Guidelines for Managing the HIV/AIDS Supply Chain

Publication date: 2006

GUIDELINES FOR MANAGING THE HIV/AIDS SUPPLY CHAIN May 2006 This publication was produced for review by the United States Agency for International Development. It was prepared by the DELIVER project. GUIDELINES FOR MANAGING THE HIV/AIDS SUPPLY CHAIN The author’s views expressed in this publication do not necessarily reflect the views of the United States Agency for International Development or the United States Government. DELIVER DELIVER, a six-year worldwide technical assistance support contract, is funded by the President’s Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Agency for International Development (USAID). Implemented by John Snow, Inc. (JSI), (contract no. HRN-C-00-00-00010-00) and subcontractors (Manoff Group, Program for Appropriate Technology in Health [PATH], and Social Sectors Development Strategies, Inc.), DELIVER strengthens the supply chains of health and family planning programs in developing countries to ensure the availability of critical health products for customers. DELIVER also provides technical management of USAID’s central contraceptive management information system. Recommended Citation DELIVER. 2006. Guidelines for Managing the HIV/AIDS Supply Chain. Arlington, Va.: DELIVER, for the U.S. Agency for International Development. Abstract Comprehensive national HIV/AIDS programs are relative newcomers to public health programs in resource limited settings. Recent global initiatives such as the Presidents Emergency Plan for AIDS Relief; the Global Fund for HIV/AIDS, Tuberculosis, and Malaria; the Clinton Foundations HIV/AIDS Initiative; and WHOs 3 by 5 Strategy have fostered an environment of rapid expansion of HIV/AIDS programs in countries by focusing fi nancial, human, and technical resources toward achieving global prevention, care, and treatment goals. As a result, in many countries, the life cycle of these HIV/AIDS programs is somewhat distorted by the political, multilateral, bilateral, and social pressure to rapidly scale up these services, and program implementation is not as systematic as managers would prefer. Frequently, implementation of HIV/AIDS supply chains occurs in a context where programs are simultaneously expanding and maturing. This concurrent pressure on programs to both evolve toward maturity and rapidly scale up, poses several challenges for the development of supply chain management systems. Also, in many countries most affected by the HIV/AIDS epidemic, the capacity of public health commodity supply chains to ensure a reliable supply of the products needed at service delivery sites is already limited; this constitutes a further challenge. The Guidelines for Managing the HIV/AIDS Supply Chain is a set of references for managers working to ensure a continuous supply of quality HIV/AIDS commodities to programs. The Guidelines highlight lessons learned from JSI and DELIVER advisors experience designing, implementing, and improving HIV/AIDS supply chains in resource limited settings. The recommendations and tools presented in the Guidelines have been developed specifi cally for programs where supply chain implementation is occurring within the context described above. Th e authors recognize that as HIV/AIDS programs continue to evolve, so will supply chain solutions. The Guidelines will be updated accordingly. DELIVER John Snow, Inc. 1616 North Fort Myer Drive, 11th Floor Arlington, VA 22209 USA Phone: 703-528-7474 Fax: 703-528-7480 Email: deliver_project@jsi.com Internet: deliver.jsi.com CONTENTS BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS: INVENTORY CONTROL SYSTEMS, LMISs, AND STORAGE AND DISTRIBUTION GUIDE FOR QUANTIFYING ARV DRUGS GUIDE FOR QUANTIFYING HIV TESTS PROCURING HIV/AIDS COMMODITIES USING U.S. GOVERNMENT FUNDS: LESSONS AND APPROACHES HIV/AIDS COMMODITY SECURITY: A FRAMEWORK FOR STRATEGIC PLANNING ASSESSING SUPPLY CHAINS FOR HIV/AIDS COMMODITIES SUPPLY CHAIN MANAGEMENT OF ARV DRUGS: CONSIDERATIONS FOR INITIATING AND EXPANDING NATIONAL SUPPLY CHAINS HIV/AIDS SERVICE DELIVERY PROGRAMS: OVERVIEW AND INSIGHTS FOR SUPPLY CHAIN MANAGERS CONTENTS iii iV GUIDELINES FOR MANAGING THE HIV/AIDS SUPPLY CHAIN BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS INVENTORY CONTROL SYSTEMS, LOGISTICS MANAGEMENT INFORMATION SYSTEMS, AND STORAGE AND DISTRIBUTION The author’s views expressed in this publication do not necessarily reflect the views of the United States Agency for International Development or the United States Government. DELIVER DELIVER, a six-year worldwide technical assistance support contract, is funded by the U.S. Agency for International Development (USAID). Implemented by John Snow, Inc. (JSI), (contract no. HRN-C-00-00-00010-00) and subcontractors (Manoff Group, Program for Appropriate Technology in Health [PATH], and Social Sectors Development Strategies, Inc.), DELIVER strengthens the supply chains of health and family planning programs in developing countries to ensure the availability of critical health products for customers. DELIVER also provides technical management of USAID’s central contraceptive management information system. This document does not necessarily represent the views or opinions of USAID. It may be reproduced if credit is given to John Snow, Inc./DELIVER. Recommended Citation DELIVER. 2006. Building Blocks for Inventory Management of HIV Tests and ARV Drugs: Inventory Control Systems, Logistics Management Information Systems, and Storage and Distribution. Arlington, Va.: DELIVER, for the U.S. Agency for International Development. Abstract Securing a dependable, uninterrupted supply of antiretroviral (ARV) drugs and HIV test kits is critical to the success of HIV testing and treatment programs. Toward this goal, a robust logistics system, supported by sufficient infrastructure, is needed to manage commodities and to strengthen the entire supply chain. ARV drugs and HIV tests, two products that are new to public health logistics systems, have special management needs. This document focuses on four elements of supply chain and pipeline management: the inventory control system, the logistics management information system, storage, and distribution. These four elements require special consideration in the context of supply chain management of ARV drugs and HIV tests. Luxuries typically built into supply chains, which relieve pressure on those managing the system, may lead to wasted financial and product resources when managing these commodities. Because of these challenges, this paper makes recommendations that follow guiding principles and lessons learned from DELIVER’s experience that have proven effective in supply chain management of ARV drugs and HIV tests. DELIVER John Snow, Inc. 1616 North Fort Myer Drive, 11th Floor Arlington, VA 22209 USA Phone: 703-528-7474 Fax: 703-528-7480 Email: deliver_project@jsi.com Internet: deliver.jsi.com CONTENTS Acronyms . v Acknowledgments. vii Executive Summary . ix Introduction . ix Special Characteristics of ARV Drugs and HIV Tests . ix Recommendations. x Introduction . 1 Inventory Control Systems . 3 Purpose of an Inventory Control System . 3 Maximum-Minimum Inventory Control Systems . 3 Special Characteristics of ARV Drugs and HIV Tests That Affect the Selection/Design of an Inventory Control System . 5 Recommendations for ARV Drug and HIV Test Inventory Control System Design and Implementation . 6 Logistics Management Information Systems . 9 Purpose of a Logistics Management Information System . 9 Link between the Logistics Management Information System and the Inventory Control System . 9 Data for Decision Making .10 Records and Reports .11 Availability of Disaggregated Data .11 Special Characteristics of ARV Drugs and HIV Tests That Affect the Design and Implementation of a Logistics Management Information System .13 Recommendations for ARV Drug and HIV Test Logistics Management Information System Design and Implementation .15 Recommendations for ARV Drug Logistics Management Information System Design and Implementation .16 Recommendations for HIV Test Logistics Management Information System Design and Implementation .19 Storage and Distribution of ARV Drugs and HIV Tests .21 Purpose of Storage and Distribution .21 Packaging .21 General Guidelines for Storage of Health Commodities .21 General Guidelines for Distribution of Health Commodities .22 CONTENTS iii Special Characteristics of ARV Drugs and HIV Test Kits That Affect Storage and Distribution .22 Recommendations for Storage and Distribution of ARV Drugs and HIV Test Kits .23 References .27 Annexes .31 Kaamanland HIV/AIDS Program ARV Drug and HIV Test Supply Chains: Completing the Worksheet for Calculating Monthly ARV Drug Orders for A Case Study .33 Kaamanland ART Program and Supply Chain .33 Kaamanland HIV Test Program and Supply Chain .34 Records and Reports for Managing ARV Drugs and HIV Tests .37 Job Aids for LMIS Records and Reports for Managing ARV Drugs and HIV Tests .49 Completing the ART Daily Activity Register .49 Completing the Monthly Summary Report of ART Patients .51 Estimated New Adult ART Patients.52 Completing the LMIS Report and Request for Antiretroviral Drugs .54 Completing the Daily Log for Usage of HIV Tests .56 Completing the LMIS Report and Request for HIV Tests .60 Completing the Report for Returning Products .61 Figures Kaamanland ARV Drug Pipeline .35 Kaamanland HIV Test Pipeline .36 Interrelationships between LMIS Records and Reports for ARV Drugs .39 Interrelationships between LMIS Records and Reports for HIV Tests .40 BUILDING BLOCKS FOR IN VENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS iv ACRONYMS AIDS acquired immunodefi ciency syndrome ART antiretroviral therapy ARV antiretroviral drugs CMS central medical stores FEFO fi rst-to-expire, fi rst-out HIV human immunodefi ciency virus HMIS health management information system LMIS logistics management information system NRL National Reference Laboratory PMTCT prevention of mother-to-child transmission SDP service delivery point STG standard treatment guidelines VCT voluntary counseling and testing WHO World Health Organization ACRONYMS v BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS vi ACKNOWLEDGMENTS This publication, which is featured on the CD Resources for Managing the HIV/AIDS and Laboratory Supply Chains, is dedicated to people around the world living with HIV/AIDS and to the many indi­viduals from communities, nongovernmental organizations (NGOs), faith-based organizations, Minis­ tries of Health, and other organizations who have consistently fought for access to antiretroviral drugs and other commodities required to provide HIV/AIDS services. The publication is also dedicated to friends and counterparts who have worked with DELIVER, the Family Planning Logistics Management project, and John Snow, Inc., since 1986 and to the thousands of committed professionals in Ministries of Health and NGOs who work daily to supply their customers and programs with essential public health commodities. Although the resources on the CD provide a focus on specific HIV/AIDS and laboratory commodities, we recognize that comprehensive HIV/AIDS and laboratory programs require the supply chain to manage and deliver a broad range of several hundred public health commodities. The U.S. Agency for International Development (USAID) contracts funded the technical assistance, in-country projects, and research that produced the experience and lessons contained in the Resources. We are deeply grate­ ful to the team of professionals in the Commodity Security and Logistics Division in the Office of Population and Reproductive Health of the USAID Global Health Bureau’s Center for Population, Health, and Nutrition— especially Mark Rilling and Sharmila Raj—for their encouragement and advice and their commitment to improv­ ing HIV/AIDS laboratory and public health programs through logistics. Numerous people helped write the documents that constitute the Resources. Sincere thanks go to the core team of dedicated technical staff who developed and wrote the components—namely, Claudia Allers, Johnnie Amenyah, Dana Aronovich, Briton Bieze, Ronald Brown, Yasmin Chandani, Abdourahmane Diallo, Aoua Diarra, Paul Dowling, Barbara Felling, Jane Feinberg, Andrew Fullem, Carmit Keddem, Mary Lyn Field-Nguer, Lisa Hare, Corynne Harvey, Erin Hasselberg, Lisa Hirschhorn, Jennifer Mboyane, Colleen McLaughlin, Naomi Printz, Gregory Roche, Eric Takang, Lea Teclemariam, Wendy Nicodemus, and Dragana Veskov. Special thanks go to Nancy Cylke, Miguel Jaureguizar, Meba Kagone, Carolyn Hairston, Carolyn Hart, Paula Nersesian, Richard Owens, Ruth Stefanos, Jennifer Antilla, and Edward Wilson for their significant contributions and valuable support. Field examples and data were generously contributed by Hannington Ahenda, David Alt, Barry Chovitz, Parfait Edah, Janne Hicks, Steve Kinzett, Catherine Lwenya, Mercy Maina, Lino Martinez, Yolanda Mikaele, Greg Miles, Cecilia Muiva, Moses Muwonge, Marilyn Noguera, Jabulani Nyenwa, Amanda Ombeva, Walter Proper, Nora Quesada, Tim Rosche, Jayne Waweru, and Steve Wilbur. The lessons drawn from DELIVER’s experi­ ence in managing HIV/AIDS and laboratory supply chains would not have been possible without these valuable contributions. The DELIVER Communications Group edited, designed, and produced the Resources. Their patience, persis­ tence, insight, and support are much appreciated. In particular, appreciation goes to Heather Davis, communica­ tions manager; Pat Shawkey, publications manager; Pat Spellman, editor; Gus Osorio, art director; Kathy Strauss, Paula Lancaster, and Susan Westrate, graphic designers; Erin Broekhuysen, communications strategist; Delphi Lee, JSI assistant webmaster; José Padua, DELIVER web manager; Madeline McCaul, communications offi cer; Jessica Phillie, publications coordinator; and Jacqueline Purtell, communications coordinator. ACKNOWLEDGMENTS vii viii BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS EXECUTIVE SUMMARY INTRODUCTION A logistics system that manages any health commodity, antiretro- When providers do not have consis­ virals (ARVs), HIV tests, or others, must have the infrastructure to tent supplies of ARVs because of non- manage and move commodities that support the supply chain as functioning supply chains, treatment can a whole. This document focuses on four elements of supply chain be severely compromised, given that pro- and pipeline management: (1) the inventory control system, (2) the viders prescribe ARV drugs in combina­ logistics management information system, (3) storage, and (4) distri- tions that can be toxic, lethal, or ineffective for antiretroviral therapy (ART). In one bution. These four elements, in particular, require special consider- country, patients were being treated ac­ ation in the context of supply chain management of ARV drugs and cording to the six following combinations HIV tests. of drugs, none of which were included in the local standard treatment guidelines While it is highly desirable for all supply chains to be as eff ective (STGs) or WHO- recommended STGs: and as efficient as possible, the need for effectiveness and efficiency is even more important when ARV drugs and HIV tests are being • ABC/AZT/3TC managed. Luxuries typically built into supply chains, which relieve AZT/ddI/NVP • pressure on those managing the system, may lead to wasted fi nan- • d4T/3TC/IDV cial and product resources when managing these commodities. Th e • d4T/3TC/NLF following discussions and recommendations for managing ARVs • d4T/ddI/NLF and HIV tests assume that the basic elements of a performing supply • 3TC/AZT/IND chain are already in place or can readily be put into place. SPECIAL CHARACTERISTICS OF ARV DRUGS AND HIV TESTS ARV drugs and HIV tests, two products that are new to public health logistics systems, have particular character­ istics that influence how they are managed. Compared to many other essential medicines, ARVs and HIV tests require special handling or adjustments to the supply chain through which they are managed. The special nature of ARVs and HIV tests will influence the design of the inventory control and logistics management information systems and the storage and distribution networks. SPECIAL CHARACTERISTICS OF ARV DRUGS AND HIV TESTS INCLUDE— • short shelf life that can range from six to 24 months • high price, including a significant jump in price when moving from first line antiretroviral therapy (ART) to alternate treatment regimens • cool storage required for some products • treatment and testing protocols that require multiple products from multiple sources to be available simultane­ ously to provide a service • dynamic technology for products leading to constantly evolving treatment and testing protocols EXECUTIVE SUMMARY ix • higher levels of accountability, including special reporting or other documentation requirements from either donors or manufacturers • greater potential for redistribution of products from one facility to another • limited number of sites authorized to use the products • limited possibility for substitution in the case of stockouts. SPECIAL CHARACTERISTICS OF ARV DRUGS INCLUDE— • high value in prolonging survival for AIDS patients • need for continued, uninterrupted resupply for patients already on ART • special ordering and information requirements for second line and alternate drug treatment if these drugs are not kept routinely at the service site. SPECIAL CHARACTERISTICS OF HIV TEST KITS INCLUDE— • other commodities needed for administration • kit contents and packaging considerations (e.g., number of tests per kit, inclusion of chase buff er, diff erent expiration dates for tests and buff er). RECOMMENDATIONS The following recommendations are guiding principles and lessons learned from DELIVER’s experience that have proven effective in supply chain management of ARVs and HIV tests. INVENTORY CONTROL SYSTEM • Reduce the length of the supply pipeline. • Use the forced ordering version of the maximum-minimum (max-min) inventory control system. • Implement a monthly reporting period and order cycle. • In a new program, phase in the inventory control system for second line drugs at facilities. • Implement a mechanism for returning products for rapid redistribution before expiry. LOGISTICS MANAGEMENT INFORMATION SYSTEM • Link routine reporting to commodity ordering. • Avoid overburdening the logistics management information system (LMIS) by collecting excessive service statis­ tics or other data that do not have direct benefit to the management of commodities. • Always collect and report dispensed-to-user data for ARVs and usage data for HIV tests; do not use issues data as a proxy. • Refrain from altering the content and formatting of the LMIS to accommodate the funding mechanism. • Convert quantities to issue of ARVs and HIV tests from units to packs at the issuing level, not the ordering level. BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS x LMIS FOR ARVS • In addition to the three essential logistics data items, limit the amount of patient data that are collected and reported to the number of new and existing patients by treatment regimen. Use these data for decision making. • If program reporting captures estimates of new patients, provide worksheets to translate patient numbers into product numbers. • Select and consistently use one unit for recording drugs. • Separate clinical/program information used for program monitoring, data collected from logistics, and patient data collected for logistics decisions. LMIS FOR HIV TESTS • In addition to the three essential logistics data items, limit other data collected and reported through the LMIS. Do track usage of HIV tests by purpose of use, brand, and use of test. • Use the individual test as the unit for recording. • Manage test-related supplies through the existing system for laboratory supplies. STORAGE AND DISTRIBUTION • When feasible, integrate the storage and distribution of ARV drugs and HIV tests. • Provide greater security during storage. • Ensure increased security during transport. • Pay special attention to fi rst-to-expire, fi rst-out. • Ensure product integrity if reissuing returned drugs. • Deliver ARV drugs and HIV tests to accredited sites only. • Consider using private or other courier/express mail facilities. • Ensure that products used together are distributed together. EXECUTIVE SUMMARY xi BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS xii INTRODUCTION A logistics system that manages any health commodity, ARVs, HIV tests, or otherwise, must have established infrastructure to manage and move commodities, all of which supports the supply chain as a whole. Th is infra­ structure includes: • A commodity resupply pipeline • An information system for gathering and using commodity data • Storage facilities • Cool storage facilities • A distribution system (pickup or delivery), based on the availability of reliable transportation • Staff/human resources to implement the system. Inventory management is a vitally important part of the logistics system for ARV drugs and HIV tests, as it deter­ mines how stock is managed during ordering, stockkeeping, distribution, and resupply. Inventory management comprises the procedures that govern how these commodities are ordered, received, stored, handled, and distribut­ ed to other facilities or dispensed to users at service delivery points (SDPs). The purpose of inventory management is to ensure a continuous supply of quality products to users whenever and wherever they are needed. This paper focuses on four elements of supply chain and pipeline management: the inventory control system, the logistics management information system, storage, and distribution. These elements require careful management in the context of ARV drugs and HIV tests. Securing a dependable, regular supply of ARV drugs or HIV tests at service delivery points is critical to the success of antiretroviral therapy (ART) programs and laboratory diagnosis. Any interruption in the supply chain will prevent diagnosis of new patients or endanger the lives of those patients already on therapy due to risk of discon­ tinuation of treatment or development of drug resistance. Frequent interruptions could lead to failure of the program. The following discussions about and recommendations for managing ARVs and HIV tests assume that the basic elements of a performing supply chain are already in place or can be put into place. Additional requirements or particular appli­ cation of the basic elements will be needed based on the special nature of ARV drugs and HIV tests. Refer to The Logistics Handbook for basic guidance on supply chain design and implementation. INTRODUCTION 1 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS 2 INVENTORY CONTROL SYSTEMS PURPOSE OF AN INVENTORY CONTROL SYSTEM An inventory control system informs the storekeeper: • when to order or issue, • how much to order or issue, and • how to maintain an appropriate stock level of all products to avoid shortages and oversupply. The continuous supply of quality ARV drugs and HIV tests can only be guaranteed through the selection, design, and proper implementation of an appropriate inventory control system. A number of strategies or inventory control systems can be adopted to manage commodities of any kind. Some of these, such as a rationing system, are more appropriate in situations where the product supply being managed, or the financial resources available to purchase the products being managed, is unsure. In a traditional rationing system, supplies are allocated based on some set of chosen criteria, for instance, to serve a certain proportion of the poorest clients, to treat a certain proportion of the priority disease burden in the region, or so that a certain product accounts for no more than a certain proportion of the available budget. However, ARV drugs and HIV tests are expected to be in full supply for a desired target number of patients, at least in the short term. To manage full-supply products eff ectively, a maximum-minimum inventory control system (also known as a max-min system) is recommended. MAXIMUM-MINIMUM INVENTORY CONTROL SYSTEMS FULL SUPPLY SITUATION Implementation of a maximum-minimum (max-min) inventory control system is most effective in a full-supply situation, where sufficient quantities of all commodities are available to meet all needs, as should be the case for an ART program and some programs that use HIV tests (e.g., voluntary counseling and testing [VCT], preventing mother-to-child transmission [PMTCT]). A max-min system allows objective resupply decisions based on need and takes into account established levels of safety stock, with the ultimate goal of having product available each and every time it is needed. Given the life­ saving nature of ART and the public health risks associated with the emergence of ARV drug resistance, uninter­ rupted product availability must be the primary concern. When developing a logistics system, one of the first decisions that will have to be made is the type of max-min inventory control system to use. There are several types of max-min inventory control systems, each of which has slightly different transportation, personnel training, and storage requirements and the other elements that comprise a supply pipeline. Among the available options are: Forced ordering: Orders are placed at regular intervals; all products are ordered/resupplied to the maximum stock level. Delivery truck variation of forced ordering: Rather than submitting orders to the supplying facility, service delivery points are visited regularly (the length of the reporting period) by a resupply truck. At the time of the visit, data are collected and resupply quantities are determined and delivered. INVENTORY CONTROL SYSTEMS 3 Continuous review: Orders are placed each time a product reaches its minimum stock level; products reaching the minimum stock level are ordered/re-supplied to the maximum stock level. Two-bin variation of continuous review: Bin sizes are determined by the system designers so that one bin equals the estimated consumption for one reporting period. When the contents of one bin has been distributed, i.e., at the end of the reporting period, a new bin is re-supplied to the dispensing facility. Standard: Orders are placed at regular intervals, but a product is ordered only if it has reached its minimum stock level; products reaching the minimum stock level are ordered/re-supplied to the maximum stock level. Refer to The Logistics Handbook for more a complete description and additional discussion of the various max-min systems. PULL OR PUSH SYSTEM In any version of the max-min system, the designer Note: Do not confuse “push system” with “rationing.” must also decide where the decision-making power Although push systems have historically been used when lies for determining reorder quantities: “pull” if commodities are rationed, not all push systems are rationing personnel receiving the supplies make the decision, systems.A true push system can be equally as if not more “push” if personnel issuing the supplies make the effective than a pull system if data are accurate and rou­ decision. tinely available. The choice of implementing a push or a pull system will depend largely on in-country capacity at each level of the supply chain as well as the availability of technology. Countries/programs that have well-trained staff at the lower levels (or the potential to train staff adequately at the lower levels) could easily choose a pull system. Countries/programs that rely on more trained staff or the availability of computerized systems at the upper levels, or those wishing to reduce the commodity management workload of lower-level staff, would choose a push system. In either case, adequate information and data have to be available; see Logistics Management Information Systems section for further discussion of this topic. LENGTH OF IN-COUNTRY COMMODITY PIPELINE The length of the commodity pipeline (determined by adding the maximum stock levels at all levels of the system) is a key consideration in commodity management. This is especially true for ARVs and HIV tests, where a commodity’s shelf life is often less than 24 months and can be as short as six months. The table below illustrates the inventory control system components of a typical multitiered supply pipeline using a forced ordering max-min system. The numbers represent months of stock. Lead Time Safety Stock Review Period/ Emergency Stock Level Level Order Interval Min Max Order Point Level Central 3 3 6 6 12 3 Regional 3 2 3 5 8 2 District 2 1 3 3 6 1 SDP 1 1 1 2 3 0.5 Total 16 29 [Min. = lead time stock level + safety stock level] [Max. = minimum + review period] [Emergency Order Point = shortest lead time in case of emergency, independent of “normal” lead time] BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS 4 The type of max-min system (forced ordering, continuous, standard) chosen will affect the length of the pipeline, as will such other factors as lead time and review period/order interval. The longer the pipeline, the longer it takes for commodities to move from the central-level supplier to the client, the more safety stock will be required in the system, and, if linked to resupply, the longer it will take data to move from the lower levels to the upper levels. The more effective and efficient the elements of the supply chain (transportation system, order turnaround time, etc.), the more effective and efficient the supply chain, and therefore, the shorter the pipeline can be. In a system for managing ARVs and HIV tests, supply chain effectiveness and efficiency must remain a top priority. SPECIAL CHARACTERISTICS OF ARV DRUGS AND HIV TESTS THAT AFFECT THE SELECTION/DESIGN OF AN INVENTORY CONTROL SYSTEM ARV drugs and HIV tests both have unique characteristics that often require that they be managed diff erently (with greater control, with greater care, using a different system) than other commodities. Managing them may require establishment of a vertical supply chain or, at a minimum, special handling within an integrated or other combined supply chain. Special characteristics of ARV drugs and HIV tests include— • short shelf life, which can range from six to 24 months • high price, including a significant jump in price when moving from first line to second line treatment regimens • high value in prolonging survival for AIDS patients • treatment and testing protocols that require multiple products from multiple sources to be available simultane­ ously to provide a service • limited possibility of substitution in the case of stockouts • high risk of drug resistance in the case of stockouts. Due to these unique characteristics, it may not be possible to integrate Removing one or more levels from them fully into existing inventory control systems. For instance, holding the distribution system for commod­ large quantities of stock in inventory at the various levels requires more ities does not necessarily mean re- money and storage space and increases the risk of pilferage, damage, moving that level for other program- and expiration. In any case, the characteristics of ARV drugs and HIV related purposes such as supervision. tests require additional system resources over and above those required In fact, lower-level personnel can play for a typical supply chain as noted above. a critical role in overseeing program activities, monitoring product avail- Inventory control system requirements for ARV drugs and HIV tests ability, and providing feedback on include— reporting or other issues, often more quickly and more effectively than can • shortest possible pipeline central-level personnel. • lower buffer stocks than other health commodities • more frequent reporting period and order interval. In view of the logistics system design elements and the key considerations already discussed, DELIVER has devel­ oped some basic recommendations for designing and implementing an inventory control system to manage ARV drugs and HIV tests. INVENTORY CONTROL SYSTEMS 5 RECOMMENDATIONS FOR ARV DRUG AND HIV TEST INVENTORY CONTROL SYSTEM DESIGN AND IMPLEMENTATION The following recommendations for ARV drug and HIV test inventory control system design and implementation will achieve pipeline efficiency while addressing the special commodity management requirements of ARV drugs and HIV tests. 1. REDUCE THE LENGTH OF THE SUPPLY PIPELINE. If ARVs or HIV tests must be managed within an existing supply chain/pipeline, reduce the length of the supply pipeline. If ARVs or HIV tests are to be managed through their own vertical pipeline(s), design the pipeline(s) to be as short as possible. From the illustrative pipeline seen in the table above, it is clear that a pipeline of 29 months is too long to manage ARVs and HIV tests, many of which are delivered in-country with about 75 percent of their shelf life remaining. Each level in the pipeline necessarily implies safety stock kept at each level, with the potential of tying up valuable financial resources in stock quantities. In addition, in countries where the number of ART and HIV testing sites is limited, if ARVs or HIV tests are moved through an existing pipeline, regions and/or districts would be required to stock products that are distrib­ uted to only a few sites in that region or district. Strategies for reducing the overall length of the supply pipeline are listed below. It must be noted that strate­ gies to reduce the pipeline must be selected based on the in-country situation and resources. Adopting a strategy that affects one element of the supply chain will have an impact on other system elements, and the operation of the supply chain will be adversely affected if an one element is not strong enough to perform under the new requirement. • Eliminate an entire level or levels from the supply chain. This is the single most effective and most common strategy for reducing pipeline length. Intermediate levels such as regional and/or district levels are usually elimi­ nated, and commodities move directly from the central level to the service delivery points. From the example in the table above, eliminating the district level alone would reduce the overall pipeline to 23 months; removing the regional level alone would reduce the overall pipeline to 21 months; and removing both the regional and district levels would reduce the overall pipeline to only 15 months. While this results in storage and distribu­ tion savings at these levels, it does require more resources for transportation at the central level. However, as the number of ART or HIV testing sites is generally limited, the additional central-level resources required for distribution are usually fewer than those required to maintain secure storage and distribution for ARVs or HIV tests at all intermediate storage facilities. • Shorten the order interval at one or more levels. While this will reduce the pipeline length by reducing the maximum stock level, it will require more frequent reporting and ordering, which may place a burden on service providers and require more frequent transportation, for example, monthly pickup/delivery instead of quarterly. Further, care must be taken that the lead time does not exceed the reporting period for placing and receiving an order. • Reduce the lead time. Overall pipeline length can be reduced by reducing the amount of time it takes to fi ll and process orders and deliver product to the receiving facility. Of course, this increases pressure on personnel and transportation resources. Automation of data collection, reporting, analysis, and order processing can also help to reduce lead times. BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS 6 • Maintain lower levels of safety stock. Safety stock is kept primarily because of uncertainty about the system’s ability to provide routine service. If uncertainty can be reduced, for instance, if suppliers consistently provide timely delivery, if customs clearance formalities are reduced or eliminated, or if communications and trans­ portation within the country are very reliable, the safety stock level can be reduced and both minimum and maximum stock levels can be reduced. 2. USE THE FORCED ORDERING VERSION OF THE MAX-MIN INVENTORY CONTROL SYSTEM. In light of the special requirements for ARV drugs and HIV tests, and to take advantage of some of the common characteristics of ART and HIV testing programs, the forced ordering version of max-min inventory control system has several key benefi ts, including— • The range/number of commodities is relatively limited/low, so all commodities can be ordered at each reporting period. • If ordering is linked to reporting, forced ordering will require that all facilities submit a report/order at each order interval, so facilities that are not reporting and/or not ordering can be identifi ed easily. • Reorders are standardized and limited to a regular cycle, reducing some of the burden on transportation. (Th is system entails less frequent orders and deliveries than does a continuous review system.) • This version requires less safety stock than the standard version. • The simple ordering decision rule makes it easier to implement. Depending on the number of ART and HIV testing sites being served, the reliability of transportation, the size of the country, and other factors, the delivery truck variation of forced ordering max-min is the best inventory control system for ARV and HIV test distribution. While the delivery truck variation of forced ordering max-min does put pressure on distribution planning and transport management, it has benefits in addition to those of the forced ordering system noted above. Th ese include— • Higher level of security: supplier vehicles can be upgraded to ensure secure cargo areas rather than retrofi tting service facility vehicles for the task. • Immediate data collection: data are collected at the moment the vehicle arrives at site; there is no delay due to data transmission so resupply decisions are based on very timely data; and there is less risk of the data/informa­ tion being lost in transmission. • Lead time is negligible, thus shortening the pipeline. • Relieves service providers of logistics duties: data collection, resupply, etc., are done by the delivery team. • Centralizes transport needs: dedicated vehicles assure supply deliveries so individual sites do not need to arrange for transportation of commodities. • Excess product close to expiry can be collected for immediate redistribution to other sites; expired product can be collected for disposal. • If a supervisor accompanies the delivery, on-the-job training and some supervisory activities can take place at the time of the delivery. INVENTORY CONTROL SYSTEMS 7 3. IMPLEMENT A MONTHLY REPORTING PERIOD AND ORDER CYCLE. A monthly order cycle limits the amount of buffer or safety stock that facilities need to hold. If ordering and reporting are linked, a monthly order ensures that program managers receive data frequently, which is especially important when expanding services. Monthly ordering and reporting allows program managers to monitor the quantities and range of products being used more frequently. Because logistics data can indicate changes in treat­ ment regimen, timely availability of this data will allow program managers and national-level commodity manag­ ers to respond to changes in product requirements and adjust procurements. It is important to note that, for a monthly reporting period to operate effectively, the lead time for filling an order must be less than one month. If a monthly ordering and reporting cycle is not possible, the next shortest cycle should be implemented. If a quarterly or greater reporting period and order cycle must be used, then it should be limited to the upper levels or, in any case, to as few levels as possible. 4. IN A NEW PROGRAM, PHASE IN THE INVENTORY CONTROL SYSTEM FOR SECOND LINE DRUGS AT FACILITIES. Starting patients on ART is never an emergency, and switching patients from a first line to a second line treatment due to failure is not widely seen as a clinical emergency. Given that second line drugs generally are signifi cantly more expensive than first line drugs, and that in new programs demand for these drugs is slow, managing second line drugs slightly differently from first line drugs can help a program reduce costs and waste. Rather than stock­ ing all facilities with supplies of second line drugs, these products can be stored centrally until a facility requires them and then provided only to those sites with patients on second line drugs. After the drugs become a regularly managed product at the facility, they can be managed alongside first line drugs at the facilities that require them. 5. IMPLEMENT A MECHANISM FOR RETURNING PRODUCTS FOR RAPID REDISTRIBUTION BEFORE EXPIRY. Despite strict adherence to stock management procedures, a facility may, at some point, find itself overstocked with ARV drugs. Overstocks may be due to any number of reasons, including slower than expected uptake of new patients, higher or lower than anticipated shifts in treatment regimens, or higher than expected rates of treatment abandonment. In a system with monthly reordering (two-month maximum stock level), if a facility has more than two months of supply, then the overstock should be returned to the supplier so those products can be redistributed and used before they expire. For systems with different maximum stock levels, drugs would have to be returned to the supplier early enough to ensure that they can be reissued and used by the patient before expiry. A special transaction record should be used to facilitate and track the return of ARV drugs and HIV tests from a lower-level facility to a higher-level facility. This record will identify the products being returned and provide proof of return by the lower-level facility and proof of receipt by the higher-level facility. See the illustrative form Report for Returning Products in the annex. BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS 8 LOGISTICS MANAGEMENT INFORMATION SYSTEMS PURPOSE OF A LOGISTICS MANAGEMENT INFORMATION SYSTEM In all programs and for all product categories, logistics managers at all levels need to make routine decisions that affect commodity availability. They need to determine how much of each product to order or resupply, to forecast future demand for a product, and to plan procurements and commodity shipments. They also need to be able to identify potential supply problems at facilities or storage sites or to handle other issues related to commodity management. Th ese Do not confuse HMIS with LMIS. decisions must be made using accurate and timely logistics data that is HMISs are intended for the collec­ provided by a logistics management information system (LMIS). Over tion and reporting of overall pro- the long term, data provided through the LMIS can also help inform gram parameters, such as incidence, policy and product selection decisions. client load, and performance, and lack the specificity that LMISs provide An LMIS helps personnel collect and manage the information necessary for managing commodities within the to support sound and objective decision making in managing the supply health program. In addition, the time required to collect and process datachain; the goal of this decision making is to ensure an uninterrupted through an HMIS would mean that supply of commodities and to identify any problems in the supply pipe- it is not available for timely logistics line. The LMIS is composed of all the forms and documentation used to decision making. maintain records and produce reports on the logistics system. An effective LMIS makes regular and timely information available to decision makers. Information is used to make short-term resupply decisions in the and to make long-term procurement and program management decisions. The need for timely and accurate commodity data increases when there is a rapidly expanding program, as is the case for HIV/AIDS programs, where demand for services and client uptake is highly unpredictable. LINK BETWEEN THE LOGISTICS MANAGEMENT INFORMATION SYSTEM AND THE INVENTORY CONTROL SYSTEM An LMIS and the inventory control system have a close relationship: the LMIS provides the data required to maintain the inventory control system. Data collected through the LMIS enables a product manager to determine how many months of stock are current­ ly kept at the facility; knowing this, the product manager will know if the supply is above, below, or within the established maximum and minimum stock levels, or if he or she needs to make an emergency order. At the end of the order interval, the product manager will compare current stocks to maximum stock level and place an order for the appropriate quantity needed to bring stock levels to maximum. Upper-level commodity managers can use the LMIS to track trends in overall consumption and adjust national level procurements, as needed. They can identify overstocks of ARVs or HIV tests and redistribute the products. Commodity managers can also use the data to determine exceptionally high levels of product expiry, and then initiate action to prevent this situation from happening in the future. LOGISTICS MANAGEMENT INFORMATION SYSTEMS 9 LMIS data can even help program managers identify incorrect prescribing or dispensing practices or detect unusu­ ally high rates of treatment failure at a particular site or in a region. This can result in targeted supervision and, thus, improve the overall quality of care for HIV/AIDS clients. DATA FOR DECISION MAKING A key underlying principle for all LMISs is that data collected and orga- Collect data only if it will be used for nized will provide a sound basis for decision making. This requires that making decisions! relevant data be collected at appropriate locations in the logistics system, be processed, and be transmitted to decision-making points, in a timely and complete manner. Additionally, decisions must be based on reliable data, so care must be taken to ensure data integrity, to avoid duplication, and to collect only the data that are actively used for decision making. Decision-making process DecisionsInformation Logistics systems for all commodities should include at least three essential data items: Dispensed to user are the data on the quantities of products given to clients/patients for their use (e.g., ARVs) or the quantities of products used by the service provider (e.g., HIV tests, which are not actually given to the clients). In some systems or for some product categories, issues data are used instead of dispensed-to-user data. Issues data refers to quan­ tities of products that are sent from upper-level facilities to lower-level facilities. Stock on hand are the data on the usable quantities of stock held at a facility. Losses and adjustments are the data on any quantity of stock that leaves the pipeline for reasons other than dispensed to user—transfers of stock from one facility to another at the same level, expiry, or damage. While using issues data as a proxy for dispensed-to-user data may be acceptable in general essential medi­ cines programs, the level of rigor and accountability required of HIV/AIDS programs makes this practice unac­ ceptable for managing ARV drugs and HIV tests. In addition, concerns for the security of ARVs from thera­ peutic, safety, and financial perspec­ tives impose greater demands for accountability. Other data may be included in an LMIS; however, an LMIS must not be so extensive that it becomes a burden on the health care personnel who implement the system or who try to collect data that are not immediately relevant for logistics management decision making. An LMIS must collect only data that will be used for decision making. Data collection forms and reports must be used to collect and transmit the data; it must also be easy to use. The logistics data that are collected and reported will be used to answer a number of questions, including— • How long will available supplies last; do we need to order more supplies now? • Where are our supplies in the pipeline; do we need to move supplies from higher to lower levels or between facilities at the same level? • Where is consumption the highest? Do those facilities need more resources? • Are we experiencing losses from the system that require us to take action? • Are supplies flowing regularly through the pipeline? Do we need to adjust the pipeline to account for bottle­ necks in the system? 10 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS RECORDS AND REPORTS As mentioned earlier, the purpose of a logistics system is to collect and process data to support decision making. Three kinds of logistics records are typically used to collect data at the points at which the commodities are managed. These records, which correspond to the three essential data items, include— • Consumption records that capture data about the products being used or dispensed (usage logs or dispensing registers). • Stockkeeping records that collect information about products in storage (bin cards, stores ledgers). • Transaction records that collect data on the movement of stocks from one point to the other (requisition and issue vouchers, waybills). In addition to the data collection records, an LMIS must include reports. Reports represent the mechanism through which logistics information is communicated from one level of the system to another. While records are used mainly to collect primary data, reports typically include processed or aggregated data. The format of the report, and the data required, is driven by the types and frequency of the decisions to be made, based on the report. Generally speaking, reports will include consolidated or aggregated consumption, stock on hand, and losses and adjustments. These data will be transmitted from the lower levels to the upper levels of the supply chain. Because of the link between inventory management and LMIS, many systems use a combined LMIS report and order or request form. The advantage of combining the reporting and ordering functions using the same form is that the data for calculating the order are readily available on the form. If the inventory system is a pull system, the person completing the report calculates the order; if it is a push system, the order quantity can be calculated and completed by the supplying facility, using the information in the report. Experience from other programs has shown that linking reporting and ordering encourages timely submission of reports. In addition to the reports that move up the system, feedback reports are often used to provide information from the higher to the lower levels of the system. In this way, lower-level facilities can gain an appreciation of how the work they do fits within the overall system and see how lower-level operations can be improved. Assuming that ARV drug or HIV test pipelines are shorter than the pipelines used for moving other kinds of commodities, as was recommended in the earlier Inventory Control System, the amount of data aggregation will be reduced. This will also reduce the risk of introducing errors into the reporting system and will help to ensure that data continue to move regularly and rapidly through the system. AVAILABILITY OF DISAGGREGATED DATA As data move from the lower levels to the upper levels, some data elements may be aggregated. For instance, a team of service providers at a facility may submit a total figure at the end of the month that shows the number of drugs dispensed. In this case, the facility would report only the total number, not the number of drugs dispensed by each individual service provider. As the data move higher through the system, however, care must be taken to ensure that upper-level decision makers have access to disaggregated data, because this data are needed for their decision making. For instance, it might be useful for ART or VCT/PMTCT program managers to know the total of all products and/or regimens dispensed in all sites/facilities, or the total quantity of products held at all sites/facilities. But for purposes of supervising the logistics system and overseeing distribution of products among the districts, the program managers would need to have the data disaggregated by service delivery point (SDP). Refer to The Logistics Handbook for more a complete description and additional discussion of logistics management information systems. LOGISTICS MANAGEMENT INFORMATION SYSTEMS 11 12 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS SPECIAL CHARACTERISTICS OF ARV DRUGS AND HIV TESTS THAT AFFECT THE DESIGN AND IMPLEMENTATION OF A LOGISTICS MANAGEMENT INFORMATION SYSTEM While an uninterrupted supply of commodities is desirable for all health programs, ARV drugs and HIV tests present unique challenges. Unlike some other medicines, one ARV cannot easily be substi­tuted for another. In addition, the requirement that different ARVs be used in specifi c combinations necessitates that these products be monitored both separately and in combination. Furthermore, ART cannot be interrupted and continued later due to the unavailability of drugs. Any failure in the supply chain to make ARVs and related supplies available at all times could lead to catastrophic outcomes, including death, treatment failure, and development of drug resistance. Like ARV drugs, there are no substitutes for HIV tests after specifi c testing protocols have been established for each test purpose; chase buffer from one test kit cannot be used with a diff er­ ent kit. An HIV test protocol may require the use of up to three different tests, all of which must be available to provide clients with reliable test results. ISSUES OF PARTICULAR CONCERN IN ARV DRUG AND HIV TEST MANAGEMENT, ALL REQUIRING ACCURATE AND TIMELY INFORMATION • need for simultaneous and uninterrupted availability at service delivery points of multiple products with diff er­ ent shelf lives from different suppliers to provide quality ART and HIV testing services • higher levels of accountability, including special reporting or other documentation requirements from either donors or manufacturers • greater potential for redistribution of products from one facility to another. ISSUES OF PARTICULAR CONCERN IN ARV DRUG MANAGEMENT, ALL REQUIRING ACCURATE AND TIMELY INFORMATION • continued uninterrupted resupply for patients already on antiretroviral therapy (ART) • special ordering and information requirements for second line and alternate drug treatments, if these drugs are not kept routinely at the service site. SPECIAL CHARACTERISTICS OF ARV DRUGS AND HIV TESTS 13 ISSUES OF PARTICULAR CONCERN IN HIV TEST MANAGEMENT, ALL REQUIRING ACCURATE AND TIMELY INFORMATION: • ensured supply of all tests and test-related consumable supplies for testing protocols • kit contents and packaging considerations (e.g., number of tests per kit, inclusion of chase buff er, diff erent expiration dates for tests and buff er) • testing protocols (serial and parallel testing). As with the inventory control system, it may not be possible to fully integrate the LMIS used to manage ARV drugs and HIV tests with the LMIS used to manage other health commodities. Certainly, a vertical system for managing ARVs, or a vertical system for managing HIV tests, would require its own vertical LMIS. At the program management level, for program planning, quantification, and procurement planning, often addi­ tional, nonessential logistics information may be needed for effective decision making. This additional information cannot be compiled from logistics data, but must come, instead, from patient and program data that should be collected routinely through the health management information system (HMIS) established for the HIV/AIDS program. Ideally, logistics managers should have access to information available through the HMIS to facilitate program planning and routine supervision. However, in the absence of a well-functioning HMIS, some (but not all) of these data elements should be collected through the LMIS. Following is a sample list of the types of additional information useful to logistics managers for program planning. Some of the information comes from primary data and some is calculated from primary data. ADDITIONAL INFORMATION USEFUL FOR ART PROGRAM MANAGEMENT: • number of patients who access ART services and receive drugs • ARV combinations and regimens • changes in overall use of regimens over time (calculated data) • rates of patients substituting single drugs due to toxicity or weight gain (calculated data) • rates of patients switching regimens (calculated data) • changes in pediatric regimen due to weight gain, intolerance, toxicity, or treatment failure • number of sites that dispense ARVs • number of patients on each regimen at each facility • correlation between the number of patients and the quantities of drugs being consumed. ADDITIONAL INFORMATION USEFUL FOR HIV TESTING PROGRAM MANAGEMENT: • number of clients/patients who access VCT or PMTCT services and are tested • number of tests used, by purposes of use, brand, and use of test • accounting for test-related supplies. 14 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS RECOMMENDATIONS FOR ARV DRUG AND HIV TEST LOGISTICS MANAGEMENT INFORMATION SYSTEM DESIGN AND IMPLEMENTATION 1. LINK ROUTINE REPORTING TO COMMODITY ORDERING There are many benefits to linking routine reports to commodity orders. For example, a system with monthly reporting and monthly ordering has inherent advantages over a system with monthly reporting and quarterly ordering. Often, commodity managers may ignore reporting that does not produce a tangible benefit or result, which is in this case, receiving commodities that result from an order linked to a report. Other advantages to link­ ing reporting and ordering are— • Supervisors can verify more easily that order quantities are realistic, using the data that are reported (consump­ tion, stock on hand, number of patients by treatment regimen). • Commodity managers will not focus on orders to the exclusion of reports. • The relationship between the data in the reports and the commodity orders is reinforced; reported data are used for decision making. While some might argue that “no report, no commodities” would penalize nonreporting facilities, it is crucial to remember that the data contained in the reports drive the entire system and ensure adequate commodity orders and procurement for the entire country. Facilities that do not submit their reports regularly and on time jeopar­ dize commodity availability and the system as a whole and, therefore, quality of care. Given the public health risks associated with treatment interruption of ART, linking ordering and reporting has proven to be an acceptable solution. However, policymakers or relevant authorities should always be involved in approving this decision. See the illustrative forms, LMIS Report and Request for Antiretroviral Drugs and LMIS Report and Request for HIV Tests, in the annex. 2. AVOID OVERBURDENING THE LMIS BY COLLECTING SERVICE STATISTICS OR OTHER DATATHAT DO NOT HAVE A DIRECT BENEFIT TO MANAGING COMMODITIES. Other data that are not required for logistics purposes may be included in the LMIS for HIV tests or ARVs, depending on the needs of the particular program’s existing information systems and logistics system design. Th e LMIS may be required to capture additional types of data, such as service statistics and epidemiological data, which are often needed by different HIV/AIDS program managers. These types of data can ultimately help in making logistics-related decisions, such as forecasting. Reporting formats should not collect any data that do not benefit commodities management. 3. ALWAYS COLLECT AND REPORT DISPENSED-TO-USER DATA FOR ARVS AND USAGE DATA FOR HIV TESTS; ISSUES DATA SHOULD NOT BE USED AS A PROXY. While the use of issues data as a proxy for dispensed-to-user or usage data may be acceptable in general essential medicines programs, the level of rigor and accountability required in ART programs makes this practice unaccept­ able for ARV drug and HIV test management. In addition, concerns for the security of ARVs and HIV tests from a therapeutic, safety, and financial perspective impose greater demands for accountability. SPECIAL CHARACTERISTICS OF ARV DRUGS AND HIV TESTS 15 4. REFRAIN FROM ALTERING THE CONTENT AND FORMATTING OF THE LMIS TO ACCOMMODATE THE FUNDING MECHANISM. The landscape of supply chain management for ARVs and HIV tests is marked by the presence of multiple donors operating with different agendas, program objectives and goals, and reporting requirements. These often compet­ ing agendas may put pressure on the respective LMIS used to manage the products, with the contents or data items included on the LMIS determined by the funding mechanism. However, aside from the few exceptions noted above, the logistics data needed to run a system does not change significantly over time: logistics data are logistics data. However, funding mechanisms constantly change. If an LMIS is designed to respond to the needs of one donor, it will need to change if that donor withdraws support and is replaced by another. Data collected on the LMIS forms should suit the particular program needs and be used for decision making; they should not, however, be dictated by individual donor requirements. If funding mechanism reporting requirements are so specific as to require additional data or information, then those data or that information should be collected and reported separately, not within the LMIS used for commodity management. 5. QUANTITIES TO ISSUE OF ARV DRUGS AND HIV TESTS SHOULD BE CONVERTED FROM UNITS TO PACKS ATTHE ISSUING LEVEL, NOT ATTHE ORDERING LEVEL. Programs frequently procure drugs from multiple suppliers. Thus, pack sizes of drugs and HIV tests frequently change. Depending on the number of funding and procurement sources that exist in a program, a central ware­ house can have multiple brands of the same ARV drug in stock at the same time, some of which may be packaged in different pack sizes. In a pull system, where facilities calculate order quantities and send these to the issuing facilities, it is strongly recommended that the ordering quantities be recorded and submitted as basic units (e.g., tablets, capsules, individual number of tests). This will allow the issuing facilities to convert the units into pack sizes based on what they have in stock and following sound warehouse practices (such as fi rst-to-expire [FEFO]). Also, this is likely to reduce errors that might occur if the issuing facility received orders in inappropriate pack sizes, had to convert them back into units, and then reconvert them into packs based on their existing stocks. RECOMMENDATIONS FOR ARV DRUG LOGISTICS MANAGEMENT INFORMATION SYSTEM DESIGN AND IMPLEMENTATION 1. IN ADDITION TOTHE THREE ESSENTIAL LOGISTICS DATA ITEMS, LIMIT THE AMOUNT OF PATIENT DATATHAT ARE COLLECTED AND REPORTED;AND TRACK THE NUMBER OF NEW AND EXISTING PATIENTS BY TREATMENT REGIMEN. USE THESE DATA FOR DECISION MAKING. To make informed program-wide decisions related to commodity use—forecasting, scale-up of programs, or other medium- or long-term planning—commodity managers, program managers, and others at the higher levels require information on the number of patients/clients by regimen, in addition to the logistics data. These data may be collected through LMIS reports or other routine HMIS reports. Unlike other public health programs that strive to meet the needs of most if not all potential clients, ART programs usually can treat only a specified number of patients, so these data help managers monitor the numbers of patients Patient data may be best collected under treatment and changes in regimen over time and forecast quantities by ART service providers, rather required for future procurements. than by commodity managers. In this case, the service provider and the Therefore, it is necessary for the LMIS, which generally focuses exclu­ commodity manager have to work sively on logistics data, to also collect limited elements of patient data. To together to complete a single report correctly determine product resupply quantities, particularly when buff er that contains data from each. stocks are not maintained, LMIS reports should include the total number of products needed to treat patients, in addition to dispensed-to-user, 16 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS stock on hand, and losses and adjustments data. (See description below *It is vital to use average monthly con- and sample forms in the annex.) sumption when determining order quantities once such data are avail-For many health commodities, consumption is relatively stable over the able.This is particularly true in cases short term and may increase or decrease gradually over the long term. In where the dispensing protocol may such a situation, the three essential data items noted earlier are sufficient call for giving patients more than for making commodity management decisions. This would also be the a review period of supply. In such case for an established ART program using a forced ordering max-min cases, month-to-month consump­ system with frequent resupply and sufficient levels of safety stock for tion will vary greatly, and the average all drugs required. For example, with monthly ordering, a two-month consumption must be captured. maximum stock level should provide enough stock to serve existing and Conversely, if you are only using the new patients. previous review period dispensed to user, and not an average, then Using logistics data alone within the max/min system, and assuming you cannot give more than a review monthly reorders and a three-month maximum stock level (one month of period worth of stock to patients, as dispensing stock, one month of lead time stock, and one month of buff er doing so would lead to stockouts. stock against uncertainty), order quantities would be determined using the standard formula, as follows: Quantity to Order = (Average Monthly Consumption* x 3) – Stock on Hand In a rapidly expanding program, however, the addition of new patients may exceed the system’s capacity to main­ tain adequate stock levels. For example, if a program is more than tripling the number of patients on ART each month, then a three-month max calculated using average monthly consumption over the past three to six months would not be enough to maintain product quantities for new patients. One strategy is simply to increase the maxi­ mum and minimum stock levels (add an additional two or three months of additional buff er against uncertainty). This may be a difficult solution in some countries because of the high additional cost this would entail. Another strategy—considering the patient data—combines logistics data with patient data to determine reorder require­ ments. In this case, patient-related data, specifically the estimated number of new patients by treatment regimen for the next month, is required. After the estimated number of new patients is known, then the drug requirements for those new patients can be determined and added to existing dispensed-to-user logistics data for calculating order quantities. Using patient data combined with logistics data, and assuming monthly reordering with a three-month maximum stock level (one month dispensing stock, one month lead time stock and one month safety stock), order quantities would be determined using the following formula: Quantity to Order = (Consumption* x 3) + (Quantity required for new patients x 3) – Stock on Hand In a situation when a program cannot fund normal levels of safety stock, then the minimum (and maximum) stock levels must be reduced. For example, a program may decide to use a two-month maximum instead of three months. This would provide enough stock for one month of consumption, three weeks of lead time stock, and a one-week safety stock. Using patient data combined with logistics data, order quantities would be determined using the following formula: Quantity to Order = (Consumption* x 2) + (Quantity required for new patients x 2) – Stock on Hand SPECIAL CHARACTERISTICS OF ARV DRUGS AND HIV TESTS 17 Note: In this example, with a two-month maximum (one month of dispensing stock + one month of lead time and safety stock); lead time must be three weeks or less. This example is referenced in the sample LMIS forms in the annex. It should be noted that the combined use of logistics data and patient data results in a much more complicated set of calculations to determine resupply quantities. If patient data is being used to project reorder quantities, then it is strongly recommended that a computerized system be used to make those calculations. Further, if a computer­ ized system is being used, then it is likely to be used more effectively in a pull system situation. 2. IF PROGRAM REPORTING CAPTURES ESTIMATES OF NEW PATIENTS, PROVIDE WORKSHEETS TOTRANSLATE PATIENT NUMBERS INTO PRODUCT NUMBERS. In addition to the three types of logistics records mentioned earlier, an LMIS for ARVs might include a register or other record specifically designed to collect patient information, such as number of patients per treatment regi­ men, that will provide the additional patient information required to manage ARV drugs. Logistics data collected through an LMIS for ARV drugs come from basic logistics records, such as stockcards and dispensing logs. The information from those sources reflects only past consumption/product use. To estimate future quantities of products needed, during the next order cycle, for instance, facility staff will need to trans­ late the number of patients who will be served into the quantities of products that will be needed to serve those patients. For this purpose, it is suggested that a worksheet be developed and implemented that guides service personnel in calculating those product quantities. The worksheet would include the number of new patients by treatment regimen and a mechanism for determining the number of drugs required for each regimen and for calculating the total quantity of each drug needed for all expected new patients. This information would then be transferred to the report and order form. (See the annex for a sample worksheet, Worksheet for Calculating Monthly ARV Drug Orders for Estimated New ART Patients.) In addition to being a useful tool for ordering, the worksheet can be used for monitoring and supervision. Peri­ odically, program managers can use the worksheet to monitor ARV drug use by cross-checking and comparing the number of patients being served and the quantities of products being requested. Because some drugs are used in multiple regimens, the worksheet could also aid program managers in monitoring prescribing and dispensing protocols. 3. SELECT AND CONSISTENTLY USE ONE UNIT FOR RECORDING DRUGS. As with all drugs and other medical supplies, data collected on LMIS records (dispensing registers, stockcards, etc.) should be recorded in the smallest unit distributed to clients. For most drugs the recorded numbers repre­ sent numbers of tablets or capsules. Because of the large volumes of drugs dispensed to treat HIV, if an ART program is consistently dispensing drugs to patients as full bottle amounts (i.e., one bottle of syrup or Zerit is packaged in bottles of 56 tablets, while generic ver­ one bottle of tablets is equivalent to a one-month sions of stavudine are packaged in bottles of 60 tablets. All supply), and the package quantities will not be other drugs used in combination with stavudine to make a changing, then the bottle can be chosen as the unit full regimen (such as efavirenz, lamivudine, and nevirapine) are also packaged in bottles of 60 tablets. A program that for recording. only tracks number of bottles would run the risk of pa- However, standard logistics practice uses the small- tients receiving four fewer tablets per month in a regimen. Similarly, when new patients are started on a nevirapine­ est possible unit (tablet, capsule, ml, etc.), and based regimen, they only receive half the standard dose the program should seriously consider following to test for toxicity and thus receive 14 or 15 tablets for that practice, given that bottle quantities vary by their first two weeks instead of the full bottle of 30 tablets. supplier and can change over time. This is particu- Tracking by bottle would make it difficult to account for larly important when tracking of paediatric solu- this dispensing practice. 18 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS tions. For example, nevirapine oral suspension is available in 20 ml, 100 ml, and 200 ml bottle sizes. If all bottle sizes are stocked at the central warehouse and supplied based on what is in stock, and if LMIS reports only capture logistics data by bottle, tracking usage and calculating resupply quantities will be difficult, if not impossible. Track­ ing liquids using ml as the basic unit will allow resupply calculations to be made accurately, while considering bottle sizes in stock. The important point is that the recording unit is consistent, and that it is known and used by all program personnel. 4. SEPARATE CLINICAL/PROGRAM INFORMATION USED FOR PROGRAM MONITORING FROM LOGISTICS AND PATIENT DATA COLLECTED FOR LOGISTICS DECISIONS. As discussed earlier, when managing ARV drugs, some patient data are needed to inform resupply and other commodity management decisions. Such data, however, are often not readily available through an HMIS or other information/data-gathering system. Thus, the tendency might be for the burden to fall to the LMIS to collect and report such data regularly and frequently. It is tempting to use the LMIS to collect other patient or program data; it is simple to add additional data collec­ tion columns to the LMIS forms and reports. However, doing so can easily create situations where the logistics data are lost, either by having reports pass through program managers before going to commodity managers or by making the data collection process so cumbersome that the logistics information is no longer collected and reported in a timely way. In any case, there is the risk that collected data are not available or used for resupply, which is the main purpose of the LMIS. Certainly, it is important to collect and use information on aspects of the ARV program aside from commodity management, such as monitoring patient adherence to their treatment regimens, toxicity rates, rates of fi rst line drug resistance, and so forth. However, a separate system should be used for collecting and using this informa­ tion. In fact, medical or program personnel should be monitoring these aspects of the program through their own reporting mechanisms not logistics/commodity managers through the LMIS. RECOMMENDATIONS FOR HIV TEST LOGISTICS MANAGEMENT INFORMATION SYSTEM DESIGN AND IMPLEMENTATION 1. IN ADDITION TOTHE THREE ESSENTIAL LOGISTICS DATA ITEMS, LIMIT OTHER DATA COLLECTED AND REPORTED THROUGH THE LMIS;AND TRACK USAGE OF HIV TESTS BY PURPOSE, BRAND, AND USE OF THE TEST. HIV tests can have multiple purposes of use: for PMTCT, clinical diagnosis, VCT, and blood safety, among others. In some countries, health workers manage separate registers for different purposes of testing and then aggregate each of these registers to report on a total number of HIV tests dispensed, according to purpose. Th e LMIS for HIV tests may be used to track quantities of HIV tests used by purpose, brand, and use of the test. Capturing these data has signifi cant benefits for program management, especially for monitoring program expan­ sion and forecasting future needs. The information is also useful from a supply chain management point of view. The donation or procurement mechanisms for each of the testing purposes may vary, and maintaining purpose of use data can help determine individual requirements during forecasting and with separate reporting requirements. Also, experience has shown that the information summarized by use of test (i.e., screening, confirmation, etc.) can be very beneficial for resup­ ply, especially in rapidly expanding programs. These programs may experience supply imbalances, which could force facilities to use non-standard tests to obtain HIV test results. For example, if facilities have been stocked out of screening or confirmatory tests and have substituted the tie-breaker for that reporting period, the program manager can use the number of tests used for screening, confirmation, and tie-breaker rather than the number of SPECIAL CHARACTERISTICS OF ARV DRUGS AND HIV TESTS 19 tests by brand to ensure correct supplies of each brand are issued after the In Ghana, there are separate ledgers for each purpose (VCT, PMTCT, qual- supply situation is corrected. ity control, etc.) for HIV testing.The Logistics data can also be supplemented by a limited amount of patient information from the ledgers is used to complete summary reporting. data. The availability of such data can tend to increase the accountability of the number of HIV tests used. Additionally, such data can contribute to long-term forecasting by showing trends in proportions by purpose, such as VCT, PMTCT, or clinical diagnosis. However, capturing data other than logistics data—for example, the numbers of clients served—is a decision that program managers should make; but the program managers must recognize that limited data should be collected to avoid making the system cumbersome or unwieldy. Data should never be collected if it will not be used for decision making. See the forms in the annex, Daily Log for Usage of HIV Tests and LMIS Report and Request for HIV Tests. 2. USE THE INDIVIDUAL TEST AS THE UNIT FOR RECORDING. Logisticians and program managers must agree on the unit of recording used to manage HIV tests based on kit contents and packaging. It is recommended that the HIV tests be recorded by test, rather than by kit. Also when a site is stocked out of its preferred screening test, it may use another brand temporarily to screen clients until the original brand is resupplied. For example, a facility may use a low number of HIV tests but be unable to use an entire HIV test kit (which may include 100 tests) before the tests expire or the facility stocks out of chase buff er but still has several tests left. The facility does not need an entire test kit, just more chase buffer. In either case, the commodity manager needs specific information on the number of tests, not the number of kits, to take the appro­ priate action. This is only possible when the unit of tracking is the test, not the kit. 3. MANAGE TEST-RELATED SUPPLIES THROUGH THE EXISTING SYSTEM FOR LABORATORY SUPPLIES. One common challenge regarding test-related supplies is managing reagents and other consumable laboratory supplies, such as lancets, pipettes, blood collection devices, and gloves. Tracking such supplies, which are used in HIV testing separately from those used for other purposes, would demand more time from service providers, create more room for error, and not provide significant program benefi ts. The only exception would be if there is no established supply chain for laboratory consumables. In this case, such products could be included in the LMIS for HIV tests to ensure their availability for HIV testing. Refer to The Guidelines for Managing the Laboratory Supply Chain for a more complete description. 20 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS STORAGE AND DISTRIBUTION OF ARV DRUGS AND HIV TESTS PURPOSE OF STORAGE AND DISTRIBUTION The purpose of a storage and distribution system is to ensure the physical integrity and safety of products and their packaging as they move from the central storage facility to service delivery points and into the hands of the clients/patients. A sound storage and distribution system will help ensure that products reach the client in usable condition, with a minimal loss or waste. Proper storage procedures help ensure that storage facilities issue only quality products and that there is little or no waste due to damaged or expired products. When all levels of the pipeline follow appropriate storage and distribu­ tion procedures, clients can be assured that they In Kenya, the National AIDS program began with a distribu- have received a quality product. tion system of delivery straight from the central level to the service delivery point.Two years into the program, as Acceptable storage facilities (warehouses, storage more than 90 sites were on board and transportation and rooms) are clean and secure, and adequate distribu­ resources had trouble coping, the system was redesigned to tion systems have dependable and secure delivery introduce delivery from the central to the district level, with vehicles. It is desirable for the pipeline to be as short the service delivery points collecting from the districts. as possible. In the context of storage and distribu­ tion, a shorter pipeline can have a positive infl uence on the security and quality of the products being distributed. Having fewer levels in a system means fewer stor­ age points and fewer instances of transporting products. Limiting the number of times products are transported reduces opportunities for product damage to occur. There are also fewer people handling the products, which can help to increase accountability and minimize loss, damage, and pilferage. PACKAGING While the major focus in storage and distribution is on the products being moved, the packaging of the product should also be considered. The packaging provides the primary protection to the product during storage and trans­ portation. The quality of the packaging should be specified during procurement, and suffi cient, sturdy packaging materials should be available for repackaging products for distribution to lower-level facilities. For protection, products should remain within their sealed outer cartons and/or inner boxes during distribution. To ensure that happens, products should be ordered and issued to the nearest packing unit quantity. For example, if 48 items are required, and 50 items are in an inner box, then 50 should be ordered and distributed. Packaging should be labeled clearly with complete product information, including the expiration date. GENERAL GUIDELINES FOR STORAGE OF HEALTH COMMODITIES ARVs and HIV tests should be stored according to a standard set of guidelines that are applicable to all health commodities. Well-functioning warehouses and storerooms at various levels will have suffi cient space, acceptable storage conditions, explicit quality assurance mechanisms, and adequate security for the products, and must follow standard storage procedures. Refer to The Logistics Handbook for more a complete description and additional discussion of standard storage guidelines for health commodities. STORAGE AND DISTRIBUTION OF ARVS AND HIV TESTS 21 GENERAL GUIDELINES FOR DISTRIBUTION OF HEALTH COMMODITIES Health commodities can usually be distributed in one of two ways: a pickup system, where the lower level comes to the supplying facility, or a delivery system, where the upper-level supplying facility brings the products to the lower-level receiving facility. Regardless of the type of distribution mechanism, transportation must be available whenever it is needed to fi ll regular or emergency orders. This is particularly important in a situation where vehicles are shared for multiple purposes, such as commodity delivery and supervisory visits. In a shared system, supervisory visit activities could take precedence over commodity delivery, which could delay the movement of commodities and could result in stockouts at the receiving facility. To the extent possible, dedicated vehicles should be available to transport products. For all products, procedures should be in place to monitor and document the movement of commodities from the upper levels to the lower levels. The following actions should be completed at each distribution/receipt: • Verify the type and quantity of products shipped and received. Never distribute products that are • Conduct visual inspection, including expiration dates, for quality assurance. soon to expire and that will not be used before the expiration date. Not only do facilities (or even customers) • Complete and sign transaction records/vouchers. receive unusable products, money and resources are also wasted in • Store the products. shipping, storing, and handling unus­ able products. • Update stock-keeping records. SPECIAL CHARACTERISTICS OF ARV DRUGS AND HIV TEST KITS THAT AFFECT STORAGE AND DISTRIBUTION As with the design and implementation of the inventory control and logistics management information systems, certain characteristics of ARV drugs and HIV tests, and how they are used, will also affect the methods used for storage and distribution of these commodities. These characteristics include— • short shelf life, ranging from six to 24 months • high price • high value in prolonging survival for AIDS patients • necessity for cool storage • limited number of sites authorized to use these products • other commodities needed for administration • use in specific combinations with other drugs. In some cases these special characteristics may require implementation of a unique procedure for handling ARV drugs or HIV tests, but in other cases all that is required is a higher level of attention to or emphasis on existing procedures. This may be particularly true if ARV drugs or HIV tests are managed within an integrated system. • ARVs are particularly sensitive to moisture. In addition to storing them in a dry, well-lit, well-ventilated store­ room, out of direct sunlight, ARVs should not be opened to repackage them. 22 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS • Treat ARVs and HIV tests as you would narcotics and controlled substances: provide a secure storage area with controlled and continuous access. • Maintain cool storage (2 to 8° Celsius; 36 to 46° Fahrenheit) and cold storage facilities, including cool chain and cold chain, as required. • Store commodities to facilitate fi rst-to-expire, first-out (FEFO) procedures and stock management. • Separate damaged, expired, and soon-to-expire commodities from usable commodities, remove them from inventory immediately, and dispose of them using established procedures. Do not issue commodities that could expire before they are distributed to and used by the client. An additional consideration for ARV drug and HIV test distribution is the increased pressure on the transporta­ tion system, due to— • lower safety stocks • more frequent resupply cycle • deliveries to accredited sites only. RECOMMENDATIONS FOR STORAGE AND DISTRIBUTION OF ARV DRUGS AND HIV TEST KITS 1. WHENEVER POSSIBLE, INTEGRATE STORAGE AND DISTRIBUTION OF ARV DRUGS AND HIV TEST KITS. Integrating the storage and distribution of ARV drugs and HIV tests can help avoid duplication of activities and result in better use of limited resources. However, it is critical to ensure that integrating these products into an existing system also makes sense from overall program and product management concerns. The feasibility of oper­ ating a fully integrated system will depend on a number of factors, including— Management and reporting structure: If a program is charged with managing its own commodities (inventory control system) and reporting structure (LMIS), then it may make more sense to manage the storage and distribu­ tion of these products separately as well. This does not necessarily require establishing a completely separate stor­ age facility; it could be accomplished by delineating a specific section of an existing storage facility for ARV drugs and HIV tests. Number of facilities involved: If the number of facilities providing ART or HIV testing is relatively small compared to the number of facilities in the country, then moving products through an existing system may be counterpro­ ductive. For example, intermediary facilities (such as regional or district warehouses) would have to hold stock that would be distributed to very few facilities, lengthening the overall supply pipeline and adding to safety stock requirements. Available resources: If a program has obtained its own vehicles, then it may make sense to use those vehicles for product distribution, rather than relying on other shared vehicles. This is especially true if ARVs or HIV tests have different ordering intervals from other items stored at a facility. STORAGE AND DISTRIBUTION OF ARVS AND HIV TESTS 23 2. PROVIDE INCREASED LEVELS OF SECURITY DURING STORAGE. Due to the high value of ARVs and HIV test kits, higher levels of security are required for these commodities. Storage facilities should have— Locked storage area(s) within the warehouse or storeroom: Locked storage areas provide an extra level of security; not everyone who enters the storage facility has access to the ARVs or HIV tests. A locked room or vault, secure cage, or other structure, can be installed within the warehouse, or a locked cabinet or armoire can be installed in a smaller storeroom. If cool storage facilities are not already locked and tightly controlled, then a more secure area inside the cooler should be installed as well. The warehouse or storeroom itself should be robust in structure with no openings or weaknesses in the walls or roof that would allow easy entry after hours. Limited access to HIV/AIDS commodities: The number of people who are allowed to access the secure storage area should also be limited. However, systems must be in place to ensure that someone with access is always available for filling regular or emergency orders, even if the total number of people with access is limited. Higher level of accountability: Because of their high price and high value, ARV drugs and HIV tests should be treated as controlled substances. In most cases, procedures for controlled substances should include a second signa­ ture on the stockkeeping and transaction records for each stock movement. Requiring the signature of someone, in addition to the storekeeper, who is responsible for storing and distributing the product helps protect the product and the storekeeper. More frequent audits: Facilities that report and order monthly should automatically conduct physical inventory and verify stock-keeping records each month when the report is completed and the order is placed. For facilities that report less frequently, a monthly physical inventory or other audit of HIV/AIDS commodities should be conducted. 3. ENSURE INCREASED SECURITY DURING TRANSPORT. Transport should have the same level of security as the product in storage. Vehicles used to transport high-value commodities must be secure, with an enclosed bed and locking doors. For personal security, drivers should be equipped with radios and be in frequent communication with their dispatchers while on delivery. In some cases, depending on the quantities of commodities being transported, or past incidence of theft, it may even be necessary to provide armed guards or other supplemental security measures. 4. PAY SPECIAL ATTENTION TO FIRST-TO-EXPIRE, FIRST-OUT. Due to the short shelf life and high cost of ARV drugs and HIV tests, special care must be taken to follow fi rst-to-expire, fi rst-out (FEFO) Remember that expiration dates stock management and to monitor product expiration dates, to ensure are based on products being stored that products are used before expiration to reduce waste. In addition, under ideal storage conditions. If a commodity managers must take action immediately if there is a risk that facility does not maintain adequate storage conditions, products may be-products will expire before they can be used. Action may include return- come unusable before their posted ing the products to the supplying facility for redistribution or directly expiration date. transferring the products to a facility that can use them before they expire and notifying the procurement and program management units. 5. ENSURE PRODUCT INTEGRITY IF REISSUING RETURNED DRUGS. In an ART program, excess supplies of drugs may be returned by patients who have switched treatment regi­ mens, or by a patient’s family in the event of the patient’s death. Although pharmaceutical guidelines around drug contamination must be respected, in some programs, these drugs may be reissued to other patients. If reissuing 24 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS occurs, these drugs must first be inspected. If the product’s packaging shows no signs of tampering or damage, and if the product is not close to expiry, it can be reissued to another patient. 6. DELIVER ARV DRUGS AND HIV TESTS TO ACCREDITED SITES ONLY. ARV drugs and HIV tests should be distributed only to sites that are accredited or otherwise authorized for their use. This is easy to control in a vertical system; only authorized sites will be submitting orders for those products. In an integrated system, however, an extra level of control or oversight may be required. This may mean separate order forms for ARV drugs and HIV tests, which are only submitted by accredited facilities, or it may mean an extra signature by program personnel authorizing the order to be filled. Keep in mind, that there should not be so many controls in place—for example, extra signatures—that movement of the commodities is delayed. 7. CONSIDER USING PRIVATE OR OTHER COURIER/EXPRESS MAIL FACILITIES. Depending on the number of sites to which commodities are being delivered and other available resources, it can be advantageous to use local courier or express mail (post office, DHL) services to distribute ARV drugs. If the number of sites is extremely limited, it may be much less expensive to distribute products through these channels, rather than maintaining one or more vehi­ cles and the personnel needed to operate In Kenya, the National AIDS program has a contract with a them. However, keep in mind that couriers local courier service to deliver ARVs on an emergency basis and must also be able to maintain product safe- to receive and forward monthly reports and orders to the nation­ ty and follow security guidelines, including al program. The arrangement has worked well and has resulted cool storage for those products that require in greater than 90 percent reporting rates for LMIS reports for it. The program is responsible for monitor- ARV drugs, although resources have been dedicated for ongoing ing the performance of the couriers. monitoring of invoices and other required paperwork. 8. ENSURE THAT PRODUCTS USED TOGETHER ARE DISTRIBUTED TOGETHER. Some HIV tests come packaged with most, if not all, consumable supplies needed to run the tests. However, several available tests do not come equipped with the necessary supplies. ARV drugs must be used in certain combinations in a specific regimen. If one drug is missing from a regimen, no substitutions can be made, and the patient cannot be treated. In both cases, ideally, all necessary products are ordered to provide the services the customers need. ARV drugs should be ordered together to ensure the proper regimen can be used. It is essential that the entire complement of products ordered is distributed together, at the same time, so that services such as HIV tests and ART can be given immediately upon receipt. If a reliable supply chain already exists for laboratory consumables, including those used with HIV tests, then that supply chain can be used to order and distribute lab supplies. It is then the job of the service provider to ensure that all necessary supplies are available where and when services are provided. STORAGE AND DISTRIBUTION OF ARVS AND HIV TESTS 25 26 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS REFERENCES Attawell, Kathy, and Jackie Mundy. November 2003. Provision of Antiretroviral Therapy in Resource-Limited Set­ tings: A Review of Experience up to August 2003. Geneva: World Health Organization and the Department for International Development (DFID). Bates, Jim, Yasmin Chandani, Kathryn Crowley, John Durgavich, and Sandhya Rao. 2000. Implications of Health Sector Reform for Contraceptive Logistics: A Preliminary Assessment for Sub-Saharan Africa. Arlington, Va.: John Snow, Inc./Family Planning Logistics Management (FPLM) for the U.S. Agency for International Development. Department of Health, Cape Town, South Africa. March 2002. Prevention of Mother to Child Transmission of HIV: Full Protocol. Cape Town, South Africa: Department of Health, Provincial Administration of the Western Cape. FPLM. 2000. Implications of Health Sector Reform for Contraceptive Supply Chain: A Preliminary Assessment for Sub-Saharan Africa. Arlington, Va.: John Snow, Inc./FPLM for the U.S. Agency for International Development. The Global Fund to Fight AIDS, Tuberculosis and Malaria. May 2005. Guide to Global Fund’s Policies on Procure­ ment and Supply Management. Available at http://www.theglobalfund.org/pdf/guidelines/ pp_guidelines_procurement_ supplymanagement_en.pdf. Hirschhorn, Lisa, Andrew Fullem, Christopher Shaw, Wendy Prosser, and Marilyn Noguera. 2004. Tool to Assess Site Readiness for Initiating Antiretroviral Th erapy (ART). Boston, Mass.: John Snow Inc., for the U.S. Agency for International Development. International Drug Dispensary (IDA) HIV/AIDS Group. 2005. IDA: Price Indicator. Available at http://www. who.int/3by5/amds/IDAPriceJune_2005.pdf. John Snow, Inc./DELIVER. 2001. Frequently Asked Questions: Logistics and Supply Chain Management of HIV Test Kits. Arlington, Va.: John Snow, Inc./DELIVER, for the U.S. Agency for International Development. John Snow, Inc./DELIVER. 2002–2004. HIV/AIDS Country Assessment Questionnaires used in Uganda, Zimbabwe, Ghana, Tanzania, and Nigeria (Internal). Arlington, Va.: John Snow, Inc./DELIVER, for the U.S. Agency for International Development. John Snow, Inc./DELIVER. 2003. Guide for Quantifying HIV Test Kits. Arlington, Va.: John Snow, Inc./ DELIVER, for the U.S. Agency for International Development. John Snow, Inc./DELIVER. 2003. ProQ: Quantifi cation Software for HIV Tests. Arlington, Va.: John Snow, Inc./ DELIVER, for the U.S. Agency for International Development. John Snow, Inc./DELIVER. 2003. ProQ Software User’s Manual. Arlington, Va.: John Snow, Inc./DELIVER, for the U.S. Agency for International Development. John Snow, Inc./DELIVER. 2004. HIV Test Kit Selection: Operational Consideration for VCT and PMTCT Services. Arlington, Va.: John Snow, Inc./DELIVER, for the U.S. Agency for International Development. John Snow, Inc./DELIVER. 2004. Importance of Logistics in HIV/AIDS Programs: Central Information Systems. Arlington, Va.: John Snow, Inc./DELIVER, for the U.S. Agency for International Development. REFERENCES 27 John Snow, Inc./DELIVER. 2004. Importance of Logistics in HIV/AIDS Programs: Financing and Procurement 2004. Arlington, Va.: John Snow, Inc./DELIVER, for the U.S. Agency for International Development. John Snow, Inc./DELIVER. 2004. Importance of Logistics in HIV/AIDS Programs: Human Capacity for Logistics. Arlington, Va.: John Snow, Inc./DELIVER, for the U.S. Agency for International Development. John Snow, Inc./DELIVER. 2004. Importance of Logistics in HIV/AIDS Programs: Logistics Management Informa­ tion Systems. Arlington, Va.: John Snow, Inc./DELIVER, for the U.S. Agency for International Development. John Snow, Inc./DELIVER. 2004. Importance of Logistics in HIV/AIDS Programs: No Product? No Program (Over­ view). Arlington, Va.: John Snow, Inc./DELIVER, for the U.S. Agency for International Development. John Snow, Inc./DELIVER. 2004. Importance of Logistics in HIV/AIDS Programs: Warehousing and Consolidated Shipping. Arlington, Va.: John Snow, Inc./DELIVER, for the U.S. Agency for International Development. John Snow, Inc./DELIVER. 2004. Importance of Logistics in HIV/AIDS Programs: Warehousing and Distribution. Arlington, Va.: John Snow, Inc./DELIVER, for the U.S. Agency for International Development. John Snow, Inc./DELIVER. 2004. The Logistics Handbook: A Practical Guide for Supply Chain Managers in Family Planning and Health Programs. Arlington, Va.: John Snow, Inc./DELIVER, for the U.S. Agency for Interna­ tional Development. John Snow, Inc./DELIVER. 2004. Logistics System Assessment Tool (LSAT). Arlington, Va.: John Snow, Inc./ DELIVER, for the U.S. Agency for International Development. John Snow, Inc./DELIVER. 2004. Supply Chain Management of Antiretroviral Drugs: Considerations for Initiating and Expanding National Supply Chains for ARV Drugs. Arlington, Va.: John Snow, Inc./DELIVER for the U.S. Agency for International Development. John Snow, Inc./DELIVER. 2005. ARV Fact Sheets. Arlington, Va.: John Snow, Inc./DELIVER, for the U.S. Agency for International Development. John Snow, Inc./DELIVER. 2005. HIV Test Fact Sheets. Arlington, Va.: John Snow, Inc./DELIVER, for the U.S. Agency for International Development. John Snow, Inc./DELIVER. 2005. Inventory Building Blocks for Inventory Management of HIV Tests and ARV Drugs: Inventory Control System, LMIS, and Storage and Distribution. Arlington, Va.: John Snow, Inc./DELIVER, for the U.S. Agency for International Development. John Snow, Inc./DELIVER. 2005. Logistics Indicators Assessment Tool (LIAT). Arlington, Va.: John Snow, Inc./ DELIVER for the U.S. Agency for International Development. Médecins Sans Frontières (MSF). June 2005. Untangling the Web of Price Reductions: A Pricing Guide for the Purchase of ARVs for Developing Countries. Available at www.accessmed.msf.org/documents/ untanglingtheweb%208.pdf. Office of the Press Secretary of the White House. 2003. “Fact Sheet: The President’s Emergency Plan for AIDS Relief.” White House, Washington D.C. Available at http://www.whitehouse.gov/news/releases/2003/01/ 20030129-1.html. Uganda Ministry of Health. 2004. Draft Report on Workshop for ART Centres: November 19 – 2, 2003. Kampala, Uganda: Ministry of Health. UNAIDS. June 2002. “HIV Voluntary Counselling and Testing: a gateway to prevention and care.” UNAIDS Best Practice Collection. http://data.unaids.org/Publications/IRC-pub02/JC729-VCT-Gateway-CS_en.pdf. (accessed March 2006). 28 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. May 2004. Guidance for Industry: Fixed Dose Combination and Co-Packaged Drug Products for Treatment of HIV. Washington, D.C.: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. U.S. Government. The President’s Emergency Plan for AIDS Relief. January 2003. Available at http://www.white­ house.gov/news/releases/2003/01/20030129-1.html. World Bank. June 2004. Battling HIV/AIDS. World Bank Guide to the Procurement of HIV/AIDS Medicines and Related Supplies. Available at http://siteresources.worldbank.org/INTPROCUREMENT/Resources/Technical- Guide-Procure-HIV-AIDS-Meds.pdf. World Bank. June 2004. HIV/AIDS Medicines and Related Supplies: Contemporary Context and Procurement. Tech­ nical Guide. Washington, D.C.: World Bank. Available at http://siteresources.worldbank.org/ INTPROCUREMENT/Resources/Technical-Guide-Procure-HIV-AIDS-Meds.pdf. World Health Organization. 2001. Blood Transfusion Safety (BTS). Screen all donated blood for infectious agents. Available at http://www.who.int/bct/Main_areas_of_work/BTS/Blood%20Screening.htm. World Health Organization. 2001. Guidelines for Using HIV Testing Technologies in Surveillance: Selection, Evalua­ tion, and Implementation. Available at WHO/CDS/CSR/EDC/2001.16 or UNAIDS/01.22E. World Health Organization. 2002. HIV/AIDS Drugs and Diagnostics of Acceptable Quality. Available at http:// www.who.int/medicines/organization/par/edl/access-hivdrugs.shtml World Health Organization (WHO). 2003 (Revision). Scaling Up Antiretroviral Therapy in Resource-Limited Set­ tings: Treatment Guidelines for a Public Health Approach. Geneva: WHO. World Health Organization (WHO). 2003. Treating 3 million by 2005: Making it Happen. Th e WHO Strategy. The WHO and UNAIDS Global Initiative to provide antiretroviral therapy to three million people with HIV/AIDS in developing countries by the end of 2005. WHO, UNAIDS, UNICEF, UNFPA, supported by World Bank. Access to HIV/AIDS Drugs and Diagnostics of Acceptable Quality. Procurement, Quality and Sourcing Project. Available at http://mednet3.who.int/prequal/ documents/prodmanuf/hiv_suppliers.pdf. REFERENCES 29 30 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS ANNEXES 1. CASE STUDY 2. SAMPLE LMIS RECORDS AND REPORTS 3. JOB AIDS ANNEX 31 32 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS KAAMANLAND HIV/AIDS PROGRAM ARV DRUG AND HIV TEST SUPPLY CHAINS: A CASE STUDY This case study describes the supply chains for ARV drugs and HIV tests for the HIV/AIDS program in the imagi­ nary country of Kaamanland, and it provides a context in which to review the records and reports that follow. While Kaamanland is imaginary, the supply pipeline, inventory control system, and logistics management infor­ mation system (LMIS) described are based on actual management systems to which DELIVER provides assis­ tance. The following pipeline diagrams and LMIS forms illustrate recommended inventory control and LMISs and are consistent with the recommendations of this document. KAAMANLAND ART PROGRAM AND SUPPLY CHAIN In Kaamanland, antiretroviral therapy (ART) is currently provided in 14 ART sites—the national teaching hospi­ tal and regional hospitals. Within the next year, ART services will be expanded and available through accredited district hospitals. At that point, ART will be available at 60 sites. ARV drugs are procured internationally by the Ministry of Health and are donated by international donors. Fore­ casting and quantification are done by program management. ARV drugs are stored in the central medical stores, which deliver drugs directly to ART sites monthly. The inventory control system is a pull system that uses forced ordering maximum-minimum. ARV drugs are stored with other essential drugs in the central medical stores, but distribution of ARV drugs is not integrated with any other health commodity distribution. ART sites use the ART Daily Activity Register to record the quantity of each drug given to patients in the dispens­ ing area. Stockcards are used to record stocks received and issued, losses and adjustments, and stock on hand for ARV drugs stored at the service site. At the end of each month, the ART service provider together with the therapeutic committee look at their existing ART patient profile and determine the number of new patients who will be starting ART the following month. They record this information on the Monthly Summary Report of ART Patients and use the new patient information from that report to complete the Worksheet for Calculating Monthly ARV Drug Orders for Estimated New Adult ART Patients, which calculates the quantity of each ARV drug needed for the new patients for the next month. The ART service provider uses the records, report, and worksheet to complete the LMIS Report and Request for Antiretroviral Drugs. The report and request is sent to the data-processing center of the Ministry of Health, where the information is compiled with reports from other ART sites. Within two days of receipt, the compiled orders are sent to the central medical stores for processing and delivery, and reports on ART sites and central warehouse activities are sent to program management for action as needed. Program managers use current information on ANNEX 33 national stock status and consumption to update quantification of drug needs, procurement plans, and shipping schedules with external suppliers. If an ART site has overstocks of any ARV drug, these drugs may be returned for redistribution to the central medi­ cal stores at the time the driver makes a routine delivery. The ART service provider and the driver use the Report for Returning Products to document the transfer of drugs. In addition to the monthly report and request, each ART site prepares and submits the Monthly Summary Report of ART Patients to the data processing center. Program management uses this information to monitor ART services. KAAMANLAND HIV TEST PROGRAM AND SUPPLY CHAIN In Kaamanland, HIV testing is conducted in a variety of settings, including voluntary counseling and testing (VCT) centers; clinics offering prevention of mother-to-child transmission (PMTCT); and national, regional, and district hospitals. HIV test kits are procured internationally by the Ministry of Health and are donated by international donors. Forecasting and quantification are done by program management. HIV tests are stored at the National Reference Laboratory and delivered directly to HIV testing sites monthly. The inventory control system is delivery truck, forced ordering maximum-minimum. HIV test kit distribution is not integrated with any other health commodity distribution. HIV testing sites use the Daily Log for Usage of HIV Tests to record the quantity of each test administered to patients and its use in the testing algorithm. Although all HIV tests are conducted in the laboratory, separate logs are maintained for HIV testing for VCT, PMTCT, and clinical diagnosis. Stockcards are used to record stocks received and issued, losses and adjustments, and stock on hand for HIV tests stored at the testing site. At the end of each month, the laboratory personnel or providers managing the HIV tests use the records and daily logs to complete the LMIS Report and Request for HIV Tests. The report and request is then given to the HIV test delivery team when it arrives at the testing site on a designated day of the follow­ ing month. During the delivery team visit, data are checked and the HIV tests are issued to the testing site. On the team’s return to the capital, the reports are submitted to the data-processing center of the Ministry of Health, where the information is compiled. Information processed from the reports, along with reports of stock levels in the National Reference Laboratory, is sent to program management for action as needed. Program managers use current information on national stock status and consumption to update the quantification of test kit needs, procurement plans, and shipping schedules with the external suppliers. 34 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS Figure 1 Kaamanland Quarterly Revised QuantificationQuarterly Revised Quantification Monthly reports from CMS: · Stock position · Deliveries and issues Monthly reports from processing center: · National stock position · Pipeline analysis · Delivery performance · Reporting rate Quarterly shipments from external supplier: · 3 months minimum stock · 6 months maximum stock Inventory system: Forced ordering max-min: · 1 months minimum stock · 2 months maximum stock LMIS forms at CMS: · Stockcards · Transaction records LMIS forms at SDP: · ART Daily Activity Registers · Monthly Summary Report of ART Patients · Worksheet for Calculating ARV Drug Quantities · LMIS Report and Request for ARV Drugs · Report for Returning Products · Program Form at SDP Monthly resupply from CMS to service point by dedicated delivery Monthly reports from SDPs: · LMIS Report and Request for ARV Drugs · Monthly Summary Report of ART Patients Monthly orders for facilities Flow of drugs Flow of information Program Management Central Medical Stores Data Processing Center ART Service Delivery Point ART Patients External Supplier ARV Drug Pipeline ANNEX 35 Figure 2 Kaamanland Quarterly Revised QuantificationQuarterly Revised Quantification Program Management National Reference Laboratory Data Processing Center External Supplier HIV Test Pipeline Monthly reports from processing center: · National stock position Copies of LMIS Report and Request for HIV Tests Quarterly shipments from external supplier: · 3 months minimum stock · 6 months maximum stock LMIS forms at NRL: · Stockcards · Transaction records Monthly resupply from reference lab delivery team to service point Inventory system: Delivery truck, forced ordering max-min: · 1 months minimum stock · 2 months maximum stock LMIS forms at Testing Site: · Daily Log for Usage of HIV Tests · Stockcards · LMIS Report and Request for HIV Tests · Transaction Records · Pipeline analysis · Delivery performance · Reporting rate LMIS Report and Request for HIV Tests picked up by delivery team Report of anticipated stock needs by delivery run HIV Testing Sites · VCT Centers · PMTCT Clinics · National, Regional, and District Hospital Laboratories Flow of drugs Flow of information 36 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS RECORDS AND REPORTS FOR MANAGING ARV DRUGS AND HIV TESTS Note: The sample forms included here are for illustrative purposes only. They were designed to complement the written guidelines and recommendations in the manual. The forms illustrate how the recommendations come together in the form of LMIS records and reports, which can then be used by a country program. For this example, the forms represent a system with a monthly reporting and ordering frequency and only include a subset of ARV drugs, rather than the comprehensive list of ARV drugs for all regimens. While the forms may be directly applicable in a country program, some modifi cation will be necessary, depending on program-specifi c requirements or characteristics (i.e., maximum stock levels, treatment protocols/testing algorithms, etc.). Nevertheless, the sample forms do reflect the recommendations and guidelines indicated throughout this manual. Furthermore, the preprinting of commodity names, units, etc., on forms should be customized to each country or program setting and should, reflect the selected standard treatment or testing guidelines. Other records, which are not included in the sample or listed below but that are critical for an eff ective LMIS and country programs, include stock-keeping records (e.g., stock cards, bin cards, etc.) that track information on commodities in the storeroom; and transaction records (e.g., issue vouchers, packing slips, etc.) that track movement of commodities between diff erent levels in the system. ART Daily Activity Register: This consumption record is used to track ARV drugs; it is maintained by the service providers who dispense drugs to patients. The quantities generated feed into the monthly consumption totals and are used to determine average monthly consumption and reorder quantities. Monthly Summary Report of ART Patients: This program report is used to report the number of patients on ART by treatment regimen. It provides data on current and estimated number of new patients by regimen, which is useful for routine ordering during rapid scale-up. Worksheet for Calculating Monthly ARV Drug Orders for Estimated New Adult ART Patients: Th is work­ sheet is used to translate the estimated number of new patients into the quantities of ARV drugs that will be required to treat the patients. The pharmacist or person responsible for ordering should complete the forms. Because pediatric dosing is non-standard, this worksheet is only applicable for estimating drug orders for adults. WHO is currently developing a web-based tool to facilitate calculations of pediatric dosages, and as DELIVER gains more experience, they will update their guidelines with useful tools for calculating pediatric orders. LMIS Report and Request for Antiretroviral Drugs: This is a combined logistics report and transaction record/ order form for ARV drugs. It provides a full report of all three essential logistics data and demonstrates the order quantity calculations. The report is submitted to the supplier and shared with program staff . Daily Log for Usage of HIV Tests: This consumption record tracks the use of HIV tests by purpose of use (VCT, PMTCT, clinical diagnosis), by brand, and by use of test (screening, confirmatory or tiebreaker). Th e service provider who conducts HIV testing maintains the log. The quantities recorded by brand feed into the monthly usage totals and are used to determine average monthly usage and reorder quantities. ANNEX 37 LMIS Report and Request for HIV Tests: This combined logistics report and transaction record/order form is used for HIV tests. It provides a full report of the three essential logistics data and demonstrates the order quantity calculations. It also includes summary use data divided by purpose and use of test. The report is submitted to the supplier and shared with the program staff . Record for Returning Products: This transaction record is used to track products (ARV drugs and HIV tests) that are returned to the supplier for redistribution or, in the case of expired drugs, for destruction. While a generic issue and receipt voucher could also be used, the specific “Report for Returning Products” includes reasons for returning products that could be important in monitoring the logistics system, service provision, and the overall program. 38 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS A RT P at ie nt R ec or ds /R eg is te r A RT D ai ly A ct iv ity R eg is te r St oc k C ar d/ Bi n C ar d W or ks he et fo r C al cu la tin g M on th ly A RV D ru g O rd er s fo r Es tim at ed N ew A du lt Pa tie nt s To ta l q ua nt iti es of e ac h dr ug di sp en se d du ri ng th e re po rt in g pe ri od A dj us tm en ts O pe ni ng B al an ce Lo ss es a nd A dj us tm en ts Q ua nt ity R ec ei ve d C lo si ng B al an ce D at a R ep or t fo r R et ur ni ng P ro du ct s M on th ly Su m m ar y R ep or t of A RT P at ie nt s LM IS R ep or t an d R eq ue st fo r A nt ir et ro vi ra l D ru gs In te rr el at io ns hi ps b et w ee n L M IS R ec o rd s an d R ep o rt s fo r A R V D ru gs R EP O RT S R EC O R D S ANNEX 39 40 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS ANNEX 41 A R T D A IL Y A C T IV IT Y R E G IS T E R Fa ci lit y: __ __ __ __ __ __ _ Q ua nt iti es D is pe ns ed Fi xe d D os e C om bi na tio ns Si ng le D ru g Fo rm ul at io ns Stavudine/Lamivudine/ Nevirapine 30/150/200 mg Tabs Stavudine/Lamivudine/ Nevirapine 40/150/200 mg Tabs Stavudine/Lamivudine 30/150 mg Tabs Stavudine/Lamivudine 40/150 mg Tabs Zidovudine/Lamivudine 300/150 mg Tabs Efavirenz 600 mg Tabs Efavirenz 200 mg Caps D ist ric t: __ __ __ __ __ __ _ D at e Pa tie nt N am e/ N um be r To ta l Q ua nt it y D is pe ns ed : Q ua nt it y D is pe ns ed fo r M o nt h (r un ni ng t o ta l) : Nevirapine 200 mg Tabs Zidovudine 300mg Tabs Stavudine 30 mg Tabs Stavudine 40 mg Tabs Lamivudine 50 mg Tabs Abacavir 300 mg Tabs Didanosine 250 mg Caps Didanosine 400 mg Caps Nelfi navir 250 mg Tabs Zidovudine syrup 10 mg/ml Lamivudine oral solution 10 mg/ml Nevirapine oral suspension 10 mg/ml Stavudine oral solution 1 mg/ml Abacavir oral solution 20 mg/ml Didanosine powder for oral solution 10 mg/ml Nelfi navir powder for oral suspension 50 mg/g ___________________________________ _____________________________ C MONTHLY SUMMARY REPORT OF ART PATIENTS Reporting Period: From __________ to ______________ mm/dd/yyyy mm/dd/yyyy Facility: ____________________________ District: __________________________________ Estimated No. Total No. Code Regimens New Patients of Patients A ADULT First Line Next Month Next Month A1 Zidovudine 300 mg + Lamivudine 150 mg + Nevirapine 200 mg A2 Zidovudine 300 mg + Lamivudine 150 mg + Efavirenz 600 mg A3 Stavudine 30 mg + Lamivudine 150 mg + Nevirapine 200 mg A4 Stavudine 40 mg + Lamivudine 150 mg + Nevirapine 200 mg A5 Stavudine 30 mg + Lamivudine 150 mg + Efavirenz 600 mg A6 Stavudine 40 mg + Lamivudine 150 mg + Efavirenz 600 mg B ADULT Second Line B1 Abacavir 300 mg + Didanosine 250 mg + Nelfinavir 250 mg B2 Abacavir 300 mg + Didanosine 400 mg + Nelfinavir 250 mg PEDIATRIC First Line C1 Zidovudine 10 mg/ml + Lamivudine 10 mg/ml + Nevirapine 10 mg/ml C2 Stavudine 1 mg/ml + Lamivudine 10 mg/ml + Nevirapine 10 mg/ml D PEDIATRIC Second Line D1 Abacavir 20 mg/ml + Didanosine 10 mg/ml + Nelfinavir 10 mg/ml Abacavir 20 mg/ml + Didanosine 10 mg/ml + Lopinavir/Ritonavir D2 80 mg/20 mg/ml Current No. Patients This Month Total: Report prepared by: Name Designation: Signature ___________________________________ 42 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS W O R K S H E E T F O R C A L C U L A T IN G M O N T H LY A R V D R U G O R D E R S F O R E S T IM A T E D N E W A D U LT A R T P A T IE N T S Total No. Estimated New Patients by Regimen For mulations No. New Patients by For mulation Fi xe d D os e C om bi na tio ns ( FD C ) Si ng le D ru g Fo rm ul at io ns ( SD F) Stavudine/Lamivudine/Nevir apine 30/150/200 mg Tabs Stavudine/Lamivudine/Nevir apine 40/150/200 mg Tabs Stavudine/Lamivudine 30/150 mg Tabs Stavudine/Lamivudine 40/150 mg Tabs Zidovudine/Lamivudine 300/150 mg Tabs Efavirenz 600 mg Tabs Efavirenz 200 mg Caps Nevir apine 200 mg Tabs Zidovudine 300 mg Caps Stavudine 30 mg Tabs Stavudine 40 mg Tabs Lamivudine 150 mg Tabs Abacavir 300 mg Tabs Didanosine 250 mg Caps Didanosine 400 mg Caps Nelfi navir 250 mg Tabs A du lt F ir st L in e R eg im en s St av ud in e 30 m g + L am iv ud in e 15 0 m g + N ev ira pi ne 2 00 m g St av ud in e 40 m g + L am iv ud in e 15 0 m g + N ev ira pi ne 2 00 m g St av ud in e 30 m g + L am iv ud in e 15 0 m g + E fa vi re nz 6 00 m g St av ud in e 40 m g + L am iv ud in e 15 0 m g + E fa vi re nz 6 00 m g Z id ov ud in e 30 0 m g + L am iv ud in e 15 0 m g + N ev ira pi ne 2 00 m g Z id ov ud in e 30 0 m g + L am iv ud in e 15 0 m g + E fa vi re nz 6 00 m g A du lt S ec o nd L in e R eg im en s A ba ca vi r 30 0 m g + D id an os in e 25 0 m g + N el fi n av ir 25 0 m g SD F A ba ca vi r 30 0 m g + D id an os in e 40 0 m g + N el fi n av ir 25 0 m g SD F To ta l n o. n ew p at ie nt s pe r dr ug ( A ) N o. p ill s/ pa tie nt /3 0 da ys ( B) 60 60 60 60 60 30 90 60 60 60 60 60 60 30 30 30 0 To ta l Q ua nt ity b y D ru g fo r 30 d ay s (C ) (C = A × B ) FD C FD C + S D F SD F FD C FD C + S D F SD F FD C + S D F SD F FD C + S D F SD F FD C + S D F SD F FD C + S D F SD F ANNEX 43 L M IS R E P O R T A N D R E Q U E S T F O R A N T IR E T R O V IR A L D R U G S Re po rt in g Pe rio d: Fr om _ __ __ __ __ _ to _ __ __ __ __ __ __ _ M ax im um S to ck L ev el : 2 M on th s m m /d d/ yy yy m m /d d/ yy yy M in im um S to ck L ev el : 1 M on th s Fa ci lit y: __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ D ist ric t: __ __ __ __ __ __ __ __ __ __ __ __ __ 44 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS Q ua nt it y R eq ui re d To ta l M ax im um B as ic O pe ni ng Q ua nt it y L o ss es / Q ua nt it y fo r N ew E st im at ed S to ck Q ua nt it y P ro du ct U ni t B al an ce R ec ei ve d A dj us tm en ts D is pe ns ed C lo si ng B al an ce P at ie nt s C o ns um pt io n Q ua nt it y N ee de d A B C D E = [ (A + B ) +/ - C ] – D F G = D + F H = G x 2 I = H – E F ix ed D o se C o m bi na ti o ns St av ud in e/ La m iv ud in e/ N ev ira pi ne Ta b 30 /1 50 /2 00 m g St av ud in e/ La m iv ud in e/ N ev ira pi ne Ta b 40 /1 50 /2 00 m g St av ud in e/ La m iv ud in e Ta b 30 /1 50 m g St av ud in e/ La m iv ud in e Ta b 40 /1 50 m g Z id ov ud in e/ La m iv ud in e Ta b 30 0/ 15 0 m g S in gl e D ru g Fo rm ul at io ns Ef av ire nz 6 00 m g Ta b Ef av ire nz 2 00 m g C ap N ev ira pi ne 2 00 m g Ta b Z id ov ud in e 30 0 m g C ap St av ud in e 30 m g Ta b St av ud in e 40 m g Ta b La m iv ud in e 15 0 m g Ta b Z id ov ud in e sy ru p 10 m g/ m l m l La m iv ud in e or al s ol ut io n m l 10 m g/ m l N ev ira pi ne o ra l s us pe ns io n m l 10 m g/ m l St av ud in e or al s ol ut io n 1 m g/ m l m l R em ar ks a nd e xp la na ti o n o f l o ss es a nd a dj us tm en ts : P re pa re d by : __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ S ig na tu re : __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ D at e: __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ DAILY LOG FOR USAGE OF HIV TESTS Purpose of HIV Tests (check one box for each register) † VCT † Blood Safety † PMTCT † Sentinel Surveillance † Clinical Diagnosis † Other: _____________________ Facility: ____________________________________ District: ______________________ Date Client Name/Number Determine Uni-Gold Bionor Other S C S C S C T Total usage based on use of test: Total usage by brand: Total usage by brand for the month (running total): T S C T T Summary of Use of Tests: Use of Test Total Total for the Month (running total) Screening: Confi rmatory: Tie breaker: Legend S = Screening C = Confirmatory T = Tie breaker ANNEX 45 46 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS L M IS R E P O R T A N D R E Q U E S T F O R H IV T E S T S Re po rt in g Pe rio d: Fr om _ __ __ __ __ __ __ __ __ __ __ t o __ __ __ __ __ __ __ __ __ __ _ m m /d d/ yy yy m m /d d/ yy yy M ax im um S to ck L ev el : 2 M on th s Fa ci lit y: __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ __ D ist ric t: __ __ __ __ __ __ __ __ __ __ __ __ __ M in im um S to ck L ev el : 1 M on th s H IV T es t B as ic U ni t O pe ni ng B al an ce Q ua nt it y R ec ei ve d L o ss es / A dj us tm en ts Q ua nt it y U se d C lo si ng B al an ce M ax im um S to ck Q ua nt it y Q ua nt it y N ee de d A B C D E = [ (A + B ) +/ - C ] - D F = D x 2 G = F - E D et er m in e Te st U ni -G ol d Te st Bi on or Te st O th er Te st Te st R em ar ks a nd e xp la na ti o ns o f l o ss es /a dj us tm en ts : S um m ar y o f U sa ge o f H IV T es ts b y P ur po se , B ra nd , a nd U se o f T es t V C T P M T C T C lin ic al D ia gn o si s B lo o d S af et y O th er To ta ls D et er m in e U ni -G ol d Bi on or O th er To ta l S cr ee ni ng To ta l C on fi r m at or y To ta l T ie b re ak er Pr ep ar ed b y: Fu ll N am e Si gn at ur e D es ig na tio n D at e _________________________________________________________________________ _________________________________________________________________________ REPORT FOR RETURNING PRODUCTS Sent to: ________________________________________________________________ Facility returning products: _________________________________________________ Product Description Quantity Returned Expiry Date Reason for Return Name of person returning the products: _________________________________________ Date ______________20___ Signature of person returning the products:_______________________________________ Carrier I CERTIFY THAT the above quantities for return were received by me except where explained below. Name of Carrier ___________________________________________________________ Date ______________20___ Carrier’s Signature __________________________________________________________ Comments: _______________________________________________________________ Receiving Facility I CERTIFY THAT the above quantities for return were received by me except where explained below. Receiver’s Name: ___________________________________________________________ Date ______________20___ Receiver’s Signature _________________________________________________________ Comments:________________________________________________________________ ANNEX 47 48 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS JOB AIDS FOR LMIS RECORDS AND REPORTS FOR MANAGING ARV DRUGS AND HIV TESTS Note: The following job aids are designed to accompany the sample forms provided for managing ARV drugs and HIV tests. For each form, the job aids provide more detail about the task, purpose, responsible person, and timeframe for completion. As with the sample forms, these have been designed to complement the written guidelines and recommenda­ tions in the manual; they represent a system with a monthly reporting and ordering frequency and only include a subset of ARV drugs, rather than the comprehensive list of ARV drugs for all regimens. Because the sample forms are modifi ed to meet program-specifi c requirements or characteristics (i.e., maximum stock levels, treatment protocols/testing algorithms, etc.), the job aids will also require modifi cation. JOB AID: COMPLETING THE ART DAILY ACTIVITY REGISTER This job aid will guide you through the process of completing the ART Daily Activity Register (DAR). Th is record is kept at the dispensing areas where the drugs are dispensed to patients. The ART DAR tracks the quantities of drugs dispensed to patients. Every time a drug is dispensed, it must be recorded in the appropriate column. The information collected will be incorporated into the LMIS Report and Request for Antiretroviral Drugs. The ART Daily Activity Register is usually kept in a book or ledger. Task: Completing the ART Daily Activity Register Completed by: Person dispensing drugs (i.e. Dispensing Pharmacist, etc.) Purpose: To record and track the number of ARV drugs dispensed to patients When to perform: Each time an ARV drug is dispensed to a patient and when calculating the running total of drugs dispensed for the month Materials needed: A blank ART Daily Activity Register, calculator, and pen Steps Actions Notes 1. Select the appropriate action: IF THEN Starting a new book or ledger Ö Continue to step number 2 Recording when dispensing drug Ö Skip to step number 3 Steps to take when starting a new book or ledger 2. ART Daily Activity Register Book or Ledger Cover: On the cover sheet write the: a. Name of the facility b. Name of the district Continue with step number 3 The book or ledger will contain daily activity registers for a number of days, depending on the size of the book or ledger. ANNEX 49 Steps Actions Notes Steps to take when starting a new page and dispensing drugs 3. Facility: Write the name of your health facility. 4. Districts: Write the name of the district where the facility is located. 5. Date: Enter the date the form was prepared. 6. Patient Name/Number: Write the name and/or number assigned to the patient receiving the ARV drugs. 7. Fixed Dose Combinations and/or Single Drug Formulations: For each patient, enter in the appropriate column the quantities of each drug you dispense. 8. Select the appropriate action: 9. IF THERE ARE NO MORE BLANK LINES ON THIS PAGE FOR MORE PATIENTS Ö YOU HAVE SEEN YOUR LAST PATIENT FOR THE DAY Ö Total Quantity Dispensed: Write the total quantity of each ARV drug dispensed by adding the quantities entered for each patient listed on the page. THEN Continue with step 9 and then go to step 3 when starting a new page Continue with step 9 Do this addition each time you complete one page. If there are products that have not been dispensed, write “0” in the spaces on the row for “totals.” Do not leave the spaces blank. 10. Quantity Dispensed for Month (running total): After a page is full, use the total quantity dispensed and previous page running total to calculate the total quantities of each product that you have dispensed so far during the month. At the end of the last day of the month, add the total quantity dispensed for each drug from the current page; add it to the running total from the previous page to calculate the total quantity of each drug dispensed for the entire month. At the beginning of a new month, with the first patient, start the running total at the bottom of each page with “0” for that month. If you have products that have not been dispensed, write “0” in the spaces on the row for “totals.” Do not leave the spaces blank. You will transfer this total quantity to column D of the LMIS Report and Request for Antiretroviral Drugs when reporting and ordering. 11. Check your calculations twice. Be sure that you have not erroneously entered page totals for one drug item with the totals for another drug item. Any error in the quantities dispensed means that you will not order the correct amount. The task is complete when— ‰ The facility and district names are filled in. ‰ Patient name and numbers and quantities of drugs dispensed to each patient are entered. ‰ The quantities of drugs recorded on each row of the page are totaled by column to calculate the total quantity dispensed for each drug. ‰ The total quantity dispensed for each drug is added to the running total quantity dispensed from the previous page to calculate the running total of the quantities dispensed for the month. ‰ The total quantities of drugs dispensed during the month are transferred to the LMIS Report and Request for Antiretroviral Drugs (at the time of reporting and ordering). 50 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS JOB AID: COMPLETING THE MONTHLY SUMMARY REPORT OF ART PATIENTS This job aid will guide you through the process of completing the Monthly Summary Report of ART Patients. The Monthly Summary Report of ART Patients provides the number of patients by regimen. This form can be used for tracking the number of ART patients, for estimating the numbers of new patients for whom you will order drugs (using the Worksheet below), and for monitoring and supervision to cross-check total numbers of patients by regimen with total quantities of drugs dispensed. Task: Completing the Monthly Summary Report of ART Patients Completed by: ART service provider or person responsible for reporting Purpose: To report the number of ART patients (current and new) by regimen When to perform: Every reporting cycle Prior to completing the Worksheet for Calculating Monthly ARV Drug Orders for Estimated New Adult ART Patients Materials needed: Blank Summary Report of ART Patients, calculator, and pen Steps Actions Notes 1. Reporting Period: Write the reporting period with day, month, and year. e.g., 15/03/2006 to 15/04/2006 2. Facility Name: Write the name of your facility. 3. District: Write the name of the district where the facility is located. For each ART Regimen: 4. 5. 6. 7. 8. Current No. Patients This Period: Write the total number of patients who are currently on the regimen. Estimated No. New Patients Next Period: Write the number of new patients who are estimated to be enrolled on each regimen. Total No. of Patients Next Period: Add the patients currently on the regimen and the estimated new patients who will be on the regimen. Total: After all the cells in the columns are filled in, add the numbers to obtain the total number of current patients, estimated new patients, and the total of all patients. Report prepared by Name/Designation/Signature: Enter the name and designation of the person preparing the report; preparer signs the report. You can obtain the number of patients on each regimen from pharmacy records, if they are tracking numbers of patients on each regimen or, more likely, from the ART clinic patient register. Current patients refer to the patients who were active during the reporting period for the report being prepared. The number of estimated new patients will probably come from the ART clinic and/or the facility head/manager. Likely sources for this data include the therapeutic committee, the ART clinic waiting list, doctors’ records, or other planning documents. Calculations will be done horizontally by row; this total represents all the current and estimated new patients on each regimen. These calculations will be done vertically to provide Total Current No. Patients this Period (across all regimens),Total Estimated New Patients for the Next Period, and overall Total of all patients for the next period. The task is complete when— ‰ The number of current patients, number of estimated new patients, and total number of patients for the next period are filled in for each regimen. ‰ The total number of current patients for this period, estimated new patients for the next period, and total number of patients for next period are calculated. ‰ The person preparing the report writes his/her name and designation and signs the report. ANNEX 51 JOB AID: COMPLETING THE WORKSHEET FOR CALCULATING MONTHLY ARV DRUG ORDERS FOR ESTIMATED NEW ADULT ART PATIENTS This job aid will guide you through the process of completing the Worksheet for Calculating Monthly ARV Drug Orders for Estimated New Adult ART Patients. The worksheet helps the pharmacist to estimate the quantities of ARV drugs that will be needed for new patients beginning treatment during the next resupply cycle. This form can also be used to estimate the quantities of ARV drugs that will be needed for continuing patients who are switching to drugs that are not kept at the facility store. Task: Completing the Worksheet for Calculating Monthly ARV Drug Orders for Estimated New Adult ART Patients Completed by: Pharmacist Purpose: To estimate the quantities of ARV drugs that will be needed for new patients who will be using ARVs, as well as the number of current patients on new regimens When to perform: When a patient starts a regimen for the first time Prior to completing the LMIS Report and Request for Antiretroviral Drugs Materials needed: Blank Worksheet for Calculating Monthly ARV Drugs Orders for Estimated New Adult ART Patients, calculator, and pen Note: The worksheet has darkened cells.You cannot write in the darkened cells.Write only in the blank cells. The worksheet is completed from left to right, starts with the estimated number of new patients for the next month, and uses those numbers to determine the number of tablets of each drug that need to be ordered for these patients. Steps Actions Notes Total No. of Estimated New Patients by Regimen: Write the total number of estimated new patients who will be enrolled on each regimen listed. No. of New Patients by Formulation: Write the number of new patients who will receive each formulation available. For each ART Regimen: 1. 2. The total number of estimated new patients by regimen can be obtained from the Monthly Summary Report of ART Patients. For the first column, and for each regimen row, enter the numbers of new patients, not the quantities of drugs. For example, there are 20 estimated new patients that will receive stavudine 30 mg + lamivudine 150 mg + nevirapine 200 mg. If no new patients will be receiving a regimen, write “0” in that box. For each regimen, allocate the total number of estimated new patients entered in the first column to one or more of the available formulations listed (FDC, FDC+SDF, or SDF). The pharmacist or person managing and dispensing stock should make this decision; they should take into account existing stocks on hand, as well as the appropriate clinical factors. The total number of patients across all the formulations within a regimen should total the number of estimated new patients for the regimen. For example, based on the 20 estimated new patients above receiving stavudine 30 mg + lamivudine 150 mg + nevirapine 200 mg, 10 will receive the triple FDC, six will receive the double FDC+SDF, and four will receive just SDFs. If no new patients will be receiving a formulation, write “0” in that box. 52 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS Steps Actions Notes 3. Fixed Dose Combinations and/or Single Drug Formulations: Enter the number of new patients by formulation into all the unshaded boxes in that row to determine the number of patients receiving each formulation of each drug. Every time a number is identified for new patients receiving a formulation of a regimen, transfer that number to all the unshaded cells in that row. Continue until all unshaded cells in the regimen rows are filled in.This indicates how many new patients will be receiving each of the drug formulations that make up the regimen.To continue the example from above, enter number 10 in the unshaded cell for the triple FDC; enter number 6 in both the unshaded cell for the double FDC and the unshaded cell for the SDF of nevirapine; enter number 4 in all three of the unshaded SDF cells for stavudine, lamivudine, and nevirapine, respectively. If no new patients will be receiving a drug, write “0” in that box. Now for each drug listed in the columns: 4. Total No. New Patients per Drug: Write the total number of new patients who will be receiving each drug. 5. Total Quantity by Drug for 30 days: Write the total quantity of each drug required to treat all new patients for the month. This calculation is done vertically.Total all the unshaded cells in each column for each drug (i.e., the numbers of new patients that will receive each drug). If no new patients will be receiving a drug, write “0” in that box. Multiply the total number of patients per drug (row A for that column) by the number of pills per patient, per 30 days (row B for that column). This is the total quantity of each drug that is needed to treat all new patients during the upcoming 30 days. Be sure to recheck all calculations in the worksheet. Mistakes in the worksheet will lead to mistakes in determining order quantities. Note: Total Quantities of Drugs for New Patients will be transferred to column F of the LMIS Report and Request for Antiretroviral Drugs. The task is complete when— ‰ The total number of patients is recorded for each regimen. ‰ The number of patients for each regimen is divided by formulation. ‰ The total number of new patients, per drug, is entered. ‰ The total quantity of drugs for 30 days is calculated and the information is transferred to the LMIS Report and Request for Antiretroviral Drugs. ANNEX 53 JOB AID: COMPLETING THE LMIS REPORT AND REQUEST FOR ANTIRETROVIRAL DRUGS This job aid will guide you through the process of completing the LMIS Report and Request for Antiretroviral Drugs. Task: Completing the LMIS Report and Request for Antiretroviral Drugs Completed by: The designated person at the SDP responsible for filling the report and placing orders Purpose: To provide logistics data to the central level To provide a report on the stock status of ARV drugs at the facility To order additional supplies of ARV drugs When to perform: At the end of the order interval (every month) Materials needed: A blank LMIS Report and Request for Antiretroviral Drugs, calculator, and pen Note: This form is prepared in quadruplicate (one original and three copies). Use a pen to fill out the top copy; make sure the writing clearly shows through on all the copies. Also, remember to write “0” in the boxes if no quantity was received or dispensed, and there were no losses or adjustments. Do not leave boxes blank. 1. Reporting Period: Write the period of reporting with day, e.g., 15/03/2006 to 15/04/2006 month, and year. 2. Facility: Write the name of the facility. 3. District: Write the name of the district where the facility is located. Steps Actions Notes For each Drug: 4. 5. 6. 7. 8. 9. Opening Balance: Write the balance on the beginning of the period of reporting. Quantity Received: Write the quantity you received during the month covered by the report. Losses and/or Adjustments: Write any losses or adjustments that occurred during the month covered by the report. Quantity Dispensed: Write the quantity that was dispensed to patients during the month covered by the report. Closing Balance: Write the total stock on hand at the end of the month covered by the report. Quantity Required for New Patients: Write the quantity of ARV drugs that will be required for the estimated new ART patients. You can find the Opening Balance on the stock card or in column E/Closing Balance of the previous report. You can find the quantity received on the stock card. You can find losses and adjustments on the stock card. Be sure to write a minus (–) sign for a negative adjustment or loss. You can find the quantity dispensed on the last page of the ART Daily Activity Register for the month. Use the Quantity Dispensed for the Month (running total) for the month covered by the report. Be sure to check the calculations. The closing balance is calculated as the beginning balance plus quantity received minus quantity dispensed plus or minus losses or adjustments. Using the column headings on the form, the formula for the calculation is— E = A + B +/– C – D The closing balance can also be verified by checking the stock card for the closing balance on the last day of the month order covered by the report, or by conducting a physical inventory of quantities in the storeroom.The stock card needs to be up-to-date; it is recommended that you conduct a physical inventory to check the closing balance. The Quantity Required for New Patients is obtained from row C of the Worksheet for Calculating Monthly ARV Drug Orders for Estimated New Adult ART Patients. 54 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS Steps Actions Notes 10. 11. 12. 13. 14. 15. 16. Total Estimated Consumption: Write in the total estimated consumption by adding the quantity dispensed during the month and the quantity required for new patients. Maximum Stock Quantity: Calculate and write the maximum stock quantity. Quantity Needed: Calculate and write the quantity of the product that you need to order. Remarks: Write additional comments and any explanations related to losses and adjustments. Prepared by: Enter the name of the person who prepared the form. Signature: Person who prepared the form signs the form. Date: Enter the date the form was prepared. This is the estimated quantity to be dispensed next month; the quantity is the total sum of the quantities dispensed for the month covered by the report being prepared (column D of this report) plus the quantities required for estimated new patients. Using the column headings on the form, the formula for the calculation is— G = D + F The maximum stock quantity is calculated by multiplying the quantity estimated to be consumed during the next month by the maximum stock level. In the example on these forms, the maximum stock level is 2 months; the total estimated consumption is multiplied by 2. Remember, although the maximum stock level remains constant at 2 months, the actual maximum quantities change every time there is an order because the quantity expected to be consumed changes every month. The Quantity Needed is determined by subtracting the closing balance/stock on hand from the maximum quantity. Using the column headings on the form, the formula for the calculation is— I = H – E If the calculation is a negative number (example, – 80), you already have enough stock so the order quantity is “0.” Be sure to write “0” as the order quantity; do not leave the box blank. It is highly recommended that the Quantity Needed should be calculated in basic units (i.e., tablets); the issuing facility will convert the quantities to the appropriate pack sizes. For example, if you reported losses or adjustments, give a brief description of the loss/adjustment. The task is complete when— ‰ The opening balances, quantities received, quantities dispensed, and losses or adjustments are filled in for each product. ‰ The closing balances are correctly calculated, filled in, and checked against the stock cards. ‰ The quantities of each drug required for new patients are transferred from the Worksheet for Calculating ARV Drug Orders for Estimated New Adult ART Patients. ‰ The total estimated consumption is calculated. ‰ The maximum stock quantities are correctly calculated and filled in. ‰ The quantities needed are correctly calculated and filled in ‰ The report/request is signed and dated; losses and adjustments are explained. ANNEX 55 JOB AID: COMPLETING THE DAILY LOG FOR USAGE OF HIV TESTS Task: Completing the Daily Log for Usage of HIV Tests Completed by: All service providers who perform HIV tests and are responsible for reporting Purpose: To track usage of HIV tests by purpose of use, brand and use of test To collect information for the LMIS Report and Request for HIV Tests When to perform: Each time an HIV test is performed At the end of each day Materials needed: A blank Daily Log for Usage of HIV Tests, calculator and pen Note: The form is printed in a book or ledger. Using the Daily Log will help you prepare your report at the end of the reporting period. Remember, when you place an order, you will need to provide the total number of tests used during the month by purpose of use, brand, and use of test. Steps Actions Notes 1. Select the appropriate action: IF THEN Starting a new book or ledger Ö Continue with step number 2 Recording when conducting a test Ö Skip to step number 3 Steps to take when starting a new book or ledger 2. Daily Log for Usage of HIV Tests Book or Ledger Cover: On the cover sheet write the: a. Name of the facility b. Name of the district Continue with step number 3 Steps to take when starting a new page and conducting tests 3. Purpose of Use of HIV Tests: Check a box for the The form refers to VCT, PMTCT, Blood Safety, etc. corresponding service provided. It is assumed that a separate Daily Log will be used for each different purpose, (i.e., tests performed for VCT will be recorded on a different Daily Log than those performed for Blood Safety, or PMTCT). 4. Facility: Write the name of your health facility. 5. District: Write the name of the district where the facility is located. 6. Date: Enter the date the form was prepared. 7. Client Name/Number: Write the name and/or number assigned to the client to be tested. 8. S, C,T: Place either a tick ( ), check (3), cross (g), or 1 (1) in each cell below the brand (Determine, Uni-Gold, Bionor, other) and below the corresponding use of the test (S for screening, C for confirmatory, and T for tie breaker). The brands of tests listed here are for illustrative purposes, but preprint the names based on the recommended standard testing algorithm for that purpose. Add an extra space for emergency use. Use a consistent method for marking off use—a tick ( ), check (3), cross (g), or 1 (1). 56 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS Steps Actions Notes 9. Select the appropriate action: IF THEN There are no more blank lines on this page for more patients Ö Continue with step 10 and 11 and then go to step 3. You have seen your last client for the month Ö Continue with step 10. You are conducting another test Ö Go back to step 6. 10. Total Usage based on Use of Test: For each brand of test (Determine, Uni-Gold, Bionor, other), total the tests by type (screening, confirmatory, and tie breaker). Do this calculation vertically. Make sure you add all the tests used for each sub-column within the overall brand column (i.e., the total number of tests used for screening, confirmatory, and tie breaker within each brand). For tests that are not used, write “0” in the spaces. Do not leave the spaces blank. 11. Total Usage by Brand: Add the numbers under S, C,T The total usage by brand consists of adding the number of and enter the total number of tests under each brand. tests used for screening and confirmation and tie-breaker for each brand. 12. Total Usage by Brand for the Month (running total): After the page is full, add the Total Usage by Brand to the previous page running total for the brand to calculate the running total number of tests used by brand for that month. At the end of the last day of the month, add the total usage by brand for the current page; add that total to the running total usage by brand from the previous page to calculate the total quantity used of each brand for the entire month. When you start to test clients for a new month, start a new running total usage by brand at the bottom of each page for that new month. For tests not used, write “0” in the spaces on the row for “totals.” Do not leave the spaces blank. You will transfer this total usage by brand for the entire month to column D of the LMIS Report and Request for HIV Tests when you report and order. 13. Summary of Use of Tests: To calculate the S, C, and T totals, calculate the total number by use of test (screening, confirmatory, and tie-breaker) by adding all the S’s for each brand, all the C’s for each brand, and all the T’s for each brand. This calculation requires going back to the row of Total Usage based on use of test and adding all the screening, confirmatory, and tie breaker tests (across brands). 14. Running Total for the Month: (under the Summary of Use of Tests) For the running total of the month of use of tests, add the number of tests by use of tests from the summary of each day. This running total is calculated in a similar way to the way the running total of usage by brand is calculated.The total for this current page is added to the running total from the previous page; the sum of the two becomes the new running total for the month. At the start of a new month, start a new running total for the new month. This number for each of the types (S, C, and T) is transferred to the summary table of HIV Tests by Purpose of Use, Brand and Use of Test on the LMIS Report and Request for HIV Tests. ANNEX 57 Steps Actions Notes The task is complete when— ‰ The purpose of use, facility name, and district are filled in. ‰ The client names and numbers, and results by use of test are entered. ‰ The total number of tests by use of test and by brand are entered. ‰ The running total usage of tests by brand for the month is calculated. ‰ The summary of use of tests is completed, including the running total for the month. ‰ The total quantities of tests organized by purpose of use for brand and use of test during the month are transferred to the LMIS Report and Request Form for HIV Tests. 58 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS JOB AID: COMPLETING THE LMIS REPORT AND REQUEST FOR HIV TESTS Task: Completing the LMIS Report and Request for HIV Tests Completed by: The designated person at the SDP responsible for filling the report and request Purpose: To provide logistics data to the central level To provide a report on the stock status of HIV tests in the facility To order additional HIV tests To provide evidence of issue and receipt of HIV tests When to perform: At the end of every order interval (every month) Materials needed: Stock on Hand and Losses/Adjustments data (from stock cards or physical inventory), usage data (from Daily Log for Usage of HIV Tests), calculator, and pen Note: This form is prepared in quadruplicate (one original and three copies). Use a pen to fill out the top copy; make sure the writing clearly shows through on all the copies. Also, remember to write “0” in the boxes if there was no quantity received or used, or no losses or adjustments. Do not leave boxes blank. 1. Reporting Period: Write the period of reporting with day, e.g., 15/03/2006 to 15/04/2006 month, and year. 2. Facility: Write the name of the facility. 3. District: Write the name of the district where the facility is located. Steps Actions Notes For each brand of HIV test: 4. 5. 6. 7. 8. Opening Balance: Write the balance of the beginning of reporting period. Quantity Received: Write the quantity you received during the month. Losses and/or Adjustments: Write any losses or adjustments that occurred during the month. Quantity Used: Write the quantity that was used during the month covered by the report. Closing Balance: Write the total stock on hand at the time of reporting. The opening balance can be found on the stock card or in column E/Closing Balance of the LMIS Report and Request for the previous month. The quantity received can be found on the stock card.This is the quantity received between the previous order and this order. Losses and adjustments can be found on the stock card. Be sure to write a minus (–) sign for a loss or a negative adjustment. The quantity used can be found on the Daily Log for Usage of HIV Tests. Use the Total by Usage Brand for the Month (running total). Be sure to check the calculations as well. The closing balance is calculated as opening balance plus quantity received minus quantity used, plus or minus losses or adjustments. Using the column headings on the form, the formula for the calculation is— E = A + B – C +/– D You can also verify the closing balance by checking the stock card for the balance at the time of reporting. It is recommended that you conduct a physical inventory of what is actually in the storeroom to ensure that the stock card has been updated. ANNEX 59 Steps Actions Notes 9. Maximum Stock Quantity: Calculate and write the maximum stock quantity. 10. Quantity Needed: Calculate and write the quantity of the tests needed. The maximum stock quantity is calculated by multiplying the quantity used during the month by the maximum stock level (2 months in this example). Remember that although the maximum stock level remains 2 months, the actual maximum stock quantities change every time there is an order because the quantities used every month change. The Quantity Needed is determined by subtracting the closing balance/stock on hand from the maximum stock quantity. Using the column headings on the form, the formula for the calculation is— G = F – E If the calculation gives a negative number (example: – 80), then you already have enough stock so the order quantity is “0.” Be sure to write “0” as the order quantity; do not leave the box blank. 11. 12. 13. Remarks and explanations of losses/adjustments: Write additional comments and any explanations related to losses and adjustments. Summary of Usage of HIV Tests by Purpose of Use, Brand and Use of Test: Within each purpose of use, record the total tests used by brand and by use of test during the month covered by the report. Name/Signature/Designation of Person and Date: The person completing the Report and Request form writes his/her name, designation, and then signs and dates the report. For example, if you reported losses or adjustments, write a brief description of the loss/adjustment. Obtain the summaries of total tests used by brand and total tests by use of test (within each purpose of use) from the totals for the month on each Daily Log for Usage of HIV Tests. Remember that each purpose will have a different log book and also, that the monthly total by brand will be on the bottom row and the monthly total by use will be in the summary table. The task is complete when— ‰ The reporting period, facility, and district name are filled in. ‰ The opening balances, quantities received, quantities used, and losses or adjustments are filled in for each product. ‰ The closing balances are correctly calculated and filled in. ‰ The maximum stock quantities are correctly calculated and filled in. ‰ The quantities needed are correctly calculated and filled in. ‰ The Summary of Usage of HIV Tests Purpose of Use, Brand, and Use of Test is completed. ‰ The person filling out the report has written his/her name, designation, signature, and the date the report is completed. 60 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS 11 JOB AID: COMPLETING THE REPORT FOR RETURNING PRODUCTS Task: Completing the Report for Returning Products Completed by: The designated person at the SDP responsible for filling the report Purpose: To provide a tracking document for products returned to the central level from the health facility level When to perform: Whenever there are surplus or unusable products that need to be returned to the central level Materials needed: A blank Report for Returning Products, calculator, and pen Note: This form is a quadruplicate with four copies (an original and three copies). Use a pen to fill out the top copy; make sure the writing clearly shows through on all the copies. This form is to return either tests or ARV drugs that are in surplus or that are unusable because they are damaged or expired, or will expire before they can be used. Products are in surplus if the SDP has two months or more of stock above the maximum stock level. 1. Sent to: Write the name of the facility to which the This will almost always be the central level. products are returned. 2. Facility returning products: Write the name of the facility. Steps Actions Notes For each product being returned: 3. 4. 5. 6. 7. 8. 9. 10. Product Description: Write the name of the product being returned. Quantity Returned: Write the quantity of the product that you are returning. Expiry Date: Write the date of expiry of the products. Reason for Nonuse: Write the reason you are returning the product (damaged, expired, etc.). Name of person returning products/Date/ Signature: The person who is returning the products writes her/his name, and dates and signs her/his name. Name of Carrier/Date/Carrier’s Signature: The person who is transporting the products from the sending facility to the receiving facility writes her/his name and date, and signs her/his name. Comments: The carrier writes any comments, as appropriate. Receiver’s Name/Date/Receiver’s Signature: The person who receives the products at the receiving facility writes her/his name and date, and signs her/his name. Comments: The receiver writes any comments, as appropriate. As with stock cards, write the form and strength of the product. As with other forms used in the system, record the quantities in order units: tablets, capsules, tests, etc. If there are multiple expiry dates for the same product, list all the different expiry dates and the quantities of each product for each of the different expiry dates In particular, note if there are any discrepancies between the products that were returned and those received by the receiving facility. The task is complete when— ‰ The name of the facility to which products are being sent and the name of the facility returning products are filled in. ‰ The description and quantity of products being returned, the expiry date, and the reason for nonuse are filled in ‰ The person filling out the report has written his/her name, signature, and the date ‰ The person transporting the products has written his/her name, signature, and the date. ‰ The person receiving the products has written his/her name, signature, and the date ANNEX 61 62 BUILDING BLOCKS FOR INVENTORY MANAGEMENT OF HIV TESTS AND ARV DRUGS GUIDE FOR QUANTIFYING ARV DRUGS The author’s views expressed in this publication do not necessarily reflect the views of the United States Agency for International Development or the United States Government. DELIVER DELIVER, a six-year worldwide technical assistance support contract, is funded by the President’s Emergency Plan for AIDS Relief (PEPFAR) through the U.S. Agency for International Development (USAID). Implemented by John Snow, Inc. (JSI), (contract no. HRN-C-00-00-00010-00) and subcontractors (Manoff Group, Program for Appropriate Technology in Health [PATH], and Social Sectors Development Strategies, Inc.), DELIVER strengthens the supply chains of health and family planning programs in developing countries to ensure the availability of critical health products for customers. DELIVER also provides technical management of USAID’s central contraceptive management information system. Recommended Citation Allers, Claudia, and Yasmin Chandani. 2006. Guide for Quantifying ARV Drugs. Arlington, Va.: DELIVER, for the U.S. Agency for International Development. Abstract Successful implementation and expansion of antiretroviral therapy (ART) services depends on the continuous availability of high-quality antiretroviral (ARV) drugs and on the supply of a wide range of HIV/AIDS-related commodities. The nature of ART and the specific characteristics of ARV drugs and how they are used pose particular challenges for managing the supply chain for ARV drugs. Quantification of health commodities is a process which includes estimating the quantities and the cost of products required to meet customer demand, and to fill the pipeline with adequate stock levels taking into account service delivery capacity, supply pipeline requirements, and resources available for procurement. Although some general considerations for managing the supply chain for ARV drugs are discussed in this guide, the primary focus and purpose of the guide are to describe the process and the methodologies used for quantifying ARV drug needs. Quantification of health commodities is a process which includes estimating the quantities and the cost of products required to meet customer demand, and to fill the pipeline with adequate stock levels taking into account service delivery capacity, supply pipeline requirements, and resources available for procurement. DELIVER John Snow, Inc. 1616 North Fort Myer Drive 11th Floor Arlington, VA 22209 USA Phone: 703-528-7474 Fax: 703-528-7480 Email: deliver_project@jsi.com Internet: deliver.jsi.com CONTENTS ABBREVIATIONS AND ACRONYMS .v ACKNOWLEDGMENTS . vii PREFACE .ix INTRODUCTION TO QUANTIFICATION .1 Definition of Terms .1 Steps in Quantification .1 Forecasting Methodologies .3 The Importance of Standardization in Quantification.4 BACKGROUND .7 Characteristics of ARV Drugs .7 Types of ART and Common ARV Drug Regimens .9 Challenges Specific to Forecasting Demand for ARV Drugs . 11 STEPS IN THE QUANTIFICATION . 13 Prerequisites to Quantifi cation . 13 Prepare Forecast Demand . 18 Adjust the Forecasted Demand . 18 Estimate Requirements . 19 Estimate Costs . 20 Determine Quantity to Procure . 20 CONSIDERATIONS FOR QUANTIFICATION OF PEDIATRIC ARV DRUGS . 23 USE OF PIPELINE SOFTWARE FOR QUANTIFICATION AND PROCUREMENT PLANNING OF ARV DRUGS . 27 SUMMARY OF CHALLENGES AND LESSONS LEARNED IN QUANTIFICATION OF ARV DRUGS. 29 Common Challenges . 29 REFERENCES. 31 APPENDIX A: SAMPLE EXCEL SPREADSHEETS FOR QUANTIFICATION OF ARV DRUGS . 35 FIGURE 1. Steps in Quantification .2 TABLES 1. Examples of Single Drug Formulations .8 2. Examples of Fixed Dose Combination Drugs .9 3. Examples of Common ARV Drug Regimens . 10 CONTENTS iii GUIDE FOR QUANTIFYING ARV DRUGS iv ABBREVIATIONS AND ACRONYMS 3TC lamivudine ABC abacavir AIDS acquired immune-defi ciency syndrome AMQR average monthly quantity required ART antiretroviral therapy ARV antiretroviral AZT zidovudine ddI didanosine d4T stavudine EFV efavirenz FDA Food and Drug Administration (U.S.) FTC emtricitabine HAART highly active antiretroviral therapy HIV human immunodefi ciency virus IDV indinavir LMIS logistics management information system LPV/r lopinavir + ritonavir MSH Management Sciences for Health NFV nelfi navir NVP nevirapine OI opportunistic infection PEP post-exposure prophylaxis PEPFAR President’s Emergency Plan for AIDS Relief PMTCT prevention of mother-to-child transmission SQV saquinavir STG standard treatment guidelines STI sexually transmitted infection TB tuberculosis TDF tenofovir VCT voluntary counseling and testing VEN vital, essential, nonessential WHO World Health Organization ZDV zidovudine ABBREVIATIONS AND ACRONYMS v GUIDE FOR QUANTIFYING ARV DRUGS vi ACKNOWLEDGMENTS This publication, which is featured on the CD Resources for Managing the HIV/AIDS and Laboratory Supply Chains, is dedicated to people around the world living with HIV/AIDS and to the many individuals from communities, nongovernmental organizations (NGOs), faith-based organizations, Ministries of Health, and other organizations who have consistently fought for access to antiretroviral drugs and other commodities required to provide HIV/AIDS services. The publication is also dedicated to friends and counterparts who have worked with DELIVER, the Family Planning Logistics Management project, and John Snow, Inc., since 1986 and to the thousands of committed professionals in Ministries of Health and NGOs who work daily to supply their customers and programs with essential public health commodities. Although the resources on the CD provide a focus on specific HIV/AIDS and laboratory commodities, we recognize that comprehensive HIV/AIDS and laboratory programs require the supply chain to manage and deliver a broad range of several hundred public health commodities. The U.S. Agency for International Development (USAID) contracts funded the technical assistance, in- country projects, and research that produced the experience and lessons contained in the Resources. We are deeply grateful to the team of professionals in the Commodity Security and Logistics Division in the Office of Population and Reproductive Health of the USAID Global Health Bureau’s Center for Population, Health, and Nutrition—especially Mark Rilling and Sharmila Raj —for their encouragement and advice and their commitment to improving HIV/AIDS laboratory and public health programs through logistics. Numerous people helped write the documents that constitute the Resources. Sincere thanks go to the core team of dedicated technical staff who developed and wrote the components—namely, Claudia Allers, Johnnie Amenyah, Dana Aronovich, Briton Bieze, Ronald Brown, Yasmin Chandani, Abdourahmane Diallo, Aoua Diarra, Paul Dowling, Barbara Felling, Jane Feinberg, Andrew Fullem, Carmit Keddem, Mary Lyn Field- Nguer, Lisa Hare, Corynne Harvey, Erin Hasselberg, Lisa Hirschhorn, Jennifer Mboyane, Colleen McLaugh­ lin, Naomi Printz, Gregory Roche, Eric Takang, Lea Teclemariam, Wendy Nicodemus, and Dragana Veskov. Special thanks go to Nancy Cylke, Miguel Jaureguizar, Meba Kagone, Carolyn Hairston, Carolyn Hart, Paula Nersesian, Richard Owens, Ruth Stefanos, Jennifer Antilla, and Edward Wilson for their signifi cant contribu­ tions and valuable support. Field examples and data were generously contributed by Hannington Ahenda, David Alt, Barry Chovitz, Parfait Edah, Janne Hicks, Steve Kinzett, Catherine Lwenya, Mercy Maina, Lino Martinez, Yolanda Mikaele, Greg Miles, Cecilia Muiva, Moses Muwonge, Marilyn Noguera, Jabulani Nyenwa, Amanda Ombeva, Walter Proper, Nora Quesada, Tim Rosche, Jayne Waweru, and Steve Wilbur. The lessons drawn from DELIVER’s experience in managing HIV/AIDS and laboratory supply chains would not have been possible without these valuable contributions. The DELIVER Communications Group edited, designed, and produced the Resources. Their patience, persis­ tence, insight, and support are much appreciated. In particular, appreciation goes to Heather Davis, commu­ nications manager; Pat Shawkey, publications manager; Pat Spellman, editor; Gus Osorio, art director; Kathy Strauss, Paula Lancaster, and Susan Westrate, graphic designers; Erin Broekhuysen, communications strategist; Delphi Lee, JSI assistant webmaster; José Padua, DELIVER web manager; Madeline McCaul, communica­ tions officer; Jessica Philie, publications coordinator; and Jacqueline Purtell, communications coordinator. ACKNOWLEDGMENTS vii viii ACKNOWLEDGMENTS PREFACE A major challenge to initiation and expansion of antiretroviral therapy (ART) services in resource-poor countries that have been most affected by the HIV/AIDS epidemic has been the limited capacity of health commodity supply chains to ensure a reliable supply of the products at service delivery sites to support HIV prevention, care, and treatment programs. Successful provision of ART services depends not only on the continuous availability of high-quality antiretroviral (ARV) drugs but also on the supply of a range of HIV/ AIDS-related commodities. These commodities include drugs for the treatment of sexually transmitted infections, tuberculosis (TB), and other opportunistic infections (OIs); HIV tests and other laboratory reagents; contraceptives; condoms; protective gear for infection prevention and health worker safety; and a host of consumable medical and laboratory supplies. A significant number of public sector programs in resource-poor countries urgently need enhanced capacity most supply chain management functions, including specifically in quantifi cation, fi nanc­ ing, procurement, and delivery of HIV/AIDS-related commodities. Global efforts to coordinate quantifi ca­ tion, financing, and procurement are also critical and must complement country-based initiatives. The nature of ART and the specific characteristics of ARV drugs and how they are used pose particular chal­ lenges for managing the supply chain for ARV drugs. Although some general considerations for managing the supply chain for ARV drugs are discussed in this guide, the primary focus and purpose of the guide are to describe the process and the methodologies used for quantifying ARV drug needs. Further technical aspects of managing the supply chain for ARV drugs are discussed in depth in other sections of the DELIVER Guide­ lines for Managing the HIV/AIDS Supply Chain. This guide for quantifying ARV drugs draws from the collective experience of DELIVER logistics advisors who have been involved in a range of activities to improve management of the supply chains for HIV/AIDS commodities in several countries that are hardest hit by the epidemic. DELIVER’s experience indicates that two of the most critical supply chain interventions for ART programs at this time are the need to: • Establish robust data collection and reporting systems to improve the availability and quality of data on ART services and commodities. • Build capacity in quantification of ARV drug requirements at the country and program levels to enhance informed decision making regarding financing and procurement of commodities, thus maximizing oppor­ tunities for continuous product availability in a country. The DELIVER experience and lessons learned in quantification of ARV drugs in eight countries have been incorporated into the step-by-step approach to quantification presented in this guide. Illustrative examples from Excel spreadsheets that were used in quantifying drug requirements for a national ART program are attached in the appendix to this guide. It is important to recognize that each country, each program, and each quantification will be unique as programs mature, as technologies and clinical practice evolve, as new drug formulations become available, and as logistics management information systems (LMIS) improve to enable more evidence-based quantifi cations. This guide is, therefore, a work in progress that will be reviewed and updated over time to reflect the growing body of knowledge and the best practices in ART and on manage­ ment of ARV drug supply chains. PREFACE ix GUIDE FOR QUANTIFYING ARV DRUGS x INTRODUCTION TO QUANTIFICATION Quantification of health commodities is a process that includes estimating the quantities and the cost of prod­ ucts as required to meet customer demand and to fill the pipeline with adequate stock levels. The process takes into account the service delivery capacity, supply pipeline requirements, and resources available for procure­ ment. Quantification consists of four distinct steps: forecasting demand, estimating requirements, calculating the costs for procuring the requirements, and, if needed, adjusting the final quantities to procure according to the amount of funding available. The results of a quantification may be used (a) to calculate specific order quantities and to plan shipment schedules for short-term procurement planning, and (b) to assist in medium- to long-term program planning and resource mobilization eff orts. DEFINITION OF TERMS Given the level of precision required to conduct accurate quantifications, it is important to clarify the use of specific terms within the context of this document that may be used and understood differently in other contexts. CUSTOMER Within the context of quantification of health commodities, the customer is the end user who is understood to be the patient, the client, or the provider who will ultimately receive, use, or consume the product within the forecast period. CUSTOMER DEMAND Therefore, customer demand refers to the specific quantities of the product to be dispensed or used to be able to meet customers’ requests or their actual rather than their potential demand for health services within the forecast period. PRODUCT WASTAGE Product wastage is the estimated quantity of product that is expected to be wasted through normal usage or through nonuse. Wastage through normal use or nonuse can occur, for example, through spillage, through incorrect measurement or damage during use, or by accounting for quantities of a product that may be returned by patients and that cannot be re-used or dispensed to other patients. Product wastage is based on an accepted standard percentage of total product consumption. STEPS IN QUANTIFICATION Figure 1 represents the steps in the quantifi cation process. INTRODUCTION TO QUANTIFICATION 1 Figure 1. Steps in Quantifi cation Forecast Demand Estimate the quantity required of each product to meet customer demand for the forecast period based on service capacity and other programmatic factors. Estimate Requirements Adjust forecasted demand to account for product wastage, lead times, buffer stock, stock on hand and quantity on order. Estimate Costs Calculate the cost per product and the total cost estimate of procuring the requirements. Use results for program planning and resource mobilization. Determine Quantity to Procure Compare funding available to the cost estimate and re-calculate the quantity to procure if needed. Use results for short-term procurement planning. Quantification FORECASTING DEMAND Forecasting demand means estimating the quantity of products (e.g., drugs to be dispensed, HIV tests or laboratory reagents to be used) to meet customer demand for a future period of time. For health commodi­ ties, the number of customers to be served and the cases to be treated, along with the forecasted demand, may need to be adjusted to reflect (a) the scope of the quantification, which may be a national-level quantifi cation or may be for a specific program, service sector, geographic region, level of service, or patient target group; (b) the purpose of use within the quantification (for example, drugs for both ART and prevention of-mother­ to- child transmission [PMTCT] services), or HIV tests for only voluntary counseling and testing (VCT) and PMTCT services; and (c) the program’s service capacity according to the volume of services that can be provided, given the existing infrastructure, staff availability and staff skills, and customer access to services. In the case of HIV tests and laboratory reagents and supplies, the forecast may need to include additional quantities for quality control and training, in addition to client testing. For products that have multiple uses, it may be necessary to forecast demand separately for each use. Examples of forecasting demand separately could include forecasting demand for an antibiotic prescribed for treating sexually transmitted infections (STIs) and OIs under different treatment guidelines, or forecasting usage of an HIV test for diagnostic or confirmatory testing under different testing protocols for PMTCT, clinical diagnosis, or VCT. ESTIMATING COSTS Th e term estimating costs involves calculating the cost of procuring all the product requirements. In addition to the commodity cost, other procurement, shipping, handling, customs clearance, storage, and distribution costs may also be included in the total cost estimate. DETERMINING QUANTITY TO PROCURE Determining the quantity to procure consists of identifying the quantities of products to be procured. If the cost estimate does not exceed the total funds available, then this step is straightforward and requires little to no adjustment of the estimated requirements. In most cases, the quantity to procure will equal the requirements estimate. If, however, the cost estimate is greater than the available funding envelope, an adjustment must be made to the estimated requirements, either by reducing the number of items to be procured or by recalculat­ ing the quantities required of each individual product. GUIDE FOR QUANTIFYING ARV DRUGS 2 For most public health programs, this step involves prioritizing the items to be purchased according to the conditions to be treated or the people to be served, and then reducing the quantity to procure to fi t available funds. In such cases, a variety of methods can be used to arrive at the final quantity of product to be procured, including the use of epidemiological profiles, or ABC and VEN (vital, essential, nonessential) analyses. For HIV/AIDS programs, this step may result in a reduction of the number of people who can be tested for HIV infection or the number of patients who can initiate ART within the period of the forecast. FORECASTING METHODOLOGIES In general, the methodology that is selected for forecasting the future demand for services and commodity needs is based on the availability and quality of data on (a) the rate of consumption of drugs or commodities used and (b) the number and type of patients receiving services, as well as on program policies and expansion plans. The following types of data may be used to guide the forecast: Demographic data based on characteristics of the target population (e.g., age, sex, geographic location, and urban or rural location) • Morbidity data on prevalence or incidence of disease or infection in the target population • Service statistics data on the number of service delivery sites, the volume of services or number of patients per site, and the type of service received • Logistics data on consumption, losses, and adjustments to inventory, and the stock on hand at the various levels of the in-country supply chain. For new and expanding programs or services and for existing programs for which those types of data may be unavailable, unreliable, or not predictive of future demand, forecasts may be based on program targets, such as the number of patients expected to access and receive treatment within the period of the forecast. Targets for expanding programs should be based on realistic service delivery and supply chain capacity, as well as on available resources. Although forecasts based on program targets are commonly used to determine commodity needs and cost estimates for procurement, program targets may also be based on the number of patients who could be treated given a specific amount of funding available and the commodity cost per patient. Forecasts that are based on demographic, morbidity, or target data alone will most often overestimate drug requirements because they do not take into account the actual volume of services being provided or that can be provided, or the quantities of commodities being dispensed or used. Wherever possible, service statistics data on the actual number of patients being treated, as well as logistics data on the actual quantities of drugs dispensed to patients or the actual quantities of commodities used, should be incorporated into the forecast. THE CONSUMPTION-BASED METHODOLOGY Th e consumption-based methodology uses logistics data on consumption of commodities in the past as a basis for projecting future needs. Estimates of increases in consumption or other changes in consumption for each product during the period of the forecast are based on past trends in consumption or product usage. Use of the consumption-based methodology requires the availability of data on the quantities of drugs actually dispensed to patients or on the commodities used at service delivery points over a specified period. In many cases, timely and accurate consumption data are not available, and, even if they are available, consumption data alone will not be indicative of future demand in new programs and in expanding programs. Assumptions will need to be made about the rate of program growth, about prescribing and dispensing practices, and about patient needs to complete the quantifi cation. INTRODUCTION TO QUANTIFICATION 3 THE ADJUSTED CONSUMPTION METHODOLOGY Th e adjusted consumption methodology is an adaptation of the consumption-based methodology that uses the consumption data of one or more facilities that have reliable data and extrapolates from that data to estimate the quantities of commodities needed at other, similar facilities for which no data or unreliable data exist. Again, this methodology requires the availability of timely and accurate consumption data on quantities of drugs dispensed to patients or quantities of commodities used at one or more service delivery sites. THE MORBIDITY-BASED METHODOLOGY In the morbidity-based methodology, the estimation of commodity needs is based on the application of standard treatment guidelines, testing algorithms, or other treatment protocols to the projected number of patients expected to receive treatment or services within the forecast period. The projected number of patients to be forecasted may be based on demographic data, morbidity data, service statistics data, program targets, or a combination of those data. Using the morbidity-based methodology for estimating commodity requirements requires that data on the actual number of patients treated or services provided and the estimated number of new patients to be diag­ nosed and treated or services to be provided within the period of the forecast must be available or must be arrived at through informed assumptions. Standard treatment guidelines, testing algorithms, or other policy guidelines should be clearly documented, disseminated, and assumed to be adhered to by all service providers who have been adequately trained. The accuracy of morbidity-based forecasts depends on the degree to which standard treatment guidelines (STGs) are followed and on the availability of prescribed drugs or commodities when they are needed In practice, forecasts may be conducted using two or more types of data and a combination of methodologies. For example, the results of a consumption-based forecast and a morbidity-based forecast may be compared and adjusted to arrive at a best estimate of future commodity requirements. THE IMPORTANCE OF STANDARDIZATION IN QUANTIFICATION A critical prerequisite for conducting quantification for any essential medicine is the existence of clear, well- defined STGs for defi ning the specific use of individual drugs for treating illnesses and conditions. Th e importance of having STGs in place is magnified in the case of new, rapidly expanding ART programs for the following reasons: • The number of experienced service providers is small relative to the number of treatment sites, and STGs are an essential tool for helping new service providers deliver quality care for patients. • ART service provision consists of providing three or more different ARV drugs in deliberate combinations and doses. Even a slight deviation from predefined combinations can have a negative impact on the health of the patient by reducing the efficacy of a given product or by resulting in adverse side eff ects. • In resource-limited environments a public health approach is used to develop the criteria for product selec­ tion and STG development, meaning that the choice of drug combinations not only are based on safety and efficacy criteria but also include cost considerations. Cost considerations are included so that programs are able to treat as many patients as possible with available funding. Without STGs, physicians may choose unaffordable ARV drug alternatives, which will increase costs for programs and individuals and which could ultimately compromise product availability. GUIDE FOR QUANTIFYING ARV DRUGS 4 Standardization of treatment guidelines is especially critical in the context of quantification. In the absence of quality logistics data, quantification will likely be conducted using the morbidity-based methodology. Standard treatment guidelines must exist and must be clearly documented and disseminated to enhance the accuracy of the quantification using this method. Because ARV drugs are provided in varying combinations to treat patients, quantification is virtually impossible without the existence of STGs. DELIVER has worked in several countries where STGs for ART have been incomplete or have been inconsistent at the time of the quantification, thereby delaying quantification and procurement until the STGs could be fi nalized. INTRODUCTION TO QUANTIFICATION 5 GUIDE FOR QUANTIFYING ARV DRUGS 6 BACKGROUND Successful ART depends on lifelong patient adherence to prescribed ARV drug regimens and on maintenance of a full supply of ARV drugs at ART sites. The threat of drug resistance and changes in patients’ responses to treatment over time make it imperative to ensure a reliable, flexible, and uninterrupted supply of quality ARV drugs that respond to patient needs and that are available when and where patients need them at an acceptable cost. One must understand the specific characteristics of ARV drugs, the ways in which they are used, and the special requirements for storing and handling them to achieve those goals. This knowledge must be incorpo­ rated into the quantification of needs to ensure procurement of the right quantities of the right drugs. CHARACTERISTICS OF ARV DRUGS ART treatment with ARV drugs has several characteristics that affect the management of the commodities and that pose unique challenges in quantifi cation. Those characteristics include, but are not limited to, the following: • ART requires lifelong treatment. • A single ARV drug regimen requires a combination of at least three different drugs, often from diff erent manufacturers, to be available concurrently. • Each drug is often used in more than one regimen. • The choice of regimens includes considerations of weight and toxicity, factors wholly unique to individual patients and factors that cannot be predicted based on data currently available in resource-poor settings. This unpredictability is particularly true for pediatric patients, where changes in weight vary signifi cantly even within a population and where body surface is a factor in calculating dosage. • Treatment failure is difficult to predict and to diagnose in resource-poor settings. • The cost of treatment is still a barrier and varies significantly by source and by the type of regimens in use (many first line regimens are generally less costly than second line regimens). Lifelong ART, which is also referred to as highly active antiretroviral therapy (HAART), requires treatment with a combination of three ARV drugs. Single-drug formulations and fixed-dose combinations of two or three ARV drugs are available for completing prescribed treatment regimens and for facilitating patient adher­ ence. A reliable and uninterrupted supply of ARV drugs is absolutely critical given that more than 90 to 95 percent adherence to ART is required for treatment regimens to be effective over the long term. Lower levels of adherence are associated with the development of drug-resistant HIV. In a twice-a-day regimen, this factor means that less than one dose every two weeks can be missed. Different doses of some ARV drugs are available to enable adjustment of treatment regimens to individual patient needs—for example, stavudine (20 mg, 30 mg, or 40 mg) and didanosine (25 mg, 100 mg, or 200 mg). Single-drug formulations must be available for substitution within first- and second line regimens because some patients develop side effects or toxicity to individual drugs, and because three completely diff er­ ent ARV drugs for second line regimens must be available for patients who develop resistance to fi rst line BACKGROUND 7 drugs. Specific formulations for pediatric treatment regimens include oral suspensions (syrups) and children’s dosages, which are adjusted for weight and body surface area measurements. In addition, quantifi cations will need to be updated to accommodate procurement of new ARV drug formulations and more user-friendly fixed-dose combinations as they become available on the market. ARV drugs are produced in tablet and capsule form and in syrup, oral solution, and oral suspension for pediatric ART. Table 1 lists common ARV drugs for adults and children, including the ARV drug class, drug name, and currently available formulations. Table 2 provides examples of fixed-dose combinations of ARV drugs. TABLE 1. EXAMPLES OF SINGLE DRUG FORMULATIONS (ILLUSTRATIVE LIST ONLY) Adult and Adolescent Formulations Pediatric Formulations Nucleoside Reverse Transcriptase Inhibitors (NRTIs) Abacavir (ABC) 300 mg tablet Abacavir (ABC) oral solution, 20 mg/mL bottle Didanosine (ddI) 125 mg, 200 mg, 250 mg, and 400 mg enteric- Didanosine (ddI) 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg coated capsules chewable tablets Didanosine (ddI) oral suspension, 10 mg/mL bottle Lamivudine (3TC) 150 mg tablet Lamivudine (3TC) oral solution, 10 mg/mL bottle Stavudine (d4T) 15 mg, 20 mg, 30 mg, and 40 mg capsules Stavudine (d4T) oral solution, 1 mg/mL bottle Zidovudine (AZT or ZDV) 100 mg and 250 mg capsules, 300 mg tablet Zidovudine (AZT or ZDV) syrup, 10 mg/mL bottle Emtricitabine (FTC) 200 mg capsule Nucleotide Reverse Transcriptase Inhibitors (NtRTIs) Tenofovir (TDF) 300 mg tablet Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTIs) Efavirenz (EFV) 50 mg, 100 mg, and 200 mg capsules Efavirenz (EFV) 600 mg tablet Nevirapine (NVP) 200 mg tablet Nevirapine (NVP) oral suspension, 10 mg/mL bottle Protease Inhibitors (PIs) Indinavir (IDV) 100 mg, 200 mg, 333 mg, and 400 mg capsules Lopinavir + ritonavir (LPV/r) 133.3 mg/33.3 mg capsulesa Lopinavir + ritonavir (LPV/r) 80 mg/mL + 20 mg/mL oral solutiona Saquinavir (SQV) 200 mg soft gel capsule, 200 mg hard gel capsule Nelfinavir (NFV) 250 mg tablet Ritonavir 100 mg capsule, 80 mg/mL oral solutionb a. Lopinavir exists in co-formulation with ritonavir (LPV/r = Kaletra®) as a boosted protease inhibitor. b. Ritonavir is a protease inhibitor that can be used alone or in combination with other protease inhibitors (lopinavir, indinavir, or saquinavir) to increase their potency, thereby allowing lower doses to be used. Lower doses can reduce the frequency and severity of side effects. GUIDE FOR QUANTIFYING ARV DRUGS 8 More information on suppliers, packaging, storage, shelf life, and pricing of those and other ARV drugs is available from ARV Drug Logistics Fact Sheets (DELIVER 2006). The World Health Organization’s publica­ tion, Scaling Up Antiretroviral Therapy in Resource-Limited Settings: Treatment Guidelines for a Public Health Approach (WHO 2003) has additional information on adult and pediatric dosing regimens and on prescribing guidelines. Those lists are not intended to be exhaustive, and readers should refer to in-country standard treat­ ment guidelines, and to other sources for up-to-date information on which drugs are available and approved for use in particular countries. A major barrier to expanding access to ART in resource-limited countries has been the high cost of ARV drugs. Costs for ARV drugs vary significantly, often depending on whether they are produced by originator manufacturers or generic manufacturers. Originator ARV drugs are generally more expensive than generic drugs, with a few exceptions. Some drug combinations are available only from generic manufacturers (e.g., most triple-fixed-dose combinations, with a few exceptions, are generic) or from originator manufacturers (e.g., LPV/r is produced as Kaletra). Voluntary licensing and price reductions by both originator manufacturers and generic manufacturers have resulted in reduced cost of ARV drugs for resource-limited countries with high HIV prevalence and morbidity. Special provisions, including fast tracking of the U.S. Food and Drug Administration (FDA) approval process, will allow FDA approval of generic manufactured drugs and, hence, will allow their procurement with U.S. government funds for Africa and for developing countries through the President’s Emergency Plan for /AIDS Relief (PEPFAR). Therefore, updated information on local and international pricing for both generic and originator ARV drugs needs to be used for completing the quantifi cation. TYPES OF ART AND COMMON ARV DRUG REGIMENS Antiretroviral therapy regimens for the prevention of mother-to-child transmission of HIV for patients with HIV/TB co-infection and for post-exposure prophylaxis (PEP) should be included in national ART guide­ lines, in addition to the standard first line and second line treatment regimens for adults and children (see table 3). Frequently, national quantifications will forecast demand for all the different regimens and purposes for ART as part of the overall requirements estimation. Table 3 illustrates how a single drug often overlaps in use between several different regimens. For example, according to the list in the table Lamivudine (or 3TC) is the backbone of all the adult and pediatric fi rst line regimens, while Didanosine (or ddI) is the backbone of all the adult and pediatric second line regimens. Miscalculations in estimating requirements of a drug such as 3TC or ddI in a country with regimens similar to those listed in the table will have a widespread effect on the majority of ARV drug regimens, while miscal­ culations in estimating requirements of a drug such as Saquinavir may not have such a widespread eff ect. TABLE 2. EXAMPLES OF FIXED DOSE COMBINATION DRUGS (ILLUSTRATIVE LIST ONLY) Double-Fixed-Dose Combination Drugs Stavudine 30 mg + lamivudine 150 mg tablet (d4T30/3TC) Stavudine 40 mg + lamivudine 150 mg tablet (d4T40/3TC) Zidovudine 300 mg + lamivudine 150 mg tablet (AZT/3TC or ZDV/3TC) Tenofovir 300 mg + emtricitabine 200 mg tablet (TDF/FTC) Triple-Fixed-Dose Combination Drugs Stavudine 30 mg + lamivudine 150 mg + nevirapine 200 mg tablet (d4T30/3TC/NVP) Stavudine 40 mg + lamivudine 150 mg + nevirapine 200 mg tablet (d4T40/3TC/NVP) Zidovudine 300 mg + lamivudine 150 mg + abacavir 300 mg tablet (ZDV/3TC/ABC) BACKGROUND 9 10 GUIDE FOR QUANTIFYING ARV DRUGS T A B L E 3 . E X A M P L E S O F C O M M O N A R V D R U G R E G IM E N S ( IL L U S T R A T IV E L IS T O N LY ) A du lt F ir st L in e R eg im en s d4 T + 3 TC + N V P A du lt S ec o nd L in e R eg im en s TD F + d dI + L PV /r A du lt H IV /T B C o -i nf ec ti o n d4 T + 3 TC + E FV Pe di at ri c F ir st - L in e R eg im en s d4 T + 3 TC + N V P Pe di at ri c S ec o nd -L in e R eg im en s A BC + d dI + N FV Pe di at ri c H IV / T B C o -i nf ec ti o n d4 T + 3 TC + A BC P M T C T Z D V + 3 TC (m ot he r) Po st -e xp o su re P ro ph yl ax is H ig h- ris k ex po su re Z D V + 3 TC + ID V d4 T + 3 TC + E F

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