Addressing the Threat of Drug-Resistant Tuberculosis A Realistic Assessment of the Challenge: Workshop Summary (2009) / Chapter Skim
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6 Global Systems for the Purchase and Delivery of TB Drugs
6 Global Systems for the Purchase and Delivery of TB Drugs
Pages 67-80
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From page 67... ...
As seen in Table 6-1, there has been substantial growth in the number of GLC-approved projects and the numbers of patients treated. In 2006, when WHO changed its global TB policy to recommend treatment of MDR TB patients under proper programmatic conditions, there were just over 5,500 patients enrolled in 32 approved projects.
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From page 68... ...
The vast majority of patients are being treated through non-GLC-approved projects under programmatic conditions that may not be ideal for treatment of MDR TB and with drugs that are not quality assured. As shown in Figure 3-1, in 2008 there were an estimated 500,000 MDR TB cases worldwide.
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From page 69... ...
As a result, deliveries of those drugs were put on hold for a considerable period of time, causing serious supply shortages and stock-outs in treatment projects. THE DRuG QuALITy ISSuE It is important that MDR TB treatment projects follow WHO treatment guidelines and that they use drugs that are quality assured.
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From page 70... ...
Thus if India, China, Russia, and the other priority countries continue to be willing to buy and treat patients with drugs of uncertain quality, it is the market for drugs of uncertain quality that will continue to grow, and manufacturers will see little return on investments in ensuring quality. Zintl added that in the short term, it may be necessary to sacrifice pricing objectives to achieve quality objectives, particularly in those high-burden countries where companies need a financial incentive to raise their quality standards.
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From page 71... ...
Nunn added that unpublished data from more than 10 years ago on first-line drug fixed-dose combinations show that many products, particularly from the Indian market, were substandard. Looking at the high rates of MDR TB in the former Soviet Union, one of the major hypotheses is drug quality.
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From page 72... ...
Such a commitment will include proper programmatic treatment and the use of drugs that are quality assured, and it will require engaging large, priority countries in pressing their pharmaceutical companies to become prequalified or, at a minimum, to be approved by stringent national regulatory authorities. A ministerial meeting is being held in Beijing in April 2009 to urge countries to make these commitments.
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From page 73... ...
NEED FOR ACCuRATE DEMAND FORECASTING Levine discussed the critical role of accurate demand forecasting, drawing on lessons learned from dealing with malaria. In a recent report, a CGD global health working group examines issues related to demand forecasting, analyzing the underlying incentives and risks borne by the various parties involved with providing or using information for demand forecasting (CGD, 2007)
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From page 74... ...
Organization responsible for Mainly District level staff: DPHO, DPHN, DTLP, DASCO, DPHO, etc or staff from the Health Centres , delivery to sub - Dispensaries come up and collect from the District level district levels Figure 6-2 R01436 fully editable
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From page 75... ...
. NOTE: BTC = Belgian Technical Cooperation, CDC = Centers for Disease Control and Prevention, CIDA = Canadian International Development Agency, DANIDA = Danish International Development Agency, DASCO = District AIDS/STD Coordinator, DFID = UK Department for International Development, DLTP = District Leprosy and TB Program, DPHN = district public health nurse, DPHO = district public health officer, EU = European Union, GAVI = Global Alliance for Vaccines and Immunization, GDF = Global Drug Facility, GOK = Government of Kenya, GTZ = Deutsche Gesellschaft für Technische Zusammenarbeit, IDA = International Dispensary Association, JICA = Japan International Cooperation Agency, JSI = John Snow Inc., KEMSA = Kenya Medical Supplies Agency, KEPI = Kenya Expanded Program on Immunization, KFW = Kreditanstalt für Wiederaufbau, KNCV = Koninklijke Nederlandse Centrale Vereniging tot bestrijding der Tuberculose (Dutch Tuberculosis Foundation)
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From page 76... ...
Translating need to actual demand is complex, and involves applying multiple layers of information about both the available financing and the capacity of the health system to provide drugs and scale up when new products are being introduced or new programs are being initiated. Demand forecasts, then, are an essential link in the supply chain and play five critical roles: 1.
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From page 77... ...
SOURCE: Global Health Forecasting Working Group, 2007. Copyright 2007 CGD, reprinted with permission.
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From page 78... ...
NOTE: The shading indicates the most powerful incentive effects. SOURCE: Global Health Forecasting Working Group, 2007.
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From page 79... ...
Ongoing monitoring of Good Manufacturing Practices at facilities is just as critical, or even more critical, than prequalification in ensuring a sustainable drug supply. Companies must learn how to navigate approval and procurement both at a local level and through an entity such as the GDF.
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