Ehnri.gov.et

International Consultative Workshop on “Anti-Malaria Drug
Efficacy Studies in Ethiopia”
The Ethiopian Health & Nutrition Research Institute, EHNRI, 8th & 9th of July 2013,
Addis Ababa, Ethiopia
Executive Summary
Background & Rationale
In line with the RBM/WHO recommendations, Ethiopia has embarked on the road to malaria elimination, and aspires to achieve two major goals by 2015, that are; eliminating malaria from the traditionally low malaria unstable transmission areas of the country, and achieve zero malaria related mortality, in all malarious parts of the country. Ethiopia, which is strongly supported by Global Fund and international partners, is moving along to achieve these goals by employing one of the efficacious Artemisinin Combination Therapies (ACTs), the Artemether-Lumefantrine (AL), which has been the first line drug against Plasmodium falciparum since 2004/5. But, alarming news of P. falciparum resistance to ACT has recently emerged in Cambodia and later spread to The parasite, in this drug resistant (DR) hot spot region of the world has developed reduced sensitivity to Artemisinin, and developed resistance to its major partner drugs in ACT, including to the long acting new partner Piperaquine (PPQ). WHO, hence, forwarded a drug resistant containment policy (DRCP) in Mekong Delta, using ACT alternative drugs in the region. If ACT failure spreads further to Africa, countries like Ethiopia may be forced to curb their elimination efforts, as was the case in 1960’s, when developing countries were obliged to abort their eradication campaigns due to Chloroquine resistance. We are now approaching the same cross road. Workshop Objectives
In line with the above rationale, an international consultative workshop on “Anti-malarial Drug Efficacy studies in Ethiopia” was organized by EHNRI, the Federal Ministry of Health(FMOH), and WHO Ethiopia office, under the theme of “Strengthening the collaborative efforts in Malaria Therapeutic Efficacy Studies (TES) in Ethiopia”. Its major  To discuss the existing Artemisinin-Lumefantrine (AL) efficacy status in the country, based on data presentations from Research Institutes, academia, FMOH and its regional health bureaus (RHBs) , as well as the international partners: CDC-USA, MACEPA-Path, Malaria Consortium, ICAP, The Carter Centre, and WWARN (World-wide Antimalarial Resistance Network), etc.  to discuss the importance of installing a uniform data collection system for the various malaria TES carried out in the country, i.e. adherence to standard WHO’s protocols, in order to have a common basis for data validity & comparability,  to point out the way forward to enhance Ethiopia’s preparedness against the  to discuss specific challenges that Ethiopia is facing in light of the ongoing Workshop Deliberations
More than 20 papers were presented in line with the 1st objective, inclusive of the relevant opening addresses. The meeting was started with welcoming speech of Dr. Almaz Abebe, Director of the Infectious/Non-Infectious Diseases’ Directorate, EHNRI, and key note speech delivered by Dr. Daddi Jimma, the D/Director of EHNRI. Key note addresses were also delivered by the representatives of the two workshop sponsors, Miss Hiwot Solomon of FMOHE and Dr Kebba Omar Jiteh, representing Dr Pierre MPELE-KILEBOU, WHO Representative of Ethiopia. Presented papers in the first session focused on 1) the available data on malaria drug resistance studies in Ethiopia and at global level 2) The effect of drug resistant Plasmodium falciparum (DRPF) on elimination effort 3)The role of antigametocidal drugs in malaria elimination including DRPF strains as well as in fighting vivax relapses 4) The impact of Rapid Diagnostic tests, drug delivery systems, and prescription patterns, in DRPF emergence and/ spread 5) The role of vector control to reduce drug pressure 6) The positive impact of community education and information provision ICC/BCC to bring about proper behavioral changes, especially in relation to adherence to drug regimen, were all presented and discussed in the context of curbing the emergence and/ spread of AL resistance in Ethiopia. More than 20 papers were presented in line with the objective, inclusive of the relevant opening addresses. The meeting was started with the welcoming speech of Dr. Almaz Abebe, Director of the Infectious/Non-Infectious Diseases’ Directorate, EHNRI, and the opening key note speech delivered by Dr. Daddi Jimma, the D/Director of EHNRI. Key note addresses were presented by representatives of the two workshop sponsors, Miss Hiwot Solomon of FMOHE & Dr Kebba Omar Jiteh of WHO. The first session points on which the presented papers focused were: 1) the available data on malaria drug resistance studies in Ethiopia and at global level 2) The effect of drug resistant Plasmodium falciparum (DRPF) on elimination effort 3)The role of antigametocidal drugs in malaria elimination including DRPF strains as well as in fighting vivax relapse 4) The impact of Rapid Diagnostic tests, drug delivery systems, and prescription patterns, in DRPF emergence &/or spread 5) The role of vector control to reduce drug pressure 6) The positive impact of community education and information provision ICC/BCC to bring about proper behavioral changes, especially in relation to adherence to drug regimen, were all presented and discussed in the context of curbing the emergence & spread of AL resistance in Ethiopia. The 2nd part of the workshop was a final break out session, where participants were grouped into three discussion teams. The following were discussion provoking points provided in line with the paper presentation session: • Standardizing efficacy data collection system (Adherence to WHO Protocol on Malaria TES), (Developing protocol for Primaquine TES, unavailable in WHO docs). As well as developing mechanisms to obtain Heath Centre/Hospital data on A-L non respondents unavailable to Sentinel researchers • Selection and Strengthening of drug resistance monitoring Sentinel sites • Establishing a collaborative network among researchers in malaria TES & Organizing central data storage system, for the country. • Strengthening BCC at a country level to reduce anti malarial drug pressure. • Inclusion of gametocidal and hypnotozoiticidal 8-aminoquinoliines like Primaquine (PQ) into the antimalarial guideline: o to assist the overall transmission reduction, o to reduce spread of DRPF strains when emerging. After thorough discussion by the three groups, the following summary recommendations were forward as agreed upon by whole groups: • Inclusion of gametocidal & hypnotozoiticidal 8-aminoquinoliines like Primaquine o to assist the overall transmission reduction, o to reduce the gamete based spread of DRPF strains when emerging. After thorough discussion by the three groups, the following summary recommendations were forward as agreed upon by whole groups: 1. Standardization of data collection: 1a/ The WHO protocol should be
considered as the minimum standard requirement to be fulfilled in all TES, and hence, need be adhered. But 1b/ if there is a need for additional data, say data on Day 0 drug level, or day 01 microscopic reading of parasitemia, or a day 07 treatment evaluation and an in vitro test results for correlation, etc. it must be a free option to perform, as long as there is need and resources to carry them out and the minimum requirements for the original study design (WHO) are not compromised. 1c/ Unlike ACT, there is no clear guideline for Primaquine TES, we recommend that WHO sees to its preparation. 2. From TES host constituent point of view, one of the major problems in efficacy
testing is the lack of enough patients to carry out the study, hence, as patient availability will dwindle in the future with the progression of the elimination process we recommend that: 2a/ Look for support from the RHBs on the involvement of the catchment Health Posts, in recruiting cases to sentinel centers, 2b/ In addition to the already identified sentinel sites at a national level, consider the enlisting of demographic sentinel sites (DSS), in patient recruitment to TES sentinel sites; or as recommended in 4b, strengthening them to perform 3. Collaboration in TES & Data Networking: 3a/ Call an all-embracing stake
holders meeting, and establish a malaria TES coordinating taskforce that leads the planning, implementation and coordination of the various TES conducted in the country, by different partners and governmental institutes, 3b/ develops the terms of reference (TOR) for data networking, that need to be accessible to all stake holders. 3c/ Prepare Memorandum of understanding (MOU) on the roles of 4. Sentinel Sites: Since most of the existing sentinel sites are less equipped and
deprived of skilled personnel to undertake drug efficacy studies, 4a/ Technical capacity building need be done to strengthen the already selected sentinel sites. 4b/ The taskforce has to make clear standard criteria that sites have to fulfill to be considered as sentinel sites. This includes the capacity to carry out TES as well as to collect the necessary malariological parameters and socio-demographic data, in the catchment area. 4c/ Based on these criteria, start evaluation of the existing sites 4d/ Ways also have to be explored by the task force on how to involve demographic surveillance sites (DSS) of universities, into the malaria TES surveillance system. 4e/ Organize a sensitization workshop on malaria TES for universities and related research institutes in the country, to widen the research opportunities of graduate students on one hand and to foster the skilled manpower base of Sentinel sites on the other. 5. Developing mechanisms to obtain Heath Centre/Hospital data on AL non
respondents.
5a/ FMOH should take the lead in creating strong collaborations with RHBs, research institutes, NGO in reporting AL non respondents. 5b/ the data capturing system of AL non respondents should be nationally prepared by FMoH and related to EHNRI, this can be done by including such cases in PHEM reports. 5c/ AL non respondent should be operationally defined by FMOH viz. If a person comes within 4 weeks time of AL treatment for P. falciparum and presents with confirmed PF manifestations should be suspected of Treatment failure (TF), be 6. IEC/BCC. 6a/ In accordance with the current BCC strategy of the country
outlined on the malaria strategic plan, strengthen its activities to include awareness creation on patient adherence to ACT drug regimen to reduce anti malarial drug pressure.6b/ Include as BCC activities, the discouragement of use of Artemisia leaf as a traditional drug for malaria . 7. Gametocidals: 7a/ In line with WHO recommendations, to interrupt malaria
transmission, include a single dose (0.75mg) PQ in combination with ACT during P. falciparum chemotherapy; 7b/Compile data on currently ongoing efforts by EHNRI and partners to map Glucose 6 Phosphate dehydogenase, G6PD, 8. P. vivax malaria. 8a/ In light of ongoing elimination efforts in Ethiopia and
considering the specific challenges associated with identifying asymptomatic individuals with liver stage parasites, P. vivax may very well turn out to be the “last man standing” in areas where elimination has almost been achieved. Drug resistance surveillance should therefore include P. vivax malaria wherever possible. 8b/ Strategies specifically targeted at P. vivax elimination need to be discussed (potentially in a P. vivax expert group under the Ministry of Health / EHNRI). 8c/ Based on G6PD deficiency data collected by EHNRI consider introduction of an-aminoquinolines for the radical cure of vivax malaria. Closing Remark: Finally the workshop was closed by, Dr. Amha Kebede, Director
General, EHNRI, who promised that EHNRI will do its level best to fulfill the recommendations forwarded. He remarked that coordinating AL resistance studies and establishing a central data base is an important initial step in preparedness to monitor the emergence of drug resistance; but this doesn’t necessarily mean EHNRI is controlling the data’s public use, said Dr.Amha. He thanked organizers and participants for successfully completing the workshop that proposed important recommendations of national significance, and stressed the relevance of periodic organization of similar consultative workshops annually/biannually. The workshop was attended by over 55 participants from FMOH/RHBs, WHO, Research Institutes, Academia, National and International partners.

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