Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant Tuberculosis Workshop Summary (2013) / Chapter Skim
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2 Logistics, Supply, and Demand
2 Logistics, Supply, and Demand
Pages 49-66
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The next section focuses on the importance of improved demand-forecasting methodology and improved information management systems in strengthening the SLD supply chain. The final section explores issues concerning national- and internationallevel drug shortages.
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There are currently 12 formulations on the WHO list of PQ SLDs for MDR TB, from only 3 manufacturers (Figure 2-1) .3 The small supplier pool for PQ SLDs exposes the global supply chain for MDR TB drugs to a significant risk of drug stock-outs should a single supplier stop production.
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Presentation at IOM workshop on Developing and Strengthening the Global Supply Chain for Second-Line Drugs for MultidrugResistant Tuberculosis. Figure 2-1 1 percent failed due to extreme deviations.4 Hedman suggested that the general scarcity of data linking patient outcomes to QA status of a particular product has inhibited the ability to derive accurate conclusions about the true risk of treatment with non-QA drugs or substandard drugs.5 She therefore noted that there is a need to mine in-country primary data from MDR TB programs to inform the market and guide SCM.
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He cited anecdotal evidence that TB drug producers "are playing with some of the standards of what is inside a tablet" by using inadequately QA API for their FPPs. Andrew Gray, University of KwaZulu-Natal, expressed similar concern that some manufacturers, particularly large firms, might have WHO PQ status and adhere to stringent quality standards in only one of multiple plants that are producing the same drug.
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In contrast to regulatory reciprocity, regulatory harmonization seeks to standardize methodologies, reduce the regulatory burden, and minimize delays. Seiter explained that in the absence of stringent regulatory oversight, the buyer needs to ensure quality of the drugs procured.
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According to Seiter, part of that system strengthening, particularly with respect to the NTP, should also include development of India's own voluntary stringent regulatory pathway. This would enable the development of a recognized "seal of approval," both for the purpose of exporting SLDs to other countries and to allow domestic procurement financed by external donors.
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Keravec maintained that the "working group" model has facilitated improved interactions between producers and regulatory authorities as they have undertaken efforts to improve drug quality and harmonize analytical methods by decentralizing quality testing to the state level. Transparency for stakeholders is ensured because reports on product quality are publicly and freely accessible.
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This section of the report provides an overview of the key roles that improved demand forecasting will need to play in addressing demand-side challenges to the SLD supply chain. O'Brien provided a synopsis of demand-forecasting fundamentally, described ways in which SLD demand forecasting methodology could be improved, and explored the impact of accurate and credible demand forecasting for suppliers.
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Finally, the results should be communicated to the consumer in a way that does the following: • satisfies the consumer's main objective; • explicates the logic behind the model; • makes assumptions clear; • anticipates questions; and • establishes the forecast's credibility. O'Brien noted that a properly designed and credible demand forecast can play a key role in aligning product prices with their true costs by reducing demand uncertainty and improving visibility into expected orders.
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For example, he suggested that countries should be permitted to procure drugs directly from manufacturers as long as they are QA through a mechanism like the Global Fund's 90-day rule, which allows a country to use second tier–level drugs if optimal quality drugs are not available within 90 days. As Andreas Seiter, Senior Health Specialist, Pharmaceuticals, Health, Nutrition, and Population, World Bank, commented, significantly lower prices can be achieved through this type of direct procurement.
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Lisa Hedman, Project Manager, WHO, stated that an evidential link between drug quality and actual patient outcomes had yet to be con cretely established and warned that current data are insufficient to sup port a "risk-based" approach to QA. She stated that available data show real problems, citing as an example a case study documented by CHAI in India in which QA policies for locally procured medicines and donor funded procurement policies were operating as discrete systems within the same country, and a quality two-tiered market emerged between QA and non-QA products.
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Fraser emphasized that improving the efficacy and breadth of information management systems could concomitantly increase demand-forecasting accuracy; increase supply chain transparency; and improve health system strength, scalability, and sustainability. He listed a number of core variables11 that should be collected and quantified with respect to the SLD supply chain, adding that although they are not difficult to collect in principle, they can be challenging to implement without good tools and training.
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Information Technology Suggestions for MDR TB Supply Chain Fraser offered several concrete suggestions, or "low-hanging fruit," that might drive efforts to improve the MDR TB SLD supply chain, as follows: • There is a need for better standardized national and international coding of medical products in order to track and map shipments. • If products all bore internationally agreed-upon bar coding con taining name, batch number, expiry data, and authentication ID data, accuracy and workflow could be dramatically improved.
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Causes of National- and Global-Level Supply Chain Shortages15 Perrin emphasized the importance of setting and maintaining international quality standards for drugs and the benefit that the WHO PQ program provides in that regard to low-income countries. He also acknowledged the Global Fund's and GDF's efforts to align their QA policy with WHO PQ and other SRAs.
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Discrepancies between actual diagnoses and the volume of SLDs ordered can result from inadequate data collection and forecasting competencies and can also lead to shortages. Potential country-level solutions that Perrin suggested include strengthening NTP leadership and centralizing SLD supply chain coordination, and increasing human capacity for consistent program management with training programs led by qualified staff from donor agencies.
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Key design criteria for the solution were usability in the targeted environment, capacity for scale-up to an unlimited number of health facilities and countries, affordability,18 availability as a subscription service with no requirement for initial or future technology investments or management, commercial sustainability for service providers, and reliability proven via initial implementation in the pilot country at scale. To date, the program has been implemented in all public health and faith-based facilities in Tanzania and in pilot districts in Kenya and Ghana, with implementation planning in progress in Cameroon and the Democratic 16 This subsection is based on the presentation by Jim Barrington, Global Program Director, Novartis.
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, or whether there are limitations on the extent to which data can be made available at the health facility level due to its high value and resulting security concerns. TB Drug Shortages in the United States19 Cegielski highlighted the issue of TB drug shortages in the United States to illustrate that the problem is not exclusive to low- and middle-income countries, nor is it limited in the United States to TB drugs alone.20 He described the results of an unpublished survey that was undertaken in 2010 through the National TB Controllers Association to assess drug shortages 19 This subsection is based on the presentation by Peter Cegielski, Team Leader for Drug Resistant TB, International Research and Programs Branch, Division of Tuberculosis Elimination, CDC.
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• here is a need for better demand forecasting, and there is a T need to distinguish between aspirational forecasting and realistic forecasting. • nnovations in information management may offer improvements I across many aspects of the SLD supply chain, from tracking of treatment to demand forecasting to reduction of stock-outs.
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