Stop TB Partnership

Global Drug Facility Technical Assistance update for March


Kenya

Stop TB Partnership’s Global Drug Facility (GDF) participated in the Kenya midterm review conducted from 23 February to 8 March, 2017 to assess the current situation of the National Tuberculosis, Leprosy and Lung Disease Program in terms of achievements, challenges, emerging needs, opportunities and best practices focusing on PSM aspects for the implementation of current strategic plan and provide recommendations on how to improve TB supply chain management for the subsequent strategic plans and Global Fund funding request. The key findings include high government commitment to support procurement of TB commodities. Seventy percent of the budget for procurement of the TB commodities is funded by the government of Kenya. On-going efforts to integrate Logistics management information system (LMIS) into District health information system (DHIS) was also noted which is expected to improve data visibility and use for decision making. However, the team also observed challenges related to sub-optimal capacity to manage TB commodities at health facility level contributing to risk of stock outs. GDF recommended the country to establish and operationalize TB commodity management teams at sub national level and strengthen capacity of TB commodities management at all levels. During the visit to Kenya, GDF along with partners validated the quantification with updated data and procurement request for shorter MDR-TB regimen, BDQ and DLM and appropriate supply plan for optimized deliveries was recommended.

Democratic Republic of Congo

Stop TB Partnership’s Global Drug Facility (GDF) conducted a technical mission in the Democratic Republic of Congo from March 1-18, 2017 at the request of the Global Fund to support the National TB Program in forecasting the needs of medicines and diagnostics for the period of 2018-2020 in view of the GF funding request. During the mission all current transition plans for new tools were reviewed and in particular for the introduction of the new child-friendly pediatric formulations. Initially planned in a phased manner, discussion are taking place to transition the entire country from January 2018, including estimation and analyses of current drug quantities unlikely to be used (“wastage”), cost of new drugs and potential savings in different scenarios for accelerated introduction. Some specific support has been provided by GDF to expedite the registration of the new child-friendly pediatric formulations which will facilitate future importation. In addition, GDF consolidated a cost estimation of the PSM-related activities of the in-country supply chain to ensure funds are adequately budgeted and included in the GF funding request. This will ensure the TB commodities are timely distributed and adequately stored to maintain their quality up to the end-users’ level. The mission was also an opportunity to review the current data collection and stock inventory system and recommended the set-up of an early warning system with regular communication with GDF and GF to allow prompt action to prevent shortage and overstock of medicines.

Bangladesh

Stop TB Partnership’s Global Drug Facility (GDF) participated in a workshop in Bangladesh from 13-16 March, 2017 organized by the Global Fund to discuss the government’s preparation to take over the procurement of first line TB drugs (FLDs). The government intends to fully procure FLDs starting in 2018 and the workshop discussed budget availability, procurement process planning and emphasized the quality standards of medicines that will be procured using domestic funding. A list of options considering the timeline and the quality assurance of procurement was presented during the workshop. The first option was to procure directly from GDF, however there were concerns especially since the government has to abide by the government public regulations for procurement. The agreement was for the NTP to discuss the option with the government procurement arm (CMSD) and the government manufacturer (EDCL), as well as to organize a high level meeting with the Ministry of Health, Ministry of Finance and the Ministry of Planning. The NTP is on track for the transition plan of the new child-friendly pediatric formulations, however, there were some delays in the implementation of the Shorter MDR-TB Regimen due to challenges in training which has been recently resolved and rescheduled. Shorter MDR-TB Regimen will be implemented from April 2017. There were also some concerns about the laboratory reagents and the installation and certification of laboratory equipment. GDF is linking the NTP to the manufacturers and some technical partners in order to support them on these issues.

Tokyo, Japan

Stop TB Partnership’s Global Drug Facility (GDF) participated in the 11th National TB Programme Managers Meeting in the Western Pacific Region (WPRO) from 19-21 March, 2017 in Tokyo, Japan. The meeting was attended by several WPRO countries including Cambodia, Philippines, Vietnam, Papua New Guinea, Mongolia, China, Singapore, Australia, New Zealand, Malaysia, South Korea and partners including WHO, GLI, USAID, Research Institute for Health, Korea Institute for Health, among others. Civil societies and patient groups were also represented. GDF provided updates on access to TB products, including the new child-friendly FDCs for treatment drug-susceptible TB in children, shorter MDR-TB regimen, new and repurposed TB medicines. GDF highlighted the technical assistance and capacity building provided to countries particularly for accelerated uptake of new tools, where GDF works with NTPs and partners in developing different scenarios to have an informed decision regarding the transition to new TB tools, including estimation and analyses of current drug quantities unlikely to be used (“wastage”), cost of new drugs and potential savings due to earlier introduction. There was a discussion around the slow uptake of new TB medicines and many countries expressed their challenges in the access since these drugs are not yet registered with the national drug regulatory authorities, hence some of them are not using and others are implementing as operational research only. GDF provided advice and linked up countries with other agencies and partners for assistance on that regard. Several side meetings were conducted with countries to discuss procurement and supply challenges and how GDF can proactively support them to improve quantification accuracy and optimize schedule of deliveries.

Ongoing Missions:

Cameroon

StopTB Partnership’s Global Drug Facility (GDF) is conducting a mission to Cameroon from 29 March to 7 April, 2017. The purpose is to participate in the program review to cover the PSM aspects and to offer specific technical assistance in reviewing the implementation plan of the new TB medicines, preventive therapy (LTBI) and shorter MDR-TB treatment regimen. This mission will also include an analysis of the procurement plans of Cameroun to transition from external to domestic funding and specific support in preparation of the PSM aspects of the funding request to the Global Fund.

Upcoming Missions:

Kazakhstan

Stop TB Partnership’s Global Drug Facility (GDF) will be conducting a mission to Kazakhstan from 1-7 April, 2017. The overall objective is to strength the National TB program and its partner KNCV Country office’s capacity on quantification, enable monitoring of the introduction of new TB tools in a rational manner and roll-out the early warning system to prevent stock-out and overstocking. GDF will facilitate training on Forecasting, Quantification, Supply Planning and Early Warning system for representatives of the central and regional (oblast) TB facilities and the principal recipient of NFM TB grant; finalize along the NTP and partners the PSM plans for introduction of new TB tools and perform adjustments, as needed; and finalize with the Principal Recipient of GF the procurement order planning for SLD and new child-friendly paediatric formulations with optimized delivery schedule.

Angola

Stop TB Partnership’s Global Drug Facility (GDF) will be conducting a mission to Angola from 24 April to 3 May, 2017. GDF will support NTP and partners to identify key challenges in quantification, order planning, stock/inventory management, distribution, storage, delivery and quality assurance; quantify first- and second-line TB medicines based on data available using QuanTB tool; discuss transition plans for the introduction of new child-friendly pediatric formulations, shorter MDR-TB regimen and new MDR-TB drugs, including estimation of quantities unlikely to be used, cost of new drugs and potential savings in different scenarios; assess the current regulatory systems and discuss options to ensure timely access to quality-assured medicines; and discuss procurement and order planning with option for transition from external to domestic funding.