Global Drug Facility Technical Assistance Update: June

Missions in May-June

Regional GDF Workshop on Forecasting, Quantification, Supply Planning and Early Warning System for Francophone African Countries (Dakar, Senegal, 12-16 June 2017)

Upcoming missions in July

Stop TB Partnership's Global Drug Facility (GDF) contributed to the DPRK Joint Monitoring Mission (JMM) from 6 to 16 May 2017. The JMM mission was composed of five international experts, along with counterparts from the DPRK, and the Principal Recipients (WHO and UNICEF) of the Global Fund grant. TB facilities were visited in the capital Pyongyang, and two teams made brief field trips to South Pyongan and to South Hamgyong.

GDF reviewed the procurement of TB and ancillary medicines with the NTP and other stakeholders and provided technical leadership in TB commodity management systems at all levels of service delivery. Technical assistance was provided in PSM and support was given in identifying key challenges in quantification, order planning, stock/inventory management, distribution, storage, delivery and quality assurance. The mission also supported the NTP to quantify FLDs and SLDs for 2017-2018 using quantification tool for TB medicines.

TB is reported to be the government’s highest health priority. NTP is currently preparing a new national TB plan for the period 2018-2022 to ensure the sustainability of current successes. Preliminary results of the national TB prevalence survey conducted in 2015/2016 were revised upwards from 550 to 640 cases per 100,000, with a bacteriologically confirmed pulmonary TB rate of 589 per 100,000 populations and a smear positive rate of 331 per 100,000. The treatment success rate has been reported to be around 90% for nearly 20 years, and case detection around 80-90%.

The JMM called for, among others, an increase in the contribution of domestic funds for the TB national programme, and the taking of the procurement of quality assured FLD to the Province of Jagang over the next year. It also called for the implementation of early warning systems to reduce the risks for stock- out. In addition, the JMM called for the setting up a holistic LMIS by incorporating key characteristics of the supply system for TB medicines and laboratories commodities.

The new, optimized, child-friendly TB pediatric formulations will soon be available in Vietnam through the Stop TB Partnership’s GDF grant in Q3 2017 and should benefit 3800 children. Before this, pediatric patients and health workers had to use the adult formulations by cutting or crushing the tablets to help patients in swallowing. GDF conducted a technical assistance mission from June 5 to 14 to support the country in the planning for a smooth transition and implementation of new pediatric formulations among others. The program and GDF agreed to work together to develop an instruction manual for the warehouse to guide the inventory management and one for the health facilities in the proper administration of the medicines. The plan for the procurement of new pediatric formulation using government funds was discussed to ensure the sustainability and uninterrupted supply.

The mission also reviewed the quantification and supply planning of the medicines and laboratory supplies, particularly new TB drugs and Xpert cartridges. The program has implemented a shorter MDR-TB regimen and bedaquiline under study protocols and is currently waiting for approval for the extension of the studies to treat more patients. Delamanid is also planned to be implemented in the country by end of 2017, in collaboration with partners and Otsuka. GDF was able to alert the program that there is potential risk of stock outs of Xpert cartridges, hence it was recommended to accelerate the procurement process.

Ngan, a TB pediatric patient, with her mother (L) and district health doctor(R)

From June 7th to 16th, the Stop TB Partnership’ GDF conducted a technical assistance mission to Malawi. The key objectives of this mission were to review progress made for the introduction of new, optimized child-friendly pediatric formulations, support the development/review of PSM transition plans for shorter MDR-TB regimen (STR) and new MDR-TB medicines (bedaquiline and delamanid), and provide technical support to address Procurement and Supply Management-related comments from the Technical Review Panel (TRP) for Global Fund grant making (2018-2020). Hence the mission was scheduled to occur at the same time with the GF grant making process.

In line with the above objectives, GDF with the country team reviewed transitions plans for STR and new medicines and jointly agreed to accelerate the process. The quantification for TB medicines was revised in line with TRP comments. GDF recommended to phase out retreatment regimen (Category II) and accelerate introduction of STR for all eligible patients and the new anti-TB medicines. In addition, companion medicines for the use of bedaquiline and delamanid which were initially not factored in were incorporated in the procurement plan. The introduction of the new anti-TB medicines will give patients/clinicians alternative options for the management of adverse drug reactions and extensive resistance to second line anti-TB medicines.

The revised quantification resulted in the saving of about USD 270, 000. Also, in an effort to minimize the wastage of medicines, GDF advised the country to cancel pending orders for retreatment regimen. These savings are valuable as they will be channelled to the procurement of other essential commodities. GDF also made a recommendation to expedite the procurement of additional quantities of new pediatric formulations and of some second line TB medicines in order to prevent treatment interruptions and expedite the introduction of new medicines and STR. Procurement process was immediately initiated as recommended.

GDF conducted its first regional workshop for the francophone Africa region in Dakar, Senegal on 12-16 June 2017. Twenty-four PSM experts from the following 12 francophone African countries attended the meeting: Benin, Cameroon, Central African Republic, Chad, Côte d'Ivoire, Democratic Republic of Congo, Guinea, Madagascar, Mali, Morocco, Niger and Senegal.

The workshop objectives were to improve national PSM practices for TB medicines and ensure a rapid and rational uptake of new TB tools. This would be achieved by developing the capacity of participants to accurately quantify their needs, implementing EWS and optimizing procurement with more frequent deliveries to prevent stock-outs and overstocking, and considering available external and domestic funding to ensure the supply of quality of medicines and the sustainability of these supplies. GDF is using the latest version of QuanTB to enable this work and supported participants to analyze their country situation relating to the procurement of TB medicines. At the end of the workshop, countries developed quantifications for FLMs and SLMs, analyzed QuanTB reports in group sessions, discussed issues related to PSM, and agreed on corrective actions to prevent impending stock-outs and expiries.

GDF will be following up and monitoring the implementation of QuanTB tool and the EWS in francophone African countries by reviewing the quantification for TB medicines on a quarterly basis, as well as updating procurement and supply plans and providing advice on any PSM-related challenges they may encounter. The workshop presented a good opportunity for GDF to support and inform regional countries on PSM procedures, new medicines and diagnostics available in the GDF catalogue, the status of individual orders, understanding the challenges they faced, and offering more tailored solutions to countries. The workshop also served as an opportunity to assess country TA needs and how GDF and global partners could address these needs, as well as to enable South- South exchanges of experience, knowledge, resources and best practices in PSM.

Stop TB Partnership's GDF mission will be conducted in South Sudan in July 2017. Its main objectives are to support the quantification and procurement planning for the Global Fund grant making, discuss PSM transition plans for new tools, review the current regulatory system and discuss procurement plans for transition from external funding to domestic funding among others.

The Global Fund requested Stop TB Partnership’s GDF support for the grant making of DRC. The consultant, Angelo Makpenon, who did the last 2 missions in DRC was asked to participate remotely to the strategic review related to PSM activities on July 5th and to join the GF team the last week of July to finalize the PSM plan and budget.

Stop TB Partnership’s GDF will participate to the Programme Review in Madagascar to cover the PSM part from 24 July to 4 August. In the following week from 7 to 11 August, GDF will support the Global Fund grant making for the PSM aspects.