Baseline Study to Assess the Extent of Monotherapy Use in the Treatment of Malaria in Liberia: Study Phase 1- Review Study Protocol

PQM assisted in drafting Liberia's medicine regulatory legislation, enacted in 2010, which established the Liberian Medicines and Health Products Regulatory Authority (LMHRA). The program has also helped strengthen the medicines quality assurance and quality control (QA/QC) capabilities in Liberia. As part of the PMI, PQM conducted three rounds of medicine quality monitoring (MQM) for antimalarials in Liberia and its suburbs. The results of the third round revealed a high failure rate for antimalarials, with over 70% of samples failing basic tests. The majority of the failed samples were monotherapies. Based on these findings, LMHRA recently enacted a ban on the use of antimalarial monotherapies. PQM was asked by USAID/Washington to carry out a survey in two African countries, Mali and Liberia, to assess the extent of use of antimalarial monotherapies. PQM selected Liberia for the study due to the results of the third round of MQM. The proposed study aims to shed light on access to monotherapies, compliance with the ban, and the public's perception of the quality of available treatment in both public and private sectors. The purposes of the trip were to finalize the baseline monotherapy study protocol with major stakeholders, plan the implementation stage of the study in the field, select a study team and define their roles, conduct one round of sampling and testing antiretrovirals (ARVs) and opportunistic infections (OI) medicines, and debrief USAID/Liberia. The trip was funded by Core Malaria and the President's Emergency Plan for AIDS Relief (PEPFAR) through USAID/Liberia. During the debriefing meeting with USAID/Liberia, PQM shared the agenda of the planned activities for the trip, including the monotherapy study. The Mission expressed the need to have the monotherapy study included in the Liberia work plan and to provide more information on the study. They also requested that the Core Malaria and PMI activities be together in one work plan. PQM also shared with the group the main activities conducted by PQM's consultant, including training LMHRA inspectors in medicines regulations inspections and inspection report writing, helping LMHRA draft the letter to ban monotherapy treatment, and coordinating the advertisement for the LMHRA Managing Director (MD) position. To complete the third round of MQM, PQM informed the group that LMHRA and PQM will be collecting medicines to treat HIV, including both ARVs and OIs, which will be tested using Minilab basic tests followed by compendial testing on failed samples. The monotherapy study involved reviewing and validating the study protocol. PQM staff, Dr. Smine and Dr. El Hadri, organized a workshop with all key local stakeholders to review the original draft of the study protocol developed by PQM. The workshop was dedicated to reviewing the study protocol on the first day, selecting the study team and defining their roles on the second day, and conducting field testing of the survey questionnaires on the third day. The revised study protocol has now been submitted for review by the Internal Review Board, and the study will be carried out as soon as all administrative and regulatory requirements are fulfilled. The study aims to assess the extent of use of antimalarial monotherapies in Liberia, compliance with the ban, and the public's perception of the quality of available treatment in both public and private sectors.