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

26 Forecast and Quantification The ability to conduct adequate quantifications suffers from a lack of experience or expertise in forecasting or supply planning among staff in the Logistics Unit, a lack of coordination and communication among donors and other stakeholders with key roles in Nigeria s many supply chains, and inaccurate and limited data. By the end of December 2010, the Government of Nigeria (GoN), in partnership with the United States Government (USG), Global Fund to fight AIDS, Tuberculosis and Malaria (GFATM) and UNITAID (Clinton Health Access Initiative (CHAI) and United Nations Children Emergency Fund (UNICEF)), was supporting over 380,000 men, women, and children on antiretroviral therapy (ART). Supply Chain Management System (SCMS) Nigeria conducted a five-year forecast for antiretroviral (ARV) drugs in 2009 and was requested by GoN to update this forecast and to include co-trimoxazole (co-trim) requirements in This activity was designed to determine the national financing needs specifically for ARV and co-trim drugs over the next six years. The objective was also to assist the government and donors in estimating long-term financing needs of HIV/AIDS programs, in terms of drug requirements, to guide resource mobilization. The forecast was particularly important in anticipation of the phase-out of UNITAID (CHAI and UNICEF) funding support in 2011 for adult second-line, pediatric and prevention of mother-to-child transmission (PMTCT) ARV drug needs. The five-year forecast and financing needs is a first step in estimating the total needs and potential financial gaps of ARV and co-trimoxazole drugs. It also provides a forum for long-term discussions on the country s clinical direction for new clients who will be enrolled on ART. Discussion of regimen requirements for existing clients who may need new regimen combinations as they develop possible resistant strains of the virus is also highlighted, as it will have cost implications. Finally, the need to ensure that the country provides resources to scale up services and bridge the gap of unmet needs for patients who are eligible but not yet enrolled in ART is discussed. SCMS made available actual data, as of the end of The data was needed to guide and generate realistic assumptions for the forecast exercise. The forecast used a morbidity-based methodology using patient targets, number of treatment episodes for each patient, and estimated number of new patients each year. The 2010 Nigeria ART treatment protocol and PMTCT Rapid Advice were used as guides to determine treatment episodes. Table 2: ART Patient Targets (Actual) ART patient target Projected ART eligible

27 % Actual as of Dec Regimen Description 2010 AZT + 3TC + EFV 7.60 AZT + 3TC+ NVP D4T30 + 3TC + EFV 0.30 D4T30 + 3TC + NVP 2.10 TDF/3TC + EFV 1.10 TDF/3TC + NVP 2.30 TDF/FTC + EFV TDF/FTC + NVP 9.80 Others Collaboration and Donor Coordination While USAID and other donors exert significant influence with the Government of Nigeria and elsewhere, they have not placed a high priority on improving coordination and communication among themselves or with the larger stakeholder community, particularly on issues related to quantification and commodity security. In some cases, donors have even helped create new parallel supply chain components (e.g., 5 procurement agents for PEPFAR alone), leading to further complications in cross-supply chain coordination and, potentially, integration. SCMS does not play a coordinating role in Nigeria, and is instead asked to do discrete, piecemeal activities. As a result, SCMS does not have visibility throughout the supply chain and is not well positioned to act as a Technical Secretariat that promotes long-term sustainable solutions. In the short term, planned activities are largely tactical, including: designing and implementing an integrated national monitoring and evaluation system for public and NGO/FBO partners, training Logistics Unit staff on quantification, working to improve policies and procedures at the Central Medical Store, and assessing the Federal distribution system. Other, more strategic activities focus on improving coordination among key stakeholders, such as establishing a Supply Chain Management Steering Committee and facilitating quarterly stakeholder meetings to address commodity security issues. If short term activities and procurements are successfully managed, these strategic activities could improve SCMS visibility and position as a thought leader. (Nigeria Country-Level Analysis PMT Briefing delivered May 15, 2007) Quality assurance systems and capacity It is the responsibility of the FCMS to ensure that products being purchased meet National Drug Regulatory Authority (NDRA) requirements in terms of registration or other forms of authorization, GMP, etc. Quality assurance systems and capacity The National Agency for food and Drug Administration and Control is responsible for medicines regulation in Nigeria.There are presently nine (9) directorates in NAFDAC headed by Directors who report to the Director-General (DG). Mandate In accordance with the enabling laws, NAFDAC is authorised to: Regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of regulated products. 27

28 Conduct appropriate tests and ensure compliance with standard specifications. Undertake appropriate investigation of the production premises and raw materials of regulated products. Compile standard specifications, regulations, and guidelines for the production, importation, exportation, sale and distribution of regulated products. Control the exportation and issue quality certification of regulated products intended for export. Establish and maintain relevant laboratories for the performance of its functions. Ensure that the use of narcotic drugs and psychotropic substances are limited to medical and scientific use only. Undertake the registration of food, drugs, medical devices, bottled water and chemicals. Undertake inspection of imported regulated products. Pronounce on the quality and safety of regulated products after appropriate analysis By the mandate and regulatory functions of NADAC, it does appear that medicines quality assurance is secured. However, linkages between NAFDAC and the federal medical stores were not clearly articulated during the assessment interview. For instance inspection of medicines prior to shipment to FCMS is unclear, just as post market surveillance at the stores premises International and national laws Nigeria is a member of the WTO. It has signed the TRIPS (Trade Related aspects of Intellectual Property Rights) and has adopted legislation within the framework of this Agreement. The Federal Ministry of Justice is responsible for overseeing compliance with IPR and WTO agreements Inventory management (including Storage Arrangements) The Central Medical Stores in Lagos have been created after the First World War in the old military compounds (5). No real changes have been made to the infrastructure since then. Over the existing 9 warehouses, 2 are said to be dedicated to ARV drugs. Five are currently under renovation whilst the remaining four are under consideration for future renovation. On the infrastructure side, the walls are thick and generally strong but they still have marks of humidity which seems to sip through the bottom. The warehouses have only one door each for both receiving and dispatch of goods. Bulk racking is almost unavailable and there is no pick face. As a consequence, standard practices height is not respected, the risk of damages is really high and boxes are opened for single units whilst multiple boxes can be opened raising even further the risk of damages and the theft risk. There are no bin allocations and one has to physically search through the warehouse to find a specific product. This is obviously a time consuming exercise and the human input is so prevalent that it increases drastically the possibilities of picking errors. Air-conditioning devices are present in the Warehouses but no temperature monitoring devices were present. Same applies to the cold rooms which are said to have temperature monitors but which couldn t be found. There is currently no sprinkler system in place and there are a few handheld fire extinguishers of small capacity. They are totally inadequate to contain any fire starting at these premises. In addition, no maintenance records exist to prove their functioning. 28

29 There are forklifts in the warehouse but not adapted to available turning space. As a result the few racking utilization is not optimized. Receiving All receiving are done manually. The CMS staff is not given prior information on inward goods and can therefore not plan receiving appropriately. The fact that there are no standardized pallets makes inventory storage planning more difficult and space has to be created for almost each inbound shipment. SOPs are not available and seems to have been in draft phase for a while but were not available to the team even in draft therefore it is clear that all staff involved in activity do not know and haven t been trained on any SOP to ensure process adherence at all times. Inventory Control There are no recording of expiry and batch number at all and therefore the First Expiry first Out system is manual and not system driven. All records are kept through the manual updating of picked stock cards which doesn t bear any mention of batch or expiry of product. The human and manual intervention may lead to "FEFO" system not being adhered to and the stock picked being updated manually, leaves room for error. There is a verification of the stock made manually by the personnel. Since the updating of stock levels for receiving and dispatch is done manually and there is no Warehouse Management System, no information is available in realtime, reporting is not optimal and no logical stock rotation can take place. The inventory at site level is not visible from central level and the total pipeline inventory and consumption may not be accurate (couldn t be assessed during this short mission). Both the stocks and warehouse are uninsured against potential risk Distribution The Distribution system is reactive and the Distribution Resource Planning not optimum. Third party distribution agents are used but not managed by CMS staff. This could compromise performance. Management Information System There is no WAN from central level to the 75 sites, there are no computers at administrative level and very limited computers at the stores. All administrative employees work manually. The Operational management reporting is largely insufficient and not all areas of operations have comprehensive data for decision-making. As a result, the accessibility to operational information is difficult and extraction of data tedious and time consuming. There is almost no data gathering via central system and format of data is not user-friendly for manipulation. As stated above, the current operational reports do not support decision-making process and therefore timely and informed decision making is hampered by the lack of current management information which is also not formatted for ease of use. Security There is neither a camera system nor any alarm and high areas of activity cannot be monitored. No historical data on activity is available and safety of the stock during non-operational hours cannot be ensured. The absence of a warehouse management system doesn t allow for the set up of internal security / control measures. Human Resources No formal individual performance reporting is done at CMS and no formal system or feedback mechanism to monitor individual performance is in place. The team has observed limited warehouse management skills and that the staff in the stores is not aware of many warehouse principles and good warehouse management practices. There are limited inventory management 29

30 skills and staffs do not have knowledge off all the components of optimal inventory management. The staff says to have basic computer skills but no computer is available to them. Some of them declare that they do not have basic computer skills and that is why reporting and other functions are paper driven. Total supply chain level, including external clients The actual treatment data is not used for forecasting and excessive inventory may be imposed on the supply chain, increasing cost and potential for increased expired products. Warehousing and distribution are not to GWP/GDP standards and the efficacy of the ARV products can be jeopardized. As Warehousing and distribution processes do not exist, the manual processes, which are not streamlined, result in increased costs and time consuming operations. The CMS does not as yet have any experience in neither accreditation nor certification programme Strategic positioning Over all the health commodity supply chain in Nigeria can best be described as ad hoc on the scale of the evolution of supply chain framework described elsewhere in this report. Roles and responsibilities are not clearly defined. The supply chain is inflexible and unable to respond to changes. Processes are undefined and not documented. Logistic information is not available and visibility is compromised. The actors in the supply chain do not collaborate systematically. There is no consensus on a supply chain strategy. 30

31 4.2. Central Medical Stores, Ghana Assessment Report Organizational Structure of the Ghana Ministry of Health Ghana operates a decentralized structure in the delivery of health services. The Ministry of Health (MoH) plays a central role in Coordination, Policy, Regulation, Monitoring and Evaluation. It has various implementation agencies set up under either legislative laws or Acts of Parliament such as the Ghana Health Service and Teaching Hospitals Act of 1996 (Act 565) and Food and Drugs Board Law, PNDCL 305B. These agencies are mandated to perform various functions in the health sector: 1. Ghana Health Service: Responsible for implementation of health services across the 10 regions in Ghana. 2. Teaching Hospitals: Responsible for Specialized Health Care Services and Research. 3. Food and Drugs Board-: Responsible for regulation of food, drugs, medical device and allied items. The Ministry of Health has 6 directorates of which the Procurement and Supply Directorate (PSD) is responsible for the Supply Chain Management policies and activities in the Health Sector in Ghana. It has three main sub-divisions, namely the Procurement Unit (PU), the Central Medical Stores (CMS) and Drug Policy. The Procurement Unit is responsible for tender administration, forecasting and quantification, contract management, monitoring, logistics and expedition. The CMS s functions include receipts, warehousing, storage, distribution and Logistics Management Information System (LMIS), The Ghana Health Service of the Ministry of Health has a Supply Chain Management Unit called the Stores, Supplies and Drug Management (SSDM) unit. This Unit is responsible for commodity management within the GHS. The chart (Fig 6) demonstrates the organisational structure of the Procurement and Supply Management. MINISTER OF HEALTH MINISTRY OF HEALTH HEADQUARTERS REGIONAL HEALTH ADMINISTRATIONS REGIONAL MEDICAL STORES GHANA HEALTH SERVICES (GHS) STORES SUPPLY AND DRUG MANAGEMENT DIVISION NACP GHANA NATIONAL DRUGS PROGRAMME PROCUREMENT UNIT PROCUREMENT & SUPPLY DIRECTORATE CENTRAL MEDICAL STORES FOOD AND DRUGS BOARD PROCUREMENT UNIT TEACHING HOSPITALS MEDICAL STORES 31

32 Figure 6: Organogram of the Ministry of Health and Related Agencies Ghana AIDS Commission (GAC), A Supra ministerial body under the office of the president has been established to provide leadership on the National HIV/AIDS agenda. The GAC is leading the coordination of the HIV/AIDS National Response since Its mandate is to coordinate the multi sectoral response for HIV/AIDS in Ghana, lead advocacy efforts and develop policy. Three National Strategic Framework documents NSP I( ), NSP II ( ) and NSP III ( ) have been developed in collaboration with stakeholders to provide guidance for implementation of HIV/AIDS related activities. Since the implementation, Ghana s HIV response has made significant progress towards achieving Universal Access to HIV service. The Ministry of Health is the key technical Ministry supporting the GAC in the HIV interventions in Ghana. Under the NACP, The HIV/AIDS Strategic Plan for the health sector is being implemented and coordinated within the sector. In 2003, through the Global Fund for AIDS, TB and Malaria the MoH/GHS has been supported to improve care and support for PLWHIV in Ghana. Highly Active Antiretroviral therapy (HAART) is provided to PLHIVs through accredited ART facilities. There are about 150 HAART sites in the country. Figure 7: Highly Active Antiretroviral therapy (HAART) 32

33 Procurement policies, systems and capacity Procurement policy is governed by the Procurement Act of 2003 (Act 663), Legislative instruments and Ministry of Health s operational guidelines and Procurement Manual. The Procurement Act allows for decentralised procurement and therefore the Ministry of runs both centralized and decentralized procurement systems. The centralized procurement activities involve procurement of items with high supplier risk and financial impact such as Condoms and Pharmaceuticals. On the other hand, the decentralized procurement activities involve procurement of items such as HIV test kits and Consumables, which have low financial impact and supplier risk. The Procurement Unit of PSD undertakes centralized procurement activities whiles the Stores, Supplies and Drugs Management (SSDM) Unit of the Ghana Health Service has responsibility for decentralized procurement activities. Request for the procurement of high-risk items emanates from the National HIV/AIDS Control Programme to the Procurement and Supply Directorate through the Director-General of the Ghana Health Service. In the case of procurement of items of low supplier risk and financial impact, Stores, Supplies and Drugs Management (SSDM) Unit within the Ghana Health Service will process any request from NACP. The chart (Fig 8) illustrates the flow of PSM activities of HIV/AIDs/STI commodities. Figure 8: The flow chart showing procurement process of HIV/AIDs/STI commodities The Public Procurement Authority (PPA) of Ghana, which is an Agency of the Ministry of Finance and Economic Planning (MOFEP) is responsible for harmonizing the process of procurement throughout the public service to (1) ensure the efficient use of public funds, (2) attain best value for money in the procurement goods, and (3) ensure that public procurement is carried out in a fair, transparent and non-discriminatory manner while also promoting a 33

34 competitive local industry. The PPA s mandate is Government-wide and includes the Ministry of Health, which is the government agency responsible for health sector. PPA is responsible for the development of public procurement policy, including rules and regulations, for monitoring all public procurements, and for ensuring adherence to established rules and regulations. The Ministry of Health operates within the confines of the Public Procurement Act 663 (ACT 663) with its Legislative Instruments. The law prescribes official rules, regulations and standards to guide the conduct of public procurement and a governance system that ensures transparency, fairness and economy in the use of public resources. Procurement of goods, services and civil works is regulated in Ghana by the Procurement Act of It specifies procurement entities, thresholds, processes, systems and documentation required for procurement. The Act however permits the use of other international and multilateral procurement systems such as the UN procurement system as enshrined in Section 96 of Act 663. The Act makes provision for manuals and documentation that are used for public sector procurement adjudication. The Act makes it mandatory for all entities to establish procurement units with an adequate number of staff and skill mix. In accordance with Act 663, the PSD and SSDM are obliged to keep documentation on all procurement activities, procedures and processes. In line with the MoH s Financial Administration guidelines, the PSD and SSDM are required to provide the Financial Unit and the National AIDs/STI Control Programme with copies of all such documentation. According to the Procurement Plan in 2011 Programme of Work, the total procurement value executed in 2011 by the Ministry of Health from all sources of funding was US120, 000, Quality assurance systems and capacity It is the responsibility of the PSD to ensure that products being purchased meet National Drug Regulatory Authority (NDRA) requirements in terms of registration or other forms of authorization, GMP, etc. The Food and Drugs Authority (FDA) was established by the Food and Drugs Law 1992 and, amended by Act 523 in The FDA law defines the role of the Food and Drugs Authority as a separate entity under the control of the MOH..The FDA is responsible for ensuring overall quality in medicines and medical supplies in Ghana; all food, medicines, cosmetics, chemical substances, and medical devices must be registered with the FDB. The FDA operates the National Pharmacovigilance Center, which monitors adverse drug effects. The FDA also updates and maintains operational guidelines for medicines regulation, including safety monitoring, stability testing, labeling requirements, importation, bioequivalence studies, advertisements, clinical trials, good storage practices, and safe disposal. The FDA has offices at the official ports of entry-tema and Takoradi Harbour; Aflao and Elubo; and Kotoka International Airport. It also has offices in six out of the 10 regions in Ghana and has plans to open offices in the 4 remaining regions at the end of FDA has a total permanent staff of 235, of which 75% have a technical or scientific background. The central inspection department for medicines has a staff of 15. FDA collaborates with WHO in various ways to increase capacity and stay on top of the technological development. Three FDA experts are involved in international inspections under the framework of the WHO Prequalification Program. 34

35 Ghana s Food and Drugs Authority has the capacity to undertake product registration, conduct GMP inspections and post market surveillance. The registration procedures of the FDA are as follows: Submission of Application and payment of appropriate fee Preliminary evaluation of product labels and package insert Conducting laboratory analysis Evaluation of product dossiers Undertaking premises inspection The FDA has an adequately equipped and staffed laboratory facility, which is responsible for conducting product testing and analysis. The Drug Quality Control Laboratory is responsible for testing quality of samples obtained from manufacturers, importers, distributors or other sources. The laboratory conducts testing prior to registration and samples are randomly selected and tested during post market surveillance. This is to ensure that both locally manufactured and imported products meet the requisite quality standards throughout the supply chain. The QCL has a physico-chemical section, a microbiology section and a medical devices testing section. It participates in the proficiency testing for drug quality control laboratories organized by WHO and passed the latest round. The QCL is expected to move into a new ultra modern laboratory building by mid-year, which would improve working conditions and allow the laboratory to seek full WHO Prequalification and related ranking. An initial pre-inspection has already been done but WHO was unwilling to conduct the full inspection before the laboratory is in its new premises. In connection with the move, an upgrade of some equipment is planned as well as an extension to include a pharmaceutical microbiology unit. The cost of the building and equipment are being financed by Government of Ghana and through Internally Generated Funds. The FDA QCL has not yet attained WHO Prequalification or ISO accreditation. An initial pre-inspection has been already done but WHO was unwilling to conduct the full inspection before the laboratory is in its new premises. In the interim, the FDA QCL is being assisted by the PSD to procure the services of a WHO Prequalified or ISO17025 accredited laboratory. The MOH has planned for this activity by setting aside 1% of the total cost of ARVs to be used to pay for QC/QA activities. The FDA has a QC system in place for all health products to be used in-country. The Central Medical Stores ensures that random quality control of consignment is performed on arrival. Upon arrival at the CMS, the Pharmacist-in-charge of the Warehouse, who has been trained in sampling techniques selects samples of each batch of product, labels them appropriately and submits to the QCL for testing. The products are quarantined and only released for distribution after receiving positive quality control results from QCL. The Central Medical Stores, Ghana Health Service and Food and Drugs Authority conduct periodic sight inspections to monitor storage practices at the 10 regional and three Teaching hospital Medical stores. The FDA conducts quality monitoring semi-annually along the entire supply chain when the products are in use. Guidelines for removal and disposal of expired and unserviceable commodities are documented in the Standard Operating Procedure Manualfor Logistics Management of Public Sector Health Commodities (2010) and Act

36 The FDA has a well-documented protocol for product recall in the Standard Operating Procedure Manuals for Quality Control Laboratories. The protocol prescribes the following line of action in case of out-of specification results are obtained: 1. The reagent(s) used in the analysis are thoroughly checked for any form of deterioration or contamination 2. The analysis procedure is repeated using a standard/reference product. 3. In the event of a negative test outcome for steps 1 &2, a senior laboratory analyst will conduct a final confirmatory test using the same procedure on the test product. 4. If step 3 produces a negative result, the product is said to have failed the test and the application is rejected. 5. If the product is at the point of entry, it will be impounded and properly destroyed. However, a product recall procedure is instituted in case the product is already in circulation International and national laws Ghana has been a member of World Trade Organization, having joined in January Since joining the WTO, Ghana has revised and adapted its national legislation in line with the WTO rules. Furthermore, Ghana is a signatory to the World Trade Organization s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs) as interpreted in the Declaration on the TRIPs Agreement and Public Health (Doha Declaration). The PR shall ensure that there shall be no patent infringement in the purchase of quality-assured health products. Ghana has a Patent law (Patent Law, 1992, PNDCL305a) that provides the patent owner the means to prevent others from making, using, or selling (importing, offering for sale) the patented invention for a limited period of time. The Law is administered by the Registrar General Department of the Ministry of Justice and Attorney General s Department. The law has been found to be compliant with the World Trade Organization (WTO) Trade Related Intellectual Property Rights (TRIPS) Agreement and Public Health. Furthermore, Ghana has developed Administrative Guidelines for implementing the TRIPS flexibilities as interpreted in the declaration on the TRIPS Agreement and Public Health in the manner that achieves the lowest possible price for products of assured quality. A number of experts have been trained in the interpretation and application of the Patent law and TRIPS flexibilities. In October 2006, Ghana issued compulsory licenses to Cipla and Strides Arcolab for the supply of first line antiretroviralmedicines as per WHO specifications. Ghana does not anticipate any challenges in patent rights during the implementation of the proposed ARV stock security since all the products used in first line treatment in the sub region are off patent. In case it occurs, the country has the required expertise and legislation to address the problem. In addition, the country will apply the lessons learnt in 2006 of issuing the Compulsory Licences to address them Coordination The Government of Ghana and the Global Fund are the main sources of funding for HIV/AIDs. As part of the counterpart financing arrangement, the Government of Ghana is providing ARVs to 12,000 new HIV positive clients each year for five years. The US Government through CDC in a Co-operative Agreement between the CDC of US and the Ghana Health Service is strengthening laboratory systems via the provision of technical assistance for quality assurance, support Blood safety and Health Management Information Systems including Laboratory Informatics. USAID is also supporting services for MARPs. DANIDA has also supported MARPs activities in the past. The GIZ of the German government supports HIV wellness and workplace programmes. 36

37 The Procurement and Supply Directorate (PSD) of the Ministry of Health and the Stores, Supplies and Drug Management Division of the Ghana Health Service coordinate all procurement and supply management activities related to multiple sources. The procurement plan covers the exact mix of multiple sources and serves as a coordination tool. The plan shall indicate various contract packages, estimated cost for each package, the procurement method and the processing steps and timelines. The plan is updated at each quarter or as required to reflect the actual project implementation needs and capacity. The method of procurement is largely dependent on the nature of the item and financial threshold as stipulated in the Ghana Public Procurement Act, 2003 (Act 663) and in accordance with the provision of multilateral and bilateral Agreement Management Information Systems (MIS) capacity Ghana has a comprehensive integrated supply system with adequately trained personnel in the public sector. The country is served by a Central medical store (CMS), 10 Regional Medical Stores (RMS) and three Teaching hospitals. The flow of commodities from the central level to the service delivery points in the accredited public and private facilities follow a 3- tier system. The system is essentially a PULL system and reporting and ordering are initiated from the service delivery points. The flow of commodity use information from the service delivery points to the central level is manual and electronic and includes information about commodity use, stock on hand and, values for these can be determined. Tools used for commodity management are Inventory Control Cards; ARV dispensary log; Monthly Report and Order Calculation Form; HIV Test Kits Monthly Usage form and, Requisition, issue and receipt voucher. In addition, the ART patients register and Monthly Summary Report of Patients on ART are used for the collection of service data and to provide information about number and type of persons on treatment as well as type of regimens. These manual forms have been incorporated into an electronic system to facilitate and improve management of commodities throughout the country. The information captured and reported by the tools are consumption/ issues, transfers and adjustments and, stock on hand. Reporting interval is monthly and quarterly for SDP s and regions respectively and data aggregation takes place regionally and centrally. Nationally, there is an ongoing process to connect the CMS, 10 RMSs, Two Teaching hospitals and, Procurement and Supply Directorate with a Wide Area Network and appropriate software for real time management of commodities including HIV. The Nordic Development Fund financed this project. The WAN is expected to support the deployment of mworks (accounting software) and msupply (inventory management software). msupply provide information such as stock on hand, losses and adjustments and, consumption which will be transmitted electronically from the RMS to the CMS and then from the CMS to the Procurement and Supply Directorate. Information from msupply will assist in forecasting, quantification and procurement planning. Currently, the electronic data system-msupply and mworks have been installed at the CMS, One Teaching hospital and One Regional Medical Stores. The Government of Ghana is seeking additional funding to deploy the softwares to the 10 sites and ICT services all public health facilities within the country. 37

38 Figure 9: Ghana Public Sector Commodity Pipeline All other end users i.e. GAC, PPAG and ADRA will collect their commodities namely condoms and Test kits from the MOH s Medical Stores. A pull inventory management system is applied based on their requirements. A max-min inventory system of 3 months and 1 month respectively applies. Re-supply is based on past consumption. For patient-related information, reporting period from district to region and region to central level is quarterly. Districts have up to a week after close of a quarter to report to the region while regions have up to 2 weeks to report to the central level. The ART patients register and Monthly Summary Report of Patients on ART are used for the collection of service data and provides about numbers of people treated and types of regimens. For inventory-related information health facilities report to districts monthly. Districts aggregate facility data and forward to regions quarterly. Regions also report to central level quarterly. At service delivery points, ARV medicines dispensed to patients will be recorded in the Drug Dispensing register on a daily basis at the ART clinic. At the end of reporting period, information from the Drug Dispensing register will be used to complete the Request, Issue and Receipt Voucher (RIRV) to the Regional Medical Stores for stock replenishment. The Regional Medical Stores will aggregate data from all the ART/PMTCT sites within the region quarterly to generate regional reports for submission to Central Medical Store. The CMS and RMSs are responsible for collecting, validating, analyzing, and utilizing logistics data while the regional health administration and NACP monitor and provide support to ensure an uninterrupted supply of commodities. The district and regional health administrations, and the NACP are responsible for collecting, validating, analyzing, and utilizing patient information. Coordinated Assistance for Reproductive Health Supplies Group (CARhs) This has been implemented in Ghana as part of Donor/Partner support and coordination mandate. It uses a procurement planning and monitoring report (PPMR) tool; defined as a monthly report that describes the stock status of contraceptives in a number of developing countries. Data is collected for the Early Warning System (EWS) is from the central level reports. Data collection 38

39 and submission takes a maximum of 7 days. At the country level, data validation process before data online submission includes: Reconcile opening and closing balances reported from CMS Reconcile same for issues, receipts and adjustments Check shipments updates. Frequency of reporting is based mainly on ease of access to data required for reporting and is currently done on a monthly basis from the central level. Feedback is received from PPMR administrators-cpt Technical Advisor(s). Results and benefits of the EWS are that stock-outs or overstocks are averted because EWS permits donors to make emergency shipments or reschedule or delay shipments. Shipment information is provided in both directions, awareness is created and capacity built in logistics management. Coordination is important at all levels with lower level staff appreciating the need to send data upwards. Accurate, timely information helps better planning and decision making Procurement and supply management cycle Product selection The Technical Working Group of the National AIDs/STI Control Program and the Expert Committee of Ghana National Drugs Programme are responsible for the selection of HIV/AIDs Commodities in line with WHO guidelines. The National Standard Treatment Guidelines (STG) is first developed and medicines recommended inthe STG are automatically migrated into the Essential Medical List. A Technical Working group for the EML reviews the medicines selected and provides inputs for additions when necessary. The STG and EML were last updated in All health products procured with Global Fund Resources are selected from the STG and EML. Forecasting procedures The forecast for HIV commodities employs multiple methodologies and tools. The summary below provides a brief overview of the various methodologies and tools used in forecasting commodities used in the management of HIV-AIDs and STIs. Forecast methodology: Morbidity-based The estimation of commodity needs is made by using morbidity or occurrence of a disease, programme targets, and service statistics. This method involved the estimation of the number of patients expected to receive treatment and the number of visits or treatment episodes to be encountered during the period of the forecast. Further, program policies and expansion plans were considered. The types of data used included the prevalence or incidence of a particular disease, demographic data and service statistics (i.e. number of patients accessing care in health facilities and the type of service received) Forecast methodology: Consumption-based Consumption based methodology involves the analyses of past consumption (dispensed to user data or issues data as proxy) trends and making assumptions about factors that are expected to influence demand during the period for which the forecast is being done. A combination of morbidity and consumption methodology is used in forecasting. Software: Pipeline This is for planning procurement and monitoring orders for public health programs. It helps to track the following; rate of consumption, order receipts, orders not yet received, stock at hand at all storage facilities, total amount of losses in the system and the lead time for any product order. 39

40 It therefore helps to track critical forecasting data, ensure timely procurement and delivery of products and maintain stock between established maximum and minimum national levels. Software: Quantimed This software offers 3 methods of forecasting; consumption, proxy consumption and morbidity for national programs. It allows for the determination of quantities of a product needed for a program, estimates their costs and calculates the appropriate order volume. Software: ProQ This software is used for quantifying HIV Test Kits and uses consumption, services, demographic and target information for this task. It allows for comparison of results from different methodologies. The National Quantification Team with technical support from USAID/DELIVER conducts annual quantification of commodities. The Quantification team is multi-sectoral and made up of representatives from NACP, Regional Medical Stores, PSD, SSDM, GAC, PPAG and ADRA. The existing electronic LMIS system for HIV/AIDs commodities provides relevant data for quantification and monitoring of stock to avoid stock out.the Central Medical Store is responsible for receipt, storage, inventory management for all procured commodities and distribution to the 10 Regional and Three Teaching Hospitals Medical Stores based on requisitions received. On a monthly basis, the 10 Regional Medical Stores in turn supply commodities to the ART and PMTCT sites based on requisitions received. A PULL system applies along the entire supply pipeline. Table 3: Types of Treatment/Testing and Number of Persons targeted per year Total number of Adult clients on ART as at December 69, Total number of Adult clients on First line ART as at 62,728 December 2012 Yearly target 15,000 1st Line Regimen Strength Distribution Number on ART Zidovudine + Lamivudine + Nevirapine 300mg + (AZT+3TC+NVP) 150mg+200mg 30% 18,818 Zidovudine + Lamivudine + Efavirenz (AZT+3TC+EFV) 300mg + 150mg + 600mg 20% 12,546 Tenofovir + Lamivudine + Nevirapine (TDF+3TC+NVP) 300 mg mg mg 24% 15,055 Tenofovir + Lamivudine + Efavirenz (TDF+3TC+EFV) 300 mg mg mg 16% 10,036 Tenofovir + Emtricitabine + Efavirenz (TDF+FTC+EFV) 300 mg mg mg 6% 3,764 Tenofovir + Emtricitabine + Nevirapine (TDF+3TC+EFV) 300 mg mg mg 4% 2,509 40

41 Inventory management (including Storage Arrangements) ARVs are received and stored at the CMS. The 10 RMSs pull their stock from the CMS and the ART/PMTCT from RMS. At each receiving bay, commodities are checked to be sure that the right products of the right quantity and quality is received. At CMS, samples are taken for analysis before items are taken on charge. Inventory control mechanisms such as bin cards,,ledgers and computerized Logistics Management Information systems are used at the various levels of supply. Commodities are stored on pallet racks that ensures optimization of the cube and 1 foot away from wall. Regular inventory of items are undertaken.to avoid theft burgllarproofings are in place in all stores. Security men are also employed at all stores. All the stores have basic fire fighting equipments in place and staff trained to use equipments. There is adequate storage space at the Central Warehouse, CMS. The CMS has a total storage capacity of at least 55,000m 3. These storage facilities are fitted with appropriate storage media (racks and shelves) and mechanical handling equipment (forklifts and ladders). Further, storage facilities have temperature regulating devices with adequate security measures. Figure 10: Site plan of Ghana CMS Cold chain storage facilities are available at the central, regional and service delivery levels for managing commodities that require cold storage. Ghana has a Logistics Management of Public Health Commodities manual i.e. Standard Operating Procedures (SOPs) with Job aids. The SOPs sets the minimum and maximum storage levels at the Central, Regional and facility level. The SOP prescribes a regiment of First-to- Expiry, First Out (FEFO), appropriate stock location system and audit trail. Stock-taking and checks which are all policies that prevent loss and expiry are stated in the SOPs. Its recommends 41

42 that high value items are kept under lock and key and are manned by adequately trained staff. Every facility in the supply chain distribution system is expected to use the SOP in carrying out their activities. Storage procedures are expected to be followed at all levels At the central warehouse and all the regional medical stores, there is a software for inventory control. At the lower levels, inventory control tools such as bin cards and ledgers are in place. Dispensed-to-user data are collected on a daily basis and aggregated into monthly reports by the service delivery points. These are sent to the Regional Medical Stores who intend transmit quarterly reports to the Central level. To further improve on data collection, an access based non commercial computerized Logistics Management Information systems has been developed by the National AIDS Control Programme, which has undergone test trial and is being rolled out at all ART sites and Medical stores. Distribution ARVs procured centrally are received and stored at the Central Medical stores (CMS) whiles the Public and Reference Laboratories and EPI cold stores are used to store Test Kits and other commodities needing refrigeration. Currently, for the public sector, ARVs are distributed to the Regional Medical Stores (RMS) from the CMS based on the pull system. The requisition is provided by information on their quarterly returns which seeks to maintain stocks between the max and min inventory levels. The sites requisition for ARVs is based on consumption information provided to the RMS on a monthly basis and with the aim of maintaining stocks between the desired max and min inventory levels. Test Kits are distributed from the National Public Health Reference Laboratory and EPI stores, which are offsite extensions of the CMS, on a quarterly basis to regional medical stores based on aggregate regional consumption and, issued on a monthly basis from the regional level to the districts and sites based also submission of monthly returns. Commodities are procured by the MoH and stored at the various storage facilities of the MoH i.e. Central Medical Stores, 10 Regional and Three Teaching Hospitals Medical Stores.. In the case of ARVs, these are distributed to the 160 ART and 3,222 PMTCT sites. Ghana is served by fairly good road network. Most regional capitals are linked to the hinterland by feeder and trunk roads that are gravelled and fairly motorable. Fluctuations in fuel pricing following international price changes has always affected the distribution of products There is Forced Ordering Inventory Control System at the RMS and ART/PMTCT site. ARVs, test kits and condoms are supplied to sites/health facilities on a monthly basis whilst the RMSs have a quarterly review period. Logistics personnel at those levels review all stock levels and order enough to bring stock levels up to the maximum. All re-supply decisions are based on a pull system. Forms are used for requisitioning and issuing medicines and health supplies. There is fairly sufficient capacity to ensure that products are distributed in a timely and safe manner using covered trucks to cart products from the CMS to the RMS. Products will be transported in safe boxes under controlled temperature where necessary. The CMS in Ghana however does not as yet have any experience on any certification nor accreditation process. 42

43 Willingness on the part of management to host regional buffer stock Ghana has had the benefit of being selected as the host for the distribution of ARVs to countries in the West African Sub region that were beneficiaries of the US President s Emergency Plan for AIDS Relief (PEPFAR) and also the cross-border initiative; Abidjan Lagos Corridor Project (ALCO) which crosses Nigeria, Benin, Togo and Cote D Ivoire and targets mobile populations that are vulnerable to HIV/AIDS. Both projects have the semblance of the regional stock security of ARVs in operational terms. There was therefore commitment by the top political hierarchy in Ghana to host the Regional buffer stock because of previous experience and other considerations. 43

44 Table 4 below summarizes the current situation in the public sector healthcare supply chain by supply chain function. Table 4: Situation Summary for Supply Chain Functions Function Selection Forecasting Procurement Storage Inventory Management Distribution Logistics Management Information System Coordination Human Resources Financing Situation Question marks on adherence to NEML although theoretically the NHIA reimbursement list should mitigate this for many items Some capacity exists but forecasting severely constrained by lack of financing to procure (CMS and RMS) and absence of data on real demand Some programs do collaborative, transparent forecasting, but not all and not always More frequent and local procurement by facilities reduces importance of forecasting (provided private sector can supply at short notice) Capacity of private sector to forecast is also questionable Supply planning not always carried out Central Level: Two procurement entities, MOH and GHS 1 so coordination a challenge No data on procurement performance so hard to diagnose problems Anecdotally, key informants say bureaucratic procedures and political interference in procurement has delayed several key procurements Release of funds for procurement: timing, bureaucratic delays pose problems for procurement At lower levels (regions, districts, hospitals) extensive procurement by tender from private sector. No data as to the extent to which these procurements follow established norms and procedures CMS has adequate capacity although there may be challenges with high volume items like treated bed-nets and condoms Capacity at RMS varies, but Global Fund grants are being employed in some regions to improve capacity Storage conditions at lower levels highly variable Shortages and levels of indebtedness mean little adherence to min, max stock rules Most lower levels pick up supplies limited active distribution (private sector normally delivers) Limited transport capacity at all levels LMIS system is in place but not functioning optimally Limited logistics data (stock levels, consumption/demand) visibility Limited and incomplete reporting Little use of automation Some coordination but tends to be informal No pre-service training in SCM Limited training Limited capacity in SCM at all levels Significant levels of indebtedness throughout the system Regions and hospitals to CMS; Districts, facilities to RMS; district health insurance schemes to facilities Slow payments likely factored into pricing decisions Long term financial sustainability of NHIS has been questioned Availability of funds for public sector procurement (and timing of funds release) a major issue 1 For procurements financed using Global Funds MOH procures medicines and GHS other health supplies 44

45 Strategic positioning Over all the Ghana supply chain system can best be described as organized on the landscape of supply chain evolution scale as presented as part of the conceptual framework of this assessment. Roles and responsibilities are being clarified under the roll out of a new supply chain master plan. The supply chain sometimes responds to changes in the environment. Processes are being defined; essential logistic data are collected and reported at least for the ART programme. The supply chain actors value collaboration although not always achieved. A supply chain strategy is currently under development 45

46 4.3. Central Medical Stores, Burkina Faso Assessment Report Management capacity of the Central Medical Store CAMEG is responsible for procurement, inventory management and distribution of medicines in the public sector in Burkina Faso. It is an autonomous including both financial and management autonomies. It is under the technical supervision of the Ministry of Health and is administered by a Board of Directors composed of eleven (11) members divided into three groups: the government represented by the Ministry of Health, the Ministry of Finance and the Ministry Commerce, health development partners and users of CAMEG. The organizational structure of CAMEG is shown in the flowchart below. 46

47 47

48 Procurement Figure 11: Organogram of CAMEG The partners in ARVs are: the Global Fund, the Clinton Foundation, the State of Burkina Faso, the Republic of China Taiwan, Brazil and Médecins Sans Frontière. Most procurement are executed by CAMEG, with the exception of the Clinton Foundation; which procures pediatric ARVs. CAMEG procurement procedures are largely influenced by Government policies and legislations. For greater efficiency, the tender procedure has been divided into two stages: the pre-selection of suppliers. The process is as follows: - International tender for selection of suppliers (1 annually) - Implementation of a file product / supplier (updated annually and based on the WHO prequalification for ARVs) - Annual evaluation of supplier performance, with the possibility of suspension. - Organization of restricted tenders based of applications (pre-qualified) - Notification of the total contract sum to selected suppliers with the delivery schedule A biannual report is made to donor on the situation of ARVs procurement. The following table shows the turnover of the CAMEG over the last three years. 48

49 Table 5: Turnover of the CAMEG at 2010, 2011 and 2012 YEAR NET SALES VARIATION IN ABSOLUTE VALUE VARIATION IN RELATIVE VALUE ,03 % ,83% The average stock of CAMEG to 31/12/2012 is F.CFA Quality Assurance It is the responsibility of the CAMEG to ensure that all health products purchased meet the requirement of NDRA in terms of registration and GMP. However, if the products are not registered, special import permits can be requested at the NDRA for emergencies. Burkina Faso has a functional national drug regulatory authority, with a system of registration of health products and inspectors qualified and competent to perform GMP inspections. There are no inspectors at the port entry points, but a permit is required for custom clearance. The NDRA has a quality policy and is committed to ISO 9001 quality approach with quality manual and procedures developed for all technical and organizational activities. A quality control laboratory well equipped with adequate facilities exist. However, there are capacity challenges in performing some analytical work. The laboratory is not accredited, but is engaged in ISO accreditation process. The quality assurance system in place at the CAMEG is to preserve the quality of the product from manufacture to the end user. A quality assurance department headed by a pharmacist has been set up at CAMEG for better monitoring. Quality at CAMEG is ensured at all levels of the supply chain cycle: manufacturing, transportation, storage and distribution. CAMEG has developed a system that allows one to check the compliance at supplier and storage levels. At each drug delivery, sampling is done for quality control in the laboratory. Regulation of the provider is linked to the quality control results. In case of non-conformity to quality control, the products are quarantined, the supplier is notified and a confirmatory test is carried out. Currently, tests are confirmed in Belgium at the quality control laboratory; SGS LAB SIMON and also at the National Laboratory of Public Health in Burkina Faso Coordination Coordination of all HIV/AIDS activities is carried out by the Permanent Secretariat of the National Council for the fight against HIV/AIDS (SP/CNLS). A ministerial decree establishes a formal framework for dialogue between the different actors. It is the committee for monitoring the management of ARVs and other inputs in the response to the HIV epidemic. This committee coordinates the development and monitoring of implementation of ARVs procurement plans, 49

50 ensure the effective implementation of a coordinated information system for the management of ARV, ensure the rational use of ARV. This committee is chaired by the General Directorate of Pharmacy, Medicines and Laboratories (DGPML) with the SP/CNLS and AIDS Control program (PSSLS) as 1 st and 2 nd vice chairs, respectively. The Central Medical Store (CAMEG) and other partners, participate in this committee. The daily coordination and centralization of data is ensured by the PSSLS which is a structure linked to the Cabinet of the Secretary General of the Ministry of Health. The following table shows the role of different actors in the pharmaceutical supply chain for ARV drugs. Table 6: The different actors in the current pharmaceutical supply chain for ARVs. Responsible Collaborators pharmaceutical regulation DGPML CAMEG, PSSLS, SP/CNLS Selection of Products PSSLS Technical Monitoring Committee Forecasting and PSSLS Technical Monitoring Committee quantification Acquisition CAMEG Fiduciary agencies, financial partners, PSSLS Distribution CAMEG Regional health Directions, PSSLS Coordination PSSLS Technical Monitoring Committee Inventory management CAMEG PSSLS, Regional health Directions Management of information PSSLS CAMEG, DGPLM Quality Assurance DGPML Quality Control Lab, CAMEG Monitoring of Inventory DGPML Technical Monitoring Committee management SP/CNLS, Inspection rational use DGPML Technical Monitoring Committee Patients, Communities Funding and advocacy SP/CNLS, Ministry of Health Partners Logistics Management Information System At CAMEG there is a logistics unit that manages the LMIS of all essential medicines including ARVs from central to intermediate levels. The logistics management unit is fully responsible for the management and use of the LMIS. There is an SOP for the LMIS. There is also an LMIS for essential medicines in district warehouses, different from that of CAMEG. A Software (LOGECT ARV) has developed by CAMEG for managing ARVs distribution system. It allows one to manage product inventory by lot according to FEFO principle with expiration warning system. This software converts therapeutic protocols to quantity of products required, quantifies the ARV for patients, manages distribution documents (order forms, delivery slips ) and tracks history of 50

51 the various operations. It produces reliable reports (distribution of patients by protocol, movement of stocks...), provides the theoretical situation of a structure during its replenishment, provides a log of operations (Changing or deleting of an operation, the author of the operation), and identifies the initiator of any document produced. CAMEG provides quarterly inventory and detailed reports for each Partner and PSSLS Selection The ARVs used are those contained in the national guidelines for management of HIV/AIDS and the National Essential Medicines List. They must have a market authorization issued by the Director General of Pharmacy, Medicines and Laboratories. The selection of products is ensured by PSSLS in collaboration with the Monitoring Committee Forecasting and quantification This activity is carried out by the subcommittee on quantification of the National Monitoring Committee for the management of ARV. The needs are expressed for 12 months and 6 months of buffer stock, and then submitted to the Monitoring Committee for validation. After this validation, the procurement plan is developed. The work of this subcommittee is under the chairmanship of the Director of the Pharmaceutical Supply. Prior to the quantification sessions, a preliminary work on the master data for quantification is performed by PSSLS and CAMEG. This preliminary work provides the number of patients and stocks projected and the evolution of the active file. A validation of master data that will be used for needs assessment and especially in the setting of targets is then carried out. The quantification method chosen is based on the consumption data. The quantification is performed using an Excel file developed for this purpose with several sheets interconnected by formulas. It is important to note here that quantification is not performed using quantification software as in other countries, but using Excel file. There is currently no validated procedure manual for the quantification process. Table 7: Types of Treatment/Testing and Number of Persons targeted per year Total Number of Adult patients under ART at December st line Regimen Dosage Distribution Number under ART Zidovudine + Lamivudine + Nevirapine 300mg (AZT+3TC+NVP) 150mg+200mg Zidovudine + Lamivudine + Efavirenz 300mg + 150mg (AZT+3TC+EFV) + 600mg Zidovudine + Lamivudine + Indinavir 36 (AZT+3TC+IDV) 51

52 1 st line Regimen Dosage Distribution Number under ART Zidovudine + Lamivudine + Indinavir/r 31 (AZT+3TC+IDV/r) Zidovudine + Lamivudine + Lopinavir/r (AZT+3TC+LPV/r) Tenofovir + Lamivudine + Nevirapine 300 mg mg (TDF+3TC+NVP) mg Tenofovir + Lamivudine + Efavirenz 300 mg mg 18 (TDF+3TC+EFV) mg TDF/3TC+LPV/r 451 Tenofovir + Emtricitabine + Efavirenz 300 mg mg (TDF+FTC+EFV) mg TDF/FTC+NVP TDF/FTC+LPV/r Storage and Inventory management CAMEG has storage facilities at the central level and nine regional outlets in Ouagadougou I, Ouagadougou II, Bobo Dioulasso, Fada N Gourma, Ouahigouya, Gaoua, Tenkodogo, Dédougou and Dori. There are guidelines and procedures established at CAMEG for the determination of levels of maximum and minimum stock for products. The maximum stock level and minimum stock for ARVs are 6 and 3 months for the central agency and 3 months and 1 month at the regional level. The ARVs are integrated with other essential medicines in the stores and stored in an air conditioned room between 18 and 25 C. In the stores, provisions have been made optimal storage conditions: cold room for sensitive products, frozen temperature storage in each store, suitable shelf, regular cleaning and disinfection of stores. A system is in place to record the temperature at air-conditioned storage areas and cold rooms, but not in the other storage rooms. Management tools are implemented (computer tracking, stock sheet, monitoring of consumption and the number of patients under treatment.) and the consumption trend is followed. Specific management tools for ARV exist: order, supply plan, stock cards, monitoring file, compliance monitoring file, patient tracking card, interview guide to ARV treatment implementation, quarterly reports. CAMEG has a good storage capacity with the construction of new warehouses. 52

53 Table 8: storage capacity of CAMEG Area of Area of Area of warehouses Area of flammabl airconditione TOTAL CAMEG for storage cold e TOTAL WAREHOUSES at ordinary room products AREA (m 2 VOLUM ) temperatur (m 2 d room E (m 3 ) ) e (m 2 (m 2 room ) ) (m 2 ) SIEGE Commercial Agency Ouagadougou I Commercial Agency Ouagadougou II Commercial Agency Bobo Dioulasso Commercial Agency Fada N'Gourma Commercial Agency Ouahigouya Commercial Agency Dédougou Commercial Agency Gaoua Commercial Agency Tenkodogo Commercial Agency Dori CURRENT TOTAL Warehouse building (Tengandogo) TOTAL TERM in IN The fleet of vehicles assigned for distribution is as follows; seven forty toner refrigerated trailers, ten forty toner trucks, ten twenty-toners, twelve seven toners and nine mini vans Distribution 53

54 CAMEG products are distributed through major sectors that are: - Public sector: Distribution depots of the districts (67) Teaching and national hospitals (04) Regional Hospitals (09) Related services of the Ministry of Health (19) Projects / NGOs (33) religious denominations (59) nonprofit associative structures (16) - Private sector Private pharmacies (165) medical Clinics (37) Private pharmaceutical wholesalers (05) The opening of commercial agencies in the regions facilitates the distribution of drugs by CAMEG. The map below shows the coverage areas of peripheral commercial agencies of CAMEG. Figure 12: AREA COVERED BY CAMEG COMMERCIAL AGENCIES IN 2013 Area covered by commercial agency of Ouagadougou Area covered by commercial agency of Bobo Dioulasso Area covered by commercial agency of Fada N Gourma Area covered by commercial agency of Ouahigouya Area covered by commercial agency of Dédougou Area covered by commercial agency of Gaoua Area covered by commercial agency of Tenkodogo Area covered by commercial agency of Dori 54

55 Table 9: Situation Summary for Supply Chain Functions of Burkina Faso Function Organization, management and polities Selection Situation Willingness of health authorities to accommodate the buffer stock Presence of policies on HIV / AIDS treatment guidelines and an EML Existence of a procurement policy, Existence of SOP for purchasing technical activities Existence of registration process and special import permit procedure for drugs not registered Existence of Comprehensive risk insurance that covers warehouses and stock Good management and financial autonomy ARVs used are captured in EML Presence of national guidelines for treatment that support the use of ARVs medicines Forecasting and Quantification Acquisitions Storage Inventory Management Distribution LMIS Carried out by a multidisciplinary committee of experts. No SOP for quantification: lack of transparency System in place to validate the accuracy and quality of the data used for quantification Supply planning done after quantification No software for the quantification There is a procurement plan. Large part of ARV purchases carried out by CAMEG Procurement by CAMEG through international competitive. Good storage capacity at CAMEG Appropriate storage and handling equipment are in place in sufficient quantities. Presence of cold chain facilities. Existence of written procedures for the storage and handling of products Proper application of management rules on min-max Integrated inventory management of ARVs Existence of appropriate inventory management tools Existence of outlets of CAMEG Well-established distribution circuit Procurement of all public sector essential medicines by CAMEG High capacity and adequacy of transportation logistics Existence of ARVs management software housed by CAMEG Good features of the ARVs management software LMIS only at CAMEG and includes patient data and data on ARV stock. PSSL does not have LMIS to ensure the visibility data 55

56 Function Situation Coordination Existence of a mechanism and a unit for coordination Good level of collaboration between the various structures involved in the coordination Presence of a monitoring committee for the management of ARVs established by ministerial decree Human Resources Availability of adequate human resource: 253 people, including 36 skilled staff Presence of a job description Absence of an human resource plan Quality Assurance Existence of a quality assurance policy at CAMEG with the establishment of a quality assurance department Presence of a functional quality control laboratory Presence of GMP inspection, system and procedure for registration of medicines, post-marketing control No inspection at entry ports or pre-shipment inspection Quality of ARVs controlled by CAMEG Strategic positioning Over all, Burkina Faso supply chain system can best be described as organized on the landscape of supply chain evolution scale as presented as part of the conceptual framework of this assessment. Roles and responsibilities are being clarified under the roll out of a new supply chain master plan. The supply chain sometimes responds to changes in the environment. Processes are being defined; essential logistic data are collected and reported at least for the ART programme. The supply chain actors value collaboration although not always achieved. 56

57 4.4. Central Medical Stores, Cote D'Ivoire Assessment Report Management capacity of PSP-CI Pharmacie de sante publique of Cote d Ivoire is an autonomous and is responsible for managing the Procurement and the supply chain of essential medicines including ARVs in La Cote D'Ivoire. It is placed under the hierarchical relationship of the Directorate General of Health and is fully subject to the public procurement system. The Organogram of PSP-CI is shown in figure below. Figure 13: Organogram of PSP-CI. UNAIDS estimates at about 200,000 the number of people needing antiretroviral therapy (ART) in Côte d'ivoire in 2010 (this number varies between 180,000 and 220,000 (source/year). In the same year, 75,237 people were reported as receiving treatment, a coverage rate of 37% Procurement The United States Government President's Emergency Plan for AIDS Relief Le Plan (USG/PEPFAR) finances the antiretroviral (ARV) drugs in Côte d Ivoire at 90 % from The purchases are made through the mechanism of Supply Chain Management System (SCMS). PSP is not being involved in the purchasing process. The contribution of PEPFAR completes the 57

58 funding of the Ivorian Government and the Global Fund Series 2 (the latter being successively managed by UNDP and CARE International). The purchases from the national budget are made by tender and the policy of prequalification product/supplier is used for this purpose. These public purchases are made by inter-ministerial committees Quality Assurance The National Drug Regulation Authority (NDRA) of Côte d Ivoire is functional and has procedures for medicines registration. The National Essential Medicines List (NEML) developed takes into account the drugs used in antiretroviral therapy. It is the responsibility of the PSP to ensure that the products purchased meet the requirement of NDRA in terms of registration. Otherwise, a special import authorization may be required at the NDRA. The NDRA has no inspectors at ports of entry, but for each shipment of products, inspectors of the NDRA move there for the controls. Quality control, though obligatory in the case of drugs, is not carried out systematically. Quality controls are assured only in the case of purchases by Government. The absence of quality control seems justified the case of PEPFAR procurement, in which quality control is provided by SCMS and even more so that the purchases are made from pre-qualified suppliers. But the manufacturer must provide, for each batch delivered, a certified copy of the corresponding bulletin of analysis as required by national laws. We note, however, the presence of a functional quality control laboratory, with a technical platform enabling them to control the quality of ARV drugs, but the results of analysis are often made with considerable delay. A procedure is in place for quarantine and destruction of affected batches in case of non-conformity with quality control Coordination There is a formal framework of cooperation between the national HIV/AIDS program (PNPEC) and PSP-CI. The national HIV/AIDS program (PNPEC), which ensures the coordination of treatment, is attached to the directorate for the fight against HIV/AIDS while the PSP, which ensures the management of the stocks, is linked to the Directorate General of Health. The general direction of the fight against AIDS and the Directorate General of Health are both central directorates of the Ministry of Health. The general direction for the fight against HIV/AIDS has separate directorates in charge of therapeutic treatment of AIDS, prevention, planning and monitoring-evaluation. The coordination of all activities of HIV/AIDS is carried out by the National Council for the fight against HIV/AIDS. There are also regional and sectoral (in ministries) committees that ensure coordination at the regional or ministerial level, respectively LMIS and data collection The Logistics Management Information System (LMIS) for ARVs implemented in 2007/2008 does not reflect all the required data in a systematic way, especially clinical data. A LMIS for 58

59 ARV stocks is implemented at PSP-CI, but it is still in a pilot phase and, as such, does not at the moment, allow data collection at the peripheral level. These data are currently manually filled into the system. The directorate of the Ministry of Health in charge of data management has only the clinical data. All data required for quantification are not available through a single system. A system of reporting of patient data (quarterly reporting) and information on ARV stocks (monthly reporting) is established, but is faced with a problem of completeness and timeliness. Therefore, the actors identified the need for active data collection in order to obtain all the data necessary for the operation of quantification. This personalized exercise involves: - Clinical data collection in pharmacies and care and treatment sites, coordinated by the directorate of the Ministry of Health in charge of data management ; - Stocks data collection in pharmacies, laboratories, testing sites for HIV at referral centers and health district are coordinated by the PSP-CI. Data are collected, reviewed and verified as appropriate, aggregated and synthesized into results that determine baseline of patient population and enlightened assumptions about future program parameters. PSP-CI, PNPEC and the structure in charge of the data management, work together to compare, review and validate all data collected Selection The Ministry of Health of Côte d'ivoire has revised the national treatment guidelines based on the recommendations of the World Health Organization which, if fully implemented, will promote consistency in the service and simplify supply management. The revised guidelines emphasize the use of fixed-dose combinations and the movement from stavudine to tenofovirbased regimens Forecasting and quantification. The forecasting and quantification of ARVs in Côte d'ivoire are made in coordinated and concerted manner and validated by a centralized body, before being translated into action. Quantifications are performed by a National Committee of quantification (CNQ) created by ministerial decree. The quantification process is supported by the PSPCI and PNPEC. All interested parties are involved in the process of quantification that is achieved through workshops. The last workshop witnessed the active participation of more than 25 people, including ministry of health officials (PNPEC, PSPCI, quality control laboratory, the direction in charge of data management) partners implementing (ACONDA Ariel Glazer, RETRO-CI) and donors (USAID, CDC, ACSM). Quantification covers a period of five years with a procurement plan for 18 months developed from years 1 and 2 of the forecast period. The procurement schedule includes plans contract packages, timelines and the partner responsible for the procurement. 59

60 The quantification is based on a projection of the growth of the population of patients, compliance to STG and on a number of assumptions about different groups of patients, the proportion of patients to whom alternative regimes are prescribed, the choice of formulations, the established algorithms and the prices of products. To reduce the complexity of the process and minimize the uncertainties inherent in the integration of several assumptions, many of these factors are assumed constant throughout the forecast period. The quantification of ARV is based on the method "morbidity" for which it is essential to have access to clinical data as well as logistical. The forecasting tool SCMS ARV (Quantimed A) is used. The use of Quantimed facilitates the creation of alternative scenarios that reflect the consideration of different values for some variables. The forecast in Quantimed are calculated on a monthly basis to more accurately reflect changes in the number of patients under treatment (persons newly eligible for the program and for those under monitoring and failure in first line). The result in terms of estimated quantities of each product by month is likely to be directly imported to the supply planning tool, PipeLine, to obtain a supply plan from 12 to 18 months. The "morbidity" method is based on the estimated number of patients on ART during the forecast period (given that new HIV infections made their entry into the program while others leave). The distribution of current and projected regimens (proportion of patients who are prescribed each alternative regime to better respond to their characteristics, adult, child, coinfected TB, HIV1 or HIV2, etc..) is then applied to the number of patients to obtain the required amounts of each formulation. Method based on the "morbidity" is seen as offering a more reliable forecast was chosen in order to model the expected evolution in product and treatment selection. An SOP is established for the quantification process but not yet validated. 60

61 Table 10: Types of Treatment/Testing and Number of Persons targeted per year Total Number of Adult patients under ART as at September Yearly target 15,000 1 st line Regimen Dosage Distribution Number under ART Zidovudine + Lamivudine + Nevirapine 300mg (AZT+3TC+NVP) 150mg+200mg 56 % Zidovudine + Lamivudine + Efavirenz 300mg + 150mg (AZT+3TC+EFV) 600mg 21 % Tenofovir + Lamivudine + Nevirapine 300 mg mg (TDF+3TC+NVP) mg 2 % Tenofovir + Lamivudine + Efavirenz 300 mg mg (TDF+3TC+EFV) mg 7 % Tenofovir + Emtricitabine + Efavirenz 300 mg mg (TDF+FTC+EFV) Tenofovir + Emtricitabine + Nevirapine (TDF+3TC+EFV) mg 300 mg mg mg Storage and Inventory management These logistics activities are routinely performed by the PSP-CI. PSP-CI has storage premises in sufficient number (09) and size. A warehouse is reserved for the storage of ARVs with an expressed capacity of 857 pallets and there is no physical separation of ARVs from the different donors. Management of ARVs is integrated into the processes of the PSP. Storage conditions are not entirely satisfactory because the storage rooms are not ventilated or air conditioned. The cold chain is however guaranteed for products that require: presence of cold room for storage and ice chests for transport. A system is set up for recording the temperature in the storage areas. Storage and handling equipment are sufficient in number and are adapted to these specific activities. PSP-CI conducts regular inventories of stock on a monthly basis. It establishes activity reports on a monthly basis also. The rhythm of supply is mainly monthly. The level of buffer stock of ARVs at the PSP is 4 months stock and maximum stock level in eight months stock. The PSP has management tools and two software s are used: software for business management and another for managing storage environments. Software is used in a pilot phase for ARVs. A management tool that tracks by batch number and expiration date is used to ensures traceability. 61

62 Distribution The PSP is responsible for drug distribution to districts, national and regional public hospitals. Distribution is coordinated at the central level because the PSP-CI has no stores at the peripheral level. A monthly distribution rhythm is used at the peripheral level and four times per month at Abidjan. NB: It is important to note that the PSP-CI is in a reform process with the support of the European Union and the French cooperation. This will enhance operational efficiency storage, warehousing and distribution. This process is expected to be completed within 3 months. Table 11: Situation Summary for Supply Chain Functions of Cote d Ivoire Function Situation Organization, management and polities Selection Forecasting Procurement Strong support of health authorities to accommodate the buffer-stock Central management in place for AIDS Presence of polities, Standard Treatment Guidelines (STG) and Essential Medicines List (EML) There is evidence of the existence of procurement policies, Existence of SOP for purchasing and technical operations Existence of procedures for special import authorization for drugs that do not have marketing authorization : asset for the buffer-stock PSP is certified ISO 9001:2005 No insurance for storage warehouses of the PSP Level of financial autonomy of the PSP insufficient ARVs in use are listed in the Essential Medicines List (EML) There are Standard Treatment Guidelines (STG) supporting the use of ARVs Existence of a mechanism for pre-qualification for the selection of pairs suppliers / products ARVs Realized by a standing multidisciplinary committee of experts (the quantification section of ARVs monitoring technical committee) Existence of a procedure manual for forecasting: transparency Forecasting using morbidity method based on the estimated number of patients on ARVs during the forecast period System in place to validate the quality and the accuracy of data used for forecasting Supply planning done after quantification Good capacity for quantification, however, suffers from the lack of real-time data Procurement plan indicating the periods of purchases for each donor and products to buy Two level of ARV procurement: 90 % by donors and 10 % by government Purchases made by the Government on call for tenders 62

63 Function Storage Inventory Management Distribution Logistics Management Information System Coordination Human Resources Quality Assurance Situation Adequate storage capacity of PSP Not physical separation of the stocks of ARVs (only computing separation was realized) : this is an assert for the buffer-stock to allow his turn-over. Adequate storage and handling equipment and sufficient number Sufficient staff and trained storage is part of the scope of ISO certification of the PSP Presence of a cold room for products to keep it fresh. warehouses unventilated, non air-conditioned (to improve) Stock-outs of ARVs mastered by good application of the management rules minmax Planning of the use of bar code in inventory management Absence de dépôt PSP au niveau périphérique Existence of SOPs for distribution Good transportation logistics Existence of ARVs management software housed in PSP (phase of implementation) Management software does not allow for the time of collecting the information at the peripheral level: these data are currently filled directly by the PSP Existence of batch management: Good traceability Dissemination of data on patients and ARV stock data between the PSP and DIPE (Department of Information, Planning and Evaluation). Poor visibility of data: need to centralize this data at a single level for better visibility Lack of a comprehensive and reliable MIS: data on the distribution of ARVs by the PSP used as an indicator of ARVs consumption (weak point) Problem of reporting data at peripheral level (completeness and timeliness): active collection organized as alternative The various committees are established by ministerial decrees Many actors in coordination: Lack of clarity on respective roles in the coordination system Existence of human resources in sufficient numbers at PSP Presence of a plan for human resource development in PSP including training Existence of a quality assurance policy at the central medical store Presence of functional Quality Control Laboratory Existence of Marketing authorization, but not post-marketing control No routine inspection at entry points, only No evidence of pre-shipment inspection Strategic positioning Over all, Cote d Ivoire s supply chain system can best be described as organized on the landscape of supply chain evolution scale as presented as part of the conceptual framework of this assessment. Roles and responsibilities are being clarified under the roll out of a new supply chain master plan. The supply chain sometimes responds to changes in the environment. Processes are being defined; essential logistic data are collected and reported at least for the ART programme. The supply chain actors value collaboration although not always achieved. 63

64 V. Comparative analyze of the Four Central Medical Store The following tools has been used for assessing the capacity and quality of storage of Central Medical Stores (CMS) and is based on MQAS (Model Quality Assurance System) of WHO and WAHO technical document for the buffer-stock of antiretroviral drugs in ECOWAS countries. The Appraisal criteria are: 0: System / procedure does not exist 1: Very low level of compliance or implementation 2: low level of compliance or implementation 3: Medium level of compliance or implementation 4: Good level of compliance or implementation 5: Implementation comprehensive and coherent, consistent with the expectations of MQAS NB: The multiplication factors 2, 3, 4 or 5 are used for the scoring to 10, or 25 points Elements of appraisal Quotation RCI Nigeria Ghana BFA 1. Political aspects Will of the health authorities and the management of the CMS to host this regional buffer stock Facilitation of the health authorities to sign an agreement with the Customs Administration for shipments Management/Organization Existence of a detailed flow chart indicating the positions and reporting relationships Existence of a written job description defining the responsibilities of all staff 2.3. Presence of an insurance for warehouses Compliance with NDRA requirement The CMS is authorized to perform distribution activities (eg, pharmaceuticals) in accordance with national legislation The importation of drugs is exclusively at designated entry ports by the competent authorities 3.3. The CMS import pharmaceutical products according to NMRA requirements (registration, special authorization)

65 3.4. Does the CMS take import licenses at the NMRA Human Resources Adequate number of staff and trained for the activities of the CMS 4.2. Existence of a plan of human resource development (including training plan) Quality system Existence of a quality assurance policy at the CMS Existence of a mechanism for prequalification for the selection of couples suppliers / products Certification/accreditation experiments of CMS Existence of a quality manual and implementation of quality policy Procedures defined are implemented and they cover all technical activities including pre-selection, purchasing, receiving, storage, distribution There is sufficient office space and storage space for storage of products, documentation, samples, reports, records and other documents Proper application and protection of systems. A backup of electronic records is done and maintained to prevent accidental data loss Implementation of a procedure for handling complaints (review of complaints, risk assessment, identification of causes) Implementation of a procedure for handling counterfeit and presumed counterfeit products Conduct of internal audits or self-inspection Documentation A comprehensive documentation system exists: Quality policy, quality manual, organizational procedures, technical procedures, guidelines, standards, records and documents related 6.2. The documents are designed, completed, revised, modified and distributed with care

66 Documents are regularly reviewed and updated. The replaced documents are removed from the circulation Existence of procedures or instructions regarding operations in the CMS that may affect product quality or distribution activities The keeping records (electronic or paper) ensure traceability throughout the supply chain Records for the receipt of the products contain at least the date, designation of product, batch numbers and expiry dates, the quantity received or supplied, and the name and address of the supplier. 7. Reception, storage and handling SOP written and followed for the receipt, sample storage and products handling Sufficient space for the receiving and the shipping of products. Reception and shipping areas separated and protected against bad weather All products are received and verified in accordance with SOP and placed in quarantine until their release (for example, meeting the requirements of the book of specifications: folder preselected, order form, certificate of analysis, WHO certificate ) 7.4. Records of each delivery (product description, quality, quantity, supplier, batch number from the supplier, date of receipt, batch number given and date of expiry) Quality control There is a system in place for quality control of products purchased Sampling plans that ensure that representative samples are taken for analysis are detailed in written procedures and are based on risk assessment. The staff in charge of sampling is qualified and experienced Existence of a suitable quality control laboratory for testing products independently in accordance with the specifications and standards approved. The laboratory meets the

67 general requirements for practices covering such facilities, policies and procedures, personnel, equipment, etc A SOP clearly describes the process and ensures that the products are not released for use until their quality has been satisfactory The results of quality control not meet specifications are treated in accordance with a procedure for investigation (cons-expertise) Products not conforming to their specifications are rejected by a procedure 9. Storage Access to storage areas is controlled to ensure that no unauthorized person has access (24 hours a day, 7 days on 7) Separate areas for the reception, storage and shipping areas designated for rejected products and or recalled, expired product or with date close, suspected counterfeit Products requiring cold chain are treated appropriately for transport, delivery, receipt and storage (cold rooms, refrigerators, coolers,...). Generators are available in case of power failure All products are stored in protective materials suitable, labeled, in proper storage conditions as specified on the label Storage areas have enough space (volume) and are sufficient in number storage areas with adequate ventilation (aeration, air conditioning...) and adequate lighting System set up for recording the temperature in the storage areas. Monitoring records are retained for a suitable period of time general protection of warehouses against thefts (windows, doors,...) and pests (rodents, insects) Existence of good storage practices Storage and handling Equipment sufficient number and appropriate Presence of control equipment against fire (fire extinguishers,...)

68 9.13. Means of transportation suitable for the carriage of pharmaceuticals Stock control Stock rotation and control is ensured by the control of batch number and expiration date A periodic reconciliation of stocks is done (vs. actual stocks registered stocks). The major differences are studied and the results are documented in accordance with written instructions Damaged containers are handled in accordance with written procedures. Any action taken is documented Regular checks are carried out according to a written procedure to identify expired products The products covered by the recall are treated in accordance with a written procedure Returned products must be treated in accordance with a written procedure ensuring physical separation and proper storage conditions Logistical Management of Information System (LMIS) Existence of a LMIS Existence of a method for data collection Existence of Good Practice on Information Management Good knowledge of management software features Good definition of inventory levels Existence of logistical support (supports of keeping stock, shipping / transaction, consumption) Existence of periodic reports Appreciation of the ability to ensure a turnover of ARVs (own stock-buffer stock) Air connection and flow

69 13.1. Easy air connections with other countries of ECOWAS (direct flights) TOTAL VI. CONCLUSIONS AND RECOMMENDATIONS 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. It emerged that the current health supply chain system in Nigeria may not be able 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. 69

70 References 1. Paul Dowling et al, Ghana healthcare supply chain and commodity security strategic review May, JSI Deliver for USAID 2. Getting products to people: The JSI framework for integrated supply management in public health, January Innocent Ibegbunam et al, Nigeria ARV and co-trimoxazole Drug requirements and financing needs ( ), June Nigeria, country-level Analysis. PMT briefing, July Isabelle Creamer, SCMS Technical Report. Nigeria Central Medical stores, August

71 Appendix: List of persons met by country NAME DESIGNATION FUNCTION Côte d Ivoire Dr KONE Mamadou Minsitère de la santé Directeur de Cabinet Adjoint Dr KONAN/KOUADIO Liliane Minsitère de la santé Conseiller technique chargé des questions de VIH/Sida Dr Joséphine DGLS Directrice générale DIBATE/CONOMBO Dr KONAN Koko DGLS Directrice prise en charge thérapeutique du Sida Dr GUELLA Michel DGLS Directeur SIHI K. Hyppolite DGLS Sous directeur enquêtes et statistiques BOMBO Pacôme DGLS BADIE Yao B. DGLS Administrateur Dr KLA Christian DGLS Directeur Dr KOUASSI Ponou DGS Armand Pr YAPI Ange Désiré PSP-CI Directeur Général Dr CODO PSP-CI Chef de la cellule ARV Dr AHOBA Iama PNPEC Chef du service PTME Dr LIKANE Liliane Huguette PNPEC 71 Chef du service soins et traitement Nigeria Mrs Celine C. ONUNKWA FMS Oshodi Assistant Director Mrs U.O. NDUKWE FMS Oshodi In charge of opportunists infection drugs and pediatric ARVs Mrs Y.T KASSIM FMS Oshodi Processing of data Mrs AKINOLA FMS Oshodi Processing of data Mrs F.O. ODERINDE FMS Oshodi In charge of ARV drugs Mrs C.I. HEMEFOR FMS Oshodi In charge of malaria drugs Mrs J.A. ADUBIARO FMS Oshodi In charge of administrative work Mrs S.A. Denloye NAFDAC Director, Laboratory Services Ghana Sherry AYITTEY Ministry of Health Minister Dr Angela EL-ADAS Ghana AIDS Director General Commission Dr Richard AMENYAH Ghana AIDS Director of Technical Services Commission Dr Joseph AMUZU Ghana AIDS Commission Kyeremeh A. Ghana AIDS Commission Kwadwo ASANTE NACP Global Fund Focal Person

72 Procurement Unit Head Naana A. FREMPONG Procurement Unit Technical officer Peter Ekow GYIMAH CMS Tema Head CMS Tema Deputy Head Seth SEANEKE FDA Head, Drug Evaluation & Registration Department Mrs Delese Mimi DARKO FDA Head, Safety Monitoring Department Burkina Faso Dr Souleymane SANOU Ministère de la santé Sécretaire Général Dr Mahamoudou COMPAORE Ministère de la santé Conseiller technique en charge des questions pharmaceutiques Dr Arsène OUEDRAOGO DGPML Directeur des Approvisionnements pharmaceutiques Dr Ould Cheik EBY DGPML Assistant Technique Dr Monique SAWADOGO/KONCOBO DGPML Assistant technique chargé de la coordination des approvisionnements pharmaceutiques Dr Natacha TOE/DJIGUEMDE DGPML Responsable homologation des produits pharmaceutiques Dr Hamadé BELEM DGPML Inspecteur Pharmaceutique Dr Eve N.R. OUEDRAOGO DGPML Responsable Contrôle Qualité Dr Laurent COMBOIGO PSSLS Chargé des Approvisionnements et de la gestion des intrants M Seydou COULIBALY CAMEG Agent Comptable 72