Global Fund Malaria Grant

Introduction

To achieve a minimum 30% reduction in malaria-associated mortality and morbidity by 2025 from 2017 rates in the program areas.

Project Objectives

• To attain core population coverage of over 80% by promptly diagnosing and treating malaria (with artemisinin-based combination therapy) through national and local providers and private medical systems in program sites by 2025.
• To reach 70% of the villages in program areas by 2025 through tailored BCC initiatives to enhance knowledge, awareness, and population responsiveness to malaria prevention and treatment interventions.
• To build national institutions’ capacity in project planning, implementation, monitoring and evaluation, and effective partnership creation to foster service delivery in program areas.
• To improve the healthcare systems in project areas through technical skills development and capacity building.
• To achieve a 75% decrease in malaria morbidity and mortality from the 2019 rates by 2025.
• To administer the Global Fund grant to fight malaria in Ghana and allocate about 47% of the funds reserved for ACTs to health centers to procure drugs and other medical supplies.

Project Areas and Beneficiaries

The program goals specified in the Round 4 proposal focus on reducing the malaria burden in young children (< 5 years) and during pregnancy by 30% by 2025 through increased access to preventive and curative interventions, including implementing the recent treatment policy in all Ghana’s 138 districts.

Key Implementing Entities

• The Ministry of Health (MoH/GHS) is the designated principal recipient (PR) that is obligated to develop a PSM plan (in partnership with Sub-recipients or SRs) proposing measures for meeting the Global Fund procurement standards. Upon evaluation by the LFA (PricewaterhouseCoopers (Gh) Ltd or PWC), the plan becomes the basis for purchasing pre-selected products or services.

The PR is obligated to promote adherence to applicable Global Fund procurement standards in all its tendering processes and other collaborative purchasing arrangements under the malaria grant.

• The SR that has been mandated to manage the grant is the National Malaria Control Program (NMCP), with technical assistance from the CCM. A primary focus area include the functional capacity development of community health workers and private providers.
• PWC is the contracted Local Fund Agent (LFA).

Relevant Issues

We developed a new PSM plan for two reasons:

1. Wide-ranging barriers and bottlenecks have affected Ghana’s implementation of the previous Global Fund malaria grant, contributing to the failure to meet timelines.
2. The PHPCP is increasingly being adopted as a replacement for earlier PSM plans. Additionally, the new funding model includes PSM elements that are integrated into the PSM system at the CN phase after the evaluation of health commodities (The Global Fund).

Therefore, Ghana’s PSM Plan can be considered outdated, and a new one is needed. Two changes should be introduced in this plan: (a) including primary stakeholders to foster ownership, eliminate resistance, and streamline the ACT supply chain and (b) meet the new requirements of the ‘Guide to Global Fund Policies on Procurement and Supply Management of Health Products’ (The Global Fund, 2018).

PR’s Capacity to Conduct PSM

The MoH, as the direct program implementer, has mandated the NMCP to manage the malaria grant. Specifically, its role pertains to procurement and supply of goods or services. Identified SRs managing pharmaceutical and health products and the PR’s management capacity are explained in subsequent sections.

The mapping of current procurement and supply resources is a critical activity of the Global Fund dialogue process. However, the systems must be transparent, financially viable, and compliant with national laws. PR recommends technical support for weaker systems that do not meet these requirements. These preconditions and procurement policies are prescribed in the ‘Guide to the Global Fund’s Policies on the Procurement and Supply Management of 2016’.

Indirect buy options involving a procurement agent (PA) will be used for goods, which account for 67% of the malaria grant portfolio for the Round 4 period. The recruitment of the PA will be per the USAID-assisted National Malaria Control Program following MoH’s International Competitive Bidding (ICB) guidelines.

The PSM processes must be aligned with international best practices in procurement. In particular, they should involve open tendering and standard warehouse operations and logistics management. Ghana’s procedures, policies, and practices need improvement to ensure a more transparent and efficient procurement system. To satisfy these requirements, the WHO country office has contracted the MMSS to handle all procurement activities. First, PR’s Procurement Unit specifies the details and volumes of artesunate-amodiaquine consignments that the country needs. The MMSS then invites supplier quotations for donor-funded ACT drugs. Intensive lobbying by local pharmaceutical firms to supply the ACTs remains a challenge. However, as the suppliers are neither WHO-prequalified nor GMP-certified – a Global Fund prerequisite – they did not qualify.

Prequalification and supplier selection must adhere to the Global Fund’s operating procedures and policies. Ghana’s government has outlined strict procurement procedures for the purchase of products or services. These guidelines are geared towards ensuring an efficient, competitive, and transparent procurement system.

The maximum 12-month budget estimate for procurement is US$37.40 million. These funds cover externally aided projects by the USAID or Global Fund. However, a discrepancy between the proposed and actual spending may arise due to currency fluctuations against the US dollar.

Entities implementing the Global Fund, including the PR, SR, and distributors, must fulfill three statutory requirements. First, they must develop quality control procedures for inbound medical consignment inventory. Second, the implementers are required to create quality assurance mechanisms for each implementation phase or component. Third, they must coordinate surveillance and establish supervisory control to promote provider compliance and patient administration of ACTs. The Global Fund malaria grant is subject to pertinent procurement laws and regulations of the Government of Ghana.

Both the approval of medicines and enforcement of good manufacturing practices are a mandate of the Ghana Food and Drug Authority (FDA). The tendering process and purchase of pharmaceuticals must reflect the International Competitive Bidding rules stated in the Global Fund’s Guidelines. These procedural standards shall also be used in procuring drugs and supplies after technical specification approvals. Funding will come from the donor funds or domestic budget allocation to the malaria project.

The Global Fund emphasizes similar contract terms as those used in the GFATM project. In the case of defective products, a national or local regulatory body can take steps to de-license or blacklist the supplier or manufacturer.

The recall mechanisms for affected drugs are less clear in Ghana. Additionally, though WHO-approved and ISO 13485 certified, available suppliers have not met WHO standards for prequalification. Since the process of procuring RDTs has commenced, introducing new technical requirements would lead to delays. Further, a countrywide shortage of RDTs may arise if procurement is prolonged. A potential negative outcome would be limited early malaria diagnosis for effective control. However, WHO-approved suppliers will be available for inclusion in the subsequent procurement process.

The local NDRA approval (less stringent) of single-sourced drugs in 2004 would also be considered in quality assurance. Its premise was that before 2004 ended, adequate WHO-prequalified or licensed products would be available in ICH/PICs countries.

The procurement authority would inspect the consignment before and after dispatch through an approved independent laboratory. In-house quality control teams would not be involved in product inspection or testing. The stakeholder consensus is that only accredited professional inspection and testing firms will complete this process.

Presently, a buffer stock scheme of 25% over the required goods will be used to cater for potential price fluctuations. Continuous monitoring of inventory levels to curb out-of-stock situations is recommended for states and districts. Additionally, a certified body has been contracted to manage NMCP logistics and supply chains. Inventory requirements in the NMCP’s manual specify the stock capacity at state, district, and sub-district warehouses. They are a part of the agency’s standard operating procedures (SOPs) for ensuring optimal stocks at all levels. The SOP mechanism ensures effective stock control to sustain demand changes.

The new system will address drug stock-outs by implementing a 25% buffer stock scheme. The goal is to ensure regular and consistent supply and availability of medicines at project sites. Administrative procedures for a new procurement activity may cause delays. Therefore, the buffer stock will cater for possible stock-outs occasioned by lengthy procedural processes.

Funding for medicines not compliant with the Global Fund QA policy will come from national budgets until the QA concerns are resolved. Before then, the Drugs and Pharmaceuticals allocation will be used to expand the LLINs coverage. To meet QA prerequisites, the NMCP has incorporated the WHO prequalification criteria into its procurement plans. The agency procured only WHO-prequalified malaria medicines and testing kits for the 2018-19 period.

Compliance with local and international patent laws is expected from PR and SRs in all their procurement activities. Related policies must be aligned with the Global Fund’s procedures and Ghanaian tendering statutes. The SRs/SSRs engaged in PSM must adhere to these guidelines following the Program Management Unit’s guidance.

Ghana gained WTO and GATT membership in October 1958 and January 1957, respectively. As a consequence, the country has adopted WTO laws on product patents and innovations. The procurement of patented drugs must be conducted in compliance with international and local regulations. Ghana’s patenting policies and guidelines for drugs and medical technologies also include provisions for licensing manufacturers.

In Ghana, vector-borne disease prevention, including malaria control, is a function of the NMCP. Government funding sourced from the Global Fund’s allocations for malaria, tuberculosis, and HIV/AIDs is the program’s main financing option. Financial support for the NMCP’s operations also comes from other donor agencies, including WHO, UNICEF, DFID, and USAID/PMI.

The NMCP’s procurement management plan estimates the demand levels and considers technical specifications in advance to avoid stock-outs and supply chain interruptions. Subsequently, a consignee list is developed and sent to the MoH/GHS to initiate the tendering process via the procurement agency (PA). A notice of the amount of products to be supplied is sent to individual states to plan for warehousing and logistics. The Logistics and Supply Chain Monitoring Agency manages consignment inventory both at the NMCP and at the recipients.

The NMCP can appeal for emergency procurement from donor organizations such as WHO to address stock shortfalls. However, a 6-months period must be allowed for processing the request. In case of other unforeseen procurement delays, the NMCP may use the VPP procedures – GF’s support service that shortens the tendering and bidding process. Therefore, fast-tracked procurement can be done to cover stock-outs but must involve GF and WHO.

Effective planning and evaluation must be based on data from different metrics. The Central Procurement Unit has implemented a comprehensive information management system for this purpose. The Management Information System (MIS) measures different aspects useful for planning, such as patients served, drug utilization rates, and inventory levels. A monthly submission of these data through the NMCP management unit is required to support planning.

LMIS reporting has some inherent weaknesses that affect the usefulness of the data. The recent Health Information System (HIS) comprises both digital and manual components. Patient data is obtained using forms completed by hospital staff and then entered into the HIS. However, the heavy employee workload associated with filling the form is a major challenge. The unintended outcomes include erroneous and incomplete data in the HIS. As a result, the data must be re-entered in further patient contacts, an extra burden for nurses and doctors. Additionally, the stock management system at a local store lacks a batch number and expiration tracking component, affecting the efficient tracing of goods throughout the supply chain.

The MoH, through the Global Fund, will install a Logistics Management System (LMS) to improve product traceability. The target facilities are pre-selected teaching hospitals, local providers and medical centers, and the Regional Medical Stores (RMS).

Additionally, the Global Fund adopts a pooled procurement system to ensure speedy tendering and delivery of drugs and other medical supplies upon receiving orders from grant implementers. However, a weak LMIS reporting mechanism is a major hindrance.

For this reason, the NMCP should acquire an efficient manual MIS that also includes an online MIS. The paper-based system should be adopted promptly by as early as 2021. It should report stock variables, including initial inventory, monthly quantity received, and the amount of products dispensed. In contrast, the web-based component will capture micro-level data at the districts. A comparison of book and warehouse inventories using the physical verification sheet (PVS) will be required to address any stock variations in any given month.

Procurement and Supply Management Cycle

Proper planning and review of requirements are critical considerations in procuring drugs and medical technologies. The details of these processes are contained in the PSM plan. Initial predictive estimates are dependent on morbidity data and institutional capabilities to provide the required services. At the same time, forecasts for on-going activities are based on historical utilization rates and projected program expansion. Predicting demand fluctuations uses previous consumption patterns and shifts in health needs.

Forecasting is an important practice in Ghana to avert drug stock-outs or costly overstocks. For anti-malarial drugs, optimal inventory must be maintained to cover unexpected surges in infections and procurement delays. The Annual Action Plans includes evaluating state-level capacities based on the current stock, technical specifications, and consumption rates in past years. Determining the appropriate product quantities relies on malaria incidence in the previous year plus a buffer stock of 25% to cover potential procurement or supply delays. Morbidity and drug use rates should be considered in the analysis.

Regular monitoring of drug and pharmaceutical product utilization levels is required. The data obtained will ensure up-to-date forecasting of expected needs. The development of a plan and stock management system can help the PR limit the possibility of stock-outs. Reports of out-of-stock events are submitted to the Global Fund biannually.

ACT

A further measure to avoid stock-outs entails delivering two or more ACT combi-blister packs to all villages. The goal is to ensure adequate drugs for all positive malaria cases presenting to the community health worker. The demand levels are based on the population demographics (age profile). Therefore, under this NMCP, ACT is supplied at greater levels than actual malarial infections in the project sites, particularly in the first year of the program.

Early identification of technical requirements for drugs before procurement would be conducted in the program. The DGHS Technical Committee provides these specifications to the NMCP. It also receives the product list, consignee records, and cost estimates meant for the PA via the Ghana Empowerment Procurement Wind (GEPW) of the MoH. GEPW, working with NMCP, develops a procurement plan that is subject to the Global Fund’s approval.

The PA relies on the NMCP request to develop the Invitation of Bids (IFB). The bidding procedures are aligned with those of the Global Fund. The Global Fund must approve the PA bid documents before the IFB can be published. However, in procurement processes under the malaria grant, the MoH approval is accepted. Another requirement is that IFB should be posted on a specific MoH and PA webpage. Additionally, for International Competitive Bidding (ICB), the invitation of bids should appear in a digital platform of the UNDB and its reports.

Competitive bidding requires bid opening to be conducted at the day and time stated in the Bid Document. Also, the bidders or their representatives must witness the exercise.

The Bid Evaluation Committee includes nominees from PA, GHS, and NMCP who review the bids and prepare a report. The Purchase Advisory Committee (PAC) comprising MoH/GHS officials and headed by the DGHS would analyze the documentation and select the successful bidder. All Global Fund guidelines on procurement would be adhered to during the tendering process and award of tenders.

A professional body would be contracted to inspect the products or consignments on behalf of PA before dispatch. The PA would also control the supply chains, including the delivery of goods to individual consignees.

Upon receipt of supplies by hospitals, the PA would pay the suppliers after scrutinizing the documents provided according to contract terms. These include the Acknowledgement of Receipt of Goods and Certificate of Final Acceptance by the consignment recipients.

EPW would manage the schedules to ensure adherence to the procurement plan timelines. This entity would also require suppliers to deliver quality goods on time at competitive prices. It would also follow up procurement procedures to avoid delays that may contribute to stock-outs.

Third-party entities can help reduce procurement lead times, especially during emergencies. However, the Ghanaian Global Fund grant has limited capacity building and skills development plans, which delay implementation. Engaging the MMSS in procuring artesunate-amodiaquine has led to lower overall costs and increased efficiency.

Balancing efficiency gains and cost savings is essential for Ghana. The higher handling fees must be evaluated against the price of medical products. Contracting third-party agencies to do procurement and shipment is a cost-effective approach that could produce favorable results for the country.

Ghana’s supply chains are inefficient due to weak inventory control and decision-making processes that are not based on data. The Secretariat of the Office of the Inspector General Global Fund will help MoH develop and document standard procedures for:

• Applying the LMIS-generated logistics data to enhance product availability to implementers in all program areas
• Promoting compliance with supportive supervision, capacity building, and quality assurance throughout the supply chain

The specific actions to be completed include:

1. Provide adequate warehousing space for drugs and medical supplies at each region, state, and district. The NMCP will also expand the existing storage system across the country. Given the need for large storage space for Long-Lasting Insecticide Nets (LLINs) and temperature requirements for Rapid Diagnostic Tests (RDTs), a budget to acquire additional warehousing facilities under the project has been proposed. The consignees have been informed to make requisite arrangements for storing ACTs, LLINs, and RDTs within the project sites. Funds for rental storage space would be made available in cases where the warehouses are inadequate.
2. The necessary guidelines for storage and inventory management are in the Operational Manual. Adopting the system of first-expiry-first-out (FEFO) and first-in-first-out (FIFO) will avoid losses related to product expiration, lowering the inventory holding costs. Physical checks will complement stock registers at each level – national, regional, and district. Current SOPs contained in government publications guide routine practices in all stores. Physical locks are used to secure the facilities, and adequate measures are adopted to deter theft in addition to an emergency response plan for fire or floods.
3. The central-level procurement delivers supplies to State and District consignees each year according to approved Annual Action Plans developed through consultations involving NMCP officials. Moreover, a monthly indent system linking sub-district centers to the district head office through the Public Health Cares (PHCs) has been implemented. Quarterly indents to the state originating from the districts also follow the same process. Emergency supplies come from buffer stocks that are 25% at Regional and State levels and 10% at the Districts.

NMCP can contract through a professional agency that will be useful in the following ways:

1. Help NMCP in forecasting annual demand levels for medicines and other medical supplies.
2. Strengthen the current inventory management systems at the three levels – state, district, and PHCs. The goal is to ensure effective drug administration in the program by creating a robust monitoring procedure and logistics management information system (LMIS) within the NMCP. These measures will help NMCP maintain an uninterrupted supply of drugs and other medical products.
3. Assist in capacity building and training of the NMCP workforce and state and district officials engaged in drug supply chain and inventory control. The agency will also assist NMCP to standardize current SOPs and implement them to ensure effective stock control.

The contract period will include regular inspections of state and district storage facilities to review their supply chain processes and address challenges if any. The efficiency requirements in the system used will be revised annually. Capacity building and training workshops for drug managers and officials at the three levels will focus on SOPs to address bottlenecks in supply management. Regular review and updating of SOPs shall be completed to align them with current policies. It is also recommended that two independent consultants be engaged in the program at the national level. Currently, the technical assistant position in the Global Fund has not been filled. Further, finance and logistics consultants should be recruited for state and district levels of the Global Fund malaria grant. Although in most States and Districts in project areas a financial consultant has already been hired, in others, the selection process is ongoing.

Reliability, efficiency, and security of the distribution system are the role of the CPU and PMU. The supply chains of pharmaceutical products and other medical supplies must be streamlined to avoid stock-outs at the hospitals and local pick-up points. The program’s decentralized model will require the hiring of more service providers to deliver products to specific facilities based on demand. The management of these entities is a function of the NDOH/CPU to ensure buffer stock that can cover three months are maintained at the storage sites.

Supply requests are made annually through the Central-level procurement to State and District consignees. The requisition is completed according to the approved Annual Action Plans prepared during NMCP officials’ meetings in Accra. In addition, a monthly indent system from the PHCs or sub-centers to districts has been implemented. It captures the opening stock, goods received/used monthly, and the quantities required in the next month. Quarterly indents from the districts to the state avoid stock-outs at the peripheral units. Buffer stocks kept at 25% at the Regions and States, and 10% at the Districts to cater for emergency needs.

The delivery of outbound stock to peripheral units involves government or hired vehicles. The quality and quantity of the supplies are confirmed through a monitoring system that entails periodic reports and assessments by supervisors visiting the decentralized units. Further, the Program Division under the Global Fund malaria grant has contracted an independent firm to manage the NMCP supply chains. The program budget includes the transportation cost of LLINs, RDTs, and other supplies. This component is critical as the terrain of the project areas is woody and hilly, and the road network is poor.

Monitoring and management of the stock quality and quantity are completed using an elaborate manual reporting system under NMCP. A custom-made electronic system, NAMMIS, has been deployed to monitor supplies and logistics in real-time. Furthermore, technical supervisors review inventories and their usage at peripheral units. During a spike in malaria cases, emergency requirements are met using buffer stocks maintained at Regional Government Medical Stores Depots (GMSD) and state-level warehouses. Supplies, including goods about to expire, can also be redirected from low-incidence areas to locations where they are needed. In addition, the competitive hiring of a third-party entity through the World Bank funding is now complete. The agency will work with the NMCP to manage the supply chains and drug inventory. The goal is to enhance the availability and accessibility of antimalarial medicines and diagnostics.

The assessment of risks and benefits of medicines should be devoid of partisan interests. Such a system should involve independent expertise in collecting, evaluating, and use of drug safety data. Training health workers and patients on safe usage of medicines can help prevent misuse of drugs.

Ghana will establish a system for collecting data on adverse/toxic reactions (pharmacovigilance) to ACTs and injection artesunate. The Regulatory pharmacovigilance, an entity in the Ghana National Drug Program (GNDP), Ghana’s drug regulator, will oversee the new program.

Educating ASHAs or health workers on the best drug storage practices will be conducted. The training programs will focus on optimal store temperature, avoiding humidity and direct sunlight, and the FEFO/FIFO principle. Further, the health supervisor will be trained on how to monitor the field storage practices and identify and dispatch drugs nearing expiry. The training of ASHA workers will entail rational drug use at the local level by program implementers. The professional agency will also equip the logistics manager, DMO, VBD consultant, and storekeepers with skills in supply chain management and logistics. These professions will, in turn, train field officials in the health centers. The orientation of field staff will also involve the national-level consultant.

A system of documenting and reporting logistics from the ASHA level to the district is required. The ASHAs will maintain received, consumed, and closing stock records. The ASHA reports should be submitted bi-monthly or monthly to the sub-centers for compilation and collation.

The peripheral-level reporting formats will be retained in the reports of drugs and commodities at other levels. Training of staff on best practices in the storage and management of medical supplies will be conducted. The information will also be included in their training manuals.

Supervisors will monitor, supervise, and manage health products at all levels. They will use standard checklists to complete these roles during their visits. This supervisory practice will be adhered to at all levels, including central-to-state, state-to-district, district-to-sub-district (block), block-to-sub-center, and sub-center-to-village.

In effect, since 2004, when ACTs were introduced in Ghana, several brands of this drug have flooded the market, with some being substandard. Measures to eliminate counterfeits and address adverse drug reactions (ADRs) to amodiaquine in local ACTs will be adopted. Quality tests of ACTs in Ghana are conducted at the London School of Hygiene and Tropical Medicine and the Georgia Institute of Technology.

The GNDP licensed a locally manufactured artesunate 200 milligrams (mg) and amodiaquine 600 mg previously used by private providers. Most public hospitals obtained artesunate-amodiaquine combination containing higher amodiaquine levels than recommended in the WHO malaria treatment guidelines from the local pharmaceutical firms. This ACT caused adverse drug reactions (ADRs), causing strong opposition to its usage.

The PR, CCM, and the GNDP must create an independent entity to manage pharmacovigilance under this program. That unit will implement pharmacovigilance procedures at all levels of healthcare delivery. The system should encompass monitoring and reporting ADRs, poor drug responses, and patient outcomes.

Therefore, quality control of the locally manufactured and imported drugs is required in Ghana. It should entail analyzing samples before registering medicines and deregistering poor quality products. The stock register should be maintained in all warehouses to support reporting.

An independent central-level agency can help streamline supply chain management under the Global Fund program. In addition, logistics managers should be recruited at each state. The end-users under this program will receive medicines at no cost. Similarly, the proposed GFATM Round 9 project will not charge beneficiaries, as has been the case with other previous public health projects.

Work Cited

The Global Fund. “Guide to Global Fund Policies on Procurement and Supply Management of Health Products”. Web.