Global Drug Facility Technical Assistance update December

During the joint Stop TB Partnership’s Global Drug Facility (GDF) and The UNION mission to Madagascar from 14 to 22 November 2016, clear road maps for the introduction of the shorter MDR-TB treatment regimen (STR) and the new pediatric formulations were developed. Based on resistance patterns detected in Madagascar the National TB Programme will switch all MDR-TB patients to the STR in 2017. Following a forecasting and quantification exercise, order planning was finalized to ensure the MDR-TB patients have access to the STR from September 2017 onwards. In the meantime, it was agreed that national treatment guidelines as well as management and training tools will be revised and updated with the support of The Union. Through the quantification exercise, GDF identified the need for accelerated orders of Cycloserine and Kanamycin to be placed for patients currently on treatment with the longer MDR-TB regimen. Taking into account available stock, lead time, distribution cycle and preparedness of the health workers, various scenarios for the introduction of the new pediatric formulations are being looked at. This will allow 210 children per month to be treated with better medicines in 2017. GDF advised the National Drug Authority on the proceedings to ensure all TB medicines including the new pediatric formulations and new drugs (e.g., Clofazimine) are registered in Madagascar and could be efficiently imported. In this regard, GDF will keep following up to ensure manufacturers provide all required information to the country.

The overall objective of the Stop TB Partnership’s GDF mission to Nepal (28 November until 7 December 2016) was to ensure country has uninterrupted access to quality-assured TB products. The mission focused on three key areas:

Switching to the new regimen and introducing new medicines require careful planning to ensure that required finance, products and technical skills are available. The mission team, in association with the country Global Fund’s Principal Recipient and the National Tuberculosis Centre, designed several scenarios showing the effects of gradual introduction of the shorter MDR-TB treatment regimen and new pediatric formulations. These scenarios were then assessed from a programmatic, supply chain and stock management perspective and decisions were taken.>

The forecast scenarios were made using the QuanTB tool, a software particularly designed for TB medicines. In the week prior to the GDF mission, three pharmacists working with the TB program were trained in the use of QuanTB, during a workshop organized by GDF in Bangkok, Thailand. During the country visit these officers demonstrated excellent understanding of QuanTB and committed to update QuanTB data (stock, pipeline, patient enrolment) on a monthly basis. By doing so, QuanTB will serve as an Early Warning System for stock out and expiry of TB medicines.

During Rwanda Mid-Term Tuberculosis National Strategic Plan review from 14 to 25 November 2016, the GDF team provided leadership in areas of Procurement and Supply Management including the transition plan for introduction of the new pediatric formulations and the shorter MDR-TB regimen for eligible patients.

Since the last GDF mission in 2012, there has been significant improvement in TB care and treatment services in Rwanda. Most of the previous recommendations have been implemented, including the recruitment of a pharmacist at the TB Division, a critical position for the national TB Programme to achieve a well-coordinated drug replenishment pull system. The pharmacist at central level and the district pharmacists take part in coordination meetings, quantification exercises and supervisory visits, and review quantities of drugs available, monitor expiry dates, over- and under-stock, stock conditions and correctness of stock cards and registers.

The GDF team discussed the implementation of the transition plan for pediatric regimens with the national TB Programme and partners, to ensure timely introduction of the new, child-friendly formulations in 2017 and to minimize the wastage of old formulations. The transition plan includes procurement planning, staff sensitization & workshops, delivery of the first batch of new formulations, distribution of the new formulations to district pharmacies and the first cohort of patients initiated on new formulations. The GDF also conducted forecasting and quantification of first- and second-line TB medicines and developed the supply plan for 2017-2018 to ensure that all patients enrolled during the Global Fund grant implementation have their treatments completed. The quantification considered the transition plan to the new pediatric formulations and shorter MDR-TB regimen.

The Stop TB Partnership’s GDF conducted a joint mission to Pakistan with the Global Fund and Systems for Improved Access to Pharmaceuticals and Services (SIAPS) program of Management Sciences for Health (MSH) from 5 until 17 November 2016 as part of its technical assistance. The mission specifically aimed at performing quantification of first-line and second-line TB medicines along with stakeholders, using the QuanTB tool to identify the procurement needs for 2017 aligned with the Global Fund budget. The mission also supported Procurement and Supply Management aspects of the transition planning for the new pediatric formulations and discussed and quantified medicine needs for the implementation of the shorter MDR-TB regimen starting in 2017. The joint mission took place in Islamabad and also included site visits in both Punjab and Sindh Provinces to further discuss Procurement and Supply Management related issues on the ground.

As part of its technical assistance GDF participated in the WHO Mid-Term TB Programme Review in Afghanistan from 19 until 27 November 2016. The GDF team carried out assessment visits to the western province of Herat and its findings and recommendations contributed to the Procurement and Supply Management part of the WHO Mid-Term Review report. During the mission GDF also successfully carried out a quantification workshop for first-line and second-line TB medicines with participants from the National TB Programme, Management Sciences for Health (MSH) and medical staff from the Afghan-Japan Communicable Disease Hospital in Kabul. During the workshop the transition plan for introduction of the new pediatric formulations was discussed, in particular on how to carry out the transition with minimal wastage of the old formulations. Discussions on the country’s future implementation plan to switch to the new shorter MDR-TB regimen were also conducted to determine the timeline for the transition. The quantification exercise that took place as a result of the discussions considered the Procurement and Supply Management and financial planning for the next years as Afghanistan is planning to cover funding gaps for medicines with government budget from 2018 onwards.

To facilitate rapid and efficient uptake by countries of new tools (i.e., medicines and regimens) GDF aims at improving the competencies of national Procurement and Supply Management specialists in forecasting, quantification, supply planning and early warning system. In this regard GDF organized its second workshop from 21 until 25 November 2016 in Bangkok, Thailand attended by 22 participants from 8 countries. Using updated materials adapted from the USAID-funded Systems for Improved Access to Pharmaceuticals and Services (SIAPS) program of Management Sciences for Health (MSH), representatives from Thailand, Bangladesh, Timor Leste, Myanmar, DPR of Korea, Indonesia, Nepal and Bhutan used QuanTB tool version 4.0 to prepare multiple quantification scenarios for procurement, taking into account their patients and stock data as well as particular Procurement and Supply Management constraints. This process also considered their current plan for introduction of the new pediatric formulations and the shorter MDR-TB regimen. The workshop created a distinctive opportunity for countries to share knowledge, to discuss their procurement plans, learn the latest update on new tools available with GDF and to assess the potential risk of stock-outs and expiries during quantification. Following the forecasting and quantification exercises some countries decided to review their initial supply plans as a potential stock-out or overstock situation appeared. During the workshop, GDF also collected the latest information on countries’ transition plans for new pediatric formulations and the introduction of the shorter MDR-TB treatment regimen to feed into the overall GDF forecasting and planning activities.

The Stop TB Partnership’s GDF led the Procurement and Supply Management team during the mid-term external evaluation of Bangladesh National TB Programme from 12 until 17 November 2016. The findings and recommendations of the mission contributed in the revision of the National TB Strategic Plan and are being considered in the development of the concept note for Global Fund funding. Technical inputs including forecasting and quantification were also provided in the planned transition to the new pediatric formulations and the programmatic implementation and scale up of the shorter MDR-TB regimen in 2017.

The Stop TB Partnership’s GDF mission to Sudan from 10 to 20 October 2016 was of high importance, as GDF joined hands with WHO and rGLC to conduct an in depth review of the Sudanese TB Program. This came after the integration of public health programs, specifically on TB, HIV/AIDS and Malaria with Non-communicable diseases. GDF reviewed the benefits of this integration in detail, especially in the context of the well-structured and integrated National Medical Supply Fund (NMSF), which caters the warehousing and distribution of HIV/AIDS, TB and Malaria drugs across the 16 states and 327 health facilities managed by the Enterprise Resource Planning (ERP) system. The integration of health systems also led to the creation of a National Technical Working Group (NTWG) for forecasting & quantification, a dedicated warehouse for TB drugs, a functional ERP system, a Quality Assurance & Drug Testing Plan and reduction of the lead time for custom clearance in the port of entry.

The GDF team reviewed the forecasting and quantification being done by NTWG to provide them with technical support in planning the deliveries of orders of second-line TB drugs, expected in 2017. The GDF team led the comprehensive 3-day quantification exercise along with NTWG, Monitoring & Evaluation staff, rGLC members, the country TB team, WHO and Sudan TB Program review teams to finalize two second-line TB drugs orders being placed with the GDF, the quantification of first-line TB drugs, and to review the medicines’ quantities for the GDF paediatric grant to Sudan for the year 2017. GDF team also supported NTWG to develop a transition plan for the introduction of the new paediatric formulations, which is planned to start from June 2017.