Global Drug Facility Update

At the request of the Global Fund (GF), GDF arranged a technical mission to Afghanistan between 24 September - 4 October to review aspects related to procurement and supply chain prior to the GF grant-making deadline of mid-October 2017. Under the new GF grant starting in 2018, the NTP/Ministry of Public Health (MoPH) will be responsible for procuring 50% of First Line Drugs (FLDs). The remaining 50% of FLDs and 100% of SLDs will remain to be funded by JICA for the next three years. The mission team, which included the CSO responsible for Afghanistan, undertook the mission to Kabul and further discussed and aligned the procedures for future TB goods procurement under the new funding arrangement. In addition, the mission team undertook a full FLD and SLD quantification together with various partners (NTP, MSH, JICA, WHO, MoPH Global Fund Coordinating Unit and staff from Afghan-Japan Communicable Disease Hospital). Together with partners, GDF reviewed Afghanistan’s plans to start the STR in Q1 2018, and uptake of new drugs Bdq and Dlm in line with the country’s MDR guidelines and pharmaceutical policy. The mission team also visited a paediatric hospital in Kabul in order to review progress of Afghanistan’s uptake of the new paediatric formulation following the last GDF grant delivered at the end of 2016.

At the request of the Ministry of Health, through WHO Gabon, GDF conducted a mission from 8 to 13 October to analyze the anti-tuberculosis drug supply and propose improvements. GDF found a very critical situation in Gabon with a total stock-out of drugs treating sensitive TB, leaving thousands of patients without treatment options, as the private sector can respond very little to the demands. The situation is not much better for patients with resistant TB, with an increasing number of cases and a waiting list that continues to grow due to lack of capacity in the country. The main recommendations from the GDF mission were to:

- urgently release funds and place orders for first-line TB medicines

- improve the acquisition process of anti-TB medicines by a better planning of needs, the provision of funds on time, the use of recognized procurement agencies (that purchase quality products, recommended by WHO, at negotiated prices)

- strengthen the regulatory environment by ensuring that all anti-TB medicines comply with national guidelines, have marketing authorization, meet the quality criteria recommended by WHO, and this both in the public and private sectors

- improve storage conditions and drug management at the health facilities for better data quality, conduct quality control and collect data for pharmacovigilance

- strengthen the capacities of the NTP by providing the staff with training in planning and needs assessment, monitoring and supervision on PSM aspects

From 11 to 20 October, Stop TB Partnership/GDF’s technical assistance mission to Myanmar successfully delivered its objectives through a string of key activities:

During the course of the mission, the team highlighted Myanmar NTP’s achievements. Among these are the government-proposed steps to procure anti-TB medicines with 100% coverage of FLD starting in 2019, a grant negotiated for 2018-2020 with the Global Fund amounting to $94 million, the program contracted additional storage capacity for the central warehouse, and a quality control system of TB medicines is in place. In addition, new TB tools and regimens are fully implemented: Bedaquiline (BDQ) - started in March 2016, Delamanid (DLM) - started in June 2016, and new pediatric formulations - started in April 2017. A shorter MDR-TB regimen (STR) is expected to be implemented in Q4 2017.

At the conclusion of the mission, the GDF team provided the following key recommendations:

GDF supported the Kingdom of Lesotho during the Joint TB/HIV Programme Review held from 23 October to 3 November. The review of the stock status using the QuanTB early warning systems (EWS) was a key activity carried out during the mission. The output showed some risk of stock-outs and potential expiries of the first-line TB medicines.

In view of this, GDF put up mitigation strategies which included plans to reduce the risk of expiries through engagement with manufacturers to split or cancel some orders. Achieving this would directly translate to savings worth $56,000 USD. The continuous use of the QuanTB EWS would greatly enhance the management of TB medicine amidst scarce resources.

Lesotho is one of the countries that has benefited from the supply of new TB medicines (Bedaquiline and Delamanid) for the management of drug-resistant TB cases. Although treatment successes have been recorded, patients are still being placed on the longer TB treatment regimen, which last 20–24 months. To enhance compliance and early recovery from disease, the mission recommended the introduction of the shorter treatment regimen with lower cost and treatment duration to enhance the quality of life of the patients.

The GDF technical assistance (TA) mission to Zimbabwe was conducted from 23 to 31 October. Zimbabwe is among the first few countries in the Anglophone region to adopt the newly optimized child-friendly pediatric formulations, which were officially launched in January 2018. At the time of the mission, all pediatric cases in facilities visited were on the new formulations and adequate stock levels were available. Preparations for the introduction of the shorter MDR-TB regimen (STR) were ongoing, with the rollout expected to start from December 2017. Further steps have also been made in the introduction of new DR-TB medicines. Bedaquiline is already in use, with Delamanid awaiting delivery scheduled for December 2017.

The mission observed some challenges, such as a lack of active Drug Safety Monitoring (aDSM) targeting the new DR-TB medicines. The system has yet to be initiated despite being one of the key World Health Organization (WHO) requirements while scaling up the new medicines. However, the mission also observed ongoing collaborative efforts between the TB and HIV program in strengthening Adverse Drug Reactions (ADR) reporting through implementation of targeted spontaneous ADR reporting. This intervention has helped to increase ADR reporting from about 100 reports in 2012 to over 1000 in 2016.

The key recommendations for this mission included the need to consider developing a roadmap for implementation of aDSM for the new DR-TB medicines and fast-track countrywide rollout of STR. The country was also advised to optimize the use of early warning systems (EWS) to minimize incidences of stock-outs and expiries which were noted during the mission, expedite delivery of pending stocks, immediately initiate procurement for medicines with low stock levels and ensure timely distribution of TB medicines to all warehouses and health facilities.

A five-day workshop was conducted by Stop TB Partnership/GDF in Islamabad, Pakistan, on 6-10 November. The participants comprised representatives from the national NTP team of both Pakistan and Afghanistan, and pharmacists from key provincial TB offices in Pakistan responsible for forecasting and inventory management of TB medicines. The workshop aimed to improve innovative PSM practices for TB medicines in Pakistan and Afghanistan and ensure earlier and rational uptake of new TB tools.

A total of 29 participants attended the workshop and provided positive feedback, particularly in the presentations of PSM concepts and the use of QuanTB tool. QuanTB is a desktop quantification tool developed by SIAPS project funded by USAID. Toward the end of the activity, all of the participants were able to utilize QuanTB using actual data from their respective offices and thus gained a better picture of their facilities and national stock supplies.

At the conclusion of the workshop, Pakistan and Afghanistan NTP both planned to implement the use of QuanTB as an early warning system to regularly quantify and review TB stocks for supply planning.

Liberia is one of the countries that regularly sources its TB medicines and diagnostics from GDF. However, a few years back, the country made procurements outside of the GDF mechanism and some of the medicines were reported to have failed quality tests, leaving the programme with critical risk for patient care.

Following this experience, the country resolved to source all of its medicines from the Global Drug Facility using both domestic financing and external funding, because of the assurance of the quality of medicines with GDF.

In addition to the supply of quality assured medicines, GDF this year provided supplies of new TB medicines (Bedaquiline and Delamanid) and training on the use of the latest version of the Quan TB tool for quantification and EWS to enhance stock management and uninterrupted supplies of TB medicines in Liberia. It is hoped that this support will facilitate attainment of commodity security across the country.