Conclusions & Recommendations

In regards to the 2017 Zithromax® shipment being held since October 2017 pending large demurrage charges, TEC recommends and concludes that:
– ITI work with Sightsavers to support The Trust in sending a letter to the President of Kenya, with copy to the Ministry of Health (MOH), Ministry of Finance, and Ministry of Foreign Affairs;
– ITI and Sightsavers consider sending a high-level delegation to follow up in person;
– Additional drug (2018 shipment) is not sent until the clearance issues of the 2017 shipment are resolved (2018 approvals are now in “RS”);
– They will defer consideration of the 2019 Zithromax® Application pending resolution of the 2017 clearance issues.

TEC recommends that the FMOH, RHB, and partners should consider including towns in future trachoma prevalence surveys.

TEC recommends to the Federal Ministry of Health (FMOH) and Regional Health Bureaus (RHB) that:
In areas that have started as a single Evaluation Unit (EU)/woreda, and in accordance with WHO’s guidelines on population size for prevalence surveys, recently-split woredas be surveyed as a single EU (comprising the original “parent” district). Note that this does NOT apply to baseline “super districts”, in which multiple woredas were combined to comprise a single EU.

TEC recommends that in light of the Zamfara theft incident, the National Program review its security practices at all state-level drug storage facilities.

TEC recommends that in the Zithromax® Applications, ITI:
-Color the font of TT prevalence greater than threshold in a different color;
-Include cumulative rounds of MDA count pre-2014 as a single column, but maintain the detailed annual breakdown in an electronic version available to TEC members;
-For TEC 19, print only Applications and provide electronic versions of the full TEC book (including detailed Applications);
-For TEC 19, include on the agenda a discussion on “persistent” TF, including:
-Clarity on geographical locations of the observed phenomenon;
-Details on current OR and program efforts already underway;
-Clarity on the questions and how TEC may advise countries

TEC recommends that ITI send acknowledgements to National Programs where districts no longer warrant MDA and have not requested Zithromax®, while acknowledging that many still have TT goals that require further intervention. TEC further recommends that ITI offer technical assistance in dossier development.

TEC acknowledges the enormous progress of National Programs and the commitment of countries and their progress in reducing the burden of trachoma, resulting in lower Zithromax® requests for the first time.

TEC recommends to ITI Supply Chain team to analyze treatments shipped versus distributed separated into POS and tablets to better understand average dosing by presentation and therefore the discrepancy between treatments shipped and distributed.

TEC notes that it would be useful to explore the impact of skipped treatments on trachoma outcomes by considering conducting early impact surveys rather than continued treatments. Information from such an exploration could advise future TEC decisions regarding requests in areas with skipped treatments, for reasons including insecurity, force majeure, etc.

TEC recommends consideration of the collection of infection data in other such situations where there is an unusual relationship between routinely-collected clinical signs (TF and TT) as this has implications for the rational use of Zithromax®.