Conclusions & Recommendations
11.3.1 - TEC Approvals for 2015: Ethiopia
Conclusion/Recommendation:
ITI should explore with the Somali Regional Health Bureau (RHB) and implementing partner whether a pilot distribution in one of the woredas can be conducted to inform the feasibility of scale-up in the first year.
Action:
The ITI National Office has contacted both the implementing partner and Somali RHB to prepare for piloting MDA in one district prior to executing in a large scale. It is scheduled to carry out the pilot exercise in mid-September. As part of this preparation, the Somali RHB has already selected a district and sent a representative to the East Amhara MDA (May 31st through June 3rd) as a learning experience. The ITI National Office will assist the Somali RHB in their preparatory exercises and preparing a detailed plan of action.
TEC 11
2014
Africa - East
Ethiopia
11.4.1 - TEC Approvals for 2015: Tanzania
Conclusion/Recommendation:
The TEC noted that in the Manyara Region, where TF1-9 prevalence is very high, there has been low and intermittent coverage during the past 8-10 years.
Action:
The districts of Hanang, Kiteto and Simanjiro are all approved for 2015 MDA and scheduled for distribution in September 2015.
TEC 11
2014
Africa - East
Tanzania
11.4.2 - TEC Approvals for 2015: Tanzania
Conclusion/Recommendation:
There are concerns that Kiteto, Simanjiro, and Hanang represent a potential reservoir of infection, influencing the control of trachoma in neighboring districts.
Action:
ITI-HQ has suggested a regional review and action plan, but the national program is yet to prioritize the completion of such actions.
TEC 11
2014
Africa - East
Tanzania
11.4.3 - TEC Approvals for 2015: Tanzania
Conclusion/Recommendation:
The TEC suggested that ITI work with implementing partners and the Manyara regional health authority to identify challenges and facilitate improvement.
Action:
ITI-HQ staff plan to visit in September 2015 and will propose strategies with the MoH and implementing partners to identify challenges and establish solutions.
TEC 11
2014
Africa - East
Tanzania
11.5.1 - TEC Recommendations Regarding Malawi Misuse of MORDOR Study Drugs
Conclusion/Recommendation:
Considering that:
- trachoma prevalence in Kasungu is 13.5% and Mchinji is 5.2%,
- the total population is approximately 1 million,
- nearly 20,000 children received study drug, of which 10,000 may have been inactive placebo, and
- the effect of accidental distribution of study drug would reduce coverage by no more than 1% (e.g., approximately 90% instead of 91%),
the TEC and assembled experts do not consider that retreatment is required to achieve the public health goal; however, if the MoH decides that they would like to retreat children who may have received placebo, ITI will support that decision.
Action:
The Malawi MoH chose to not re-treat Kasungu and Mchinji and not to have an information campaign in those areas. ITI has remained committed to provide support to the MoH on request.
TEC 11
2014
Africa - Central/Southern
Malawi
research, Zithromax® donation criteria
11.5.2 - TEC Recommendations Regarding Malawi Misuse of MORDOR Study Drugs
Conclusion/Recommendation:
The TEC recommended that ITI applies lessons learned through this situation to the supply chain and in particular to consider utilizing different consignees for donated vs. study drugs.
Action:
ITI-HQ has initiated mutually agreed upon steps in Tanzania and Niger in order to avoid similar situations. In both locations the consignee for the study drug is different than that of the program drug. Malawi has put in place steps to make it impossible for the study drug to be confused with the program drug.
TEC 11
2014
Africa - Central/Southern
Malawi
recommendations for ITI management, supply chain
11.5.3 - TEC Recommendations Regarding Malawi Misuse of MORDOR Study Drugs
Conclusion/Recommendation:
The TEC and assembled experts recognized that ethical, reputational, and communication issues may arise as a result of this incident, and trust that the MoH, study investigators, and their partners will give these issues due consideration, act in a transparent way, and put in place appropriate actions. ITI are willing to support the program if requested to do so.
Action:
ITI-HQ has initiated mutually agreed upon steps in Tanzania and Niger in order to avoid similar situations. In both locations the consignee for the study drug is different than that of the program drug. Malawi has put in place steps to make it impossible for the study drug to be confused with the program drug.
TEC 11
2014
Africa - Central/Southern
Malawi
supply chain
11.6.1 - TEC Recommendations Regarding Zithromax® Production Shortage Scenario
Conclusion/Recommendation:
The TEC recommended that in the eventuality of a shortage of Zithromax®, ITI consider the following when allocating drug:
- Continue where trachoma MDA is already underway (avoid skipped treatments)
- Delay starting new districts, but consider issues of contiguous areas bordering existing treatment areas and potential to lose new funding
- To ensure the drugs are used in a timely and efficient manner upon receipt, enhance liaison with national programs to ensure:
> increased rigor in the ‘green light’ checklist,
> demonstrated funding, and
> that the proportion of POS and tablets is appropriate for the country needs
-Assess the probability of success, taking into consideration security concerns
Action:
Action items from this recommendation have largely superseded by the e-TEC in April. However, prior to April, the following actions were taken:
- Countries prioritized districts with continuing MDA so that no treatment would be skipped. New districts planned for first distribution in 2014 were put on hold in Ethiopia; this affected projects funded by DFID and the Queen Elizabeth Diamond Jubilee Trust, and caused more concern with availability of donor funds than with the ministries.
- Districts not started in 2014 have been reclassified as starting in 2015 and prioritized for in-country inventory. This particularly affects Ethiopia—all new districts in Ethiopia that were planned to start in 2014 had everything in place for distribution by June 2015.
- All countries were requested to provide physical stock count in January 2015 listing location, lot number, and expiry date. This was taken into account when calculating shipments for 2015. POS was shipped assuming four doses per bottle when reconstituted rather than three. All clearances were in place prior to just-in-time shipments by air. The only country in which this caused some problem was Ethiopia, in which FMHACA were uncomfortable about the short notice between scheduling and shipping.
- Despite instituting the TEC recommendations, it became clear in Q1 of 2015 that these measures were still insufficient to address the production delays and thus a new recommendation was established at the e-TEC in April 2015.
TEC 11
2014
Zithromax® donation criteria
11.7.1 - TEC Recommendation Regarding Operational Research on Alternative Treatment Strategies
Conclusion/Recommendation:
The TEC recommended that operational research be conducted exploring feasible alternative treatment strategies, particularly exploring the cost and effectiveness (measured by infection and clinical disease) of MDA to an entire district population followed by treatment targeting children only.
Action:
ITI-HQ has started discussions with potential implementing organization for the recommended operational research and expects to be able to share a proposal by November 2015.
TEC 11
2014
alternative treatment strategies, research
11.8.1 - TEC Recommendation Regarding Strengthening Zithromax® Supply Chain
Conclusion/Recommendation:
The TEC recommended that the ITI-Africa Regional Office should strengthen Zithromax® supply chain support to partner countries to ensure effective drug inventory management and reduce drug expiry/wastage.
Action:
The ITI Regional Office is working very closely with the African countries to address supply chain strengthening needs.
The ITI National Office is coordinating with each region and the supporting partners to ensure no drug expires and plan timely use of such drugs by mobilizing from place to place. For example, GTM, a local NGO supporting work in Oromia, had drug that was about to expire in December 2014. When the ITI National Office learned of the issue, it encouraged GTM to plan distribution in one of its project districts which commenced in December 26. All drugs that were about to expire were differently marked and provided to specific teams in such a way that it could be utilized immediately and prior to distribution of newer drug. These teams were closely supervised to ensure compliance of the directives, which lead to the use of 19 boxes of POS prior to its expiration. Likewise, and as a result of the shortage of Zithromax® in country, FHF mobilized drug from different project districts and were able to conduct MDA in five districts of Finfine zone of Oromia. This effort will continue in the future; partners and the FMoH/RHBs are becoming more familiar with the practice and are supportive to its implementation.
TEC 11
2014
recommendations for ITI management, supply chain