Global Drug Facility Technical Assistance Update August

The Stop TB Partnership’s Global Drug Facility (GDF) conducted a technical assistance (TA) mission to the Republic of South Sudan from July 23rd to August 6th 2017. The mission provided an opportunity to work with and support the country to review progress made in the implementation of a shorter MDR-TB regimen (STR), which was adopted in April 2017, and assesses the country’s readiness to transition to the optimized child-friendly TB pediatric formulations. Besides providing support in ensuring accelerated uptake of new tools, the GDF team also provided TA in the review of TB medicines quantification data and developing a supply plan for 2018-2020 in preparation for the 2018-2020 Global Fund (GF) grant making, as well as in the assessment of the TB procurement supply management system.

Based on the quantification review, which took into consideration pipeline stocks, 2018-2020 patient projections and PSM costs, the estimated budget for TB medicines procurement was revised from USD $1,516,867, initially submitted to the GF as part of the concept note for the next three years, to USD $2,072,705. This is equivalent to a 36% increment from the original TB medicine budget. In response to the GF Technical Review Panel’s comment on the need to consider increasing DR-TB targets, GDF also supported the country to develop the second quantification scenario for second line TB medicines (SLDs) to be further discussed during the grant making process. The quantification exercise happened together with stock status analysis using the QuanTB tool where potential stock-outs, overstocks and wastage were highlighted.

Overall, the GDF mission recommended the need to expedite distribution and implementation of new pediatric formulations, which were delivered in South Sudan since March 2017, to adjust the current supply plan for first-line TB medicines (FLDs) based on stock status analysis. Staggered FLDs delivery schedule was proposed in order to avoid potential wastage, particularly of USD $50,848 worth of new pediatric formulations likely to expire if delivered as originally planned. The country was also advised to expedite delivery of some items and revise SLDs procurement request to ensure adequate stocks are maintained while transitioning to the next grant as well as to cancel new orders for FLDs worth USD $773, 319 to avoid overstocks. The need to effectively implement the QuanTB tool as an early warning system was highly emphasized to prevent stock-outs and overstocking in the future. The key mission findings were shared with various stakeholders during the debrief meeting led by the Director of Preventive Services and attended by Executive Director for National Medical stores, TB Program Manager, WHO and other in-country partners such as Challenge TB (pictured above).

The Stop TB Partnership’s GDF conducted a technical mission to the Democratic Republic of Congo (DRC) from 31 July to 04 August. During the mission, GDF consultanted, along with NTP staff, the updating stock level as of June 2017 for FLD and SLD at central level and regional level for the 27 provinces. It also reviewed the forecasting and costs of FLD, SLD and laboratory consumables and equipment for the GF grant making period covering 2018-2020. GDF along with NTP developed the orders and procurement plans of FLD and SLD for 2017/2018, based on the revised quantification and distribution plans for new pediatric formulations to all health facilities by September 2017 for effective use starting January 2018. GDF also supported the country to establish a quarterly early warning system and regular communication to GDF and the Global Fund on situations of impending risk of stock-out or expiries. As next steps, GDF recommended NTP to place orders for FLD and SLD by the end of August 2017, based on the revised quantification for the period 2017/2018, and also submitted the quantification revisal and finalization during the grant-making based upon updated data to the Global Fund for approval.

The StopTB Partnership’s GDF conducted a technical mission to Madagascar from 24 July to 11 August 2017. The first two weeks were dedicated to the joint National TB Programme review, and the third week to the quantification for the next Global Fund grant.

The mid-term National TB Programme review was coordinated by WHO and included members from GDF (PSM leader), the Green Light Committee and the Union. During the review, it was agreed among partners that the country needs to update the diagnostic algorithm for MDR-TB cases and review/update current treatment regimens. This could impact the quantification and procurement of TB medicines in the future. When these changes are in place, GDF recommends strict vigilance of case enrollment and stock levels, and regular updates of quantification and procurement plans.

The quarantine of TB medicines is another finding of the mission affecting the pharmaceutical management. A change in the regulations requires that all medicines imported in the country are registered with implications to the supply chain. GDF medicines received in June 2017 were in quarantine since the time of the mission while awaiting for the registration procedure to be completed. As a consequence, shelf life of medicines is reduced, the distribution plan can be disrupted and stock-outs of TB medicines may occur impacting the regular quantification exercises and procurement planning of the NTP. GDF also found regulatory issues, as the simplified registration procedure put in place by the NRA for medicines used by the national public health programmes, requires samples to be collected and tested by the National QC Laboratory. GDF interacted with MOH in this regard and the Secretary General indicated that a regulation could be applicable which waives the registration requirement and could be applicable to paediatric formulations and medicines used for treatment of DR-TB.

Quantification for the next GF grant to cover the period of January 2018 - December 2020 was developed along with the NTP, Global Fund Secretariat and Partners. The QuanTB tool was used during the working sessions by previously trained national staff. The GDF mission on November 2016 defined the procurement planning for 2017. Procurement of Ethanbutol 100mg, (the only order that was placed and agreed upon by GF) performed by the central medical store with government budget, was unsuccessful due to the lack of registered product in country.

A SLD order may be needed to prevent risk of disruption on MDR-TB case enrolment. Quantity equivalent to 35 MDR-TB treatments will be received in September 2017 (as per previous quantification). However, the enrolment rate could be higher since the NTP plans to change the algorithm to treat all patients positive to Genexpert with SLDs (as per WHO recommendation). Treatment for XDR-TB cases may also be needed in the short term. The National TB Programme review identified, through a research project, that there are patients with INH resistance and resistance to Fluoroquinolones and/or injectable SLD. An XDR-TB regimen needs to be formulated with TA support and endorsed at country level. For these problems GDF recommended NTP to regularly update the case enrollment and stock levels to review the quantification and supply planning, and apply the early warning system and prevent stock-outs

The Stop TB Partnership’s GDF will participate in the Joint TB, HIV, Community and Home Based Care (CHBC) and Viral Hepatitis review from 4 to 15 September in Botswana. The main objectives of this mission are to: support the program review on the assessment of the PSM system; review/discuss the PSM transition plans for new pediatric formulations, STR and new medicines; provide technical support for the Global Fund funding request on PSM aspects; and review the quantification for FLD and SLD for 2018-2020 and procurement plan, among others.

GDF will also conduct a mission from 4 to 14 September in Ukraine to follow-up on the implementation of new drugs, particularly Bedaquiline, and facilitate training-of-trainers on PSM and quantification, as agreed during a previous mission conducted in July 2017.

The Stop TB Partnership’s GDF will conduct a joint mission with GLC in Nigeria from 11 to 20 September. The main objectives of this mission are to: update the PSM transition plans for STR; new medicines and new pediatric formulations; provide technical support for Global Fund grants; review the quantification of FLD and SLD; and develop optimized procurement plans with more frequent delivery schedules.