West African Health Organization

Transcription

1 West African Health Organization Assessment of Central Medical Stores to host Regional Antiretroviral Medicines Stock Security in Four Countries Report March 2013 Pharm. Samuel BOATENG Dr B. Gérard Josias YAMEOGO 1

2 ACRONYMS LIST OF KEY ACRONYMS AND ABBREVIATIONS USED AIDS ART ARV CMS CAMEG DGPML DPM ECOWAS EML FEFO FDA FMS GAC GDP GHS HIV ISO LMIS MQAS NACA NACP NAFDAC NASCA NDRA PEPFAR PNPEC PSM PSP-CI PLHIV PMTCT SOP STG STI USAID WAHO WHO Acquired Immune Deficiency Syndrome Antiretroviral Treatment Antiretroviral Centrale Medical Store Centrale d Achat des Médicaments Essentiels Génériques Direction Générale de la Pharmacie, du Médicament et des Laboratoires Direction de la Pharmacie et du Médicament Economic Community Of West African States Essential Medicines List First expiry First Out Food and Drug Authority Federal Medical Stores Ghana AIDS Commission Good Distribution Practices Ghana Health Service Human Immunodeficiency Virus International Organization for Standardization Logistic Management Information System Model Quality Assurance System National Agency for the Control of AIDS National AIDS Control Programme National Agency for Food and Drug Administration and Control National AIDS/STI Control Programme National Drug Regulatory Authority President's Emergency Plan for AIDS Relief Programme National de Prise En Charge médicale des PvVIH Procurement and Supply Management Pharmacie de Santé Publique de Côte d Ivoire People Living with AIDS Prevention of Mother-to-Child Transmission Standard Operating Procedures Standard Treatment Guidelines Sexually Transmitted Infection United States Agency for International Development West African Health Organization World Health Organization 2

3 TABLE OF CONTENT TABLE OF CONTENT... 3 EXECUTIVE SUMMARY... 4 I. BACKGROUND... 7 II. CONCEPTUAL FRAMEWORK FOR THE ASSESSMENT III. LIMITATIONS OF THE REVIEW IV. FINDINGS AND ANALYSIS V. COMPARATIVE ANALYZE OF THE FOUR CENTRAL MEDICAL STORE..64 VI. CONCLUSIONS AND RECOMMENDATIONS

4 EXECUTIVE SUMMARY BACKGROUND AND PURPOSE This report describes the purpose, methods, and findings from a recent assessment of the central medical stores in Ghana, Nigeria, Cote d Ivoire and Burkina Faso. The West African Health organization commissioned a team to carry out this review to help decide where best to locate a Regional Antiretroviral Drug Stock Security and where to channel its support for strengthening the public sector healthcare supply chain. METHODOLOGY The review is a two-part activity that entails (1) a desk review that synthesized broad systems issues; (2) Country visits to assess the commodity security situation, meet with key program stakeholders, and develop possible options for locating a Regional ARV stock security in the West African Sub-region. This report synthesizes finding from parts one and two. The review team examined both the overall public sector supply chain for essential drugs as well as supply chain systems for the HIV/AIDS programme in the study countries. In partnership with the group JURTA PSM, WAHO has commissioned an analysis of a sample of four Central Medical Stores in ECOWAS countries, to identify one which will be able to host regional buffer stock of antiretroviral drugs. This evaluation was sequenced in three phases:(i) the holding of a preparatory meeting between the consultants and resource persons at WAHO,( ii) assessment visits to the four selected countries,(iii) the presentation-discussion of the results and the finalization of assessment report in select committee composed of consultants and resource persons of WAHO. The objective of the site visits was to collect in each of the four countries, information related to the mode of supply management of ARVs and then analyze the data collected in order to draw up conclusion on the capacity of the selected country to host the regional ARV stock security. The evaluation grid developed for this purpose allows collecting objective information which allows the appreciation of the general situation of the pharmaceutical supply chain and the capacity and conditions of medical store facilities. The WHO MQAS model for assessment and JSI integration of supply chain evaluation framework were employed in this assessment. FINDINGS In general context, people refer to the integrated supply chain almost exclusively in terms of product integration, meaning the extent to which all essential commodities are stored and distributed together using the same process or system. Critics often attack verticalization, by which they mean the existence of different systems for different program items, particularly those commodities associated with the family planning, HIV/AIDS, and malaria programs. Supply chain integration posits seamless linkages between: functions (e.g., quantification and procurement), levels (e.g. central and region), 4

5 partners (e.g. MOH & GHS), and commodities (e.g., HIV and malaria) Any claims that the current public sector healthcare supply chain in any of the study countries is integrated either in theory or in practice are not borne out by evidence. The supply chain suffers from deficiencies in the extent of integration not just across commodities but also across functions, levels and partners. There are various degrees of challenges with data visibility, trust and coordination, alignment of incentives and objectives, systems, flexibility, roles and responsibilities, clarity and the existence of too many non-value added processes, and often too many levels. The CMS assessment has been undertaking using the WHO/PSM/PAR/ 'Model Quality Assurance System for procurement Agencies ('MQAS') and the JSI integrated supply chain evolution framework. The major criteria used are: political, managerial and organizational aspects, compliance with drug regulations, human resources, quality system and documentation, inventory management (reception, storage, handling), quality assurance including quality control, stock control, the LMIS, the ability to ensure a turnover of ARVs (stock-specific safety stock) and flight connections. The main results emerging from the assessment and analysis are: - In all the countries visited, there was a strong endorsement of health authorities to the principle of regional buffer storage of ARVs and especially the willingness to host this stock security and to support and assist the process ; - The sources of funding for antiretroviral drugs are 80-90% from foreign partners, primarily Global Fund, PEPFAR and Clinton Foundation, the rest being provided by the national budget ; - The forecasting of antiretroviral drugs suffers from the lack of data drug use. Standard Treatment guidelines orient the choice of drugs and quantification committees are established in most countries. However, validation of the data used in the quantification process is not always carried out. All this contributes to the lack of reliability of the quantification of needs and thus increase the risk of stock-outs or expiration of drugs. - The Central Medical Stores of countries visited are sufficiently involved in the quantification process of antiretroviral drugs in collaboration with national programs of fight against HIV/AIDS, and in some cases, with the NDRA; - Most of the Central Medical Stores visited are more or less adequately equipped in inventory management and have good storage capacity in terms of volume and storage and handling equipment, although in some cases, the conditions of storage of medicines need to be improved. - With regards to compliance with drug regulation, all four countries have medicine regulation system and essential medicine list (EML) including antiretroviral drugs that are respected by the Central Medical Store. The importation of drugs is exclusively at the designated entry ports and import licenses are requested on the NDRA at each custom entry point. 5

6 It emerged that the current health supply chain system in Nigeria may not be able to support the establishment of Regional ARV stock security for the following reasons although Nigeria currently has the largest active file of HIV/AIDS patient among the four counties under review; The supply chain is at an ad hoc phase of evolution. Roles are not clearly defined, the supply chain is inflexible and may not be able to respond to changes, processes are undefined and adequately documented, logistic information is not comprehensively available or shared, supply chain actors do not collaborate systematically. Overall there appears to be little consensus on the supply chain strategy. This is further collaborated by evidence from the 'MQAS' evaluation of the supply system. Although there was willingness on the part of management of the Federal Central Medical Stores to host the Regional ARV stock security and existence of a relatively strong National Drug Regulatory system for drug quality assurance and some storage capacity, there were major weaknesses. There were weak management capacity, documentation, inventory and logistics management information systems and coordination. Even though some partners are already intervening to improve on the current situation, it may take medium to longer term to turn the situation around to remedy some of the defects that have been identified. On the other hand, the supply chain systems in Ghana, Cote d Ivoire and Burkina Faso seem to have evolved to a stage that can be considered organized though not fully integrated and high performing. The following are some best practices that the review team observed; roles and responsibilities are better clarified and documented, the supply chain sometimes response to changes in the environment, relatively stronger management systems, processes are defined and better run, logistic data are collected and reported, actors value collaboration though not always achieved, the supply chain strategy is under development. There are some evidences of information visibility and transparency. The three countries have the critical mass of infrastructure and requisite systems to support the successful implementation of a Regional ARV stock security. From a clearly technical perspective therefore, any of the three countries namely; Ghana, Cote d Ivoire and Burkina Faso could conveniently be selected to host the Regional ARV stock security. There is however the need in the short term to improve on coordination activities and information visibility within the supply chain system, if the stock security is to function optimally. 6

7 I. BACKGROUND 1.1. Epidemiological situation Figure 1 shows the epidemiological situation of HIV / AIDS in different countries of the ECOWAS. The highest prevalence s are recorded respectively in Côte d'ivoire (3.9 %), Nigeria (3.6 %) and Togo (3.3 %). Figure 1: Prevalence of HIV/AIDS in ECOWAS countries. 7

8 1.2. Situation of access to ARV treatment in ECOWAS countries Table I presents the situation of universal access to antiretroviral treatment (ART) in ECOWAS countries. In 2010, the number of patients on antiretroviral therapy was 633,718 with 80% of the active file recorded in the four countries concerned by our assessment: Nigeria, Ghana, Ivory Coast and Burkina Faso. Table 1: Number of patients on ART in 2009, 2010 and 2013 estimates Estimation 2013 Bénin Burkina Faso Cabo Verde Côte d Ivoire The Gambia Ghana Guinée Guinée Bissau Liberia Mali Niger Nigeria Sénégal Sierra Leone Togo CEDEAO Only 36% of patients (adults and children) who need ART have access. The ART and PMTCT coverage in 2010 in ECOWAS countries is presented in Figure 2. 8

9 100% 90% 80% 70% 60% 50% 40% 30% 65% 91% 82% 20% 10% 0% 35% 18% 9% ART Adults ART Children PMTCT 2010 Met 2010 Unmet Figure 2: ART and PMTCT coverage in 2010 in ECOWAS countries 1.3. Context for assessment Despite the advances registered in recent years in ECOWAS Member States, only 30% of patients who need ARVs have access to treatment. In addition, over the last 12 months, supplies of ARVs in the region have experienced major disruptions related among others is the uncertainties surrounding the Global Fund, which has caused delays in the disbursement of country subsidies, having an impact on medicines availability. In 2012, countries such as Guinea-Bissau, Togo, Benin, Mali, Ghana, Guinea, Burkina Faso, Cape Verde and Niger have experienced stock outs in one or several medicines. To allow countries to overcome the shortages, the ECOWAS Multisectoral Committee on HIV/AIDS requested WAHO to work with Partners to organize an emergency integrated stock security. The idea is to create a stock security with a regional focus, capable to respond to alerts of stock outs at country level. A pre-funded stock security will be integrated into a National Central Medical Store for more flexibility and rapid response to requesting countries. It is proposed to focus the stock security, mainly on first line treatments at risk of rupture. The stock will be a regional security and instantaneous relay that will reduce delivery times compared 9

10 with the incompressible normal delivery time from the warehouse of a manufacturer (production time) and / or supplier (wholesaler). Regulation by inter-rotation between the products of the stock security and own stocks of the host structure is essential to avoid losses through expiration. Distinguish physical inventory may or may not be effective between the two stocks (depending on the existing management modes and benefit obligations of the host), but the financial and computer differentiation is required. Following the development of a technical note on the stock security, it has been defined in the context of JURTA PSM consultation to conduct the following activities for the implementation of this stock security: Set the Size of the Stock Security Define the Criteria for Identification of the Partner Central Medical Store Make an assessment of the Partner Central Medical Store that could apply to host the stock security Define the Operating and Logistical Management procedures Discuss with national authorities on the requirements of the stock security procedures Validate the operating and logistical management procedures of the stock security and propose the Partner Central Medical Store to host the stock security Approve a procedure / mechanism for reimbursement for the medicines delivered and receive the commitment of countries Select the Partner Central Medical Store Provide a platform for collaboration between ECOWAS and local producers of essential medicines Develop and sign with the national authorities, the agreement document related to the operating conditions of the stock security Strengthen the capacity of the Partner Central Medical Store Supply the partner Central Medical Store with ARVs Monitor and evaluate operations of the stock security To this end, it is proposed to define the objectives, methodology, expected results, activities and deadlines to permit completion of the first two steps: (i) define the operational procedures and logistics management of stock security and (ii) to analyze the Central Medical Stores potential candidates to host the stock security and discuss with national authorities on the requirements of stock security. Objectives To develop the guideline of procedures and logistical management of the ARVs stock security. To analyze the Central Medical Stores potential candidates and suggest which will store the stock security. 10

11 1.4. Approach This work will be developed in collaboration with JURTA PSM. WAHO will constitute a team of two consultants 1. To develop a guideline of procedures and logistical management of the ARVs stock security, 2. To develop a report on analysis of the Central Medical Stores potential candidates and suggest which will store the stock security. The analysis will be made on the basis of the following criteria: Willingness of the management and its board of directors to host this regional buffer stock ; Existence of a current and common stock in sufficient ARVs (Central Store from a country with a strong active file of patients) to ensure control (high inter-rotation) between own stock / stock for addressing shortage '; Computerization of stock management and good control of management features software by the central store (Reliable differentiated management of own stocks and buffer stock) ; Experience on any certification/accreditation process Modern and functional Means of storage and facilities (area T <25 C, assisted handling, housekeeping, security guarantee against theft and fire...) ; Storing ability at sufficient controlled temperature; Ease of flight connections with other countries in the region and / or developed road network with neighboring countries; Ownership by and political involvement of the Government of the host country (facilitating the signing of an MOU with the customs administration for shipping); Compliance with national drug regulation: responsible pharmacist, authorized pharmaceutical wholesaler; Defined and Applied Internal procedures (BPD). This report describes the purpose, methods, and findings from a recent assessment of the public sector healthcare supply chain in La Cote D'Ivoire, Ghana, Nigeria and Burkina Faso. Purpose of the assessment: WAHO commissioned this assessment to help to Develop procedures and logistical management of the stock security of ARVs. Assessment report on the Central Medical Stores to store the security stock. Determine where best to channel its support for improving the supply chain This current assessment aims to identify underlying problems and constraints, and explore options for improving system functioning. Specific objectives of the review are to: 11

12 1) Develop a comprehensive understanding of the constraints to commodity security in the four study countries including the strengths and limitations of the existing supply chain. 2) Identify possible solutions to address these constraints, and the benefits and challenges that these solutions could pose, with a particular focus on supply chain for ARV commodities. 3) Develop an approach for WAHO to tackle issues of commodity security in the four study countries. 4) Recognizing that achieving some elements of commodity security will require long-term strategies, identify actions that can provide near-term relief and ensure availability of priority commodities. Methodology 1. An initial country visit to assess the commodity security situation, meet with key program stakeholders. 2. Desk review of documents 12

13 II. CONCEPTUAL FRAMEWORK FOR THE ASSESSMENT The underlying conceptual framework for the review postulates that availability of commodities and the performance of the health supply chain depends on underlying systems supports (e.g. governance, human resources, information systems, and financing) and how well key supply chain elements are functioning (e.g., procurement, storage and distribution, transportation, and management) and integrated (1) Integration of supply chain According to the US States Departments Global health initiative (2) Integrating health services at the point of contact ensures the delivery system is designed to meet the holistic needs of an individual when they go to a health facility. Upstream integration ensures joint programming among institutions to increase efficiency and effectiveness. Integrating these services should improve the overall care an individual receives at a facility. As health care facilities increasingly offer integrated health care packages, all the products required for provision of these services need to be available. Historically, this has contributed to an understanding of integration as putting all products together on one truck. However, integration is not only about providing holistic health services or distributing products together on the same truck; it can be a framework to characterize supply chain improvements within public health. Supply chain integration is a performance-improving approach that develops seamless linkages between the various actors, levels, and functions within a supply chain to optimize customer service. The objectives of supply chain integration are to improve efficiency and reduce redundancy while also enhancing product availability. Supply chain integration strives to better connect demand with supply, which can both improve customer service and lower costs. However, it is not always possible to simultaneously achieve all these various objectives; a designer may need to make tradeoffs and balance competing priorities while working toward the ultimate goal of better serving customers. Supply chain integration needs to make overall supply chain performance better. A well-functioning supply chain should not be characterized simply by whether or not products are delivered in the same trucks or stored in the same warehouse. These design features may be important but they are not the fundamental traits that need to be in place to improve customer service. Rather, well-functioning (integrated) supply chains are characterized by clarity of roles and clarification of roles can help improve communication and accountability, responsibilities, agility, streamlined processes, visibility of information, trust and collaboration, and alignment of objectives. 13

14 Figure 3. The Logistics Cycle Functions Figure 3 depicts supply chain operations as a cycle of basic functions, including product selection, quantification, and inventory management. These functions are performed by particular actors at various levels; to be efficient, the cycle must be driven by accurate and timely logistics information. Serving customers is at the top, or starting point, of the diagram. These functions must be linked seamlessly. For example, product selection decisions must be connected to the quantification process; the correct products need to be forecasted. Similarly, there needs to be linkages between LMIS and quantification; collected logistics data should be used to inform the quantification process. Furthermore, product selection can have an impact on storage and distribution, as the characteristics of new products be they large dimensions or particular handling instructions can change warehouse and transport requirements. Monitoring and evaluation activities should identify recommendations for system improvements, and they should be acted on. Seamless linkages also describes the communication and information sharing that helps ensure stakeholders are working under the same assumptions and with consistent information in order to make their decisions. As these functions are assumed by actors at different levels, a new vision of an integrated supply chain should connects customers (demand) with products (supply) and narrow the gap between them by improving the flow of products and information. A key element of supply chain integration is improving the linkages between supply and demand. Better knowledge about demand can contribute to improved planning and less waste. Better information about supply can facilitate product selection, budget planning, and resource allocation. Frequent and accurate communication among chain partners regarding demand and supply can help reduce uncertainty and enhance collaborative planning, such as sharing results from forecasting exercises. Ultimately, the result of an integrated supply chain is seamless linkages that connect demand and supply throughout the supply chain to better serve customers. Figure 2 is a graphic of an integrated supply chain that has a number of levels through which products and information pass, with actors performing particular functions at each level. This diagram depicts actors as the people involved throughout the supply chain, including government staff working at health facilities and Central Medical Stores (CMS), drug selection 14

15 committees, nongovernmental organization program implementers, donors, and others. Levels include the service delivery, sub national (provincial, regional, district, etc.), national, and international levels within a given health system. Functions refer to the steps in the logistics cycle (i.e., product selection, quantification, procurement, inventory control, storage, distribution, and LMIS). Products ( supply ) travel through the supply chain, and integration efforts are undertaken in order to improve the efficiency and effectiveness with which these products ultimately reach customers. The chain is seamlessly linked and extends from suppliers of raw materials to customers served by service delivery points (SDPs). Cutting across the actors, functions, and levels are the characteristics of an integrated supply chain. Some of these characteristics can be considered as both inputs (i.e., the conditions and traits that enable and drive toward an integrated supply chain) as well as results (i.e., the key attributes that are present in an integrated supply chain). Figure 4. An Integrated Supply Chain Key Characteristics of an Integrated Supply Chain. Integrated supply chains demonstrate six key attributes Clarity of roles and responsibilities: Roles, responsibilities, and processes (such as reporting or resupply procedures) are established and publicized throughout the supply chain. Agility: Logistics functions are performed quickly, accurately and effectively so products, information, and decisions can move swiftly through the supply chain to respond promptly to customer needs. Streamlined processes: Bureaucratic hurdles and processes that impede the flow of information and commodities are eliminated. Visibility of information: Data are visible throughout the supply chain, usually through computerization, so stakeholders at different levels can see where products are and what the demand is, and use this information to better meet customers needs. Trust and collaboration: A collaborative environment exists that can help break down existing functional and organizational barriers to improve supply chain performance. Alignment of objectives: Organizations and levels have a compatible vision, goals, and objectives to ensure consistency in direction within the supply chain. 15

16 Supply chain Evolution (2) Ad hoc Organized Integrated Clarity of roles and responsibilities Roles are not clearly defined Role sand responsibilities are clarified and documented High performing teams are formed and are empowered Agility The supply chain is inflexible, unable to respond to changes The supply chain sometimes response to changes in the environment The supply chain respond rapidly response to changes in customer needs Streamlined Processes Processes are undefined and undocumented Process are defined and well run Process are optimized and improved continuously Visibility of information Trust and collaboration Logistics information is not available or shared Supply chain actors do not collaborate Systematically Logistic data are collected and reported Actors value collaboration but not always achieved Supply and demand information are visible throughout the supply chain and are used too effect decisions Supply chain partner collaborate and trust each other Alignment of Objectives There is no consensus on the supply chain strategy The supply chain strategy is under development A comprehensive supply change strategy is defined and implemented Improved supply chain performance 16

17 The overall goal of integrating the actors, levels, and functions in the supply chain is to improve customer service for public health commodities. Integration strives to take a holistic approach that acknowledges the dynamic elements in a system and how the various characteristics are interconnected. Figure 2 illustrates six key characteristics for an integrated supply chain, which are further described subsequently. Also included in each section is a set of activities or interventions that contribute to achieving the integration characteristic.. Clarification of Roles, Responsibilities, and Processes This includes establishing and publicizing roles, responsibilities, and processes (such as reporting or resupply procedures) up and down the supply chain. These should be developed according to the various logistics functions as shown in Figure 3. Such clarification can be achieved through drafting and disseminating job descriptions and contracting documents, or conducting a process mapping exercise. Clarification can help expedite communication and improve accountability, which should translate into improved customer service. Roles, Responsibilities, and Processes are clarified when the Following Activities/Interventions have Occurred/are Occurring: Job descriptions for all key logistics positions written and disseminated Contract documents circulated, with appropriate tasks and activities clearly documented and outsourced to third- party logistics providers, as appropriate System design conducted SOPs for logistics system developed, disseminated, and followed, for each level of the system Tasks shifted to optimize staff time LMU established Process mapping and situation analysis conducted Supervision guidelines developed and supervision visits undertaken as scheduled. Agility In order to respond to fluctuations in supply and demand, or a changing policy environment, a supply chain must be agile and carry out its functions with speed and flexibility. Logistics tasks should be performed quickly, accurately and effectively. The faster that products, information, and decisions move through a supply chain, the faster it can respond to customer needs. Procurement should be able to rapidly respond to demand and bring the products needed to clients. If STGs change, for example, requiring a different ARV regimen for treatment of HIV, the procurement process should be agile enough that it can quickly obtain and supply the appropriate medicines in country. However, demand for medicines may be unpredictable, leading to inaccurate forecasts and stock outs or overstocks. Where procurement processes are slow and unwieldy as is often the case for public procurement with long lead times, bureaucratic delays, and little or no means to respond to emergencies, errors in forecasting are compounded. However, policies and procedures can be put in place to increase the flexibility of the procurement process, such as supplier prequalification, framework contracts or emergency procurement protocols. 17

18 Public financing can have rigid budget cycles and slow fund disbursement; therefore introducing a diverse mix of financing including donor support, cost recovery and revolving drug funds (RDFs) can enhance the flexibility and responsiveness of the procurement process. In terms of distribution, most capacity-limited settings do not have the ability to undertake emergency distribution. In general, distribution schedules are set in advance, with monthly delivery being the most frequent distribution possible (some sites may receive shipments bimonthly or quarterly). A truly agile distribution system would be able to deliver on a more frequent basis, daily or weekly, but obviously costs may preclude this. One possibility to improve agility is to use a courier service for emergency distribution, in addition to the regular distribution schedule. An agile supply chain should be able to respond to results from continuous monitoring; it should have the capacity to quickly act on feedback from reports to improve performance and better serve customers. Agility and flexibility improve the manageability and efficiency of the supply chain. Agility is Apparent When the Following Activities/Interventions have occurred/are Occurring: Procurement processes are flexible and lead times are shortened Forecast periods are short Supply plans are flexible and can be modified if necessary Financing is diversified, funds can be disbursed quickly, and with different disbursement schedules There is a system to provide emergencies distribution, including SOPs, trained staff and courier service or emergency vehicles Warehouses or containers can be rented or renovated to accommodate additional products Storage facilities can maintain lower inventory, if data quality and distribution are assured LMIS is robust enough to provide timely consumption data Streamlined Processes This entails eliminating bureaucratic hurdles that can separate supply and demand information, or actions or processes that do not add value to the supply chain, which impede the flow of information and commodities. Such hurdles may include cumbersome and lengthy order approval processes, duplicative LMIS forms, inventory management procedures, or financial management. Streamlining the number of levels in a system can help shorten the pipeline to the end user and improve efficiencies by bringing the supplier closer to the user, decreasing stock levels, and reducing redundancies. Furthermore, the fewer touches in the resupply process, the better in terms of responsiveness, timeliness, and accuracy. Processes are streamlined when the Following Activities/Interventions have Occurred/are Occurring: System assessment conducted and used to inform system design Process mapping conducted A system designed and implemented that better connects supplier and user, reducing the number of levels in the system Transportation analysis undertaken and new routings identified and implemented 18

19 Warehouse assessment conducted and new layout and flow designed and implemented Cost analysis undertaken and costing tool utilized. Visibility of Information An integrated supply chain is one in which data are visible up and down the chain, from end to end. Different actors and different levels should be able to see where products are and what demand is. In this way, the virtual gap between supply and demand is reduced and transparency of data and information is improved. Strategies to improve visibility include using technology to collect, analyze, and share data, and establishing mechanisms that support planning and coordination. Furthermore, improving visibility of total supply chain costs (i.e., costs of all the partners up and down the chain) helps actors make rational decisions to help avoid unnecessary costs or duplication of costs. Information on contraceptives is often invisible in both national and global supply chains. Manufacturers and donors may not know what real demand is, in-country partners may not know who is buying what and when, SDP staff may not know what is stocked in their district or central warehouses, and the MOH may not know how much is stocked in SDPs. The Coordinated Assistance for Reproductive Health Supplies (CARhs) group is a coalition of international organizations that focuses on reproductive health and coordinates to prevent national stock outs of contraceptives. The CARhs group increases visibility of information through the Procurement Planning and Monitoring Report (PPMR) and the RHInterchange. The PPMR is a monthly report that describes national stock status of contraceptives; it includes commodity security updates and stock status data. By providing visibility into information about national contraceptive supply chains, it supports planning, coordination, and strategic allocation of resources. The RHInterchange is a website that helps coordinate contraceptive orders and shipments by gathering and storing data from the central procurement offices of major contraceptive donors and governments, and providing access to timely information that can be used for pipeline monitoring, commodity management, and planning. These two tools help improve visibility of information among global and national partners. As actors become more willing to share their information and increase data visibility, it builds trust among partners; with greater trust comes even more comfort in sharing information. Subsequently, donors and governments are able to make better informed decisions about timing and quantities of shipments, responses to emergency orders, and allocation of resources. Information is Visible When the Following Activities/Interventions have Occured/are Occuring: Data from monitoring and evaluation activities used to design and implement supply chain improvements LMIS have been introduced and include feedback reports Technology is appropriately used to facilitate LMIS data aggregation, analysis, and sharing of data with stakeholders Quantification is informed by product selection decisions and LMIS data National quantifications facilitated and supply plans regularly reviewed and updated Routine logistics system performance reports are generated and shared up and down the supply chain Procurement and financing plans and timetables are developed, updated, and shared 19

20 Data from supervision reports are shared and used to identify interventions for improvement. Trust and Collaboration Trust and collaboration need to be present between the actors and levels, both within institutions and among organizations participating in the end-to-end supply chain. Nurturing a collaborative environment can help to break down existing functional and organizational barriers to improve supply chain performance? Trust and Collaboration are Fostered When the Following Activities/Interventions have Occurred/are Occurring: Logistics technical working groups and committees have been established, meetings are regularly held, and minutes are documented, disseminated, and used for program planning. Promised funds from stakeholders are disbursed, used as agreed on, and shared with technical working groups and committees. Information is being shared through mechanisms such as in-country LMIS, RHInterchange, PPMR, CARhs, etc. Alignment of Objectives This refers to having aligned vision, goals, and objectives across organizations (partners, clients, stakeholders) and levels in order to ensure consistency in direction within the chain. All too often, stakeholders focus on their own interests and priorities and disregard those of partners, resulting in poor supply chain performance. Misaligned objectives can contribute to excess inventory, stock outs, inaccurate forecasts, and poor customer service. Stakeholders must recognize that a problem exists and then determine its root cause and introduce, align, or redesign objectives. In order to align objectives of different stakeholders, the incentives of these stakeholders must be acknowledged. The various actors must be motivated to complete their respective tasks in a manner that is consistent with the common goal, recognizing that the performance of the supply chain is dependent on how well all the links in the chain work together, not on how well each one performs independently. For example, a donor may want to introduce a parallel reporting mechanism for an ARV therapy program it is supporting. The donor s incentive is to report on the number of clients treated with the medicines it is providing in order to justify expenditures and advocate for additional resources. Meanwhile, the MOH wants to institute a single, streamlined national reporting structure. Its incentive is to reduce the reporting burden on health delivery staff. Both the donor and the MOH share the same overall objective of putting clients on treatment, but they may have different strategies and incentives to achieve that objective. Differing incentives must be managed so that common objectives can be reached. Properly aligned supply chains can lead to lower costs, less stored inventory, higher quality, and improved service. In order to create alignment, risks, costs, and rewards should be distributed fairly across the system. Objectives are Aligned When the Following Activities/Interventions Have Occurred/are Occurring: Supply Chain Master Plan developed collaboratively and consultatively with all stakeholders 20

21 Performance management plans and indicators agreed on and developed Indicators regularly shared with stakeholders Joint strategic planning workshops have been undertaken LMU quarterly meetings are supported and actively attended. These fundamental building blocks of clarity of roles and responsibilities, agility, streamlining processes, visibility of data, trust and collaboration, and alignment of objectives are key to improving the main functions within the supply chain: namely, product selection, quantification, procurement, inventory control systems, storage, distribution, and LMIS. Different actors within the supply chain may have different priorities and motivating factors; however, an integrated system is able to collect sufficient, accurate information about demand and supply and ensure that this information flows to the right people at the various levels, in a timely manner, so that supply chain decisions are fully and consistently informed Model Quality Assurance System The diagnostic tool of Model Quality Assurance System for Procurement Agencies (MQAS) (4) was adopted to document the Quality Assurance process, their adequacy and effectiveness to ensure the quality of medicines through proper inventory management. A short list of key indicators derived from MQAS was used. We targeted indicators relating to: - Equipments and Resources: premises, equipment, material resources; - Quality policy and documentation: written instructions and procedures, records; - Receipt and storage of purchased products: Quality control before shipment, Receiving, Quality Control after purchase (Sampling & Scrap) Storage of materials and products (Personal, storage areas, storage conditions, labeling and containers, Inventory Management); - Particular emphasis was placed on capacity and storage conditions (volume or surface area available, cold chain, temperature controlled area, monitoring and records of temperature, product packaging, traceability) - The Information Management 21

22 III. LIMITATIONS OF THE REVIEW The brief time in country relative to the complexity of the issues compelled the team to concentrate on a select group of key informants. One result is that the great majority of interviewees were at the national level, and thus the findings under-represent the views of regional and local stakeholders. Given the decentralized nature of the health sector, this is an important limitation. Moreover, the team did not meet with a number of key national stakeholders including development partners. Because of time limitation the review also used secondary data sources when examining the functioning of the supply system. Nonetheless, the team found widespread consensus that, despite major progress over the past years, major problems still exist in system functioning. A more comprehensive accounting of the extent of these problems was beyond the scope of the current review. As for any review relying on key informants, uncertainty exists around the degree to which respondents were frank in expressing their views, interests, and priorities. First, a courtesy bias may have influenced respondents when asked to comment on activities related directly or indirectly to the project s past or current work. A similar courtesy bias may extend to informant observations on other colleagues or institutions within the health sector. At the same time, informants are aware of the problems in the supply chain, and their views on the roots of those problems and possible solutions may be affected by their current position and institutional affiliation. Due to the paucity of requisite information, some of the team's observations are extrapolated from previous assessment reports within a reasonable degree of objectivity. Especially in the case of Nigeria, the assessment design did not take us to Abuja where we could interview key persons at both the political and policy levels. In addition the key informant at the Federal medical stores in Lagos has just assumed position as head and therefore was not comprehensive enough with some of her responses. 22

23 IV. FINDINGS AND ANALYSIS 4.1. Federal Central Medical Stores, Nigeria assessment report Organizational Structure of the Nigeria Ministry of Health The Federal Ministry of Health (FMoH) of Nigeria plays a central role in Coordination, Policy, Regulation, Monitoring and Evaluation of Health services in Nigeria. It has responsibility to manage health services for the prevention and control of communicable and non-communicable diseases. The functions include the following Coordinate the efforts of state, local government and private health care providers and development partners to ensure effective implementation. Ensure the provision of adequate equipment in tertiary and specialized hospital services. Provide technical assistance to state ministries of health in the development of plans, technical materials, policies and standards to properly perform their functions. Issue and promote adherence to norms and standards, and provide guidelines on health matters, and any other matter that affects public health, promoting adherence to norms and standards for the training of human resources for health. Supervise the provision of health services for the management, prevention and control of communicable and non-communicable diseases e.g. HIV/AIDS. It has six departments of which the Procurement department is responsible for the Supply Chain Management policies and activities in the Health Sector in Nigeria. The chart (Fig 5) demonstrates the organisational structure of the Federal Ministry of Health of Nigeria. FEDERAL MINISTER OF HEALTH NACA NAFDAC FEDERAL MINISTRY OF HEALTH Procurement Family Health Finance and Accounts Health Planning, Research and Statistics PUBLIC HEALTH DEPARTMENT Hospital Services Federal Central Medical Stores State Ministries of Health NASCAP 23

24 Nigeria has been hit hard by the HIV/AIDS epidemic. With an estimated adult HIV prevalence of around 4.4%.There are an estimated 3.9 million Nigerians living with the HIV virus. In spite of the concerted efforts at halting and reversing the spread of HIV/AIDS epidemic by multiple stakeholders, Nigeria remains among the top five countries of the world in terms of its HIV/AIDS burden. (3) Nigeria s response to the pandemic is led by the National Agency for the Control of AIDS (NACA) and implemented by several key government agencies at the Federal and State level as well as a host of private and non-government organisations. NACA was established in 2000 with a mandate to coordinate and manage a multi-sectoral response to HIV/AIDS. Its role is to provide policy guidance and mobilise resources to support the widespread implementation of activities across sectors. NACA s primary public sector partners are the Federal Ministries, especially of Health, and in particular the National AIDS/STI Control Programme (NASCAP). NACA also works closely with State Action Committees on AIDS (SACAs) to coordinate efforts at the State level. Nigeria commenced response activities as soon as the first case of HIV/AIDS was diagnosed and this was expanded in With the establishment of the Presidential Council on AIDS and the National Action Committee on AIDS, a coordinated effort to provide comprehensive prevention and care services have been implemented through a number of plans including the HIV/AIDS Emergency Action Plan (HEAP) the HIV/AIDS Health Sector Plans and the National Strategic Framework (NSF). These focus on scaling up access and quality of HIV/AIDS services and include a wide range of interventions such as BCC, FLHE, VCT, Blood safety, PMTCT, Palliative care, ART, Home based care, support for OVC and PABA and adequate treatment of STI.While some of the interventions are being implemented widely, others are still in need of massive scaling up while few are in their formative stages Procurement policies, systems and capacity The Mission of the Procurement department is to ensure full implementation of the Ministry s yearly appropriation, through proactive and efficient procurement management system. The department is headed by a Director, with two major divisions; Capital and Recurrent and operating through seven unit vis-à-vis: Evaluation Tenders Price intelligence Works Donor Funds BPP/Hospital Liaising Direct Procurement Functions Carry out needs assessment Aggregates various departmental work plan Prepare Ministry s Procurement plan Carry out transparent Procurement process Carry out procurement audit on the Ministry, Agencies/programmes and parastatals Recommend contractors for payment Carry out Monitory and Evaluation of Procurement process within the ministry, agencies/programmes and parastatals Provide up-to-date information on budget performance 24

25 Goal The goal is to process all procurement needs of the ministry in line with PPA Act 2007 and other external regulation to engender public confidence, probity, accountability and ultimately value for money. Procurement policies and guidelines are in place to ensure good pharmaceutical procurement practice Overview Nigeria s HIV/AIDS supply chain landscape is characterized by multiple supply chains owned and operated by various Federal, State, NGO, and FBO stakeholders. The Federal Ministry of Health (FMOH) is charged with oversight and management of these supply chains, many of which include separate procurement, warehousing, and distribution systems. To meet its mandate, the FMOH recently created a Logistics Unit to collect and distribute supply chain data and, as a result, improve visibility into and across all the disparate supply chain systems. To be successful, this Logistics Unit must: be supported by systems that provide accurate data; understand how the data can be used to improve supply chain logistics and planning; and identify ways to integrate or otherwise coordinate the many disparate supply chain systems. In this context, following issues have been identified in relation to Information Sharing, Capacity Building, and Procurement (4): Information Sharing Information is at the center of the challenges facing supply chain systems in Nigeria if accurate data is not collected and shared in a consistent, comprehensive manner, it cannot be used to drive effective decisions. State Ministries of Health (SMOHs) and state-run ART sites have no information system to manage data collection and distribution. While information systems exist for federal sites, data is not routinely entered into those systems, and the data that is entered is not widely collected or shared by any group. As a result, the information that is available to implementers is incomplete, fragmented, inaccuracy, and, consequently, not used. Capacity Building Even if accurate information was available to implementers, logistics and warehousing staff lack the skills and motivation needed to appropriately use that information. Staff in the newly created central Logistics Unit lack expertise and experience in analyzing collected data for forecasting and supply planning. Nigeria s national warehouse, the Central Medical Store, lacks policies and procedures to promote accountability, effective oversight, and efficient management Procurement and supply management cycle Procurement and Distribution: Procurement and distribution systems must more effectively communicate and coordinate to meet scale up targets. There are currently six separate procurement systems in Nigeria (FMOH, SCMS, AXIOS, Harvard, IDA, and Crown Agents), all of which largely operate independently of each other. Distribution systems are similarly plentiful and uncoordinated, with the FMOH and SMOHs running their own parallel distribution networks. Coordinated procurement agencies can lower drug prices through combined orders and improved negotiation position. Coordinated, distribution systems can lower the cost of sending commodities by combining orders and streamlining routes. These cost savings and process improvements are necessary for existing resources to meet government scale up targets, which call for a quintupling of people receiving ART over a three-year period. 25