.40% 7,290 7,711 8,146 Number of failures: Female condom users (D2) D2 = C2 x failure rate in %: Female condoms 5.40% 270 303 337 Number of failures: Oral pill users (D3) D3 = C3 x failure rate in %: Oral pills 5.50% 27,500 28,611 29,755 Number of failures: Injectable users (D4) D4 = C4 x failure rate in %: Injectables 1.70% 15,725 16,300 16,891 Number of WRA (15–49) with unmet contraception need (E) E = B x % of WRA with unmet contraception need 27% 1,350,000 1,377,000 1,404,540 Total CPR of modern method of contraception (F) F = Annual increase in CPR of 1% 1% 44% 45% 46% WRA (15–49) at risk of pregnancy due to rape and in need of ECPs (G) G = Incidence of rape x B x (100%-F): Incidence of rape (gender-based violence) 4% 112,000 112,200 112,363 Number of WRA (15–49) with a need for ECPs (H) H = D1 + D2 + D3 + D4 + (E + G) 1,512,785 1,542,125 1,572,033 Number of WRA (15–49) who have a need for and are aware of ECPs (I) I = % awareness x number in need of ECPs (H) (% increase in awareness of 1% per year) 20% 302,557 323,846 345,847 20% 21% 22% Number of WRA (15–49) who have a need for, are aware of, and have access to/use ECPs (J) J = # that are aware (I) x % with access to ECPs 60% 181,534 194,308 207,508 Number of WRA (15–49) who have access to/use ECPs from the public sector (K) K = J x % who use from public sector 35% 63,537 68,008 72,628 Number of WRA (15–49) who have access to/use ECPs from the social marketing sector (L) L = J x % who use from social marketing sector 50% 90,767 97,154 103,754 Number of WRA (15–49) who use specific type/brand of ECP from the public sector (M) M = K x % who use levonorgestrel 1.5 mg of 1 tab 100% 63,537 68,008 72,628 Number of WRA (15–49) who use specific type/brand of ECP from the social marketing sector (N) N1: # using levonorgestrel 1.5 mg of 1 tab = L x % who use levonorgestrel 1.5 mg of 1 tab 65% 58,999 63,150 67,440 N2: # using levonorgestrel 0.75 mg of 2 tabs = L x % who use levonorgestrel 0.75 mg of 2 tabs 35% 31,768 34,004 36,314 P1: Quantity for the public sector = M x O; 1 63,537 68,008 72,628 Page | 23 PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 Quantity of levonorgestrel 1.5mg of 1 tab needed in the public and social marketing sectors (P) where O = 1 blister of 1 tab P2: Quantity for the social marketing sector = N1 x O; where O = 1 blister of 1 tab 1 58,999 63,150 67,440 Quantity of levonorgestrel 0.75 mg of 2 tabs needed in the social marketing sector (R) R = N2 x Q; where Q = 1 blister of 2 tabs 1 31,768 34,004 36,314 Total quantity of levonorgestrel 1.5 mg of 1 tab needed in the public and social marketing sectors (S) S = P1 + P2 122,536 131,158 140,068 Total quantity of levonorgestrel 0.75 mg of 2 tabs needed in the public and social marketing sectors (T) T = R 31,768 34,004 36,314 Note: ▪ This is an example to show how the algorithm can be translated to calculations using an Excel tool. Quantification teams need to adapt the Excel tool and the examples provided to their context. Page | 24 Example: Contraceptive implants PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 Total population (A) A: Population = population of the previous year + (population of the previous year x PGR) (annual PGR is 2%) 2% 20,000,000 20,400,000 20,808,000 Total number of WRA (15–49 years) (B) B = A x % of WRA out of the total population 25% 5,000,000 5,100,000 5,202,000 Total number of implant users (C) C = B x CPR of implants in % (CPR of implants with annual increase of 0.20%) 0.2% 175,000 188,700 202,878 3.50% 3.70% 3.90% Number of implant users in the public sector (D) D = C x % who use from public sector 83% 145,250 156,621 168,389 Number of implant users in the social marketing sector (E) E = C x % who use from social marketing sector 14% 24,500 26,418 28,403 BOX 2. EXAMPLE OF COUNTRY FORECAST FOR CONTRACEPTIVE IMPLANTS BASED ON MORBIDITY/DEMOGRAPHIC METHOD Country X would like to estimate the quantities of contraceptive implants to be consumed by clients of its public - sector RH/FP program as well as a social marketing program over the next two years. The program has decided to use two types of contraceptive implants. Only the 2-rod-5-year implant is available in the public sector, while two types—2-rod-5-year implant and 1-rod-3-year implant—are available through the social marketing sector. The following data and assumptions were discussed and agreed to be used for the forecast. The quantification team has agreed to use global averages as proxy when local data are not available. Available data and assumptions ▪ Total population as of current year (CSO: census): 20,000,000 ▪ Population growth rate (CSO): 2% ▪ Percentage of WRA (15–49 years) (based on CSO projections): 25%; estimated to remain the same ▪ Based on DHS data, trends, HMIS data, and program objectives, the quantification team estimates CPR for contraceptive implants is 3.5% in the current year and is expected to grow by 3.7% and 3.9% in years 1 and 2, respectively. ▪ Percentage of clients accessing contraceptive implants by source (based on DHS): ○ Public sector: 83% ○ Social marketing sector: 14% ○ Private sector: 3% ▪ The following annual discontinuation rates were assumed for the two types of implants based on global data used as a proxy: ○ Levonorgestrel 75 mg/rod, 2-rod-5-year: 28% ○ Etonogestrel 68 mg/rod, 1-rod-3-year: 42% ▪ Brand (product) mix by sector (based on DHS, HMIS, and program objectives): ○ Public sector: ─ Levonorgestrel 75 mg/rod, 2-rod-5-year: 65% ─ Etonogestrel 68 mg/rod, 1-rod-3-year: 35% ○ Social marketing sector: ─ Levonorgestrel 75 mg/rod, 2-rod-5-year: 55% ─ Etonogestrel 68 mg/rod, 1-rod-3-year: 45% ▪ Episodic use: 1 insertion per new adopter Calculate the quantities of contraceptive implants required over the next two years Page | 25 PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 Number of implant users by brand/type in the public sector (F) F1: # using 2-rod-5-year implant in the public sector = D x % who use the product 65% 94,413 101,804 109,453 F2: # using 1-rod-3-year implant in the public sector = D x % who use the product 35% 50,838 54,817 58,936 Number of implant users by brand/type in the social marketing sector (G) G1: # using 2-rod-5-year implant in the social marketing sector = E x % who use product 55% 13,475 14,530 15,622 G2: # using 1-rod-3-year implant in the social marketing sector = E x % who use the product 45% 11,025 11,888 12,781 Number of public-sector users who need insertion of implants each year (H)* H1: Annual discontinuation rate: 2-rod-5-year - public sector 28% 33,827 36,154 H2: Annual discontinuation rate: 1-rod-3-year - public sector 42% 25,332 27,142 Number of social marketing -sector users who need insertion of implants each year (J)* J1: SM: Annual discontinuation rate: 2-rod-5-year - social marketing sector 28% 4,828 5,160 J2: Annual discontinuation rate: 1-rod-3-year - social marketing sector 42% 6,523 6,996 *H & J: # of users who need insertion of implants by type/brand each year = (users in current year – users in the previous year) + (number of users that discontinue use during the current year) Number of users that discontinue use during the current year = total number of users in the previous year x discontinuation rate per year (%) Example: H1: # that need insertion of levonorgestrel 75 mg/rod, 2-rod 5-year in the public sector = (F1 – users in the previous year) + (# of users in the previous year x discontinuation rate in %) Total quantity of each type/brand of implant needed in the public and social marketing sectors (K) K1: Quantity of levonorgestrel 75 mg/rod, 2-rod-5-year: public and social marketing sectors (H1 + J1) 38,655 41,314 K2: Quantity of etonogestrel 68 mg/rod, 1 rod-3-year: public and social marketing sectors (H2 + J2) 31,854 34,138 Notes: ▪ This is an example to show how the algorithm can be translated to calculations using an Excel tool. Quantification teams need to adapt the Excel tool and the examples provided to their context. ▪ In theory, the only implant clients who require a product in a given period are new adopters and clients who have reached the useful life of their implant and elect to have it removed and a new implant inserted. To convert the number of clients in a period to the quantity of products needed to serve them, you need to know the proportion of new users in the period and the proportion of users who have had implants inserted in the period who will have them removed and new ones inserted. ▪ There were two options provided for the calculation of implant insertions per year in the 2016 version of this document. In this version we have adapted option 2, which is more accurate and results in higher implant needs, to include slight modifications to the calculation of discontinuation rates. In the old version, the discontinuation rate for option 2 is calculated by taking the reciprocal of the CYP (1/CYP), while in this version we have used global data on the discontinuation rate by type of implant (see the proxy data for more detail). However, it is important to note that the global implant discontinuation averages by type of implant are not very different from the ones calculated using the reciprocal of the CYP. For example, the global discontinuation rate for etonogestrel 68 mg/rod, 1-rod-3-year implant is 42%, while the result of 1/CYP is (1/2.5 = 0.40 = 40%). Page | 26 Example: Female Condoms PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 Total population (A) A: Population = population of the previous year + (population of the previous year x PGR) (annual PGR is 2%) 2% 20,000,000 20,400,000 20,808,000 Total number of WRA (15–59 years) (B) B = A x % women 15–59 years 28% 5,600,000 5,712,000 5,826,240 Number of sexually active women 15–59 years excluding CSWs (C) C = B x % sexually active women 15–59 years 61% 3,416,000 3,484,320 3,554,006 Number of CSWs (D) D = B x % CSWs 0.30% 16,800 17,136 17,479 Number of sexually active women 15–59 years (excluding CSWs) with a need for female condoms (E) E = C x % sexually active women 15–59 years with a need for female condoms 0.25% 8,540 8,711 8,885 BOX 3. EXAMPLE OF COUNTRY FORECAST FOR FEMALE CONDOMS BASED ON MORBIDITY/DEMOGRAPHIC DATA Country X would like to estimate the quantities of female condoms to be consumed by clients of their public sector RH/FP and National AIDS Control programs and social marketing program over the next two years. Since it is difficult to separate the use for FP and prevention of STIs, it was agreed to forecast the requirements for the two programs together. The following data and assumptions were discussed and agreed to be used for the forecast. The quantification team has agreed to use global averages as proxy when local data are not available. Available data and assumptions ▪ Total population as of current year (CSO census): 20,000,000 ▪ Population growth rate (CSO): 2% ▪ Percentage of women aged 15–59 years (Based on CSO projections): 28%; estimated to remain the same ▪ Percentage of sexually active women (DHS) (i.e., women 15–59 years excluding female CSWs) (DHS): 61% ▪ Estimated proportion of female CSWs (local study): 0.3% of women 15–59 years ▪ Percentage of sexually active women 15–59 years (excluding female CSWs) with a need for female condoms for prevention of pregnancy and/or STIs (percentage of women using female condom at last intercourse) (DHS): 0.25% ▪ Percentage of female CSWs with a need for female condoms for prevention of pregnancy and/or STIs (local studies): 10% ▪ Percentage of women in need and aware of female condoms (DHS): ○ Sexually active women 15–59 years (excluding female CSWs): 50% ○ Female CSWs: 90% ▪ Percentage of women who are aware and use/access female condoms (DHS, local studies, expert opinion) : ○ Sexually active women 15–59 years (excluding female CSWs): 60% ○ Female CSWs: 80% ▪ Percentage of clients accessing female condoms by source: ○ Sexually active women 15–59 years (excluding female CSWs) (DHS): public sector (DHS): 25%; social marketing sector: 45% ○ Female CSWs: public sector: 35%; social marketing sector: 55% (from DHS, local studies) ▪ Quantity of female condoms used per woman per year (CYP factor) ○ Sexually active women 15–59 years (excluding female CSWs) (global average used as proxy): 120 ○ Female CSWs (local studies): 150 Calculate the quantities of female condoms required over the next two years Page | 27 PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 Number of CSWs with a need for female condoms (F) F = D x % CSWs with a need for female condoms 10% 1,680 1,714 1,748 Number of sexually active women 15–59 years excluding CSWs who are aware of female condoms (G) G = E x % sexually active women 15–59 years aware of female condoms 50% 4,270 4,355 4,443 Number of CSW who are aware of female condoms, per year (H) H = F x % CSWs aware of female condoms 90% 1,512 1,542 1,573 Number of sexually active women 15–59 years excluding CSWs who are aware of and use/have access to female condoms (I) I = G x % sexually active women 15–59 years who use female condoms 60% 2,562 2,613 2,666 Number of CSW who are aware of and use/have access to female condoms (J) J = H x % of CSWs who use female condoms 80% 1,210 1,234 1,258 Number of sexually active women 15–59 years excluding CSWs who have access to female condoms by sector (K) K1 = I x % with access from the public sector 25% 641 653 666 K2 = I x % with access from the social marketing sector 45% 1,153 1,176 1,199 Number of CSWs who have access to female condoms by sector (L) L1 = J x % with access from the public sector 35% 423 432 440 L2 = J x % with access from the social marketing sector 55% 665 679 692 Quantity of female condoms required by sexually active women 15–59 years excluding CSWs by sector (N) M = CYP 120 215,208 219,512 223,902 Public sector (N1) = M x K1 76,860 78,397 79,965 Social marketing sector (N2) = M x K2 138,348 141,115 143,937 Quantity of female condoms to be used/required by CSWs by sector (P) O = Average number of female condoms used per CSW per year 150 163,296 166,562 169,893 Public sector (P1) = O x L1 63,504 64,774 66,070 Social marketing sector (P2) = O x L2 99,792 101,788 103,824 Quantity of female condoms needed in the public sector per year (Q1) Sum of public sector requirements (Q1) = N1 + P1 140,364 143,171 146,035 Quantity of female condoms needed in the social marketing sector per year (Q2) Sum of social marketing sector requirements (Q2) = N2 + P2 238,140 242,903 247,761 Total quantity of female condoms needed in public and social marketing sectors per year (R) Sum of public and social marketing sector requirements (R) = Q1 + Q2 378,504 386,074 393,796 Notes: ▪ This is an example to show how the algorithm can be translated to calculations using an Excel tool. Quantification teams need to adapt the Excel tool and the examples provided to their context. Page | 28 REFERENCES 1. World Health Organization. https://www.who.int/reproductivehealth/topics/family_planning/contraceptive_prevalence/en/ 2. UN (2019) Family Planning and the 2030 Agenda for Sustainable Development Data Booklet United Nations Department of Economic and Social Affairs 3. USAID | DELIVER PROJECT, Task Order 4. 2011. Quantification of Health Commodities: Contraceptive Companion Guide. Forecasting Consumption of Contraceptive Supplies. Arlington, Va.: USAID | DELIVER PROJECT, Task Order 4. Available at: https://apps.who.int/medicinedocs/documents/s21863en/s21863en.pdf 4. ICEC 2018 Emergency contraceptive pills. Medical and Service Delivery Guidance. Available at: https://www.cecinfo.org/wp-content/uploads/2018/12/ICEC-guides_FINAL.pdf 5. Emergency contraception. World Health Organization. World Health Organization; 2018. Available at: http://www.who.int/mediacentre/factsheets/fs244/en/ 6. International Consortium for Emergency Contraception. Available at: https://www.cecinfo.org/country-by- country-information/status-availability-database/ec-knowledge-and-ever-use-among-women-of-reproductive- age-by-country/# 7. Medical eligibility criteria for contraceptive use, 5th edition, 2015. Available at: https://apps.who.int/iris/bitstream/handle/10665/181468/9789241549158_eng.pdf 8. Family Planning and Reproductive Health Indicators Database: Family Planning Couple-years of protection (CYP). Available at: https://www.measureevaluation.org/prh/rh_indicators/family-planning/fp/cyp 9. The RESPOND Project 2014. Reality Check: A planning and advocacy tool for strengthening family planning programs: Version 3. User’s Guide. New York, EngenderHealth. Available at: http://www.respond- project.org/archive/files/4/4.1/4.1.4/RealityCheck-Files/Reality-Check-User-Guide-Version3.pdf 10. Polis CB et al., 2016 Contraceptive Failure Rates in the Developing World: An Analysis of Demographic and Health Survey Data in 43 Countries, New York: Guttmacher Institute. Available at: https://www.guttmacher.org/report/contraceptive-failure-rates-in-developing-world 11. WHO/UNFPA (2019) Recommendations for condom storage and shipping temperatures. Available at: https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS19_804_condom_storage_and_s hipping_temperatures.pdf?ua=1 12. USAID Global Health Supply Chain Program-Procurement and Supply Management Single Award IDIQ. 2018. Contraceptive Security Indicators Report. Washington, D.C.: Chemonics International Inc. Available at: https://www.ghsupplychain.org/sites/default/files/data/FullReport.pdf https://www.who.int/reproductivehealth/topics/family_planning/contraceptive_prevalence/en/ https://apps.who.int/medicinedocs/documents/s21863en/s21863en.pdf http://www.who.int/mediacentre/factsheets/fs244/en/ https://www.cecinfo.org/country-by-country-information/status-availability-database/ec-knowledge-and-ever-use-among-women-of-reproductive-age-by-country/%23 https://www.cecinfo.org/country-by-country-information/status-availability-database/ec-knowledge-and-ever-use-among-women-of-reproductive-age-by-country/%23 https://www.cecinfo.org/country-by-country-information/status-availability-database/ec-knowledge-and-ever-use-among-women-of-reproductive-age-by-country/%23 https://www.measureevaluation.org/prh/rh_indicators/family-planning/fp/cyp http://www.respond-project.org/archive/files/4/4.1/4.1.4/RealityCheck-Files/Reality-Check-User-Guide-Version3.pdf http://www.respond-project.org/archive/files/4/4.1/4.1.4/RealityCheck-Files/Reality-Check-User-Guide-Version3.pdf https://www.guttmacher.org/report/contraceptive-failure-rates-in-developing-world https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS19_804_condom_storage_and_shipping_temperatures.pdf?ua=1 https://www.who.int/medicines/areas/quality_safety/quality_assurance/QAS19_804_condom_storage_and_shipping_temperatures.pdf?ua=1 https://www.ghsupplychain.org/sites/default/files/data/FullReport.pdf Page | 29 2. POSTPARTUM HEMORRHAGE: PREVENTION, DIAGNOSIS, AND TREATMENT INTRODUCTION Globally, obstetric hemorrhage is the leading cause of maternal mortality, accounting for 27% of all maternal deaths. Most of these deaths are due to PPH and occur in LMICs.1 PPH is commonly defined as a blood loss of 500 ml or more within 24 hours after birth.2 It is difficult to predict who will have PPH based on risk factors; two-thirds of women who have PPH present no risk factors.3 Therefore, all women are considered at risk, and prevention must be incorporated into care provided at every birth. WHO2 affirms that the majority of PPH-associated complications and deaths could be avoided through the use of prophylactic uterotonics during the third stage of labor regardless of mode of birth (vaginal birth or caesarean section) or birth setting (hospital or community setting). Even with the provision of prophylaxis, women may develop PPH. A recently published Cochrane review estimates that 24% of pregnant women experience PPH without prophylaxis, and that prophylactic oxytocin given during the third stage of labor reduces the incidence by half to 12%.4, WHO also recommends treatment of PPH with a therapeutic uterotonic and intravenous tranexamic acid (TXA), supplemented by additional interventions based on the cause of the bleeding and the woman’s clinical status. With recent innovations and WHO recommendations, there are now more medication options to prevent and treat PPH. However, countries must determine the appropriate interventions for use at the community, primary, and referral levels. WHO2 recommends oxytocin, HSC, misoprostol, ergometrine/methylergometrine, or oxytocin and ergometrine fixed-dose combination to manage PPH, but in settings where multiple options are available, WHO recommends the use of oxytocin. In settings where oxytocin is unavailable or its quality cannot be guaranteed, use of another effective uterotonic is recommended. The WHO CHAMPION trial, conducted across 10 countries between 2015 and 2018, found that HSC “was noninferior to oxytocin for the prevention of blood loss of at least 500 ml or the use of additional uterotonic agents.”5 WHO updated its recommendations for PPH treatment in 2017 to include TXA6 and its recommendations for PPH prevention in 2018 to include HSC.2, drawing on the CHAMPION trial and a 2018 Cochrane review7. Comprehensive management of PPH requires prompt detection and diagnosis. The use of calibrated drapes has been shown to substantially improve the early detection of PPH8,9,10 and, when paired with the WHO first- response treatment bundle, as in the E-MOTIVE trial in Kenya, Nigeria, Tanzania, and South Africa, can lead to timely treatment and improved outcomes.11 Page | 30 Figure 5: A diagram of the E-MOTIVE intervention In 2023, WHO published new guidance on the assessment and treatment of PPH,1 with two major recommendations: 1. “For all women giving birth, routine objective measurement of postpartum blood loss is recommended to improve the detection and prompt treatment of postpartum hemorrhage. Methods to objectively quantify blood loss, such as calibrated drapes for women having vaginal birth, can achieve this.” 2. “A standardized and timely approach to the management of PPH, comprising an objective assessment of blood loss and use of a treatment bundle supported by an implementation strategy, is recommended for all women having a vaginal birth. The care bundle for the first-line treatment of PPH should include rapid institution of uterine massage, administration of an oxytocic agent and tranexamic acid, intravenous fluids, examination of the genital tract and escalation of care.” PRODUCT CHARACTERISTICS AND OTHER FORECASTING CONSIDERATIONS OXYTOCIN Oxytocin is an injectable medicine that is recommended as the medicine of choice for prevention and treatment of PPH at HFs.12 It is more effective and safer than misoprostol for both prevention and treatment of PPH. MISOPROSTOL Misoprostol is taken orally in tablet form for prevention and/or treatment of PPH and is recommended in settings where skilled health personnel are not present to administer injectable uterotonics (such as home births), where maintaining cold chain is difficult (such as in HFs where cold chain is not available), and where oxytocin is unavailable or its quality cannot be guaranteed. Advance distribution of misoprostol for self- administration has been adapted in some countries where country guidelines and policies allow. https://www.birmingham.ac.uk/research/bctu/trials/womens/emotive/e-motive Page | 31 HSC Carbetocin is a long-acting synthetic analogue of oxytocin, and both heat-stable and non-heat stable formulations are available.2 It is an injectable medicine. The use of the heat stable form (HSC) for prevention of PPH is recommended in settings where cost is comparable to other effective uterotonics and where oxytocin is unavailable or its quality cannot be guaranteed (including where it is difficult to maintain cold chain).2 TXA TXA is an injectable coagulant and antifibrinolytic agent. Early use of intravenous TXA (within three hours of birth) in addition to standard care with uterotonics,a is recommended for women with clinically diagnosed PPH following vaginal birth or caesarean section as reinforced in the recently updated guidelines from WHO.1 CALIBRATED DRAPES Calibrated drapes are medical devices, consisting of drapes with calibrated funnel-shaped blood collection pouches, used to objectively measure blood loss after vaginal childbirth, aiding in the early detection of PPH. The drapes are placed under the buttocks of the laboring woman and unrolled after the baby is born to capture blood in a calibrated pouch. The collection pouch is frequently marked at 50ml intervals and can include trigger marks at 300 ml and 500 ml to guide the timely detection and treatment of PPH. Calibrated drapes are being manufactured in multiple countries in Africa and Asia including India, Kenya, Nigeria, and South Africa. There are no standard specifications for calibrated drapes, with variations seen in their design and the materials used, although target product profiles for drapes and blood loss measurement are currently being developed by UNICEF and the Concept Foundation. Given the importance of calibrated drapes for the detection and diagnosis of PPH, quality (e.g., materials used, non-leakage) must be considered as a key element of the selection criteria for procurement. To give an idea of the price of drapes, as the product is not yet included in UNICEF or UNFPA catalogues, it is estimated to be within the range of $0.50-$1, excluding shipment costs,13 but actual prices will depend on the quotes and terms procurers are given. Some calibrated drapes have detachable components, and there is some interest in exploring reusable components and materials. Currently, other blood loss measurement products exist in addition to calibrated drapes.14 For example, a reusable drape with detachable disposable pouch or a reusable calibrated obstetric tray. The available evidence on postpartum blood loss measurement is largely from trials that used calibrated drapes, which this guidance focuses on. a Should not be administered with oxytocin from the same iv bag, as mixing certain oxytocin and TXA products before administration may reduce the concentration of oxytocin, leading to under-dosing – further analysis is being conducted Page | 32 IMPORTANT NOTES: ◼ Since the use of HSC for prevention of PPH and TXA for treatment of PPH administered together with uterotonics and the use of calibrated drapes for detection of PPH are recent recommendations by WHO, 2 the quantification team will need to develop and agree on assumptions for initial adoption/demand and about the factors and interventions that may affect future changes in demand for these products. This may also apply to misoprostol, not so new, but which may still be being scaled up in some settings. Introduction and scale up of new products is a long process; for example, medicines need to go through the process of registration, guidelines need to be updated and disseminated, training materials need to be updated, and health care workers need to be trained. ◼ Table 6 presents the key characteristics and health system considerations for each of the medicines. For more detailed information on oxytocin and misoprostol, refer to the chapter in the “Manual for procurement and supply of quality assured MNCH commodities.”15 ◼ Table 7 presents the key characteristics and health system considerations for calibrated drapes. ◼ In addition, uterine balloon tamponades16 and nonpneumatic antishock garments can be used to control bleeding and stabilize women suffering from obstetric hemorrhage and shock in PPH cases and who are not responding to standard first line treatment. Country teams are advised to consider both in their quantifications according to national policy. Page | 33 Table 6: Summary of product characteristics: Oxytocin, HSC, TXA, and Misoprostol PARAMETER OXYTOCIN HSC TXA MISOPROSTOL Prevention of PPH: Dosage 1 amp of 10 IU per case 1 amp of 100 mcg per case Not indicated 400 mcg or 600 mcg per case (2–3 tabs of 200 mcg) Treatment of PPH: Dosage Up to 4 amp of 10 IU per case Not indicated 1 amp of 1 g per case (as an adjunct treatment in addition to uterotonic) 800 mcg per case (4 tabs of 200 mcg) Presentation 10 IU in 1 ml amp; 5 IU in 1 ml amp 100 mcg in 1 ml amp 1 g in 1 ampoule of 10 ml 500 mg in 1 ampoule of 5 ml 200 mcg oral tablets Administration IM or IV IV*, simultaneously with uterotonics but not to be mixed in the same IV infusion bag as oxytocin due to potential reduction in concentration of oxytocin18 Orally for PPH prevention and treatment Storage condition Store at 2°C to 8°C (in cold chain)17 Store at or below 40°C for up to 6 months; or at or below 30°C for longer periods Store at or below 25°C Store at or below 25°C Must be packaged in double aluminum blisters; is sensitive to humidity Additional supplies required for administration IV infusion set (for IV only), syringes, needles, and alcohol swabs Level of use HFs where appropriately skilled health personnel and infrastructure are present Suitable for oral administration during home deliveries or in low-level HFs where there is no cold chain available Supply chain considerations19 Requires functional cold chain Shelf life of 18–48 months Procure in 10 IU amp rather than 5 IU amp to minimize complexity and maximize efficiency, as unit costs are the same Does not require cold chain Shelf life of 36 months Does not require cold chain Shelf life of 36 months Does not require cold chain Shelf life of 24 months In blisters of 3 tablets for prevention and blisters of 4 tablets for treatment Additional comments19 Not indicated for postabortion care Not indicated for treatment of PPH** or postabortion care. It is contra-indicated for labor induction or augmentation of labor Not indicated for prevention of PPH, labor induction, augmentation of labor, or postabortion care Contra-indicated for augmentation of labor * There is ongoing work studying the efficacy of IM TXA for prevention of PPH. If found efficacious, IM TXA would then be suitable for deliveries in low-level HFs as well. ** A current study, expected to end in 2027, is evaluating the efficacy of HSC for treatment of PPH. Until the efficacy is confirmed, HSC should ONLY be used for PREVENTION of PPH. Page | 34 Table 7: Summary of product characteristics: Calibrated drapes PARAMETER CALIBRATED DRAPES Recommended uses • Objective measurement of blood loss after delivery to determine PPH Components/features • Single-piece drape - Blood collection pouch often marked at 50ml intervals that can include trigger marks at 300 mL and 500 mL - Straps, ties, or adhesive to keep drape in place Administration • Placed under buttocks of the laboring woman in a delivery bed in a health facility and unrolled after the baby is born Storage condition • Clean, dry, able to withstand ambient temperatures - no cold chain storge required Additional supplies required for administration • Delivery bed, IV fluids, safe delivery supplies, disinfectants • Uterotonics and tranexamic acid if PPH is diagnosed Level of use • Delivery suite in health centers or hospitals Other supply chain considerations • Rate of wastage/damage • Proper disposal through standard biohazard disposal procedures • Shelf life of calibrated drapes is typically a minimum of 2 years under standard storage conditions IMPORTANT NOTES: ◼ Quantification teams are advised to consider several factors in selecting the appropriate regimens/medicine for the appropriate level of use. Such factors include national treatment policies, cold chain availability, consistency and capacity, training and qualifications of health care workers available at each level of care, and availability of equipment. For example, misoprostol oral tablets would be the best choice for community-level or lower-level HFs where cold chain capacity is not available or is not consistently functional, where appropriately skilled health personnel and equipment are not present, and/or inpatient care is not possible. On the other hand, oxytocin is preferred at hospitals where cold chain capacity is usually adequate, trained professionals and equipment are available, and inpatient care is possible. HSC can be used at HFs where trained professionals and equipment are available, but where cold chain is not available or is not consistently functional. More details on consideration for selection of regimens/medicines by level of care is available from “Uses of Medicines for Prevention and Treatment of Post-partum Hemorrhage and Other Obstetric Purposes.”19 REQUIRED DATA AND POTENTIAL SOURCES: MORBIDITY METHOD OF FORECASTING A number of data points are required to forecast demands of medicines and supplies recommended for the prevention, diagnosis, and treatment of PPH. Table 8 summarizes the main data types and potential sources for the morbidity method of forecasting of uterotonics, TXA, and calibrated drapes, in addition to the relevant common data on population, proportion of pregnant women, and proportion of deliveries by level and sector provided in the introduction of Table 1 of this supplement. Page | 35 Table 8: Data and potential sources for forecasting of uterotonics, TXA, and calibrated drapes using morbidity method DATA FOR USE IN CALCULATION OF SOURCE NOTES MEDICINES DRAPES Miscarriage rate.17* X X DHS, HMIS, national maternal morbidity and mortality surveys, special surveys DHS data may be outdated; HMIS data may not be complete; may need to apply estimated annual growth/reduction rate Proportion/number of public HF and home deliveries (separately) that are provided uterotonics for prevention of PPH X Proportion/number of public HF and home deliveries (separately) that are not provided uterotonics for prevention of PPH** X Proportion/number of public HF vaginal deliveries*** X Proportion/number of public HF vaginal deliveries that are provided calibrated drapes for diagnosis of PPH X Incidence/number of PPH among deliveries without prevention by level of care (incidence without prevention) X Incidence/number of PPH among deliveries with prevention of PPH by level of care (incidence after prevention) X Proportion/number of women with PPH with prevention of PPH that seek care from the public health facilities X Proportion/number of women with PPH without prevention of PPH that seek care from the public health facilities X Type and respective proportion of regimens/medicines given for prevention and/or treatment of PPH in the public health sector X HMIS, national maternal morbidity and mortality surveys, special surveys; national STG, WHO STG HMIS data may not be complete; actual practice may be different from STGs; need to consider expert opinion and program/ strategic plans Type and respective proportion of calibrated drapes used for diagnosis of PPH in the public health facilities X Quantity of each medicine (specific formulation and dosage) used for the prevention and/or treatment of PPH per case X National STG, WHO STG, expert opinion, programmatic/strategic plans Guidelines may be outdated; may not include new WHO recommendations; actual practice may be different from STGs, consider the actual practice if guidelines are relatively old and not followed *Miscarriage rate is the percentage of pregnancies lost within the first 28 weeks of gestation. Page | 36 **There could be many reasons for not providing prevention doses, including noncompliance to treatment recommendations, unavailabilit y of products, and refusal by pregnant women. Quantification teams may reduce the percentage of home deliveries that are not provided with uterotonics for prevention of PPH. It could be 0% if there is clear indication that the proportion given uterotonics is close to 100%. *** Calibrated drapes are used only in vaginal deliveries and not for cesarean section deliveries. Page | 37 CALCULATION ALGORITHMS TO FORECAST MEDICINES FOR PREVENTION AND TREATMENT OF PPH AND DEVICES FOR DIAGNOSIS OF PPH Conventional morbidity method calculations are applied to forecast medicines for prevention and treatment of PPH as well as single-use (disposable) calibrated drapes. Figures 6 to 8 below provide the algorithms that can be followed to calculate the forecast requirements. Figure 6: Forecasting algorithm for medicines used for prevention of PPH based on morbidity method Page | 38 Figure 7: Forecasting algorithm for medicines used for treatment of PPH based on morbidity method Page | 39 IMPORTANT NOTES: ◼ To get the total requirements of each medicine for both prevention and treatment of PPH, add the requirement for prevention and treatment (i.e., L [from figure 6] + X [from figure 7]). For example, oxytocin 10 IU amp = L1 + X1. ◼ Assumptions need to be made on how much HSC will be used compared to oxytocin for PPH prevention. One approach is to estimate the number of women giving birth in the health facilities without cold chain equipment and use this to determine the proportion and quantity of HSC to be used. ◼ While the forecasting guidance provided here is specifically to calculate the need for management of PPH, the products are also used for other purposes. For example, on average, an estimated 9.6% of pregnancies per year are induced and may require oxytocin or misoprostol.20 ◼ In addition, up to 20% of pregnancies may require oxytocin for augmentation of labor. Countries should take these and other uses of the products into account when preparing forecasts. The same logic used in forecasting the need for management of PPH will apply for these other uses as well. ◼ Similarly, TXA is used for non-PPH conditions such as prevention of bleeding after trauma. The quantity calculated here should be added to whatever is needed for other uses. ◼ While these algorithms provide an approach to estimate projected needs of medical products to diagnose, prevent and treat PPH, they are based on the assumption that the products that will be procured, distributed, and used are quality assured to ensure optimal patient outcomes and efficient resource use. Without quality assurance, achieving similar positive patient outcomes and resource efficiency will not be possible. Page | 40 Figure 8: Forecasting algorithm for single-use calibrated drapes used for diagnosis of PPH based on morbidity methodb b If reusable devices are used in a country, the forecast will be based on the daily number of facility deliveries, the time required to disinfect each reusable tray, and the device's lifespan. Page | 41 PROXY DATA AND SOURCES If local data are not available, quantification teams may use the following data as proxy. Table 9: Average quantity of medicines per case MEDICINE DOSAGE QUANTITY PER CASE A Oxytocin 10 IU per ampoule Prevention: 10 IU Treatment: Up to 40 IU 1 ampoule Up to 4 ampoules B Misoprostol 200 mcg tablet Prevention: 600 mcg Treatment: 800 mcg 3 tablets 4 tablets C HSC 100 mcg in 1 ml amp Prevention: 100 mcg 1 ampoule D TXA 1 g in 1 ampoule of 10 ml Treatment: 1 g 1 ampoule Table 10: Summary of incidence rates IMPORTANT NOTE: ◼ Quantification teams are advised to consult the provided reference for the proxy data as many contain country - or region-specific information that can be applied to the specific region or country under consideration, rather than relying on global averages. ◼ It is possible that with the increased use of drapes, there may be a resultant increase or reduction in the number of diagnosed cases of PPH depending on whether there is currently an overestimation or underestimation based on current empiric practices. For example, in the E-MOTIVE trial, PPH detection was less in the intervention group (8.5%) with use of drapes than in the control group (16.7%)11. ◼ In some cases, repeated doses may need to be administered to achieve clinical outcomes – quantification teams are advised to use local experience to inform the forecast as appropriate. PARAMETER VALUE A Miscarriage rate (%)21 10%–15% B Incidence of PPH in pregnant women who have received prophylaxis 5% C Incidence of PPH in pregnant women without prophylaxis4 10% D Vaginal delivery rate Cesarean section rate (%)22 95–85% (5–15%) Page | 42 EXAMPLES BOX 4. EXAMPLE OF COUNTRY FORECAST FOR PREVENTION AND TREATMENT OF PPH Country X recommends the use of oxytocin OR HSC for prevention of PPH for facility deliveries, and oxytocin AND tranexamic acid (TXA) for treatment of PPH cases identified or referred to its HFs. In country X, misoprostol is recommended for prevention of PPH for home deliveries only. CHWs are recommended to refer cases of PPH to HFs. Available data and assumptions ▪ Total population as of current year (CSO census): 20,000,000 ▪ Population growth rate per year: 2% ▪ % of pregnant women out of total population: 4% ▪ Miscarriage rate: 10% ▪ % of deliveries in public HFs: 50%, with annual increase of 4 percentage points (54% in year 1 and 58% in year 2) ▪ % of home deliveries: 45%, with annual reduction of 4 percentage points (41% in year 1 and 37% in year 2) ▪ % of home deliveries provided with prevention for PPH in the current year is estimated to be 30%; expected to grow to 35% and 40% in years 1 and 2, respectively ▪ Compliance to the PPH prevention recommendations for HF births (use of oxytocin OR HSC) in the current year is estimated to be 80%; expected to grow to 85% and 90% in years 1 and 2, respectively ▪ In the current year, 60% and 40% of the HF deliveries are estimated to be given preventive oxytocin and HSC, respectively. The country plans to increase the HF level use of HSC by 10% points annually and reduce that of oxytocin for prevention of PPH by the same magnitude. ▪ Compliance to the PPH prevention recommendations for home births (use of misoprostol) in the current year is estimated to be 30%; expected to grow to 35% and 40% in years 1 and 2, respectively ▪ Incidence of PPH in women who were not given uterotonics for prevention of PPH is 24% (global average) ▪ Incidence of PPH in women who were given uterotonics for prevention of PPH is 12% (global average) ▪ Referral of home deliveries with PPH: 85% ▪ Compliance to PPH treatment recommendations (use of oxytocin AND TXA) in the current year is estimated to be 96%; expected to grow to 98% and 100% in years 1 and 2, respectively ▪ Available formulations: o Oxytocin: 10 IU ampoule o HSC: 100 microgram ampoule o Misoprostol: 200 micrograms tablet o Tranexamic acid: 1 gram ampoule ▪ Dosage recommendations per one women/case (from the national STG) o Oxytocin for prevention of PPH: 10 IU (1 ampoule) o HSC for prevention of PPH: 100 mcg (1 ampoule) o Misoprostol for prevention of PPH: 600 micrograms (3 tablets) o Oxytocin for treatment of PPH: 40 IU (4 ampoules) o Tranexamic acid for treatment of PPH: 1 gram (1 ampoule) Calculate the quantities of oxytocin 10 IU ampoules, misoprostol 200 microgram tablets, HSC 100 mcg ampoules and TXA ampoules required by the program (in the public health sector) for the two-year forecast period. Page | 43 Example: Prevention of PPH PARAMETER INPUT CURRENT YEAR* FORECAST YEAR 1 FORECAST YEAR 2 Total population (A) A: Population = previous year* population + (previous year population x PGR) (annual PGR is 2%) 2% 20,000,000 20,400,000 20,808,000 Total pregnancies (B) B = A x % of pregnant women out of total population 4% 800,000 816,000 832,320 Total deliveries (C) C = B x (100 % - miscarriage rate in %) (miscarriage rate of 10%) 10% 720,000 734,400 749,088 Number of public HF deliveries (D) D = C x % of deliveries in public HFs (annual increase in compliance of 4%) 4% 360,000 396,576 434,471 50% 54% 58% Number of public HF deliveries provided with prevention for PPH (E) E = D x % compliance (annual increase in compliance of 5%) 5% 288,000 337,090 391,024 80% 85% 90% Number of public HF deliveries given oxytocin for prevention of PPH (F1) F1 = E x % of deliveries given oxytocin (annual decrease of 10%) -10% 172,800 168,545 156,410 60% 50% 40% Number of public HF deliveries given HSC for prevention of PPH (F2) F2 = E x % of deliveries given HSC (annual increase of 10%) 10% 115,200 168,545 234,614 40% 50% 60% Number of home deliveries (G) G = C x % of home deliveries (annual decrease of 4%) -4% 324,000 301,104 277,163 45% 41% 37% Number of home deliveries provided with misoprostol for prevention of PPH (H) H = G x % compliance (annual increase in compliance of 5%) 5% 97,200 105,386 110,865 30% 35% 40% Quantity of oxytocin 10 IU ampoules needed for prevention of PPH (J1) J1 = F1 x I1; where I1: # of ampoules needed per case for prevention = 1 x 10 IU = 1 ampoule of 10 IU 1 172,800 168,545 156,410 Quantity of HSC 100 mcg ampoules needed for prevention of PPH (J2) J2 = F2 x I2; where I2: # of ampoules needed per case for prevention = 1 x 100 mcg = 1 ampoule of 100 mcg 1 115,200 168,545 234,614 Quantity of misoprostol 200 mcg tablet needed for prevention of PPH (K) K = H x I3; where I3: # of tablets needed per case for prevention = 3 x 200 mcg = 3 tablets of 200 mcg 3 291,600 316,159 332,595 Total quantity of oxytocin 10 IU ampoules needed for prevention of PPH (L1) L1 = J1 172,800 168,545 156,410 Total quantity of HSC 100 mcg ampoules needed for prevention of PPH (L2) L2 = J2 115,200 168,545 234,614 Total quantity of misoprostol 200 mcg tablet needed for prevention of PPH (L3) L3 = K 291,600 316,159 332,595 Page | 44 *For the population for the current year, insert the total population from our respective source, and population figures for forecast year 1 and forecast year 2 are calculated based on the previous year population and the annual PGR. For example, the population for forecast year 1 is calculated by multiplying the population in the current year (i.e., the previous year to forecast year 1) by the annual PGR. Example: Treatment of PPH PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 Number of public HF deliveries NOT provided with prevention for PPH (M) M = D x % of facility deliveries that do NOT receive prevention (annual reduction in noncompliance of 5%) -5% 72,000 59,486 43,447 20% 15% 10% Number of public HF deliveries that develop PPH after prevention (N) N = E x % of deliveries that develop PPH after prevention (incidence of PPH after prevention) 12% 34,560 40,451 46,923 Number of public HF deliveries that develop PPH without prevention (O) O = M x % of deliveries that develop PPH without prevention (incidence of PPH without prevention of 10%) 24% 17,280 14,277 10,427 Number of public HF PPH cases treated (P) P = (N + O) x % compliance (annual increase in compliance of 2%) 2% 49,766 53,633 57,350 96% 98% 100% Number of home deliveries NOT provided with prevention for PPH (Q) Q = G x % of home deliveries that do NOT receive prevention (annual reduction in noncompliance of 5%) -5% 226,800 195,718 166,298 70% 65% 60% Number of home deliveries that develop PPH after prevention (R) R = H x % of deliveries that develop PPH after prevention (incidence of PPH after prevention of 5%) 12% 11,664 12,646 13,304 Number of home deliveries that develop PPH without prevention (S) S = Q x % of deliveries that develop PPH without prevention (incidence of PPH without prevention) 24% 54,432 46,972 39,911 Number of home PPH cases referred to public HFs (T) T = (R + S) x % of home PPH cases referred to public HFs 85% 56,182 50,676 45,233 Number of home PPH cases treated at public HFs (U) U = T x % compliance (annual increase in compliance of 2%) 2% 53,934 49,662 45,233 96% 98% 100% Number of PPH cases given oxytocin for treatment (V1) V1 = (P+U) x % given oxytocin 100% 103,701 103,295 102,583 Number of PPH cases given TXA for treatment (V2) V2 = (P+U) x % given TXA 100% 103,701 103,295 102,583 Page | 45 PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 Quantity of oxytocin 10 IU ampoules needed for treatment of PPH cases (X1) X1 = V1 x W1; where W1: # of ampoules needed per case for treatment = 4 ampoules 4 414,803 413,181 410,332 Quantity of TXA 1g ampoules needed for treatment of PPH cases (X2) X2 = V2 x W2; where W2: # of ampoules needed per case for treatment = 1 ampoule 1 103,701 103,295 102,583 Total Quantities for PPH PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 Total quantity of oxytocin 10 IU ampoules needed for PPH (Y1) Y1 = L1+X1 587,603 581,726 566,742 Total quantity of HSC 100 mcg ampoules needed for PPH (Y2) Y2 = L2 115,200 168,545 234,614 Total quantity of misoprostol 200 mcg tablets needed for PPH (Y3) Y3 = L3 291,600 316,159 332,595 Total quantity of TXA 1 g ampoules needed for PPH (Y4) Y4 = X2 103,701 103,295 102,583 IMPORTANT NOTES: ◼ Quantities of the same product needed for prevention and treatment are added to obtain the total need of each medicine for PP H management. ◼ This is an example to show how the algorithm can be translated to calculations using an Excel tool. Quantification teams need to adapt the Excel tool and the examples provided to their context. Page | 46 Example: Single-use (disposable) calibrated drapes to diagnose PPH PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 Total population (A) A: Population = previous year population + (previous year population x PGR) (annual PGR is 2%) 2% 20,000,000 20,400,000 20,808,000 Total pregnancies (B) B = A x % of pregnant women out of total population 4% 800,000 816,000 832,320 Total deliveries (C) C = B x (100 % - miscarriage rate in %) (miscarriage rate of 10%) 10% 720,000 734,400 749,088 Number of public HF deliveries (D) D = C x % of deliveries in public HFs (estimated annual increase in public facility delivery of 4%) 4% 360,000 396,576 434,471 50% 54% 58% Number of public HF vaginal deliveries (E) E = D x % of vaginal deliveries in the public HFs (estimated annual reduction in public HF vaginal deliveries of 2%) 2% 324,000 348,987 373,645 90% 88% 86% Number of public HF deliveries provided with calibrated drapes for PPH diagnosis (F) F = E x % compliance (estimated annual increase in usage of 20%) 20% 129,600 209,392 298,916 40% 60% 80% BOX 5. EXAMPLE OF COUNTRY FORECAST FOR CALIBRATED DRAPES Country X recommends the use of single-use (disposable) calibrated drapes for diagnosis of PPH for health facility deliveries. Available data and assumptions • Total population as of current year (CSO census): 20,000,000 • Population growth rate per year: 2% • % of pregnant women out of total population: 4% • Miscarriage rate: 10% • % of deliveries in public HFs: 50%, with annual increase of 4 percentage points (54% in year 1 and 58% in year 2) • % of vaginal deliveries in the public HFs is assumed to be 90% in the current year with expected annual 2% points decrease (88% in year 1 and 86% in year 2). Meaning, cesarean section deliveries at the public HFs are estimated at 10% in the current year with estimated annual increase by 2% points. • Compliance to the use of disposable calibrated drapes for diagnosis of PPH among women giving birth at public health facilities in the current year is estimated to be 40%; expected to grow to 60% and 80% in years 1 and 2, respectively (i.e., annual increase of 20% points per year) • Available presentation of drapes: o Single-use (disposable) calibrated drapes calibrated at 300ml and 500ml • One drape is used per woman delivering Calculate the quantities of single-use (disposable) calibrated drapes required by the program (in the public health sector) for the two-year forecast period. Page | 47 PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 Quantity of disposable calibrated drapes needed for diagnosis of PPH (H) H = F x G; where G: # of Disposable Calibrated Drapes needed per case for diagnosis of PPH = 1 Disposable Calibrated Drape 1 129,600 209,392 298,916 Note: This is an example to show how the algorithm can be translated to calculations using an Excel tool. Quantification teams need to adapt the Excel tool and the examples provided to their context. The increase in usage of drapes may not increase in a linear fashion, i.e., the same percentage increase each year. Countries will need to review this as part of the forecast review. Page | 48 REFERENCES: 1. WHO recommendations on the assessment of postpartum blood loss and treatment bundles for postpartum. World Health Organization, 2023. Available at: https://iris.who.int/bitstream/handle/10665/375231/9789240085398-eng.pdf?sequence=1 2. WHO recommendations for the prevention of postpartum hemorrhage. World Health Organization, 2018. Available at: https://apps.who.int/iris/bitstream/handle/10665/277276/9789241550420-eng.pdf?ua=1 3. Sheldon W, Blum J, Vogel JP, Souza JP, Gülmezoglu AM, Winikoff B, WHO Multicountry Survey on Maternal and Newborn Health Research Network. (2014). Postpartum haemorrhage management, risks, and maternal outcomes: findings from the World Health Organization Multicountry Survey on Maternal and Newborn Health. BJOG: An International Journal of Obstetrics & Gynaecology, 121, 5–13 4. Postpartum Prophylactic oxytocin for the third stage of labour to prevent postpartum haemorrhage. Available at: https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD001808.pub3/full 5. Widmer M, Piaggio G, Nguyen TM, et al. Heat-stable carbetocin versus oxytocin to prevent hemorrhage after vaginal birth. New England Journal of Medicine 2018;379(8):743-52. 6. WHO recommendation on tranexamic acid for the treatment of postpartum haemorrhage. World Health Organization, 2017. Available at https://www.who.int/publications/i/item/9789241550154 7. Gallos ID, Papadopoulou A, Man R, Athanasopoulos N, Tobias A, Price MJ, et al. Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis (Review). Cochrane Database Syst Rev. 2018;CD011689. doi: 10.1002/14651858. CD011689.pub3. 8. Web Annex A. Methods of assessing postpartum blood loss for the detection of postpartum haemorrhage: evidence-to-decision framework. In: WHO recommendations on the assessment of postpartum blood loss and use of a treatment bundle for postpartum haemorrhage. Geneva: World Health Organization; 2023. Available at: https://iris.who.int/bitstream/handle/10665/375198/9789240085411-eng.pdf 9. Ambardekar, S., Shochet, T., Bracken, H. et al. Calibrated delivery drape versus indirect gravimetric technique for the measurement of blood loss after delivery: a randomized trial. BMC Pregnancy Childbirth 14, 276 (2014). https://doi.org/10.1186/1471-2393-14-276 10. Diaz V, Abalos E, Carroli G. Methods for blood loss estimation after vaginal birth. Cochrane Database of Systematic Reviews 2018, Issue 9. Art. No.: CD010980. https://doi.org/10.1002/14651858.CD010980.pub2 11. Gallos, I., Devall, A., Martin, J., Middleton, L., Beeson, L., Galadanci, H., Alwy Al-Beity, F., Qureshi, Z., Hofmeyr, G. J., Moran, N., Fawcus, S., Sheikh, L., Gwako, G., Osoti, A., Aswat, A., Mammoliti, K. M., Sindhu, K. N., Podesek, M., Horne, I., Timms, R., … Coomarasamy, A. (2023). Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage. The New England journal of medicine, 389(1), 11–21. https://doi.org/10.1056/NEJMoa2303966 12. WHO recommendations for the prevention and treatment of postpartum haemorrhage. World Health Organization, 2012. Available at: https://apps.who.int/iris/bitstream/handle/10665/75411/9789241548502_eng.pdf 13. Williams, E.V., Goranitis, I., Oppong, R. et al. A cost-effectiveness analysis of early detection and bundled treatment of postpartum hemorrhage alongside the E-MOTIVE trial. Nat Med 30, 2343–2348 (2024). https://doi.org/10.1038/s41591-024-03069-5 14. Esau, J., Morris, T., Muller, C., Els, C., & de Waard, L. (2024). Two Postpartum Blood Collection Devices: The Brass-V Drape and MaternaWell Tray-As Experienced by Birth Attendants and Birthing Women-A https://iris.who.int/bitstream/handle/10665/375231/9789240085398-eng.pdf?sequence=1 https://apps.who.int/iris/bitstream/handle/10665/277276/9789241550420-eng.pdf?ua=1 https://www.cochranelibrary.com/cdsr/doi/10.1002/14651858.CD001808.pub3/full https://www.who.int/publications/i/item/9789241550154 https://iris.who.int/bitstream/handle/10665/375198/9789240085411-eng.pdf https://doi.org/10.1186/1471-2393-14-276 https://doi.org/10.1002/14651858.CD010980.pub2 https://doi.org/10.1056/NEJMoa2303966 https://apps.who.int/iris/bitstream/handle/10665/75411/9789241548502_eng.pdf https://doi.org/10.1038/s41591-024-03069-5 Page | 49 Questionnaire-Based Randomised Study. Obstetrics and gynecology international, 2024, 6605833. https://doi.org/10.1155/2024/6605833 15. Manual for procurement and supply of quality assure maternal newborn and child health commodities. USAID 2019. Available at: https://www.ghsupplychain.org/procurement-and-supply-quality-assured-maternal- newborn-and-child-health-commodities 16. WHO recommendation on Uterine balloon tamponade for the treatment of postpartum haemorrhage World Health Organization, 2021. Available at: https://iris.who.int/bitstream/handle/10665/340796/9789240013841-eng.pdf?sequence=1 17. WHO, n.d. Why we need to talk about losing a baby. Available at: https://www.who.int/news- room/spotlight/why-we-need-to-talk-about-losing-a-baby 18. Pete Lambert, Alessandra Tomazzini, Philip Wright, Claire McEvoy, Ioannis D. Gallos, Anne Ammerdorffer, Lester Chinery, Arri Coomarasamy, Ahmet Metin Gülmezoglu. The compatibility of oxytocin and tranexamic acid injection products when mixed for co-administration by infusion for the treatment of postpartum haemorrhage: An in vitro investigation. Obstetrics & Gynaecology. 2023. Available at: https://obgyn.onlinelibrary.wiley.com/doi/full/10.1111/1471-0528.17398 19. USAID & RHSC Coalition 2019 Uses of medicines for prevention and treatment of post-partum hemorrhage and other obstetric purposes. A summary of information on recommended uses, contraindications and supply chain considerations for program managers and procurement managers. Available at: https://www.rhsupplies.org/uploads/tx_rhscpublications/Uses_of_Medicines_for_Prevention_and_Treatment _of_Post-partum_Hemorrhage_and_Other_Obstertric_Indications.pdf 20. Wei S, Wo BL, Qi HP, Xu H, Luo ZC, Roy C, Fraser WD. Early amniotomy and early oxytocin for prevention of, or therapy for, delay in first stage spontaneous labour compared with routine care. Département d'Obstétrique-Gynécologie, Université de Montréal, Hôpital, Canada. Cochrane Database System. Sept 12, 2012. Available at: http://www.ncbi.nlm.nih.gov/pubmed/22972098 21. Neilson JP, Gyte GM, Hickey M, Vazquez JC, Dou L. Medical treatments for incomplete miscarriage (less than 24 weeks). PMID: 20091626, PMCID: PMC4042279, DOI: 10.1002/14651858.CD007223.pub2. Available at: https://pubmed.ncbi.nlm.nih.gov/20091626/ 22. WHO statement on caesarean section rates. World Health Organization, 2015. Available at: https://iris.who.int/bitstream/handle/10665/161442/WHO_RHR_15.02_eng.pdf https://doi.org/10.1155/2024/6605833 https://www.ghsupplychain.org/procurement-and-supply-quality-assured-maternal-newborn-and-child-health-commodities https://www.ghsupplychain.org/procurement-and-supply-quality-assured-maternal-newborn-and-child-health-commodities https://iris.who.int/bitstream/handle/10665/340796/9789240013841-eng.pdf?sequence=1 https://www.who.int/news-room/spotlight/why-we-need-to-talk-about-losing-a-baby https://www.who.int/news-room/spotlight/why-we-need-to-talk-about-losing-a-baby https://obgyn.onlinelibrary.wiley.com/doi/full/10.1111/1471-0528.17398 https://www.rhsupplies.org/uploads/tx_rhscpublications/Uses_of_Medicines_for_Prevention_and_Treatment_of_Post-partum_Hemorrhage_and_Other_Obstertric_Indications.pdf https://www.rhsupplies.org/uploads/tx_rhscpublications/Uses_of_Medicines_for_Prevention_and_Treatment_of_Post-partum_Hemorrhage_and_Other_Obstertric_Indications.pdf http://www.ncbi.nlm.nih.gov/pubmed/22972098 https://pubmed.ncbi.nlm.nih.gov/20091626/ https://iris.who.int/bitstream/handle/10665/161442/WHO_RHR_15.02_eng.pdf Page | 50 3. PREVENTION AND TREATMENT OF HYPERTENSIVE DISORDERS IN PREGNANCY INTRODUCTION Hypertensive disorders in pregnancy are an important, common, and treatable cause of severe morbidity, long- term disability, and death among both pregnant women and their babies and account for approximately 14% of all maternal deaths worldwide.1 Globally, about 10% of all pregnancies are affected by hypertensive disorders of pregnancy (i.e., gestational hypertension, chronic hypertension, pre-eclampsia, eclampsia).2 In 2018, WHO updated its recommendations on antihypertensive medicines for severe hypertension in pregnancy based on important new evidence. Accordingly, the following two major recommendations were issued:2 1. All pregnant women with severe hypertension should be treated with antihypertensive medicines. 2. The drug of choice and route of administration should be based primarily on the prescribing clinician's experience with the particular medicine, its cost, and its local availability, while ensuring that the medication has no adverse fetal effects. Hypertensive disorders of pregnancy, pre-eclampsia, and eclampsia stand out as major causes of maternal and neonatal mortality and morbidity.2 Generally, the onset of a new episode of hypertension during pregnancy (with persistent diastolic blood pressure >90 mm Hg) and the occurrence of proteinuria (>0.3 g/24 h) is used as the criteria for identifying pre-eclampsia.2 When severe hypertension, substantial proteinuria, or substantial maternal organ dysfunction occur, pre-eclampsia is classified as severe.2 Eclampsia is characterized by generalized seizures in women with pre-eclampsia, given that the seizures are not attributable to other causes, such as epilepsy.2 Pre-eclampsia is present in 4.6% (2–8%) of pregnancies, and it usually becomes apparent in the second half of pregnancy. About 26% of pre-eclampsia cases develop to severe pre-eclampsia.2,3 The incidence of eclampsia in pre-eclamptic pregnancies after treatment with MgSO4 was found to be 0.8%, while 1.9% of those given placebo developed eclampsia,4 showing that prophylaxis with MgSO4 reduces the risk of eclampsia in women with pre-eclampsia by more than 50%. The incidence of eclampsia in the general pregnant population without prophylaxis is 0.5%.5 The 2011 WHO recommendations on using magnesium sulfate, an anticonvulsant, for prevention and treatment of eclampsia2 still apply and include: 1. Use MgSO4 for prevention and treatment of eclampsia in women with severe pre-eclampsia in preference to other anticonvulsants. Capacity for clinical assessment of women and administration of calcium gluconate are essential components of the package of services for the delivery of magnesium sulfate. 2. Use the full intravenous (IV) or intramuscular (IM) magnesium sulfate regimens to prevent and treat eclampsia. HFs using magnesium sulfate should have calcium gluconate available in case of magnesium sulfate toxicity. 3. For settings where it is not possible to administer the full magnesium sulfate regimen, administer loading dose and transfer to a higher-level HF immediately. Page | 51 PRODUCT CHARACTERISTICS AND OTHER FORECASTING CONSIDERATIONS ANTIHYPERTENSIVES Administration of antihypertensive medications can reduce the risk of maternal stroke or cerebrovascular events that occur with severe hypertension in pregnancy. They may also be used for treatment of other hypertensive disorders during pregnancy, including chronic (pre-existing) hypertension. If antihypertensive medication for acute treatment of severe hypertension cannot be used intravenously, oral treatment can be given.6 WHO recommends antihypertensive medications (hydralazine, labetalol, nifedipine immediate-release capsules, or methyldopa) for acute treatment of severe hypertension in pregnancy.6 Note: In this document, guidance is provided only on acute treatment of severe hypertension in pregnancy. Quantification teams need to factor in forecasts of the same or similar medicines for the treatment of chronic hypertension during and after pregnancy as needed and calculate the total requirements. HYDRALAZINE Hydralazine is a vasodilator that lowers blood pressure and allows blood to flow more easily through veins and arteries. For treatment of severe gestational hypertension, the injectable form of the medicine is recommended. METHYLDOPA Methyldopa is an oral antihypertensive medicine that stimulates central alpha-adrenergic receptors, resulting in a decreased sympathetic outflow to the heart, kidneys, and peripheral vasculature. LABETALOL Labetalol lowers blood pressure by decreasing systemic vascular resistance by α1-blockade and at the same time counteracts the reflex tachycardia from vasodilation through its β-blocker effect. Both oral and injectable formulations are recommended for the treatment of severe gestational hypertension. NIFEDIPINE Nifedipine is a calcium channel blocker that inhibits cardiac and vascular smooth muscle contraction, thereby dilating main coronary and systemic arteries. Immediate-release nifedipine capsules are recommended for the treatment of severe gestational hypertension. The immediate release formulations are not widely available in the global market, and calcium channel blockers are not included in the most recent WHO recommendations for use of antihypertensive drugs for nonsevere hypertension in pregnancy because they are reported to probably increase the risk of developing proteinuria and/or pre-eclampsia.7 https://www.sciencedirect.com/topics/medicine-and-dentistry/systemic-vascular-resistance https://www.sciencedirect.com/topics/medicine-and-dentistry/tachyarrhythmia https://www.sciencedirect.com/topics/medicine-and-dentistry/vasodilatation Page | 52 Table 11: Summary of product characteristics: Antihypertensives PARAMETER HYDRALAZINE LABETALOL METHYLDOPA NIFEDIPINE Acute treatment of severe hypertension in pregnancy: Dosage ▪ 5 mg IV slowly, repeat every 5 minutes or 12.5 mg IM every two hours until the blood pressure goal has been achieved ▪ The maximum dose is 20 mg per 24 hours ▪ Assume 3 days of treatment as an average ▪ IV: 10 mg IV, if response is inadequate after 10 minutes, administer 20 mg. The dose can be doubled to 40 mg and then 80 mg with 10-minute intervals between each increased dose until blood pressure is lowered below threshold. The maximum total dose is 300 mg. ▪ Oral: 200 mg, repeat dose after one hour until the treatment goal is achieved ▪ The maximum daily dose is 1,200 mg ▪ Assume 3 days of treatment as an average ▪ 750 mg orally, repeat dose after 3 hours until the treatment goal is achieved ▪ The maximum dose is 3 g in 24 hours ▪ Assume 3 days of treatment as an average ▪ 5–10 mg orally, repeat dose after 30 minutes if response is inadequate until optimal blood pressure is reached ▪ The maximum total dose is 30 mg in the acute treatment phase of 90 minutes ▪ Assume 3 days of treatment as an average Presentation ▪ Hydralazine HCl 20 mg powder for injection in 2 ml vials ▪ Labetalol HCl IV solution 20 mg/4 ml ampoule ▪ Labetalol HCl 200 mg tablet ▪ Methyldopa 250 mg tablet ▪ Nifedipine immediate release 5 mg, 10 mg capsules Administration ▪ IV ▪ IV, Oral ▪ Oral ▪ Oral Storage condition ▪ Store at 20°C to 25°C ▪ Tablets: Store between 2°C and 30°C; protect from light and excessive moisture ▪ Injections: Store between 20°C and 25°C; do not freeze; protect from light ▪ Store between 20°C and 25°C; protect from light ▪ Immediate- release capsule: Store between 15°C and 25°C; prevent from freezing; protect from light and moisture Additional supplies required for administration ▪ IV infusion set (for IV only), syringes, needles, and alcohol swabs, 5% dextrose in water solution, normal saline solution ▪ None6 Level of use ▪ Every HF in which births are attended by qualified professionals who can monitor hypertension of pregnant women Supply chain considerations ▪ Do not require cold chain ▪ Some antihypertensive products, such as labetalol and nifedipine immediate-release capsules, may not be widely available in the market, especially for developing countries ▪ Shelf lives of these formulations range from 36 to 60 months Page | 53 MAGNESIUM SULFATE (MGSO4) MgSO4 is an injectable anticonvulsant. It is recognized by WHO as the safest, most effective, and lowest-cost medicine for treating pre-eclampsia and eclampsia.8 MgSO4 is a lifesaving drug and should be available in all health care facilities throughout the health system, but there are often stock-outs. In addition to issues related to availability, there are various sociocultural and policy- based issues hindering its use: health care service providers may not be aware of magnesium sulfate as a treatment option, do not know how to administer it correctly, or are concerned about potential issues with toxicity and side effects for the patient. Current practices and plans to increase use of magnesium sulfate should be considered during forecasting. For more detailed information on MgSO4, refer to the chapter in the manual for procurement and supply of quality-assured MNCH commodities.8 Note: MgSO4 is a lifesaving medicine and should be available in all HFs where antenatal care (ANC) is provided for pregnancies or deliveries are attended. The quantification team needs to consider forecasting requirements of MgSO4 based on allocations for each type of HF, especially when there are lower-level HFs that need to provide the first dose of MgSO4 and refer to higher-level HFs for full treatment and or when the quantity of MgSO4 forecasted is too small to allow distribution of adequate quantities of the medicine to each HF where the medicine is needed. For details on such methodology of forecasting, see the algorithm (figure 9) and associated example below. CALCIUM GLUCONATE Calcium gluconate is an injectable that is used as an antidote to reverse the adverse effects of MgSO4. There is a less than 1.3% (0–8.2%) chance of adverse effect from administration of MgSO4 that may affect breathing. Even though the risk is minimal, calcium gluconate is a lifesaving drug and should be available in all health care facilities throughout the health system where MgSO4 is administered. Note: The estimated number of cases with toxicity from magnesium sulfate, and therefore the forecasted demand for calcium gluconate ampoules, could generally be too small if calculated using the morbidity method; thus, the forecasting of calcium gluconate demands a different methodology. Given this, allocation by type of HF depending on the average number of ANC services/deliveries applied to forecast initial demand for distribution is recommended. For details on such methodology of forecasting, see the algorithm (figure 10) and associated example below. For both MgSO4 and calcium gluconate, this methodology of allocation would probably result in over- quantification/forecast but ensures that each facility has a minimum stock. To minimize wastage, it is important to implement a number of approaches, including procurement for multiyear use at once, procuring products with long shelf lives, continuous reporting and assessment of availability and stock levels at HFs, and rotation of stock as needed depending on shelf life and consumption rate. Page | 54 Table 12: Summary of product characteristics: Magnesium sulfate and calcium gluconate PARAMETER MAGNESIUM SULFATE CALCIUM GLUCONATE Prevention of eclampsia: Dosage* ▪ Pritchard regimen (IV/IM) ○ 44 ampoules of 1 g in 2 ml per case OR ○ 9 ampoules of 5 g in 10 ml per case ▪ Zuspan regimen (IV) ○ 28 ampoules of 1 g in 2 ml per case OR ○ 6 ampoules of 5 g in 10 ml per case *Assuming 1 ampoule for each dose given and not allowing any open ampoule to be kept for later administration. Notes: ○ Based on the country guidelines, first-level HFs may need to give loading dose and refer to hospitals to continue with the full treatment. ○ The above quantities per case are for cases without convulsion after the loading dose. ○ Table 17 provides details on calculation of quantity per case, including for those with convulsion after the loading dose. ▪ Not indicated Treatment of eclampsia: Dosage ▪ The same as above ▪ Not indicated Treatment of MgSO4 toxicity, especially respiratory arrest ▪ Not applicable ▪ 1 g in 10 ml (10% solution) IV slowly over 3 minutes until respiration begins Presentation ▪ The WHO recommended presentation is 50% weight/volume solution, which is equivalent to 0.5 g in 1 ml9 ▪ Common presentations include 1 g in 2 ml (50%) ampoule and 5 g in 10 ml (50%) ampoule solutions for injection ▪ 100 mg/ml in 10 ml ampoule solution for injection Administration IM or IV IV Storage condition ▪ Store below 30°C8 ▪ Do not freeze ▪ Store between 15°C and 30°C Additional supplies required for administration ▪ IV infusion set (for IV only), 2% lidocaine solution (for IM only), syringes, needles, and alcohol swabs, calcium gluconate (antidote for magnesium sulfate toxicity) ▪ IV infusion set, syringes, needles, and alcohol swabs Level of use ▪ Every HF in which births are attended by qualified professionals should monitor pre-eclampsia/eclampsia and administer magnesium sulfate ▪ More and more countries are recommending that lower-level HFs administer a loading dose and then refer when they identify a woman with severe pre-eclampsia or eclampsia ▪ Every HF with qualified professionals where magnesium sulfate is used for the prevention or treatment of eclampsia Supply chain considerations ▪ Does not require cold chain ▪ Shelf life of 24–60 months ▪ 5 g in 10 ml ampoule is preferred to 1 g in 2 ml ampoule to reduce number of ampoules per case ▪ Does not require cold chain ▪ Shelf life of 36 months ▪ Assessment shall be made to decide the number of ampoules to be available at each HF by type and distribute accordingly ▪ Since the demand for this product could be too small, countries need to consider procurement of the product for multiyear use with long shelf lives to minimize expiries Page | 55 REQUIRED DATA AND POTENTIAL SOURCES: MORBIDITY METHOD OF FORECASTING MAGNESIUM SULFATE, CALCIUM GLUCONATE, AND ANTIHYPERTENSIVES FOR SEVERE HYPERTENSION IN PREGNANCY Several data points are required to forecast future demands of magnesium sulfate and calcium gluconate solutions as well as antihypertensives. Table 13 summarizes the main data types and potential sources for the morbidity method of forecasting (for both) and facility-based allocation (for calcium gluconate), in addition to the common data provided in the introduction of this supplement. Table 13: Data and potential sources for forecasting of antihypertensive medicines for severe hypertension in pregnancy using morbidity method DATA SOURCE NOTES Proportion/number of pregnancies at public HFs with severe hypertension HMIS, national maternal morbidity and mortality surveys, special surveys HMIS data may not be complete; may need to apply estimated annual growth/reduction rate; include those that are referred from community or the private sector Proportion/number of pregnancies at public HFs with severe hypertension that are given antihypertensive medicines for treatment Proportion/number of pregnancies at public HFs with severe hypertension that are given specific antihypertensive medicines (hydralazine, methyldopa, labetalol, nifedipine) Quantity (formulations and dosages) of specific antihypertensive medicines (hydralazine injection, methyldopa tablets, labetalol, nifedipine) to be given for treatment of severe hypertension in pregnancy National STG, WHO STG, expert opinion Guidelines may be outdated; may not include new WHO recommendations; actual practice may be different from STGs, consider the actual practice if guidelines are relatively old and not followed; parenteral treatment duration varies between patients depending on clinical evolution Table 14: Data and potential sources for forecasting of magnesium sulfate and calcium gluconate using morbidity method DATA SOURCE NOTES Incidence/number of severe pre-eclampsia (pregnancies with severe pre- eclampsia) by sector/level of care DHS, HMIS, national maternal morbidity and mortality surveys, special surveys Survey data may be outdated; HMIS data may not be complete; may need to apply estimated annual growth/reduction rate; include those that are referred from community or the private sector Proportion/number of pregnancies at public HFs with severe pre- eclampsia that are given MgSO4 for prophylaxis of eclampsia Incidence/number of women with eclampsia among those with severe pre- eclampsia who have not received prophylaxis: home pregnancies, HF pregnancies (incidence of eclampsia without prophylaxis) Proportion/number of home pregnancies with eclampsia that are referred to public HFs for treatment Incidence/number of women with eclampsia among those with severe pre- eclampsia who have received prophylaxis (incidence of eclampsia after prophylaxis) Page | 56 DATA SOURCE NOTES Proportion/number of eclampsia cases at public HFs that are given MgSO4 for treatment by level of care (i.e., lower level where prereferral loading dose is given and higher-level HFs where capability for cesarean section is available and full treatment can be administered) Quantity of MgSO4 used per one case (formulation and dosage of MgSO4): for prophylaxis of eclampsia, when convulsion occurs after the loading dose, for treatment of eclampsia (separately) National STG, WHO STG, expert opinion, programmatic/strategic plans Guidelines may be outdated; may not include new WHO recommendations; use expert opinion if the practice is different from what the guidelines prescribe Proportion/number of cases that develop MgSO4 toxicity after prophylaxis and treatment HMIS, national maternal morbidity and mortality surveys, special surveys HMIS data may not be complete; may need to apply estimated annual growth/reduction rate; include those that are referred from community or the private sector Proportion/number of cases with MgSO4 toxicity that are treated with calcium gluconate Quantity of calcium gluconate to treat one case (formulation and dosage of calcium gluconate) National STG, WHO STG, expert opinion Guidelines may be outdated; may not include new WHO recommendations; actual practice may be different from STGs, consider the actual practice if guidelines are relatively old and not followed; parenteral treatment duration varies between patients depending on clinical evolution Average number of calcium gluconate 100 mg/mL in 10 ml ampoules to be allocated by type of HF and for specific period MNCH program; rapid assessment studies; MNCH strategic plans Allocation should consider the number of births by facility type, qualifications of health professionals, and number of cases of magnesium toxicity per facility type Page | 57 Figure 9: Forecasting algorithm for medicines used for acute treatment of severe hypertension in pregnancy based on morbidity method Page | 58 Figure 10: Forecasting algorithm for MgSO4 used for prophylaxis and treatment of eclampsia based on morbidity method *All cases are assumed to be given MgSO4 only for the prevention or the treatment of eclampsia, according to WHO’s recommendation, and no other anticonvulsants such as diazepam are used. Refer to table 11 for more option on regimen types and quantity per case. Page | 59 IMPORTANT NOTE: ◼ MgSO4 is a lifesaving medicine and should be available in all HFs where ANC is provided for pregnancies or deliveries are attended. The quantification team needs to consider forecasting requirements of MgSO 4 based on allocations for each type of HF, especially when there are lower-level HFs that need to provide the first dose of MgSO4 and refer to higher-level HFs for full treatment or when the quantity of MgSO4 forecasted is too small to allow distribution of adequate quantities of the medicine to each HF where the medicine is needed. See figure 11 for the allocation method. Figure 11: Forecasting algorithm for MgSO4 used for prophylaxis and treatment of eclampsia based on allocations by facility type *Consider other HF types, or subgroups of the ones indicated above, that are not included in the algorithm and quantities for each, as applicable, based on your local context. Page | 60 Figure 12: Forecasting algorithm for calcium gluconate used to treat toxicity of MgSO4 based on allocations by facility type *Consider other HF types, or subgroups of the ones indicated above, that are not included in the algorithm and quantities for each, as applicable, based on your local context. Note: Applicable to both MgSO4 and calcium gluconate ■ To determine the average quantity of allocation per facility level per year, consider the incidence of cases by level; capacity to administer the products (e.g., health center may be allowed to administer the loading/prereferral dose of MgSO4 only); and the minimum possible pack size for distribution to HFs. ■ Quantification teams need to consider many factors, such as the actual usage rate, pack sizes, shelf life, and frequency of distribution, to decide whether to use the allocation method only or combine it with the morbidity method. ○ For example: Once MgSO4 and calcium gluconate are distributed based on the allocation method for the first year of quantification, the morbidity method can be used to estimate actual demand and replenish what is used during each year of the remaining quantification years; expiry dates should be considered. ■ Alternatively, the quantification team may use a combination of the two methods of forecasting, applying the allocation methods for the HFs where the number of cases is estimated to be low (such as health centers) and applying the morbidity method for those HF types that have relatively high incidence of cases, which allows for smooth distribution of the medicines considering the lowest distribution pack sizes. Page | 61 PROXY DATA AND SOURCES If local data are not available, quantification teams may use the following data as proxy. 1. Incidence of severe hypertension in pregnancy, pre-eclampsia, severe pre-eclampsia, and eclampsia and toxicity of MgSO4. Table 15: Summary of global incidence rates PARAMETER VALUE A Incidence of pre-eclampsia2,3 4.6% (2–8%) B Incidence of severe pre-eclampsia among pregnancies with pre-eclampsia4 26% C Incidence of eclampsia in pre-eclamptic pregnancies without MgSO4 prophylaxis 4 1.9% D Incidence of eclampsia in pre-eclamptic pregnancies after MgSO4 prophylaxis 4 0.8% E Incidence of eclampsia in general pregnant population without prophylaxis5 0.5% F Incidence of severe hypertension in pregnant population2,3,4* 1.2% G Incidence of MgSO4 toxicity (respiratory depression) 10 1.3% *For lack of readily available information on the incidence of severe hyperextension in pregnant women, the same incidence rate as that of severe pre-eclampsia is suggested by WHO experts to be used as proxy in the absence of local data (4.6% x 26% = 1.2%). 2. Dosage and average quantities per case by regimen type for antihypertensives Note: This only considers severe hypertension during pregnancy, not control of moderate or chronic hypertension or hypertensi on of the postpartum period that needs treatment of a longer duration and assumes treatment duration of three days. Table 16: Quantity of each antihypertension per case FORMULATIONS QUANTITY PER CASE A Methyldopa 250 mg tablet 36 tablets (9 g) B Labetalol 200 mg tablet 18 tablets (3,600 mg) C Labetalol HCl 20 mg/2 ml solution in ampoule 45 ampoules (9 g) D Hydralazine HCl 20 mg powder for injection in 2 ml vial 3 vial (60 mg) 3. Dosage and average quantities per case by regimen type for MgSO4 Table 17: Summary on calculations of number of ampoules per case by regimen type and strength REGIMEN TYPE DOSAGE # OF 1 G/2 ML AMPOULES # OF 5 G/10 ML AMPOULES Pritchard Loading dose 4 g 4 x 1 = 4 x 1 = 1 2 injections of 5 g 2 x 5 = 10 2 x 1 = 2 Maintenance dose 6 injections of 5 g every 4 hours for 24 hours 6 x 5 = 30 6 x 1 = 6 Total for regimen without additional convulsion after the loading dose 44 9 If convulsion occurs after loading dose, administer 2 g in 4 ml and continue with the maintenance dose 2 x 1 = 2 1 x 1 = 1 Total for regimen with additional convulsion after the loading dose 46 10 Zuspan Loading dose 4 g 4 x 1 = 4 1 x 1 = 1 Maintenance dose 1 g every hour for 24 hours 24 x 1 = 24 5 Total for regimen without additional convulsion after the loading dose 28 6 Page | 62 REGIMEN TYPE DOSAGE # OF 1 G/2 ML AMPOULES # OF 5 G/10 ML AMPOULES If convulsion occurs after loading dose, administer 2 g in 4 ml and continue with the maintenance dose 2 x 1 = 2 1 x 1 = 1 Total for regimen with additional convulsion after the loading dose 30 7 IMPORTANT NOTE: ◼ Quantification teams are advised to refer to the sources of data provided as a reference for proxy data as most have country- or region-specific data that can be used for the region or country under consideration instead of the global average. BOX 6. EXAMPLE OF COUNTRY FORECAST FOR ANTIHYPERTENSIVES FOR SEVERE HYPERTENSION IN PREGNANCY BASED ON MORBIDITY METHOD Country X’s STG recommends the use of methyldopa oral tablet, hydralazine injection, and labetalol injection and tablet for acute treatment of severe hypertension in pregnancy. The guideline states that pregnancies with severe hypertension identified at hospitals should be given injectable antihypertensives preferably, but those at first -level HFs can be treated with oral antihypertensives without the need for referral. Available data and assumptions: ▪ Total population as of current year (CSO census): 20,000,000 ▪ Percentage increase in population per year: 2% ▪ Percentage of pregnant women out of total population: 4% ▪ Percentage of pregnancies with severe hypertension: 1.3% (based on HMIS reports) ▪ ANC attendance at public HFs: 81% in the current year; expected to increase by 1.5 percentage points over the forecast period ▪ Percentage of case treated by level of public health care (based on HMIS reports): ○ First-level HFs: 70% and assumed to increase by 3 percentage points per year ○ Hospitals: 30% and assumed to decrease by 3 percentage points per year ▪ Compliance to treatment recommendations: (based on HMIS reports) ○ 80% at first-level health public facilities with an increase of 2 percentage points per year ○ 90% in public hospitals with an increase of 1 percentage point per year ▪ Percentage of cases treated with specific regimens, formulations by level of care, and quantity per case were agreed according to the table below. Based on the national STGs and expert opinion, the quantification team has agreed to forecast for 24 hour treatment per case and assumed each patient will need the maximum daily dose by average. First-level HFs Regimen Formulations Quantity per case Methyldopa 65% Methyldopa 250 mg tablet 36 tablets (9 g) Labetalol 35% Labetalol 200 mg tablet 18 tablets (3,600 mg) Hospitals Regimen Formulations Quantity per case Methyldopa 10% Methyldopa 250 mg tablet 36 tablets (9 g) Labetalol 40% Labetalol 200 mg tablet 15% 18 tablets (3,600 mg) Labetalol HCl 20 mg/2 ml solution in ampoule 85% 45 ampoules (9 g) Hydralazine 50% Hydralazine HCl 20 mg powder for injection in 2 ml vial 3 vial (60 mg) Calculate the quantity of the recommended antihypertensives for acute treatment of severe hypertension in pregnancies in the public sector over the next two years. Page | 63 Example: Severe hypertension in pregnancy PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 Total population (A) A: Population = previous year population + (previous year population x PGR) (annual PGR is 2%) 2% 20,000,000 20,400,000 20,808,000 Total pregnancies (B) B = A x % of pregnant women out of total population 4% 800,000 816,000 832,320 Number of pregnancies with severe hypertension (C) C = B x incidence of severe hypertension in pregnant women 1.3% 10,400 10,608 10,820 Number of public HF pregnancies with severe hypertension (D) D = C x % of pregnancies with severe hypertension identified in all public HFs (ANC attendance in public HFs) (annual increase of 1.5%) 1.5% 8,424 8,752 9,089 81.0% 82.5% 84.0% Number of pregnancies with severe hypertension identified at first-level public HFs (E) E = D x % of cases in first-level public HFs (annual increase of 3%) 3% 5,897 6,389 6,908 70% 73% 76% Number of pregnancies with severe hypertension identified at public hospitals (F) F = D x % of cases in public hospitals (annual decrease of 3%) -3% 2,527 2,363 2,181 30% 27% 24% Number of first-level public HF severe hypertension cases treated with antihypertensives (G) G = E x % treated with antihypertensives (annual increase of 2%) 2% 4,717 5,111 5,526 80% 82% 84% Number of public hospital severe hypertension cases treated with antihypertensives (H) H = F x % treated with antihypertensives (annual increase of 1%) 1% 2,274 2,127 1,963 90% 91% 92% Number of first-level public HF severe hypertensive cases treated with specific regimens of antihypertensives (I) I1: # treated with methyldopa = G x % of treated with methyldopa 65% 3,066 3,322 3,592 I2: # treated with labetalol = G x % of treated with labetalol 35% 1,651 1,789 1,934 Number of public hospital severe hypertensive cases treated with specific regimens of antihypertensives (J) J1: # treated with methyldopa = H x % of treated with methyldopa 10% 227 213 196 J2: # treated with labetalol = H x % of treated with labetalol 40% 910 851 785 J3: # treated with hydralazine = H x % of treated with hydralazine 50% 1,137 1,063 982 Quantity of each medicine required to treat severe hypertension in pregnancy at first-level public HFs (L) L1: Quantity of methyldopa 250 mg tab for first-level HFs = I1 x % treated x K1; where K1: quantity per case = 36 tabs 100% 36 110,388 119,596 129,310 L2: Quantity of labetalol 200 mg tab for first-level HFs = I2 x % of treated x K2; where K2: quantity per case = 18 tabs 100% 18 29,720 32,199 34,814 Page | 64 PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 Quantity of each medicine required to treat severe hypertension in pregnancy at public hospitals (N) N1: Quantity of methyldopa 250 mg tab for hospitals = J1 x % treated x M1; where M1: quantity per case = 36 tabs 100% 36 8,188 7,656 7,068 N2a: Quantity of labetalol 200 mg tab for hospitals = J2 x % of treated x M2a; where M2a: quantity per case = 18 tabs 15% 18 2,456 2,297 2,120 N2b: Quantity of labetalol 20 mg/2 ml solution for injection in amp for hospitals = J2 x % of treated x M2b; where M2b: quantity per case = 45 amps 85% 45 34,800 32,538 30,037 N3: Quantity of hydralazine 20 mg powder for injection in 2 ml vial for hospitals = J3 x % of treated x M3; where M3: quantity per case = 3 vials 100% 3 3,412 3,190 2,945 Total quantity of each medicine required to treat severe hypertension in pregnancy in public health sector (O) O1: Quantity of methyldopa 250 mg tab = L1 + N1 118,576 127,252 136,378 O2: Quantity of labetalol 200 mg tab = L2 + N2a 32,176 34,496 36,935 O3: Quantity of labetalol 20 mg/2 ml solution for injection in amp = N2b 34,800 32,538 30,037 O4: Quantity of hydralazine 20 mg powder for injection in 2 ml vial = N3 3,412 3,190 2,945 Note: ▪ This is an example to show how the algorithm can be translated to calculations using an Excel tool. Quantification teams need to adapt the Excel tool and the examples provided to their context. Page | 65 BOX 7. EXAMPLE OF COUNTRY FORECAST FOR MAGNESIUM SULFATE BASED ON MORBIDITY METHOD Country X’s STG recommends the use of MgSO4 for the prevention and treatment of eclampsia. The STG recommends the use of MgSO4 for pregnant women with severe pre-eclampsia in HFs to prevent eclampsia. Compliance to this recommendation is currently at 50%; however, there is a plan to scale up to 80% within the next three years. The guideline recommends treatment of cases that develop eclampsia with or without prophylaxis with the same regimen and dosage that is used for prevention. The Pritchard regimen is used in the country. The quantification team has agreed to use global averages as proxy when local data are not available. Available data and assumptions: ▪ Total population as of current year (CSO census): 20,000,000 ▪ Percentage increase in population per year: 2% ▪ Percentage of pregnant women out of total population: 4% ▪ Percentage of pregnancies with pre-eclampsia: 4.6% (based on HMIS reports) ▪ Percentage of deliveries with severe pre-eclampsia out of pre-eclamptic cases: 26% (proxy) ▪ ANC attendance at public HFs: 81% in the current year; expected to increase by 2 percentage points per year ▪ Percentage of deliveries happening in the community: 45% ▪ Compliance to prevention recommendations: 50% current year; assumed to increase to 60% and 70% in years 1 and 2, respectively ▪ Currently only 50% of deliveries with severe pre-eclampsia are given MgSO4 for prevention of eclampsia at public HFs, and there is a plan to scale this up to 80% in three years (i.e., 60% in year 1 and 70% in year 2) ▪ Incidence of eclampsia after prophylaxis in severe pre-eclampsia cases: 0.8% (proxy) ▪ Incidence of eclampsia in severe pre-eclampsia cases without prophylaxis: 1.9% (proxy) ▪ Incidence of eclampsia in pregnant population (among those that deliver in the community without prophylaxis): 0.5% (proxy) ▪ Percentage of eclamptic cases identified by CHWs and referred to public HFs is only 30% in the current year, but there is a plan to increase it to 45% in three years (i.e., 35% in year 1 and 40% in year 2) ▪ Recommended formulation and quantity per case (both prevention and treatment): 9 ampoules of 5 g/10 ml MgSO4 (STG) ▪ Compliance to treatment recommendations: 95% current year and was assumed to remain the same (HMIS) Calculate the quantity of MgSO4 required for prevention and treatment of eclampsia in the public sector over the next two years. Page | 66 Example: Prevention of eclampsia PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 Total population (A) A: Population = previous year population + (previous year population x PGR) (annual PGR is 2%) 2% 20,000,000 20,400,000 20,808,000 Total number of pregnancies (B) B = A x % of pregnant women out of total population 4% 800,000 816,000 832,320 Number of public HF pregnancies (C) C = B x % of pregnancies in public HFs (ANC attendance) (annual increase of 2%) 2% 648,000 677,280 707,472 81% 83% 85% Number of pre-eclampsia cases in public HFs (D) D = C x incidence of severe pre-eclampsia 4.6% 29,808 31,155 32,544 Number of severe pre-eclampsia cases in public HFs (E) E = D x incidence of severe pre-eclampsia in pre-eclamptic cases 26.0% 7,750 8,100 8,461 Number of severe pre-eclampsia cases in public HFs provided with MgSO4 for prevention of eclampsia (F) F = E x % given MgSO4 for prophylaxis (% increase per year of 10%) 10.0% 3,875 4,860 5,923 50% 60% 70% Quantity of MgSO4 5 g/10 ml ampoules required for the prevention of eclampsia (H) H = F x G; where G: Quantity per case (without convulsion after loading dose) = 9 amps 9 34,875 43,741 53,307 Example: Treatment of eclampsia PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 Number of public HF severe pre-eclamptic cases that develop eclampsia after prophylaxis (I) I = F x % of pregnancies given MgSO4 for prevention that still develop eclampsia (incidence after prophylaxis) 0.8% 31 39 47 Number of public HF severe pre-eclamptic cases not provided MgSO4 that develop eclampsia (J) J = (E-F) x % of pre-eclamptic cases that develop eclampsia without prevention (incidence without prophylaxis) 1.9% 74 62 48 Number of public HF eclampsia cases treated with MgSO4 (K) K = (I + J) x % of cases treated (compliance to treatment recommendations) 95.0% 99 95 91 Number of home pregnancies (L) L = B x % of home pregnancies not attending ANC services at HFs 45.0% 360,000 367,200 374,544 Number of home pregnancies with eclampsia (M) M = L x incidence of eclampsia in pregnant women without prophylaxis 0.5% 1,800 1,836 1,873 Number of home pregnancies with eclampsia that are referred to public HFs for treatment (N) N = M x % of referral to public HFs for treatment; (increase per year of 5%) 5.0% 540 643 749 30% 35% 40% Number of referred eclampsia cases given MgSO4 at public HFs for treatment of eclampsia (O) O = N x % of cases treated; (% compliance to treatment recommendations) 95.0% 513 610 712 Quantity of MgSO4 5 g/10 ml ampoules required for treatment of eclampsia (Q) Q= (K+O) x P; where P: quantity of MgSO4 5 g/10 ml amp per case = 9 amps 9 5,512 6,353 7,222 Total for prevention and treatment of eclampsia Note: ▪ This is an example to show how the algorithm can be translated to calculations using an Excel tool. Quantification teams need to adapt the Excel tool and the examples provided to their context. Total quantity of MgSO4 5 g/10 ml ampoules required for the prevention and treatment of eclampsia (R) R = H + Q 40,387 50,094 60,529 Page | 67 BOX 8. EXAMPLE OF COUNTRY FORECAST FOR MGSO4 BASED ON ALLOCATION BY HF TYPE The maternal and child health guidelines of the country state that MgSO4 is used for prevention and treatment of eclampsia. The country has three levels of hospitals—national, regional, and district hospitals—plus health centers. As a strategy to increase the use of MgSO4 and appropriate management of pre-eclampsia/eclampsia, the MOH wanted to allocate MgSO4 to each facility to make the product available where it can potentially be needed, including health centers where a prereferral dose should be given before a woman is referred to a hospital for full treatment. The Pritchard regimen is used in the country, and a 5 g/10 ml MgSO4 ampoule is the recommended formulation. Available data and assumptions: ▪ Type and number of HFs where MgSO4 is expected to be used per year ○ National hospitals: 5 ○ Regional hospitals: 10 ○ District hospitals: 80 ○ Health centers: 500 (The number of hospitals is expected to remain the same over the forecast year) ▪ Average quantity of 5 g/10 ml MgSO4 ampoule required (allocated) per year per facility type ○ National hospitals: 450 ampoules per year (considering 50 cases per year, 9 ampoules per case) ○ Regional hospitals: 450 ampoules per year (considering 50 cases per year, 9 ampoules per case) ○ District hospitals: 900 ampoules per year (considering 100 cases per year, 9 ampoules per case) ○ Health centers: 150 ampoules per year (considering 50 cases of referral per year, 3 ampoules per case) Notes: ▪ Based on HMIS, it was found that most of the deliveries with complications happen at district hospitals ▪ The lowest distribution pack size was assumed to be 10 ampules Calculate the quantity of MgSO4 sulphate 5g/10ml, ampoule required for distribution to all facilities in the public sector. Page | 68 Example: MgSO4 using allocation by facility PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 # of public HFs where MgSO4 is supposed to be used by type (A) The number of public HFs by type is assumed to remain the same over the forecast period # of national hospitals (A1) 5 5 5 # of regional hospitals (A2) 10 10 10 # of district hospitals (A3) 80 80 80 # of health centers (A4) 500 500 500 Quantity of MgSO4 5 g/10 ml amp needed per year per facility type (C) National hospitals (C1) C1 = A1 x B1; where B1 = average quantity per national hospital per year 450 2,250 2,250 2,250 Regional hospitals (C2) C2 = A2 x B2; where B2 = average quantity per regional hospital per year 450 4,500 4,500 4,500 District hospitals (C3) C3 = A3 x B3; where B3 = average quantity per district hospital per year 900 72,000 72,000 72,000 Health centers (C4) C4 = A4 x B4; where B4 = average quantity per health center per year 150 75,000 75,000 75,000 Total quantity of MgSO4 5 g/10 ml amp needed per year (D) D = C1 + C2 + C3 + C4 153,750 153,750 153,750 Note: ▪ This is an example to show how the algorithm can be translated to calculations using an Excel tool. Quantification teams need to adapt the Excel tool and the examples provided to their context. Page | 69 BOX 9. EXAMPLE OF COUNTRY FORECAST FOR CALCIUM GLUCONATE BASED ON ALLOCATION BY HF TYPE Country X recommends the use of calcium gluconate injection for treatment of toxicity due to MgSO 4. The maternal and child health guidelines of the country state that all heath facilities where MgSO4 is used for prophylaxis and treatment of eclampsia need to maintain calcium gluconate injections to treat potential toxicity due to MgSO 4 administration. The management of eclampsia, both prevention and treatment, is expected to be carried out at hospitals, and health centers are expected to administer a prereferral dose before a woman is referred to a hospital for full treatment. The country has three levels of hospitals—national, regional, and district—plus health centers. Since the quantity of calcium gluconate forecasted based on the morbidity method is too low to make effective distribution of the product to all facilities where it may be needed, the quantification team has agreed to use allocation by facility to estimate requirements. Available data and assumptions: ▪ Type and number of HFs where MgSO4 is expected to be used per year ○ National hospitals: 5 ○ Regional hospitals: 10 ○ District hospitals: 80 ○ Health centers: 500 (The number of hospitals and health centers is expected to remain the same over the forecast year) ▪ Average quantity of calcium gluconate 1 g/10 ml ampoule required (allocated) per year per facility type ○ National hospitals: 5 ampoules per year ○ Regional hospitals: 5 ampoules per year ○ District hospitals: 10 ampoules per year ○ Health centers: 5 ampoules per year (Based on the HMIS, it was found that most deliveries with complications happen at district hospitals) Note: The lowest distribution pack size was assumed to be 5 ampules Calculate the quantity of calcium gluconate 1 g/10 ml ampoules required for treatment of MgSO4 toxicity in the public sector over the next two years. Page | 70 Example: Calcium gluconate for MgSO4 toxicity using allocation by facility PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 # of public HFs where MgSO4 is supposed to be used by type (A) The number of public HFs by type is assumed to remain the same over the forecast period # of national referral hospitals (A1) 5 5 5 # of regional hospitals (A2) 10 10 10 # of district hospitals (A3) 80 80 80 # of health centers (A4) 500 500 500 Quantity of calcium gluconate 1 g/10 ml amp required per year per facility type (C) National referral hospitals (C1) C1 = A1 x B1; where B1 = average quantity per national referral hospital per year 5 25 25 25 Regional hospitals (C2) C2 = A2 x B2; where B2 = average quantity per regional hospital per year 5 50 50 50 District hospitals (C3) C3 = A3 x B3; where B3 = average quantity per district hospital per year 10 800 800 800 Health centers (C4) C4 = A4 x B4; where B4 = average quantity per health center per year 5 2,500 2,500 2,500 Total quantity of calcium gluconate 1 g/10 ml amp required per year (D) D = C1 + C2 + C3 + C4 3,375 3,375 3,375 Note: ▪ This is an example to show how the algorithm can be translated to calculations using an Excel tool. Quantification teams need to adapt the Excel tool and the examples provided to their context. Page | 71 REFERENCES 1. WHO 2018; Drug treatment for severe hypertension in pregnancy. Available at: https://apps.who.int/iris/bitstream/handle/10665/277234/9789241550437-eng.pdf?ua=1 2. WHO recommendations for prevention and treatment of pre-eclampsia and eclampsia 2011. Available at: https://www.who.int/reproductivehealth/publications/maternal_perinatal_health/9789241548335/en/ 3. Abalos E, Cuesta C, Grosso AL, Chou D, Say L. Global and regional estimates of preeclampsia and eclampsia: a systematic review. Eur J Obstet Gynecol Reprod Biol. 2013; 170(1):1–7. Available at: https://doi.org/10.1016/j.ejogrb.2013.05.005 PMID: 23746796 4. The Magpie Trial Collaborative Group 2002 Do women with pre-eclampsia, and their babies, benefit from magnesium sulphate? The Magpie Trial: a randomised placebo-controlled trial Lancet volume 359, issue 9321, p1877-1890. Available at: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(02)08778- 0/fulltext 5. Incidence of eclampsia and related complications across 10 low- and middle resource geographical regions: Secondary analysis of a cluster randomised controlled trial; PLoS Med. 2019 Mar 29; 16(3): e1002775. Available at: https://pubmed.ncbi.nlm.nih.gov/30925157/ 6. WHO 2017 Managing Complications in Pregnancy and Childbirth. Available at: https://apps.who.int/iris/bitstream/handle/10665/255760/9789241565493-eng.pdf?sequence=1 7. WHO, 2020. WHO recommendations on drug treatment for non-severe hypertension in pregnancy. Available at: https://www.who.int/publications/i/item/9789240008793 8. USAID 2019 Manual of procurement and supply of quality assured maternal, newborn and child health commodities. Available at: https://www.ghsupplychain.org/key-initiatives/manual-procurement-and-supply- quality-assured-maternal-newborn-and-child-health 9. WHO Model List of Essential Medicines. 21stList. (2019). Available at: http://www.who.int/medicines/publications/essentialmedicines/en/. 10. Smith JM, Lowe RF, Fullerton J, Currie SM, Harris L, Felker-Kantor E. An integrative review of the side effects related to the use of magnesium sulfate for pre-eclampsia and eclampsia management. PMID: 23383864; PMCID: PMC3570392; DOI: 10.1186/1471-2393-13-34. Page | 72 4. REDUCTION OF RISK OF RESPIRATORY DISTRESS SYNDROME IN PRETERM BIRTHS INTRODUCTION Preterm birth (i.e., birth where the baby is born before the 37th week of gestation) is the leading global cause of perinatal and neonatal mortality and morbidity.1 An estimated 10% (5–18%) of live births globally are preterm. Preterm infants are particularly vulnerable to complications due to lung immaturity, inability to maintain blood sugar, feeding difficulty, poor body temperature regulation, and high risk of infection.2,3 Mortality and morbidity from preterm birth can be reduced through interventions delivered to the mother during pregnancy and to the preterm infant after birth.3 In 2015, WHO1 recommended ACS therapy for women at risk of preterm birth from 24 to 34 weeks of gestation when the following conditions are met: 1. Gestational age assessment can be accurately undertaken 2. Preterm birth is considered imminent 3. There is no clinical evidence of maternal infection 4. Adequate childbirth care is available (including the capacity to recognize and safely manage preterm labor and birth) 5. The preterm newborn can receive adequate care if needed (including resuscitation, thermal care, feeding support, infection treatment, and safe oxygen use) This treatment accelerates fetal lung development and reduces risk of respiratory distress syndrome, which is one of the most common life-threatening complications of prematurity.4 ACS should be administered when preterm birth is considered imminent (i.e., within seven days), and the greatest effect is seen when there is a 24- to 48-hour gap between first dose and birth. The accuracy of estimation of gestational age is crucial to reduce the probability of harm exceeding benefit.5 Safety concerns exist for the use of ACS in LMICs, and strict adherence to WHO recommended criteria is essential. Studies have demonstrated an increased risk of neonatal deaths associated with inaccurate estimation of gestational age as well as an increased risk of maternal infections.6 Current coverage of use of ACS for preterm birth varies widely, with 90% coverage of indicated cases in high- income countries and an estimated 10% coverage in low- and middle-income, high-burden countries.7 PRODUCT CHARACTERISTICS AND OTHER FORECASTING CONSIDERATIONS DEXAMETHASONE AND BETAMETHASONE Dexamethasone is currently the preferred ACS as it is as effective and significantly cheaper and more widely available than betamethasone. Some countries may have both betamethasone and dexamethasone in their treatment guidelines and EML. In that case, program managers will need to decide whether both will continue to be made available. If both medicines continue to be made available, then the proportion that will be treated with betamethasone and the proportion that will be treated with dexamethasone will need to be calculated. The proportion likely to be treated with each product will depend on programmatic factors. Page | 73 Table 18: Summary of product characteristics: dexamethasone and betamethasone PARAMETER DEXAMETHASONE BETAMETHASONE Improvement of fetal lung maturation: Dosage ▪ 24 mg of dexamethasone8 ▪ 4 doses of 6 mg IM, 12 hours apart ▪ 2 doses of betamethasone 12 mg IM, 24 hours apart8 Presentation ▪ 4 mg/ml dexamethasone phosphate (as disodium salt) solution for injection in 1ml ampoule ▪ 6 mg/ml (3 mg/ml betamethasone sodium phosphate + 3 mg/ml betamethasone acetate) aqueous solution for injection in 1 ml vial Administration IM Storage condition ▪ Some manufacturers state 20°C–25°C storage while others allow a wider temperature storage range of 15°C–30°C ▪ Protect from light ▪ Do not freeze Additional supplies required for administration ▪ Syringes, needles, alcohol swabs, sharps containers Level of use ▪ Generally, it is recommended to use ACS at the hospital level; expansion of use of ACS to lower levels such as health centers is not recommended. ▪ The medicines should be administered by a trained health worker/skilled birth attendant and are not recommended for home-based births.9 ▪ Recent studies of implementation of ACS in LMICs10 indicate that these products should be used in HFs that meet the following conditions: ○ Providers who are able to accurately assess and determine gestational age and risk of imminent preterm birth ○ Adequate childbirth care is available, including reliable, timely, and appropriate identification and treatment of maternal infection, and patient safety and compliance are monitored, including postdischarge complications and adverse events11 ○ Adequate postdelivery care for preterm newborns is available Supply chain considerations ▪ Do not require cold chain ▪ Shelf life of 36 months REQUIRED DATA AND POTENTIAL SOURCES: MORBIDITY METHOD OF FORECASTING A number of data points are required to forecast ACS. Table 19 summarizes the main data types and potential sources for the morbidity method of forecasting, in addition to the common data provided in the introduction of this supplement. Table 19. Data and potential sources for forecasting of ACS using morbidity method DATA SOURCE NOTES Incidence/number of preterm births (pregnant women at risk of preterm birth) DHS, HMIS, national maternal morbidity and mortality surveys, special surveys, national or WHO STGs DHS data are usually outdated; HMIS data may be incomplete; may need to apply estimated annual growth/reduction rate; consider expert opinion; national STGs may not include new WHO recommendations. Proportion/number of pregnant women at risk of preterm birth with access to public HFs that meet WHO’s conditions for use of ACS Proportion/number of pregnant women at risk of preterm birth with access to appropriate public HFs who are treated with ACS to improve fetal lung maturation in public HFs Type and respective proportion of ACS given to improve fetal lung maturation of premature infants in public HFs Quantity of each medicine used to treat one case (formulations and dosage of the respective ACS) National STG, WHO STG, expert opinion Guidelines may be outdated; may not include new WHO recommendations; actual practice may be different from STGs, consider the actual practice if guidelines are relatively old and not followed; parenteral treatment duration varies between patients depending on clinical evolution Page | 74 Figure 13: Forecasting algorithm for ACS based on morbidity method IMPORTANT NOTES: ◼ *6 ampoules if no wastage is considered or 8 ampoules if 0.5 ml is wasted during administration of each dose. ◼ Quantification teams are advised to consider other indications of the ACSs. The total quantity of ACSs required is the sum of what is needed for improvement of fetal lung maturation, necrotizing endocarditis (NEC) and intracranial hemorrhage and other indications if and when the same formulations are used. Page | 75 PROXY DATA AND SOURCES If local data are not available, quantification teams may use the following data as proxy. Table 20: Summary of proxy data and sources PARAMETER VALUE 1 Average quantity per case: ▪ 4 mg dexamethasone phosphate (as disodium salt) solution for injection in 1 ml ampoule8 ▪ 4 doses of 6 mg, 12 hours apart (6 or 8 ampoules) 2 Average quantity per case: ▪ 6 mg/ml (3 mg/ml betamethasone sodium phosphate + 3 mg/ml betamethasone acetate) aqueous solution for injection in 1 ml vial8 ▪ 2 doses of 12 mg IM, 24 hours apart (4 ampoules) 3 Incidence of preterm birth2,3 ▪ 10% (5–18%) IMPORTANT NOTE: ◼ Quantification teams are advised to refer to the sources of data provided as a reference for proxy data as most have country- or region-specific data that can be used for the region or country under consideration instead of the global average. BOX 10. EXAMPLE OF COUNTRY FORECAST FOR ANTENATAL CORTICOSTEROIDS BASED ON MORBIDITY METHOD Country X, a Southern African country with a similar epidemiological profile to Malawi, recommends the use of dexamethasone injection for pregnant women at risk of preterm birth to reduce the risk of respiratory distress syndrome in preterm babies. Compliance to this recommendation is only about 15%; however, there are plans to scale up use to 45% over three years through improved ANC attendance, diagnosis of risk conditions, intensive training, supervision, and information, education and communication and behavior change communication campaigns. The guideline states the need for full adherence by HF staff to the criteria on administration of dexamethasone given the identified risks. Available data and assumptions: ▪ Total population as of current year (CSO census): 20,000,000 ▪ Annual population growth % increase: 2% ▪ Pregnancy rate out of total population: 4% ▪ ANC attendance at public HFs: 80% in the current year and expected to grow to 83% in year 1 and 86% in year 2 (ANC attendance in this example is a proxy for # of facility-based births) ▪ Country X does not have complete data on the incidence of preterm birth in the country; therefore, the incidence of preterm birth from Malawi, which is 18% of all births, is taken as a proxy. This incidence rate is expected to remain the same throughout the forecast period. ▪ Currently, only 15% of preterm births at public HFs are estimated to be given ACS by HFs that are trained and capacitated to evaluate and support pregnancies that need ACS, but there is a plan to scale this up to 45% in three years (i.e., 25% in year 1 and 35% in year 2) ▪ The quantification team has agreed to quantify dexamethasone 4 mg/ml in 1 ml ampoule ▪ Recommended dosage from STGs: IM injections of dexamethasone spaced 12 hours apart totaling 24 mg (i.e., 6 ampoules per case) Calculate the quantities of dexamethasone 4 mg/ml in 1 ml ampoule required by the program (in the public health sector) for the two-year forecast period. Page | 76 Example: ACS PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 Total population (A) A: Population = population of the previous year + (population of the previous year x PGR) (annual PGR is 2%) 2% 20,000,000 20,400,000 20,808,000 Total pregnancies (B) B = A x % of pregnant women out of total population 4% 800,000 816,000 832,320 Number of pregnant women receiving ANC services at public HFs who meet WHO’s criteria (C) C = B x % of pregnant women attending ANC services at public HFs (annual increase in ANC of 3%) 3% 640,000 677,280 715,795 80% 83% 86% Public HF pregnancies at risk of preterm birth (D) D = C x incidence of preterm birth (proxy from Malawi) 18% 115,200 121,910 128,843 Number of pregnant women at risk of preterm birth likely to be given ACS (E) E = D x % attending or referred to public HFs that fulfill conditions for use of ACS (scale up annual increase of 10%) 10% 17,280 30,478 45,095 15% 25% 35% Number of public HF preterm birth pregnancies treated with specific ACS regimen (F) F = E x % treated with dexamethasone 100% 17,280 30,478 45,095 Quantity of dexamethasone 4 mg/ml amp (H) H = F x G; where G: Quantity of dexamethasone 4 mg/ml 1 ml amp per case = 6 6 103,680 182,866 270,571 Note: ▪ This is an example to show how the algorithm can be translated to calculations using an Excel tool. Quantification teams need to adapt the Excel tool and the examples provided to their context. Page | 77 REFERENCES 1. WHO 2015 Recommendation on antenatal corticosteroid therapy for women at risk of preterm birth from 24 weeks to 34 weeks of gestation, Nov 2015. Available at: https://extranet.who.int/rhl/topics/preconception-pregnancy-childbirth-and-postpartum-care/pregnancy- complications/preterm-birth/who-recommendation-antenatal-corticosteroid-therapy-women-risk-preterm- birth-24-weeks-34-weeks 2. Preterm birth, factsheet. World Health Organization, Media centre. November 2012. Available at: http://www.who.int/mediacentre/factsheets/fs363/en/ 3. WHO 2015 WHO recommendations on interventions to improve preterm birth outcomes. Available at: 4. https://www.healthynewbornnetwork.org/issue/antenatal-corticosteroids/ 5. Hodgins S. (2018) Antenatal corticosteroids: primum non nocere. Glob Health Sci Pract.;6(4):620-623. Available at: https://doi.org/10.9745/GHSP-D-18-00461 6. Hodgins S. Caution on corticosteroids for preterm delivery: learning from missteps. Global Health: Science and Practice December 2014, 2(4):371–373. Available at: https://doi.org/10.9745/GHSP-D-14-00197 7. Liu et al 2015 BMC Pregnancy Childbirth 15, S3 Antenatal corticosteroids for management of preterm birth: a multi-country analysis of health system bottlenecks and potential solutions. 8. Brownfoot FC, Crowther CA, Middleton P. Different corticosteroids and regimens for accelerating fetal lung maturation for women at risk of preterm birth. Cochrane Database of Systematic Reviews 2008, Issue 4. Art. No.: CD006764. DOI: 10.1002/14651858.CD006764.pub2. 9. Antenatal Corticosteroids (ACS) for Fetal Maturation in Threatened Preterm Birth: Critical Path Discussion Draft. March 2013. Available at: http://www.healthynewbornnetwork.org/sites/default/files/resources/ANCS%20Care%20Group%20- %20For%20HNN%20130305.pdf 10. Althabe F, Belizan JM, McClure EM, et al. A population-based, multi-faceted strategy to implement antenatal corticosteroid treatment versus standard care for the reduction of neonatal mortality due to preterm birth in low-income and middle-income countries: the ACT cluster-randomized trial. Lancet 2014. 11. Adapted from notes developed by the Antenatal Corticosteroids Working Group of the UN Commission on Life-Saving Commodities for Women and Children. October 2014 Page | 78 5. NEWBORN RESUSCITATION AND ESSENTIAL CARE AROUND THE TIME OF BIRTH INTRODUCTION Intrapartum-related hypoxic event is the failure of a newborn to establish and sustain breathing, leading to a decrease in oxygen perfusion to various organs. It kills around 700,000 newborns every year, accounting for 25% of all newborn deaths.1 Additionally, there are an estimated 1.02 million intrapartum stillbirths every year, an unknown number of which may be live born but misclassified as fresh stillbirth.2 In general, about 3–6% of all newborns (up to 6 million) require basic neonatal resuscitation.3 A high number of neonatal deaths can be prevented through effective neonatal resuscitation and immediate care, including drying, keeping the baby warm, suctioning, stimulation as needed after assessment, and positive-pressure ventilation if the newborn has not established spontaneous respirations. However, poor quality of newborn care due to lack of availability of basic resuscitation equipment and poor resuscitation skills of health care providers remains a major bottleneck in reducing neonatal mortality in low-resource settings.1 PRODUCT CHARACTERISTICS AND OTHER FORECASTING CONSIDERATIONS In 2013, the WHO medical devices team, in collaboration with other international stakeholders, held a consultative meeting to develop technical specifications for neonatal resuscitation devices, specifically a resuscitation bag with masks, a suction machine, and single use and reusable suction devices.1 Consequently, WHO produced the WHO Technical Specifications of Neonatal Resuscitation Devices in 2016.1 The following summary of the technical specifications and health system considerations is based on this document. Neonatal resuscitation medical products are used in clinical settings for newborns who have not established spontaneous and/or effective respiration as well as for pre- and in-service training. In this document, clinical resuscitation devices considered include self-inflating neonatal resuscitation bag and masks and single use and reusable suction devices. Medical products for training include pre- and in-service training manikins for which we provide the data required in this document, with potential sources but with no technical specifications or steps for calculations. SELF-INFLATING NEONATAL RESUSCITATOR (REUSABLE) (RESUSCITATION BAG AND MASK) Initiation of positive-pressure ventilation is recommended within one minute after birth if the baby has not started breathing after initial steps of resuscitation, thorough drying, and additional stimulation.4 A self-inflating neonatal resuscitation bag with mask is the most standard basic neonatal ventilation device to ventilate a neonate with a body weight less than 5 kg because of its automatic re-expansion feature and simplicity of use. SUCTION DEVICES (BULBS) A suction device is a portable, hand-held device designed to provide gentle suction to clear excessive secretions from the mouth and nose of newborns if they are obstructing the baby’s breathing or if the infant is having difficulty clearing secretions on their own. Both single-use and reusable suction devices are used in clinical settings. Single-use bulbs must be discarded after use, whereas reusable suction devices need to be precleaned, disassembled, cleaned, sterilized, reassembled, and properly stored before the next use.1 Page | 79 Table 21: Product characteristics: Reusable self-inflating resuscitators and suction devices PARAMETER NEONATAL SELF- INFLATING RESUSCITATOR (REUSABLE) MULTIUSE MANUAL SUCTION DEVICES (BULBS) SINGLE-USE MANUAL SUCTION DEVICES (BULBS) Recommended uses ▪ Ventilation of a neonate without spontaneous or effective breathing ▪ Clearing airways of newborns’ secretions (clear or meconium-stained) if either the mouth or nose is blocked with secretions. A neonate who does not start breathing after thorough drying and stimulation may require suctioning before ventilation. Components/features ▪ Mask (face mask sizes 0 and 1 for term and preterm newborns, respectively); ventilation bag with pressure relief valve1 ▪ Manual/handheld and compressible bulb with a tip that can be inserted into the nares1 ▪ Can be opened to be properly cleaned and disinfected1 Manual/handheld and compressible bulb with a tip that can be inserted into the nares1 Administration ▪ Mouth and nose ▪ Mouth first then nose ▪ Mouth first then nose Storage condition ▪ Storage at -40oC–+60oC ▪ Avoid dust and exposure to insects, animals, chemicals, and direct sunlight Additional supplies required for administration ▪ Clean ambient air ▪ Clean ambient air Level of use Can be used anywhere where appropriately skilled health personnel are present, including for home deliveries (for single-use suction bulbs) Other supply chain considerations ▪ Should be procured as a complete kit (face mask, ventilation bag with pressure relief valve) ▪ Clear instructions must be included for assembly, reassembly, cleaning, and disinfection ▪ Besides proper reprocessing and assembly, no other maintenance is required ▪ Life span may vary greatly depending on the quality, amount of time used, and how it is reprocessed ▪ Clear instructions must be included for assembly, reassembly, cleaning. and disinfection ▪ Besides proper reprocessing and assembly, no other maintenance is required ▪ Life span may vary greatly depending on the quality, amount of time used, and how it is reprocessed. ▪ Should be discarded after use Further information on specifications and consideration can be found in the toolkit for procuring quality-assured, basic neonatal resuscitation medical products.5 This toolkit is intended to help with the quantification of medical product needs, development of effective procurement plans, and writing specifications for national tenders. It provides information on where and how to procure quality-assured neonatal resuscitation medical products and addresses international shipping considerations. REQUIRED DATA FOR FORECASTING AND POTENTIAL SOURCES A number of data points are required to forecast future demands/needs of resuscitation devices. Table 22 summarizes the main types of data and potential sources for the morbidity method of forecasting in addition to the common data provided in the introduction of this supplement. Page | 80 Table 22: Data and potential sources for forecasting of resuscitation devices and manikin DATA SOURCE NOTES Average number and types of rooms where a newborn may require resuscitation in each type of HF (i.e., delivery rooms/wards, theaters, emergency rooms, neonatal wards, neonatal ICUs/special care) Program reports, MOH, regional health bureaus, guidelines, survey results, strategic plans/program targets. Obtain the information from higher- and lower-level sources and rectify. Data may not be readily available or complete. Need to consult with experts and professionals at sample HFs. Average number of each resuscitation medical product needed by room for each HF type MOH, regional health bureaus, survey results, expert opinion The average number of each reusable resuscitation device needed by room could be significantly different from one type of room to the other for the same facility type. Need to consult with experts and professionals at sample HFs. Proportion/number of live births in public HFs with birth asphyxia per year HMIS, RMNCH program reports, other survey reports, strategic plans/program targets Country-specific data may not be available or may be incomplete; consult experts in the area. Use global data from similar counties if country-specific data are not available; refer to WHO resources indicated in this document.3 Proportion/number of births in public HFs that need suction devices to treat birth asphyxia per year Proportion/number of live birth asphyxia cases in public HFs that need suction devices and that are attended by skilled birth attendants DHS, HMIS, RMNCH program reports, other survey reports, STG, strategic plans/program targets DHS data may be outdated; HMIS data may not be complete or readily available; consult experts in the area Proportion/number of birth asphyxia cases attended by skilled birth attendants that need single-use suction bulb HMIS, RMNCH program reports, other survey reports, STG, strategic plans/program targets Average number of training manikins needed by HF type per year MOH, regional health bureaus, district medical offices, expert opinion Data may not be readily available; could differ from facility to facility; need to consider expert opinion Number of midwifery, nursing, and medical schools Ministry of Education, MOH, strategic plans/program targets Average number of students per class (per school) per year Ministry of Education, MOH, strategic plans/program targets; school curriculums Curriculum could differ from school to school depending on how many classrooms would be conducting resuscitation training at the same time in each school Number of students per manikin Surveys, expert opinion Two learners per manikin is used in the Helping Babies Breathe initiative6 CALCULATIONS FOR REUSABLE RESUSCITATION DEVICES The method proposed for the forecast of reusable resuscitation devices is different from the conventional morbidity method because quantities of products are not dependent on the number of cases. However, conventional morbidity method calculations are applied to forecast single-use suction bulbs. In addition, when the number of cases that need the medical products is too small, it may not be possible to distribute the small quantities based on the annual number of cases to all HFs where they are needed. Because timely access to the devices is required to save the lives of newborns, it is critical that these devices be available in all HFs. For these reasons, the forecasting method presented for reusable resuscitation devices discussed here is based on the number of rooms in HFs where the devices must be present. Page | 81 PATH has developed a forecasting tool to estimate the need for reusable resuscitation devices, which is available at https://www.path.org/resources/quantification-tool-for-basic-neonatal-resuscitation-commodities-version-2/. The Microsoft Excel-based tool is designed to provide estimates of product quantities for planning and cost simulations and can be used at the national, regional, district, or HF level. The forecasting tool is set up to provide initial estimated needs for neonatal resuscitation medical products for a one-year period. It is advised that the tool be adjusted in future years to accommodate for the average lifespan of each medical product at each level of the system. It is also advised that some reserves be stocked at all levels to cover additional needs, breakages, and losses. Procurement staff should consult with staff in labor units regarding additional quantities needed. It is necessary to have enough functional resuscitation equipment available in each unit to accommodate the number of patients who may need resuscitation, taking into consideration that equipment might be going through reprocessing and thus cannot be used at a given time. Estimated numbers will also have to consider malfunctioning equipment due to loss of parts or faulty reprocessing. Figure 14: Forecasting algorithm for reusable resuscitation devices (bag and mask and multiuse suction device) based on allocation by facilities IMPORTANT NOTES: ◼ The detailed steps for forecasting reusable devices are shown in https://www.path.org/resources/quantification-tool- for-basic-neonatal-resuscitation-commodities-version-2/. ◼ Steps A and B above are included under step 1 in that tool and step C is step 2; the rest of the steps described above are included under the results tab as calculation results. https://www.path.org/resources/quantification-tool-for-basic-neonatal-resuscitation-commodities-version-2/ https://www.path.org/resources/quantification-tool-for-basic-neonatal-resuscitation-commodities-version-2/ https://www.path.org/resources/quantification-tool-for-basic-neonatal-resuscitation-commodities-version-2/ Page | 82 Figure 15: Forecasting algorithm for single use suction bulb (device) based on morbidity method PROXY DATA AND SOURCES If local data are not available, quantification teams may use the following data as proxy. Table 23: Summary of proxy data and sources IMPORTANT NOTE: ◼ Quantification teams are advised to refer to the sources of data provided as a reference for proxy data as most have country- or region-specific data that can be used for the region or country under consideration instead of the global average. PARAMETER VALUE A Incidence of newborns who need suction and/or basic neonatal resuscitation3 3%–6% Page | 83 Example: Single-use resuscitation device PARAMETER INPUT CURRENT YEAR FORECAST YEAR 1 FORECAST YEAR 2 Total population (A) A: Population = previous year population + (previous year population x PGR) (annual PGR is 2%) 2% 20,000,000 20,400,000 20,808,000 Total number of live births (C) C = (A/1000) × B; where B = CBR (# of live births per 1,000 population per year) 35 700,000 714,000 728,280 Number of public HF live births (D) D = C x % of public HF live births (annual increase of 5%) 5% 350,000 392,700 436,968 50% 55% 60% Number of live births at public HFs that need suction or resuscitation devices (E) E = D x % of live births that need suction or resuscitation devices 3% 10,500 11,781 13,109 Number of public HFs that need single-use suction device/bulb (F) F = E x % of live births estimated to need/use single-use suction device 35% 3,675 4,123 4,588 Quantity of single-use suction bulbs required at public HFs (H) H = F x G; where G: Quantity of single-use suction bulb per case = 1 1 3,675 4,123 4,588 Note: ▪ This is an example to show how the algorithm can be translated to calculations using an Excel tool. Quantification teams need to adapt the Excel tool and the examples provided to their context. BOX 11. EXAMPLE OF COUNTRY FORECAST FOR SINGLE-USE SUCTION DEVICE/BULB BASED ON MORBIDITY METHOD Country X’s STG recommends the use of single-use and reusable suction devices for newborns requiring suction. Not all HFs have the multiuse devices. In this country, rural health centers do not have reusable suction devices because they lack the proper training and infrastructure to clean and disinfect them; thus, single -use devices/bulbs are recommended at these HFs. Available data and assumptions: ▪ Total population as of current year (CSO census): 20,000,000 ▪ Annual population growth % increase: 2% ▪ CBR: 35 live births per 1,000 population, based on DHS data ▪ Proportion of live births attended at public HFs: 50% in the current year; expected to increase by 5 percentage points per year ▪ Incidence of newborns who need suction: 3% based on data from HMIS ▪ % of deliveries/births at rural health centers (from HMIS): 35%; expected to remain the same during the forecast period Calculate the quantity of single-use resuscitation bulbs required to meet program needs over the next two years. Page | 84 REFERENCES 1. WHO 2016 Technical specificati

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