Article

Breaking through Barriers
Delivering Essential Medicines in the Developing World

Five years ago, a fisherman in a remote village on Lake Victoria could buy a 7 UP at the local shebeen but could not get free medicine for his daughter living with AIDS from the district hospital 30 kilometers away, let alone from his community health post. Why was that?

Around the world, a cornucopia of medicines, food and other vital goods move from producer to consumer in an efficient, cost-effective and secure manner, while generally maintaining the quality of the product. This is the work of supply chains – the network of freight forwarders, warehouses and transportation systems through which products flow. In most villages in Africa, one can find a bottle of cola or a pack of cigarettes, because someone profits at each step of the supply chain in getting these products to the consumer. But when it comes to delivering life-saving medicines – which are often subsidized and provided free – the road they travel is often filled with detours, barriers and breakdowns. This has been especially true of medicines and other supplies needed to prevent, diagnose and treat HIV and AIDS.

Progress... to a point
The price of ARVs, long the most visible barrier to providing antiretroviral therapy to people in developing countries, has fallen dramatically from thousands of dollars per patient per year to as low as $120. Still, access is limited by many factors, including a lack of systems to procure essential drugs, HIV test kits, and laboratory supplies from manufacturers, and then reliably deliver them to facilities that test for HIV or care for persons living with the virus.

The solutions start with answering four basic questions for each product: How much do we need? Where do we get it from? How do we get it into the country and keep it secure? How do we get it to the people who need it?

Quantification – How much do we need?
The first step to ensuring the availability of products at clinics, laboratories and other health facilities is figuring out how much of each one will be needed over a given period. This can be tricky when many programs still lack a defined set of protocols that tell health workers which tests are used for detection and confirmation of HIV infection, or which ARV drugs are used for first-line or second-line treatment. So often before even discussing how much is needed, the difficult question of what to quantify must be answered. once the products are selected, in order to forecast future needs, the next step is getting data about how much of each item (ARV drug, HIV test, gloves, etc.) is being used in each facility each month. Because many antiretroviral treatment programs are relatively new, and given the often chaotic nature of scale-up, reliable reporting from multiple sites for dozens or hundreds of products on how much has been consumed, how much is still in the system, and what's been lost through damage, theft or expiry, is elusive. Further complicating the matter is the need to estimate how many patients will have to change to second- or third-line treatment.

Logistics management information systems have been developed to collect data on a regular basis, and this, combined with patient service statistics and other data, can be used to develop estimates of future need for each product. These estimates must then be compared to program scale-up goals, availability of funds, and a realistic assessment of whether the goals will be reached and the funds will be available to procure the products.

Procurement – Where do we get it from?
Once the products and quantities are determined, they need to be procured – purchased or donated – from a quality source for as reasonable a cost as possible. The process is complex and can be daunting. Procuring ARV drugs and rapid HIV tests requires very detailed technical specifications, such as drug formulation and packaging, to ensure that a tender results in quality bids and a contract for high quality products. Simply ensuring that bidders are both reputable and able to deliver the product in the right quantity, the right quality and formulation, at the right time and place and for the right cost, requires significant effort, experience and skill that many health ministries lack.

Donor coordination essential
In many cases there are multiple procurement mechanisms, but no guarantee of coordinated efforts. Lack of coordination can result in shortages or overstocks that lead to valuable medicines or rapid HIV tests expiring unused. But there are models of coordination. In Tanzania, the government decided it would use a combination of its own funds and those from the Global Fund to Fight AIDS, Tuberculosis and Malaria to procure drugs that were not procured through PEPFAR.

Although costs for many ARV drugs have fallen dramatically, some programs require limited amounts, which prevent them from getting the best prices. But there are solutions. The Clinton Foundation has negotiated contracts with a number of manufacturers of lower priced generic ARVs and rapid HIV tests. "About 60 countries can now buy medicine off our low-cost contracts," President Bill Clinton told participants at the XVI International AIDS Conference in Toronto last year. PEPFAR has begun pooling procurement for the programs it supports in order to take advantage of bulk prices.

Freight Forwarding and Inventory: How do we manage it effectively?
Once the procurement contracts are signed, products need to get from the manufacturer or wholesaler to the country or program that will use them. There are many potential detours and breakdowns at this critical step. For instance, if the product is a single bulk shipment, it can overwhelm the in-country storage systems, which are often already at capacity. Multiple deliveries of smaller amounts can be a good solution. Another common problem with medicines, especially as drug regimens change and new drugs are introduced, is that the medicine may not be registered with the national drug authority – (See article on p. 14) changes to formulations or packaging alone can cause medicines to encounter delays in customs because the changes were not submitted to the drug authority.

Another all-too-common but less widely known problem is corruption, as ARV and other drugs intended for developing countries are diverted and sold into informal channels. Moreover, counterfeits often get slipped into the supply chain, either to cover up a diversion or by disreputable distributors. Fortunately, there are models of inventory management and quality assurance systems that can limit the opportunities for diversion and uncover the existence of counterfeit or poor quality drugs. (See article on p. 6)

Delivering: How Do We Get It to the People Who Need It?
The last part of the journey is often the most problematic: distributing drugs from the central warehouses to the clinics and patients who need them. Delivery vehicles need gas and spare parts, especially when traveling the rutted and washed out roads of rural Africa. Local warehouses and clinics need dry, cool, secure storage areas, and sometimes refrigeration, to maintain the quality of the products they store. People need to be trained to know when and how to order new supplies, and given the tools to manage what they have: to report what's been used, what's been lost or damaged or redistributed, what remains, and then to order more. Because of these challenges, clinics and hospitals can face product stockouts or expired drugs.

SCMS – Making Supply Chains Work
PEPFAR has recognized the vital role of the supply chain in attaining the u.S. government's goal of "2-7-10" (treating 2 million people with antiretrovirals, caring for 7 million people living with HIV/AIDS, and preventing 10 million new infections by 2010). In late 2005, PEPFAR launched the Supply Chain Management System (SCMS) as a mechanism to help ensure an uninterrupted supply of medicines and other health commodities to enable scale-up in the developing world.

SCMS brings together 17 organizations, each offering unique capabilities to take advantage of best practices in the public and private sectors. SCMS conducts national quantifications and aggregates these at the global level. To take advantage of bulk prices and shorten the procurement process, it pools procurements, pre-qualifies bidders, produces very detailed technical specifications, and awards long-term contracts to both innovator (branded) and generic suppliers of ARV drugs and the many other products needed for prevention, care and treatment programs. SCMS has set up well-stocked regional distribution centers (RDC) in southern Africa, east Africa, West Africa and one in Georgia, uSA, to serve Latin America and the Caribbean. The RDCs will help to ensure a rapid, reliable and sustainable supply of essential drugs and other vital commodities for care and treatment programs as they scale up to serve more people.

SCMS is working in many of the countries hardest hit by the AIDS epidemic, partnering with local health ministries, non-governmental agencies, faith-based organizations and others to help build the capacity of national supply chains. The focus is on strengthening existing systems and building local capacity. SCMS monitors product quality and is working with in-country partners to strengthen their operations, including transportation, storage facilities and security. This is vital, since HIV/AIDS is a long-term problem that requires long-term solutions, including supply chains that are sustainable, locally owned and managed by skilled and committed people.

By developing a global management information system that can track products from source to customers around the world, SCMS will benefit not only PEPFAR-supported programs, but also those supported by other donors and funders. Quantifications are made available to all donors and programs, and in-country system improvements affect all products in the system regardless of how or by whom they were procured. SCMS is working with the World Health organization (WHo) on global forecasts of ARVs and active pharmaceutical ingredients to support current programs and the anticipated growth in patient numbers during 2007/2008. The conclusion of this work will be shared with manufacturers to support their production and investment planning.

SCMS facilitates collaboration and coordination among global donors and service providers to avoid duplication of effort and to coordinate procurements to prevent stockouts or overstocks. Together with the Centers for Disease Control and Prevention (CDC) and WHo, SCMS is consolidating a list of laboratory supplies that have been used throughout Africa where a proliferation of different equipment and consumable supplies has made establishing reliable supply chains very complex. The aim is to develop a more standardized list of recommended supplies as a guide to users and laboratory managers.

Delivering Hope
Today, somewhere on Lake Victoria, a rural fisherman's daughter may well be one of the fortunate people receiving treatment for HIV/AIDS thanks to better supply chains that allow the doctor at the district hospital to provide her with free and effective ARV drugs, and allow the local health clinic to provide her with medicines to keep her healthy and to prevent the transmission of HIV to her child.

The author would like to acknowledge the contribution of Christopher Wright to this article.

For further information visit http://www.scms.pfscm.org or contact scmsinfo@pfscm.org

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