Amendment 1 Attachment 7_Attachment J.7g PPM-Malaria Implementation Guide-final.pdf

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Supply Chain Strengthening (SCS) Activity Federal contract opportunity
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US Agency for International Development Ethiopia

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This federal contract opportunity solicitation issued by the US Agency for International Development Ethiopia seeks supply chain strengthening services to support its activities. The solicitation requests proposals for services including supply management, warehousing and distribution, transportation and logistics support, commodity security, and information technology solutions to strengthen Ethiopia's health commodity supply chain systems. Proposals are due by the date specified in the solicitation, and the agency intends to award a single-award IDIQ contract for an one base year plus four option years.

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1 |

First Edition

October 2020

Addis Ababa, Ethiopia

I | P a g e

FOREWORD

Malaria has been one of the major public health problems of the country. About 75% of the landmass of the country is considered malarious and around 52% of the population of Ethiopia is at risk of malaria. In the past 15 years, the government has given a high priority for malaria prevention and control evidenced by scaling up of key anti-malaria interventions. Because of the unprecedented investment and sustained high coverage of such interventions, the country witnessed a marked reduction of malaria morbidity and mortality.

Being encouraged by the success made in reversing the toll of malaria and noting the global move against the disease, Federal Ministry of Health is committed to the elimination of malaria from the whole country by 2030. Since the decrease in malaria burden is not uniform, a sub-national elimination approach will be pursued to achieve nationwide elimination. This endeavor calls for enhancing the existing efforts in the fight against the disease and establish a collaboration with important actors, like the private health sector. Especially, in elimination setting, strengthening surveillance, data reporting and proper management of malaria cases is very critical. This cannot be achieved without bringing private health service providers onboard. Therefore, this PPM for malaria implementation guide is prepared to ensure active involvement of the private health sectors. Establishing the public private mix is believed to play a pivotal role in achieving the elimination endeavor and effective implementation of anti-malaria interventions.

Thus, it is my firm believe that the envisaged public private mix will immensely contribute in the national effort of eliminating malaria. Towards this end, I can assure that the Federal Ministry of Health will do its level best in facilitating a fruitful collaboration.

Dereje Duguma (MD, MPH)

State Minister of Health

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ACKNOWLEDGEMENTS

The development of this first edition of public-private mix (PPM) of malaria implementation guide is a reflection of the commitment of the Federal Ministry of Health and its development partners for ensuring access and strengthening malaria elimination endeavor in Ethiopia.

The Federal Ministry of Health (FMOH) acknowledges all stakeholders who technically involved in developing the first edition of the PPM-malaria implementation guide. Special thanks goes to FMOH-

National Malaria Elimination Program Team, President’s Malaria Initiative (PMI) and the United States

Agency for International Development (USAID), Ethiopian Medical Laboratory Association, ICAP-Ethiopia, Abt/Private Health Sector Project (PHSP), Malaria Consortium, Malaria Control and Elimination

Partnership in Africa (MACEPA) at PATH, World Health Organization (WHO), Regional Health Bureaus

(RHBs), Ethiopian Pharmaceutical Supply Agency (EPSA), Ethiopian Pharmaceuticals Association, Administration for Refugees and Returnees Affairs (ARRA) and Ethiopian Public Health Institute (EPHI).

Finally, the Ministry appreciates the Abt. associate/PMI and WHO for financial support provided for the development and printing of the implementation guide.

Hiwot Solomon (BSc, MPH) Director, Disease Prevention and Control Federal Ministry of Health

III | P a g e

ABBREVIATIONS

AL Artemether - Lumefantrine

ARRA Administration for Refugees and Returnees Affairs

CSO Civil Society Organization

DHIS District Health Information System

EFDA Ethiopian Food and Drug Authority

EPHI Ethiopian Public Health Institute

EPSA Ethiopian Pharmaceuticals Supply Agency

EQA External Quality Assurance

FBO Faith-Based Organization

FEFO First-to-Expire-First-Out

FMOH Federal Ministry of Health

HB Hemoglobin

HCMIS Health Commodities Management Information System

HF Health Facility

HMIS Health Management Information System

HSTP Health Sector Transformation Plan

IEC Information, Education and Communication

IM Intramuscular

IP Inpatient

IPD Inpatient Department

IPLS Integrated Pharmaceuticals Logistic System

IQC Internal Quality Control

IRS Indoor Residual Spraying

IV Intravenous

LLIN Long Lasting Insecticidal Net

LSI Look ahead Seasonality Index

MACEPA Malaria Control and Elimination Partnership in Africa

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MOU Memorandum of Understanding

MPR Malaria Program Review

NGO Non-Governmental Organization

NMEP National Malaria Elimination Program

OPD Outpatient Department

PCMRR Private Clinic Monthly Report and Resupply Form

PCRR Private Clinic Reporting and Requisition

PHSP Private Health Sector Project

PMI President’s Malaria Initiative

PPM Public Private Mix

PPMED Policy, Planning, Monitoring and Evaluation Directorate

PPM-H Public Private Mix for Health

PPP Public-Private-Partnership

PSM Procurement and Supply Management

RDT Rapid Diagnostic Test

RHB Regional Health Bureau

RRF Report and Requisition Form

RRLs Regional Reference Laboratories

SBCC Social and Behavioral Change Communication

SOP Standard Operating Procedure

THO Town Health Office

TWG Technical Working Group

USAID United States Aid for International Development

WHO World Health Organization

WMR World Malaria Report

WoHO Woreda Health Office

ZHO Zonal Health Office

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CONTENTS

FOREWORD ................................................................................................................................................ I

ACKNOWLEDGEMENTS ......................................................................................................................... II

ABBREVIATIONS ....................................................................................................................................III

UNIT 1: INTRODUCTION

UNIT 2: PRINCIPLES AND VALUES OF PUBLIC-PRIVATE MIX

UNIT 3: PROGRAM COORDINATION AND MANAGEMENT

UNIT 4: ROLES OF STAKEHOLDERS IN PPM-MALARIA

UNIT 5: REQUIREMENTS FOR PPM HEALTH FACILITIES

UNIT 6: PATIENT CARE IN THE PPM-MALARIA PROGRAM

UNIT 7: SERVICE COST AND REFERRAL

UNIT 8: PHARMACEUTICALS SUPPLY MANAGEMENT SYSTEM

UNIT 9: REGULATORY STANDARDS

UNIT 10: MONITORING AND EVALUATION

ANNEXES

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UNIT 1: INTRODUCTION

1.1 Background

Malaria is a parasitic infectious disease caused by protozoan parasites of the genus Plasmodium and is transmitted by the bite of Anopheles mosquitoes. The disease is characterized by recurrent symptoms of chills, fever and generalized body pain. The five Plasmodium species of human malaria are P. falciparum, P. vivax, P. ovale, P. malariae and P. knowlesi. However, P. falciparum and P. vivax are the two most common Plasmodium species etiologies in Ethiopia. P. falciparum is the main species that causes severe and potentially fatal malaria and P. vivax and P. ovale have dormant liver stages, the hypnozoites, which can become activated and invade the blood to cause clinical relapse several months or years after the first infecting mosquito bite.

In 2018, an estimated 228 million cases of malaria occurred worldwide compared with 251 million cases in 2010 and 231 million cases in 2017 (WMR 2019). In Ethiopia, malaria has showed a declining trend for over a decade. According to the Health Management Information System (HMIS) report of 2019, the number of reported malaria cases declines from 3.8 million in 2012 to 1.5 million cases in the year 2019.

Similarly, the 2020 malaria program review (MPR) also indicated that there were significant reductions

(more than 40% reductions) in malaria morbidity and mortality between 2016 and 2019. This significant decline in number of cases and deaths has motivated the Federal Ministry of Health (FMOH) to launch the malaria elimination program in the country, which is in line with the WHO recommendation. This in turn demands for bringing all sectors and cadres onboard in order assure access to all and not to miss any malaria case throughout the country.

In 2004, the WHO recommended widening of the scope of Public-Private Mix (PPM) to include all public and private health care providers not formally linked to government-funded malaria programs. PPM became a comprehensive approach to engage relevant health care providers through public-private

(between the government malaria program and the private sector), public-public (between the government malaria program and other public sector care providers) and private-private (between civil society organizations or private hospitals and community-based private providers) partnerships to deliver standardized, high quality malaria care to all. Thus, PPM implies engaging relevant care providers in the implementation of integrated malaria activities. Experience and evidence from other high-burden settings show that PPM can improve surveillance, and assists in more rational use of antimalarial drugs

2 | P a g e and procurement drugs and other supplies needed. Similarly, the PPM approach in tuberculosis program globally and at national level has proved to be an effective approach in TB case detection as well as proper treatment of cases.

In response of an ever-increased demand for antimalarial interventions, therefore, the national malaria elimination program began to actively explore how to expand its interventions into the private health sectors. PPM-malaria implementation guide is believed to be one of the mechanisms to reach the private sector and the guide was developed to smoothen the intended PPM implementation. Detail on the implementation guide presented as follows.

1.2 Rationale of PPM-Malaria

Engagement of the private health sector in antimalarial interventions is a key for advancing the national malaria elimination agenda. In Ethiopia, a strong political commitment to encourage the contribution of the private health sector to the health care delivery system of the country and an ever-increasing interest within the private health sector in health investments have necessitated for public-private partnership.

Therefore, this PPM-malaria implementation guide is developed to create an enabling environment for ensuring equity, accessibility and quality of care in managing malaria patients. Besides, it informs and guides relevant stakeholders to enhance the coordination, implementation, monitoring and evaluation of PPM malaria activities. Moreover, the guide facilitates the timely detection, recording and reporting of malaria cases to the appropriate government structure.

1.3 Goal of PPM-Malaria

The goal of PPM-malaria in Ethiopia is to support the achievement of the national malaria elimination goal, which aims at eliminating malaria nationwide by 2030.

The national malaria elimination objectives are:

To reduce malaria case incidence to zero by 2030.

To reduce malaria mortality rate to zero by 2030.

By 2030 and beyond, to prevent reestablishment of malaria in Ethiopia.

1.4 General Objective of PPM-Malaria

The overall objective is to establish clear framework that creates enabling environment for the partnership between public and private to advance national malaria elimination agenda by expanding malaria services in the PPM –malaria sites by 2021 and beyond.

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1.5 Specific Objective of PPM-Malaria

Improve equity and access for effective and affordable malaria case management services in private sectors.

Optimize the allocation and the use of available resources in private health sectors.

Ensure the accurate diagnosis and quality of care for malaria patients.

Implement continuous malaria laboratory external quality assurance (EQA) system at private sectors.

Improve referral linkage and communication among public and private health care providers.

Build capacity of health workers in both the public sector and the private sector.

Improve surveillance and reporting in private health facilities.

Facilitate monitoring and learning platforms for public private mix.

Strengthen other sector actors such as large private farms and education sector.

1.6 Expected Outcomes of PPM-Malaria

Increased access to quality malaria diagnosis, care and treatment services for the community;

Improved and standardized management of malaria cases and rational use of anti-malaria drugs;

Improved collaboration and interaction among various entities- the public sector, Non-

Government Organizations (NGOs), Civil Society Organizations (CSO), etc.

Increased community awareness, participation and ownership in the malaria prevention activities.

Improved data registration and reporting into the government system/DHIS.

Strengthened malaria prevention, control and elimination measures

Improved malaria laboratory EQA implementation to the PPM health facilities.

Improved efficient resource utilization by all partners.

1.7 Intended Users

The intended users of these PPM-malaria implementation guide are policy makers, program managers, public health facilities operated by the public and private sectors and health professional associations, all health sector care providers, private healthcare owners/providers, and development partners who are interested in incorporating high-quality malaria service delivery through a PPM with the national standards.

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UNIT 2: PRINCIPLES AND VALUES OF PUBLIC-PRIVATE MIX

2.1 National Policy Document

The current FMOH policy document, HSTP, emphasizes the need for collaboration and recommends the following:

“The health sector itself cannot be the exclusive domain of the public sector, but should be a collaborative endeavor through public/ private partnership, the involvement of the NGO sector and private for-profit health delivery system” (HSTP August 2015: 146).

According to WHO, PPM is about combining different skills and expertise in a framework of defined responsibilities, roles, accountability and transparency to attain a common goal of achieving universal access to the best quality health care that may be unattainable by independent action.

2.2 The Principles of PPM

The principles include:

Securing close working relationship between public and private partners

Establishing parity of relationship among public and private sector partners

Nurturing public-private partnerships

Sustaining collaboration among partners

Being equitable and inclusive

Creating enabling policy environment for PPM for health (PPM-H).

2.3 Values of PPM

The values include:

Participation, accountability, transparency, consensus-building

Leadership vision, capacity and ownership

Community centered health planning and implementation

Comply with public service code of conduct

Abiding by the code of professional ethics

Remaining flexible and ready to accommodate new health developments.

2.4 The PPM Care Model for Ethiopia

PPM-Malaria in Ethiopia will be implemented under a strong framework of organization, coordination

5 | P a g e and management at different levels of the health structure using a care model that fits into the existing health service delivery system as seen below in Figure 1.

Figure 1. PPM basic care model of Ethiopia

FMOH

(EPSA, EPHI, EFDA, PPMED)

Regional local health offices (RHBs, Labs, Hubs, regulatory agencies, ZHO, WoHO/THO)

Main structures (Hospitals,health centers and health posts)

Malaria diagnosis and treatment providers

Work place health facilities

(Mega projects health facilities, work place clinics)

Other Government health facilities

(defense, police, refugee, university, prison

HF, etc.)

Private for-profit health facilities:

(Hospitals, Clinics, diagnostic labs, drug outlets)

Private for non- profit health facilities

(FBO clinics, NGO clinics, etc.)

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UNIT 3: PROGRAM COORDINATION AND MANAGEMENT

3.1 Service Areas for Engaging the Private Sectors in PPM-Malaria

Private sector and all other qualified providers outside the jurisdiction of the NMEP are encouraged to engage in PPM in the delivery of malaria components including:

Participation in diagnostics and treatment delivery services

Ensuring quality assurance services

Community malaria care services

Mentoring, supportive supervision and monitoring of performance

Delivering community level malaria interventions

Participate in operational research and surveys

Monitoring, evaluation and malaria surveillance

3.2 Procedures for Engaging Private Facilities in PPM-Malaria

There are a series of activities that, when conducted step-by-step, create a roadmap for the successful implementation of a PPM-malaria program. These are:

Establishment of taskforce

Consensus building and sensitization meetings

Site selection

Facility readiness and service availability assessment

Capacity enchantment

Memorandum of understanding (MOU)

Service initiation

Referral linkage

Community awareness and service promotion

Logistics management

Monitoring and evaluation

Supportive supervision and reporting.

3.3 Consensus Building and Sensitization Meetings

This is a very essential step in the implementation of the PPM-malaria program. It is a forum that is organized to engage regional health bureaus (RHBs), federal regulatory and supply overseeing authorities, 7 | P a g e

Woreda/Town Health Office officials, and private providers in the initial planning process. The meeting should serve as a forum to thoroughly explain the approach, targets, and timeline of implementation. Logistics, supervision, reporting and training is addressed by participants during this meeting. The consensus and sensitization meeting is expected to help participants understand the concept of the PPM-malaria initiative, the roles and responsibilities regarding who does referral, treatment, provision of drugs, supplies as well as reporting requirements. It also serves as a platform to share experiences by participants. The forum enables the participants to know about the site selection criteria to assure transparency.

3.4 Site Selection

All PPM health facilities including primary clinics, which fulfills the regulatory requirements as per the national standard will be included for the PPM-malaria activities. Based on the requirements, the local health offices will prepare and provide the list of potential facilities to the team to conduct facility readiness assessment and site selection.

3.5 Facility Readiness and Service Availability Assessment

Using a standardized questionnaire, a team composed of RHB, regional laboratory, local health office malaria experts and partners conduct facility readiness assessment of potential private health facilities including, resources available and the needs of the facility. The assessment should detail each facility’s current infrastructure, human resources, and training requirements for staff, laboratory facility and equipment, the number of clients and motivation of the facility to commit to the PPM/malaria program.

3.6 Capacity Enhancement

Technical capacity enhancement should be based on need assessment findings of the facilities. To maintain quality of service in program implementation, health care providers should be updated with current recommendations to provide the best level of service. Training is also necessary to encourage adherence to national protocols and guidelines and standardization in patient care.

3.7 Memorandum of Understanding

The MOU establishes a formal relationship between the RHB/ local health structure and the private health facility. It should clearly articulate the roles and responsibilities of both the RHB and the PPM health facility to implement PPM malaria activities.

3.8 Service Initiation Evaluation

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Once the PPM health facility signs the MOU, a team composed of local health office experts and other stakeholders will conduct service initiation evaluation. After the evaluation, facilities will be supplied with anti-malarial drugs, RDT, and registration books, monitoring and evaluation tools that will enable them to initiate the services and onsite coaching from the very inception of the program.

Subsequent supplies will be refilled based on their consumption rate and submitted RRF.

3.9 Referral Linkage

An effective referral linkage as per the existing referral network facilitates the provision of care that the patients need, ensures continuity of care and track patient progress. Full cooperation and coordination by the government and PPM health facilities allows for better referral and feedback system, handles complex and difficult cases diagnosis, provides appropriate follow-up and monitoring, and prevents transmission of the disease and the emergence of drug resistant parasite strains.

3.10 Service Promotion

Promotion of PPM services to create public awareness about available malaria services in the private health sector is essential. The community should be aware that anti-malaria drugs are dispensed for free to the community and also the malaria tests are done with minimal service cost. There should be posters, leaflets and others IEC/SBCC materials to create public awareness on the malaria facts and the availability of malaria diagnostic and treatment services at the PPM-health facilities.

3.11 Drug Logistics Management

Logistics are the critical part of the program. Facilities must be assured that they will receive timely and adequate supplies of drugs as per integrated pharmaceuticals logistics system (IPLS) regulation based on consumption and submission of activity reports (See details under the Pharmaceutical Supplies

Management section).

3.12 Monitoring, Evaluation and Surveillance

The national monitoring, evaluation and surveillance system must be in place to ensure appropriate use of resources, to assure quality of services rendered, and to generate data for decision-making. Monitoring and evaluation will help to evaluate the outcomes of the program implementation while measuring both short and long-term impacts. Partners, regional authorities and facility staff need to facilitate and undertake program monitoring through supportive supervision and by organizing program review meetings with all stakeholders.

Surveillance also facilitates the timely submission of cases to the appropriate health offices to support

9 | P a g e the malaria elimination program.

3.13 Supportive Supervision

This is an important task to be carried out by using standardized checklist to establish and ensure quality assurance mechanisms at the PPM health facilities. It also ensures the adherence to national guidelines by the health facilities in the provision of care, laboratory services, drugs and other commodities and overall facility maintenance including; facility infrastructure (ventilation, waste disposal, etc.) as well as record keeping and reporting.

The program needs to work closely with the local health structure to conduct quarterly joint supportive supervision. It is recommended to supervise the new PPM facilities intensively on a monthly basis for the first three to six months.

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UNIT 4: ROLES OF STAKEHOLDERS IN PPM-MALARIA

PPM-malaria program implementation process requires the committed and rigorous contributions of various stakeholders within the national health system. Identifying the role and responsibilities of each stakeholder assists the partnership to be effective at all levels. Stakeholders in malaria PPM and their roles presented as follows.

4.1 Federal Ministry of Health

Provides overall leadership and coordination, stewardship and oversight of the PPM initiative.

Considers PPM as one of the agendas in case management technical working group

(TWG).

Develops and distributes national policy, guidelines and manuals for engaging PPM health facilities in malaria elimination strategies.

Regulates to assure that the PPM-malaria sites are staffed, equipped and operational to deliver expected malaria care results.

Sets national targets and provides direction for the expansion of PPM-malaria.

Creates smooth communication and partnership with other governmental organizations, private health employers association, professional associations and PPM facilities.

Builds the capacity of relevant stakeholders to effectively implement and manage PPM program.

Ensures mobilization and allocation of adequate resource for implementation of PPM activities.

Leads and coordinates the national PPM technical working group.

Ensures recording and reporting of PPM program activities through the national health system.

Monitors and evaluates the implementation of PPM initiative.

Provides ongoing technical support to the regions for strengthening implementation PPM activities.

Ensures use of standard manuals, reporting formats, job aides and other standard operating systems (SOPs) in implementation of PPM activities.

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4.2 Regional Health Bureaus

Lead, support and monitor the implementation of PPM malaria activities in their respective administrative areas.

Consider PPM as one of the agendas for TWG meetings.

Assess readiness based on developed criteria and engage PPM malaria facilities to deliver the standard malaria prevention, control and elimination services.

Sign MOU with the PPM health care facilities to formally engage them in the provision of malaria prevention, control and elimination services.

Facilitate the distribution of malaria reagents, anti-malarial drugs and other necessary supplies through the national supply system.

Distribute national PPM malaria implementation guide, national malaria treatment guidelines, recording, reporting, and other provider support tools and formats.

Provide appropriate trainings to the PPM health care providers.

Conduct regular supportive supervision, program monitoring and evaluation.

Timely collect, review, compile and submit PPM malaria performance report to next level.

4.3 Regional Health and Health Related Regulatory Offices

Ensure that malaria care is delivered according to national standards.

Involve during site assessment, selection and authorization of services.

Ensure that PPM sites comply with the procedure to be followed in service delivery and take regulatory measures on facilities that do not comply.

Prepare and submit report on regulatory matters to RHBs.

4.4 Zonal Health Departments and Woreda/Town Health Offices

Identify private health facilities, which are capable to deliver quality malaria services.

Participate in the assessment, selection and preparation of the PPM health facilities for malaria services.

Identify training needs of PPM health facilities and communicate to the regional health bureau.

12 | P a g e

Provide and ensure timely delivery of commodities (anti-malarial drugs, reagents and other commodities) to PPM sites with the relevant recording and reporting and IPLS tools for proper recording and timely reporting of malaria services.

Distribute national PPM malaria implementation guideline, national malaria treatment guidelines and other provider support tools and formats.

Conduct quarterly integrated supportive supervision by using national/regional standard tools.

Monitor PPM implementation regularly.

Coordinate random slide rechecking and onsite evaluation for EQA participating health facilities.

Ensure the PPM malaria sites receive regular EQA support and feedback.

Timely collect, compile, review and submit PPM malaria performance report to next level.

Strengthen the referral linkage and communication system of government and private health care providers.

Conduct integrated annual review meeting on PPM malaria implementation status.

4.5 Ethiopian Food and Drug Authority (EFDA)

Ensures that malaria care is delivered according to national standards.

Involves during site assessment, selection and authorization of services.

Conducts pharmacovigilance monitoring

Submits report to FMOH.

. 4.6 Ethiopian Pharmaceuticals Supply Agency (EPSA)

Supplies anti- malaria drugs and commodities to the PPM-malaria sites based on report and requisition form (RRF)/private clinics reporting and requisition (PCRR).

Ensures all the PPM malaria health facilities are linked to IPLS or health commodities management information system (HCMIS).

Aligns the role and responsibility of EPSA with signed SOP-Addendum to address the private health sector.

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Includes PPM malaria sites during the national malaria pharmaceuticals and other supplies quantification.

Monitors inventory of malaria pharmaceuticals in the PPM health care facilities.

Receives reports and requests from PPM health care facilities and distributes anti-malarial drugs, reagent and supplies accordingly.

Maintains regular pharmaceuticals supply for PPM health care facilities as per need.

Enhances the capacity of PPM health care facilities in area of pharmaceutical supply management and rational pharmaceutical use through provision of technical support.

4.7 Ethiopian Public Health Institute (EPHI)

Ensures the implementation of blinded rechecking program in PPM Malaria sites in the country.

Follows the implementation of corrective actions and provides training and technical support for private health facilities through regional reference laboratories.

Provides public private disaggregate report annually to the FMOH.

Involves private health sector representatives in the annual review meetings.

4.8 Regional Reference Laboratories (RRLs)

Coordinate the implementation of blinded rechecking program for PPM malaria sites along with public health facilities in their respective region.

Perform blinded rechecking for PPM malaria sites, which are not covered by EQA centers and sub-regional laboratories.

Send feedback results to PPM malaria sites within the specified period on the national Malaria

Diagnosis EQA guidelines.

Follow the implementation of corrective actions and provide training and technical support to PPM malaria site laboratories in their respective region.

Involve PPM malaria site laboratories in annual review meetings.

4.9 Sub-Regional and EQA Center Laboratories

Perform blinded rechecking to PPM malaria site laboratories along with the public peripheral laboratories schedule.

Send feedback results to PPM malaria site laboratories within the specified period on the national

Malaria Diagnosis EQA guidelines.

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Follow the implementation of corrective actions and provide technical support to PPM malaria site laboratories.

Provide quarterly disaggregated report to RRLs.

4.10 Government Health Facilities

Facilitate the referral and communication mechanisms between government and private providers.

Link PPM-malaria sites with community malaria services at the health post level.

Manage patients with suspected severe malaria referred from private facilities; and admit cases with a confirmed severe malaria.

4.11 PPM-Malaria Facilities

Provide malaria management in line with the FMOH standards.

Provide anti-malaria drugs free of charge and the laboratory service as per the agreed subsidized cost.

Record and report all malaria program activities using national health information system data tools to the next level.

Ensure malaria management are delivered by appropriately trained/oriented personnel.

Monitor and control the quality of malaria reagents through regular internal quality control

(IQC).

Properly store and manage medicines and anti-malaria reagents using IPLS tools.

Report and request malaria program supplies through IPLS.

Maintain a strong referral and communication network with all malaria treatment and care providers.

Collaborate and communicate with local health offices for effective PPM malaria implementation.

Store and select positive and negative blood film slides as indicated in the national Malaria

Diagnosis EQA guidelines.

Participate regularly in malaria laboratory EQA organized by the RRLs/sub-regional laboratories/

EQA sites.

Take corrective actions and report to RRLs/ sub-regional/EQA centers laboratories.

Document the feedbacks of supportive supervision, clinical mentoring and EQA

15 | P a g e performances.

4.12 Health Professional and Private Health Facilities Employers’ Associations

Advocate for PPM to support the national malaria elimination program.

Participate and assist in the formulation of enabling national policies and guidelines.

Provide technical and operational support to expedite the PPM malaria implementation processes.

Collaborate with FMOH/RHBs in capacity enhancement of health care providers on the national malaria diagnosis and management standards.

Ensure the PPM health facilities provide quality malaria diagnosis, referral and treatment services.

4.13 Partners

Provide the necessary technical and financial support for effective implementation of PPM malaria services.

Collaborate with the regions in site assessment, selection and initiation of malaria service in PPM sites.

Ensure delivery of quality malaria services in PPM sites as per the national standard.

Closely work with the local health offices and PPM malaria sites to generate and disseminate evidences and best practices.

Assist regions in organizing capacity building trainings for PPM health care providers.

Plan and implement malaria control activities in close collaboration with FMOH/RHBs.

4.14 Development Project Sites or Other Private Investors

Establish a health clinic or health post that can provide the malaria prevention, control and elimination interventions.

Collaborate with the regions and partners for the initiation of malaria service in the PPM sites.

Monitor the delivery of quality malaria services in the sites as per the national standard.

Plan and implement malaria control activities in close collaboration with FMOH/ RHBs/ partners.

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UNIT 5: REQUIREMENTS FOR PPM HEALTH FACILITIES

For the PPM- health facilities to participate in the provision of malaria services will depend on the level of services expected to provide. Generally, the health facilities that agree to participate should fulfill the following criteria:

Have license/renewed license by the respective government bodies.

Have a basic infection prevention set up.

Participate and adhere to the national malaria program, PPM-malaria implementation guide, and other essential guidelines.

Sign the MOU to participate according to the type of service provision.

Participate in voluntary activities to serve the community.

The health facilities are expected to provide malaria diagnosis and treatment services and refer patients for any other needed care to other facilities. Health facilities agreeing to provide diagnostic and treatment services should give both services in the same compound to minimize inconvenience and expense to the patients.

5.1 Physical and Equipment Requirements

The PPM malaria health facilities should fulfill all the criteria needed as per the national standard for each level. The facility infrastructure, medical equipment availability, human resources profile and allowed services

5.2 Human Capacity Enhancements

Initiation of PPM-malaria must begin with a readiness assessment of private health facilities signing the

MOU with the RHB. Service providers in these health facilities will be updated with the standard case management of malaria for clinicians, malaria laboratory diagnosis for laboratory technicians and IPLS training for pharmacy professionals and malarial focal persons depending on the set up. Supportive supervision is also an essential component of the implementation process, which will be carried out frequently in the initial phase then as per the regional or the national recommendation.

The timeframe for the malaria case management training for service providers in the PPM health facilities is 5 days. The national malaria laboratory diagnosis training for laboratory professionals will be given for 3-

17 | P a g e days and the IPLS training for the pharmacy professionals will be for 3 days. Those trained staff need to update the remaining staff at facility level with the recent updates.

Subsequent orientations may have to be offered “on the job,” combined with ongoing supportive supervision. Moreover, subsequent clinical seminars will be carried out to update the OPD providers on the current malaria case management protocols.

Supportive supervision, program and clinical mentoring are also important activities to follow the proper implementation and assurance of quality of care in PPM activities. The data captured through the checklists should show standards of care including treatment completion, outcome, data quality and patient satisfaction.

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UNIT 6: PATIENT CARE IN THE PPM-MALARIA PROGRAM

6.1 Case Diagnosis and Management

PPM- facilities will follow the same diagnostic and case management standards as outlined in the

National Malaria Guidelines, including case definitions, diagnostic procedures, classifications, treatment and follow-up. For malaria diagnosis, classification and treatment refer the National Malaria Guidelines, FMoH, 4th edition, 2018.

Note: Treatment table with drug doses to be printed and posted on the walls at the private health facilities.

6.2 General Definitions

Clinical diagnosis: This criterion should be followed by parasitological confirmation and is not recommended to make malaria diagnosis alone.

Parasitological diagnosis: Making the diagnosis of malaria based on RDT or microscopy.

Uncomplicated malaria: It is symptomatic malaria, in the presence of asexual forms of malaria parasites in blood sample without signs of severity or evidence of vital organ dysfunction. The treatment of uncomplicated malaria is as described in the national Malaria Guidelines, 4th edition.

Advice the following important messages to patients with malaria:

He/she has got malaria.

If treatment is not sought early and taken properly, malaria is a killer disease.

Whenever a family member has a fever, take them to the nearest health facility, immediately or at least within 24 hours.

To take/give enough food and fluid (especially fatty meal to enhance drug absorption and to avoid risk of hypoglycemia).

Do not interrupt taking medication. Take all (full course) of the anti-malarial drugs, prescribed by the health personnel.

Do not share drugs with others, including family members.

Come back to the health facility after three days if no improvement in symptoms after malaria treatment or any time if there is worsening of symptoms.

All family members, especially women and children should sleep under LLINs every night

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Management of treatment failure: Strictly follow the National Malaria Guidelines, 4th edition, 2018

Severe malaria:

Diagnosing severe malaria: For diagnosis and management of severe malaria the National Malaria

Guidelines, 4th edition, should be followed.

Referral:

If the PPM facility is not allowed to admit and provide inpatient services for patients with any danger signs, the health care providers are encouraged to refer patients to the higher health institution level. Patients will receive first dose of IV/IM Artesunate OR rectal Artesunate in children under 6-year of age before referral as pre-referral treatment.

Clinical indicators of severe malaria

Altered or decreased consciousness (e.g. confusion, coma, etc.)

Patient sleepy, confused, unable to walk or sit-up

Not able to drink or eat (in case of children not able to breast feed)

Convulsions, or recent history of convulsions

Persistent vomiting

Dark urine, "Coca-Cola urine"

Spontaneous bleeding; gum bleeding, epistaxis

Failure to pass urine in the last 24 hours

Difficulty of breathing

Yellow eyes (Jaundice)

Extremely pale mucosa (e.g. conjunctiva of the eye)

Systolic blood pressure of < 80 mmHg.

The following essential laboratory tests (where available) should be performed to aid management of the severe malaria patient and differential diagnosis:

• Parasitological test (microscopy)

• Blood glucose level

• Hemoglobin (Hb) estimation or packed cell volume (hematocrit)

• Lumbar puncture

• White blood count

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Laboratory Indicators of Severe Malaria

Hypoglycemia (blood glucose < 40mg/dl);

Metabolic acidosis (plasma bicarbonate < 15mmol/liter);

Severe normocytic anemia (Hb < 5g/dl, packed cell volume < 15%);

Hemoglobinuria; (Dark color of urine/ Cola color urine in the absence of hematuria )

Hyperparasitaemia (>2% of red blood cells parasitized or >100,000 parasites per microliter);

Hyperlactatemia (lactate > 5mmol/liter);

Acute kidney injury (serum creatinine 3 mg/dl or greater).

Chemoprophylaxis:

Persons who travel to malaria-endemic areas are at risk of acquiring malaria. Health workers should advise all persons traveling to such areas to avoid mosquito bites, specifically by using mosquito repellent and sleeping under LLINs at night. Chemoprophylaxis is an option and Mefloquine and atovaquone-proguanil can be used as anti-malarial chemoprophylaxis in Ethiopia.

Nationally Recommended Parasitological Diagnostics

1. Hospitals, specialty clinics and Higher Clinics: Should use microscope

2. Medium clinics: Should use RDTs

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UNIT 7: SERVICE COST AND REFERRAL

It is important that the cost of RDT and anti-malarial drugs (artemether-lumefantrine (AL), primaquine, artesunate, chloroquine) will not passed on to patients seeking malaria diagnosis and treatment in the

PPM health care facilities so that the services may be accessed by the majority of patients regardless of income level. This enables improved equity of health care services in PPM health care facilities. However, to ensure continuity of service and provider’s commitment to the program, the private health facilities may need a reasonable service fee to cover other direct costs (microscopy reagents) and indirect costs (card for consultation, consumables) in making malaria services available for users. There should be clearly presented statements that describe all service related fees.

Each region negotiates the cost of malaria services through joint action of PPM health care facilities and the RHBs/local health authorities as stipulated in locally signed MOU/service agreements.

7.1 Service Areas Where No Charges Incurred

The national malaria control and elimination program is expected to procure all necessary commodities for the PPM malaria sites and the patient will receive the following service free of charge:

Malaria microscopy and RDT services including quality assurance to malaria lab service:

The PPM centers will be supplied with all the necessary commodities required for malaria diagnosis.

However, the health facilities may incur reasonable indirect discounted costs for service charge and other consumables (gloves, cotton …) that the facility uses for the diagnosis process and when the PPM facility make available the supplies from a commercial sector.

Pharmaceuticals and dispensary services:

The national program procures all anti-malarial drugs and RDTs; no cost will be incurred for procuring and dispensing these drugs and RDTs through a PPM health care facility.

7.2 Services Areas Where Patients Might be Charged

Additional laboratory tests other than direct malaria smear microscopy or RDT.

Ancillary medicines prescribed for malaria patients, as long as the program does not procure them.

Medical consultations at outpatient or for inpatient services.

7.3 Patient Referral Services

A patient is said to be referred when he/she is sent to another health facility for better diagnosis, consultation and management and/or other programmatic reasons.

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To strengthen the referral and feedback system between facilities providing malaria elimination service, RHBs and town health offices should map, prepare and communicate the list of facilities providing inpatient malaria services to all health facilities located in the catchment. When a medical referral or transfer is needed, the referring facility should complete the referral form and send it with the patient, addressed to the appropriate health institution and the receiving facility should send the feedback to the referring facility.

7.4 Certification and De-certification

Certification is the process by which the FMOH/RHB officially documents that a PPM facility of any size has met the appropriate criteria to provide the services requiring certification. The certification also would require compliance with a uniform set of national standards and procedures essential for proper delivery of standardized, quality malaria care. Certified facilities may be de-certified for PPM, following repeated warnings, for providing poor-quality malaria services. Causes for de-certification include unnecessary financial exploitation of patients such as selling anti-malarial drugs and charging clients beyond the agreed

RHB diagnostic charge. De-certification involves revocation of the MOU in place, stopping distribution of drugs and RDTs supplies, announcement of facility de-certification, and potentially taking legal actions as deemed necessary.

7.5 PPM Quality Assurance Mechanism

A. Access to quality assured smear microscopy services is one of the key elements of the malaria control strategy:

PPM facility laboratories perform all duties of malaria microscopy as indicated in the laboratory manual including internal and external quality control system.

PPM facility laboratories will follow national standards and participate in external quality assurance.

B. Standardized reporting and recording system for monitoring of malaria program will be implemented, as per the national guidelines.

C. Ensure timely delivery and adequate supplies of drugs and other consumables to the private health facilities

D. Identify indicators to monitor the national malaria elimination program (NMEP) activities

E. Training of staff and supervision will also be regularly conducted by FMOH/RHB in the private sector to assure the quality and standardization of services provided.

F. Improve health care services by conducting operational research activities in PPM health care facilities.

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7.6 Incentives

Incentives are usually most effective when they are not financial. Apart from serving the society, public-private partnerships tend to retain clients and garner recognition from the health system and national program. Distribution of drugs and reagents by the national program free of charge is the one of indirect incentives. The program also offers training, supportive supervision, EQA of microscopy services, and other general support to PPM health care facilities for better case management as well as enhanced patient satisfaction and confidence in the health care providers. This is of great importance for the perceived benefits of PPM to private health providers as consumer satisfaction is of key significance and determines future health-seeking behavior.

7.7 Procedure for Service Close-out

PPM health care facilities should follow service closure procedures whenever they decide to end malaria service provision.

A) The PPM health care facility should communicate with the responsible local health office its plan to close-out the service with a written application at least three months prior to the planned close-out date.

B) Health facilities must return all unused and unconsumed supplies (anti-malarial drugs, reagents, registers and other M&E tools) to the respective health offices.

C) The respective health offices dissolve the MOU and issue a testimonial letter for legal termination of the service.

If the PPM health care facility is to be closed for reasons of legal issues or regulatory concerns, the regulatory body must give a transition period for the facility/clinic to take necessary steps for safe and complete closure of services.

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UNIT 8: PHARMACEUTICALS SUPPLY MANAGEMENT SYSTEM

In order to achieve sustainable program implementation, it is essential to ensure that every health unit involved in malaria elimination activities has adequate and uninterrupted supply of drugs, laboratory reagents, medical supplies and equipment with assured safety, quality and efficacy.

8.1 IPLS and Private Health Facilities

According to IPLS, EPSA will supply malaria drugs to public health facilities. EPSA will also supply directly to

PPM sites whenever they are accessible. For inaccessible PPM sites, deliveries will be made via WoHO to

‘woreda pass through’ health facilities or to their catchment health centers or hospitals and the PPM sites collect the pharmaceuticals from these institutions. EPSA is scaling up the system in the public health system, and ultimately all PPM health facilities, which are eligible to provide malaria treatment services will receive the pharmaceuticals directly from EPSA.

Delivery and collection of pharmaceuticals are scheduled every two months for PPM facilities that collect pharmaceuticals directly from EPSA and every month for PPM clinics that collect their pharmaceuticals from WoHO and the nearby health facilities/woreda health office. PPM malaria treatment facilities accessible to EPSA hubs can have a maximum of four months’ stock and a minimum of one week stock at any given time whereas PPM clinics, which are linked to nearby health centers/woreda health office can have a maximum of two months’ stock and a minimum of one week, stock at any given time too. Look ahead Seasonality Index (LSI) will be considered at catchment supplier health facilities. The list of pharmaceuticals that PPM health facilities get from EPSA is limited to those listed in the guide for programmatic and clinical management of malaria.

8.2 Drug Consumption Recording and Reporting Forms

The private health facilities are required to use and routinely update the formats to monitor and report pharmaceuticals consumption. These formats include:

8.2.1 Bin Card

This is a tool used to monitor pharmaceuticals usage in the facility. Each facility is required to immediately register all pharmaceuticals issued from the facility store to dispense to clients or to be used for diagnostic purposes.

8.2.2 Drug Consumption Register

This register contains all the necessary patient-related information, and the type and quantity of drugs taken by the patients. It is updated whenever a patient consumes a dose of drugs. The data should be

25 | P a g e aggregated on a monthly basis and can be used to quantify the future needs of the facilities.

8.2.3 Report and Requisition Form and Private Clinic Monthly Report and Resupply Form

At the end of their reporting period, i.e., every two months from facilities that are directly accessible to EPSA hub, every month, for all PPM-malaria facilities are required to fill the Private Clinic Report and

Resupply Form (PCMRR) and submit it to the respective supplier health center/woreda health office on monthly basis. The RRF and PCMRR contain data such as beginning balance, quantity received, loss/adjustment, ending balance and consumption in the report section; and quantity requested for the coming period in the…

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